EDAN iM80 User Manual - page 13
Patient Monitor User Manual Indication for Use and Safety Guidance
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WARNING
6
Magnetic and electrical fields are capable of interfering with the proper performance
of the device. For this reason make sure that all external devices operated in the
vicinity of the monitor comply with the relevant EMC requirements. X-ray equipment
or MRI devices are a possible source of interference as they may emit higher levels of
electromagnetic radiation.
7
Route all cables away from patient’s throat to avoid possible strangulation.
8
Devices connecting with monitor should be equipotential.
9
Accessory equipment connected to the analog and digital interfaces must be certified
according to the respective IEC/EN standards (e.g. IEC/EN 60950 for data processing
equipment and IEC/EN 60601-1 for medical equipment). Furthermore all
configurations shall comply with the valid version of the standard IEC/EN 60601-1-1.
Therefore anybody, who connects additional equipment to the signal input or output
connector to configure a medical system, must make sure that it complies with the
requirements of the valid version of the system standard IEC/EN60601-1-1. If in doubt,
consult our technical service department or your local distributor.
10
Only patient cable and other accessories supplied by EDAN can be used. Or else, the
performance and electric shock protection can not be guaranteed, and the patient
may be injuried.
11
Do not rely exclusively on the audible alarm system for patient monitoring. Adjustment
of alarm volume to a low level or off during patient monitoring may result in a hazard
to the patient. Remember that the most reliable method of patient monitoring
combines close personal surveillance with correct operation of monitoring equipment.
12
When interfacing with other equipment, a test for leakage current must be performed
by qualified biomedical engineering personnel before using with patients.
13
During monitoring, if the power supply is off and there is no battery for standby, the
monitor will be off, and only the patient information and alarm settings can be saved.
After reconnecting the power supply, the user should turn on the monitor for
monitoring.
14
Keep away from fire immediately when leakage or foul odor is detected.
15
The device and accessories are to be disposed of according to local regulations after
their useful lives. Alternatively, they can be returned to the dealer or the manufacturer
for recycling or proper disposal. Batteries are hazardous waste. Do NOT dispose
them together with house-hold garbage. At the end of their life hand the batteries over
to the applicable collection points for the recycling of waste batteries. For more
detailed information about recycling of this product or battery, please contact your
local Civic Office, or the shop where you purchased the product.
16
Dispose of the package material, observing the waste control regulations and keeping
it out of children’s reach.
17
After defibrillation, the screen display recovers within 10 seconds if the correct
electrodes are used and applied based on the manufacturers’ instructions.
18
This equipment is not intended for family usage.