EXIAS E1 Analyzer Instructions For Use en

ELECTROLYE
ANALYZER
Instructions
for use
Local representative of EXIAS Medical GmbH
For EXIAS distributor:
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containing your contact information here.
Manufacturer
EXIAS Medical GmbH Phone: +43 (316) 922953
Kratkystraße 2 E-Mail: [email protected]
8020 Graz – Austria www.exias-medical.com
Document information
Manual version Software version Revision date Remark

1.0 min. 1.00.04 Nov. 2019 1st Release
1.1 min. 1.00.04 Nov. 2019 Correction of symbols
in chapter 6
Copyright
2019, EXIAS Medical GmbH, all rights reserved.

The contents of this document may not be reproduced in any form or communicated to any
third party without the prior written consent of EXIAS.
All documents are protected in terms of copyright law. The transfer and duplication of
documents, even in extracts, as well as the utilization and communication of their contents
are not permitted unless expressly granted in writing.
Violations are punishable and require compensation.
All rights to exercise industrial property rights are reserved for EXIAS.
Brandname
EXIAS Medical is a trademark of EXIAS Medical GmbH.
Edition
Version 1.1, Nov 2019

1 Table of contents
Table of contents
Document information ........................................................................... 1-3
Copyright .................................................................................................. 1-3
Brandname ............................................................................................... 1-3
Edition ....................................................................................................... 1-3
Table of contents
1 Introduction
Purpose and use of this document ....................................................... 1-3
Text convention ....................................................................................... 1-4
Symbols .................................................................................................... 1-5
Abbreviations ........................................................................................... 1-7
2 Safety Information
General safety instructions .................................................................... 2-3
Biohazard exposure, precautions and disposal .................................. 2-3
Applied standards ................................................................................... 2-5
Disinfection .............................................................................................. 2-6
IT security advisory .................................................................................. 2-7
Electrical safety and electromagnetic compatibility ............................ 2-8
Limitations of the e|1 Analyzer ............................................................ 2-8
3 Product Description
Intended use ............................................................................................ 3-3
e|1 Analyzer ........................................................................................... 3-3
Consumables ........................................................................................... 3-5
Accessories ............................................................................................... 3-9
4 Specifications
System Characteristics ............................................................................ 4-3
Sample Types ........................................................................................... 4-3
Measurement Parameters ..................................................................... 4-3
Calculated Parameters ............................................................................ 4-4
Performance Characteristics .................................................................. 4-5
Interference ............................................................................................4-13
Linearity ..................................................................................................4-15
Environmental Parameters ..................................................................4-16
Technical Specifications ........................................................................4-17
5 System Installation
Choosing a location ................................................................................. 5-3
Unboxing and checking contents .......................................................... 5-4
Installation and setup ............................................................................. 5-5
Inserting the e|1 Cartridge .................................................................... 5-6
2 e|1 Analyzer
Instructions for Use · Vers. 1.1 1
1 Table of contents
6 Sample Measurement
Preanalytics .............................................................................................. 6-3
Limitations of clinical analysis ................................................................ 6-5
Measuring procedure ............................................................................. 6-6
Measurement evaluation ....................................................................... 6-9
7 Quality Control
Quality Control Concept ......................................................................... 7-3
Recommended QC regimen of EXIAS Medical ..................................... 7-3
Important information for evaluating QC results ................................ 7-4
QC measurement .................................................................................... 7-5
QC consequences .................................................................................... 7-9
8 Replacement of Consumables
Replacement of e|1 Cartridge ............................................................... 8-3
Removing and reinserting the e|1 Cartridge ....................................... 8-7
Replacement of e|1 Printer paper ........................................................ 8-8
9 System Functions
Main Screen .............................................................................................. 9-3
Results ....................................................................................................... 9-5
Menu ......................................................................................................... 9-8
Alarms / Warnings .................................................................................9-25
Cartridge .................................................................................................9-26
Login ........................................................................................................9-27
10 Troubleshooting
Troubleshooting Concept .....................................................................10-3
Error Messages ......................................................................................10-7
11 Theoretical Foundations
Reference intervals and critical limits .................................................11-3
Calculated values ...................................................................................11-6
Measuring principle ..............................................................................11-7
Calibration Principle ..............................................................................11-9
12 Appendix
Order List ................................................................................................12-3
Index .......................................................................................................13-1
2 e|1 Analyzer
2 Instructions for Use · Vers. 1.1
Chapter 1
Introduction
1 Introduction
1 Introduction
Purpose and use of this document
Purpose and use of this document

These Instructions for Use provide all information and data needed for the safe operation of the
EXIAS e|1 Analyzer. This document is intended only for qualified operators who have been trained
and authorised by EXIAS Medical, or by representatives of EXIAS Medical.
Every effort has been made to ensure that the information contained in this manual is correct and up
to date at the time of printing. Please contact your local representative, if you want to ensure that you
are referring to the latest and current version of the Instructions for Use.
EXIAS Medical reserves the right to make any changes necessary without notice as part of ongoing
product development.
This manual should be stored properly where it will not be damaged and available and accessible
while using the EXIAS e|1 Analyzer.
A table of contents at the beginning of this manual, as well as an index at the end of this manual,
assist in finding different information quickly.
EXIAS Medical GmbH is accountable for the proper functionality, safety and performance of the
e|1 Analyzer only if the following conditions are met:
1 The e|1 Analyzer is installed and used in accordance to manufacturer specifications. Please refer
to chapters System installation and Specifications in this document.
2 All preanalytical considerations are met while performing measurements with patient samples. For
further information see section Preanalytics in chapter Sample Measurement.
3 All consumables, accessories and spare parts used together with the device must be proprietary
products either delivered by EXIAS Medical or approved by EXIAS Medical.
4 All operators of the device must be trained and familiar with the operation of the device. The
operators must be trained either by authorized EXIAS Medical personnel, or persons trained and
authorized by EXIAS Medical.
5 All technical interventions on the device must be carried out either by authorized EXIAS Medical
personnel, or persons trained and authorized by EXIAS Medical. This includes any repair,
modification or adjustments that may be required or attempted to the device.
No warranty or liability claims will be entertained, if the instrument is applied in areas other than
those described or if the necessary prerequisites and safety measures are not observed.
2 e|1 Analyzer
Instructions for Use · Vers. 1.1 1-3
1 Introduction
Text convention
Text convention
Symbols are used in the manual:
Symbol Description
123 Instruction
Note
Caution:
All sections/passages that are marked with this symbol describe procedures and/or
indicate conditions or dangers that could damage or lead to a malfunction of the
e|1 Analyzer.
Warning:
Sections marked with this symbol contain information that must be observed to
avoid potential injuries (to patients, operators and third parties).
Biological hazard:
All sections and parts of texts that are marked with this symbol describe procedures
that may involve risk of infection.
Electricity hazard:
Risk of property damage and personal injury due to electrical voltage.
Wear eye protection!
Wear protective gloves!
Wear protective clothing!
2 e|1 Analyzer
1-4 Instructions for Use · Vers. 1.1
1 Introduction
Symbols
Symbols
Symbols used on labels and on packaging of EXIAS Medical products are in accordance with
ISO 15223-1:2016 (1), ISO 780:2015(2), IEC 60417-1:2002(3), Directive 98/79/EC(4) and Directive 2012/19/
EU(5).
Symbol Description
Conformité Européenne:
This product complies with the requirements of the European directive 98/79/EC
on in vitro diagnostic medical devices.
Batch code
Use-by date
The product should not be used after expiry of the specified date.
If a day is not indicated, apply the last day of the respective month.
Temperature limitation -2°C to +30°C

The conditions necessary to preserve the product's shelf life before opening.
In vitro diagnostic medical device
Manufacturer
Date of manufacture (YYYY-MM)
Catalogue number
Consult Instructions for Use
Serial number (model plate)
Fragile, handle with care
(1) ISO 15223-1:2016: Medical devices - Symbols to be used with medical device labels, labelling and
information to be supplied - Part 1: General requirements.
(2) ISO 780:2015: Packaging - Distribution packaging - Graphical symbols for handling and storage of
packages.
(3) IEC 60417-1:2002: Graphical symbols for use on equipment - Part 1: Overview and application.
(4) Directive 98/79/EC on in vitro diagnostic medical devices (IVDD).
(5) Directive 2012/19/EU on waste electrical and electronic equipment (WEEE).
2 e|1 Analyzer
1 Introduction
Symbols
Symbol Description
Handle with care
Keep dry
Biological risk
Caution
Consult Instructions for Use
This side up
Direct current
Polarity
Do not throw in trash
Cartridge
Contains sufficient for <n> test
Do not re-use
Power on / Power off
USB Interface
Ethernet Interface
2 e|1 Analyzer
1 Introduction
Abbreviations
Abbreviations
Abbreviation Description
A
A Ampere
AC Alternating current
C
CE Conformité Européenne (European Conformity)
Cl- Chloride ion concentration
CLIA Clinical Laboratory Improvement Amendments
CLSI Clinical and Laboratory Standard Institutes
cm Centimeter
D
dB Decibel
dl Deciliter
DC Direct current
DIN German Institute for Standardization (Deutsches Institut für Normung)
E
EN European standard
EU European union
G
GB Gigabyte
H
Hct Hematocrit
Hz Hertz
I
iCa Ionized calcium
ISO International Organization for Standardization
IVD In vitro diagnostic
K
K+ Potassium ion concentration
kg Kilogram
L
LCD Liquid cristal display
LIS Laboratory information system
l Liter
M
MB Megabyte
MHz Megahertz
mg Milligram
2 e|1 Analyzer
1 Introduction
Abbreviations
Abbreviation Description
mm Millimeter
mmol Millimol
MW Mean value
N
Na+ Sodium ion concentration
P
Negative decadic logarithm of the molar concentration of hydrogen ions
pH
in a solution
Q
QC Quality control
S
SD Standard deviation
U
USB Universal serial bus
V
V AC Volt - alternating current voltage
V DC Volt - direct current voltage
2 e|1 Analyzer
Chapter 2
Safety Information
General safety instructions
General safety instructions

The EXIAS e|1 Analyzer as well as its consumables and accessories left the factory in a flawless
condition.
To ensure that this condition is maintained and for safe operation, the operator must follow the
instructions and warnings described in of these Instructions for Use.
• Do not operate the device in an explosive environment or in the vicinity of explosive or
combustible mixtures of anesthetics with air, oxygen or nitrous oxide.
• If objects or liquids enter the inside of the device, the device must be disconnected from its power
supply and checked by qualified personnel before further use by.
• Service must be carried out by authorized personnel only. The device is suitable for long-term
operation indoors.
• Mechanical damages, which could affect the normal operation of the device or could present a
hazardous situation for operating persons, have to be repaired by authorized personnel.
• The device is maintenance-free, as all wear and tear parts are replaced by changing the
e|1 Cartridge. Recurring inspections are to be carried out according to local regulations,
respectively according to IEC 62353.
• The e|1 Analyzer may only be operated by persons whose qualifications enable them to comply
with the safety measures that are necessary for operating the device.
• The device shall only be operated by professionals in the field of health-care according to product
training received by an EXIAS Medical trainer or a trainer authorized by EXIAS Medical.
• This device is intended to be used only for the specific purpose described in these Instructions for
Use.
• To ensure the performance and accuracy of the device over long term, it is recommended to use
only the consumables, accessories and spare parts specifically designed and tested for this
analyzer.
• To ensure the quality of the e|1 Analyzer, quality control measurements must be performed daily.
For further instructions see chapter 7 Quality Control.
• Do not use expired consumables or accessories.
• It is obliged to have the measurement results evaluated by a medical professional before further
actions related to the measured values taken.
Biohazard exposure, precautions and disposal

The e|1 Analyzer is designed to reduce risk emerging from biohazard exposure for the operator. The
e|1 Cartridge automatically collects used biological specimen samples. This sealed cartridge is then
disposed after use, without further necessary treatment. The used e|1 Cartridge must NEVER be
opened or dismantled since it contains biohazardous waste.
It is important that used e|1 Cartridges and sample containers are disposed with care,
according to local regulations for biohazardous material.
Warning:
Do not dispose the e|1 Analyzer with regular garbage.
The e|1 Analyzer may has been in contact with biological samples.
It is important that e|1 Analyzer is disposed according to local regulations for biohazardous
material.
2 e|1 Analyzer
Biohazard exposure, precautions and disposal
Warning:
Perform disinfection routine, before transportation of the e|1 Analyzer.
The e|1 Analyzer may have been in contact with biological samples.
As precaution, suitable safety equipment must be worn in order to prevent direct contact with
biological substances:
Wear protective clothing!
Wear protective gloves!
Wear eye protection!
If necessary, a face mask shall be worn. If spraying of blood appears to be possible a face shield is also
required.
The external Quality-Control material of the e|1 Analyzer is filled in glass ampoules. The substances
are not reactive still caution is advised regarding sharp edges arising from the intended use of these
ampoules. The ampoules are not allowed to be disposed with regular domestic refuse.
2 e|1 Analyzer
Applied standards
Applied standards
The instrument is compliant to following standards:
Product safety
• EN 61010-1:2013 Safety requirements for electrical equipment for measurement, control and
laboratory use (Part 1: General requirements).
• EN 61010-2-081:2013 Safety requirements for electrical equipment for measurement, control and
laboratory use (Part 2-081: Particular requirements for automatic and semi-automatic laboratory
equipment for analysis and other purposes).
• EN 61010-2-101:2013 Safety requirements for electrical equipment for measurement, control, and
laboratory use (Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical
equipment).
Electromagnetic compatibility (EMC)
Emission: Class B according to

• EN 61326-1:2013 Electrical equipment for measurement, control and laboratory use – EMC
requirements (Part 1: General requirements).
• EN 61326-2-6:2013 Electrical equipment for measurement, control and laboratory use – EMC
requirements (Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical equipment.
Immunity according to
• EN 61326-1:2013, table 1- Immunity requirements for basic electromagnetic environment
• EN 61326-2-6:2013, table 101 - Immunity requirements for IVD medical equipment
2 e|1 Analyzer
Disinfection
Disinfection
Use disinfection to minimize the risk of handling parts that have been in contact with biological
specimens.
EXIAS recommends a disinfection procedure for the device’s surfaces and its touch-display. In addition,
the specific laboratory regulations must be observed to minimize the risk of infection
Note:
Disinfection of device’s surfaces:
Only use liquid, alcoholic (about 70%) surface disinfectants, e.g. Isopropanol 70% and/or disinfectant
with typically 0.5% to max. 1.0% of the active substance benzalkonium chloride.
Bleaching agents of any kind may not be used.
For disinfection, the device must not be sprayed directly (neither outside, nor in the interior). First
apply cleaning agent to a damp cloth and then disinfect the device.
After disinfecting the device, wait 15 minutes to allow the disinfectant to evaporate.
Disinfection of the Touch-Display

To perform the disinfection of the display, choose the following functions:
[Menu] > Utilities > [Clean device]

The touch-sensitive layer of the screen is deactivated for 30 seconds. Within this period of time the
Touch-Display may be cleaned by wiping a damp cloth soaked with disinfectant across the surface.
Caution:
Only disinfect with a damp cloth (e.g. soaked in disinfectant).
Do not use water or sprays.
Disinfection of the device’s surfaces

Disinfect all external surfaces of the device with the disinfectant in accordance with laboratory
regulations.
2 e|1 Analyzer
IT security advisory
IT security advisory
There is no anti-virus software installed on the e|1 Analyzer.
External storage media may be infected with computer malware (malware such as viruses, trojans,
spyware, etc.) and may transfer such programs to the system.
Therefore, it is important to take these important precautions to prevent the transmission of malware.
Caution:
Failure to observe the following recommendations may result in data loss, loss of integrity of patient
results or unavailability of the system, which may put patients at risk.
• Check all external storage devices with an anti-virus program (on another PC) to ensure that they
are malware-free before using them with the e|1 Analyzer.
• Recheck the external storage device between use on different systems in order to avoid cross-
interference.
• Portable storage media, particularly USB memory drives/sticks, should never be used at home or
at public computer systems and then connected to a work- or customer-system.
• Do not use the USB ports to connect other external storage devices unless stated in e|1 Analyzer
specific documentation.
• Keep all external storage devices in a secure place so that they can be accessed only by authorized
personnel.
• Do not add, move or delete any files or software unless stated in e|1 Analyzer specific
documentation.
• Never copy and install any non-EXIAS software on the device.
• Use remote services only to connect to the service network.
• Make sure only validated computers are connected to the instrument system network.
• Ensure that other computers connected to the same network as the device are properly secured
and protected from malware.
2 e|1 Analyzer
Electrical safety and electromagnetic compatibility
Electrical safety and electromagnetic compatibility

Warning:
The power cord must be plugged into a grounded power receptacle. When using an extension cord,
make sure it is properly grounded.
• The power cable must conform to country-specific requirements.

• Any rupture of the power cable may result in hazardous operating conditions for the operating
personnel.
• Intentional disconnection of the grounding is not permitted.
• The device is not suitable for operation with a direct current power supply.
• Use the original power supply for the e|1 Analyzer only. The power supply must not be repaired
or opened.
Warning:
Place the power supply in a way, that it can be easily unplugged.
• In case of malfunction of the instrument, it must be possible to disconnect the power supply
immediately.
Warning:
The USB ports must not be used in connection with devices, that use their own power supply.
• A failure of the power supply could cause severe damage to the e|1 Analyzer.
Warning:
Make sure that the power supplies of all connected devices use protective ground.
• All connected devices (e.g. switches) must conform to national and international standards.
• If protective ground is not available, use a network isolator for galvanic isolation.
Warning:
Do not use this device near sources of strong electromagnetic radiation (e.g. unshielded intentional RF
sources), as these can impede proper operation.
• Make sure, the electromagnetic environment was evaluated, before operating the instrument.
Limitations of the e|1 Analyzer

Warning:
Do not use the instrument outside the operation conditions, see chapter 4 Specifications.
• Implemented protection measures may become ineffective.
Warning:
Whole blood samples from patients may contain drugs and / or compounds which interfere with the
determination of desired parameters, see chapter 6 Sample Measurement
Warning:
The analyzer is not meant to be used by lay persons. It is a device for near-patient testing, but not for
self-testing. The handling by a professional is always obliged.
2 e|1 Analyzer
Chapter 3
Product Description
Intended use
Intended use
The EXIAS e|1 Analyzer is a semi-automated in-vitro diagnostic medical device to quantitatively
measure the electrolytes Sodium (Na+), Potassium (K+), Calcium (Ca2+) and Chloride (Cl-) as well as pH
and Hematocrit (Hct) in human whole blood, serum, plasma and aqueous solutions.
The device is dedicated for the use in laboratories and Point-of-Care (POC) environments. It is
intended for profes-sional use only. The analyzer works with a multi-use cartridge consumable which
optionally includes on-board Quality Control (oQC).
e|1 Analyzer
The e|1 Analyzer is a system consisting of the e|1 Instrument, including touch screen, printer,
removable cover, and the e|1 Cartridge.
A Touch Display
B Sample Input Unit (e|1 Cartridge)
C Removable cover
Figure 3-1
Touch display
The 7’’ LCD color touch screen enables intuitive and simple operation of the device and can be cleaned easily.
Figure 3-2
2 e|1 Analyzer
e|1 Analyzer
Rear panel
On the rear panel of the e|1 Instrument there are the built-in printer, the ON/OFF button, the power
supply plug as well as USB and Ethernet ports.
B
C
D
E
A Printer D Ethernet port

B ON / OFF button E 2x USB ports
C Power supply plug
Figure 3-3
Note:
Pressing the (On/Off) button does not disconnect the instrument from power supply. For a total
disconnection from power supply, the power cable of the device must be unplugged.
2 e|1 Analyzer
Consumables
Printer
The integrated low noise thermal printer, for printing measurement and QC results, includes an "easy
load" mechanism, which allows a quick and easy change of the 2" paper roll.
Figure 3-4 Printer
Consumables
Note:
For material numbers and order information see chapter 12 Appendix.
e|1 Cartridge
The e|1 Cartridge is a multi-use consumable intended for up to 600 sample measurements used in
the e|1 Analyzer. The e|1 Cartridge contains the sample input mechanism, all fluidic components,
the measuring cell, the calibration fluids and, dependent on the model of the cartridge, the quality
control solutions.
The waste of measured samples and the used calibration and control fluids are also collected inside
the cartridge.
The advantage of this all-in-one cartridge concept is that all parts which encounter biological samples
and all wear and tear components are collected in one cartridge. Hence, no additional maintenance
steps are necessary, besides replacement of the cartridge by the operator.
On an integrated memory chip lot-specific data is stored to provide specific concentration information
of the solutions. Additionally, data such as the cartridge type and expiration date, are stored. This data
is checked automatically for validity by the e|1 Analyzer when a cartridge is inserted into the system.
2 e|1 Analyzer
Consumables
Figure 3-5
Depending of the number of required sample measurements and of the need of an on-board quality
control, six different types of measuring cartridges are available:
e|1 Cartridge 150 up to 150 samples within 28 days
e|1 Cartridge 150 oQC up to 150 samples within 28 days including on board QC
Note:
The counted samples include patient samples, as well as all QC samples run on the device within 28
days.
Sample modes
The sample input module enables the application of different sample containers like sample tubes,
syringes or capillary tubes. A sample probe is used for aspirating the sample out of tubes, syringes or
ampoules. Capillary tubes are attached to a rubber fill port.
Syringe / sample tube mode Capillary tube mode
Figure 3-6
2 e|1 Analyzer
Consumables
Fluids
For calibrating the e|1 Analyzer the “standby” and “calibration” solutions are used. For cartridge types
with on-board QC, additionally three quality control solutions (Level 1, 2 and 3) are integrated.
The individual solutions are filled in impermeable and gas-tight bags. They are closed with a valve that
is opened by inserting the cartridge into the e|1 Instrument for the first time.
The five solutions consist of inorganic salts: Sodium chloride, Potassium chloride, Sodium Acetate and
Calcium chloride. The buffer system is based on 2- (4- (2-hydroxyethyl) -1-piperazinyl)) -ethane
sulfonic acid (HEPES) and its alkali metal salts.
Part of the solutions are also a preserving agent mixture based on Isothiazolinones and 5-bromo-5-
nitro-1,3-dioxane with total active substance concentrations <50 ppm and a wetting agent, based on
polyethylene glycol and polypropylene glycol with total concentrations <50 ppm.
Tubing
The multi-channel distribution valve operates automatically and releases the fluids required for device
operation and measurement. All fluid paths are integrated, including the pump tubing for the
peristaltic pump to transport the fluids. The peristaltic pump itself is part of the instrument.
Waste
An integrated waste pouch absorbs all used fluids as well as the measured sample material. At the
end of the operating time of the e|1 Cartridge, the used e|1 Cartridge must be disposed as
biohazardous waste.
Electrical contacts
At the top of the e|1 Cartridge, the contact plate is located. It performs as the electrical interface to
the e|1 Instrument when the cartridge is correctly inserted. The electronics inside the cartridge are
used for reading signals of potentiometric sensors, for measuring temperatures and temperature
control, for positioning of samples and for reading stored data.
Figure 3-7
Note:.
The contact surface must not be touched when dealing with and/or handling the cartridge.
2 e|1 Analyzer
Consumables
Memory chip
The integrated memory chip stores the following information:
• Cartridge type
• Lot specific concentration of ingredients of the solutions
• Lot number / Serial number
• Expiration date
• Installation date
• Maximum and remaining number of samples (including QC samples)
• Maximum and remaining in-use time
Printer paper
The printer paper on the e|1 Analyzer is a BPA free thermal paper with 2 inch width (57 mm) and a
length of 25 m.
Figure 3-8
Note:
The printout will bleach, if it is exposed to light for a long time.
2 e|1 Analyzer
Accessories
Accessories
Note:
For material numbers and order information see chapter 12 Appendix.
QC Material
The e|1 QC material is an assayed quality control material used for manual Quality Control
measurements to monitor the performance of the e|1 Analyzer. It is not intended to be used with
analyzers from other manufacturers.
The e|1 QC material is designed to detect instrument malfunctions that would affect analytical
results. As this is not a blood-based material, it may not detect circumstances that would affect the
testing of biological samples.
The product is intended to be used as a quality control material and not as a calibration standard. Its
use should not replace other aspects of a complete quality control procedure.
The e|1 QC material is providing analyte concentrations within the clinical range and is available in
three different levels filled in sealed glass ampoules, each containing 2,5 ml of solution.
e|1 QC-1 Quality Control 30 Pcs. of Level 1 Quality Control Ampoules
Figure 3-9 QC material
The material consists of buffered aqueous solutions containing electrolytes (Na, K, Ca and Cl). The
electrical conductivities provide control means for hematocrit measurement of the e|1 Analyzer.
• Level 1 contains low reference values for Na, K, Cl, pH and Hct, high value for Ca
• Level 2 contains normal values for all parameters
• Level 3 contains high reference values for Na, K, Cl, pH and Hct, low value for Ca
Note:
The e|1 Analyzer is not designed to accept commercial liquid QC materials from 3rd party providers.
Note:
The quality control solutions contain no preservative and no human or biological material.
2 e|1 Analyzer
Accessories
Note:
Further information can be found in the enclosed insert sheet of the QC material.
Barcode scanner
The e|1 barcode scanner is an optional accessory connected to the e|1 Instrument via the USB
interface.
The scanner can be used for easy reading of patient or operator data and external QC material (lot
number, target values, etc.) which are available as 1D barcodes.
Figure 3-10
Note:
Press the button on the bottom to enable the scanner. The scanner beeps and the LED on the top
flashes once to indicate a successful scan of the barcode.
Recommendations for ensuring good barcode scanning quality:

• The label or piece of paper with the printed barcode should be smooth and without folds.
• The printed barcode must not be distorted during the printing process (ensure good quality ink,
printer ribbon or toner).
• Do not use printing materials with shiny or reflective surfaces.
• Try different scanning angles and distances between scanner and paper.
2 e|1 Analyzer
Accessories
Capillary tubes
EXIAS Medical offers heparinized single-use Capillary tubes as sample receptacles. The capillaries are
intended for fast collection, transport and automated processing of blood for pH/blood gas,
electrolyte, oximetry and metabolite analysis. The tubes are made of plastic and heparinized with 100
I.U. balanced heparin to avoid blood clotting. The volume of the tubes is 50 microlitres and meant to
be used in combination with systems of EXIAS. One box contains four (4) dispensers for 100 capillaries
each.
Figure 3-11
Note:
Further information can be found in the enclosed insert sheet of the Capillary tubes.
2 e|1 Analyzer
Accessories
2 e|1 Analyzer
Chapter 4
Specifications
4 Specifications
4 Specifications
System Characteristics
System Characteristics
Sample volume 20 μl
Time to display 25 Seconds
Calibration times 30 Seconds for 2 point calibration
Table 4-1 General performance features
Sample Types
• Whole blood
• Serum
• Plasma
• Aqueous solutions
• Recommended QC-materials
Measurement Parameters
Parameter specified for: specified range Unit Conversion

+
Na B/S/P/Q 85 - 200 mmol/l
K+ B/S/P/Q 1.0 - 15.0 l mmol/l
Cl- B/S/P/Q 60 - 150 mmol/l
Ca2+ B/S/P/Q 0.1 - 3.2 mmol/l = 4,008 mg/dl
HCT B 10 - 75 HCT%
pH B/S/P/Q 6.7 - 8.0 pH
Table 4-2 Measurement parameters
B Whole blood
S Serum
P Plasma
Q Aqueous solutions
2 e|1 Analyzer
4 Specifications
Calculated Parameters
Calculated Parameters
Parameter specified for: specified range

tHb(c) (a) B Reported value for HCT required
2+ Reported value for pH and Ca2+ required. The pH
nCa B/S/P/Q
reported value must be between 7.2 and 7.6 units.
Table 4-3 Calculated parameters
(a) Note: Calculation of tHb(c) requires Mean Corpuscular Heamoglobin Concentration (MCHC) as mandatory input
value. A default value of 34 g/dL is considered, and can be changed during measurement if required.
For detailed information of the calculated parameters see chapter 11 Theoretical Foundations
section Calculated values.
2 e|1 Analyzer
4 Specifications
Performance Characteristics
Accuracy of measurement
The accuracy of a measurement result is a combination of trueness and precision, where trueness is
affected by systematic error (bias) and measurement precision by random error (standard deviation).
Both characteristics contribute as individual components to the total error measurement and affect
the measurement accuracy, which is evaluated in Trueness of measurement as Total Analytical Error.
Precision
The precision of the EXIAS e|1 Analyzer displays the variability in results of repeated measurements
of homogeneous samples and represent the random measurement error. Thus precision is a
qualitative concept. Precision is defined at two extreme sets of conditions: repeatability, when the
main controllable factors are kept constant, and reproducibility, when the main controllable factors
can vary. These controllable factors are: analyzer, reagent lots, calibration material, location,
environmental conditions or time.
The estimates for repeatability and reproducibility are based on 8 samples x 20d x 2runs x 2replicates
x 7devices in single (per device; run nested within day) and pooled (all devices; days nested in
cartridge, run nested in day, replicates nested in run) evaluation, as well as 11 samples x 3devices x
5day x 5replicates (day nested in device; each site represents a single lot)) evaluation, whereat 3
different lots and aqueous (QC) as well as plasma-based samples are incorporated in the experiment.
The following tables show the standard deviation (SD) and coefficient of variation (CV [%]) of the
repeatability and reproducibility of each measured parameter of the e|1 Analyzer.
(a) The precision is defined for different sample types (ST) aqueous solutions (Q – QC material level 1-
3) and plasma (P – at low, native and high concentration).
(b) For the aqueous solutions the pooled precision estimates and the weighted average of the
variances (weighting-factor N) are the results of the [3x5x5] experiment day nested in site (each site
represents a single device and single lot/cartridge) and single-site experiment [20x2x2] run nested
in site, replicates nested in run. Respectively [7x20x2x2] days nested in cartridge, run nested in day,
replicates nested in run.
(c) For plasma the multisite-experiment [3x5x5], day nested in site (each site represents a single device
and single lot/cartridge) was used to define its precision depending on low, native and high
concentration.
The reproducibility of plasma alters due to limited stability of biological samples (day-to-day-
variability)
(d) The overall precision of the parameter is the pooled precision estimates and the average of the
variances.
The precision study is conducted and analyzed in accordance with CLSI EP05-A3.

2 e|1 Analyzer
4 Specifications
Sodium (Na+)
Repeatability Reproducibility Unit
ST(a) Pool N Level SD CV% SD CV%
oQC1 635 119.4 0.36 0.30% 0.45 0.38% mmol/L, %
Q(b) oQC2 635 136.1 0.27 0.19% 0.36 0.27% mmol/L, %
oQC3 631 161.1 0.30 0.18% 0.39 0.24% mmol/L, %
low 75 118.6 0.16 0.13% 1.06 0.89% mmol/L, %
(c)
P native 60 141.3 0.35 0.25% 1.03 0.73% mmol/L, %
high 75 154.0 0.30 0.19% 1.31 0.85% mmol/L, %
(d)
overall - - 0.25 0.18% 0.66 0.48% mmol/L, %
+
Table 4-4 Precision Sodium (Na )
Potassium (K+)
oQC1 635 1.98 0.023 1.15% 0.025 1.28% mmol/L, %
Q(b) oQC2 635 4.39 0.012 0.27% 0.017 0.38% mmol/L, %
oQC3 631 6,54 0.020 0.31% 0.027 0.41% mmol/L, %
low 75 2.52 0.006 0.24% 0.021 0.83% mmol/L, %
(c)
P native 60 3.87 0.009 0.23% 0.029 0.75% mmol/L, %
high 75 6.19 0.031 0.50% 0.065 1.05% mmol/L, %
(d)
overall - - 0.016 0.46% 0.031 0.70% mmol/L, %
Table 4-5 Precision Potassium (K+ )
Calcium (Ca2+)
oQC1 635 1.494 0.009 0.59% 0.015 0.98% mmol/L, %
Q(b) oQC2 635 1.129 0.005 0.43% 0.008 0.71% mmol/L, %
oQC3 631 0.596 0.006 0.93% 0.009 1.45% mmol/L, %
low 75 0.813 0.004 0.50% 0.006 0.76% mmol/L, %
P(c) native 55 1.076 0.006 0.53% 0.013 1.22% mmol/L, %
high 75 1.447 0.007 0.47% 0.019 1.31% mmol/L, %
(d)
overall - - 0.006 0.81% 0.013 1.57% mmol/L, %
Table 4-6 Precision Calcium (Ca2+)
2 e|1 Analyzer
4 Specifications
Chloride (Cl-)
oQC1 635 83.0 0.38 0.45% 0.50 0.60 mmol/L, %
Q(b) oQC2 635 100.9 0.50 0.49% 0.59 0.58% mmol/L, %
oQC3 631 131.4 0.49 0.38% 0.62 0.48% mmol/L, %
low 75 75.1 0.25 0.33% 0.81 1.08% mmol/L, %
P(c) native 60 104.2 0.71 0.68% 1.42 1.36% mmol/L, %
high 75 113.7 0.62 0.55% 0.88 0.77% mmol/L, %
(d)
overall - - 0.46 0.43% 0.74 0.74% mmol/L, %
-
Table 4-7 Precision Chloride (Cl )
pH (pH)
oQC1 635 7.142 0.002 0.03% 0.003 0.05% pH, %
Q(b) oQC2 635 7.397 0.001 0.02% 0.002 0.02% pH, %
oQC3 631 7.642 0.002 0.03% 0.004 0.05% pH, %
low 75 7.184 0.002 0.03% 0.013 0.18% pH, %
P(c) native 60 7.477 0.006 0.07% 0.019 0.25% pH, %
high 75 7.642 0.006 0.07% 0.014 0.18% pH, %
overall (d) - - 0.003 0.04% 0.009 0.15% pH, %
Table 4-8 Precision pH (pH)
Hematocrit (HCT)
oQC1 635 58.3 0.35 0.59% 0.37 0.63% HCT%, %
Q(b) oQC2 635 45.5 0.51 1.13% 0.57 1.26% HCT%, %
oQC3 619 25.2 0.46 1.83% 0.52 2.07% HCT%, %
low HCT%, %
B(c) native 153 - 0.50 1.19% 0.92 2.19% HCT%, %
high HCT%, %
(d)
overall - - 0.45 1.64% 0.53 2.00% HCT%, %
Table 4-9 Precision Hematocrit (HCT)
2 e|1 Analyzer
4 Specifications
Trueness of measurement
Measurement trueness is the performance characteristic representing lack of systematic
measurement error in a series of measurement result from a homogeneous sample. Thus the bias is
evaluated which requires a suitable reference material and measurement procedure that is used to
determine a reference quality value of the e|1 Analyzer. This is achieved by performing method-
comparison-experiments.
The clinical method-comparison-experiments were performed within the performance evaluation
study on three (3) independent clinical sites with three (3) e|1 Analyzers. An extended nonclinical
method-comparison-experiment was performed within an inhouse study in laboratories of EXIAS
Medical with up to eight (8) e|1 Analyzers. For both studies Roche cobas b 221 analyzers were used
as reference devices. Heparinized whole blood left-over samples and contrived blood samples were
analyzed in the course of both studies (two (2) replicates per sample).
The following tables show the results of measurement trueness of each parameter of the e|1
Analyzer. For the clinical and non-clinical study a specific number of sample (N) was measured.
(a) As regression a Deming-Regression is defined with y=b1 x + b0 and R² representing the Pearson´s
correlation coefficient.
(b) The bias is based on a regression analysis with a confidence interval of 95% using a jackknife
approach. For the comparison of the e|1 Analyzer and Roche cobas b221 the cobas b221 was
adjusted by user correction.
(c) The Total Analytical Error (TAE) is defined as percentiles corresponding to lower and upper values.
(d) The Allowable Total Error (ATE) defines the maximum error for patient result that a single result can
show with a probability of 95 %
The method comparison study is conducted and analyzed in accordance with CLSI EP09-A3, EP14-A2
and EP21 2nd Edition.
2 e|1 Analyzer
4 Specifications
Sodium (Na+)
Information Value Unit
Clinical Study 1294
Samples (N)
Non Clinical Study 586
min 85.4 mmol/L
Covered Range
max 191.1 mmol/L
b0 0.5622 mmol/L
Regression(a) b1 0.9946 1
R² 0.9943 1
concentration bias
85 0.1 mmol/L
120 -0.1 mmol/L
Bias (b) 135 -0.2 mmol/L
145 -0.2 mmol/L
155 -0.3 mmol/L
200 -0.5 mmol/L
Limit low high
TAE (c) -2.3 2.0 mmol/L
Accuracy ATE (d) -6.7 6.7 mmol/L
ATE:TAE ratio 2.9 3.4 1
pwithin,% 100 %
Table 4-10 Method comparison Sodium (Na+)
Potassium (K+)
Clinical Study 1325
Samples (N)
min 1.05 mmol/L
Covered Range
max 14.88 mmol/L
b0 0.0162 mmol/L
R² 0.9991 1
concentration bias
1 0.01 mmol/L
2.5 -0.01 mmol/L
Bias (b) 3.5 -0.01 mmol/L
5.1 -0.03 mmol/L
6.2 -0.04 mmol/L
15 -0.11 mmol/L
Limit low high
TAE (c) -0.15 0.1 mmol/L
pwithin,% 100 %
Table 4-11 Method comparison Potassium (K+)
2 e|1 Analyzer
4 Specifications
Calcium (Ca2+)
Clinical Study 1300
Samples (N)
min 0.1 mmol/L
Covered Range
max 3.173 mmol/L
b0 0.019 mmol/L
R² 0.9911 1
concentration bias
85 0.019 mmol/L
120 0.018 mmol/L
Bias (b) 135 0.018 mmol/L
145 0.018 mmol/L
155 0.018 mmol/L
200 0.017 mmol/L
Limit low high
TAE (c) -0.049 0.074 mmol/L
pwithin,% 100 %
Table 4-12 Method comparison Calcium (Ca2+)
Chloride (Cl-)
Clinical Study 1321
Samples (N)
min 71.4 mmol/L
Covered Range
max 149.5 mmol/L
b0 0.1928 mmol/L
(a)
Regression b1 0.9968 1
R² 0.9747 1
concentration bias
60 0.0 mmol/L
80 -0.1 mmol/L
Bias (b) 98 -0.1 mmol/L
107 -0.1 mmol/L
120 -0.2 mmol/L
150 -0.3 mmol/L
Limit low high
TAE (c) -3.1 3.5 mmol/L
pwithin,% 99.78 %
Table 4-13 Method comparison Chloride (Cl-)
2 e|1 Analyzer
4 Specifications
pH (pH)
Clinical Study 1154
Samples (N)
min 6.850 pH
Covered Range
max 7.903 pH
b0 -0.0379 pH
R² 0.9829 1
concentration bias
6.7 -0.007 pH
7.2 -0.005 pH
Bias (b) 7.32 -0.005 pH
7.43 -0.004 pH
7.6 -0.003 pH
8 -0.002 pH
Limit low high
(c)
TAE -0.039 0.032 pH
Accuracy ATE (d) -0.088 0.088 pH
pwithin,% 99.41 %
Table 4-14 Method comparison pH (pH)
Hematocrit (HCT)
Clinical Study 1227
Samples (N)
min 12.6 HCT%
Covered Range
max 74.9 HCT%
b0 -1.2967 HCT%
(a)
Regression b1 1.0231 1
R² 0.991 1
concentration bias
10 -1.1 HCT%
20 -0.8 HCT%
Bias (b) 36 -0.5 HCT%
53 -0.1 HCT%
60 0.1 HCT%
75 0.4 HCT%
Limit low high
TAE (c) -1.7 1.5 HCT%
Accuracy ATE (d) -6.6 6.6 HCT%
pwithin,% 99.8 %
Table 4-15 Method comparison HCT (HCT)
2 e|1 Analyzer
4 Specifications
Analytical Sensitivity
The analytical senstitivity of the e|1 Analyzer is described by its Limits of Detection (LoB, LoD) and
Limits of Quantitation (LoQ). These limits are determined for K in plasma, Ca2+ in plasma and HCT in
whole blood, thus plasma. The detection limits for Na+, Cl-, and pH are not determined since the
measuring rage exceeds pathological variations. However, the LoQ for Na+, Cl-, and pH can be
determined. All limits are listed in the following tables:
Limit Definition
Limit of Blank (LoB) concentration at which there is a 95 % probability that a sample is analyte-free.
Limit of Detection (LoD) concentration at which there is a 95 % probability that a sample contains analyte.
Limit of Quantitation (LoQ) lowest amount of analyte in a sample that can be quantitatively determined with
acceptable precision and trueness.
Table 4-16 Definition of limits of analytical sensitivity
Sample Limits
Analyte Unit
Type N LoB N k LoD N k LoQ
Sodium (Na+) P - - - - - 55 4 75,2 mmol/L
Potassium (K+) S 212 0,25 305 4 0,26 305 4 0,26 mmol/L
Calcium (Ca2+) S 100 0,00 290 4 0,016 290 4 0,016 mmol/L
Chloride (Cl-) P - - - - - 55 4 44,1 mmol/L
pH (pH) P - - - - - 67 3 6,65 pH
Hematocrit (HCT) B 103 1,67 240 4 2,97 240 4 2,97 HCT%
Table 4-17 Limits of analytical sensitivity
Analytical Specificity
The analytical specificity describes how different endogenous substances and drugs potentially
interfere with parameters measured on the e|1 Analyzer and how precise the measurement detects
only those analytes to be detected. Here the following substances must be taken into consideration:
• substances used for patient treatment (e.g. therapeutic drugs, anticoagulants, etc.);
• substances ingested by the patient (e.g. over the counter medications, alcohol, vitamins, foods,
etc.);
• substances added during sample preparation (e.g. preservatives, stabilizers);
• substances encountered in specific specimens’ types (e.g. hemoglobin, lipids, bilirubin, proteins);
• analytes of similar structure (e.g. precursors, metabolites) or medical conditions unrelated to the
test condition including specimens negative for the assay but positive for a condition that may
mimic the test condition).
2 e|1 Analyzer
4 Specifications
Interference
Interference
Interferences can be significant sources of error in clinical analysis. While the precision can be
determined by internal QC and the correctness can be determined by verifying reference samples,
possible sources of interference cannot be identified during ongoing operation. For this reason, the
effect of potentially interfering substances is determined.
For additional information, refer to Interference Testing in Clinical Chemistry; Approved Guideline EP-7
Vol, 25; No. 27 of the Clinical and Laboratory Standard Institutes (CLSI).
Substances without effect

The following substances were tested and do not show any effect on the measurement parameters
and do not violate the specifications.
Generic name (substance) Concentration Tested analyte

Ammonium chloride * 0.151 mmol/L Na+, K+, Cl-, Ca2+, pH
L- Ascorbic acid * 0.298 mmol/L Na+, K+, Cl-, Ca2+, pH
Bilirubin, conj. (Bilirubin ditaurate, disodium salt) * 0.684 mmol/L Na+, K+, Cl-, Ca2+
Calcium (total, calcium chloride dihydrate) * 5 mmol/L Na+, K+, pH
Chloride (sodium salt) * 120 mmol/L K+, Ca2+, pH
Dobesilate * 0.144 mmol/L Na+, K+, Cl-, pH
Dopamine (HCl) * 0.004 mmol/L Na+, K+, Cl-, Ca2+, pH
Ethanol * 130 mmol/L Na+, K+, Cl-, Ca2+, pH
Fluorescein * 0.904 mmol/L Na+, K+, Cl-, Ca2+, pH
Fluoride * 0.063 mmol/L Na+, K+, Cl-, Ca2+, pH
Ibuprofen * 1.06 mmol/L Na+, K+, Cl-, Ca2+
Intralipid 2% Na+, K+, Cl-, Ca2+, pH
Iodide (sodium iodide) 1 mmol/L Na+, K+, Cl-, Ca2+, pH
L-Lactate (sodium salt) * 10 mmol/L K+, Cl-, Ca2+
Lithium (lithium chloride) 3.2 mmol/L Na+, K+, Cl-, Ca2+, pH
Nitroprusside (Nitroprusside sodium dihydrate) 2.35 mmol/ Na+, K+, Cl-, Ca2+, pH
Oxalate (dipotassium salt monohydrate) * 0.09 mmol/L Na+, K+, Cl-, Ca2+, pH
Perchlorate (sodium salt monohydtrate) 1.5 mmol/L Na+, K+, Cl-, Ca2+, pH
Phosphate (phosphate buffer) * 3.9 mmol/L Cl-, Ca2+
pH value high * (sodium carbonate) pH 8 K+, Cl-
pH value low (acetic acid) pH 6.8 Na+, K+, Cl-
Potassium (potassium chloride) * 8 mmol/L Na+, Cl-, Ca2+, pH
Protein total (albumine) * 120 g/l Na+, K+, Cl-
Salicylic acid (sodium salicylate) * 0.207 mmol/L Na+, K+, Cl-, Ca2+, pH
Sodium (sodium acetate) * 170 mmol/L Na+, K+, Cl-, Ca2+, pH
Thiocyanate (potassium salt) 0.898 mmol/L Na+, Cl-, Ca2+, pH
Zinc (zinc chloride) 0.17 mmol/L Na+, K+, Cl-, Ca2+, pH
Table 4-18 Substances not interfering the measurement result
* The substance and concentration are listed in the recommendation for Interference Testing in Clinical Chemistry;
Guideline EP07, 3rd ed. of the Clinical and Laboratory Standards Institute.
2 e|1 Analyzer
4 Specifications
Interference
Substances with effect

The following substances were tested and do show an effect on the measurement parameters violate
the specifications.
Generic name Concentration Unit Analyte Analyte Effect of ATE Unit

(substance) level substance
Benzalkonium 0.0285 [mmol/L] Na+ 140.4 6.6 ± 0.4 4.2 [mmol/L]
chloride
0.0285 [mmol/L] Ca2+ 1.101 0.274 ± 0.009 0.160 [mmol/L]
0.0214 [mmol/L] Na+ 140.4 5.0 ± 0.3 4.2 [mmol/L]
0.0214 [mmol/L] Ca2+ 1.101 0.200 ± 0.006 0.160 [mmol/L]
0.0143 [mmol/L] Na+ 140.4 3.6 ± 0.2 4.2 [mmol/L]
0.0143 [mmol/L] Ca2+ 1.101 0.152 ± 0.005 0.160 [mmol/L]
Bromide 4.0 [mmol/L] Cl- 103.3 13.6 ± 0.9 6.0 [mmol/L]
(sodium salt)
3.0 [mmol/L] Cl- 103.3 10.4 ± 0.6 6.0 [mmol/L]
-
2.0 [mmol/L] Cl 103.3 6.9 ± 0.4 6.0 [mmol/L]
1.0 [mmol/L] Cl- 103.3 3.4 ± 0.2 6.0 [mmol/L]
-
Cefoxitin * 15.50 [mmol/L] Cl 103.6 6.3 ± 0.3 6.0 [mmol/L]
11.63 [mmol/L] Cl- 103.6 4.8 ± 0.4 6.0 [mmol/L]
+
Citrate (trisodium salt 40 [mmol/L] K 3.74 -0.93 ± 0.00 0.40 [mmol/L]
dihydrate) *
40 [mmol/L] Cl- 102.6 16.2 ± 0.4 6.0 [mmol/L]
+
30 [mmol/L] K 3.74 -0.76 ± 0.00 0.40 [mmol/L]
30 [mmol/L] Cl- 102.6 12.1 ± 0.4 6.0 [mmol/L]
+
20 [mmol/L] K 3.74 -0.55 ± 0.00 0.40 [mmol/L]
20 [mmol/L] Cl- 102.6 8.6 ± 0.2 6.0 [mmol/L]
10 [mmol/L] K+ 3.74 -0.30 ± 0.00 0.40 [mmol/L]
10 [mmol/L] Cl- 102.6 4.1 ± 0.3 6.0 [mmol/L]
CO2 (total, sodium 35.00 [mmol/L] Cl- 101.4 6.9 ± 0.5 6.0 [mmol/L]
hydrogencarbonate) *
26.25 [mmol/L] Cl- 101.4 4.9 ± 0.3 6.0 [mmol/L]
+
EDTA (disodium salt 15.00 [mmol/l] K 4.41 -0.40 ± 0.00 0.40 [mmol/L]
dihydrate) *
Heparin 300 [kU/L] Ca2+ 1.177 -0.322 ± 0.002 0.160 [mmol/L]

(lithium salt) *
300 [kU/L] pH 7.419 0.167 ± 0.003 0.059 pH
2+
229.3 [kU/L] Ca 1.177 -0.243 ± 0.002 0.160 [mmol/L]
229.3 [kU/L] pH 7.419 0.096 ± 0.002 0.059 pH
2+
158.5 [kU/L] Ca 1.177 -0.169 ± 0.002 0.160 [mmol/L]
158.5 [kU/L] pH 7.419 0.061 ± 0.002 0.059 [mmol/L]
87.8 [kU/L] Ca2+ 1.177 -0.085 ± 0.003 0.160 [mmol/L]
87.8 [kU/L] pH 7.419 0.027 ± 0.003 0.059 pH
2+
Magnesium (chloride, 4.100 [mmol/l] Ca 1.051 0.259 ± 0.003 0.160 [mmol/L]
hexahydrate) *
3.075 [mmol/l] Ca2+ 1.051 0.206 ± 0.003 0.160 [mmol/L]
2+
2.05 [mmol/l] Ca 1.051 0.139 ± 0.004 0.160 [mmol/L]
Table 4-19 Substances interfering the measurement result
* The substance and concentration are listed in the recommendation for Interference Testing in Clinical Chemistry;
Guideline EP07, 3rd ed. of the Clinical and Laboratory Standards Institute.
2 e|1 Analyzer
4 Specifications
Linearity
Linearity
The linearity study is conducted to demonstrate that measurements across the claimed measuring
range for each parameter are linear (are directly proportional to the concentration of the analyte in
the test-result). Five (5) 5 e|1 Analyzers were used in the course of the nonclinical studies to evaluate
the linearity of the e|1 Analyzer. Three (3) cartridge-lots were analyzed in the course of the
experiments. Fundamental linearity can be demonstrated for all analytes in all investigated sample
types based on k = 7 - 9 equally spaced intermediate concentrations prepared by proportionately
mixing the high and low pools, measuring N = 5 replicates per pool and device.
The linearity evaluation is conducted and analyzed in accordance with CLSI EP06-A.
The following table shows the linearity of the measurement parameters.
(a) The covered range represents the range within which linearity can be demonstrated. This
measuring range was covered in nonclinical studies.
(b) Linearity goals are specified for lower (min) and upper (max) measurement range.
Covered Linearity
Analyte Unit
Range (a) Goals (b)
min max k min max
+
Sodium (Na ) 72.2 222.1 9 1.20 1.80 mmol/L
Potassium (K+) 0.83 16.42 9 0.10 0.24 mmol/L
2+
Calcium (Ca ) 0.000 3.426 9 0.04 0.08 mmol/L
Chloride (Cl-) 46.6 182.9 9 1.80 2.25 mmol/L
pH (pH) 6.656 8.095 9 0.0134 0.016 pH
Hematocrit (HCT) 6.4 74.6 11 1.6 2.0 HCT%
Table 4-20 Linearity of all measurement parameter
2 e|1 Analyzer
4 Specifications
Environmental Parameters
Environmental Parameters
Operating, Storage and Transport Conditions
e|1 Analyzer
Operating conditions
Ambient temperature: between +15°C and +32°C
Sea level: between -100 and +4000 m sea level
Relative humidity: between 15% and 90% rel. humidity (not condensed)
Storage and transport conditions in original packaging

Temperature: between -20°C and +50°C
Humidity between 15% and 90% rel. humidity (not condensed)
e|1 Cartridge
Storage conditions in original packaging / shelf life
Temperature: between +2°C and +25°C up to 6 months
Humidity: between 15% and 90% rel. humidity (not condensed)
Transport conditions in original packaging

Temperature: between +2°C and +30° up to 7 days
including 24 hours at + 40° C (to cover temperature peaks
during transport)
QC-Material
Temperature: between +2°C and +25 °C up to 48 months

Temperature: between +2°C and +45°C up to 5 days
Capillary tubes
Temperature: between +2°C and +30 °C up to 3 years

Temperature: between +2°C and +30°C
2 e|1 Analyzer
4 Specifications
Technical Specifications
Device
Electrical data Mains voltage range: 24V DC

Current: 2.5A
Required power: max. 60 W
Classification Protection class: I (1)
Overvoltage category: I (1)
Contamination level: II (2)
Dimensions Width: 20 cm
Heigth: 32 cm
Depth: 27 cm
Weight 4 kg
Power supply
Type Manufacturer MEAN WELL USA Inc.

Manufacturer part number GSM60A24-P1J
Electrical data Mains voltage range: 100 - 240VAC
Frequency: 50/60 Hz
Current: 1.4 – 0.7A
Protection Short circuit / overload / over voltage /
over temperature
Connection Inlet 3 pole AC, class 1, IEC320-C14
Outlet Barrel connector, 2.1mm ID x 5.5mm
OD x 11mm
Outside Inside
Printer
Type: "Easy load" thermal printer

Paper width: 2"
Touch Display
Format: 7"
Resolution: 800 x 480 pix
2 e|1 Analyzer
4 Specifications
2 e|1 Analyzer
Chapter 5
System Installation
Choosing a location
Choosing a location
A well-chosen location is important for trouble-free operation of the e|1 Analyzer. Before you begin
setup, choose a site that is convenient for your sampling needs and meets the following physical
requirements:
• The analyzer should be placed on a flat surface.
• The electrical outlet must be well grounded.
• The analyzer should not be placed in direct sunlight, or direct draft of air-conditions.
• To allow enough air to circulate there should be substantial space around the unit.
• The analyzer should not operate close to strong electromagnetic fields, such as those created by
electric motors and X-ray equipment.
• The analyzer should not be placed next to explosive gases or vapours.
For further necessary environmental conditions refer to chapter 4 Specifications, section
Environmental Parameters.
2 e|1 Analyzer
Unboxing and checking contents
Unboxing and checking contents

Before installation, the instrument, consumables and accessories should be checked for
completeness and potential damage.
The following items are included in the standard delivery of the e|1 Analyzer
• e|1 Analyzer
• Power Supply Unit
• Printer Paper (box of 5)
The e|1 Cartridge is a consumable and is ordered separately
The e|1 Barcode scanner, e|1 QC material and Capillary tubes are optional accessories and are
ordered separately.
Caution:
Before installing the e|1 Analyzer or using the e|1 Cartridge it must be assured that the products
have room temperature. Cold temperature while storage or transportation can lead to condensation,
which may cause malfunction of the system. Hence the products must be acclimatized to room
temperature for at least two (2) hours before use.
2 e|1 Analyzer
Installation and setup
Installation and setup

Place the e|1 Analyzer on the surface where it shall be installed and connect the power supply unit to
the rear panel at point C.
Switch on the instrument by pressing the ON/OFF button B.
B
C
D
E
A Printer
B ON/OFF button
C Power supply plug
D Ethernet port
E 2x USB ports
Figure 5-1 Rear panel
The analyzer goes through the initial boot-up routine that may take 3 to 5 minutes. This initial routine
ends with the anaylzer displaying a message that no e|1 Cartridge is currently inserted.
Setting Date, Time and Language

Before inserting the e|1 Cartridge it is important to set the local date, time and region where the
anaylzer is being installed. This ensures that the installation date of installed cartridge will be correct.
Also the language of the device can be changed.
[Menu] > [Settings] > [Date/time]
Here Date/time can be set. For further instructions see chapter 9 System Functions, section Settings.
[Menu] > [Settings] > [Language]
Here the language can be edited. For further instructions see chapter 9 System Functions, section
Settings. The default language for shipped devices is English.
2 e|1 Analyzer
Inserting the e|1 Cartridge

To insert the e|1 Cartridge, press Insert on the Alarms / Warnings-Screen to start the installation
workflow. The analyzer provides step-by step instructions, with animated pictures to guide the
operator, for further instructions see chapter 8 Replacement of Consumables, section Replacement
of e|1 Cartridge.
Figure 5-2
It is recommended to hold the anaylzer with one hand, when inserting the e|1 Cartridge. This helps
inserting the cartridge correctly. Inserted properly, the cartridge locks into the system and makes an
audible clicking sound.
Figure 5-3
If the cartridge is confirmed, initialization of unused cartridges takes about 30 minutes.

The e|1 Analyzer can be programmed to run automatic on-board quality control measurements
(oQCs), or request for manual QC after a cartridge replacement. For further instructions see chapter 9
System Functions, section Settings.
2 e|1 Analyzer
Current state of the e|1 Cartridge on-board

The operator can access cartridge information anytime. Next to the cartridge icon on the main screen
remaining days as well as measurements left are listed.
Figure 5-4
By pressing the icon, a detailed summary of the cartridge on-board is listed. This includes information
like the serial and lot number, the expiration date, remaining in-use time, and remaining samples.
Figure 5-5
A warning is provided by the system either if the cartridge is only valid for two (2) more days, or if only
20 more samples are left.
Note:
The installation date of the cartridge, any later removals, and re-insertions are stored on cartridge
chip-data, and not on analyzer.
2 e|1 Analyzer
Note:
If removed from analyzer and stored outside, the active e|1 Cartridge is usable if re-inserted within
72 hours. After 72 hours the cartridge is invalid and has to be replaced.
If the analyzer is switched off (or has a power-fail) with the cartridge on-board, the cartridge is usable
if analyzer’s power is restored or switched-on within 72 hours.
If the analyzer has a system-stop with no actions, the cartridge is reusable if the last fluidic action has
been less than 72 hours ago.
2 e|1 Analyzer
Chapter 6
Sample Measurement
Preanalytics
Preanalytics
Sample collection
Warning:
When drawing blood samples, the generally applicable safety precautions must be followed. When
handing blood samples, the risk for transmission of HIV, Hepatitis B and C viruses or other blood
borne pathogens exists. Appropriate blood sampling techniques must be used to minimize the risk for
operating personnel.
Blood collection for analysis must be performed by qualified personnel.
To avoid direct contact with biological agents, wear suitable protective equipment, such as laboratory
clothing, protective gloves, safety glasses and if necessary, surgical masks. In addition, a face shield is
required, if there is a risk of splashing. Suitable disinfection procedures must be applied.
Guidelines and additional information about handling blood samples are provided in CLSI document M29-A3,
"Protection of Laboratory Workers from Occupationally Acquired Infections; Approved Guidelines - 3rd edition
2005" and other documents.
Warning:
Under no circumstances pressure may be applied to the puncture site. If the blood sample is mixed
with tissue, fluid coagulation may begin prematurely despite sufficient heparinization of the sample
collection containers. Incorrect sample collection or the use of unsuitable sample collection
containers can cause errors and interfere with measured values. The measuring of hemolyzed blood
samples may lead to sustained deviations particularly of sodium and potassium.
For detailed information about drawing blood and storing and handling blood samples, refer to CLSI Document
H11-A4, "Procedures for the collection of arterial blood specimens; Approved Standard (Fourth Edition 2004)".
Anticoagulants
Warning:
Only use Li-heparin or balanced heparin salts as anticoagulants for whole blood analysis in the e|1
Analyzer. Other anticoagulants such as EDTA, citrate, oxalates, fluorides and ammonium
anticoagulants have a significant effect on blood pH and other parameters and should not be used.
2 e|1 Analyzer
Preanalytics
Sample containers
A Sample tube B Capillary tube C Syringe
Figure 6-1
Sample tubes
Each laboratory should determine the admissibility of the sample containers used. These products
vary from manufacturer to manufacturer and sometimes from lot to lot.
It is necessary that sample tubes are filled at least three (3) cm below the rim.
Syringes
If products with liquid heparin as an anticoagulant are used, the sample container should not be
larger than needed for the required blood volume to minimize the effects of the anticoagulant's blood
thinning. Normally, plastic syringes are used.
Note:
To ensure safe operation, use only syringes with an inner luer diameter of at least 2 mm.
Capillary tubes
Warning:
It is strongly recommended to use the plastic capillary tubes offered by EXIAS. The capillary tubes are
designed and tested to minimize risk of injury in case of possible foreseeable misuse.
If glass capillary tubes are used, there is a potential risk that the glass capillary could break, if it is not
removed during the measurement procedure.
When using stirring bars these must be removed before sample input to prevent clogging the sample
path of the e|1 Analyzer.
Sample handling
Whole blood
Whole blood samples should be taken with heparinized syringes, capillaries or with the sample tube
and analyzed as soon as possible after collection. Immediately after removal, air bubbles must be
removed from the sampling container.
Immediately after withdrawing the sample with syringes, it should be mixed thoroughly with
anticoagulant by rolling the sample between both hands.
The samples must be marked correctly, observing the usual documentation procedures.
Caution:
Immediately before the measurement, a blood sample must be resuspended!
Within a few minutes sample can change significantly leading to incorrect Hct results.
2 e|1 Analyzer
Limitations of clinical analysis
Limitations of clinical analysis

The determined performance data can be influenced by known and unknown factors.
See section Interferences in chapter 4 Specifications for more details about the influence of
interfering substances.
General
Various substances are listed in the literature that may affect the measurement result of the sample
material blood, plasma or serum.
For the e|1 Analyzer, an attempt was made to identify or assess these possible influences.
Since it is not possible to check all drugs or substances, the overall patient status must always be
evaluated in case of abnormal deviations of the measurement results.
Electrolyte
It is known that the potassium value of a patient can vary by up to 20% compared to the normal state
because of compression bandages. A blood sample should not be taken from patients wearing a
pressure bandage. Generally, local hemolysis caused by pressure must be avoided before drawing
blood.
2 e|1 Analyzer
Measuring procedure
Measuring procedure
The parameters that should not be measured can be deactivated temporarily by pressing the
respective parameter before selecting a sample mode.
By selecting a sample mode (either sample tube, capillary tube or syringe) on the main screen, the
measurement procedure is initiated.
123
Animated pictures shall help the operator and guide step-by-step through the procedure:
Figure 6-2
Attach sample container and hold it in place!
Warning:
In capillary mode, make sure that the capillary is not pressed too hard (danger of injury).
If the sample container is correctly attached, press [Yes] to start the aspiration process.
2 Aspirating sample.
Figure 6-3
While the sample is being aspirated, the sample container must be held. It is important to
avoid fractioning which might lead to incorrect or no results.
2 e|1 Analyzer
Measuring procedure
3 Remove sample container as the acoustic signal is generated.
Figure 6-4
Caution:
If the sample container is not removed within five (5) seconds, an acoustic signal will sound,
The button [Yes] will start to flash and after another five (5) seconds the sample input unit
will be automatically retracted.
Confirm with [Yes], the measuring process is started.
4 Measurement in progress.
Figure 6-5
During the measurement process, the operator may enter additional information about
the patient, the sample or login name (if not already logged-in). The editable fields are
underlined in gray and dropdown fields (e.g. sample type) are marked accordingly.
2 e|1 Analyzer
Measuring procedure
5 The result screen appears.
A Standard values for the normal range - these can be configured in the settings
Figure 6-6
After completion of the measurement, the previously selected parameters are shown on
the display. If results are outside the specified range, the values will be colored red and
arrows will indicate increased or decreased measurement results.
Mandatory fields are marked with *. If these fields remain emty, the measurement will end
automatically after five (5) minutes. Instead of showing a result, the error message “Missing
mandatory entries” will be displayed.
Note:
If errors occurred during the measurement, no or not all measured values could be determined. A
corresponding error text is then displayed instead of measurement results and ranges.
If the sample type is changed after completion of the measurement, so if the measurement results are
already displayed, the measurement results will be recalculated. During this recalculation, the text
"Calculation in progress ..." is displayed instead of the results.
Start printing by pressing [Print] if you need a printout.
Note:
If the “Auto-Print immediately” option is activated in Settings, a printout will be created automatically,
if the required fields are filled in and all results are available.
If the “Auto-Print when finished” option is activated in Settings, a printout will be created automatically,
when [Finish] is pressed.
The measuring procedure will be completed automatically after a timeout of 1 minute or by pressing
[Finish].
2 e|1 Analyzer
Measurement evaluation
If the reported patient results do not reflect the patient’s condition, the test should be repeated using
a fresh sample. If results are still suspect, please run a liquid QC (oQC or Manual QC,
see chapter 7 Quality Control) to ensure that the analyzer is performing according to specification. If
the controls are within range, there may be an interfering substance in the sample.
Interfering substances in the patient’s sample may cause erroneous results. Treatment to a patient
should never be administered based solely on the results that are shown on the device’s display and
printout. It is advised that a trained and knowledgeable medical professional checks the history and
prognosis of the patient’s condition, before proceeding with any treatment.
See also section Interferences in chapter 4 Specifications for more details about the influence of
interfering substances.
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2 e|1 Analyzer
Chapter 7
Quality Control
7 Quality Control
7 Quality Control
Quality Control Concept
Quality Control Concept

Quality Control, as part of an overall quality assurance program, consists of tests and procedures. The
quality control monitors and evaluates the analytical performance of the system, to assure the
reliability of patient’s test results. EXIAS Medical recognizes the importance of effective quality control
for the e|1 Analyzer and offers various options to meet these needs.
The e|1 Analyzer is designed in a way that the complete analytical process is monitored and
evaluated. This means from sample aspiration, through measurement to generation of the test result.
The quality control material follows the same path through the analyzer as the patient sample.
Detecting immediate errors: By meeting the minimum CLIA requirement of one control every eight
hours, it would be difficult to immediately detect errors without additional quality assurance activities
such as frequent calibration. The e|1 Analyzer calibrates 2 points of the analytical system every 12
hours by default. Otherwise it continuously monitors the sensor signals, including 1 point calibrations
and post calibrations after each patient sample and QC measurement. A measurement parameter /
analyte that fails to meet strict slope, drift or noise limits is immediately made unavailable for
measurement.
In deciding how much QC is necessary, the test site must strictly adhere to the manufacturer’s
minimum operating requirements and consider the instrument’s performance specifications (long-
term precision and accuracy), and local regulations.
The e|1 Analyzer offers two options:
1 Aqueous based QC material integrated within the e|1 Cartridge: The e|1 Cartridge is
available with integrated on-board QC (oQC). These cartridges include 3 levels of QC material. The
operator can program the e|1 Analyzer to run QCs automatically at fixed intervals. The oQC can
also be triggered manually at any time as required. The target values of the parameters are
included on the cartridge’s storage and automatically uploaded when the cartridge is installed.
2 Aqueous based QC material offered as a package of 30 glass ampoules: This material is
offered in three levels (3) packaged in a box of 30 ampoules (one (1) box per level). The ampoules
can be run manually (mQC) whenever necessary. Alternatively, the system is programmable to
remind the operator at certain times to run the manual QC. The target ranges are provided as
barcodes in the insert sheet and must be entered to the device once.
The laboratory must establish the number, type and frequency of testing control materials using, if
applicable, the performance specifications verified or established by the laboratory, or based on local
regulations.
Recommended QC regimen of EXIAS Medical

At least 2 levels should be run on each day by the device. The levels should be ideally rotated over the
entire week. The recommended oQC setting on the device is as shown below. This default oQC setting
can be easily set by pressing [Set oQC] in the QC planner settings and changed by the operator based
to local regulations and needs, see chapter 9 System Functions.
Time Monday Tuesday Wednesday Thursday Friday Saturday Sunday

06:10 Level 1 Level 3 Level 2 Level 1 Level 3 Level 2 Level 1
18:10 Level 2 Level 1 Level 3 Level 2 Level 1 Level 3 Level 3
2 e|1 Analyzer
7 Quality Control
Important information for evaluating QC results
It is important and highly recommended that quality control tests are performed immediately after
replacing the e|1 Cartridge as this represents a complete change of analytical components like
calibrating solutions and measurement sensors. This should be done before resuming patient testing.
The e|1 Analyzer has a setup possibility where all 3 Levels are automatically run (with oQC cartridge)
as soon as the cartridge is replaced, see chapter 9 System Functions. Cartridges without integrated
QC, the system alerts the operator to conduct quality control.
Important information for evaluating QC results

QC results are evaluated by examining whether the value of each parameter lies within a specified
expected range or not.
• Measured value is within the expected range
o No follow-up action! The parameter is ok.
o The QC result is acceptable and the parameter remains enabled for patient measurements. The
display and printout of the QC result shows the measured result in comparison to the target
values.
• Measured value is outside expected range
o The QC result is not acceptable. The parameter is locked if the option “lock parameter in case of
failed QCs” is activated in the QC settings. The parameter may only be released for further
patient measurements after the problem has been resolved and only after the same QC level
has been passed again.
Caution:
If the error persists, replace the e|1 Cartridge. If the error remains after the cartridge replacement,
please contact your local customer support.
2 e|1 Analyzer
7 Quality Control
QC measurement
QC measurement
The following QC options are offered by the system:
• automatic on-board QC measurement (optional),
• manual on-board QC measurement (optional),
• manual QC measurement with e|1 Quality Control ampoules (Level 1 - Level 3).
On-board QC measurement
Note:
An on-board QC measurement can only be performed if an e|1 Cartridge with on-board QC option is
used.
An on-board QC measurement starts automatically at the predefined times according to the settings
in the QC planner.
Starting from the main screen, please call up the following function:
[Menu] > Administration > [Settings] > [Quality control / Calibration] > [QC planner]
Perform QC measurement
Starting from the main screen, call up the following function:
[Menu] > [Actions] > [QC measurement]
Manual on-board QC measurement
Note:
A manual on-board QC measurement can only be performed if an e|1 Cartridge with on-board QC is
used.
The manual on-board QC measurement will be performed by pressing the desired level, e.g. [Start
oQC L1] -, [Start oQC L2] - or [Start oQC L3].
2 e|1 Analyzer
7 Quality Control
QC measurement
Manual QC measurement
The manual QC measurement must be performed using the e|1 Quality Control material.
Indications for use of e|1 Quality Control material

Before use allow the ampoules at least four (4) hours to equilibrate to room temperature.
Before use, turn the ampoule three times upside down to mix the content. Tap the ampoule to make
sure there is no liquid in the ampoule head. Protect fingers with gauze, tissue or gloves and carefully
snap off the neck of the ampoule. Immediately introduce the solution to the analyzer. Aspirate directly
from the ampoule.
Expected values
Lot specific values printed on the insert sheet represent the mean values and the acceptable ranges
for all parameters. Make sure, level and lot number on insert sheet and ampoules match.
Expected value ranges are provided as a guide for evaluating the performance of the analyzer. A
laboratory may establish its own expected values and control limits. The established values should be
within the expected ranges shown on the insert sheet
Manual QC measurement is performed by pressing [Start manual QC].
Please follow the instructions on the screen.
With animated pictures, the operator is guided step-by-step through this procedure:
123
1 Scan QC material barcode from ampoule (or from insert sheet) or enter it via the virtual
keyboard.
If a new lot of QC Material is used, scan the 2 bange barcodes from the insert sheet or enter
them via the virtual keyboard.
Figure 7-1
Press [Continue].
If the QC material lot has already been used , the range barcodes are remembered by the
analyzer and do not need to be scanned again.
2 Open ampoule.
2 e|1 Analyzer
7 Quality Control
QC measurement
Caution:
To prevent injuries, protect your hands with gloves when breaking open the ampoule. Use the control
material within half a minute after opening. Never use an ampoule twice.
3 Attach ampoule and hold it in place!

Press [Yes] to start the aspiration process.
4 Aspirating sample.
While the sample is being aspirated, the sample container must be held. It is important to
ensure that no air bubbles occur because they could falsify the measurement result or an
invalid measurement value could be calculated.
Please wait…
5 Remove ampoule.
Caution:
If the ampoule is not removed within 5 seconds, an acoustic signal will sound, [Yes] starts to
flash and after another five (5) seconds the sample input unit will be automatically.
The measuring process is aborted.
By pressing [Yes], the measuring process will be started.

6 Measurement in progress.
Figure 7-2
After completion of the measurement, the results will be displayed.

If the QC status of a parameter is within the expected range (QC range), the parameter is
evaluated to be OK and displayed with a green checkmark. If the result is outside the expected
range, the evaluation is nOK which is indicated by a red X.
2 e|1 Analyzer
7 Quality Control
QC measurement
Figure 7-3
By pressing [Print] the results are printed out.

If any problems occurred during the measurement procedure (e.g. wrong material was used,
air bubbles were aspirated) the result can be rejected by pressing [Reject].
In that case the result will not be saved and the QC consequences will not apply.
The measuring procedure will be completed automatically after a timeout of one (1) minute or
by pressing [Accept].
Afterwards the device is ready to measure.
2 e|1 Analyzer
7 Quality Control
QC consequences
QC consequences
If the QC result for a parameter is out of the expected range and "QC lock" is activated in Settings, the
affected parameter is marked as locked in the main screen.
If several QC measurements for different levels fail, the parameter will be locked for each level.
Locked parameters are also listed in the Alarms / Warnings screen.
2 e|1 Analyzer
7 Quality Control
QC consequences
2 e|1 Analyzer
Chapter 8
Replacement of
Consumables
Replacement of e|1 Cartridge

The e|1 Cartridge needs to be replaced once the provided number of samples are run, or 28 days
after its first use by an e|1 Analyzer, whichever comes first.
The counted samples include patient samples, as well as all QC samples run by the device within 28
days.
Depending of the number of performed tests and the number of days the cartridge was used by the
device, the analyzer detects that the e|1 Cartridge needs to be replaced.
A corresponding error message is displayed on the Alarms/Warnings Screen.
Caution:
Before inserting a new e|1 Cartridge it must be acclimatized to room temperature. If the cartridge
was stored in a cooled environment (e.g. refrigerator), acclimatization can take up to two (2) hours.
Press the [Replace] button from the Alarm/Warning Screen or press [Cartridge Replacement] from
123 the Menu and follow the instructions shown on the screen. The user will be guided step by step
through the process by animated pictures:
1 Prepare a new e|1 Cartridge.
2 Remove cover and take out e|1 Cartridge.
Warning:
Dispose the e|1 Cartridge according to local regulations regarding disposal of biologically
contaminated and hazardous waste.
3 Insert new e|1 Cartridge.
It is recommended to hold the analyzer with one hand, while inserting the e|1 Cartridge to prevent
the analyzer from slipping backwards.
Insert the cartridge into the device until you hear a clear click sound.
Figure 8-1
2 e|1 Analyzer
4 The e|1 Cartridge data is read by the analyzer
The analyzer reads the cartridge-data out of the storage of the inserted e|1 Cartridge and displays it
on screen.
If the cartridge has already been used, the remaining number of tests and the remaining in-use time
are shown according to the read data.
Press [Yes] to confirm the usage of the inserted cartridge.
Figure 8-2
If the expiration date of the cartridge will lie before the time-of-use is reached, a warning and an info
button is displayed. The usage of each cartridge is limited.
If there are no remaining samples left on the inserted e|1 Cartridge, this will be detected by the
e|1 Analyzer and the inserted cartridge will no longer be usable:
This e|1 Cartridge cannot be used anymore.
Figure 8-3
The exchange process must be terminated by selecting [No] and repeated with a new or suitable
e|1 Cartridge.
2 e|1 Analyzer
5 Close cover and confirm with [Continue].
6 The e|1 Cartridge initialization starts. Confirm with [Yes].
Caution:
At the beginning of the initialization the sample input unit moves into the capillary position.
After the sample input initialization the e|1 Cartridge is checked. Please wait until the
7 cartridge check is finished. In case of any error an information message appears.
8 After a successful cartridge check, the e|1 Cartridge initialization continues. The complete
initialization takes 20 minutes for cartridges being used for the first time. If the cartridge has
already been used, it only takes ten (10 minutes for the cartridge to initialize. Within this
period of time also calibrations are conducted automatically.
The remaining time of the cartridge initialization is displayed in minutes.
After initializing the e|1 Cartridge, perform quality control measurements in all three (3)
levels (1 = low, 2 = normal, 3 = high).
Note:
The e|1 Analyzer can be configured to perform automatic on-board quality controls (oQCs), or requests for manual
quality control, after a cartridge replacement (see chapter 9 System Functions).
[Menu] > Administration > [Settings] > [Quality control] > [QC settings]
Note:
If the new installed e|1 Cartridge does not contain on-board QC, external QC measurements must be
performed (see chapter 7 Quality Control).
Current status of the e|1 Cartridge on-board

The current state of the e|1 Cartridge is depicted on the main screen next to the cartridge icon. Here
left measurements and days the cartridge can be used are listed. By pushing the cartridge icon more
details regarding the cartridge are shown. This information includes cartridge type, serial and lot
number, expiration date, remaining in-use time and remaining tests.
2 e|1 Analyzer
Figure 8-4
Figure 8-5
Note:
An almost expired cartridge on-board gives a warning when two (2) days are remaining, or 20 samples
are remaining, whichever comes first.
Note:
• If removed from analyzer and stored outside, an active e|1 Cartridge is usable if re-inserted
within 72 hours. After 72 hours the cartridge is invalid.
• If the analyzer is switched off (or has a power-fail) with the cartridge on-board, the cartridge is
usable if analyzer’s power is restored or switched-on within 72 hours.
• If the analyzer has a system-stop with no fluidic actions, the cartridge will be reusable if the last
fluidic action has been less than 72 hours ago.
2 e|1 Analyzer
Removing and reinserting the e|1 Cartridge
Removing and reinserting the e|1 Cartridge

It is possible to trigger the e|1 Cartridge replacement workflow with:
[Menu] > [Cartridge replacement]

This can be done to remove and re-insert the cartridge on-board.
Figure 8-6
2 e|1 Analyzer
Replacement of e|1 Printer paper

If the printer paper is used up, the device will detect that a printer pater replacement is required.
Therefore a warning is depicted.
Figure 8-7
Press the [Resolve] button and follow the instructions on the screen!
With the help of animated pictures, the operator is guided step by step through the procedure:
123
1 Open shutter and printer cover.
2 Remove empty paper roll and recycle it.
3 Insert new paper roll correctly according to the screen animation.
Figure 8-8
Note:
If the printer paper is inserted in the wrong direction, the print out will not be visible. The thermal
paper can only be printed on one side.
2 e|1 Analyzer
4 Hold paper, close printer cover and shutter.
5 To make sure the paper replacement was successful, a test page can be printed.
6 Complete the process with [Finish]. The device will then return to the main screen.
2 e|1 Analyzer
2 e|1 Analyzer
Chapter 9
System Functions
9 System Functions
9 System Functions
Main Screen
Main Screen
The main screen is displayed when the e|1 Analyzer is ready for measurement. The availability of all
parameters is displayed and all device functions can be accessed from the main screen.
A Navigation bar C Parameter selection field

B Status bar D Measurement mode
Figure 9-1
Navigation bar
A white arrow in the navigation bar indicates the section.
Icon Description
Measurement / Main Screen
By pressing the syringe icon, the system switches to the main screen. A measurement can
be started, and the status of the parameters is displayed.
Results
By pressing the result icon, an overview list of the sample measurement, quality control
measurements and calibration results is displayed.
Menu
Via the menu icon further actions, the administration section incl. settings, utilities and
device information can be accessed.
Alarms / Warnings
Icon is displayed, if an alarm or warning occurs. Pressing the alarm / warning icon shows
more information and error resolving options.
e|1 Cartridge information
The cartridge icon shows the actual status of the currently inserted cartridge. Detailed
information is displayed by pressing the cartridge icon.
Log-in / log-out
Pressing the operator icon, registered operators can login or logout.
Actual date / time
Table 9-1 Navigation bar
2 e|1 Analyzer
9 System Functions
Main Screen
Status bar
The status bar informs the operator about the current system status, upcoming calibrations or quality
control measurements and shows symbols about the connectivity status.
Parameter selection field and information

Symbol Description
Parameter is activated and ready for measurement.
Parameter is deselected for next measurement.
Parameter is not ready for measurement since it is not calibrated.
Parameter is not ready for measurement due to QC lock.
Parameter permanently deactivated.
Table 9-2 Parameter selection field
Measurement modes
Symbol Description
Sample tube
Capillary tube
Syringe
Table 9-3 Measurement mode
2 e|1 Analyzer
9 System Functions
Results
Results
By pressing the result icon, an overview list of the sample measurement, quality control measurement
and calibration results sorted by date is displayed.
Press the patient, QC or CAL icon to switch between the overview lists.
By pressing a specific result, detailed information is displayed.
Use the press and hold gesture to select multiple results and print or delete them.
Note:
The export of patient and QC results is possible by using the export result workflow, see section Export
results.
Figure 9-2
Measurement results
The measurement results are shown in a list with Date/time of measurement, Patient-ID and Patient
name. By press on one record, detailed Information of the selected measurement is shown. The result
can either be printed or deleted.
Patient information can also be updated.
Note:
Changes do not affect measured or calculated results.
2 e|1 Analyzer
9 System Functions
Results
Figure 9-3
Quality control results and calibration results
The overview list shows the evaluation of quality control measurement and calibration results, and the
results can be printed either in the overview list by selecting several results or in the detail view.
Quality control results can be deleted.
Note:
Quality control measurement results can only be deleted by an operator with corresponding access
rights. For further information, see section Authentication.
Figure 9-4
2 e|1 Analyzer
9 System Functions
Results
Figure 9-5
2 e|1 Analyzer
9 System Functions
Menu
Menu
Via the menu icon several system features are accessible.
• Actions: QC measurement, Start calibration, Cartridge replacement, Printer paper replacement.
• Administration: Patient management, Operator management, Settings, Power off.
• Utilities: Clean screen, Export results, Troubleshooting, Export log files, Software and Language
update, Protected service functions.
• Information: Instrument, Cartridge, Event log, Software, License information.
Figure 9-6
Menu > Actions

The action section lists all actions that the operator may need to perform routinely:
• Performing on-board or manual QC measurements
For further instructions see chapter 7 Quality Control.
• Performing a calibration.
By pressing [Start Calibration], a 2 point calibration is triggered which takes about 30 seconds
• Replacing the e|1 Cartridge
For further instructions see chapter 8 Replacement of Consumables.
• Replacing the e|1 Printer paper
For further instructions see chapter 8 Replacement of Consumables.
Patient management
By pressing [Patient management] in the administration section an overview of all patient data
stored on the instrument can be displayed. Existing patients can be edited, and new patients added.
2 e|1 Analyzer
9 System Functions
Menu
Figure 9-7
Note:
The patient management feature is only accessible when the patient management is activated in the
system settings. See section System settings.
New patient:
Press [New] to create a new patient.
When creating a new patient, either the patient's last name or patient ID must be entered.
Edit patient:
Press on patient in the overview list to edit the patient information or delete the patient.
Press [Results] to see all related Results.
Figure 9-8
2 e|1 Analyzer
9 System Functions
Menu
Operator management
By pressing [Operator management] in the administration section an overview of all operators
stored on the instrument can be displayed. Existing operators can be edited, and new operators
added.
Figure 9-9
New operator:
Press [New] to create a new operator
When creating a new operator, Login name and Last name must be entered, and the Permission must
be selected.
When saving a new operator, a password can be assigned. If a temporary password is used, the
operator is reminded to change the password at the first login.
Edit operator:
Press an operator in the overview list to edit the operator information, reset the password or delete
the operator.
If the password is reset, a temporary password can be defined. The operator is reminded to change
the password at the first login. For further instruction see section Login.
Operator permission
The permission can be set to User or Admin. Operators with user permission cannot make any settings
or changes in operator management and results cannot be deleted.
Permission if no operator is logged in, see section Authentication.
Settings
The Settings are divided into the following sections:
Measurement
• Parameter settings
• Data input
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Menu
Quality control / Calibration

• QC materials
• QC settings
• QC planner
• CAL planner
System
• Date / time
• Language
• System settings
• Network
• Display
• Printer
Security
• Authentication
• Remote access
Note:
After changing a setting, press Save to save the setting.
Parameter Settings
Press [Parameter Settings] in the measurement section to display parameter related settings.
Select a parameter from the list to enable/disable it, change the unit or press [Ranges ...] to change or
redefine ranges.
Figure 9-10
Activate / deactivate measured and calculated parameters

The calculated parameters tHb (C) and nCA2+ are deactivated per default.
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Menu
Note:
To calculate tHb (c) the input of MCHC [g/dl] is mandatory. By activating tHb (c) the input field is
selected automatically. The MCHC input field cannot be removed or set as not mandatory as long as
the calculated value tHb (c) is active.
Note:
To calculate tHb (c) the parameter Hct must be activated.
To calculate nCa2+ the parameters pH and Ca must be activated.
Note:
If a deactivated parameter is activated, a calibration is performed automatically.
Ranges and limits

By pressing [Ranges …] the existing ranges and limits for the selected parameter can be edited or new
ranges can be added.
Reference ranges and critical limits can be defined for all sample types in combination with the
following age and sex categories:
• Unspecified
• > 1 year, female
• > 1 year, male
• <= 1 year
The ranges are used for the measurement if the input fields Sample type, Gender and Age are filled in.
For further information on reference intervals and critical limits, see chapter 11 Theoretical
Foundations. For further information on input data see section Input data.
Press [Reset] to reset all ranges of a parameter to factory settings.
Data input
Press [Data input] in the measurement section to edit the input fields displayed during sample
measurement and on the printout. Input fields can be rearranged and set as mandatory inputs.
Note:
During measurement, no measurement results are displayed as long as mandatory input fields are
not filled in.
A mandatory input is also fulfilled by a default value.
Note:
The input field Sample Type always stays mandatory. This cannot be changed.
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9 System Functions
Menu
Figure 9-11
For some input fields a default value can be defined.

The following input fields are factory set:
• Sample type
• Patient ID
• Patient
• Operator.
Pressing [Edit List] allows to change input fields. The input fields can be easily dragged and dropped
from the Available input fields to Selected input fields.
Figure 9-12
Note:
The input field Sample Type cannot be removed from the selected input fields, as the sample type
affects the measurement result.
Quality control materials

Pressing [QC materials] in the Quality control / Calibration section displays a list of quality control
materials for manual and on-board quality control measurements stored on the instrument.
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Menu
Note:
The expiration date of the on-board quality control material is not displayed, it corresponds to the
expiry date of the cartridge.
For further information see section Cartridge information.
Figure 9-13
By pressing a specific material, the ranges for this material are displayed.
Use the press and hold gesture to select multiple materials and delete them.
Note:
Only materials that do not have an entry in the results can be deleted.
For further information on quality control results, see Results.

By pressing [Add] a new quality control material can be added manually by scanning the material and
range barcode.
Note:
The on-board quality control material is automatically added by inserting the cartridge.
Quality control material for manual quality control measurements can also be added using the quality
control measurement workflow.
For further information on quality control results, see chapter 8 Replacement of Consumables and
chapter 7 Quality control.
Quality control settings
Pressing [QC settings] in the Quality Control / Calibration section displays the following settings:
• Quality control mandatory after cartridge replacement
By selecting the check box, a quality control measurement level 1 to 3 is required after each cartridge
change.
Note:
If a cartridge with on-board quality control material is used, one quality control measurement per level
is performed automatically.
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9 System Functions
Menu
If a cartridge without on-board quality control is used, a warning or alarm corresponding to the setting
of the QC consequences is displayed.
• QC Consequences
By enabling QC consequences, parameter will be locked in case of failed quality control
measurements.
Note:
A QC lock can be resolved by a manual or an on-board quality control of the corresponding level.
• Quality control follow-up measurement

For cartridges with on-board quality control, up to two (2) automatically performed follow-up
measurements can be set for failed on-board quality control measurements. This setting has no
influence on manual quality control measurements.
Figure 9-14
Quality Control planner
Pressing [QC planner] in the Quality control / Calibration section displays a list of all planned quality
control measurement.
Figure 9-15
• QC Consequences
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9 System Functions
Menu
By enabling QC consequences, parameter will be locked in case of failed quality control

measurements.
The factory settings do not provide any planned quality control measurements. Press [Set oQC] to
load the recommended QC plan for on-board quality control cartridges. For further information, see
chapter 7 Quality control.
Press [New] to plan a new quality control measurement by entering level (1 to 3), type (on-board or
manual), start time and weekdays.
Figure 9-16
By pressing a specific planned quality control measurement, the configuration of level, type, start time
and weekday can be changed.
Use the press and hold gesture to select multiple planned QCs and delete them.
Note:
If a planned QC is not performed, a warning will be displayed.
If the QC sequences are activated, an alarm will be displayed after 15 minutes and the parameters will
be QC-locked.
Calibration planner
Pressing [CAL planner] in the Quality control / Calibration section displays settings for planed
calibrations (start time and interval) and the current calibration interval.
For further information see chapter 11 Theoretical Foundations.
Date / time
By pressing [Date / time] in the system section the time and date as well as its layout, the region and
time zone and a time server can be set.
Note:
Time and date must be updated, and region and time zone must be set before installing any new
software.
For further information see chapter 5 System Installation.
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9 System Functions
Menu
Depending on the region and time zone, the system automatically switches between summer and
winter time.
Figure 9-17
The time can be updated by pressing [Synchronize] if a time server is set and an internet connection
is established.
For further information reagrding network connection, see section Network.
Language
The language used on the device can be changed by pressing [Language] in the System section. To do
this, select the desired language and save the changes.
Note:
After saving the language settings, a reboot must be performed to apply the setting correctly.
System settings
By pressing [System settings] in the system section, the instrument name and the hospital
information can be set, and the patient management can be activated or deactivated.
The device ID (consisting of “e1-“ and serial no.) is factory set as instrument name.
Instrument name and hospital information can be added to the printout, for further information see
section Printer.
The patient management feature in the menu is only accessible if patient management is activated.
For further information on patient management, see section Patient management.
Note:
If patient management is activated, Patient ID is added as input field.
For further information on data input field, see section Data input.
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9 System Functions
Menu
Network
By pressing [Network] in the system section, general network settings, ethernet and wireless settings
can be set.
General network settings

Press [General] to set gateway, search domain and host name, and add a new or delete a selected
DNS name server.
Figure 9-18
Ethernet settings
Press [Ethernet] to set IPv4 settings and display IPv6 address and MAC address.
By selecting manual (static), IPv4 Address and subnet mask can be set.
Wireless settings
Press [Wireless] to enable wireless, select a network, set IPv4 settings and display IPv6 address and
MAC address.
Figure 9-19
To establish a wireless connection, follow the steps below:

123
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9 System Functions
Menu
1 Connect a WiFi dongle and enable Wireless connection.
2 Press [Select Network] and [Scan] to display available networks.
3 Select the network, enter network key and press [Connect].
Note:
To enable a wireless connection, a WiFi dongle must be connected to the device.
In case of problems with the dongle used, contact your local representative of EXIAS Medical.
Display
The brightness of the display can be adjusted to the ambient conditions.
Printer
By pressing [Printer] in the System section, automatic printout of sample and quality control
measurement results and layout settings can be adjusted.
• Auto printout off:
During a sample or quality control measurement printouts can be generated by pressing [Print].
• Auto printout immediately:
As soon as mandatory inputs have been made and the sample measurement results have been
derived, a printout is generated. Each time an input field is changed, a printout will be made.
• Auto printout when finished:
During a sample or quality control measurement a printout can be generated by pressing [Finish]
or [Accept].
Note:
The serial number of the instrument and the cartridge are always printed.
Note:
All mandatory input fields must be filled-in to view and print the results.
Authentication
By pressing [Authentication] in the Security section, a logout time can be set, to automatically log out
the operator.
The authentication level can be set to:
• No login required
No operator must be logged in to use all functions.
• Login required for extended functions
To use extended functions, such as Settings and Operator management, operators with admin
permissions must be logged in.
If no operator is logged in, the access rights correspond to those of an operator with user
permissions.
• Login required for basic and extended functions.
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9 System Functions
Menu
Operators with “user” permission must be logged in to perform basic functions like measurements,
view results or enter the menu. Operators with “Administrator” permission must be logged in to
perform extended functions such as Settings and Operator management.
Figure 9-20
Remote access
Press [Remote access] in the security section to enable or disable screen sharing and external
connection.
Note:
An Internet connection must be established to perform remote access.
For further information see section Network.
Power off
Press [Power off] in the administration section to shut down or reboot the analyzer.
Note:
If the analyzer is switched off for more than 72 hours, the cartridge can not be used any more.
Menu > Utilities

The utilities section includes the following features:
Clean screen, export of results and log files, troubleshooting, software and language update and
protected service functions.
For further instructions on troubleshooting see chapter 10 Troubleshooting.
[Protected service function] can only be accessed by service personnel.
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Menu
Clean screen
Pressing [Clean Screen] in the utilities section deactivates the touch display for 30 seconds to clean
the surface.
For further instructions on disinfection see chapter 2 Safety Information.
Export results
Warning:
A failure of the power supply could cause severe damage to the e|1 Analyzer.
To export measurement and/or QC results to USB flash drive, press [Export results] in the utilities
section. The result period can be set.
The guided export workflow is started by pressing [Export].
Note:
All common USB 2.0 sticks that use FAT32 formatting can be used.
Export log file
Warning:
A failure of the power supply could cause severe damage to the e|1 Analyzer.
To export logfiles to USB flash drive or upload to customer support press [Export log files]. The period
can be set.
The guided export workflow is started by pressing [Export] or [Upload].
If Upload is used, an internet connection must be established, for further instructions see Settings >
System > Network.
Note:
All common USB 2.0 sticks that use FAT32 formatting can be used.
Software and language update
A guided workflow for updating software or language can be performed by pressing [USB Update] or
[Network Update].
If network update is used, an internet connection must be established, for further instructions see
section Network.
When using USB update, a bootable stick must be used, contact your local representative of EXIAS
Medical for further instructions.
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9 System Functions
Menu
Note:
After the update, the instrument is restarted.
After the restart, QC measurements Level 1, 2 and 3 must be performed.
For further instruction see chapter 7 Quality control.
Menu > Information
Instrument information
Press [Instrument] in the Information section to display the following information about the
instrument:
• Instrument type and Serial no.: e|1 Analyzer and Serial no.
• Instrument name: Can be set, see section System Settings.
• Hostname: Can be set, see section Network. The device ID (consisting of “e1-“ and serial no.) is
factory set as host name.
• Hospital info: Can be set, see section System Settings.
• Service info: Is set by your local representative of EXIAS Medical.
• LAN IP address and MAC address: see section Ethernet
• WiFi IP address and MAC address: see section Wireless
• Patient samples: The patient sample counter represents all sample measurements performed on
this instrument. In the case of a leasing contract, this counter can be reset by the local
representative.
• QC samples: The quality control sample counter represents all quality control measurements (on-
board and manual) performed on this instrument. In the case of a leasing contract, this counter
can be reset by the local representative.
Cartridge information
Press [Cartridge] in the information section to display the following information about the cartridge:
Cartridge Type: example given “e|1 Cartridge 600 oQC”
• Status of the Cartridge: valid or in case of a cartridge warning or invalid . The Status
equals the colour of the Cartridge Symbol in the navigation bar, see section Cartridge.
• Serial no. and Lot not.
• Expiry date and maximum in-use time
• Maximum samples: depending of the e|1 Cartridge type 600, 300 or 150 samples, including QC
measurement.
• Installation date: Date of fist installation of this cartridge.
• Remaining in-use time and remaining samples (incl. QC)
Remaining QC samples: Displayed only when a cartridge with on-board QC is inserted.
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9 System Functions
Menu
Figure 9-21
Event log
Press [Event log] in the information section to display all events listed by date.
Figure 9-22
Detailed information can be displayed by pressing the event.
Note:
Each alarm, warning or information contains an error number. This number enables a more precise
error analysis. In case of contacting your local representative of EXIAS Medical, please provide the
error number.
For further instruction see chapter 10 Troubleshooting.
Software
Pressing [Software] in the Information section displays the installed software. If packages are
installed, they are listed as modifications.
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Menu
License information
All licenses are displayed in the information section when pressing [License information].
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9 System Functions
Alarms / Warnings
Alarms / Warnings
In case of an alarm or warning, an alarm or warning icon is displayed in the navigation bar.
By pressing the alarm or warning icon, all events are listed, and a corresponding resolving action is
offered.
Figure 9-23
If detailed information is available for an event, an information icon is displayed next to the text. The
detailed information can be displayed by pressing on the event.
Note:
Each alarm or warning contains an error number. This number enables a more precise error analysis.
In case of contacting your local representative of EXIAS Medical, please provide the error number.
For further instructions see Chapter 10 Troubleshooting.
Note:
All events that have occurred can also be viewed in the event log.
For further instructions see section Event log.
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9 System Functions
Cartridge
Cartridge
By pressing the cartridge icon detailed cartridge information is displayed, see section Cartridge
information.
The cartridge icon changes the color according to the cartridge status:
Icon Cartridge status Description
Valid Cartridge valid
• Remaining in-use time <= 2 days

Warning • Expiry date <= 2 days
• Remaining samples <= 20 samples
• Cartridge invalid
Alarm
• No cartridge inserted
Table 9-4 Catridge status
In case of a cartridge alarm or warning, an alarm or warning icon is displayed, and the cause is listed in
the Warnings / Alarms, for further information see section Alarms/Warnings.
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Login
Login
An already created operator can log in by pressing the login icon.
To log in, the login name must be entered or selected in the dropdown list.
If an operator is logged in, the first and last name are displayed next to the icon on the Main Screen.
Figure 9-24
If the login icon is pressed when an operator logs in, the operator can be logged out, or the operator's
password can be changed. Further instructions on creating an operator see section Operator
Management.
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Login
2 e|1 Analyzer
Chapter 10
Troubleshooting
10 Troubleshooting
10 Troubleshooting
Troubleshooting Concept
The Navigation bar on the left side of the main screen has an Alarm / Warning indicator icon, which is
visible as soon as an issue occurs. Press the icon to show all current alarms or warnings.
For each alarm or warning, there is an action demanded by the device to resolve the issue.
Examples:
Figure 10-1 Selecting alarm icon
Figure 10-2 Selecting warning icon
Dependent on the situation the screen may display more than one alarms and/or warnings. Some
displayed errors may be shown only as consequence of the main alarm, as seen below.
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10 Troubleshooting
Figure 10-3 Analyzer may show more than one qlarm and/or warning
The Info icon may also be displayed, depending of the error. By pressing that icon, additional relevant
information concerning the alarm or warning is shown.
Figure 10-4
If a parameter is not available, it will be shown on main screen by the crossed-out parameter. By
pressing the crossed-out parameter, the reason is shown.
Figure 10-5 Main screen with crossed parameters
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10 Troubleshooting
Figure 10-6 Pressing a crossed out parameter
Self-diagnosis and self-checks

The e|1 Analyzer continuously monitors all analytical, fluidic and thermal processes in the
background. If a problem is detected, a system check is started and the analyzer tries to fix the
problem automatically. If the system check fails, an alarm will be displayed.
Figure 10-7
Automatic clot-detection and de-clotting routines

The e|1 Analyzer includes a built-in clot detection. If a patient sample has a clot, this will
automatically be detected by the system and a “declotting” routine is started to remove the clot out of
the fluid path.
Troubleshooting routines
The e|1 Analyzer provides several troubleshooting utilities available in Menu – Troubleshooting. The
following system functions may be called here:
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10 Troubleshooting
• Fluids Check
• Signal Quality
• Clean Sample Port
• Declotting
Menu – Troubleshooting – Fluidics check and Signal Quality

These two routines are meant to be used by the customer service personnel of your local distributor.
Please use these functions only, if your service responsible will advise you to do so.
Menu – Troubleshooting – Sample Port Cleaning

The sample port cleaning could be used to:
• clean the yellow sample port if contaminated as this might lead to tightness problems and
different kind of aspiration errors:
Press Clean Sample Port and take a clean earbud dipped in distilled water to clean it.
• clean the needle if contaminated:
Press Clean Needle and use a tissue moistened in distilled water to clean it.
This routine may also be used to check if the needle is damaged or slightly bent, in which case the
system might have aspiration issues. This usually requires a cartridge replacement (see chapter 8
Replacement of Consumables)
• When finished, press Close Sample Port and check, if sample port closes correctly.
Warning:
Whenever the sample port or needle is cleaned, there is a risk of infection since the port is used to
aspirate biological samples. Always use protective gloves during the cleaning procedure.
Menu – Troubleshooting – De-Clotting

The de-clotting process may also be triggered manually, if the user has the suspicion that there is a
clot or a minor blockage in the measuring path causing sample aspiration or fluidic errors.
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10 Troubleshooting
Error Messages
Error Messages
Sampling errors during Patient Measurements
Sampling Error codes: 1301, 1302, 1304, 1305, 1309

Check the last patient sample
• Ensure sample is adequately heparinized.
• Ensure sample is presented to device on time.
• Check available sample volume.
• Ensure sample is homogeneous, without fragmentation, foam or air-bubbles.
• For Neonatal samples, ensure capillary used contains enough heparin.
• For syringe samples, ensure adequate volume. The aspiration needle should not
touch the piston while aspirating sample.
Repeat the patient sample
“Clot in Path” System Stop. Error codes: 5301, 5302, 5304, 5305
Error indicates that the automated de-clotting routine of the system attempted to clear the clot /
blockage in the measuring path, was not successful.
Go to Menu – Troubleshooting – De-clotting
Run the de-clotting once or twice.
Go to Menu – Troubleshooting – Clean sample port (and select routine clean sample port)
Check the sample-port for visible clots/contamination. Clean it with an earbud dipped in
distilled water.
Caution Biohazard. Please take precautions and wear gloves.
Replace e|1 Cartridge if this does not resolve the problem.
Parameter/s not calibrated
Sensor Drift Error Nos: 2623, 2624, 2641

Sensor Slope Error Nos: 2621, 2622
Sensor Noise error Nos: 2610, 2611, 2612, 2613
Check if an improper (unspecified) sample was recently run on device (e.g. Undiluted
Urine etc.)
Go to Menu – Start calibration to run a full 2pt calibration.
Remove and re-insert the e|1 Cartridge.
Go to Results – Cal results.
Select the last 2 point calibration in the list, and check the slope value of the parameter.
If the slope value is on borderline, repeat the calibration, and if possible, wait two (2)
hours for the parameter to stabilise again.
Replace the e|1 cartridge if the slope is falling distinctly outside the range, even after
waiting.
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10 Troubleshooting
Error Messages
QC results out of range (for onboard as well as manual QC)
Go to Menu – Start calibration

This triggers an automatic 2 point calibration. Repeat in case of an error message.
Rerun QC again and check, if ranges are met.
Go to Results – Cal results.
Select the last 2 point calibration in the list, and check the slope value of the parameter.
If the slope value is borderlining, repeat the calibration, and if possible, wait two (2)
hours for the parameter to stabilise again.
For On-board QC measurements of Cartridge
Go to Menu – Troubleshooting – Clean sample port (and select routine clean sample
port)
Check the sample-port for visible clots or contamination. Clean it with an earbud dipped
in distilled water.
Replace e|1 cartridge if this does not resolve the problem.
Fluidic and aspiration errors

Note: These errors may occur after a Calibration, Patient Sample or QC sample.
Rinse error No: 1321, 1322, 1324, 1325, 1329

System stop: Rinse error No: 5321, 5322, 5324, 5325, 5329
Internal fluidic error Nos: 1311, 1312, 1314, 1319
System Stop: Internal fluidic Error Nos: 5311, 5312, 5314, 5319
Go to Menu – Start calibration
This triggers an automatic 2 point calibration.
• Rerun Patient Sample / QC if error occurred after measurement / QC
Prime all solutions in e|1 Cartridge
Go to Menu – Troubleshooting - Fluidic check
Press [Start] to run routine 2-3 times to prime all the solutions.
Go to Menu – Troubleshooting – Clean sample port (and select routine clean sample
port)
Check the sample-port for visible clots or contamination. Clean it with an earbud dipped
in distilled water.
Go to Menu – Troubleshooting – Clean sample port (go to sub-routine clean needle)
Check the needle to see if it is damaged or bent. Replace e|1 Cartridge if needle is bent
or damaged.
Remove and re-insert the e|1 Cartridge
Replace e|1 cartridge if test shows repeated not ok.
Call Service if replaced e|1 Cartridge fails to resolve the problem.
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Error Messages
Errors related to e|1 Cartridge
No e|1 Cartridge Inserted: Error Ns: 5251

Error indicates that the e|1 cartridge has been removed / is not inserted in the system.
e|1 Cartridge removed: Error No: 5252
Error indicates that the e|1 Cartridge was removed suddenly, without using the predetermined
workflow to do so.
Insert the e|1 Cartridge using the predetermined workflow
If the system still depicts this error message
Reboot the System
e|1 Cartridge Data invalid: Error No: 5253

Reboot the System
Insert e|1 Cartridge correctly: Error No: 5254

Error indicates that the e|1 cartridge was inserted incorrectly, outside the dedicated workflow to
do so.
Remove and re-insert the e|1 Cartridge, using the dedicated workflow.
Reinsert e|1 Cartridge: Error No: 5255

Error indicates that the e|1 cartridge was inserted correctly, but did not contact the measuring cell
heating circuit.
Reboot the System
Replace e|1 cartridge if problem persists.
e|1 Cartridge expired: Error No: 5259

Error indicates that the system was switched off, or was in a system stop, for longer than 72 hours.
e|1 Cartridge expired: Error code: 5273
Error indicates that the e|1 Cartridge was removed and left outside the analyzer for more than 72
hours.
Replace e|1 cartridge
e|1 Cartridge depleted: Error No: 5261, 5262

Error indicates that the Cal-1 or standby solution inside the e|1 Cartridge is empty
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10 Troubleshooting
Error Messages
e|1 Cartridge Onboard expiry: Error No: 5271

Error indicates that e|1 Cartridge has been on board longer than the specified 28 days.
e|1 Cartridge Tests used up: Error No: 5272

Error indicates that the specified number of tests (600, 300 or 150) of the e|1 Cartridge have been
used up.
e|1 Cartridge Shelf life: Error No: 5274

Error indicates that the e|1 Cartridge is old in terms of shelf-life. It has exceeded the expiry date.
e|1 Cartridge Rotary valve: Error No: 1340

System Stop: 5340
Error indicates that the rotary valve on the e|1 Cartridge is worn-out.
Clean sample port
Run fluid Check
Reboot the System
e|1 Cartridge Priming error (after insertion of Cartridge) Error No: 1350, 1351, 1352, 1353, 1354,
1355, 1356, 1357
System Stop: 5350, 5351, 5352, 5353, 5354, 5355, 5356, 5357
Error indicates the system detected aspiration issues from the Cartridge, at the aspiration after
inserting a new cartridge.
Check if the new cartridge was stored too cold before inserting (moisture and
condensation?)
Prime all the Solutions in e|1 Cartridge:
Go to Menu - Troubleshooting - System Fluidic check
Press [start] to run routine 3 times to prime the solutions.
Replace e|1 Cartridge if this does not resolve the error.
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10 Troubleshooting
Error Messages
Temperature errors related to e|1 Cartridge
Temperature control error: Error No: 1212, 1213

System Stop Error code: 5212, 5213
Error indicates that the temperature measured by the new cartridge is completely outside (below
or above) the specified electronic range.
Go to Menu – Diagnostics – Electronics Check value Sensor NTC.
If not OK, reboot the System
Remove and re-insert the e|1 Cartridge again
If still not OK, replace the e|1 Cartridge
Call Service if replaced e|1 Cartridge fails to resolve the problem
Check Cartridge Temperature: Error No: 1214, 1215

System Stop Error code: 5214, 5215
Error indicates that the system has measured the current temperature of newly inserted e|1
Cartridge to be too low or too high.
Remove the e|1 Cartridge
Check if the e|1 Cartridge was stored in the refrigerator and inserted without
acclimatization or too warm (in non air-conditioned room with ambient temp. above 31°
deg. Centigrade).
The recommended storage temperature for the e|1 Cartridge is from 15 - 25°
Centigrade and 25…30° for 48h.
Keep the cartridge ~40min outside the analyzer to acclimatize.
Reinsert the e|1 Cartridge after its temperature has returned within specified range.
Or, use a different e|1 Cartridge from stock that was stored according to
specifications.
Temperature Control Error: No: 1216,

System Stop Error code: 5216
Error indicates that the calibration of the temperature measurement circuit / coil failed.
Reboot the Analyzer
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Error Messages
Check room temperature: Error No: 1217, 1218, 1219

System Stop Error code: 5217, 5218, 5219
Error indicates that the system has measured the ambient room temperature to be too cold or too
warm.
Remove the e|1 Cartridge. Switch off the e|1 System.
Error 1217 / 5217: Check if the room temperature is too cold. Is the System placed
directly under the draft of air conditioning? Is the window close to the system opened
during cold weather period?
Error 1218 / 5218 and 1219/5219: Check if the room temperature is too warm. Is the air
condition of the laboratory / hospital working properly? Is the system placed in direct
sunlight? Is there enough space on both sides of the instrument?
The recommended ambient room temperature for the analyzer is from 15 - 32°
Centigrade.
Wait for the room temperature and system temperature to return within specified
range.
Switch-on the system and reinsert the e|1 Cartridge
Internal Temperature errors
Internal Temp error: Nos: 1400,1407, 1408, 1409, 1411, 1412, 1413, 1415, 1440, 1441, 1442,
1443, 1444, 1445
System Stop Error code: 5400, 5417, 5408, 5409, 5411, 5412, 5413, 5415, 5440, 5441, 5442, 5443,
5444, 5445
Error indicates that the System experienced issues with the control function of the internal
temperature
Remove the e|1 Cartridge.
Switch-off the system. Disconnect the power supply pin on the back panel.
Wait about 2 minutes and then switch-on.
Reinsert the e|1 Cartridge in the designated workflow, if the analyzer will not detect
that there is a cartridge.
2 e|1 Analyzer
Chapter 11
Theoretical Foundations
Reference intervals and critical limits

Warning:
The reference intervals presented in this chapter are for general information purposes only. Individual
laboratories should generate their own set of reference intervals.
Sodium
Reference intervals
Blood / Plasma / Serum > 1 year (female / male) 135.0 - 145.0 mmol/l
≤ 1 year 133.0 - 142.0 mmol/l
Table 11-1 Reference intervals(1)
Critical limits Lower limit Upper limit

Blood / Plasma / Serum 120.0 mmol/l 155.0 mmol/l
Table 11-2 Critical limits(2)
Potassium
Reference intervals
≤ 1 year 3.50 - 6.10 mmol/l

(1) L. Thomas, Labor und Diagnose, Elektronische Auflage ed., TH-Books-Verlags-Gesellschaft

Frankfurt/Main, 2016, Tab. 8.2-1
(2) C. A. Campbell, A. Georgiou, J. I. Westbrook and A. R. Horvath, "What Alert Thresholds Should Be
Used to Identify Critical Risk Results: A Systematic Review of the Evidence," Clinical chemistry,
vol. 62, pp. 1445-1457, 2016, Tab. 4
Used to Identify Critical Risk Results: A Systematic Review of the Evidence," Clinical chemistry,
vol. 62, pp. 1445-1457, 2016, Tab. 3
2 e|1 Analyzer
Ionized calcium
Reference intervals
Blood / Plasma / Serum > 1 year (female / male) 1.120 - 1.320 mmol/l 4.49 - 5.29 mg/dl
≤ 1 year 1.100 - 1.300 mmol/l 4.41 - 5.21 mg/dl

Blood / Plasma / Serum 0.821 mmol/l or 3.29 mg/dl 1.549 mmol/l or 6.21 mg/dl
Chloride
Reference intervals
≤ 1 year 96.0 - 110.0 mmol/l
Table 11-7 Reference intervals(6) (7)

(4) K. Dörner, Klinische Chemie und Hämatologie, 8. Auflage, Thieme, Stuttgart-NewYork, 2013, p. 533
Used to Identify Critical Risk Results: A Systematic Review of the Evidence," Clinical chemistry, vol.
62, pp. 1445-1457, 2016, Tab. 3
(6) N. Rifai, A. R. Horvath and C. T. Wittwer, Tietz Textbook of Clinical Chemistry and Molecular
Diagnostics, 6. ed., Elsevier, 2017, p. 2188
2 e|1 Analyzer
Hct
Reference intervals % Packed cell volume % Packed cell volume

(red blood cells)
Blood > 1 year (male) 40.0 - 53.0 0.40 - 0.53
> 1 year (female) 36.0 - 48.0 0.36 - 0.48
≤ 1 year 30.0 - 43.0 0.35 - 0.70

Blood 20.0% 60.0%
pH
Reference intervals
Blood, arterial > 1 year (female / male) 7.350 - 7.450
≤ 1 year 7.090 - 7.500
Blood, venous > 1 year (female / male) 7.320 - 7.430
≤ 1 year 7.320 - 7.430
Blood, mixed venous(a) 7.350 - 7.430
(a) L. Thomas, Labor und Diagnose, Elektronische Auflage ed., TH-Books-Verlags-Gesellschaft Frankfurt/Main, 2016, Tab. 9-2

Blood, arterial or capillary < 7.200 >7.600

(9) N. Rifai, A. R. Horvath and C. T. Wittwer, Tietz Textbook of Clinical Chemistry and Molecular
Diagnostics, 6. ed., Elsevier, 2017, p. 6784
(10)C. A. Campbell, A. Georgiou, J. I. Westbrook and A. R. Horvath, "What Alert Thresholds Should Be
Used to Identify Critical Risk Results: A Systematic Review of the Evidence," Clinical chemistry, vol.
62, pp. 1445-1457, 2016, Tab. 3
2 e|1 Analyzer
Calculated values
Calculated values
Calculated values based on measurement results of the e|1 Analyzer
Warning:
The validity of calculated results of the e|1 Analyzer must be carefully examined by a clinical-medical
specialist before any clinical decision is reached based on these values.
nCa2+ Ionized calcium value standardized to pH = 7.40 ion concentration units [mmol/L](11)
݊‫ܽܥ‬ଶା ሺ‫ ܪ݌‬ൌ ͹ǤͶͲሻሾ݉݉‫݈݋‬Ȁ‫ܮ‬ሿ ൌ ‫ܽܥ‬ଶା ሾ݉݉‫݈݋‬Ȁ‫ܮ‬ሿ ή ͳͲ௞ήሺ௣ுି଻Ǥସ଴ሻ
whole blood: k=0.22

plasma/serum: k=0.24
Note: No calculation without valid Ca2+ and pH-value

The equation is applicable for 7.2 ≤ pH ≤ 7.6
tHbc tHb (total hemoglobin) as a function of HCT(12)
‫ܥܪܥܯ‬ሾ݃Ȁ݈݀ሿ
‫ܾܪݐ‬௖ ሾ݃Ȁ݀‫ܮ‬ሿ ൌ ‫ܶܥܪ‬ሾΨሿ ή
ͳͲͲ
Note: No calculation without valid HCT value

Input range based on adult reference range(13) 30 ≤ MCHC [g/dL] ≤ 38
(11)Thode, J.; Fogh-Andersen, N.; Wimberley, P.D.; Moller Sorensen, A.; Siggaard-Andersen, O.: Relation
between pH and ionized calcium in vitro and in vivo man. Scand. J. clin. Lab. Invest., 43, Suppl. 165,
79-82, 1983
(12)Schmidt Robert, Thew Gerhard. Physiologie des Menschen, 26. Auflage. Springer-Verlag (p.607f)
(13)Thomas, Lothar: Labor und Diagnose: Indikation und Bewertung von Laborbefunden für die
medizinische Diagnostik; 7. Auflage. Frankfurt am Main: TH- Books- Verl.- Ges., 2008, S. 677 f.
2 e|1 Analyzer
Measuring principle
Measuring principle
Measuring principle for Electrolytes and pH

The e|1 Analyzer measures sodium (Na+), potassium (K+), ionized calcium (Ca2+), chloride (Cl-) and pH
(pH) using potentiometric electrode technology. The potential of each electrode is measured relatively
to a mathematically stabilized reference electrode, whereat the measured potential varies with a
specific ion dissolved in the sample. The voltage is theoretically dependent on the logarithm of the
ionic activity, as described by the Nernst equation.
Equation 1 Nernst-equation
ܴܶ
‫ܧ‬௜ ൌ ‫ܧ‬଴ǡ୧ ൅ ݈݊ሺܽ௜ ሻ
‫ݖ‬௜ ‫ܨ‬
with
Ei electrical potential (EMF) of ion i

E0,i Standard Potential
R Gas Constant
T Absolute Temperature
F Faraday constant
zi charge number of ion i
ai activity of ion i
The ideal ion-selective electrode would be ion specific, i.e. it would respond only to the ion to be
detected and not react to other ions. In practice, ion selective electrodes often have cross sensitivity to
other ions. Thus, an ion-selective electrode is rarely completely ion-specific, and potential cross-
influences of other ions must therefore be taken into account for accurate analysis. A quantitative
description can be made with the Nikolsky-Eisenman equation
Equation 2 extended Nernst-Equation (Nikolsky-Eisenman)
ܴܶ
‫ܧ‬௜ ൌ ‫ܧ‬଴ǡ୧ ൅ ή ݈݊൫ܽ௜ ൅ ௜௝ǡொா ൯‫݆׊‬ǣ ݆ ് ݅
‫ݖܨ‬௜
with
௭೔
௜௝ǡொா ൌ ෍ ‫ܭ‬௜௝ ή ܽ௝ ௭ೕ
௝
Kij cross-sensitivity – factor for ion i, sensitivity for ion j
2 e|1 Analyzer
Measuring principle
A comparative measurement method is used to determine the analytes’ concentrations. This means
that the solution to be analyzed (sample) and the operating solution “SBY” are measured sequentially
in succession. The difference between the two measured potentials is related in the direct
(logarithmic) context, or in the extended context of Nikolsky-Eisenman to the activities of the sample.
Since the activities are known for the operating solution “SBY”, the activities ai,Sample(n)[mmol L-1]
(respectively the concentrations γ·ai,Sample(n)[mmol L-1] of the ions in the sample can be calculated as
ܽ௜ǡௌ௔௠௣௟௘ ሺ݊ሻሾ݉݉‫ିܮ݈݋‬ଵ ሿ
ாೄೌ೘೛೗೐ ሾ௠௏ሿିாೄ್೤ ሾ௠௏ሿାாೃ೐೑ ൫௔ሺ௡ିଵሻ൯ሾ௠௏ሿ
ൌ ൫ܽ௜ǡௌ௕௬ǡொா ሾ݉݉‫ିܮ݈݋‬ଵ ሿ൯ ή ͳͲ ௌሾ௠௏ௗ௘௖ షభ ሿ െ ܽ௜௝ǡௌ௔௠௣௟௘ǡொா ሺ݊ െ ͳሻሾ݉݉‫ିܮ݈݋‬ଵ ሿ
with
ESample [mV] EMF potential developed in sample solution
ESby [mV] EMF potential feveloped in operating solution “SBY”
ERef [mV] mathematically stabilization of reference electrode
-1] electrode slope
S [mV dec
ai,Sby,QE [mmol L-1] activity of the ion in operating solution “SBY” compensated for
cross-sensivity-activity
aij,Sample,QE [mmol L-1] cross-sensivity-activity of sample
ai,Sample [mmol L-1] activity of ion in the sample
The electrode slope S [mV dec-1] is calculated in the course of 2P-CAL (respectively 2P*-CAL) using
calibrant “CAL” and operating solution “SBY”, which both have known activities for the analytes.
Measuring principle for Hct

The Hematocrit (HCT) measurement is based on the conductivity measurement. The lowering of the
plasma conductivity is determined by the displacement of the plasma by cellular components
(erythrocytes). The conductivity measuring section for hematocrit measurement is regularly checked
based on the known conductivity of the operating solutions.
Limitations of the measurement technology

The reported patient result can be influenced by various factors. The influence of a large number of
substances were investigated and documented for the e|1 Analyzer. For details see chapter 4
Specification section Interferences.
However, it is not possible to evaluate all interfering substances (drugs and their degradation
products in the samples). In the event of abnormal deviations of the measurement results, the
operator must evaluate the entire clinical picture of the patient and, if necessary, carry out extended
measurements.
2 e|1 Analyzer
Calibration Principle
All necessary calibrations to maintain the availability of the e|1 Analyzer are done automatically by
the system and include transport of calibration solutions to the sensor according to defined patterns
as well as detection and evaluation the electronic signal outputs.
For this purpose, two calibration solutions are used, which are integrated in pouches, made of water
vapor-tight material, and are integrated into the e|1 Cartridge. Both solutions are aqueous buffered
saline solutions with fixed values for the parameters Na+, K+, Ca2+, Cl-, pH and HCT.
SBY The operating solution “SBY” has mid-level analyte activities (corresponding to normal physiological
values) and ensures rapid readiness of the sensor. The solution is used in a 1P calibration and serves
as a reference point after each measurement.
CAL The calibrant “CAL” has analyte activities that are different from the operating solution and allows the
system to determine sensor-specific properties (i.e. mainly electrode slope S)
There are different types of automatic calibrations done by the system, depending on the requirement
at a specific time:
Post-CAL The “Post-CAL” is performed as part of all measurement and calibration workflows
2P-CAL The electrode slope S [mV dec-1] is calculated in the course of 2P-CAL (respectively 2P*-CAL) using
calibrant “CAL” and operating solution “SBY”, which both have known activities for the analytes.
(duration: 30sec)
2P*-CAL If the system detects deviations (due to e.g. sample induced drift or insufficient wetting) in the signal
quality of the sensors, additional 2P-calibrations will be carried out automatically (shown as 2P*-CAL,
duration: 30sec)
1P-CAL The “1P-CAL” will be triggered by the system to maintain operational readiness only if no other system
actions (measurement, QC-measurement, 2P-CAL, 2P*-CAL) are performed for more than 4h.
Depending on the life cycle of the e|1 Cartridge, the calibration scheme is adapted to corresponding
operational modes (sensor phase):
Run In Within the first 6 hours of operation of the e|1 Cartridge, the system is in the so-called “Run In”
phase. In this phase, a tighter calibration scheme (a 2P-CAL is triggered every 30 minutes) is necessary
to maintain readiness for measurement and to provide accurate results.
Stable By default, a 2P-CAL is performed every 12 hours, but the user can shorten the interval to 4 or 8 hours
2 e|1 Analyzer
2 e|1 Analyzer
Chapter 12
Appendix
12 Appendix
12 Appendix
Order List
Order List
EXIAS Medical offers different products for the in-vitro diagnostic measurement. The following Table
12- 1 lists the names of the products as well as their associated reference-/ material numbers.
Product name Mat No. Units/Quantities

Product
e|1 Analyzer M000204 1 piece
Consumables
e|1 Cartridge 150 M000338 1 piece
e|1 Cartridge 150 oQC M000339 1 piece
e|1 Printer paper M000322 1 box of 5 rolls
Accessories
e|1 QC-1 Quality Control M000293 1 box à 30 ampoules
e|1 Barcode scanner M000323 1 piece
Capillary tubes (100 pcs.) M000326 1 box of 4 dispenser boxes to 100 pcs. each dispenser box
Table 12-1 Order List of EXIAS Medical
2 e|1 Analyzer
12 Appendix
Order List
2 e|1 Analyzer
13 Index
Index
A
Abbreviation, 1-7
Abbreviations, 1-7
Accessories, 12-3
Authentication, 9-19
Auto-Print, 6-8
B
Barcode scanner, 3-10
Biohazard, 2-3
C
Calculated values, 11-6
Calibration planner, 9-16
Calibration Principle, 11-9
Capillary mode, 6-6
Capillary tubes, 3-11
Clot-detection, 10-5
Consumable change
– Printer paper replacement, 8-8
– Replace e|1 Cartridge, 8-3
Copyright, 1-3
Critical limits, 11-3
D
Data input, 9-12
Disinfection, 2-6
– Device surfaces, 2-6
– Touch-Display, 2-6
Disposal, 2-3
E
e|1 Cartridge, 3-5, 5-7
e|1 QC material, 3-9
Edition notice, 1-3
Electrical safety, 2-8
Electromagnetic compatibility, 2-5, 2-8
Expected values, 7-6
Export results, 9-21
G
General safety instructions, 2-7
2 e|1 Analyzer
13 Index
I
Important information for evaluating QC results, 7-4
Input modes, 3-6
Inserting the e|1 Cartridge, 5-6
Intended use, 3-3
Interface, 3-5
Interference, 4-13
– Substances without effect, 4-13
IT security advisory, 2-7
L
Language, 9-17
License information, 9-24
Limitations of clinical analysis, 4-15, 6-5
– Electrolyte, 6-5
– General, 6-5
M
Main screen, 9-3
– Measurement modes, 9-4
– Navigation bar, 9-3
– Parameter selection field and information, 9-4
Manual on-board QC measurement, 7-5
Manual QC measurement, 7-6
Measurement evaluation, 6-9
Measurement results, 6-8, 9-5
Measuring principle, 11-7
Measuring procedure, 6-6
N
Network, 9-18
Note on the use of this manual, 1-3
O
On-board QC, 7-5
On-board QC measurement, 7-5
Operating conditions, 4-16
Operator management, 9-10
Order List, 12-3
P
Parameter Settings, 9-11
Patient management, 9-8
Perform QC measurement, 7-5
Performance features, 3-3
Pre-analytics, 4-3, 5-3, 7-3
2 e|1 Analyzer
13 Index
Preanalytics, 6-3
Printer, 3-5
Printer paper, 3-8
Printer paper replacement, 8-8
Q
QC Consequences, 9-15
QC consequences, 7-9
QC material, 7-3
QC measurement, 7-5
QC results, 7-4
Quality control, 7-3
– General, 7-3
Quality control materials, 9-13
Quality Control planner, 9-15
R
Reference intervals, 11-3
Remote access, 9-20
Remove sample container, 6-7
Replace e|1 Cartridge, 8-3
Results, 9-5
Revision history, 1-3
S
Safety information, 2-3
Samole containers
– Sample tubes, 6-4
Sample collection
– Syringes, 6-4
Sample handling, 6-4
– Glass sample container, 6-4
Sample tubes, 6-4
Settings, 9-10
Software and language update, 9-21
Storage and transport conditions, 4-16
Symbols, 1-5
T
Text convention, 1-4
Touch display, 3-3
Troubleshooting Concept, 10-3
2 e|1 Analyzer
13 Index
V
Visual identification
– Front view, 3-3
– Rear panel, 3-4
2 e|1 Analyzer

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Manual version Software version Revision date Remark

2019, EXIAS Medical GmbH, all rights reserved.

EXIAS Medical is a trademark of EXIAS Medical GmbH.

Version 1.1, Nov 2019

Purpose and use of this document

Wear eye protection!

Wear protective gloves!

Wear protective clothing!

Temperature limitation -2°C to +30°C

In vitro diagnostic medical device

Date of manufacture (YYYY-MM)

Consult Instructions for Use

Serial number (model plate)

Fragile, handle with care

Handle with care

Do not throw in trash

Contains sufficient for <n> test

Power on / Power off

General safety instructions

Biohazard exposure, precautions and disposal

Wear protective clothing!

Wear protective gloves!

Wear eye protection!

Electromagnetic compatibility (EMC)

Emission: Class B according to

Disinfection of the Touch-Display

[Menu] > Utilities > [Clean device]

Disinfection of the device’s surfaces

Electrical safety and electromagnetic compatibility

• The power cable must conform to country-specific requirements.

Limitations of the e|1 Analyzer

• Implemented protection measures may become ineffective.

A Printer D Ethernet port

Figure 3-4 Printer

Syringe / sample tube mode Capillary tube mode

Figure 3-9 QC material

Recommendations for ensuring good barcode scanning quality:

Parameter specified for: specified range Unit Conversion

Parameter specified for: specified range

Substances without effect

Generic name (substance) Concentration Tested analyte

Substances with effect

Generic name Concentration Unit Analyte Analyte Effect of ATE Unit

Heparin 300 [kU/L] Ca2+ 1.177 -0.322 ± 0.002 0.160 [mmol/L]

Operating, Storage and Transport Conditions

Storage and transport conditions in original packaging

Transport conditions in original packaging

Transport conditions in original packaging

Transport conditions in original packaging

Electrical data Mains voltage range: 24V DC

Type Manufacturer MEAN WELL USA Inc.

Type: "Easy load" thermal printer

Unboxing and checking contents

Installation and setup

Figure 5-1 Rear panel

Setting Date, Time and Language