Arthrex AR-1627-03, Instructions For Use Manual

Page: 15 / 377

INSTRUCTIONS FOR USE
Document Number: 80028275
Page 15
Issue Date: 30 MAR 2020
Version: B Ref Blank Template: 80025118 Ver. E
Sterilization Instruction:
This device is not intended to be sterilized. Equipment damage may occur.
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 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