Sterilization Instruction; Cleaning And Disinfection Instruction; List Of Applicable Standards - AMATECH F-ABMT1 Instrucciones De Uso

INSTRUCTIONS FOR USE

4.3 Sterilization Instruction:

This device is not intended to be sterilized. Equipment damage may occur.

4.4 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. no
1 EN 62366-1
2 EN ISO 14971
3 EN 1041
4 EN ISO 15223-1
5 EN ISO 10993-1
Document Number: D-720282
Version: C
Standards Description
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
Page 15 Issue Date: 17 MAR 2020
Ref Blank Template: 80025118 Ver. E