Haag-Streit OCTOPUS 600 User manual

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© HAAG‑STREIT AG, 3098 Koeniz, Switzerland ‑ HS Doc. no. 1500.7220367.04060 – 6. Edition / 2016 – 09
DEUTSCHENGLISH FRANÇAIS ITALIANO ESPAÑOL NEDERLANDS
PORTUGUÊS SVENSKA
DEUTSCHENGLISHFRANÇAISITALIANOESPAÑOLNEDERLANDS PORTUGUÊS SVENSKA
DOC. no. 1500 1500.1400209.04000
INSTRUCTIONS FOR USE
Perimeter
OCTOPUS®600
6. Edition / 2016 – 09
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© HAAG‑STREIT AG, 3098 Koeniz, Switzerland ‑ HS Doc. no. 1500.7220367.04060 – 6. Edition / 2016 – 09
DEUTSCHENGLISH FRANÇAIS ITALIANO ESPAÑOL NEDERLANDS
PORTUGUÊS SVENSKA DEUTSCHENGLISHFRANÇAISITALIANOESPAÑOLNEDERLANDS PORTUGUÊS
SVENSKA
INSTRUCTIONS FOR USE
Perimeter
OCTOPUS®600
6. Edition / 2016 – 09
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 600 perimeter is designed for the examination, analysis and documen-
tation of the field of sight, especially the light difference sensitivity and other func-
tions of the human eye.
Contraindication
WARNING!
Certain light stimuli with a high contrast and certain frequencies as pre-
sented 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 previously dis-
played any signs of epilepsy or similar conditions. Should the patient
feel unwell during the examination or if there is any indication of a con-
sciousness disturbance, the examination must be interrupted immedi-
ately. A standard white/white (SAP) examination can be performed as
an alternative.
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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© HAAG‑STREIT AG, 3098 Koeniz, Switzerland ‑ HS Doc. no. 1500.7220367.04060 – 6. Edition / 2016 – 09
DEUTSCHENGLISH FRANÇAIS ITALIANO ESPAÑOL NEDERLANDS
PORTUGUÊS SVENSKA
DEUTSCHENGLISHFRANÇAISITALIANOESPAÑOLNEDERLANDS PORTUGUÊS SVENSKA
Contents
1. Safety ................................................................................... 4
1.1 Areas of application of the device...........................................................................4
1.2 Patient population ...................................................................................................4
1.3 Ambient conditions..................................................................................................4
1.4 Shipment and unpacking ........................................................................................4
1.5 Installation warnings ..............................................................................................4
1.6 Operation and environment ....................................................................................5
1.7 Disinfection .............................................................................................................5
1.8 Warranty and product liability..................................................................................5
1.9 Symbols ..................................................................................................................6
2. Introduction.......................................................................... 6
2.1 Device description...................................................................................................6
2.2 System components ...............................................................................................6
2.3 Device overview......................................................................................................6
2.4 User interface (14) ..................................................................................................7
2.5 Housing...................................................................................................................7
2.6 Forehead rest..........................................................................................................7
2.7 Chin rest (optional)..................................................................................................7
2.8 Near correction lens................................................................................................7
2.9 Patient-side cover ..................................................................................................7
2.10 Corrective lenses ....................................................................................................7
2.11 Connections............................................................................................................8
2.11.1 USB ports................................................................................................................8
2.11.2 Mains connection....................................................................................................8
2.11.3 Ethernet port ...........................................................................................................8
2.12 LED background lighting.........................................................................................8
2.13 Fixation control........................................................................................................8
2.14 Examination data ....................................................................................................8
3. Appliance assembly / installation ...................................... 8
3.1 Transporting the appliance......................................................................................8
3.2 Connecting the patient response button .................................................................8
3.3 Connecting the electric power supply cable............................................................9
4. Safesystemcongurationinaccordance
with EN 60601-1 ................................................................. 10
4.1 System versions, OCTOPUS 600 with printer ......................................................10
5. Commissioning...................................................................11
5.1 Switching on the appliance ...................................................................................11
5.2 Switching off the appliance ...................................................................................11
6. Operation.............................................................................11
6.1 Setting up the patient ...........................................................................................11
7. Software/Helpmenu/Errormessages...........................11
8. Technical data.....................................................................11
8.1 OCTOPUS 600 .....................................................................................................11
8.2 Infrared illumination...............................................................................................11
8.3 Dimensions ...........................................................................................................12
8.4 Field of sight .........................................................................................................12
9. Maintenance....................................................................... 12
9.1 Repairs..................................................................................................................12
9.2 Cleaning................................................................................................................12
9.3 Applied parts.........................................................................................................12
A. Appendix ............................................................................ 12
A.1 Accessories / spare parts......................................................................................12
B. Legalregulations............................................................... 13
C. Classication ..................................................................... 13
D. Disposal.............................................................................. 13
E. Standards ........................................................................... 13
F. RoHS China........................................................................ 13
F.1 RoHS declaration..................................................................................................13
G. Information and manufacturer's declaration
 concerningelectromagneticcompatibility
(EMC) .................................................................................. 14
G.1 General .................................................................................................................14
G.2 Table 1: Emitted interference ................................................................................14
G.3 Table 2: Immunity..................................................................................................15
G.4 Table 3: Immunity (not life-support equipment).....................................................16
G.5 Table 4: Recommended safe distances (not life-support equipment) .................177
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© HAAG‑STREIT AG, 3098 Koeniz, Switzerland ‑ HS Doc. no. 1500.7220367.04060 – 6. Edition / 2016 – 09
DEUTSCHENGLISH FRANÇAIS ITALIANO ESPAÑOL NEDERLANDS
PORTUGUÊS SVENSKA DEUTSCHENGLISHFRANÇAISITALIANOESPAÑOLNEDERLANDS PORTUGUÊS
SVENSKA
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 users are ophthalmologists, optometrists, opticians, orthoptists or other trained
specialists. The examination is performed in slightly darkened examination rooms.
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
1.4 Shipmentandunpacking
• Before you unpack the appliance, check whether the packaging shows traces of
incorrect handling or damage. If this is the case, notify the transport company that
has delivered the goods to you. Unpack the equipment together with a represent-
ative 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 (risk of
condensation).
• Check the appliance for damage after it is unpacked. Return defective applianc-
es in the appropriate packaging.
• Store packaging material carefully, so that it can be used for possible returns or
when moving.
1.5 Installationwarnings
DANGER!
Never use the device in potentially explosive environments where vol-
atile solvents (alcohol, benzine, etc.) and combustible anaesthetics are
in use.
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 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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© HAAG‑STREIT AG, 3098 Koeniz, Switzerland ‑ HS Doc. no. 1500.7220367.04060 – 6. Edition / 2016 – 09
DEUTSCHENGLISH FRANÇAIS ITALIANO ESPAÑOL NEDERLANDS
PORTUGUÊS SVENSKA
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1.6 Operation and environment
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
defined 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 comply
with the EN 60601-1 standard or be connected through galvanic iso-
lation to external networks (safety isolating transformer).
WARNING!
• 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 experi-
enced individuals.
• Turning off the eye monitoring functions is not recommended. In all
other cases, the user must monitor the eye personally during the
examination.
• All users must be appropriately trained and familiarised with the
contents of the instructions for use, especially in regard to the safety
information contained therein.
NOTE!
• This appliance must only be operated by qualified and trained per-
sonnel. The owner is responsible for their training.
• This appliance may only be used for the purpose described
in these instructions for use.
• The device must be set up in a medical room in such a way that no
direct light falls on it from any side.
• Keep these instructions for use in a place where they are accessible
to those working with the device at all times. Warranty claims can
only be made if the instructions in 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 Oc-
topus 600.
• Turn the device off if it will not be used for an extended period of time.
• Do not expose the device to direct sunlight.
• Protect the device with the dust cover when not in use.
1.7 Disinfection
NOTE!
The device does not need to be disinfected. For more information on
cleaning, please refer to the 'Maintenance' and 'Applied parts' section.
1.8 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:
•
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© HAAG‑STREIT AG, 3098 Koeniz, Switzerland ‑ HS Doc. no. 1500.7220367.04060 – 6. Edition / 2016 – 09
DEUTSCHENGLISH FRANÇAIS ITALIANO ESPAÑOL NEDERLANDS
PORTUGUÊS SVENSKA DEUTSCHENGLISHFRANÇAISITALIANOESPAÑOLNEDERLANDS PORTUGUÊS
SVENSKA
1.9 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
12 RoHS China Protective earth (ground)
European certificate of
conformity Manufacturer
Year of production Serial number
HS reference number
Test symbol of CSA with ap-
proval for USA
2. Introduction
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 con-
trol 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.
• New operating system software and perimetry software can be downloaded and
updated by visiting www.HAAG-STREIT.com.
2.2 System components
The Octopus 600 comprises the following components:
• Octopus 600
• Patient response button (Type B application part)
• Keyboard/mouse (optional)
2.3 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
1
2
3
4
5
6
7
8
9
10
11
12
13
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© HAAG‑STREIT AG, 3098 Koeniz, Switzerland ‑ HS Doc. no. 1500.7220367.04060 – 6. Edition / 2016 – 09
DEUTSCHENGLISH FRANÇAIS ITALIANO ESPAÑOL NEDERLANDS
PORTUGUÊS SVENSKA
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2.6 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).
(a)
2.7 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.
2.8 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.
2.9 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.
2.10 Corrective lenses
Patients' ametropia can be corrected with the supplied corrective lenses. A correc-
tive 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 patients
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.
Overview of user side
14. User interface with touch screen
15. Power on/off button
14
15
2.4 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.
2.5 Housing
• The optical components and electronics are protected from light and soiling by
housing covers.
• For servicing, see Section 'Maintenance'.
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.
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© HAAG‑STREIT AG, 3098 Koeniz, Switzerland ‑ HS Doc. no. 1500.7220367.04060 – 6. Edition / 2016 – 09
DEUTSCHENGLISH FRANÇAIS ITALIANO ESPAÑOL NEDERLANDS
PORTUGUÊS SVENSKA DEUTSCHENGLISHFRANÇAISITALIANOESPAÑOLNEDERLANDS PORTUGUÊS
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2.11 Connections
16. 4 x USB 2.0 port
17. Mains switch
18. Fuse holder with two fuses 3.15 AH / 250 V
19. Mains connection
20. Ethernet port
16
17
18
19
20
2.11.1 USB ports
There are a total of 4 USB 2.0 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 iso-
lating transformer as per EN 60601-1 or operated with a medically ap-
proved power supply.
2.11.2 Mains connection
The power cable must correspond to the nationally applicable safety requirements.
2.11.3 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.
2.12 LEDbackgroundlighting
In the Octopus 600, LEDs are used as light sources for the periphery and stimu-
lus. 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.
2.13 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 fix-
ation control function increases the reliability of the examination results. Precise
positioning of the examined eye is performed by motorised fine adjustment of the
forehead rest (5).
2.14 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.
3. Appliance assembly / installation
3.1 Transportingtheappliance
• Transport the appliance over larger distances in its origi-
nal 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.
3.2 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 con-
nected to the RJ12 socket
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© HAAG‑STREIT AG, 3098 Koeniz, Switzerland ‑ HS Doc. no. 1500.7220367.04060 – 6. Edition / 2016 – 09
DEUTSCHENGLISH FRANÇAIS ITALIANO ESPAÑOL NEDERLANDS
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• 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.
b)
a)
c)
3.3 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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© HAAG‑STREIT AG, 3098 Koeniz, Switzerland ‑ HS Doc. no. 1500.7220367.04060 – 6. Edition / 2016 – 09
DEUTSCHENGLISH FRANÇAIS ITALIANO ESPAÑOL NEDERLANDS
PORTUGUÊS SVENSKA DEUTSCHENGLISHFRANÇAISITALIANOESPAÑOLNEDERLANDS PORTUGUÊS
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4. Safesystemcongurationinaccordance
with EN 60601-1
4.1 System versions, OCTOPUS 600 with printer
WARNING!
Printers connected via the USB port (27) must be connected to a safe-
ty 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.
1.5 m
21 22
28
28
28
23 24
26
26
23
27
25
Version I:
Version II:
Printer connected via USB port (27)
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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© HAAG‑STREIT AG, 3098 Koeniz, Switzerland ‑ HS Doc. no. 1500.7220367.04060 – 6. Edition / 2016 – 09
DEUTSCHENGLISH FRANÇAIS ITALIANO ESPAÑOL NEDERLANDS
PORTUGUÊS SVENSKA
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5. Commissioning
5.1 Switchingontheappliance
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.
5.2 Switchingofftheappliance
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 pow-
er supply. When servicing, always use the mains switch (17) and dis-
connect 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.
6. Operation
6.1 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 correct
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 de-
fines the relevant area of the pupil 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. It is strongly recommended to make a
backup before running a software update.
8. Technical data
8.1 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 x 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
Stimulus colour: White
USB port: USB 2.0 - Standard
Ethernet port: 1000 Base-T (1Gbit)
Internal memory SSD: 32 GByte
8.2 Infrared illumination
Light source: LED
Wavelength: 940 nm
Angle of radiation: ±22°
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© HAAG‑STREIT AG, 3098 Koeniz, Switzerland ‑ HS Doc. no. 1500.7220367.04060 – 6. Edition / 2016 – 09
DEUTSCHENGLISH FRANÇAIS ITALIANO ESPAÑOL NEDERLANDS
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8.3 Dimensions
Dimensions (W x D x H): 467 x 508 x 500 mm
Weight: 12.7 kg
Shipping dimensions (W x D x H): 600 x 800 x 1030 mm
Shipping weight: 26 kg
8.4 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°
9. Maintenance
WARNING!
• Housing parts may be removed and repairs performed only by appro-
priately trained and authorised skilled personnel. Incorrect repairs 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.
9.1 Repairs
To ensure long-term safe and error-free functioning, we recommend having an
authorised professional check the Octopus 600 every two years. Further infor-
mation and the corresponding technical documentation for this are available from
HAAG-STREIT or your local representative.
9.2 Cleaning
Occasional dusting with a soft cloth is sufficient. Stubborn dirt particles can be re-
moved with a soft cloth dampened with water or alcohol. Fingerprints and dust on
the user screen can be removed using a soft, moist cloth.
NOTE!
Do not allow the appliance to become wet and do not use solvents or
abrasive cleaning products under any circumstances.
A dust cover is delivered with the Octopus 600 as an accessory. Cover the appli-
ance when the room is being cleaned or if it is not used for longer periods.
NOTE!
The appliance must not be switched on when covered (heat build-up,
fire hazard).
9.3 Applied parts
Applied parts such as the eye patch, patient response button and forehead and
chin rest (optional) as well as other parts such as the corrective lenses and the pa-
tient-side cover are made of easy-to-clean plastics.
NOTE!
• These applied parts should be disinfected prior to every examination
(e.g., with 70% isopropyl alcohol) in order to comply with general hy-
giene requirements and prevent the transmission of infections..
• The corrective lenses can also be cleaned in an ultrasound bath.
A. Appendix
A.1 Accessories / spare parts
Component Type HS art. no. Note
Chin rest - 7220636 1x
Compact table CT 01 1802281 See separate IFU*:
Instrument table IT 01 7220034 See separate IFU*:
Corrective lens set RL basic set 1806170 Set comprising 12 correc-
tive lens
Corrective lens +4 dpt 1806184 1x
Corrective lens +3 dpt 1806183 1x
Corrective lens +2 dpt 1806182 1x
Corrective lens +1 dpt 1806181 1x
Corrective lens -1 dpt 1806191 1x
Corrective lens -2 dpt 1806192 1x
Corrective lens -3 dpt 1806193 1x
Corrective lens -4 dpt 1806194 1x
Corrective lens -5 dpt 1806195 1x
Corrective lens -6 dpt 1806196 1x
Corrective lens -7 dpt 1806197 1x
Corrective lens -8 dpt 1806198 1x
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© HAAG‑STREIT AG, 3098 Koeniz, Switzerland ‑ HS Doc. no. 1500.7220367.04060 – 6. Edition / 2016 – 09
DEUTSCHENGLISH FRANÇAIS ITALIANO ESPAÑOL NEDERLANDS
PORTUGUÊS SVENSKA
DEUTSCHENGLISHFRANÇAISITALIANOESPAÑOLNEDERLANDS PORTUGUÊS SVENSKA
Patient response button Octopus 600 1806150 1x
Dust cover 1802304 1x
Eye patch set 1802349 2x / set
*IFU = 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 'EMC'.
• The Octopus 600 is a Class IIa device in accordance with Appendix IX of Direc-
tive 93/42/EEC. 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 the appliance from
HAAG-STREIT at any time.
• This appliance fulfils the European Directive 2011/65/EC.
C. Classication
Standard EN 60601-1 Perimeter Octopus 600 acc. to protection class I
Applied part: Type B
Operating mode: Continuous operation
CE Directive 93/42/EEC Class IIa
Standard EN 62471 Exempt group
Standard EN ISO 15004-2 Group 1
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 ISO 9022
EN 60601-1-2 EN ISO 10993
EN ISO 15004-1, -2 EN 1041
EN ISO 12866 EN 15223-1
EN 62471
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
field 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.
F.1 RoHS declaration Name of sub-assembly
Camera mount. (Distance ring 1820224) Camera mount. (Front threaded ring 1820153) Stepping motor mount. (Short coupling flange 1802009) Ribbon cable clip (1008504)
Lead (Pb) ■■■○
Mercury(Hg) ○ ○ ○ ○
Cadmium (Cd) ○○○○
Chromium VI compounds (Cr6+) ○○○○
Polybrominated biphenyl (PBB) ○○○○
Polybrominated diphenyl ether (PBDE) ○○○■
■Contains ○Does not contain
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DEUTSCHENGLISH FRANÇAIS ITALIANO ESPAÑOL NEDERLANDS
PORTUGUÊS SVENSKA DEUTSCHENGLISHFRANÇAISITALIANOESPAÑOLNEDERLANDS PORTUGUÊS
SVENSKA
G.2 Table 1: Emitted interference
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
G. Information and manufacturer's declaration
 concerningelectromagneticcompatibility
(EMC)
G.1 General
The Octopus 600 fulfils the requirements on electromagnetic compatibility according
to EN 60601-1-2. The instrument is constructed in such a way that the generation
and emission of electromagnetic interference is limited to the extent that other de-
vices are not disturbed in their use in accordance with the regulations and so that it
itself has appropriate immunity to electromagnetic interference.
WARNING!
• In terms of EMC, electrical medical devices and systems are subject
to special measures and must be installed in accordance with the
EMC information contained in these instructions for use.
• Portable and mobile HF communication systems may interfere with
electrical medical devices.
• Connecting third-party systems to the same extension cable can
compromise safety.
• Any third-party device must be connected in compliance with the EN
60601-1 standard.
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DEUTSCHENGLISH FRANÇAIS ITALIANO ESPAÑOL NEDERLANDS
PORTUGUÊS SVENSKA
DEUTSCHENGLISHFRANÇAISITALIANOESPAÑOLNEDERLANDS PORTUGUÊS SVENSKA
G.3 Table 2: Immunity
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
± 15 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.
200 A/m
30 A/m
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DEUTSCHENGLISH FRANÇAIS ITALIANO ESPAÑOL NEDERLANDS
PORTUGUÊS SVENSKA DEUTSCHENGLISHFRANÇAISITALIANOESPAÑOLNEDERLANDS PORTUGUÊS
SVENSKA
G.4 Table 3: Immunity (not life-support equipment)
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
3 Vrms D= 1.2
Radiated RF EN 61000-4-3 3 V/m
80 MHz – 2.5 GHz
5 V/m
80 MHz – 2.5 GHz
D= 1.2 80 MHz – 800 MHz
D= 2.3 800 MHz – 2.5 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 range b 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 3 V/m.
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© HAAG‑STREIT AG, 3098 Koeniz, Switzerland ‑ HS Doc. no. 1500.7220367.04060 – 6. Edition / 2016 – 09
DEUTSCHENGLISH FRANÇAIS ITALIANO ESPAÑOL NEDERLANDS
PORTUGUÊS SVENSKA
DEUTSCHENGLISHFRANÇAISITALIANOESPAÑOLNEDERLANDS PORTUGUÊS SVENSKA
G.5 Table 4: Recommended safe distances (not life-support equipment)
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 = 1.2
80 MHz – 800 MHz
D = 1.2
800 MHz – 2.5 GHz
D = 2.3
0.01 0.12 0.12 0.23
0.1 0.38 0.38 0.73
1 1.2 1.2 2.3
10 3.8 3.8 7.3
100 12 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 2.5 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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DEUTSCHENGLISH FRANÇAIS ITALIANO ESPAÑOL NEDERLANDS
PORTUGUÊS SVENSKA DEUTSCHENGLISHFRANÇAISITALIANOESPAÑOLNEDERLANDS PORTUGUÊS
SVENSKA
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© HAAG‑STREIT AG, 3098 Koeniz, Switzerland ‑ HS Doc. no. 1500.7220367.04060 – 6. Edition / 2016 – 09
DEUTSCHENGLISH FRANÇAIS ITALIANO ESPAÑOL NEDERLANDS
PORTUGUÊS SVENSKA
DEUTSCHENGLISHFRANÇAISITALIANOESPAÑOLNEDERLANDS PORTUGUÊS SVENSKA
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© HAAG‑STREIT AG, 3098 Koeniz, Switzerland ‑ HS Doc. no. 1500.7220367.04060 – 6. Edition / 2016 – 09
DEUTSCHENGLISH FRANÇAIS ITALIANO ESPAÑOL NEDERLANDS
PORTUGUÊS SVENSKA
Should you have any further questions, please contact your HAAG-STREIT representative at:
1250
http://www.haag-streit.com/contact/contact-your-distributor.html
HAAG-STREIT AG
Gartenstadtstrasse 10
3098 Koeniz, Switzerland
Phone [phone]
Fax [phone]
eMail [email protected]
Internet www.haag-streit.com
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