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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 system standard IEC
60601-1. Anyone who connects additional equipment to the signal input part or
signal output part is configuring a medical system, and is therefore, responsible
that the system complies with the requirements of the system standard IEC
60601-1. The unit is for exclusive interconnection with IEC 60601-1 certified
equipment in the patient environment and IEC 60XXX certified equipment out-
side of the patient environment. If in doubt, consult the technical services
department or your local representative.
Caution! Use suitable mounting apparatus to avoid risk of injury. it shall be
mounted by trained and authorized personnel on adequate allowances
for quality of materials used to make the connection
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 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
nected to a supply mains with protective earth.
20.
Remove the power cord to fully turn off the device.
21.
Only use the power cord with following specification: 18AWG min., type SJT,
UL/CSA listed, length: 1.8m, hospital grade if for USA/Canada market
22.
Installation is only to be carried out by manufacture authorized and trained per-
sonnel
23.
Device is intended to be used as SIP/SOP facing downward
v
POC-615-12 Series User Manual
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