SLE 2000 HFO, Руководство по обслуживанию

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Issue 10 (01/10/2004) Page 247 of 258
19.1.15 SI 020901 Cleaning, Disinfection and Sterilisation of SLE ventilators.
Subject: Cleaning, Disinfection and Sterilisation of SLE
ventilators.
Equipment: SLE 2000, SLE2000 HFO, SLE2000 HFO Plus
Serial Numbers: All
Service information Number: SI020901
Date: 24/09/2002
Introduction
The MDA has issued a safety notice SN 2001(28) “Compatibility of medical devices and
reprocessing equipment with Decontamination agents,” which states that manufactures of
medical devices should state decontamination agents that are compatible with there products.
The following is an extract from Medical Devices Agency safety notice SN 2001(28)
The Medical Devices Agency continues to receive reports about damage to medical devices or
their components and to reprocessing equipment following contact with incompatible
decontamination agents.
The damage is usually the result of reactions between the decontamination agent and the
materials of construction of the device or reprocessing unit. Such damage may affect the
performance or functionality of the device or the effectiveness of the decontamination
procedure.
Manufacturers of reusable medical devices are required to provide information on how
to decontaminate their devices. This information should include the types of
decontamination agent that may be used, together with a warning of any agents or
processes that are known to be detrimental to the device.
Due to SN 2001(28) we are issuing more detailed guidelines for the Cleaning, Disinfection and
Sterilisation of our products, to be used in conjunction with those already in the user manuals.
Cleaning, Disinfection and Sterilisation Guidelines.
We recommend the following agents:
Ventilator outer casings and pole: Liquid cleaner or detergent. (As recommended by an
appropriate hospital authority).
Do not use any strong solvent cleaners on the front panels or labels.
Main and rotating jets: 70% Isopropranol alcohol (AZO wipes).
Do not use Haz Tab on the main and rotating jet or manifold as this may cause corrosion over
time.
Exhalation block: Standard autoclave at a 134 degrees Celsius for 3 minutes
or at 121 degrees Celsius for 20 minutes. No limit to
number of autoclave cycles
Measures to prevent contamination of SLE ventilators whilst in use.
We recommend that in line bacterial filters are used between the patient circuit and the
exhalation block and the fresh gas port and humidifier supply line.We also recommend that
single use patient circuits are used where possible.