Aircraft Medical McGRATH MAC EMS 운영자 매뉴얼 - 페이지 10

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Aircraft Medical McGRATH MAC EMS 운영자 매뉴얼

3 Maintenance and Decontamination

3.1 Decontamination

The device should be decontaminated immediately after each patient use. Decontamination
should be carried out in accordance with local regulations. Follow hospital policy and protocol when
handling and cleaning soiled items.
The following methods of decontamination were developed using standard equipment and practices
common to global healthcare facilities and according to regulatory requirements using the guidance
given in AAMI TIR 12 (Designing, Testing, Labelling Reusable Medical Devices for Reprocessing in Health
Care Facilities: A Guide for Device Manufacturers) and ISO 17664:2004 (Sterilization of medical devices
Information to be provided by the manufacturer for the processing of resterilizable medical devices).
The instructions provided have been validated by Aircraft Medical as being capable of preparing the
device for re-use. It remains the responsibility of the processor to ensure that the reprocessing as
actually performed using equipment, materials and personnel in the reprocessing facility achieve the
desired result. This normally requires validation and routine monitoring of the process.
Thorough cleaning and rinsing are vital for the decontamination of the device. The purpose of
cleaning and rinsing is to remove soiling and to reduce the number of microbiological agents.
Thorough rinsing is important for removing any residual cleaning agents from the medical device.
The following methods have been approved by Aircraft Medical:
PRODUCT
McGRATH® MAC
Disposable
Laryngoscope Blade
McGRATH® MAC EMS
with McGRATH® 3.6V
EMS Battery fitted
McGRATH® MAC EMS
with McGRATH® 3.6V
EMS Battery removed
McGRATH®
3.6V EMS Battery
*Wherever practical a High Level Disinfection or Sterilization is preferred to a wipe-based process.
RAPID
CLEANING
DISINFECTION*
Supplied Sterile
Supplied Sterile
Do Not
Do Not
Reprocess
Reprocess
Cleaning (Manual) -
Disinfectant Wipe
Non-Immersive
Cleaning (Manual) -
Disinfectant Wipe
Immersive
Cleaning (Manual) -
Disinfectant Wipe
Non-Immersive
HIGH LEVEL
STERILIZATION
DISINFECTION
Supplied Sterile
Supplied Sterile
Do Not
Do Not
Reprocess
Reprocess
STERRAD®
50/100S/200/
NX/ 100NX
High Level
STERRAD®
Disinfectant
50/100S/200/
Immersion /
NX/ 100NX
Chemical Disinfector
Ethylene Oxide
Sterilization
9