01.54.455875-1.2 Calibrant Fluid Pack User Manual

Calibrant Fluid Pack User Manual
Calibrant Fluid Pack

User Manual
[Intended Use]
The calibrant fluid pack is intended to be used to calibrate blood gas and blood chemistry sensors. It
should be used with EDAN i15 Blood Gas and Chemistry Analysis System. The EDAN i15 Blood Gas
and Chemistry Analysis System is intended 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 a calibrant fluid pack. 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 calibrant fluid pack contains calibrant solutions which are used to calibrate blood gas and blood
chemistry sensors. The calibrant solutions contain the following components: gases (oxygen, carbon
dioxide, nitrogen), salts (alkali halide), glucose, lactic acid, organic buffers.
[Specifications]
100 tests /pack
200 tests /pack
[Storage and Expiration]
Calibrant fluid packs should be stored at 2 - 8C (avoid freezing) with the ambient pressure of 65 -
106.6kPa. They should be kept away from direct sunlight and heat. A calibrant fluid pack expires 30 days
after its installation or after exceeding the expiration date as labeled on the package, whichever comes
first.
[Warnings and Precautions]
 A calibrant fluid pack is for in vitro diagnostic use only.
 If the pouch has been damaged or there is any leakage, the calibrant fluid pack should not be used.
 Use a calibrant fluid pack before its expiration date as labeled on the package.
 Replace a calibrant fluid pack following this user manual instruction.
-1-
 Never replace a calibrant fluid pack when the analyzer is off.
 A calibrant fluid pack is intended for single use only. If a calibrant fluid pack is removed from the
system, it can not be inserted into the system again.
[Applicable Instruments]
EDAN i15 Blood Gas and Chemistry Analysis System
[Replacing a Calibrant Fluid Pack]
1. Examine the expiration date on the package of a calibrant fluid pack to ensure it has not expired.
2. Remove the calibrant fluid pack from its package, and equilibrate it to room temperature. The
calibrant fluid pack needs to stand at room temperature for at least 24 hours.
3. Wipe any moisture from the foil pouch with a dry clean cloth.
4. On the Main screen, press (Setup) to go to the System Setup screen.
5. Press (Replace Cal Pack).
6. Open the foil pouch, and remove the calibrant fluid pack from it.
7. Remove the calibrant fluid pack cap, and remove the key by pushing it with your finger in the
direction as shown by the arrow in the picture below.
Key Valve
NOTE:
Avoid pushing the valve when removing the key.
8. Unlock the calibrant fluid pack chamber lock with the key, pull the calibrant fluid pack ejector to
open the calibrant fluid pack chamber door on the right side of the analyzer.
9. Remove the used calibrant fluid pack from the system.
10. Scan the bar code on the new calibrant fluid pack foil pouch with the bar code scanner.
11. Insert the new calibrant fluid pack into its chamber, and push it gently to make sure that it clicks
into place. The system will go to the screen for the next procedure.
12. Close the chamber door.
13. Lock the calibrant fluid pack chamber lock to close the chamber door securely.
14. Press OK in the pop up message, and the system will go to the Main screen.
-2-
[Interpretation of Results]
A parameter that fails the calibration test will be flagged with ---.
[Reference Ranges]
Target values assigned to the calibrant solutions are traceable to NIST standards.
Parameter Target Value Parameter Target Value
pH 7.352 pO2(mmHg) 155.0
pCO2(mmHg) 42.7 Na+(mmol/L) 151.1
K+(mmol/L) 5.07 Ca++(mmol/L) 1.19
Cl-(mmol/L) 105 Glu(mmol/L) 5.07
Lac(mmol/L) 1.98 —— ——
Note: Target values for the parameters, which are programmed in the bar code of a calibrant fluid pack,
may vary with the lot number of a calibrant fluid pack.
[Limitations]
 The system is only intended to analyze whole blood samples.
 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.
[References]
 Package Containing a Reference Liquid for Blood Gas Equipment; U.S. Patent, 4, 116, 336; Sept.26,
1978.
 Temperature Stabilized Fluid Calibration System; U.S. Patent, 5, 223, 433; June 29, 1993.
[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: info@edan.com.cn
[EC Representative Information]
Shanghai International Holding Corp. GmbH (Europe)
Eiffestrasse 80, D-20537 Hamburg Germany
Telephone: +49-40-2513175
Fax: +49-40-255726
-3-
E-mail: antonjin@yahoo.com.cn
[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
Manufacturer Council Directive 98/79/EEC
concerning medical devices
Authorized Representative in the

Trademark
European Community
Sufficient for n tests
01.54.455875-12
-4-

01.54.455875-1.2 Calibrant Fluid Pack User Manual

Uploaded by

Copyright:

Available Formats

01.54.455875-1.2 Calibrant Fluid Pack User Manual

Uploaded by

Document Information

Original Title

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

01.54.455875-1.2 Calibrant Fluid Pack User Manual

Uploaded by

Copyright:

Available Formats

Calibrant Fluid Pack User Manual

Calibrant Fluid Pack

4. On the Main screen, press (Setup) to go to the System Setup screen.

5. Press (Replace Cal Pack).

Parameter Target Value Parameter Target Value

pH 7.352 pO2(mmHg) 155.0

pCO2(mmHg) 42.7 Na+(mmol/L) 151.1

K+(mmol/L) 5.07 Ca++(mmol/L) 1.19

Cl-(mmol/L) 105 Glu(mmol/L) 5.07

may vary with the lot number of a calibrant fluid pack.

Consult instructions for use Caution!

Batch code Do not reuse

In vitro diagnostic device Temperature limitation

The device complies with the European

Manufacturer Council Directive 98/79/EEC

concerning medical devices

Authorized Representative in the

Sufficient for n tests

You might also like

Pfad - The Proxy pFad of © 2024 Garber Painting. All rights reserved.