Addendums; Magnetic Resonance Imaging Environment; Symbol Explanation - BIO-MED DEVICES IC-2A Instruction Manual

ADDENDUMS

MAGNETIC RESONANCE IMAGING ENVIRONMENT

WARNING: ONLY AN IC-2A ORIGINALLY MANUFACTURED BY BIO-MED DEVICES
FOR MRI USE OR RECEIVING AN MRI CONVERSION BY BIO-MED DEVICES IS TO BE
USED IN AN MRI ENVIRONMENT. THESE UNITS WILL BE DESIGNATED BY AN MRI
LABEL AND AN "M" AS A SUFFIX TO THE SERIAL NUMBER.
WHEN USING THE IC-2A/MRI VENTILATOR IN AN MRI ENVIRONMENT, THE
FOLLOWING PRECAUTIONS MUST BE TAKEN:
• THE VENTILATOR MUST NOT BE PLACED INSIDE THE MRI BORE (SEE
APPENDIX B).
• DO NOT USE ANY ACCESSORIES, INCLUDING OXYGEN AND AIR CYLINDERS,
REGULATORS, MOUNTING BRACKETS AND SUPPORT STANDS, THAT ARE
MADE OF ANY METAL THAT COULD BE ATTRACTED BY A MAGNET.

SYMBOL EXPLANATION

Attention, See Instructions for Use
Date of Manufacture
SN
Serial Number
REF
Catalog Number
The CE mark displayed on this product signifies that this device is in compliance
with the European Medical Devices Directive (Council Directive 93/42/EEC). As a
prerequisite for the CE mark, Bio-Med Devices operates under an ISO 13485
compliant quality system (covering the design and manufacture of medical
devices). The four-digit code underlying the CE mark (0086) pertains to Bio-
Med's Notified Body, the British Standards Institute, whose function is to
investigate and attest to the validity of CE-mark claims.
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