HAAG-STREIT

OCTOPUS 900 Instructions For Use 1st Edition August 2011

Instructions For Use

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INSTRUCTIONS FOR USE Perimeter

OCTOPUS 900®

EyeSuite Perimetry 1st Edition / 2011 – 08

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DOK. no. 1500 1500.1400209.04000

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INSTRUCTIONS FOR USE Perimeter

OCTOPUS 900 1st Edition / 2011 – 08

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Foreword

EyeSuite Perimetry

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We thank you for deciding for a HAAG-STREIT device. Provided you comply carefully with the regulations in these operating instructions, we can guarantee you reliable and unproblematic use of our product.

Purpose of use

The Perimeter OCTOPUS 900 is designed for the examination, analysis and documentation of the field of sight, especially the light difference sensitivity and other functions of the human eye. The application is by trained personnel in examination rooms at room temperature. CAUTION: Federal law restricts this instrument to sale by or on the order of a physician or practitioner.

1.1 1.2 1.3 1.4 1.5 1.6 1.7

2.1 2.1.1 2.1.2 2.1.3 2.1.4 2.1.5 2.1.6 2.1.7 2.1.8 2.1.9 2.1.10 2.1.11 2.1.12 2.1.13 2.1.14 2.1.15

Safety ...4

Ambient conditions... 4 Shipment and unpacking... 4 Installation warnings... 4 General... 5 Transporting the appliance... 5 Warranty and product liability... 6 Pictograms and type plate... 6

Introduction...7

Description of the instrument... 7 Housing... 9 Cupola... 9 Forehead rest... 9 Chin rest... 9 Swing arm... 9 Refractive lens holder... 9 Patient-response button... 10 Mains connection... 10 Light sources... 10 Light intensities... 10 Stimulus... 10 Background lighting... 10 Fixation marks... 10 Fixation control... 10 Examination data... 11

Octopus 900 control unit / PC... 11

Support stand...12

Appliance assembly / installation...15

4.1 4.1.1 4.1.2

5.1 5.1.1 5.1.2

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Contents

3.1

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Minimum PC requirements... 11

Safe system configuration in accordance with IEC / EN 60601-1... 13 System variant I, OCTOPUS 900 with laptop as control unit... 13 System variant II, OCTOPUS 900 with PC as control unit... 14

Legal regulations...16

Operation / software instructions...16

Care and maintenance...16

Classification...17

10.

EMC...17

11.

Standards...17

12.

Environment...17

Additional information...18

EMC Supplement...19

8.1 8.1.1 8.1.2 8.1.3 8.2

A.1 A.2 A.3

B.1 B.2 B.3 B.4 B.5 B.6 B.7 B.8

Cleaning... 16 Cleaning the cupola... 16 Response button, chin and forehead rest, eye occluder... 17 Display, control panel... 17 Light sources... 17

Manufacturer... 18 OCTOPUS 900 technical data... 18 OCTOPUS support stand (optional) technical data... 18

General... 19 System components... 19 Connecting cables... 19 Significant operating characteristics... 19 Table 1: Emitted interference... 19 Table 2: Interference immunity... 20 Table 3: Immunity (not life-support equipment)... 21 Table 4: Recommended safe distances (not life-support equipment)... 22

OCTOPUS 900... 15 Support stand... 15 Software... 16

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Safety

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1.2 Shipment and unpacking • Before unpacking the appliance, check whether the packaging shows traces of

Symbols

Symbols correspond to the standards EN 980 and ISO 15223-1. Further symbols used in these instructions for use: FORBIDDEN! If these instructions are not complied with, material damage and / or danger to users and patients can be expected. WARNING! These instructions must be complied with absolutely to guarantee safe operation of the instrument and to avoid any danger to users and / or to patients. NOTE! Important notes. Please read carefully.

1.1

Ambient conditions

Transport: Temperature Atmospheric pressure Rel. humidity

-10°C to +55 700 hPa to 1060 hPa 10% to 95%

Storage

Temperature Atmospheric pressure Rel. humidity

-10 to +55 700 hPa to 1060 hPa 10% to 95%

Use:

Temperature Atmospheric pressure Rel. humidity

+15 to +40 700 hPa to 1060 hPa 20% to 75%

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• • • •

incorrect handling or damage. If this is the case, notify the transport company that has delivered you the goods. Unpack the appliance together with a representative of the transport company. Make a report on any damaged parts. This must be signed by you and by the representative of the transport company. Leave the instrument a few hours in the packaging before unpacking (condensation). Check the appliance for damage after it is unpacked. Return defective appliances in the appropriate packaging. Keep packaging material carefully, so that it can be used for possibly returning the appliance or when moving.

1.3 Installation warnings • The plug, cable and protective conductor connection of the socket must function perfectly.

• Make sure that the appliance is connected only to power supplies as defined •

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on the type plate. The appliance must be separated absolutely from the mains before maintenance and cleaning work is performed. Computers and further ancillary devices (printers, etc.) must comply with the IEC/CEN 60601-1 standard, or else be connected through galvanic isolation to external networks (isolating transformer, galvanic Ethernet isolator, etc.)

1.4

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General NOTES! • The present appliance may be used only for the purpose described in these instructions for use. • Installation only by trained skilled personnel. • The appliance may not be transported, stored or operated outside the specified ambient conditions (see section 1.1). • The appliance is used in a room in the medical area with attenuated light. • Keep these instructions for use at a place where they are accessible at any time to persons who work with the appliance. • Warranty claims can be made only if the instructions in these instructions for use are complied with. • The manufacturer of the appliance is not liable for loss or damage due to unauthorised handling of the same. All warranty claims arising in this case are null and void. • Do not use the appliance in areas endangered by explosion, do not keep any volatile solvents (alcohol, benzine, etc.) and combustible anaesthetics in its vicinity. • Always remove the dust cover before switching the appliance on. The light sources can be destroyed by overheating. Make sure on the other hand that the appliance is switched off before it is covered. • Housing parts may be removed and repairs performed only be appropriately trained and authorised skilled personnel. Considerable hazards for operating staff and patients can arise due to incorrect repairs. • Only original spare parts and original accessories may be used for repairs. • The software must be installed by trained personnel. • The PC on which the EyeSuite software is installed may not contain any other software which could restrict the correct operation of EyeSuite. • Please switch the computer off if it is not used for a long time.

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WARNINGS! • The physician or the operator is obliged to inform the patient about the safety instructions concerning him and to ensure that these instructions are complied with. • The examination of the patients, the operation of the appliance and the interpretation of the results may be performed only by trained and experienced persons (who can explain the tests to the patient and who are competent in the manual acquisition, processing and deletion of data). All users must be correspondingly trained and familiar with the contents of the instructions for use, especially with regard to the safety instructions contained in them.

1.5

Transporting the appliance

Transport the appliance over larger distances in its original packaging. For short distances, grasp and lift the appliance with both hands holding it underneath (see section 5.1).

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1.6 Warranty and product liability • The appliance and accessories are manufactured from high-quality materials and •

• • •

according to the latest methods. They have left our factory in perfect condition. Should you have any complaints despite this, please contact your dealer. The manufacturer grants on the appliance a warranty, the duration of which is determined by the relevant authorised local HAAG-STREIT dealer and which must be enquired there. Malfunctions and defects which are caused by materials and design come under the manufacturer's warranty. Malfunctions and defects which are caused by incorrect use and external influences are excluded from the warranty. All warranty claims are rejected after interventions by unauthorised persons. If a product damaged by incorrect handling continues to be used, this can lead to personal injury. In this case no liability is assumed by the manufacturer. 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 you the goods. Unpack the appliance together with a representative of the transport company. Make a report on any damaged parts. This must be signed by you and by the representative of the transport company.

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1.7

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Pictograms and type plate

a) Manufacturer b) Serial number c) HS order number d) Read the instructions for use attentively e) Disposal instructions f) Date of manufacture g) Product classification Type B h) Pull out the mains plug! i) Protective conductor connection j) Pushing forbidden. Appliance can tilt due to pushing on the side. k) This appliance fulfils the European Directive 2002/95/EC (RoHS).

•

• • •

Product: Perimeter Type: Octopus 900 Input: 100-120V/145VA 220-240V/165VA 50/60Hz, T3.15AL HAAG-STREIT AG Gartenstadtstrasse 10 3098 Koeniz, Switzerland

• XXXX

SN XXXXX

Made in Switzerland Caution: Federal law restricts this device to sale by or on the order of a Physician or Practitioner

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Introduction

2.1 Description of the instrument • The OCTOPUS 900 is an automatic projection Perimeter for the examination of

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the whole field of sight (90°). The system is divided into the examination unit (OCTOPUS 900) and control unit (notebook, PC). The examination unit communicates through an Ethernet connection with the external PC. The OCTOPUS 900 is operated via the software installed on the PC. If required, it is possible to operate the Perimeter from a bright side room. Integrated patient monitoring increases the reliability of the examination results. The OCTOPUS 900 is used by clinical users and for research purposes, since its flexibility is practically unlimited. Because of its spherical cupola geometry by Goldmann, the OCOTOPUS 900 tests the entire field of sight up to 90° eccentricity. Thanks to the flexibility of this instrument, all perimetric questions can be answered – both in the 30° and 90° range, with kinetic perimetry, static perimetry or flicker perimetry. New PC and perimetry software can be downloaded and updated by going to www.haag-streit.com.

Overview 1. Top cover for stimulus projector 2. Front cover 3. Housing / cupola 4. Forehead rest 5. Rear panel 6. TFT display 7. Refractive lens holder with IR illumination 8. Control panel 9. Chin cup with integrated sensors for detecting the head position 10. Chin rest 11. IR cover 12. Mark for optimum eye height 13. Connection socket for patient response button

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LCD-Display The high-contrast TFT colour display enables the video image to be observed under a large angle of view. The following messages are shown on the display: 14. Display of a ' ' during the stimulus presentation 15. Display of a ' ' if the patient response button is pressed 16. The crosshairs help to centre the eye, scale = 1mm interval 17. Warning or error message 18. Display of left (OS) or right eye (OD) Control panel The control panel is made of a pleasant hard-wearing rubber material. All buttons are backlit with white light to make navigation easy in a darkened room. The light sources can be switched off if required, except for the display brightness setting. 19. Turning the refractive lens holder in and out 20. Start examination 21. Display brightness setting 22. Chin rest positioning left, right, up, down

14 15

17 18 Figure 6-2 19 20

Connections 23. Mains switch 24. Holder for two 3.15A T3, 15A/250V fuses 25. Mains connection 26. Ethernet connection 27. Plug-in mains power unit WARNING! All externally connected devices must comply with the standards relevant to safety.

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Figure 6-3

22 23 24 25

Figure 6-4

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2.1.1 Housing

The optical components and electronics are protected from light and dust by five housing covers. They can be removed in just a few moments for servicing. Once the four screws in the back panel have been removed, the panel, hood and both IR covers can be lifted out. The optical unit and electronic components of the OCTOPUS 900 are now accessible.

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The cupola of the OCTOPUS 900 has a diameter of 600mm and thus conforms to the Goldmann standard. Test zones with eccentricity up to the following levels can be measured: • Nasal 89° • Temporal 89° • Superior 60° • Inferior 70°

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2.1.5 Swing arm

An automatic swing arm allows the refractive lens holder to be turned in and out during the examination without changing the position of the patient. This swing arm can be operated either at the control panel or on the control unit (PC) with the computer mouse. Once the refractive lens holder has been swung in, it can be finely adjusted to the correct distance from the eye being examined.

WARNING! Always disconnect the appliance from the mains power supply by pulling out the mains cable before opening the appliance. Housing components may be removed only by correspondingly trained and authorised skilled personnel.

2.1.2 Cupola

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NOTE! Always use the control panel buttons of the appliance or on the PC to swing the refractive lens holder in or out. Do not attempt to move the refractive lens holder manually.

2.1.6 Refractive lens holder

Refractive lenses can be used during examinations with 30° eccentricity. The corresponding lenses are inserted before the examination. The refractive lens holder can be tilted forward by about 25° to make it easier to change the refractive lenses.

2.1.3 Forehead rest

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A wide, ergonomically designed forehead rest allows the patient to have a comfortable posture during the examination.

2.1.4 Chin rest

The chin rest and thus the position of the patient's head is adjusted with the four buttons. Fine adjustment can also be performed at the control unit (PC) using the mouse. Sensors in the chin rest detect the correct position of the patient's head. There is an optional attachment for the chin rest for examining children. (HS-Part number 1820075)

Figure 6-5

Figure 6-6

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2.1.7 Patient-response button

The patient-response button is connected to the bottom of the forehead rest holder (RJ11 plug connection).

2.1.8 Network connection

The Ethernet connection is located at the back of the appliance. Always use a shielded cable of category 5e permitting transmissions of 100MHz without interference. This network connection is electrically isolated and has a dielectric strength of 4kV according to IEC / EN 60601-1.

2.1.9 Light sources

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2.1.12 Periphery or background lighting

The white background brightness amounts to 31.4 or 4asb for W/W perimetry. You can also select a yellow background with 314asb for B/Y perimetry. The background brightness consists of two light sources, each equipped with several LEDs. The background LEDs have a service life of >20,000h and are thus maintenance-free. The backgound brightness is measured by a separate light sensor.

2.1.13 Fixation marks

Three different fixation marks can be selected and their brightness changed electronically in 10 steps. A green LED, which is maintenance-free with a service life of >20,000h, serves as light source.

2.1.10 Light intensities

The light intensity of stimulus and periphery is measured with independent light sensors and adjusted to the preset nominal values each time the Perimeter is switched on.

The stimulus light is projected indirectly into the cupola via a mirror unit. Five different diaphragm diameters can be selected in the user-defined programs. The attenuation of the stimulus intensity is infinitely adjustable via an electronic control unit. Stimulus presentations of 100-500ms are permitted. A mechanical lock and optical damping elements are no longer required. White stimulus for W/W perimetry and optionally blue and red stimulus for B/Y and R/W are possible. The stimulus intensity is detected with a light sensor which also serves as reference point for the system of coordinates of the test zones. The stimulus LED has a service life of >20,000h and is thus maintenance-free.

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2.1.15 Examination data

All examination data are transmitted via the Ethernet interface to the control unit (PC / laptop), where they are saved and managed in a database. It is possible to export data to a server. Examination data can also be printed out on a printer connected to the control unit.

Octopus 900 control unit / PC

A standard PC can be used as control unit (PC) for the Perimeter. The control unit (PC) software runs on WINDOWS XP SP3, WINDOWS VISTA SP2 and WINDOWS 7.

3.1 Minimum PC requirements • Pentium IV or equivalent • 2GB RAM for Windows XP, 3GB RAM for Windows Vista and 7 • 160GB free hard disk space • CD-ROM / DVD drive • T100 (100MHz) Ethernet interface • Screen resolution 1280x1024

LEDs are installed for periphery or background illumination, fixation assistance and stimulus. LEDs develop only very low heat losses and active cooling is therefore not required.

2.1.11 Stimulus

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Figure 6-7 (Centre point)

Figure 6-8 (Cross marks)

Figure 6-9 (Circle)

2.1.14 Fixation control

The examined eye of the patient is illuminated with IR LEDs, photographed by a CMOS camera and displayed on the LCD display. The built-in automatic fixation control function increases the reliability of the examination results. Precise positioning of the examined eye is performed by motorised fine adjustment of the chin rest.

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Support stand

Safe system configuration in accordance with IEC / EN 60601-1 4.1.1 System variant I, OCTOPUS 900 with laptop as control unit

28. Table top with holders for the patient-response button 29. Electrical connection box 30. Patient-response button 31. Electrical lifting column 32. Stand base with castors

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If a medically approved control unit (PC) or a control unit (PC) with medically approved power supply unit without printer and without optional LAN connection is in operation, neither a safety isolating transformer nor a distance of > 1.5 m from the OCTOPUS 900 are required. For reasons of safety, it is recommended that the distance of > 1.5 m is complied with if at all possible. Otherwise all non-medical devices must be operated through a safety isolating transformer.

4.1

An electronically adjustable support stand (option) enables the height of the appliance to be adjusted easily to the height of the patient. The support stand offers ample leg room and is wheelchair-compatible.

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NOTE! A network switch (*) must always be interposed for perfect operation 28

33. Voltage selector switch in electrical connection box 34. Power socket for connecting the OCTOPUS 900 29 30

WARNING! Check that the mains voltage is correct before connecting to the power supply.

** If the control unit (notebook, PC) and printer are more than1.5 m distant from the OCTOPUS 900, then in accordance with IEC 60601-1 / EN 60601-1 the safety isolating transformer can be omitted.

Mains connection

LAN connection

** Safety isolating transformer

Mains connection

Ethernet cable LAN (optional)

Power Supply

35. Mains connection with fuse holder on electrical connection box.

36. Up/down switch on electrical connection box. WARNING! Take special care when dealing with patients in wheelchairs to ensure that the table tops does not come into contact with the patient's legs when it is lowered.

* Network switch

Figure 6-10

33 34 Figure 6-11 USB cable

Figure 6-12

35 Figure 6-14 36

Laptop / Control unit < 1.5 m **

Figure 6-13

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4.1.2 System variant II, OCTOPUS 900 with PC and monitor as control unit

5.1

** If the control unit (notebook, PC) and printer are more than1.5 m distant from the OCTOPUS 900, then in accordance with IEC 60601-1 / EN 60601-1 the safety isolating transformer can be omitted.

Mains connection

LAN connection

** Safety isolating transformer

Mains connection

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Appliance assembly / installation OCTOPUS 900

Transporting or moving the appliance (only short distances): a) Stand in front of the appliance and grasp the cupola with both hands and lift the appliance (Figure 6-16) b) Stand to one side of the appliance with one hand on the front cover and with the other hand on the back cover, then take a firm hold and lift the appliance (Figure 6-17, Figure 6-18). Connecting the patient response button to the connection socket The connection socket for the response button is located below on the front cover. The retaining catch on the connection plug of the response button faces forwards. FORBIDDEN! Apart from the patient response button, no other cable may be connected to the RJ11 socket!

Ethernet cable LAN (optional) Power Supply

Figure 6-16

Figure 6-17

Figure 6-18

37. Front cover 38. Cupola housing 39. Connection plug with retaining catch

38 39

• Push the connection plug into the connection socket so far until your hear •

* Network switch

Ethernet Kabel *

USB cable PC / Control unit

Figure 6-15

•

the retaining catch click into place. To remove the response button, push the retaining catch towards the headrest and pull the cable downwards. Connect the OCTOPUS 900 and PC with two Ethernet cables via the network switch provided with the instrument. A computer network can also be connected via the network switch. You will find further information in section 4.1 'Safe system configuration in accordance with IEC / EN 60601-1'. Connect the electric power supply cable. The built-in mains power units operate with the voltages specified in the Technical Data section. It is not necessary to select the voltage on the appliance. If a support stand was also supplied, the OCTOPUS 900 can be connected to the power socket in the electrical connection box of the support stand.

5.1.1 Support stand

The support stand is supplied in a separate package. Assemble the support stand in accordance with the instructions supplied with it and ensure that you select the correct mains voltage before connecting the power supply cable.

< 1.5 m **

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• Warranty claims can be made only if the instructions in these instructions for use are complied with.

5.1.2 Software WARNING! The software must be installed by trained personnel in accordance with separate installation instructions.

Legal regulations

• HAAG-STREIT AG maintains a quality management system in accordance with • •

EN ISO 13485:2003. The appliance was developed and designed taking the IEC / EN 60601-1, IEC / EN 60601-1-2, IEC 60825-1, EN ISO 15004-1 and EN ISO 10343 standards into account. Compliance of the instrument with the directive 93/42/EEC (Annex II) is confirmed by the CE marking. The appliance is a Class 1 device corresponding to this directive. You can request a copy of the declaration of conformity for the appliance from HAAG-STREIT at any time.

Operation / software instructions

Operation of the appliance for performance of an examination, as well as the description of the EyeSuite software are described in a separate operating manual and can be called up in the EyeSuite software using the 'F1' key.

Care and maintenance WARNING! • The housing components of the Perimeter appliance may be removed only by suitably qualified service personnel. • The ON/OFF switch does not isolate the Perimeter from the mains. Before removing the housing components, ensure that the appliance is unplugged from the mains power socket. • Repairs may be made only by correspondingly trained and authorised skilled personnel. Considerable hazards for patients and operating staff can arise due to incorrect repairs. • If components have to be replaced, only original spare parts from HAAG-STREIT or your dealer may be installed.

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The OCTOPUS 900 is practically maintenance-free and requires only minimum care to work to your complete satisfaction. We nevertheless recommend that you have the Perimeter appliance serviced regularly by a qualified technician. HAAG-STREIT or your local dealer will be pleased to supply you with further information.

8.1

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Cleaning

Occasional dusting with a soft cloth is sufficient. Stubborn dust particles can be removed with a soft cloth dampened with water or alcohol. NOTE! Do not allow the appliance to become wet and do not use any other solvents. A dust cover is included in the accessories of the OCTOPUS 900. Cover the appliance when the room is being cleaned or if it is not used for longer periods. Always remove the dust cover before switching on the power. NOTE! The appliance must not be switched on when covered (heat build-up, fire hazard).

8.1.1 Cleaning the cupola

The inner surface of the cupola is coated with a special paint finish designed to ensure optimum results in perimetric examinations. It is not necessary to clean this inner surface in the normal case. Should dust be visible in the cupola, you can remove this by gentle wiping with a soft, dry and fluff-free cloth. A soft cloth dampened slightly with mild soapsuds may be used for local cleaning only in emergencies, such as if spots have arisen due to patients' sneezing. For EyeSuite version i3.000 and higher, the software checks the properties of the cupola periodically and signals the need for dusting as required. Should your appliance be operated with an older version of the software, please contact your HAAG-STREIT dealer for a software update.

8.1.2 Response button, chin and forehead rest, eye occluder These components are all made of easy-to-clean plastic materials. To keep them hygienically clean, disinfect them after every patient.

8.1.3 Display, control panel

Fingerprints and dust can be removed using a soft, moist cloth.

8.2

Light sources

In contrast to other perimetric devices, LEDs are used in the OCTOPUS 900 as light sources for background and stimulus. These have a service life of >20,000h. If any of the LEDs should notwithstanding have to be replaced, please contact your dealer's customer service department.

Classification

Standard IEC 60601-1 / EN 60601-1 Operating mode: CE Directive 93/42/EEC

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Perimeter OCTOPUS 900 acc. to protective class I. Application part Type B Continuous operation Class I

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11. Standards IEC / EN60601-1 IEC / EN 60601-1-2 EN ISO 15004-1 EN ISO 12866 IEC 60825-1 CIE S 009/E

12. Environment

• Electrical and electronic devices must be disposed of separately • •

from domestic refuse. This appliance was made available for sale after 13.08.2005. Disposal through the local collecting point or your HAAG-STREIT dealer. This guarantees that no hazardous substances get into the environment and valuable raw materials are recycled.

10. EMC

The OCTOPUS 900 fulfils the requirements on electromagnetic compatibility according to IEC / EN 60601-1-2. The instrument is built so that the generation and emission of electromagnetic interference is limited to the extent that other devices are not disturbed in their use in accordance with the regulations and so that it itself has appropriate immunity to electromagnetic interference.

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Additional information Manufacturer

HAAG-STREIT AG Gartenstadtstrasse 10 3098 Koeniz / Schweiz

A.2

OCTOPUS 900 technical data

Type designation: Power requirements: Power consumption: Operating frequency: Fuses: Classification: Dimensions (W x D x H): Weight: Shipping dimensions (W x D x H): Shipping weight: Ambient temperature: Humidity: Functional principle: Measurement principle: Patient positioning: Fixation control: Eccentricity: Measurement range: Measurement accuracy: Maximum stimulus intensity: Stimulus colour I: Stimulus colour II: Stimulus colour III: Stimulus size: Stimulus duration: 18 Stimulus interval: Background intensity I: Background colour I: IFU_Octopus900-7220343_04010_eng.indd 18-19 Background intensity II:

OCTOPUS 900 100 – 120 VAC, 220 – 240 VAC 145 VA, 165 VA 50 / 60 Hz 2 x T3.15 AL 250 V Class I, type B 648 mm x 519 mm x 796 mm 25 kg 800 mm x 600 mm x 900 mm 40 kg Operation: +15°C ... +40°C Storage, transport: -10°C ... +55°C Operation: 20% ... 75% Storage, transport: 10% ... 95% Projection cupola perimeter Bracketing procedure Adjustable headrest Permanent video-based fixation control 90° 0 ... 47 dB 0.5 dB 3185 cd/m² (10‘000 asb) White (wide spectrum white LED) Blue (LED white with 440 nm filter) Red (LED white with 610 nm filter) Goldmann I, II, III, IV and V 100 ms, 200 ms, 500 ms, freely selectable Adaptive, fix 1.5 ... 4 sec 4 asb (1.27 cd/m²), 31.4 asb (10 cd/m2) White (LED) 314 asb (100 cd/m²)

Measurement principle: Patient positioning: Fixation control: SVENSKA NEDERLANDS Eccentricity: Measurement range: Measurement accuracy: Maximum stimulus intensity: Stimulus colour I: Stimulus colour II: Stimulus colour III: Stimulus size: Stimulus duration: Stimulus interval: Background intensity I: Background colour I: Background intensity II: Background colour II: Interface: Display:

A.3

Bracketing procedure Adjustable headrest Permanent video-based fixation control 90° 0 ... 47 dB 0.5 dB 3185 cd/m² (10‘000 asb) White (wide spectrum white LED) Blue (LED white with 440 nm filter) Red (LED white with 610 nm filter) Goldmann I, II, III, IV and V 100 ms, 200 ms, 500 ms, freely selectable Adaptive, fix 1.5 ... 4 sec 4 asb (1.27 cd/m²), 31.4 asb (10 cd/m2) White (LED) 314 asb (100 cd/m²) Yellow (LED white with OG530 filter) Ethernet T100 Colour TFT display (320 x 240 pixels)

OCTOPUS support stand (optional) technical data

Type designation: Power requirements: Power consumption: Fuses: Dimensions (W x D x H): Support surface: Weight: Shipping dimensions: Shipping weight: Functional principle:

IT 02 (HS-Ref. 7220004) 100 V / 60 Hz, 115 V AC / 60 Hz, 250 V / 50 Hz 100 / 115 V / 1 A, 250 V / 0.5 A 2 x T4AH 250 V 600 x 520 x 680 / 880 mm 0.31 m² (600 x 520 mm) 15 kg 650 x 570 x 730 mm 20 kg Lifting column (infinitely adjustable electrically)

SVENSKA

B.1

NEDERLANDS

EMC Supplement

B.3

General

WARNING! • Electrical medical devices and systems are subject to special measures concerning EMC and must be installed in accordance with the EMC instructions contained in this accompanying document. • Portable and mobile HF communication systems may interfere with electrical medical devices.

B.2

ESPAÑOL

System components

The OCTOPUS 900 system consists of the following devices: • OCTOPUS 900 • PC or laptop

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Connecting cables

The following connecting cables are provided: • Electric power supply lead CH: HS item No. 1001319, max. length = 2.50m • Electric power supply lead USA HS item No. 1001316, max. length = 3.10m • Patient response button HS item No. 1802032 WARNING! The operation of lines or equipment other than those listed may lead to a higher emission or to reduced interference immunity of the OCTOPUS 900 system.

B.4

Significant operating characteristics

B.5

Table 1: Emitted interference

The OCTOPUS 900 system is an automatic projection perimeter for examining the light difference sensitivity of the human eye for the whole field of sight (90°).

Guidelines and manufacturer's declaration – Electromagnetic emissions The OCTOPUS 900 system is designed to be operated in an environment as described below. The customer or user of the OCTOPUS 900 system should ensure that it is operated in such an environment. Emitted interference measurements Compliance

Electromagnetic environment / Guidelines

HF emissions pursuant to CISPR11

Group 1

The OCTOPUS 900 system uses HF energy exclusively for its internal functioning. Therefore, its HF emission is very low, and interference with neighbouring equipment is unlikely.

HF emissions pursuant to CISPR11

Klasse B

Emission of harmonics pursuant to IEC61000-3-2

Class A

The OCTOPUS 900 system is suitable for use in facilities other than the residential area and facilities such as those directly connected to a public grid which also supplies buildings used for residential purposes.

Emission of voltage fluctuations / flickers pursuant to IEC 61000-3-3

Not applicable

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ENGLISH

B.6

DEUTSCH

FRANÇAIS

ITALIANO

ESPAÑOL

NEDERLANDS

SVENSKA

B.7

Table 2: Interference immunity

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Table 3: Immunity (not life-support equipment)

Guidelines and manufacturer's declaration – electromagnetic immunity

Guidelines and manufacturer's declaration – Electromagnetic immunity

The OCTOPUS 900 system is designed to be operated in an environment as described below. The customer or user of the OCTOPUS 900 system should ensure that it is operated in such an environment.

Immunity test Electrostatic discharge (ESD) pursuant to IEC61000-4-2

IEC 60601 test level ±6 kV contact discharge ±8 kV air discharge

Compliance level ±6 kV contact discharge ±8 kV air discharge

±2 kV for power lines

Electromagnetic environment / Guidelines

Electromagnetic environment - Guidelines

Flooring should be made of wood or concrete, or be covered with ceramic tiles. If the floor is covered with synthetic material, the relative air humidity must be at least 30%.

Portable and mobile radio equipment shall not be used any closer to the OCTOPUS 900 system, including the cables, than the recommended safe distance calculated in accordance with the equation appropriate for transmission frequency.

Electrical fast transients / bursts pursuant to IEC61000-4-4

±2 kV for power lines

The quality of the supply voltage should conform to that of a typical business or hospital environment.

Surges pursuant to IEC 61000-4-5

±1 kV for symmetrical voltages ±2 kV for asymmetrical voltages

The quality of the supply voltage should conform to that of a typical business or hospital environment.

Voltage drops, short interruptions and fluctuations in the supply voltage according to IEC61000-4-11

< 5% UT(> 95% drop in UT) for ½ period < 40% UT(> 60% drop in UT) for5 periods < 70% UT(> 20% drop in UT) for 25 periods < 5% UT(> 95% drop in UT) for 5 s

< 5% UT(> 95% drop in UT) for ½ period < 40% UT(> 60% drop in UT) for 5 periods < 70% UT(> 20% drop in UT) for 25 periods < 5% UT(> 95% drop in UT) for 5 s

The quality of the supply voltage should conform to that of a typical business or hospital environment If the user of the OCTOPUS 900 system requires continued function even in the event of interruptions in the energy supply, the OCTOPUS 900 system should be powered from an uninterruptible power supply or a battery.

NOTE: UT = grid AC voltage before application of the test levels.

Immunity test

IEC 60601 test level

Compliance level

Recommended distance:

Conducted HF interference pursuant to IEC61000-4-6

3Veff 150 kHz - 80 MHz

3Veff

D = 1.2

Radiated HF interference pursuant to IEC61000-4-3

3 V/m 80 MHz -2,5 GHz

3Veff

D = 1.2 D = 2.3

P 80 MHz - 800 MHz P 800 MHz - 2,5 GHz

With P as the nominal output of the transmitter in watts (W) in accordance with the specifications of the transmitter manufacturer and D as the recommended safe distance in metres (m). According to an on-site investigation(a), the field strength of stationary radio transmitters is lower for all frequencies than the compliance level(b). Interference is possible in the environment of devices that bear the following symbol. NOTE 1: for 80 MHz and 800MHz the higher value shall apply. NOTE 2: these guidelines may not apply in all situations. Electromagnetic wave propagation is influenced by the absorption and reflection of buildings, objects and people. a) The field strength of stationary transmitters, e.g. base stations of cordless telephones and land mobile services, amateur radio stations, AM and FM radio and television broadcasting stations, may not, in theory, be precisely predetermined. To determine the electromagnetic environment resulting from stationary HF transmitters, an on-site inspection is recommended. If the calculated field strength at the site of the OCTOPUS 900 system exceeds the above-mentioned compliance level, the OCTOPUS 900 system must be monitored with regard to its normal operation at each application site. If any unusual operating characteristics are observed, it may be necessary to take additional measures, e.g. reorientation or relocation of the OCTOPUS 900. b) Above the frequency range of 150kHz to 80 MHz the field strength is less than 3 V/m.

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B.8

DEUTSCH

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NEDERLANDS

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DEUTSCH

ENGLISH

Table 4: Recommended safe distances (not life-support equipment)

Recommended safe distances between portable and mobile HF communication devices and the OCTOPUS 900. The OCTOPUS 900 is designed for operation in an electromagnetic environment in which radiated HF interference is controlled. The customer or user of the OCTOPUS 900 can help to prevent electromagnetic interference by maintaining minimum distances between portable and mobile HF communication systems (transmitters) and the OCTOPUS 900, as recommended 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 P

80 MHz - 800 Mhz D = 1.2 P

800 MHz - 25 GHz D = 2.3 P

0.12 0.01 0.12 0.23 0.38 0.1 0.38 0.73 1.2 1 1.2 2.3 3.8 10 3.8 7.3 12 100 12 23 For transmitters with a nominal output not listed in the above table the distance (m) D can be calculated using the equation that applies to the respective column, where P is the nominal output of the transmitter in watts (W) in accordance with the specifications of the transmitter manufacturer.

NOTE 1: to calculate the recommended safe distance of transmitters in the frequency range of 80 MHz to 2.5GHz an additional factor of 10/3 was used to reduce the probability of interference from a mobile/portable communication device 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.

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DEUTSCH

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For further questions please contact your HAAG-STREIT representative at:

http://www.haag-streit.com/contact/contact-your-distributor.html

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IFU_Octopus900-7220343_04010_eng.indd 24

PRODUCTS CERTIFIED FOR BOTH THE U.S AND CANADIAN MARKETS, TO THE APPLICABLE U.S. AND CANADIAN STANDARDS

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

23.08.2011 07:25:54

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