Purpose; Indications; Contraindications; Intended Patient Population - Riester Rcs-100 Gebrauchsanweisung

1.4 Purpose

The Riester Camera System (RCS-100) is a portable and multifunctional
electronic imaging diagnostic system with three interchangeable modu-
les (otoscope (OT), Dermatoscope ( DE) and General (GE). This camera
system can be operated by healthcare professionals to capture images
and videos in specific working environments.
Specification of the application parts:
OT: For taking pictures and videos of the eardrum.
DE: For taking pictures and videos of the skin.
GE: For capturing digital images and videos in general, e.g. mouth/pha-
rynx, other body parts, injuries etc.

1.4.1 Indications

The instruments serve as an aid to the trained clinician in the detection,
diagnosis, monitoring, treatment or alleviation of illnesses, injuries and
disabilities.
Specification of the application parts:
OT: For taking pictures and videos of the eardrum.
DE: For taking pictures and videos of the skin.
GE: For capturing digital images and videos in general, e.g. mouth/pha-
rynx, other body parts, injuries etc.
Specification of the other accessories:
LA 4° adapter: Adapter for connecting endoscopes up to Ø 4 mm.
LA 9° adapter: Adapter for connecting endoscopes from Ø 5 mm.
Compatible with a wide range of endoscopes on the market from all
leading manufacturers (e.g. Wolf, Storz, Olympus, Schölly)
In combination with endoscopes:
For taking pictures and videos of the throat, nose, ears, frontal sinus
and pharyngeal area

1.4.2 Contraindications

There are no known contraindications.

1.4.3 Intended patient population

The device is intended for all patients.
1.4.4 Intended operator/user
The camera system can be used by healthcare professionals to record
images and videos as described in the operating instructions and in the
working environment specified therein.
Specified working environment:
• Professional environment of healthcare facilities:
Medical offices, dental offices, clinics, limited care facilities, freestan-
ding surgical centres; freestanding birthing centres; multiple treat-
ment facilities; hospitals (emergency rooms, patient rooms, intensive
care units, operating rooms except near RF surgical equipment, out-
side the RF-shielded room of an ME system for magnetic resonance
imaging).

1.4.5 Required skills/operator training

The operators should have the appropriate qualifications to operate this
RCS-100 Riester Camera System. All connections and links are clearly
explained in the user manual.
The user must strictly adhere to the specifications in the user manual.
1.4.6 Environmental conditions
The device is intended for use in rooms with a controlled environment.
The device must not be exposed to adverse/harsh environmental con-
ditions.

1.5 Warnings/caution

The camera may become warm if used for long periods of time.
There may be a risk of ignition of gases if the device is operated
in the presence of flammable mixtures or mixtures of pharmaceuticals
with air or with oxygen or nitrous oxide.
The device must not be operated in rooms in which flammable mixtures
or mixtures of pharmaceuticals and air or oxygen or nitrous oxide are
present, e.g. operating theatres.
Keep the camera as far away as possible from electromagnetic
equipment (such as microwave ovens, TVs, video games, etc.).
Do not use the camera near radio transmitters or high-voltage li-
nes.
Never leave the camera and the battery in a car or on a car bonnet
in the summer. Doing so may cause leakage of the battery electrolyte,
overheating, fire, or a battery explosion due to the high temperature.
If the optical lens and control unit get wet, do not attempt to dry with
a heater, microwave, autoclave, or UV light.
Do not extend the supplied cables. Do not keep the power cord near
any heat source.
Disposal of used ear specula must be performed in accordance
with current medical practices or local regulations regarding disposal of
infectious biological medical waste.
Disposal of spent lithium batteries must be performed in accordan-
ce with local regulations regarding disposal of Li-battery waste.
Do not attempt to remove the product casing to prevent or correct
a product malfunction.
No modification of this device is allowed. Such modifications can
affect performance and cause hazardous radiation exposure
Warning: only use the speculum provided by the manufacturer.
Check the accessories and their packaging for any sign of damage.
Do not use them if damage is found.
The disposal of specula must meet requirements of local laws and
regulations.
If the device is unlikely to be used for an extended time period, have
the rechargeable battery removed by a skilled or trained person prior to
shipping or storage.
Resetting the factory data will cause recorded files to be lost.
This device only supports the TOSHIBA FlashAir Wifi-SD card (avai-
lable as an option). The use of other brands of Wifi-SD/SD cards is not
guaranteed.
The PC should meet the EN 60950-01 standard.
The device may not be sterilized.
Protect the camera from excessive vibration, force, or pressure.
Avoid using the camera under the following conditions, which may da-
mage the lens, the handset and may also cause the camera to malfunc-
tion or prevent recording:
• Dropping the camera, or hitting it against a hard surface.
• Exerting excessive force on the lens.
The camera is not protected from dust, splash resistant, or waterproof.
Do not use the camera in locations with excessive dust, sand, or where
water may come in contact with the camera. Particular attention should
be paid to the lens and the gaps around the buttons.
In extremely dusty or sandy locations, or if the camera is exposed to rain
or moisture, irreparable damage can occur.
For proper functioning and safe handling, the LA 4° and LA 9° adap-
ters must be screwed on as far as they will go and locked.
For proper function and safe handling, the endoscopes must be
inserted and locked into the LA 4° and LA 9° adapters as far as they
will go.
Condensation
(when lens or monitor fog up)
Condensation may occur when the camera is exposed to sudden chan-
ges of temperature or humidity. Avoid these conditions because they
may soil the lens or the monitor, cause mould, or damage the camera.
If condensation does occur, turn off the camera and wait for about two
hours before using it. Once the camera adjusts to the surrounding tem-
perature, the fogging will clear naturally.
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