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Patient Monitor User Manual
13
Do not rely exclusively on the auditory 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.
14
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.
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/EN 60601-1. If in doubt,
consult our technical service department or your local distributor.
15
The monitor is equipped with wireless AP/Wi-Fi to receive RF electromagnetic energy.
Therefore, any other equipment complying with CISPR radiation requirements may
also interfere with the wireless communication and make it interrupted.
16
Only patient cable and other accessories supplied by EDAN can be used. The
performance and electric shock protection cannot be guaranteed, and the patient may
be injured otherwise. Prior to use, check if the casing of a disposable or sterilized
accessory is intact. Do not use it if its casing is damaged.
17
When interfacing with other equipment, a test for leakage current must be performed
by qualified biomedical engineering personnel before using with patients.
18
If several items of medical equipment are interconnected, pay attention to the sum of
the leakage currents, otherwise it may cause shock hazard. Consult your service
personnel.
19
During monitoring, if the power supply is off and there is no battery for standby, the
monitor will be off. The settings configured by the user can be stored, and settings not
configured by user keep no change. That is, the last settings used will be recovered
when the power is restored.
20
If leakage or foul odor is detected, ensure that there's no fire around.
21
Wireless LAN equipment contains an intentional RF radiator that has the potential of
interfering with other medical equipment, including patient implanted devices. Be sure
to perform the electromagnetic compatibility test, before installation and any time new
medical equipment is added to the Wireless LAN coverage area.
22
The packaging is to be disposed of according to local or hospital's regulations;
otherwise, it may cause environmental contamination. Place the packaging at the
place which is inaccessible to children.
WARNING
- 3 -
Intended Use and Safety Guidance
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