Blood gas/Electrolytes analyzer

BGE-800 Series
User Manual

BIOBASE GROUP

Version 2020.08
 Content
1. General introduction.........................................................................................................................1
1.1 Intended use..................................................................................................................................1
1.2 Model family................................................................................................................................ 1
1.3 Product features............................................................................................................................1
1.4 Main parts.....................................................................................................................................2
1.4.1 General overview..................................................................................................................2
1.4.2 Sensor system....................................................................................................................... 4
1.4.3 Barcode scanner....................................................................................................................4
1.4.4 Reagent cassette....................................................................................................................5
1.4.5 Requested circumstance........................................................................................................6
2. Operating and safety information........................................................................................................6
2.1 Oerator’s qualifications................................................................................................................ 6
2.2 Operating environment.................................................................................................................6
2.3 Prevention of EMI........................................................................................................................ 7
2.4 Electric shock............................................................................................................................... 7
2.5 Personnel injuries......................................................................................................................... 7
2.6 Biological hazards........................................................................................................................ 7
2.7 Chemical hazards......................................................................................................................... 8
2.8 Waste hazards...............................................................................................................................8
2.9 Cleaning and sterilization.............................................................................................................8
2.10 Disposal...................................................................................................................................... 8
2.10.1 Disposal of instrument........................................................................................................8
2.10.2 Disposal of battery..............................................................................................................9
2.10.3 Disposal of sample port, electrode, pump tubes, Cal pack.................................................9
2.11 Operation.................................................................................................................................... 9
2.12 Maintenance............................................................................................................................... 9
2.13 Sample........................................................................................................................................ 9
2.13.1 Sample sources................................................................................................................. 10
2.13.2 Sample requirements........................................................................................................ 10
2.13.3 Anticoagulant.................................................................................................................... 11
2.13.4 Sample collection devices.................................................................................................11
2.13.5 Sample storage..................................................................................................................12
2.14 Reagents, calibrators, and controls...........................................................................................12
3. Flow path...........................................................................................................................................13
3.1 Flow path of flush.......................................................................................................................14
3.2 Flow path of Cal A..................................................................................................................... 15
3.3 Flow path of Cal B..................................................................................................................... 16
3.3 Flow path of sample test.............................................................................................................16
4. Specifications and parameters...........................................................................................................17
4.1 Parameters.................................................................................................................................. 17
4.1.1 Measuring parameters.........................................................................................................17
4.1.2 Calculated parameters.........................................................................................................18
4.1.3 Input parameters................................................................................................................. 18
4.1.4 Electrode Parameters.......................................................................................................... 18
4.2 Specifications............................................................................................................................. 18
4.3 Sample type................................................................................................................................ 20
4.4 The speed of analysis................................................................................................................. 20
4.5 The volume of sample................................................................................................................ 20
4.6 Output ways................................................................................................................................20
4.7 Dimensions.................................................................................................................................20
 4.8 Fuse protector............................................................................................................................. 20
4.9 Memory...................................................................................................................................... 20
4.10 Printer....................................................................................................................................... 20
4.11 Battery...................................................................................................................................... 20
5. Installation.........................................................................................................................................21
5.1 Operating environment...............................................................................................................21
5.2 Unpacking and check................................................................................................................. 21
5.3 Electrodes installation................................................................................................................ 22
5.3.1 Electrodes preparation........................................................................................................ 22
5.3.2 Electrodes introduction.......................................................................................................22
5.3.3 Electrodes installation.........................................................................................................25
5.4 Barcode scanner installation.......................................................................................................26
5.5 Pump tube installation................................................................................................................ 27
5.6 Cal pack installation................................................................................................................... 29
5.7 Auto QC installation(optional)...................................................................................................31
5.8 Printer paper installation............................................................................................................ 32
5.9 Install the battery........................................................................................................................ 33
5.10 Check for correct installation................................................................................................... 34
5.11 Open up.................................................................................................................................... 35
5.12 Self test..................................................................................................................................... 35
5.13 Shut down.................................................................................................................................36
5.13.1 Within 24 hour..................................................................................................................... 36
5.13.2 Beyond 24 hour....................................................................................................................36
6 Menu introduction............................................................................................................................37
6.1 Main menu................................................................................................................................37
6.1.1 General introduction........................................................................................................... 37
6.1.2 Basic operation................................................................................................................... 38
6.1.3 Menu structure.................................................................................................................... 38
6.2 Test menu................................................................................................................................... 39
6.3 1 Point calibration and 2 point calibration menu..................................................................... 41
6.4 Flush menu............................................................................................................................... 41
6.5 QC menu...................................................................................................................................42
6.5.1 QC lot management............................................................................................................ 42
6.5.2 QC test................................................................................................................................ 44
6.6 Data management menu............................................................................................................. 44
6.7 Maintenance menu..................................................................................................................... 45
6.8 System Setup menu.................................................................................................................... 45
6.9 Expendable menu....................................................................................................................... 46
7 Calibration..........................................................................................................................................47
7.1 General information................................................................................................................... 47
7.2 1 Point Calibration......................................................................................................................47
7.3 2 Point Calibration......................................................................................................................49
7.4 Calibration intervals................................................................................................................... 51
7.5 pO2 zero calibration....................................................................................................................52
7.6 Calibration data.......................................................................................................................... 52
8 Quality Control.................................................................................................................................. 54
8.1 General information................................................................................................................... 54
8.2 Preparing QC solutions.............................................................................................................. 54
8.3 Lot number management............................................................................................................54
8.4 QC test........................................................................................................................................57
8.5 QC plot data................................................................................................................................58
8.6 QC plot....................................................................................................................................... 59
9 Patient sample analysis...................................................................................................................... 59
9.1 Collect samples...........................................................................................................................60
9.1.1 Collect syringe samples...................................................................................................... 60
9.1.2 Collect capillary samples....................................................................................................61
9.2 Analyze the sample.................................................................................................................... 61
9.3 Check the test result................................................................................................................... 63
10 Setup system.................................................................................................................................... 65
10.1 Correlation................................................................................................................................65
10.2 Reference Range.......................................................................................................................66
10.3 Unit...........................................................................................................................................67
10.4 Test parameters.........................................................................................................................67
10.5 Calibration intervals................................................................................................................. 68
10.6 Date and time............................................................................................................................68
10.7 Language Setting......................................................................................................................69
10.8 Version..................................................................................................................................... 69
10.9 Replace Sample port.................................................................................................................70
10.10 LIS interface........................................................................................................................... 70
10.11 Printer..................................................................................................................................... 72
10.12 Self test................................................................................................................................... 73
10.13 Power Off............................................................................................................................... 73
10.14 Other utilities..........................................................................................................................74
11 Maintenance..................................................................................................................................... 74
11.1 Maintenance functions..............................................................................................................75
11.1.1 Clean................................................................................................................................. 75
11.1.2 Deproteinize......................................................................................................................76
11.1.3 Condition.......................................................................................................................... 77
11.2 Sterilization...............................................................................................................................78
11.3 Daily maintenance.................................................................................................................... 78
11.4 Weekly maintenance.................................................................................................................79
11.5 Monthly maintenance............................................................................................................... 79
11.6 Every 3 months.........................................................................................................................79
11.7 Every 6 months.........................................................................................................................80
11.8 As necessary............................................................................................................................. 80
12 Troubleshooting............................................................................................................................... 80
12.1 Liquid pathway problem.......................................................................................................... 80
12.2 ISE Electrodes problem............................................................................................................81
12.2.1 Only one electrode............................................................................................................81
12.2.2 More than two electrodes..................................................................................................81
12.3 Blood gas electrodes problem.................................................................................................. 82
12.4 Correlation coefficients......................................................................................................... 83
A Appendix........................................................................................................................................... 84
A.1 Potential range for electrodes.................................................................................................... 84
A.2 Interference substances..............................................................................................................85
A.3 Reference Range for adult......................................................................................................... 87
A.4 Table of Critical values..............................................................................................................87
A.5 Calculations............................................................................................................................... 88
A.5.1 Temperature corrections.....................................................................................................88
A.5.2 Calculate parameters..........................................................................................................89
A.6 Working principle...................................................................................................................... 91
A.6.1 ISE electrodes.................................................................................................................... 92
A.6.2 pCO2 electrode...................................................................................................................93
A.6.3 pO2 electrode......................................................................................................................93
 A.6.4 Hct electrode...................................................................................................................... 94
A.6.5 Glu/Lac electrode...............................................................................................................94
A.7 References................................................................................................................................. 94
A.8 Warranty.................................................................................................................................... 95
A.8.1 Warranty guidelines........................................................................................................... 95
A.8.2 Warranty limitation............................................................................................................ 96
B Appendix Barcode scanner initialization........................................................................................96
B.1 Apply for LV880(32B)...............................................................................................................97
B.2 Apply for LV880........................................................................................................................98
Index.......................................................................................................................................................100
 Preface
1. About this manual
Thank you very much for purchasing our products.
This manual provides the information and procedures necessary to operate and
maintain the BGE-800 series Blood gas/Electrolyte. It's designed to meet the needs of
medical personnel who use the system on a daily basis and perform routine maintenance
and troubleshooting. All the BGE-800 series products are very similar in basic operation
and maintenance, most of the information and procedures provided here also applied to
other BGE-800 series models.
2. Conventions used in this manual
The following text and symbol conventions are used throughout this manual:
Italic To indicate a document reference.
CAPITAL This indicates a displayed menu.
Underline This indicates a command that appears under a menu.
“message” This indicates a quoted message displayed on the LCD.
3. Understand the symbols
This section describes the symbols that may appear on the exterior of the system. These
symbols provide you with either important information or warning for proper operations.

In vitro diagnostic Medical devices

Complies with IVD directive 98/79/EC

Biohazard Warning

Caution to alter the user to possible personnel injury or damage to the analyzer.

Note provides specific information in the form of recommendation, pre-

requirements etc.

Place upward

Consult instructions for uses

Serial NO

Special disposal procedures shall be followed.

For single use only.

Caution for hand injuries

Hot surface warning

Caution for electric shock

European representative

Manufactured date

Manufacturer
1. General introduction
1.1 Intended use
1.The BGE-800B analyzer system is an automated analyzer for determining pO2, pCO2,
potassium(K+), sodium(Na+), chloride(Cl-), ionized Ca(Ca2+), pH, Glucose(Glu),
Lactate(Lac) and tHb in the arterial, venous and capillary whole blood sample.
2.This analyzer is intended for using by trained technologists, nurses, physicians and
therapists in a laboratory environment,near patient or point-of-care setting.

1.2 Model family

Models are different when configuration changes. This manual describes the model of
BGE-800B. But it is also applied to other models listed below. The differences for these
model are:
1. All related menus and displays such as Calibration, Test, Setup show specified
parameters only.
2. Calculated parameters are different.
3. Hct calibration is not supported for BGE-800 series
4. Auto QC is not supported for BGE-800 series.
The table below describes the determined parameters of those models:
Model Parameters
BGE-800B
pH、pCO2、pO2、Hct、K+、Na+、Cl-、Ca2+、Glu、Lac
Gaslite 80E

1.3 Product features

 640*480 color LCD screen with a resisitive touch panel
 Temperature electrode ensures a contant temperature of 37℃±0.2℃
 Distinguish the abnormal samples and give out an alarm,such as sample with
bubble, insufficient sample and no sample
 Wash the inside and the outside of the inlet probe automatically
 Accept samples obtained from syringe and capillary tube
 The internal mini thermal printer support the printing width of 80mm
 The backup battery can support the system to test at least 30 samples
 Support internet
 Support LIS HL7
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 Automatically stores the results of the QC, calibration and sample test (can store up to 5000 of
each one) for checking
 Support auto and manual calibration, cleaning and QC, the system proceeds self-checking when
open up
 The system supports print sample analysis report or sample analysis plot
 Print test report and diagnosis report in A4/A5 paper
 Support barcode scanning for consumables, patient information
 Detect the ambient pressure automatically or you can type in the value by you eself
 Support update the software online
 Print the data of calibration, test and QC
 The system can proceed self-adjust when the temperature exceeds the normal range
 The system can export the calibration data, test data, QC data

1.4 Main parts

This analyzer consists of 8 parts: touch screen, measurement module, pump,
reagent cassette, sampler, flow path board, battery cassette, printer.

1.4.1 General overview

The display interface for BGE-800B is designed on the base of personal computer, the data
management system is based on the RS232 port or the LIS data management system using
RJ45 as internet port.
Front view of the analyzer

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 Part Function
Touch screen Communication interface between the operater and the
analyzer
Measurement module All the samples are tested here
Pump Provide pressure to move the fluid in the tube
Reagent cassette Store reagent and waste
Sampler To aspirate samples and all kinds of test reagent
Flow path board An intergrated borad for controlling fluid flow tubes

Rear view of the analyzer

Part Function
Power cord socket For connecting the power cord
Battery switch For turning the backup battery on and off
RJ45 Ethernet network Ethernet interface connection
port
RS232 serial port For tranferring data
RS232 serial port For connecting scanner
Nameplate Describe the basic information and configuration of the
analyzer
USB slave To connect to PC
USB host To connect to U disk,keyboard and mouse

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 Printer Thermal printer to print data and plots
Fan For dissipating heat
Battery cassette The internal battery provides power for the analyzer when
power off

1.4.2 Sensor system

The sensor of this analyzer combines microelectrode technology and applied to
measure the content of the blood gas.
 pH
 pCO2
 pO2
 Hct
 K+
 Na+
 Cl-
 Ca2+
 Glu
 Lac
1.4.3 Barcode scanner

The barcode contains the lot number and use life of the product, and the barcode
scanner is used to scan the barcode so the system can control the consumables effectively.

The scanner just can be used to input barcode, please don't use it in any
other processes to avoid interfere.

 Scan the barcode of reagent cassette

 Scan the barcode of the electrode
 Scan the barcode of the QC pack
 Scan the barcode of the pump tube
 Scan the barcode of the sample port

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 Specifications
Light source Visible laser diode, wave length 650mm
Scanning speed 48±2 per second
Supported port RS232,PS2 keyboard,USB
Dimension 95mm×70mm×160mm
Weight 128g
Voltage 5V
Working current 85mA
Static current 36mA
Laser security Comply with the national laser security standard
Working temperature 0℃-45℃
Storage temperature -20℃-60℃
Humidity Relative Humidity:5%-95%(no condensation)

1.4.4 Reagent cassette

The analyzer system perform calibrations by measuring the calibration solution of the
reagent cassette, the reagent contains 2 kinds of accurate concentration eletrolyte solution
which are set in the vacuum package separately. In addition, the waste solution produced
during the calibration and the test would be collected in the waste cassette, and the
calibration solution and the waste solution are sealed in the reagent cassette, thus avoid the
environment pollution effectively.

The reagent cassette provide the neccesary solution for calibrating the pH, pCO2,pO2, Na+,
K+, Ca2+, Cl-, Hct, Glu, Lac including three calibration solution。

Reagent Configuration Function Storage

Cal A Calibrate pH, pCO2, pO2, Please store the
Calibration Na , K , Ca , Cl , Glu, Lac reagent at 5-25℃,
+ + 2+ -

solution electrode avoid exposure

package under sunshine.
Cal B Calibrate pH, pCO2, pO2,
Na+, K+, Ca2+, Cl- electrode And don't freeze
it.
Cal E Calibrate Glu, Lac electrode
Flush solution Flush the flow path
Clean solution Clean the lipid of the flow
path
Waste pack Collect waste
QC package QCH/QCM/QCL Auto quality control

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 The reagent cassette may have biohazard risk when the solution is run out,
please dispose it according to the related biohazard regulation in your
country.

1.4.5 Requested circumstance

 Operation temperature: 15-30℃
 Relative humidity: ≤80%
 Ambient pressure: 86kPa-106kPa
 Input power: 100V-240V, allowable deviation ±10%, 50Hz/60Hz ± 1Hz, power
150VA, get away from the electro-application which may cause electromagnetism
interference
 Operating platform area: length × width(1.5×0.6) m2
 Requested working position: Apart from other analyzer at least 0.5m
 Connect to earth: Please ensure the analyzer connect to the earth rightly before use

2. Operating and safety information

This section contains important information concerned with safety operation. The operator
shall read through this section first and respect the notices and warning that are described
in this section. Ignorance of such notices may cause system failures and even personal
injuries.

2.1 Operator’s qualifications

This analyzer shall be operated by skilled or trained medical personnel. It is crucial for the
hospital or organization that employs this analyzer to carry out a reasonable
service/maintenance plan. Ignorance of this warning may result in function failure or
shorten its life expectancy. Operate the analyzer only under the specified condition listed in
this manual. Otherwise, the system may not work normally or even damage is caused to the
analyzer.

2.2 Operating environment

This instrument shall be installed and operated under the environmental requirements listed
in this manual. The violation of such operation may result in unreliable results and even
system failures.
Ambient temperature: 15~30℃
Relative humidity: Up to 85% noncondensing
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 Atmosphere pressure: 86~106Kpa
Other requirement: Avoid direct sunshine and a well ventilated environment.

2.3 Prevention of EMI

Devices which make big noise may interfere this instrument and this instrument
should be kept away from noisy surrounding.
1. The electromagnetic devices such as mobile or radio transmitter should be turned off in the
room where the instrument is installed.
2. CRT display is not recommended to be used with this instrument.
3. Other medical instruments should be avoided to be operated nearby.
4. The electromagnetic wave generated by this instrument may interfere with other
instruments close to this system and cause them fail to function.

2.4 Electric shock

The following rules shall be strictly observed to prevent the hazards of electric shock.

1. None authorized personnel are permitted to open the cover while power is connected.
2. Spilled reagent or specimen can cause system failure or electric shock when they enter into
the interior of the analyzer. Reagent or specimen shall not be placed on the analyzer. Turn
off the analyzer immediately if spill of reagent or specimen is observed.
3. There are two delayed fuse inside the power module and their specification is F3.15A
250VAC. The replacement of the fuse should be performed by authorized personnel only. It
is totally prohibited for the operator to do so.
4. The power supply should be in accordance with the requirement of 100-240V~ 50/60Hz.
Any power supply other than this requirement can cause system failure.
5. Earth grounding is essential to the safety and operation of the analyzer. The socket shall
ground to earth to protect the operator from shocks and prevent electric interferences.

2.5 Personnel injuries

The following rule should be strictly observed to avoid possible injuries when operating
the analyzer.

Never put your hand or fingers into any opened component or touch the probe
when the analyzer is under operation.

2.6 Biological hazards

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 The following rule should be observed to prevent possible biological hazards.

Improper handling of specimen can lead to biological infections. Avoid any

direct contact with specimens, reagents, controls, calibrators or wastes. Wear
protective gloves, suits or protective goggles where appropriate.

2.7 Chemical hazards

The following rules shall be observed to prevent possible chemical hazards.

Some reagents may be harmful to your skin. Special precautions should be

taken with such reagents. Avoid direct contact with your skin and eyes. Rinse
thoroughly with water if such accident is happened. And see the
ophthalmologist if it gets into your eyes.

2.8 Waste hazards

The following rules shall be observed to prevent waste hazards to the environment and
human body.
Some chemical substances contained in Cal pack, quality controls, wastes, used
gloves and sample port which may contain or contact with bio hazardous
materials should be disposed in compliance with national or local regulations .
(Bio hazardous, dangerous solution)

2.9 Cleaning and sterilization

It is suggested that operators should strictly comply with national or local regulations as
well as the following:

Clean the surface with blenching water of low concentration.

Sterile the surface with hydrogen peroxide solution of 2%.

Never use organic solution to clean or sterile the surface.

Always wear disposal gloves to avoid potential bio hazardous infections.

2.10 Disposal

2.10.1 Disposal of instrument

Some chemical substance contained in the analyzer may be managed by local wasted
regulation and disposal. Please refer to it for more details before the disposal of waste
analyzer.

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 2.10.2 Disposal of battery
Sealed lead batteries contain heavy metals such as lead which can contaminate the
environment when batteries are improperly disposed of. Please refer to local wasted
regulation and disposal for more details.

2.10.3 Disposal of sample port, electrode, pump tubes, Cal pack

Disposal of sample port, electrodes, pump tubes and cal pack should comply with national
or local regulations . (Bio hazardous, dangerous waste)

Always wear disposal gloves to avoid potential bio hazardous infections.

2.11 Operation
Please follow the instructions listed in this manual to operate the instrument. Improper
operation may result in unreliable results or even system failures or injuries.

2.12 Maintenance
1. Please follow the instructions in this manual to maintain this instrument. Improper
maintenance may result in unreliable results or even system failures or injuries.
2. Use soft cloth and water to clean the surface. A small quantity of soap is permitted to be
added into the water where appropriate.
3. Organic solvent such as ethanol is totally prohibited. Wipe dry the surface after cleaning.
4. The power supply should be cut off before cleaning. Necessary precautions should be
taken to prevent water from spilling into inside the instrument.
5. Check pump tube periodically and replace pump tube when necessary. The tubing is
recommended to be replaced for every 6 months to prevent them from aging or blockage.

The instrument should be re calibrated after main components such as

electrodes or Cal Pack have been replaced.

2.13 Sample
This section describes sample requirement, collection and handling techniques for pH,
blood gas, and electrolyte analysis. There is complete sample handling and storage
information in the standard Clinical Chemistry procedures published by CLSI. For detailed
information about sample collection, please refer to CLSI document C27-A, Blood Gas
Preanalytical Considerations: Specimen Collection, Calibration, and Controls.

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 Wear disposal gloves and other appropriate precautions to avoid potential
infections during these operations

2.13.1 Sample sources

The system can analyze sample obtained from the following sources:
1. Arterial blood
It is commonly recommended for use in blood gas studies because it accurately reflects acid-
base physiology and oxygenation status.
2. Venous blood
Venous blood can provide satisfactory pH and pCO2 values, however, venous pO2 values may
not be significant in routine clinical study without simultaneous study of arterial pO2.
3. Mixed venous blood
Mixed venous blood(pulmonary artery) blood may be obtained from a pulmonary artery
catheter after carefully clearing the catheter of infusion fluid. Take appropriate precautions to
prevent mixing of pulmonary capillary blood with the pulmonary artery blood.
4 Capillary blood
Capillary blood, when carefully collected under the proper conditions, resembles arterial blood
and can be used for blood gas studies if the sample limitations are understood. Only small
quantities of blood are required for capillary blood analysis.

2.13.2 Sample requirements

1. Whole blood sample in a full plastic syringe or a capillary with balanced heparin is
required.
2. Complete anti-coagulation is essential as microscopic aggregates in a sample can adversely
affect a blood gas analysis.
3. A specimen is considered unacceptable if it is not run within 15 minutes at the point of
patient care or not received in a bath with water and ice, has air bubbles in the syringe, is
collected in an inappropriate collection device, is inadequately labeled or if clots are
present.
4. Whole blood is most commonly obtained from a radial or brachial artery or from a
cardiopulmonary bypass circuit. Venous blood for pulmonary artery blood gases may draw
in a heparinized syringe or from a bypass circuit. When drawing a sample from the
cardiopulmonary bypass circuit, care must be taken to draw outline solutions before
sampling to ensure that sample reflects patient's current condition.

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2.13.3 Anticoagulant
1. Calcium titrated(balanced) heparin and lithium heparin are the only acceptable
anticoagulant.
2. Do not use anticoagulants such as EDTA, citrate, oxalate and fluoride since they may
significantly alter pH, ionized calcium, chloride and metabolites.
3. Heparin final concentration should not exceed the limits previously reported. The
recommended concentration is 15-20U/mL. Higher heparin concentration can affect
potassium and sodium.
4. A blank syringe must be heparinized first before collecting blood sample. Exclude the air
from the disinfected syringe, then draw the anticoagulant of 1000 unit/mL heparin, pull
the plunger to make the anticoagulant wet full wall, and push it back to discharge the
excess. Remaining heparin in the needle and syringe dead space is enough for the anti-
coagulation of 2mL whole blood.

2.13.4 Sample collection devices

Syringe
1. Use a heparinized syringe with proper lubricant. Please do not use oil or mineral oil as
lubricant because of the high gas solubility of Alkanes may affect the test result.
2. Please do not use tourniquet when arterial puncture. Because blood retardant may increase
the reading of pCO2 and lower the reading of pH of the capillary blood.
3. No bubbles should be in the sample and should be entered the syringe. When the syringe is
filled with blood, the sample should be carefully inspected to see if air bubbles are present.
If present, they must be expelled immediately(within 3 seconds).
4. At the end of blood sampling discard the needle and place a cap over the tip of the syringe.
Mix the blood sample with the anticoagulant by gentle inversion and rolling of the syringe
between the hands, for at least 20 seconds.
Capillary tube
1. Capillary tube that contains appropriate balanced heparin are required to collect capillary
sample from the earlobe, fingers, feet, etc.
2. Sample volume for capillary tube should be greater than 200uL. When collecting capillary
sample, anticipate some sample loss due to clotting and capping.
3. Fill capillary tubes completely and mix the sample thoroughly.
4. Use only capillary tubes with fire-polished cap to prevent damage to sample port.

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 2.13.5 Sample storage
1. For optimal results, samples should be analyzed within five minutes.
2. If a sample cannot be measured within 15 minutes after drawing, it must be placed in a
bath containing ice and water to slow down the metabolic process. Ice water stored
samples are stable for up to 30 minutes.
3. The pO2 value may be affected by the time interval between sampling and analysis.
4. It should be noted that potassium levels are generally affected by icing. Potassium
elevations of several mmol/L have been observed after only a few minutes on ice.
Adequate precautions should be taken to avoid cell hemolysis, resulting in falsely elevated
potassium values.

2.14 Reagents, calibrators, and controls

Reagents, calibrators and controls are required by this analyzer for its normal functions.
The usage, storage of reagents, calibrators and controls should be observed the instructions
in the reagent manuals. Improper operations can lead to wrong results even if they are in
the period of validity.
Recalibration is required after replacing Cal pack or after maintenance. Without
recalibration the analyzer will give wrong results.
Reagents Configurations Functions Storage
Cal pack Cal A Calibrate pH, pCO2, Stored at 5-25℃.
pO2, Na+, K+, Ca2+, Cl- Do not freeze.
, Glu, Lac electrode
Cal B Calibrate pH, pCO2,
pO2, Na+, K+, Ca2+, Cl-
electrode
Cal E Calibrate Glu, Lac
electrode
Flush solution Flush the flow path
Clean solution Clean the lipid of the
flow path
Waste Collect waste
Refill solution For 0.8mL*5 Refill ISE electrode Stored at 5-25℃.
ISE Do not freeze.
Refill solution for 20mL/bottle Refill REF electrode Stored at 5-25℃.
REF Do not freeze.
Deproteinizer Dilutor+Enzyme Deprotein electrode Stored at 0-4℃.

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 Conditioner 0.8mL*5 Condition electrode Stored at 5-25℃.
Do not freeze.
Auto QC cartridge H/M/L Auto Quality control Stored at 5-25℃.
Do not freeze.
Quality controls H*10/M*10/L*10 Manual Quality Stored at 5-25℃.
control Do not freeze.

3. Flow path
The following chart shows the flow of fluid through this system.

Valve:
V1/V2: Air valve
V3/V11: Flush valve
V5: Clean valve
V7/V6//V4: Cal A/Cal B/Cal E
V6: flush
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 Pump
p1/p2/p3: Waste/Flush/Aspiration
Liquid sensor
J1/j2/j3: Reagent Cassette sensor/ Measurement module front sensor/ Measurement
module back sensor

3.1 Flow path of flush

Flow path of flush-1

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3.2 Flow path of Cal A

Flow path of A-1

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 Flow path of A-2

3.3 Flow path of Cal B

Same as Flow path of A.

3.3 Flow path of sample test

Flow path of sample test-1

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 Flow path of sample test-2

4. Specifications and parameters

4.1 Parameters

4.1.1 Measuring parameters

The table below describes the measuring parameters and the measuring range of this
analyzer:
Parameters Units Measuring range
pH 6.000～9.000
Kpa （1.607～26.67）kPa
pCO2
MmHg （8.0～200.0mmHg）
Kpa （0～106.7）kPa
pO2
MmHg （0～800.0mmHg）
mmol/L
Sodium ion(Na+) 20.0～200.0 0 mmol/L
mEq/L
mmol/L
Potassium ion(K+) 0.50～15.00 mmol/L
mEq/L
Calcium ion (Ca2+) mmol/L 0.10～5.00 mmol/L
Chloride ion(Cl-) mmol/L mEq/L 20.0～200.0 0 mmol/L

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 Hct % 12～65%
B.P. mmHg 500～800 mmHg
Glu mmol/L (1.1～66.7)mmol/L
Lac mmol/L (0.4～30.0)mmol/L

4.1.2 Calculated parameters

The table below describes the calculated parameters which would used by this analyzer:
Parameters Units Reference range Resolution
HCO3- mmol/L (0.00～99.00) mmol/L 0.01mmol/L
TCO2 mmol/L (0.00～99.00) mmol/L 0.01mmol/L
BEecf mmol/L (-30.00～+30.00) mmol/L 0.01mmol/L
BEb mmol/L (-30.00～+30.00) mmol/L 0.01mmol/L
sO2 % (0～100)% 0.01%
P50 mmHg (0.00～750.60)mmHg 0.01mmHg
SBC mmol/L (0.00～99.00) mmol/L 0.01mmol/L
A-DO2 mmHg (0.00～800.00)mmHg 0.01mmHg
RI 0.00～35.00 0.01
AG mmol/L (0.0～99.0) mmol/L 0.1mmol/L
tHb g/dL (1.0～25.9)g/dL 0.1g/dL

4.1.3 Input parameters

The table below describes the input parameters that should be typed in by users:
Parameter Units Input range Resolution
Patient ℃ (12.0～45.0)℃ 0.1℃
temperature ℉ (53.6～113.0)℉ 0.1℉
FIO2 % (20.0-100.0)% 0.1%
g/L (10.00～250.00) g/L 0.01g/L
tHb (d) g/dL (1.00～25.00) g/dL 0.01g/dL
mg/dL (1000.00～25000.00) mg/dL 0.01 mg/dL

4.1.4 Electrode Parameters

Electrode Normal range Inner solution range Slope range
pH 70mV-170mV <70mV or >170mV +16mV~+28mV
pCO2 500mV-2500mV -75mV/Dec~-30mV/Dec
pO2 0mV-500mV +1.5pA/mmHg~+10pA/mmHg
Na +
45mV-120mV <45mV or >120mV -10.63mV~-6.07mV
K+ 45mV-140mV <45mV or >140mV +12.04~+21.07mV
Ca2+ 35mV-100mV <35mV or >100mV +6.6mV~+10.5mV
Cl+ 50mV-120mV <35mV or >100mV +3.9mV~+7.8mV

4.2 Specifications

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This section provides the requirements, specifications and typical performance of the
analyzer.

Dimension
Size Length Width Height
Value(mm) 400 574 344
Weight
Main unit 22.3kg
Power requirements and consumption
Power supply AC100~240V
Rating Consumption 100VA
Fuse 2×F3.15AL 250VAC
Built-in Battery 2×12V 2.3AH Sealed lead-acid battery
Operation environment
Ambient temperature 5~40℃
Relative humidity Up to 80% noncondensing
Atmosphere pressure 86Kpa~106Kpa
Storage and transportation conditions:
Temperature -20℃~+60℃
Humidity Up to 95% noncondensing
Sample volume
Typical 200µL
Sample type
Type Arterial, Venous, Dialysate, Capillary
Screen
Type 10” TFT Touch screen
Interface
Interface Descriptions
RS 232 Serial port
USB
TCP/IP Internet/Ethernet
Barcode Barcode reader
Printer
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 Type Thermal printer
Resolution 240×128 pixel
Full graphics 8 dots/mm
Printing speed 15mm/s
Paper 80 mm(W) × 30 mm(D)

4.3 Sample type

Human blood

4.4 The speed of analysis

20 pcs/H

4.5 The volume of sample

About 120μL

4.6 Output ways

LCD display and print out, series port

4.7 Dimensions
Length×Width×Height: 344mm×400mm×574
Net weight of the analyzer:25kg

4.8 Fuse protector

2×F3.15AL250V

4.9 Memory
RAM;64Mb flash:256Mb

4.10 Printer
Auto thermal printer:
Paper width:80mm(W)×50mm(D)
Speed:15mm/s
Resolution:240×128 pixel

4.11 Battery
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 Internal battery: 2×12V 2.3AH
Charging time: 6 hours to get full charge
Maximum using time: 30

5. Installation
5.1 Operating environment
The installation of the analyzer should be proceed in such environment:
1 Temperature : 15-30℃.
2 Relative humidity :≤80% (without condensate).
3 Power supply :100-220V~50Hz/60Hz.
4 Atmosphere pressure: 86~106KPa
5 The earth of the socket shall be well grounded and keep way the analyzers from
possible electromagnetic interference.
6 Working area: L*W (1.5*0.6) and at least 0.5m far from other analyzers.
7 Others: Avoid sunlight irradiation, erosive gas, great temperature change and dust.

The analyzer is intended for indoor use only.

A switchable Power socket should be equipped to control power supply.

Always wear disposal gloves to avoid biohazardous infections when handling or

operating this analyzer.

Front cover shall be kept close when operation. Open it by skilled or trained
medical personal only where appropriate.

5.2 Unpacking and check

Unpack and remove the analyzer and the accessories from the cartoon. Place them on a
solid work table and check them with packing list. If any missing or damage is found,
please contact our distributors.
Please keep the carton and poly foam for future repacking in case of movement or
repairing.

Never put your fingers into reagent pack housing at the bottom. The sharp pin
inside can cause bodily injury.

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5.3 Electrodes installation

5.3.1 Electrodes preparation

1 Electrodes used on this system can be categorized into the following groups according to
their different functions:
2 Reference electrode: Fixed type with internal solution.
3 ISE electrodes: K+/Na+/Cl-/Ca2+/pH. Refillable. When solution less height than 1/2,user
need to dry the electrode and refill .The refilling solution has to be replaced for every 3
months.
4 pO2 and pCO2.electrodes: Fixed type with internal solution.
5 TH electrode: Maintenance-free.
6 Hct electrode: Maintenance-free.
7 Metabolite electrode: Glu and Lac.
Tips: Preservative solution is filled in the flow path of Glu/Lac electrode to maintain its quality. Make
sure to wipe the electrode body by tissues if body get wet with the solution when the seal is peeled off.
Otherwise the solution will get crystallized, which makes bad impact on analysis.

5.3.2 Electrodes introduction

pO2 and pCO2 electrodes
1. Take out electrodes from their boxes. Insert O ring one left side.
2. Place upward and flip the bottom to exclude air bubble.
3. Clean exterior surface with tissue.

pO2 and pCO2 electrode

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 pO2 and pCO2.electrode are independent electrodes. Their performance is
limited to electrode itself only and irrelevant to other electrodes.

Air bubbles above membrane can lead to electrode problem.

TH and Hct electrodes

1. Take out electrodes from their boxes.
2. Insert O ring on left side.
3. Clean exterior surface with tissue.

TH and Hct electrode

TH is essential to the correct control of temperature. The problem of TH can

lead to overheat in the measuring chamber.

ISE electrodes

Screw out electrode head Empty original solution

Take out electrodes from the box.Replace refill solution if it is less than 1/2 height of
internal cavity. Follow the below procedure to replace refill solution of electrode.
Here we take Na+ electrode as reference:
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 Aspirate refill solution Inject refill solution
a) Screw out the electrode head. Empty original refill solution.
b) Cut open one vial of refill solution for ISE. Aspirate it with a new syringe.
c) Put needle into the electrode and lean it against the internal cavity. Push plunger slowly
until refill solution reaches 2/3 height of internal cavity.

d) Dry the screw hole of electrode with tissue.

e) Screw in the electrode head. Wipe dry the surface of electrode.
f) Flip the bottom to exclude air bubbles.
1.Empty the remaining refill solution before adding new.
2.The refill solution should be around 2/3 to 3/4 height of internal cavity.
3.Replace refill solution of ISE for every 3 months.
4.Missing or broken O ring can cause leakage or blockage.

Reference electrode
1. Take out the reference electrode.
2. Remove the tape on both sides that covers the sample hole.
3. Install O ring on both sides.
4. Screw out the cap on the right cavity.

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 5. Use a syringe to aspirate refill solution for reference(20mL), then inject into
reference electrode. The solution surface should reach at least 1/3 height of right
cavity.
6. Flip the bottom if there is any air bubbles above membrane area on the left cavity.

Refill reference electrode

1. Refill solution for can be filled directly.
2. It is normal if there is little crystal in left cavity.
3. REF electrode functions as the common terminal for all electrodes.

Refill solution for ISE is totally different from refill solution for REF. Never
mix use those two solutions under any circumstances.

5.3.3 Electrodes installation

Please install the electrodes according to the following steps:
1. Open the cover of the analyzer.
2. Open the door of measuring chamber by pressing the latch on upper right corner.
3. Wipe dry the internal surface of measuring chamber by tissue.
4. Install electrode one by one. Aim at contact point of measuring chamber first, then lift up
and push forward until it is in place.
5. The installation should be started from left to right. Hct should be installed before
reference electrode. Press left the handle and lift up the plastic stopper beside the handle.
Press down the stopper and resume the handle after installation.
6. Level all electrodes with thumb by pressing them inward.
7. Close the door of measuring chamber.
8. Close the door of analyzer.

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 Exclude air bubble above membrane area before installation of Gas electrodes
and ISE electrodes.
Measuring chamber and electrode surface should be cleaned before installation.

Improper installation can cause leakage or blockage in the sample pathway.

Reinstall electrode when there is problem of leakage or blockage after
installation.

The following picture shows you the specific position of all the electrodes, you can
take it as reference:

5.4 Barcode scanner installation

1. Take out the scanner and connect the series bus of the scanner to the RS232 port on the rear
panel of the analyzer.

2. The indicator of the scanner turns on when the connection is ok.

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5.5 Pump tube installation
There are 3 pumps on this system just below the measuring chamber. These pumps have
different functions. From left to right they are : Waste pump, Reagent pump and aspiration
pump.
 Waste pump: Pump waste dripped from sample port
 Flush pump: Aspirate flush solution.
 Aspiration pump: Aspirate sample and other solutions from measuring chamber.
Please install the pump tube according to the following steps:
1. Click “Expendable” in the main menu to enter the expendable management
interface.
2. Take out the pump tube and use the barcode scanner to scan the barcode on
package.

3. Take down the Tygon tube connected to the ends of the old pump tube.
(Skip to next step if it's your first time to install pump tubes)

4. Take the old pump tubes out slowly by rotating the pump wheel anticlockwise.
(Skip to next step if it's your first time to install pump tubes)

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 5. Put the one end of the new pump rube to the pump slot.
(Please take the pump tubes out when it comes to long term transportation)

6. Rotate the pump wheel the pimp tube will be squeezed into the gap, put the
the other end of the tube in the slot when all the tube is squeezed into the gap.

7. Rotate the pump wheel clockwise and anticlockwise until the pump tube is
placed in the gap perfectly.

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 8. Then insert the Tygon tube into the steel tube of the pump tube, and ensure the
joint length is no less than 5mm.

9. The table below shows how to connect the pump tube to the Tygon tubes correctly:

Left Sample port

Waste pump
right Waste inlet
Left Flush inlet
Flush pump
right Flush outlet
Up Measuring chamber
Aspiration pump
Down Waste inlet

Never put your hand into the tube slot to avoid possible injuries.

5.6 Cal pack installation

Click “Expendable”, the expendable menu appears as below

1. Click “Expendable”, the expendable menu appears as below.

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2. Take out the cal pack and scan the barcode on it.

3. Tear off the protection membrane on the new cal pack and pull out glass plug on the pack.

3. Hold the both ends of the pack, slowly insert the pack into the reagent cavity at the bottom
of the analyzer.

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 On board life for cal pack is one monthly only. Extended use of cal pack can
lead to wrong test results.

There is possibility of waste leakage from cal pack when operation. Special
cautions shall be always taken while handling cal pack or operating analyzer.
Used Cal pack which may contain or contact with biohazard materials should
be disposed in accordance with local regulations of government

Connecting pin inside the reagent housing is sharp and dangerous. Never stretch
your fingers into the housing to avoid possible injuries.

Cal pack on this system is for single use only. Reuse of Cal pack is not
permitted once it is pulled out.

5.7 Auto QC installation(optional)

1. Pull out old Auto QC cassette from its housing.
2. Tear off the tape on the new cartridge. Hold label side upward and point its connecting side
at the lower left housing of the analyzer. Push it gently until it is in place.

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 Connecting pin inside the reagent housing is sharp and dangerous. Never stretch
your fingers into the housing to avoid possible injuries.

Cal pack on this system is for single use only. Reuse of Cal pack is not
permitted once it is pulled out.

5.8 Printer paper installation

Follow the steps below to load/replace the printer paper:
1. Press the release switch to disengage the printer cover and remove the old paper if
necessary.

2. Load a new roll of paper inside the compartment, with the free end of the paper coming
forward off the roll from the bottom. Ensure the free end of the paper extends beyond the
lip of the printer cover.

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 3. Then close the printer cover, get rid of the redundant paper outside, the installation is
complete.

The inside of the printer might be hot. To reduce the risk of injury from a hot
component, allow the surface to cool before touching it.

5.9 Install the battery

The internal battery can provide power when AC power failure, the battery switch on the
rear panel of the analyzer determines whether the battery works.
Please install the battery according to the following steps:
1. Use a screwdriver to screw off the 4 screws on the rear panel of the analyzer.

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 2. Plug in the battery.

3. Push the battery into the unit of the analyzer and tighten the 4 screws.

Please pay attention to the positive and negative pole of the battery, you can
install it as the label shown on the battery box.

5.10 Check for correct installation

1. Electrodes are installed correctly. Their positions match the labels and internal solution is
more than ½. Electrodes are leveled to the measuring chamber. The lock knob is tightly
fixed. The door of measuring chamber is closed correctly.
2. Pump tubes are inserted into the housing slot. Tubes are correctly connected and no tube is
left opened.
3. When cal pack is correctly placed, no free space should be left when pushing inward.
4. Probe is horizontally inserted inside sample port. Sample port should be locked on its base
without free room to shift.
5. Front door is closed after above check is finished.
6. Probe cover is installed and probe is covered.
7. The voltage of power supply matches the requirement listed on rear label.

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5.11 Open up
1. Turn off the switch on power socket
2. Insert the power cord into the socket of the analyzer.
3. Plug another end of power cord into a grounded outlet.
4. Turn on the switch on power socket and start up the analyzer.
5. Turn on the switch on the rear panel of the analyzer to enable UPS support.

1.An ungrounded power supply can lead to drift problem of all electrodes.
2.High-power analyzer with the same outlet can interfere with the analyzer.

Power switch on the rear panel is for UPS control only. Power outlet should be
equipped with a switch to control power supply.

Battery of UPS should be recharged before use. Open UPS switch and keep
power on to recharge battery.

5.12 Self test

After power on, self test will be performed first to check important system functions. A
series of test including test of probe, sensors, motors and liquid/air detection will be started.
In this process, probe moves in and out to determine its home position. Flush solution is
aspirated and emptied to set up liquid and air reference with the cooperation of pumps and
valves. If one of these tests is failed, error message will be prompted and the system is
stopped and waited for user interruption.
Press OK to enter main menu while self test still continues on the background until finished.
Perform 2 Point Calibration after self test is passed.

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 If self test is failed for a second time, power off the analyzer and start trouble
shooting. Please refer to the section of trouble shooting.

Self test is required to be performed after maintenance of probe, probe wiper

since probe position may be shifted.

For new electrodes, if the problem of drift is happened, feed fresh serum to
activate electrode for 30 minutes, then check again.

5.13 Shut down

Power switch on the rear panel is for UPS control only.
Unplug power cord to switch off the system. A switchable adapter is
recommended for daily routine use.

5.13.1 Within 24 hour

If the analyzer will be used within 24 hours:
1. Turn off the switch on the rear panel to disable UPS.
2. Unplug power cord to switch off the analyzer.

5.13.2 Beyond 24 hour

If the analyzer won't be used within 24 hours, perform the following procedures:
1 Perform Wash.
2 Remove cal pack from its housing and place cal pack in a safety place.
3 Remove Electrodes from measuring chamber and place it into box.

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 4 Release pump tube.
5 Turn off the switch on the rear panel to disable UPS.
6 Unplug power cord to switch off the analyzer.
7 Open battery cover to remove battery.
8 Clean the surface of analyzer and put it into carton box

6 Menu introduction
6.1 Main menu

6.1.1 General introduction

When the self test is finished, the system will enter into the main menu automatically.There
are 9 icons on the main menu:

1. Test 2. Flush 3. Maintenance

4. 1 PT Calibration 5. QC 6. System Setup
7. 2 PT Calibration 8. Data Manager 9. Expendable

1 Point Calibration, 2 Point Calibration and Flush are shortcut menus. Calibration or Flush
can be directly activated by clicking the menu.
Temp is the temperature of measuring chamber.
Baro pressure and temperature are displayed after date and time.
All test can be found under Test menu.

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6.1.2 Basic operation
1. Menu activation
All menus can be activated or selected by direct click on the menu. Click Main Menu to
return to home if it is displayed on the top of window.
2. Activate command
Click command icon directly to activate an operation. Click OK to confirm or save, Click
Cancel or Return to exit.
3. Select option
Click the marquee before an option to select or cancel it.
4. Data input
A. The system support virtual keypad to edit or enter data. Click data field to pop up virtual
keypad and click OK to close after finished.
B. There are two kinds of keypad. One is for digital input only. Another one is for letter,
symbol and number.

Click to switch number input, click to input symbol, click to input letter.

6.1.3 Menu structure

The menu structure described as below:

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6.2 Test menu
1. Click “Test” on the main menu, the test interface appears as below:

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2. Select the sample type, then select parameters(You cannot select the one not selected in
“Test Parameters” menu).
3. Put the syringe at the sample port, click “Go” , then probe starts to aspirate
the sample. A sign saying “Please remove sample” shows on bottom of the screen when the
aspiration is finished, the system starts to test the sample.

4. We can see a series motion of the machine part when the system starts to test. Meanwhile,
the user can type into the corresponding patient information such as “Patient ID” ,
“P.Name”(Patient name), “Age”(Patient age), “Temp”(Patient temperature), “Hb”(Total
hemoglobin value measured from other analyzer) and “FIO2”(Fraction of inspired oxygen).

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6.3 1 Point calibration and 2 point calibration menu
Click “1 Point Calibration” or “2 Point Calibration” on the main menu, the system
conducts the corresponding calibration, the result of the calibration displayed on the screen
automactically.( Please see more details about calibration in chapter 7)

The status bar located at the left top of the screen, and the status changes along with the
process.
For more detailed information, please refer to chapter 7.

6.4 Flush menu

Click” Flush” on the main menu, the picture below appears. The system will back to the
main menu automactically when the flush is finished.
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6.5 QC menu
Quality control means the use of the control materials of known values to monitor the
precision and accuracy of the measuring channels. Click”QC” ,the QC menu appears as
below:

For more detailed information, please refer to chapter 8.

6.5.1 QC lot management

Click “QC Lot Manager” to enter the QC lot number management interface before QC test.
Type in the lot number and related figures, then the lot number can be selected to proceed
with test.

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 Icon Function
More To check and edit the data of the test results
Add To add a new lot number
Delete Delete the data base of a lot number
Empty DB Empty the data base of all the lot number

Add a new lot number:

1. Click “Add” in the above interface, the picture displayed as below:

2. Input the lot number and the expired data, a dialog box appears when the lot number has
already existed, the user can edit the old lot number according to the actual condition.
3. Select the QC level.

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 4. Edit the mean and the 2SD values. Please ensure the effective lot number and expired date
have been input before edit or the edit cannot be done. Click “Save” when all the data are
input, a dialog box saying “Save current changes and exit?” appear, click “OK” to save.

5. The interface of Level 1 to level 3 are very similar, the status bar which level you are editing.
Here we take level 1 as reference to describe the interface.

6.5.2 QC test
Click”QC”, select an effective lot number as the current lot number, then click”Go” the test
interface appears on the screen. The status bar at the left corner shows the current status of
the system.
 The QC pack should be stored in room temperature.
 Don't shake the QC solution before openning, making the
solution keep stable.
 Push off two drops of the solution form the syringe before
feeding the it to the analyzer.

6.6 Data management menu

Click “Data Manager” the data management interface appears, there are 5 icons in this
interface: Test Result, CAL Results, Data Export, QC Plot Data, QC Plot. You can check
the results of test calibration and QC and also export the data out.

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6.7 Maintenance menu
Click “Maintenance button, users can perform the “Clean” “Deproteinize” and “Condition”
according to the note.
There's no need to aspirate clean solution when conduct clean because specific clean
solution existed in the reagent pack.

But users need to feed solution to the sample port when conducting ”Deproteinize” and
“condition”. Users can also set the maintenance period.

6.8 System Setup menu

Click “System Setup” the setup menu appears as below:

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 For more detailed information, please refer to chapter 10.

6.9 Expendable menu

1. Click “Expendable”, the expendable menu appears as below, the red sentence at the top
describes which expendable is expired, and reminds users to replace the old one.

2. The barcode need to be scanned when the expendable is expired, click “Enter Barcode” to
scan the barcode of new expendable or you can input the barcode manually. The barcode of
every reagent pack just corresponding to one client code, the reagent pack which doesn't
match the client code cannot be used, and the related test cannot proceed.
3. Click “List” the detailed information of the expendable appears on the screen.

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7 Calibration
7.1 General information
Sensor calibration is the process of relating sensor electrical outputs to know analyte
values. Calibration establishes a relationship between the electrical output of a sensor and
the concentration of the analyte measured by the sensor. The relationship between the
sensor signal and the concentration of a measured analyte is linear. Once the relationship is
established, concentration of sample can be calculated once its response is measured.

mV

Vb

Va

Ca Cb mmol/L

Fig. 7.1: 2 PT calibration model

Hct just needs one point calibration, and Hct should be separated from others.

7.2 1 Point Calibration

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 1 PT calibration can associate electrode response with ion concentration of Cal A for all
parameters except Hct. It defines the first point in 2 PT calibration. Cal A is used in 1 PT
calibration.
1. Select 1 Point Calibration under Main menu to start.

Option Detailed information

Cal A Calibrate 1-Point of pH, pCO2, pO2, Na+, K+, Ca2+, Cl- , Glu, Lac electrode
Cal E Calibrate 2-Point of Glu, Lac electrode
Calibrate 1-Point of pH, pCO2, pO2, Na+, K+, Ca2+, Cl- , Glu, Lac electrode
Cal A and E
and 2-Point of Glu, Lac electrode
2. First flush solution is aspirated to wash sample path.
3. Then Cal A solution is aspirated and moved to measuring chamber for test. Press Stop to
interrupt calibration if an early exit is desired.
4. 1 Point Calibration will try 3 times if one or more parameters failed. Once it is passed,
“Pass” will be displayed on the status column.
5. After test, flush solution is aspirated again to wash flow path.

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 There are 4 possible results of 1 point calibration:
Pass Calibration is passed
The mV difference from two consecutive tests exceeds the limit. It means
Drift
electrode is unstable.
Unstable Unstable mV reading within limited time.
Over Range mV exceeds the limit range of electrodes.

“Calibrating A1”: Status area. Here “A1” means the first trial of 1 point calibration.
If calibration A1 is failed, the system proceeds calibration A2 automactically.
“00:00”. Calibration timer.
“Voltage” : Electrode response in mV format.
“Concentration” : Concentration from Cal A in the format of mmol/L for
K/Na/Cl/Ca/Glu/Lac and mmHg (or kPa) for pCO2 and pO2.
“Status”: Calibration Status. When calibration is failed, electrode problem is displayed.

The second column shows equal mark(=) when mV reading is stable.

7.3 2 Point Calibration

2 PT calibration defines 2 points from Cal A, Cal E and Cal B. All parameters except Hct
are calibrated here. Cal A and Cal B are tested in this calibration.
1. Select 2 PT calibration under Main menu to start.

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2. Cal A, Cal E and Cal B are aspirated respectively for test. Before and after each test, flush
solution is aspirated to wash flow path.
3. If calibration A1 failed, the system proceeds calibration A2. Each test will try 3 times until
it is passed. “2 point calibration finished” is present after 3 trials regardless of the
calibration result.
4. If both Cal A, Cal E and Cal B is passed, Return button is displayed. The result windows
will be present for 2 minutes if without user interruption.

There are 4 possible results of this calibration.

Pass System is ready for test.

Unstable Unstable mV reading within limited time.
Drift The mV difference from two consecutive tests exceeds the limit.
Over Range mV exceeds the limit range of electrodes.

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 Abnormal Slope(mVb-mVa) is out of limit range. It means a narrow linearity range.

7.4 Calibration intervals

Auto calibration is available on this system and it is intended for maintain and monitor the
status of electrode and minimize possbile electrode drift. It is initiated automatically by the
system on preset time. The interval between each calibration can be set up on this system
and there are four options avaiable for selection: 60 minutes, 120 minutes, 180 minutes,
240 minutes.

1. Enter System setup and select Calibration intervals. The system default interval for one
time calibration is 60 minutes, the two point calibration interval is always four times of the
on point calibration interval.
2. There are four options available: 60 minutes, 120 minutes, 180 minutes and 240 minutes.
Click the circle before option to select one option and re-click to deselect.
3. Press OK to save changes.

The cycle of auto calibration is pre-defined as following:

Every 3 times of 1 point calibration followed by one time of 2 point calibration.

Interval of 1 point calibration

1 point calibration 1 point calibration 1 point calibration 2 point calibration

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 2 point Calibration will be performed after 3 times of 1 point calibration in auto
calibration mode.

7.5 pO2 zero calibration

pO2 Calibration requires two points at least and one of its two points is tested against zero
oxygen. Normally zero point is roughly a fixed value but it may vary a little under some
circumstances. Anaerobic water is required for this calibration.

1 In Test window,make sure pO2 Calibration is passed,prepare anaerobic water and aspirate it
with syringe.
2 Insert syringe to sample port,test it twice and put down the Voltage(mV) of pO2.
3 Select pO2 zero calibration under Other Utilities,enter the average of two results.
4 After calibration, the results window is shown as below.

Recommended frequency for pO2 calibration is several times one month.

7.6 Calibration data

Calibration data are automatically kept by the system. This function provides user a useful
method to learn about performance and status of electrodes especially when there is an
electrode problem.
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1 Select Cal Results under Data Manager.
2 Enter date range for searching. Press Search to start search. Available calibration data are
displayed on the right window. Click function extended more function icons will appear,
click the corresponding icon to perform functions.

3 Select the Cal you need and click more to get more information, slope=Cal B - Cal A.
Click print to print the Cal result.

4 The following table describes the possible results of the calibration:

Status error code Description
Drift A Voltage difference from two consecutive Cal A exceeds limit.
Drift E Voltage difference from two consecutive Cal E exceeds limit.
Drift B Voltage difference from two consecutive Cal B exceeds limit.
Over range Voltage response of electrode exceeds limit.
Abnormal Voltage difference between Cal A , Cal E and B exceeds limit.

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 Cal type Description
A 1,2 or 3 First ,second or third trials of Cal A
E 1,2 or 3 First ,second or third trials of Cal E
B 1,2 or 3 First ,second or third trials of Cal B

8 Quality Control
8.1 General information
Quality control is essential to monitor the accuracy and precision of the complete
analytical system to detect immediate errors due to system failure, adverse environment
conditions, and operator performance.
Quality control includes 3 levels of solutions to covers the entire clinically significant
range: low(Acidosis), Middle(Normal) and high(Alkalosis). Quality control must be
performed before any patient sample testing and they are required for every 8 hours of
patient testing. Each lab should establish its own QC program. 2 level of QC are required
for every 4 hours and a third for 24 hours. 3 levels of aqueous Blood gas controls and 2
levels of hematocrit controls are required to be performed weekly on this system.
Additional quality control should be run after any troubleshooting or maintenance which
might alter performance.

2 point Calibration should be passed before performing Quality control.

8.2 Preparing QC solutions

QC solutions are usually filled in ampoules. Please use a syringe to aspirate the QC
solution and feed the solution to the system.

 Please store QC ampule in the room temperature ranging from 15 to

30℃.
 Don't shake the ampule before open it to keep the solution stable.
 Expel air bubbles from syringe and cap it carefully after transferring
QC sample from ampoule to a syringe.
 Push off the first two drops from the syringe.

8.3 Lot number management

Click “QC Lot Manager” before test and type in the lot number and related figures for

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 subsequently selection.

Click “QC Lot Manager” the picture shown as below:

The table below describes the function of the icon:

Icon Function
More To check and edit the data of the test
Add Add a new lot number
Delete Delete a lot number
Empty DB Empty all the data base

Add a new lot number:

1. Click “Add” on the lot number management interface, the interface for inputting lot number
and related figures shown as below:
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2. Input the lot number and expired date, if the input number is the same with an exist one, a
warning will pop up to remind you to edit the existed lot number according to the real
condition.

LOT NO must be entered firstly. Otherwise there is a warning message popped

up requiring for entering a LOT NO.

3. Select the QC level

4. Edit the “Mean” and “2SD” figure, please make sure an valid lot number and expired date
have been input already. Click “OK” to save it.

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 Range = 2SD. Normally it should be equal to Mean - Min or Max - Mean

8.4 QC test
1. Select the lot number and the QC level, click “Go”, a dialog box saying “Place qc sample in
the sample port. Press ok to continue!” appears , put the syringe containing QC solution at
the sample port.

2. Remove the syringe when the aspiration is finished. Then the system starts to test, the
picture shown as below, the status of the test shown at the left top of the interface.

3. The system starts to clean the flow path after test, Click “Print” to print the result of the QC
test.
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8.5 QC plot data
This function can manage QC data stored on this system. QC data can be searched by
specifying a data range. Listed records can be further viewed by specifying levels.
1. Select QC plot Data under Data manager. Input data range and select the level ,the related
QC plot data appears.

2. Select an item, click “More” to see the detailed information. Click “print” to print the
result out.

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8.6 QC plot
The system can plot one recent QC result of one day stored in the current QC file for each
parameter and level, and this system can plot the recent 30 days QC results in total. Click
“ Data Manager” “ QC Plot” to check the QC plot, the picture shown as below:

Green dot: Values within ±2SD.

Yellow dot: Values between ±2SD and ±3SD.
Red dot: Values beyond ±3SD.

9 Patient sample analysis

Sample test is designed to be easily followed through a 3-step operation on this system.
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 Both syringe and capillary are supported by the system and they are automatically
recognized. The supported sample includes most of human fluid such as arterial, venous,
serum, plasma and dialysate.
To avoid introduction of clotted blood samples into the analyzer, which may give
inaccurate measurement results and interfere with analyzer function, we recommends the
followings:
 Exclusive use of pre-heparinized sampling devices
 Exclusive use of dry heparin, preferably of sodium or lithium
 Don't use liquid heparin, as this causes dilution of the sample
 Use heparin in sufficient concentration. The recommended concentration depends
on the sampling device and specific blood sample. Please refer to documentation
for specific sampling devices.
Sample collection, handling, storage are not covered in this section. Please refer
to appendix Sample collection for more details.

Always wear gloves to avoid bio-hazardous infections while performing all

these tests concerned in this chapter.

9.1 Collect samples

9.1.1 Collect syringe samples

The arterial blood is the most preferred and recommended type of blood for blood gas
analysis while the venous blood is generally not recommended for blood gas analysis.
Please collect the samples according to the following steps:
1. Prepare a heparinized syringe which the volume is not less than 2mL. And the
concentration of the heparin should be about 50-80IU/mL.The minimum volumes
required by the system to analyze the syring sample is 90μL, the syringe should aspirate
at least 1mL sample.
 Insufficient heparin may produce slotted blood which may block the flow
path of the analyzer, but too much heparin may has bad influence on the
result of cCa2+ and Hct.
 Minimum height of sample in the syringe should be higher than 10mm. Or
the probe will touch the plunger of the syringe.
2. It is very important to mix the sample thoroughly with heparin immediately after sampling
by inverting the sampler several times and then rolling the sample between your palms.

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  During storage blood cells tend to settle. If complete mixing is not
achieved before analysis, results may be significantly different from
actual values.
 Expel bubbles out from the syringe.

9.1.2 Collect capillary samples

1. The following are recommended capillary sample sites:
Earlobe
Finger tip
Fetal scalp
Big toe(for baby)
Heel(for baby)
2. Mix the sample with heparin which the concentration is about 70IU/mL immediately after
collection to prevent blood from clotting

9.2 Analyze the sample

1. Select the sample type and parameters on the test menu.(Put the capillary sample at the at
the sample port then click “capillary” when test capillary samples, the system will aspirate
the sample and skip to step 3)

2. Prepare the sample and insert the syringe device into the sample port firstly, click ”Go”, the
system starts to aspirates the sample.

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3. If the sampler lever detects no sample, the system will give out continuous beeps reminding
you to put the sample at the sample port. Click return to start again.

4. Remove the sample device when aspiration finished, then you can see a series motion of the
system. Meanwhile you can input the corresponding sample information of the patient, click
“Confirm input”.

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5. The system perform washing at the end of the analysis and display the related data on the
screen. When the test is finished the system will return back to test interface after 3 minutes.
 If you don't remove the sample after aspiration, the washing for sample
port would pollute the sample.
 Aspiration for any samples on the system is automatic. Never inject
samples under any circumstances.

9.3 Check the test result

1 Click “Data Manager” select test results, the interface of test data shown as below, you can
search patient test results by inputting patient ID or data range.

2 Click More to get the detailed information of the result, click print to print the result
through the internal thermal. And if other formats (A4 or A5) of the result is needed please
connect the analyzer to an external printer to print.

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3 Click “Analysis Report”, an analysis report of the patient appears for your reference.

4 Click set up icon to set the normal range for parameters.

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10 Setup system
This chapter shows useful information about system setup. Use these function to configure
and control your system. Most of these functions are required to be set up on first start-up
and not required by normal operation once they have been set up. Change system setup
only when necessary.

10.1 Correlation
When test results is other than target value or methodology, it can be corrected by using
correlation coefficients through slope and intercept by using a model of y=ax+b where a is
slope, b is intercept, x is test results and y is target value. Only mathematical calculation is
involved with correlation. The slope and intercept are got from a regression analysis of test
results against results from reference system.

1 Click “Correlation” input the pass word “77”, the picture appears as below, user s can also
edit the data and click “OK” to save.
2 The first column is Slope (default 1.0), and the second column shows Intercept (default
0.0).
3 Click data field to activate virtual keypad. Change to numeric layout and input correct
numbers. Press OK when finished.
4 Click another data field to finish another input.
5 Press OK to save and press Return to exit.

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 Correlation coefficients must be re-calculated if new electrode is replaced.

10.2 Reference Range

Reference range decides if a result is out of expected range and mark it on the test report.
Reference range can be varied and represent different clinical meaning if samples are
drawed from neonant ,infant, male or female.
1. Enter Reference range under System Setup
2. Click data field to activate virtual keypad. Change to numeric layout and input correct
numbers. Press OK when finished.
3. Click another data field to finish another input.
4. Press OK to save and exit. Press Return to exit without saving.

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 Each lab should establish its own reference range for the evaluation of patent
results.

↑↓will be printed on test reports if the value exceeds reference range limit.

10.3 Unit
Click "Unit" to select unit (mmHg or kPa)for the values according to your preference.

Click “Edit” and input the password “77”, user can set the Hb calculation value.(Hb value
ranging from 0.10 to 0. 99).

10.4 Test parameters

All parameters can be selected or deselected under Test parameters. This will enable or
disable a test channel. This is useful when one electrode has problem or unwanted
parameters are present.
1 Enter Test parameters under System Setup .
2 Click the mark before parameters to select or deselect it, the parameter is selected when the
mark before it turns purple.
3 Re-click the mark to toggle between selection and deselection.
4 Click OK to save and exit. Press Return to exit without saving.
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 Calibration will be performed if one channel is activated.

10.5 Calibration intervals

The system can perform calibration periodically according to calibration interval set. The
system default interval for one-point calibration is 60 minutes, and the system performs
two-point calibration automatically after 3 times of one point calibration.

10.6 Date and time

Set the date and time for the system, which may have an effect on expired date of
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 consumables.

10.7 Language Setting

Select the language that the system uses to present information on the screen.

10.8 Version
The version of software appears as below:

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10.9 Replace Sample port
Click “Replace Sample port”, the probe will go backward, which is convenient to take
down the sample port. Click OK to check if the sample port is replaced ok.

10.10 LIS interface

The LIS interface appears as below:

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 1. Click “HL7 Server Setting” to set server IP and server port, select “Enabled”and click
“save&Link” .

2. Click “Local Network setting”, enter the IP address to establish a connection to LIS.

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10.11 Printer
This menu controls the setup of printer.
1 Select Printer.
2 There are two options to control the printer and test report.

1. Click “Select Item” to choose the parameters needed to print(for USB printer only).

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10.12 Self test
Click “Self Test” the system will start to perform self test.

10.13 Power Off

Always shut down the analyzer using the Power Off button. Turning the analyzer off
directly by using the power switch at the rear of the analyzer may cause file corruption.

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10.14 Other utilities
Click “other utilities” to enter this interface, click the corresponding icon to set the
related value.

11 Maintenance
This section includes the recommended maintenance procedures for the analyzer. The
frequency of preventive maintenance operations is based on average workload of 20 to 30
samples per day with a normal analyzer use. Facilities with heavier workloads should
schedule maintenance operations more frequently.

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 Wear disposable gloves to avoid contact with potentially infectious materials
while maintaining the analyzer.

11.1 Maintenance functions

There are four maintenance functions available on this system: Clean, Deproteinize,
Condition and Wash. Only wash is under Main menu and the other 3 functions can be
found under Maintenance menu. The upper window shows status information. A progress
bar with percentage is provided to show a direct view of the procedure of a maintenance
cycle when it is activated.

11.1.1 Clean

Replace the Glu and Lac electrode with Maintenance electrode C before cleaning the
sample path. Reinstall them within 2 hours.
Clean can remove fat built up in the sample pathway. It can also be used to maintain
electrodes. Clean solution from Cal pack is used in this procedure.
1. Select Clean under Maintenance.
2. Clean solution is then aspirated to clean the pathway.
3. Clean procedure lasts around 1 minute. Press Return for an early exit.
4. 2-PT calibration is performed automatically after performing Clean.

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11.1.2 Deproteinize
Replace the Glu and Lac electrode with Maintenance electrode C before cleaning the
sample path. Reinstall them within 2 hours.
Use Deproteinize to remove protein in sample path. It can also be used to maintain
electrodes.
1. Select Deproteinize under Maintenance.
2. Prepare the Deproteinizer
Take out one pair of enzyme and dilutor. Add the dilutor into the enzyme. Shake the vial
for several times then wait for 2 minutes until the enzyme power is completely dissolved. It
should be a clear solution.
3. Aspirate Deproteinizer with a syringe and insert the syringe into sample port.
4. Press OK to aspirate.
5. The whole procedure lasts 30 minutes. Press Return for an early exit.
6. 2-PT calibration is performed automatically after exiting Deproteinize.

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 Feed fresh serum instead of deproteinizer when activating new electrodes.
Manual rotate reagent pump until serum is moved out of PCO2 and PO2 area
since those two electrodes do not need activation.

11.1.3 Condition
Replace the Glu and Lac electrode with Maintenance electrode C before cleaning the
sample path. Reinstall them within 2 hours.
Conditioning is effective to Na+ and pH electrodes. Perform it only when Na+ or pH has
problem.
1. Select Condition under Maintenance.
2. Take out one piece of conditioner and transfer condtioner to a syringe. Then insert it into
sample port. Press OK to start.
3. The condition procedure lasts 5 minutes. Press NO to stop if an early exit is desired. 2 PT
calibration is automatically performed after exiting Condition.

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11.2 Sterilization
The purpose of sterilization is to minimize the danger of infection when contacting with
blood-contaminated parts.
The sterilization should be performed routinely.
The operator is recommended to comply with sterilization procedures and special
requirement of lab.

Only use liquid disinfector such as 2% hydrogen peroxide. Never use organic
solution or alcohol to clean or sterilize the surface.

Do not pour any liquid such as the disinfector directly on the surface, or it will
cause electrical short circuit.

The following parts need to be sterilized periodically.

1. Sample port and Sample port plastic box
2. Liquid flow path
3. LCD touch panel
4. Exterior surface

11.3 Daily maintenance

The maintenance operations described here are recommended to be performed everyday
just before or after routine measurements.
1 Clean sample port, sample door.
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 2 Clean the front cover of the analyzer.
3 Check print paper.
4 Perform wash cycle.
5 Near day off, do Deproteinize or cleaning to maintain electrodes if necessary.

11.4 Weekly maintenance

The maintenance operations described here are recommended to be performed every week
at the end of the routine measurements.
1 Sterilize exterior and interior surface, touch panel, probe, probe door, sample port
2 Take out reference electrode and shake it for several times to avoid crystal formation.
3 Clean the pathway to prevent blockage.
4 Perform Deproteinize and clean to maintain electrodes.

Careful cautions should be taken when sterilizing probe to avoid injury and
potential infections.

11.5 Monthly maintenance

1. Check the solution level of K+, Na+, Cl- , Ca2+ and pH electrodes. Replace the refill solution
of K+, Na+, Cl- , Ca2+ and pH electrodes if it is less than 2/3.

For K+, Na+, Cl-, Ca2+ and pH electrodes, empty the remaining refill solution
before filling new.

2. Take out reference electrode, remove crystal if there is too much. Refill if the solution is
not enough.
3. Clean all the pathway to avoid blockage.
4. Perform Hct calibration.
5. Perform pO2 calibration.

11.6 Every 3 months

1. Replace refill solution for K+, Na+, Cl- , Ca2+ and pH electrodes
2. Check pump tube.
3. Replace probe wiper.
i. Screw out two screws( as 1 shows in below).Take off the cover.
ii. Release probe by lifting up its black end (as 2 shows in below).
iii. Lift up the housing part as 3 shows in below.

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 iv. Remove sample port from housing part and replace with a new one.
v. Install housing part and resume probe and cover.
vi. Enter Other Utilities, select Self test to start self test.

Reinstall sample port and probe if there is problem with reagent test.

11.7 Every 6 months

1. Replace pump tube
2. Check O ring of electrode
3. Check connection of tube

11.8 As necessary
The performance of electrodes will decrease with the increasing tests of samples. It needs
routine maintenance to ensure its accuracy and prolong its life time.
1. Clean
Perform this cycle to remove fat colt inside sample path and electrodes. Every 10 samples
to clean once.
2. Deproteinize
Every 30 samples to deproteinize electrodes. Also perform it when K+, Cl-, Ca2+ has
problem.
3. Condition
Perform this cycle when Na or pH has problem.

12 Troubleshooting
This section covers the trouble shooting procedures of the analyzer.
The analyzer can perform self test when power up. It will detect most of the problem
except electrodes.

Wear disposable gloves to avoid contact with potentially infectious materials

while troubleshooting the analyzer.

12.1 Liquid pathway problem

There are potentially biohazards when leakage of blockage is present in sample
pathway. Careful cautions should be taken when applying a syringe to sort out
this kind of problem in case of any accidental spill or spray.

Problem Possible causes Measures

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 Problem Possible causes
Cal pack is run out
Cal pack is loose
Electrodes is not installed correctly
No Cal A Lever of measuring chamber is loose
No Cal E
O ring of electrodes is broken
No Cal B
No flush solution Blockage
Leakage
Blockage in the probe
Blockage in the waste tube
12.2 ISE Electrodes problem
ISE electrodes include K, Na, Ca, Cl, pH and reference electrode.
12.2.1 Only one electrode
Problem Possible causes
Refill solution is less than 3/4
Coat of internal core is broken
OR
Incomplete installation
Air bubble above membrane
Membrane is polluted
Electrode case is cracked
Abnormal
Internal core is broken
Lifetime is exhausted
Need activation (only for new)
Liquid on the surface
Drift Incomplete installation
Insufficient refill solution
Rusty electrode head
Air bubbles above membrane
12.2.2 More than two electrodes
All ISE electrodes share a common reference electrode. The problem of reference electrode
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Measures
Replace new one
Re insert.
Level the electrode
Push tight.
Replace O ring
Check by injecting water
Check by injecting water
Clean
Clean by injecting water
Measures
Empty and replace new
Replace new electrode
Press and level with thumb
Fillip and exclude
Deproteinize or cleaning
Replace new electrode
Replace new electrode
Replace new electrode
Activate with fresh serum for 30
mins
Take out and clean
Press and level with thumb
Replace new refill solution
Replace new electrode
Fillip and exclude
 and regent system can affect all the electrodes. When more than two electrodes have
problem, reference electrode and reagent system should be checked first.

Problem Possible causes Measures

Poor grounded power supply Connect earth
Air bubble in REF electrode Exclude air bubble
Crystal formation in REF Clean
REF is unstable Replace
Drift or Take out electrodes and clean all
Liquid in the measuring chamber
Abnormal or surfaces
OR O ring is missing or broken Replace new
Membrane is polluted Deproteinize or cleaning
Blockage in the liquid flowpath Check with syringe
Leakage in the liquid flowpath Check with syringe
Air bubble in the liquid pathway Check leakage or blockage

12.3 Blood gas electrodes problem

Both pO2 and pCO2 electrode are an independent electrode. The following describes the
problem with electrode only without consideration of reagent system. Blockage and
leakage should be sorted out first when there is air bubble observed.

Problem Possible causes Measures

Air bubble above membrane
Lifetime is exhausted
OR
Incomplete installation
Air bubble above membrane
Air bubbles above membrane
Membrane is polluted
Abnormal
Deteriorate Cal pack
Lifetime is exhausted
Air bubbles above membrane
Membrane is polluted
Drift Liquid on the surface
Incomplete installation
Broken O ring
Rusty electrode head
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Fillip and exclude
Replace new electrode
Press and level with thumb
Fillip and exclude
Fillip and exclude
Deproteinize or clean
Replace new cal pack
Replace new electrode
Fillip and exclude
Deproteinize or clean
Take out and clean
Press and level with thumb
Replace O ring
Replace new electrode
12.4 Correlation coefficients
When high or low test result is present compared with a standard or reference system. The
electrode requires correction to match standard value through correlation coefficient factor.
The performance of electrode is also affected by the protein or fat clot of samples. It is
recommended to do routine QC test to monitor this affection. Once the result is higher or
lower than normal level, it is required to correct the electrode by adjusting coefficient
factor.

INTERCEPT=YH-SLOPE*XH Or INTERCEPT=YL-SLOPE*XL
Where: YH, YL is the target value of the High level, Low level QC
XH, XL is the average test value excluding the highest and lowest test value.

The program in the System Setup>>Correlation is used to change slope and intercept
values.
The following procedure is performed on the basis of Quality control materials.
Prepare the Quality Control Materials of 3 levels from same manufacturer.
1. Enter System Setup>>Correlation. Reset slope and intercept as 1.00 and 0.00. Press OK
to save.
2. Open a vial of QC level 1, transfer it to a syringe. Cap the syringe after excluding air
bubble.
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 3. Insert syringe into sample port.
4. Enter QC test and select level 1 to start test.
5. Open another vial and repeat QC level 1 test for at least 4 times.
6. Repeat step 2-5 for level 2/3.
7. New an excel sheet, input test results and target values for each parameters.
8. Use linearity regression functions provided by excel to calculate slope and intercept.
K_Test K_Target y=ax+b
5.72 5.7 SLOPE INTERCEPT CORRELATION FACTORS
5.71 5.7 1.096444 -0.57389 0.999978
5.72 5.7
5.73 5.7
Note:
3.90 3.7
Function available in EXCEL
3.89 3.7
SLOPE(array y,array x) INTERCEPT(array y,array x)
3.90 3.7
3.90 3.7
3.90 3.7

9. Enter System Setup>>Correlation. Enter respective slope and intercept, press OK to save.
10. Enter QC test and select level 2, test QC level 2 and compare with target value.
11. If the result is still a little low or high, just fine adjust intercept accordingly. After
adjustment, recheck with QC level 2.

Input results from reference system instead of target vaue when comparing
with a reference system.

A Appendix
A.1 Potential range for electrodes
Range limit (mV) mV(CAL B) – mV(CAL A) difference limit
K 45 ~ 140 12~ 21.0
Na 45 ~ 120 -4.2 ~ -7.3
Cl 50 ~ 120 5.4 ~ 10.8
Ca 35 ~ 100 6.6 ~ 10.5
pH 70 ~ 170 16 ~ 28
Li 50 ~ 150 5.0 ~ 9.0
pCO2 500 ~ 2500 -30 ~ 75 mV/Dec
pO2 0 ~ 500 +1.5 ~ 10 pA/mmHg
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 When response potential of the electrode is outside the normal range, the system prompts
OR error.
When potential difference of Cal B-Cal A falls beyond above limit, the system prompts
abnormal error.

A.2 Interference substances

Analyte Interferent Effect On Analyte Result
A hemolysis occurred in the
Increase (↑)
sample
Heparin potassium anticoagulant Increase (↑)
Contamination in container Increase (↑)
Procaine Decrease(↓)
Ammonium carbonate Increase (↑)
K+
Nystatin Increase (↑)
Amphotericin Increase (↑)
Lidocaine Decrease(↓)
Perchlorate Decrease(↓)
Benzalkonium chloride Increase (↑)
Thiopental sodium Decrease(↓)
Heparin sodium anticoagulant Increase (↑)
Contamination in container Increase (↑)
Bromide Increase (↑)
Na+
Ammonium carbonate Increase (↑)
Benzalkonium chloride Increase (↑)
Thiopental sodium Increase (↑)
Contamination in container Increase (↑)
Bromide Decrease(↓)
Nitrates Increase (↑)
Salicylate Increase (↑)
Ammonium carbonate Decrease(↓)
Cl-
Iodide Increase (↑)
Thiocyanate Increase (↑)
Perchlorate Increase (↑)
Citrate Decrease(↓)
Acetylcysteine Decrease(↓)

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 Contamination in container Increase (↑)
Procaine Decrease(↓)
Bromide Increase (↑)
Salicylate Decrease(↓)
Ammonium carbonate Decrease(↓)
Nystatin Decrease(↓)
Amphotericin Decrease(↓)
Lidocaine Decrease(↓)
iCa2+
Thiocyanate Decrease(↓)
Perchlorate Decrease(↓)
Benzalkonium chloride Increase (↑)
Thiopental sodium Decrease(↓)
Acetylcysteine Decrease(↓)
Acetaminophen Decrease(↓)
Magnesium Increase (↑)
Lactate Decrease(↓)
Heparin lithiumanticoagulant Increase (↑)
Li+
Contamination in container Increase (↑)
Thiopental sodium Decrease(↓)
pH
Halothane Decrease(↓)
Thiopental sodium Increase (↑)
pCO2
Halothane Increase (↑)
pO2 Halothane Decrease(↓)
Crystal dilution Decrease(↓)
Hct
Colloid dilution Decrease(↓)
Acetaminophen Increase (↑)
Acetylcysteine Decrease(↓)
Sodium fluoride Decrease(↓)
Potassium oxalate Increase (↑)
Mannose Increase (↑)
Glu
Thiocyanate Increase (↑)
Galactose Increase (↑)
2-deoxy D-Glucose Increase (↑)
Ascorbic acid Increase (↑)
Uric acid Increase (↑)
Lac Glycolic acid Increase (↑)
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 Thiocyanate Increase (↑)
Acetoacetate Increase (↑)
D-Glucose Decrease(↓)
Sodium fluoride Decrease(↓)
Ascorbic acid Increase (↑)
Uric acid Increase (↑)

Other than above factors, electromagnetic interference, irradiation of strong light, degraded
calibrate, additives and preservatives in the QC materials, imperfection of the grounding,
unstable power supply, dry out of electrode refill solution, chloride layer falling off the
silver stick of the electrode or corrosion and moist of grounding points are all the
inducements to imperfection in calibration and testing.

A.3 Reference Range for adult

Parameters Samples Reference Range Unit
pH(37℃) Whole blood, arterial 7.35 ~ 7.45
35 ~ 45 mmHg
M
Carbon dioxide 4.66 ~ 6.38 kPa
Whole blood, arterial
Partial Pressure (pCO2) 32 ~ 45 mmHg
F
4.26 ~ 5.99 kPa

Oxygen Partial Pressure 83 ~ 108 mmHg

Whole blood, arterial
(pO2) 11.04 ~ 14.36 kPa
Sodium(Na+) Serum, Plasma 136 ~ 146 mmol/L
Potassium(K+) Serum, Plasma 3.5 ~ 5.1 mmol/L
Chloride(Cl-) Serum, Plasma 98 ~ 106 mmol/L
Calcium Ionized(Ca2+) Serum, Plasma 1.12 ~ 1.23 mmol/L
TCO2 Serum, Plasma 23 ~ 29 mmol/L
HCO3− Serum, Plasma 22–26 mmol/L
BE Serum, Plasma −2 to +2 mmol/L
SBC Serum, Plasma 21 ~ 27 mmol/L
sO2% 95 ~100 %

A.4 Table of Critical values

A critical value is a value at such variance with normal as to represent a path physiological
state which is life threatening unless some action is taken immediately and for which an

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 appropriate action is possible. It is the laboratory’s responsibility to communicate these
values immediately and flawlessly to the responsible clinicians. Each laboratory should
determine its own critical values. The above values are stated for reference purposes only.

Parameters Value Possible Effect

<7.2 Complex interwoven patterns of acidosis, alkalosis
and anoxemia
pH
>7.6 Complex interwoven patterns of acidosis, alkalosis
and anoxemia
<20 mmHg Complex interwoven patterns of acidosis, alkalosis
and anoxemia
pCO2
>70 mmHg Complex interwoven patterns of acidosis, alkalosis
and anoxemia
<40 mmHg Complex interwoven patterns of acidosis, alkalosis
pO2
and anoxemia
<10 mmol/L Complex interwoven patterns of acidosis, alkalosis
TCO2 and anoxemia
Complex interwoven patterns of acidosis, alkalosis
>40mmol/L and anoxemia
Extremes of dehydration, vascular collapse, or
<120 mmol/L
edema, hypervolemia, heart failure
Sodium(Na+)
Extremes of dehydration, vascular collapse, or
>160 mmol/L
edema, hypervolemia, heart failure
Potassium(K+) <2.5 mmol/L Muscle weakness, paralysis, cardiac arrhythmias
Over hydration, congestive failure, chronic
<80 mmol/L
Chloride(Cl-) respiratory acidosis, metabolic alkalosis
>115mmol/L
Dehydration, excessive infusion of normal saline
Calcium(Ca2+) None established

A.5 Calculations
A.5.1 Temperature corrections
In order to obtain a more accurate reflection of in vivo conditions, pH, pCO2 and pO2
values are often corrected according to the patient body temperature. The system
automatically performs these calculations according to the experimental relationship
proposed by NCCLS:

pH
 -0.0147  0.0065  (7.4  pH)
T
Where pH is that measured at 37℃

Page 88 of 106
  log10 pCO 2
=0.019
T
 log10 pO2 5.49  10 -11  pO 23.88 +0.071
=
T 9.72  10 -9  pO 23.88 +2.30

A.5.2 Calculate parameters

The following parameters are calculated by the system utilizing measured parameters and
operator’s entries:
1. Bicarbonate concentration is calculated by the Henderson-Hasselbalch equation:
HCO3 
pH  pK  log
 pCO2
2. Where pK=6.095
α=0.0307=solubility coefficient of CO2 in plasma at 37℃
The equation can be rearranged as:
log HCO3 - =pH +log( pCO2  0.0307)  6.095

3. Total dissolved carbon dioxide is calculated from the measured pCO2 value according to
the equation proposed by NCCLS:
TCO 2  HCO3   0.0307  pCO 2

4. Blood base excess or “in vitro” base excess is defined as the titratable base of blood and
may be experimentally determined by titration with strong acid or base to a plasma pH of
7.400 with pCO2=40 mmHg and at 37.0℃. The analyzer derives this parameter from the
measured pH and pCO2 according to the following equation:
BE b  (1  0.014Hb )  (HCO 3   24.8  (1.43Hb  7.7)  ( pH  7.4))

The hemoglobin value employed in this calculation is the Hemoglobin value of blood
under examination which is known and entered by the operator via keyboard as the input
parameters of the patient prior to measuring.
5. Base excess of extracellular fluid (or in vivo base excess or standard base excess) is a
measure of the metabolic component of the acid-base balance in a patient.
This parameter may be determined experimentally titrating a model of extracellular fluid to
a pH of 7.400 with pCO2=40 mmHg and at 37.0℃. It is calculated according to the
equation proposed by NCCLS:
BEecf  HCO3   24.8  16.2  (pH  7.4)

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6. Standard bicarbonate of blood is defined as the bicarbonate concentration in plasma
obtained from blood which has been equilibrated at 37.0℃ with a gas of pCO2 =40 mmHg
and pO2 higher than 100 mmHg. It is calculated according to the following equation:
SBC  25  0.78BE b  0.002Hb  (sO 2%  100)

7. The Anion Gap is the difference in the measured cation and the measured anion in serum,
plasma, or urine. It is calculated according to the following equation :
AG  Na   K   (Cl   HCO 3 - )

The anion gap is normally 8-16 mmol/L . It provides information about the level of anions
(including sulfate, phosphate, organic acids such as ketone bodies and lactic acid, and
proteins) that are not routinely measured in laboratory tests.
8 Oxygen saturation measures the percent of hemoglobin which is fully combined with
oxygen. It is calculated from the measured value of pO2, pH and pCO2 according to the
equation proposed by. NCCLS :
( pO2 )3  150 pO2 
sO2 %= 100
( pO2 )3  150 pO2   23400
Where:

pO2   pO2  e 2.3026(0.48( pH 7.4)0.0013(HCO 3 25))

Normally, oxygen saturation on room air is in excess of 95%. With deep or rapid breathing,
this can be increased to 98-99%. While breathing oxygen-enriched air (40% - 100%), the
oxygen saturation can be pushed to 100%.
8. The Alveolar-arterial oxygen gradient (A-a gradient) is a measure of the difference
between the alveolar concentration of oxygen and the arterial concentration of oxygen. It is
used in diagnosing the source of hypoxia.
AaDO2 (mmHg )  A  pO2 (T )

Where A is Alveolar oxygen expressed as:

1  FiO2
A=FiO2  (BP  pH 2O )  pCO2 (T )(FiO2  )
0.8
Where BP= barometric pressure=760 mmHg at sea level.
pH 2O  100.0244T 0.7655  0.4

A normal A-a gradient for a young adult non-smoker breathing air, is between 5-10 mmHg.
Normally, the A-a gradient increases with age. For every decade a person has lived, their
A-a gradient is expected to increase by 1 mmHg.

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 9. Respiratory index (RI) is a measure of the oxygenation function of lung, and an increase in
RI reflects the presence of pulmonary shunting in a variety of conditions including
atelectasis, pulmonary contusion, and pulmonary thromboembolism. The RI was calculated
from arterial blood gas assay as follows:
AaDO2
RI 
pO2
where AaDO2 is the alveolar-arterial oxygen gradient.
10. P50 is defined as the partial pressure of oxygen in a hemoglobin solution having an oxygen
saturation of 50%. For oxygen saturation between 40% to 90%, the relation between PO2
and sO2 is approximately quite well by the Hill equation.
1 sO2
log P50  log pO2   log
2.7 sO2
11. Calcium correction
Ionized calcium values are dependent on sample pH. The calcium value adjusted to pH of
7.40 reflects the true ionized calcium concentration of blood normalized to pH 7.40.
Calcium is corrected according to the following equation.
Ca ++ (7.4)  Ca ++ measured  10 0.19(7.4 pHmeasured )

The adjusted calcium value is valid only when pH is between 7.2 and 7.6.

A.6 Working principle

The measurement on this system involves 4 types of electrode systems to determine pO2,
pCO2, K+, Na+, Cl-, Ca2+, pH and tHb. The electrodes are based on electrochemical
technology which can convert ion concentration or partial pressure into electrical current or
voltage. Typically, each electrode has a membrane designed to be highly selective for one
specific ion or gas over others. When the blood sample contacts the electrode inside
measuring chamber, it produces an electrical output that corresponds to either an ion
concentration or a partial pressure.
The measurement of electrical output from an electrode is accomplished through
potentiometry or amperometry. Potentiometric measures the voltage across the membrane
when ion is diffused. A reference electrode is introduced in this method to determine the
potential of electrode. Amperometry determines the current generated in the circuit by the
chemical reaction due to gas diffusion.

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A.6.1 ISE electrodes
Ion measurement is performed using two separated electrodes: ISE electrode and a
reference electrode. Each electrode represents a half-cell in which an electrical potential is
developed. ISE electrode is a silver-silver chloride electrode surrounded by a solution of
constant ion concentration and enclosed by a membrane sensitive to specific ion. Reference
electrode provides a stable potential regardless of sample ion. It is a silver-silver chloride
electrode filled with saturated solution potassium chloride. A leaky membrane permits
current flow from reference electrode through sample. Both electrodes are connected to the
measuring chamber and bridged by sample to form a close circuit when a voltmeter is
connected
Potential response of electrode is corresponding to ion concentration in the sample. It can
be expressed by the following equations:
Ecell = Em - Eref -Ej
Where
Ecell is electrode potential response
Em is measured electrode potential
Eref is measured electrode potential
Ej is liquid junction potential

pH electrode
The relationship between ion activity and potential is expressed by Nernst equation

2.303RT
E  E0  logC xf x
nF
Where:
E= electric potential of ion-selective electrode in the solution being measured
E0= standard electrode potential of ion-selective electrode
n =electrovalence of the ion being measured
R=gas constant (8.314 J/K.mol)
Page 92 of 106
 T=absolute temperature (273+t℃)
F=Faraday constant (96487 c/mol)
Cx=concentration of the ion being measured
fx=activity coefficient of the ion being measured
In given conditions such as room temperature, Nernst equation shows that electrode
potential of ion-selective electrode is linear to the logarithm of the activity (or
concentration) of the ion being measured.

A.6.2 pCO2 electrode

The pCO2 electrode system uses principles similar to those for pH measurement. It
employs a Severinghaus pCO2 electrode, which combines a glass pH-measuring electrode
and a silver-silver chloride reference electrode. A membrane permeable to CO2 but not to
H+ separates the sample from the measuring system. The pCO2 electrode also contains a
spacer( usually a porous membrane of Dacron or nylon) that acts as a support from an
aqueous HCO3- layer. As CO2 diffuses through the membrane and into the support, the pH
of the electrolyte changes because of the change in carbonic acid concentration as follows:

The output of this modified pH electrode is proportional to the pCO2 present in the sample.

pCO2 electrode

A.6.3 pO2 electrode

pO2 is measured by using a polarographic electrode system consisting of a platinum
cathode ( in the center of a glass rode) and a silver-silver chloride anode. An O2-permeable
membrane separates the blood sample from the measuring system. O2 that diffuses through
the membrane is reduced at the cathode when a 0.7V potential is applied between the
anode and cathode (polarizing voltage). The following reaction represents the reduction
occurring at the cathode.

Page 93 of 106
 The circuit is completed when silver is oxidized at the anode:

The current developed by these reactions is directly proportional to the pO2 in the sample.

pO2 eletrode

A.6.4 Hct electrode

Hematocrit is defined as the percentage of red blood cells versus the total blood volume.
The principle of Hct is carried out by measuring the relative electrical conductivity of cells
and their supporting medium.
A Hct electrode is inserted into sample pathway. The electrode is calibrated with one
solution of known conductivity. When sample is inside the electrode, its conductivity can
be measured through two electrode heads.

A.6.5 Glu/Lac electrode

The glucose and lactate biosensors are based on the glucose oxidase or lactate
oxidase, which converts glucose/lactate according to the following reactions:
Glucose: Glucose + H2O + O2 → Gluconic Acid + H2O2
Lactate: Lactate + H2O + O2 → pyruvate + H2O2
The quantification of glucose/lactate can be achieved via electrochemical detection of the
enzymatic release of H2O2:
H2O2 → O2 + 2H+ + 2e−

A.7 References
The section lists the references for this manual.

Page 94 of 106
 1. Clinical and Laboratory Standard Institution. Blood Gas and pH Analysis and Related
Measurements; Approved Guideline-Second Edition. CLSI document. C46-A2 (Vol 29, No
9); 2009
2. Clinical and Laboratory Standard Institution. Definitions of Quantities and Conventions
Related to Blood pH and Gas Analysis; Approved Standard;. CLSI document. C12-A (Vol
14, No 11); 1994
3. Clinical and Laboratory Standard Institution. Standardization of Sodium and Potassium
Ion-Selective Electrode Systems to the Flame Photometric Reference Method; Approved
Standard-Second Edition. CLSI document. C29-A2 (Vol 20, No 17); 2000
4. Clinical and Laboratory Standard Institution. Ionized Calcium Determinations:
Precollection Variables, Specimen Choice, Collection,and Handling; Approved Guideline-
Second Edition. CLSI document. C31-A2 (Vol 21, No 10); 2001
5. Clinical and Laboratory Standard Institution. Protection of laboratory Workers from
analyzer Biohazards and Infectious Disease Transmitted by Blood, Body Fluids and Tissue;
Approved Guideline-Third Edition. CLSI document. M29-A3 (Vol 25, No 10); 2005
6. Clinical and Laboratory Standard Institution. Clinical laboratory Waste Management;
Approved Guideline-Second Edition. CLSI document. GP05-A2 (Vol 22, No 3); 2002
7. Carl A. Burtis PhD, David E. Bruns MD. In:Tietz NW, editor, Fundamentals of clinical
chemistry, 6th Edition. Philadelphia: WB Saunders,2007
8. Severinghaus JW, Bradley AF. Electrodes for Blood pO2 and pCO2 determination. J Appl
Physiol 1968;13:515-520

A.8 Warranty
A.8.1 Warranty guidelines
Warranty period for analyzer is 1 year from the shipping date.
Warranty period for K+/Na+/Cl-/Ca2+/pH/Hct /TH electrodes are 1 year from the shipping
date,
Warranty period for pO2/ pCO2 are 6 months from the shipping date.
BioBase undertakes to provide free repair, and parts replacement for products within the
warranty period.
BioBase undertakes to provide the supply of spare parts (including Standard solution,
electrode) and provide life-long maintenance services.
BioBase is responsible for safety, reliability and performance of this product only on the
conditions that:

Page 95 of 106
 1. The electrical installation of the relevant room complies with the applicable national and
local requirements; the product is used in accordance with the operation instructions.
2. Any problems arising from the product defects or improperly packing or other
consequences in connection with the product quality.

A.8.2 Warranty limitation

This warranty covers only those defects that arise as a result of normal use of the product
and does not cover any other problems, including those that arise as a result of:
1. Improper maintenance or modification that has been made to the system by unauthorized
personnel.
2. The system has been operated using other than BioBase brand accessories, or consumables
supplies and /or reagents not having the same grade, quality and composition as defined by
BioBase.
3. The system has not been installed within 90 days of shipment to the customer's facility
unless otherwise specified.
4. The customer has not performed appropriate customer maintenance procedures, as outlined
in the system user manual.
5. This system has been misused or used for a purpose for which it was not intended.
6. The system has been damage in transit to the customer or damaged to the customer while
moving or relocating it without supervision by a BioBase representative.
7. Damage was caused by floods, earthquakes, tornado, hurricanes or other natural or man-
made disasters.
8. Damage was caused by Acts of war, vandalism, sabotage, arson, or civil commotion.
9. Damage was caused by electrical surges or voltages exceeding the tolerance outlined in the
system user manual.
10. Damage was caused by water from any source external to the system.
11. The customer has purchased an alternative agreement whose terms of warranty supersede
this agreement.
BioBase or its authorized distributors will invoice customers, at current standard labor and
parts rates, for systems repaired to correct damage or malfunctions due to any of reasons
listed above.

B Appendix Barcode scanner initialization

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 Please pay attention to the type of Barcode scanner, there are three types: LV880,
LV880(32B) and NLS-HR100.

B.1 Apply for LV880(32B)

If “Barcode error!” appears when scanning the barcode of consumable, please initialize the
scanner according to the following steps:
1.Make sure the scanner is well connected to analyser;
2.Please scanner the barcode as below one by one:
Steps Barcodes
1.Scan function: initialization Settings

0B

2.Output mode: Serial mode

000602

3.Buzzer: Sound enabled

0B142
4.Scan interface - Serial port: 19200 baud
rate

Page 97 of 106
 000706

5.Handshake protocol: None

001200

6.Data Bits: 8
00081
7.Stop Bits: 1
00090

8.Parity: None

00100

3. After initialization, scan the barcode of consumable again. If it does not works，please
connect representative.

B.2 Apply for LV880

If “Barcode error!” appears when scanning the barcode of consumable, please initialize the
scanner according to the following steps:
1.Make sure the scanner is well connected to analyser;
2.Please scanner the barcode as below one by one:

Page 98 of 106
 Steps Barcode
1.Scan function: initialization Settings

0B

2.Output mode: Serial mode

000601

3.Buzzer: Sound enabled

0B142
4.Scan interface - Serial port: 19200
baud rate
000706
5.Handshake protocol: None
001200

6.Data Bits: 8
00081
7.Stop Bits: 1
00090
8.Parity: None
001000
3. After initialization, scan the barcode of consumable again. If it does not works，please
connect representative.

B.3 Apply for NLS-HR100

Page 99 of 106
 If “Barcode error!” appears when scanning the barcode of consumable, please initialize the
scanner according to the following steps:
1. Make sure the scanner is well connected to analyzer;
2. Please scanner the barcode as below one by one:
Steps Barcodes

1.Code Programming ON

2.Baud Rate:19200

3.Data Bit,No Check,1 Stop Bit

4. Code Programming OFF

3. After initialization, scan the barcode of consumable again. If it does not works，please
connect representative.

Index
Page 100 of 106
 １ Ｍ
1 Point Calibration.......................................
Calibration 50 Maintenance
２ Every 6 months........................................82
Monthly maintenance.............................. 81
2 Point Calibration.......................................
Calibration 51
probe wiper..............................................81
Ａ Sterilization............................................. 80
Abnormal............................................... 53, 55 Maintenance functions
Ambient temperature....................................20 Condition................................................. 79
Arterial blood............................................... 11 Mixed venous blood..................................... 11
Atmosphere pressure....................................21 Model family..................................................1
family
Ｂ Ｏ
Battery..........................................................20 Operating and safety information..................
information 7
Ｃ Operating information
Maintenance......................................
Maintenance 10, 13
Cal A............................................................ 50
Operating environment..............................7
environment
Cal B............................................................ 51
Prevention of EMI.....................................
EMI 7
Calculate parameters.................................... 91
Operation environment................................ 20
Calibration data............................................
data 54
Over Range................................ 50, 51, 52, 55
Calibration intervals.....................................53
intervals
Capillary blood.............................................11 Ｐ
Capillary tube...............................................13 Pass...............................................................50
Concentration............................................... 51 Patient sample analysis................................
analysis 62
Correlation coefficients.............................85 pO2 zero calibration.....................................54
calibration
Ｄ Power supply................................................20
Principle
Deproteinize................................................. 14
Hct electrode......................................96, 97
Dimension.................................................... 20
pO2 electrode.......................................... 96
Drift............................................50, 51, 52, 55
Printer...........................................................21
Ｆ Full graphics............................................ 21
Fuse.............................................................. 20 Paper........................................................21
Ｇ Printing speed.......................................... 21
Printer...........................................................74
Printer
Green............................................................61
Pump
Ｉ Aspiration pump...................................... 31
Installation Flush pump.............................................. 31
Auto QC installation................................33
installation Waste pump............................................. 31
Cal pack installation................................
installation 31 Ｒ
Check.......................................................36
Check
Reagent
Electrode preparation
Auto QC cartridge................................... 14
ISE electrodes..................................... 25
Cal pack...................................................13
Reference electrode............................ 26
Conditioner..............................................14
Printer paper installation.........................
installation 34
Deproteinizer........................................... 14
Intended use...................................................
use 1
Quality controls....................................... 14
Intercept....................................................... 67
Refill solution For ISE............................ 14
Interface....................................................... 21
Refill solution for REF............................ 14
Barcode....................................................21
Red............................................................... 61
RS 232..................................................... 21
Reference electrode......................................26
TCP/IP..................................................... 21
Reference Range..........................................
Range 68
USB......................................................... 21
References.................................................... 97
Interference substances................................ 87
Relative humidity
Page 101 of 106
 Operation................................................. 20 Drift.................................................... 84
Storage.....................................................21 OR.......................................................84
Ｓ Single ISE
Abnormal............................................ 83
Sample sources.............................................11
Drift.................................................... 83
Sample volume.............................................21
OR.......................................................83
Screen.......................................................... 21
Self test.........................................................37
test Ｕ
Shut down....................................................
down 38 Unit...............................................................69
Unit
single use................................................33, 34 Unstable........................................... 50, 51, 52
Slope.............................................................67 Ｖ
Specifications
Venous blood................................................ 11
Calculated parameters............................. 19
virtual keypad...............................................40
Electrode Parameters...............................20
Voltage..........................................................51
Input parameters...................................... 20
Specifications..........................................
Specifications 20 Ｗ
Status............................................................51 Warnings and precautions
Ｔ Biological hazards.....................................
hazards 8
Chemical hazards......................................
hazards 9
Temperature
Cleaning and sterilization..........................9
sterilization
Operating environment............................20
Electric shock............................................
shock 8
Storage.....................................................21
Personnel injuries......................................
injuries 8
Troubleshooting
Waste hazards............................................9
hazards
Blood gas
Warranty.......................................................98
Abnormal............................................ 84
Weight.......................................................... 20
Drift.................................................... 84
Within 24 hour............................................. 38
OR.......................................................84
Working principle.........................................93
Liquid pathway problem
No Cal A............................................. 83 Ｙ
No Cal B............................................. 83 Yellow.......................................................... 61
No flush.............................................. 83
More than one ISE
Abnormal............................................ 84

Page 102 of 106

Page 103 of 106
BIOBASE GROUP
6th floor, no. 2 building, 9 gangxing road, High-tech Zone, Jinan,shandong, China
Tel: +86-531-81219803/01
Fax: +86-531-81219804
Inquiry: export@biobase.com
Complaints: customer_support@biobase.cc
After-sales service: service_sd@biobase.cc; service_ivd@biobase.cc
Web: www.biobase.cc/www.meihuatrade.com / www.biobase.com

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