Maintenance/Accuracy Check/Calibration/Applied Standards; Applied Standards; Care Instructions; General Information - Riester RVS-200 Gebrauchsanweisung

LED 3.5 V for ri-scope®L otoscopes L2/L3/EliteVue Kelvin = 4000, CRI = 92
Item no.: 10625
pack of 6 XL bulbs, 3.5 V, ri-scope® L1 otoscope
Item no.: 10487
pack of 6 XL bulbs, 3.5 V, ri-scope® otoscope L2/L3
Item no.: 10607
pack of 6 XL 3.5 V bulbs, ri-scope® ophthalmoscope L1, L2, L3
Item no.: 10608
Spare parts and accessories
A detailed list can be found in „Instruments for ENT," Ophthal¬mologic Instruments, which
you can find at www.riester.de
https://www.riester.de/en/productdetails/d/ri-scoper-l-premium-ent-and-ophthalmic-in-
struments/other-ri-scope-l-accessories/

8. Maintenance/accuracy check/calibration/applied standards

The instruments and their accessories require no special maintenance. If an instrument
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.
Making changes to the device is not allowed!

8.1 Applied standards

Reference to d. standards:
• IEC 60601-1
• IEC 60601-1-2

9. Care instructions

9.1 General information

The cleaning and disinfecting of the medical devices serves to protect the patient, the user
and third parties and to maintain the value of the medical devices.
The product design and materials used make it impossible to define an upper limit on max.
feasible treatment cycles. The service life of medical devices is determined by their function
and careful handling.
Before return for repair, defective products must have undergone the prescribed reproces-
sing procedure.
Warning:
• We recommend that before cleaning or disinfection the device is removed from the power
supply.
• The diagnostic instruments are not sterile devices; they cannot be sterilised
• Never place the instrument heads and handles in liquids!
• Make sure that no liquids penetrate the housing interior!
• The article is not approved for machine reprocessing and sterilisation. This will lead to
irreparable damage!
If a reusable device shows signs of material deterioration, it should no longer be used and
should be disposed of/claimed according to the procedures described in the disposal/war-
ranty sections.

9.2 Cleaning and disinfection

To avoid possible cross-contamination, the diagnostic instruments and their handles must
be cleaned and disinfected regularly.
The diagnostic instruments together with their handles can be cleaned on the outside using
a damp cloth (if necessary, moistened with alcohol) until they are visually clean. Use dis-
infectant (e.g. disinfectant Bacillol AF from Bode Chemie GmbH (time 30s)) only according
to the instructions of use of the respective manufacturer of disinfectant. Only disinfectants
with proven effectiveness according to national directives should be used. After disinfecting,
wipe the instruments with a damp cloth to remove potential residue.
Please make sure that the cloth is moistened but NOT wet, so that no moisture penetrates
the openings in the diagnostic instrument or its handle.
Make sure that all glass and lenses are only cleaned with a dry and clean cloth.

9.3 Processing of reusable ear specula

Cleaning: manual
Required equipment: mildly alkaline cleaner (e.g. neodisher Mediclean, Dr. Weigert 404333
has been validated) 15°C / 59°F -50°C / 122°F, cleaning brush (Interlock 09098 and 09050
have been validated), tap water/running water 20±2°C / 68±35,6°F of at least drinking water
quality, tub/basin for cleaning agent, lint-free cloths (Braun Wipes Eco 19726 have been
validated).
1. The cleaning solution is prepared according to the manufacturer's instructions for the
cleaning agent (neodisher Mediclean 0.5% has been validated).
2. Completely immerse the medical devices in the cleaning solution.
3. Make sure that all surfaces are completely wetted with cleaning solution.
4. Carry out all subsequent steps below the liquid level to prevent the contaminated liquid
from splashing.
5. Brush the hard-to-reach areas of the immersed ear specula with a soft brush during the
exposure time. Pay attention to the critical, hard-to-reach places where a visual assess-
ment of the cleaning effect is not possible.
6. The total exposure time in the cleaning solution is at least 10 minutes (10 minutes has
been validated).
7. Remove the medical devices from the cleaning solution.
8. Rinse the medical devices under running tap water (at least drinking water quality) for
at least 1 minute (1 minute has been validated) to completely remove any supernatant or
residual cleaning solution. Check that the device is clean; if soiling is visible, repeat the
above steps.
9. Dry with a lint-free cloth.
Disinfection: manual
Required equipment: Disinfectant (e.g. CIDEX OPA, Johnson & Johnson 20391 has been
validated), demineralised water (demineralised water free of facultative pathogenic microor-
ganisms according to the KRINKO/BfArM recommendation) 20±2°C, sterile, lint-free cloths.
1. Prepare the disinfectant solution according to the manufacturer's instructions (CIDEX
OPA is a ready-to-use solution; the concentration must be checked using test strips, see
manufacturer's instructions) (CIDEX OPA has been validated).
2. Completely immerse the ear specula in the disinfectant solution.
3. Exposure time of the disinfectant solution according to the manufacturer's instructions
for high-level disinfection (CIDEX OPA for 12 minutes has been validated).
4. Remove the ear specula from the disinfectant solution and place them in a tub/basin
containing demineralised water for at least 1 minute (1 minute has been validated).
5. Repeat the step twice with fresh demineralised water.
6. Place the ear specula on a clean, dry cloth and allow to dry.
Further information for the user:
For information on cleaning and disinfection, refer to the current DIN EN ISO 17664 stan-
dard.
The homepage of RKI Guideline – KRINKO/BfArM also regularly provides information about
developments regarding cleaning and disinfection for the reprocessing of medical devices.
Single use ear specula
For single use only
Caution: Repeated use can lead to infection.

10. Disposal

Caution!
The used medical device must be disposed of in accordance with current medical practices
or local regulations on the disposal of infectious biological medical waste.
Batteries and electrical/electronic devices may not be treated as domestic waste and must
be disposed of in accordance with local regulations.
If you have any questions about the disposal of products, please contact the manufacturer
or their representative.

11. Electromagnetic compatibility

The instrument satisfies the requirements for electromagnetic compatibility. Please note
that under the influence of unfavourable field strengths, e.g. when operating cell phones or
radiological instruments, malfunctions cannot be ruled out.
In accordance with the requirements of IEC60601-1-2:2014, the electromagnetic compatibi-
lity of this device has been verified in a test.
• During installation and operation of the device, observe the following instructions:
• To avoid electromagnetic interference with the device's operation, do not use it simulta-
neously with other electronic equipment.
• Do not use or stack the device near, on or under other electronic equipment to avoid
electromagnetic interference when operating the device.
• Do not use the device in the same room as other electronic devices, such as e.g. life-sa-
ving equipment that can have a major impact on a patient's life and treatment outcomes,
or any other measuring or treatment device that uses weak electrical currents.
• Do not use cables or accessories that are not specified for the device because that may
increase the emission of electromagnetic waves from the device and decrease the immu-
nity of the device to electromagnetic interference.
• Do not touch the pins connecting the control unit to the lenses or the signal pad on the
lenses without special precautions.
Medical electrical equipment is subject to special precautions in terms of electromagnetic
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, situated 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 ne-
cessary 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 antenna
cables and external antennas, should not be used in closer proximity than 30 cm (12 inches)
to parts and cables of the ri-scope L instrument head specified by the manufacturer. Failure
to comply may result in a reduction of the device's performance characteristics.
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