Patient Monitor User Manual Intended Use and Safety Guidance
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WARNING
30 The monitor should not be used adjacent to or stacked with other equipment. If
adjacent or stacked use is necessary, you must check that normal operation is
possible in the necessary configuration before you start monitoring patients.
31 Portable and mobile RF communications equipment can affect medical electrical
equipment, refer to the recommended separation distances provided in Appendix A2
EMC Information.
32 The medical electrical equipment needs to be installed and put into service according
to the EMC Information provided in this user manual.
33 Do not service or maintain the monitor or any accessory which is in use with the
patient.
34 Setting alarm limits to extreme values may cause the alarm system to become
ineffective. It is recommended to use the default settings.
35 The monitors are intended for use by trained healthcare professionals in hospital
environments.
36 Operation of the equipment exceeding specified physiological signal or the
operational specification may cause inaccurate results.
37 The appliance coupler or mains plug is used as isolation means from supply mains.
Position the monitor in a location where the operator can easily see the screen,
access the operating controls and access the disconnection device.
38 The equipment can provide protective means to prevent the patient from being
burned when used with HF SURGICAL EQUIPMENT. The equipment can protect
against the effects of the discharge of a defibrillator. Use only the accessories
approved by the manufacturer.
39 After defibrillation, the ECG display recovers within 10 seconds if the correct
electrodes are used and applied based on the manufacturers’ instructions.
40 Only recommended batteries can be used for the monitor.
41 When the monitor is used with HF surgical equipment, the transducer and the cables
must be avoided from conductive connection to the HF equipment. This is to protect
against burns to the patient.
42 Extreme care must be exercised when applying medical electrical equipment. Many
parts of the human/machine circuit are conductive, such as the patient, connectors,
electrodes, transducers. It is very important that these conductive parts do not come
into contact with other grounded, conductive parts when connected to the isolated
patient input of the device. Such contact would bridge the patient's isolation and
cancel the protection provided by the isolated input. In particular, there must be no
contact of the neutral electrode and ground.
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