Starrsed Diluent

Intended Purpose

Product for the automatic dilution of blood samples in Starrsed ESR analyzers. The product is ready to use; refer to the instrument manual for instructions.

Instructions For Use

The product is for use on the Starrsed analysers only. Refer to the Starrsed instrument manual for detailed instructions.

Starrsed ST:

1. Open the box by tearing off the perforated part on top of the box.
2. Remove the container screw cap and pull the neck of the bottle pack out of the cardboard box.
3. Refill the onboard container on the Starrsed instrument according to the instructions in the instrument manual.

All other Starrsed instruments:

1. Remove level sensor and spacer from the empty container in the instrument.
2. Remove empty container.
3. Place the new container.
4. Open the box by tearing off the perforated part on top of the box.
5. Remove the container screw cap and pull the neck of the bottle pack out of the cardboard box.
6. Install the level sensor and spacer according to the pictures provided in the Starrsed instrument manual.
7. Make sure to place the appropriate level sensor in the container by matching the color code on the tube and on the container label.
8. Select the PRIME function in the Starrsed instrument software to perform the prime.

Chemical/Physical Data

Contains an isotonic amount of citrate (<3.5% by weight) together with the preservative sodium azide (< 0.5% by weight).

The latest version of the Safety Data Sheet is available on the website www.rrmechatronics.com.

Transport/Storage/Packaging

Stability during transport: 5 - 60 °C (maximum of 14 days)

Store at: 5 - 35 °C in dry conditions in well sealed containers.

Starrsed Diluent is supplied in 5 Liter containers, dimensions: LxWxH 19x19x19 cm.

Safety

Any serious incident that has occurred in relation to this product must be reported to the distributor and/or manufacturer and the competent local authorities.

Shelf Life

After production: 3 years, but no longer than the expiry date.

In-use stability: Maximum of 3 months at advised temperature of 5 till 25°C.

Ecological Information

Water hazard class (D) (Self-assessment): Slightly hazardous for water.

Do not allow undiluted product or large quantities of it to reach ground water, water course or sewage system.

Disposal

Recommendation: Must not be disposed of together with household garbage. Do not allow product to reach sewage system. Disposal must be made according to official regulations.

Recommended cleaning agent: Water, if necessary with cleaning agent.

Supplier Information

RR Mechatronics Manufacturing B.V.

De Corantijn 13, 1689 AN ZWaag, The Netherlands

Website: www.rrmechatronics.com

[CE marking] [In Vitro Diagnostic]

Revision History

Rev. 5:

• Revision due to IVDR-registration, intended purpose description modified
• Website added under manufacturer address
• Component description and safety chapter added