Haag-Streit OCTOPUS 600 User manual

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DEUTSCHENGLISH FRANÇAIS ITALIANO ESPAÑOL NEDERLANDS
PORTUGUÊS SVENSKA
DEUTSCHENGLISHFRANÇAISITALIANOESPAÑOLNEDERLANDS PORTUGUÊS SVENSKA
© HAAG‑STREIT AG, 3098 Koeniz, Switzerland ‑ HS‑Doc. no. 1500.7220367‑04110 – 2022 – 10
INSTRUCTIONS FOR USE
Perimeter
OCTOPUS¨600
11. Edition / 2022 – 10

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DEUTSCHENGLISH FRANÇAIS ITALIANO ESPAÑOL NEDERLANDS
PORTUGUÊS SVENSKA
© HAAG‑STREIT AG, 3098 Koeniz, Switzerland ‑ HS‑Doc. no. 1500.7220367‑04110 – 2022 – 10
INSTRUCTIONS FOR USE
Perimeter
OCTOPUS¨600
11. Edition / 2022 – 10
Preface
Thank you for choosing a Haag-Streit device. Provided you comply carefully with the
regulations in these instructions for use, we can guarantee reliable and trouble-free
use of our product.
WARNING!
Read the instruction manual carefully before commissioning this product.
It contains important information regarding the safety of the user and pa-
tient.
NOTE!
For USA only: 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. 1500.7220367‑04110 – 2022 – 10
Contents
¥ 1 Safety...................................................................................................................................................4
◦ 1.1 Comments on these instructions for use........................................................................................4
◦ 1.2 Ambient conditions.........................................................................................................................4
◦ 1.3 Shipment and unpacking ...............................................................................................................4
◦ 1.4 Installation warnings ......................................................................................................................4
◦ 1.5 Operation, environment .................................................................................................................5
◦ 1.6 Disinfection ....................................................................................................................................6
◦ 1.7 Warranty and product liability ........................................................................................................6
◦ 1.8 Reporting obligation.......................................................................................................................6
◦ 1.9 Description of symbols...................................................................................................................6
¥ 2 Intended purpose / intended use .......................................................................................6
◦ 2.1 Device description..........................................................................................................................6
▪ 2.1.1 Intended users....................................................................................................................7
◦ 2.2 Medical purpose.............................................................................................................................7
▪ 2.2.1 Indications...........................................................................................................................7
▪ 2.2.2 Part of the body ..................................................................................................................7
▪ 2.2.3 Patient population...............................................................................................................7
▪ 2.2.3.1 Contraindications.....................................................................................................7
◦ 2.3 Principles of operation ...................................................................................................................7
▪ 2.3.1 Operating environment .......................................................................................................7
◦ 2.4 Clinical benefit................................................................................................................................7
¥ 3 Introduction .....................................................................................................................................8
◦ 3.1 Device description..........................................................................................................................8
◦ 3.2 System components ......................................................................................................................8
◦ 3.3 Device overview.............................................................................................................................8
◦ 3.4 User interface (14) .........................................................................................................................9
◦ 3.5 Housing..........................................................................................................................................9
◦ 3.6 Forehead rest.................................................................................................................................9
◦ 3.7 Chin rest (optional).........................................................................................................................9
◦ 3.8 Near correction lens.......................................................................................................................9
◦ 3.9 Patient-side cover ........................................................................................................................10
◦ 3.10 Corrective lenses .......................................................................................................................10
◦ 3.11 Connections...............................................................................................................................10
▪ 3.11.1 USB ports .......................................................................................................................10
▪ 3.11.2 Mains connection............................................................................................................10
▪ 3.11.3 Ethernet port...................................................................................................................10
◦ 3.12 LED background lighting............................................................................................................10
◦ 3.13 Fixation control...........................................................................................................................10
◦ 3.14 Examination data .......................................................................................................................10
¥ 4 Device assembly / installation ...........................................................................................11
◦ 4.1 Transporting the device ...............................................................................................................11
◦ 4.2 Connecting the patient response button ......................................................................................11
◦ 4.3 Connecting the electric power supply cable.................................................................................11
¥ 5 Safe system configuration in accordance with EN 60601................................ 12
◦ 5.1 System versions, Octopus 600 with printer .................................................................................12
¥ 6 Commissioning........................................................................................................................... 13
◦ 6.1 Switching on the device............................................................................................................... 13
◦ 6.2 Switching off the device............................................................................................................... 13
¥ 7 Operation........................................................................................................................................ 13
◦ 7.1 Setting up the patient................................................................................................................... 13
¥ 8 Software / Help menu / Error messages...................................................................... 13
¥ 9 Technical data ............................................................................................................................. 13
◦ 9.1 Octopus 600 ................................................................................................................................13
◦ 9.2 Infrared illumination .....................................................................................................................14
◦ 9.3 Dimensions.................................................................................................................................. 14
◦ 9.4 Field of sight ................................................................................................................................14
¥ 10 Maintenance............................................................................................................................... 14
◦ 10.1 Repairs ...................................................................................................................................... 14
◦ 10.2 Cleaning and disinfection .......................................................................................................... 14
▪ 10.2.1 Device in general............................................................................................................ 15
▪ 10.2.2 Touch screen.................................................................................................................. 15
▪ 10.2.3 Applied parts ..................................................................................................................15
▪ 10.2.4 Tools............................................................................................................................... 15
◦ 10.3 Dust cover .................................................................................................................................15
¥ 11 Appendix ...................................................................................................................................... 15
◦ 11.1 Accessories / consumables / spare parts / upgrade.................................................................. 15
◦ 11.2 Legal regulations .......................................................................................................................16
◦ 11.3 Classification ............................................................................................................................. 16
◦ 11.4 Disposal..................................................................................................................................... 16
◦ 11.5 Observed standards ..................................................................................................................16
◦ 11.6 Information and manufacturer’s declaration concerning electromagnetic compatibility (EMC). 16
▪ 11.6.1 General........................................................................................................................... 16
▪ 11.6.2 Emitted interference .......................................................................................................17
▪ 11.6.3 Electromagnetic immunity environment tested (part 1).................................................. 18
▪ 11.6.4 Electromagnetic immunity environment tested (part 2).................................................. 19
▪ 11.6.5 Recommended separation distances between portable and mobile RF communications
equipment and this product....................................................................................................... 21

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1Safety
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 op-
eration of the product and to avoid any danger to users and to patients.
NOTE!
Important information, please read carefully.
1.1 Comments on these instructions for use
NOTE!
In these instructions for use the point is used as decimal separator.
1.2 Ambient conditions
Transport Temperature −40 °C ... +70 °C
Air pressure 500 hPa ... 1060 hPa
Relative humidity 10 % ... 95 %
Storage Temperature −10 °C ... +55 °C
Air pressure 700 hPa ... 1060 hPa
Relative humidity 10 % ... 95 %
Use Temperature +10 °C ... +35 °C
Air pressure 800 hPa ... 1060 hPa
Relative humidity 30 % ... 90 %
1.3 Shipment and unpacking
• Before unpacking the device, check whether the packaging shows traces of im-
proper handling or damage. If this is the case, notify the transport company that
delivered the goods to you.
• Unpack the device 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.
• Leave the device in the packaging for a few hours before unpacking it (condens-
ation).
•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 potential returns or
when moving.
1.4 Installation warnings
WARNING!
• Do not modify this device without authorization of the manufacturer.
Installation and repairs may only be performed by trained special-
ists.
• Any third-party device must be connected in compliance with the EN
60601-1 standard.
• Only original Haag-Streit spare parts may be used.
• Use of this device adjacent to or stacked with other equipment
should be avoided because it could result in improper operation. If
such use is necessary, this device and the other equipment should
be observed to verify that they are operating normally.
• Grounding reliability can only be achieved when unit is connected to
a hospital grade receptacle. (Not valid for EU countries).
NOTE!
• The device must be set up in a medical room in such a way that no
direct light falls on it from any side.
• The use of accessories other than than those listed may result in
higher emissions or lower interference immunity of the Octopus 600.
• The software must be installed by trained personnel.

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1.5 Operation, environment
DANGER!
Never use the device in potentially explosive environments where volat-
ile solvents (alcohol, petrol, etc.) and flammable anaesthetics are in use.
WARNING!
•Certain light stimuli with a high contrast and certain frequencies as
presented in the Octopus 600 with the pulsar method can trigger
episodes of photosensitive epilepsy or consciousness disturbances
in isolated cases. This can also occur in patients who have not pre-
viously displayed any signs of epilepsy or similar conditions. Should
the patient feel unwell during the examination or if there is any indic-
ation of a consciousness disturbance, the examination must be in-
terrupted immediately. A standard white/white (SAP) examination
can be performed as an alternative.
• 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 device is only connected to power supplies as
defined on the type plate. The device must be disconnected from the
mains by pulling out the plug before any maintenance and cleaning/
disinfecting work is performed.
•Computers and further ancillary devices (printers, etc.) must comply
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 the operator is obliged to inform the patient about the
safety instructions concerning him 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 exper-
ienced individuals.
• Turning off the eye monitoring functions is not recommended. In all
other cases, the user must monitor the eye personally during the ex-
amination.
• All users must be appropriately trained and familiarised with the con-
tents of the instructions for use, especially with regard to the safety
instructions contained therein.
• This device must not be operated near of high frequency surgical
equipment and the radio frequency shielded room of a medical elec-
trical system for magnetic resonance imaging, where the intensity of
electromagnetic disturbances is high.
• Portable radio frequency communications equipment (including peri-
pherals such as antenna cables and external antennas) should be
used no closer than 30 cm (12 inches) to any part of the device, in-
cluding cables specified by Haag-Streit. Otherwise, degradation of
the performance of this device could result.
• If unexpected disturbances of the software are observed – the soft-
ware may be stopped or needs to be restarted – the cause could be
a cell phone or radio frequency telephone in the immediate vicinity
to the device. Increase the distance to the device until the interfer-
ence disappears.
NOTE!
• This device must only be operated by qualified personnel. The own-
er is responsible for their training.
• This device may only be used in accordance with the instructions in
the 'Intended purpose / intended use' chapter.
• Keep these instructions for use in a place where they are accessible
at all times to those working with the device. Warranty claims can
only be made if the instructions for use have been complied with.
• Always remove the dust cover before switching the device on. The
device may otherwise become damaged due to overheating. Like-
wise, make sure that the device 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 Oc-
topus 600.
• Turn the device off if it will not be used for an extended period of
time.

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• Do not expose the device to direct sunlight.
• Protect the device with the dust cover when not in use.
1.6 Disinfection
NOTE!
The applied parts of the device should be disinfected prior to every ex-
amination with a new patient. For more information, please refer to the
'Maintenance' chapter.
1.7 Warranty and product liability
• Haag-Streit products must be used only for the purposes and in the manner de-
scribed 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 damaged product 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.
• For USA only: This product is covered by a limited warranty, which may be re-
viewed at www.haag-streit-usa.com.
1.8 Reporting obligation
NOTE!
Any serious incident that has occurred in relation to the device must be
reported to Haag-Streit and the competent authority of the Member
State in your country.
1.9 Description of symbols
Follow instruction for use Read the instructions for use
attentively
General warning, read the ac-
companying documentation
European certificate of con-
formity
Date of manufacture Manufacturer
Haag-Streit reference number Serial number
Trademark of the manufacturer
Haag-Streit AG
Notes on disposal, see the 'Dis-
posal' chapter
Listed European Authorized
Representative Medical Device
Testsymbol of TÜV Rheinland
with approval for INMETRO
Brasil
MET Listed Mark with approval
for USA and Canada
Type B applied part Protective earth (ground)
2Intended purpose / intended use
The Octopus 600 perimeter is designed for the examination, analysis and docu-
mentation of the field of sight, especially the light difference sensitivity and other
functions of the human eye.
2.1 Device description
The Octopus 600 is a screen perimeter for examining the central field of sight (30°).
The device can be employed autonomously, i.e., the examination and control com-
ponents are integrated in the device. Integrated, automatic fixation monitoring in-
creases the reliability of the examination results.

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2.1.1 Intended users
Users are qualified medical professionals such as ophthalmologists, optometrists,
opticians, nurses and researchers or other qualified specialists as permitted by local
legislation. The interpretation of measurement data is restricted to professionals with
the appropriate educational background as permitted by local legislation.
2.2 Medical purpose
This device has the following medical purposes:
• Diagnosis and monitoring of pathologies affecting the visual pathways
• Diagnosis and monitoring of visual field losses
• Investigation of the physiological state of the visual pathway
2.2.1 Indications
The use of this device's standard perimetry feature is indicated for the following
medical conditions:
1. Localisation of pathology affecting the afferent visual pathways
◦ Anterior segment pathology
◦ Retinal pathology
◦ Optic nerve pathology
◦Chiasmal pathology
◦ Retrochiasmal pathology
2. Quantitation of pathological involvement
2.2.2 Part of the body
This device is intended for the examination of the visual field of the human eye.
2.2.3 Patient population
This device is intended for use on human patients with the physical ability to sit in
front of a perimetry device with their head resting against the headrest in a steady
position and the mental ability to follow instructions. Patients must be at least 6
years old.
2.2.3.1 Contraindications
There are no known contraindications to perimetry. However, it should be noted that
the testing procedure is lengthy and arduous to the patient.
2.3 Principles of operation
Perimetry, in general, presents the patients with visual clues of varying intensity at
different locations in their visual fields and examines the patients response (or lack
thereof). Following methods have been implemented:
Static Perimetry
The patient sits at the device facing the projection screen, fixating onto a target in
the middle of the screen. Dots of light are projected onto the screen. If the patient re-
gisters them he may register this by pressing a button. If the patient fails to register
a cue, the same cue appears again in a higher light intensity. Should the patient not
see the cue again, this is noted by the device and the program continues at a differ-
ent location.
Pulsar
Pulsar is a flicker contrast test used for glaucoma detection. The stimulus consists of
two images, the phase and counterphase images that alternate with a frequency of
10 Hz over 500 ms. When flicker-sensitivity is reduced, the phase and counterphase
images result in an overlapped image that is no longer visible. The Pulsar method
tests flicker and contrast sensitivity that are affected in glaucoma.
2.3.1 Operating environment
This device is intended to be used in professional health care facilities such as hos-
pitals, physician's, optometrist's and optician's practices. For optimal use of the
device, the ambient lighting should be attenuated. The headrest and the patient re-
sponse button should be disinfected between patients.
2.4 Clinical benefit
The clinical benefits of perimetry are the detection of functional losses caused by
pathologies of the visual pathways; differential diagnostic purposes for identification
and localisation of a visual deficits; monitoring of acute and chronic disease pro-
cesses; and evaluation the efficacy of treatments in order to preserve the patient's
visual function.
The clinical benefits of the product outweigh the remaining residual risks to the pa-
tient.

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3Introduction
3.1 Device description
• The Octopus 600 is a screen perimeter for examining the central field of sight
(30°). The device can be employed autonomously, i.e., the examination and
control components are integrated in the device.
• Integrated, automatic fixation monitoring increases the reliability of the examina-
tion results.
• The Octopus 600 is employed by clinical users and for research purposes.
3.2 System components
• The Octopus 600 comprises the following components:
• Octopus 600
• Patient response button (Type B application part)
• Keyboard/mouse (optional)
3.3 Device overview
Overview of patient side
1. Upper part of housing
2. Right shell
3. Capacitive button for operating the forehead rest
4. Left shell
5. Forehead rest with integrated sensor for detecting the head position
6. Infrared eye illumination
7. Near correction lens +3.25 dpt
8. Patient-side cover
9. Corrective lenses
10. Corrective lens compartment
11. Automatically closing cover
12. Patient response button
13. Patient response button connection

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Overview of user side
14. User interface with touch screen
15. Power on/off button
3.4 User interface (14)
• A high-contrast display allows operation of the Octopus 600 at a large angle of
view.
• The user interface is optimised for use on a touch screen and guarantees rapid
and reliable operation of the device.
• The high resolution of the display allows the accurate reproduction of examina-
tion results.
Keyboard/mouse (optional)
• If required, a keyboard and a mouse can be connected via a USB port for con-
trol purposes.
• We recommend choosing a wireless connection.
3.5 Housing
• The optical components and electronics are protected from light and soiling by
housing covers.
• For servicing, see 'Maintenance' chapter.
WARNING!
Always disconnect the device from the mains power supply by pulling
out the mains cable before opening the device. Housing components
may be removed only by correspondingly trained and authorised skilled
personnel.
3.6 Forehead rest
A wide, ergonomically designed forehead rest (5) allows the patient to maintain a
comfortable posture during the examination. The forehead rest can be moved for-
wards and backwards by pressing the triangular buttons (a).
3.7 Chin rest (optional)
The optional chin rest can be used to stabilize the patient. The height can be freely
adjusted using the rotating knobs on the side.
3.8 Near correction lens
The near correction lenses (7) integrated in the device also make it possible to ac-
commodate older patients on the examination screen.

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3.9 Patient-side cover
The cover on the patient side (8) can be equipped with two corrective lenses. The
magnetic holder on the corrective lenses allows simple, quick positioning.
3.10 Corrective lenses
Patients' ametropia can be corrected with the supplied corrective lenses. A correct-
ive lens set is composed of 12 spherical corrective lenses (9) from –8 dpt to +4 dpt.
NOTE!
• In cases of cylindrical ametropia > 1 dpt, we recommend that pa-
tients wear their own glasses or contact lenses for the examination
insofar as this is possible and the field of sight is not restricted.
• To protect the lenses from soiling and damage, they should be put
back in the compartment provided for right after use.
3.11 Connections
16. 2 × USB 3.0 connection (top), 2 × USB 2.0 connection (bottom)
17. Mains switch
18. Fuse holder with two fuses 3.15 AH / 250 V
19. Mains connection
20. Ethernet port
3.11.1 USB ports
There are a total of 4 USB ports (16) available. They can be used to connect USB
components such as keyboards, mice, USB sticks, USB hard disks or printers.
WARNING!
This connection is not galvanically isolated. Devices such as printers
can only be connected via USB if they are equipped with a safety isolat-
ing transformer as per EN 60601-1 or operated with a medically ap-
proved power supply.
3.11.2 Mains connection
The power cable must correspond to the nationally applicable safety requirements.
3.11.3 Ethernet port
There is an Ethernet port on the side of the device. Always use a shielded cable of
category 5e permitting transmissions of up to 1 GHz without interference. This Eth-
ernet port is electrically isolated and has a dielectric strength of 4 kV according to
EN 60601-1.
3.12 LED background lighting
In the Octopus 600, LEDs are used as light sources for the periphery and stimulus.
The light intensity of the background lighting is measured with two independent light
sensors and adjusted to the preset nominal values each time the perimeter is
switched on. These nominal values are defined in the factory by Haag-Streit. The
LED background lighting of the examination display is set via an adjustable power
source. The intensity of the display can also be varied via grey stages.
3.13 Fixation control
The examined eye of the patient is illuminated with infrared LEDs (6), photographed
by a CMOS camera and displayed on the user monitor. The built-in automatic fixa-
tion control function increases the reliability of the examination results. Precise posi-
tioning of the examined eye is performed by motorised fine adjustment of the fore-
head rest (5).
3.14 Examination data
The examination data are stored on the integrated solid-state drive (SSD) or in an
external database via the Ethernet port. It is also possible to export the examination
data to a USB storage device via a USB port.

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4 Device assembly / installation
4.1 Transporting the device
• Transport the device over larger distances
in its original packaging.
• For short distances, grasp the device with
two hands holding the side shells on the left
and right and lift it.
• Unplug the power source before moving the
device.
4.2 Connecting the patient response button
The connection socket for the patient response button is below the holder. The re-
taining bar on the connection plug is oriented towards the patient side.
DANGER!
Apart from the patient response button, no other cables may be connec-
ted to the RJ12 socket
• Push the connection plug (a) into the connection socket (c) until you hear the re-
taining bar click into place.
• To remove the patient response button, press the retaining catch (b) towards the
plug (a) and pull the cable away downwards.
4.3 Connecting the electric power supply cable
• The power unit for the Octopus 600 is designed for the voltages specified on the
type plate.

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5 Safe system configuration in accordance with EN 60601
5.1 System versions, Octopus 600 with printer
WARNING!
Printers connected via the USB port (27) must be connected to a safety isolating transformer as shown in the diagram below, in accordance with EN 60601-1.
NOTE!
For version II: If the distance from the Octopus 600 (21) to the printer (22) is larger than 1.5.m, the safety isolating transformer (24) may be dispensed with as
shown in the diagram below, in accordance with EN 60601-1.
Version I: Printer connected via USB port (27)
Version II: Printer connected via Ethernet port (28)
21. Octopus 600
22. Printer
23. Mains connection
24. Safety isolating transformer
25. Support stand
26. LAN connection
27. Printer connection via USB port.
28. Printer connection via Ethernet port. *
* This Ethernet port is electrically isolated in the Octopus 600 and has a dielectric strength of 4 kV according to EN 60601-1.

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6 Commissioning
6.1 Switching on the device
Before connecting the Octopus 600 to a suitable power socket, it must be ensured
that the mains switch (0/I) (17) is set to OFF (0). The mains switch is on the right of
the base of the device viewed from the user's side. Then set the mains switch (0/I)
to ON (I). The device is now in standby mode. The device can be switched on with
the Power On/Off button (15). The operating system and then the application are
started automatically. The device is ready for use after approximately one minute.
6.2 Switching off the device
Once the Power On/Off button (15) is pressed, a confirmation prompt appears. As
an alternative to the Power On/Off button, the device can also be switched off via
the software menu [File] - [Exit]. After approximately 15 seconds, the LED display on
the Power On/Off button goes out and the device enters standby mode.
WARNING!
• To avoid losing data, always switch the device off with the Power
On/Off button (15) first and then the mains switch.
• The Power On/Off button does not disconnect the device from the
power supply. When servicing, always use the mains switch (17)
and disconnect the device from the power supply.
NOTE!
If the mains switch is still switched on, the device is in standby mode
and consumes little power.
7Operation
7.1 Setting up the patient
• The corrective lenses are selected so that the patient sees the fixation mark on
the examination screen clearly. The patient's glasses can be used as an aid for
this.
• The patient sits comfortably in front of the device and places his forehead on the
forehead rest. The forehead rest (and optional chin rest) can be set to the cor-
rect position. The user chooses the eye to be examined (OS or OD). Then the
video image for fixation control appears. This is equipped with a rectangle which
defines the relevant area of the pupil position.
8 Software / Help menu / Error messages
The software's help section contains instructions and help for performing an examin-
ation 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. It is strongly recommended to make a
backup before running a software update.
9 Technical data
9.1 Octopus 600
Type designation Octopus 600
Mains voltage: 100 – 240 VAC
Power consumption: 100 VA
Power consumption in standby: 3W
Operating frequency: 50 / 60 Hz
Fuses: 2 × T 3.15 AH 250 V
Functional principle: Binocular screen perimeter
Examination principle: Subjective test using bracketing procedure
Patient positioning: Adjustable forehead rest
Fixation control: Permanent video-based fixation control
Eccentricity: 30°
Dynamic range: 0 – 35 dB / src
Stimulus intensity: 0.015 – 150 cd/m²

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Stimulus colour: White
USB port: USB 2.0 / USB 3.0 - standard
Ethernet port: 1000 Base-T (1Gbit)
Internal memory SSD: 32 GByte
9.2 Infrared illumination
Light source: LED
Wavelength: 940 nm
Angle of radiation: ±22°
9.3 Dimensions
Dimensions (W × D × H): 467 × 508 × 500 mm
Weight: 12.7 kg
Shipping dimensions (W × D × H): 600 × 800 × 1030 mm
Shipping weight: 26 kg
9.4 Field of sight
On the screen of the Octopus 600 it is possible to examine up to the following ec-
centricity:
• Monocular field of sight horizontally 30°
• Monocular field of sight vertically 27°
10 Maintenance
WARNING!
• Housing parts may be removed and repairs performed only by ap-
propriately trained and authorised skilled personnel. Incorrect re-
pairs can pose considerable risks for operating staff and patients.
• The Power On/Off button (15) does not disconnect the device from
the power supply. When servicing, always use the mains switch (17)
and disconnect the device from the power supply by pulling out the
plug.
• If components have to be replaced, only original spare parts from
Haag-Streit or its representative may be installed.
10.1 Repairs
To ensure long-term safe and error-free functioning, we recommend having an au-
thorised professional check the device every two years. Further information and the
corresponding technical documentation for this are available from Haag-Streit or
your local representative.
NOTE!
Calibration of the device will only be carried out by the manufacturer.
10.2 Cleaning and disinfection
WARNING!
• Before carrying out cleaning and disinfection work, the device must
always be disconnected from the mains by pulling out the plug.
• The efficacy of the disinfectants are determined by the disinfection
manufacturers.
• The efficacy of the disinfectants mentioned was not tested on their
correct disinfection effect on the applied parts.
• The efficacy of the disinfectants must be validated by means of the
user's disinfection process.
•Comply with the stipulated exposure time.
• Observe the manufacturer's safety instructions.
• Too strong or aggressive disinfectants or cleaning liquids e.g. hydro-
gen peroxide will damage the finish and coating of the device.
• Do not use sprays.
• Do not use any towels that drip.
• Wring out any soaked towels before use when necessary.
• Ensure that no liquid penetrates the device.

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10.2.1 Device in general
Regular dusting of the device is sufficient. More stubborn dirt can be removed using
a cleaning towel dampened with water or alcohol at maximum 70%. The cleaning in-
tervals for cleaning the complete device shall be performed within reasonable time
(e.g. once a week).
10.2.2 Touch screen
Fingerprints and dust on the touch screen can be removed using a display towel.
10.2.3 Applied parts
NOTE!
In order to comply with general hygiene requirements and to prevent the
transmission of infections, the applied parts should be disinfected prior
to every examination with a new patient.
• Forehead rest and optional chin rest
• Patient response button
• Eye patch
•Corrective lenses
• Patient side cover
10.2.4 Tools
Use the following tools for cleaning and disinfection operations:
•Cleaning/disinfecting towel: Commercially available soft and lint-free cleaning
towel
• Display towel: Commercially available wipes for cleaning screens
•Cleaning/disinfecting liquid: Use e.g. 70% isopropyl alcohol, or ready-for-use
disposable 70% ethanol disinfectant wipes. Surface-friendly disinfectants (con-
taining aldehyde or aldehyde-free) are also permitted, such as Kohrsolin FF.
NOTE!
The corrective lenses can also be cleaned in an ultrasound bath.
10.3 Dust cover
A dust cover is delivered with the device. Cover the device when the room is being
cleaned or if it is not used for longer periods of time. Always remove the dust cover
before switching on the power.
WARNING!
The device must not be switched on when covered (Heat build-up, fire
hazard).
11 Appendix
11.1 Accessories / consumables / spare parts / upgrade
Component Type REF Note
Chin rest - 7220636 1x
Instrument table * HSM 600 7220625
7220626
7220627
7220628
230 V
110 V
230 VLAN
110 VLAN
Corrective lens set RL basic set 1806170 Set comprising 12
corrective lens
Corrective lens +4 dpt 1806184S 1x
Corrective lens +3 dpt 1806183S 1x
Corrective lens +2 dpt 1806182S 1x
Corrective lens +1 dpt 1806181S 1x
Corrective lens -1 dpt 1806191S 1x
Corrective lens -2 dpt 1806192S 1x
Corrective lens -3 dpt 1806193S 1x
Corrective lens -4 dpt 1806194S 1x
Corrective lens -5 dpt 1806195S 1x

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Corrective lens -6 dpt 1806196S 1x
Corrective lens -7 dpt 1806197S 1x
Corrective lens -8 dpt 1806198S 1x
Patient response button Octopus 600 1806150 1x
Dust cover 1802304 1x
Eye patch set 1802349 2x / set
* See separate instructions for use
11.2 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 chapter 'Observed standards'.
•This is a Class IIa device in accordance with Appendix Appendix VIII of EU
2017/745 (Medical Device Regulation). By affixing the CE mark we confirm that
our device complies with the applicable standards and directives.
• You can request a copy of the declaration of conformity for this device from
Haag-Streit at any time.
•This device fulfils the European Directive 2011/65/EC.
11.3 Classification
Standard EN 60601-1 Protection class I
Applied part Type B
Operating mode Continuous operation
EU 2017/745 (Medical Device Regulation) Class IIa
Standard EN 62471 Exempt group
Standard EN ISO 15004-2 Group 1
11.4 Disposal
Electrical and electronic devices must be disposed of separately from
household waste! This device 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 sub-
stances enter the environment and that valuable raw materials are re-
cycled.
11.5 Observed standards
EN 60601-1 ISO 9022
EN 60601-1-2 EN ISO 10993
EN ISO 15004-1, -2 EN 1041
EN ISO 12866 EN 15223-1
EN 62471
11.6 Information and manufacturerÕs declaration concerning
electromagnetic compatibility (EMC)
11.6.1 General
This device fulfills the requirements on electromagnetic compatibility according to
IEC 60601-1-2:2014 (4th Edition). The device 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
device itself is suitably immune to electromagnetic interference.
WARNING!
• Electrical medical devices and systems are subject to special EMC
measures and must be installed in accordance with the EMC in-
structions contained in this accompanying document.
• Use of accessories, transducers and cables other than those spe-
cified or provided by Haag-Streit could result in increased electro-
magnetic emissions or decreased electromagnetic immunity of this
device and result in improper operation.

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• Third-party devices may only be connected in compliance with the
IEC 60601-1 standard.
WARNING!
Avoid damages due to high electrostatic discharges (ESD). Electrostatic
discharges with voltages exceeding 6 kV to USB ports may influence the
device.
• The firmware of the device may be disturbed. This requires a soft-
ware restart and a repetition of the investigation.
• Furthermore it cannot be excluded that ESD with higher voltages
may destroy internal electronic components of the device.
11.6.2 Emitted interference
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 envir-
onment.
Emission test Compliance Electromagnetic environment - guidance
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 do-
mestic purposes.
Harmonics emissions
IEC 61000-3-2
Class A
Voltage fluctuations/flicker emissions
IEC 61000-3-3
Pst = 1.0
Plt = 0.65
Pst: Power short term flicker
Plt: Power long term flicker

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11.6.3 Electromagnetic immunity environment tested (part 1)
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 envir-
onment.
Immunity test IEC 60601 test level Compliance level Electromagnetic environment Ð guidance
± 8 kV contact
± 2, ± 4, ± 8, ± 15 kV air
± 8 kV contact
± 2, ± 4, ± 8, ± 15 kV air
Floors should be wood, concrete or
ceramic tile. If floors are covered with
synthetic material, the relative humidity
should be at least 30%.
Electrical fast transient/burst
IEC 61000-4-4
± 2 kV, 100kHz for power supply lines *
± 1 kV, 100 kHz for input/output lines *
± 2 kV, 100kHz for power supply lines *
± 0.5, ± 1 kV, 100 kHz for input/output
lines *
Mains power quality should be that of a typical com-
mercial or hospital environment.
*Not applicable for DC and I/O if cable < 3 m.
Surge
IEC 61000-4-5
± 0.5, ± 1 kV line(s) to line(s) *
± 0.5, ± 1, ± 2 kV line(s) to earth *
± 1 kV line(s) to line(s) *
± 0.5, ± 1, ± 2 kV line(s) to earth *
Mains power quality should be that of a typical com-
mercial or hospital environment.
*Not applicable for DC and I/O if cable < 3 m.
Voltage dips, short interruptions
and voltage variations on power
supply input lines
IEC 61000-4-11
0% UT: 0.5 cycle at 0°, 45°, 90°, 135°,
180°, 225°, 270° and 315°
0% UT: 1 cycle at 0°
0% UT: 250/300 cycles at 0°
70% UT: 25/30 cycles at 0°
0% UT: 0.5 cycle at 0°, 45°, 90°, 135°,
180°, 225°, 270° and 315°
0% UT: 1 cycle at 0°
0% UT: 250/300 cycles at 0°
70% UT: 25/30 cycles at 0°
Mains power quality should be that of a typical com-
mercial or hospital environment.
If the user of this product requires continued opera-
tion during power mains interruptions, it is recom-
mended that this product be powered from an unin-
terruptible power supply or battery.
UTis the a.c. mains voltage (100 – 240 V) prior to
application of the test level.
Power frequency (50/60 Hz)
magnetic field
IEC 61000-4-8
30 A/m
50/60 Hz
30 A/m
50/60 Hz
Power frequency magnetic fields should be at levels
characteristic of a typical location in a typical com-
mercial or hospital environment.

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11.6.4 Electromagnetic immunity environment tested (part 2)
Portable and mobile RF communications equipment should be used no closer to any part of this product, including cables, than the recommended separation distance calcu-
lated from the equation applicable to the frequency of the transmitter.
These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. Field strengths
from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast
cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be con-
sidered.
Immunity test IEC 60601 test level Compliance level Electromagnetic environment - guidance
Conducted RF
IEC 61000-4-6
3 Vrms
150 kHz – 80 MHz outside ISM
bands and radio amateur band *
6 Vrms
150 kHz – 80 MHz in ISM bands
and radio amateur band *
3 Vrms
150 kHz – 80 MHz outside ISM
bands and radio amateur band *
6 Vrms
150 kHz – 80 MHz in ISM bands
and radio amateur band *
If the measured field strength in the location in which this product
is used exceeds the applicable RF compliance level, this product
should be observed to verify normal operation. If abnormal per-
formance is observed, additional measures may be necessary,
such as reorienting or relocating this product.
Minimum separation distance shall be calculated by following
equation:
E is the immunity test level in [V/m]
d is the minimum separation in [m]
P is the maximum power in [W]
RF wireless equipment maximum output power and separa-
tion distance tested (at 30 cm):
TETRA 400: max 1.8 W
GMRS 460, FRS 460: max 2 W
LTE Band 13 and 17: max 0.2 W
GSM 800/900: max 2 W
TETRA 800: max 2 W
iDEN 820: max 2 W
CDMA 850: max 2 W
LTE Band 5: max 2 W
Radiated RF
IEC 61000-4-3
3 V/m
80 MHz – 2.7 GHz
80% AM 1 kHz
5 V/m
80 MHz – 2.7 GHz
80% AM 1 kHz
Proximity field from RF wireless
communication equipment
IEC 61000-4-3
27 V/m
380 – 390 MHz
50% PM 18 Hz
28 V/m
430 – 470 MHz
FM ± 5 kHz deviation, 1kHz sine
9 V/m
704 – 787 MHz
50% PM 217 Hz
28 V/m
800 – 960 MHz
50% PM 18 Hz
28 V/m
1700 – 1990 MHz
50% PM 217 Hz
27 V/m
380 – 390 MHz
50% PM 18 Hz
28 V/m
430 – 470 MHz
FM ± 5 kHz deviation, 1kHz sine
9 V/m
704 – 787 MHz
50% PM 217 Hz
28 V/m
800 – 960 MHz
50% PM 18 Hz
28 V/m
1700 – 1990 MHz
50% PM 217 Hz

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28 V/m
2400 – 2570 MHz
50% PM 217 Hz
9 V/m
5100 – 5800 MHz
50% PM 217 Hz
28 V/m
2400 – 2570 MHz
50% PM 217 Hz
9 V/m
5100 – 5800 MHz
50% PM 217 Hz
GSM 1800/1900: max 2 W
CDMA 1900: max 2 W
DECT: max 2 W
LTE Band 1, 3, 4, 25: max 2 W
UMTS: max 2 W
Bluethooth: max 2 W
WLAN 802.11b/g/n: max 2 W
RFID 2450: max 2 W
LTE Band 7: max 2 W
WLAN 802.11 a/n: max 0.2 W
Interference may occur in the vicinity of equipment marked with the
following symbol:
* The ISM (industrial, scientific and medical) bands between 150 kHz and 80 MHz are: 6.765 – 6.795 MHz, 13.553 – 13.567 MHz, 26.957 – 27.283 MHz, 40.66 – 40.7
MHz. The amateur radio bands between 0.15 MHz and 80 MHz are: 1.8 MHz – 2 MHz, 3.5 – 4.0 MHz, 5.3 – 5.4 MHz, 7 – 7.3 MHz, 10.1 – 10.15 MHz, 14 – 14.2 MHz,
18.07 – 18.17 MHz, 21.0 – 21.4 MHz, 24.89 – 24.99 MHz, 28.0 – 29.7 MHz, 50.0 – 54.0 MHz.
If the measured field strength in the location in which this product is used exceeds the applicable RF compliance level above, this product should be observed to verify nor-
mal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating this product.