Sterilization; Spare Parts And Accessories; Maintenance; Electromagnetic Compatibility - Riester EliteVue Manual De Instrucciones

requirements. After disinfecting, wipe the instrument with a damp cloth to remove possible
disinfectant residue.
ATTENTION!
− Never place the instrument head with grip in liquids! Make sure that no liquids penetrate
the housing interior!
− The article is not approved for machine reprocessing and sterilisation. This can cause ir-
reparable damage!

7.3. Sterilization

a) Reusable ear funnels
The ear funnels can be sterilized in the steam sterilizer at 134 °C and 10 minutes hold time.
b) Single-use ear funnel
For one-time use only
Danger: Repeated use may result in infection.

7.4 Spare parts and accessories

You can find a detailed explanation in our brochure Instruments for ENT, which can be down-
loaded at www.riester.de https://www.riester.de/en/productdetails/d/ri-scoper-l-premi-
um-ent-and-ophthalmic-instruments/ri-scoper-l-otoscopes/

7.5. Maintenance

The instruments and their accessories require no special maintenance. If an instrument
needs to be inspected for any reason, please send it to us or to an authorised Riester dealer in
your area. We will provide you with the name of an authorized dealer upon request.
7.6. Notes:
Ambient temperature:
Relative humidity:
Transport and storage temperature: -10° to +55°
Relative humidity:
Barometric pressure:

7.7 ELECTROMAGNETIC COMPATIBILITY

ACCOMPANYING DOCUMENTS ACCORDING TO
IEC 60601-1-2, 2014, Ed. 4.0
Attention:
Medical electrical equipment is subject to special precautions regarding electromagnetic
compatibility (EMC).
Portable and mobile radio frequency communication devices can affect medical electrical
equipment. The ME device is for operation in an electromagnetic environment or home health
care and is intended for professional facilities such as industrial areas and hospitals.
The user of the device should ensure that it is operated within such an environment.
Warning:
The ME device may not be stacked, arranged or used directly next to or with other devices.
When operation is required to be close to or stacked with other devices, the ME device and
the other ME devices must be observed in order to ensure proper operation within this arran-
gement. This ME device is intended for use by medical professionals only. This device may
cause radio interference or interfere with the operation of nearby devices. It may become
necessary to take appropriate corrective measures, such as redirecting or rearranging the
ME device or shield.
The rated ME device does not exhibit any basic performance features in the sense of EN60601-
1, which would present an unacceptable risk to patients, operators or third parties should the
power supply fail or malfunction.
Warning:
Portable RF communications equipment (radios) including accessories, such as antenna ca-
bles and external antennas, should not be used in closer proximity than 30 cm (12 inches) to
parts and cables of the EliteVue instrument head with hand grips specified by the manu-
facturer. Failure to comply may result in a reduction of the device's performance features.
Directives and manufacturer's declaration - Electromagnetic emissions
The EliteVue device is intended for operation in an electromagnetic environment as specified below. The
customer or the user of the EliteVue device should ensure that it is used in such an environment.
Emissions testing
HF emissions according to
CISPR 11
HF emissions according to
CISPR 11
Emissions of harmonics
EC61000-3-2
Emissions of voltage
fluctuations, flicker
IEC61000-3-3
14
0° to +40°
30% to 70%, non-condensing
10% to 95%, non-condensing
800 hPa - 1100 hPa
Compliance Electromagnetic environment - Instructions
The EliteVue uses RF energy exclusively for internal
Group 1 functions. Therefore, its RF emissions are very low
and unlikely to disturb nearby electronic devices.
The EliteVue is intended for use in all establish-
ments, including residential areas and those direc-
Class B
tly connected to a public supply network that also
supplies buildings used for residential purposes.
Not applicable
Not applicable