RESIGHT 500 and 700 Manual and Electrical Fundus Viewing System Instructions for Use Ver 11.0 June 2020

RESIGHT 500 / RESIGHT 700

About this manual

Orientation aids

Applicable area

Trademarks

Manufacturer

These Instructions for Use are part of the delivery package. •

Carefully read them before using the device.

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Keep them at the site of use of the device.

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Store them for the entire service life of the device.

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Pass them on to every subsequent owner or user of the device.

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The table of contents at the beginning of these Instructions for Use provides an overview of all subjects.

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A list of abbreviations, key words and technical terms in the annex facilitates the search for specific terms.

These instructions for use applies to devices with the following identification: –

302721-9030-000 (RESIGHT 700)

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302721-9020-000 (RESIGHT 500)

OPMI, Invertertube, RESIGHT and VISULUX is/are a trademark / trademarks or registered brand/brands of Carl Zeiss Meditec AG or other companies of the ZEISS Group in Germany and/or other countries. Carl Zeiss Meditec AG Goeschwitzer Strasse 51–52 07745 Jena Germany

Fax: + 49 (0) 7364 - 20 4823 E-mail: [email protected] Internet: www.zeiss.com/med

Subject to changes in design and scope of delivery and as a result of ongoing technical development. Printed in Germany. Copyright

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© Carl Zeiss Meditec AG 2020 All rights reserved. Reprints and reproductions - including excerpts - are not permitted. However, this user manual may be digitized and archived for internal use. Access to this data by third parties is not permitted and must be prevented.

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Contents Safety measures Key to symbols ... 7 Hazard symbols ...7 Information symbols...8 Target group ...8 Field of use ... 9 Intended use ...9 Indications...9 Normal use...10 Notes for the operator... 12 Duties of the operator ...12 Requirements to be met by the user ...13 Warranty and liability...14 Requirements for operation... 15 Before every use ...15 During use...15 After every use ...15 Safety devices...16 Symbols and labels on the device ...17 Labels on the RESIGHT 700 fundus viewing system...17 Labels on the RESIGHT 500 fundus viewing system...20 Labels on the adapter plates...22

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RESIGHT 500 / RESIGHT 700

System Overview General information...23 Components of RESIGHT 500 / 700 ... 24 Controls and connections ... 26

Preparations for use Mounting RESIGHT 500 and RESIGHT 700...29 Mounting the adapter plate and focusing unit ... 30 Removing the adapter plate and focusing unit ... 34 Configuring the foot control panel ...36 Configuration on the S8, S88 and S81 suspension systems (OPMI VISU 200 / 210 / OPMI Lumera T)... 36 Electrical controls of the S88 / OPMI Lumera T... 37 Settings on the OPMI LUMERA 700 ... 42 Attaching resterilizable components...44

Operation Limiting the carrier system's downward movement ...49 Setting up and operating RESIGHT ...52

What to do in the event of malfunctions Failure of RESIGHT 700...67 Malfunctions of the focusing function ...68 Troubleshooting ...69 For your safety... 69 Malfunctions of the RESIGHT 700 fundus viewing system ... 69

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Care and maintenance Retrofitting the accessory port ... 71 Care of the device...71 Preparation of non-sterilizable components ...72 Preparation of resterilizable components ...74 General principles ...74 Pre-cleaning ...75 Machine cleaning and disinfection...78 Manual cleaning and disinfection ...80 Control ...82 Maintenance ...83 Packing for sterilization...84 Sterilization ...86 Storage ...88 Use in the sterile area ...89 Disposal...89 Reusability ...89 Material resistance ...90 Environmental protection measures ...91 Disposal notes for RESIGHT 700 ...91

System data Technical data ... 93 EMC - electromagnetic compatibility of RESIGHT 700 ... 96 Electromagnetic radiation disturbance ...97 Electromagnetic immunity ...98 Electromagnetic immunity for non-life-supporting ME equipment and ME systems...100 Recommended safety distances ...102

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Ordering data ...103 Consumables ... 104 Approval data ...105 Ambient conditions...106

Indexes List of technical terms ...107 List of abbreviations ...107 Keyword index...109

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Safety measures

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 important information concerning matters relevant to instrument safety.

Hazard symbols The following safety information has been incorporated into the Instructions for Use. Please note this information and be particularly careful in these cases. WARNING

Indicates a hazard which can lead to death or severe injury if it is not prevented.

CAUTION

Indicates a hazard which can cause minor to moderate injury if it is not prevented.

NOTE

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Indicates a hazard which can cause damage to material if it is not prevented.

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Safety measures

RESIGHT 500 / RESIGHT 700

Information symbols The following information symbols are used in these instructions for use: –

Listing

 Requirements for an action •

Prompt for action

 Result of an action Additional information and tips

Target group These Instructions for Use are intended for physicians, medical and/or technical staff and nurses who prepare, operate or maintain the system after appropriate training. It is the duty of the equipment owner/operator to train and brief all the operating staff. Service work not described in these Instructions for Use must only be performed by specialists trained by ZEISS.

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Field of use Intended use The fundus viewing system is an accessory for surgical microscopes which is used for surgery on the posterior segment of the eye. It is used for stereoscopic imaging of the posterior segment and the retina.

Indications Information on the indication of use, contraindications and the target patient group is set out in the following table.

Indication of use

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Medical discipline:

Ophthalmology

Indication:

The main applications for the RESIGHT 500 / 700 fundus viewing system comprise all eye surgery procedures performed on the posterior segment of the eye. The fundus viewing system is used for all surgical procedures requiring visualization of the posterior eye segment (e.g. the vitreous body) and / or the fundus, such as retinal detachment, macular membranes or holes, glasslike opacity, etc.

Contraindication:

Provided that the RESIGHT 500 / 700 fundus viewing system is used within its indication of use, there are no known contraindications.

Patient target group:

No restrictions

Age:

No restrictions

Gender:

All

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Safety measures

RESIGHT 500 / RESIGHT 700

Normal use The RESIGHT 500 und RESIGHT 700 are intended exclusively for ophthalmic surgical procedures in the posterior eye segment. The fundus viewing system is mounted on the objective lens below the surgical microscope, and is swiveled into the beam path of the surgical microscope. The RESIGHT 700 is an electric powered fundus viewing system. The RESIGHT 500 is a fundus viewing system which can be operated manually. Both devices (the manual and electric versions) enable the steroscopic viewing of the posterior eye segment (known as the fundus) that is required for special surgical methods. The complete system comprises a focusing unit which is fitted on the surgical microscope using a dovetail mount and consists of a sterilizable lens support with sterilizable aspheric lenses and sterilizable asepsis caps for the focus buttons on the focusing unit. The device is intended for use in hospitals, clinics or other medical facilities for humans. Before surgery: A sterile person opens the product's sterile packaging and fits the sterile parts, i.e. the lens support, aspheric lenses and sterile asepsis caps for the focusing buttons, on the part of the product that remains mounted on the microscope (focusing unit). A surgical assistant then positions the product over the patient's eyes by positioning the surgical microscope on which the product is mounted so that it is ready for surgery. During surgery: The focus for the fundus viewing system can be controlled manually using the rotary knobs on each side. With the electric version, the focusing function can also be controlled via the foot control panel. The internal focus ensures that the surgical microscope no longer needs to be moved vertically. Accordingly, when working on the anterior segment of the eye, you can push the fundus viewing system out of the way without causing any blurring of the images viewed through the surgical micorscope. In order to obtain different magnifications and fields of view, the surgeon or surgical assistant can switch between normal view or wide angle view by changing the resterilizable ophthalmoscopy lenses in the lens support.

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After surgery: Once the procedure is finished, the surgeon swings the microscope, together with the products mounted on it, out of the operating area into the parked position. The sterile parts of the product, such as the lens support, aspheric lenses and sterile caps can be removed from the product by a sterile person and resterilized. The part of the product that remains on the microscope (focusing unit) can be cleaned and disinfected. The sterilizable aspheric ophthalmoscopy lenses are fitted on the swiveling lens support mechanism of the sterilizable lens support, and can both be mounted opposite each other at an angle of 180°. During surgery on the posterior segment of the eye, the surgical assistant can adjust the magnification of the surgical area by turning the lens rotator through 180° so as to switch to the other aspheric lens which has a different magnification or other characteristics for special patient requirements, e.g. if the eyes are small or deep-set. After surgery the aspheric lens is removed from the lens rotator and reprocessed separately.

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Safety measures

RESIGHT 500 / RESIGHT 700

Notes for the operator The correct use of the system is absolutely vital for safe operation. Therefore, please thoroughly familiarize yourself with the contents of these Instructions for Use before starting up the system. Please also observe the respective Instructions for Use of any additional equipment.

Duties of the operator • Use this instrument only for the applications described. CAUTION

Risk of infection due to non-sterile accessories! The patient or user may become contaminated if sterile accessories are not used. •

CAUTION

The products contained in the asepsis sets must be cleaned, disinfected and sterilized before each use. This also applies to the first use after delivery.

Live current in device housing! If either the user or the patient come in contact with the device housing while it is under a live current, this may result in paralysis of the muscles in the heart or extremities. Additional devices may only be connected if they meet the relevant IEC or ISO standards.

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Check that the connecting components which are relevant to system safety (details in the instructions for use) have been properly connected and that screw connections have been firmly tightened.

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For further information on the operation of the surgical microscope and the suspension system used, please see the relevant instructions for use.

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This device must not be modified without the manufacturer's approval. If the instrument is modified, suitable inspections and testing must be completed to ensure that it can still be used safely.

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Observe the legal regulations for accident prevention and occupational health and safety applicable in the country concerned.

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Use suitable packaging only to transport the instrument over longer distances (e.g. relocation, return for repair, etc).

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When mounting this accessory, please make sure that the admissible total weight of the surgical microscope is not exceeded. Detailed information can be found in the user's manual of the respective surgical microscope.

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Please ensure that sufficient space is available for focus positioning when the RESIGHT 500 or RESIGHT 700 fundus viewing system is mounted on the surgical microscope.

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For the RESIGHT 700 fundus viewing system, please note the EMC information (electromagnetic compatibility) in the "System data" chapter on page 96.

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If a serious incident occurs in connection with this medical device affecting the operator or another person, the operator (or person responsible) must report it to the manufacturer or seller of the medical device. In the European Union, the operator must report serious incidents of this kind to the competent authority in his or her country.

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Additional equipment which you connect to medical electrical devices must demonstrably comply with the applicable IEC or ISO standards (e.g. IEC 60950 for data processing equipment). In addition, all configurations must meet the normative requirements for medical systems (see IEC 60601-1, section 16). Anyone connecting additional equipment to medical electrical devices is a system configurer and as such responsible for compliance of the system with the normative requirements for systems. Please note that local legislation takes priority over the above-mentioned normative requirements. If you have any questions, please contact your local dealer or ZEISS Service.

Requirements to be met by the user

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This device must only be used by properly instructed and trained personnel. It is the duty of the customer or institution operating the equipment to train and instruct all staff using it.

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Please keep these Instructions for Use where they are easily accessible at all times for the persons operating the system.

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Safety measures

RESIGHT 500 / RESIGHT 700

Warranty and liability Warranty and liability depend on the applicable contractual stipulations. NOTE

Loss of warranty The manufacturer is not liable for damage caused by unauthorized persons tampering with the system. Furthermore, this will forfeit any rights to claim under warranty.

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Requirements for operation  The connecting components have been properly connected. The screw connections have been firmly tightened.  All cables and plugs are in perfect condition.

Before every use •

Make sure that all requirements specified above are fulfilled.

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Please check that the RESIGHT fundus viewing system can be easily moved in and out.

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Ensure that the lens holder can be properly moved into and out of position.

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If you have mounted the RESIGHT fundus viewing system on the underside of the microscope and steeply tilt the microscope, the RESIGHT fundus viewing system may unintentionally move in and injure the patient. Remove the RESIGHT fundus viewing system before steeply tilting the microscope.

During use

After every use Please note the following general guidelines within your area of responsibility for the sterility of the products during use:

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Use only procedures validated by ZEISS to clean, disinfect and sterilize.

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Adhere to the validated parameters with each cycle.

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Safety measures

RESIGHT 500 / RESIGHT 700

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Disinfect, clean and sterilize the instrument in accordance with this user's manual. Insufficient, incorrect or wrong preparation can lead to infections in the patient or medical staff.

Safety devices 1 Focusing unit locking screw This screw is used to secure the focusing unit on the adapter plate of the surgical microscope. Fig. 1: Safety devices

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1

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Safety measures

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 illegible, please contact us or one of our authorized representatives. We will supply a replacement.

Labels on the RESIGHT 700 fundus viewing system 1 Observe disposal regulations Electrical or electronic devices must not be disposed of as normal domestic waste. For more information on the disposal of electrical and electronic devices, please see the chapter on "Maintenance and care." 2 Focusing units identification –

- Focusing unit with a new locking knob and OCT-capable optics [as of SN 14xxx and higher]

The options for combining the focusing units with the adapter plates are described on page 29. 3 UDI label

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MD labeling

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Date of manufacture

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Machine readable label (barcode)

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UDI device identifier (UDI-DI)

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UDI production identifier (UDI-PI)

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Safety measures

RESIGHT 500 / RESIGHT 700

4 RESIGHT 700 system label

LH175 LH200

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Manufacturer's symbol

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Manufacturer name (company name)

Carl Zeiss Meditec AG

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Manufacturer's address

Goeschwitzer Strasse 51–52 07745 Jena, Germany

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Serial number (SN)

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Device name

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Material number (REF)

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CE label

RESIGHT 700

5 Lens holder label These labels identify the lens holders –

LH175 for the main objective lens with focal length f = 175 and

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LH200 for the main objective lens with focal length f = 200

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Fig. 2: Labels on the RESIGHT 700 fundus viewing system

1 2 3 4

5

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Labels on the RESIGHT 500 fundus viewing system 1 Focusing unit identification –

- Focusing unit with a new locking knob and OCT-capable optics [as of SN 14xxx and higher]

The options for combining the focusing units with the adapter plates are described on page 29.

2 UDI label –

MD labeling

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Date of manufacture

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Machine readable label (barcode)

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UDI device identifier (UDI-DI)

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UDI production identifier (UDI-PI)

3 "RESIGHT 500" system label

LH175 LH200

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Manufacturer's symbol

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Manufacturer name (company name)

Carl Zeiss Meditec AG

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Manufacturer's address

Goeschwitzer Strasse 51–52 07745 Jena, Germany

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Serial number (SN)

–

Device name

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Material number (REF)

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CE label

RESIGHT 500

4 Lens holder label These labels identify the lens holders –

LH175 for the main objective lens with focal length f = 175 and

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LH200 for the main objective lens with focal length f = 200

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