Haag-Streit OCTOPUS 900 Instructions For Use Manual
1
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PORTUGUÊS
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© HAAG-STREIT AG, 3098 Koeniz, Switzerland - HS Doc. no. 1500.7220343.04070 – 7. Edition / 2016 – 11
DOC. no. 1500 1500.1400209.04000
INSTRUCTIONS FOR USE
Perimeter
OCTOPUS 900
®
EyeSuite Perimetry
7. Edition / 2016 – 11
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DEUTSCHENGLISH FRANÇAIS ITALIANO ESPAÑOL NEDERLANDS
PORTUGUÊS
SVENSKA
© HAAG‑STREIT AG, 3098 Koeniz, Switzerland ‑ HS Doc. no. 1500.7220343.04070 – 7. Edition / 2016 – 11
INSTRUCTIONS FOR USE
Perimeter
OCTOPUS 900
®
EyeSuite Perimetry
7. Edition / 2016 – 11
Introduction
Thank you for choosing a HAAG-STREIT device. Provided you comply carefully
with the regulations in this instructions for use, we can guarantee the reliable and
unproblematic use of our product.
Purpose of use
The Octopus 900 perimeter is designed for the examination, analysis and documentation of the eld of sight, especially the light difference sensitivity and other functions of the human eye.
Contraindication
No contraindications are known for perimetric examinations. For this reason, it is
not necessary to take any measures here.
WARNING!
Read the instruction manual carefully before commissioning this product. It contains important information regarding the safety of the user
and patient.
NOTE!
Federal law restricts this device to sale by or on the order of a physician
or licensed practitioner.
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© HAAG‑STREIT AG, 3098 Koeniz, Switzerland ‑ HS Doc. no. 1500.7220343.04070 – 7. Edition / 2016 – 11
Contents
1. Safety ....................................................................... 4
1.1 Areas of application of the device ......................................................... 4
1.2 Patient population ................................................................................. 4
1.3 Ambient conditions ................................................................................. 4
1.3 Shipment and unpacking ....................................................................... 4
1.4 Installation warnings ............................................................................. 4
1.4 Operation and environment .................................................................. 4
1.6 Disinfection ............................................................................................ 5
1.7 Warranty and product liability .................................................................5
1.8 Symbols ................................................................................................. 5
2. Introduction .............................................................. 6
2.1 Device description .................................................................................. 6
2.2 System components .............................................................................. 6
2.3 Device overview .................................................................................... 6
2.4 LCD display ............................................................................................ 7
2.5 Control panel .......................................................................................... 7
2.6 Connections ........................................................................................... 7
2.7 Housing .................................................................................................. 7
2.8 Cupola .................................................................................................... 7
2.9 Forehead rest ......................................................................................... 7
2.10 Chin rest ................................................................................................. 8
2.11 Swing arm .............................................................................................. 8
2.12 Refractive lens holder ........................................................................... 8
2.13 Patient-response button ......................................................................... 8
2.14 Network connection ............................................................................... 8
2.15 Light sources .......................................................................................... 8
2.16 Light intensities ...................................................................................... 8
2.17 Stimulus ................................................................................................. 8
2.18 Periphery or background illumination ..................................................... 8
2.19 Fixation marks ........................................................................................ 8
2.20 Fixation control ....................................................................................... 9
2.21 Examination data ................................................................................... 9
3. Appliance assembly / installation .......................... 9
3.1 Transporting the appliance .....................................................................9
3.2 Connecting the patient response button ................................................ 9
3.3 Connect the network cable ................................................................. 10
3.4 Connect the electric power supply cable ............................................. 10
4. Safesystemcongurationinaccordance
with EN 60601-1 .....................................................10
4.1 System variant I, Octopus 900 with
laptop as control unit ............................................................................ 10
4.2 System variant II, Octopus 900 with
PC and monitor as control unit ............................................................. 11
5. Commissioning ...................................................... 12
5.1 Switching on the appliance .................................................................. 12
5.2 Switching off the appliance ..................................................................12
6. Operation ................................................................ 12
6.1 Setting up the patient .......................................................................... 12
7. Software/Helpmenu/Errormessages ..............12
8. Technical data ........................................................12
8.1 Octopus 900 ......................................................................................... 12
8.2 Infrared illumination .............................................................................. 12
8.3 Field of sight ........................................................................................ 12
8.4 Octopus 900 control unit / PC .............................................................. 13
9. Maintenance ........................................................... 13
9.1 Repairs ................................................................................................. 13
9.2 Cleaning ............................................................................................... 13
9.2.1 Cupola .................................................................................................. 13
9.2.2 Response button, chin and forehead rest, eye occluder ...................... 13
9.2.3 Display, control panel ...........................................................................13
9.2.4 Light sources ........................................................................................ 13
A. Appendix ................................................................14
A.1 Accessories / spare parts .....................................................................14
B. Legalregulations ...................................................14
C. Classication .........................................................14
D. Disposal .................................................................. 14
E. Standards ............................................................... 14
F. RoHS China ............................................................ 14
G. Information and manufacturer's declaration
concerningelectromagneticcompatibility
(EMC) ......................................................................15
G.1 General ................................................................................................ 15
G.2 Emission (Standard table 1) ................................................................. 15
G.3 Immunity (Standard table 2) ................................................................. 16
G.4 Immunity for non-life-support devices (Standard table 4) .................... 17
G.5 Recommended safe distances for non-life-support devices
(Standard table 6) ................................................................................ 18
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© HAAG‑STREIT AG, 3098 Koeniz, Switzerland ‑ HS Doc. no. 1500.7220343.04070 – 7. Edition / 2016 – 11
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 to use in professional health care facility environment, like
doctor's practices, hospitals and optometrists and opticians premises, except near
of HF surgical equipment and RF shielded rooms of ME-systems for magnetic resonance imaging. Some portable radio frequency equipment, like cell phones or RF
telephone equipment including antennas may interference medical devices. Such
equipment has to be kept in a distance of more than 30 cm (12 inches) from any
part of the instrument. Inobservance of this precaution may lower the correct function of the instrument.
1.2 Patient population
The patient must be capable of sitting up straight and keeping his head still. He/she
must be physically and mentally able to cooperate well and is mentally capable of
following 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%
Application height < 2,000 m above sea level
1.3 Shipmentandunpacking
• Before you unpack the appliance, check whether the packaging shows traces of
improper handling or damage. If it does, notify the transport company that delivered the goods to you. Unpack the equipment together with a representative of
the transport company. Compile a report on any potentially damaged parts. This
report must be signed by you and by the representative of the transport company.
• Leave the device in the packaging for a few hours before unpacking it (risk of con-
densation).
• Check the appliance for damage after it is unpacked. Return defective appliances
in the appropriate packaging.
• Store the packaging material carefully so that it can be used for possible returns
or when moving.
1.4 Installationwarnings
WARNING!
•
Do not modify this equipment without authorization of the manufacturer
.
Installation and repairs may only be performed by trained specialists.
Any third-party device must be connected in compliance with the
EN 60601-1 standard.
Only original HS replacement parts may be used.
The device must not be stacked or placed in close proximity to other
electronic devices.
•
•
•
NOTE!
• The Octopus 900 must be placed in a completely darkened room.
• The use of accessories other than than those listed may result in
higher emissions or lower interference immunity of the Octopus 900
system.
• The software must be installed by trained personnel.
1.4 Operation and environment
DANGER!
Never use the device in potentially explosive environments where volatile solvents (alcohol, petrol, etc.) and flammable anaesthetics are in
use.
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© HAAG‑STREIT AG, 3098 Koeniz, Switzerland ‑ HS Doc. no. 1500.7220343.04070 – 7. Edition / 2016 – 11
WARNING!
• To avoid the risk of suffering an electric shock, this device may only
be connected up to the mains with a ground connection.
• The plug, cable and ground connection of the socket must be functioning perfectly.
• Make sure that the appliance is only connected to power supplies as
dened on the type plate. The appliance must be disconnected from
the mains by pulling out the plug before any maintenance and cleaning work is performed.
• Computers and further ancillary devices (printers, etc.) must com-
ply with the EN 60601-1 standard or be connected through galvanic
isolation to external networks (safety isolating transformer, galvanic
Ethernet isolator, etc.)
• The doctor or operator is obliged to inform the patient of the safety instructions which concern the patient and to ensure that these instructions are complied with.
• The examination of the patient, the use of the device and the interpretation of the results may only be conducted by trained and experi-
enced individuals.
• All users must be appropriately trained and familiarised with the contents of the instructions for use, especially with regard to the safety
information contained therein.
NOTE!
• This equipment must only be operated by qualied and trained personnel. The owner is responsible for their training.
• This device may only be used in accordance with the instructions in
"Purpose of use".
• Keep these instructions for use in a place where they are accessi-
ble to those working with the device at all times. Warranty claims can
only be made if these instructions for use are complied with.
• Always remove the dust cover before switching the appliance on. The
device may otherwise become damaged due to overheating. Likewise, make sure that the appliance is switched off before attaching
the dust cover.
• Only original spare parts and original accessories may be used
for repairs. The use of accessories other than than those listed may
result in higher emissions or lower interference immunity of the Octopus 900 system.
• Turn the system off if it will not be used for an extended period of
time.
1.6 Disinfection
NOTE!
The device does not need to be disinfected. For more information on
cleaning, please refer to the 'Maintenance' section.
1.7 Warranty and product liability
Haag-Streit products must be used only for the purposes and in the manner des-
cribed in the documents distributed with the product.
The product must be treated as described in the ‘Safety’ chapter. Improper handling can damage the product. This would void all guarantee claims.
Continued use of a product damaged by incorrect handling may lead to personal
injury. In such a case, the manufacturer will not accept any liability.
Haag-Streit does not grant any warranties, either expressed or implied, including
implied warranties of merchantability or fitness for a particular use.
Haag-Streit expressly disclaims liability for incidental or consequential damage
resulting from the use of the product.
This product is covered by a limited warranty granted by your seller.
This product is covered by a limited warranty, which may be reviewed at
www.haag-streit-usa.com.
•
•
•
•
•
•
For US
A only:
•
1.8 Symbols
Read the instructions for use
attentively
General warning: Read the ac-
companying documentation
Type B applied part
Notes on disposal, see the
'Disposal' chapter
Testsymbol of TÜV Rheinland
with approval for INMETRO
Brasil
Test symbol of CSA with ap-
proval for USA
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DEUTSCHENGLISHFRANÇAISITALIANOESPAÑOLNEDERLANDS
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© HAAG-STREIT AG, 3098 Koeniz, Switzerland - HS Doc. no. 1500.7220343.04070 – 7. Edition / 2016 – 11
European certificate of
conformity
Do not push! The appliance
may tilt if pushed on the side.
Year of production Manufacturer
HS reference number
Serial number
2. Introduction
2.1 Device description
• The Octopus 900 is an automatic projection Perimeter for the examination of the
entire eld of sight (90°).
• The system is divided into the examination unit (Octopus 900) and control unit
(notebook, PC). The examination unit communicates with the external PC via an
Ethernet connection. The Octopus 900 is operated using the software installed on
the PC. The Perimeter may be operated from a bright side room if necessary.
• Integrated patient monitoring increases the reliability of the examination results.
• The Octopus 900 is used by clinical users and for research purposes, since its
exibility is practically unlimited.
• The Octopus 900 tests the entire eld of sight up to 90° eccentricity because of
its spherical cupola geometry by Goldmann. Thanks to the exibility of this instrument, all perimetric questions can be answered – in both the 30° and 90° range,
with kinetic perimetry, static perimetry or icker perimetry.
• New PC and perimetry software can be downloaded and updated by going to
www.haag-streit.com.
2.2 System components
The Octopus 900 system comprises the following components:
• Octopus 900
• Patient response button
• Keyboard/mouse (optional)
2.3 Device overview
1. Top cover for stimulus projector
2. Front cover
3. Housing / cupola
4. Forehead rest (application part)
5. Rear panel
6. TFT display
7. Refractive lens holder with IR illumi-
nation
8. Control panel
9. Chin cup with integrated sensors for
detecting the head position
10. Chin rest (application part)
11. IR cover
12. Mark for optimum eye height
13. Connection point for
14. patient response button (application part)
1
2
3
4
5
6
7
8
9
10
11
12
13
14
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