Abbott i-STAT 1 System Manual page 604

MANUFACTURER'S QUALITY SYSTEM INSTRUCTIONS (CONTINUED)
The list below defines the i‑STAT System MQSI components.
Number
4 Ensure Proper Cartridge Storage
A. Ensure that refrigerator storage conditions for stored cartridges are between
2˚C – 8˚C (35˚F – 46˚F).
B. Ensure that cartridges are not exposed to temperatures exceeding 30˚C (86˚F).
C. Ensure that cartridges are not used after the expiration date printed on the individual
package and box.
D. Ensure that cartridges are not outside the refrigerator for longer than the timeframe
indicated on the cartridge box.
E. Ensure that a cartridge is used immediately after it is removed from its package.
F. Ensure that a cartridge taken from refrigerated storage is allowed to stand in its
package at room temperature for 5 minutes before use, or that a box of cartridges
stands at room temperature for one hour before use.
5 Ensure Thermal Probe Check is Performed
Ensure the thermal probe check is performed every 6 months on each handheld reader.
This check can be performed in conjunction with the handheld software updates.
Train Staff on Avoidance of Pre- and Post-analytical Errors
6
Ensure that users are trained to avoid pre‑analytical errors such as those associated with
sample collection, delays in testing, inadequate sample mixing, and post‑analytical errors
(results reporting and communication).
7 Update Software then Check with External Simulator
Update the i‑STAT System software as provided by Abbott Point of Care (APOC). Check the
handheld with the external Electrical Simulator after software updates.
The thermal probe reading can also be taken from this check.
While the following are not manufacturer's quality system instructions, they are laboratory practices
centered on quality.
Number
Review Interferences with Staff
1
Review "Factors that Affect Results" listed in the Cartridge and Test
Information sheets with clinical staff. Cartridge and Test Information sheets
are located on the Abbott Point of Care website
Customer‑Info‑Center/Cartridge‑and‑Test‑Info‑Sheets.aspx).
2 Train Staff on Backup System Measures
Ensure that users are trained on the backup provisions for testing should they be unable to
utilize the i‑STAT System in their area.
Backup provisions in many facilities include the use of a spare handheld reader, backup lot of
cartridges, sharing of the handheld reader, or use of a laboratory system.
i‑STAT is a registered trademark of the Abbott Group of Companies in various jurisdictions.
2
MQSI Description
Activity Description
(www.abbottpointofcare.com/
Art: 721317-01C Rev. Date: 29-Aug-12