![background image](http://html1.mh-extra.com/html/abbott/i-stat-alinity/i-stat-alinity_operation-manual_3045656115.webp)
i-STAT ACT Controls
The i
‑
STAT ACT Control Level 1 and ACT Control Level 2 are intended for use to verify the integrity of
newly received i
‑
STAT ACT cartridges. The controls produce clotting times expected for moderate and
high level heparinization to indicate that the cartridges are functioning properly.
Storage
i-STAT ACT controls contain two levels, Level l and Level 2. ACT controls consist of two vials for each level
of control. One vial contains lyophilized plasma and the other vial contains the diluent (calcium chloride
solution). One box contains 5 vials of lyophilized plasma and 5 vials of diluent. Lyophilized plasma and
the diluent should be refrigerated at 2 to 8°C (35 to 46°F) until the expiration date printed on the box
and vial labels. Do not use beyond the expiration date.
Warnings and Precautions
Handle this product using the same safety precautions used when handling any potentially infectious
material. The human plasma used in the preparation of this product has been tested by FDA-approved
test methods and found negative/non-reactive for HIV-1, HIV-2, HBsAg, and HCV. However, no known
test method can offer complete assurance that products derived from human blood will not transmit
infectious disease.
Ranges
Assigned ranges are found on i
‑
STAT Value Assignment Sheets (VAS) located on
www.globalpointofcare.abbott/en/support/istat-brand/vas-i-stat-alinity.html
. Follow facility policy
regarding control results that do not fall within assigned ranges.
Disposal
Dispose of this product as biohazardous waste according to all local, state, and national regulations.
Reconstitution Instructions
Prior to testing, i
‑
STAT ACT Control vials containing the lyophilized plasma and diluent should stand at
room temperature (18° to 30°C or 64° to 86°F) for a minimum of 45 minutes.
Note: Vials left out at room temperature for more than 4 hours should be discarded.
Pour the entire contents of the diluent into the lyophilized plasma vial. See further instructions under
Procedure for Testing
Prerequisites
•
Vials, cartridges, and instruments must be at the same temperature.
•
i
‑
STAT ACT Control vials containing the lyophilized plasma and diluent should stand at room
temperature (18 to 30°С or 64 to 86°F) for a minimum of 45 minutes.
•
i
‑
STAT ACT Control testing must be performed IMMEDIATELY (less than 30 seconds) AFTER
COMPLETING THE RECONSTITUTION AND MIXING STEPS.
77
i-STAT Alinity — System Operations Manual
Art: 745533-01 Rev. H
Rev. Date: 02-Nov-2022
Summary of Contents for i-STAT Alinity
Page 1: ......
Page 12: ...xii i STAT Alinity System Operations Manual Art 746982 01 Rev E Rev Date 02 Nov 2022 ...
Page 24: ...xxiv i STAT Alinity System Operations Manual Art 746983 01 Rev H Rev Date 11 Nov 2020 ...
Page 39: ......
Page 44: ...6 i STAT Alinity System Operations Manual Art 745526 01 Rev H Rev Date 04 Mar 2021 ...
Page 48: ...10 i STAT Alinity System Operations Manual Art 745527 01 Rev N Rev Date 13 Oct 2022 ...
Page 84: ...46 i STAT Alinity System Operations Manual Art 745531 01 Rev G Rev Date 04 Mar 2021 ...
Page 88: ...50 i STAT Alinity System Operations Manual Art 745529 01 Rev G Rev Date 04 Mar 2021 ...
Page 96: ...58 i STAT Alinity System Operations Manual Art 745530 01 Rev D Rev Date 16 May 2022 ...
Page 100: ...62 i STAT Alinity System Operations Manual Art 745578 01 Rev C Rev Date 04 Mar 2021 ...
Page 108: ...70 i STAT Alinity System Operations Manual Art 745525 01 Rev E Rev Date 04 Mar 2021 ...
Page 110: ...72 i STAT Alinity System Operations Manual Art 745532 01 Rev D Rev Date 04 Mar 2021 ...
Page 134: ...96 i STAT Alinity System Operations Manual Art 745524 01 Rev I Rev Date 02 Nov 2022 ...
Page 147: ......
Page 164: ...126 i STAT Alinity System Operations Manual Art 747079 01 Rev F Rev Date 28 Apr 2020 ...
Page 167: ......
Page 176: ...136 i STAT Alinity System Operations Manual Art 746298 01 Rev M Rev Date 13 Oct 2022 ...
Page 250: ...210 i STAT Alinity System Operations Manual Art 746300 01 Rev N Rev Date 02 Nov 2022 ...
Page 290: ...250 i STAT Alinity System Operations Manual Art 746300 01 Rev N Rev Date 02 Nov 2022 ...
Page 296: ...256 i STAT Alinity System Operations Manual Art 746304 01 Rev H Rev Date 29 Oct 2019 ...