RESIGHT 500 and 700 Instructions for Use Ver 8.1 Nov 2014

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.

•

Keep them at the site of use of the device.

•

Store them for the entire service life of the device.

•

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

–

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

–

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)

–

302721-9020-000 (RESIGHT 500)

–

OPMI®, Invertertube®, RESIGHT® and VISULUX® are registered trademarks of Carl Zeiss.

Carl Zeiss Meditec AG Goeschwitzer Strasse 51-52 07745 Jena Germany

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

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

Page 2

© Carl Zeiss Meditec AG 2014 All rights reserved. Reprints and reproductions, including excerpts, are not permissible. However, these Instructions for Use may be digitized and archived for internal use. Access to this data by third parties is not permissible and must be prevented.

Version 8.1 G-30-1695-en

RESIGHT 500 / RESIGHT 700

Contents Safety Measures Key to symbols ... 7 Hazard symbols ...7 Information symbols...8 Target group ... 8 Field of use ... 9 Intended use ...9 Normal use...9 Notes for the operator... 10 Duties of the operator ...10 Requirements to be met by the user ...11 Warranty and liability...11 Requirements for operation... 12 Before every use ...12 During use...12 After every use ...12 Safety devices... 13 Symbols and labels on the device ... 14 Labels on the RESIGHT 700 fundus viewing system...14 Labels on the RESIGHT 500 fundus viewing system...16 Labels on the adapter plates...16

System Overview General information ... 19

Version 8.1 G-30-1695-en

Page 3

RESIGHT 500 / RESIGHT 700

Components of RESIGHT 500 / 700 ... 20 Controls and connections ... 22

Preparations for use Mounting RESIGHT 500 and RESIGHT 700...25 Mounting the adapter plate and focusing unit ... 26 Removing the adapter plate and focusing unit ... 30 Configuring the foot control panel ...32 Configuration on the S8, S88 and S81 suspension systems (OPMI VISU 200 / 210 / OPMI Lumera T)... 32 Electronic control via the S8, S88, S81 suspension systems ... 33 Configuration in the OPMI LUMERA 700 for software versions 2.0, 2.5 or 3.0 ... 38 Attaching resterilizable components...40

Operation

Limiting the carrier system's downward movement ... 44 Setting up and operating RESIGHT ... 46

What to do in the event of malfunctions Failure of RESIGHT 700...61 Troubleshooting ...62 For your safety... 62 Malfunctions of the RESIGHT 700 fundus viewing system ... 62

Care and Maintenance Retrofitting the accessory port ...65

Page 4

Version 8.1 G-30-1695-en

RESIGHT 500 / RESIGHT 700

Care of the device... 65 Preparation of non-sterilizable components ...66 Preparation of resterilizable components ... 68 Basic information...68 Pre-cleaning ...69 Machine cleaning and disinfection...72 Manual cleaning and disinfection ...74 Control ...76 Maintenance ...77 Packing for sterilization...78 Sterilization ...81 Storage ...83 Use inside the sterile area ...84 Reusability ...84 Material compatibility ...84 Environmental protection measures ... 86 Disposal notes for RESIGHT 700 ...86

System Data Technical data ... 87 EMC - electromagnetic compatibility of RESIGHT 700 ... 90 Electromagnetic radiation disturbance ...91 Electromagnetic immunity ...92 Recommended safety distances ...96 Ordering data ... 97 Consumables...100 Classification ... 101 Ambient conditions ... 102

Version 8.1 G-30-1695-en

Page 5

RESIGHT 500 / RESIGHT 700

Indexes List of technical terms ...103 List of abbreviations ...103 Keyword index...105

Page 6

Version 8.1 G-30-1695-en

RESIGHT 500 / RESIGHT 700

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

Version 8.1 G-30-1695-en

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

Page 7

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 hints

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.

Page 8

Version 8.1 G-30-1695-en

RESIGHT 500 / RESIGHT 700

Safety Measures

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.

Normal use RESIGHT 500 and RESIGHT 700 are fundus imaging systems that are attached underneath the surgical microscope on the objective lens and are pivoted into the beam path of the surgical microscope. Both units enable stereoscopic imaging of the posterior segment of the eye (so-called fundus), which is required for special surgical procedures. You have the choice between the electrically controlled RESIGHT 700 fundus imaging system and the manually operated RESIGHT 500 fundus imaging system. In the electrical version, you can control the focusing function via a foot control panel. Due to the internal focus, there is no longer a need for shifting the surgical microscope in vertical direction. Therefore, for working in the anterior segment of the eye, the fundus imaging system can be slid out without causing the surgical microscope image to become blurred. You can switch between normal and wide-angle imaging by exchanging the re-sterilizable aspheric lenses on the lens holder. The system is intended for use in hospitals, clinics or other human medicine institutions. For disposal, please comply with the instructions in this manual as well as the applicable legal regulations in your country.

Version 8.1 G-30-1695-en

Page 9

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

Page 10

•

Use this instrument only for the applications described.

•

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.

•

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

•

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.

•

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

•

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

•

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.

•

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.

•

For the RESIGHT 700 fundus viewing system, please note the EMC information (electromagnetic compatibility) in the "System data" chapter on Page 90.

Version 8.1 G-30-1695-en

RESIGHT 500 / RESIGHT 700

Safety Measures

•

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 60601-1-1 or Section 16 of the 3rd edition of IEC 60601-1). 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 •

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

•

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

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.

Version 8.1 G-30-1695-en

Page 11

Safety Measures

RESIGHT 500 / RESIGHT 700

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.

•

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

•

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

•

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:

Page 12

•

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

•

Adhere to the validated parameters with each cycle.

Version 8.1 G-30-1695-en

RESIGHT 500 / RESIGHT 700

Safety Measures

•

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

Version 8.1 G-30-1695-en

1

Page 13

Safety Measures

RESIGHT 500 / RESIGHT 700

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 [as of SN 12xxx - 13999]

–

- 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 25. 3 Date of manufacturing This graphical symbol indicates the manufacturing date of the device.

4 RESIGHT 700 system label

Page 14

–

Manufacturer's symbol

–

Manufacturer name (company name)

Carl Zeiss Meditec AG

–

Manufacturer's address

Goeschwitzer Strasse 51-52 07745 Jena, Germany

–

Serial number (SN)

–

Device name

RESIGHT 700

Version 8.1 G-30-1695-en

RESIGHT 500 / RESIGHT 700

LH175 LH200

Safety Measures

–

Material number (REF)

–

CE label

5 Lens holder label These labels identify the lens holders –

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

–

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

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

1 2 3 4

5

Version 8.1 G-30-1695-en

Page 15

Safety Measures

RESIGHT 500 / RESIGHT 700

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

- Focusing unit with a new locking knob [as of SN 12xxx - 13999]

–

- 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 25. 2 "RESIGHT 500" system label

LH175 LH200

–

Manufacturer's symbol

–

Manufacturer name (company name)

Carl Zeiss Meditec AG

–

Manufacturer's address

Goeschwitzer Strasse 51-52 07745 Jena, Germany

–

Serial number (SN)

–

Device name

–

Material number (REF)

–

CE label

RESIGHT 500

3 Lens holder label These labels identify the lens holders –

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

–

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

Labels on the adapter plates 4 Adapter plate identification Adapter plates that are labeled with with all focusing units

or

can be combined

Adapter plates that are not labeled with the version number can only be combined with focusing units up to SN 11999 (see Page 25).

Page 16

Version 8.1 G-30-1695-en

RESIGHT 500 / RESIGHT 700

Safety Measures

Fig. 3: Labels on the RESIGHT 500 fundus viewing system

1

2

3

Fig. 4: Labels on the adapter plates

4

Version 8.1 G-30-1695-en

Page 17

Safety Measures

Page 18

RESIGHT 500 / RESIGHT 700

Version 8.1 G-30-1695-en

RESIGHT 500 / RESIGHT 700

System Overview

System Overview General information You have the choice between the electrically controlled RESIGHT 700 fundus viewing system and the manually operated RESIGHT 500 fundus viewing system. In the electrical version, you can control the internal focus via a foot control panel. RESIGHT 700 This version must only be used on the following surgical microscopes: –

OPMI VISU 200 / 210 (on S8, S81 and S88 suspension systems)

–

OPMI Lumera T and OPMI LUMERA 700

The electrical communication between the RESIGHT 700 fundus viewing system and the surgical microscope occurs via the "accessory port upgrade kit" that is integrated in the suspension system. The upgrade kit is installed in the suspension system by our service personnel. In addition to the control electronics, it contains an additional remote connector to control external devices. CAUTION

Risk of injury! If the switching voltage is too high or the switching current on the remote connector is too high, the housing can be live and injure operating personnel and patients. •

Use no more than 24V/0.5A for the remote connector.

RESIGHT 500 This version must only be used on the following surgical microscopes:

Version 8.1 G-30-1695-en

–

OPMI VISU 150 / 160 / 200 / 210 (on S7, S8, S81 and S88 suspension systems)

–

OPMI Lumera, Lumera T, OPMI Lumera i and OPMI LUMERA 700

Page 19

System Overview

RESIGHT 500 / RESIGHT 700

Components of RESIGHT 500 / 700 1 Adapter plate Used for permanently mounting the device on the surgical microscope. 2 Adapter plate with an attaching device for VISULUX (optional) Used for permanently mounting the device on the surgical microscope. 3 Focusing unit with internal focus Used for focusing and positioning on the surgical microscope. Focusing units exist in the following versions: –

Original focusing unit Without a label indicating the version number (up to SN 11999)

–

Focusing unit with a new locking knob With a label indicating the version number 13999]

–

[as of SN 12xxx -

Focusing unit with a new locking knob and OCT-capable optics With a label indicating the version number [as of SN 14xxxx]

The options for combining the focusing units with the adapter plates are described on Page 25. 4 Lens support (resterilizable) Used to mount and change the aspheric lens. The lens support can be turned in 30° increments to set the optimum working position. It is available in the LH175 and LH200 versions. NOTE

For correct visualization of the fundus image, the lens support must correspond to the focal length of the main objective lens. Therefore, if you use a main objective lens with a focal length of f=200 mm on the surgical microscope, you must use the LH200 lens support. If you use both lens support versions, we would recommend marking them on the sterilization packaging to avoid confusion. 5 Aspheric lenses (resterilizable) The aspheric lens is primarily selected based on the retina section to be viewed and the magnification required. For very small pupils, it may be necessary to select a lens with a higher refractive power.

Page 20

–

The green aspheric lens 60D has a refractive power of 60 diopters and is used to display the area of the fundus.

–

The yellow aspheric lens 128D has a higher refractive power and thus an enlarged viewing angle. This enables you to observe a larger area of the fundus.

Version 8.1 G-30-1695-en