Spare Parts And Accessories; Maintenance; Notices; Emc Requirements - Riester ri-scope Instrucciones Para El Uso

bed down with alcohol or a suitable disinfectant.
PLEASE NOTE!
• Never immerse the instrument heads and handles in liquids! Take care to
ensure that no liquids get inside the casing!
• This item is not approved for automated reprocessing and sterilization.
These procedures cause irreparable damage!
Sterilization
a) Reusable ear specula
The ear specula can be sterilized in the steam sterilizer at 134°C with 10 mi-
nutes hold time.
b) Single-use ear specula
For single use only
WARNING: Repeated use can cause infections.

15. Spare parts and accessories

You can find a detailed list in our Instruments for E.N.T. and Ophthalmologic
Instruments brochure, which you can download at www.riester.de.

16. Maintenance

These instruments and their accessories do not require any specific maintenan-
ce.Should an instrument have to be examined for any specific reason whatsoe-
ver, please return it to the Company or an authorised Riester dealer in your
area. Addresses to be supplied on request.

17. Notices

Ambient temperature:
Relative humidity:
Transport and storage
temperature:
Relative humidity:
18 Electromagnetic compatibility
Medical electrical equipment is subject to special precautionary measures with
regard to electromagnetic compatibility (EMC).
Portable and mobile high-frequency communication equipment can influence
medical electrical equipment. This ME device is intended for operation in an
electromagnetic environment as specified below. The user of the device should
ensure that it is operated in such an environment.
The ME device must not be used directly next to or arranged in a stack with
other devices. If the device has to be operated near to or in a stacked arran-
gement with other devices, then the ME device should be monitored in order
to verify that it operates as intended in this arrangement. This ME device is
intended exclusively for use by professional medical staff. This device can cause
radio interference and can disrupt the operation of equipment nearby. Suitable
remedial measures, such as for instance re-alignment, re-arrangement of the
ME device or shielding, can become necessary.
Guidelines and manufacturer's declaration - electromagnetic emissions
The ri-scope® L is intended for operation in an electromagnetic environment as specified below. The
customer or the user of the ri-scope® L should ensure that it is used in such an environment.
Emission measurements
HF emissions according to
CISPR 11
HF emissions according to
CISPR 11
Harmonics emissions
according to EC61000-3-2
Voltage fluctuation / flicker
emissions according to
IEC61000-3-3
The ri-scope® L is intended for operation in an electromagnetic environment as specified below. The customer or the
user of the ri-scope® L should ensure that it is used in such an environment.
Immunity tests
Electrostatic discharge
(ESD)
according to IEC61000-4-2
Fast transient electrical
interference/bursts
according to IEC61000-4-4
Surges
IEC61000-4-5
Voltage dips, short-time
interruptions and
fluctuations in the supply
voltage according to
IEC61000-4-11
0°C to +40°C
30% to 70% non-condensing
-10°C to +55°C
10% to 95% non-condensing
Compliance
Group 1
Class B
Not applicable
Not applicable
IEC 60601 test level
± 6 kV contact discharge
± 8 kV air discharge
± 2 kV for power lines
± 1 kV for input and
output lines
± 1 kV voltage phase-to-
phase
± 2 kV voltage phase-to-
earth
<5% U
T
(>95 % drop in U )
T
for 0.5 cycles
40% U
T
(60 % drop in U )
T
for 5 cycles
70 % U
T
(30 % drop in U )
T
for 25 cycles
Electromagnetic environment - guidelines
The ri-scope® L employs HF energy solely for an
internal function. Its HF emission is therefore
very low and it is unlikely that neighboring
electronic devices will be affected by
interference.
The ri-scope® L is intended for use in all
facilities, including living quarters and such as
are directly connected to a public power supply
that also supplies buildings that are used for
residential purposes.
Compliance level
± 6 kV contact discharge
± 8 kV air discharge
Not applicable
Not applicable
Not applicable
Electromagnetic environment -
guidelines
Floors should be made of wood
or concrete or be covered with
ceramic tiles. If the floor is
covered with a synthetic material,
the relative air humidity must be
at least 30%.
The quality of the supply voltage
should correspond to that of a
typical business or hospital
environment.
The quality of the supply voltage
should correspond to that of a
typical business or hospital
environment.
The quality of the supply voltage
should correspond to that of a
typical business or hospital
environment
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