DIAMENTOR E2
For Your Safety
6
D651.131.00/05 en
Safety Information
DANGER
Explosion Hazard – The product is not de-
signed for use in areas of medical locations
where an explosion hazard may occur. An ex-
plosion hazard may result from the use of
flammable anesthetics, skin cleansing agents
and disinfectants. Furthermore, the product is
suitable for use in an oxygen-enriched atmos-
phere only with certain restrictions. The atmos-
phere is oxygen-enriched when the room air
contains more than 25 % oxygen or nitrous
oxide.
WARNING
Shock Hazard – Strictly observe the following
warnings. Failure to do so may endanger the
lives of the patient, the user and other persons
involved.
− The product is a system device of
IEC 60601-1 protection class II in
combination with functional earth. It may be
put into operation only when connected to a
properly installed power outlet with earthing
contact.
− The installation of the product may only be
performed by trained electro-technical staff.
− Before using the product, the user must as-
certain that it is in correct working order and
operating condition.
− Inspect the connection cables for damage
before use. Replace damaged cables and
connectors immediately.
− When disconnecting the device from the
power line, first remove the connector from
the wall outlet. Then disconnect the cable
from the device.
− Devices on which moisture condensation
has developed as a result of temperature
changes must not be switched on unless
completely dry.
− Liquids must not enter neither the display
unit nor the adapter. If liquids have entered
the product, it must be thoroughly inspected
before being used again.
− Extension cords must not be used.
Operation in the patient environment:
With all peripheral devices connected, the
product represents a medical system. The
product may be operated in the patient envi-
ronment only if
− no peripheral devices are connected to the
serial interface or
− the peripheral devices connected meet the
requirements IEC 60601-1/
ANSI/AAMI ES 60601-1 /
CAN/CSA-C22.2.No.60601-1
− the peripheral devices connected meet the
requirements IEC 60950-1 / UL 60950-1 and
are operated outside the patient environ-
ment.
Exclusion of operation as device with pa-
tient contact:
− The device is not for use in direct contact
with the patient. Neither the device nor any
peripheral device may have contact to the
patient.
− Never touch the patient and open connec-
tors of the device at the same time.
Exclusion of operation as a controlling in-
strument:
− The device is only for use to measure the
dose within radiation field. The product must
not be used to control radiodiagnostic
equipment or radiotherapy units.
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