General Safety; Important Notes For Safety - Riester RVS-100 Manual Del Usuario

ason make sure that all external devices operated in the
vicinity of the monitor comply with the relevant EMC requi-
rements. Mobile phone, X-ray equipment or MRI devices
are a possible source of interference as they may emit
higher levels of electromagnetic radiation.
• Before connecting the monitor to the power line, check
that the voltage and frequency ratings of the power line
are the same as those indicated on the monitor's label or
in this manual.
• Always install or carry the monitor properly to avoid da-
mage caused by drop, impact, strong vibration or other
mechanical force.
Note:
• Put the monitor in a location where you can easily see the
screen and access the operating controls.
• Keep this manual in the vicinity of the monitor so that it
can be obtained conveniently when needed.
• The software was developed in compliance with IEC 62304.
The possibility of hazards arising from software errors is
minimized.
• This manual describes all features and options. Your mo-
nitor may not have all of them.

2.2 General Safety

Warning: This monitor is neither a therapeutic instrument
nor a device that can be used at home.
1. Safety precautions for installation
• Connect the power cord to a properly grounded socket.
Only connect device to A/C power sockets designated for
use by medical equipment.
• Avoid putting the monitor in a location where it easily
shakes or wobbles.
• Enough space shall be left around the monitor so as to
guarantee normal ventilation.
• Make sure the ambient temperature and humidity are sta-
ble and avoid the occurrence of condensation in the ope-
ration process of the monitor.
Warning: Never install the monitor in an environment
where flammable anesthetic gas is present.
2. Monitor conforms to the safety requirements of IEC 60601-
1. This monitor is protected against defibrillation effects.
3. Notes on symbols related to safety Type CF applied part,
defibrillation protected.
The unit displaying this symbol contains an F-Type
isolated (floating) applied part providing a high degree of
protection against shock, and is defibrillator-proof. The
type CF applied parts provide a higher degree of protec-
tion against electric shock than that provided by type BF
applied parts.
Attention! Please refer to the documents accompanying
this monitor, such as the instruction manual.
4. When a defibrillator is applied on a patient, the monitor
may have some disruption in its display of waveforms.
Warning: When conducting defibrillation, do not come into
contact with the patient, the bed or the monitor. Otherwise
serious injury or death could result.
5. To guarantee the safe operation of the monitor, the moni-
tor is provided with various replaceable parts, accessories
and consumables. Please use the products provided or
designated by the manufacturer.
6. Safety and accuracy are assured only by the device and
accessories provided or designated by the manufacturer.
If the monitor is connected to other undesignated electri-
cal equipment or devices, safety hazards and/or excessive
leakage current may occur.
7. To guarantee the normal and safe operation of the monitor,
a preventive check and maintenance should be conducted
of the monitor and its parts every 6-12 months (including
performance and safety check) to verify that the instru-
ment can be operated safely, properly, and accurately.
Caution: The monitor does not contain any user-servi-
ceable parts. The repair of the instrument must be con-
ducted by technical personnel authorized by the manuf-
acturer.

2.3 Important Notes for Safety

• Patient Number
The monitor can only be applied to one patient at one time.
• Interference
Do not use a mobile phone in the vicinity of the monitor. High level
of electromagnetic radiation emitted from such devices may re-
sult in strong interference with the monitor performance.
• 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 service technician before
it is used again.
• Accuracy
If the accuracy of any value displayed on the monitor or printed
on a printout paper is questionable, determine the patient's vital
signs by alternative means. Verify that the equipment is working
correctly.
• Alarm
Do not rely exclusively on the audible alarm system for patient
monitoring. Adjustment of alarm volume to a low level or off
during patient monitoring may result in a hazard to the patient.
Remember that the most reliable method of patient monitoring
combines close personal surveillance and correct operation of
monitor. The functions of the alarm system for monitoring the pa-
tient must be verified at regular intervals.
• Before Use
Before putting the system into operation, please visually inspect
all connecting cables for signs of damage. Damaged cables and
connectors must be replaced immediately. Before using the sys-
tem, the operator must verify that it is in correct working order
and operating condition. Periodically, and whenever the integrity
of the product is in doubt, test all functions.
• Cables
Route all cables away from patient's throat to avoid possible
strangulation.
• Disposal of package
When disposing of the packaging material, please observe the
applicable waste control regulations and keep it out of children's
reach.
• Explosion hazard
Do not use this equipment in the presence of flammable anesthe-
tics, vapors or liquids.
• Leakage current test
When interfacing with other equipment, a test for leakage current
must be performed by qualified biomedical engineering personnel
before using with patients.
• Battery
The device is equipped with a battery. The battery discharges even
when the device is not in use. Store the device with a fully charged
battery and take out the battery, so that the service life of the bat-
tery will not be shortened.
• Disposal of accessories and device
Disposable accessories are intended for single use only. They
should not be reused as performance could degrade or contami-
nation could occur. The service life of this monitor is 5 years. At
the end of its service life, the monitor, as well as its accessories,
must be disposed of in compliance with the guidelines regulating
the disposal of such products. If you have questions concerning
disposal of products, please contact manufacturer or its repre-
sentatives.
• EMC
Magnetic and electrical fields are capable of interfering with the
proper performance of the device. For this reason, make sure that
all external devices operated in the vicinity of the monitor comply
with the relevant EMC requirements. X-ray equipment or MRI de-
vices are a possible source of interference as they may emit higher
levels of electromagnetic radiation. Also, keep mobile phones or
other telecommunication equipment away from the monitor.
• Instruction for use
For continuous safe use of the monitor, it is necessary that listed
instructions are followed. However, instructions listed in this ma-
nual can in no way can supersede established medical practices
concerning patient care.
• Loss of data
Should the monitor at any time temporarily lose patient data, clo-
se patient observation or alternative monitoring devices should be
used until monitor function is restored.
If the monitor does not automatically resume operation within
60s, restart the monitor using the power switch. Once monitoring
is restored, you should verify correct monitoring state and alarm
function.
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