M3 Vital Signs Monitor User Manual Intended Use and Safety Guidance
- 4 -
WARNING
29 If leakage or foul odor is detected, ensure that there’s no fire around.
30 Only NIBP and SpO
2
applied parts of the monitor are defibrillation-proof. When a
defibrillator is applied, keep other accessories away from the patient. Otherwise, it
may result in damaging the monitor or harming the patient.
31 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 access the
disconnection device.
32 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.
33 The equipment can provide protective means to prevent the patient from being
burned when used with HF SURGICAL EQUIPMENT. Use only EDAN-approved
accessories.
34 Without any external memory, all data measured (including trend data, review data,
alarm events and so on) are cleared either when the monitor is turned off or when the
monitor is powered down in the process of monitoring.
35 Only items that have been specified as part of the system or specified as being
compatible with the system can be connected to the system.
36 SHOCK HAZARD - Don't connect electrical equipment, which has been supplied as a
part of the system, directly to the wall outlet when the non-medical equipment is
intended to be supplied by a multiple portable socket-outlet with an isolation
transformer.
37 SHOCK HAZARD - Don't connect electrical equipment, which has not been supplied
as a part of the system, to the multiple portable socket-outlet supplying the system.
38 Do not touch accessible parts of medical or non-medical electrical equipment in the
patient environment and the patient simultaneously, such as USB connector, VGA
connector or other signal input/output connectors.
39 Connecting any accessory (such as external printer) or other device (such as the
computer) to this patient monitor makes a medical system. In that case, additional safety
measures should be taken during installation of the system, and the system shall provide:
a) Within the patient environment, a level of safety comparable to that provided by
medical electrical equipment complying with IEC/EN 60601-1, and
b) Outside the patient environment, the level of safety appropriate for non-medical
electrical equipment complying with other IEC or ISO safety
40 Additional multiple socket-outlet or extension cord can’t be connected to the system.
41 Setting alarm limits to extreme values may cause the alarm system to become
ineffective. It is recommended to use the default settings.