Manual - Element RC - ENG

Download as pdf or txt
Download as pdf or txt
You are on page 1of 38

Product Manual

Veterinary Chemistry Analyzer


element RC

__________________________________________________________________________
Vers. 20200402ENG Page 1
Thank you for choosing the element RC fully automated dry biochemistry analyzer.
This manual is configured to provide you with the following instructions:
Features, dimensions, principles of measurement, instructions for use, maintenance,
packaging, storage, and shipping. Please review this instruction manual carefully before use.
To ensure analyzer performance, please note all Warning, Caution and Prompt messages.

__________________________________________________________________________
Vers. 20200402ENG Page 2
TABLE OF CONTENTS

SECTION 1: USING THIS MANUAL ..................................................................................... 5


1.1 Scope of Application................................................................................................ 5
1.2 Warning and Safety Symbols .................................................................................. 5
1.3 element RC Analyzer Use ....................................................................................... 6
1.4 Compliance with Safety Measures .......................................................................... 7
SECTION 2: INTRODUCTION .............................................................................................. 8
2.1 Analyzer Appearance .............................................................................................. 8
2.2 Basic Introduction .................................................................................................... 8
2.3 Detection Principle .................................................................................................. 9
2.4 Analyzer Structure and Components ....................................................................... 9
2.5 Analyzer Function ..................................................................................................10
2.6 Scope of Application...............................................................................................10
2.7 Executive Standard ................................................................................................10
2.8 Electromagnetic Compatibility Statement ...............................................................11
2.9 Technical Parameters ............................................................................................12
SECTION 3: INSTRUMENT INSTALLATION ......................................................................13
3.1 Operating Environment ..........................................................................................13
3.2 Installation ..............................................................................................................14
3.2.1 Installing the instrument ..................................................................................14
3.2.2 Insert printer paper ..........................................................................................14
3.2.3 External printer ................................................................................................14
SECTION 4: COMMON OPERATIONS ...............................................................................15
4.1 Startup ...................................................................................................................15
4.2 Commonly Used Buttons ........................................................................................15
4.2.1 Main Screen Buttons .......................................................................................16
4.2.2 Soft keyboard ..................................................................................................19
SECTION 5: TESTING AND RESULTS ...............................................................................20
5.1 Sample Requirements ............................................................................................20

__________________________________________________________________________
Vers. 20200402ENG Page 3
5.1.1 Sample handing ..............................................................................................20
5.2 Test Rotor Preparation ...........................................................................................20
5.2.1 Reagent rotor storage and disposal.................................................................21
5.2.2 Pipette patient sample .....................................................................................22
5.3 Sample Test ...........................................................................................................23
5.4 Test Procedure Precautions ...................................................................................25
5.5 Print Results ...........................................................................................................26
5.5.1 Built-in printer print reports ..............................................................................26
SECTION 6: SERVICE AND MAINTENANCE .....................................................................27
6.1 Analyzer Cleaning ..................................................................................................27
6.2 Software Upgrade ..................................................................................................27
6.2.1 USB flash drive upgrade .................................................................................28
6.3 Troubleshooting .....................................................................................................29
SECTION 7: PACKING, STORAGE AND TRANSPORTATION ..........................................30
7.1 Packing, Storage and Transportation .....................................................................30
SECTION 8: EXPLANATION AND RISK WARNING ON EMC ...........................................31
8.1 Explanation and Risk Warning on EMC ..................................................................31
8.1.1 Operating Mode ..............................................................................................32

__________________________________________________________________________
Vers. 20200402ENG Page 4
SECTION 1: USING THIS MANUAL
1.1 Scope of Application
Those qualified to use this analyzer include:
1. Users who received operation training from qualified scil personnel.
2. Users who received the operation training from authorized distributors of scil.
scil reserves the right to revise the instructions and issue software updates.
No individual or organization may reproduce, modify or translate the contents of this manual
without the written consent of scil.
scil has the final interpretation of the contents of this manual.
The illustrations used in this manual are shown as representative samples, which may differ
from the actual products. If there is any difference, the physical product shall prevail.
Be sure to use the analyzer in accordance with the conditions specified in this manual.
Failure to do so may result in failure of analyzer or inaccurate test results.

1.2 Warning and Safety Symbols


This information should be followed to avoid potential harm.
WARNING
Please refer to any symbols in this manual.

All safety precautions and cautions listed in this manual must be


CAUTION
followed.

IMPORTANT Important prompt message during operation.

Hazardous blood sample and test kits may be present during


BIOHAZARD
operation. Use proper protective gear.

Grounding
Do not modify the ground.
Protection

__________________________________________________________________________
Vers. 20200402ENG Page 5
1.3 element RC Analyzer Use
Follow the instructions below before operation:
❖ Please check the analyzer contents and packing list.
❖ Please read documents included with the analyzer.

WARNING

The analyzer should be protected from working in humid and corrosive environments. Do not
use flammable or explosive gas around the equipment.
Do not remove covers or other parts that are secured with screws to avoid electrical shock
that may result from exposure to hazardous voltage or injury from moving parts.
Wear protective gloves, lab coat and safety goggles.
It is the user’s responsibility to provide a compatible electromagnetic working environment to
ensure the analyzer will perform as intended.
The analyzer complies with the requirement of equipment emission and immunity in GB/T
18268. The analyzer is designed and tested according to Class A equipment in GB 4824.
Do not use this analyzer near strong radiation sources (such as unshielded FR sources), as
this may interfere with the normal operation of the analyzer.

CAUTION

Avoid installation locations where water may splash on the equipment.


Plug the power cable into an outlet with a grounding receptacle. Electrical shock may occur if
the equipment is not grounded to a protective earth.
Make sure that all cables have been properly connected.

BIOHAZARD

When handling samples (blood) and cleaning or maintaining the analyzer, always follow the
biohazard procedures in accordance with the sample handling rules of your facility.
Use proper protective gear (gloves, lab coat, safety goggles).
Used consumables such as rotors, tips, tubes and cloths used to clean the equipment are
infectious waste. Process this waste in compliance with any applicable local, state or country
regulations.

__________________________________________________________________________
Vers. 20200402ENG Page 6
When discarding the analyzer that may be contaminated with blood samples, follow
applicable regulations for your country and dispose of appropriately.

1.4 Compliance with Safety Measures


For using analyzer safely and efficiently, please observe the following precautions:
1. Avoiding failure of analyzer
The installation environment of the analyzer should meet the requirements of the
installation environment in this manual.
2. Preventing electric shock
Do not open the shell of the analyzer without the authorization of scil and prevent the
introduction of liquids into the analyzer. Please contact scil Technical Support Services
with any questions. Ensure that the power cord is in good condition before use. Do not
use a damaged electric cord to prevent electric shock.
3. Biohazard
Protective gloves should be worn during biochemical testing operations to prevent
biological contamination. If the blood sample is accidently touched, immediately rinse
the contaminated area thoroughly under running water and disinfect.
4. Operating reagent rotor
Reagent beads may contain corrosive substances, follow the instructions strictly in
accordance with the manual. The operator will not contact the reagent beads sealed in
the reagent rotor during normal use unless the reagent rotor fails. If reagent beads are
released, avoid direct contact with reagent rotor and avoid breathing reagent dust.
5. Disposing reagent rotor
Used reagent rotors should be disposed of in accordance with applicable regulations.

__________________________________________________________________________
Vers. 20200402ENG Page 7
SECTION 2: INTRODUCTION
2.1 Analyzer Appearance

2.2 Basic Introduction


Product name: Fully automated dry chemistry analyzer

Model: element RC Veterinary Chemistry Analyzer (element RC Analyzer)

Size: 7.87" (200 mm) width x 9.92" (252 mm) depth x 11.77" (299 mm) height

Weight: 10.1 lbs (4.6 kg)

Accessories: Power cable, Mini-pipette

The element RC Analyzer features simple operation. The analyzer requires Li-Hep whole
blood, Li-Hep plasma or serum sample. Required sample volume is 100μl. Automatic sample
analysis is completed by pipetting patient sample in the test rotor and loading into the
analyzer.
The element RC Analyzer will report results after 12 minutes of analysis. The analysis results
are automatically displayed and printed after the analysis is completed. Furthermore, the
results are transmitted to the practice management software if the instrument is connected.
The Analyzer has four USB ports for connecting external printers, a mouse, keyboard, or
other supported devices.

__________________________________________________________________________
Vers. 20200402ENG Page 8
2.3 Detection Principle
element RC Analyzer is a bio-based analyzer with microcomputer. It is used in conjunction
with the available test rotors to detect the concentration of biochemical substances in the
patient sample, and utilizes the corresponding methods of end- point, rate, two-point method,
and the eight-segment wavelength synchronous detection.
element RC Analyzer uses the principle of absorption spectroscopy. The absorption
spectrum is mainly used for biochemical reaction tests, and its working principle is as follows:
Multiple sets of detection reagents are pre-loaded in the test rotor to form an independent
reaction chamber. The patient sample is added to the test rotor, and then the test rotor is
placed in the analyzer. The system is controlled by the computer processor, and the
biochemical substance in the blood enters the individual reaction chambers and chemically
reacts with the corresponding specific reagent to produce a color change. The absorption
spectrum is used to detect the change, and the calculation is performed by the analyzer
computer to determine the concentration of the biochemical substance present in the patient
blood sample. The turbidimetric method is mainly used for detection with immunochemical
tests, and the working principle is antigen/antibody complex. After binding, an immune
complex is formed, and the turbidity of the complex polymerization occurs within a pre-
defined time frame. When light passes through the solution, it can be absorbed by the
immune complex. The higher the immune complex, the more light is absorbed. The amount
of light absorbed is proportional to the amount of immune complex within a certain range.
The absorbance value is measured by the optical path component transmission, and the
content of the complex is proportional to the absorbance value. Similarly, when the amount
of the antibody is constant, the absorbance value is also proportional to the antigen content,
and the concentration and the content of the immune complex are analyzed to determine the
concentration of the immune complex.

2.4 Analyzer Structure and Components


The analyzer consists of the machine shell, core components, thermostatic temperature
control components, a two- dimensional bar code scanning acquisition component, printer
component, optical path component, LCD capacitive display+ touchpad, operating software
and a power cord.
The analyzer is compact, lightweight and easy to transport.
Analyzer components:
❖ An outer plastic shells.
❖ A variable speed motor that controls the rotation of the test rotor (machine core
components).
❖ A photometer for testing the concentration of substances in a liquid (light path
components).

__________________________________________________________________________
Vers. 20200402ENG Page 9
❖ Two microprocessors for controlling instrument and processing test calculations
(Constant temperature, temperature control components, and two-dimensional bar
code scanning acquisition component).
❖ A thermal printer for printing results (printer components).
❖ 7.0-inch color capacitor multi-touch screen (display screen).
❖ Multiple selection features related to testing and results processing (operating
software).

2.5 Analyzer Function


❖ 7.0-inch touch screen, Android operation system with multi-language support.
❖ Single channel test, no cross contamination.
❖ Advanced optical inspection system, built-in 8 wavelength filters: 340, 405, 450, 505,
546, 600, 630, 850 nm
❖ Test methods: End point, rate, fixed time.
❖ Sample information storage can be satisfied with customer information storage
demand.
❖ Intelligent real-time quality control guaranteed accurate test results.
❖ Support for external mouse and keyboard (USB).
❖ Built-in thermal printer.

2.6 Scope of Application


The element RC is suitable for biochemical analysis of Li-Hep whole blood, Li-Hep plasma
and serum when used in conjunction with the available test rotors. It is for veterinary
medicine use only.

2.7 Executive Standard


❖ The main performance indicators of this product are designed and manufactured in
strict accordance with YY/T 0655–2008 "Dry Chemical Analyzer".
❖ The electrical safety of the product complies with the provisions of GB 4793.1–2007
(Safety requirements for electrical equipment for measurement, control and laboratory -
Part 1: General Requirement). The environmental test of the product meets the
requirements of GB/T14710–2009 (Environmental Requirements and Test Methods for
Medical Electrical Equipment).
❖ This product meets the special requirements of YY0648–2008 medical equipment
Section 2-101 of (Safety Requirements for Electrical Equipment for Measurement,
Control, and Laboratory Use).
NOTE: Repeating any of the tests in GB 4793.1–2007 on the equipment may damage
equipment and increase the risk of danger!

__________________________________________________________________________
Vers. 20200402ENG Page 10
2.8 Electromagnetic Compatibility Statement
❖ This equipment complies with GB/T18268.1–2010 (IEC61326–1:2005, IDT )
"Electromagnetic compatibility requirements for electrical equipment for measurement,
control and laboratory – Part 1: General requirements" and GB/T18268.26–2010
(IEC61326–2–6:2005, IDT ) Electromagnetic compatibility requirements for electrical
equipment for measurement, control and laboratory use Part 26: Particular
requirements for in vitro diagnostic (IVD) medical equipment.
❖ The following usage requirements should be strictly observed during use, otherwise
electromagnetic interference may be caused to other equipment or the electromagnetic
interference resistance of the equipment may be reduced or even the basic
performance may be lost.
❖ This equipment is designed and tested according to Class A equipment in GB4824. In
a domestic environment, this equipment may cause radio interference and precautions
may be required.
❖ Portable and mobile RF communications equipment may affect the description of
medical electrical equipment: Portable and mobile RF communications equipment may
affect the normal operation of this equipment, and portable and mobile RF
communications equipment should be guaranteed to meet certain spatial distances.
See Appendix A, “Recommended Isolation Distances Between Portable and Mobile RF
Communications Equipment and Equipment.”
❖ It is recommended to evaluate the electromagnetic environment before the equipment
is used. This equipment should not be used close to or stacked with other equipment.
Except for cables, connecting cables and other accessories sold by the manufacturer
as spare parts for internal components, the components cannot be replaced or repaired
without permission. Otherwise it may cause excessive electromagnetic interference or
disturbance.
❖ Do not use this device near strong radiation sources (such as unshielded RF sources)
as this may interfere with proper operation of the device.

__________________________________________________________________________
Vers. 20200402ENG Page 11
2.9 Technical Parameters
Sample type Lithium heparin whole blood, Lithium heparin plasma and serum

Sample volume 100μl

Bar code Two-dimensional bar code

Testing time 12 minutes/sample

Testing principle Absorption spectroscopy, Transmission turbidimetry

Testing method End point, Rate, Fixed time

Absorbance 0.001 Abs

Cross infection 0

QC & Calibrate Real time Full-auto finish

Work environment Temperature: 50ºF–86ºF (10ºC–30ºC) Humidity: 30%-70%

Light source 12 V/20 W, halogen tungsten lamp’s life span is over 2500 hours

Power supply AC 240 V, 50 Hz

Rated power 120 VA

Back dividing light technology, 8 band wavelength synchronization


Optic system
detection: 340, 405, 450, 505, 546, 600, 630, 850 nm

7 inch 800*480 multi-touch screen, Android system, Multi-language


Display
support

Storage LAX 500,000 results

Printer Built-in thermal printer

Connectors 4 USB, one network port

Weight 10.1 lbs. (4.6 kg)

__________________________________________________________________________
Vers. 20200402ENG Page 12
SECTION 3: INSTRUMENT INSTALLATION
3.1 Operating Environment
To ensure optimal performance, the instrument should be installed in accordance with the
following environmental conditions:
❖ Elevation not to exceed 6500 feet (2000 m)
❖ Temperature: 50ºF–86ºF (10ºC–30ºC)
❖ Relative humidity: 30%–70%
❖ Barometric pressure: 860 hPa ~1060 hPa.

The analyzer should be installed according the following conditions:


❖ Level, stable surface
❖ Temperature and humidity control
❖ Avoid direct sunlight or excessive heat
❖ Avoid sources of vibration or electrical noise and interference (bench top centrifuge)

Do not install the instrument in following conditions:


❖ Excessively high humidity, in the presence of corrosive gases, in dusty or unfiltered air,
or near strong electromagnetic interference
❖ Without circulating air or adequate ventilation
❖ In direct sunlight or near other heat sources
❖ Unsteady or tilted work surface
❖ Near a centrifuge or other source of vibration or electrical noise

Requirements for power supply:


❖ AC 240 V, 50 Hz, rated power: 120 VA
❖ The instrument cannot use the same power supply socket with some high-power
equipment including centrifugal, refrigerator, oven, etc.
❖ The power supply should earth well and connect the power supply with three-cores
wire; the voltage between the neutral line and earth line < 5 V.

__________________________________________________________________________
Vers. 20200402ENG Page 13
3.2 Installation
3.2.1 Installing the instrument
1. Remove the instrument from shipping carton and place it on a stable, level surface.
2. Inspect for any damage.
3. Connect the power cord to the analyzer.
4. Press the power switch at the back of the instrument, the indicator light will illuminate
below the screen. The system will enter startup and perform a self-test.

3.2.2 Insert printer paper


Spindle
Print Cover
Paper
Print Paper Roll

NOTE: 50 x 57 mm thermal printer paper has been installed during analyzer installation.

Replacing printer paper


1. Open printer cover.
2. Remove printing paper packaging, then place into analyzer with loose end forward.
3. Hold the loose end and route paper under the outlet on the printer door.
4. Close the printer cover.

3.2.3 External printer


This analyzer is compatible with printers using HP PCL3 GUI printer language, HP Deskjet or
other. Refer to your printer’s owner manual for additional information.

__________________________________________________________________________
Vers. 20200402ENG Page 14
SECTION 4: COMMON OPERATIONS
4.1 Startup
Startup screen: Initialization screen:

4.2 Commonly Used Buttons


The system will automatically enter the interface as shown below in figure 4-1 after analyzer
starts up. Confirm the date and time on the top border is correct.

There are 4 main buttons on the touch


screen interface.
1. Test
2. Reports
3. QC
4. Settings

__________________________________________________________________________
Vers. 20200402ENG Page 15
4.2.1 Main Screen Buttons
1. Test
Run patient sample from this screen.
NOTE: Section 5.3 for further information.

2. Reports
Review prior test results. Select a report
and select to view results.

From the Reports screen, select “ ”


for additional options to the right.
Select Back to exit to Reports screen.

__________________________________________________________________________
Vers. 20200402ENG Page 16
3. QC
Quality control sample lot information and
target ranges can be added in the menu.

4. Settings
Configure the element RC Analyzer:
A. Information settings
B. Parameter settings
C. Print settings
D. Connection settings
E. Log export
F. Others

A. Information settings
Set analyzer date/time and enter clinic or
hospital name.

Select the box for System Time to make


changes.

__________________________________________________________________________
Vers. 20200402ENG Page 17
B. Parameter settings
Change individual assays, such as units,
reference ranges, etc.
NOTE: Do not make changes to
parameters unless advised to do so by a
scil representative.

C. Printing settings
Select the internal printer and turn on
automatic results printing.

D. Connection settings
Select data transmission settings.
NOTE: Do not make changes to
parameters unless advised to do so by a
scil representative.

E. Log export
Export test result data to a USB device
(U:drive). USB device should be FAT32
formatted.

__________________________________________________________________________
Vers. 20200402ENG Page 18
5. Other settings
Do not make changes to parameters
unless advised to do so by a scil
representative.

4.2.2 Soft keyboard


The soft keyboard is a built-in keyboard.
Users can select the field where information
is entered and typed in the window, once
the cursor starts blinking and the soft
keyboard is activated.

__________________________________________________________________________
Vers. 20200402ENG Page 19
SECTION 5: TESTING AND RESULTS
5.1 Sample Requirements
WARNING

Always follow biohazard procedures in accordance with the sample handling rules of your
facility when handling samples (blood).

5.1.1 Sample handing


1. Collect whole blood sample using 22 g (or larger) needle.
2. Gently invert tube several times to ensure proper mixing of sample with lithium heparin.

CAUTION

❖ Whole blood must be analyzed or transformed to plasma and serum within 30 minutes
after collection.
❖ Do freeze or shake the sample vigorously, this can hemolyze the sample.
❖ If the sample cannot be analyzed immediately after collection, it should be processed
into serum or plasma and stored in sealed sample tube at -20°C. Avoid repeated
freezing-thawing cycles.
❖ The patient should be fasted for 12 hours prior to glucose testing.
❖ Check the patient sample for clots or hemolysis. Avoid running icteric or lipemic
samples. The analyzer has a built-in centrifugal function - testing will begin after the
anticoagulated whole blood has been spun into plasma. Lithium heparin is the only
recommended anticoagulant, as it will not interfere with on biochemistry analysis.
❖ Always wear proper protective gear when handling patient samples.

5.2 Test Rotor Preparation


Test rotors are single use only. The rotors contain diluent at the center and separate tunnels
leading to cuvettes with individual testing reagents to avoid cross contamination.

__________________________________________________________________________
Vers. 20200402ENG Page 20
5.2.1 Reagent rotor storage and disposal
❖ Store test rotors in the refrigerator between 2–8°C.
❖ Remove test rotor from refrigerator and allow to warm up to room temperature for 20
minutes in sealed pouch prior to sample analysis.
❖ Test rotors in sealed pouches can be stored at room temperature for a maximum of 48
hours.
❖ Do not expose the test rotor to direct sunlight, or temperatures over 32°C.
❖ Remove test rotor from sealed pouch, hold the rotor by the edge only to avoid
contamination. Test rotors should be used within 10 minutes after opening the sealed
pouch. Once test rotors have been removed from the sealed pouch, they should not be
returned to the refrigerator.
❖ Patient information can be written on the test rotor in the grey area.
❖ Avoid marking or damaging the barcode at the center of the test rotor.
❖ Insert test rotor into analyzer immediately after pipetting patient sample. Do not shake
rotor after patient sample has been pipetted.
❖ Test rotors are single use only. Used test rotors should be disposed of in accordance
with regulations.
❖ Damaged test rotors should be disposed of immediately. Avoid contact with reagents
contained within rotors.

Labeling area

__________________________________________________________________________
Vers. 20200402ENG Page 21
5.2.2 Pipette patient sample
1. Use the supplied 100μl pipette and
disposable tip to pipette patient
sample into the sample port.
Fill the sample well to the fill line.

2. Pipette tips are single use, do not re-


Fill port
use to avoid sample contamination.
Fill line

3. Hold the test rotor horizontally by the


edges when insert into the analyzer
drawer.

CAUTION

❖ Do not mark or damage QR code on test rotor.


❖ Do not touch pipette tip.
❖ Place pipette tip approx. 1/16 in (2–3 mm) below the surface of the sample when
pipetting.
❖ Keep the pipette plunger pressed down until the pipette tip is removed from the sample
port on test rotor.
❖ Clean any sample on test rotor or around sample port before placing test rotor in
analyzer.

__________________________________________________________________________
Vers. 20200402ENG Page 22
5.3 Sample Test
Turn on the analyzer, if it is not already powered on.

1. The element RC Analyzer will


begin a self-check diagnostic.
2. The analyzer will warm the
incubator to proper testing
temperature, ~5 minutes.
3. From the Welcome screen, tap
on TEST.
4. Tap on WORKLIST or NEXT to
enter the patient information

5. Enter the patient ID, select the


species and sample type. Tap
on SAVE

6. The drawer will open and the


“Please load disc” page
displays on the screen. Insert
the rotor. Tap on CONFIRM
and the drawer will close.
NOTE: Center the test rotor in
drawer to avoid errors.

__________________________________________________________________________
Vers. 20200402ENG Page 23
7. The analyzer scans the
QR code on the test
rotor and begins
countdown. Patient
information can be
added by touching
SAMPLE INFO.

8. Touch STOP to
terminate current
patient sample
analysis.
9. Touch OK when the
test is terminated.
CAUTION
Test rotor and patient sample will
no longer be valid after
terminating testing.

NOTE: If QR code scanning is


unsuccessful, the system will
display a pop-up prompt.
If a barcode error prompt pops up,
touch OK and remove the test
rotor to inspect the QR code for
damage or contamination. If the
QR code is damaged the test rotor
must be replaced.

10. When the test time has


elapsed, the test is
completed, and the test
results can be
viewed/transmitted/
printed.

__________________________________________________________________________
Vers. 20200402ENG Page 24
5.4 Test Procedure Precautions
Analyzer
❖ Use grounded power supply and supplied power cord.
❖ Confirm the ambient temperature of the analyzer is 10ºC–30ºC.
❖ Do not disconnect power during operation.
❖ Close the drawer when the analyzer is not in use.
❖ Pinch hazard – keep fingers clear when analyzer drawer is opening and closing.
❖ Do not disassemble the analyzer.
Test Rotor
❖ Do not use expired test rotors. Check expiration date on sealed pouch.
❖ Store test rotors at 2ºC–8ºC. Use gloves when handling test rotors, handle test rotors
by the edges.
❖ After pipetting patient sample, place horizontally to prevent overflow.
❖ Test rotors are single use; do not re-use.
❖ Test rotors must be used within 10 minutes of removal from sealed pouch.
❖ Analyze test rotor immediately after pipetting patient sample.
Sample
❖ Whole blood should be used within 30 minutes after sampling to prevent hemolysis.
❖ Do not place sample in the refrigerator or shake vigorously.

__________________________________________________________________________
Vers. 20200402ENG Page 25
5.5 Print Results
5.5.1 Built-in printer print reports

Sample report
The results of the analysis are automatically stored,
and the user can choose to print using the built-in
printer.
The header information of the printed report includes:
hospital name, patient name, medical record number,
sample number, age range, gender, blood sample, test
rotor ID, instrument ID, software version and test time.
The printed result section has four columns, profile
name, test value result, reference range and units.
Results outside the reference range will be marked with
H (high) and L (low) next to the result and will not be
displayed until the header information of the printed
report is filled out.
WAT= internal check of the sample volume
EMP= internal self-check
CHE= absorbance monitoring
represents a chemical monitoring hole absorbance.
The above indicators are divided into three levels:
0—better 1—general 2—poor

When the WAT, EMP, and CHE indicator value is "2",


please contact technical support for assistance.

__________________________________________________________________________
Vers. 20200402ENG Page 26
SECTION 6: SERVICE AND MAINTENANCE
The element RC Analyzer requires minimal maintenance to ensure optimal performance.

6.1 Analyzer Cleaning


Air filter
Inspect air filter weekly. Clean as needed by removing and rinsing with water. Blot dry and
replace.

Casing
Clean the outside of the machine as needed with a mild detergent and a soft wet cloth. Do
not spray or pour any detergent or liquid directly onto the instrument. Dry the analyzer with a
soft dry cloth.

Display
Wipe the display regularly with a damp, lint-free towel.

NOTE: Clean and maintain the test chamber regularly, based on usage.

6.2 Software Upgrade


The software may require periodic upgrades. This product supports USB flash drive or
wireless network upgrade.
Please read the upgrade steps carefully before upgrading software. Confirm that the
software upgrade package and software version is correct.

__________________________________________________________________________
Vers. 20200402ENG Page 27
6.2.1 USB flash drive upgrade
1. Prepare a file system for the USB drive in FAT32 format. If the format is incorrect or
cannot be confirmed, please format it on the computer and back up the data on the
USB flash drive before formatting.
USB drive formatting process: insert USB drive into the computer ► select the USB
drive ► right click ► format ► select "FAT32" file system ► start ► confirm ► format
completion prompt ► confirm.
2. Obtain the software compression package from scil’s Technical Support Services.
3. Unzip the upgrade package to get the "upgradepackage" directory, which should be
placed in the root directory of the USB drive.
4. Unplug the USB flash drive from the computer and plug it into the USB port on the back
of the analyzer.
5. Turn on the analyzer or restart the analyzer.
6. The analyzer starts and the software prompts the version upgrade information. Make
sure the upgraded version number is consistent with the version number of the
software compression package, then touch [Yes]. The software will begin the upgrade.
7. During the software upgrade process, the user will be prompted to complete the
upgrade. After the instrument upgrade is complete, the instrument will need to be
restarted. Turn the analyzer off and on again.
8. After the software upgrade is completed, it is automatically initialized, and the upgrade
is completed.

NOTE: If the upgrade fails [during upgrade], please restart the analyzer. If the upgrade is still
unsuccessful, please contact scil Technical Support Services.

__________________________________________________________________________
Vers. 20200402ENG Page 28
6.3 Troubleshooting
Description Solution
Mixing error, check sample for proper mixing or use
W2021, W2022, W2023, W2024,
serum / plasma to rerun the test
W2041, W2051

Restart the analyser and rerun the test


E1002, E1003, E1023

The rotor or QR of the rotor is damaged


E1012, E1024, W2061, W2062
Restart the analyser and rerun the test
Used rotor or damaged QC code
W3001
Rerun the test with a new rotor

Sample distribution error caused by a severe lipemia


W3003
or a high HCT
Centrifuge the sample and use plasma or serum to
rerun the rotor

The current rotor is not supported due to a low


M4002
software version
Check the date setting of the analyser
Please contact the technical service and update the
device

The rotor is expired


M5041
Check the date setting of the analyser and rerun the
test with a new rotor

Internal printer error


M5002
check printer for proper loading of paper

external printer error


M5021, M5022
check printer connection
check printer for proper loading of paper

NOTE: Contact scil Technical Support Services for additional troubleshooting.

__________________________________________________________________________
Vers. 20200402ENG Page 29
SECTION 7: PACKING, STORAGE AND
TRANSPORTATION
7.1 Packing, Storage and Transportation
This instrument is packaged in a cardboard box outer shell and high-quality foam for shock
protection. Do not stack the analyzer.
Transportation temperature: -20ºC–55ºC
Storage temperature: 0ºC–40ºC
Relative humidity: ≤ 85%.

Carton case symbols:

This Fragile Keep Stacking Humidity Pressure For Use Recycled


Side Dry Limitation UP 85% 700- Within Package
Up 1060 Temperature
hpa Limits

__________________________________________________________________________
Vers. 20200402ENG Page 30
SECTION 8: EXPLANATION AND RISK WARNING ON
EMC
8.1 Explanation and Risk Warning on EMC
This product has passed the EMC test and meets GB/T 18268.1–2010 "Electromagnetic
compatibility requirements for electrical equipment for measurement, control and laboratory
use - Part 1: General requirements" and GB/T 18268.26–2010 "Measurement, control and
laboratory Electromagnetic compatibility requirements for electrical equipment - Part 26:
Particular requirements for in vitro diagnostic (IVD) medical devices.
The following usage requirements should be strictly observed during use, otherwise it may
cause electromagnetic interference to other equipment or reduce the anti-electromagnetic
interference capability of this product, or even lose its basic performance.
This product belongs to Group 1 Class A equipment of GB 4824–2013 and is suitable for use
in all facilities that are not directly connected to the public low-voltage power grid of the
residential home.
Portable and mobile RF communications equipment may affect the description of medical
electrical equipment: Portable and mobile RF communications equipment may affect the
normal operation of this product, and portable and mobile RF communications equipment
should be guaranteed to meet certain spatial distances and specific requirements. See the
requirements in Table 4.
If the equipment cable connection is faulty, please contact our company for repair or
replacement, otherwise it may cause excessive electromagnetic interference. If the
equipment is faulty, please contact scil’s Technical Support Services. Do not repair or
replace the components yourself, otherwise it may cause excessive electromagnetic
interference.

WARNING

In addition to the transducers and cables sold by the manufacturer of the equipment or
system as spare parts for internal components, the use of accessories, transducers and
cables outside the specified regulations may lead to increased emission or reduced immunity
of equipment or systems.

WARNING

Devices or systems should not be used close to or overlay other devices. If they must be
used close to or overlay, they should be observed to verify that they can operate normally
under the configuration they are using.
__________________________________________________________________________
Vers. 20200402ENG Page 31
This product belongs to professional IVD equipment and needs to pay attention to the
following preventive warnings:
❖ The emission and immunity requirements specified in Tables 1 to 4 shall be met.
❖ It is recommended to evaluate the electromagnetic environment prior to use.
❖ Do not use this equipment near strong radiation sources (such as unshielded RF
sources), as this may interfere with normal operation of the equipment.

Basic performance
The equipment should work normally, and the bias of glucose (GLU) test results should meet
the requirements of 2.3 in the technical requirements.

Test method
Three measurements were made on the same quality control sample of GLU, and the
allowable error was calculated according to the method listed in 3.3 in the technical
requirements.

8.1.1 Operating Mode


Normal test mode: The device is powered on, and the GLU accuracy reagent disk is loaded
for normal testing.

__________________________________________________________________________
Vers. 20200402ENG Page 32
Table 1 – Guide and manufacturer's statement—electromagnetic emissions. The product is
intended to be used in the electromagnetic environment specified.

Emission Test Compliance Environmental Guidance

Radio frequency emission Group 1 The product uses RF energy only for its internal
functions. Therefore, its RF emissions are low
GB 4824
and there is little possibility of interference with
electronic equipment.

Radio frequency emission Class A The product is suitable for use in all facilities
that are not directly connected to the home and
GB 4824
to the public low-voltage grid of the residential
home.
Harmonic emission Not applicable
GB 17625.1

Voltage fluctuation/ Not applicable


Scintillation emission GB
17625.2

Table 2 – Guide and manufacturer's statement—electromagnetic immunity. The product is


intended to be used in the electromagnetic environment specified.

Immunity test IEC 61326 Test Level Coincidence level Environmental


Guide Guidance

Electrostatic rotorharge ±4 Kv Contact ±4 kV Contact The floor should be


rotorharge rotorharge made of wood,
GB/T 17626.2
concrete or ceramic
±8 kV Air rotorharge ±8 kV Air rotorharge
tiles. If the floor is
covered with synthetic
materials, the relative
humidity should be at
least 30%.

Electrical Fast ±1 kV to power cord ±1 kV to power cord Network power supply


Transient/Burst should have the quality
of use in typical
GB/T 17626.4
commercial or hospital
environments.

Electrical surge ±1 kV Line to line ±1 kV Line to line Network power supply


should have the quality
GB/T 17626.5 ±2 kV Line to ground ±2 kV Line to ground
of use in typical
commercial or hospital

__________________________________________________________________________
Vers. 20200402ENG Page 33
environments.

Voltage dip, short 0%Ut, Continue 1 0%Ut, Continue 1 Network power supply
interruption and voltage cycle cycle should have the quality
change on the power of use in typical
(On Ut, 100% sag) (On Ut, 100% sag)
input line commercial or hospital
environment.
GB/T17626.11
If the users of this
product need to run
continuously during
power interruption, it is
recommended to use
un-interruptible power
supply or battery power
supply.

40%Ut, Continue 5 40%Ut, Continue 5 Network power supply


cycles cycles should have the quality
of use in typical
(On Ut, 60% sag) (On Ut, 60% sag)
commercial or hospital
environment.
70%Ut, Continue 25 70%Ut, Continue 25
cycles cycles If the users of this
product need to run
(On Ut, 30% sag) (On Ut, 30% sag)
continuously during
5%Ut, Continue 5s 5%Ut, Continue 5s power interruption, it is
recommended to use
(On Ut, 95% sag) (On Ut, 95% sag) un-interruptible power
supply or battery power
supply.

EMF 3A/m 3A/m If abnormal work


occurs, it is necessary
(50/60Hz) GB/T 17626.8
to keep the product
away from the power
frequency magnetic
field or install a
magnetic shield in the
place. The power
frequency magnetic
field in the anticipated
installation site should
be measured to meet
the requirements below
the level.

NOTE: Ut refers to the AC network voltage before the voltage is applied.

__________________________________________________________________________
Vers. 20200402ENG Page 34
Table 3 – Guide and manufacturer's statement—electromagnetic immunity. The product is
intended to be used in the electromagnetic environment specified.

Immunity test IEC 61326 Test Coincidence Environmental Guidance


level
Level Guide
Test Level Guide

Radio frequency 3V (Effective 3 V (Effective Portable and mobile radio frequency


communication equipment should not be
conduction GB/T value) 150 value)
closer to any part of the product than
17626.6 kHz~80 MHz recommended isolation distance,
including cables, which should
be calculated using a formula
corresponding to the transmitter
Radiated 3 V/m 3 V/m frequency.
electromagnetic
80 MHz~2.0 GHz
field GB/T
17626.3 Recommended isolation distance d=1.2
√P
d=1.2 √P 80 MHz~800 MHz d=2.3 √P
800 MHz~2.0 GHz

In formula:
P—Maximum output rated power of the
transmitter provided by the transmitter
manufacturer in Watt (W).
d—The recommended isolation distance
is in meters (m). Fixed RF transmitter field
strength, through the electromagnetic field
survey to determine, each frequency
range
B should be lower than the level in line
with.
Disturbance may occur near equipment
marked with the following symbol .

NOTE: For 80 MHz and 800 MHz frequencies, higher frequency band formulas should be
used.
NOTE: These guidelines may not be suitable for all situations. Electromagnetic propagation
is affected by the absorption and reflection of buildings, objects and human bodies. Fixed

__________________________________________________________________________
Vers. 20200402ENG Page 35
transmitters, such as wireless (cellular/cordless) telephones and ground mobile radio base
stations, amateur radios, AM/FM radio broadcasting and television broadcasting, cannot
accurately predict their electric field in theory. In order to evaluate the electromagnetic
environment of fixed radio frequency transmitter, the survey of electromagnetic field should
be considered. If the measured product is located in a place where the electric field is higher
than the above RF level, the product should be observed to verify its normal operation. If
abnormal performance is observed, supplementary measures may be necessary, such as
reorienting the direction or location of the product. In the whole frequency range from 150
KHz to 80 MHz, the Electric field should be less than 3 V/m.

__________________________________________________________________________
Vers. 20200402ENG Page 36
Table 4 – Recommended isolation distance between portable and mobile radio frequency
communication equipment and products.

Maximum rated Isolation distance corresponding to different frequencies of transmitter/m


output power of
transmitter W

150 KHz~80 MHz 80 MHz~800 MHz 800 MHz~2.0 GHz


d=1.2√P d=1.2√P d=2.3√P

0.01 0.12 0.12 0.23

0.1 0.38 0.38 0.73

1 1.2 1.2 2.3

10 3.8 3.8 7.3

100 12 12 23

The product is expected to be used in radio frequency radiation disturbance controlled


electromagnetic environment. Depending on the maximum output power of the
communication equipment, the buyer or user of the product can prevent electromagnetic
interference by maintaining the minimum distance between the portable and mobile radio
frequency communication equipment (transmitter) and the product.
For the maximum rated power of the transmitter not listed in the table above, the
recommended isolation distance (d), in meters (m), can be determined by the formula in the
corresponding transmitter frequency bar, where (P) is the maximum rated output power of
the transmitter provided by the transmitter manufacturer, in watts ( W ).

NOTE: At 80 MHz and 800 MHz frequencies, the formula of higher frequency band should
be adopted.

NOTE: These guidelines may not be suitable for all situations. Electromagnetic propagation
is affected by the absorption and reflection of buildings, objects and human bodies.

__________________________________________________________________________
Vers. 20200402ENG Page 37
Service-Contact:

scil animal care company GmbH


Dina-Weissmann-Allee 6
68519 Viernheim
Germany

Telefone: +49 6204 7890 – 0


Fax: +49 6204 7890 – 200
E-Mail: info-de(at)scilvet.com

__________________________________________________________________________
Vers. 20200402ENG Page 38

You might also like