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14.
When networking with electrical devices, the operator is responsible for ensur-
ing that the resulting system meets the requirements set forth by the following
standards:
–
EN 60601-1 (IEC 60601-1) Medical electrical equipment
Part 1: General requirements for safety
–
EN 60601-1-2 (IEC 60601-1-2) Medical electrical equipment
Part 1-2: General requirements for safety
Collateral standard: Electromagnetic compatibility; Requirements and tests
15.
Accessory equipment connected to analog and digital interfaces must be in
compliance with the respective nationally harmonized IEC standards (i.e. IEC
60950 for data processing equipment, IEC 60065 for video equipment, IEC
61010-1 for laboratory equipment, and IEC 60601-1 for medical equipment.)
Furthermore, all configurations shall comply with the IEC 60601-1 system stan-
dard. Anyone who connects additional equipment to the signal input part or sig-
nal output part is configuring a medical system, and is therefore, responsible
that the system complies with the requirements of the IEC 60601-1 system stan-
dard. The unit is for exclusive interconnection with IEC 60601-1 certified equip-
ment in the patient environment and IEC 60XXX certified equipment outside of
the patient environment. If in doubt, consult the technical services department or
your local representative.
Caution! Use suitable a mounting apparatus to avoid risk of injury. it shall be
mounted by trained and authorized personnel with adequate allowances
for quality of materials used to make appropriate connections.
16.
Grounding reliability can only be achieved when the equipment is connected to
an equivalent receptacle marked "Hospital Only" or "Hospital Grade".
17.
Use a power cord that matches the voltage of the power outlet, which has been
approved and complies with the safety standard of your particular country.
Note!
Environmental protection
Follow national requirements to dispose of the unit.
18.
WARNING - Do not modify this equipment without authorization of the manufac-
turer.
19.
WARNING - To avoid risk of electric shock, this equipment must only be con-
nected to a supply mains with protective earth.
20.
Remove the power cord to fully turn off the device.
21.
Only use a power cord with the following specifications: 18AWG min., type SJT,
UL/CSA listed, length: 1.8m, hospital grade if for the USA/Canada market.
22.
Installation is only to be carried out by authorized and trained personnel.
23.
The device is intended to be used as SIP/SOP, facing downward.
24.
Do not place the power cord where it is difficult to disconnect.
v
POC-624-02 Series User Manual
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