SVENSKA NEDERLANDS PORTUGUÊS ESPAÑOL ITALIANO FRANÇAIS DEUTSCH ENGLISH

INSTRUCTION MANUAL
Perimeter

OCTOPUS® 600
2. edition / 2013 – 09

© HAAG‑STREIT AG, 3098 Koeniz, Switzerland ‑ HS Doc. no. 1500.7220367.04020 – 2. edition / 2013 – 09 DOC. no. 1500 1500.1400209.04000 1

01-IFU_Octopus600-7220367_04020_eng.indd 1 23.09.2013 08:03:11

ENGLISH DEUTSCH FRANÇAIS ITALIANO ESPAÑOL PORTUGUÊS NEDERLANDS SVENSKA

INSTRUCTION MANUAL Introduction

Thank you for choosing a HAAG‑STREIT appliance. Provided you comply carefully
Perimeter with the regulations in this instruction manual, we can guarantee the reliable and

OCTOPUS® 600
unproblematic use of our product.

Purpose of use
2. edition / 2013 – 09 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 instructions for use carefully before commissioning the Octo‑
pus 600. They contain important information concerning the safety of
the user and patient.

NOTE!
Federal law restricts this device to sale by or on the order of a physici‑
an or practitioner.

2 © HAAG‑STREIT AG, 3098 Koeniz, Switzerland - HS Doc. no. 1500.7220367.04020 – 2. edition / 2013 – 09

01-IFU_Octopus600-7220367_04020_eng.indd 2 23.09.2013 08:03:11

 SVENSKA NEDERLANDS PORTUGUÊS ESPAÑOL ITALIANO FRANÇAIS DEUTSCH ENGLISH

Contents

1. Safety .................................................................................... 4 6. Operation..............................................................................11

1.1 Areas of application of the device............................................................................4 6.1 Setting up the patient ............................................................................................11
1.2 Patient population....................................................................................................4
1.3 Ambient conditions...................................................................................................4 7. Software / Help menu / Error messages............................11
1.4 Shipment and unpacking.........................................................................................4
8. Technical data......................................................................11
1.5 Installation warnings ...............................................................................................4
8.1 OCTOPUS 600......................................................................................................11
1.6 Operation and environment.....................................................................................5
8.2 Infrared illumination................................................................................................11
1.7 Disinfection..............................................................................................................5
8.3 Dimensions............................................................................................................12
1.8 Warranty and product liability...................................................................................5
8.4 Field of sight ..........................................................................................................12
1.9 Symbols...................................................................................................................6
9. Maintenance........................................................................ 12
2. Introduction........................................................................... 6 9.1 Repairs...................................................................................................................12
2.1 Device description....................................................................................................6
9.2 Cleaning.................................................................................................................12
2.2 System components................................................................................................6
9.3 Applied parts..........................................................................................................12
2.3 Device overview.......................................................................................................6
2.4 User interface (14)...................................................................................................7 A. Appendix............................................................................. 12
2.5 Housing....................................................................................................................7 A.1 Accessories / spare parts.......................................................................................12
2.6 Forehead rest...........................................................................................................7
2.7 Near correction lens.................................................................................................7 B. Legal regulations................................................................ 13
2.8 Patient-side cover ...................................................................................................7
C. Classification...................................................................... 13
2.9 Corrective lenses.....................................................................................................7
2.10 Connections.............................................................................................................8 D. Disposal............................................................................... 13
2.10.1 USB ports.................................................................................................................8
2.10.2 Mains connection.....................................................................................................8 E. Standards............................................................................ 13
2.10.3 Ethernet port............................................................................................................8
2.11 LED background lighting..........................................................................................8
F. RoHS China......................................................................... 13
F.1 RoHS declaration...................................................................................................14
2.12 Fixation control.........................................................................................................8
2.13 Examination data.....................................................................................................8 G. Information and manufacturer's declaration
3. Appliance assembly / installation....................................... 8 concerning electromagnetic compatibility
3.1 Transporting the appliance.......................................................................................8 (EMC)................................................................................... 14
3.2 Connecting the patient response button..................................................................8 G.1 General..................................................................................................................14
3.3 Connecting the electric power supply cable.............................................................9 G.2 Table 1: Emitted interference.................................................................................14
G.3 Table 2: Immunity...................................................................................................15
4. Safe system configuration in accordance
G.4 Table 3: Immunity (not life-support equipment)......................................................16
with EN 60601-1.................................................................. 10 G.5 Table 4: Recommended safe distances (not life-support equipment)....................17
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

© HAAG‑STREIT AG, 3098 Koeniz, Switzerland - HS Doc. no. 1500.7220367.04020 – 2. edition / 2013 – 09 3

01-IFU_Octopus600-7220367_04020_eng.indd 3 23.09.2013 08:03:11

ENGLISH DEUTSCH FRANÇAIS ITALIANO ESPAÑOL PORTUGUÊS NEDERLANDS SVENSKA

1. Safety 1.4 Shipment and unpacking

FORBIDDEN! • Before you unpack the appliance, check whether the packaging shows traces of
Failure to comply with the instructions can result in material damage incorrect handling or damage. If this is the case, notify the transport company that
and pose a danger to users and patients. 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
WARNING! must be signed by you and by the representative of the transport company.
These warnings must absolutely be complied with to guarantee safe • Leave the device in the packaging for a few hours before unpacking it (conden‑
operation of the device and to avoid sation).
any danger to users and to patients. • Check the appliance for damage after it is unpacked. Return defective applianc‑
NOTE! es in the appropriate packaging.
Important information: please read carefully. • Store packaging material carefully, so that it can be used for possible returns or
when moving.

1.1 Areas of application of the device 1.5 Installation warnings

The users are ophthalmologists, optometrists, opticians, orthoptists or other trained
FORBIDDEN!
specialists. The examination is performed in slightly darkened examination rooms.
Never use the device in potentially explosive environments where vol‑
1.2 Patient population atile solvents (alcohol, benzine, etc.) and combustible anaesthetics are
The patient must be capable of sitting up straight and keeping his head still. He/she in use.
must be physically and mentally able to cooperate well and is mentally capable of WARNING!
following the examination. Patients must be at least 6 years old. ••Installation, repairs and modifications may only be performed by
1.3 Ambient conditions trained specialists.
Transport: Temperature from -40 °C to +70 °C ••Any third-party device must be connected in compliance with the IEC/
Air pressure from 500 hPa to 1060 hPa EN 60601-1 standard.
Relative humidity from 10% to 95% NOTE!
Storage: Temperature from -10 °C to +55 °C ••The device must be set up in a medical room in such a way that no
Air pressure from 700 hPa to 1060 hPa direct light falls on it from the side or patient's side.
Relative humidity from 10% to 95% ••The use of accessories other than than those listed may result in
Use: Temperature from +10 °C to +35 °C higher emissions or lower interference immunity of the Octopus 600.
Air pressure from 800 hPa to 1060 hPa ••The software must be installed by trained personnel.
Relative humidity from 30% to 90%
Application height < 2,000 m above sea level

4 © HAAG‑STREIT AG, 3098 Koeniz, Switzerland - HS Doc. no. 1500.7220367.04020 – 2. edition / 2013 – 09

01-IFU_Octopus600-7220367_04020_eng.indd 4 23.09.2013 08:03:11

 SVENSKA NEDERLANDS PORTUGUÊS ESPAÑOL ITALIANO FRANÇAIS DEUTSCH ENGLISH

1.6 Operation and environment NOTE!

WARNING! ••Keep these instructions for use in a place where they are accessible
••To avoid the risk of suffering an electric shock, this device may only to those working with the device at all times. Warranty claims can
be connected up to the mains with a ground connection. only be made if the instructions in these instructions for use are
••The plug, cable and ground connection of the socket must be func‑ complied with.
tioning perfectly. ••Always remove the dust cover before switching the appliance on. The
••Make sure that the appliance is only connected to power supplies as device may otherwise become damaged due to overheating. Like‑
defined on the type plate. The appliance must be disconnected from wise, make sure that the appliance is switched
the mains by pulling out the plug before any maintenance and clean‑ off before attaching the dust cover.
ing work is performed. ••Only original spare parts and original accessories may be used
••Computers and further ancillary devices (printers, etc.) must comply for repairs. The use of accessories other than than those listed may
with the EN 60601-1 standard or be connected through galvanic iso‑ result in higher emissions or lower interference immunity of the Oc‑
lation to external networks (safety isolating transformer). topus 600.
••Turn the device off if it will not be used for an extended period of time.
WARNING!
••The doctor or the operator is obliged to inform the patient about the
safety instructions concerning him and to ensure that these instruc‑
1.7 Disinfection
tions are complied with. NOTE!
••The examination of the patient, the use of the device and the inter‑ The device does not need to be disinfected.
pretation of the results may only be conducted by trained and experi‑
enced individuals. For more information on cleaning, please refer to the 'Maintenance' section.
••Turning off the eye monitoring functions is not recommended. In all
other cases, the user must monitor the eye personally during the 1.8 Warranty and product liability
examination. • The product should be treated as described in the “Safety” chapter. Improper
••All users must be appropriately trained and familiarised with the handling can damage the product. This would void all guarantee claims.
contents of the instructions for use, especially in regard to the safety • Continued use of a product damaged by incorrect handling may lead to personal
information contained therein. injury. In this case, the manufacturer accepts no liability.

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 the side or patient's side.

© HAAG‑STREIT AG, 3098 Koeniz, Switzerland - HS Doc. no. 1500.7220367.04020 – 2. edition / 2013 – 09 5

01-IFU_Octopus600-7220367_04020_eng.indd 5 23.09.2013 08:03:11

ENGLISH DEUTSCH FRANÇAIS ITALIANO ESPAÑOL PORTUGUÊS NEDERLANDS SVENSKA

1.9 Symbols 2.3 Device overview

Overview of patient side
Read the instructions for use General warning: Read the ac‑
1. Upper part of housing
attentively companying documentation
2. Right shell
Product classification type B. 3. Capacitive button for operating the forehead rest
Device includes type B appli‑ Disposal instructions. 4. Left shell
cation parts, namely patient See 'Disposal' section. 5. Forehead rest with integrated sensor for detecting the head position
response button 6. Infrared eye illumination
7. Near correction lens +3.25 dpt
Test symbol of CSA 8. Patient‑side cover
12 RoHS China
with approval for USA 9. Corrective lenses
10. Corrective lens compartment
European certificate of con‑ Ground connection 11. Automatically closing cover
formity 12. Patient response button
13. Patient response button connection
Year of production Manufacturer
1
2
3
2. Introduction 4
2.1 Device description 5
6
• The Octopus 600 is a binocular screen perimeter for examining the central field 7
of sight (30°). The device can be employed autonomously, i.e., the examination 8
and control components are integrated in the device. 9
• Integrated, automatic fixation monitoring increases the reliability of the examina‑ 10
tion results. 11
• The Octopus 600 is employed by clinical users and for research purposes. 12
• New operating system software and perimetry software can be downloaded and 13
updated by visiting www.HAAG‑STREIT.com.

2.2 System components

The Octopus 600 comprises the following components:
• Octopus 600
• Patient response button
• Keyboard/mouse (optional)

6 © HAAG‑STREIT AG, 3098 Koeniz, Switzerland ‑ HS Doc. no. 1500.7220367.04020 – 2. edition / 2013 – 09

01-IFU_Octopus600-7220367_04020_eng.indd 6 23.09.2013 08:03:12

 SVENSKA NEDERLANDS PORTUGUÊS ESPAÑOL ITALIANO FRANÇAIS DEUTSCH ENGLISH

Overview of user side 2.6 Forehead rest

14. User interface with touch screen A wide, ergonomically designed forehead rest (5) allows the patient to maintain a
15. Power on/off button comfortable posture during the examination. The forehead rest can be moved for‑
wards and backwards by pressing the triangular buttons (a).

(a)

14

15

2.4 User interface (14) 2.7 Near correction lens

• A high‑contrast display allows operation of the Octopus 600 at a large angle of The near correction lenses (7) integrated in the device also make it possible to ac‑
view. commodate older patients on the examination screen.
• The user interface is optimised for use on a touch screen and guarantees rapid 2.8 Patient-side cover
and reliable operation of the device. The cover on the patient side (8) can be equipped with two corrective lenses. The
• The high resolution of the display allows the accurate reproduction of examina‑ magnetic holder on the corrective lenses allows simple, quick positioning.
tion results.
Keyboard/mouse (optional) 2.9 Corrective lenses
• If required, a keyboard and a mouse can be connected via a USB port for con‑ Patients' ametropia can be corrected with the supplied corrective lenses. A correc‑
trol purposes. tive lens set is composed of 12 spherical corrective lenses (9) from –8 dpt to +4 dpt.
• We recommend choosing a wireless connection. NOTE!
• In cases of cylindrical ametropia > 1 dpt, we recommend that patients
2.5 Housing wear their own glasses or contact lenses for the examination insofar
• The optical components and electronics are protected from light and soiling by as this is possible and the field of sight is not restricted.
housing covers. • To protect the lenses from soiling and damage, they should be put
• For servicing, see Section 8 'Care and maintenance'. back in the compartment provided for them.
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.

© HAAG‑STREIT AG, 3098 Koeniz, Switzerland ‑ HS Doc. no. 1500.7220367.04020 – 2. edition / 2013 – 09 7

01-IFU_Octopus600-7220367_04020_eng.indd 7 23.09.2013 08:03:15

ENGLISH DEUTSCH FRANÇAIS ITALIANO ESPAÑOL PORTUGUÊS NEDERLANDS SVENSKA

2.10 Connections 2.11 LED background lighting

16. 4 x USB 2.0 port In the Octopus 600, LEDs are used as light sources for the periphery and stimu‑
17. Mains switch lus. The light intensity of the background lighting is measured with two independ‑
18. Fuse holder with two fuses 3.15 AH / 250 V ent light sensors and adjusted to the preset nominal values each time the perimeter
19. Mains connection is switched on. These nominal values are defined in the factory by HAAG‑STRE‑
20. Ethernet port IT. 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.
16
2.12 Fixation control
17 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‑
18 ation control function increases the reliability of the examination results. Precise
positioning of the examined eye is performed by motorised fine adjustment of the
19
forehead rest (5).
20
2.13 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
2.10.1 USB ports data to a USB storage device via a USB port.
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. 3. Appliance assembly / installation
WARNING! 3.1 Transporting the appliance
This connection is not galvanically isolated. Devices such as printers • Transport the appliance over larger distances in its origi‑
can only be connected via USB if they are equipped with a safety iso‑ nal packaging.
lating transformer as per EN 60601‑1 or operated with a medically ap‑ • For short distances, grasp the device with two hands
proved power supply. holding the side shells on the left and right and lift it.
2.10.2 Mains connection
The power cable must correspond to the nationally applicable safety requirements.

2.10.3 Ethernet port 3.2 Connecting the patient response button

There is an Ethernet port on the side of the device. Always use a shielded cable of The connection socket for the patient response button is below the holder. The re‑
category 5e permitting transmissions of up to 1 GHz without interference. This Eth‑ taining bar on the connection plug is oriented towards the patient side.
ernet port is electrically isolated and has a dielectric strength of 4 kV according to FORBIDDEN!
EN 60601‑1. Apart from the patient response button, no other cables may be con‑
nected to the RJ12 socket

8 © HAAG‑STREIT AG, 3098 Koeniz, Switzerland ‑ HS Doc. no. 1500.7220367.04020 – 2. edition / 2013 – 09

01-IFU_Octopus600-7220367_04020_eng.indd 8 23.09.2013 08:03:15

 SVENSKA NEDERLANDS PORTUGUÊS ESPAÑOL ITALIANO FRANÇAIS DEUTSCH ENGLISH

• 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 and pull the cable away downwards.
a)
b)

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.

© HAAG‑STREIT AG, 3098 Koeniz, Switzerland - HS Doc. no. 1500.7220367.04020 – 2. edition / 2013 – 09 9

01-IFU_Octopus600-7220367_04020_eng.indd 9 23.09.2013 08:03:15

ENGLISH DEUTSCH FRANÇAIS ITALIANO ESPAÑOL PORTUGUÊS NEDERLANDS SVENSKA

4. Safe system configuration 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 (27) may be
dispensed with as shown in the diagram below, in accordance with EN
60601-1.

23 24

21 27 22
28 26

28
28 26

25

X 23
26. LAN connection
Version I: Printer connected via USB port (27) 27. Printer connection via USB port.
Version II: Printer connected via Ethernet port (28) 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.
21. Octopus 600
22. Printer
23. Mains connection
24. Safety isolating transformer
25. Support stand

10 © HAAG‑STREIT AG, 3098 Koeniz, Switzerland - HS Doc. no. 1500.7220367.04020 – 2. edition / 2013 – 09

01-IFU_Octopus600-7220367_04020_eng.indd 10 23.09.2013 08:03:16

 SVENSKA NEDERLANDS PORTUGUÊS ESPAÑOL ITALIANO FRANÇAIS DEUTSCH ENGLISH

5. Commissioning 7. Software / Help menu / Error messages

5.1 Switching on the appliance The software's help section contains instructions and help for performing an exam‑
Before connecting the Octopus 600 to a suitable power socket, it must be ensured ination and descriptions of the error messages. The help can be opened via the F1
that the mains switch (0/I) (17) is set to OFF (0). The mains switch is on the right of key or in the [?] - [Help] menu.
the base of the device viewed from the user's side. Then set the mains switch (0/I) WARNING!
to ON (I). The device is now in standby mode. The device can be switched on with The software must be installed by trained personnel in accordance with
the Power On/Off button (15). The operating system and then the application are separate installation instructions. It is strongly recommended to make a
started automatically. The device is ready for use after approximately one minute. backup before running a software update.

5.2 Switching off the appliance

Once the Power On/Off button (15) is pressed, a confirmation prompt appears. As 8. Technical data
an alternative to the Power On/Off button, the device can also be switched off via 8.1 OCTOPUS 600
the software menu [File] - [Exit]. After approximately 15 seconds, the LED display Type designation Octopus 600
on the Power On/Off button goes out and the device enters standby mode. Mains voltage: 100 – 240 VAC
WARNING! Power consumption: 100 VA
To avoid losing data, always switch the device off with the Power On/ Power consumption in standby: 3W
Off button (15) first and then the mains switch. Operating frequency: 50 / 60 Hz
The Power On/Off button does not disconnect the device from the pow‑ Fuses: 2 x T 3.15 AH 250 V
er supply. When servicing, always use the mains switch (17) and dis‑ Functional principle: Binocular screen perimeter
connect the device from the power supply. Examination principle: Subjective test using bracketing procedure
NOTE! Patient positioning: Adjustable forehead rest
If the mains switch is still switched on, the device is in standby mode Fixation control: Permanent video-based fixation control
and consumes little power. Eccentricity: 60°
Dynamic range: 0 – 35 dB / src
6. Operation Stimulus intensity: 0.015 – 150 cd/m²
6.1 Setting up the patient Stimulus colour: White
• The corrective lenses are selected so that the patient sees the fixation mark on USB port: USB 2.0 - Standard
the examination screen clearly. The patient's glasses can be used as an aid for Ethernet port: 1000 Base-T (1Gbit)
this. Internal memory SSD: 32 GByte
• The patient sits comfortably in front of the device and places his forehead on
the forehead rest. The forehead rest can be set to the correct position. The user 8.2 Infrared illumination
chooses the eye to be examined (OS or OD). Then the video image for fixation Light source: LED
control appears. This is equipped with a rectangle which defines the relevant Wavelength: 940 nm
area of the pupil position. Angle of radiation: ±22°

© HAAG‑STREIT AG, 3098 Koeniz, Switzerland - HS Doc. no. 1500.7220367.04020 – 2. edition / 2013 – 09 11

01-IFU_Octopus600-7220367_04020_eng.indd 11 23.09.2013 08:03:16

ENGLISH DEUTSCH FRANÇAIS ITALIANO ESPAÑOL PORTUGUÊS NEDERLANDS SVENSKA

8.3 Dimensions NOTE!

Dimensions (W x D x H): 467 x 508 x 500 mm Do not allow the appliance to become wet and do not use solvents or
Weight: 12.7 kg abrasive cleaning products under any circumstances.
Shipping dimensions (W x D x H): 600 x 800 x 1030 mm A dust cover is delivered with the Octopus 600 as an accessory. Cover the appli‑
Shipping weight: 26 kg ance when the room is being cleaned or if it is not used for longer periods.
8.4 Field of sight NOTE!
On the screen of the Octopus 600 it is possible to examine up to the following ec‑ The appliance must not be switched on when covered (heat build-up,
centricity: fire hazard).
• Binocular field of sight horizontally 30° 9.3 Applied parts
• Binocular and monocular field of sight vertically 27° Applied parts such as the eye patch, patient response button and forehead rest
• Monocular field of sight horizontally 60° (decentral fixation) as well as other parts such as the corrective lenses and the patient-side cover are
made of easy-to-clean plastics.
9. Maintenance NOTE!
WARNING! ••These applied parts should be disinfected prior to every examination
••Housing parts may be removed and repairs performed only by appro‑ (e.g., with 70% isopropyl alcohol) in order to comply with general hy‑
priately trained and authorised skilled personnel. Incorrect repairs can giene requirements and prevent the transmission of infections..
pose considerable risks for operating staff and patients. ••The corrective lenses can also be cleaned in an ultrasound bath.
••The Power On/Off button (15) does not disconnect the device from
the power supply. When servicing, always use the mains switch (17) A. Appendix
and disconnect the device from the power supply by pulling out the
A.1 Accessories / spare parts
plug. Component Type HS art. no. Note
••If components have to be replaced, only original spare parts from
Compact table CT 01 1802281 See separate IU*:
HAAG‑STREIT or its representative may be installed.
Instrument table IT 01 7220034 See separate IU*:
9.1 Repairs Corrective lens set RL basic set 1806170 Set comprising 12 cor‑
To ensure long-term safe and error-free functioning, we recommend having an rective lens
authorised professional check the Octopus 600 every two years. Further infor‑ Corrective lens +4 dpt 1806184 1x
mation and the corresponding technical documentation for this are available from Corrective lens +3 dpt 1806183 1x
HAAG‑STREIT or your local representative. Corrective lens +2 dpt 1806182 1x
9.2 Cleaning Corrective lens +1 dpt 1806181 1x
Occasional dusting with a soft cloth is sufficient. Stubborn dirt particles can be re‑ Corrective lens -1 dpt 1806191 1x
moved with a soft cloth dampened with water or alcohol. Fingerprints and dust on Corrective lens -2 dpt 1806192 1x
the user screen can be removed using a soft, moist cloth. Corrective lens -3 dpt 1806193 1x
Corrective lens -4 dpt 1806194 1x
Corrective lens -5 dpt 1806195 1x

12 © HAAG‑STREIT AG, 3098 Koeniz, Switzerland - HS Doc. no. 1500.7220367.04020 – 2. edition / 2013 – 09

01-IFU_Octopus600-7220367_04020_eng.indd 12 23.09.2013 08:03:16

 SVENSKA NEDERLANDS PORTUGUÊS ESPAÑOL ITALIANO FRANÇAIS DEUTSCH ENGLISH

Corrective lens -6 dpt 1806196 1x E. Standards

Corrective lens -7 dpt 1806197 1x EN 60601-1 ISO 9022
Corrective lens -8 dpt 1806198 1x EN 60601-1-2 EN ISO 10993
Patient response button Octopus 600 1806150 1x EN ISO 15004-1, -2 EN 1041
Dust cover 1802304 1x EN ISO 12866 EN 15223-1
Eye patch set 1802349 2x / set EN 62471
*IU = Instructions for use

B. Legal regulations F. RoHS China

• HAAG‑STREIT maintains a quality management system in accordance with EN Environment friendly use period (EFUP). The following formula applies for products
ISO 13485. The device was developed and designed in accordance with all the that can be repaired:
Technical service life x 125%
standards listed in section 'EMC'. EF =
(Daily use)x 365
• 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 125% = Factor for products which can be repaired. Daily use = service use, from
with the applicable standards and directives. field tests Average data: 21,900 patients/year, 10 minutes/patient.
• You can request a copy of the declaration of conformity for the appliance from
HAAG‑STREIT at any time. 21900X8,5
Daily use 8.5 hours per day
• This appliance fulfils the European Directive 2011/65/EC. 60X365
Technical service life ~ 30,000 hours.
C. Classification 30000X125%
Standard EN 60601-1 Perimeter Octopus 600 acc. to protection class I 8,5X365
12.1 years 12
Applied part: Type B Consequently, the environment friendly use period is approx. 12 years.
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 represent‑
ative. This guarantees that no hazardous substances enter the en‑
vironment and that valuable raw materials are recycled.

© HAAG‑STREIT AG, 3098 Koeniz, Switzerland - HS Doc. no. 1500.7220367.04020 – 2. edition / 2013 – 09 13

01-IFU_Octopus600-7220367_04020_eng.indd 13 23.09.2013 08:03:16

ENGLISH DEUTSCH FRANÇAIS ITALIANO ESPAÑOL PORTUGUÊS NEDERLANDS SVENSKA

F.1 RoHS declaration Name of sub-assembly G. Information and manufacturer's declaration

concerning electromagnetic compatibility

(Front threaded ring 1820153)

Stepping motor mount. (Short

(EMC)

coupling flange 1802009)

(Distance ring 1820224)
G.1 General

Ribbon cable clip

Camera mount.

Camera mount.
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

(1008504)
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
Lead (Pb) ■ ■ ■ ○ itself has appropriate immunity to electromagnetic interference.
Mercury (Hg) ○ ○ ○ ○ WARNING!
Cadmium (Cd) ○ ○ ○ ○ ••In terms of EMC, electrical medical devices and systems are subject
Chromium VI compounds (Cr6+) ○ ○ ○ ○ to special measures and must be installed in accordance with the
Polybrominated biphenyl (PBB) ○ ○ ○ ○ EMC information contained in these instructions for use.
Polybrominated diphenyl ether (PBDE) ○ ○ ○ ■ ••Portable and mobile HF communication systems may interfere with
■ Contains ○ Does not contain electrical medical devices.
WARNING!
••Connecting third-party systems to the same extension cable can
compromise safety.
••Any third-party device must be connected in compliance with the IEC/
EN 60601-1 standard.

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.
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
Emission of harmonics Class A the public low-voltage power supply network that supplies buildings used for domestic purposes.
according to EN 61000-3-2

14 © HAAG‑STREIT AG, 3098 Koeniz, Switzerland - HS Doc. no. 1500.7220367.04020 – 2. edition / 2013 – 09

01-IFU_Octopus600-7220367_04020_eng.indd 14 23.09.2013 08:03:16

 SVENSKA NEDERLANDS PORTUGUÊS ESPAÑOL ITALIANO FRANÇAIS DEUTSCH ENGLISH

G.3 Table 2: Immunity

Guidance and manufacturer's declaration – electromagnetic immunity
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.
Immunity test standard EN 60601 test level Compliance level Electromagnetic environment – guidance
Electrostatic discharge (ESD) ± 6 kV contact ± 6 kV contact Floors should be wood, concrete or ceramic tile. If floors are
EN 61000-4-2 ± 8 kV air ± 8 kV air covered withs ynthetic material, the relative humidity should
be at least 30%.
Electrical fast transient / burst ± 2 kV for power supply lines ± 2 kV for power supply lines Mains power quality should be that of a typical commercial
EN 61000-4-4 or hospital environment.
Surge ± 1 kV for symmetrical voltages ± 1 kV for symmetrical voltages Mains power quality should be that of a typical commercial
EN 61000-4-5 ± 2 kV for asymmetrical voltages ± 2 kV for asymmetrical voltages or hospital environment.
Voltage dips, short interruptions < 5% UT (> 95% drop in UT) < 5% UT (> 95% drop in UT) Mains power quality should be that of a typical commercial
and voltage variations on power for ½ cycle for ½ cycle or hospital environment. If the user of this product requires
supply lines < 40% UT (> 60% drop in UT) < 40% UT (> 60% drop in UT) continued function even in the event of interruptions in the
EN 61000-4-11 for 5 cycles for 5 cycles energy supply, this product should be powered from an un-
< 70% UT (> 30% drop in UT) < 70% UT (> 30% drop in UT) interruptible power supply or a battery.
for 25 cycles for 25 cycles
< 5% UT (> 95% drop in UT) < 5% UT (> 95% drop in UT)
for 5 s for 5 s
NOTE: UT= the AC mains voltage prior to application of the test level.

© HAAG‑STREIT AG, 3098 Koeniz, Switzerland - HS Doc. no. 1500.7220367.04020 – 2. edition / 2013 – 09 15

01-IFU_Octopus600-7220367_04020_eng.indd 15 23.09.2013 08:03:16

ENGLISH DEUTSCH FRANÇAIS ITALIANO ESPAÑOL PORTUGUÊS NEDERLANDS 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 specified 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:
Conducted RF EN 61000-4-6 3 Vrms 3 Vrms D = 1.2
150 kHz – 80 MHz
Radiated RF EN 61000-4-3 3 V/m 3 V/m D = 1.2 80 MHz – 800 MHz
80 MHz – 2.5 GHz 80 MHz – 800 MHz D = 2.3 800 MHz – 2.5 GHz

Where P is the maximum output power rating of thet ransmitter in watts (W) according to the transmitter manufacturer and D is the recommended separation
distance in metres (m). Field strengths from fixed 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 fixed 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 fixed RF transmitters, an electromagnetic
site survey should be considered. 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 normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating
this product.
b. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 10 V/m.

16 © HAAG‑STREIT AG, 3098 Koeniz, Switzerland - HS Doc. no. 1500.7220367.04020 – 2. edition / 2013 – 09

01-IFU_Octopus600-7220367_04020_eng.indd 16 23.09.2013 08:03:16

 SVENSKA NEDERLANDS PORTUGUÊS ESPAÑOL ITALIANO FRANÇAIS DEUTSCH ENGLISH

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.
Safe distance according to transmission frequency (m)
150 kHz – 80 MHz 80 MHz – 800 MHz 800 MHz – 2.5 MHz
Nominal output of the transmitter (W) D = 1.2 D = 1.2 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 D can 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) according to the specifications of the transmitter manufacturer.
NOTE 1: To calculate the recommended safe distance of transmitters in the frequency range of 80 MHz to 2.5 GHz an additional factor of 10/3 was used to reduce the
probability of a mobile/portable communication device causing interference if inadvertently brought into the patient area.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic wave propagation is influenced by absorption and reflection of buildings, objects and people.

© HAAG‑STREIT AG, 3098 Koeniz, Switzerland - HS Doc. no. 1500.7220367.04020 – 2. edition / 2013 – 09 17

01-IFU_Octopus600-7220367_04020_eng.indd 17 23.09.2013 08:03:17

ENGLISH DEUTSCH FRANÇAIS ITALIANO ESPAÑOL PORTUGUÊS NEDERLANDS SVENSKA

18 © HAAG‑STREIT AG, 3098 Koeniz, Switzerland - HS Doc. no. 1500.7220367.04020 – 2. edition / 2013 – 09

01-IFU_Octopus600-7220367_04020_eng.indd 18 23.09.2013 08:03:17

 SVENSKA NEDERLANDS PORTUGUÊS ESPAÑOL ITALIANO FRANÇAIS DEUTSCH ENGLISH

© HAAG‑STREIT AG, 3098 Koeniz, Switzerland - HS Doc. no. 1500.7220367.04020 – 2. edition / 2013 – 09 19

01-IFU_Octopus600-7220367_04020_eng.indd 19 23.09.2013 08:03:17

ENGLISH DEUTSCH FRANÇAIS ITALIANO ESPAÑOL PORTUGUÊS NEDERLANDS SVENSKA

Should you have any further questions, please contact your HAAG‑STREIT representative at:
http://www.haag-streit.com/contact/contact-your-distributor.html

PRODUCTS CERTIFIED FOR BOTH THE U.S

AND CANADIAN MARKETS, TO THE APPLI-
C US CABLE U.S. AND CANADIAN STANDARDS

Manufacturer:
HAAG-STREIT AG
Gartenstadtstrasse 10
1250 3098 Koeniz, Switzerland
Phone +41 31 978 01 11
Fax +41 31 978 02 82
eMail [email protected]
Internet www.haag-streit.com

20 © HAAG‑STREIT AG, 3098 Koeniz, Switzerland - HS Doc. no. 1500.7220367.04020 – 2. edition / 2013 – 09

01-IFU_Octopus600-7220367_04020_eng.indd 20 23.09.2013 08:03:17