en

ICT CLEANING FLUID PRECAUTIONS (Continued)

1E50 Precautions for Users (Continued)
• The following warning and precaution apply to
This package insert contains information for the use of ICT Cleaning :
Fluid on the ARCHITECT c Systems.
Contains sodium azide.
Package insert instructions must be carefully followed. Reliability of EUH032 Contact with acids liberates very toxic gas.
assay results cannot be guaranteed if there are any deviations from the
instructions in this package insert. NOTE: Refer to Section 8 of the ARCHITECT System Operations
Manual for proper handling and disposal of products containing
Read Highlighted Changes Revised November 2012 sodium azide.
• The following warnings and precautions apply to
INTENDED USE and prepared for
For use as a cleaning solution to remove protein from the ICT unit and use (e.g., Working ICT Cleaning Fluid):
c System probes. Danger. The Working ICT Cleaning Fluid contains a
Refer to the ARCHITECT System Operations Manual for appropriate protease enzyme from Aspergillus and sodium azide.
placement of the prepared solution on the system. Hazard
H334 May cause allergy or asthma symptoms or
CONTENTS / MATERIALS PROVIDED breathing difficulty if inhaled.
1E50-20 ICT Cleaning Fluid EUH032 Contact with acids liberates very toxic gas.
• 1 x 150 mL Prevention
P261 Avoid breathing mist/vapors/spray.
• 10 x 12 mL P285 In case of inadequate ventilation wear
respiratory protection.
Reactive Ingredients Concentration
Response
P304+P340 IF INHALED: Remove victim to fresh air and
Protease enzyme 10.4 g/L keep at rest in a position comfortable for
Inactive Ingredients: contains sodium breathing.
azide (0.1%). P311 Call a POISON CENTER or doctor/physician.
• These materials and their containers must be disposed of in a safe
PRECAUTIONS way.
Precautions for Users • Safety Data Sheets are available at www.abbottdiagnostics.com or
contact your local representative.
•
• For In Vitro Diagnostic Use. STORAGE AND STABILITY
• Do not use components beyond the expiration date. Unopened ICT Cleaning Fluid components are stable until the expiration
• Do not mix materials from different kit lot numbers. date when stored at 15 to 30°C.
• Do not mix solutions prepared at different times. Once opened, the is stable until the expiration
• Do not reuse the solution containers, bottles, or caps due to the risk date when stored at 15 to 30°C.
of contamination and the potential to compromise performance. Prepared, capped Working ICT Cleaning Fluid is stable for 14 days when
• The following warnings and precautions apply to stored at 2 to 8°C, but no longer than the expiration date.
:
Danger. contains a protease INSTRUCTIONS FOR USE
enzyme from Aspergillus. 1. Tap the bottle right side up on a flat
Hazard surface before opening, to remove excess material from the cap.
H315 Causes skin irritation. IMPORTANT: Wait several minutes before removing the cap to allow
H319 Causes serious eye irritation. suspended particles to settle.
H334 May cause allergy or asthma symptoms or
breathing difficulty if inhaled. 2. Hold the bottle right side up on a flat
H335 May cause respiratory irritation. surface. Carefully remove the cap to avoid inhaling lyophilized
Prevention material.
P280 Wear protective gloves/protective clothing/eye 3. Prepare the Working ICT Cleaning Fluid by adding 12 mL of
protection. to the bottle.
P261 Avoid breathing dust. IMPORTANT: Allow the liquid to run down the inside of the bottle to
P271 Use only outdoors or in a well-ventilated area. minimize aerosolization of lyophilized material.
P285 In case of inadequate ventilation wear
respiratory protection.
P264 Wash hands thoroughly after handling.
Response
P304+P341 IF INHALED: If breathing is difficult, remove
victim to fresh air and keep at rest in a
position comfortable for breathing.
P305+P351 IF IN EYES: Rinse cautiously with water for
+P338 several minutes. Remove contact lenses, if
present and easy to do. Continue rinsing.
P302+P352 IF ON SKIN: Wash with plenty of water.
P342+P311 If experiencing respiratory symptoms: Call a
POISON CENTER or doctor/physician. 4. Replace the cap and mix by gentle inversion. Document the date of
P337+P313 If eye irritation persists: Get medical advice/ preparation.
attention. 5. Load the Working ICT Cleaning Fluid as directed when performing
P332+P313 If skin irritation occurs: Get medical advice/ daily maintenance procedure 6070-Daily maintenance, as-needed
attention. maintenance procedure 6062-Wash ICT with Cleaning Fluid, or
P362 Take off contaminated clothing and wash as-needed maintenance procedure 6058-Clean R2 Probe*.
before reuse. * This procedure is available beginning with ARCHITECT System
software v8.00.

1
INDICATIONS OF INSTABILITY OR DETERIORATION
Instability or deterioration should be suspected if there are visible
signs of leakage, extreme turbidity, microbial growth, or if ICT module
calibration does not meet the ARCHITECT System Operations Manual
criteria.

LIMITATIONS OF THE PROCEDURE

Accurate and reproducible results are dependent upon properly
functioning instruments and reagents, storage of product as directed,
and good laboratory technique.

TRADEMARKS
The ARCHITECT c System family of instruments consists of c 4000,
c 8000, and c 16000 instruments.
ARCHITECT, c 4000, c 8000, c 16000, and c System are trademarks of
Abbott Laboratories in various jurisdictions.
All trademarks are property of their respective owner(s).

ICT CLEANING FLUID

1E50

Customer Service: Contact your local representative or find

country-specific contact information on
www.abbottdiagnostics.com.
Key to Symbols Used
After reconstitution store at
Contains sodium azide. Contact with
acids liberates very toxic gas.
DANGER: SENSITIZER Danger: Respiratory Sensitizer Abbott Laboratories
Abbott Park, IL 60064 USA
Identifies products to be used
together
ABBOTT
Global Trade Item Number Max-Planck-Ring 2
65205 Wiesbaden
ICT Cleaning Solution Germany
+49-6122-580
ICT Lyophilized Cleaning Solution
Information needed for United States
of America only
PRODUCT OF CANADA Product of Canada
November 2012
Warning: Severe Irritant 305161/R03
©2009, 2012 Abbott Laboratories