Do not use cartridge if this date has passed. To avoid waste, take only a few days worth of cartridges out of refrigerator. Room Temperature Storage Store cartridges at room temperature up to 30˚C (86˚F) for no more than 14 days. It is recommended (but not required) that refrigerated storage be equipped with a 24-hour temperature monitor, and that the temperature record be reviewed each day. Refrigerated cartridges may be used until date shown on cartridge box and pouch. Required procedures for cartridge storage: Refrigerated Storage Store cartridges at 2 to 8˚C (35 to 46˚F). If any result is still outside its range, do not use the cartridges. If any result is outside its range in the Value Assignment sheet, repeat the test. If window “4” is not red, take one cartridge from each CHEM8+ lot in the shipment and test with i-STAT CHEM8+ Level 1 control (See “Test a Control Sample” for instructions). Record temperature reading on “Receipt of New Cartridges” log found in the System Resources section of this Manual. If the “4” window is red, do not use cartridges. Mark an “x” in each of the spaces corresponding to a red window. Fill out information in “Received” section at bottom of card. Read strip immediately as it will change once it is exposed to room temperature. Find card with temperature strip attached. Open box marked “Refrigerate Upon Arrival”. Required procedure for handling new cartridge shipments: 1. Follow the procedures in this guide including recommended recordkeeping to ensure your facility is in compliance with the CLIA Certificate of Waiver program. However, a CHEM8+ Level 1 control sample must be tested with each new shipment of cartridges, each new lot of cartridges, and monthly to check cartridges in storage. Quality Control Requirements Quality checks are automatically performed during each test. Trying to pull a cartridge out of the Handheld while Potential Sources of Damage to the Handheld “Cartridge Locked” message is displayed. Handheld and peripherals not suitable for use in oxygen enriched atmosphere. Use safety tips when transferring sample from a blood collection tube to a cartridge. Needles: take care to prevent needle sticks. Barcode scanner: Do not look into laser beam coming from scanner, or point into eyes of someone else. Place Handheld and peripherals on a stable surface. Since blood spots may not be noticeable on the Handheld and since a cartridge could contaminate the inside of the Handheld, treat the Handheld as capable of transmitting infection. See Start-up section of Manual for instructions. Decontaminate Handheld if blood is spilled on it. Discard contaminated (blood soiled) items in a biohazard waste container. Do not use a cartridge if blood is spilled on it. Use gloves and wash hands after handling blood or blood soiled items. To protect yourself and others from infection: Do not perform blood or control fluid testing in areas where food and drink are stored or consumed. Use of expired cartridges Potential Sources of Harm to the Operator Test samples within 10 minutes of collection.Īny deviations will cause inaccurate results. Test only fresh whole blood samples collected in tubes with lithium heparin anticoagulant.įill tubes to capacity. Incorrect cartridge storage Incorrect sample collection and/or sample handling: Precautions Potential Sources of Error in Patient Results For assistance, contact Technical Support: 800.284.0702 or email:techsvc See the Start-up Section of the “i-STAT System Manual for Waived Tests” for how to prepare a new or replacement Handheld for use. Critical Values Ask your clinician to record critical values on the Test Range table in this guide. Contact your local sales person to schedule training as needed. Additionally, training can be done over the phone. It shows how to fill a cartridge and insert it into the Handheld. View the video companion CD to the Quick Reference Guide that comes with this guide. This guide contains information needed to get accurate results with the CHEM8+ cartridge and Handheld. Carefully read the section on Cartridge Storage. Training Requirements Read this whole guide before testing patient samples. Further, the instructions provided in this guide must be followed, or your facility may be in non-compliance with the CLIA Certificate of Waiver program. Regulatory Requirements To use the CHEM8+ cartridge and i-STAT 1 Handheld Analyzer (Handheld) for patient testing, your facility must have a CLIA Certificate of Waiver, and meet all applicable state and local laboratory testing laws. The CHEM8+ cartridge has tests for sodium, potassium, chloride, total carbon dioxide, ionized calcium, glucose, urea nitrogen, creatinine and hematocrit. I-STAT CHEM8+ Cartridge Quick Reference Guide ®
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