lenstar LS 900 - 1 Safety; Areas of Application of the Device; Patient Population; Ambient Conditions

4
DEUTSCHENGLISH FRANÇAIS ITALIANO ESPAÑOL NEDERLANDS
PORTUGUÊS
SVENSKA
DEUTSCHENGLISHFRANÇAISITALIANOESPAÑOLNEDERLANDS
PORTUGUÊS
SVENSKA
© HAAG-STREIT AG, 3098 Koeniz, Switzerland – HS-Doc. no. 1500.7220055.04100 – 10. Edition / 2015 – 06
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 device 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 device is intended for use in doctor’s practices, hospitals, optometrists’ and op‑
ticians’ premises.
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 fol‑
lowing the examination. Patients must be at least 6 years old.
1.3 Ambient conditions
Transport: Temperature
Air pressure
Relative humidity
from
from
from
−40°C
500 hPa
10%
to
to
to
+70°C
1060 hPa
95%
Storage:
Temperature
Air pressure
Relative humidity
from
from
from
−10°C
700 hPa
10%
to
to
to
+55°C
1060 hPa
95%
Use:
Temperature
Air pressure
Relative humidity
from
from
from
+10°C
800 hPa
30%
to
to
to
+35°C
1060 hPa
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 representa‑
tive of the transport company.
• Leave the device in the packaging for a few hours before unpacking it (condensation).
• Check the device for damage after it is unpacked.
• Return defective devices in the appropriate packaging.
• Store packaging material carefully, so that it can be used for possible returns or when
moving.
• Only use the original packaging material for moving the device.
• Check that the contents of the packaging correspond to the contents specied on the
leaet included in the packaging.
1.5 Installation warnings
WARNING!
• Only use a HAAG‑STREIT approved external medical power supply (EN
60601‑1).
• The plug, cable and socket must function perfectly.
• Before carrying out maintenance or cleaning work, the device must al‑
ways be disconnected from the mains by unplugging the power supply
or plug.
• Computers and further ancillary devices (printers, etc.) must comply with
the EN 60601‑1 standard, or be connected with galvanic isolation to ex‑
ternal networks (isolating transformer, galvanic Ethernet isolator, etc.).
• For connection to PC, use only the supplied USB cable (2 m).
• The power supply must be positioned in such a way that proper heat dis‑
persion is guaranteed.
• The device should be set up in such a way that the plug is always eas‑
ily accessible and the device can easily be disconnected from the pow‑
er supply.
1.6 Operation, environment
DANGER!
• It is not permitted to make modications to the measuring device.
• It is expressly forbidden to open the device!
• Never use the device in potentially explosive environments where volatile
solvents (alcohol, benzine, etc.) and combustible anaesthetics are in use.
WARNING!
• The doctor or the operator is under an obligation to inform the patient
about safety instructions concerning them and to ensure that these in‑
structions are complied with.
• Only staff trained and experienced in the assessment of measuring data
and calculations and the manual entry, editing and deletion of data may
examine patients, operate the device and interpret results.
01-IFU_LS900-7220055-04100_eng.indd 4 17.06.2015 10:55:57