Arthrex AR-1627-15, Instructions For Use Manual

Page: 16 / 387

INSTRUCTIONS FOR USE
Document Number: 80028278
Page 16
Issue Date: 30 MAR 2020
Version: B Ref Blank Template: 80025118 Ver. E
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
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