Test Cartridge User Manual

Test Cartridge
User Manual
[Intended Use]
The test cartridges are intended to be used with EDAN i15 Blood Gas and Chemistry Analysis System. The EDAN i15 Blood Gas

and Chemistry Analysis System is designed for the quantitative measurement of blood gases, blood chemistries, and hematocrit in

whole blood samples. The system is for in vitro diagnostic use and is intended for use only by trained technologists, nurses,

physicians and therapists. It is intended for use in a laboratory environment, near patient or point-of-care settings.

[Important]
Please read this instruction and the EDAN i15 Blood Gas and Chemistry Analysis System User Manual before using test

cartridges. If you have any questions and/or need assistance, please contact EDAN or its authorized distributors.

[Principle]
The EDAN i15 Blood Gas and Chemistry Analysis System utilizes potentiometry and amperometry to determine the

concentrations of blood gases and blood chemistries, and utilizes conductivity to determine the concentration of hematocrit.

[Components]
The test cartridge contains the fillport, the fluidic chamber, electrical contacts, and an array of sensors. The sensors contained

depend on the test cartridge type.

[Test Cartridge Types]

Test cartridges are available in different configurations concerning the parameters reported by them. For details, please refer to

the table below:

Cartridge Type Measured Parameters Calculated Parameters

cH , HCO3 act, HCO3 std, BE(ecf), BE(B), BB(B), ctCO2, sO2(est), Ca++(7.4),
+ - -

pH, pCO2, pO2, Na+, K+,

BG8 AnGap, tHb(est), pO2(A-a), pO2(a/A), RI, pO2/FIO2, cH+(T), pH(T), pCO2(T),
Cl-, Ca++, Hct
pO2(T), pO2(A-a)(T), pO2(a/A)(T), RI(T), pO2(T)/FIO2

cH+, HCO3-act, HCO3-std, BE(ecf), BE(B), BB(B), ctCO2, sO2(est), pO2(A-a),

BG3 pH, pCO2, pO2 pO2(a/A), RI, pO2/FIO2, cH+(T), pH(T), pCO2(T), pO2(T), pO2(A-a)(T),

pO2(a/A)(T), RI(T), pO2(T)/FIO2

[Storage]
Test cartridges should be stored at 4 - 30C until the expiration date as labeled on the package. They should be kept out of direct

sunlight and heat.

[Warnings and Precautions]

 Test cartridges are for in vitro diagnostic use only.

 If the pouch has been damaged, the test cartridge should not be used.

 Only test cartridges provided by EDAN or its authorized distributors should be used.

 Only test cartridges properly stored should be used.

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 Test cartridges should be kept out of direct sunlight and heat.

 Test cartridges should not be dropped or stressed.

 Never reuse test cartridges.

 Never touch the fillport or electrical contacts of a test cartridge.

 Use test cartridges before the expiration date as labeled on the package, and use them immediately after removing them

from their pouches.

 The analyzer, test cartridges and the testing environment should be at the same temperature prior to a test.

 Perform the sample test immediately after its collection to get the most accurate results. Measure samples for blood gases

and Ca++ within 10 minutes, and measure samples for other analytes within 30 minutes.

 The sample is contained in the test cartridge, so test cartridges should be disposed of as biohazardous waste,
complying with local regulatory guidelines.

[Applicable Instruments]
EDAN i15 Blood Gas and Chemistry Analysis System

[Sample Collection and Preparation]

Blood samples should be collected according to proper medical guidelines containing collection details, such as site selection,

collection procedures, sampling devices, sample handling, etc. Sterile techniques should be followed to prevent the site from

being contaminated.

Only those sample devices containing the proper amount of calcium-titrated (balanced) heparin or lithium heparin as the

anticoagulant should be used to collect whole blood samples. If calcium-titrated (balanced) heparin is used as an anticoagulant,

the minimum heparin-to-blood ratio should be 2.3 units of heparin per 1.0mL of blood sample. If a sample is analyzed for ionized

calcium, the maximum heparin-to-blood ratio should be 15 units of heparin per 1.0mL of blood sample; if not, the maximum

heparin-to-blood ratio should be 50 units of heparin per 1.0mL of blood sample.

NOTE:

Don’t use the following anticoagulants: EDTA, citrate, and oxalate, because they have a great influence on test results

for pH and electrolytes.

Samples can be introduced into the system with the following devices: syringes and capillary tubes. It is recommended that

VITREX® Blood Gas Capillary Tubes with a minimum volume, filled of 175μL (Article Number: 182413) should be used.

NOTE:

 The system uses 110μL samples for analysis, and make sure it can aspirate enough sample.

 The minimum fill volume for a 1mL syringe is 200μL.

 The minimum fill volume for a 2mL syringe is 800μL.

 The minimum fill volume for a 5mL syringe is 1.5mL.

 Dislodge bubbles from the syringe, and cover it as soon as the sample is collected. Cork should never be used

to cover the syringe.

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 Test Cartridge User Manual
 A capillary tube should be filled to capacity and covered securely. Cork or clay should never be used to cover the

capillary tube.

[Quality Control (QC) Tests]

Follow the procedures below to perform a control test:

1. Examine the package label of controls to ensure they have not expired.

2. Remove an ampoule from the box of controls and equilibrate it to room temperature.

If oxygen is to be measured, the ampoule needs to stand at room temperature for at least 4 hours. If not, the ampoule needs

to stand at room temperature for 30 minutes.

3. Press the On/Off button on the left hand side of the analyzer to turn it on.

4. Enter the user name and password manually (or enter the user name with the bar code scanner), and then press .

5. On the Main screen, press (Setup).

6. Select the desired control type.

Press (BG) to perform a control test for blood gases and blood chemistries.

Press (Hct) to perform a control test for Hct.

7. Press Scan Barcode, and scan the bar code on a new cartridge foil pouch.

8. Open the foil pouch and remove the cartridge from it.

NOTE:

For sample introduction with a capillary tube or an ampoule, insert a capillary adaptor/ampoule adaptor into the fillport

after removing the cartridge.

9. Press Scan Barcode, and scan the bar code on the controls user manual.

NOTE:

Keep the controls user manual for a future control test use.

10. Mix the controls completely by shaking the ampoule gently, and then gently tap the tip of the ampoule carefully with your

fingernail to remove any solution.

11. Open the ampoule by snapping off the top and immediately transfer control solution by slowly drawing an appropriate

amount of solution with a syringe or capillary tube from the bottom of the ampoule.

NOTE:

When using an ampoule for sample introduction, you need not transfer control solution. Insert the ampoule into the

adaptor after opening it, and directly go to step 13.

12. Insert the syringe or capillary tube into the fillport of the cartridge.

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 Test Cartridge User Manual
NOTE:

 When using a syringe, discard the first 2 drops of solution first, then remove the needle from it, and finally insert

it into the fillport.

 When using a capillary tube, directly insert the capillary tube into the adaptor till the tube reaches the interface

between the adaptor and the cartridge.

 To avoid inaccurate test results, make sure there are no bubbles in the sample. If bubbles continually exist, use a

new ampoule and syringe or capillary tube to collect samples again.

13. Gently insert the cartridge into the cartridge port, and carefully press down to ensure that it clicks into place. If it is

properly inserted, the system will start to aspirate calibrant.

14. The system automatically aspirates calibrant, performs calibration, aspirates samples, performs control test and displays

test results.

15. View the results.

NOTE:

 The system will indicate whether the results are within or outside the acceptable ranges with Under Control/Out

of Control.

 If a parameter fails calibration, the system will not be able to determine whether it is under control, and will

display Calibration Failure to prompt you.

 The system will not report the result for a parameter failing the control test in the patient sample analysis, if QC

Lockout function is enabled in Setup. To report the result for the parameter, repeat the control test till the

parameter passes it.

 If the results are outside the acceptable ranges, check the following items first, and then perform another test.

 Refer to the user manual to confirm that the test procedures are correct.

 Test cartridges and controls are stored properly and have not expired.

 The system passes the electronic simulator test.

If all the above items are verified, but the results are still outside the acceptable ranges, please stop using the

system and contact EDAN or its authorized distributors for assistance.

16. Remove the test cartridge from the analyzer.

17. Press Print to print the results.

18. Press Home to return to the Main screen.

[Blood Sample Analysis]

1. Press the On/Off button on the left hand side of the analyzer to turn it on.

2. Enter the user name and password manually (or enter the user name with the bar code scanner), and then press .
3. Press the button for the patient sample type on the Main screen. √ indicates that the button is selected. The default type is

Arterial.

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4. Press Scan Barcode, and scan the bar code on a new cartridge foil pouch.

5. Open the foil pouch and remove the cartridge from it.

NOTE:

For sample introduction with a capillary tube, insert a capillary adaptor into the fillport after you removing the cartridge.

6. Roll the syringe or capillary tube between palms and gently invert it end over end for several times to mix the sample

completely.

7. Insert the syringe or capillary tube into the fillport of the cartridge.

NOTE:

 When using a syringe, discard the first 2 drops of blood sample first, then remove the needle from it, and finally

insert it into the fillport.

 When using a capillary tube, directly insert the capillary tube into the adaptor till the tube reaches the interface

between the adaptor and the cartridge.

 To avoid incorrect test results, make sure there are no trapped bubbles or clots in the sample.

8. Gently insert the cartridge into the cartridge port, and carefully press down to ensure that it clicks into place. If the

cartridge is inserted properly, the system will automatically start to aspirate calibrant.

9. Enter the parameters for patient information, and press OK. The system will go to the screen for aspirating calibrant,

calibrating, sampling, measuring or sample results.

NOTE:

If the screen has not been touched for 10 seconds after the test is complete, the test results will be displayed

automatically even if you do not press OK.

10. View the test results.

11. Remove the test cartridge from the analyzer.

12. Press Home to return to the Main screen.

[Interpretation of Results]
Symbol Description

> or < The result is above or below the measurement range.

↑ or ↓ The result is above or below the reference range.

--- This measured parameter fails calibration.

xxx This measured parameter fails quality control (QC) tests, and QC lockout function is enabled in Setup.

This measured parameter fails quality control (QC) tests, and QC lockout function is disabled in Setup.

*** The result for this calculated parameter is valid, but the measured parameter used to determine the

calculated parameter fails quality control (QC) tests, and QC lockout function is disabled in Setup.

??? The result for this measured parameter is invalid.

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NOTE:

 If test results are inconsistent with the clinical assessment, the sample should be tested again with a new test cartridge.

 Never make treatment decisions according to test results containing symbols as described above.

[Reference Ranges]
Because reference ranges may vary with demographic factors such as age, gender and heritage, it is recommended that the

individual institutions should establish their own reference ranges according to the population being tested. The following

reference ranges are for reference only.

Reference Range
Parameter Measurement Range
Arterial Venous

pH 7.35 - 7.45 7.31 - 7.41 6.5 - 8.0

pO2(mmHg) 80 - 105 35 - 40 10 - 700

pCO2(mmHg) 35 - 45 41 - 51 10 - 150
+
Na (mmol/L) 138 - 146 138 - 146 100 - 180
+
K (mmol/L) 3.5 - 4.9 3.5 - 4.9 2.0 - 9.0

Cl-(mmol/L) 98 - 109 98 - 109 65 - 140

Ca++(mmol/L) 1.12 - 1.32 1.12 - 1.32 0.25 - 2.50

Hct(%) 38 - 51 38 - 51 10 - 75

[Limitations]
 Test cartridges are used to analyze whole blood samples only.

 The results given by the system should be examined based on the overall clinical condition of the patient, and it should not

be a substitute for regular checking.

 Mix the sample thoroughly prior to sample introduction to avoid inaccurate results.

 To avoid inaccurate test results, make sure there are no clots or bubbles in the sample.

[References]
1. CLSI. Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline - Second Edition.

CLSI document EP5-A2 [ISBN 1-56238-542-9], CLSI, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania

19087-1898 USA, 2004.

2. CLSI. Method Comparison and Bias Estimation Using Patient Samples; Approved Guideline - Second Edition (Interim

Revision). CLSI document EP09-A2-IR [ISBN 1-56238-731-6], CLSI, 940 West Valley Road, Suite 1400, Wayne,

Pennsylvania 19087-1898 USA, 2010.

[Performance Characteristics]
Repeatability was estimated using one lot of test cartridges, and 20 replicates of each level were successively analyzed on one i15

Blood Gas and Chemistry Analysis System. QC Materials used were RNA Medical® QC823 Blood
®
Gas●Electrolyte●Metabolite●BUN Controls and RNA Medical QC900 Hematocrit Controls. In the table below, SD refers to the

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standard deviation.

Parameter Level Mean SD

1 7.161 0.0061

pH 2 7.401 0.0104

3 7.565 0.0074

1 68.63 2.650

pCO2 2 43.97 1.368

3 24.41 1.886

1 65.3 2.95

pO2 2 103.0 3.02

3 150.8 4.189

1 114.6 0.83

Na+ 2 140.1 0.83

3 168.7 0.92

1 1.92 0.014
+
K 2 4.51 0.041

3 6.70 0.047

1 78.8 0.62
-
Cl 2 96.7 0.84

3 127.1 0.76

1 1.47 0.029
++
Ca 2 1.16 0.026

3 0.46 0.009

Low 20.3 0.93

Hct
High 49.7 0.47

In the comparison study, samples were analyzed in parallel on the i15 Blood Gas and Chemistry Analysis System and the

Rapidpoint 400 system. Two replicates of each sample were analyzed on each system. In the following method comparison data

table, N denotes the total number of patients’ sample, and Sy.x denotes the standard error of estimate.

Correlation
Parameter N Slope Intercept Sy.x Range
Coefficient

pH 215 1.0259 -0.1934 0.9919 0.0126 7.137 – 7.720

pCO2 215 0.9394 1.4498 0.9868 1.5950 11.5 – 73.8

pO2 215 0.9811 1.3173 0.9986 2.0303 20.4 – 191.0

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+
Na 215 0.9813 2.3952 0.9961 1.1661 102.3 – 164.9
+
K 215 1.0068 -0.0409 0.9983 0.0594 2.55 – 6.70
-
Cl 215 0.9955 0.2967 0.9961 0.9802 77 - 132

Ca++ 215 0.9987 0.0019 0.9910 0.0265 0.61 – 1.73

Hct 215 0.9729 1.0199 0.9932 0.7518 23 - 53

[Manufacturer Information]
EDAN Instruments, Inc.

3/F-B, Nanshan Medical Equipments Park, Nanhai Rd 1019#, Shekou, Nanshan Shenzhen, 518067 P.R. China

Telephone: +86 755-2689 8326

Fax: +86 755-2689 8330

E-mail: [email protected]

[EC Representative Information]

Shanghai International Holding Corp. GmbH (Europe)

Eiffestrasse 80, D-20537 Hamburg Germany

Telephone: +49-40-2513175

Fax: +49-40-255726

E-mail: [email protected]

[Date of Approval for Package Insert]

September, 2013

[Labeling and Information]

Consult instructions for use Caution

Batch code Do not reuse

In vitro diagnostic device Temperature limitation

Use by Recycle

The device complies with the European Council

Manufacturer
Directive 98/79/EEC concerning medical devices.

Authorized Representative in the European

Trademark
Community

Sufficient for n tests

01.54.455876-11

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