OCTOPUS 900 Instructions For Use 4th Edition July 2013

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INSTRUCTION MANUAL Perimeter

Introduction

EyeSuite Perimetry

Purpose of use

OCTOPUS 900® 4. Edition / 2013 – 07

SVENSKA

Thank you for choosing a HAAG‑STREIT appliance. We can guarantee that our product will be reliable and unproblematic to use, provided you carefully comply with the rules in this instruction manual.

The Octopus 900 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

No contraindications are known for perimetric examinations. For this reason, it is not necessary to take any measures here. WARNING! Read the instructions for use carefully before commissioning the Octo‑ pus 900. 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 physi‑ cian or practitioner.

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Contents 1.

1.1 1.2 1.3 1.4 1.5 1.6 1.7 1.8 1.9

2.

2.1 2.2 2.3 2.4 2.5 2.6 2.7 2.8 2.9 2.10 2.11 2.12 2.13 2.14 2.15 2.16 2.17 2.18 2.19 2.20 2.21

Safety ...4

Areas of application of the device... 4 Patient population... 4 Ambient conditions... 4 Shipment and unpacking... 4 Installation warnings ... 4 Operation and environment... 5 Disinfection... 5 Warranty and product liability... 5 Symbols... 6

Introduction...6

Device description... 6 System components... 6 Device overview ... 6 LCD display... 7 Control panel... 7 Connections... 7 Housing... 8 Cupola... 8 Forehead rest... 8 Chin rest... 8 Swing arm... 8 Refractive lens holder... 8 Patient-response button... 8 Network connection... 8 Light sources... 9 Light intensities... 9 Stimulus... 9 Periphery or background illumination... 9 Fixation marks... 9 Fixation control... 9 Examination data... 9

3.

Appliance assembly / installation...10

4.

Safe system configuration in accordance with EN 60601-1... 11

3.1 3.2

4.1 4.2

5.

5.1 5.2

Transporting the appliance... 10 Connecting the patient response button... 10

System variant I, Octopus 900 with laptop as control unit... 11 System variant II, Octopus 900 with PC and monitor as control unit... 12

6.

Operation...13

7. 8.

Software / Help menu / Error messages...13 Technical data...13

6.1

8.1 8.2 8.3 8.4 8.5

9.

Setting up the patient ... 13

Octopus 900... 13 Infrared illumination... 13 Field of sight ... 13 Octopus 900 control unit / PC... 13 Minimum PC requirements... 13

Maintenance...14

9.1 9.2 9.3 9.4 9.5 9.6 9.7

Repairs... 14 Cleaning... 14 Cupola... 14 Response button, chin and forehead rest, eye occluder... 14 Display, control panel... 14 Light sources... 14 Application parts... 14

A.

Appendix...14

B. C. D. E. F.

Legal regulations...15 Classification...15 Disposal...15 Standards...15 RoHS China...15

G.

Information and manufacturer's declaration concerning electromagnetic compatibility (EMC)...16

A.1

F.1.

G.1 G.2 G.3 G.4 G.5

Accessories / spare parts... 14

RoHS declaration... 15

General... 16 Emission (Standard table 1)... 16 Immunity (Standard table 2)... 17 Immunity for non-life-support devices (Standard table 4)... 18 Recommended safe distances for non-life-support devices (Standard table 6)

19

Commissioning...12

Switching on the appliance... 12 Switching off the appliance... 12

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1.

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Safety

FORBIDDEN! Failure to comply with the instructions may result in property damage and pose a danger to users and patients. WARNING! These warnings must absolutely be heeded in order 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 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 from −40°C to +70 °C Air pressure from 500 hPa to 1,060 hPa Relative humidity from 10% to 95% Storage:

Temperature from −10°C to +55°C Air pressure from 700 hPa to 1,060 hPa Relative humidity from 10% to 95%

Use:

Temperature from +10°C to +35°C Air pressure from 800 hPa to 1,060 hPa Relative humidity from 30% to 90%

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1.4 Shipment and unpacking • Before you unpack the appliance, check whether the packaging shows traces of

improper handling or damage. If it does, notify the transport company that deliv‑ ered the goods to you. Unpack the equipment together with a representative of the transport company. Compile a report on any potentially damaged parts. This report must be signed by you and by the representative of the transport company. • Leave the device in the packaging for a few hours before unpacking it (conden‑ sation). • Check the appliance for damage after it is unpacked. Return defective appliances in the appropriate packaging. • Store the packaging material carefully so that it can be used for possible returns or when moving.

1.5

Installation warnings

FORBIDDEN! Never use the device in potentially explosive environments where vola‑ tile solvents (alcohol, benzine, etc.) and combustible anaesthetics are in use.

WARNING! ••Installation, repairs and modifications may only be performed by trained specialists. ••Any third-party device must be connected in compliance with the EN 60601-1 standard. NOTE! ••The Octopus 900 must be placed in a completely darkened room. ••The use of accessories other than than those listed may result in higher emissions or lower interference immunity of the Octopus 900 system. ••The software must be installed by trained personnel.

Application height < 2,000 m above sea level

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1.6

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WARNING! ••The doctor or operator is obliged to inform the patient of the safety in‑ structions which concern the patient and to ensure that these instruc‑ tions are complied with. ••The examination of the patient, the use of the device and the inter‑ pretation of the results may only be conducted by trained and experi‑ enced individuals. ••All users must be appropriately trained and familiarised with the con‑ tents of the instructions for use, especially with regard to the safety information contained therein. NOTE! ••This applicance 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.

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NOTE! ••Keep these instructions for use in a place where they are accessi‑ ble to those working with the device at all times. Warranty claims can only be made if these instructions for use are complied with. ••Always remove the dust cover before switching the appliance on. The device may otherwise become damaged due to overheating. Like‑ wise, make sure that the appliance is switched off before attaching the dust cover. ••Only original spare parts and original accessories may be used for repairs. The use of accessories other than than those listed may result in higher emissions or lower interference immunity of the Octo‑ pus 900 system. ••Turn the system off if it will not be used for an extended period of time.

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 com‑ ply with the EN 60601-1 standard or be connected through galvanic isolation to external networks (safety isolating transformer, galvanic Ethernet isolator, etc.)

ITALIANO

1.7

Disinfection

NOTE! The device does not need to be disinfected.

For more information on cleaning, please refer to the 'Maintenance' section.

1.8 Warranty and product liability • The product should be treated as described in the “Safety” chapter. Improper han‑ dling can damage the product. This would void all guarantee claims.

• Continued use of a product damaged by incorrect handling may lead to personal injury. The manufacturer assumes no liability in such cases.

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DEUTSCH

1.9

12

2.

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• New PC and perimetry software can be downloaded and updated by going to

Symbols Read the instructions for use attentively

General warning: Read the accompanying docu‑ mentation

Product classification type B Device includes type B appli‑ cation parts, namely patient response button.

Disposal instructions See "Disposal" section.

RoHS China

Test symbol of CSA with approval for USA

European certificate of conformity

Ground connection

This appliance fulfils the Euro‑ pean Directive 2002/95/EC (RoHS).

Do not push! The appliance may tilt if pushed on the side.

Year of production

Manufacturer

Introduction

2.1 Device description • The Octopus 900 is an automatic projection Perimeter for the examination of the

www.HAAG‑STREIT.com.

2.2

System components

2.3

Device overview

The Octopus 900 system comprises the following components: • Octopus 900 • Patient response button • Keyboard/mouse (optional) 1. Top cover for stimulus projector 2. Front cover 3. Housing / cupola 4. Forehead rest (application part) 5. Rear panel 6. TFT display 7. Refractive lens holder with IR illumination 8. Control panel 9. Chin cup with integrated sensors for detecting the head position 10. Chin rest (application part) 11. IR cover 12. Mark for optimum eye height 13. Connection point for 14. patient response button (application part)

entire field of sight (90°).

• The system is divided into the examination unit (Octopus 900) and control unit

(notebook, PC). The examination unit communicates with the external PC via an Ethernet connection. The Octopus 900 is operated using the software installed on the PC. The Perimeter may be operated from a bright side room if necessary. • Integrated patient monitoring increases the reliability of the examination results. • The Octopus 900 is used by clinical users and for research purposes, since its flexibility is practically unlimited. • The Octopus 900 tests the entire field of sight up to 90° eccentricity because of its spherical cupola geometry by Goldmann. Thanks to the flexibility of this instru‑ ment, all perimetric questions can be answered – in both the 30° and 90° range, with kinetic perimetry, static perimetry or flicker perimetry. 6

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15 16

1 2 3

17

4 5

18

6

19

7 8 9 10 11 12 13 14

2.5

Control panel

The control panel is made of a comfortable and hard‑wearing rubber material. All buttons are backlit with white light to make navigation easy in a darkened room. The light sources can be switched off if required, except for the display brightness set‑ ting. 20. Turn the refractive lens holder in and out 21. Start examination 22. Display brightness setting 23. Position chin rest left, right, up, down 20 21 22

2.4

LCD display

The high‑contrast TFT colour display enables the video image to be observed under a large angle of view. The following messages are shown on the display: 15. Display of a ' ' during the stimulus presentation 16. Display of a ' ' if the patient response button is pressed. 17. The crosshairs help to centre the eye, scale = 1 mm interval 18. Warning or error message 19. Display of left (OS) or right eye (OD)

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2.6

Connections

23

24. Mains switch 25. Fuse holder for two fuses T3.15 AL / 250 V 26. Mains connection 27. Ethernet port 28. Plug‑in mains power unit

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WARNING! All externally connected devices must comply with the standards rel‑ evant to safety. 24 25 26 27

PORTUGUÊS

An automatic swing arm allows the refractive lens holder to be turned in and out during the examination without changing the position of the patient. This swing arm can be operated with the computer mouse at either the control panel or on the con‑ trol unit. Once the refractive lens holder has been swung in, it can be finely adjusted to the correct distance from the eye being examined. NOTE! Always use the control panel buttons on the appliance or PC to swing the refractive lens holder in or out. Do not attempt to move the refrac‑ tive lens holder manually.

Housing

The optical components and electronics are protected from light and dust by five housing covers. They can be removed for servicing with just a few actions. Once the four screws in the back panel have been removed, the panel, hood and both IR covers can be lifted out. The optical unit and electronic components of the Octopus 900 are now accessible WARNING! Always disconnect the appliance from the mains power supply by pull‑ ing out the mains cable before opening the appliance. Housing compo‑ nents may be removed only by correspondingly trained and authorised skilled personnel.

2.8

Cupola

2.9

Forehead rest

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2.11 Swing arm

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2.7

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2.12

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.

The cupola of the Octopus 900 has a diameter of 600 mm and thus conforms to the Goldmann standard.

A wide, ergonomically designed forehead rest allows the patient to maintain a com‑ fortable posture during the examination.

2.10 Chin rest

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

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2.13 Patient-response button

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

2.14 Network connection

The Ethernet port is located at the back of the appliance. Always use a shielded cat‑ egory 5e cable which enables transmissions of 100 MHz without interference. This network connection is electrically isolated and has a dielectric strength of 4 kV ac‑ cording to EN 60601‑1.

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2.15 Light sources

LEDs are installed for periphery or background illumination, fixation assistance and stimulus. LEDs emit very low amounts of heat, so active cooling is not required.

2.16 Light intensities

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

2.17 Stimulus

The stimulus light is projected indirectly into the cupola via a mirror unit. Five differ‑ ent diaphragm diameters can be selected in the user-defined programs. The attenu‑ ation of the stimulus intensity is infinitely adjustable via an electronic control unit. Stimulus presentations of 100-500 ms are permitted. A mechanical lock and optical damping elements are no longer required. White stimulus for W/W perimetry and optionally blue and red stimulus for B/Y and R/W are possible. The stimulus intensity is detected using a light sensor, which also serves as reference point for the system of coordinates of the test zones. The stim‑ ulus LED has a service life of >30,000 h and is thus maintenance-free.

2.18 Periphery or background illumination

The white background brightness amounts to 31.4 or 4 asb for W/W perimetry. You can also select a yellow background with 314 asb for B/Y perimetry. The back‑ ground brightness consists of two light sources, each equipped with several LEDs. The background LEDs have a service life of >30,000 h and are thus maintenancefree. The background brightness is measured by a separate light sensor.

(Centre point)

(Cross markers)

(Circle)

2.20 Fixation control

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

2.21 Examination data

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

2.19 Fixation marks

Three different fixation marks can be selected and their brightness changed elec‑ tronically in 10 steps. A green LED, which is maintenance-free and has a service life of >30,000 h, serves as light source.

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3.

3.1

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Appliance assembly / installation Transporting the appliance

Transporting or moving the appliance (only short distances): a) Stand in front of the device, grasp the cupola with both hands and lift the device (Figure 7‑1), or b) Stand to one side of the appliance with one hand on the front cover and with the other hand on the back cover, then take a firm hold and lift the appliance (Figure 7‑2, Figure 7‑3).

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3.2

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Connecting the patient response button

The connection socket for the response button is located at the bottom of the front cover. The retaining catch on the connection plug of the response button faces for‑ wards. FORBIDDEN! No other cable may be connected to the RJ11 socket other than the patient response button! 29. Front cover 30. Cupola housing 31. Connection plug with retaining catch

• Push the connection plug into the

Figure 7‑1

Figure 7‑2

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Figure 7‑3

connection socket until your hear the retaining catch click into place. To re‑ move the response button, push the retaining catch towards the headrest and pull the cable downwards. • 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 'Safe system configuration in accordance with 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 Oc‑ topus 900 can be connected to the power socket in the support stand's electrical connection box.

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4. 4.1

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Safe system configuration in accordance with EN 60601-1

ITALIANO

NOTE! A network switch (*) must always be interposed for perfect operation. LAN connection

Mains connection

DEUTSCH

**

Ethernet cable LAN (optional)

*

FRANÇAIS

ENGLISH

Neither a safety isolating transformer nor a distance of > 1.5 m from the Octopus 900 is required if a medically approved control unit or a control unit with medically approved power supply unit without printer and without optional LAN connection is being operated. For safety reasons, it is recommended to maintain a distance of > 1.5 m if at all possible. Otherwise, all non-medical devices must be operated through a safety isolating transformer.

System variant I, Octopus 900 with laptop as control unit

Mains connection

ESPAÑOL

safety isolating transformer

Control unit network switch

USB cable

< 1.5 m **

Laptop / Control unit

** If the control unit (notebook, PC) and printer are more than 1.5 m away from the Octopus 900, then the safety isolating transformer can be dispensed with in accord‑ ance with EN 60601-1.

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4.2

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5.

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

** If the control unit (notebook, PC) and printer are more than 1.5 m away from the Octopus 900, then the safety isolating transformer can be dispensed with in accord‑ ance with EN 60601-1.

Mains connection

5.1

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Commissioning

Switching on the appliance

Before connecting the Octopus 900 to a suitable power socket, it must be ensured that the mains switch (24) is set to OFF '0'. The power socket is on the rear of the base of the device. Then set the mains switch to ON 'I'. The device will be ready for use after a couple of seconds.

**

Mains connection

LAN connection

safety isolating transformer

Control unit

Ethernet cable LAN (optional)

Ethernet cable *

*

Network switch

USB cable PC / control unit

< 1.5 m **

5.2

Switching off the appliance

Set the network switch (24) to OFF '0'. There is no special shutdown procedure.

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6.

6.1

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Operation

Setting up the patient

The patient sits comfortably in front of the device and places his/her chin on the chin rest. The forehead rest can be set to the correct position.

7.

Software / Help menu / Error messages

8.

Technical data

The software's help section contains instructions and help for performing an exami‑ nation and descriptions of the error messages. The help can be opened via the F1 key or in the [?] - [Help] menu. WARNING! The software must be installed by trained personnel in accordance with separate installation instructions.

8.1

Octopus 900

Type designation Mains voltage: Power consumption: Operating frequency: Fuses: 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:

Octopus 900 100 – 120 VAC, 220 – 240 VAC 145 VA, 165 VA 50 / 60 Hz 2 x T3.15 AL 250 V 648 mm x 519 mm x 796 mm 25 kg 800 mm x 600 mm x 900 mm 40 kg See chapter 1.1 See chapter 1.1 projection cupola perimeter Bracketing procedure Adjustable headrest Permanent video-based fixation control 90° 0 ... 47 dB 0.5 dB

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ITALIANO

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: Ethernet port: Display:

FRANÇAIS

ENGLISH

3185 cd/m² (10000 asb) 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)

8.2

Infrared illumination

8.3

Field of sight

8.4

Octopus 900 control unit / PC

Cupola emission: Light sources: LED Wavelength: 875 nm Angle of radiation: ±8.5°

DEUTSCH

Refractive lens holder emission Light sources: LED Wavelength: 880 nm Angle of radiation: ±20°

The Octopus 900 makes it possible to examine up to the following eccentricity: • Nasal 89° • Temporal 89° • Superior 60° • Inferior 70° A standard PC can be used as control unit for the Perimeter. The control unit soft‑ ware runs on WINDOWS XP SP3, WINDOWS VISTA SP2, WINDOWS 7 and WIN‑ DOWS 8.

8.5 Minimum PC requirements • Pentium IV or equivalent • 2 GB RAM for Windows XP, 3 GB RAM for Windows Vista, 7 and 8 • 160 GB free hard disk space • CD-ROM / DVD drive • T100 (100MHz) Ethernet port • Screen resolution 1,280 x 1,024 13

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9.

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Maintenance

WARNING! ••The housing components of the Perimeter appliance may only be re‑ moved 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 only be conducted by suitably trained and authorised skilled personnel. Incorrect repairs may result in considerable haz‑ ards for patients and operating staff. ••If components have to be replaced, only original spare parts from HAAG‑STREIT or your dealer may be installed. ••Warranty claims can be made only if the instructions in these instructions for use have been complied with.

9.1

Repairs

9.2

Cleaning

We recommend having an authorised professional check the Octopus 900 every two years to ensure long-term and trouble-free functioning. Further information and the corresponding technical documentation for this are available from HAAG‑STRE‑ IT or your local representative. Occasional dusting with a soft cloth is sufficient. Stubborn dust particles can be re‑ moved with a soft cloth dampened with water or alcohol. NOTE! Do not allow the appliance to become wet and do not use other sol‑ vents of any kind. A dust cover is included in the accessories of the Octopus 900. Cover the appliance when the room is being cleaned or if it is not used for longer periods. Always re‑ move the dust cover before switching on the power. WARNING! The appliance must not be switched on when covered (heat build-up, fire hazard).

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NEDERLANDS

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9.3

Cupola

9.4

Response button, chin and forehead rest, eye occluder

9.5

Display, control panel

9.6

Light sources

9.7

Application parts

A.

Appendix

The inner surface of the cupola is coated with a special paint finish designed to en‑ sure optimum results in perimetric examinations. It is not necessary to clean this in‑ ner surface in normal cases. Should dust be visible in the cupola, you can remove it by gently wiping with a soft, dry and fluff-free cloth. A soft cloth dampened slightly with mild soapsuds may only be used for local cleaning in emergencies, such as if spots have appeared due to patients' sneezing. These components are all made of easy-to-clean plastic materials. Disinfect them after every patient to keep them hygienically clean. Fingerprints and dust can be removed using a soft, moist cloth. In contrast to other perimetric devices, LEDs are used in the Octopus 900 as light sources for background and stimulus. These have a service life of >30,000h. If any of the LEDs still has to be replaced, please contact your dealer's customer service department. Application parts such as the eye patch, patient response button, chin rest and fore‑ head rest are made of plastics which are easy to clean. NOTE! These application parts should be disinfected prior to every examina‑ tion (e.g., with 70% isopropyl alcohol) in order to comply with general hygiene requirements and prevent the transmission of infections.

A.1

Accessories / spare parts

Component

Type

HS art. no.

Note

Instrument table Patient response button Dust cover

IT 01 Octopus 900

7220034 1802032 1803061

See separate IU*: 1x 1x

1802349

2x / set

Eye patch set *IU = Instructions for use

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SVENSKA

B.

NEDERLANDS

Legal regulations

• HAAG‑STREIT maintains a quality management system in accordance with EN

ISO 13485. The device was developed and designed in accordance with all the standards listed in section E, 'Standards'. • The Octopus 900 is a Class IIa device in accordance with Appendix IX of Directive 93/42/EEC. By 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.

C.

Classification

Standard EN 60601-1 Application part: Operating mode: CE Directive 93/42/EEC Standard EN 62471

D.

ESPAÑOL

PORTUGUÊS

F.

ITALIANO

Perimeter Octopus 900 acc. to protection class I Type B Continuous operation Class IIa Exempt group

Disposal

Technical service life x 125% (Daily use)x 365

EF =

125% = Factor for products which can be repaired. Daily use = service use, from field tests Average data: 21,900 patients/year, 10 minutes/patient. 8.5 hours per day

30000X125% 8,5X365

12.1 years

Technical service life ~ 30,000 hours.

EN 62471 EN ISO 10993-1

ISO 9022

12

Consequently, the environment friendly use period is approx. 12 years.

F.1.

RoHS declaration

Name of sub-assembly

Ribbon cable clip (1008504)

EN ISO 15004-1 EN ISO 12866

21900X8,5 60X365

Stepping motor mount. (Short coupling flange 1802009)

Standards

ENGLISH

RoHS China

from household waste! This appliance was made available for sale after the 13th August 2005. • For correct disposal, please contact your HAAG‑STREIT representa‑ tive. This guarantees that no hazardous substances will enter the en‑ vironment and that valuable raw materials will be recycled.

EN 60601-1 EN 60601-1-2

DEUTSCH

Environment friendly use period (EFUP). The following formula applies for products that can be repaired:

Daily use

• Electrical and electronic devices must be disposed of separately

E.

FRANÇAIS

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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G. G.1

DEUTSCH

FRANÇAIS

ITALIANO

ESPAÑOL

Information and manufacturer's declaration concerning electromagnetic compatibility (EMC) General

The OCTOPUS 900 fulfils the requirements on electromagnetic compatibility ac‑ cording to EN 60601-1-2. The instrument is built so that the generation and emis‑ sion of electromagnetic interference is limited to the extent that other devices are not disturbed in their use in accordance with the regulations and so that the instru‑ ment itself is suitably immune to electromagnetic interference.

G.2

PORTUGUÊS

NEDERLANDS

SVENSKA

WARNING! ••In terms of EMC, electrical medical devices and systems are sub‑ ject 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. WARNING! ••Connecting third-party systems to the same extension cable can com‑ promise the system's safety. ••Third-party devices may only be connected in compliance with the EN 60601-1 standard.

Emission (Standard table 1)

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 environment. Emission test RF emissions CISPR 11

Compliance Group 1

RF emissions CISPR 11 Emission of harmonics according to EN 61000-3-2

Class B Class A

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Electromagnetic environment - guidance 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. 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.

© HAAG‑STREIT AG, 3098 Koeniz, Switzerland - HS Doc. no. 1500.7220343.04040 – 4. Edition / 2013 – 07

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G.3

NEDERLANDS

PORTUGUÊS

ESPAÑOL

ITALIANO

FRANÇAIS

DEUTSCH

ENGLISH

Immunity (Standard table 2)

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 environment. Immunity test standard Electrostatic discharge (ESD) EN 61000-4-2

EN 60601 test level ± 6 kV contact ± 8 kV air

Compliance level ± 6 kV contact ± 8 kV air

Electrical fast transient / burst EN 61000-4-4 Surge EN 61000-4-5 Voltage dips, short interruptions and voltage variations on power supply lines EN 61000-4-11

± 2 kV for power supply lines

± 2 kV for power supply lines

± 1 kV for symmetrical voltages ± 2 kV for asymmetrical voltages < 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 3 A/m

± 1 kV for symmetrical voltages ± 2 kV for asymmetrical voltages < 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 0.3 A/m

Power frequency (50/60Hz) magnetic field EN 61000-4-8

Electromagnetic environment – guidance Floors should be wood, concrete or ceramic tile. If floors are covered withs ynthetic material, the relative humidity should be at least 30%. Mains power quality should be that of a typical commercial or hospital environment. Mains power quality should be that of a typical commercial or hospital environment. 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 uninterruptible power supply or a battery.

Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.

NOTE: UT= the AC mains voltage prior to application of the test level.

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G.4

DEUTSCH

FRANÇAIS

ITALIANO

ESPAÑOL

PORTUGUÊS

NEDERLANDS

SVENSKA

Immunity for non-life-support devices (Standard table 4)

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 environment. 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 calculated from the equation applicable to the frequency of the transmitter. Immunity test standard Conducted RF EN 61000-4-6 Radiated RF EN 61000-4-3

EN 60601 test level 3 Vrms 150 kHz – 80 MHz 3 V/m 80 MHz – 2.5 GHz

Compliance level 3 Vrms

Recommended distance: D = 1.2

3 V/m 80 MHz – 800 MHz

D = 1.2 D = 2.3

80 MHz – 800 MHz 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 broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be 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.

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G.5

NEDERLANDS

PORTUGUÊS

ESPAÑOL

ITALIANO

FRANÇAIS

DEUTSCH

ENGLISH

Recommended safe distances for non-life-support devices (Standard table 6)

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 recommended below in accordance with the maximum output of the communication system. Safe distance according to transmission frequency (m) 80 MHz – 800 MHz 150 kHz – 80 MHz Nominal output of the transmitter (W) D = 1.2 D = 1.2 0.12 0.12 0.01 0.38 0.38 0.1 1.2 1.2 1 3.8 3.8 10 12 12 100

800 MHz – 2.5 MHz D = 2.3 0.23 0.73 2.3 7.3 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.

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ENGLISH

DEUTSCH

FRANÇAIS

ITALIANO

ESPAÑOL

PORTUGUÊS

NEDERLANDS

SVENSKA

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

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

C

US

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

Manufacturer:

1250

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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

© HAAG‑STREIT AG, 3098 Koeniz, Switzerland - HS Doc. no. 1500.7220343.04040 – 4. Edition / 2013 – 07

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