Cleaning And Disinfection Instruction; List Of Applicable Standards - AMATECH F-70300 Instructions D'utilisation

INSTRUCTIONS FOR USE

Cleaning and Disinfection Instruction:

 Clean the device after Each use.
 Clean and disinfect using a quaternary ammonium disinfecting/cleaning
solution following the manufacturers recommendation for achieving low-
level disinfection.
 Read the cleaning product's directions and follow the instructions on the
label. Use caution in areas where fluid migration may occur.
 After use of disinfectant, clean the device with alcohol-based wipes.
 Dry product with a dry, absorbent and lint free cloth.
 Make certain the product is dry prior to reinstalling or storing to avoid
damage.
WARNING: Damage may result if product is cleaned with bleach.
CAUTION: DO NOT IMMERSE IN ANY LIQUID.
CAUTION: DO NOT USE BLEACH OR PHENOLICS.
5

List of Applicable Standards:

Sl. no Standards
EN 62366-1
1.
EN ISO 14971
2.
EN 1041
3.
EN ISO 15223-1
4.
EN ISO 10993-1
5.
IEC 60601-2-46
6.
ISTA
7.
Document Number: 80028280
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 18
Description
Issue Date: 25 MAR 2020
Ref Blank Template: 80025118 Ver. E