Anda di halaman 1dari 3

INSTRUCTIONS FOR USE

250/350 Reference Fluid

VITROS Chemistry Products 250/350 Reference Fluid

176 5304

Intended Use

For in vitro diagnostic use only.


VITROS 250/350 Reference Fluid is used in the potentiometric measurement of sodium (Na+), potassium (K+), and chloride
(Cl-) on VITROS 250/350 Chemistry Systems.

Reagents
VITROS 250/350 Reference Fluid is an aqueous solution of electrolytes and a polymeric agent.

Reactive Ingredients
1.2 M Cesium chloride, 0.2 M sodium bicarbonate, and 0.07 M potassium hydroxide

Other Ingredients
Polyvinylpyrrolidone

Warnings and Precautions

For in vitro diagnostic use only.


This product is non-hazardous for usual handling.

Personal Protection and Ventilation


Wear impervious gloves and proper protective clothing. Safety glasses are recommended. Good general ventilation in the
work area is recommended. Minimize the potential for production of aerosols.

Accidental Spillage and Disposal


Flush to sewer with large amounts of water.

First Aid

Inhalation Remove to fresh air. Seek medical advice.


Skin Wash skin after each contact with soap and plenty of water for at least 15 minutes. If symptoms are present after
washing, seek medical advice.
Eye Immediately flush eyes, including under the eyelids, with plenty of water for at least 15 minutes. Seek medical
advice.
Ingestion Seek medical advice if needed.

Transportation
This product is not classified as a dangerous substance for transportation purposes. However, package with adequate
protection to prevent breakage and ship under refrigerated conditions.

Storage
IMPORTANT:

Do not freeze.

Fluid Storage and Stability for 250/350 Reference Fluid

Version 7.0

Reagent
Unopened

Refrigerated

Opened

Room temperature
On-analyzer

Storage Condition
28 C (3646 F)
1828 C (6482 F)

Pub. No. J11430_EN

Stability
Until expiration date if
pouch is sealed
24 hours
24 hours

1 of 3

INSTRUCTIONS FOR USE

250/350 Reference Fluid

Materials Provided

Materials Provided
30 pouched reservoirs (6 mL each) of VITROS 250/350 Reference Fluid

Testing Procedure
Note:

Replace the disposable tip whenever the reference fluid reservoir is replaced or
every 8 hours, whichever occurs first.

Note:

Calibrate Na+, K+, and Cl- with every reference fluid lot change.

1.
2.
3.
4.
5.
6.

Warm the unopened pouch to internal system temperature (minimum 30 minutes maximum 24 hours).
Open the pouch and remove the fluid reservoir.
Mix thoroughly by gentle inversion. DO NOT SHAKE.
Remove the stopper and immediately place the reservoir on the system as instructed in the VITROS Operators Manual.
Analyze samples as instructed in the VITROS Operators Manual.
Discard reservoir with the remaining fluid after 24 hours.

Glossary of Symbols

Revision History
Date of Revision
2014-09-05
2012-02-28
2005-04-05
2005-02-11
2004-09-13

2 of 3

Version
7.0
6.0
5.0
4.0
3.0

Description of Technical Changes*


Glossary of Symbols: added Date of Manufacture
Glossary of Symbols: updated wording
Updated 250 Reference Fluid to 250/350 Reference Fluid
Intended Use added VITROS 350 Chemistry System
Glossary of Symbols Updated data

Pub. No. J11430_EN

Version 7.0

INSTRUCTIONS FOR USE

Revision History

Date of Revision
2003-04-30

Version
2.0

2002APR19

1.0 English
only

250/350 Reference Fluid


Description of Technical Changes*
New organization and sections consistent with IVD Directive
Reactive Ingredients changed potassium hydroxide amount from 0.06 M to
0.07 M
New format, technically equivalent to 2000MAR27.

* The change bars indicate the position of a technical amendment to the text with respect to the previous version of the document.

When this Instructions For Use is replaced, sign and date below and retain as specified by local regulations or laboratory
policies, as appropriate.

Signature

Obsolete Date

Ortho-Clinical Diagnostics
50-100 Holmers Farm Way
High Wycombe
Buckinghamshire
HP12 4DP
United Kingdom
Ortho-Clinical Diagnostics, Inc.
100 Indigo Creek Drive
Rochester, NY 14626
VITROS is a trademark of Ortho-Clinical Diagnostics, Inc.
Ortho-Clinical Diagnostics, Inc., 20022014.

Version 7.0

Pub. No. J11430_EN

3 of 3