INSTRUCTIONS FOR USE

VITROS Chemistry Products 250/350 Reference Fluid 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

Reagent Storage Condition Stability
Unopened Refrigerated 2–8 °C (36–46 °F) Until expiration date if
pouch is sealed
Room temperature 18–28 °C (64–82 °F) ≤ 24 hours
Opened On-analyzer ≤ 24 hours

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

Glossary of Symbols

Revision History
Date of Revision Version Description of Technical Changes*
2014-09-05 7.0 Glossary of Symbols: added Date of Manufacture
2012-02-28 6.0 Glossary of Symbols: updated wording
2005-04-05 5.0 Updated 250 Reference Fluid to 250/350 Reference Fluid
2005-02-11 4.0 Intended Use — added VITROS 350 Chemistry System
2004-09-13 3.0 Glossary of Symbols– Updated data

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 INSTRUCTIONS FOR USE
Revision History 250/350 Reference Fluid

Date of Revision Version Description of Technical Changes*

2003-04-30 2.0 • New organization and sections consistent with IVD Directive
• Reactive Ingredients – changed potassium hydroxide amount from 0.06 M to
0.07 M
2002APR19 1.0 – English New format, technically equivalent to 2000MAR27.
only
* 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., 2002–2014.

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