Haag-Streit OCTOPUS 900 Instructions For Use Manual

Haag-Streit OCTOPUS 900 Instructions For Use Manual

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SVENSKA
NEDERLANDS
ESPAÑOL
ITALIANO
FRANÇAIS
DEUTSCH
ENGLISH
PORTUGUÊS
INSTRUCTIONS FOR USE
Perimeter
OCTOPUS 900
¨
EyeSuite Perimetry
11. Edition / 2022 – 10
1
© HAAG‑STREIT AG, 3098 Koeniz, Switzerland ‑ HS‑Doc. no. 1500.7220343‑04110 – 2022 – 10

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Summary of Contents for Haag-Streit OCTOPUS 900

  • Page 1 SVENSKA NEDERLANDS ESPAÑOL ITALIANO FRANÇAIS DEUTSCH ENGLISH PORTUGUÊS INSTRUCTIONS FOR USE Perimeter OCTOPUS 900 ¨ EyeSuite Perimetry 11. Edition / 2022 – 10 © HAAG‑STREIT AG, 3098 Koeniz, Switzerland ‑ HS‑Doc. no. 1500.7220343‑04110 – 2022 – 10...
  • Page 2 SVENSKA PORTUGUÊS INSTRUCTIONS FOR USE Preface Perimeter Thank you for choosing a Haag-Streit device. Provided you comply carefully with the regulations in these instructions for use, we can guarantee reliable and trouble-free OCTOPUS 900 ¨ use of our product. WARNING! Read the instruction manual carefully before commissioning this product.
  • Page 3: Table Of Contents

    ▪ 2.2.3.1 Contraindications.....................7 ◦ 9.3 Field of sight ..........................15 ◦ 2.3 Principles of operation ........................7 ◦ 9.4 Octopus 900 control unit / PC...................... 15 ▪ 2.3.1 Operating environment .......................7 ¥ 10 Maintenance ..........................15 ◦ 2.4 Clinical benefit..........................7 ◦...
  • Page 4: Safety

    10 % ... 95 % NOTE! Temperature +10 °C ... +35 °C • The Octopus 900 must be placed in a completely darkened room. Air pressure 800 hPa ... 1060 hPa • The use of accessories other than than those listed may result in...
  • Page 5: Operation, Environment

    1.7 Warranty and product liability instructions contained therein. • Haag-Streit products must be used only for the purposes and in the manner de- • This device must not be operated near of high frequency surgical scribed in the documents distributed with the product.
  • Page 6: Intended Purpose / Intended Use

    2.1 Device description 1.8 Reporting obligation The Octopus 900 is an automatic projection Perimeter for the examination of the en- NOTE! tire field of sight (90°). The system is divided into the examination unit (Octopus Any serious incident that has occurred in relation to the device must be 900) and control unit (notebook, PC).
  • Page 7: Part Of The Body

    SVENSKA NEDERLANDS ESPAÑOL ITALIANO FRANÇAIS DEUTSCH ENGLISH PORTUGUÊS 2.3.1 Operating environment The use of this device's Goldmann kinetic perimetry feature is indicated when un- able to perform static perimetry due to difficulties particular to the patient or for the This device is intended to be used in professional health care facilities such as hos- following medical conditions: pitals, physician's, optometrist's and optician's practices.
  • Page 8: Introduction

    • 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 device, all perimetric questions can be answered –...
  • Page 9 IR cov- light sources can be switched off if required, except for the display brightness set- ers can be lifted out. The optical unit and electronic components of the Octopus 900 ting.
  • Page 10: Cupola

    PORTUGUÊS 3.8 Cupola 3.12 Refractive lens holder The cupola of the Octopus 900 has a diameter of 600 mm and thus conforms to the Refractive lenses can be used during examinations with 30° eccentricity. The cor- Goldmann standard. responding lenses are inserted before the examination. The refractive lens holder can be tilted forward by about 25°...
  • Page 11: Device Assembly / Installation

    Installation and repairs may only be performed by trained special- ists. 3.19 Fixation marks • Contact your Haag-Streit representative for installation, repairs and Three different fixation marks can be selected and their brightness changed elec- modification work on the system. The contact details are available at tronically in 10 steps.
  • Page 12: Connecting The Patient Response Button

    Octopus 900. However, the switch is only active when the Octopus 900 is turned on. You will find further information in chapter 'Safe system configuration in accordance with EN 60601-1'.
  • Page 13: Safe System Configuration In Accordance With En 60601

    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 in being operated. For safety reasons, it is recommended to maintain a distance of > 1.5 m if at all possible.
  • Page 14: Commissioning

    9 Technical data 6.1 Switching on the device 9.1 Octopus 900 Before connecting the Octopus 900 to a suitable power socket, it must be ensured Type designation Octopus 900 that the mains switch (24) is set to OFF '0'. The power socket is on the rear of the...
  • Page 15: Infrared Illumination

    Further information and the 9.3 Field of sight corresponding technical documentation for this are available from Haag-Streit or your local representative. The Octopus 900 makes it possible to examine up to the following eccentricity: NOTE! • Nasal 89° • Temporal 89°...
  • Page 16: Device In General

    Fingerprints and dust can be removed using a display towel or a cleaning/disinfect- ing towel respectively. 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 10.2.3 Cupola...
  • Page 17: Appendix

    EN ISO 10993 * See separate instructions for use 11.2 Legal regulations • Haag-Streit maintains a quality management system in accordance with EN ISO 13485. The device was developed and designed in accordance with all the standards listed in chapter 'Observed standards'.
  • Page 18: Information And Manufacturer's Declaration Concerning Electromagnetic Compatibility (Emc)

    • Use of accessories, transducers and cables other than those spe- cified or provided by Haag-Streit could result in increased electro- magnetic emissions or decreased electromagnetic immunity of this device and result in improper operation.
  • Page 19: Emitted Interference

    SVENSKA NEDERLANDS ESPAÑOL ITALIANO FRANÇAIS DEUTSCH ENGLISH PORTUGUÊS 11.6.2 Emitted interference This product is intended for use in the electromagnetic environment specified below. The customer or the user of this product should assure that it is used in such an envir- onment.
  • Page 20: Electromagnetic Immunity Environment Tested (Part 1)

    ENGLISH DEUTSCH FRANÇAIS ITALIANO ESPAÑOL NEDERLANDS SVENSKA PORTUGUÊS 11.6.3 Electromagnetic immunity environment tested (part 1) This product is intended for use in the electromagnetic environment specified below. The customer or the user of this product should assure that it is used in such an envir- onment.
  • Page 21: Electromagnetic Immunity Environment Tested (Part 2)

    SVENSKA NEDERLANDS ESPAÑOL ITALIANO FRANÇAIS DEUTSCH ENGLISH PORTUGUÊS 11.6.4 Electromagnetic immunity environment tested (part 2) Portable and mobile RF communications equipment should be used no closer to any part of this product, including cables, than the recommended separation distance calcu- lated from the equation applicable to the frequency of the transmitter.
  • Page 22 ENGLISH DEUTSCH FRANÇAIS ITALIANO ESPAÑOL NEDERLANDS SVENSKA PORTUGUÊS 28 V/m 28 V/m GSM 1800/1900: max 2 W 2400 – 2570 MHz CDMA 1900: max 2 W 2400 – 2570 MHz 50% PM 217 Hz 50% PM 217 Hz DECT: max 2 W LTE Band 1, 3, 4, 25: max 2 W 9 V/m 9 V/m...
  • Page 23: Recommended Separation Distances Between Portable And Mobile Rf Communications

    SVENSKA NEDERLANDS ESPAÑOL ITALIANO FRANÇAIS DEUTSCH ENGLISH PORTUGUÊS 11.6.5 Recommended separation distances between portable and mobile RF communications equipment and this product This product is intended for use in the electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of this product can help pre- vent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and this product as recom- mended below, according to the maximum output power of the communication equipment.
  • Page 24 ENGLISH DEUTSCH FRANÇAIS ITALIANO ESPAÑOL NEDERLANDS SVENSKA PORTUGUÊS Should you have any further questions, please contact your Haag-Streit representative at: www.haag-streit.com/haag-streit-group/contact/haag-streit-distributors/distributors HAAG-STREIT AG Gartenstadtstrasse 10 3098 Koeniz, Switzerland Phone +41 31 978 01 11 +41 31 978 02 82 eMail info@haag-streit.com...

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