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Patient Monitor User Manual
23
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.
24
After defibrillation, the ECG display recovers within 10 seconds if the correct
electrodes are used and applied based on the manufacturers' instructions.
25
Clinical decision making based on the output of the device is left to the discretion of
the provider.
26
This equipment is not intended for home usage.
27
Do not service or maintain the monitor or any accessory which is in use with the patient.
28
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.
29
Assembly of the monitor and modifications during actual service life shall be
evaluated based on the requirements of IEC60601-1.
30
The monitors are MR Unsafe. The monitors are not intended for use in an MRI
environment.
31
Only recommended batteries can be used for the monitor.
32
Additional multiple socket-outlets or extension cords can't be connected to the
system.
33
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.
34
Connecting any accessory (such as external printer) or other device (such as the
computer) to this 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 standards.
35
All the accessories connected to system must be installed outside the patient vicinity,
if they do not meet the requirement of IEC/EN 60601-1.
36
The medical electrical equipment needs to be installed and put into service according
to the EMC Information provided in this user manual.
WARNING
- 4 -
Intended Use and Safety Guidance
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