Zeiss S7 / OPMI VISU 160 Instructions For Use Manual
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Zeiss S7 / OPMI VISU 160 Instructions For Use Manual

Zeiss S7 / OPMI VISU 160 Instructions For Use Manual

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ZEISS
®
S7 / OPMI
VISU 160
Instructions for Use
G-30-1528-en
Version 6.0
2016-01-12

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Summary of Contents for Zeiss S7 / OPMI VISU 160

  • Page 1 ZEISS ® S7 / OPMI VISU 160 Instructions for Use G-30-1528-en Version 6.0 2016-01-12...
  • Page 2 – You will also find a detailed table of contents at the beginning of each chapter. – The index facilitates searching via keywords. The following Instructions for Use apply to the S7 / OPMI VISU 160 with the Scope following suspension systems and identifications: –...
  • Page 3 S7 / OPMI VISU 160 Chapter overview Chapter: Safety Measures Chapter: System Overview Chapter: Preparations for use Chapter: Operation Chapter: What to do in the event of malfunctions Chapter: Care and Maintenance Chapter: System Data Chapter: Index Version 6.0 G-30-1528-en...
  • Page 4 S7 / OPMI VISU 160 Version 6.0 Page 4 G-30-1528-en...

  • Page 5: Table Of Contents

    S7 / OPMI VISU 160 Safety Measures Safety Measures Key to symbols .................. 7 Hazard symbols ...................7 Information symbols..................7 Target group ..................8 Field of application ................8 Intended use ....................8 Normal use....................8 Liability and warranty................9 Notes for the operator..............10 Requirements for operation.............
  • Page 6 Safety Measures S7 / OPMI VISU 160 Version 6.0 Page 6 G-30-1528-en...

  • Page 7: Key To Symbols

    S7 / OPMI VISU 160 Safety Measures Key to symbols We would like to inform you about safety aspects which must be observed when handling this device. This chapter contains a summary of the most im- portant information concerning matters relevant to instrument safety.

  • Page 8: Target Group

    Normal use S7 / OPMI VISU 160 has been designed for surgical procedures in the field of ophthalmology. Through its specific illumination system, the halogen light source, the clip-on RESIGHT fundus viewing system and its mechanical con- struction, it is adapted to the ophthalmic needs of the anterior and posterior segments of the eye.

  • Page 9: Liability And Warranty

    S7 / OPMI VISU 160 Safety Measures Use the protective devices offered to reduce radiation exposure in patients with a high degree of retinal impairment. These devices include the blue bar- rier filter and the retinal protection device. Liability and warranty Warranty and liability depend on the applicable contractual stipulations.

  • Page 10: Notes For The Operator

    • Please observe all symbols and labels attached to the device (see Page 26)! • Only use original accessories or consumables approved by Carl Zeiss. Legal regulations • Observe the legal regulations for accident prevention and occupational health and safety applicable in the country concerned.
  • Page 11 (see section "Care and Maintenance"). • Modifications and repairs of this device or any equipment operated to- gether with this device may only be performed by ZEISS service staff or other persons authorized by ZEISS. Optics and light •...
  • Page 12 Safety Measures S7 / OPMI VISU 160 • Avoid looking directly into the light source, e.g. into the microscope ob- jective lens or into the light guide, in order to prevent damage to the eye! • Start with the lowest brightness setting and gradually increase brightness up to the necessary and still admissible level.

  • Page 13: Requirements For Operation

    Safety Measures Requirements for operation Prior to the very first use A ZEISS Service representative or an expert authorized by ZEISS will install the system. Please make sure that the following requirements continue to be met for further operation:  The connecting components have been properly connected. The screw connections have been firmly tightened.

  • Page 14: Before Every Use

    (connectors, jacks). If a connector/plug cannot be plugged in easily, check whether the plug fits the socket. If you discover a plug-in connector is damaged, have the ZEISS service team or an authorized professional repair • Position the suspension system in such a way that you can slide or swing it away from the patient at any time.

  • Page 15: During Use

    S7 / OPMI VISU 160 Safety Measures • Prior to using the wireless foot control panel (FCP WL), make sure that its batteries are fully charged. The system may malfunction if the FCP WL is not provided an adequate level of power.
  • Page 16 You will find the values recommended by ZEISS in the table "Maximum radiation exposure times" on Page 21. Any deviation from these values is only permissible when medically justi- fied.

  • Page 17: After Every Use

    "What to do in the event of malfunctions attach a sign to the system stat- ing it is out of order and inform ZEISS Service. • Do not pull at the light guide, power cord or any other connecting cables.

  • Page 18: Measures To Prevent Phototoxic Injury

    ZEISS has addressed this aspect by providing its systems with a device for con- tinuously varying the brightness of the light source. This permits the surgeon to optimally adapt the light intensity at the patient's eye to the conditions ex- isting in each case.
  • Page 19 The peak intensity of a filament is consider- ably higher than that of an even and extended light source such as a light guide. This is the reason why ZEISS uses fiber optic illumination in its surgical micro- scope systems. Version 6.0...

  • Page 20: Exposure Time To Light

    This problem has been solved by ZEISS by the use of a retinal protection device that can be swung into the mi- croscope's illumination beam path and a blue barrier filter (retina protection filter).
  • Page 21 S7 / OPMI VISU 160 Safety Measures The brightness control scale comprises a range of values from 0.1 to 1.5. The stipulations of standard DIN EN ISO 15004-2:2007 result in maximum ra- diation exposure times for the different illumination configurations as speci- fied in the table below.
  • Page 22 Safety Measures S7 / OPMI VISU 160 H. Stiller, and B. Rassow, "Light hazards to the patient's retina from oph- List of references thalmic instruments," Applied Optics-OT 30, 2187-2196 (1991). American Conference of Governmental Industrial Hygienists, "Documenta- tion of the Threshold Limit Values for physical agents. 7th Edition," (American Conference of Governmental Industrial Hygienists, Cincinnati, 2001).
  • Page 23 S7 / OPMI VISU 160 Safety Measures Version 6.0 G-30-1528-en Page 23...

  • Page 24: Safety Devices Of The Suspension Systems

    Safety Measures S7 / OPMI VISU 160 Safety devices of the suspension systems Light sources 1 Manual switching to the backup lamp The lamp housing contains a backup lamp which is automatically swung into the illumination beam path when the first lamp fails. If this automatic function fails, you can switch on the backup lamp by pressing this button.
  • Page 25 S7 / OPMI VISU 160 Safety Measures Lifting column of the S7 ceiling mount Selector switch for setting the optimum viewing height of the surgical microscope or for downward movement into the working position. As long as you keep the selector switch in the turned position, the lifting column moves downward (1) or upward (2), depending on the switch posi- tion.

  • Page 26: Symbols And Labels On The Device

    Safety Measures S7 / OPMI VISU 160 Symbols and labels on the device CAUTION Note the warning labels and notes! • If you notice that any label is missing on your system or has become illeg- ible, please contact us or one of our authorized representatives. We will supply a replacement.
  • Page 27 S7 / OPMI VISU 160 Safety Measures Version 6.0 G-30-1528-en Page 27...
  • Page 28 Safety Measures S7 / OPMI VISU 160 5 "Light guide connector" indicating label This label shows how to correctly connect the light guide. 6 Intensity of 6° illumination 7 "Manual zoom adjustment" label This label identifies the two directions of rotation for increasing or re- ducing the zoom.
  • Page 29 S7 / OPMI VISU 160 Safety Measures Version 6.0 G-30-1528-en Page 29...

  • Page 30: Labels On S7 Floor Stand

    Safety Measures S7 / OPMI VISU 160 Labels on S7 floor stand 1 "Risk of crushing" label Fingers may be pinched between the carrier and suspension arms. Do not touch this area while the surgical microscope is being moved. 2 "Maximum load" warning label The maximum load on the suspension arm must not exceed 14 kg.
  • Page 31 S7 / OPMI VISU 160 Safety Measures Version 6.0 G-30-1528-en Page 31...
  • Page 32 Safety Measures S7 / OPMI VISU 160 8 "Observe the Instructions for Use" label Please comply with the Instructions for Use. 9 Plate "Date of manufacture" This plate indicates the date of manufacture for the device (year-month). 10 Rating label The rating label provides the following information: –...
  • Page 33 S7 / OPMI VISU 160 Safety Measures Version 6.0 G-30-1528-en Page 33...
  • Page 34 Safety Measures S7 / OPMI VISU 160 12 "Transport position" label Indicates the transport position of the device. Always move the device into this position before transport to avoid damaging the device. 13 SIP label The SIP label contains the following information: –...
  • Page 35 S7 / OPMI VISU 160 Safety Measures Version 6.0 G-30-1528-en Page 35...

  • Page 36: Labels On The Connection Panel

    Safety Measures S7 / OPMI VISU 160 Labels on the connection panel 1 "Potential equalization" label (floor stand only) Identifies the potential equalization connection for other active devices or to redundantly connect with the grounding conductor. 2 Warning sign "Power output socket" (floor stand only) Only connect devices with the correct electrical ratings.

  • Page 37: Additional Labels On S7 Floor Stand (Instrument Tray Option)

    S7 / OPMI VISU 160 Safety Measures Additional labels on S7 floor stand (instrument tray option) 1 "Maximum load on instrument tray" indicating label The maximum load of accessories on the instrument tray must not exceed 13 kg. Version 6.0...

  • Page 38: Labels On S7 Ceiling Mount

    Safety Measures S7 / OPMI VISU 160 Labels on S7 ceiling mount 1 "Risk of crushing" label Fingers may be pinched between the carrier and suspension arms. Do not touch this area while the surgical microscope is being moved. 2 "Maximum load" warning label The maximum load on the suspension arm must not exceed 14 kg.
  • Page 39 S7 / OPMI VISU 160 Safety Measures 10 "Balance setting" label - Balance + Balance setting must be performed after all accessories have been mounted on the microscope. Version 6.0 G-30-1528-en Page 39...
  • Page 40 Safety Measures S7 / OPMI VISU 160 11 SIP label The SIP label contains the following information: – Manufacturer (company name) – Manufacturer's contact data, i.e., phone number, fax number and email address of the local contact of the national ZEISS sales organization.
  • Page 41 S7 / OPMI VISU 160 Safety Measures 13 Rating label (for S7 ceiling mount with lifting column) The rating label provides the following information: – Manufacturer's symbol – Manufacturer (company name) Carl Zeiss Meditec AG – Manufacturer's address Goeschwitzer Strasse 51-52 07745 Jena, Germany –...

  • Page 42: Additional Label On S7 Ceiling Mount With Lifting Column

    Safety Measures S7 / OPMI VISU 160 Additional label on S7 ceiling mount with lifting column 1 "Lifting column operation" indicating sign Switch for moving the vertical position upward or downward. 2 Lifting column activation time This label represents the maximum permissible operating time as well as the subsequent mandatory rest phase for the lifting column and indicates the ratio between the operating time and the rest phase.
  • Page 43 S7 / OPMI VISU 160 Safety Measures Version 6.0 G-30-1528-en Page 43...
  • Page 44 Safety Measures S7 / OPMI VISU 160 Version 6.0 Page 44 G-30-1528-en...
  • Page 45 S7 / OPMI VISU 160 System Overview System Overview Surgical microscope................. 48 System components ..................48 Description of components................50 Illumination system..................54 Controls, displays, connections ..............56 Binocular tubes and eyepieces ..............62 Light source..................68 S7 floor stand ..................71 Features ....................71 Setup......................72 Controls and connections ................74 Connector panel..................80...
  • Page 46 System Overview S7 / OPMI VISU 160 Foot control panel .................104 Version 6.0 Page 46 G-30-1528-en...
  • Page 47 S7 / OPMI VISU 160 System Overview Version 6.0 G-30-1528-en Page 47...

  • Page 48: Surgical Microscope

    System Overview S7 / OPMI VISU 160 Surgical microscope System components 1 S7 ceiling mount with rigid column 2 S7 ceiling mount with lifting column 3 S7 floor stand 4 Surgical microscope with 180° tiltable tube and magnetic eyepieces. The overall system comprises a suspension system and a microscope. All op- tions described in these Instructions for Use can be ordered separately.
  • Page 49 S7 / OPMI VISU 160 System Overview Version 6.0 G-30-1528-en Page 49...

  • Page 50: Description Of Components

    System Overview S7 / OPMI VISU 160 Description of components The surgical microscope comprises the following components: 1 X-Y coupling The X-Y coupling allows motorized fine positioning of the surgical micro- scope in a horizontal plane. The range of travel is 40 mm x 40 mm.
  • Page 51 S7 / OPMI VISU 160 System Overview Version 6.0 G-30-1528-en Page 51...
  • Page 52 System Overview S7 / OPMI VISU 160 2 Carrier arm for the surgical microscope The carrier arm incorporates a tilt device. This allows the viewing direction of the surgical microscope to be adapted to the requirements of the sur- gical field. Using the knob for fine tilt, you can position the surgical micro- scope in a range from +90°...
  • Page 53 S7 / OPMI VISU 160 System Overview Version 6.0 G-30-1528-en Page 53...

  • Page 54: Illumination System

    System Overview S7 / OPMI VISU 160 Illumination system The illumination system has been designed for use in ophthalmology. A light guide directs the light from the light source in the suspension system to the surgical microscope. A retinal protection device is provided to protect the patient's eye from photo- retinitis.
  • Page 55 S7 / OPMI VISU 160 System Overview Version 6.0 G-30-1528-en Page 55...

  • Page 56: Controls, Displays, Connections

    System Overview S7 / OPMI VISU 160 Controls, displays, connections 1 Securing screw 2 X-Y coupling 3 Actuator button – Recenters the X-Y coupling. – Resets the focus to its initial position in the focusing range Press this button to start the recentering movement. To stop this move- ment, press the button again.
  • Page 57 S7 / OPMI VISU 160 System Overview Version 6.0 G-30-1528-en Page 57...
  • Page 58 System Overview S7 / OPMI VISU 160 8 Dust cover 9 Handgrips for positioning the microscope 10 Display of the zoom system's magnification factor 11 Securing screw Version 6.0 Page 58 G-30-1528-en...
  • Page 59 S7 / OPMI VISU 160 System Overview Version 6.0 G-30-1528-en Page 59...
  • Page 60 System Overview S7 / OPMI VISU 160 12 DeepView (DoF, depth of field) button Press this button to activate the depth-of-field optimized mode. The green LED in the button is lit. This mode is recommended for viewing the ante- rior segment of the eye.
  • Page 61 S7 / OPMI VISU 160 System Overview Version 6.0 G-30-1528-en Page 61...

  • Page 62: Binocular Tubes And Eyepieces

    System Overview S7 / OPMI VISU 160 Binocular tubes and eyepieces You can mount a 180° tiltable tube, an Invertertube or a 45° inclined tube on the surgical microscope as required (see the following pages). 180° tiltable tube 1 PD adjustment knob The correct position has been reached when the two eyepiece images merge into one.
  • Page 63 S7 / OPMI VISU 160 System Overview Version 6.0 G-30-1528-en Page 63...
  • Page 64 System Overview S7 / OPMI VISU 160 Invertertube (option) The tiltable tube has an inverter function and has been designed for oph- thalmic use. Many wide-angle observation systems for the posterior segment of the eye provide an inverted intermediate image which is viewed through the microscope.
  • Page 65 S7 / OPMI VISU 160 System Overview Version 6.0 G-30-1528-en Page 65...
  • Page 66 System Overview S7 / OPMI VISU 160 Widefield eyepieces with magnetic coupling NOTE Eyepieces have a magnetic field! Please note that the usual rules for the handling of magnets must be ob- served for eyepieces removed from the tube: • Do not place the eyepiece near instruments which may be magnetizable.
  • Page 67 S7 / OPMI VISU 160 System Overview Version 6.0 G-30-1528-en Page 67...

  • Page 68: Light Source

    System Overview S7 / OPMI VISU 160 Light source The illumination system consists of a halogen light source and has been de- signed for fiber illumination. The lamp housing contains a backup lamp which automatically swings into the illumination beam path when the first lamp fails.
  • Page 69 S7 / OPMI VISU 160 System Overview 6 Filter selector The filter selector knob has four positions: No filter Blue barrier filter (retina protection filter): when operating on the eye, always use this filter to protect the patient's eye against unnecessary radiation.
  • Page 70 System Overview S7 / OPMI VISU 160 Version 6.0 Page 70 G-30-1528-en...

  • Page 71: S7 Floor Stand

    S7 floor stand Features The S7 floor stand is a suspension system for Zeiss surgical microscopes. It is used to power and control the motorized functions of a surgical microscope. The hallmarks of this stand are its superb mobility and easy operation. The motorized functions of the connected surgical microscope can be controlled using a foot control panel.

  • Page 72: Setup

    System Overview S7 / OPMI VISU 160 Setup 1 Suspension arm 2 Lamp housing 3 Carrier arm 4 Control panel 5 Connection panel 6 Grab handle 7 Bracket for foot control panel 8 Cable supports (2x, on the right and left of the stand column)
  • Page 73 S7 / OPMI VISU 160 System Overview Version 6.0 G-30-1528-en Page 73...

  • Page 74: Controls And Connections

    System Overview S7 / OPMI VISU 160 Controls and connections Suspension arm 1 Lamp housing of the halogen light source The lamp module contains a backup lamp which is automatically swung into the illumination beam path when the first lamp fails.
  • Page 75 S7 / OPMI VISU 160 System Overview Version 6.0 G-30-1528-en Page 75...
  • Page 76 System Overview S7 / OPMI VISU 160 Carrier arm, stand column, stand base 1 Control and display panel The control and display panel permits you to control all electrical functions of the S7 floor stand. 2 Friction Use this knob to adjust the friction of the swivel movement of the carrier arm.
  • Page 77 S7 / OPMI VISU 160 System Overview Version 6.0 G-30-1528-en Page 77...
  • Page 78 System Overview S7 / OPMI VISU 160 Control panel 1 LED display Display of the set values for lamp brightness or motor speed (for focusing, zoom, Y-Y coupling). 2 Four LEDs for assigning the LED display to the function selected via arrow keys (4): lamp brightness or motor speed (for focusing, zoom, X-Y coupling).
  • Page 79 S7 / OPMI VISU 160 System Overview Version 6.0 G-30-1528-en Page 79...

  • Page 80: Connector Panel

    Connector panel CAUTION Danger! Electrical voltage! • Only connect medical devices and accessories intended by ZEISS for use with this system to power outlet socket (5). When connecting other devices, make sure that safety is guaranteed re- garding admissible touch currents and ground leakage currents as per IEC 60601-1:2005.
  • Page 81 S7 / OPMI VISU 160 System Overview Version 6.0 G-30-1528-en Page 81...

  • Page 82: Instrument Tray (Option)

    The maximum load on instrument tray (1) must not exceed 13 kg! The tray has been designed, for example, for mounting MediLive Trio from Zeiss: – MediLive Trio is secured on the instrument tray using two stud bolts.
  • Page 83 S7 / OPMI VISU 160 System Overview Version 6.0 G-30-1528-en Page 83...
  • Page 84 System Overview S7 / OPMI VISU 160 Version 6.0 Page 84 G-30-1528-en...

  • Page 85: S7 Ceiling Mount With Rigid Column

    S7 ceiling mount with rigid column Features The S7 ceiling mount with rigid column is a suspension system for Zeiss sur- gical microscopes. It is used to power and control the motorized functions of a surgical microscope. The hallmarks of the system are its superb mobility and easy operation.

  • Page 86: Design

    System Overview S7 / OPMI VISU 160 Design 1 Ceiling flange 2 Column 3 Control panel 4 Connector panel 5 Lamp housing 6 Suspension arm 7 Carrier arm Version 6.0 Page 86 G-30-1528-en...
  • Page 87 S7 / OPMI VISU 160 System Overview Version 6.0 G-30-1528-en Page 87...

  • Page 88: Carrier And Suspension Arms

    System Overview S7 / OPMI VISU 160 Carrier and suspension arms 1 Lamp housing of the halogen light source The lamp module contains a backup lamp which is automatically swung into the illumination beam path when the first lamp fails.
  • Page 89 S7 / OPMI VISU 160 System Overview Version 6.0 G-30-1528-en Page 89...

  • Page 90: Connector Panel

    System Overview S7 / OPMI VISU 160 Connector panel 1 Opening for the system cable from an external video camera 2 Remote socket for controlling external devices (e.g. MEDIALINK 100) with a max. breaking capacity of 24V / 0.5A. 3 Connector for control component (option) Here, a foot control panel can be connected.
  • Page 91 S7 / OPMI VISU 160 System Overview Version 6.0 G-30-1528-en Page 91...
  • Page 92 System Overview S7 / OPMI VISU 160 Control panel 1 LED display Display of the set values for lamp brightness and motor speed of the zoom, focusing and X-Y coupling functions. 2 Four LEDs for assigning the LED display to the function selected via arrow keys (4): lamp brightness, motor speed for zoom, focusing and X-Y coupling.
  • Page 93 S7 / OPMI VISU 160 System Overview Version 6.0 G-30-1528-en Page 93...

  • Page 94: S7 Ceiling Mount With Lifting Column

    S7 ceiling mount with lifting column Features The S7 ceiling mount with lifting column is a suspension system for Zeiss sur- gical microscopes. It is used to power and control the motorized functions of a surgical microscope. The hallmarks of the system are its superb mobility and easy operation.
  • Page 95 S7 / OPMI VISU 160 System Overview Version 6.0 G-30-1528-en Page 95...

  • Page 96: Controls, Displays, Connections

    System Overview S7 / OPMI VISU 160 Controls, displays, connections Ceiling flange with lifting column 1 Lifting column 2 Selector switch For setting the optimum viewing height of the surgical microscope or for downward movement into the working position. As long as you keep the selector switch in the turned position, the lifting column moves downward (3) or upward (4), depending on the switch po- sition.
  • Page 97 S7 / OPMI VISU 160 System Overview Version 6.0 G-30-1528-en Page 97...

  • Page 98: Carrier And Suspension Arms

    System Overview S7 / OPMI VISU 160 Carrier and suspension arms 1 Lamp housing of the halogen light source The lamp module contains a backup lamp which is automatically swung into the illumination beam path when the first lamp fails.
  • Page 99 S7 / OPMI VISU 160 System Overview Version 6.0 G-30-1528-en Page 99...

  • Page 100: Connection Panel

    System Overview S7 / OPMI VISU 160 Connection panel 1 Opening for the system cable from an external video camera 2 Remote socket for controlling external devices (e.g. MEDIALINK 100) with a max. breaking capacity of 24V / 0.5A. 3 Selector switch for setting the optimum viewing height of the surgical microscope or for upward movement into the standby position.
  • Page 101 S7 / OPMI VISU 160 System Overview Version 6.0 G-30-1528-en Page 101...
  • Page 102 System Overview S7 / OPMI VISU 160 Control panel 1 LED display Display of the set values for lamp brightness and motor speed of the zoom, focusing and X-Y coupling functions. 2 Four LEDs for assigning the LED display to the function selected via arrow keys (4): lamp brightness, motor speed for zoom, focusing and X-Y coupling.
  • Page 103 S7 / OPMI VISU 160 System Overview Version 6.0 G-30-1528-en Page 103...
  • Page 104 System Overview S7 / OPMI VISU 160 Foot control panel The foot control panel permits you to control various functions of the suspen- sion system and surgical microscope. The assignment of the functions to the buttons on the foot control panel is shown on the following pages.
  • Page 105 The joystick K is used to control the XY coupling. The default settings (focus/zoom) of the rocker switches are preconfigured Rocker switches horizontally or vertically for each country. However, ZEISS Service can change the settings at any time. The horizontal factory settings are: –...
  • Page 106 System Overview S7 / OPMI VISU 160 Version 6.0 Page 106 G-30-1528-en...
  • Page 107 S7 / OPMI VISU 160 Preparations for use Preparations for use Attaching the equipment...............110 Mounting the tube, the eyepieces and the objective lens......110 Microscope accessories, changing ............114 Connections................... 116 Connecting the light guide ..............116 Connecting the suspension system - S7 floor stand........118 Connecting the suspension system - S7 ceiling mount with rigid column ....................120...
  • Page 108 Preparations for use S7 / OPMI VISU 160 Optimizing the red reflex ................ 139 Relocating the S7 floor stand ............140 Preparing the system for sterile use ..........142 Attaching asepsis caps ................142 Applying drapes..................143 Version 6.0 Page 108 G-30-1528-en...
  • Page 109 S7 / OPMI VISU 160 Preparations for use Version 6.0 G-30-1528-en Page 109...

  • Page 110: Attaching The Equipment

    Preparations for use S7 / OPMI VISU 160 Attaching the equipment Mounting the tube, the eyepieces and the objective lens CAUTION Risk of injury caused by lowering of the surgical microscope! • Never mount or remove accessory equipment on the surgical microscope during surgery.
  • Page 111 S7 / OPMI VISU 160 Preparations for use Version 6.0 G-30-1528-en Page 111...
  • Page 112 Preparations for use S7 / OPMI VISU 160 • Insert widefield eyepieces (7) as far as they will go into the mounts (6) in- tended for them. The magnetic coupling reliably secures them in position. • Loosen friction adjustment knob (1) again and adjust the degree of friction as required.
  • Page 113 S7 / OPMI VISU 160 Preparations for use Version 6.0 G-30-1528-en Page 113...

  • Page 114: Microscope Accessories, Changing

    Preparations for use S7 / OPMI VISU 160 Microscope accessories, changing You can change the microscope accessories in reverse order to that described before. CAUTION Risk of injury! The swivel arm may move downward when accessories are changed. • Make sure that the maximum permissible load on the suspension arm is not exceeded.
  • Page 115 S7 / OPMI VISU 160 Preparations for use Version 6.0 G-30-1528-en Page 115...

  • Page 116: Connections

    Preparations for use S7 / OPMI VISU 160 Connections Connecting the light guide • Insert the end of the light guide into light guide socket (4) of the micro- scope as far as it will go and press light guide (1) into cable clips (2) and (3).
  • Page 117 S7 / OPMI VISU 160 Preparations for use Surgical microscope, shown rotated Version 6.0 G-30-1528-en Page 117...

  • Page 118: Connecting The Suspension System - S7 Floor Stand

    Preparations for use S7 / OPMI VISU 160 Connecting the suspension system - S7 floor stand NOTE Risk of tripping! Inappropriate routing of cables increases the risk of tripping. • Always run cables in a manner that will not impede the user's move- ments.
  • Page 119 S7 / OPMI VISU 160 Preparations for use Version 6.0 G-30-1528-en Page 119...

  • Page 120: Connecting The Suspension System - S7 Ceiling Mount With Rigid Column

    Preparations for use S7 / OPMI VISU 160 Connecting the suspension system - S7 ceiling mount with rigid column • Check the voltage indicated at (2). The suspension system is set at the factory to the rated voltage used in the country of destination.
  • Page 121 S7 / OPMI VISU 160 Preparations for use Version 6.0 G-30-1528-en Page 121...

  • Page 122: Connecting The Suspension System - S7 Ceiling Mount With Lifting Column

    Preparations for use S7 / OPMI VISU 160 Connecting the suspension system - S7 ceiling mount with lifting column • Check the voltage indicated at (2). The suspension system is set at the factory to the rated voltage used in the country of destination.
  • Page 123 S7 / OPMI VISU 160 Preparations for use Version 6.0 G-30-1528-en Page 123...

  • Page 124: Connecting The Strain Relief Device

    Preparations for use S7 / OPMI VISU 160 Connecting the strain relief device Use the strain relief device to prevent the connected cables from being pulled out inadvertently. • Form the cable into a loop (2). • Open flap (3).

  • Page 125: Pairing With The Wireless Foot Control Panel (Fcp-Wl)

    S7 / OPMI VISU 160 Preparations for use Pairing with the wireless foot control panel (FCP-WL) Pairing means the fixed relative assignment of the suspension system and foot control panel. It is required for wireless operation. On first-time pairing, it may take up to 20 s until the radio link between the suspension system and the foot control panel has been established.

  • Page 126: Adjusting The System - S7 Floor Stand

    Preparations for use S7 / OPMI VISU 160 Adjusting the system - S7 floor stand Balance setting of the suspension arm CAUTION Risk of crushing - mind your fingers! Fingers may be crushed in the areas marked with the "Risk of crushing" label.
  • Page 127 S7 / OPMI VISU 160 Preparations for use • Lower the surgical microscope until it can be focused on the surgical field (depending on the focal length of the objective lens), while at the same time allowing for a sufficient safety distance from the surgical field.

  • Page 128: Adjusting The System - S7 Ceiling Mount With Rigid Column

    Preparations for use S7 / OPMI VISU 160 Adjusting the system - S7 ceiling mount with rigid column Balance setting of the suspension arm CAUTION Risk of crushing - mind your fingers! Fingers may be crushed in the areas marked with the "Risk of crushing" label.
  • Page 129 S7 / OPMI VISU 160 Preparations for use • Lower the surgical microscope until it can be focused on the surgical field (depending on the focal length of the objective lens), while at the same time allowing for a sufficient safety distance from the surgical field.

  • Page 130: Adjusting The System - S7 Ceiling Mount With Lifting Column

    Preparations for use S7 / OPMI VISU 160 Adjusting the system - S7 ceiling mount with lifting column Setting an ergonomic working height CAUTION Injury to the patient! • Do not activate the lifting column during surgery! • Do not use the lifting column for focusing.
  • Page 131 S7 / OPMI VISU 160 Preparations for use Version 6.0 G-30-1528-en Page 131...

  • Page 132: Balance Setting Of The Suspension Arm

    Preparations for use S7 / OPMI VISU 160 Balance setting of the suspension arm CAUTION Risk of crushing - mind your fingers! Fingers may be crushed in the areas marked with the "Risk of crushing" label. • Do not touch these areas while the system is being moved or brought into its working / transport position.
  • Page 133 S7 / OPMI VISU 160 Preparations for use – The limit of downward travel is only effective in the lower part of the sus- pension arm's vertical movement range (starting from the arm's horizontal position). – If you wish to use the suspension arm's full range of vertical movement, lower the suspension arm as far as it will go and then firmly retighten lock- ing lever (2).

  • Page 134: Adjusting The System - General

    • Adjust the illumination intensity as required for the selected type of illu- mination and the radiation exposure time. You will find the values recom- mended by ZEISS in the table "Maximum radiation exposure times" on Page 21. • Turn on the unit at power switch (5).
  • Page 135 S7 / OPMI VISU 160 Preparations for use Version 6.0 G-30-1528-en Page 135...

  • Page 136: Adjusting The Tilt Angle

    Preparations for use S7 / OPMI VISU 160 Adjusting the tilt angle Using knob (1), you can position the surgical microscope in a range from + 90° through - 90° (+ in the direction of the surgeon and - in the opposite direction).

  • Page 137: Adjusting The Surgical Microscope

    S7 / OPMI VISU 160 Preparations for use Adjusting the surgical microscope Notes on adjustment – It is recommended to provide the interpupillary distance as well as the re- fraction values for the different users to adjust the surgical microscope more quickly and to preset the values in the scope of the preparation.
  • Page 138 Preparations for use S7 / OPMI VISU 160  Now, the microscope is adjusted in such a way that the image is sharply defined over the complete magnification range without any renewed fo- cusing during the magnification setting. If this is not the case, repeat the procedure.

  • Page 139: Optimizing The Red Reflex

    S7 / OPMI VISU 160 Preparations for use Optimizing the red reflex Optimizing on the surgical microscope For optimum visualization of the red reflex on the surgical microscope, please check that: • the objective lenses are free from contamination, • the light guide is undamaged and correctly connected, •...

  • Page 140: Relocating The S7 Floor Stand

    Preparations for use S7 / OPMI VISU 160 Relocating the S7 floor stand CAUTION Risk of crushing - mind your fingers! Fingers may be crushed in the areas marked with the "Risk of crushing" label. • Do not touch these areas while the system is being moved or brought into its working / transport position.
  • Page 141 Transport over long distances! The device may only be transported over long distances (e.g. move, returning for repair etc.) within its original packaging or in a special return packaging. • Please contact your dealer or ZEISS Service. Version 6.0 G-30-1528-en...

  • Page 142: Preparing The System For Sterile Use

    Attaching asepsis caps For sterile use, the system can be equipped with resterilizable products. The asepsis sets available from ZEISS contain caps and handgrips which can be sterilized in autoclaves. For detailed information on sterilization, please refer to the enclosed instructions "Preparation of resterilizable products" for the re- spective asepsis sets.

  • Page 143: Applying Drapes

    S7 / OPMI VISU 160 Preparations for use Applying drapes You can also use disposable sterile drapes to cover the system. When draping the system, make sure there is enough slack in the drapes to allow for move- ment of the microscope carrier and surgical microscope.
  • Page 144 Preparations for use S7 / OPMI VISU 160 Version 6.0 Page 144 G-30-1528-en...
  • Page 145 S7 / OPMI VISU 160 Operation Operation Checklist ..................146 When using a fundus viewing system (e.g. RESIGHT) .......149 Positioning the S7 floor stand ............150 Procedure ..................152 Switching the device on and off ............152 Version 6.0 G-30-1528-en Page 145...

  • Page 146: Checklist

    Operation S7 / OPMI VISU 160 Checklist For safety reasons, the device must not be used if a malfunction was noticed before the start of a procedure. • Correct the malfunction (see "What to do in the event of malfunctions“) or contact ZEISS Service.
  • Page 147 S7 / OPMI VISU 160 Operation Accessories  Further equipment of the system (illumination facility, video system, etc.) has been checked based on the respective Instructions for Use and is in proper working condition. Suspension system NOTE Impairment of lamp's function! •...
  • Page 148 Operation S7 / OPMI VISU 160 • Check that all functions assigned to the respective buttons on the foot control panel are working properly. Please observe the Instructions for Use of the foot control panel. Version 6.0 Page 148 G-30-1528-en...

  • Page 149: When Using A Fundus Viewing System (E.g. Resight)

    • When using a fundus viewing system (e.g. RESIGHT 500 or RESIGHT 700 by ZEISS), which is usually placed between the surgical microscope and the patient, make sure that the patient is neither put at risk nor injured by the motorized focusing system or the movement of the suspension system arm.

  • Page 150: Positioning The S7 Floor Stand

    Operation S7 / OPMI VISU 160 Positioning the S7 floor stand NOTE Unintentional movement of the system! Position the suspension system in such a way that you can move it away from the patient at any time. • Loosen pressed brake tabs (2) on the steerable casters.
  • Page 151 S7 / OPMI VISU 160 Operation Version 6.0 G-30-1528-en Page 151...

  • Page 152: Procedure

    • Adjust the illumination intensity as required for the selected type of illu- mination and the radiation exposure time. You will find the values recom- mended by ZEISS in the table "Maximum radiation exposure times" on Page 21. • Use the retina protection filter (blue barrier filter). It protects the patient's retina against unnecessary (blue) radiation and increases the recom- mended exposure time by factor 3.
  • Page 153 S7 / OPMI VISU 160 Operation CAUTION Risk of burns caused by light! Changing the magnification on the folding tube also changes the light inten- sity. Light can cause burn injuries. • After adjusting the magnification always check the light intensity and the illuminated-field diameter.
  • Page 154 Operation S7 / OPMI VISU 160 • Swing the surgical microscope over the surgical field into an ergonomic position within the working distance. • Press the reset button on the X-Y coupling.  The X-Y coupling moves to its center position.
  • Page 155 S7 / OPMI VISU 160 What to do in the event of malfunctions What to do in the event of malfunctions Failure of main functions ...............156 Failure of the X-Y coupling ..............156 Failure of the zoom function..............157 Failure of the focusing function ...............158 Failure of the illumination function ............159...

  • Page 156: Failure Of Main Functions

    What to do in the event of malfunctions S7 / OPMI VISU 160 Failure of main functions Failure of the X-Y coupling Failure of the X-Y coupling Motorized control of the X-Y coupling is not possible. • Position the surgical microscope by moving it manually in X and Y direc- tions.

  • Page 157: Failure Of The Zoom Function

    S7 / OPMI VISU 160 What to do in the event of malfunctions Failure of the zoom function Failure of the zoom function In the event that the zoom function can no longer be controlled via the foot control panel, adjust the zoom factor manually at the microscope.

  • Page 158: Failure Of The Focusing Function

    What to do in the event of malfunctions S7 / OPMI VISU 160 Failure of the focusing function CAUTION Risk of collision! During manual focusing of the operation field via the suspension arm, the pa- tient may be injured or mounted accessories may be damaged.

  • Page 159: Failure Of The Illumination Function

    S7 / OPMI VISU 160 What to do in the event of malfunctions Failure of the illumination function Failure of the illumination function In the event that the light intensity can no longer be controlled via the foot control panel, regulate the illumination manually at the suspension system.

  • Page 160: Lamp Failure Of The Halogen Light Source

    What to do in the event of malfunctions S7 / OPMI VISU 160 Lamp failure of the halogen light source NOTE Overheating of the lamp module! If ventilation grids are covered e.g. by drapes, this may lead to overheating of the lamp housing and deactivation of the lamp.

  • Page 161: Causes Of Malfunctions And Remedies

    S7 / OPMI VISU 160 What to do in the event of malfunctions Causes of malfunctions and remedies For your safety • This system is a high-grade technological product. To ensure optimum performance and safe working order, we recommend having it checked by our service representative as part of regular scheduled maintenance.
  • Page 162 What to do in the event of malfunctions S7 / OPMI VISU 160 Problem Possible cause Remedy Surgical field illumination on Light guide not properly in- Insert light guide as far as it Page 116 microscope not working. serted in microscope.
  • Page 163 S7 / OPMI VISU 160 Care and Maintenance Care and Maintenance Care of the device................164 Cleaning ....................164 Sterilization .....................165 Disinfection .....................165 System maintenance..............166 Maintenance intervals................166 Safety check ....................167 Replacing the halogen lamp ..............168 Disposal....................170 Version 6.0 G-30-1528-en Page 163...

  • Page 164: Care Of The Device

    • Remove dust from the optical surfaces using a squeeze blower or a clean, grease-free brush. For the regular cleaning of objective lenses and eyepieces of the surgical mi- croscope, we recommend the optics cleaning set available from ZEISS. For the catalog number, please see the section "Device data". Prevention of fogging To protect the eyepiece optics from fogging, we recommend using an anti- fogging agent.

  • Page 165: Sterilization

    • Make sure that the operating staff is briefed about the sterile operation of the system. The asepsis sets available from ZEISS contain rubber caps and hand grips that can be sterilized in autoclaves. For detailed information on sterilization, please see the enclosed instructions "Preparation of resterilizable products"...

  • Page 166: System Maintenance

    Any other maintenance activities that are not described here in detail require device-specific knowledge. Please contact your local ZEISS Service or an authorized partner for per- forming maintenance activities in due time. Interval...

  • Page 167: Safety Check

    S7 / OPMI VISU 160 Care and Maintenance Safety check CAUTION Risk of injury! Cables and plug connections may come loose and parts of the housing may become live. • Make sure that the regular technical safety checks required for this sys- tem in accordance with the applicable national regulations are performed on schedule and to the stipulated extent.

  • Page 168: Replacing The Halogen Lamp

    Care and Maintenance S7 / OPMI VISU 160 Replacing the halogen lamp NOTE Risk of burns caused by hot lamp! If you change the lamp shortly after it has failed, the lamp will still be very hot. • Allow the lamp to cool down before changing it.
  • Page 169 S7 / OPMI VISU 160 Care and Maintenance Version 6.0 G-30-1528-en Page 169...

  • Page 170: Disposal

    Care and Maintenance S7 / OPMI VISU 160 Disposal User information on the disposal of electrical and electronic devices This symbol means that the product must not be disposed of as normal do- mestic waste. The correct disposal of electrical or electronic devices helps to protect the en-...
  • Page 171 Electromagnetic immunity for ME equipment and ME systems ....187 Electromagnetic immunity for non-life-supporting ME equipment and ME systems..................188 Recommended safety distances between portable and mobile RF communication equipment and the S7 / OPMI VISU 160.....190 System combinations..............191 Version 6.0 G-30-1528-en...

  • Page 172: Technical Data

    System Data S7 / OPMI VISU 160 Technical data Surgical microscope Optics Component Features Magnification 4.3x - 25.5x motorized zoom system with apochromatic optics, 1:6 zoom ratio, magnification factor γ = 0.4x - 2.4x. Focusing Motorized, focusing range 50 mm.
  • Page 173 S7 / OPMI VISU 160 System Data Mechanics Component Features Microscope tilt mech- With self-locking control gear, manually adjustable anism via rotary knob. Tilt angle ± 90° X-Y coupling Adjustment range: max. 40 mm x 40 mm Automatic centering at the press of a button Weight Approx.

  • Page 174: Suspension Systems

    System Data S7 / OPMI VISU 160 Suspension systems Electrical data (applies to all S7 suspension systems) Component Properties Power connection Only connect the floor stand to wall outlets which are provided with a properly connected protective ground conductor. Rated voltage...
  • Page 175 S7 / OPMI VISU 160 System Data S7 floor stand Mechanics Component Features Carrier arm Length: 450 mm Swivel angle: 360° Suspension arm Length: 750 mm Swivel angle: 296° Vertical lift: +400 mm / -320 mm Coupling Swivel angle: 270°...
  • Page 176 System Data S7 / OPMI VISU 160 S7 ceiling mount with rigid column Mechanics Component Features Carrier arm Length: 450 mm Swivel angle: 296° Suspension arm Length: 750 mm Swivel angle: 296° Vertical lift: + 400 mm / - 320 mm Coupling Swivel angle: 270°...
  • Page 177 S7 / OPMI VISU 160 System Data S7 ceiling mount with lifting column Mechanics Component Features Carrier arm Length: 450 mm Swivel angle: 296° Suspension arm Length: 750 mm Swivel angle: 296° Vertical lift: + 400 mm / - 320 mm Coupling Swivel angle: 270°...
  • Page 178 System Data S7 / OPMI VISU 160 Technical data of lifting column Rated voltage 24 VDC Current consumption Vertical lift, total 350 mm Lifting force 2000 N Lifting speed 5.5 mm/sec Interval (operation / pause) 1 min / 9 min Version 6.0...

  • Page 179: Ordering Data

    System Data Ordering data Operate the device only with accessories included in the scope of delivery and recommended by ZEISS. The contact partners in charge of your country are listed on the Internet on the following website: www.zeiss.com/med For authorized ZEISS partners, the contractual product configurations, acces- sories and spare parts apply.
  • Page 180 System Data S7 / OPMI VISU 160 Eyepieces Description Cat. No. 10x push-in widefield eyepiece 305542-0000-000 12.5x push-in widefield eyepiece, asph. 305543-9901-000 The eyepieces are also available with a focusing aid (1 eyepiece with "format" reticle). Objective lenses Description Cat. No.
  • Page 181 S7 / OPMI VISU 160 System Data Ordering data for country-specific cables for S7 floor stand Description Order number Europe 000000-0301-997 000000-0147-000 000000-0400-264 Switzerland 309850-9011-000 Argentina 000000-0434-527 China 000000-0475-507 Brazil 000000-0527-730 Accessories for coobservation Description Cat. No. Stereo coobservation tube 000000-1063-869 Assistant's microscope 8°, f = 200 mm...
  • Page 182 System Data S7 / OPMI VISU 160 Foot control panels Description Order number Wired foot control panel, 14 functions 304970-9055-000 (FCP) Wired foot control panel, 14 functions 304970-9060-000 (FCP WL) Cable for foot control panel, 3 m cable length 304970-8735-000...

  • Page 183: Regulatory Information

    S7 / OPMI VISU 160 System Data Regulatory information S7 / OPMI VISU 160 Electrical safety The medical device complies with the requirements according to – IEC 60601-1:2005, – IEC 601-1:1988+A1:1991+A2:1995, – CAN/CSA-C22.2 No. 601.1-M90. Classification by level of protection against elec-...

  • Page 184: Ambient Conditions

    System Data S7 / OPMI VISU 160 Ambient conditions For operation Feature Permissible range Temperature + 10°C ... + 40°C Rel. Humidity 30% ... 75% Air pressure 700 hPa ... 1060 hPa For transportation and storage Feature Permissible range Temperature - 40°C ...

  • Page 185: Emc (Electromagnetic Compatibility)

    EMC (electromagnetic compatibility) Observe the EMC measures listed below when operating the device: • Only use spare parts approved by ZEISS for this device. • Do not use any portable or mobile RF communication equipment in the vicinity of the device as this may impair the device's function.

  • Page 186: Electromagnetic Interference

    The S7 / OPMI VISU 160 is intended for operation in an electromagnetic envi- ronment as specified below. The customer or the user of S7 / OPMI VISU 160 is responsible for ensuring that the device is operated in such an environment.

  • Page 187: Electromagnetic Immunity For Me Equipment And Me Systems

    System Data Electromagnetic immunity for ME equipment and ME systems The S7 / OPMI VISU 160 is intended for operation in an electromagnetic envi- ronment as specified below. The customer or the user of the S7 / OPMI VISU 160 is responsible for ensuring that the device is operated in such an environ- ment.

  • Page 188: Electromagnetic Immunity For Non-Life-Supporting Me Equipment And Me Systems

    Electromagnetic immunity for non-life-supporting ME equipment and ME systems The device S7 / OPMI VISU 160 is intended to be operated in one of the elec- tromagnetic environments specified below. The customer or the user of the device S7 / OPMI VISU 160 is responsible for ensuring that it is operated in such an environment.
  • Page 189 S7 / OPMI VISU 160 System Data Interference re- IEC 60601 Compliance level Electromagnetic environment - sistance test level Guidelines Tests In theory, the field strengths of stationary transmitters such as base stations for cell phones and mobile land radio equipment, amateur radio stations, AM and FM radio and TV transmitters cannot be predicted accu- rately.

  • Page 190: Recommended Safety Distances Between Portable And Mobile

    Recommended safety distances between portable and mobile RF communication equipment and the S7 / OPMI VISU 160 The device S7 / OPMI VISU 160 is intended for use in an electromagnetic en- vironment in which RF disturbances are controlled. The customer or the user...

  • Page 191: System Combinations

    S7 / OPMI VISU 160 System Data System combinations The device S7 / OPMI VISU 160 can be extended with the accessories offered by ZEISS (see ordering data/accessories) to form an already tested system. This system combination has been approved by ZEISS.
  • Page 192 System Data S7 / OPMI VISU 160 Version 6.0 Page 192 G-30-1528-en...
  • Page 193 S7 / OPMI VISU 160 Index Index Symbols +90° position ..................136 Numerics 180° tiltable tube ..................62 2° illumination ..................54 Actuator button ..................56 Adjusting lever for 6° illumination .............60 Adjusting the balance of the tilt motion ..........136 Adjusting the eyepieces ................137 Adjusting the interpupillar distance ............137...
  • Page 194 Index S7 / OPMI VISU 160 Ceiling anchor ...................13 Ceiling flange ..................86, 94 Characteristics, illumination ..............18 Checklist ....................146 Clamping screw for limiting downward movement ........74 Collision and crushing, risk of ..............82 Column .....................86 Composition, spectral ................18 Connecting the light guide ..............116 Connection panel ..................72...
  • Page 195 S7 / OPMI VISU 160 Index Field of application ..................8 Field of use ....................8 Filter selector ....................69 First use ....................13 Focus of the light source ................19 Focusing function, failure of ..............158 Foot control panel ..................104 button assignment ..............105 Friction ...................74, 76, 88, 98 Grab handle ..................72, 76...
  • Page 196 Index S7 / OPMI VISU 160 Liability and warranty ..................9 Lifting column ..................94, 96 Light guide socket ..................60 Light source ....................68 Light source, focus ..................19 Light stop selector ..................60 Light-emitting diodes ..............78, 92, 102 Limiting downward movement ..............74 Limiting the suspension arm's downward movement ....126, 128, 132 Locking tab ....................76...
  • Page 197 S7 / OPMI VISU 160 Index Regulatory information ................183 Relocating the system ................140 Remote socket ................80, 90, 100 Replacing the halogen lamp ..............168 Retinal protection device ................60 S7 floor stand ...................71 Safety check ...................167 Selector switch ...................25, 96 Setting ergonomic working height ............130 Setting up the suspension system ............134...
  • Page 198 Index S7 / OPMI VISU 160 X-Y coupling ..................50, 56 X-Y coupling, failure ................156 Yellow filter ....................24 Zoom function, failure of ................157 Version 6.0 Page 198 G-30-1528-en...
  • Page 199 S7 / OPMI VISU 160 (Blank page, for your notes . . .) Version 6.0 G-30-1528-en Page 199...
  • Page 200 Carl Zeiss Meditec AG Fax: + 49 (0)7364 - 20 4823 Goeschwitzer Strasse 51-52 E-Mail: info.meditec@zeiss.com 07745 Jena Internet: www.zeiss.com/med Germany...

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