Statutory Recommendations; Compliance; Electromagnetic Compatibility; Medical Device Vigilance - SOPRO COMEG 640-45L Manuel D'utilisation

E N G L I S H
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• Bacterial filter
The use of a hydrophobic bacterial filter is essential for preventing cross-contamination with the patient
• Please follow the conditions of use and storage.
• Do not expose the device to too much dust.
• This device must only be opened by a technician approved by the manufacturer.
• In order to prevent any danger of electrocution, fire, short circuits or dangerous emissions, do not insert metal objects into the device.
• Do not expose the device to water spray or splashes, and do not install it in a very humid area.
• Use only the ancillary equipment delivered with the device or suggested by the manufacturer as an option.
• Do not connect this device to any other device.
• This insufflator must not be used in the presence of flammable anesthetics.
• This device has not been designed for use in an ionizing environment.
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STATUTORY RECOMMENDATIONS

A. COMPLIANCE
This device was designed and manufactured by a company with a certified quality system.
It complies with the requirements of European directive 93/42/EEC on medical devices.
Consequently it complies in particular with the specific standards relating to electrical safety (IEC) and electromagnetic compatibility (EMC).
B. ELECTROMAGNETIC COMPATIBILITY
Although this product complies with standards on electromagnetic compatibility (Appendix XII) it is possible that, in very particular circumstances, it could interfere
with other devices, or even that other devices or an adverse electromagnetic environment could interfere with it.
To prevent similar situations, we recommend to:
• check the quality of the electrical network (and in particular the earthing of all the devices and trolleys)
• keep the device away from electromagnetic sources (for example mobile phones, GSM phones, compressors, motors, transformers, HF generators in general etc).
C. MEDICAL DEVICE VIGILANCE
Like any medical device, this device is subject to the provisions related to medical device vigilance; therefore any serious malfunction must without fail be promptly
reported to the proper authority and to the manufacturer, giving as much detailed information as possible.
Please refer to the last page for the manufacturer's contact details.
D. END OF LIFE
This device carries the recycling symbol in accordance with European directive 2002/96/CE on Waste Electrical and Electronic Equipment (DEEE or WEEE).
By following the correct procedures for disposing of this device you will be contributing to the prevention of any consequences that could be harmful to the
environment or human health.
The symbol to be found on the device and/or in the accompanying documentation indicates that this product may on no account be treated as household
waste. It must therefore be delivered to a waste collection point for the recycling of electrical and electronic equipment.
For rejecting the device, please observe the standards applied in the country of installation.
To obtain complete details about the treatment, recovery and recycling of this appliance, please contact your closest dealer to know how to proceed.
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