PROCEDURE MANUAL FOR THE i-STAT SYSTEM
21
REV. DATE: 16-Oct-12 ART: 714446-00L
solution. If necessary, tap the tip of the ampule to send solution back into the bottom section of the ampule. Protect
fingers with gauze, tissue, or glove, or use an ampule breaker to snap off the tip of the ampule at the neck.
3 Immediately transfer the solution from the ampule into a plain capillary tube or plain syringe, and then immediately
transfer the solution into a cartridge. Immediately seal the cartridge and insert it into a handheld. It is important not to
expose the solution to room air since this will alter the results.
When using a capillary tube, fill from the bottom of the ampule. Avoid drawing solution from the surface by
placing a finger over the far end of the tube as it is inserted into the ampule. Once the open end of the tube rests at
the bottom of the ampule, uncover the other end to allow filling by capillary action.
When using a syringe (1cc or 3cc syringes with 16 to 20 gauge needles are recommended), slowly draw
approximately 1 mL of solution from the bottom of the ampule. If air is trapped between the leading edge of the
solution and the plunger, do not invert the syringe to expel it; this will not affect solution near the tip of the
syringe. If air bubbles are continually drawn into the syringe, or if a bubble is trapped near the tip of the syringe,
discard the ampule and syringe and use a fresh ampule and syringe. Expel one or two drops from the syringe
before filling the cartridge.
Do not use solution left in the syringe, ampule, or capillary tube for additional testing of the cartridges that
contain sensors for ionized calcium, pH, PCO
2
, or PO
2
. However, cartridges without these sensors may be tested
with remaining fluids if within 10 minutes of opening the ampule.
4. Compare results to the Value Assignment Sheet ranges. Ensure that the lot number printed on the Value Assignment Sheet
matches the lot number on the label of the ampule and that the software version above the target value table matches the
software version in the handheld. If all results are within expected ranges, use the cartridges as needed. Transmit the results
to the Central Data Station.
Procedure for testing CHEM8+ cartridges with i-STAT CHEM8+ controls.
1. Equilibrate the ampule for approximately 30 minutes at room (ambient) temperature.
2. Immediately before use, shake the ampule vigorously for 5-10 seconds to equilibrate the liquid and gas phases. To
shake, hold the ampule at the tip and bottom with forefinger and thumb to minimize increasing the temperature of
the solution. If necessary, tap the tip of the ampule to send solution back into the bottom section of the ampule.
3. Protect fingers with gauze, tissue or glove, or use an ampule breaker to snap off the tip of the ampule at the neck.
4. Immeditely transfer the solution from the ampule into a plain capillary tube or plain syringe, and then immediately
transfer the solution into a cartridge.
5. Immediately seal the cartridge and insert it into a handheld – it is important not to expose the solution to room air
since this will alter the results.
When using a capillary tube, fill from the bottom of the ampule. Avoid drawing solution from the surface by
covering the far end of the tube as it is inserted into the ampule. Once the open end of the tubes at the bottom
of the ampule, uncover the other end to allow filling by capillary action.
When using a syringe (1 cc or 3 cc syringes with 16-20 gauge needles are recommended), slowly draw
approximately 1 mL of solution from the bottom of the ampule. If air is trapped between the leading edge of
the solution and the plunger, do NOT invert the syringe to expel it; this will not affect solution near the tip of
the syringe. If air bubbles are continually drawn into the syringe, or if a bubble is trapped near the tip of the
syringe, discard the ampule and syringe and use a fresh ampule and syringe. Expel one or two drops from the
syringe before filling the cartridge.
Do not use solution left in the syringe, ampule, or capillary tube for additional testing of CHEM8+ cartridges.
6. Compare results to the value assignment sheet ranges. Check that the lot number on the control ampule matches the
lot number on the package insert that the software version listed on the insert matches the software installed in the
handheld. If all results are within expected ranges, use the cartridges as needed. Transmit the results to the Central
Data Station.
Procedure for testing cartridges with RNA Medical Hematocrit controls
1. If stored refrigerated, the control material should be equilibrated to room temperature for at least four (4) hours
prior to use. If stored at room temperature, no equilibration of the control material is necessary.
2. Gently invert the ampule to mix the solution. Tap the ampule to restore the liquid to the bottom of the ampule.
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