EDAN iM80 User Manual - page 14
Patient Monitor User Manual Indication for Use and Safety Guidance
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CAUTION
1
Electromagnetic Interference - Ensure that the environment in which the patient
monitor is installed is not subject to any sources of strong electromagnetic
interference, such as radio transmitters, mobile telephones, etc.
2
Keep the environment clean. Avoid vibration. Keep it far away from corrosive
medicine, dust area, high temperature and humid environment.
3
Do not immerse transducers in liquid. When using solutions, use sterile wipes to avoid
pouring fluids directly on the transducer.
4
Do not use autoclave or gas to sterilize the monitor, recorder or any accessories.
5
The device and reusable accessories could be sent back to the manufacturer for
recycling or proper disposal after their useful lives.
6
Disposable devices are intended for single use only. They should not be reused as
performance could degrade or contamination could occur.
7
Remove a battery whose life cycle has expired from the monitor immediately.
8
Avoid liquid splash on the device. The temperature must be kept between 5
°C and
40
°C while working. And it should be kept between -20°C and 55°C during
transportation and storage.
9
To ensure patient safety, use only parts and accessories manufactured or
recommended by EDAN.
10
Federal law restricts this device to sale by or on the order of a physician.
NOTE:
1
Position the device in a location where the operator can easily see the screen and
access the operating controls.
2
The monitor can only be used on one patient at a time.
3
If the monitor gets damp or liquid pours on the monitor, please contact the service
personnel of EDAN.
4
This monitor is not a device for treatment purposes.
5
The pictures and interfaces in this manual are for reference only.
6
Regular preventive maintenance should be carried out every two years. You are
responsible for any requirements specific to your country.
1.3 Explanation of Symbols on the Monitor
This symbol indicates that the equipment is IEC/EN60601-1 Type CF
equipment. The unit displaying this symbol contains an F-Type isolated
(floating) patient applied part providing a high degree of protection
against shock, and is suitable for use during defibrillation.