Haag-Streit Eyestar 900, Инструкция по эксплуатации

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DEUTSCH ENGLISH FRANÇAIS ITALIANO ESPAÑOL NEDERLANDS PORTUGUÊS SVENSKA
© HAAG‑STREIT AG, 3098 Koeniz, Switzerland – HS‑Doc. no. 1500.7220686.04020 – 2. Edition / 2021 – 05
1 Safety
DANGER!
Failure to comply with these instructions may result in material damage
or pose a danger to patients or users.
WARNING!
These warnings must absolutely be complied with to guarantee safe
operation of the product and to avoid any danger to users and to
patients.
NOTE!
Important information: Please read carefully.
1.1 Areas of application of the device
The Eyestar 900 is an optical non contact Biometer providing measurements and
imaging of the eye from the cornea to the retina based on Swept Source OCT,
reflective Keratometry and Video image analysis technology. This device is intended
to be used in professional health care facilities such as hospitals, physician's,
optometrist's and optician's practices. For optimal use of the device, the ambient
lighting should be attenuated.
WARNING!
• This device must not be operated near of high frequency surgical
equipment and the radio frequency shielded room of a medical
electrical system for magnetic resonance imaging, where the
intensity of electromagnetic disturbances is high.
• Portable radio frequency communications equipment (including
peripherals such as antenna cables and external antennas) should
be used no closer than 30 cm (12 inches) to any part of the device,
including cables specified by Haag-Streit. Otherwise, degradation of
the performance of this device could result.
• If unexpected disturbances are observed the cause could be a cell
phone or radio frequency telephone in the immediate vicinity to the
Eyestar 900. Increase the distance to the device until the
interference disappears.
• Use of accessories, transducers and cables other than those
specified or provided by Haag-Streit could result in increased
electromagnetic emission or decreased electromagnetic immunity of
this device and result in improper operation.
1.2 Patient population
The patient must be capable of sitting up straight and keeping his head still. He must
be physically and mentally able to cooperate well and mentally capable of following
the examination. Patients must be at least 6 years old.
1.3 Ambient conditions
Temperature −40 °C ... +70 °C
Air pressure 500 hPa ... 1060 hPa
Transport
Relative humidity 10 % ... 95 %
Temperature −10 °C ... +55 °C
Air pressure 700 hPa ... 1060 hPa
Storage
Relative humidity 10 % ... 95 %
Temperature +10 °C ... +35 °C
Air pressure 800 hPa ... 1060 hPa
Use
Relative humidity 30 % ... 90 %
1.4 Shipment and unpacking
• Before unpacking the device, check whether the packaging shows traces of
improper handling or damage. If this is the case, notify the transport company
that delivered the goods to you. Unpack the equipment together with a
representative of the transport company. Make a report of any damaged parts.
This report must be signed by you and by the representative of the transport
company.