Operation condition:
• For indoor use only
• Ambient temperature: 10°C to +40°C
• Relative humidity: 15 % to 95 %, rel. non-condensing
• Atmospheric pressure: 700 hPa ~ 1060 hPa
• Storage condition:
• Ambient temperature: 0°C to +45°C
• Relative humidity: 15 % to 95 %, rel. non-condensing
Note:
It is recommended to remove the battery if the device is sto-
red over 2 weeks.
15 Environment
• Follow the local governing ordinances and recycling plans
regarding disposal or recycling of device components.
Especially when disposing of the lithium ion battery, circuit
board, plastic parts that contain brominated flame retar-
dant, LCD, or power cord, be sure to follow the local gover-
ning ordinances.
• When disposing of packing materials, sort them by mate-
rial and follow local ordinances and recycling regulations.
• Inappropriate disposal may contaminate the environment.
• When disposing of specula, or contact plate, follow the
disposal procedures for medical waste such as needles,
infusion tubes, metal instruments for surgery as specified
by your medical facility to avoid infection outside the facility
and environmental pollution.
16 Standards
Electrical safety IEC 60601-1 2005 (EN 60601-1 2006)
EMC and regulatory compliance IEC60601-1-2:2014
ELECTROMAGNETIC COMPATIBILITY
ACCOMPANYING DOCUMENTS ACCORDING TO
IEC 60601-1-2, 2014, Ed. 4.0
EMC (electromagnetic compatibility)
The instrument satisfies the requirements for electromag-
netic compatibility. Please note that under the influence of
unfavorable field strengths, e.g. during the operation of wire-
less telephones or radiological instruments, adverse effects
on function cannot be excluded.
The electromagnetic compatibility of this device has been
verified by test according to the IEC60601-1-2:2014 require-
ments.During installation and operation of the device, obser-
ve the following instructions:
• Do not use the device simultaneously with other electronic
equipment to avoid electromagnetic interference with the
operation of the device.
• Do not use or stack the device near, on, or under other
electronic equipment to avoid electromagnetic interference
with the operation of the device.
• Do not use the device in the same room as other electronic
equipment, such as life-support equipment that has major
effects on the life of the patient and results of treatment,
or any other measurement or treatment equipment that
involves small electric current.
• 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
immunity of the device to electromagnetic disturbance.
• Do not touch the pins connecting the control unit to the
lenses or the signal pad on the lenses without special
precautions.
Attention:
Medical electrical equipment (ME) is subject to special
precautions regarding electromagnetic compatibility (EMC).
Portable and mobile radio frequency communication devices
can affect medical electrical equipment. The ME device is for
operation in an electromagnetic environment of home health
care and intended for professional facilities such as industri-
al 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 operation is required to
be close to or stacked with other devices, the ME device and
the other ME devices must be observed in order to verify pro-
per operation within this arrangement. This ME device is only
intended for use by medical professionals. This device may
cause harmful interference or interfere with the operation of
nearby devices. It may become necessary to take appropriate
measures, such as redirecting or re arranging the ME device
or shield.
The ME device assessed does not exhibit any essential per-
formance features in the sense of EN60601-1, which would
present an unacceptable risk to patients, operators or third
parties in the event that it should present an outage or the
power supply should disconnect.
Warning:
Portable RF communications equipment (radios) including
accessories, such as antenna cables and external antennas,
should not be used in closer proximity to modules than spe-
cified by the RCS-100 parts and lines manufacturer 30 cm
(12 inch). Failure to comply may result in a reduction in the
device's performance features.
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