Sources of Reagent Error
• Sealed cartridges should be refrigerated (2° C to 8° C) in sealed foil pouches when
not in use.
Sources of Procedural Error
• Carefully follow the instructions for the preparation of the QC Level 1 control
material. For correct reconstitution, the full vial of diluent water must be poured into
the vial of lyophilized control. Failure to do so may result in inaccurate results.
• Timing - Do not use controls if they have been reconstituted for more than 2 hours
Sample Preparation
The entire contents of the diluent water vial must be placed into the Level 1 vial for
proper concentration, and thoroughly mixed.
Storage Instructions
Calcium chloride cartridges and QC materials must be protected from temperature
extremes above 35°C. Haemonetics recommends that the cartridges and QC
materials be refrigerated at 2°C to 8°C after receipt and prior to use; however,
storage of up to one month at temperatures not exceeding 25°C will not have an
adverse effect on the labeled shelf life or expiry date of the product. Cartridges are for
single use only and must be discarded after use.
Analyzer
Refer to the TEG
Specimen Collection and Preparation for Analysis
No specimen collection is required for running this quality control test. No additives or
preservatives are necessary to maintain the integrity of the material, but reconstituted
QC Level 1 material must be used within 2 hours of reconstitution.
Materials Provided
• Ten (10) Calcium Chloride cartridges, ten (10) QC Level 1 vials and ten (10) Water
vials, each sealed with a desiccant pack in a foil pouch. Each cartridge contains four
(4) channels of dried calcium chloride.
• Twelve (12) transfer pipettes
Materials Required (but not supplied)
TEG
6s Analyzer (Source: Haemonetics)
®
Test Procedure
1. Remove one cartridge pouch from refrigerated storage.
2. Tear open the pouch, remove the cartridge and vials, and discard the pouch and
desiccant pack.
3. Prepare the QC sample according to the following instructions:
a. Allow the control vial and the diluent water vial to sit for approximately 10 minutes
to equilibrate to room temperature.
b. Make sure the lyophilized material is on the bottom of the control vial. You may
need to tap the vial a few times.
c. Remove the seal and stopper of the control vial, taking care to avoid sharp metal
edges.
2 / EN
6s User Manual.
®