EDAN iM3 User Manual page 10

Vital Signs Monitor User Manual
9 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.
10 Route all cables carefully to avoid possible entanglement, apnea, or electrical
interference. For the device mounted over the patient, sufficient precautionary
measures should be taken to prevent it from falling on the patient.
11 Devices connecting with monitor should be equipotential.
12 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.
13 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.
14 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 accessory is
intact. Do not use it if its casing is damaged.
15 When interfacing with other equipment, a test for leakage current must be performed
by qualified biomedical engineering personnel before using with patients.
16 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.
17 In monitor mode, when monitoring is in process, 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. In round or spot-checking
mode, the patient type will be restored to adult by default, and the monitor is in status
with no patients, and other settings processing after power off are the same with that
in monitor mode.
WARNING
- 2 -
Intended Use and Safety Guidance