Cleaning And Disinfection Instruction; List Of Applicable Standards - AMATECH Bariatric Armboard F-80200 Instructions D'utilisation

INSTRUCTIONS FOR USE

Cleaning and Disinfection Instruction:

WARNING:
 Do not use bleach or products that contain bleach to clean the device. Injury or
equipment damage can occur.
 After each use, clean the device with alcohol-based wipes.
 Do not put the device into water. Equipment damage can occur.
 Use a cloth and a quaternary ammonium disinfecting/cleaning solution to clean and
disinfect the device.
 Read and follow the manufacturer's recommendation for low-level disinfection.
 Read and follow the cleaning product's instructions. Use caution in areas where
liquid can get into the mechanism.
 Wipe the device with a clean, dry cloth.
 Make sure that the device is dry before you store it or use it again.
CAUTION: DO NOT IMMERSE PADS IN ANY LIQUID
CAUTION: DO NOT USE BLEACH OR PHENOLICS ON PADS

5. List of Applicable Standards:

Sl.
Standards
no
1. EN 62366-1
2. EN ISO 14971
3. EN 1041
4. EN ISO 15223-1
5. EN ISO 10993-1
6. IEC 60601-2-46
7. ISTA
Document Number: 80028256
Version: B
Medical devices - Part 1: Application of usability engineering to
medical devices
Medical devices- Application of risk management to medical
devices.
Information supplied by the manufacturer of medical devices
Medical devices - Symbols to be used with medical device
labels, labelling and information to be supplied - Part 1: General
requirements
Biological evaluation of medical devices - Part 1: Evaluation and
testing within a risk management process
Medical electrical equipment - Part 2-46: Particular requirements
for the basic safety and essential performance of operating
tables
International Safe Transit Association standards for package
testing
Page 15
Description
Ref Blank Template: 80025118 Ver. E
Issue Date: 18 MAR 2020