Contraindications; Intended Patient Population; Intended Operators/Users; Required Skills/Operator Training - Riester RVS-200 Gebrauchsanweisung

1.4.2 Contraindications

They are not intended for flight transport, ambulance or home use.

1.4.3 Intended patient population

The device is intended for neonates to geriatric patients.
1.4.4 Intended operator/user
The device is to be operated by a doctor, a nurse or technician in hospitals, medical institu-
tions, clinics, doctor's offices.

1.4.5 Required skills/operator training

The operators should have the appropriate qualifications to operate the RVS-200 Wall Dia-
gnostic Station and RVS-200 Extension Module for the RVS-100 Vital Data Monitor.

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 conditions.

1.5 Warnings/caution

The monitor with wall unit is intended for use only by clinical professionals or under their
guidance. It must only be used by personnel who have received adequate training in its use.
Any unauthorized or untrained personnel must not operate the device.
Please observe the operating instructions for the RVS-100!
• Before the system is put into operation, ensure that the RVS-100, the RVS-200 and the
accessories are working flawlessly.
• If the integrity of the external protective conductor in the installation or its configuration
is in question, the device must be operated with its internal power source.
• To avoid the risk of explosion, the RVS-100 and RVS-200 devices must not be used in the
vicinity of flammable anaesthetics or other flammable substances used in combination
with air, oxygen-enriched environments, or nitrous oxide.
• Do not open the RVS-100 and RVS-200 housings; there is danger of electric shock. All
servicing and future upgrades must only be carried out by personnel trained and authori-
zed by the manufacturer.
• When using the monitor with electrosurgical units (ESU), it is essential to ensure the
safety of the patient.
• To avoid the risk of electric shock, this device must only be connected to a mains supply
with a grounding connection (included).
Please observe the operating instructions for the RVS-100!
• To ensure patient safety, only parts and accessories specified in this manual may be
used.
• At the end of its service life the monitor, as well as its accessories, must be disposed
of in compliance with the regulations covering the disposal of such products. Please
contact us if you have any questions regarding disposal of the product.
• Magnetic and electrical fields are capable of interfering with the proper performance
of the device. For this reason you should ensure that all other external devices that are
operated in the vicinity of the monitor comply with the relevant EMC requirements.
• Mobile phones, X-ray equipment or MRI devices are a possible source of interference as
they may emit high levels of electromagnetic radiation.
• Before connecting the monitor to the power line, check that the voltage and frequency of
the power line are correct according to the Information on the label of the monitor or in
these operating instructions.
• Always install or carry the monitor properly to avoid damage caused by dropping, impact,
strong vibration or other mechanical force.
The RVS-100 and RVS-200 are neither therapeutic instruments nor devices for use at home.
Never install the RVS-100 and RVS-200 in an environment where flammable anaesthetic
gases are present.
The RVS-200 does not contain any parts that can be repaired by users. All repairs of the
device must always be conducted by a technician authorized by the manufacturer.
Important safety instructions
Please observe the operating instructions for the RVS-100!
• Protection against ingress of liquid
To avoid electric shock or device malfunction, liquids must not be allowed to enter the
device. If liquids have entered the device, take it out of service and have it checked by a
echnician before it is used again.
• Before use
Before putting the system into operation, please visually inspect all connecting cables for
signs of damage. Damaged cables and
connections must be replaced immediately.
Before using the system, the operator must verify that it is in correct working order and
operating condition. At regular intervals and whenever the integrity of the product is in
doubt, all functions must be tested.
• Electric cables
Route all cables away from the patient's neck to avoid possible strangulation.
• Disposal of packaging
When disposing of the packaging material, pay attention to the relevant waste regulations.
Keep out of the reach of children.
• Explosion hazard
Do not use this equipment in the presence of flammable anaesthetics, vapours or liquids.
• Disposal of accessories and device
Disposable accessories are intended for single use. They should not be reused as their
function may be impaired or they may be contaminated. The service life of this RVS-200
station is 5 years. At the end of its service life the RVS-200, as well as its accessories,
must be disposed of in compliance with the directives regulating the disposal of such
products. If you have questions regarding the disposal of the product, please contact the
manufacturer.
• EMC
Magnetic and electrical fields are capable of interfering with the proper performance of
the device. For this reason you should ensure
that all other external devices that are operated in the vicinity of the RVS-200 comply with
the relevant EMC requirements.
X-ray equipment or MRI devices are a possible source of interference as they may emit
higher levels of electromagnetic radiation. Also, mobile phones
and other telecommunication equipment should not be used in the vicinity of the monitor.
• Instructions for use
To ensure safe use of the monitor, it is necessary to follow these operating instructions
carefully. However, the instructions listed in this manual in no way supersede established
medical practices regarding patient care.
• Keep the packing materials out of the reach of children. Disposal of packing materials
should conform with applicable waste regulations.
• Contamination may have occurred during storage of the RVS-200 station. Before use,
please check that the packaging, especially of disposable accessories, is still intact. In
case of any damage, do not use the RVS-200 with patients.
• Make sure that the RVS-200 is used under the intended conditions, otherwise the techni-
cal specifications given in this instruction manual will not be achieved, possibly resulting
in damage to equipment as well as other unexpected results.
Please ensure that the wall selected for the installation of the RVS-200
has sufficient load-bearing capacity!
If a second handle is removed from the handle holder, it switches on and the first handle
in use is switched off. Only one handle can ever be operated at a time.
When replacing the instrument heads, do not touch the patient at the same time, otherwise
the patient will receive an electric shock.
Instrument heads
The temperature of the bulb XL of the L1 otoscope, the human operating otoscope and the
veterinary operating otoscope is between 41°C / 105,8°F and 43°C / 109,4°F. Do not touch!
Because prolonged intense light exposure can damage the retina, the use of the device for
eye examination should not be unnecessarily prolonged and the brightness setting should
not be higher than needed for a clear view of the target structures.
The pin of the bulb must be inserted into the guide groove on the ophthalmoscope's inst-
rument head!
• We recommend that before cleaning or disinfection the device is removed from the power
supply.
• Never insert the instrument heads and instrument handles into liquids! Take care while
cleaning and disinfecting that no liquid enters the instrument!
• The devices are not designed for machine maintenance or sterilisation. This may lead to
irretrievable damage!
Caution!
The caution symbol indicates a potentially dangerous situation that can lead to minor or
moderate injuries. The symbol may also indicate unsafe practices.
RVS-200
Safety precautions for installation.
Please observe the operating instructions for the RVS-100!
• Connect the power cord to a properly grounded socket. Avoid using the same electrical
circuit to which appliances such as air conditioners that are regularly switched on and off
are connected.
• Avoid putting the RVS-100 and RVS-200 in wobbly or unstable locations.
• Enough space should be left around the devices to ensure normal ventilation.
• Make sure that the ambient temperature and humidity are stable, and avoid the occur-
rence of condensation during the operation of the devices.
Caution: The RVS-200 does not contain any parts that can be repaired by users. Repair of
the instrument must be conducted by technical personnel authorised by the manufacturer.
All serious incidents related to the product must be reported to the manufacturer and the
competent authority of the Member State in which the user and/or the patient is resident.
Please observe the operating instructions for the RVS-100

2. First use

2.1 Scope of delivery

Item no.:
1961-RRXXE
RVS-200 NIBP (Riester) + SpO2 (Riester) extension module 2 handles, without heads, 1 user
manual
1961-RRBXE
RVS-200 NIBP (Riester) + SpO2 (Riester) + Pred. Temp Oral (blue), 1 user manual
1961-RRBPE
RVS-200 NIBP (Riester) + SpO2 (Riester) + Pred. Temp Oral (blue) and printer, 1 user manual
1961-RNXXE
RVS-200 NIBP (Riester) + SpO2 (Nellcor), 1 user manual
1961-RNBXE
RVS-200 NIBP (Riester) + SpO2 (Nellcor) + Pred. Temp Oral (blue), 1 user manual
1961-RNBPE
RVS-200 NIBP (Riester) + SpO2 (Nellcor) + Pred. Temp Oral (blue) and printer, 1 user manual
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