04665244001V9.

Activator
Order information
Analyzer(s) on which kit(s) can be used
COBAS INTEGRA systems
04663632 190 Activator (9 × 12 mL) cobas c systems
cobas c 111 system

English Use fresh material each day and return the unused material to storage at
2‑8 °C.
Intended use
The Activator is an auxiliary maintenance reagent recommended during the 2nd week:
daily service tasks for the conditioning of the ISE electrodes, tubing and Thaw the frozen material and gently swirl the contents until mixed and at
samples probes. After the Activator is placed on the system it is pipetted room temperature. Use this material for daily service tasks (750 μL
automatically when required for service actions. The primary purpose of the Activator per Cobas sample cup). Use fresh material each day and return
Activator is to activate the ISE electrodes, to coat the ISE tubing and the the unused material to storage at 2‑8 °C.
sample probes which ensures correct handling and pipetting of sample Roche/Hitachi cobas c 111 system (without ISE unit)
material after the daily cleaning procedures. 1st week:
Summary Firstly transfer three aliquots of 3 mL of reconstituted material to new
adequate plastic or glass vials with stoppers. Store these vials tightly
Activator is a lyophilized human serum. capped at (-15)‑(-25) °C for use during second, third and fourth week.
Reagents - working solutions Keep the remaining material in the original glass bottle for use as required
Lyophilized human serum without chemical additives. during weekly service tasks. Return the unused material to storage at
Precautions and warnings 2‑8 °C.
For in vitro diagnostic use for health care professionals. Exercise the 2nd, 3rd and 4th week:
normal precautions required for handling all laboratory reagents. Thaw the frozen material weekly and gently swirl the contents until mixed
and at room temperature. Use this material as required during weekly
Infectious or microbial waste: service tasks. Return the unused material to storage at 2‑8 °C.
Warning: handle waste as potentially biohazardous material. Dispose of
waste according to accepted laboratory instructions and procedures. Discard the original glass bottle as well as the vials and remaining contents
regardless of residual volume after weekly usage.
Environmental hazards:
Apply all relevant local disposal regulations to determine the safe disposal. Roche/Hitachi cobas c 111 system (with ISE unit)
Safety data sheet available for professional user on request. 1st week:
Firstly transfer approximately 6.5 mL of reconstituted material to a new
All human material should be considered potentially infectious. All products adequate plastic or glass vial with stopper. Store the freshly filled vial tightly
derived from human blood are prepared exclusively from the blood of capped at (-15)‑(-25) °C for use during the second week.
donors tested individually and shown to be free from HBsAg and antibodies
to HCV and HIV. The testing methods use assays that have been approved Keep the remaining material in the original glass bottle for use as required
by the FDA or that are in compliance with the legal rules applicable to during weekly service tasks. Return the unused material to storage at
placing in vitro diagnostic medical devices for human use on the market in 2‑8 °C.
the European Union. 2nd week:
However, as no testing method can rule out the potential risk of infection Thaw the frozen material and gently swirl the contents until mixed and at
with absolute certainty, the material should be handled with the same level room temperature. Use this material as required during weekly service
of care as a patient specimen. In the event of exposure, the directives of the tasks. Return the unused material to storage at 2‑8 °C.
responsible health authorities should be followed.1,2 Discard the original glass bottle as well as the vials and remaining contents
For USA: Caution: Federal law restricts this device to sale by or on the regardless of residual volume after weekly usage.
order of a physician. Note
Reagent handling The reconstituted material must be kept stoppered and stored at adequate
Carefully open one bottle containing the lyophilized Activator, avoid the loss temperature. Do not pool Activator from different stored vials due to clotting
of lyophilisate and pipette in 12.0 mL of distilled/deionized water. Carefully effects. Do not use a lid for the 11 mL vial of the Activator when placed on
close the bottle and dissolve the contents completely by gentle swirling the ISE rack for COBAS INTEGRA systems.
within 30 minutes. Avoid the formation of foam. The final volume of The on-board stability for the Activator material in a new 11 mL vial is
reconstituted material will be 13 mL. Then proceed according to the weekly 4 days maximum for all COBAS INTEGRA systems.
handling recommendation.
Excessive use of plasma samples will invoke additional service procedures
Weekly handling recommendation on COBAS INTEGRA systems. These procedures will use additional
COBAS INTEGRA systems Activator material. In some cases more material will be required than
1st day: recommended in the weekly handling.
Transfer approximately 6.5 mL of reconstituted material to a new 11 mL Bacterial contamination of the Activator will lead to system contamination
plastic vial supplied in the Activator Bottle Set. Place the freshly filled 11 mL and have a negative impact on pipetting and ISE function. To avoid this
vial on the ISE rack in the position reserved for the Activator. Return the possibility please make sure that only new 11 mL vials are used, and that
unused material to storage at 2‑8 °C. the recommended protocol is followed.
4th day: Storage and stability
Discard the 11 mL vial and remaining contents regardless of residual
volume. Transfer the remaining reconstituted material from the originally Stability of the lyophilized Activator:
prepared bottle into a new 11 mL vial and place on the ISE rack in the at 15‑25 °C 5 days
position reserved for the Activator.
Roche/Hitachi cobas c systems at 2‑8 °C up to the stated expiry date
1st week: Stability of the reconstituted Activator:
Firstly transfer approximately 6.5 mL of reconstituted material to a new
adequate plastic or glass vial with stopper. Store the freshly filled vial tightly at 15‑32 °C 4 days
capped at (-15)‑(-25) °C for use during the second week. at 2‑8 °C 7 days
Keep the remaining material in the original glass bottle and decant sufficient
material daily for service tasks (750 μL Activator per Cobas sample cup). at (-15)‑(-25) °C 28 days (when frozen once)

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04665244001V9.0

Activator
The possible cloudy appearance of the reconstituted material has no effect
on the functionality of the Activator. Store the Activator tightly capped when
not in use.
Materials provided
See “Reagents – working solutions” section for reagents.
Materials required (but not provided)
▪ Activator Bottle Set (50 x 11 mL), Cat. no. 04745086 (for
COBAS INTEGRA systems)
▪ Adequate plastic or glass vials with stopper
▪ Cobas sample cup, Cat.no. 10394246 (Roche/Hitachi cobas c systems)
▪ Distilled or deionized water
▪ Roche system reagents and clinical chemistry analyzer
▪ General laboratory equipment
References
1 Occupational Safety and Health Standards: Bloodborne pathogens.
(29 CFR Part 1910.1030). Fed. Register.
2 Directive 2000/54/EC of the European Parliament and Council of
18 September 2000 on the protection of workers from risks related to
exposure to biological agents at work.
For further information, please refer to the appropriate operator’s manual for
the analyzer concerned, the respective application sheets and method
sheets of all necessary components.
A point (period/stop) is always used in this Method Sheet as the decimal
separator to mark the border between the integral and the fractional parts of
a decimal numeral. Separators for thousands are not used.
Any serious incident that has occurred in relation to the device shall be
reported to the manufacturer and the competent authority of the Member
State in which the user and/or the patient is established.
Symbols
Roche Diagnostics uses the following symbols and signs in addition to
those listed in the ISO 15223‑1 standard (for USA: see dialog.roche.com for
definition of symbols used):
Contents of kit
Reagent
Volume after reconstitution or mixing
GTIN Global Trade Item Number

FOR US CUSTOMERS ONLY: LIMITED WARRANTY

Roche Diagnostics warrants that this product will meet the specifications
stated in the labeling when used in accordance with such labeling and will
be free from defects in material and workmanship until the expiration date
printed on the label. THIS LIMITED WARRANTY IS IN LIEU OF ANY
OTHER WARRANTY, EXPRESS OR IMPLIED, INCLUDING ANY IMPLIED
WARRANTY OF MERCHANTABILITY OR FITNESS FOR PARTICULAR
PURPOSE. IN NO EVENT SHALL ROCHE DIAGNOSTICS BE LIABLE
FOR INCIDENTAL, INDIRECT, SPECIAL OR CONSEQUENTIAL
DAMAGES.
COBAS, COBAS C and COBAS INTEGRA are trademarks of Roche.
All other product names and trademarks are the property of their respective owners.
Additions, deletions or changes are indicated by a change bar in the margin.
© 2021, Roche Diagnostics

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www.roche.com
+800 5505 6606

Distribution in USA by:

Roche Diagnostics, Indianapolis, IN
US Customer Technical Support 1-800-428-2336

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