Professional Documents
Culture Documents
P/N:01.54.455736
MPN: 01.54.455736012
Statement
This manual will help you to better understand the operation and maintenance of the product. It
is reminded that the product should be used strictly in compliance with this manual. User
operation failing to comply with this manual may result in malfunction or accident for which
EDAN INSTRUMENTS, INC. (hereinafter called EDAN) can not be held liable.
EDAN owns the copyrights of this manual. Without prior written consent of EDAN, any
materials contained in this manual shall not be photocopied, reproduced or translated into other
languages.
Materials protected by the copyright law, including but not limited to confidential information
such as technical information and patent information contained in this manual, shall not be
disclosed to any irrelevant third party.
The user shall understand that nothing in this manual grants him, expressly or implicitly, any
right or license to use any of the intellectual properties of EDAN.
EDAN holds the rights to modify, update, and ultimately explain this manual.
EDAN only considers itself responsible for any effect on safety, reliability and performance of
the equipment if:
The electrical installation of the relevant environment complies with national standards, and
EDAN will make available on request circuit diagrams, component part lists, descriptions,
calibration instructions, or other information that will assist service personnel to repair those
I
parts of the equipment that are designated by EDAN as repairable by service personnel.
WARNING
A WARNING label advises against certain actions or situations that could result in personal
injury or death.
CAUTION
A CAUTION label advises against actions or situations that could damage equipment, produce
inaccurate data, or invalidate a procedure.
NOTE
II
Table of Contents
1 Warranty and Service ..................................................................................................................... 1
2 Safety Guide ...................................................................................................................................... 4
2.1 Introduction.............................................................................................................................. 4
3 Installation ........................................................................................................................................ 7
3.1 Unpacking Inspection.............................................................................................................. 7
4 Functional Checks.......................................................................................................................... 12
4.1 Switching On Check.............................................................................................................. 12
4.4 Diagnostics............................................................................................................................. 12
5 Maintenance.................................................................................................................................... 24
5.1 Maintenance Inspection ........................................................................................................ 24
7 Troubleshooting ............................................................................................................................. 32
7.1 Booting Failures .................................................................................................................... 32
............................................................................................. 39
.......................................................... 39
................................................................ 40
IV
9.3.7 Replacing the Power Board....................................................................................... 56
V
i15 Blood Gas and Chemistry Analysis System Service Manual Warranty and Service
EDAN provides a one-year-warranty for the warranted products. The warranty period begins on
the date the products are shipped to customers. If a customer promptly notifies EDAN of
replacement
will be performed by trained individuals in a workmanlike manner.
Limitation of Warranty
Direct, indirect or final damage and delay caused by the following situations for which EDAN is
not responsible may void the warranty:
Damage caused by operating beyond the environmental specifications for the medical
product.
Improper use.
Service Procedure
Fill in the SCF with detailed information including: Model Name, Serial Number (SN) and
Problem Phenomena.
EDAN should not have any obligation to take over the case without this information. The
form can be downloaded at: http://www.edan.com.cn
Department.
-1-
i15 Blood Gas and Chemistry Analysis System Service Manual Warranty and Service
Within Warranty:
i) After receiving the Return Material Authorization (RMA) form from EDAN service
department, the customer sends EDAN the defective parts and informs about the shipment
tracking number. Then we will dispatch new part(s) to your confirmed address with
confirmed shipping invoice.
ii) The customer signs the Declaration Form and sends it back by email or fax. This form is
legally certificated to make sure the customer or end-user will return the defective parts to
EDAN on time. We will, at this option, dispatch the replacement one(s) with confirmed
shipping invoice.
NOTE:
Both Return Material Authorization Form and Declaration Form are offered by
EDAN service department once the SCF is confirmed by a service engineer.
The customer is responsible for freight & insurance charges when the equipment
is shipped to EDAN for service, including custom charges. EDAN is responsible
for the freight, insurance & custom charges from EDAN to the customer.
Out of Warranty:
After receiving the RMA form from the service department, the customer sends defective
parts to EDAN in advance. We will analyze the problems and discuss with the customer
about either repairing or replacing the part(s). Once the maintenance fee is invoiced and paid,
we will dispatch good part(s) to the confirmed address.
NOTE:
The customer is responsible for any freight & insurance charge for the returned
product.
Before the shipment of the materials, the customer must obtain an RMA form from our
service department, in which the RMA number, description of returning parts and shipping
instructions are included. The RMA number should be indicated on the outside of the
shipping container.
NOTE:
EDAN should not have any obligation to the end-user or customer who returns the
-2-
i15 Blood Gas and Chemistry Analysis System Service Manual Warranty and Service
Please disassemble the parts with anti-static facility, and never touch the parts with naked
hand.
Contact Information
If you have any question about maintenance, technical specifications or malfunctions of devices,
do not hesitate to contact us.
E-mail: support@edan.com.cn
-3-
i15 Blood Gas and Chemistry Analysis System Service Manual Safety Guide
2 Safety Guide
2.1 Introduction
This service manual is a reference for periodic preventive maintenance and corrective service
procedures for the i15 blood gas and chemistry analysis system. It provides information on
troubleshooting, assembly procedures, and instructions for functional testing as well as
performance verification. The manual is intended for use only by technically qualified service
personnel.
WARNING
Strictly follow the instructions as described in this manual during service. Otherwise the
system may be damaged, or personal injury may occur.
WARNING
3. The system is intended for use only by trained technologists, nurses, physicians and
therapists.
4. SHOCK HAZARD Do not attempt to connect or disconnect a power cord with wet
hands. Make sure your hands are clean and dry before touching a power cord.
6. The system should be serviced only by authorized and qualified personnel. EDAN
does not assume any responsibility for damage or injury if modifications or repairs
are carried out by unauthorized personnel.
7. Service personnel should be familiar with the operation of the system. Refer to i15
Blood Gas and Chemistry Analysis System User Manual for details.
-4-
i15 Blood Gas and Chemistry Analysis System Service Manual Safety Guide
WARNING
8. Use and replace the substitutive parts provided or recommended by EDAN only.
11. Do not directly solder the lead wire or the battery terminal.
12. Do not touch the stitch of a calibrant fluid pack or the stitch of a vacuum pump.
CAUTION
1. The system is designed for continuous operation. Avoid splashing water over the
system.
2. Use this system at a temperature between 10°C and 31°C. Outside this range, the
system may produce inaccurate results.
3. Do not use the system in a dusty environment with bad ventilation or in the presence
of corrosives.
4. Do not operate the system rudely, or the system may produce incorrect test results.
5. Make sure that there is no intense electromagnetic interference source around the
analyzer, such as radio transmitters, mobile phones, etc. Attention: large medical
electrical equipment such as electrosurgical equipment, radiological equipment and
magnetic resonance imaging equipment is likely to bring electromagnetic
interference.
6. Do not use the analyzer after its life cycle, and it should be disposed of according to
local regulations after its life cycle.
-5-
i15 Blood Gas and Chemistry Analysis System Service Manual Safety Guide
-6-
i15 Blood Gas and Chemistry Analysis System Service Manual Installation
3 Installation
WARNING
To avoid electrical shock, do not remove any cover or board. Should problems or
malfunctions occur, unplug the power cord and power adaptor. Only qualified service
personnel should carry out servicing and troubleshooting.
Visually examine the package prior to unpacking. If there are any signs of mishandling or
damage, contact the carrier to claim for damage. After unpacking the device, customers should
follow the PACKING LIST to check the product carefully and to make sure no damage occurred
during transportation. Then, install the device according to the installation requirements and
procedures. If there is any problem, contact the manufacturer or the authorized local distributors
immediately.
Keep the analyzer away from equipment with strong electric field and strong magnetic field.
NOTE:
The requirements above also apply when your analyzer is powered by a rechargeable
lithium battery.
-7-
i15 Blood Gas and Chemistry Analysis System Service Manual Installation
Please place the analyzer on a secure table surface with environments that meet the requirements
as described in section 3.2.
1. Insert the power adaptor into the power connector on the analyzer.
NOTE:
To avoid the analyzer and other electronic devices being damaged by electrical
power spikes, a surge protector is recommended.
WARNING
2. A calibrant fluid pack is intended for single use only. If a calibrant fluid pack is
removed from the system, it can not be inserted into the system again.
1. Examine the expiration date on the package of a calibrant fluid pack to ensure it has not
expired.
2. Remove the calibrant fluid pack from its package, and equilibrate it to room temperature.
The calibrant fluid pack needs to stand at room temperature for at least 24 hours.
3. Wipe any moisture from the foil pouch with a dry clean cloth.
-8-
i15 Blood Gas and Chemistry Analysis System Service Manual Installation
6. Open the foil pouch, and remove the calibrant fluid pack from it.
NOTE:
7. Remove the calibrant fluid pack cap, and remove the key by pushing it with your finger in
the direction as shown by the arrow in the picture below.
Key Valve
NOTE:
-9-
i15 Blood Gas and Chemistry Analysis System Service Manual Installation
8. Unlock the calibrant fluid pack chamber lock with the key, and then pull the calibrant fluid
pack ejector to open the calibrant fluid pack chamber door.
9. Remove the used calibrant fluid pack from the system. The system will go to the screen for
the next procedure, and the scanner will be turned on automatically.
If the bar code is scanned successfully, the system will beep and the scanner will be turned
off automatically. If the scanned data is valid, the system will display the screen for the next
procedure. If the scanned data is invalid, a message will pop up to prompt you.
If the scanner is turned off automatically, press first, and then scan the bar code.
11. Insert the new calibrant fluid pack into its chamber, and push it gently to make sure that it
- 10 -
i15 Blood Gas and Chemistry Analysis System Service Manual Installation
clicks into place. The system will go to the screen for the next procedure.
13. Lock the calibrant fluid pack chamber lock to close the chamber door securely.
14. Press OK in the pop up message. The system will then go to the Main screen.
- 11 -
i15 Blood Gas and Chemistry Analysis System Service Manual Functional Checks
4 Functional Checks
This section describes the procedure of a complete functional test to support recommended
preventive-maintenance schedules.
WARNING
Press the On/Off button on the left side of the analyzer to turn it on.
Check if the power indicator lights up, and if the screen lights up in a few seconds.
If any failure occurs, refer to section 7.1 Booting Failures for details.
Observe if some characters are missing, or if there are bright spots or dark shadows on the LCD
screen. Observe if fonts and symbols displayed on the LCD screen are normal.
If any failure occurs, refer to section 7.2 Display Failures for details.
Touch any available button on the touch screen to check if it is working properly.
If you touch the center of a button but the analyzer does not execute the right operation, calibrate
the touch screen. Refer to section 4.4 Dignostics for details.
If any operation failure occurs, refer to section 7.3 Touch Screen Failures for details.
4.4 Diagnostics
This function let you view the information for some modules, check the functioning of the pump,
valve, printer, and internal electronic simulator, calibrate the touch screen, export data, reset the
system password, reset the system setup to the factory setup, online update the analog board,
- 12 -
i15 Blood Gas and Chemistry Analysis System Service Manual Functional Checks
scan the system ID bar code, view software running logs, and clear data stored in the analyzer. It
helps to troubleshoot.
NOTE:
Only service engineers and engineers from the manufacturer can perform this action.
No. To Press
View the analog board information. Analog board software
version (it should be the latest version), front end board ID (it
should be consistent with the tracing list), ambient
1. temperature (it should be 10 C - 35 C), ambient pressure (it Analog Board
should be 730mmHg - 760mmHg), the heater 1 temperature
(it should be 10 C - 35 C), and the heater 2 temperature (it
should be 10 C - 35 C).
View the power board information. Power board software
version (it should be the latest version), 5V voltage (it should
be 4.5V - 5.5V), 12V voltage (it should be 11.5V - 12.5V),
printer voltage (it should be 12V - 20V), input current (it
2. Power Board
should be smaller than 1A), power board temperature (it
should be 10 C - 50 C), the rate of the exhaust fan (it should
be 0 8000 cycles/min, and for temperature below 29 C, the
exhaust fan does not run).
- 13 -
i15 Blood Gas and Chemistry Analysis System Service Manual Functional Checks
9. Export the original data stored in the analyzer to *.txt format. Export Data
10. Reset the system password to the factory one. Reset Password
11. Restore the system setup to the factory setup. Factory Setup
12. Online update the analog board. Analog Update
13. Scan the system ID bar code. System ID
14. View the logs about the software running. System Log
Delete all the data stored in the analyzer. Perform this action
15. Clear Data
after scanning the system ID bar code before shipment.
1. Press the On/Off button on the left hand side of the analyzer to turn it on.
2. Enter the user name and password manually, and then press .
To scan the bar code of the user name, press first, and then scan the bar code.
- 14 -
i15 Blood Gas and Chemistry Analysis System Service Manual Functional Checks
3. On the Main screen, press to go to the Quality Control screen, and then press .
4. Gently insert the external electronic simulator into the cartridge port, and press down to
ensure it clicks into place. If the electronic simulator is inserted properly, the system will
automatically perform a simulator test.
NOTE:
- 15 -
i15 Blood Gas and Chemistry Analysis System Service Manual Functional Checks
6. The system automatically displays the test result upon the completion of the test.
NOTE:
Upon the completion of the test, the message Please Remove Cartridge will be
displayed on the status bar at the bottom of the screen, and the simulator will be
ejected.
If the system passes the external simulator test, it can be used to analyze samples.
If the system fails the external simulator test, re-perform the test after the simulator
has been cleaned and completely dried or use another simulator to re-perform the
- 16 -
i15 Blood Gas and Chemistry Analysis System Service Manual Functional Checks
test. If the external simulator test succeeds, the analyzer can be used to run samples.
If the external simulator test still fails, run an internal simulator test. If the internal
simulator test succeeds, perform the external simulator test after the POGO PIN has
been cleaned and completely dried. If the external simulator test fails, the cam needs
to be replaced. If the external simulator test succeeds, the analyzer can be used to
run samples. If the internal simulator test fails, check the wire between the cam and
the analog board. If the wire connects well, run the internal simulator test again. If the
internal simulator test still fails, replace the cam.
9. Remove the external simulator from the system, and put it back.
NOTE:
1. Examine the package label of controls to ensure they have not expired.
2. Remove an ampoule from the box of controls and equilibrate it to room temperature.
If oxygen is to be measured, the ampoule needs to stand at room temperature for at least 4
hours. If not, the ampoule needs to stand at room temperature for 30 minutes.
3. Press the On/Off button on the left hand side of the analyzer to turn it on.
4. Enter the user name and password manually, and then press .
To enter the user name with the bar code scanner, press first, and then scan the user
name bar code.
- 17 -
i15 Blood Gas and Chemistry Analysis System Service Manual Functional Checks
Press to perform a control test for blood gases and blood chemistries.
7. Press Scan Barcode, and scan the bar code on a new cartridge foil pouch.
If the bar code is scanned successfully, the system will beep and the scanner will be
automatically turned off. If the scanned data is valid, the system will display the screen for
the next procedure. If the scanned data is invalid, a message will pop up to prompt you.
8. Open the foil pouch and remove the cartridge from it.
- 18 -
i15 Blood Gas and Chemistry Analysis System Service Manual Functional Checks
NOTE:
When inserting an ampoule adaptor into the fillport of a test cartridge, make sure the
indent of the adaptor is on the upside as shown in the picture below:
9. Press Scan Barcode, and scan the bar code on the controls user manual.
If the bar code is scanned successfully, the system will beep and the scanner will be
automatically turned off. If the scanned data is valid, the system will display the screen for
the next procedure. If the scanned data is invalid, a message will pop up to prompt you.
- 19 -
i15 Blood Gas and Chemistry Analysis System Service Manual Functional Checks
NOTE:
Keep the controls user manual for a future control test use.
10. Mix the controls completely by shaking the ampoule gently, and then tap the tip of the
ampoule carefully with your fingernail to remove any solution.
NOTE:
Avoid heating the ampoule with your hands when shaking the ampoule.
11. Open the ampoule by snapping off the top and immediately transfer control solution by
slowly drawing an appropriate amount of solution with a syringe or capillary tube from the
bottom of the ampoule.
NOTE:
When using an ampoule for sample introduction, you need not transfer control
solution. Insert the ampoule into the adaptor after opening it, and directly go to step
13.
Take protective measures when opening the ampoule, such as using gloves, tissue,
etc.
12. Insert the syringe or capillary tube into the fillport of the cartridge.
NOTE:
When using a syringe, discard the first 2 drops of solution first, then remove the
needle from it, and finally insert it into the fillport.
- 20 -
i15 Blood Gas and Chemistry Analysis System Service Manual Functional Checks
When using a capillary tube, directly insert the capillary tube into the adaptor till the
tube reaches the interface between the adaptor and the cartridge.
To avoid inaccurate test results, make sure there are no bubbles in the sample. If
bubbles continually exist, use a new ampoule and syringe or capillary tube to collect
samples again.
13. Gently insert the cartridge into the cartridge port, and carefully press down to ensure that it
clicks into place.
For a valid cartridge, the indicator in the cartridge port will turn green, and the system will
automatically aspirate calibrant. For an invalid cartridge, the indicator will turn red, the
cartridge will be ejected and a message will pop up to prompt you.
NOTE:
The cartridge can not be removed from the analyzer until the measurement is
complete.
- 21 -
i15 Blood Gas and Chemistry Analysis System Service Manual Functional Checks
17. The system automatically analyzes the sample upon the completion of sampling.
- 22 -
i15 Blood Gas and Chemistry Analysis System Service Manual Functional Checks
18. The system automatically displays the test results upon the completion of the test.
NOTE:
The system will indicate whether the results are within or outside the acceptable
ranges with Under Control/Out of Control.
If a parameter fails calibration, the system will not be able to determine whether it is
under control, and will display Calibration Failure to prompt you.
The system will not report the result for a parameter failing the control test in the
patient sample analysis, if QC Lockout function is enabled in Setup. To report the
result for the parameter, repeat the control test till the parameter passes it.
If the results are outside the acceptable ranges, check the following items first, and
then perform another test.
Refer to the user manual to confirm that the test procedures are correct.
Test cartridges and controls are stored properly and have not expired.
The system passes the electronic simulator test.
If all the above items are verified, but the results are still outside the acceptable
ranges, please return the analyzer to EDAN for service.
20. Remove the test cartridge from the system.
21. Press Print to print the results.
22. Press Home to return to the Main screen.
- 23 -
i15 Blood Gas and Chemistry Analysis System Service Manual Troubleshooting
5 Maintenance
5.1 Maintenance Inspection
WARNING
Failure on the part of the responsible individual institution employing this equipment to
implement a satisfactory maintenance schedule may cause undue equipment failures.
6 Principle Introduction
The system utilizes potentiometry and amperometry to determine the concentrations of blood
gases and blood chemistries, and utilizes conductivity to determine the concentration of Hct.
Many parameters can also be calculated such as cH+, HCO3 -act, HCO3 -std, BE(ecf), BE(B),
BB(B), and so on.
Methods
Measurements are performed on undiluted specimens. Undiluted methods are also called direct
methods, whereas methods that dilute the sample are called indirect methods.
For electrolytes, direct methods measure the free ion concentration of analyte (apparent or free
ion activity) per unit volume of plasma water, and indirect methods measure the concentration of
analyte per unit volume of plasma. It is known that the direct method gives the clinically
significant result for electrolytes. When there is disagreement between the methods, such as when
the patient has abnormal total protein or lipid levels, it results from interference on the indirect
method. At normal levels of protein and lipids the systematic offset between methods is often
corrected for in commercial direct measuring instruments so that the normal ranges for all
instruments are in agreement. Sensors have been calibrated in the manufacture so that normal
ranges are in agreement with indirect reference methods at normal levels of total protein and
lipids.
Direct measurement of hematocrit by the conductometric technique gives a result related to the
non-conducting excluded volume fraction of the sample. Red blood cell volu me is the
predominant component of the nonconducting volume, but proteins, lipids, and white blood cells
also contribute. Elevated hematocrit readings are expected at abnormally elevated levels of these
components. Decreased hematocrit readings are expected at abnormally low levels of protein,
such as found in hemodiluted samples taken from cardiopulmonary bypass. Osmotic imbalance
causes a discrepancy between direct (conductometric, spun) and indirect (Coulter) measurements
because of variation in the meancell volume.
Sensors
Sensor refers to the electrode embedded in test cartridges. There are three different types of
sensors:
- 25 -
i15 Blood Gas and Chemistry Analysis System Service Manual Troubleshooting
Potentiometric Sensor
Amperometric Sensor
Conductometric Sensor
For potentiometric sensors, the analyte activity in the sample is calculated from the Nerst
equation:
Where E denotes the potential, denotes the activity of an ion, and S denotes the slope of the
sensor.
- 26 -
i15 Blood Gas and Chemistry Analysis System Service Manual Troubleshooting
In whole blood, the cellular constituents, red and white blood cells and platelets do not conduct
electricity, while plasma does. For a sample whose electrolyte concentration is given, the more
cells, the less conductivity. The total cell concentration of the whole blood is determined from:
CPB
When samples with abnormally low protein levels are tested, the system need to use the CPB
compensation algorithm. The CPB compensation algorithm is specially intended for use when
samples are taken from patients on cardiopulmonary bypass. It also applies to the adult whose
protein levels are abnormally low.
cH+
HCO3-act
HCO3-std
HCO3-std = 24.5 + 0.9 × A + [(A - 2.9)2 × (2.65 + 0.31 × tHb (est))] / 1000 [mmol/L]
Where A = BE (B) [0.2 × tHb (est) × (100 - sO2 (est))] / 100, tHb (est) can be entered by users,
and the default value for tHb (est) is 15g/dL.
- 27 -
i15 Blood Gas and Chemistry Analysis System Service Manual Troubleshooting
BE (ecf)
BE (B)
BE (B) = (1 - 0.014 × tHb (est)) × [HCO 3-act - 24.8 + (1.43 × tHb (est) + 7.7) × (pH - 7.40)]
[mmol/L]
Where tHb (est) can be entered by users, and the default value for tHb (est) is 15g/dL.
BB (B)
Buffer Base
Where tHb (est) can be entered by users, and the default value for tHb (est) is 15g/dL.
ctCO2
Ca++ (7.4)
AnGap
An approximation of the difference between measured cations and measured anions in the
sample
tHb (est)
- 28 -
i15 Blood Gas and Chemistry Analysis System Service Manual Troubleshooting
Where MCHC is the mean corpuscular hemoglobin concentration, and can be entered by users.
The default value for MCHC is 34g/dL. The unit for Hct is %PCV.
sO2 (est)
[%]
pO2 (A-a)
pO2 (a/A)
RI
Respiratory index: the ratio of the alveolar-arterial blood oxygen-pressure difference to arterial
pO2
pO2 / FIO2
pH (T)
cH+ (T)
- 29 -
i15 Blood Gas and Chemistry Analysis System Service Manual Troubleshooting
pCO2 (T)
pO2 (T)
[mmHg]
pO2 (A-a) (T) = pO2 (A) (T) - pO2 (a) (T) [mmHg]
pO2 (a/A) (T) = pO2 (a) (T) / pO2 (A) (T) [mmHg]
RI (T)
Respiratory index: the ratio of the alveolar-arterial blood oxygen-pressure difference to arterial
pO2 when both values are corrected for patient temperature
pO2 (T)/FIO2
The ratio of arterial pO2 to the fraction of inspired oxygen corrected for the entered patient
temperature
mOsm
- 30 -
i15 Blood Gas and Chemistry Analysis System Service Manual Troubleshooting
The analyzer is configured with a RJ45 interface. It is used to connect the analyzer to a computer
for updating or to a DMS.
The analyzer is configured with a DB9 interface. It allows engineers from the manufacture and
service personnel to troubleshoot
The analyzer is configured with 4 USB interfaces. It is used to connect external devices
supporting USB protocol to the analyzer, such as a USB drive, a mouth, a printer, a scanner.
NOTE:
Only the following external scanners should be connected to the analyzer through
USB ports: Honeywell 1900.
Only the following external printers should be connected to the analyzer through
USB ports: HP LaserJet P401DN, and HP LaserJet P1606DN.
- 31 -
i15 Blood Gas and Chemistry Analysis System Service Manual Troubleshooting
7 Troubleshooting
EDAN supports replacement of PCB and major subassemblies for the analyzer. When
replacement is necessary, follow the procedures described in chapter 9 Disassembling the
Analyzer.
- 32 -
i15 Blood Gas and Chemistry Analysis System Service Manual Troubleshooting
mouse. Touch screen drive board is Replace the touch screen drive
defective. board.
- 33 -
i15 Blood Gas and Chemistry Analysis System Service Manual Troubleshooting
- 34 -
i15 Blood Gas and Chemistry Analysis System Service Manual Troubleshooting
The printer casing was not Open the printer casing, and shut
Paper jam or slant
shut properly. the casing again.
- 35 -
i15 Blood Gas and Chemistry Analysis System Service Manual Troubleshooting
NOTE:
Only service engineers and engineers from the manufacturer can enter the diagnosis
database.
Diagnosis data help to troubleshoot. The diagnosis database displays diagnosis data for the most
recent month by default, and it can store up to 500 data entries. The following operations can be
performed in the diagnosis database: exporting diagnosis data to a removable disk (such as a
USB drive), viewing the details of diagnosis data, searching for and printing diagnosis data, etc.
2. Press Search.
- 36 -
i15 Blood Gas and Chemistry Analysis System Service Manual Troubleshooting
2. Press Details.
- 37 -
i15 Blood Gas and Chemistry Analysis System Service Manual Troubleshooting
To Do this
Export Insert a removable disk into the analyzer, and then press Export.
NOTE:
If no diagnosis data is selected before pressing Export/Print, all of the data stored in the
diagnosis database will be exported / printed.
- 38 -
i15 Blood Gas and Chemistry Analysis System Service Manual Module s Malfunction Verification
NOTE:
For all the interfaces, the first pin is the one with a square solder pad.
3) Measure the voltage to earth of the pins listed below with a multimeter:
1. TP8 1.71~1.89V
2. TP9 3.13~3.47V
3. TP12 0.95~1.05V
4. TP13 0.95~1.05V
5. TP14 2.37~2.63V
6. TP49 3.13~3.47V
- 39 -
i15 Blood Gas and Chemistry Analysis System Service Manual Module s Malfunction Verification
4) Compare the measurement results with the reference ranges in the list. If there is a result
exceeding its reference range, it is confirmed that the main control board malfunctions, and
it is recommended to replace the main control board.
4) Measure the voltage to earth of the pins listed below with a multimeter.
1. TP12 11.40~12.60V
2. TP13 4.75~5.25V
3. TP9 4.75~5.25V
- 40 -
i15 Blood Gas and Chemistry Analysis System Service Manual Module s Malfunction Verification
5) Compare the measurement results with the reference ranges in the list. If there is a result
exceeding its reference range, it is confirmed that the power board malfunctions, and it is
recommended to replace the power board.
Follow the steps below to verity the touch screen drive board:
4) Measure the voltage to earth of the pins listed below with a multimeter.
1. TP<+3V3> 3.3V±0.165V
- 41 -
i15 Blood Gas and Chemistry Analysis System Service Manual Module s Malfunction Verification
5) Compare the measurement results with the reference ranges in the list. If there is a result
exceeding its reference range, it is confirmed that the touch screen drive board malfunctions,
and it is recommended to replace the touch screen drive board.
3) Connect the bar code scanner to a computer through the USB port.
5) If you fail to operate the bar code scanner, it is confirmed that the bar code scanner
malfunctions, and it is recommended to replace the bar code scanner.
NOTE:
It is necessary that the SNAPI Sample Application software has been loaded on the
computer before connecting the bar code scanner to the computer. If the software has
- 42 -
i15 Blood Gas and Chemistry Analysis System Service Manual Disassembling the Analyzer
2. Switch off the analyzer and remove the power supply before disassembling the
analyzer.
3. After any repair of the analyzer, perform functional checks prior to use.
1. A cross-head screwdriver
2. A M3 nut driver
1. Carefully place the analyzer upside down on a flat surface covered with cloth or other
protecting pad.
2. With a cross-head screwdriver, remove the 7 screws securing the upper assembly to the lower
assembly.
3. Hold both upper and lower assembly simultaneously, and place the analyzer upward again.
4. Unlock the calibrant fluid pack chamber lock with the key, and then pull the calibrant fluid
pack ejector to open the calibrant fluid pack chamber door.
5. Slightly lift up the upper assembly, and disconnect the connecting wire on the shrouded &
ejector IDC header to separate the upper assembly and the lower assembly.
6. Carefully lift up the upper assembly, and place it upside down on the left side of the lower
assembly.
7. Disconnect the printer cable to earth to disassemble the upper and lower assembly.
- 43 -
i15 Blood Gas and Chemistry Analysis System Service Manual Disassembling the Analyzer
2 4
1 Upper assembly
5 Lower assembly
4. Hold the left side of the main control board with your hand, sway it back and forth, and
remove the main control board carefully.
- 44 -
i15 Blood Gas and Chemistry Analysis System Service Manual Disassembling the Analyzer
Install a main control board in the reverse order. Refer to the following illustration when
connecting wires, and ensure they are all correctly connected.
1 2 3 4 5
No. Connect to
1 Upper assembly
3 Speaker
5 Wi-Fi board
Follow the steps below to remove the chamber door detection board:
- 46 -
i15 Blood Gas and Chemistry Analysis System Service Manual Disassembling the Analyzer
Follow the steps below to remove the ambient temperature detection board:
- 47 -
i15 Blood Gas and Chemistry Analysis System Service Manual Disassembling the Analyzer
- 48 -
i15 Blood Gas and Chemistry Analysis System Service Manual Disassembling the Analyzer
- 49 -
i15 Blood Gas and Chemistry Analysis System Service Manual Disassembling the Analyzer
- 50 -
i15 Blood Gas and Chemistry Analysis System Service Manual Disassembling the Analyzer
Steps NOTE
Dismantle the
upper
assembly
- 51 -
i15 Blood Gas and Chemistry Analysis System Service Manual Disassembling the Analyzer
- 52 -
i15 Blood Gas and Chemistry Analysis System Service Manual Disassembling the Analyzer
- 53 -
i15 Blood Gas and Chemistry Analysis System Service Manual Disassembling the Analyzer
Assemble
Cam
- 54 -
i15 Blood Gas and Chemistry Analysis System Service Manual Disassembling the Analyzer
Assemble
main control
board.
Tightly secure the analog board and
the main control board with 5-M3*6
screws screwed by torque (3.0 4.0
kg.cm)
Assemble
upper and
lower cover
- 55 -
i15 Blood Gas and Chemistry Analysis System Service Manual Disassembling the Analyzer
5. Remove the two screws fixing the fan and then the fan can be removed.
Install a power board in the reverse order. Refer to the following illustration when connecting
wires, and ensure they are all correctly connected.
- 56 -
i15 Blood Gas and Chemistry Analysis System Service Manual Disassembling the Analyzer
1 4
3
No. Connect to
2 Exhaust fan
3 Battery
Install a power interface board in the reverse order. Ensure the wire is correctly connected.
- 57 -
i15 Blood Gas and Chemistry Analysis System Service Manual Disassembling the Analyzer
Install an exhaust fan in the reverse order. Ensure the wire is on the left side of the exhaust fan as
shown in the picture above.
- 58 -
i15 Blood Gas and Chemistry Analysis System Service Manual Disassembling the Analyzer
2. Disconnect the wire connecting the speaker on the main control board.
To install a speaker:
Install a speaker in the reverse order. Ensure that the wire is correctly connected to the main
control board.
2. Disconnect the wires connecting the bar code scanner on the main control board.
Install a bar code scanner in the reverse order. Ensure that the wire is correctly connected to the
main control board.
- 59 -
i15 Blood Gas and Chemistry Analysis System Service Manual Disassembling the Analyzer
NOTE:
After installing a new bar code scanner, the bar code scanner should be set.
1. Press the power button on the left side of the analyzer to turn it on.
- 60 -
i15 Blood Gas and Chemistry Analysis System Service Manual Disassembling the Analyzer
4. Enter the user name and password in the User Login screen.
5. Press Setup Diagnostics System ID. The bar code scanner will be turned on
automatically.
7. Check whether the last 12 digits of the scanned data are consistent with those of the system
ID. If they are consistent, the bar code scanner is successfully set.
- 61 -
i15 Blood Gas and Chemistry Analysis System Service Manual Disassembling the Analyzer
- 62 -
i15 Blood Gas and Chemistry Analysis System Service Manual Disassembling the Analyzer
Operation Procedures
If there is any need to replace the vacuum pump because of some damages, please replace the
vacuum pump as the following procedures:
- 63 -
i15 Blood Gas and Chemistry Analysis System Service Manual Disassembling the Analyzer
- 64 -
i15 Blood Gas and Chemistry Analysis System Service Manual Disassembling the Analyzer
- 65 -
i15 Blood Gas and Chemistry Analysis System Service Manual Disassembling the Analyzer
- 66 -
i15 Blood Gas and Chemistry Analysis System Service Manual Disassembling the Analyzer
- 67 -
i15 Blood Gas and Chemistry Analysis System Service Manual Disassembling the Analyzer
- 68 -
i15 Blood Gas and Chemistry Analysis System Service Manual Disassembling the Analyzer
- 69 -
i15 Blood Gas and Chemistry Analysis System Service Manual Disassembling the Analyzer
Disassemble the As the following picture shows, remove the two screws and separate the
front board cover from the front board.
- 70 -
i15 Blood Gas and Chemistry Analysis System Service Manual Disassembling the Analyzer
As the following picture shows, remove the four screws and separate the
cover from the front board.
- 71 -
i15 Blood Gas and Chemistry Analysis System Service Manual Disassembling the Analyzer
- 72 -
i15 Blood Gas and Chemistry Analysis System Service Manual Disassembling the Analyzer
- 73 -
i15 Blood Gas and Chemistry Analysis System Service Manual Disassembling the Analyzer
- 74 -
i15 Blood Gas and Chemistry Analysis System Service Manual Disassembling the Analyzer
1) Observe whether there are foreign objectives around the internal surface of the needle (in
many cases, the foreign objects will be accumulated in the point of the needle).
2) If the operator can obviously feel the obvious resistance when pulling or pushing the piston
of the syringe, the point of the needle has been blocked by the foreign objects.
2. If the needle has been blocked, clean the needle as the following procedures:
2) Insert the 1mL syringe into the L-shaped needle and then move out the 1mL syringe from the
needle.
3) Quickly push the piston of the vacuum pump to blow out the foreign objects from the
needle.
- 75 -
i15 Blood Gas and Chemistry Analysis System Service Manual Disassembling the Analyzer
If the L-shaped needle has been blocked heavily, the needle can be changed as the following
procedures:
1. Disco
2.
3.
the joint to prevent air leakage.
Clean Cali
1.
needle in accordance with Step 5 and Step 6.
2. As Picture 12 shows, make sure the valve of the calibrant fluid pack is closed.
3. Use the syringe to aspirate the air. If the piston of the syringe can be moved smoothly, it
proves the distance between the needle and the air valve has not been blocked.
4. As Picture 13 shows, close air valve by pressing it with hands and then open the valve of
calibrant fluid pack.
5. Use the syringe to aspirate calibration solutions. If the piston of the syringe can be moved
smoothly and the calibration solutions can be aspirated smoothly, it proves that the distance
between the valve of the calibrant fluid pack and the needle has not been blocked.
6. As Picture 14 shows, insert 1mL or 2mL syringe into the needle. Quickly pull the piston
outward so that the foreign object can be aspirated out.
NOTE:
After the valve of the calibrant fluid pack has been opened, the calibration solution can only be
aspirated out, or it will be contaminated.
- 76 -
i15 Blood Gas and Chemistry Analysis System Service Manual Disassembling the Analyzer
Follow the steps below to remove the touch screen drive board:
Install a touch screen drive board in the reverse order. Refer to the following illustration when
- 77 -
i15 Blood Gas and Chemistry Analysis System Service Manual Disassembling the Analyzer
1 2 3
No. Connect to
1 Touch screen
2 Lower assembly
3 LCD screen
4 Printer
5 Power button
- 78 -
i15 Blood Gas and Chemistry Analysis System Service Manual Disassembling the Analyzer
LCD Stander
To install a LCD:
Install a LCD in the reverse order. Ensure the wires are all correctly connected.
- 79 -
i15 Blood Gas and Chemistry Analysis System Service Manual Disassembling the Analyzer
Install a print controller board in the reverse order. Refer to the following illustration when
connecting wires, and ensure they are all correctly connected.
- 80 -
i15 Blood Gas and Chemistry Analysis System Service Manual Disassembling the Analyzer
3. Pull the printer head carefully, and remove wires on the printer head.
Install a printer head in the reverse order. Refer to the following illustration when connecting
wires, and ensure they are all correctly connected.
- 81 -
i15 Blood Gas and Chemistry Analysis System Service Manual Replaceable Parts
3 Cartridge Type Error. support this kind of test Update the analog software.
cartridge.
1) The barcode scanner
Maybe Cartridge 1) Clean the barcode
has been
Barcode Destroyed. scanner.
4 contaminated.
Scan Again or Try 2) Change a new test
2) The barcode has been
Another Cartridge. cartridge.
damaged.
The Software Version
does Not Match with The main control software Update the main control
5 Test Cartridge. Please and the analog software software and the analog
Update the Software have not been updated. software.
Immediately.
Calibrant Pack 1) The calibrant fluid
1) Change a new calibrant
Expired.Confirm Date pack expired.
21 fluid pack.
Setup and Calibrant 2) The system date is
2) Correct system date.
Pack's Expiration Date. wrong.
- 82 -
i15 Blood Gas and Chemistry Analysis System Service Manual Replaceable Parts
- 83 -
i15 Blood Gas and Chemistry Analysis System Service Manual Replaceable Parts
- 84 -
i15 Blood Gas and Chemistry Analysis System Service Manual Replaceable Parts
handle it properly.
3)
electrical contacts
have been
contaminated.
1) 1) Check whether the
properly because the structural parts have
poor connection of been damaged or the
Abnormal Cam wire. wire connection is not
Location, Please Call 2) Some structural parts secured.
2056
for Technical have been damaged. 2) Clean the sensor used to
Assistance. 3)
properly to detect the position.
corresponding 3) Reboot the analyzer for
position. testing.
1) If this failure occurs
- 85 -
i15 Blood Gas and Chemistry Analysis System Service Manual Replaceable Parts
- 86 -
i15 Blood Gas and Chemistry Analysis System Service Manual Replaceable Parts
volume collected
by 5mL syringe is
less than 1.5mL.
Under electronic simulator Re-conduct electronic
Insertion Error,
test mode, the test simulator test with a
2082 Cartridge is Inserted
simulator.
during Simulator Test.
into the analyzer.
1) Improper operation
Insertion Error, 1) Operate properly
2) The test cartridge is
2084 Simulator is Inserted 2) Change a new test
contaminated leading
during Sample Test. cartridge
to a poor connection
1) Poor wire connection
causes that the motor
fails to work normally. 1) Check whether the
2) structural part has been
slips off. damaged, whether the
3) There is a lot of dust wire connection is not
Pump Sensor
secured and whether the
Malfunctions, Please
2086 pump. screw slips off. If yes,
Call for Technical
4) The structural part is please fix it.
Assistance.
damaged. 2) Remove the dust within
5) The sensor has some
3) Clean the pump and
detect the check the sensor
corresponding
position.
Input Current
The power adaptor or the Change power adaptor or
7001 Abnormal
battery has some problems. battery.
USB Disk Cannot be recognized. The system Use the correct type of the
Identified USB Disk.
USB Disk.
Format USB disk or change
U disk Error
recognize the USB disk. a new USB disk.
- 88 -
i15 Blood Gas and Chemistry Analysis System Service Manual Replaceable Parts
- 89 -
i15 Blood Gas and Chemistry Analysis System Service Manual Replaceable Parts
- 90 -
i15 Blood Gas and Chemistry Analysis System Service Manual Replaceable Parts
computer.
problems.
be opened.
1) Remove the test
cartridge firstly and
1) The key is not then turn off the
removed from the analyzer and finally
The calibrant fluid pack
calibrant fluid pack remove the calibrant
when installing the fluid pack from the
the analyzer.
pack. analyzer.
2) Improper operation 2) Instruct the operator to
correctly install the
calibrant fluid pack.
- 92 -
i15 Blood Gas and Chemistry Analysis System Service Manual Replaceable Parts
- 93 -
i15 Blood Gas and Chemistry Analysis System Service Manual Replaceable Parts
- 94 -
i15 Blood Gas and Chemistry Analysis System Service Manual Replaceable Parts
sensor.
Train the personnel who is
The calibration The volume of blood
responsible for sample
succeeds while one or sample is not enough or
collection to normalize the
several items have no there are bubbles in the
procedures of sample
test results. blood sample.
collection and test.
1) Re-conduct test with a
pH has no test result 1) The occasional failure
new test cartridge.
occasionally or other of test cartridge.
2) Train the personnel who
parameters have no test 2) The sample has some
is responsible for
results occasionally. problems.
sample collection to
- 95 -
i15 Blood Gas and Chemistry Analysis System Service Manual Replaceable Parts
normalize the
procedures of sample
collection and test.
1) Re-conduct QC test.
The test results are 2) Train the personnel who
Controls test fails.
displayed with *** is responsible for
sample collection.
The barcode scanner Re-
connection is loose. wire,
- 96 -
i15 Blood Gas and Chemistry Analysis System Service Manual Replaceable Parts
11 Replaceable Parts
WARNING
Only the replaceable parts supplied by EDAN or its authorized distributors should be
connected to the analyzer.
Speaker 01.14.038010
LCD 01.16.045068
- 97 -
- 98 -