21
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
Compliance
Electromagnetic environment - guidelines
HF emissions according to
CISPR 11
Group 1
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.
HF emissions according to
CISPR 11
Class B
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.
Harmonics emissions
according to EC61000-3-2
Not applicable
Voltage fluctuation / flicker
emissions according to
IEC61000-3-3
Not applicable
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
IEC 60601 test level
Compliance level
Electromagnetic environment -
guidelines
Electrostatic discharge
(ESD)
according to IEC61000-4-2
± 6 kV contact discharge
± 8 kV air discharge
± 6 kV contact discharge
± 8 kV air discharge
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%.
Fast transient electrical
interference/bursts
according to IEC61000-4-4
± 2 kV for power lines
± 1 kV for input and
output lines
Not applicable
The quality of the supply voltage
should correspond to that of a
typical business or hospital
environment.
Surges
IEC61000-4-5
± 1 kV voltage phase-to-
phase
± 2 kV voltage phase-to-
earth
Not applicable
The quality of the supply voltage
should correspond to that of a
typical business or hospital
environment.
Voltage dips, short-time
interruptions and
fluctuations in the supply
voltage according to
IEC61000-4-11
<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
Not applicable
The quality of the supply voltage
should correspond to that of a
typical business or hospital
environment
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:
0°C to +40°C
Relative humidity:
30% to 70% non-condensing
Transport and storage
temperature:
-10°C to +55°C
Relative humidity:
10% to 95% non-condensing
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.
