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Physio Control 11131-000040 Instrucciones De Uso página 27

Palas esterilizables de desfibrilación interna

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  • MEXICANO, página 563
Automated Washer Cleaning (Alternate/CE)
The internal paddles must be cleaned using an automated washer/disinfector compliant with
ISO 15883 (series). Manual Cleaning must not be used.
To clean the internal paddles using an automated washer, follow the steps below.
1. Inspect internal paddles as described in Pre-Cleaning Inspection (Alternate/CE) (on page
26).
2. Clean the internal paddles within one hour of use.
3. Place internal paddles in the washer according to your protocols and the washer
manufacturer's instructions. The internal paddles may be fully immersed, including cables
and connector. Water must be able to circulate freely around the paddles. Do not overcrowd
the washer, and do not wrap cables around the paddles.
4. Wash internal paddles using the following automated washer parameters.
Cycle
Prewash
Main Wash
Rinse
Purified Water Rinse
Disinfect
Dry
*Use purified water, highly purified water, or sterile water with less than 10 cfu/ml and 0.25
EU/ml.
Thermal disinfection was validated for the Automated Cleaning cycle. Both A
minute) and A
3000 (90°C/5 minute) have been validated as effective for disinfection.
0
5. Inspect internal paddles as described below in Post-Cleaning Inspection.
Post-Cleaning Inspection (Alternate/CE)
1. After the internal paddles have been cleaned, inspect the paddles to ensure that no visible
soil remains. If any soil is found, repeat the cleaning procedure.
2. Inspect the internal paddles for deterioration or defects as described in step 2 of the
Pre-Cleaning Inspection (Alternate/CE) (on page 26).
Duration
2 minutes
2 minutes
9 minutes
4 minutes
5 minutes
7 minutes or until no
visible water is left on
the device
Sterilizable Internal Defibrillation Paddles Instructions for Use
Fluid Type
Tap water
Heated tap water with
detergent neodisher
®
MediClean forte
Alkaline-based
detergent
(pH10.4-10.8)
Hot tap water
Heated purified water*
Heated purified water*
Not applicable
English
Target Temperature
16°C (61°F)
Per detergent
manufacturer's
directions 40° to
60°C (104°F to
140°F) or 45°C
(113°F)
82°C (180°F)
66°C (151°F)
90°C (194°F)
116°C (241°F)
600 (90°C/1
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27

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