Troubleshooting Guide i-STAT Blood Gas Analyzer

i-STAT System
Troubleshooting
Guide
This guide contains company
confidential information and is not to be
distributed to customers.
Suggestions to improve this guide should be e-mailed to Abbott Point of Care Technical
Support for the i-STAT System [email protected].
i-STAT System Troubleshooting Guide Art: 715627-00H Rev Date: 30-Nov-12

Table of Contents
1.0 Required Information for Business Partners ............................................ 1

1.1 Q04.01.007 and F04.01.007.01 for Business Partners ......................... 1
1.2 Other Abbott Support Organizations .................................................. 1
1.3 Product Information ................................................................................ 2
1.4 Description of Problem ........................................................................... 3
1.5 Determination of Reportable Adverse Event ....................................... 4
1.6 Investigation ............................................................................................. 5
1.7 Failure mode assignment ...................................................................... 5
1.8 Resolution ................................................................................................. 5
1.9 Returns ..................................................................................................... 5
2.0 Codes and Messages ................................................................................... 6
2.1 General Information ................................................................................ 6
2.2 Summary of Messages and Quality Check Codes ............................... 9
2.3 Cause and Resolution for Codes.......................................................... 12
2.3.1 Codes associated with Portable Clinical Analyzer and the
i-STAT 1 ......................................................................................... 12
2.3.2 Codes Associated with Immunoassay Tests on the i-STAT
1 Analyzer (Series 300) ................................................................ 37
2.4 Electronic Simulator............................................................................. 42
2.5 Electronic Simulator Failure Codes ...................................................... 43
3.0 Analyzer Non-coded Message Problems for i-STAT 1 and i-STAT PCA
............................................................................................................................ 45
4.0 Advanced Quality Features (AQF) ............................................................ 52
4.1 Positive Patient ID Messages .......................................................... 52
4.2 Pass/Fail Messages........................................................................... 52
4.3 Cartridge Quality Control Schedule Messages ............................ 52
4.4 Operator Competency Notification ..................................................... 53
5.0 Wireless Codes and Messages ........................................................... 53
6.0 Flagged Results .......................................................................................... 54
6.1 Star-out (***) ........................................................................................... 54
Description .................................................................................... 54
Troubleshooting steps ................................................................. 55
6.2 Out-of-Range Results (<, >, <>) ......................................................... 59

AQF Note: If “Control Results Display Format” is set to suppressed all
QC results will be flagged as <> ................................................................ 60
6.3 Over-Range Results (↑ and ↓) ............................................................. 60
7.0 Mechanical Cartridge Defects .................................................................. 61
8.0 Discrepant Patient Results ........................................................................ 63
8.1 General Causes ....................................................................................... 63
8.2 Specific Causes by Analyte ................................................................... 69
9.0 Unacceptable Precision or Bias ................................................................ 77
9.2 Factors Affecting Precision ................................................................... 79
9.3 Accuracy Expectations ........................................................................... 80
9.4 Calculated Values ................................................................................... 81
9.5 Factors that affect Accuracy in a Method Comparison .................... 82
9.6 Comparative Methods........................................................................... 83
9.7 Round-off Error Associated with Calculated Values ......................... 83
10.0 Controls or Calibration Verification Set Out of Range or Shift in
Values................................................................................................................. 84
10.1 Operator Induced:................................................................................ 84
10.2 Control Problem................................................................................... 87
10.3 Cartridge Problem .............................................................................. 88
11.0 External Quality Control Failure ............................................................. 88
11.1 Proficiency Testing Material ............................................................... 88
11.2 Third Party Quality Control Material (eg. Eurotrol) ......................... 90
12.0 Special Procedures................................................................................... 91
12.1 Pin conditioning ................................................................................... 91
12.2 Cleaning the Thermal Probes ............................................................. 92
12.3 Flip Latch Procedure ............................................................................ 92
12.4 Copying ISD files from a Central Data Station to a diskette .......... 93
13.0 Printers ...................................................................................................... 94
13.1 HP Printer to be used with the 200 series analyzer ........................ 94
13.2 Martel printer MCP8850B, for 200 series analyzer .......................... 95
13.3 Martel printer, for 300 series analyzer .............................................. 95
13.4 i-STAT Printer for 300 Series Handheld ........................................ 96
14.0 Docking Stations ...................................................................................... 97
14.1 IR Link .................................................................................................... 97
14.2 i-STAT 1 Downloader .......................................................................... 98

14.2.1 No longer charges the i-STAT rechargeable battery
pack or charge indicator light is continuously blinking red
(Models DRS, DRN, DRC) ............................................................ 98
14.2.2 Downloader no longer transmits data (Models: DRS/DS,
DRN/DN, and DRC) ...................................................................... 98
14.2.3 DRC-300 Downloader Recharger Combination ......... 102
15.0 Central Data Station Version 5 ............................................................. 104
16.0 i-STAT DE ................................................................................................ 115
16.1 How to Get Into DE Customization and DE System ...................... 115
16.2 Moving a Handheld in the PWeb Tree While Using Assignment 116
16.7 STATNotes .......................................................................................... 117
17.0 Wireless Transmission ........................................................................... 118
17.1 General Setup ..................................................................................... 118
17.2 Troubleshooting Ad Hoc Connection ............................................. 119
17.3 Troubleshooting Wireless Configuration ....................................... 119
17.4 Troubleshooting Wireless Communication .................................... 119
18.0 Interface not working ............................................................................ 120
19.0 COM Port to USB Adapters and PS2 to USB Adapters ..................... 121
19.1 PS2 to USB Adapter ........................................................................... 121
19.2 Nine Pin Null Modem to USB Adapter ........................................... 121
20.0 Packaging and Shipping Errors ............................................................ 123
Appendix A Contact Information for Adverse Events, Complaints and
Reports ............................................................................................................ 130
Appendix B – Shipping Issues .................................................................. 131
Shipping using gel packs .................................................................................. 131
Shipping using dry ice ............................................................................... 138

BLANK PAGE

1.0 Required Information for Business Partners
1.1 Q04.01.007 and F04.01.007.01 for Business Partners
Q04.01.007 “Customer Contact Reporting Requirements for Business Partners”, defines the
manner in which customer complaints are to be forwarded to Abbott Point of Care (APOC)
Technical Support regarding the i-STAT System.
F04.01.007.01 “Abbott Point of Care Customer Contact Form for Business Partners” must be
completed for every customer contact. When an Adverse Event occurs, it must be reported
within 24 hours. When a Product Malfunction occurs, it must be reported within 15 days of
occurrence. A copy of this form is located on the Distributor page on the APOC website
(www.abbottpointofcare.com).
Form F04.01.007.01
The Incident Number is the unique identification number assigned to a customer complaint.
This number allows cross-reference of documentation.
The date entered into business partner/APOC complaint system for the Business Partner is
when the customer complaint is received. The date entered into business partner/APOC
complaint system for Abbott Point of Care Technical Support is the date when form
F04.01.007.01 is received by Abbott Point of Care Technical Support (date on e-mail or fax).
The date closed in the business partner complaint system for the Business Partner is when
the customer is contacted with the final resolution.
For Reportable Customer Complaints, all customer details are requested but are not
required. Abbott Point of Care Technical Support will not contact your customer directly.
For Adverse Events, the Customer Information must be complete. Abbott Point of Care
Technical Support may have to contact your customer directly regarding the circumstances
of the Adverse Event. An Adverse Event must be reported according to local law and to
Abbott Point of Care Technical Support according to the section on Adverse Event Reporting
in Q04.01.007.
1.2 Other Abbott Support Organizations
Follow the procedure agreed upon between the support services groups. Support for
the Abbott Diabetes Care PCx glucose meter and PCx Plus glucose test strips is
determined locally.

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1.3 Product Information
Record the required information for the component that is the likely cause of the problem. If the cause
cannot be immediately attributed to one component, record the information for all components
implicated in the problem.
Analyzer • Serial number

The serial number is listed on the status page and on a label on the underside of the
analyzer.
• Software
The CLEW and application Version are listed on the status page of the analyzer.
Note: The standard application Version of software begins with the letters
JAMS. This document may refer to JAMS rather than to application Version.
• Battery Voltage
The battery voltage is listed on the status page of the analyzer.
Cartridge • Type: such as 6+ or EG7+

• Sensor or sensors: such as PO2 and sodium
• Lot number: found on box and cartridge pouch or portion pack (immunoassays)
• Analyzer software: CLEW and application Version
• Other information that may be required:
• quality control results on in-coming cartridges
• current quality control results
• the box number found below the lot number on the box.
• the expiration dates of refrigerated stock and room temperature stock for the
cartridges in question
• diagnostic files (requires a Central Data Station)
• failure rate (not only percentage but sample size as well.)
• How long they were out of the refrigerator.
Electronic • Serial number: On underside of simulator

Simulator • Analyzer Software: CLEW and application Version
Control Fluids • Control Type & Level(s) (such as i-STAT Level 1)

• Lot number
• Cartridge type and lot number
• Analyzer software: CLEW and Version
• If not an i-STAT control, the name and manufacturer of the control, the contents as stated
in the package insert, the matrix (such as aqueous, bovine-serum based) and the expected
range for the test(s) in question.
External Quality • Name of program with name and address of program distributor
Assurance or • Sample identification number
Proficiency • Acceptable range and how determined (reference method, peer group)
Testing Samples • Matrix: such as aqueous, human serum, bovine serum, fluorocarbon
• How supplied: ready-to-use, frozen, lyophilized with reconstituting fluid
• Analyzer software: CLEW and Version

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1.4 Description of Problem
This is the customer's description of the problem. Details that should be included are listed below.
Note for Abbott Diagnostics Division Technical Support (ADD): ADD problem codes are more general
than the complaint codes used by Abbott Point of Care Technical Support. In order to assign the more
specific codes for trending purposes, the following details must be entered in the comment section of the
ADD complaint handling system.
Type of Such as control results out-of-range, Electronic Simulator failure, unexpected patient
Problem result, star-outs (***) instead of results, or broken analyzer.
Start of Date the customer first noticed the problem.

Problem
Rate and Scope Assess by asking such questions as:

of Occurrence • Is the problem occurring at one, several, or all sites within the hospital?
• Which site or sites?
• Is the problem occurring on one patient, one type of patient (same diagnosis or
treatment) or all patients? If same diagnosis or treatment, obtain details, including
a list of medications, and all results from cartridge.
• One cartridge type or all types?
• Which sensor or sensors?
• If one cartridge type only, one lot or all lots?
• At approximately what rate is the problem occurring, such as 1 out of 10 cartridges
or 1 out of 10 patients, one or all analyzers?
• For equipment complaints, make a note if this is an out-of-box failure (analyzer did
not work upon receipt or was functional for only a few runs before a failure
occurred.)
• Make a note about operator experience (new customer, new operators)
• Analyzer Customization. Is analyzer set to CPB, K2 or K3,?
• Analyzer Customization: Is analyzer set to appropriate ACT option?
• Sample Type. Was sample arterial, venous, capillary, etc…?
• Sample Container. Was the sample collected with or without an anticoagulant.?
Syringe or tube? Was tube filled according to manufacturer’s instructions? Obtain
the manufacturers name and lot number of tube.
• Sample Handling. What was the time period between sample draw and cartridge
filled?

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1.5 Determination of Reportable Adverse Event
Business Refer to Q04.01.007 “Customer Contact Reporting Requirements for Business

Partners Partners. If answer Yes or Not Sure to whether complaint is a Reportable Adverse
Event, forward form F04.01.007.01 to Abbott Point of Care Technical Support
within 24 hours.
ADD Follow ADD internal procedures Q14.03.012 for gathering information and
documentation.

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1.6 Investigation
Record results of any procedures you requested your customer to perform. Record any additional
information or data you request your customer to obtain. An APOC Technical Specialist will forward you
the results of any investigation preformed by APOC. Each entry in the Investigation section should be
dated.
1.7 Failure mode assignment
APOC Technical Support will designate the cause of failure when an investigation is performed.
1.8 Resolution
The resolution should include how the complaint was closed with the customer.
Examples of Resolutions
• Review labeling and directions for use.

• Replacement functioning according to directions for use and specifications.
• Product repaired and returned.
• Next cartridge functioned properly.
• Customer unable to return product.
1.9 Returns
For • APOC Technical Support and local support service will determine if a product must
Investigations be returned to APOC as part of an investigation. (Business Partners use form
F04.01.007.01.)
• No product will be accepted by APOC without prior authorization.
• The Incident number assigned by APOC Technical Support becomes the Returned
Goods Authorization (RGA) number. This number must be written on the shipping
label.
• The local technical support service will arrange for shipment of product to APOC.
Cartridges and control materials must be shipped with cold packs to prevent
degradation.
For Repair • Distributor Repair Center: Follow Distributor Bulletin “i-STAT Products Repair
Policy”.
• ADD: Follow procedure agreed upon by APOC and ADD support services.
• Warranty: Please follow the instructions in your Abbott Point of Care contract for
any Warranty claims.

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2.0 Codes and Messages
2.1 General Information
When the analyzer’s quality check software detects a problem with the environmental conditions, the
placement of the sample in the cartridge, the cartridge itself or the analyzer itself, it halts the test and
displays a message and a quality check code. The message is in two parts: the cause and the action to be
taken by the operator. One code is assigned to each specific failure. One message may cover several
different codes. Example:
Unable to Position Sample (cause) Use Another Cartridge (action) Code 31, 34 or 44.
Quality check code and message information for the customer is contained in the System Manual in the
Technical Bulletin “Analyzer Coded Messages”. The additional information on causes in this section of the
guide is proprietary and is for internal use only.
The internal quality check system is aggressive. In order to detect all problems, a few good test cycles will
be rejected.
While a new customer can be expected to have a slightly higher cartridge rejection rate as new operators
learn to use the system, an experienced customer should be able to keep the cartridge rejection rate at or
below 5%. If an experienced customer complains of a high rate of cartridge rejection, the cause needs to
be determined. If the cause is operator related, the customer may need re-training.
Important! Increased Code Frequency and Technical Support Response
While quality check codes have causes specific to the operator, the cartridge, the analyzer or the
environment, a frequently occurring code could have an entirely different cause. Whenever the same
quality check code occurs frequently and operator error has been ruled out as the cause, determine if the
code occurs on only one lot number of cartridges or on only one analyzer.
If a code occurs frequently on one lot number of cartridge, there may be a manufacturing issue. Contact
APOC Technical Support as soon as possible. APOC may require the return of these cartridges as part of
an investigation. If a manufacturing problem is verified, APOC Technical Support will inform support
organizations about any no-charge replacement plan.
If a code occurs frequently on only one analyzer, section 2.3 will indicate if a special procedure may fix the
problem. If not, the analyzer must be returned for repair.

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Environmental Codes A code in the range of 1 to 15 plus code 95 indicates a condition related to
the state of the analyzer. These conditions either do not require a
corrective action (such as “Analyzer Interrupted, Use Another Cartridge”), or
have a simple corrective action (such as “Dead Batteries, Replace
Batteries”).
Cartridge Codes A code in the range of 19 to 49 (plus 79-81 and 87) indicates an error
condition relating to the cartridge, sample placement by the operator, or
sample movement in the cartridge. In most cases a new cartridge must be
used. These are usually one-time occurrences. As stated above in
“Increased Code Frequency and Technical Support Response”, if a particular
code persists on one analyzer, there may be an electro-mechanical
problem with this analyzer and it may need to be repaired. If the code
persists on one lot number of cartridges, there may be a manufacturing
problem.
In the case of persistent codes 79, 80, and 81 (Cartridge Error, Use Another
Cartridge), the cause is more likely to be the analyzer than the cartridge.
(See section 2.3.)
Analyzer Codes Code 23 and codes in the range of 50 to 97 (except code 95), indicate an
electronic, software, or mechanical failure in the analyzer. There are two
types of analyzer failures: one-time failures from which the analyzer can
usually recover and persistent failures from which the analyzer may not be
able to recover. The message “Analyzer Error, Use Electronic Simulator”
indicates a temporary failure. In most cases if the analyzer passes the
simulator test, it can continue to be used. The message “Analyzer Error,
See System Manual” indicates a failure from which the analyzer may not
recover. In these cases the battery voltage should be checked and both
the simulator and a cartridge tested to see if the failure is persistent. If
persistent, the analyzer must be repaired. Note: Whenever there is an
external Electronic Simulator failure, a defective simulator must be ruled
out as the cause of the failure.
Immunoassay Cartridge Codes in the range of 120 to 151 indicate a failure during an immunoassay
Codes cartridge test cycle. In most cases, a new cartridge will have to be used.
Only the i-STAT 1 Analyzer with the Immuno symbol can run immunoassay
cartridges and the analyzer must be customized according to the directions
in the Procedure for Cartridge Testing (Section 12) of the i-STAT 1 System
Manual.

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Use of the Central Data Station to determine type and rate of codes
The CDS lists all quality check codes that are stored in the analyzer. In CDS Version 4, look under System
 Quality Check Code Viewer. In CDS Version 5, select Data Viewer  QC Codes. Click on Customize
Viewer on the toolbar and select a date range. Quality Check Codes are also collated in the Reports.
Quality Check Codes that are not stored
For cartridges that include calibrant fluid, only those codes that occur after the calibrant fluid is
released are stored in the analyzer and transmitted to the CDS. Codes that are not stored are
environmental codes 2-14 and Analyzer Error codes 53, 63, 67, 70, 72 and 86. Codes which may
or may not be stored are: Environmental code 1, Analyzer Error codes 52, 60, 61, 62, 66, 73, 74
and 82 and Cartridge Error codes 43, 47 and 48.

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2.2 Summary of Messages and Quality Check Codes
CAUSE MESSAGE ACTION MESSAGE RELATED CODES RELATED CODES

Portable Clinical Analyzer i-STAT 1 Analyzer
(Series 200) (Series 300)
Dead Batteries Replace Batteries 1 1
Batteries Changed Ready for Use 7 NA (Not Applicable)
Temperature Out of Check Status Page 2 2, 108, 109

Range
Temperature In Ready for Use 10 NA

Range
Cartridge Error Use Another 20, 22, 24, 25, 26, 27,28, 29, 32, 20, 22, 24, 25, 26, 27, 28, 29,
Cartridge 33, 40, 41,42, 43, 45, 46, 75, 79, 32, 33, 40, 41, 42, 43, 45, 46,
80, 81, 87 75, 79, 80, 81, 87, 120, 121,
122, 123, 124, 125, 126, 127,
128, 129, 130, 131, 132, 133,
134 135, 136, 137, 138, 139,
142, 143, 144, 145, 146, 148,
149, 150, 151
Cartridge Preburst Use Another 21 21

Cartridge
Sample Positioned Use Another 35, 36 35, 36

Short of Fill Mark Cartridge
Sample Positioned Use Another 30,37 30,37

Beyond Fill Mark Cartridge
Insufficient Sample Use Another 38, 39 38, 39

Cartridge
Unable to Position Use Another 31, 34, 44 31, 34, 44

Sample Cartridge
Cartridge Not Reinsert Cartridge 47 47

Inserted Properly
Cartridge Type Not Use Another 69 69

Recognized Cartridge

-9-
Invalid or Expired See Manual 12,13 12,13

CLEW

New Software Use Electronic 3 3

Installed Simulator
Analyzer Interrupted Ready for Use 5,6,9 5, 6, 9
Analyzer Interrupted Use Another 4,8 4, 8,

Cartridge
Analyzer Error Use Electronic 50, 51, 52,54, 58, 59,60, 61, 62, 50, 51, 52, 54, 58, 59, 60, 61,
Simulator 64, 88 62, 64, 88
Analyzer Error See Manual 10,14,15,16,17,18,, 23, 48, 14,,16,17,18,, 23, 48, 53, 55,
53, 55, 56, 57, 63, 65, 66, 67, 56, 57, 63, 65, 66, 67,68, 70,
68, 70, 71, 72, 73, 74, 76, 77, 71, 72, 73, 74, 76, 77, 78, 82,
78, 82, 83, 84, 85, 86, 89, 90, 83, 84 85, 86, 89, 90, 91, 92,
91, 92, 93, 94 93, 94, 96, 97, 98, 99, 147
Date Invalid Check Clock on 11 11

Status Page
Test Cancelled by N/A 95, 141

Operator
Lot Expired N/A 140
Poor Contact See Manual 49 49

Detected
Barcode Type Does N/A 15

Not Match Sample
Type

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No Clot Detected See Manual 19 19

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2.3 Cause and Resolution for Codes
2.3.1 Codes associated with Portable Clinical Analyzer and the i-STAT 1
Note: The Portable Clinical Analyzer is referred to as the 200 series and the i-STAT1 Analyzer as the 300
series.
Message Problem and Cause Resolution and Comments
1 Dead batteries - Battery voltage is too low to Change batteries. Remind customer to
Replace properly move the motor or to heat watch for the BAT message on the 200
Batteries the cartridge. A “dead battery” has a series or the Battery Low message and
voltage of less than 6 Volts during flashing battery icon on the 300 series.
motor motions or heating. The
battery voltage on the Status page is UltraLife lithium batteries are
the unloaded battery voltage. It is recommended. Different batteries can be
possible for battery to read greater used if they meet the height specification of
than 6 Volts on the Status page and 48.7± 0.5 mm.
still give a Code 1.
If a cartridge is in the analyzer when this
code occurs, another cartridge will have to
be used.
Note: there is an internal lithium battery

that maintains the clock and memory.
Patient results are not lost if code 1 is
displayed. Expected life of internal battery
is approximately 7 years.
If persistent on only specific handheld(s)

after performing the listed troubleshooting,
the handheld(s) must be repaired.
2 Temperature The analyzer's reading of ambient Move the analyzer to an area where the
Out of Range - temperature is outside the operating temperature is in the operational range: 16
Check Status temperature range: to 30 °C for cartridges or 15 to 40°C for
Page 200 series: 16 to 30°C glucose test strips.
300 series: The temperature can be monitored on the

1. Operating range for analyzer: 15 status page since a temperature reading is
to 40 °C. made each time the display key is pressed
2. When a cartridge is inserted: 16 on the 200 series or the On/Off key is
to 30 °C. pressed on the 300 series.
3. When a glucose test strip is
inserted: 15 to 40°C. If the 300 series has been kept in a
4. During a cartridge test cycle: 16 Downloader/Recharger located in a warm
to 32 °C. room, take the analyzer out of the

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Downloader/Recharger.
If the analyzer is used in a cold operating

theater, it may be necessary to place it on a
towel to keep it off a cold surface or to
place it, along with the cartridges, in a
polystyrene box to keep the temperature
within the 18 to 30°C operating
temperature range for cartridges.
For use in transport, a box with a thermal or

cold pack may be necessary.

3 New Software Software version changed since last Run an external simulator immediately after
Installed - Use power down of instrument. new software has been installed.
Electronic Code 3 may also be displayed after
Simulator a new customization profile is If display is garbled after a software update,
received. remove batteries while the display is on.
Then replace the batteries and run the
simulator.
Do Not Remove Many things can prevent the 1. The batteries may be low. Check battery
Cartridge. mechanism from resetting. If the voltage on the Status Page.
Analyzer Not mechanism can reset, the “Analyzer 2. There may be a loose connection in the
Reset. Replace Interrupted” message will be battery compartment due to loose
Batteries. displayed. contacts, batteries that are not seated
correctly, or batteries that are too short
No code If the analyzer cannot reset the to make a good connection. UltraLife
appears with “Analyzer Not Reset” message will lithium batteries are recommended.
this message be displayed. Different batteries can be used if they
meet the height specification of 48.7±
0.5 mm.
If analyzer does not reset, the analyzer
must be repaired. If a cartridge or
simulator is stuck in the analyzer, ask
the customer not to force it out.
4 Analyzer When about to start a test cycle the The used cartridge should be discarded.
Interrupted - analyzer detects that the last test
Use Another cycle was not completed and, Remind the customer not to remove the

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Cartridge therefore, the cartridge it has batteries while the display is still on.
detected must be a used cartridge.
The analyzer must power ITSELF off If the problem is persistent and the
or notice a cartridge being removed operator is not removing the batteries
before it will start a new test cycle. before power down:
1. The batteries may be low. Check battery
This code can occur if the batteries voltage on the Status Page.
are removed before the analyzer 2. There may be a loose connection in the
powers itself down. battery compartment due to loose
contacts, batteries that are not seated
This code can also occur if the correctly, or batteries that are too short
microprocessor hangs up during a to make a good connection. UltraLife
test cycle lithium batteries are recommended.
Different batteries can be used if meet
height specification of 48.7±0.5 mm.
3. If persistent on only specific handheld(s)

after performing the listed
troubleshooting, the handheld(s) must
be repaired.
5 Analyzer When attempting to refresh the See Resolution for Code 4

Interrupted - screen, the analyzer detects nothing
Ready for Use in memory to refresh. This can
happen if power is interrupted
during the shut-down period during
which the image on the screen is
stored. Removing the batteries
before the analyzer powers down
will also cause this code.
6 Analyzer When attempting to refresh the See Resolution for Code 4.

Interrupted - screen, the analyzer detects that the
Ready for Use image saved in memory has been
corrupted. This can happen if the
batteries are removed while the
analyzer is undergoing its own,
controlled power down.
A defective internal lithium battery

could also cause this problem
7 Batteries This code occurs when the batteries No action necessary.

Changed - are changed on a 200 series after a

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Ready for Use code 1 (Dead Batteries). The

analyzer detects the jump in the
battery voltage from less than 6 to
greater than 8.
8 Analyzer Mechanism did not reset after last See Resolution for Code 4.
Interrupted - cartridge run. If mechanism can
Use Another reset when the DIS key is pressed,
Cartridge Code 8 is displayed.
9 Analyzer When attempting to refresh the See Resolution for Code 4.

Interrupted - screen, the analyzer detects that the
Ready for Use mechanism is not in its fully reset
position. If the analyzer successfully
resets after the display key is
pressed, code 9 is displayed.
10 Temperature in 200 series only: Code 10 occurs Ready code. No action necessary.
Range- Ready when the display key is pressed after
for Use a code 2 has been displayed and the
temperature has returned to the
operating range.
11 Date Invalid - 1. Analyzer's date is set before the Have customer change the date. (The Enter
Check on Status release date stored in the CLEW. key must be pressed to save the changes.)
Page 2. The date is invalid, such as 13 for Then run a simulator. After the result is
month. displayed, check that the correct date is
3. The accuracy of the real-time maintained. (Check the Status page on the
clock is checked at the start of a 200 series and the Test Menu on the 300
coagulation test cycle. Code 11 series). If date cannot be maintained, the
occurs if the clock is out of analyzer must be repaired.
specification.
A defective internal lithium battery If code 11 occurs during coagulation test
or real-time clock could cause failure cycle, the analyzer must be repaired.
to maintain the correct date.
12 Invalid or The analyzer's CLEW software has Check real-time clock in analyzer. This code
Expired CLEW - expired. Fifteen days before the will be displayed if the date in the analyzer
See Manual expiration date the analyzer alerts has been set after the CLEW expiration date.
the operator to the pending If the CLEW has expired, remind the
expiration of the software. On the customer of the warning, which appears 15
200 series, “SFT” will appear in the days before the software expiration date.
message box (where “LCK” is Send new software if necessary and
displayed). On the 300 series the determine why the customer does not have

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message “CLEW Expiring, Update the most recent CLEW so that any mailing
Required” is displayed when the problems can be identified and corrected.
On/Off key is pressed.
13 Invalid or 1. CLEW not compatible with the 1. Check the Status Page for CLEW and
Expired CLEW - installed Version of application Version against the most recent
See Manual software. software release information.
2. No CLEW installed. 2. Download CLEW software again.
Corrupt CLEW. 3. For 200 series must disable
customization or the Update CLEW
column on the CDS until all analyzer
software is updated. Then update the
CLEW on the CDS before turning
customization back on or enabling the
Update CLEW column.

14 Analyzer Error - Customization profile in analyzer Transmit customization profile from the
See corrupt. CDS. The Customization profile is
Manual transmitted when the analyzer downloads
to the CDS. Customization must be enabled
on the CDS. If no data management system
is in use, follow step below to restore
factory settings.
For 300 series meter:
If code 14 continues after the customization

is retransmitted, then ‘Restore Factory
Settings’ in the meter’s customization
pathway and then place meter in
downloader to retransmit the CDS
customization.
Code 14 can also occur if there is an

operator list in the meter and customization
is set to ‘warn/lock out’ but “Use Operator
List’ is not checked in the CDS
customization workspace.
For 200 series meter:

If code 14 continues after the customization

- 16 -
was retransmitted or no data management

system present, install CLEW/JAMS software
on C drive if not already installed, close
programs, go to start then run and type:
C:/bins/jammlite -config
The Jammlite window will display. Select
the appropriate Market, Language and Unit
Set. Click on ‘Update’ in the jammlite
window and follow the directions on the pc
screen, [place meter in ir-link, press DIS key,
when ‘menu’ displays, press the * key] The
pc will display when the meter has been
updated.

15 Barcode Does On Chemistry and Coag Cartridges The user should run another cartridge,
Not Match the Panel Value in the barcode does being careful to scan the barcode from the
Cartridge Type not match that determined by the portion pack of the cartridge being run on
code pins. This occurs when: the analyzer.
a. the cartridge requires a
barcode (the barcode If persistent on multiple cartridges and the
will start with a 2) handheld(s), through troubleshooting, have
b. the analyzer is been found not to be root cause, cartridges
configured for must be investigated.
information first If persistent on only specific handheld(s)
c. the analyzer is after performing the listed troubleshooting,
configured for the handheld(s) must be repaired.
Scheduled QC
On Immuno Cartridges:
a. If the bin chip does not match
the product type as indicated by
the barcode
b. If the code pin does not match
the expected code pin as
indicated by the barcode
16 Not used
17 Not used

- 17 -
18 Not used
19 No Clot No clot was detected during the Check sample collection method and run
Detected PT/INR cycle another cartridge. If code 19 reappears, run
See Manual the sample on an alternate methodology.
If persistent on multiple cartridges and the
handheld(s), through troubleshooting, have
been found not to be root cause, cartridges
must be investigated.
20 Cartridge Error - No calibrant fluid detected by the If persistent on only specific handheld(s)
Use Another hematocrit sensor within the allowed Use the ceramic cartridge or the alternative
Cartridge time after the calibrant is released. pin conditioning procedure. See Special
Caused by: Procedures in section 12.1 of this guide.
1. No calibrant fluid
2. Damaged hematocrit sensor If next cartridge functions correctly, suspect
Contact problem a cartridge defect.

20 Cartridge Error - No calibrant fluid detected by the If persistent on only specific handheld(s)
Use Another hematocrit sensor within the allowed Use the ceramic cartridge or the alternative
Cartridge time after the calibrant is released. pin conditioning procedure. See Special
Caused by: Procedures in section 12.1 of this guide.
3. No calibrant fluid
4. Damaged hematocrit sensor If next cartridge functions correctly, suspect
Contact problem a cartridge defect.

21 Cartridge Fluid detected on the sensors too 1. Check that operator not pressing on
Preburst - Use soon. Causes include: center of cartridge.

- 18 -
Another 1. Operator pressed too hard on 2. Check that operator not inserting a
Cartridge the center of the cartridge used cartridge. Operator may have
releasing calibrant fluid, reagent gotten a code and decided to reinsert
or wash solution. the same cartridge. Check time between
2. Operator inserted a used code 21 and the previous test in stored
cartridge. results on the analyzer. If the time
3. Cartridge frozen and calibrant, between the two cartridges is about a
reagent or cal pack burst while minute, a used cartridge was probably
thawing. inserted.
4. Cartridge problem if persistent 3. If an increase in code 21 is noted on a
(preburst error message can be new shipment or on all cartridges
displayed on any product type.) stored in one area, check storage
conditions.

22 Cartridge Error - Coagulation cartridges only. If next cartridge functions properly, suspect
Use Another Problem with mixing of sample and a defective cartridge.
Cartridge reagent caused bad signal. Causes:
1. Sample related: air bubbles in If persistent on multiple cartridges and the
sample, clotted sample, used handheld(s), through troubleshooting, have
cartridge, cartridge not closed been found not to be root cause, cartridges
properly. must be investigated.
2. Cartridge problem If persistent on only specific handheld(s)
23 Analyzer Error - Noise was detected. Typically due to If persistent on only specific handheld(s)
See Manual poor contact between analyzer Use the ceramic cartridge or the alternative
connector pins and cartridge pads. pin conditioning procedure. See Special
Procedures in section 12.1 of this guide.

24 Cartridge Error - Analyzer keeps a running average of If next cartridge functions properly, suspect
Use Another the calibrant resistance reading for a defective cartridge.

- 19 -
Cartridge each cartridge type. Code 24 occurs

if this reading is too far below this If this code is due to a new lot number,
average. Causes: typically 2 to 3 but up to 5 cartridges must
1. new cartridge lot be run per analyzer for the analyzer to learn
2. compromised calibrant fluid the new resistance average.
3. punctured calibrant pack with
evaporation If persistent on multiple cartridges and the
damaged hematocrit electrode handheld(s), through troubleshooting, have
25 Cartridge Error – Coagulation cartridges only. Problem Next cartridge should function properly.
Use Another with mixing of sample and reagent.
Cartridge If persistent on multiple cartridges and the
26 Cartridge Error - Internal quality checks for Next cartridge should function properly.
Use Another coagulation cartridge failed.
Causes: handheld(s), through troubleshooting, have
1. Premature substrate been found not to be root cause, cartridges
activation must be investigated.
2. Abnormally low levels of If persistent on only specific handheld(s)
substrate after performing the listed troubleshooting,
Invalid fluid motion the handheld(s) must be repaired.
27 Cartridge Error - Error detected after calibration. If persistent on only specific handheld(s)
Use Another Caused by bubbles in calibrant fluid, Use the ceramic cartridge or the alternative
Cartridge compromised calibrant fluid, or poor pin conditioning procedure. See Special
contact between analyzer and Procedures in section 12.1 of this guide.
cartridge.

- 20 -
If next cartridge functions properly, suspect

a defective cartridge.

28 Cartridge Error - Defective cartridge or poor contact If persistent on only specific handheld(s)
Use Another between analyzer and cartridge. Use the ceramic cartridge or the alternative
Cartridge pin conditioning procedure. See Special


29 Cartridge Error - Defective hematocrit sensor or over If persistent on only specific handheld(s)
Use Another filled cartridge. Use the ceramic cartridge or the alternative
Cartridge pin conditioning procedure. See Special


30 Sample Operator overfilled cartridge. Review proper procedure with customer.

- 21 -
Positioned
Beyond Fill Mark Defective cartridge. Review stored results in analyzer or quality
– Use Another check codes on CDS for other operator-
Cartridge related errors and recommend re-training if
necessary.
If operator Error can be ruled out and
if persistent on multiple cartridges and the
OR
persistent on only specific handheld(s) after
performing the listed troubleshooting, the
handheld(s) must be repaired.
31 Unable to The sample did not move from the Review proper procedure with customer.
Position Sample sample well and chamber. Causes:
- Use Another 1. Cartridge is not sealed If the code is occurring in the neonatal unit,
Cartridge a. Closure left open by discuss sample handling procedure for heel
operator puncture that will help prevent clotting: use
b. Closure leaked due to a capillary tube with anticoagulant, the
blood around seal blood must flow freely, the first drop must
c. Cartridge leak due to be wiped away, squeezing must be avoided,
assembly error sample must be tested immediately.
2. Blood sample clotted.
3. Cartridge grossly overfilled with A missing gasket or leaky cartridge can be
sample. identified if the customer has the cartridge
4. Defective cartridges. when calling Technical Support .


Use the ceramic cartridge or the alternative
pin conditioning procedure. See Special

32 Cartridge Error - See code 27 See code 27

Use Another

- 22 -
Cartridge
33 Cartridge Error - Defective cartridge. If next cartridge functions correctly, suspect

Use Another If persistent on specific analyzer(s), defective cartridge.
Cartridge mechanism damage.
34 Unable to See Code 31. See code 31.

Position Sample
- Use Another Analyzer wear can also cause Code
Cartridge 34.
35 Sample Operator did not get the sample up See Resolution for code 30.
Positioned Short to the fill mark or left the sample
of Fill Mark - well completely empty.
Use Another
Cartridge
36 Sample Operator did not get the sample up See Resolution for code 30.
Positioned Short to the fill mark before sealing the
of Fill Mark – cartridge.
Use Another
Cartridge
37 Sample Operator overfilled the cartridge. See Resolution for code 30.
Positioned
Beyond Fill Mark
– Use Another
Cartridge
38 Insufficient Not enough sample in sample well If persistent on only specific handheld(s)
Sample- Use or bubbles in sample. Use the ceramic cartridge or the alternative
Another pin conditioning procedure. See Special
Cartridge Procedures in section 12.1 of this guide.
See Resolution for code 30.

- 23 -
39 Insufficient Coagulation cartridges only: Review cartridge filling procedure for

Sample- Use cartridge under filled, insufficient coagulation cartridges.
Another sample in well or not completely
Cartridge closed or cartridge leaking. A missing gasket or leaky cartridge can be
identified if the customer has the cartridge
when calling Technical Support .


39 Insufficient Coagulation cartridges only: Review cartridge filling procedure for

Sample- Use cartridge under filled, insufficient coagulation cartridges.
Another sample in well or not completely
Cartridge closed or cartridge leaking. A missing gasket or leaky cartridge can be
identified if the customer has the cartridge
when calling Technical Support .


40 Cartridge Error – Amperometric pin in analyzer did Analyzer makes a correction in motor
Use Another not make physical contact with movement.
Cartridge amperometric sensor contact pad in If persistent on specific handheld(s) Use the
cartridge. ceramic cartridge or the alternative pin
conditioning procedure. See Special

- 24 -
41 Cartridge Error - 1. Defective cartridge: no calibrant If persistent on specific handheld(s) Use the
Use Another fluid detected or calibrant fluid ceramic cartridge or the alternative pin
Cartridge arrived too late. conditioning procedure. See Special
Poor contact between analyzer and Procedures in section 12.1 of this guide.
cartridge


42 Cartridge Error - Calibrant fluid detected on hemtocrit See Resolution for Code 21.
Use Another sensor before allowed arrival time.
Cartridge Differs from Code 21 in that
resistance reading for calibrant fluid
is out of specification in code 42.
This indicates that the calibrant pack
was burst some time earlier than just
before the cartridge is inserted into
the analyzer.
43 Cartridge Error - Amperometric sensor out of If persistent on only specific handheld(s)

Use Another specification. Caused by a preburst Use the ceramic cartridge or the alternative
Cartridge calibrant fluid pack, contaminated pin conditioning procedure. See Special
contact pad or a dirty analyzer Procedures in section 12.1 of this guide.
connector.
See Resolution for Code 21.
44 Unable To Coagulation cartridges only: Next cartridge should function properly.

Position Sample 1. Cartridge leak (see 1 and 2
– Use Another under Code 31) If persistent on multiple cartridges and the
Cartridge 2. Bubble in sample handheld(s), through troubleshooting, have
Defective cartridge been found not to be root cause, cartridges

- 25 -
45 Cartridge Error – Noise during conductivity Next cartridge should function properly.
Use Another measurement. A segment of
Cartridge calibrant fluid was seen during air
segment, when only air is expected. If code occurs twice in 50 runs, Code 55
Cartridge defect. results.
Running cartridges not yet at room

temperature.
46 Cartridge Error - Coagulation cartridges only. See Resolution for Code 44

Use Another
Cartridge
47 Cartridge Not Cartridge or external Electronic Run a cartridge or simulator by inserting it

Inserted Simulator not staying against start straight into the analyzer until it clicks into
Properly - switch. place. If code 21, 42 or 43 occurs after a
Reinsert 1. Operator not inserting cartridge cartridge is reinserted it means that the
Cartridge or simulator all the way code 47 occurred after the calibrant fluid
2. Misaligned start switch pack was burst.
Verify blue cap on external simulator is not

impeding insertion

48 Analyzer Error - The analyzer connector pins made If operator error is ruled out and the
See Manual contact with the cartridge or external problem is persistent, the analyzer must be
Electronic Simulator contact pads repaired.
too soon. Can be caused by not
inserting simulator straight or by a
mechanical misalignment in the
analyzer or by fiber contamination
between shorting bar and contact
pins.

- 26 -
49 Poor Contact The system detected a contact If persistent on specific handheld(s) Use the
Detected/ See problem with one of the connector ceramic cartridge or the alternative pin
Manual pins while reading the identification conditioning procedure. See Special
chip in the immunoassay cartridge. Procedures in section 12.1 of this guide.

50 Analyzer Error - The motor moved too far. If testing immunoassay cartridges, run the
Use Electronic ceramic cartridge or an alternate pin
Simulator Causes when running immuno- conditioning procedure. See Special
Cartridges: Procedures in Section 12.1 of this Guide.
1. Sample bubbles
2. Poor electrical connection The Electronic Simulator alone cannot
between cartridge and analyzer confirm whether or not there is a problem
with the motor.
Check battery voltage. run an Electronic

Simulator. If the analyzer passes the
simulator test, run a cartridge with a blood
or control sample. If the analyzer fails the
simulator test or if the code reoccurs, the
analyzer must be repaired.
51 Analyzer Error - The motor moved for too long a The Electronic Simulator alone cannot
Use Electronic period of time. On coagulation confirm whether or not there is a problem
Simulator cartridges this could be due to with the motor.
inability to position sample. A low
battery could cause this code instead Check battery voltage. and run an Electronic
of code 1. Simulator. If the analyzer passes the
simulator test or the code reoccurs, the
For coagulation cartridge, next cartridge

should function properly.

- 27 -
52 Analyzer Error – The motor stalled while moving. Check battery voltage. run the Electronic
Use Electronic Causes include: Simulator twice, then run a cartridge with
Simulator 1. Not inserting cartridge or sample. If the analyzer passes the simulator
simulator straight test and a quality check code does not
2. Low or incorrectly inserted occur with the sample, continue to use the
batteries analyzer. If the analyzer does not pass the
3. Damaged mechanism or simulator test or a quality check code
electronics. occurs with the sample, the analyzer must
On coagulation cartridges this could be returned for repair.
be due to inability to position
sample.
52 Analyzer Error – The motor stalled while moving. Check battery voltage. run the Electronic
Use Electronic Causes include: Simulator twice, then run a cartridge with
Simulator 4. Not inserting cartridge or sample. If the analyzer passes the simulator
simulator straight test and a quality check code does not
5. Low or incorrectly inserted occur with the sample, continue to use the
batteries analyzer. If the analyzer does not pass the
6. Damaged mechanism or simulator test or a quality check code
electronics. occurs with the sample, the analyzer must
On coagulation cartridges this could be returned for repair.
be due to inability to position
sample.
53 Analyzer Error - Software installed is incompatible Install current software.

See Manual with the revision of the analyzer. This
can happen if old software is If persistent on only specific handheld(s)
installed into a new analyzer. after performing the listed troubleshooting,
54 Analyzer Error- Analyzer error The analyzer usually recovers from this
Use Electronic condition when the electronic simulator is
Simulator run. If code persists after running the
electronic simulator, the analyzer must be
returned for repair.

- 28 -
55 Analyzer Error- A segment of calibrant fluid was The analyzer will not recover, and must be
See Manual seen during the air segment, twice in returned for repair.
50 runs.
This code applies to non-immuno, non-
Running cartridges not yet at room coag cartridges only.
temperature.
56 Analyzer Error- Excessive noise detected on The noise may be the result of electronic
See Manual temperature readings interference. The analyzer should be moved
to a different location away from potential
sources of interference. If the code persists
in the new area, the analyzer should be
57 Analyzer Error- Hybrid-to potentiometric pin Run an Electronic Simulator. The analyzer
See Manual connection failure. Can be caused by may be used if it passes the simulator test. If
fiber contamination. the problem persists, the analyzer must be
58 Analyzer Error - Analyzer error. Conductivity gain Check battery voltage. Run an Electronic
Use Electronic error. Simulator. The analyzer may be used if it
Simulator passes the simulator test.

59 Analyzer Error - Analyzer error. Calibrant data The Electronic Simulator alone cannot
Use Electronic collection was delayed for too long confirm whether or not there is a problem
Simulator from the end of the motor motion. with the motor.
Check battery voltage. Run an Electronic


- 29 -
60 Analyzer Error - Analyzer error. The Electronic Simulator alone cannot

Use Electronic confirm whether or not there is a problem
Simulator with the motor.

61 Analyzer Error - Analyzer error. Check battery voltage. Insert an Electronic

Use Electronic Simulator. The analyzer may be used if it
Simulator passes the simulator test.

62 Analyzer Error - Analyzer error. The Electronic Simulator alone cannot

Use Electronic confirm whether or not there is a problem
Simulator with the motor.

63 Analyzer Error - Analyzer error. Check battery voltage. Run an Electronic

See Manual Simulator. The analyzer may be used if it
passes the simulator test.


- 30 -
64 Analyzer Error- The EEPROM is not able to be read. This is an electronics parts problem.
Use Electronic Run electronic simulator.
Simulator If code persists after running electronic
simulator, repair analyzer.
65 Analyzer Error - Analyzer error. Flash corrupt. Reinstall current software and then see
See Manual Analyzer will probably not recover. Resolution for code 52.
66 Analyzer Error - Thermistor is out of specification. Check the Temperature reading on the
See Manual Temperature measurements cannot status page. If there are dashes (---) instead
be made. of a temperature reading, the thermistor
has been damaged. This is frequently
caused by an operator attempting to
remove a cartridge while the locked
message is displayed. The analyzer must be
repaired.
67 Analyzer Error - Analyzer error. See Resolution for code 52.

See Manual
68 Analyzer Error - Damaged pins or dirt on shorting See Resolution for code 52.
See Manual bar. Can be caused by fiber
contamination.

- 31 -
69 Cartridge Type The analyzer software recognizes the If a new cartridge type requires new
Not Recognized cartridge types by code pin readings. software, customer must update software.
- Use Another If this recognition cannot be made Determine if the customer got new
Cartridge this code appears. cartridges without new software and, if so,
Causes: perform a quality check on your software
New cartridge type distribution procedure.
Defective cartridge.
Expired cartridge lot. If software is correct, suspect a defective
Defective analyzer connector with cartridge.
simulator.
The cartridge expiration date is
For coagulation cartridges the programmed into the barcode of
analyzer reads the Bin chip to immunoassay and CHEM8+ cartridges. An
determine what the correct product expired lot of immunoassay and CHEM8+
is. When it cannot do that, QC code cartridges will cause a code 140. New
69 is produced software may or may not recognize the
code pins assigned to an expired lot of non-
Immunoassay and CHEM8+ immunoassay and CHEM8+ cartridges. It is
cartridge- barcode on box was the customer’s responsibility to monitor
scanned instead of on the portion cartridge expiration dates.
pack.
Run ceramic cartridge or alternate pin
Displayed on 200 analyzer when condition procedure. See Special
running immunoassay and CHEM8+ Procedures in Section 12.1 of this Guide. If
cartridges. code persistent on one analyzer, the
If code occurs when running an external

electronic simulator, remove the blue
protective cap from the simulator. If
simulator then passes, contact support
services for a new blue cap.
If running immunoassay or CHEM8+

cartridges, scan barcode on cartridge
portion pack ONLY.
For multiple code 69s on coagulation

cartridges, the cartridges must be
investigated.

- 32 -
70 Analyzer Error - Can occur on 200 series analyzer if If occurs after a software update, reseat the
See Manual DIS key is pressed before an batteries to reset the analyzer, reinstall
Electronic Simulator is run after a software and then run the Electronic
software update. Simulator.
Other analyzer errors. See Resolution for code 52.
71 Not used
72 Analyzer Error - Analyzer error. Analyzer will See Resolution for code 52.
See Manual probably not recover.
See Manual probably not recover. After this code
occurs, code 72 will persist.
76 Not used

- 33 -
77 Not used
79 Cartridge Error - There are two thermal probes If the next cartridge functions properly,
80 Use Another (heating towers) in analyzer. Each suspect a defective cartridge.
81
Cartridge has one thermistor and two wires to
which a voltage is applied to heat Trying to remove a cartridge or simulator
the cartridge. These codes occur before the Locked message is removed or
when the physical contact between before results are displayed can damage the
the back-side metallization on the probes. Review proper procedure with the
cartridge and the wires is not good. Point of Care Coordinator.
Bad contact can be caused by:
1. Dirt in the probe contact area If the code persists on one analyzer,
2. Bent or broken probes. perform the Thermal Probe Cleaning
3. Poor metallization in the procedure. See Special Procedures in
cartridge's probe contact surface Section 12.2 of this guide.

If the code persists over one lot number of

cartridges, suspect a manufacturing defect
in the cartridge lot and cartridges must be
investigated.
82 Analyzer Error - The two pressure transducers do not See Resolution for code 52.
See Manual agree within specified limit.
83 Analyzer Error- Underlying hardware failure in the i- Handheld must be repaired

See Manual STAT1 wireless handheld.
84 Analyzer Error- Underlying hardware failure in the i- Handheld must be repaired

See Manual STAT1 wireless handheld.
86 Analyzer Error - Thermistor out of specification on If this code is encountered on a 300 series
See Manual 300 series analyzer with analyzer stored in a Downloader/Recharger
rechargeable battery pack. (any model DRS, DRN, or DRC), move the
Adequate air flow needed by Downloader/Recharger to an open location
downloader. free of obstructions and external heat
sources such as heater vents or other

- 34 -
electronic equipment.
Determine if the analyzer or the

rechargeable battery is at fault. One of the
two following procedures can be used:
1. If a second rechargeable battery is
available, insert it into the suspect
analyzer and perform the procedures
listed under Resolution for code 52. If
the analyzer passes the simulator tests
and the code does not recur with a
cartridge, the first rechargeable battery
is faulty. If the code recurs, the suspect
2. If a second analyzer is available, insert
the suspect battery pack into the second
analyzer and perform the procedures listed
under Resolution for code 52. If code 86
occurs on the second analyzer, the battery
pack is defective. If the code does not
occur, the suspect analyzer must be
repaired.
87 Cartridge Error - Reference electrode reading out of If the next cartridge functions properly,
Use Another spec. suspect a defective cartridge. See
Cartridge “Increased Code Frequency and Technical
Support Response” in Introduction to
section 2 of this guide.
Use the ceramic cartridge or alternative pin

condition procedure. See Special
90 Analyzer Error - Analyzer error. Analyzer will Review the correct cartridge and simulator
See Manual probably not recover. procedure with customer.
300 series: Operator selected the See Resolution for code 52.
simulator test path and tried running
a cartridge.

- 35 -
92 Analyzer Error - The two pressure transducers do not See Resolution for code 52.
See Manual agree within specified limit.
93 Analyzer Error - Power supply error at start of cycle. If occurs after software update, remove
See Manual Rare: can be falsely triggered after a batteries while display is on. Replace
software update. batteries and run a simulator. If code
recurs, the analyzer must be repaired.
94 Analyzer Error - Memory allocation error. A software See Resolution for code 52.
See Manual self-test failure. Analyzer will
probably not recover.
95 Test Cancelled Operator did not enter required Operator training.

by Operator information on the 300 series before
power down.
96 Analyzer Error - Electronic failure. See Resolution for code 52.

See Manual
97 Analyzer Error - Electronic failure. See Resolution for code 52.

See Manual
98 Not used
99 Not used

- 36 -
2.3.2 Codes Associated with Immunoassay Tests on the i-STAT 1 Analyzer (Series 300)
120 Cartridge Error- Problem with movement of analysis Next cartridge should run successfully.
Use Another fluid.
121 Cartridge Error- Problem with movement of analysis See resolution for code 120.
Use Another fluid.
Cartridge
Use Another fluid.
Cartridge
123 Cartridge Error- Reagent compromised. Storage temperature too high, seal on
Use Another cartridge pack broken and reagents
Cartridge dehydrated, or defective cartridge.
See resolution for code 120.
Use Another fluid. Dry segment after wash not
Cartridge found.
125 Cartridge Error- Problem with movement of analysis See resolution for code 120
Use Another fluid. Not enough analysis fluid or
Cartridge few bubbles during wash. (QCC not
turned on)
126 Cartridge Error- Quality control during cartridge run Review proper testing procedure with
Use Another failed to verify the integrity of the customer.
Cartridge analysis fluid.
Use the ceramic cartridge or the alternative
pin conditioning procedure. See Special

- 37 -
127 Cartridge Error- Wet sensor detected before initial Review proper testing procedure with
Use Another sample movement. customer.
Cartridge
Defective cartridge, used cartridge, See resolution for code 120.
or cartridge very overfilled.
128 Cartridge Error- Invalid sample type including Review proper testing procedure.
Use Another hematocrit greater than 65%PCV or Use correct patient sample type or i-STAT
Cartridge air bubble in sample. control. Check if hematocrit is > 65 %PCV.
129 Cartridge Error- Analysis Fluid has been mixed with See resolution for code 120.
Use Another sample.
Cartridge
130 Cartridge Error- Fluidic error or air bubble in sample. Verify correct sample and cartridge
Use Another handling.
Cartridge
Review proper testing procedure with
customer.
131 Cartridge Error- Under filled cartridge or air bubble Verify correct sample and cartridge
Use Another in sample. handling.
Cartridge
customer.
132 Cartridge Error- Fluidic failure or bubble in sample. Verify correct sample and cartridge
Cartridge
customer.
133 Cartridge Error- Sensor becomes wet during dry Verify correct sample and cartridge
Use Another analysis phase. handling.

- 38 -
Cartridge
customer.
134 Cartridge Error Total mix cycle number outside of See resolution for code 120.
– Use Another range.
Cartridge
135 Cartridge Error Sample transit time is too short. See resolution for code 120.
– Use Another
Cartridge
136 Cartridge Error Sample transit time is too short. See resolution for code 120.
– Use Another
Cartridge
137 Cartridge Error Sample transit time is too long. See resolution for code 120.
– Use Another
Cartridge
138 Cartridge Error- Very short initial sample pass. Verify correct sample and cartridge
Cartridge. Typically caused by a leading sample
bubble or under filled cartridge. Review proper testing procedure with
customer.
140 Lot Expired Lot number encoded in cartridge Use cartridge with proper dating.
barcode.
141 Test Canceled Operator failed to scan cartridge Review proper testing procedure with
by Operator barcode within allowed period of customer.
time after the cartridge has been
identified. See resolution for code 120
142 Cartridge Error- Analysis fluid mixed with sample See resolution for code 120.
Use Another during capture cycle.
Cartridge
143 Cartridge Error- Analysis fluid mixed with sample See resolution for code 120.

- 39 -
Use Another during capture cycle.

Cartridge
144 Cartridge Error- Time too long between end of See resolution for code 120.
Use Another analysis fluid capture to the start of
Cartridge the analysis phase.
145 Cartridge Error- Sample not detected on initial push. Verify correct sample and cartridge
Use Another Can be caused by a cartridge leak, handling.
Cartridge failure to close cartridge clip
completely, or an under filled Review proper testing procedure with
cartridge. customer.
146 Cartridge Error- Overfilled cartridge. Verify correct sample and cartridge
Cartridge
customer.
147 Analyzer Error Analyzer not capable of running Immunoassay cartridges can be tested only
– See Manual immunoassay or CHEM8+ cartridges on a 300 series Analyzer with the immuno
or capable analyzer not customized symbol.
to run immunoassay or CHEM8+ Additionally, immunoassay and CHEM8+
cartridges. cartridges must be customized for
Note: PCA handhelds can not run 1. Cartridge information first required
CHEM8+ or Immunoassay cartridge. 2. Cartridge lot number required
148 Not Used
149 Cartridge Error The curves for the reference current Run another cartridge.
/ Use Another are much larger than the analyte
Cartridge current so as to be out-of- If issue persists use another test method.
specification.
150 Cartridge Error The slopes of the analyte sensor or Run another cartridge. Retest on plasma
/ Use Another reference sensor signals are out-of- sample (for BNP only).
Cartridge range. Applies only to low current
levels. If issue persists use another test method.

- 40 -
151 Cartridge Error Reference or analyte sensor signals Run another cartridge.
/ Use Another are not as expected at the end of the
Cartridge dry analysis phase when compared If issue persists use another test method.
to the start of the dry analysis phase.

- 41 -
2.4 Electronic Simulator
General The Electronic Simulator is used to test the analyzer’s ability to take precise and
Information sensitive signal readings from the cartridges. The simulator test has only two results:
PASS or FAIL. A letter failure code is displayed with a FAIL message. A simulator failure
usually indicates a problem with the analyzer. The simulator test has very tight limits
and a certain number of false failures should be expected. If an analyzer fails the
simulator test, the test should be repeated to verify the failure. See the failure
code list below for G and L failures before repeating the test. Failures can also be
caused by a faulty external simulator or, in the case of the internal simulator, a faulty
cartridge. See the information below to rule out a faulty simulator or cartridge before
sending the analyzer for repair.
Note that the external and internal Electronic Simulator may also give quality check
codes described in the previous section.
External An external Electronic Simulator that has been dropped and damaged can cause
Simulator failures. To rule out a faulty simulator, run the simulator in another analyzer. If the
same code or if another code is displayed on more than one analyzer, the simulator is
probably faulty. If another simulator is available, it can be run in the suspect analyzer.
If PASS is displayed with the second simulator, the first simulator is faulty.
Internal Troubleshooting Internal Code G and L:

Simulator If internal simulator lockout is enabled:
(may be caused 1. Rerun the cartridge in the same analyzer to ensure the FAIL was not due to a
by a cartridge one-time spike of electrical noise
problem) 2. If the test fails again, rerun the cartridge in another analyzer if immediately
available
NOTE: the cartridge should NOT be run if there has been more than a 3
minute delay from the time it was filled.
3. If the cartridge fails in more than one analyzer, use another cartridge.
Note: When Lockout is enabled, the analyzer will continue to perform the
internal electronic simulator test each time a cartridge is inserted until the
test (internal or external) passes.
If internal simulator lockout is not enabled:

1. Rerun the cartridge in another analyzer if immediately available.
NOTE: the cartridge should NOT be run if there has been more than a 3
minute delay from the time it was filled
NOTE: When lockout is not enabled, the analyzer will run the next
cartridge without performing the internal electronic simulator test until
the specified time has elapsed.
2. If another analyzer is not immediately available, verify the analyzer by running
an external electronic simulator. If PASS is displayed, continue to use the
analyzer. If FAIL is displayed, check the conditions list below before requesting
the analyzer to be repaired.

- 42 -
For all other internal simulator failure codes run an external Electronic Simulator. If
PASS is displayed, continue to use the analyzer. If FAIL is displayed, check the
conditions list below before requesting the analyzer to be repaired.
2.5 Electronic Simulator Failure Codes

B Potentiometric channel bias error. Channel Repeat simulator test. If FAIL displays again
input current is too large. verify root cause is with handheld and not
external simulator by either running an
internal simulator, running a different
external simulator on the handheld in
question, or running the in question external
simulator on a different handheld.
If the internal simulator or a different external

simulator displays FAIL, or the in question
simulator ran on a different handheld
displays PASS, repair handheld in question.
If the internal simulator or a different external

simulator displays PASS, or the in question
simulator run on a different handheld
displays FAIL, repair external simulator in
question.
G Amperometric channel gain error occurs if the Clean simulator contacts and inside of blue
measured current out of specification. cap with alcohol.
Could be caused by contaminated contact pads See resolution for code B

on external simulator.
L Potentiometric channel error. Resistance Allow analyzer to equilibrate in new

between channels has dropped below environment and repeat after 30 minutes.
specifications. L can occur if moisture
condenses on the pins when the analyzer is See resolution for code B.
moved from a hot and humid area to a cooler
area. When the moisture evaporates the L will
not recur.
R Resistance error. Two resistance values are See resolution for code B.
measured during a simulator test cycle. R is
displayed if the smaller of the two resistance
values read is out of spec.

- 43 -
r Resistance error. Two resistance values are See resolution for code B.
measured during a simulator test cycle. r is
displayed if the larger of the two resistance
values read is out of spec.
t The individual probe temperature differences See resolution for code B.

are incorporated into a running average. t is
displayed if the running average exceeds 0.1C.
23, 47, The blue simulator cover is impeding proper Remove the blue cover completely from the
69 simulator positioning in the meter; pins do not simulator. If the simulator passes, contact
set properly. Technical Support for a new blue cover.

- 44 -
3.0 Analyzer Non-coded Message Problems for i-STAT 1 and i-STAT PCA
Problem Description Cause and Resolution
No activation Analyzer activates when a cartridge is Defective keypad. Analyzer must be repaired.
inserted but not when the display key is
pressed on a 200 series or when the
On/Off key is pressed on a 300 series.
Analyzer activates when the display key Defective start switch. Analyzer must be
is pressed on a 200 series or when the repaired.
On/Off key is pressed on a 300 series,
but does not activate when a cartridge
or simulator is inserted.
200 series and 300 series with Problem with disposable batteries:
disposable batteries: No activation • Check battery orientation
when display or On/Off key is pressed • Change batteries
AND when cartridge or Electronic • Check that brand of battery used is not too
Simulator is inserted. short to make proper contact: disposable
batteries must be 48.2 to 49.2 mm in height
including the contacts.
• Check contacts in the 200 series to ensure
they are not bent out of position.
Problem with boot code – 200 series only:

• Press and hold the * key then press the
display key.
• If the display screen turns completely blue,
if blue bars scroll across display for 3 to 4
seconds, or if the display turns on for only
one second, the analyzer must be repaired.
• If the display does not turn on see Software
below.
Software: There may be no software or the

software may be corrupt. Try updating the
analyzer with the most recent software.
Analyzer dropped and damaged
If persistent on only specific handheld(s) after

handheld(s) must be repaired

- 45 -
300 series and rechargeable battery: Problem with rechargeable battery in 300
No activation when display or On/Off series:
key is pressed AND when cartridge or • Ensure that an i-STAT supplied
Electronic Simulator is inserted. rechargeable battery is being used.
• Rechargeable battery may be damaged,
discharged, defective or at the end of its
lifetime.
1. Use alternate i-STAT rechargeable
battery or disposable batteries to verify
that analyzer functions properly. If
analyzer does not work with alternate
battery, the analyzer software may be
corrupt. Try updating the analyzer with
the most recent software. If the update
does not fix the problem, the analyzer
must be repaired.
2. If analyzer works with different battery,
troubleshoot the suspect rechargeable
battery as follows:
• Damage: Check battery for
physical damage or chemical
leakage.
• Discharge: Charge per instructions
in System Manual.
• Defective or expired: If battery
does not function after charging,
replace battery. (Expected lifetime
of rechargeable battery is the lesser
of 1 year or 400 recharge cycles.)
Analyzer will activate and beep but the Problem with the display screen.
display screen is blank.
Analyzer must be repaired.
Barcode 1. Wrong barcode type or length 1. If correct barcode type or length cannot be
scanner on selected in customization. determined by customer, have customer
i-STAT 1 Not fax a copy of a barcode to you. By the
Working or process of trial and error, the correct
displays barcode type can be determined.
invalid length 2. New or repaired analyzer not
or invalid customized correctly for barcode 2. All bar coded types are active in the default
number type. settings. However, if the site has
customized their analyzers for only one bar

- 46 -
code type, or if a different check digit was

3. Customer not aligning barcode selected for I2 of 5 or Code 39, check digit,
reader on barcode correctly or full ASCII or alphanumeric , or if digits are
barcode is not completely flat. truncated, a new or repaired analyzer must
be customized before it can read the bar
4. No or disfigured red light emitted codes.
when Scan key is pressed.
3. Refer to Procedure under Laser Barcode
5. Barcode is beyond handheld’s Scanner in Section 2 of the i-STAT1 System
scanner capability/specificity. Manual.
4.
• Operator pressed and released the Scan
key. The Scan key must be continually
pressed during the scanning operation.
• Light is only emitted when analyzer is
prompting for information entry.
• Light is only lit for 3 seconds.

5. Verify barcode is designed within

capabilities of the handheld’s scanner.
Battery life Expected usage from two 9-volt lithium • Check that two batteries are being used.
shorter than batteries: • Check that lithium and not alkaline
expected batteries are being used. Alkaline batteries
200 series: a minimum of 400 have a shorter life than lithium batteries.
thermally controlled cartridges*, or 100 • Check that contacts in the series 200
coagulation cartridge test cycles. battery compartment have not been bent
so they do not make good contact with the
300 series: a minimum of 400 batteries.
thermally controlled cartridges, about • Verify if customer is using a rechargeable
100 coagulation cartridges, 1000 battery pack for the i-STAT 1.
glucose test strips, or 40 to 60 • Verify if customer is using a i-STAT 1
immunoassay cartridges. Wireless handheld.
Battery life will depend on use of If persistent on only specific handheld(s) after
backlight feature, barcode scanner, performing the listed troubleshooting, the
length of time-out, and mix of handheld(s) must be repaired.
cartridges used.

- 47 -
Expected usage from rechargeable

battery: 30% of lithium 9V batteries.
Note that when not in use, the
rechargeable battery loses 10 – 30% of
charge over 30 days. Minimum battery
life is the lesser of 1 year or 400
recharge cycles.
Expected usage from i-STAT Wireless

handhelds: 30% of lithium 9V batteries.
Cartridge 200 series only. The handheld(s) must be repaired.

door stuck
Cannot insert Cannot insert cartridge or simulator all Check for damaged simulator.
Cartridge or the way into analyzer.
Simulator If simulator is not damaged and the issue is
persistent, the handheld(s) must be repaired.
Cartridge nor When inserted, neither Cartridges nor See Special Procedure Section 12.3 to perform
Simulator Simulators lock into place. the Flip Latch procedure.
lock
into place If persistent the handheld(s) must be repaired.
Time and/or New or repaired analyzers are shipped Time and date on new or repaired analyzers
date incorrect from the USA with the local time at the should be checked and changed if necessary
factory. before being put into use.
Customer may be confusing time and The time and date saved with results cannot be
date displayed with a set of results with edited.
the real time, which is displayed on the
Status page of the 200 series analyzer
and on the Test and Administration
menu pages of the 300 series analyzer.
The analyzer software recognizes leap If a Data manager is being used, the time and
year but not the beginning and end of date in the 300 series analyzer can be updated
daylight savings time. via the computer.
If the time and/or date are incorrect, If the correct time and date are not maintained,
record this date and time and have there may be a problem with internal lithium
customer change time and date battery or real-time clock. The analyzer must be
properly. (See i-STAT System Manual repaired.

- 48 -
for instructions to set time and date.

The Enter key must be pressed to save
changes.) Use analyzer password GVRI
if password is unknown. Run an
external Electronic Simulator or
cartridge and check the status page on
the 200 series or Administration page
on the 300 series to ensure that the
correct time and date have been
maintained.
Cartridge is When debris wedges itself between a If persistent on only specific handheld(s) Use
misidentified code pin and the shorting bar just as the ceramic cartridge or the alternative pin
the analyzer is resetting itself after the conditioning procedure. See Special
last cartridge run, it can cause the next Procedures in section 12.1 of this guide.
cartridge to be misidentified.
Barometric Reading on Status page not agreeing The barometric pressure must be read at the
pressure with external barometer. elevation of the hospital and must not be
corrected to sea level pressure. The barometric
The barometric pressure transducers pressure can vary due to different weather
are calibrated in the factory and should patterns.
not drift more than 1% over the 300 to
999.9 mmHg range. If the drift is If persistent on only specific handheld(s) after
greater than 1% the analyzer will performing the listed troubleshooting, the
display Code 82 or 92 and the analyzer handheld(s) must be repaired.
must be returned for repair. Code 82
occurs when the average difference
(averaged over several runs) between
the two pressure transducers exceeds 7
mmHg. Code 92 occurs when a single
difference between the two transducers
exceeds 12 mmHg.
Cartridge or The cartridge or simulator cannot be Replace batteries and press DIS or On/Off key.
simulator removed with gentle pulling. The If cartridge is not released, the analyzer must
stuck in analyzer may display “Do Not Remove be returned. Ask the customer not to force the
analyzer Cartridge, Analyzer Not Reset. Replace cartridge or simulator out of the analyzer.
Batteries,” or the display may be blank.
Cartridge For example: cracked casing, broken Product must be repaired.

- 49 -
door broken charging pins or contacts, damaged

(or any other ports, loose internal parts.
cosmetic
damage
regardless of
product)
Battery door A replacement battery door or carrier should be

or carrier sent to the customer.
broken An analyzer should not be returned for repair
for a broken or lost battery door or carrier.
Analyzer hot *i-STAT 1 handhelds using disposable If customer is using a battery carrier, verify what
to touch 9V batteries and a battery carrier must battery carrier is being used.
/smoking use an APOC battery carrier with fuse. Return handheld/product and battery carrier
for investigation.
Data lost All results are deleted from the 200 If these two causes are ruled out, the EEPROM
series when software is updated and may have crashed or corrupted or the internal
when the customization profile is lithium battery is dead. To verify that the
changed. analyzer must be returned for repair, ask the
customer to run the Electronic Simulator or a
Data can also be deleted in the Utility cartridge. After the test is completed, ask the
menu. customer to look for this result under stored
results. If the result is not stored, the analyzer
must be repaired.
Blue, Black or Series 200 only: If the display key is Reseat the batteries to reset the analyzer and
garbled pressed before the Electronic Simulator run the Electronic Simulator.
display when is run after a software update, the
display key analyzer will attempt to display Code 3 If persistent on only specific handheld(s) after
pressed “New Software Installed, run the performing the listed troubleshooting, the
Electronic Simulator.” If changes to the handheld(s) must be repaired.
software prevent the display of Code 3,
a blue or blue patterned (garbled)
screen will be displayed.
Series 300: Display is not functioning.
No operator On the 200 & 300 series analyzer: Customization can prevent this from occurring:
and/or Results will be saved with no a minimum and maximum digit length for ID
patient ID identification numbers if the operator numbers can be required.
recorded with presses the Enter key without entering
results or numbers.
Quality Check

- 50 -
Codes A quality check code occurred before

ID numbers could be entered.
On the 200 series analyzer only:

A cartridge or simulator was inserted
before the identification numbers for
the previous cartridge were entered.
Results will be stored without ID
numbers on the series 200.
On the 300 series analyzer:

Code 95 “Test Cancelled By Operator”
will be stored in place of results when
operator has not entered required
information.
*For software update troubleshooting see the “Care and Software Updates” section of the i-STAT 1 and i-
STAT PCA System manuals.

- 51 -
4.0 Advanced Quality Features (AQF)
4.1 Positive Patient ID Messages
Message Screen it appears on Cause

Year of Birth Patient ID entry screen Year of Birth failed confirmation method.
Invalid Number
Is Not In List Patient ID re-enter/continue screen Year of Birth and ID combination is not in ID
list.
ID Not In Patient ID entry screen ID is not in ID list.
Valid ID List Patient ID re-enter/continue screen
No PPID List Warnings page Patient list does not exist or invalid.
4.2 Pass/Fail Messages

Lot Not In eVAS Solution lot number entry Entered lot number not found in eVAS.
Does Not Match Solution lot number entry Entered solution lot number does not match
Selected Level user selected level.
Invalid eVAS Warnings page eVAS does not exist or invalid.
Lot Not In eVAS Cartridge lot number entry Entered lot number not found in eVAS.
Invalid Length Solution lot number entry A blank lot number was entered when analyzer
configured for manual or automatic pass/fail.
Lot Expired Solution lot number entry Entered solution lot number is expired.
Invalid Number Solution lot number entry Scanned APOC lot number has an invalid
format.
Select Outcome Results page Displayed during a cartridge QC test. Prompt
1-PASS for user to select pass or fail if analyzer
2-FAIL configured for manual pass/fail.
Mark QC PASS? Results page Displayed during a cartridge QC test. Prompt
1-Yes for user to confirm pass or fail if analyzer
2-No configured for manual pass/fail.
Mark QC FAIL? Results page Displayed during a cartridge QC test. Prompt
1-Yes for user to confirm pass or fail if analyzer
2-No configured for manual pass/fail.
4.3 Cartridge Quality Control Schedule Messages

Does Not Match Solution lot number entry Entered solution lot number does not match
Scheduled Fluid scheduled solution type.
Does Not Match Cartridge lot number entry Entered cartridge lot number does not match
Scheduled scheduled cartridge type.
Cartridge
Control Required Cartridge lot number entry Cartridge locked because QC due.
Patient Testing
Disabled
i-STAT QC Test Menu This message is displayed if ALL cartridges are
Past Due disabled because their cartridge QC is past
Cartridge Testing due. Analyzer is configured for Info First.
Disabled
This message is also displayed if ANY cartridge

- 52 -
is past due. Analyzer is configured for Non Info
First.
QC Past Due-Not Test Menu This message is displayed if ANY cartridge is
All disabled because their cartridge QC is past
Cartridges Are due. Analyzer is configured for Info First (a
Active For Testing new menu option is added to the Test Menu
that allows the user to view Inactive Cartridges).
i-STAT QC Due Test Menu A cartridge QC is due. Displays the date and
Complete Before QC Select Schedule screen time of the end of the cartridge QC grace
DDMMMYY QC Select Cartridge screen period.
HH:MM QC Select Fluid screen
Next i-STAT QC Test Menu Displays when the next cartridge QC is due.
DDMMMYY QC Select Schedule screen
HH:MM QC Select Cartridge screen
QC Select Fluid screen
i-STAT QC QC Select Schedule screen Displays when schedule is past due.
Past Due QC Select Cartridge screen
QC Select Fluid screen
4.4 Operator Competency Notification
If the handheld does not display the notification at the designated time, check the customization
settings in the data management system and compare the customization number in the handheld
against the customization number for that location.
5.0 Wireless Codes and Messages

E20B Handheld failed to associate to the Incorrect network settings entered into
access point because the access point Handheld.
rejected association request
Verify all network settings were correctly
entered into the handheld.
E210 Handheld is unable to connect to the Verify that the data management system is
data management system open and running.
Verify data management system IP address

was correctly entered into the handheld.
E212 Handheld cant obtain an IP address Issues with DHCP server.
from DHCP server and there is no IP
address present in handheld Verify with facility IT department of DHCP
network status.
E21E Network is not configured and no SSID Handheld has not yet been configured for
name is assigned to handheld wireless communication.
E21F Handheld is unable to ping the data Verify that the data management system is
management system open and running.

- 53 -
Verify data management system IP address
was correctly entered into the handheld.
E220 Handheld is receiving no response from Verify that signal strength is not <65dbm. If it
facilities access points after 3 attempts is move to a location where a higher signal
strength is obtained.
Verify with facility IT department of Network

status.
iE53D Handheld is unable to receive setup Verify Ad hoc connection was successfully
from the Wireless Configuration established/setup.
Application
Verify no other Wireless Configuration
Application is running at the same time.
Verify no other Wireless Handheld is setup to

receive the wireless configuration.
30000 Did not reboot the WiM after updating Select “1-Continue” if error condition 30000 is
the WiM firmware observed.
6.0 Flagged Results
Flags are symbols that are displayed instead of results. The type of flag indicates the type of problem that
is preventing a result from being reported.
6.1 Star-out (***)
Description
When a sensor does not pass internal quality checks, the result is suppressed and *** are displayed. The
*** symbol is referred to as a “star-out”. Other terms used by i-STAT include “a starred result” and “star-
out rate”.
If results for another sensor are dependent on the starred sensor, its results are also suppressed. For
example, if in an EC4+ Cartridge the sodium result is starred, the potassium and hematocrit result will also
be starred, but the glucose results will be reported. Reported results are reliable. Star-outs due to an
occasional defective sensor should be expected to occur at a rate of 2 to 3% or no more than 3 out of one
individual box.
Sensor Interdependencies
Primary Sensor Dependent Sensors Dependent Calculated Values

Na K, Cl, Hct, BUN anion gap, Hb
pH and PCO2 PCO2 and pH HCO3, BE, TCO2, anion gap, sO2
Hct Hb
Hct (fluidics problem - Cl, urea, glucose, PO2 anion gap, sO2, Hb
see note) lactate, creatinine
PO2 sO2

- 54 -
K or Cl anion gap
Note 1: Bicarbonate will not display if TCO2 is disabled.
Note 2: If a fluidics problem (movement or quality of calibrant or sample) is the cause of the
hematocrit star-out, the sensors listed are also starred out.
If three or more cartridges star-out one after the other, the cause may be hematocrit learning or a contact
problem. If the overall star-out rate increases to 10% or greater, a manufacturing problem should be
suspected. Other causes for the increase rate of star-outs should be ruled out before reporting a possible
manufacturing problem.
Troubleshooting steps
Potential Causes of Suppressed Star-out Results can be found on the following pages
1. For Hct Star-outs only, if persistent on only specific handheld(s) use the ceramic cartridge or the
alternative pin conditioning procedure. See Special Procedures in section 12.1 of this guide.
2. Rule out all potential causes listed below.
3. Draw a fresh sample and retest. If star-outs are persistent, check the supply of cartridges with control
solution.
a. If star-outs continue only on patient samples, see interfering substances section.
b. If controls are out of range or star-outs continue, investigate lot and use a different lot or
method of testing.
4. When star-outs occur and analyzer and operator errors have been ruled out, a cartridge
manufacturing problem should be suspected:
a. Ask the customer for a list of box numbers for the suspect cartridge lot.
b. Ask the customer to test controls on cartridges from boxes with numbers as far away from
the suspect box as possible. If star-outs do not occur on these cartridges, the customer can
use these boxes.
c. Ask the customer to send the suspect box and possibly the boxes with numbers close to the
suspect box. Cartridges may need to be returned for investigation.
d. If the customer has a Central Data Station, obtain one or more diagnostic files (ISD files). See
Special Procedures in Section 12.4. ISD files are very helpful in determining if there is a
manufacturing problem. If the customer does not have a CDS, ISD files should be collected
by a field or technical support representative. (Visit the customer site with a lap top computer
with the CDS software, or have cartridges sent to the Technical Support department.)
e. Forward this information to Abbott Point of Care Technical Support as soon as possible.
5. Determine if the customer requires replacement cartridges to continue use of the i-STAT System.
6. If Abbott Point of Care verifies a cartridge lot problem, cartridges will be replaced according to a plan
organized by Abbott Point of Care.
7. If all potential causes have been ruled out, cartridges have been confirmed NOT to be root cause, and
if star-out results are still persistent on ONLY specific handheld(s) after performing the listed
troubleshooting, the handheld(s) must be repaired.

- 55 -
Causes of Star-outs (***)
Problem Cause Resolution and Comments
Contact problem Debris carried into the analyzer on Avoid placing cartridge on fibrous
cartridges collects on the pins in material while filling.
the analyzer creating noise. Noise
can cause both star-outs and Code Corrected by pin conditioning procedure
23. or ceramic cartridge for HCT only. See
Section 12.1, Special Procedures.
Material from the contact pads
builds up on the pins – typically
affects hematocrit.
Hematocrit learning
(Rcal learning) Analyzer keeps a running average See resolution of Code 24
of the calibrant resistance reading
for each cartridge type. Code 24
occurs if this reading is too far
below this average. Causes:
1. new cartridge lot
2. compromised calibrant fluid
3. punctured calibrant pack with
Evaporation
4. damaged hematocrit electrode
Manufacturing There may be a rare, persistent Since the defect rarely affects the entire
defect that affects a part of the run, it is important to follow the
manufacturing run. instructions under “Troubleshooting
steps” found at the beginning of this
section.
Wrong sample type Blood gas/chemistry cartridges: Use

only fresh whole blood or blood
with lithium heparin or sodium
heparin anticoagulant. For ionized
calcium measurements, use
balanced or low volume heparin
anticoagulant. Tubes must be filled
to capacity.
Aged or stored patient serum may
contain products of metabolism
that could interfere with the

- 56 -
sensors.
EDTA samples are allowed only for
the Glucose and BNP cartridge.
Coagulation cartridges: Use only

fresh whole blood without
anticoagulant. Use only plastic
when collecting a sample for ACT
and PT/INR. (It is recommended
that samples for PT/INR be
collected directly from a finger
puncture.)
APOC can test external quality control
Immunoassay cartridges: For cTnI samples to determine if they are
and CK-MB, use only fresh whole compatible. APOC can also investigate
blood or plasma collected with the cause of discrepant results.
heparin anticoagulant. Collection
devices with heparin should be
filled to manufacturer’s stated
volume since high levels of heparin
can depress cTnI results. Mix tubes
gently at least 10 times. Capillary
tubes and direct skin punctures
should not be used with cTnI, CK-
MB, or BNP cartridges.
BNP requires the use of EDTA whole
blood or plasma samples collected
in plastic syringes or evacuated
tubes containing EDTA. The use of
glass vessels is not recommended
because the BNP molecule has been
shown to be unstable in glass tubes.
Commercial quality control or

external quality control (EQAS)
samples containing fluorocarbons
or fixed-cells will not be compatible
with the sensors. Samples
containing aged serum or
preservatives may not be
compatible.
Expiration date Cartridges should not be used Have the customer verify that cartridges
exceeded beyond their labeled or room that have not expired are functioning
temperature expiration dates. properly.

- 57 -
Sensors tend to loose stability after

the expiration date. Star-outs are
common on cartridges that are just
past their expiration date.
Interfering substance If sensor star-outs are occurring on Verify that the correct sample type is
one patient or on patients who are being collected.
on the same medication or who are Verify that the sample was not
undergoing the same procedure, contaminated by being drawn above or
interfering substances should be close to an I.V. or from a line that was
suspected. not cleared properly.
Forward diagnosis and medications to
Abbott Point of Care Technical Support
for possible investigation.
Improper sample The PO2 sensor will be starred if an Review proper sample handling.
handling: PO2 air bubble is trapped over the
sensor. Air bubbles can be created
in a control ampoule during the
shaking step, can be introduced
into a sample by trying to tap out
an air bubble formed at the leading
edge of the barrel in a syringe
(technique used with bench-top
blood gas analyzers), or can be
introduced by trapping air in a
capillary tube.
Incorrect cartridge Urea (BUN) can be starred if the Room temperature storage for cartridges
storage: Urea cartridges are exposed to high is between 18 and 30°C [64 to 86°F] for
temperatures. up to two weeks.
Punctured Pouch: pH and PCO2 can be starred if the If the box is damaged or if punctured
pH/PCO2 cartridge pouches have been pouches are noticed in newly received
punctured or if testing is delayed cartridges, have the customer return the
after the cartridge is removed from defective product and replace as
its pouch. necessary.
Shipping procedures should be
investigated as a possible cause of
damaged boxes.
cTnI/ BNP/ CK-MB High levels of non-specific binding If frozen plasma is being tested, the
detected on the reference sensor tubes should be centrifuged to remove

- 58 -
can be caused by clotting. clots or fibrin strands.

Electrical fault during analysis cycle
may occur with highly processed
samples (such as proficiency testing
or external quality control materials
or samples containing very low
total protein).
6.2 Out-of-Range Results (<, >, <>)
Result outside the These symbols or “flags” indicate that Draw a fresh sample and use a fresh
analytical the result is below (<) or above (>) the cartridge. If the flags repeat, test by
measurement range measurement range (reportable another method.
for the test range) of the test.
It is not always necessary to test by
Results that are dependent on a result another method if the less than or
that is flagged with < or > are flagged greater than result is sufficient for the
with <>. See the table under Star- clinician. For example, a urea less than
outs for sensor dependencies in the measurement range can be
section 4.1 of this document. expected in pregnant women and has
no clinical significance.
The value after the < or > flag is the
lower or upper end of the
measurement range. See the Cartridge
and Test Information section of the
i-STAT System Manual for a table with
Reportable Ranges.
If K2 or K3 EDTA anticoagulant is used,

potassium will be > 9 mmol/L and
ionized calcium will be < 0.25 mmol/L.
Additional quality The “< >“ flag is displayed for TCO2,

check when TCO2 is pH, PCO2, HCO3, anion gap, base
outside reportable excess and sO2 if the TCO2 result is <1
range or >80 mmol/L. Because the values
outside this range are essentially non-
physiological, the TCO2 range check is

- 59 -
used as an additional quality check of

the underlying pH and PCO2 results.
Calibration Verification No < or > displayed when results are

test path outside measurement range.
Calibration Verification is a linearity
test performed to confirm that the
calibration of the instrument has
remained stable throughout the
reportable range. The < and > flags
are not used in the Calibration
Verification test path. This allows
results below and above the
measurement ranges to be reported.
RNA Medical Control < > displayed rather than results. The control must be tested using
for Hematocrit the Quality test path on the i-STAT1
Analyzer.
AQF Note: If “Control Results Display Format” is set to suppressed all QC results will be flagged as <>
6.3 Over-Range Results (↑ and ↓)
Action Ranges Upper and lower limits can be entered Unless the result is unexpected, the
into the i-STAT 1 CDS customization customer should not be calling about
profile for each test to indicate results marked with an Action Range
decision or critical limits. These limits arrow. It is possible that the wrong
are identified by displaying an up or action range was programmed into the
down arrow after the result. These Central Data Station Version 5
limits can only be entered via a CDS Customization section.
Version 5.
AQF Note: Out of range QC results will be flagged with ↑ or ↓ depending

of range

- 60 -
7.0 Mechanical Cartridge Defects
Problem Primary Action Secondary Action
Punctured pouch Do not use the cartridge if the pouch is Investigate shipping as possible cause.
punctured. See Punctured cartridge
pouch-pH/PCO2 under Causes of Star-
outs, section 6.1 of this document.
Snap closure failure Could be a new operator problem. If Abbott Point of Care Technical Support
an experienced operator notices that a may request that cartridges be returned
particular lot of cartridge is hard to for investigation.
close or pops open after closure, an
investigation by Abbott Point of Care
should be requested.
Cartridge will not fill Sample will not flow to fill mark or Check that the cartridge is not resting
operators have difficulty getting on a padded surface, which may cause
sample to fill mark. the air vent to be blocked.
If the calibrant pack has been burst and
calibrant fluid is in the fluid path,
sample will not be able to move up to
the fill mark.
Cartridges reaching their expiration
date may become more difficult to fill.
The blood gas/chemistry/hematocrit
cartridges are treated to make the
blood flow quickly to the fill mark. On
rare occasions, cartridges may be
difficult to fill. If multiple cartridges are
difficult to fill, contact APOC Technical
Support. Cartridges will need to be
returned for investigation.
Missing or The customer may notice a missing

misaligned gasket blood port/well gasket or may get a
(rare) code 31 or 34 indicating that the
cartridge was not sealed properly.
Visible leak Customer may get a code 31 or 34 Usually a rare one-time occurrence.
indicating that the cartridge was not
sealed properly if the two halves of the
cartridge were not pressed together
sufficiently during the manufacturing
process. In this case blood may be
seen outside the fluid path. The

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Problem Primary Action Secondary Action
cartridge seal may be compromised if

exposed to extreme heat.
Foreign material Customer may notice a foreign material If possible, such a cartridge should be
found in cartridge or (hair, etc) or a mark on cartridges (test returned to APOC Technical Support.
contact pad marked cartridge). These should not be used.

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8.0 Discrepant Patient Results
Any complaint regarding the accuracy of a patient result must be considered a Potentially
Reportable Event until proven otherwise. Every attempt must be made to differentiate between
discrepant results and a system bias. Discrepant results are isolated to one patient or one patient type. A
bias affects all patient results.
Problem Information Required (Distributors must complete form F04.01.007.01 and ADD must either
use this form or supply the information requested on this form to ensure that all pertinent information is
documented)
Include:
Cartridge type, lot number and box number
Analyzer software
All results - not just the one questioned
Reason for believing the result was not accurate
Scope
Severity
Control results
Factors that could affect results
8.1 General Causes
Cause Explanation/Recommendation Comments
Wrong sample type Only fresh whole blood samples can APOC can recommend only those
be tested. sample types that have been
cleared by the FDA.
Suitable whole blood sample types can
be obtained from an artery, a vein, or • Plasma from
skin puncture (when applicable). heparinized whole
blood is an acceptable
sample type for cTnI
and CK-MB
immunoassays. Plasma
from EDTA whole blood
is an acceptable sample
type for BNP.
• All collection devices
must be filled to their
stated volume.
Wrong anticoagulant Use of the wrong anticoagulant can Ionized calcium: Balanced or
cause *** or unexpected results. Only reduced volume heparin should be
fresh whole blood without used. Sodium or lithium heparin at
anticoagulant or with lithium heparin concentrations found in some blood
or sodium heparin anticoagulant filled gas syringes, in evacuated tubes,
to their stated volume can be used. and in capillary tubes will decrease

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ionized calcium and sodium.

Plasma samples using EDTA as the Evacuated tubes must be filled to
anticoagulant filled to their stated stated volume.
volume are used for the BNP test.
Coagulation tests: only plastic
collection devices without
anticoagulant can be used.
BNP requires the use of EDTA whole

blood or plasma samples collected
in plastic syringes or evacuated
tubes containing EDTA filled to the
stated volume.
Glucose and BNP cartridge: EDTA is

an acceptable anticoagulant. (EDTA
is the anticoagulant used for
hemoglobin A1C tests).
Immunoassay cartridges: (except

BNP) heparinized whole blood and
plasma are acceptable sample
types. Evacuated tubes should be
filled to stated volume. Whole
blood without heparin is a
recommended sample type for cTnI
and CK-MB tests if tested within
one minute of the patient draw.
Check Product Updates for any
changes to this information.
Too much heparin Underfilling collection devices will All collection devices must be filled
increase the heparin to blood ratio. to their stated volume.
Ionized calcium will be affected the
most – levels will decrease with
increasing amounts of heparin. Other
tests, such as sodium and cTnI may
also be affected.
The use of manually heparinized
If too much liquid heparin is used, syringes is not recommended.
results will also be decreased
according to the degree of the
dilution.

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Sample Contamination • IV fluid: blood drawn from a site

above an I.V. may be
contaminated with the I.V. fluid.
All results could be affected by the
dilution. Some results could be
affected by an interfering
substance in the I.V. fluid.
• Indwelling line: samples can be
contaminated by a saline heparin
drip and other medications in a
drip. The line should be flushed
with 5 ml of saline and the first 5
ml of blood or six dead space
volumes should be discarded.
Residual line fluid can collect in a
stopcock or collection port. For
this reason, it is best to draw more
sample than is needed to reduce
the affect of any contamination by
this residual fluid.
• Hemodilution: hemodilution of
more than 20% with priming
solution in cardiopulmonary
bypass pumps, plasma volume
expanders or some other fluids
may cause clinically significant
errors on sodium, chloride, ionized
calcium and pH results. These
errors are associated with
solutions, such as normal saline
and Ringer’s Lactate, that do not
match the ionic characteristics of
plasma. The use of physiologically
balanced multi-electrolyte
solutions containing low-mobility
ions such as gluconate can prevent
these errors. Examples of these
solutions are:
• Normasol-R(Abbott
Laboratories)
• PlasmaLyte-A (Baxter
Healthcare Corporation)
• Isolyte-S (B Braun Medical)
• Plasma expanders: dilutions with
plasma expanders above 50% may

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decrease hematocrit results.
Delayed testing Affects of Delayed Testing Acceptable Time to Test
• Glucose: decreases over time • Samples collected with

(about 5 to 10 % per hour anticoagulant for glucose,
depending on white blood cell urea, creatinine,
count and presence of bacteria) electrolytes, hematocrit,
• pH: anaerobic condition - BNP, CK-MB and cTnI
decreases over time should be tested within 30
• pH: aerobic condition - increases minutes of draw.
over time • Samples for pH, blood
• PCO2: anaerobic conditions - gases and ionized calcium
increases over time should be tested within 10
• PCO2: aerobic conditions - minutes of draw.
decreases over time • Samples for lactate should
• iCa: goes in opposite direction of be tested immediately.
pH • Samples for coagulation
• PO2: anaerobic conditions - tests should be tested
decreases over time immediately.
• PO2: exposure to air - moves • Samples collected without
toward PO2 of room air (160 anticoagulant or in capillary
mmHg) tubes should be tested
• K: begins to increase after 30 immediately.
minutes • Samples collected in a 1 mL
• Lactate: begins to increase syringe should be tested
immediately (70% in 30 minutes) immediately if cartridge
• ACT and PT/INR: clotting begins includes a hematocrit test.
immediately
• Hematocrit results will be
affected if testing is delayed and
the sample is not well mixed
immediately before testing. This Sample handling for hematocrit:
is because the red blood cells • For blood collected in a
settle out of the plasma. tube: mix by gentle
inversion 8 to 10 times.
• For blood collected in a
syringe: mix by rolling
between the palms for five
seconds in one direction,
then for five seconds in a
second direction, then by
inverting for five seconds.
Discard two to three drops
of blood before filling

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cartridge. It may not be

possible to re-mix blood
in a 1 mL syringe
adequately.
Insert filled cartridge into analyzer
immediately.
Iced samples: Increased Samples for blood gas analysis are The i-STAT System Manual advises
PO2 and potassium results sometimes transported in bags with cartridge testing before icing. If
ice and water to prevent time-delay icing a sample before testing on the
changes in the results. At lower i-STAT System is unavoidable, the
temperatures, the hemoglobin affinity sample must be warmed by rolling
for oxygen is increased (the the syringe in the palms of the
hemoglobin-oxygen dissociation curve hands for a least one minute before
is shifted to the left) and the solubility testing.
of oxygen in plasma is increased
causing an increase in PO2. Larger
bench top blood gas analyzers warm
the sample to at least room
temperature before the sample
reaches the measurement
compartment, thus reversing the affect
of icing. The i-STAT analyzer cannot
warm the sample to room temperature
before the sample reaches the sensors.
Note that icing causes a slow non-

reversible increase in potassium results
over time.
Known Interfering A sample may contain substances that Interfering substances known at the
substances may cause different methods to have time that this guide was released
different types and sizes of are listed under each analyte in this
measurement error. These interfering section. Refer to the CTI sheets and
substances cause a method to detect recent Product Updates for the
more or less of the analyte than is most up-to-date information on
actually present in the sample. known interfering substances.
Unknown interfering There is the possibility that an • Verify that cartridges perform to
substance unknown interfering substance is specifications by using i-STAT
causing the unexpected result. controls or controls
recommended by APOC.
• Retest the sample to rule out an
outlier.

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• If sample collection is
suspected, a fresh sample
should be drawn and tested
using another cartridge.
Samples from indwelling lines
can be contaminated if the line
is not cleared adequately before
the sample is withdrawn.
• If the same result is reported,
the sample should be tested by
another method.
Request a list of medications for an
investigation.
Incorrect analytes When debris wedges itself between a If persistent on only specific
displayed for cartridge code pin and the shorting bar just as handheld(s) Use the ceramic
type the analyzer is resetting itself after the cartridge or the alternative pin
last cartridge run, it can cause the next conditioning procedure. See
cartridge to be misidentified. Special Procedures in section 12.1
of this guide.
If persistent on only specific

handheld(s) after performing the
listed troubleshooting, the

- 68 -
8.2 Specific Causes by Analyte
All sample collection devices must be filled to their stated volume.
Analyte Possible Cause and Effects
Sodium • Wrong anticoagulant: Use of ONLY Lithium or Sodium Heparin is recommended

• Use of blood gas syringes with high concentration of heparin. Pre-heparinized syringes
labeled for the measurement of electrolytes is recommended
• Delay in testing: literature states no affect up to four hours
• System Manual recommends testing within 30 minutes of sample draw.
• Icing: no affect
• Known interfering substances:
• Refer to corresponding Cartridge and Test Information Sheet (CTI sheet)
Potassium • Sample collection

• Wrong anticoagulant: Use of K3 or K2 EDTA anticoagulant will cause potassium to
read >9. Other non-heparin anticoagulants may cause different errors or
star-outs.
• Wrong sample type: serum samples will have higher results than plasma or
whole blood by about 0.1 to 0.7 mmol/L. Platelets and RBC’s release potassium
in the clotting process.
• Hemolysis will increase potassium results.
 Hemolysis can be caused by residual alcohol used to clean the puncture
site, by muscle activity such as clenching the fist during blood draw,
by excessive squeezing of a heel or finger puncture site.
• Tissue fluid contamination can affect potassium results.
 Wipe away first drop of blood from heel or finger puncture.
• Blood begins to clot after about 3 minutes if there is no anticoagulant in the
sample. If testing is delayed and the blood begins to clot, quality check codes
31 and 34 usually occur. However, it may be possible that the sample has only
very small clots that could affect the hematocrit and increase the potassium
results.
• Delay in testing: will cause potassium to increase slowly over time.
• Icing: will cause potassium results to increase over time
o Refer to corresponding Cartridge and Test Information Sheet (CTI sheet)
Chloride • Hemodilution of the plasma by more than 20% associated with priming cardiopulmonary
bypass pumps, plasma volume expanders or other fluid administration therapies using
certain other fluids may cause clinically significant error on sodium, chloride, ionized
calcium and pH results.
• Wrong anticoagulant
• Delay in testing: literature states no effect up to 4 hours

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Ionized • Cartridge handling: cartridges that have been frozen should be discarded; they may give higher
calcium than expected iCa results. If it is suspected that the cartridges have been frozen, test with
controls.
• Sample collection
• Prolonged tourniquet application and forearm exercise can increase ionized calcium due
to a decrease in pH caused by localized production of lactic acid.
• Anticoagulant: heparin binds calcium so results will be decreased if lithium or sodium
heparin is used and the tubes are not filled to capacity. Use only pre-heparinized blood
gas syringes that are labeled for the measurement of ionized calcium and fill to capacity.
These syringes contain heparin that has been balanced or titrated with ionized calcium
and sometimes with other electrolytes to prevent the heparin from binding the iCa and
electrolytes in the sample. Otherwise the iCa results will be much lower than expected.
• Hemodilution of the plasma by more than 20% associated with priming
cardiopulmonary
bypass pumps, plasma volume expanders or other fluid administration therapies using
certain other fluids may cause clinically significant error on sodium, chloride, ionized
calcium and pH results.
• Sample handling
• iCa results are affected by pH. If pH is increased due to delays in testing under aerobic
conditions, iCa will be decreased. If pH is decreased due to delays in testing under
anaerobic conditions, iCa will be increased.
• Normalized or pH corrected values
It is not necessary to adjust or normalize ionized calcium results to a pH of 7.4 if testing
is
performed within 10 minutes of the blood draw. Blood is a living tissue. Cellular
metabolism including consumption of glucose and oxygen and production of carbon
dioxide and acids continues after blood is collected into a syringe or tube. Since the
blood
sample is isolated from the circulatory system, products of metabolism build up. If
testing
is delayed, the increase in acids causes the pH to decrease which in turn causes ionized
calcium to increase. If the blood is exposed to air, PCO2 will decrease (escape into the
atmosphere) causing the pH to increase which in turn causes ionized calcium to
decrease.
These changes are not significant if the blood is tested within 10 minutes of draw. If
testing is delayed, as it used to be when it took an hour to transport samples to a lab,
then the changes to ionized calcium could be clinically significant. In an attempt to
account for this artifactual change, algorithms were developed that used the measured
pH to extrapolate the measured ionized calcium result back to what it would be if the
pH had been 7.4. CLSI (Clinical and Laboratory Standards Institute) recommends better
sample handling for accurate ionized calcium results and does not recommend the use

- 70 -
of algorithms to adjust the results since there is no universally recognized algorithm; all
the algorithms have a limited range in which the adjusted results are valid and variations
in albumin, types of ions which bind ionized calcium and general inter-individual
variations limit the value of pH adjusted ionized calcium results.
• Wrong unit set: mmol/L, mEq/L and mg/dL have different numeric values
pH • Sample handling
• Venous stasis (prolonged tourniquet application) and forearm exercise may decrease pH
due to local production of lactic acid.
• Exposing the sample to air will cause pH to increase due to the loss of CO2, and allowing
the sample to stand at room temperature without exposure to air will cause pH to
decrease
at a rate of 0.03 units per hour due to the production of CO2.
• Hemodilution of the plasma by more than 20% associated with priming cardiopulmonary bypass
pumps, plasma volume expanders or other fluid administration therapies using certain other
fluids
may cause clinically significant error on sodium, chloride, ionized calcium and pH results
.
o Refer to corresponding Cartridge and Test Information Sheet (CTI sheet)
PCO2 • Sample handling

• Exposing the sample to air allows CO2 to escape which causes PCO2 to decrease and pH
to increase and HCO3 and TCO2 to be under-estimated.
• Allowing the sample to stand without exposure to air allows CO2 to increase, which
cause
PCO2 to increase, pH to decrease, and HCO3 and TCO2 to be over estimated.
PO2 • Cartridge handling

• PO2 will be decreased if cold or unequilibrated cartridges are used.
• Sample handling
• Exposure to air will cause PO2 to increase if below the partial pressure of oxygen in room
air (about 160 mmHg) and to decrease if above.
• Allowing the sample to stand without exposure to air will cause PO2 to decrease due to
the continued consumption by metabolism in the blood.
• Testing of ice cold blood will cause the PO2 results to be overestimated by about 10%.

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Glucose • Sample handling: glucose decreases over time – about 5 to 10 % per hour depending on white
blood cell count and presence of bacteria.
Urea • Known interfering substances:

Creatinine • Known interfering substances

Refer to corresponding Cartridge and Test Information Sheet (CTI sheet)
Lactate • Sample collection: For steady state lactate concentration, patient should rest for 2 hours and
fasting before blood draw and blood should be drawn without a tourniquet or immediately
after tourniquet is applied. Otherwise, results will be increased.
• Sample handling: after blood draw, lactate increases by as much as 70% within 30 minutes
at 25°C as a result of glycolysis. Test immediately after blood draw.

Hematocrit • Customization setting for EDTA (K2EDTA or K3DTA): See Section 9.5, Comparative Methods,
Hematocrit
• Sample handling
Sample handling is the most common cause for discrepant or unexpected hematocrit results.
If testing is not immediate, the sample must be remixed to re-suspend the cells. It may not be
possible to adequately re-suspend cells in a 1 mL syringe. See section 6, Delayed Testing for
proper mixing instructions.
Blood begins to clot in approximately 3 minutes if there is no anticoagulant in the sample. If

testing is delayed and the blood begins to clot, quality check codes 31 and 34 usually occur.
However, it may be possible that the sample has only very small clots, which could affect the
hematocrit and increase the potassium results.
• The CPB sample type should be used to compensate for the low total protein in patients
on the pump in cardiovascular surgery.
• CPB should be used until patient returns to pre-operative osmotic status. Osmotic
status can be estimated by total protein values. When patient returns to normal level

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of total protein will depend on how quickly pump fluid is removed from patient.
• Note: Customers may ask if the CPB sample type can be used to correct for other
conditions 3 with low total protein.
The CPB algorithm is based on the premise that the red blood cells and total protein are diluted
equally. (See Theory section of i-STAT1 System Manual or Technical Bulletin on hematocrit and
open-heart surgery.) This is not the case in other conditions of low protein such as burn patients
and neonates. However, some hospitals have validated the use of CBP for neonates.

ACT • Sample collection: anticoagulant in collection device will prolong the clotting time . The use of
glass collection devices will decrease the clotting time.. Use only plastic syringes or tubes. Any
delay in testing will decrease the clotting time. Do not use skin puncture to collect sample.
• Sample handling: analyzer must remain level during the testing cycle. A level surface includes
running the handheld in the downloader recharger. If the handheld is not kept level during
testing the ACT result may be affected by more than 10%.
• Interfering substances: Do not use ACT Celite if patient received aprotinin:, Clotting time will
be greater than expected.
• Insufficient flushed line. If blood must be drawn from an indwelling line, possible heparin
contamination and specimen dilution should be considered. The line should be flushed with
5 mL of saline and the first 5 mL of blood or six dead space volumes should be discarded.

PT/INR • Sample collection: directly from finger puncture into cartridge. Hanging drop without milking
should be formed before touching finger to cartridge. First drop does not have to be wiped
away.
No delay in testing allowed.
• The presence of exogenously added heparin, citrate, oxalate or EDTA from blood collection
devices will interfere with test results.
• Glass syringes or tubes may prematurely activate coagulation, resulting in accelerated clotting
times and lower INR’s. Venous samples must be collected in plastic syringes or tubes.
• Analyzer must remain level during the testing cycle. A level surface includes running the
handheld in the downloader recharger.
• Lupus anticoagulant antibodies could potentially interfere with multiple PT/INR methodologies
And should be tested on other laboratory instruments known to be insensitive to these
antibodies.
• Cubicin (daptomycin for injection) has been found to cause a concentration-dependent false
prolongation of PT and elevation of INR when using the i-STAT PT/INR test. Use another PT/INR
method to obtain results.
• Samples contaminated with chlorhexidine gluconate may report a false prolongation of the PT

- 73 -
and elevation of the INR.

Troponin I • Anticoagulants other than heparin will decrease cTnI results.

(cTnI) • Partially clotted samples can decrease or increase cTnI results, cause a quality check code or
star-outs. Use collection devices with heparin and mix the sample and blood sample
adequately immediately after collection. Gently invert a collection tube 8 to 10 times to mix
blood with anticoagulant.
• If the cTnI is high, partial clotting can decrease cTnI by 10-30% depending on the severity
of clotting.
• If the cTnI is very low or zero, clotting has the potential to cause a falsely elevated result
or a star-out.
• Grossly hemolyzed samples can decrease cTnI results or cause a quality check code.
• Hematocrit values above 65 %PCV may increase the imprecision of the test or cause a quality
check code.
• The analyzer must remain level during testing. Motion during the test cycle can cause star-outs
or quality check codes. A level surface includes running the handheld in the downloader
recharger.
• A large proportion of patient specimens contain endogenous antibodies, e.g. heterophile
antibodies, human-acquired anti-animal antibodies and autoantibodies that can in some cases
interfere with immunoassays giving rise to falsely elevated or depressed results – all
immunoassays
are subject to such interference. These potential interferents can arise from diagnostic or
therapeutic
treatments with antibody-containing agents, but also through less specific contact with animals
and animal materials. The generation of potentially interfering antibodies in response to
bacterial
infections has also been reported. (Immunoassay interference by Endogenous Antibodies;
Proposed
Guideline I/LAA30-P Vol. 27 No. 9)
• The i-STAT cTnI assay is specifically designed to minimize the effects of antibody interferences.
Assay results that are not consistent with other clinical observations should be considered
carefully
and the possibility of interference should be recognized. Additional guidance concerning the
interpretation of results is available at
http://www.fda.gov/medicaldevices/safety/alertsandnotices/tipsandarticlesondevicesafety/ucm109362.htm
• Results from different troponin assays are not generally comparable. cTnI and cTnT are distinct
molecules and results are not interchangeable or comparable. In addition, significant variations
in absolute troponin values may be observed for a given patient specimen with different
analytical

- 74 -
methods.

BNP Partially clotted samples can result in elevated BNP readings above the reference range, as well as
quality check codes. To prevent this from occurring, upon drawing the whole blood sample into a
EDTA collection tube, the sample should be inverted gently at least 10 times to ensure even
dissolution of the anticoagulant.
Grossly hemolyzed samples can cause a decreased alkaline phosphatase activity, resulting in
decreased detection of BNP, increases assay backgrounds, and/or quality check codes.
Hematocrits in the range of 0-60% PCV have been demonstrated not to affect results. Samples
with hematocrit levels above this range have demonstrated increases in the test imprecision and
quality check codes.
The analyzer must remain on a level surface with the display facing up during testing. A level
surface includes running the handheld on the downloader recharger. Motion of the analyzer during
testing can increase the frequency of suppressed results or quality check codes.
A large proportion of patient specimens contain endogenous antibodies, e.g. heterophile antibodies,
human-acquired anti-animal antibodies and autoantibodies that can in some cases interfere with
immunoassays giving rise to falsely elevated or depressed results – all immunoassays are subject to
such interference. These potential interferents can arise from diagnostic or therapeutic treatments
with antibody-containing agents, but also through less specific contact with animals and animal
materials. The generation of potentially interfering antibodies in response to bacterial infections has
also been reported. (Immunoassay interference by Endogenous Antibodies; Proposed Guideline
I/LAA30-P Vol. 27 No. 9)
The i-STAT BNP assay is specifically designed to minimize the effects of antibody interferences.
Assay
results that are not consistent with other clinical observations should be considered carefully and the
possibility of interference should be recognized.
Measurements of BNP should occur prior to nesiritide (Natrecor) recombinant BNP treatment, or
2 hours post-treatment.
i-STAT BNP cartridges require the use of EDTA whole blood or plasma samples collected in plastic
syringes or evacuated tubes containing EDTA. The use of glass vessels is not recommended because
the BNP molecule has been shown to be unstable in glass tubes.
The use of whole blood or plasma samples containing anticoagulants other than EDTA such as
oxalate
and citrate will cause deactivation of the alkaline phosphatase, resulting in decreased BNP readings.

- 75 -
Performance characteristics have not been established for samples taken from capillary tubes and
direct skin punctures (e.g. finger sticks) so these sample types should not be used with the BNP
cartridge.
When drawn into an evacuated tube containing EDTA, samples should not be used unless the blood
collection tube is manufacturer’s stated volume

TCO2 Exposing the sample to air allows CO2 to escape, which causes TCO2 to be under-estimated.
(Measured) Under-filling blood collection tubes may also cause decreased TCO2 results. The use of partial draw
tubes (evacuated tubes that are adjusted to draw less than the tube volume, e.g. a 5 mL tube with
enough vacuum to draw only 3 mL) is not recommended for use with the i-STAT System because
of the potential for decreased TCO2 values. Bubbling of the sample with a pipette when filling a
cartridge will cause loss of CO2 in the blood.
Allowing blood samples to stand (without exposure to air) before testing allows TCO2 to be
over-estimated, due to metabolic processes.

CK-MB Partially clotted samples can result in elevated CK-MB readings above the reference range, as well as
quality check code errors. To prevent this from occurring, upon drawing the whole blood sample
into
a heparinized collection tube, the sample should be inverted gently at least 10 times to ensure even
distribution of the heparin anticoagulant.
Grossly hemolyzed samples can cause a decreased alkaline phosphatase activity, resulting in
decreased
detection of CK-MB, increased assay backgrounds, and/or quality check codes.
Hematocrits in the range of 0-70% PCV have been demonstrated not to affect results. Samples with
hematocrit levels above this range have demonstrated increases in the test imprecision and quality
check codes.
The analyzer must remain on a level surface with the display facing up during testing. A level surface
includes running the handheld on the downloader recharger. Motion of the analyzer during testing
can increase the frequency of suppressed results or quality check codes.
A large proportion of patient specimens contain endogenous antibodies, e.g. heterophile antibodies,
human-acquired anti-animal antibodies and autoantibodies that can in some cases interfere with
immunoassays giving rise to falsely elevated or depressed results – all immunoassays are subject to
such interference. These potential interferents can arise from diagnostic or therapeutic treatments

- 76 -
with antibody-containing agents, but also through less specific contact with animals and animal
materials. The generation of potentially interfering antibodies in response to bacterial infections
has also been reported. (Immunoassay interference by Endogenous Antibodies; Proposed Guideline
I/LAA30-P Vol. 27 No. 9)
The i-STAT CK-MB assay is specifically designed to minimize the effects of antibody interferences.
Assay results that are not consistent with other clinical observations should be considered carefully
and the possibility of interference should be recognized.
The use of whole blood or plasma samples containing anticoagulants other than heparin such as
EDTA, oxalate, and citrate will cause deactivation of the alkaline phosphatase, resulting in decreased
CK-MB readings. Capillary tubes and direct skin punctures (e.g. finger sticks) should not be
used
with the CK-MB cartridge.
When drawn into an evacuated tube containing heparin, samples should not be used unless the
blood collection tube is filled to manufacturer’s stated volume.
9.0 Unacceptable Precision or Bias
Software
Occasionally a customer may report that a change in results was noted after a software update.
The i-STAT System is standardized to give laboratory equivalent results. Re-standardization is passed on
to customers via software updates twice a year. CLEW includes the coefficients used to calculate results
from raw signals. i-STAT adjusts these coefficients to prevent results from changing over time. If for any
reason a clinically significant change is made, this information will be included in the software update
packet. However, a customer may notice a small change if this change causes the bias between i-STAT
and lab analyzer to exceed their allowable limits. Check with i-STAT Technical Support, who will escalate
the issue to PQA, if a customer claims that a difference in results was observed after a software update.
Performance Verification
It is important that studies to verify manufacturer’s performance claims or to verify that a system
meets the medical needs of the clinicians be performed using trained operators and a proper protocol.
Whenever possible, an i-STAT Implementation Project Manager or the Distributor’s technical
representative should be present at the start of a performance verification to ensure that a proper
protocol and proper procedures are used.
Information required for an investigation

• Name of comparative method

- 77 -
• Copy of protocol and data
9.1 Precision Expectations

Note: See Technical Bulletin Art: 730270-00A for Tri Level Control Information
Abbott Point of Care performance verification protocols recommend testing a minimum of two levels of
control 20 times each over a period of two days. Each handheld should be included in the Precision
study. The mean, standard deviation (SD) and % coefficient of variation (%CV) are calculated.
Results of this study can be compared to the Precision Data listed in CTI sheets when i-STAT or
CHEM8+ Controls are used. Refer to the precision data in the TriControl Technical Bulletin (723270) when
TriControls are used. These data are considered to be "typical." Some customers will do better and some
may do worse. If the customer’s results are lower or equal to those in the CTI sheet, then they can be
considered acceptable. If they are greater, they still may be acceptable. The Chi-square test can be
performed to determine if those results are statistically equivalent to the precision data in the CTI sheets
or TriControl Technical Bulletin. This accomplished by multiplying the SDs in the CTI sheet or TriControl
Technical Bulletin with a Chi-square multiplier that is dependent on the number of controls and replicates
that are tested. If the customer’s SD results are less than or equal to this number, these results can be
considered statistically consistent with those in the CTI sheets or TriControl Technical Bulletin.
Chi-Square Multipliers for use when 2 levels of control are tested
Sample size (n) Multiplier

4 1.77
8 1.51
10 1.45
11 1.43
12 1.41
13 1.39
14 1.38
16 1.35
20 1.31
24 1.29
28 1.26
32 1.25
36 1.23
40 1.22
44 1.21
48 1.20
52 1.19
56 1.19
60 1.18
64 1.17
68 1.17
72 1.16
76 1.16
80 1.16
Note: This table provides multipliers for determination of upper 97.5% Confidence Limit for Simple
Standard Deviation.

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Imprecision tends to increase in all systems toward the high and/or low ends of the measurement range.
This can be due to statistics rather than performance.
Add to 9.2 Factors Affecting Precision table:
Protocol Followed The APOC performance verification protocols should be followed

exactly. Deviations in the number of replicates tested, or using
multiple lots of controls or cartridges can increase imprecision.
Note: The performance characteristics of Eurotrol controls has

not been established. Precision studies using Eurotrol controls may not meet
criteria presented in CTI sheets.
9.2 Factors Affecting Precision
The directions for use found in the i-STAT system manuals must be followed exactly.
Sample Handling PO2 in the i-STAT Level 1 aqueous control is especially susceptible to incorrect
- sample handling with values increasing from a target value of around 77 mmHg
Controls (10.3 kPa) toward the partial pressure of oxygen in room air (approximately 160
mmHg) with exposure to air.
Other manufacturers' controls may have an interfering substance, which increases

the imprecision (decreases the precision).
Blood may not be suitable for precision studies because the analytes may not be
Sample Handling stable for the time period needed to perform the study. Blood gases, pH, lactate,
– Blood ionized calcium and glucose should not be expected to remain stable over the time
needed to test 10 to 20 replicates.
Precision data (Syy) for whole blood can be calculated if duplicate measurements are
performed in the method comparison study.
The cartridges must be out of the refrigerator for the correct amount of time, must
Cartridge be stored correctly over time and must be within the expiration date for both
Handling refrigerated and room temperature storage.

- 79 -
9.3 Accuracy Expectations
Accuracy The expected system difference between the i-STAT System and major laboratory
Expectations systems such as Ortho Vitros, Beckman systems, Roche systems and blood gas
systems from Siemens, Radiometer and Instrument Laboratories (IL) should not be
medically significant based on data collected by i-STAT and its customers. There is
no general consensus for medically allowable differences. Expectations will differ
from hospital to hospital. As a guideline, two different systems should agree within
the following plus or minus range to avoid having to provide clinicians with two
different reference ranges.
Sodium 4 mmol/L
Potassium 0.5 mmol/L
Chloride 6%
Ionized calcium 5% or 0.05 mmol/L
pH 0.04 units
PCO2 8% or 0.67 kPa (5 mmHg)
PO2 10% or 0.67 kPa (5 mmHg)
Glucose 10% or 0.33 mmol/L (6 mg/dL)
Urea 9% or 0.71 mmol/L
BUN 9% or 2.0 mgN/dL
Lactate 12% or 0.6 mmol/L
Creatinine 15% or 26.5 umol/L (0.3mg/dL)
Hematocrit 6%
TCO2 [measured/calc] +/- 3 SD
Note: The College of American Pathologists interprets the 6% criterion

for hematocrit as 6% of the PCV and NOT 6% PCV.
PT/INR: The INR should allow agreement with another system between 0.9-
6.0 PT/INR. Agreement within ± 0.4 is usually acceptable.
ACT: There is no global reference method or standard for the activated

clotting time (ACT) test. The ITC Hemochron instrument is often
considered to be the reference method due to its historic market presence.
The i-STAT1 Analyzer ACT results can be customized to match results from
the traditional Hemochron test tube-based instrument, which performs tests
without a pre-warming cycle. The time to clot is longer without pre-
warming.
(Hemochron is a registered trademark of International Technidyne

Corporation, Edison, NJ, USA.)
cTnI, BNP, and CK-MB: Results from different instruments/methods can be

disparate owing to differences in calibration and assay specificity. While
considerable progress in standardizing cTnI assays has been made,
differences in results from different methods are expected. Correlation
slopes ranging from 0.5 to 1.5 are anticipated between troponin

- 80 -
methods/assays. Though similar considerations apply to CK-MB, correlation
slopes between methods are expected to be closer to 1. In the case of BNP,
there is considerable difference in calibration from one manufacturer to
another to the extent that correlation slopes are quite variable. The table
below summarizes the expected ranges of correlation slopes for correlations
i-STAT and other methods.
Analyte Range of Slope Values**

cTnI 0.5 to 1.5
BNP 0.7 to 2.5
CK-MB 0.8 to 1.3
**Note that while the indicated ranges are anticipated for method
correlation slopes, values for individual samples can vary widely from
one method to another, e.g. though two methods may correlate with a
slope of 1.00, it’s expected that some individual results from such a
correlation may vary by a factor of two or more.
9.4 Calculated Values
Hemoglobin Hemoglobin is estimated by multiplying the hematocrit as a decimal fraction by the

average MCHC (mean corpuscular hemoglobin concentration) of 34. The
hemoglobin value will be inaccurate and should not be used when the MCHC is
outside the reference (normal) range of 32 to 36. When performing a method
comparison, the hematocrit used on the i-STAT system should be compared to the
calculated hematocrit from an automated cell counter or to the measured value
from the spun microhematocrit method.
The comparison of the calculated hemoglobin on the i-STAT System to the

measured hemoglobin on blood gas analyzers should be avoided. This is a
comparison of “apples to oranges”.
Oxygen Calculated oxygen saturation will not be accurate if abnormal hemoglobins such as
Saturation carboxyhemoglobin (smokers and carbon monoxide poisoning) and methemoglobin
(nitric oxide therapy) are elevated, if the pH, PCO2 and temperature are abnormal
and if 2,3-diphosphoglycerate concentration is abnormal. Fetal hemoglobin
(neonates) and glycolysated hemoglobin (diabetics) also affect results.
Anion Gap A difference in the calculated anion gap may be due to the difference in equations:
i-STAT: (Na + K) - (Cl + HCO3)

i-STAT CHEM8: (Na + K)-[Cl+(TCO2-1)]
Alternative: Na - (Cl + HCO3) or Na - (Cl +TCO2)
Base Excess BEecf (extracellular fluid) and BEbld (blood) are calculated differently and will differ in

- 81 -
value in some conditions that affect acid-base balance. When comparing BE results
with another type of analyzer, use the same BE. The cause of discrepant results is
usually a difference in the pH and/or PCO2 and HCO3 results.
HCO3 HCO3 is the most abundant buffer in the blood plasma, is an indicator of buffering
Bicarbonate capacity of blood. Regulated primarily by the kidneys, HCO3 is the metabolic
component of acid-base balance. Causes of primary metabolic acidosis (decrease in
HCO3) are ketoacidosis, lactate acidosis (hypoxia), and diarrhea. Causes of primary
metabolic alkalosis (increase in HCO3) are vomiting and antacid treatment.
TCO2 TCO2 is either measured on plasma by automated chemistry analyzers or is

Total Carbon calculated from pH and PCO2 measured on whole blood gases analyzers. TCO2 is
Dioxide measure of carbon dioxide which exists in several states: CO2 in physical solution or
loosely bound to proteins, HCO3 or CO3 ions, and carbonic acid (H2CO3).
Bicarbonate ions make up all but approximately 2 mmol/L of the total carbon
dioxide of plasma. Measurement of TCO2 as part of an electrolyte profile is useful
chiefly to evaluate HCO3 concentration. TCO2 and HCO3 are useful in the
assessment of acid-base imbalance along with pH and PCO2 and electrolyte
imbalance.
9.5 Factors that affect Accuracy in a Method Comparison
It is important to follow a good protocol when performing a method comparison. Contact APOC Technical
Support to obtain the current recommended protocol(s).
Sample handling The same sample must be tested on both systems in as short a time frame as
possible:
• Immediately for lactate and coagulation tests

• Within 10 minutes for pH, blood gases and iCa
• Within 30 minutes for electrolytes, glucose, urea, creatinine and hematocrit,
troponin, CK-MB and BNP.
• If the comparative system requires plasma, the samples must be tested on the i-
STAT System, spun down immediately and the plasma tested on the
comparative system immediately.
• Hematocrit results will be affected if testing is delayed and the sample is not
well mixed immediately before testing.

- 82 -
9.6 Comparative Methods
Quality Control Before beginning a method comparison, control results on the comparative analyzer
should be reviewed to ensure there is no sign of a drift or shift in control results.
Whenever a significant method bias is discovered, the customer should be asked if
controls on the comparative instrument are reading low or high.
Hematocrit i-STAT analyzers can be customized to agree with the centrifugal microhematocrit
method using samples collected in either K3EDTA or K2EDTA anticoagulant. K2EDTA
results are 4.25% higher than K3EDTA results.
Results from K2EDTA and K3EDTA tubes are equivalent on cell counters. However,
these results will depend on how the cell counter was calibrated. If the manufacturer
of the cell counter calibrates the cell counters that are used to assign values to the
calibrates with samples collected in K3EDTA, hematocrit results on this
manufacturer’s cell counters will be 4.25% lower than results from cell counters
calibrated using K2EDTA samples.
The choice of the K2EDTA or K3EDTA setting on the i-STAT analyzers depends on
how the cell counter is calibrated and not on the EDTA type used to collect samples.
Sometimes customers are unaware that there is a choice of settings and use the
default K3EDTA setting.
i-STAT hematocrit too low: analyzer may be on K3EDTA setting when it should be on
K2EDTA setting.
i-STAT hematocrit too high: analyzer may be on K2EDTA setting when it should be
on K3EDTA setting.
See K2EDTA and K3EDTA Customization for Hematocrit on the i-STAT System
Technical Bulletin, Art: 716240 for more detail.
Ionized Calcium Normalized results should not be compared to results from the i-STAT System.
9.7 Round-off Error Associated with Calculated Values
Calculated values displayed on the analyzer and the corresponding values determined using the
equations provided in the i-STAT Systems Manual may differ due to the rounding-off of displayed analyte
concentrations. Rounding of the displayed value is necessary to properly represent the analyte
concentration to the customer. Therefore, a manual calculation is limited by the resolution of the analyte
concentrations displayed on the analyzer. However, the analyzer uses the full precision of the analyte
concentrations to determine calculated values

- 83 -
The round-off error (difference between the rounded number displayed on the analyzer screen and the
actual number stored in the analyzer memory) associated with each value displayed on the analyzer is
equal to plus or minus half of the displayed resolution of that value. For example, the maximum round-
off error associated with the calculated Anion Gap (AG) [AG (Chem8+) = (Na + K) – (Cl + (TCO2 – 1)] is
determined as follows:
Resolution (mmol/L) Round-off Error (mmol/L)

Na 1 ± 0.5
K 0.1 ± 0.05
Cl 1 ± 0.5
TCO2 1 ± 0.5
AG (calculated) N/A ± 1.55 (sum of error for
displayed values)
10.0 Controls or Calibration Verification Set Out of Range or Shift in Values
10.1 Operator Induced:
Rule out operator before investigating a cartridge or control problem.
Control Type Possible Cause Explanation
i-STAT Controls Wrong control Value Assignment Lot number on insert must match
Sheet for the lot number of control or lot number on ampule or vial.
calibration verification set. Determine if operator error or
shipping problem.
Using wrong ranges for cartridge type. Each Level 1, Level 2 and Level 3
control Value Assignment Sheet
has a separate set of values for:
o G, E3+, EC4+, 6+, EC8+
o G3+, CG4+, EG6+, EG7+,
CG8+, Crea
o CHEM8+ and the Cardiac
Markers each have a separate
control
The Value Assignment Sheet may
also include values for separate
lot numbers of any cartridges
type.
Wrong Value Assignment Sheet(VAS) The CLEW listed at the top of the
for the CLEW in the analyzer. Value Assignment Sheet must
match the CLEW in the analyzer.

- 84 -
o Note: VAS are no longer

included in box. The VAS can
be obtained from the APOC
web site or by contacting
APOC.
Temperature strip windows 3 and/or 4 Determine if there was a shipping

red upon arrival. problem or if the customer did
not refrigerate the cartridges
upon arrival. If there was a
shipping problem, replace the
cartridges and resolve the
shipping problem. If the
customer did not refrigerate the
cartridges upon arrival, the
Distributor can decide whether or
not to replace the shipment.
Cartridges or controls out of date. Use correct dated material.
Not following instructions for use for Oxygen results are most affected
cartridges and/or controls. by not following directions:
Cartridges with a PO2 sensor and
controls to test cartridges with
PO2 must be equilibrated to
room temperate: one hour for a
box of cartridges or 5 minutes for
one cartridge and 4 hours for an
ampule of control. Samples
should not be exposed to air.
Use of a 1 or 3 cc syringe and a
needle with a larger bore (18 or
20 gauge) are recommended.
Best results are obtained when a

plain (non-heparin) capillary tube
is used to transfer sample from
ampule to cartridge. Do not use
disposable transfer pipettes.
Ionized calcium: plain capillary

tubes should be used. The
ionized calcium in balanced
heparin tubes can cause an

- 85 -
increase in iCa results in aqueous

controls.
Coagulation: directions for mixing

not followed.
Troponin & BNP: directions for

storage not followed. Must
remain frozen in non-defrosting
freezer until thawed for use.
Must be used within prescribed
time after thawing.
CK-MB control is a ready-to-use

liquid control requiring no
reconstitution or frozen storage.
Shift in mean value due to cartridge lot As long as the control values are
number change. in the ranges published in the
Value Assignment Sheet, the
cartridges are functioning
properly. Lot-to-lot variation may
cause shifts in the mean values.
The mean value in the Value
Assignment Sheet is the average
mean of all lots.
Customer using own range in place of Was range established using only
insert range. one lot number? If so, the
customer must accumulate data
over several lot numbers before
establishing a mean and SD.
Was the change noticed after a

software update? If so, the mean
may have to be re-established.
Customer using third party statistical As long as control values are in

program to determine linearity of the ranges published in the Value
blood gas parameters. Assignment Sheet, the cartridges
should be considered valid for
patient testing.

- 86 -
The RNA Medical Is customer following instructions

Hematocrit Control is a for use and storage?
quality control material
used for verifying the
performance of hematocrit
sensors in
i-STAT cartridges. The
product is a buffered
aqueous solution
containing electrolytes and
non-conductive
ingredients.
Non-i-STAT controls A cartridge problem cannot be Is the control compatible with the
confirmed until i-STAT controls are i-STAT sensors? See Section 11.1
tested. in this guide.
Is customer following
manufacturer's instructions for
use?
Was range established using only

one lot number of cartridge? If
so, the customer must
accumulate data over several lot
numbers before establishing a
mean and SD.
Was the change noticed after a

software update? If so, the mean
may have to be re-established.
10.2 Control Problem

If the problem is occurring on more than one lot of cartridge and with one level of control only,
then the problem is probably being caused by the control. Have the customer try another box of the level
in question. If the customer does not have a second box, one may have to be shipped. If a new box
corrects the problem, have the questionable box of controls returned for verification of the problem. If
the problem is verified, search the data base for similar problems and, if found, notify APOC Technical
Support. Otherwise, the customer may have stored the controls improperly.

- 87 -
If the customer only has one type and lot of cartridge and one lot of control, the customer could
be sent one box of cartridges and one box of controls to perform a cross check to determine
which component is causing the problem.
Note: record values for all tests, not just those reported to be out of range. Patterns may emerge that
may help determine the cause of the problem.
10.3 Cartridge Problem

If the problem is occurring on only one lot of cartridges - especially if more than one level of
control is reading out-of- range, the problem is probably the cartridge. Have the customer return the
cartridges for investigation. Search the data base for a similar problem and escalate the problem if other
reports have been made. Otherwise, the customer may have stored the cartridges improperly.
Have the customer return the cartridges for investigation.
Note: record values for all tests, not just those reported to be out-of-range.
Note: while split-sample testing can help distinguish between a cartridge and a control problem, the
interpretation of the data depends on a previously well-done performance verification, which clearly
defines the agreement between the i-STAT cartridge(s) and comparative instruments. The customer tests
a patient sample on the i-STAT analyzer and the comparative instrument, which has demonstrated good
control results. If the results from the i-STAT System match the comparative instrument's results, the i-
STAT cartridges are by inference, functioning correctly.
11.0 External Quality Control Failure

11.1 Proficiency Testing Material
Information Required • Name of proficiency testing (external quality control) provider,

including address and phone number if available;
• specific name of survey;
• sample identification number;
• tests sites and results;
• type and lot number of cartridge; and
• software version installed in the analyzer.
Sample types
For blood gas and Samples that are NOT compatible with the i-STAT sensors are:
chemistry cartridges • fluorocarbon-based samples
• samples with fixed cells for hematology instruments
• samples without electrolytes
Samples with known matrix effects:
• Euro-Trol: pH
• RNA: pH

- 88 -
Samples can be sent to i-STAT for evaluation.
For ACT and PT/INR Typically proficiency (external quality control) samples for coagulation
tests are lyophilized and are reconstituted with distilled or deionized
water. For the i-STAT coagulation tests, these samples must be
reconstituted with calcium chloride. Follow proficiency providers
instructions for appropriate concentration needed.
For cTnI
Samples collected in EDTA are not compatible. Fresh frozen plasma or
serum samples should be compatible. However, cartridges are not
calibrated to quantitate cTnI in serum.
Unacceptable Results Interfering substances:

• Interfering substances cause results to be higher or lower
than expected.
Bias due to matrix affect:

• Samples that are not fresh whole blood should be expected to
give different results on different systems that use fresh whole
blood for patient testing.
Results compared to wrong method or instrument group:

• Different methods or instruments can give different results on
proficiency samples due to matrix affects or due to a real bias.
Transcription error
Correct sample used for testing:

o some surveys contain both aqueous and whole blood.

- 89 -
11.2 Third Party Quality Control Material (eg. Eurotrol)
- Verify if the 3rd party quality material has run successfully before
- Verify if the 3rd party quality material runs successfully on other Cartridge types/Lots
- Verify shipment and storage of the cartridges being used
- Verify the cartridge type and lot
- Verify cartridge handling is as per ART 714373-00
- Ship customer NCR of APOC quality material and review proper sample handling
Did the APOC quality material pass within range using the same cartridges?
No Yes
- Verify Shipment of the APOC quality

- Document troubleshooting steps along
material and storage
with lot numbers of APOC quality material
- Verify sample and cartridge handling
sent and that no issue was seen when
- Verify customer is using the correct VAS
using the recommended quality material
- Try the quality material on different cartridge
types or lots that corresponds with the
- Refer customer to 3rd part vendor
material sent or send a new box of cartridges
for further investigation.
Did the different cartridge types, lots, or new cartridges test within range using
the APOC quality material?
No Yes
- Elevate the incident to Product Quality - Elevate the incident to Product Quality
- have both the cartridges and APOC - Have the original cartridges used sent
quality material sent back for investigation in for investigation

- 90 -
12.0 Special Procedures
12.1 Pin conditioning

Ceramic Conditioning Cartridge
In case of contact related errors such as suppressed (***) results for hematocrit and Quality Check
Codes 20, 22, 23, 27, 28, 29, 31, 32, 34, 38, 41, 43, 49, 50, 69, 87, and 126, they may be reduced by
restoring an analyzer with the reusable i-STAT Ceramic Conditioning Cartridge.
Detailed Instructions:
Using an 1. Run an external Electronic Simulator

i-STAT Ceramic If the analyzer is configured with the Internal Electronic Simulator enabled, run an
Conditioning external Electronic Simulator. Running the external Electronic Simulator ensures the
Cartridge (CCC) Internal Simulator cycle will not execute during the restoration cycle, which could lead
to the premature termination of restoration cycle.
2. Run the CCC two times
Initiate the CCC cycle as you would initiate an external Electronic Simulator cycle. The
instrument will identify the CCC as an external Electronic Simulator and display a
Simulator Failure Code (i.e: rRGL) when the cycle is complete. Disregard the code, as
this is expected behavior.
3. Update the CCC Usage Log
Update the CCC Usage Log to keep track of the number of restoration cycles
performed with the current ceramic strip in the CCC. If necessary, replace or rotate
the ceramic strip so the CCC is ready for future use. Refer to sections below for the
CCC Usage Log and maintenance instructions.
4. Return the analyzer to service
Note: For CCC usage logs and maintenance refer to ART 721215.
Alternative Pin Conditioning
In case of contact related errors such as suppressed (***) results for hematocrit and Quality Check Codes
20, 23, 27, 28, 29, 31, 32, 34, 38, 41, 43, 49, 50, 69, 87, and 126 , it may be helpful to perform this pin
conditioning procedure to improve the contact between the analyzer contact pins and the cartridge
contact pads.
Inform user that a reusable ceramic cartridge is available from APOC for pin conditioning. The directions
for use can be found in ART 721215. The procedure below is to be performed only if the ceramic cartridge
is not available.
1. Remind user of instruction in i-STAT Manual -- “Whenever handling the analyzer,

cartridges, and peripherals exercise universal precautions to protect yourself from
blood-borne pathogens.”
2. Take a new cartridge and lightly scratch the surface of the contact pads.
3. Run the cartridge and let the analyzer run through the cycle. Ignore any error codes.
Repeat this step 5 times.

- 91 -
4. Test a fresh cartridge filled with control fluid. If codes continue, the analyzer must be
replaced.
12.2 Cleaning the Thermal Probes
Codes 79-81 can be caused by dirt on the thermal probes, although most often these codes are
due to bent or broken probes. To clean the probes:
1. Remind user of instruction in i-STAT Manual -- “Whenever handling the analyzer,

cartridges, and peripherals exercise universal precautions to protect yourself from blood-
borne pathogens.”
2. Obtain a new thermal cartridge.
3. Looking at the underside of the cartridge locate the two depressions (half circles   )
under the sensors.
4. Drop alcohol into the depressions, then shake off the excess alcohol.
5. Run the cartridge like a test. Ignore error codes, if any.
6. Repeat previous steps using another new cartridge.
7. Run a new thermal cartridge filled with blood or a control fluid. If codes continue, the
analyzer must be replaced.
12.3 Flip Latch Procedure
In case of cartridge or simulator not locking into place, perform the flip latch procedure.
1. Inspect the condition of the simulator as shown in the pictures below.

2. Send customer a Flip Latch tool if they don’t already have one.
3. Insert the Latch Return Tool into the cartridge port of the handheld with the arrow
facing up and in the direction of the port.
4. Push the tool into the cartridge port until it stops and a click is heard and then
remove by pulling it from the handheld.
5. Insert a cartridge to assure it locks.
6. Run a simulator twice to rule out the simulator as cause of the issue.
Broken simulator-will cause a flip latch issue

- 92 -
Worn simulator bracket which will eventually break causing the flip latch issue. This will not
cause a flip latch issue.
12.4 Copying ISD files from a Central Data Station to a diskette
i-STAT Diagnostic (ISD) files are generated when the DIS - * keys are used to transmit a current
test record from a series 200 analyzer or on the 300 series analyzer the Transmit Data, Most
Recent options to the Central Data Station. These files contain valuable information used in
assessing causes of star outs and some quality check codes.
Procedure for CDS Version 5

1. With the handheld out of the downloader, power it on and navigate to the Administration
Menu
2. Select 6 – Transmit Data
3. With the Transmit Data screen showing, place the analyzer in the downloader
4. Select 1 – Most Recent
5. This sends all 8 files. The last 8 files are always available regardless of whether the analyzer
has been downloader or not. NOTE: with the i-STAT 1, ISD files are only generated when the
user transmits by going into the menu and selecting 6 –Transmit Data, then 1 – Most Recent.
6. Click on My Computer
7. Click on C:
8. Click on istat32
9. Click on ISD
10. Highlight the files to be copied
11. Click on Send to under File
12. Click on Mail Recipient
13. Send to “[email protected]”
Procedure for CDS Version 4

1. Click on My Computer
2. Click on C:
3. Click on istatcds
4. Click on ISD
5. Highlight the files to be copied
6. Click on Send to under File
7. Click on Mail Recipient
8. Send to ‘[email protected]

- 93 -
13.0 Printers
13.1 HP Printer to be used with the 200 series analyzer
1) Customer complaining that the printer is not operating properly, faint characters or missing
characters.
If you suspect that the printer is not operating properly, run the self-test. If the printer fails the self-test,
put in fresh batteries, rerun the test to verify the results. If the printer fails again, it requires service.
To perform the self-test, disconnect the AC adapter, then turn off the printer, hold down the paper feed
key while turning the printer on, then release the paper feed key. You should see a list of characters
including numbers, letters and symbols. The battery voltage will appear at the end of the self-test.
Readings of 0,1 are low and should be changed. A high battery reading is 5.
2) Customer complaining of frequent change of batteries.

Battery life for alkaline batteries is approximately 6000 print lines of continuous printing. To prolong
battery life,
• set print contrast to lightest comfortable setting
• turn the printer off when it is not in use
• use the optional AC adapter
You should install fresh batteries when any of the following conditions occur:
• the print contrast is uncomfortably low, even when the print contrast controls is set to the highest
contrast
• printing slows because the print head moves across the paper at a much slower speed
• printing halts before all information on a line has been printed
• the battery condition index printed at the end of the self test is 1 or 0
Printer requires 4 1.5 V alkaline AA batteries.
3) Customer complains that printer stopped in the middle of a test result.

If you turn the printer off while it is printing, the print head may stop in the middle of the line. To return
the print head to the left side of the paper, turn the printer on, then off. Leaving the print head in the
middle of a line causes temporary lightening of characters in that column; continued printing restores the
print contrast in that position.
4) Customer complains incorrect character was printed.

A character was received incorrectly. The  character is printed if the printer detects incorrect data due to
interference with or interruption of the stream of incoming information. Common causes for incorrect
data are improper positioning of the printer, obstruction of the infrared beam, or interference from
another infrared source. The  character is printed if information is lost because the printer cannot print
fast enough to keep up with incoming data.
5) Customer claims the paper is not feeding properly.

Make sure the paper is positioned properly.
1) tear or cut paper evenly; do not use paper with folds or uneven edges. Position paper in door (paper
facing up close to the print head. While pushing the paper into the slot, hold down the paper feed key
until the paper emerges. Close the door.

- 94 -
Do not use the AC adapter without the batteries installed, because the printer may require supplemental
battery power during heavy printing. Use only HP F1011A AC/DC adapter.
13.2 Martel printer MCP8850B, for 200 series analyzer
1) The Status indicator will flash three times repeatedly to show that the batteries are nearly exhausted. If
the printer is not operating properly, printing faint characters or missing characters, run the self-test. If
the printer fails the self-test, put in fresh batteries and rerun the self-test to verify the results. If the
printer fails again, it requires service. To perform the self-test: disconnect the AC adapter. With the
printer off, press and hold the Mode button for approximately 2 seconds, then release the button. To
prolong battery life, use the optional AC adapter when possible. Because the printer may require
supplemental power during heavy printing, batteries should be installed when using the AC adapter.
2) The Status indicator will flash repeatedly to denote that the paper has run out. Use the Mode button
to feed through the last few centimeters of paper and fit a new roll. Do not operate printer without
paper.
13.3 Martel printer, for 300 series analyzer
The Martel thermal portable printer can receive data directly from the analyzer via IR transmission or
through a data cable connected to a downloader.
1) Printer is not printing

Before putting the printer into use, the printer should be turned off and plugged into power and
allowed to charge for 9 to 16 hours.
*If SN is below 240223657, must charge for 16 hours.
*If SN is above 240223657, must charge for 9 hours.
2) Status Light
a. Solid LED light
The battery needs to be recharged for all printer serial numbers when the Status LED lights
continuously (solid) during printing. If the battery becomes exhausted, printing will become faint, erratic,
paper will not advance or will no longer print at all. Should this happen, turn the printer off and leave
plugged into power to recharge for 1 hour before attempting to print again.
If recharging the battery does not or temporarily resolves printing issues, and all listed troubleshooting
has been exhausted, expect the battery to be the root cause of the experienced issues and it is necessary
to replace the rechargeable battery, which is acquired via APOC, in order to resolve the printing issue. If
however, the Martel printer does not have an accessible battery door in order to replace the Martel
rechargeable battery pack, the Martel printer must be replaced.
b. Flashing LED light

The status light will flash to indicate that the paper has run out. To replace the paper, open the
paper lid by squeezing the lid and remove any remaining paper by pressing the paper feed
button. DO NOT pull paper through the printer mechanism. Reel off a few centimeters from
a new roll of paper and check that the end has a clean straight edge. Slide the leading edge of
the paper through the paper entry slot, with the leading edge of the paper feeding forwards

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from the bottom of the roll, until resistance is felt. Press the paper feed button and feed the
paper through the printer mechanism. Keep the paper feed button depressed until enough
paper is fed through the mechanism to pass through the paper exit slot. Position the new paper
roll in the paper cup and close the lid.
3) Printer not printing directly from the analyzer.

• To print directly from the analyzer, point the analyzer’s infrared communication window at the
printer’s IR LED window on its left side, ensure that the results to be printed are displayed, and
press the print key on the analyzer. The printer must be within 1 to 5 inches (2.5 to 12.7 cm) of
the analyzer and must not be too close to the analyzer. Do not move the analyzer or printer until
printing is complete.
• Clean the IR window of printer and analyzer with a soft dry cloth.
13.4 i-STAT Printer for 300 Series Handheld
Printer is not printing. The POWER indicator light is green and the STATUS indicator light is green.
• Check that the results are displayed on the handheld, or that results have been selected from List
under Data Review.
• If printing directly from the handheld, check that the distance between the analyzer and printer is
between 1 – 5 inches.
• Perform printer self test to ensure that printer is functioning. Turn the printer off. While pressing
the Paper Feed button, press down on the Power button until the printout begins, and then let go
of both buttons. Ensure that the resulting printout is clear and complete.
• If printing from a downloader, reposition the printer or shield the IR window to prevent direct
line-of-sight between a fluorescent light if present and the IR window.
Printer is not printing. The POWER indicator light is red/orange or does not illuminate when printer is
turned on.
• Recharge the battery for 3 hours.
Symptoms Indicating that the Rechargeable Battery Requires Replacement:

1. A steady Orange or Red POWER indicator light on the printer, even after charging it for the
recommended 3 hours.
2. Loss of battery capacity, indicated by a shorter interval between charges.
If recharging the battery does not or temporarily resolves printing issues, and all listed troubleshooting
has been exhausted, expect the battery to be the root cause of the experienced issues and it is necessary
to replace the rechargeable battery, which is acquired via APOC, in order to resolve the printing issue
CAUTION:
i-STAT printers in the 110XXXX serial number series that are unplugged from the AC adapter and
turned off may experience battery drain that can leave the battery unable to be charged.
To verify the i-STAT printer rechargeable battery is able to be charged, perform a self test while
the printer is plugged in and the last line of the self test printout with either read “Charging
Enabled” or “Charging Disabled”. If Charging Disabled is shown, replace the customer’s i-STAT
printer rechargeable battery pack.

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To avoid these rechargeable battery issues from happening:
1. Charge the battery within 2 days after the low battery indicator illuminates
2. DO NOT place the printer into storage with the battery installed
Printer is not printing and STATUS indicator is red.

• Print head temperature is out of range. Printing will be inhibited until print head temperature
returns to normal level.
Printer is not printing and STATUS indicator is orange.

• Printer is out of paper.
Printer is feeding paper, but nothing is printed.

• Check that the paper is feeding from under the roll.
14.0 Docking Stations
14.1 IR Link
The IR receiver in the IR Link converts the infrared signals from the handheld analyzer to electrical signals
which are transmitted to the Central Data Station via a gray cable. The cradle ensures the proper
alignment during data transmission. The status light indicates when the computer is ready to receive a
transmission (green), not ready (red), and when transmission is in progress (blinking). The receiver
indicates when a transmission was successful with a single high pitched beep or not successful with three
low tone pitched beeps.
1) Is the IR link green, red or no light?
• If the light is green, try to resend the data. The IR link is ready to accept the data.
• If the light is red and is at a remote site (not directly attached to the CDS) then reboot the
system, the IR link could have lost its connection. To reboot the system, close all programs,
turn off the 8/16 port terminal server and turn off the CDS computer. (make sure you follow
directions for proper shut-down procedure of the CDS computer; do not just turn off the
power supply, as this will cause a start-up error). Wait 10 seconds, then turn on the 8/16 port
terminal server and then turn on the CDS computer.
• If the light is red, try another port on the CDS.
• If the light is still red, troubleshoot the MSS1 or CoBox.
• If the light is red and the IR link is connected directly to the CDS, change the IR link and cable.
Try another port on the CDS.
• If the IR Link still has no light, try another IR link, cable and power adapter then reboot the
system.

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14.2 i-STAT 1 Downloader
14.2.1 No longer charges the i-STAT rechargeable battery pack or charge indicator light is
continuously blinking red (Models DRS, DRN, DRC)
• Verify that the handheld is using a i-STAT rechargeable battery pack. If not, explain to customer
that the downloader is only able to recharge the i-STAT rechargeable battery pack.
• Verify that all downloader charging pins are present and in tact. If not repair downloader
• Verify that all handheld charging contacts are present and in tact. If not repair handheld
• Verify that the downloader is connected using all supplied cables that are functioning as
intended. If not connect the downloader using supplied cables.
• If the above troubleshooting does not resolve the charging issues the downloader must be
repaired.
14.2.2 Downloader no longer transmits data (Models: DRS/DS, DRN/DN, and DRC)
• Computer hung up
• Faulty Downloader power cord and or power adapter
• Incorrect programming of Downloader
• Hospital firewall
• CDS server operating system active if using Windows XP
• Cable out of the wall data jack
• CDS switched off [no downloaders will function]
• Part or all of Network is down [all or certain downloaders will not function]
• Downloader no longer recognizes a handheld is in proximity to transmit.
1. Is this a new i-STAT 1 installation?

a. Is the computer dedicated to the CDS program or are other programs running?
i. May be a conflict. Delete other programs.
b. Is the correct type of Downloader being used?
i. Serial Downloader: The label on base displays Serial Downloader and the serial
number begins with DS or DRS. It is recommended that a serial Downloader be
connected directly to the computer using a COM port not allocated to another
application or to USB with a serial converter.
ii. Network Downloader: The label on the base displays Network Downloader and
the serial number begins with DN or DRN. A Network Downloader must be
connected to an active Ethernet connection. This is the responsibility of the
hospital network IT department.
c. Is the CDS configured correctly for the Downloader? Check CDS setup at wcds32 config.
i. Serial Downloader
1. Serial Ports Tab: If computer has only one COM port available, it must be
configured for either the Series 200 or the Series 300
2. “Enable serial communications” must be checked.
ii. Network Downloader
1. Network Port Tab: Is the default IP address viable at this site? Is the TCP
port [default 6004] blocked by the hospital firewall?
2. “Enable network communications” must be checked.

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3. Is it possible to ping/telnet to the Network Downloader’s ip address?
• Go to Start, Run and in the run line enter CMD. This will open the
command.exe window.
• Ensure that you are at the root letter drive:

if your see the following: H:\>Documents and Settings - type in:
"cd H:\" this will let you get to the root letter drive.
• PING : type in "ping 192.168.47.77", hit enter,

If it replies then perform tracert
• TRACERT: type "tracert 192.168.47.77", hit enter, if the

downloader has an IP address that is static, it will display a final reply
with that same IP address. If the final reply is a hostname instead of
the IP address, verify that the hostname is not for another device on
the network such as a printer or a computer. If it is, that is why it
pings but also why the downloader doesn’t download. If the IP
address is displayed, then perform TELNET.
• TELNET : type in "telnet 192.168.47.77 9999", hit enter, if you see

a Lantronix message and directions to hit enter, hit enter - this will
open up the device configuration. If telnet is not availible, proceeed
to WEB BROWSER step.
In the top area you will see the server configuration (IP address of
the downloader, subnet and gateway address of the network jack it
will be plugged into) The channel 2 configuration is the settings for
communication to your i-STAT data management system (the remote
IP address should match the IP address for your data management
system).
If the settings are incorrect or have appeared to go back to default,
reconfigure the downloader by selecting 0:Server Configuration and
enter in the IP address for the downloader and gateway and subnet
for the network jack it will be connected to. Or/And slect 2 for
channel configuration and enter correct settings.
If the settings are correct, replace.
• WEB BROWSER : Close the command.exe window and open the

web-browser window. In the address line enter HTTP:// followed by
the IP address, hit enter. A lantronix server window displaying the
configuration page will display. If it does not display, perform
hyperterminal.
reconfigure the downloader by selecting 0:Server Configuration and
enter in the IP address for the downloader and gateway and subnet
for the network jack it will be connected to. Or/And select 2 for
channel configuration and enter correct settings.
If the settings are correct, replace.

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• HYPERTERMINAL : Obtain the DN or DRN from its location and
connect to it directly using hyperterminal with the DB9 to DB9 cable.
Verify the configuration settings.
reconfigure the downlaoder by selecting 0:Server Configuration and
enter in the ip address for the downlaoder and gateway and subnet
for the network jack it will be connected to. Or/And slect 1 or 2 for
channel configuration and enter in correct settings. If the settings are
correct, replace.
4. Is it possible to ping/telnet to the IP address of the CDS?

5. Has the correct Ethernet cable been connected between the Network
Downloader and the network data jack? Abbott Point of Care does not
supply this cable.
6. Check the light configuration:
Initial power up (Boot Process)
1. Yellow (Data Activity) Will blink 1 time and stay on
2. Red (Boot) Will blink 8 times and go off (about 5 seconds)
3. Green (Link) Will blink 1 time and stay on
4. Green (Power) Will blink 1 time and stay on
During operation:
1. Yellow (Data Activity) On –Note Will blink when activity is occurring
2. Red (Boot) Off
3. Green (Link) On
4. Green (Power) On
d. Is an IP address programmed into the network Downloader?

i. See Downloader Programming section in the i-STAT 1 System Manual. Must
configure channel 0 for the server and channel 2 for the computer under Change
Setup.
2. Is the green light on the Downloader lit or red/green light on Rechargeable Downloader? If yes,
see 3 below. If no:
a. Check that the Downloader power adapter is plugged into a power outlet and into the
Downloader.
b. If the Downloader is plugged in, there may be a fault in the power adapter and/or cord.
i. If another Downloader with power adapter and cord is available, replace the
suspect Downloader’s adapter and cord with the other adapter and cord. If the
Downloader works with the other adapter and cord, ask the customer to
determine if the adaptor or cord is faulty and replace the faulty part. If the
suspect Downloader does not function with the other adaptor and cord, replace
the Downloader.
ii. If no other adaptor and cord are available, complete the troubleshooting
procedure to eliminate all other possible causes before replacing the
Downloader, adaptor and cord.

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3. Does the red light come on when the analyzer is placed between the arms of the Downloader, or
blue light for the Downloader/Recharger? Does the handheld turn on when placed into the
downloader? If yes, proceed to 4. If no:
a. Reposition the analyzer in the Downloader until the red or blue light comes on.
b. Try another handheld and downloader.
i. If handheld won’t turn on and battery has been ruled out, repair handheld.
ii. If downloader proximity light won’t illuminate when handheld is docked and
cable connections have been ruled out, repair downloader.
4. Do the arrows on the analyzer display circle when the analyzer is placed in the Downloader? If
yes, see 5 below. If no:
a. Has a new software program been loaded recently?
i. May be a conflict. Delete other program.
b. Check connection to CDS:
i. Is network cable connected to the Downloader and the wall?
ii. A power surge may have caused the CDS program to hang-up.
1. Exit the CDS program.
2. Reboot the computer.
iii. If it’s a Network Downloader, ask the IT department to ping and telnet to the IP
address (Model DRC’s configuration is not able to be viewed using telnet.
See DRC section for additional information). Sometimes the IT department
changes an IP address without informing everyone involved. If the IP address has
been changed by IT, it must be changed in the Downloader and Location
Workspace on the CDS.
c. Check that Autotransmit has not been disabled.
i. If Customization is enabled, check on the CDS: Click Administration, click
Customization, enter password, double click Preferences, look on Instrument tab
for the Autotransmit selection.
ii. If Customization is not enabled on the CDS, check Customization on the analyzer.
d. Check that the analyzer battery power is not low.
5. Check for operator errors:

a. Does the operator click the Refresh button on the CDS to see newly transmitted results?
b. Is the Date Range for the Data Viewer correct?
i. In the Results Viewer, or Data Viewer where results are not appearing, click on the
arrow beside the Customize button on the tool bar. Then click on Date Range.
Enter a range of dates that will include the missing data.
c. Is the CDS software current? The CDS and analyzer software must be compatible.
Incompatible software may prevent some or all data from being transmitted from the
analyzer to the CDS.
i. While in the CDS application, click on Help  About to view the current software
version.
ii. Note that as of the date for this version of the Troubleshooting Guide, all CDS
Version 5 and analyzer software versions are compatible. However, this may not
be true in the future.
d. Check that nothing has been changed in wcds32 config (see 1 above).

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e. Is the date in the analyzer correct? Transmission may be successful, but the data is listed
in chronological order and may be buried in earlier data.
f. Is the low battery message displayed on the analyzer? If yes, change batteries.
6. After confirming that none of the above resolves the problem, try this one last step:
a. Restore Factory Default settings on the Analyzer using the keypad.
b. Try to Download. If successful, re-customize the analyzer with the customer’s settings.
Run a cartridge or a simulator. Download again. Depending on the test just performed,
check for transmission in the Patient, Control or Simulator Data Viewer.
7. As a last resort, it may be necessary to reinstall the CDS software. Before reinstalling, certain files
can be copied and e-mailed to i-STAT Technical Support to identify and possibly fix the problem
without reinstalling the software.
a. Go to My Computer, C drive, istat32\Bin. Click on View Details. Locate and copy
istat32.log and istat32.db
b. E-mail files to: [email protected]
8. Reinstallation of the CDS software

a. Copy the database
i. Click on Administration, Database Maintenance, Backup Database File. Specify
Directory.
b. Remove i-STAT Central Data Station program. (Do not remove i-STAT Central Data
Station License Pack or i-STAT CDS Interface.)
i. Click Start, Settings, Control Panel, Add and Remove Programs.
c. Insert CDS CD into drive and allow program to reinstall.
d. Restore database.
9. Customization will not transmit to the handhelds

a. Cause: CDS version update was performed prior to updating the handhelds to the newly
released CLEW/JAMS
b. Correct by updating the handhelds to the newly released CLEW/JAMS
If transmission issues are persistent when troubleshooting on only specific downloaders, the downloaders
must be repaired.
14.2.3 DRC-300 Downloader Recharger Combination
1. Unable to Enter into the i-STAT Log in Screen to Configure Network Settings
o Confirm that user has administrative rights to the computer they are using
o Confirm PC is connected to DRC using a standard network cable. The PC should be
disconnected from the network.
o Confirm PC network configuration is set correctly
o Confirm proxy settings are disabled
o Confirm that power has been applied to DRC in the correct sequence
o Reset DRC back to factory settings
o Confirm correct data manager port number is in use
o Confirm data manager IP address is entered before DRC network settings.

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2. Unable to Configure Serial USB Connectivity
o Confirm that user has administrative rights to the computer they are using
o Confirm both drivers have been installed successfully
3. Data No Longer Transmits

• Verify downloader and data manager IP addresses, subnet mask, and Gateway are correct.
i. Once the DRC has been configured and connected to the facility’s network, you
can view the DRC’s configuration page by using Internet Explorer and navigating
to the DRC’s configured IP Address using any computer on the same node of the
network.
• DRC-300 firmware less than 1.03 may cause intermittent transmission interruptions. Set
number of connections in data management to 256 (see figure 1). See illustration under
step 9.1 of DRC-300 Technical Bulletin, Art: 728690 of where the firmware is displayed.
• Serial numbers DRC-55140 and above will have firmware 1.03 which will not be affected
by the number of simultaneous network connections.
• If the customer has the older firmware 1.02 and troubleshooting has not resolved the
intermittent transmission issues, have the downloader replaced with a downloader
containing the updated firmware
• If the customer has the updated firmware 1.03 and troubleshooting has not resolved the
intermittent transmission issues, have the downloader sent in for investigation (level 2)
and replace the downloader
• See 14.2.2 for additional troubleshooting steps.
Figure 1. Instructions on how to update the data manager connections to 256

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15.0 Central Data Station Version 5
15.1 Introduction:
This document is intended to provide assistance / direction for resolving common problems encountered
with the CDS software (version 5.x only). For example, instrument transmission failures (not related to
downloader configuration) are discussed as well as conditions that prevent CDS from running, cause it to
run slowly or crash are discussed. Although some discussion of database maintenance (Archiving and DB
backup) is included, it is assumed that the user is knowledgeable of the use of CDS. Other than the basic
requirement for a stand alone PC workstation and a validated Windows operating system, hardware
problems are not discussed.
1. Description Central Data Station (CDS):

The Central Data Station software (Data Manager) is used for capturing, displaying and exporting i-STAT
data only. It is designed to run on a standalone data manager for i-STAT data only.
2. CDS Requirements (Hardware and Operating Environment):

The following requirements are non negotiable. Refer to the i-STAT Technical Bulletin (i-STAT Central
Data station Workstation Requirements) for details.
 Hardware - Standalone PC workstation or Server
 Windows Operating System – CDS validation studies have been performed on the below
listed windows operating systems. Other operating systems cannot be supported.
 Rack or Tower Server - Windows Server 2000
 Standalone Workstation - Win 2000
 Standalone Workstation - Win XP Pro (32 bit only)
 Serial Ports – PC Workstations should have at least two serial ports for connecting a serial
downloader and ASTM interface. USB to serial converters can be used but are problematic.
The use of a Rack or Tower Server may preclude the use of serial devices due to their remote
location.
 Central Data Station software - Most recent version
3. Understand the Situation Prior to Troubleshooting:

Prior to attempting to resolve the problem, it is prudent to ask some probing questions and scan
some CDS software folders for clues. The following are presented in the chronological order to be
followed.
 Verify Hardware being used:

1. What is the CDS loaded on (stand alone PC workstation or a server)?
2. What Windows operating system is loaded on the workstation?
3. Are you using Serial / Network Downloaders?
4. Does the workstation have serial ports or are USB converters used?

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 Verify Supported Operating System:
1. What Win Operating System is on CDS workstation (Win 2000 or XP)?
2. Windows Server 2000 is the only acceptable / validated server OS.
 Verify that CDS is the only data manager software running on the PC:
1. Is there any other software running on this PC that is receiving transmissions (Serial
or Network) form another device / analyzer.
 What is the Situation:

1. What’s not working?
2. Is this a new startup or has the CDS been in use for some time?
3. What version of CDS are you running (5.24, 5.25 etc.)?
4. How long has this been working without a problem?
5. Can you pin point the time and date it stopped working?
6. Was anything changed, added or deleted on or around that date?
 Preferences
 Operator Workspace
 Instrument and Location Workspace
 Customization Workspace
 LIS Interface
4. Known Problems that will interfere with / disable CDS
1. CDS loaded on unsupported windows operating system – Some of our customers are
running CDS on servers and standalone workstations with non-validated 32 bit operating
systems. CDS will not run on 64 bit operating systems. Although the application seems to
work on some 32 bit systems, it cannot be supported when problems arise. The only
resolution that we can suggest is to move CDS to a supported operating system.
2. Data Repeater - This a software product supplied by Abbott Diabetes (ADC) that will allow a
networked standalone PC to connect with a serial downloader. This software interferes with
serial port assignments and cannot be installed on CDS if CDS is going to connect with a
serial downloader.
3. Other Data Management Systems - Any other data management system used for glucose
or other POC testing can potentially disrupt serial and network transmissions. The only
resolution that we can suggest is to move CDS to a standalone workstation.
4. Remote Desktop Protocol - Customer using RDP to connect to CDS can interfere with serial
ports resulting in sporadic failure of serial downloader. The use of a console RDP session
may resolve this problem.

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5. CDS Database has to many test records in database - Once the database size gets to
about 250 mgb (about 125,000 test records – 2K / record), the following manifestations can
occur. See Appendix A for procedure on replacing CDS database.
 Users will notice a slow down in response when the try to execute a search, trend
or switch views.
 Analyzer transmissions from Serial and Network Downloader’s will be slow,

sporadically fail or fail completely.
 The external LIS Interfaces will have sporadic transmission failures that will
progress to complete global failure of all transmissions (inbound to the CDS and
outbound to the LIS).
 There will be a large number of zero byte files (sometimes thousands) in the
Download and Exceptions folders.
 Test records that can be displayed on the analyzer (patient / quality) are not in
the CDS. Downloaders are working but analyzers report “No Unsent records”.
 Refer to 15.2 for direction on replacing CDS Database that has too many test
records. Additionally, refer to 15.2 information on how to Prevent CDS Database
from accumulating too many test records.
6. Interference by running anti-virus software (Symantec) – When the software runs it

has the potential to shut down CDS. Refer customer to their IT department to verify anti-
virus to CDS compatibility.
5. Typical Situations and Possible Resolutions:
• Interface Failure (No transmission from Analyzers to CDS and CDS to LIS):
Observations:
 Transmissions from the analyzer to the CDS and from the CDS to the LIS will be
slow, sporadic or stopped.
 An interface error message (723 Data Stream not Connected) may be displayed on
the CDS screen if LIS interface I sprovided by APOC.
 The local drive folders istat32\download and istat32\download\exceptions have

numerous temp files (could be thousands of zero byte files).
Possible Cause:
1. The most likely cause is a network outage. It is prudent to verify that the network
is operational from the port that the CDS is connected to. Verify by connecting to
the internet and by pinging CDS from another location.

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2. Scanning software employed by information technology or malicious software can
scan / ping the port (6004) at a high rate (every few milliseconds). This prevents
the CDS software from reading the binary transmission from the analyzer and
writing the test results to the database before being interrupted by another scan
on port 6004. This causes temp files to be generated at a tremendous rate.
However, since the transmission did reach the CDS, the analyzer may report “No
Unsent Records”.
Possible Resolution:
Work with IT to find and eliminate cause for scanning port 6004. Delete all files in the
download and exceptions folders. Turn off Autosend (interface tab in CDS configuration and
set an appropriate limit on the number of days for transmit-all. Do a transmit-all from each
analyzer (use the analyzer menu, access #6 Transmit Data / all). Examine all new test records
and manually send to LIS if necessary.
• Test records (Patient / Quality) in Analyzer not displayed in the CDS:
Observations:
1. Some test records in the analyzer are not displayed in the CDS after downloading
and clicking refresh.
2. Downloaders appear to be working as other test records are getting to the CDS.
3. Analyzers indicate “No Unsent Results”
4. An interface error message (723 Data Stream not Connected) may be displayed on
the CDS screen if an APOC LIS interface is installed.
5. The local drive folders istat32\download and istat32\download\exceptions have

some temp files.
Possible Cause:
The presents of log files (and their associated binary test record files) in the exceptions
directory indicates that there were test records (Quality / Patient – can’t tell by looking at the
log files) that were successfully transmitted to the CDS but could not be entered into the
database because the process was blocked by some network service (Anti Virus / Firewall
etc.) When this happens, the analyzers report that there are no unsent results because the
transmission is actually in the CDS.
Possible Resolution:
The binary test record files could be moved to download directory and when the CDS is
restarted it would process them. However this is too risky. It could result in duplicate entries
for the same patient (cartridge and run time) in the CDS and duplicate entries in the LIS
entries. Thus, the log and binary files should be deleted.

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Lost test records can be recovered by following:
1. DOC the analyzers so that all / any unsent records are sent.
2. Turn off the Autosend (LIS interface)
3. Use the analyzer utility menu to do a send all
4. Look for results that were missing (they will now be displayed)
5. Review test records (time period of potentially missing records) for any Patient
records that were not sent to the LIS and manually send if necessary.
6. Turn LIS interface Autosend back on
7. Resume normal operation
• CDS fails to connect with the database (istat32.db):
The following series of error messages are displayed (in order presented) when the CDS
cannot connect with the database:
Reason for failure: The following can cause the database connection failure:
1. Inadequate Security / Permissions – In cases where individual logins are used

(users have their own usernames and passwords), they may not have adequate
permissions to run the CDS application. Individual users must have Permissions set
to Full Control. The following shows the Security Properties of the ISTAT32 folder.
Note that all permissions must be checked except for check for last box (special
permissions).

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- 109 -
2. ODBC connection missing/changed:
If the System Data Source was deleted or its configuration changed the CDS
application will not be able to connect with the database. The following pictures
depict the ODBC data source configuration.
System Data Source Name – i-STAT CDS Ver. 5x
Configuration – i-STAT CDS Ver. 5x

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Advanced Configuration – i-STAT CDS Ver. 5x
15.2 Replacing CDS Database that has too many test records:
 Replacing existing CDS Database with empty database:
1. The CDS utility for compacting the database (Istat32.db) to located in Database
Maintenance Workspace (Database File Tab). Compacting a database that is already
to large is not a viable option. It would take a several days to accomplish. It’s
recommended for high volume sites to archive data monthly and for low volume sites
every six months.
2. Replacing existing database with an empty database:
Use the following procedure to replace a database that is still usable.
a. Copy database to another location for safe keeping.

b. Run CDS and open Database Maintenance workspace.
c. Starting with the oldest records, archive (don’t delete) all test records in 6
month chunks.
d. Open customization workspace and backup preferences and STATNotes.
e. Install new empty database.
f. Open Database Maintenance Workspace and restore the last 6 months data.
g. Open the Customization Workspace and restore Preferences and STATNotes.
h. Test Downloaders and external interface to LIS.
i. Customer will have to manually enter Operators and Inventory information.

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• Preventing CDS Database from accumulating too many test records:
 Backing up database and Archiving data
1. Setting Auto Backup via WCDS32 config: This utility backs up the entire database files
(Istat32.db and Istat32.log) to a specified location and time on local or network drive.
Availability of Network drives is dependent on the user’s login privileges and IT
policies.
2. Database Maintenance Workspace (Archive Test Results): This utility backs up test
records into the below listed text files (local or network drive). Options are available to
Backup only, Backup and Delete and Delete only. Options are also available to delete
details only or delete details and demographics.
A.AV – Result values

A.CD – Chart Page / STATNotes values
A.ED – Extra data
A.TR – Demographics data
A.PR – Preference data
3. Database Maintenance Workspace (Database File): This utility backs up the entire
database files (Istat32.db and Istat32.log) to a specified location (now when the button
is clicked) on the local or network drive. Availability of Network drives is dependent on
the user’s login privileges.
• Moving CDS to New PC
1. Copy istat32log and istat32db

o Close CDS
o Go to C drive
o Istat32 folder
o Bin folder
2. Install CDS database Setup CD
3. Install CDS Version 5.XX CD (must be the same as what was used in the old PC or old
PC must have been updated with the version being used)
4. Obtain license key when prompted to complete installation
5. Install latest CLEW/JAMS software
6. Enable serial/network communications in CDS Customization
7. Connect interface if applicable
15.3 CDS Customization
15.3.1 Changing Analyzer Customization
Unable to enable an analyte at the handheld that has customization from a data management
program
When an analyte is disabled in “Apply By Panel” that analyte cannot be enabled at the handheld
unless the analyzer is set to factory settings first.

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15.3.2 STATNotes
 Note - STATNotes must be purchased and should not be enabled unless customer
has proof of purchase. This can be verified by customer service. The product number is
06F24-07.
• Enabling STATNotes on CDS
If the STATNotes option is grayed out do the following:
1. Close CDS and run WCDS32 configfull

2. Click on the Options tab
3. Select “Allow STATNotes Page Management”
4. Click Accept
5. Access customization workspace
6. Open Preferences
7. Click Test Tab
8. Select Enable STATNotes
• Transferring STATNotes from one CDS PC to another one
 If database is intact and usable, transfer Istat32.db and Istat32.log to C:

\Istat32\Bin on
the new workstation.
 If the database is corrupted / unusable:
1. Transfer the STATNotes backup file *.ACP to new workstation.

2. Restore STATNotes (Database Maintenance Workspace)
3. Apply location based STATNotes (Database Maintenance Workspace)
 If the database is unusable and they don’t have a STATNotes backup file, STATNotes
will have to be hand entered.
• Transferring STATNotes from CDS to DE
The following table shows that exporting STATNotes form CDS to DE is version specific.
STATNotes built with CDS 5.24 can’t be imported into DE.
CDS Version DE Version

CDS 5.20 DE 1.9
CDS 5.21 DE 1.9
CDS 5.22 DE 1.10 and 2.0
CDS 5.23 DE 1.10 and 2.0

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CDS 5.24 None (Causes file corrupted error
if attempted)
CDS 5.25 (PWeb-DE 2.0) RALS DE 2.2
CDS 5.26 DE 2.3
• Can customers add/delete/change items in STATNotes
Yes (Technically) – However, adding or changing STATNotes can seriously affect the LIS
interface. The interface vender must always be contacted prior to making any changes.
The customer should consult with their Implementation Project Manager for assistance
before making any changes to STATNotes.
• Printing STATNotes definition from CDS

2. Click on Tools
3. Manage STATNotes
4. Click OK
5. Click Print (Base Page Items)
6. Click Print (Parameter Page Items)
7. Open Base Pages window by clicking Base Pages button
8. Click Print (Base Pages)
9. Click Close button
10. Open Parameter Pages window by clicking “Parameter Pages button
11. Click Print (Parameter Pages)
• Disabling STATNotes Temporarily to Conduct Proficiency Testing
1. Select the location that the analyzer is assigned to

2. Uncheck "Uses Default" if it is checked.
3. Double click on the preference and select the "Test" tab
4. Under Chart page, uncheck "Enable StatNotes"
5. Click OK and dock the analyzer to pick up the new preference

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16.0 i-STAT DE
16.1 How to Get Into DE Customization and DE System
DE customization
1. Go to PWeb
2. get the servername from the PWeb URL
3. get the facility name from the tree
4. enter the information into the DE customization URL template
http://servername/ActiveX/custom.aspx?inst=facilityname&Option=1
EXAMPLE ONLY
Eg. of DE customization URL for PWeb illustration:

http://gtslab2/ActiveX/Custom.aspx?inst=landmarkhospital&Option=1
DE System
1. Go to PWeb
2. get the servername from the PWeb URL
3. enter the information into the DE system URL template
http://servername/ISTATDESYSTEM
Eg. of DE system URL for PWeb illustration: http://gtslab2/ISTATDESYSTEM

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16.2 Moving a Handheld in the PWeb Tree While Using Assignment
Go into DE system and then into view instrument.
Find the facility under the drop down menu and locate the location the handheld is to be moved to.
You will find that the handheld had not yet crossed to the desired location within DE system because
PWeb will not update DE by only moving a handheld in the tree. PWEB can only update DE with a
customization change or operator change.
Go into PWEB, highlight the original location that the handheld came from within the tree, and then go to
the administrative menu.
Go to organizational settings and then to location.
Under location put a check in the ALL box of the locations (downloader sites) and then press edit.
In edit press save.
Repeat the above process while highlighting the location that the handheld will be going to within the
tree.
Once complete verify that the handheld is in the correct location with DE system
Dock the handheld to pick up the location's customization.
16.3 Submenus in DE Customization Workspace Not Available
If sub menus are unable to be accessed (see example below at the red arrow), verify the customer is
accessing DE customization from Windows Internet Explorer. If they are not have them access DE from
Windows Internet Explorer.

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16.4 DE Reboots routinely and Customization Changes Don’t Hold
Database connection is being lost due to antivirus software. Exceptions need to be set on the virus
scanner and the firewall to exclude istat32 folder and all subfolders and files to prevent scanning of ports
6000-6004 and 2638. This will need to be set by IT at the policy level.
16.5 “Not on List” Displays in Handheld When Operator Certification Expires
For any system using DE, when an operator certification expires it translates to the DE as “Operator Not
on List” and therefore will display “Operator Not on List” instead of “Certification Expired”. The handheld
will perform the actions customized for operator not on list.
16.6 Changing Analyzer Customization
Unable to enable an analyte at the handheld that has customization from a data management
program
When an analyte is disabled in “Apply By Panel” that analyte cannot be enabled at the handheld
unless the analyzer is set to factory settings first.
16.7 STATNotes
Note - STATNotes must be purchased and should not be enabled unless customer
has proof of purchase. This can be verified by customer service. The product number is
06F24-07.
• Enabling STATNotes on DE
1. At the address bar of the internet explorer type

“http://usadotnet/istatdesystem?customchart=2” and press return.
2. Select View and Set Configuration
3. Select enable STATNotes
4. Click OK
5. Click customer specific link to connect with customization workspace and continue
with STATNotes.
• Transferring STATNotes from One Institution to Another
Typical Situation - Customer wants to add new hospital (institution) to their PWeb and
they want to import the same / similar STATNotes into the new institution?
1. Backup STATNotes (Database Maintenance Workspace) to *.ACP

2. Restore CDS STATNotes (*.ACP) into DE
3. Apply location based STATNotes profiles

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• Can customers add/delete/change items in STATNotes
Yes (Technically) – However, adding or changing STATNotes can seriously affect the LIS
interface. The interface vender must always be contacted prior to making any changes.
The customer should consult with their Implementation Project Manager for assistance
before making any changes to STATNotes.
• Printing STATNotes Definition
The entire STATNotes definition can be exported to a Text or Excel file and printed form
there:

2. Click on Tools
3. Manage STATNotes
4. Click OK
5. Click Print (Base Page Items)
6. Click Print (Parameter Page Items)
7. Open Base Pages window by clicking Base Pages button
8. Click Print (Base Pages)
10. Open Parameter Pages window by clicking “Parameter Pages button
11. Click Print (Parameter Pages)
• Disabling STATNotes Temporarily to Conduct Proficiency Testing
1. Select the location that the analyzer is assigned to

2. Uncheck "Uses Default" if it is checked.
3. Double click on the preference and select the "Test" tab
4. Under Chart page, uncheck "Enable StatNotes"
5. Click OK and dock the analyzer to pick up the new preference
17.0 Wireless Transmission
17.1 General Setup

1. Setup the Ad-Hoc connection between a computer with wireless connection capability and the
i-STAT 1 wireless analyzer
2. Configure the i-STAT 1 wireless analyzer using the Wireless Configuration Setup Utility.
A. Remember to verify the IP address of the data mgt sys.
B. If applicable, verify the IP address, gateway, and subnet mask being set in the handheld
3. Verify connection between the i-STAT 1 wireless and the data mgt sys.

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17.2 Troubleshooting Ad Hoc Connection
• Has the computer being used been restarted lately?
• Do you have admin rights to the computer being used?
• Are the WiFi specifications met as per ART 726066?
• Does the i-STAT 1 wireless handheld have WiFi enabled?
• Is only 1 wireless handheld being configured at a time?
• Was the correct IP (192.168.3.100) entered?
• Are all existing networks disconnected?
• Is “Abbott-Configuration” entered correctly?
• Is the Ad-Hoc Network check box, checked?
• Is the Abbott-Configuration Network listed at the top of the network page?
• Is the signal strength of both the wireless handheld and computer being used > -65 dbm?
If the above steps have been verified escalate to customer’s Network Department.
17.3 Troubleshooting Wireless Configuration

• Has the computer being used been restarted lately?
• Are the WiFi specifications met as per ART 726066?
• Does the i-STAT 1 wireless handheld have WiFi enabled?
• Is only 1 wireless handheld/configuration utility being setup at a time?
• Was the correct SSID, Authentication type, Encryption type, Security Key, entered?
• Is the only box that is checked under the server tab, the full server output box?
• Was the “Start Server” button pressed on the configuration utility?
• Was the wireless handheld set to receive the setup?
• Is the signal strength of both the wireless handheld and computer being used > -65 dbm?
• After verifying the above to be successful, is the wireless state: Associated?
• After verifying the above to be successful, is it possible to connect to the test server?
If the above steps have been verified escalate to customer’s Network Department.
17.4 Troubleshooting Wireless Communication

• Are results pending to be sent via WiFi?
• Is the signal strength of the wireless handheld > -65 dbm?
• Does the wireless handheld transmit data successfully when docked at a download site?
• Is the data management system running?
• Can other wireless handheld transmit data wirelessly?
• Is wireless enabled in both the wireless handheld and the data management system?
• Is the wireless handheld configured for wireless communication?
• Are the IP addresses, gateway, and subnet mask setup correctly in the wireless handheld?
• Is it possible to ping the server via the wireless handheld?
• Is it possible to test the server via the wireless handheld?
• After verifying the above to be successful, is it possible to transmit data?
If the above steps have been verified escalate to customer’s Network Department

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18.0 Interface not working
This troubleshooting information will only be helpful after the interface program has worked successfully.
1. Check to see if the LIS (host) is down.

2. Check that the interface cable is connected to the LIS (host) terminal and the CDS.
3. Check the Unsent Records Viewer to determine if the result was rejected by the LIS (host).
4. Check the Interface Tab in wcd32 config to ensure that “Enable external interface” and
“Autosend” are checked and that settings have not been changed.
5. Check that settings in the interface32.exe program have not been changed.
6. Check the status in the Sent column after pressing Refresh. If the status is still Sent*, there
may be a problem with the LIS (host).
7. Has a new test been added by i-STAT? If yes, the interface must be updated.
8. What type of interface is being used: ASTM, HL7 or Data File?
*CDS 5.X “SENT” column in Patient Data Viewer
Sent displays No: This is the initial value when a data record is entered into the database. These records
CAN be sent by pressing F9.
Sent displays Pending: This value means that the record is in the queue waiting to be processed by the
Interface. These records CANNOT be re-sent.
Sent displays In Progress: This value means that the record is currently being processed by the Interface.
These records CANNOT be re-sent.
Sent displays Forwarded: HL7 Protocol only. This indicates that the Record has been forwarded to the
receiving system but has not yet received an acknowledgement indicating whether or not the LIS
successfully processed the record. These records CAN be re-sent by pressing F9.
Sent displays Yes: This value means that the i-STAT interface application successfully processed the
record. These records CANNOT be re-sent.
For Data File Protocol only: Yes means that a Data File was successfully created in the c:\istat32\send
directory. It does not necessarily mean that the record was processed by the LIS. It is up to the receiving
system to provide a status update to the CDS, [see INTER32-SPC-011.DOC]
Sent displays Unsuccessful: This value means that the record send was NOT successful. The Interface
Comment will provide some limited information as to why a record send was unsuccessful. These records
CAN be re-sent by pressing F9.
If the above troubleshooting steps do not resolve data transmission issues to the LIS/HIS refer to
interface vendor.

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19.0 COM Port to USB Adapters and PS2 to USB Adapters
19.1 PS2 to USB Adapter
Using a PS2 to USB adapter may cause transmission issues. Connect the PS2 connector to a PS2
keyboard input to eliminate this issue.
19.2 Nine Pin Null Modem to USB Adapter
The first step is to ensure that you have installed the USB driver as per the
manufacturers instructions. The driver will create a virtual serial port. The port
number will vary depending on the configuration of your computer.
Try to always use the same USB port on your computer. The driver may install
multiple virtual ports if you switch ports. Each time a new virtual port is created it will
be assigned the next consecutive COM port number.
Verifying that the driver is installed correctly:
1. Make sure the adapter is plugged into a USB port on the computer.
2. From the Windows Start button, select Run…
3. Type devmgmt.msc and press Enter or click the Ok button. The Device Manager
should open.
4. Look for an item Ports (COM & LPT). Expand it by clicking on the plus sign in
front of the text. You should see something similar to this:
If the driver is installed correctly you should see an entry similar to the one shown
under Ports.

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The virtual COM port number is indicated in brackets. This is the port number you
will need to select in applications that use serial ports to access data.
5. If you don’t see a new COM port or the Ports entry is not visible at all, then the
driver has not been loaded correctly.
19.3 Resetting COM Ports
In some occasions another piece of hardware will be plugged into the com port
needed for the istat downloader to do the software update. After the downloader is
setup you may find that the com port is not available in the Jammlite utility, which is
because the computer is holding the com port for the original piece of hardware. In
order to break the hold follow the below instructions:
1) restart the computer with the downloader completely setup
(if this does not work continue to step 2)
2) manually reset the com ports

a. with the downloader connected, right click on my computer
b. select “manage”
c. double click on “device manager”
d. double click on “ports”
e. right click on each communication port and select disable
f. Wait ~ to 30 seconds and then right click each communication port and
select enable.
g. With the downloader still connected, restart the computer.
(if this does not work, the customer should try using another computer to perform
the software update)

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20.0 Packaging and Shipping Errors
20.1 Packaging Error
• Mislabeled cartridge pouch or box

• Incorrect cartridge count in box
o 25 per box except 24 in PT/INR box.
• Incorrect cartridge in pouch
• Wrong cartridge type recognized by analyzer
o Example: CG4+ on label, EG7+ results displayed.
• Incorrect or inconsistent lot number(s)
• Incorrect or inconsistent labeling of Value Assignment sheets and control ampules/vials
• Cartridge pouches damaged
o If customer complains of damage to pouches, it must be determined if the damage
occurred in the shipment between i-STAT and logistics company, logistics company
and customer or Business Partner warehouse or between Business Partner warehouse
and customer.
• Missing desiccant in PT/INR cartridge pouch
20.2 Shipping Error
Shipping errors from i-STAT to Business Partners should be reported to APOC Technical Support
• Missing or wrong package insert for Controls

o Control inserts should be checked in Business Partner warehouse since inserts are
updated from time-to-time by i-STAT.
• Missing temperature strip or ice packs in shipment of controls and cartridges
• Temperature strip indicated compromised product
• Incorrect product shipped
o Includes language, units, decimal separator and simulator schedule in analyzer.
o Cartridges
• Damaged product received
• Short dated product received
o Short date will be defined by i-STAT and Business Partner.
o Short dated material may be offered to customer at reduced price or may be due to
allocation.
• Incorrect amount of product shipped or incorrect product shipped or missing product
• Missing or incorrect information in System Manual
• Software update packet not received
• Over label missing or incorrect
20.3 Shipping Error – Business Partner

It is presumed that the Distributor will track problems with shipments from his warehouse to his
customers and that these errors will be reported to i-STAT according to Q04.01.007.

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20.4 Shipping Error- Customer
i-STAT Cartridges Shipping and Handling
The intent of this document is to assemble information that will clarify/simplify answering
customer questions about the potential of cartridges being compromised due to heat during
shipment. It also intends to clarify what customers are expected to do after the receipt and
confirmation that product was not compromised during shipment.
The following sections cover cartridge labeling as it is found today on the cartridge box and in
the system and procedure manuals
Cartridge Labeling
• Packaging: The room temperature storage time labeled on the cartridge box represents the
maximum time that cartridges can be at room temperature (18º C to 30º C).
For example:
Products
All other products
G Cartridge 06F09-01, -02
03P83-25
03P83-25
E3+ Cartridge 06F08-01, -02
03P82-25
600-9004-25
6+ Cartridge 06F05-01, -02
03P80-25
600-9005-25
EC4+ 06F07-01, -02
Cartridge 03P81-25
EC8+ 06F04-01, -02
Cartridge 03P79-25
600-9007-25
CREA 06F10-01, -02
Cartridge 03P84-25
600-9003-25
Celite ACT 07G01-01, -02
Cartridge 03P86-25
600-9006-25
Kaolin ACT 07G81-01, -02
Cartridge 03P87-25
PT/INR 04J50-01, -02
Cartridge 03P89-25
cTnI 06F15-03, -04
(Troponin I) 03P90-25
Cartridge 600-9009-25

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Products
CHEM8+ 03M88-01, -02
cartridge 03P91-25
600-9008-25
CK-MB 06F25-01, -02
Cartridge 03P92-25
BNP 06F30-01, -02
Cartridge 06F30-01, -02
600-9010-25
Blood Gas products with APOC4
packaging.
Cartridge Type
CG8+ cartridge 03P88-25
600-9001-25
EG6+ cartridge 03P77-25
600-9008-25
EG7+ cartridge 03P76-25
600-9012-25
CG4+ cartridge 03P85-25
600-9000-25
G3+ cartridge 03P78-25
Illustration 1: Room temperature storage specifications
• System manual: The following statement is provided:

Storage conditions: The main supply of cartridges should be stored at 2-8 º C (35-46 º F).
Cartridges must be at room temperature before removing them from their pouches. Allow 5
minutes for an individual cartridge and one hour for a box of cartridges to come to room
temperature. Cartridges in use may be stored at room temperature (18-30 º C or 64-86 º F)
for the time frame indicated on the cartridge box. The cartridge box contains a line used to
indicate the room temperature expiration date. (ART 714365, section 3-4)
• Procedure manual: The following statement is provided
Supplies and storage requirements -Cartridges

Cartridges are sealed in individual pouches or portion packs. Store the main supply of
cartridges at a temperature between 2º and 8º C(35-46º F). Do not allow cartridges to
freeze. Cartridges may be stored at room temperature (18-30 º C or 64-86 º F) for the time
frame indicated on the cartridge box. Cartridges should not be returned to the refrigerator
once they have been at room temperature and should not be exposed to temperatures
above 30º C (86 F). If the pouch has been punctured, the cartridge should not be used. Write
the date on the cartridge box or individual cartridge pouches to indicate the room
temperature expiration date. Cartridges should remain in pouches until time of use. Do not
use after the labeled expiration date (ART 714446).
Shipment of cartridge products

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Shipper containers are prepared to include cartridge boxes, gel packs, and a temperature strip.
Abbott Point of care has data that supports a 5-day shipment window. This shipping window is
in addition to the 14-day at room temperature specification
Purpose of shipping content:

• Shipper container
o Is intended to be packed as tightly as possible to avoid shipping damages
(internal movements) and keep the area as cool as possible over the shipping
period.
• Gel packs:
o Included frozen, and intended to avoid drastic temperature changes during
shipment as the temperature will slowly change during the shipping time.
o It is not uncommon for cartridges to be received from the shipper (ex FEDEX) at
room temperature if the shipment conditions exceed the frozen lifetime of the ice
bricks included in the shipping container.
o As long as the temperature strip limits have not been exceeded, the product has
not been compromised and cartridges can be refrigerated and retain the full
labeled room temperature storage time.
o APOC has factored the worst case acceptable shipping conditions into account
when establishing the room temperature storage time.
• Temperature strip card:
o Is included in the shipper container on the side or top area of the cartridge box
area
o Strip is activated (i.e able to measure the temperature accumulation) by the
shipper by removing the tab on the left (perforated area)
o Measures the temperature accumulation over the shipping period.

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Illustration 2: Temperature strip on card
o There are 4 regions on the temperature strip

 The strip include 2 different sections that will be activated differently
• Section 1: Regions 1A-3C: The first three regions monitor the
accumulation of heat over time. The card indicators will change as
temperature and time is accumulated (for example: temperatures –
degrees- over a period of time –days.) Region 4 is a distinct region
than those covered by 1-3 and will only be activated by a sudden
change in temperature greater than 34ºC (93ºF).
o Temperature Accumulation
 The graph below shows the temperature strip on the y-axis and the
number of days on the x-axis. It is the parameters of temperature
accumulation over a period of time that will activate the color changes

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Receipt of product at medical facility
• When product is received at the facility, the person unpacking the shipment will examine
the temperature strip and confirm that boxes 3 and 4 are not colored. If this is true,
product can be refrigerated for use until expiration. As needed, product will be sourced
to the different areas and the room temperature dating expiration will be managed
locally.
• Medical facilities/laboratories (ex: Point of Care coordinators) will follow normal product
receipt procedures from the i-STAT System manual Quality Control (ART 714376, section
14-1) or from the appropriate regulatory bodies.
o Verifying newly received cartridges
 Verify that the transit temperatures were satisfactory using the four-
window temperature indicator strip included in the shipping container
 From each lot in each shipment of cartridges, analyze multiple levels of i-
STAT controls (or RNA® Medical controls if testing for hematocrit) using
any verified analyzer.
• This is not a manufacturer’s system instruction; it is a suggestion
to comply with regulatory requirements.
• Product will then be stored between 2-8 º C (35-46 º F) until needed.

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SEE APPENDIX B FOR COMPLAINT HANDLING AND DIRECTIVES FOR SHIPPING ERRORS:
APOC TECHNICAL SUPPORT USE ONLY

- 129 -
Appendix A Contact Information for Adverse Events, Complaints and Reports
Reportable Complaints and Return Goods Authorizations
e-mail: [email protected]
Fax: Technical Support at + 1 609 419 9372
Adverse Events
Fax: + 1 609 419 9372
Monthly Reports
Fax: + 1 609 419 9372

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Appendix B – Shipping Issues
Shipping using gel packs

If then Complaint Complaint Comments
Documentation classification
I received a The The product Include Level 1 The gel packs are
shipment and temperature has not been • temperature not intended to
the gel packs strip doesn’t compromised. strip state be in a frozen
are no longer show color Proceed per • conclusion that state when
frozen. Can I in window 3 your product has not received at the
use the or in incoming been medical facility.
cartridges? window 4 product compromised They are intended
procedure during shipping to avoid drastic
temperature
changes during
shipment as the
temperature will
slowly change
during the
shipping time
The The product Include: Level 2
temperature may have • temperature
strip shows been strip state
color in compromised • waybill number
window 3 or during (attach
in window 4 shipment. photocopy if
Do not use possible)
the product • any information
and we will that can help
replace it identify what
happened
during shipping
/receiving
I received a The The product Include Level 1 The gel packs are
shipment and temperature has not been • temperature not intended to
the ice packs strip doesn’t compromised. strip state be in a frozen
and shipment show color Proceed per • conclusion that state when
appears warm. in window 3 your product has not received at the
Can I use the or in incoming been medical facility.
cartridges? window 4 product compromised They are intended
procedure during shipping to avoid drastic
temperature
changes during
shipment as the
temperature will
slowly change
during the

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shipping time
The The product Include: Level 2
temperature may have • temperature
strip shows been strip state
color in compromised • waybill number
window 3 or during (attach
in window 4 shipment. photocopy if
happened
during shipping
/receiving
I received a The The product Include Level 1

shipment and temperature has not been • temperature
the strip doesn’t compromised. strip state
temperature show color Proceed per • conclusion that
strip has color in window 3 your product has not
in zone 1 or in incoming been
window 4 product compromised
procedure during shipping
I received a The The product Include Level 1
shipment and temperature has not been • temperature
the strip doesn’t compromised. strip state
temperature show color Proceed per • conclusion that
strip has color in 3 or in your product has not
in zone 1-2 window 4 incoming been
product compromised
procedure during shipping
I received a The The product Include: Level 2
shipment and temperature may have • temperature
the strip shows been strip state
temperature color in compromised • waybill number
strip has color window 3 or during (attach
in zone 1-2-3 in window 4 shipment. photocopy if
happened
during shipping
/receiving
I received a The The product Include: Level 2

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shipment and temperature may have • temperature
the strip does been strip state
temperature show color compromised • waybill number
strip has color in window 4 during (attach
in zone 4 shipment. photocopy if
happened
during shipping
/receiving
I received my The product The product Include: Level 2 Products shipped

product frozen. has been may have • temperature with dry ice and
Can I use it? received been strip state are to be frozen:
frozen and compromised • waybill number Cardiac controls
is shipped during (attach Cardiac Markers
on gel packs shipment. photocopy if Controls Level 1
Do not use possible) (06F12-02)
Cardiac Markers
Controls Level 2
(06F13-02)
replace it identify what Cardiac Markers
happened Controls Level 3
during shipping (06F14-02)
/receiving
i-STAT BNP Control
Level 1 06F12-18
i-STAT BNP Control
Level 2 06F12-19
i-STAT BNP Control
Level 3 06F12-20
The product The product Include information Level 1 Products shipped
has been has not been showing that the with dry ice and
received compromised. product was properly are to be frozen:
frozen and Proceed per frozen upon receipt Cardiac controls
is intended your Cardiac Markers
to be incoming Controls Level 1
shipped on product (06F12-02)
Cardiac Markers
dry ice procedure
Controls Level 2
(Place
(06F13-02)
contents in Cardiac Markers
Freezer ≤ Controls Level 3
-18ºC (-1ºF) (06F14-02)
i-STAT BNP Control

Level 1 06F12-18

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i-STAT BNP Control
Level 2 06F12-19
i-STAT BNP Control
Level 3 06F12-20
My shipment The product The product Include: Level 2 Only products
does not shipment may have • temperature shipped with gel
include a does not been strip state packs include a
temperature include a compromised • waybill number temperature strip
strip temperature during (attach
strip shipment and photocopy if
it not possible possible)
to assess the • any information
shipping that can help
conditions. identify what
Do not use happened
the product during shipping
and we will /receiving
replace it
My shipment The Review Include: Level 2
does not shipment temperature • temperature
include gel does not strip strip state
packs include gel information • waybill number
packs and is (are any (attach
intended to regions photocopy if
be shipped colored?) possible)
with gel The product • any information
packs may have that can help
been identify what
compromised happened
during during shipping
shipment and /receiving
it not possible
to assess the
shipping
conditions.
Do not use
the product
and we will
replace it
The This product Include Level 1 Products shipped
shipment is intended to • if dry ice with dry ice and
does not be shipped remains in the are to be frozen:
include gel on dry ice. shipping Cardiac controls
packs and is The product container. Cardiac Markers
intended to has not been • If controls are Controls Level 1
be shipped compromised. still frozen (06F12-02)

- 134 -
with dry ice Cardiac Markers
Controls Level 2
(06F13-02)
Cardiac Markers
Controls Level 3
(06F14-02)
i-STAT BNP Control

Level 1 06F12-18
i-STAT BNP Control
Level 2 06F12-19
i-STAT BNP Control
Level 3 06F12-20
The The The product Include:

temperature temperature may have • photocopy of Level 2
strip is not strip was not been temperature
activated activated compromised monitoring card
(tab was not during and attach to
removed by shipment and incident to
shipper) it not possible show that strip
to assess the was not
shipping activated
conditions. • waybill number
Do not use (attach
the product photocopy if
and we will possible)
replace it
The The product Ask customer to Level 1
temperature has not been photocopy Temperature
was properly compromised. monitoring card and
activated Proceed per attach to incident
(tab was your
removed, incoming
but no color product
visible in procedure
window 1-2-
3-4
The gel packs The The product If needed replace Level 2
have leaked temperature has not been cartridges soiled by gel
into to the strip does compromised. pack product
shipping not show Proceed per
container color in your Include:
regions 1-2 incoming • waybill number
product (attach
procedure photocopy if
possible)

- 135 -
• Any shipping
related
information that
can help
identify what
happened
Temperature The product Include: Level 2
strip shows may have • waybill number
color in been (attach
window 3 compromised photocopy if
and/or 4 during possible)
shipment and • Any shipping
it not possible related
to assess the information that
shipping can help
conditions. identify what
Do not use happened
the product
and we will
replace it
The The The product If needed replace wet Level 2
boxes/shipping temperature has not been boxes of cartridges
container is strip does compromised.
wet not show Proceed per Include:
color in your • waybill number
regions 1-2 incoming (attach
product photocopy if
procedure possible)
• Any shipping
related
information that
can help
identify what
happened
The The product If needed replace wet Level 2
temperature has not been boxes of cartridges
strip does compromised.
not show Proceed per Include:
color in your • waybill number
regions 3-4 incoming (attach
product photocopy if
procedure possible)
• Any shipping
related
information that
can help

- 136 -
identify what
happened
My shipment The The product Level 1 Based on the 14
was left at temperature has not been days expiration
room strip does compromised. dating, there is
temperature at not show Proceed per only 7 days left at
the receiving color in your room temp
dock for 7 days regions 1-2 incoming Based on 2
product months
procedure. expiration dating,
there is 53 days
left
Temperature The product Level 2
strip shows may have
color in been
window 3 compromised
and/or 4 during
shipment and
it not possible
to assess the
shipping
conditions.
Do not use
the product.
Customer
must replace
the order.
Customer The change The customer Level 1 After
packs in location must confirmation that
cartridges in a occurs after document product was not
cooler with ice the initial locally how compromised
packs and receipt of they support during shipping,
drives the cartridges at the location the customer is
cartridges to the facility change and responsible for
satellite monitoring. generating own
hospital. supporting data
Customer used to show product
a temperature is not
strip in one of compromised
the coolers from their actions
and the
temperature May suggest that
read 10 each location
degrees upon gets shipments
arrival. vs. central
location

- 137 -
shipment.
Customer The The product Include Level 1
received temperature has not been • temperature
another strip doesn’t compromised. strip state
shipment of show color Proceed per • conclusion that
cartridges that in window 3 your product has not
the or in incoming been
temperature window 4 product compromised
strip indicated procedure during shipping
the shipment
was acceptable
however the
temperature in
the window
was not 2-8
degrees
Celcius
Shipping using dry ice

I received The controls The product may Document if any Level 2 Products
the cardiac are no be compromised dry ice remains shipped with dry
controls longer and will be in the shipping ice and are to be
Cardiac frozen replaced container frozen:
Markers Document Cardiac Markers
Controls waybill number Controls Level 1
Level 1 (06F12-02)
(06F12-02) Cardiac Markers
Cardiac Controls Level 2
Markers (06F13-02)
Controls Cardiac Markers
Level 2 Controls Level 3
(06F13-02) (06F14-02)
Cardiac
Markers i-STAT BNP
Controls Control Level 1
Level 3 06F12-18
(06F14-02) i-STAT BNP
Control Level 2
i-STAT BNP 06F12-19
Control Level i-STAT BNP
1 06F12-18 Control Level 3
i-STAT BNP 06F12-20
Control Level
2 06F12-19

- 138 -
i-STAT BNP
Control Level
3 06F12-
20and they
are no
longer
frozen
I received The controls This product is Document if dry Level 1 Products
the cardiac are still intended to be ice remains in shipped with dry
controls frozen shipped on dry the shipping ice and are to be
Cardiac ice and has not container. frozen:
Markers been Cardiac Markers
Controls compromised in Controls Level 1
Level 1 (06F12-02)
shipment
(06F12-02) Cardiac Markers
Cardiac Controls Level 2
Markers (06F13-02)
Controls Cardiac Markers
Level 2 Controls Level 3
(06F13-02) (06F14-02)
Cardiac
Markers i-STAT BNP
Controls Control Level 1
Level 3 06F12-18
(06F14-02) i-STAT BNP
Control Level 2
i-STAT BNP 06F12-19
Control Level i-STAT BNP
1 06F12-18 Control Level 3
i-STAT BNP 06F12-20
Control Level
2 06F12-19
i-STAT BNP
Control Level
3 06F12-
20but there
is no gel
packs
I received Frozen This product is Document if dry Level 1 Only products
cardiac products not intended to ice remains in shipped with gel
controls (cardiac be monitored the shipping packs include a
Cardiac controls) with the container. temperature
Markers were temperature strip
Controls received strip and has not
Level 1
without a been
(06F12-02)
temperature compromised.
Cardiac
Markers strip Proceed per your
Controls incoming
Level 2 product

- 139 -
(06F13-02) procedure
Cardiac
Markers
Controls
Level 3
(06F14-02)
i-STAT BNP
Control Level
1 06F12-18
i-STAT BNP
Control Level
2 06F12-19
i-STAT BNP
Control Level
3 06F12-20
but the
shipment
does not
include a
temperature
strip

- 140 -

Troubleshooting Guide i-STAT Blood Gas Analyzer

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Troubleshooting Guide i-STAT Blood Gas Analyzer

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i-STAT System

i-STAT System Troubleshooting Guide Art: 715627-00H Rev Date: 30-Nov-12

1.0 Required Information for Business Partners ............................................ 1

i-STAT System Troubleshooting Guide Art: 715627-00H Rev Date: 30-Nov-12

i-STAT System Troubleshooting Guide Art: 715627-00H Rev Date: 30-Nov-12

i-STAT System Troubleshooting Guide Art: 715627-00H Rev Date: 30-Nov-12

i-STAT System Troubleshooting Guide Art: 715627-00H Rev Date: 30-Nov-12

1.1 Q04.01.007 and F04.01.007.01 for Business Partners

1.2 Other Abbott Support Organizations

i-STAT System Troubleshooting Guide Art: 715627-00H Rev Date: 30-Nov-12

Analyzer • Serial number

Cartridge • Type: such as 6+ or EG7+

Electronic • Serial number: On underside of simulator

Control Fluids • Control Type & Level(s) (such as i-STAT Level 1)

i-STAT System Troubleshooting Guide Art: 715627-00H Rev Date: 30-Nov-12

Start of Date the customer first noticed the problem.

Rate and Scope Assess by asking such questions as:

i-STAT System Troubleshooting Guide Art: 715627-00H Rev Date: 30-Nov-12

Business Refer to Q04.01.007 “Customer Contact Reporting Requirements for Business

i-STAT System Troubleshooting Guide Art: 715627-00H Rev Date: 30-Nov-12

1.7 Failure mode assignment

• Review labeling and directions for use.

i-STAT System Troubleshooting Guide Art: 715627-00H Rev Date: 30-Nov-12

2.1 General Information

Important! Increased Code Frequency and Technical Support Response

i-STAT System Troubleshooting Guide Art: 715627-00H Rev Date: 30-Nov-12

i-STAT System Troubleshooting Guide Art: 715627-00H Rev Date: 30-Nov-12

Quality Check Codes that are not stored

i-STAT System Troubleshooting Guide Art: 715627-00H Rev Date: 30-Nov-12

CAUSE MESSAGE ACTION MESSAGE RELATED CODES RELATED CODES

Dead Batteries Replace Batteries 1 1

Batteries Changed Ready for Use 7 NA (Not Applicable)

Temperature Out of Check Status Page 2 2, 108, 109

Temperature In Ready for Use 10 NA

Cartridge Preburst Use Another 21 21

Sample Positioned Use Another 35, 36 35, 36

Sample Positioned Use Another 30,37 30,37

Insufficient Sample Use Another 38, 39 38, 39

Unable to Position Use Another 31, 34, 44 31, 34, 44

Cartridge Not Reinsert Cartridge 47 47

Cartridge Type Not Use Another 69 69

i-STAT System Troubleshooting Guide Art: 715627-00H Rev Date: 30-Nov-12

Invalid or Expired See Manual 12,13 12,13

CAUSE MESSAGE ACTION MESSAGE RELATED CODES RELATED CODES

New Software Use Electronic 3 3

Analyzer Interrupted Ready for Use 5,6,9 5, 6, 9

Analyzer Interrupted Use Another 4,8 4, 8,

Date Invalid Check Clock on 11 11

Test Cancelled by N/A 95, 141

Lot Expired N/A 140

Poor Contact See Manual 49 49

Barcode Type Does N/A 15

i-STAT System Troubleshooting Guide Art: 715627-00H Rev Date: 30-Nov-12

No Clot Detected See Manual 19 19

i-STAT System Troubleshooting Guide Art: 715627-00H Rev Date: 30-Nov-12

Message Problem and Cause Resolution and Comments

Note: there is an internal lithium battery

If persistent on only specific handheld(s)

300 series: The temperature can be monitored on the