Haag-Streit OCTOPUS 900 User manual

1
DEUTSCHENGLISHFRANÇAISITALIANOESPAÑOLNEDERLANDS PORTUGUÊS SVENSKA
© 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 DEUTSCHENGLISHFRANÇAISITALIANOESPAÑOLNEDERLANDS 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 documen-
tation of the eld of sight, especially the light difference sensitivity and other func-
tions 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 pro-
duct. 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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DEUTSCHENGLISH FRANÇAIS ITALIANO ESPAÑOL NEDERLANDS
PORTUGUÊS SVENSKA
DEUTSCHENGLISHFRANÇAISITALIANOESPAÑOLNEDERLANDS PORTUGUÊS SVENSKA
© 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. Safesystemcongurationinaccordance
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/Helpmenu/Errormessages..............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. Legalregulations...................................................14
C. Classication .........................................................14
D. Disposal..................................................................14
E. Standards ...............................................................14
F. RoHS China............................................................14
G. Information and manufacturer's declaration
 concerningelectromagneticcompatibility
(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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PORTUGUÊS SVENSKA DEUTSCHENGLISHFRANÇAISITALIANOESPAÑOLNEDERLANDS PORTUGUÊS
SVENSKA
© 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 reso-
nance 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 func-
tion 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 Shipmentandunpacking
• Before you unpack the appliance, check whether the packaging shows traces of
improper handling or damage. If it does, notify the transport company that deliv-
ered 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 Installationwarnings
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 vola-
tile solvents (alcohol, petrol, etc.) and flammable anaesthetics are in
use.
WARNING!
The device must be switched off after every use. Otherwise there is a
risk of overheating when a protective dust cover is used.
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DEUTSCHENGLISHFRANÇAISITALIANOESPAÑOLNEDERLANDS PORTUGUÊS SVENSKA
© 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 func-
tioning perfectly.
• Make sure that the appliance is only connected to power supplies as
dened on the type plate. The appliance must be disconnected from
the mains by pulling out the plug before any maintenance and clean-
ing 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 in-
structions which concern the patient and to ensure that these instruc-
tions are complied with.
• The examination of the patient, the use of the device and the inter-
pretation of the results may only be conducted by trained and experi-
enced individuals.
• All users must be appropriately trained and familiarised with the con-
tents of the instructions for use, especially with regard to the safety
information contained therein.
NOTE!
• This equipment must only be operated by qualied and trained per-
sonnel. 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. Like-
wise, 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 Octo-
pus 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 hand-
ling 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 PORTUGUÊS SVENSKA
© 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 instru-
ment, 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 (applica-
tion part)
1
2
3
4
5
6
7
8
9
10
11
12
13
14
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© HAAG-STREIT AG, 3098 Koeniz, Switzerland - HS Doc. no. 1500.7220343.04070 – 7. Edition / 2016 – 11
2.4 LCD display
The high-contrast TFT colour display enables the video image to be observed under
a large angle of view. The following messages are shown on the display:
15. Display of a ' ' during the stimulus presentation
16. Display of a ' ' if the patient response button is pressed.
17. The crosshairs help to centre the eye, scale = 1 mm interval
18. Warning or error message
19. Display of left (OS) or right eye (OD)
15
16
17
18
19
2.5 Control panel
The control panel is made of a comfortable and hard-wearing rubber material. All
buttons are backlit with white light to make navigation easy in a darkened room.
The light sources can be switched off if required, except for the display brightness
setting.
20. Turn the refractive lens holder in and out
21. Start examination
22. Display brightness setting
23. Position chin rest left, right, up, down
20
21
22
23
2.6 Connections
24. Mains switch
25. Fuse holder for two fuses T3.15 AL / 250 V
26. Mains connection
27. Ethernet port
28. Plug-in mains power unit
WARNING!
All externally connected devices must comply with the standards rel-
evant to safety.
24
25
26
27
28
2.7 Housing
The optical components and electronics are protected from light and dust by  ve
housing covers. They can be removed for servicing with just a few actions. Once
the four screws in the back panel have been removed, the panel, hood and both IR
covers can be lifted out. The optical unit and electronic components of the Octopus
900 are now accessible
WARNING!
Always disconnect the appliance from the mains power supply by pull-
ing out the mains cable before opening the appliance. Housing compo-
nents may be removed only by correspondingly trained and authorised
skilled personnel.
2.8 Cupola
The cupola of the Octopus 900 has a diameter of 600 mm and thus conforms to the
Goldmann standard.
2.9 Forehead rest
A wide, ergonomically designed forehead rest allows the patient to maintain a com-
fortable posture during the examination.
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PORTUGUÊS SVENSKA DEUTSCHENGLISHFRANÇAISITALIANOESPAÑOLNEDERLANDS PORTUGUÊS
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© HAAG‑STREIT AG, 3098 Koeniz, Switzerland ‑ HS Doc. no. 1500.7220343.04070 – 7. Edition / 2016 – 11
2.10 Chin rest
The chin rest (and thus the position of the patient's head) is adjusted with the four
buttons. Fine adjustment can also be performed at the control unit (PC) using the
mouse. Sensors in the chin rest detect the correct position of the patient's head.
There is an optional attachment for the chin rest for examining children.
(HS Part Number 1820075)
2.11 Swingarm
An automatic swing arm allows the refractive lens holder to be turned in and out
during the examination without changing the position of the patient. This swing arm
can be operated with the computer mouse at either the control panel or on the con-
trol unit. Once the refractive lens holder has been swung in, it can be nely adjusted
to the correct distance from the eye being examined.
NOTE!
Always use the control panel buttons on the appliance or PC to swing
the refractive lens holder in or out. Do not attempt to move the refrac-
tive lens holder manually.
2.12 Refractive lens holder
Refractive lenses can be used during examinations with 30° eccentricity. The corre-
sponding lenses are inserted before the examination. The refractive lens holder can
be tilted forward by about 25° to make it easier to change the refractive lenses.
2.13 Patient-response button
The patient-response button is connected to the bottom of the forehead rest holder
(RJ11 plug connection).
2.14 Network connection
The Ethernet port is located at the back of the appliance. Always use a shielded cat-
egory 5e cable which enables transmissions of 100 MHz without interference. This
network connection is electrically isolated and has a dielectric strength of 4 kV ac-
cording to EN 60601-1.
2.15 Lightsources
LEDs are installed for periphery or background illumination, xation assistance and
stimulus. LEDs emit very low amounts of heat, so active cooling is not required.
2.16 Lightintensities
The light intensity of stimulus and periphery is measured with independent light sen-
sors and adjusted to the preset nominal values each time the Perimeter is switched
on.
2.17 Stimulus
The stimulus light is projected indirectly into the cupola via a mirror unit. Five differ-
ent diaphragm diameters can be selected in the user-dened programs. The atten-
uation of the stimulus intensity is innitely adjustable via an electronic control unit.
Stimulus presentations of 100-500 ms are permitted. A mechanical lock and optical
damping elements are no longer required.
White stimulus for W/W perimetry and optionally blue and red stimulus for B/Y and
R/W are possible. The stimulus intensity is detected using a light sensor, which also
serves as reference point for the system of coordinates of the test zones. The stim-
ulus LED has a service life of >30,000 h and is thus maintenance-free.
2.18 Peripheryorbackgroundillumination
The white background brightness amounts to 31.4 or 4 asb for W/W perime-
try. You can also select a yellow background with 314 asb for B/Y perimetry. The
background brightness consists of two light sources, each equipped with several
LEDs. The background LEDs have a service life of >30,000 h and are thus mainte-
nance-free. The background brightness is measured by a separate light sensor.
2.19 Fixation marks
Three different xation marks can be selected and their brightness changed elec-
tronically in 10 steps. A green LED, which is maintenance-free and has a service life
of >30,000 h, serves as light source.
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© HAAG-STREIT AG, 3098 Koeniz, Switzerland - HS Doc. no. 1500.7220343.04070 – 7. Edition / 2016 – 11
(Centre point) (Cross markers) (Circle)
2.20 Fixation control
The examined eye of the patient is illuminated with IR LEDs, photographed by a
CMOS camera and displayed on the LCD display. The built-in automatic  xation
control function increases the reliability of the examination results. Precise position-
ing of the examined eye is performed by motorised  ne adjustment of the chin rest.
2.21 Examination data
All examination data are transmitted via the Ethernet interface to the control unit
(PC / laptop), where they are saved and managed in a database. It is possible to
export data to a server. Examination data can also be printed out on a printer con-
nected to the control unit.
3. Appliance assembly / installation
WARNING!
Do not modify this equipment without authorization of the manufacturer.
Installation and repairs may only be performed by trained specialists.
Contact your HAAG-STREIT representative for installation, repairs and
modification work on the system. The contact details are available at
www.haag-streit.com.
Only original HS replacement parts may be used.
•
•
3.1 Transportingtheappliance
Transporting or moving the appliance (only short distances):
a) Unplug the power source before moving the device.
b) Stand in front of the device, grasp the cupola with both hands and lift the device
(Figure 7-1), or
b) Stand to one side of the appliance with one hand on the front cover and with
the other hand on the back cover, then take a  rm hold and lift the appliance
(Figure 7-2, Figure 7-3).
Figure 7-1 Figure 7-2 Figure 7-3
3.2 Connectingthepatientresponsebutton
The connection socket for the response button is located at the bottom of the front
cover. The retaining catch on the connection plug of the response button faces for-
wards.
DANGER!
No other cable may be connected to the RJ11 socket other than the
patient response button!
29. Front cover
30. Cupola housing
31. Connection plug with retaining catch
• Push the connection plug into the
connection socket until your hear the
retaining catch click into place. To re-
move the response button, push the
retaining catch towards the headrest
and pull the cable downwards.
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PORTUGUÊS SVENSKA DEUTSCHENGLISHFRANÇAISITALIANOESPAÑOLNEDERLANDS PORTUGUÊS
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© HAAG‑STREIT AG, 3098 Koeniz, Switzerland ‑ HS Doc. no. 1500.7220343.04070 – 7. Edition / 2016 – 11
3.3 Connect the network cable
Connect the Octopus 900 and PC with two Ethernet cables via the network switch
provided with the instrument. A computer network can also be connected via the
network switch. You will nd further information in section 4 'Safe system congura-
tion in accordance with EN 60601-1'.
3.4 Connect the electric power supply cable
The built-in mains power units operate with the voltages specied in the Technical
Data section. It is not necessary to select the voltage on the appliance. If a support
stand was also supplied, the Octopus 900 can be connected to the power socket in
the support stand's electrical connection box.
4. Safesystemcongurationinaccordance
with EN 60601-1
4.1 System variant I, Octopus 900 with
laptop as control unit
NOTE!
A network switch (*) must always be interposed for perfect operation.
*
**
< 1.5 m **
Mains connection LAN connection Mains connection
safety isolating transformer
Ethernet cable LAN
(optional)
network switch
Laptop / Control unit
USB cable
Control unit
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DEUTSCHENGLISH FRANÇAIS ITALIANO ESPAÑOL NEDERLANDS
PORTUGUÊS SVENSKA
DEUTSCHENGLISHFRANÇAISITALIANOESPAÑOLNEDERLANDS PORTUGUÊS SVENSKA
© HAAG‑STREIT AG, 3098 Koeniz, Switzerland ‑ HS Doc. no. 1500.7220343.04070 – 7. Edition / 2016 – 11
** If the control unit (notebook, PC) and printer are more than 1.5 m away from the
Octopus 900, then the safety isolating transformer can be dispensed with in accor-
dance with EN 60601-1.
Neither a safety isolating transformer nor a distance of > 1.5 m from the Octopus
900 is required if a medically approved control unit or a control unit with medical-
ly approved power supply unit without printer and without optional LAN connection
is being operated. For safety reasons, it is recommended to maintain a distance
of > 1.5 m if at all possible. Otherwise, all non-medical devices must be operated
through a safety isolating transformer.
4.2 System variant II, Octopus 900 with
PC and monitor as control unit
** If the control unit (notebook, PC) and printer are more than 1.5 m away from the
Octopus 900, then the safety isolating transformer can be dispensed with in accor-
dance with EN 60601-1.
*
**
Mains connection Mains connection
Ethernet cable
LAN (optional)
Ethernet cable *
< 1.5 m **
PC / control unit
Control unit
USB cable
safety isolating transformerLAN connection
Network
switch
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PORTUGUÊS SVENSKA DEUTSCHENGLISHFRANÇAISITALIANOESPAÑOLNEDERLANDS PORTUGUÊS
SVENSKA
© HAAG‑STREIT AG, 3098 Koeniz, Switzerland ‑ HS Doc. no. 1500.7220343.04070 – 7. Edition / 2016 – 11
5. Commissioning
5.1 Switchingontheappliance
Before connecting the Octopus 900 to a suitable power socket, it must be ensured
that the mains switch (24) is set to OFF '0'. The power socket is on the rear of the
base of the device. Then set the mains switch to ON 'I'. The device will be ready for
use after a couple of seconds.
5.2 Switchingofftheappliance
Set the network switch (24) to OFF '0'. There is no special shutdown procedure.
6. Operation
6.1 Settingupthepatient
The patient sits comfortably in front of the device and places his/her chin on the chin
rest. The forehead rest can be set to the correct position.
7. Software/Helpmenu/Errormessages
The software's help section contains instructions and help for performing an exam-
ination and descriptions of the error messages. The help can be opened via the F1
key or in the [?] - [Help] menu.
WARNING!
The software must be installed by trained personnel in accordance with
separate installation instructions.
8. Technical data
8.1 Octopus 900
Type designation Octopus 900
Mains voltage: 100 – 120 VAC, 220 – 240 VAC
Power consumption: 145 VA, 165 VA
Operating frequency: 50 / 60 Hz
Fuses: 2 x T3.15 AL 250 V
Dimensions (W x D x H): 648 mm x 519 mm x 796 mm
Weight: 25 kg
Shipping dimensions (W x D x H): 800 mm x 600 mm x 900 mm
Shipping weight: 40 kg
Ambient temperature: See chapter 1.3
Humidity: See chapter 1.3
Functional principle: projection cupola perimeter
Measurement principle: Bracketing procedure
Patient positioning: Adjustable headrest
Fixation control: Permanent video-based xation control
Eccentricity: 90°
Measurement range: 0 ... 47 dB
Measurement accuracy: 0.5 dB
Maximum stimulus intensity: 3185 cd/m² (10000 asb)
Stimulus colour I: White (LED)
Stimulus colour II: Blue (LED white with 440 nm lter)
Stimulus colour III: Red (LED white with 610 nm lter)
Stimulus size: Goldmann I, II, III, IV and V
Stimulus duration (ms): 100, 200, 500, 1000, freely selectable
Stimulus interval: Adaptive, x 1.5 ... 4 sec
Background intensity I: 4 asb (1.27 cd/m²), 31.4 asb (10 cd/m²)
Background colour I: White (LED)
Background intensity II: 314 asb (100 cd/m²)
Background colour II: Yellow (LED white with OG530 lter)
Ethernet port: Ethernet T100
Display: Colour TFT display (320 x 240 pixels)
8.2 Infrared illumination
Cupola emission: Refractive lens holder emission
Light sources:
Wavelength:
Angle of radiation:
LED
875 nm
±8.5°
Light sources:
Wavelength:
Angle of radiation:
LED
880 nm
±20°
8.3 Fieldofsight
The Octopus 900 makes it possible to examine up to the following eccentricity:
• Nasal 89° • Temporal 89° • Superior 60° • Inferior 70°
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© HAAG‑STREIT AG, 3098 Koeniz, Switzerland ‑ HS Doc. no. 1500.7220343.04070 – 7. Edition / 2016 – 11
8.4 Octopus 900 control unit / PC
A standard PC can be used as control unit for the Perimeter. The control unit soft-
ware runs on WINDOWS VISTA SP2, WINDOWS 7, WINDOWS 8 and WINDOWS
10
NOTE!
The minimum requirements for PCs can be found in the EyeSuite in-
structions for use.
9. Maintenance
WARNING!
• The housing components of the Perimeter appliance may only be re-
moved by suitably qualied service personnel.
• The ON/OFF switch does not isolate the Perimeter from the mains.
Before removing the housing components, ensure that the appliance
is unplugged from the mains power socket.
• This device must not be modied without the manufacturer's approval.
Installation and repairs may only be performed by trained specialists.
• Contact your HAAG-STREIT representative for installation, repairs
and modication work on the system. The contact details are avail-
able at www.haag-streit.com.
• Warranty claims can be made only if the instructions in these instruc-
tions for use have been complied with.
9.1 Repairs
We recommend having an authorised professional check the Octopus 900 every
two years to ensure long-term and trouble-free functioning. Further information and
the corresponding technical documentation for this are available from HAAG-STRE-
IT or your local representative.
9.2 Cleaning
Regular dusting of the device with a soft cloth is sufcient. More stubborn dirt can
be removed using a soft, lint-free cloth dampened with water or alcohol at maximum
70%.
NOTE!
Do not allow the appliance to become wet and do not use other sol-
vents of any kind.
A dust cover is included in the accessories of the Octopus 900. Cover the appliance
when the room is being cleaned or if it is not used for longer periods. Always re-
move the dust cover before switching on the power.
WARNING!
The appliance must not be switched on when covered (heat build-up,
re hazard).
9.2.1 Cupola
The inner surface of the cupola is coated with a special paint nish designed to en-
sure optimum results in perimetric examinations. It is not necessary to clean this in-
ner surface in normal cases. Should dust be visible in the cupola, you can remove
it by gently wiping with a soft, dry and uff-free cloth. A soft cloth dampened slightly
with mild soapsuds may only be used for local cleaning in emergencies, such as if
spots have appeared due to patients' sneezing.
9.2.2 Response button, chin and forehead rest, eye occluder
These components are all made of easy-to-clean plastic materials. Disinfect them
after every patient to keep them hygienically clean.
NOTE!
These application parts should be disinfected prior to every examina-
tion (e.g., with 70% isopropyl alcohol) in order to comply with general
hygiene requirements and prevent the transmission of infections.
9.2.3 Display, control panel
Fingerprints and dust can be removed using a soft, moist cloth.
9.2.4 Lightsources
In contrast to other perimetric devices, LEDs are used in the Octopus 900 as light
sources for background and stimulus. These have a service life of >30,000h. If any
of the LEDs still has to be replaced, please contact your dealer's customer service
department.
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PORTUGUÊS SVENSKA DEUTSCHENGLISHFRANÇAISITALIANOESPAÑOLNEDERLANDS PORTUGUÊS
SVENSKA
© HAAG‑STREIT AG, 3098 Koeniz, Switzerland ‑ HS Doc. no. 1500.7220343.04070 – 7. Edition / 2016 – 11
A. Appendix
A.1 Accessories / spare parts
Component Type HS art. no. Note
Instrument table IT 02 7220004 See separate IU*:
Patient response button Octopus 900 1802032 1x
Dust cover 1803061 1x
Eye patch set 1802349 2x / set
*IU = Instructions for use
B. Legalregulations
• HAAG-STREIT maintains a quality management system in accordance with EN
ISO 13485. The device was developed and designed in accordance with all the
standards listed in section E, 'Standards'.
• The Octopus 900 is a Class IIa device in accordance with Appendix IX of Directive
93/42/EEC. By afxing the CE mark we conrm that our device complies with the
applicable standards and directives.
• You can request a copy of the declaration of conformity for the appliance from
HAAG-STREIT at any time.
C. Classication
Standard EN 60601-1 Perimeter Octopus 900 acc. to protection class I
Application part: Type B
Operating mode: Continuous operation
CE Directive 93/42/EEC Class IIa
Standard EN 62471 Exempt group
D. Disposal
Electrical and electronic devices must be disposed of separately from
household waste!
This appliance was made available for sale after the
13th
August 2005. For correct disposal, please contact your
HAAG-STREIT
representative. This will guarantee that no hazardous
substances enter the environment and that valuable raw materials are
recycled.
E. Standards
EN 60601-1 EN ISO 15004-1 EN 62471 ISO 9022
EN 60601-1-2 EN ISO 12866 EN ISO 10993-1
F. RoHS China
Environment friendly use period (EFUP). The following formula applies for products
that can be repaired:
EF =
21900 X 8,5
60
X 365
30000 X 125%
8,5
X 365 12
125% = Factor for products which can be repaired. Daily use = service use, from
eld tests Average data: 21,900 patients/year, 10 minutes/patient.
Technical service life x 125%
(Daily use)x 365
Daily use 8.5 hours per day
12.1 years
Technical service life ~ 30,000 hours.
Consequently, the environment friendly use period is approx. 12 years.
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PORTUGUÊS SVENSKA
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© HAAG‑STREIT AG, 3098 Koeniz, Switzerland ‑ HS Doc. no. 1500.7220343.04070 – 7. Edition / 2016 – 11
G. Information and manufacturer's declaration
 concerningelectromagneticcompatibility
(EMC)
G.1 General
The OCTOPUS 900 fulls the requirements on electromagnetic compatibility ac-
cording to EN 60601-1-2:2007 (IEC 3. Edition) + EN 60601-1-2:2015 (IEC 4. Edi-
tion). The instrument is built so that the generation and emission of electromagnetic
interference is limited to the extent that other devices are not disturbed in their use
in accordance with the regulations and so that the instrument itself is suitably im-
mune to electromagnetic interference.
WARNING!
Avoid damages due to high electrostatic discharges (ESD). Electrostatic
discharges with voltages exceeding 6 kV to some parts of the instrument,
like patient answer button or display, may influence the instrument.
The firmware of the instrument may be disturbed, such that the IR illu-
mination for eye tracking turns off. This requires a software restart and
a repetition of the investigation.
Furthermore it cannot be excluded that ESD with higher voltages may
destroy internal electronic components of the instrument
•
•
WARNING!
• Electrical medical devices and systems are subject to special EMC
measures and must be installed in accordance with the EMC instruc-
tions contained in this accompanying document.
The operation of other lines or equipment than those listed may lead
to higher emissions or may reduce the device's resistance to interfe-
rence.
Third-party devices may only be connected in compliance with the
EN 60601-1 standard.
•
•
G.2 Emission (Standard table 1)
The information is based on the requirements of EN 60601-1-2:2007 (IEC 3rd edition) and EN 60601-1-2:2015 (IEC 4th edition).
Guidance and manufacturer's declaration – electromagnetic emissions
This product is intended for use in the electromagnetic environment specified below. The customer or the user of this product should assure that it is used in such an envi-
ronment
RF emissions CISPR 11 Group 1 This product uses RF energy only for its internal function. Therefore, its RF emissions are very low and
are not likely to cause any interference in nearby electronic equipment.
RF emissions CISPR 11 Class B This product is suitable for use in all establishments, including domestic establishments and those
directly connected to the public low-voltage power supply network that supplies buildings used for
domestic purposes.
Emission of harmonics according to
EN 61000-3-2
Class A
Voltage fluctuations / flicker emissions
according to EN 61000-3-3
Fulfilled
Emission test Compliance Electromagnetic environment - guidance
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© HAAG‑STREIT AG, 3098 Koeniz, Switzerland ‑ HS Doc. no. 1500.7220343.04070 – 7. Edition / 2016 – 11
G.3 Immunity (Standard table 2)
The information is based on the requirements of EN 60601-1-2:2007 (IEC 3rd edition).
Guidance and manufacturer's declaration – electromagnetic immunity
This product is intended for use in the electromagnetic environment specifi ed below. The customer or the user of this product should assure that it is used in such an envi-
ronment.
Immunity test standard EN 60601 test level Compliance level Electromagnetic environment – guidance
Electrostatic discharge (ESD)
EN 61000-4-2
± 6 kV contact
± 8 kV air
± 6 kV contact
± 8 kVair
Floors should be wood, concrete or ceramic tile. If fl oors are
covered withs ynthetic material, the relative humidity should
be at least 30%.
Electrical fast transient / burst
EN 61000-4-4
± 2 kV for power supply lines ± 2 kV for power supply lines Mains power quality should be that of a typical commercial
or hospital environment.
Surge
EN 61000-4-5
± 1 kV for symmetrical voltages
± 2 kV for asymmetrical voltages
± 1 kV for symmetrical voltages
± 2 kV for asymmetrical voltages
Mains power quality should be that of a typical commercial
or hospital environment.
Voltage dips, short interruptions
and voltage variations on power
supply lines
EN 61000-4-11
< 5% UT(> 95% drop in UT)
for ½ cycle
< 40% UT(> 60% drop in UT)
for 5 cycles
< 70% UT(> 30% drop in UT)
for 25 cycles
< 5% UT(> 95% drop in UT)
for 5 s
< 5% UT(> 95% drop in UT)
for ½ cycle
< 40% UT(> 60% drop in UT)
for 5 cycles
< 70% UT(> 30% drop in UT)
for 25 cycles
< 5% UT(> 95% drop in UT)
for 5 s
Mains power quality should be that of a typical commercial
or hospital environment. If the user of this product requires
continued function even in the event of interruptions in the
energy supply, this product should be powered from an un-
interruptible power supply or a battery.
Power frequency (50/60Hz)
magnetic fi eld EN 61000-4-8
3 A/m Power frequency magnetic fi elds should be at levels char-
acteristic of a typical location in a typical commercial or hos-
pital environment.
NOTE: U
T
= the AC mains voltage prior to application of the test level.
30 A/m
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© HAAG‑STREIT AG, 3098 Koeniz, Switzerland ‑ HS Doc. no. 1500.7220343.04070 – 7. Edition / 2016 – 11
G.4 Immunity for non-life-support devices (Standard table 4)
The information is based on the requirements of EN 60601-1-2:2007 (IEC 3rd edition).
Guidance and manufacturer's declaration – electromagnetic immunity
This product is intended for use in the electromagnetic environment specifi ed below. The customer or the user of this product should assure that it is used in such an envi-
ronment.
Electromagnetic environment – guidance
Portable and mobile RF communications equipments hould be used no closer to any part of this product, including cables, than the recommended separation distance cal-
culated from the equation applicable to the frequency of the transmitter.
Immunity test standard EN 60601 test level Compliance level Recommended distance(c):
Conducted RF EN 61000-4-6 3 Vrms
150 kHz – 80 MHz
5 Vrms D= 0.7
Radiated RF EN 61000-4-3 3 V/m
80 MHz – 2.7 GHz
3 V/m
80 MHz – 2.7 GHz
D= 1.2 80 MHz – 800 MHz
D= 2.3 800 MHz – 2.7 GHz
Where Pis the maximum output power rating of thet ransmitter in watts (W) according to the transmitter manufacturer and Dis the recommended separation
distance in metres (m). Field strengths from fi xed RF transmitters, as determined by an electromagnetic site survey a, should be less than the compliance level
in each frequency rangeb Interference may occur in the vicinity of equipment marked with the following symbol:
NOTE 1: At 80 MHz and 800 MHz the higher frequency applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.
a. Field strengths from fi xed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broad-
cast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fi xed RF transmitters, an electromagnetic
site survey should be considered. If the measured fi eld strength in the location in which this product is used exceeds the applicable RF compliance level above, this
product should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating
this product.
b.
c.
Over the frequency range 150 kHz to 80 MHz,
Possible shorter distances outside the ISM bands do not contribute to improved application in this table.
fi eld strengths should be less than 5 V/m.
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© HAAG‑STREIT AG, 3098 Koeniz, Switzerland ‑ HS Doc. no. 1500.7220343.04070 – 7. Edition / 2016 – 11
G.5 Recommended safe distances for non-life-support devices (Standard table 6)
The information is based on the requirements of EN 60601-1-2:2007 (IEC 3rd edition).
Recommended safe distances between portable and mobile HF communication devices and this device.
This product is designed to be operated in an electromagnetic environment in which radiated HF interference is controlled. The customer or user of this product can help to
prevent electromagnetic interference by maintaining minimum distances between portable and mobile HF communication systems (transmitters) and this product, as rec-
ommended below in accordance with the maximum output of the communication system.
Nominal output of the transmitter (W)
Safe distance according to transmission frequency (m)
150 kHz – 80 MHz
D = 0.7
80 MHz – 800 MHz
D = 1.2
800 MHz – 2.5 GHz
D = 2.3
0.01 0.07
0.2
0.7
2.2
7
0.12 0.23
0.1 0.38 0.73
1 1.2 2.3
10 3.8 7.3
100 12 23
For transmitters with a nominal output not listed in the table above, the distance Dcan be calculated in meters (m) using the equation for the respective column, in which P
is the nominal output of the transmitter in watts (W)
NOTE 1: At 80 MHz and 800 MHz the higher frequency applies.
NOTE 2: To calculate the recommended safe distance of transmitters in the frequency range of 80 MHz to 2.7 GHz an additional factor of 10/3was used to reduce the
probability of a mobile/portable communication device causing interference if inadvertently brought into the patient area.
These guidelines may not apply in all situations. Electromagnetic wave propagation is influenced by absorption and reflection of buildings, objects and people.NOTE 3:
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