Blood Gas System

GASTAT 600 series

Model 601,602i

OPERATION MANUAL
Pilot Edition

5-5-1 NAKAMACHIDAI TSUZUKI-KU YOKOHAMA 224-0041 JAPAN TEL: +81-45-948-1961 FAX: +81-45-948-1962 email:oversea@technomedica.co.jp

Disclaimer
No part of this document may be reproduced or issued to third parties in any form whatsoever without the express permission of Techno Medica. The materials in this document is provided for general information and is subject to change without notice. Techno Medica assumes no liability for damages incurred directly or indirectly from errors, omissions or discrepancies between the instrument and the manual.

Copyright 2003 Techno Medica Co., Ltd. All rights reserved.

Preface
Thank you very much for purchasing our GASTAT. Techno Medica shall not be responsible for any accident or malfunction that occurs as a result of negligence to the directions or cautions in this manual. Please read this manual carefully beforehand to prevent the occurrence of such an accident or malfunction and to take full advantage of all GASTAT functions. Please keep this manual importantly after you finish reading it.

GENERAL INFORMATION
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INSTRUMENT OVERVIEW Front view

Display

Printer

Measurement unit Sample port

CAL cassette Flush solution

Human detect sensor

Waste

Display Measurement unit Flush solution Printer Sample port CAL cassette Human detect sensor Waste

Touch panel displays message and test results. Sample chamber including electrodes. Cleaning solution is inside the bottle. Prints out test results and messages. Place syringe or capillary to measure sample. Calibration solution is inside the bottle. It also contains the cleaning solution. In the night time it detects human and turn of the power of the display automatically. Waste goes inside this bottle.

Rear view

FAN

Battery switch

Communication port

AC inlet

Barcode reader inlet

Battery switch AC inlet FAN Communication port Barcode reader inlet

Switch it ON to start power failure protection. Connect AC power Cools down inside the instrument. Do not close. Connection for TCP/IP and RS232C Connect barcode reader

DISPLAY OVERVIEW
Status field 5

Home screen

START key

Function key Message field

Message field START key Status field Function key

Instruction, error message and animated guidance appears on this field. Press this key whenever you start measurement. Instrument status appears on this field. Press this key to access to use multiple function.

Function Screen

Help key

Return key

Help key Return key

Press this key in case you want to know the meaning of each function. Press this key to return to previous screen.

STANDARD ACCESSORIES
The following are the accessories which come along with the instrument when you purchase the instrument. Contact to your local Techno Medica representatives when you find any discrepancy. Thermal paper AC power cord Barcode reader Maintenance kit Spare pump tube 1roll 1pc 1pc 1set 1bag Electrode CAL cassette Flush solution Waste bottle 1 for each parameter 1 cassette 1 bottle 1 bottle

SET UP PROCEDURE
Conduct the following procedure when you first install the instrument into your facility.

1. Load reagents. Load Flush bottle (See page 9) Load Waste bottle(See page 9) Load CAL Cassette(See page 17) 2. Connect AC power cord to AC inlet. 3. Set to Battery switch to ON in order to enable the power failure protection. 4. Instrument starts to warm up himself to 37.While it gets room temp, load electrodes and thermal paper. Load electrode. (See page 10) Load thermal paper.(See page 18) 5. When instrument gets 37, it starts Calibration and Home screen appears as left. 6. Put Front cover housing to the instrument.

Note : Blood gas must be measured at 37. Due to this reason, instrument warm up the measurement unit. It takes bout 2 hours to stabilize when room temperature is at 35.

LOAD FLUSH SOLUTION

Conduct the following procedure to load the Flush solution when installation. See page 41 if you want to learn about replacement procedure.

1. Remove cap of Flush solution. 2. Read the barcode attached at the bottom of the Flush solution with barcode reader. And then insert into the instrument body. BIOHAZARD Handle with great care so that the reagent does not get into your eyes or mouth, or contacts your skin. If unavoidable, wash with water immediately and consult with medical doctor.

LOAD WASTE BOTTLE

Conduct the following procedure when you load the waste bottle. See page 42 if you want to learn about replacement procedure. 1. Remove cap of Waste bottle. 2. Insert into the instrument body. Note : Do not mix up the position of Flush solution and Waste bottle.

PREPARE ELECTRODE
Ref/pH/Na/K/Cl/Na electrodes are shipped separately with electrode body and internal solution. Conduct the following procedure to feed internal solution. PCO2/PO2/Hct/TH electrodes are shipped in a complete style so that you do not need to feed internal solution.

Light blue : Na electrode internal solution Light green : K/Cl/Ca electrode internal solution Pink : pH electrode internal solution No color : Ref electrode internal solution.

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pH, Ref electrode front view

KCL tank

pH electrode side view

Electrode terminal

KCL tablet Sample flow

Electrode core pH electrode Ref electrode

pH electrode

PO2, PCO2 electrode front view

PO2, PCO2 electrode side view

Ref terminal

Electrode terminal

Electrode core Sample flow PO2 electrode PCO2 electrode PO2,PCO2 electrode

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TH electrode front view

TH electrode side view

Electrode terminal

Sample flow

TH electrode

TH electrode

Hct electrode front view

Hct electrode side view

Electrode terminal

Sample flow

12

Prepare Ref electrode

1. Remove Electrode core with Spanner. Spanner is included in the maintenance kit.

2. Connect Electrode core to the electrode body.

3. Tighten the Electrode core firmly with Spanner.

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4. Open the tip of internal solution package.

5. Aspirate Ref internal solution with syringe. Syringe is included in the maintenance kit.

KCL tank

6. Inject solution to the KCL tank till solution reaches to the KCL tank hole. 7. Shake electrode till solution reaches to the Sample flow of the electrode.

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Prepare pH/Na/K/Cl/Ca electrode

1. Remove Electrode core with Spanner. Spanner is included in the maintenance kit.

2. Open the tip of internal solution package.

3. Feed solution to the electrode body. 4. Tighten the Electrode core firmly with Spanner. 5. Shake electrode till solution reaches to the Sample flow of the electrode.

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LOAD ELECTRODE
Conduct the following procedure when you load electrodes. See page 43 if you want to learn about replacement procedure. 1. Remove Front cover housing.

2. Open Measurement unit door.

3. Read barcode of the electrode with barcode reader. 4. Load electrode to the corresponding position. Position of the electrodes are written on the Measurement unit. 5. Confirm electrode is loaded properly. And then put the Front cover housing back. Important : Confirm that Flow line of the electrodes are straight from left to right.

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LOAD CAL CASSETTE

Conduct the following procedure when you load the CAL Cassette. See page 38 if you want to learn about replacement procedure. 1. Peel off seal of CAL Cassette.

2. Read the barcode attached at the bottom of the CAL Cassette with barcode reader.

3. Make sure that the label of the Cassette is heading up side and then insert Cassette into the instrument body. Make sure to insert it vertical straight. Do not forcibly insert it in case it shall not go smoothly.

BIOHAZARD Do not put your fingers inside the CAL Cassette inlet unless otherwise you may injure your finger with the needle inside.

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LOAD THERMAL PAPER

Conduct the following procedure when you load the Thermal paper. Replacement procedure is also the same. 1. Open Printer door. If there is Thermal paper core remain inside the printer, remove it.

2. Load the Thermal paper. Make sure that end of the paper should be come out from the printer a little.

3. Close printer door.

Caution : Printer may be still too hot for paper replacement. Conduct paper replacement after printer get cold.

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OPERATION PROCEDURE MEASURE BLOOD SAMPLE

1. Confirm if instrument is at Home Screen before measurement. Ready must be shown on the upper left corner of the screen.

2. Please Syringe or Capillary to the sample port. Type of the sample container shall be automatically detected.

3. Press START key.

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4. START key changes to dark blue color.

5. Instrument aspirates the sample.

6. Instrument starts measurement.

7. Remove Syringe of Capillary after left screen appears.

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Important : As shown on the right picture, Sample flap goes down when instrument is ready for the measurement, If not, sample flap goes up to cover sample port. In such case, you can not place Syringe of capillary.

Instrument moistens the flow line periodically to stabilize the instrument status. Instrument shall be ready for measurement after 10 seconds moistening.

Important : Sample handling and Syringe requirement. Make sure to use heparinlized sample unless otherwise blood clots inside the flow line. Remove air bubble in the sample when you find it inside the syringe. Roll syringe 20-30 times and dispose first 1-2 drop of sample before measurement. Make sure remove needle of the syringe before measurement. Instrument can not accept the syringe which the plunger moves naturally with gravity. Instrument can not accept the syringe which the distance between the syringe tip and the plunger is smaller than 18mm. Because aspiration nozzle of the instrument pushes the plunger when measurement ,and the syringe drops out form the sample port. Use Techno Medica recommended capillary syringe. Contact to local Techno Medica representative for requirement.

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MEASURE DIALYSATE SAMPLE

1. Dialysate sample can not measure when instrument shows left screen. Press Function key to change the instrument to Dialysate analysis mode.

2. Select Sample type.

3. Select from either Dialysate 1-3. Each Dialysate mode must have the corresponding correction factor in order to adopt to several type of Dialysate unless otherwise test results are less accurate. Correction factor must pre-entered before measurement. See page 34 to enter correction factor.

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4. START key at Home screen changes to orange color when you successfully changed the instrument to Dialysate analysis mode. 5. Measure Dialysate sample as same procedure as when you measure blood sample.

Note : After you finish measurement of Dialysate sample, change the instrument to Blood analysis mode (START key at Home screen is in light blue color) in order to prepare for blood measurement. Dialysate 1-3 has the same correction factor when instrument has shipped out from Techno Medica. Change the correction factor when it is necessary.

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QUALITY CONTROL PROCEDURE GASTROL CONTROL

GASTROL is Techno Medica Exclusive aqueous control for GASTAT-600 series. Contact to your local Techno Medica representatives for purchasing.

1. Press Function key.

2. Select QC.

3. Select GASTROL.

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4. Select corresponding Level which you want to measure. Instrument changes to GASTROL analysis mode. ie) If you want to use GASTROL Level 1, press Level 1.

5. START key at Home screen changes to pink color when you successfully changed the instrument to GASTROL analysis mode. 6. Shake GASTROL ample more than 15 seconds to uniform the density of the GASTROL. And then break the tip of the ample.

7. Insert GASTROL ample to the adaptor.

8. Place GASTROL to the sample port.

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9. Press START key.

Important : Before you conduct the GASTROL measurement, you must enter Typical value for the each Level. There are 2 alternatives to enter Typical value. 1. Read barcode of the data sheet of GASTROL to enter the value automatically. 2. Access to the right screen and enter the value manually with numerical keypad.

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 You can confirm the Quality control history in X-Y graph in right screen.

Techno Medica recommends daily Quality control with using GASTROL. Also Quality control is recommended whenever maintained the instrument or instrument gives erroneous test results. GASTROL is aqueous solution contains known concentration of gas. Use GASTROL immediately after opening the ample unless otherwise pH,PCO2 and PO2 values are altered by the room air, and quality control can not be performed properly. Due to this reason, GASTROL should be single use and can not perform more than 2 quality control with one ample. CAUTION : Brake the ample with great care unless otherwise you may injure your fingers with glass. Keep Adapter clean.

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ISE CRS CONTROL

ISE CRS is Techno Medica Exclusive ISE control serum which has absolute value and approved by Standard reference center, Japan. Contact to your local Techno Medica representatives for purchasing.

1. Press Function key.

2. Select QC.

3. Select CRS.

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4. Select corresponding Level which you want to measure. Instrument changes to CRS analysis mode. ie) If you want to use ISE CRS Low Level , press Low.

5. START key at Home screen changes to green color when you successfully changed the instrument to CRS analysis mode. 6. Aspirate ISE CRS with ordinary syringe and place it to sample port. Press START key to measure.

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Important : Before you conduct the CRS measurement, you must enter Typical value for the each Level. There are 2 alternatives to enter Typical value. Value entering procedure is as same as GASTROL.

ISE is a control serum with known concentration of electrolytes. After opening the ISE CRS ample, electrolyte starts concentration and quality control can not be performed immediately. Due to this reason, ISE CRS can be use 3 times with one ample but it should be used within 15 minutes.

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MULTIPLE FUNCTION ENTERNING PATIENT IFORMATION

1. Press Enter patient info after measurement.

2. Select corresponding item and use numerical key pad to enter information. P-ID(patient ID), P-Temp(Patient temperature), FiO2 and Hb can be entered.

If you do not enter typical value, test results are calculated based on the following initial value. Also the initial value can be changed. Patient temperature Hb FiO2 Barometric pressure 37 15g/dl 21% Actual measurement value or 760Torr.

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SEARCHING TEST RESULTS

1. Select data manager.

2. Search test results with either Date P-ID(Patient ID) Seq(Sequence test number)

3. Test results appears on screen on your demands. If you press Print, test results can be printed out. If you press Print again, asid base graph can be printed out.

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4. If you press Acid base graph, past 3 data can be shown on Masoro&Siegel Acid bas graph. If you press Transition graph, you can monitor the test results transition in the same patient in graph.

Masoro&Siegel Acid bas graph.

mmol/L 6 7.0 100 n mol /l -90 7.130 - 80 Acidosis 33 -70 -60 7.3Acidosis 48 7.457 -40 7.575 30 Metabolic Alkalosis -50 Respiratory Alkalosis Chronic Respiratory Acute Respiratory Metabolic Acidosis 9 12 15 18 21 24 27

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7.7- 20 8.0- 10 8.6 - 0 10 100 20 30

Acute

Respiratory

Alkalosis

40 [Torr]

50

60

70

80

90

ENTER MULTIPLE PARAMETERS

1. Press Other utilities.

2. Access to either Correction factor Normal value Calculated test Unit set Measured test that you want to enter/change the parameter.

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Correction Factor
You can enter Correction Factor for each measured test for both Blood analysis mode Dialysate analysis mode.

Normal value
You can enter normal value for each measured test.

Normal value
You can shut down the measured test when you do not want or in case electrode has problem. Remove check mark on your demands.

Calculated test
You can select calculated test you want to print. Remove check mark when you do not want to print out.

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Unit set
You can select units for each measured test on your demands.

Initial values set

You can enter initial values as a default. These values will be applied to all of the test results. Normally, 760is entered to BP as an initial value of barometric pressure. If you enter 0 to BP, actual barometric pressure shall be measured directly by the system.

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OTHER FUNCTIONS Cleaning

You can clean the instrument with in use of Flush solution Internal cleaner contained in CAL Cassette. Note: External cleaner is not in use currently. It is optional function if it is necessary in the future by manufacture. Important : In case you select Internal Cleaner, you can not stop the cleaning even you press STOP key. You need to wait till cleaning is over.

Calibration
You can calibrate the instrument whenever you want.

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Barcode
You can select the barcode type when you want to enter Patient Id into the instrument with barcode reader. If there is discrepancy between barcode type of the container and the configuration, instrument can not read the barcode.

Self Diagnosis
You can check instrument status if it is working without any problem.

Net work
Configure this net work settings when you want to connect the instrument with computer, or intercommunicate several analyzer without using computer.

MAINTENANCE
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Press Maintenance key whenever you want to maintain the instrument.

REPLACE CAL CASSETTE

1. Press CAL Cassette.

2. Pull CAL Cassette vertically straight and remove from the instrument body.

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3. Peel off seal of CAL Cassette.

4. Read the barcode attached at the bottom of the CAL Cassette with barcode reader.

5. Make sure that the label of the Cassette is heading up side and then insert Cassette into the instrument body. Make sure to insert it vertical straight. Do not forcibly insert it in case it shall not go smoothly.

6. Press END key to start calibration with the new CAL Cassette. Once you start calibration, you can not stop till it complete.

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BIOHAZARD Do not put your fingers inside the CAL Cassette inlet unless otherwise you may injure your finger with the needle inside. Important : Once you load the new CAL Cassette, you can use 1 month. Display shows replacement message when time has come. Monthly consumption does not affected by a number of sample. CAL Cassette is single use. Once you remove the CAL Cassette, you can not put it back to the instrument body since instrument does not accept the same Cassette.

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REPLACE FLUSH SLUTION

1. Press Flush sol. 2. Pull Flush solution vertically straight and remove from the instrument body.

3. Remove cap of Flush solution. 4. Read the barcode attached at the bottom of the Flush solution with barcode reader. And then insert into the instrument body. 5. Press END key on the display.

Important : Monthly consumption of the cassette depends on a number of sample. Display shows replacement message when time has come. Flush solution is single use. Once you remove the Flush solution, you can not put it back to the instrument body since instrument does not accept the same bottle. BIOHAZARD Handle with great care so that the reagent does not get into your eyes or mouth, or contacts your skin. If unavoidable, wash with water immediately and consult with medical doctor.

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REPLACE WASTE BOTTLE

1. Press Waste bottle. 2. Pull Waste bottle vertically straight and remove from the instrument body.

3. Remove cap of Waste bottle. In case you want to use empty Flush solution bottle as Waste bottle, peel off duplicated label of the Flush bottle so that the new Waste label turns out. 4. Insert into the instrument body. 5. Press END key.

Important :

Sensor detects the Waste level. However, check the waste level periodically (every
morning/afternoon) to avoid mis-ditection. BIOHAZARD Waste bottle is a medical waste and must be lawfully disposed of accordingly.

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REPLACE ELECTRODE
1. Press Electrode.

2. Remove Front cover housing.

3. Open Measurement unit door.

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4. Read barcode of the electrode with barcode reader. 5. Load electrode to the corresponding position. Position of the electrodes are written on the Measurement unit. 6. Confirm electrode is loaded properly. And then put the Front cover housing back. Important : Confirm that Flow line of the electrodes are straight from left to right.

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REPLACE SAMPLE PORT

Sample port should be replaced once per 3 month. 1. Press Port.

2. Remove Front cover housing.

3. Pull Sample port up-ward and remove it. CAUTION : Take great care when you remove the sample port unless otherwise it damages the mechanical movement of the sample port.

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4. Read barcode of new Sample port.

5. Place new Sample port. 6. Put the Front cover housing back. 7. Press END key.

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REPLACE PUMP TUBE

Pump tube should be replaced once by 6 months. 1. Press Tube.

2. Remove Front cover housing.

3. Read barcode of vinyl bag of Sample tube. 4. Peel the bag and take the tubes out from the bag.

BIOHAZARD Sample tubes are medical waste and must be lawfully disposed of accordingly.

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5. Load new Sample tube. 3pcs of tubes should be replaced at once. 6. Put the Front cover housing back. 7. Press END key.

Important : Confirm that tubes are loaded to the pump unit properly unless otherwise it cause problem for bringing in the solution into the flow.

WIPE DISPLAY
1. Press Display cleaning

2. Wipe display with dry cloth whil left screen appears.

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CHECK MEINTENANC HISTORY

1. Press Maintenance history.

2. You can check when is the time to change the electrode.

3. You can check when is the time to replace CAL Cassette Flush solution Pump tube Sample port.

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FREQUENTLY ASKED QUESTIONS

Questions Answer When do I need to replace the It should be replaced once per 3months.In case sample port? rubber of the sample port get old, it causes solution leakage or generates clot inside the flow line. When do I need to replace the pump It should be replaced once per 6months. In case tube? tube get old, it causes solution leakage. What happens when electric black Instrument has power failure protection which out? enables to run the instrument 30 minutes with battery. In case electric black out seems to last more than 30 minutes, turn on the power after 30 minutes and power up the instrument again when electric recovery. What I can do when sample port In case blood is remaining only at the aspirating become dirty with blood. nozzle, wipe with cotton moistened with water. If whole unit is dirty, Techno Medica recommends to replace it to the new sample port. How can I store the sample in case it Put the rubber cap on the syringe and stir syringe can not be measured immediately. to mix with Heparine well. Sink inside the iced water but do not freeze it. Sample will last for 2 hours in such condition.

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TROUBLE SHOOTING
Errors Instruments does not powered up. Corrective actions Check AC power cord is connected firmly. After you put the cord firmly and instruments runs well, probable cause may be bad battery. In such case, battery should be replaced.

Instruments does not responds at all Check AC power cord is loosen , or particulary after thunder bolt. battery switch is OFF. If not, fuze should be replace on the following manner. 1. Switch OFF the battery switch. 2. Disconnect the power cord first from the AC inlet side and then instrument side. 3. Remove fuze box. 4. Replace 2pcs of fuze. Make sure to put new fuze firmly. 5. Connect the power cord first from the instrument side and then AC inlet side. 6. Switch ON the battery switch. CAL Cassette replacement message Push the CAL Cassttte once again to the remains after you replace CAL instrument body side. Cassette. Waste bottle replacement message Waste ditection may be wrong. Dispose the waste appears even waste is not full. bottle anyway. Sample is not measurement. detected when Conduct Flush cleaning and try measurement once more. In case sample is not detected again, replace pump tube.

Sample/Flush solution leaks out Sample port is old or clot is generating inside the from sample port. flow line. Replace Sample port or remove clot. Measurement error appears after Conduct 2 point calibration and verify if measurement. calibration complete without any problem. If there is no error, remove bubble inside the sample and measure once again. If there is error in calibration, see next chapter.

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ERROR MESSAGES
Errors Drift error Unstable error Slope error Level error Corrective action Remove air bubble inside the electrode. Remove electrode from measurement unit and shake the electrode to remove the bubble, and then conduct 2 point calibration. In case internal solution of electrode is small, feed the internal solution, and then conduct 2 point calibration. Verify flow line Verify if CAL 1 and CAL 2 solution inside the CAL Cassette is bring into the measurement unit. Flow is OK: Most probable cause is bad electrode. Flow is NG: In case you find the bubble in this duration, or CAL and CAL 2 solution does not stop at the measurement unit, conduct Flush solution cleaning. If problem still remains, first replace the sample port, next change the pup tube and then finally replace the electrode.

Level error in all of Conduct flush solution cleaning. If problem still the measured test remains, check the sensor level. If sensor level is OK, replace pump tube. If sensor level is NG, contact to your local Techno Medica representatives.

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SPECIFICATIONS
SPECIMEN Model name TESTS AVAILABLE (Measured)
pH PCO2 PO2 Na
K+
+

Whole blood, Serum, Plasma, Dialysate 600

6.000-8.000 10.0-200.0Torr 5.0-760Torr 80.0-200.0mmol/L 1.00-10.00mmol/L 50.0-200.0mmol/L 0.5-5.0mmol/L 10.0-500.0mg/dL 0.4-30.0mmol/L 15.0-65.0 500-800Torr
2+

601

602i

603ie

Cl

Ca

Glc Lac Hct BP

TESTS AVAILABLE (Calculated)

HCO3 BE TCO2 O2CT BB SBE SBC

O2SAT

AaDO2 RI Hb cCa AG

FUNCTION

RS232, TCP/IP interface Self-contained help function Animated guidance Dialysate mode Power failure protection

Option

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ENTERED PARAMETERS SAMPLE VOLUME ANALYSIS TIME DISPLAY

Patient ID, Patient temp, Hb, FiO2, BP 100 l Syringe 45l Capillary (pH, PCO2, PO2, Hct) About 60 sec 7.2-inch full color LCD, touch panel

CALIBRATION DATA STORAGE PRINTER BARCODE READER

ENVIRONMENTAL REQUIREMENTS

Automatic, programmable 1 and 2-point calibration 500 data Line thermal Up to 14 kinds of barcode readable Temperature 10-30C Humidity 5-80% AC85-264V 50/60Hz, 150W 366W467D487H (mm) 15Kg Barcode navigation Reagent and waste level detection Zero maintenance electrode No gas needed Save mode Easy maintenance
Specifications subject to change without notice.

POWER DIMENSIONS WEIGHT OTHER

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