AMATECH F-70801, Instructions For Use Manual, Page: 21 / 593

INSTRUCTIONS FOR USE
Document Number: 80028263
Page 21
Issue Date: 25 MAR 2020
Version: B Ref Blank Template: 80025118 Ver. E
 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. no Standards Description
1. EN 62366-1
Medical devices - Part 1: Application of usability
engineering to medical devices
2. EN ISO 14971
Medical devices- Application of risk management
to medical devices.
3. EN 1041
Information supplied by the manufacturer of
medical devices
4. EN ISO 15223-1
Medical devices - Symbols to be used with
medical device labels, labelling and information
to be supplied - Part 1: General requirements
5. EN ISO 10993-1
Biological evaluation of medical devices - Part 1:
Evaluation and testing within a risk management
process
6. IEC 60601-2-46
Medical electrical equipment - Part 2-46:
Particular requirements for the basic safety and
essential performance of operating tables
7. ISTA
International Safe Transit Association standards for
package testing