Spare Parts And Replacement Light Bulbs; Maintenance; Instructions - Riester e-scope Gebrauchsanweisung

The homepage of RKI Guideline – KRINKO/BfArM also regularly provides informa-
tion about developments regarding cleaning and disinfection for the reprocessing of
medical devices.
Single use ear specula
For one-time use only
Caution:
Repeated use can lead to infection.

4.9. Spare parts and replacement light bulbs

for e-scope® ophthalmoscope
XL 2.5 V, pack of 6, art.no. 10605
LED 3.7 V,
https://www.riester.de/productdetails/d/e-scoper-pocket-instrments/e-scoper-otos-
copes/
for e-xam
XL 2.5 V, pack of 6, art.no. 11178
LED 2.5 V,
https://www.riester.de/en/productdetails/d/penlights/e-xam-penlight/

5. Maintenance

The instruments and their accessories require no special maintenance. If an instru-
ment needs to be tested for any reason, please send it to us or an authorised Riester
dealer in your area, the details of which we will provide you with upon request.

6. Instructions

Ambient temperature: 0° 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
CAUTION!
There may be a risk of ignition if the device is operated in the presence of flammable
mixtures of pharmaceuticals and air, oxygen, nitrous oxide or anaesthetic gases. Sa-
fety information according to international standard IEC 60601-1 "Medical electrical
equipment - Part 1: General requirements for basic safety and essential performan-
ce": It is not permitted to open the battery handle in the vicinity of the patient or to
touch batteries and the patient simultaneously.
7. Electromagnetic compatibility
according to IEC 60601-1-2, 2014, Ed. 4.0
Caution:
Medical electrical equipment is subject to special precautions in terms of electroma-
gnetic compatibility (EMC).
Portable and mobile radio frequency communication devices can affect medical
electrical equipment. The ME device is intended for operation in a home health care
electromagnetic environment and 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 use close to or stacked with other devices is required, the ME device
and the other ME devices must be monitored to ensure intended operation within
this configuration. This ME device is intended for use by medical professionals only.
This device may cause radio frequency 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 ME device assessed does not exhibit any essential performance characteristics
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 an-
tenna cables and external antennas, should not be used in closer proximity than 30
cm (12 inches) to parts and cables of the e-scope® instrument head with handles
specified by the manufacturer. Failure to comply may result in a reduction of the de-
vice's performance features.
28
art.no. 14051
art.no. 12320