SDI 4 Instruction Manual Rev 01 Feb 2020

Notes on this instruction manual The SDI® 4 has been manufactured and tested according to strict quality criteria. To ensure safe operation, it is essential that you use the device correctly. For this reason, you should thoroughly familiarize yourself with the contents of this instruction manual before operating the device. In particular, pay attention to the safety instructions. This operating manual describes the following SDI® 4 models:   

SDI® 4c SDI® 4e SDI® 4m

Due to ongoing development, the diagrams shown in the instruction manual may depict minor changes to the actual device delivered. If you have any questions or would like additional information about your device, please do not hesitate to call us or to contact us by mail or fax. Our service team will gladly assist. OCULUS Optikgeräte GmbH

OCULUS is certified according to EN ISO 13485, setting high standards of quality where development, manufacture, quality assurance and service regarding the entire range of products are concerned.

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Instruction Manual SDI® 4 (G/54320/EN 0220 Rev01)

Table of Contents

Table of Contents 1

Scope of Delivery...1

2

Graphic Symbols SDI® 4...2

3

Safety Instructions...3 3.1 3.2

About this Manual ...3 3.1.1 Used Graphic Symbols...3 Safety Instructions for Use ...4

4

Proper Use ...7

5

Description of the Unit...8

6

Functional description ...9

7

Initial Operation ... 10 7.1 7.2

8

Operation... 13 8.1 8.2

9

Preliminary Steps... 10 Attach the SDI® 4 to an Operation Microscope ... 10 Prior to each Use ... 13 Practical Tips for Use... 13

Care and Maintenance ... 14 9.1 9.2 9.3

Removing the Accessories... 14 Cleaning ... 14 Sterilization of the Rubber Cap... 15

10 Transport and Storage ... 15 11 Troubleshooting... 15 12 Guarantee and Service... 17 12.1 Assumption of Liability for Functions and Damage ... 17 12.2 Manufacturer’s and Service Addresses... 18 13 Disposal of Used Devices... 18 14 Order Information, Accessories and Replacement Parts... 19 15 Technical Data ... 20 15.1 Datasheet for plug-in power supply unit GEM12I 09-P1J (54905)... 23

Instruction Manual SDI® 4 (G/54320/EN 0220 Rev01)

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Table of Contents

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Instruction Manual SDI® 4 (G/54320/EN 0220 Rev01)

1 Scope of Delivery

1

Scope of Delivery SDI® 4

Product (versions) 

SDI® 4m with two protective dust covers and transportation lock

54302



SDI® 4m (Leica Version) with two protective dust covers and transporting lock

54312



SDI® 4e with two protective dust covers and transportation lock

54300



SDI® 4e (Leica Version) with two protective dust covers and transportation lock

54310



SDI® 4c with two protective dust covers and transportation lock

54320



SDI® 4c (Leica Version) with two protective dust covers and transportation lock

54330

Accessories for each SDI® 4 

Sterilisable rubber cap

54335



Hexagon screw driver

05490061



Plastic carrying case with liners



Instruction Manual



Conditioning Instructions

G/54320/EN/... G/55185/xxxx/en

Accessories for SDI® 4c and SDI® 4e 

For SDI® 4c only: Cable duct usable with steam autoclave

54178



Optional: Plug-in power supply GEM12I 09-P1J

54905



Optional: extension cable for voltage power supply plug (approx. 5 m)

54898

Required accessories:   

Combination foot switch SDI® 4c Footswitch for SDI® 4e Optional: extension cable to SDI® 4e foot switch (aprrox. 5 m)

54881 54883 54885

We reserve the right to make changes to deliverables as a part of any technical improvements.

Instruction Manual SDI® 4 (G/54320/EN 0220 Rev01)

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2 Graphic Symbols SDI® 4



If transport damage is discovered from the shipment, please file a complaint with the shipping company immediately.  Have the damage confirmed on the bill of lading so that an orderly handling of the complaint for damages is possible.

2

Graphic Symbols SDI® 4 2

1

3 4 5 6

12 11 13 10 1 2 3/5 4 6

Company logo + manufacturer CE marking UDI number Matrix Disposal in household trash is prohibited (SDI® 4c and SDI® 4e only 7 Protection class (SDI® 4c and SDI® 4e only) Fig. 2-1: Example: Graphic Symbols SDI® 4e

9

8

7

8 9 10 11 12

Power supply Date of manufacture Serial number of the device Reference number Name of device

13

Heed Instruction Manual

Pictograms on the packaging Keep dry

Transport

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Permitted temperature range for transport

up

Storage

fragile

Permitted temperature range for storage

Instruction Manual SDI® 4 (G/54320/EN 0220 Rev01)

3 Safety Instructions

3

Safety Instructions

Attention All safety-related instructions for use of the SDI® 4 are given in the Instruction Manual for the unit. It is therefore imperative that you read and understand the whole Instruction Manual before you use the SDI® 4.

3.1

About this Manual 

Carefully read through the Instruction Manual.  Make sure to keep the instruction manual in a safe place and available to operating personnel at all times.  Observe the legal regulations with regard to accident prevention.

3.1.1

Used Graphic Symbols

Attention Denotes a potentially hazardous situation which can easily result in minor physical injury or property damage.

Note

☞

Denotes situations which could result in incorrect findings, denotes user instructions and useful or other important information.

Denotes important information about the product and its use, which require special attention.

Instruction Manual SDI® 4 (G/54320/EN 0220 Rev01)

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3 Safety Instructions

3.2

Safety Instructions for Use Attention Risk of personal injury or property damage due to improper operation 

Observe the following safety instructions.

Risk of personal injury or property damage due to equipment modifications that could jeopardize safety 

This equipment may not be modified without the permission of the manufacturer. Changes or modifications may only be made by OCULUS Service and authorized dealers.

Instructions for operating personnel 

Ensure that the SDI® 4 is used only by duly trained physicians and operating theatre personnel, who, due to their training or their knowledge and practical experience, can guarantee proper handling of the device. Only OCULUS or an authorized dealer is allowed to train the personnel.

Transport and storage instructions Refer to the notes in sect. 10, page 15. Instructions for setup and connection   



 

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Only OCULUS, an authorized dealer or trained personnel are allowed to setup and connect the SDI® 4. Comply with the legal provisions in force in your country, and with the hygiene and waste disposal regulations of the hospital or clinic. Set up the SDI® 4 so that the power plug is easy to access. That way, you can easily disconnect it from the power supply for any repairs or maintenance work. Do not use excessive force to plug in the electrical plugs for the OCULUS BIOM® 5. If you are unable to make a plug connection, check whether the plug fits the socket. If you find damage to the plug connector, have the damage corrected by our service department. Heed unconditionally the operating in-structions and safety advice of the operating microscope and of the additional equipment. Familiarize yourself with all safety features and devices before you put the unit into initial operation.

Instruction Manual SDI® 4 (G/54320/EN 0220 Rev01)

3 Safety Instructions

Operation and Maintenance Information      



Before initial operation: Let OCULUS or an authorized dealer train you in the operation of the SDI® 4. Never operate a damaged SDI® 4. Inform the supplier of any damage. Only operate the SDI® 4 with the original accessories supplied by us and only when the unit is in a technically perfect condition. Only operate the equipment after your have read and understood the Instruction Manual. Do not touch the patient and the device at the same time. If a malfunction occurs that you cannot rectify by following in the instructions in the troubleshooting table (sect. 11, page 15), you must not use the device. Clearly mark the unit as non-operational and get in touch with our service personnel. The sterilisable rubber cap for the adjusting knob of the SDI® 4 must be sterilised before the first and before each subsequent use. It is imperative that you heed the cleaning, disinfection and sterilisation instructions given in the Conditioning Manual. A sterilisation of the SDI® 4 is not possible.

Instructions for disassembly and disposal 

When disconnecting electrical connections, pull on the respective plug and not on the cable itself. Take hold of the plug, do not pull on the cable.  Dispose of the equipment in compliance with the corresponding legal requirements. Comply with the hygiene and disposal regulations of the hospital or clinic. Patient environment information Patient environment is the area where patients can come into contact with any part of a medical electrical equipment (ME equipment) or with another person being in contact with the ME equipment. In the patient environment, use devices that conform to IEC 60601-1. If a multiple power socket is to be used, or if a device is to be used that does not meet the IEC 60601-1 standard, use an isolating transformer.

Instruction Manual SDI® 4 (G/54320/EN 0220 Rev01)

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3 Safety Instructions

EMC and Electrical Safety Information The SDI® 4c, a connected BIOM® 5 and a microscope constitute a Medical Electrical System (ME System) in accordance with DIN EN 60601-1. If you connect any more devices, they too become part of the ME System. 

Make sure that all devices of the ME System meet the provisions of IEC 60601-1 or of IEC 60950-1

Use the plug-in power supply unit included in the scope of delivery.

Attention Use of a Multiple Socket Extension Cord Risk of personal injury or material damage caused by unsafe multiple socket extension cord If you use a multiple socket extension cord to connect the SDI® 4 to the power supply, you must heed the following information: 

Use a multiple socket extension cord that complies with the requirements of DIN EN 60601-1:2005 section 16.  Do not place the multiple socket extension cord on the floor.  Do not use more than one multiple socket extension cord.  Plug only the SDI® 4 into this multiple socket extension cord. If you use a multiple socket extension cord, it must be supplied with power via an isolating transformer. Electromagnetic Compatibility (EMC / Cables) Risk of personal injury or damage to property due to electromagnetic interference Portable and mobile HF communications appliances (high frequency) can affect medical, electric equipment. 

Make sure that portable and mobile RF communications equipment do not cause interference.  Recommendation: Maintain a minimum distance of 4 m. If the distance is shorter, you must ensure that the SDI® 4 functions correctly.

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Instruction Manual SDI® 4 (G/54320/EN 0220 Rev01)

4 Proper Use

4

Proper Use These stereoscopic diagonal inverters SDI® 4m/4e/4c reverse the picture of indirect monitoring systems (BIOM® 5, wide-angle contact lenses) true to side for the human eye during minimal invasive posterior segment surgery. The device must only be used by duly trained physicians and operating theatre personnel, who, due to their training or their knowledge and practical experience, can guarantee proper handling of the device. Only OCULUS or an authorized dealer is allowed to train the personnel. The SDI® 4 is designed for use in hospitals and clinics in conjunction with the appropriate operation microscopes. These operation microscopes must have been designated as adaptable by the company OCULUS Optikgeräte GmbH. 

Make certain that the following connection types are used for the power supply.

Contraindication not known

Instruction Manual SDI® 4 (G/54320/EN 0220 Rev01)

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5 Description of the Unit

5

Description of the Unit

1

8 7 6

2

5

4 1 Top dust cover 2 Transporting lock for star knob 3 Star knob 4 SDI® 4e Fig. 5–1: Unit Components SDI® 4e

3

5 Bottom dust cover 6 Indicator lamp 7 Connection for a foot switch (optional) 8 Power supply connection

1

9 8 7

2

6 5

4 1 Top dustcover Transporting lock for star knob 3 Star knob 4 SDI® 4c 5 Bottom dust cover Fig. 5–2: Unit Components SDI® 4c

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6 7 8 9

3

Indicator lamp Connection for a foot switch Power supply connection BIOM® 5c connection, pivotable

Instruction Manual SDI® 4 (G/54320/EN 0220 Rev01)

6 Functional description

6

Functional description The SDI® 4 (Stereoscopic Diagonal Inverter) is used to reinvert images, e.g. that of a BIOM® 5 or a wide angle contact lens. SDI® 4e/4c On the SDI® 4e/4c, the image can be inverted by pressing an optional foot switch. You can also operate the inverting optics manually with the star knob. You can recognize the position of the optical system by the indicator light. If it is illuminated, the optic system and the image inversion feature are activated. If adjusting mechanically by hand when the electric power switch is turned on, turn the star knob clockwise until you feel it click into position. The indicator lights up shortly before the final position is reached. For SDI® 4c only If you are using the SDI® 4c in conjunction with the BIOM® 5c, the image inversion function is controlled by the position of the BIOM® 5c. When the BIOM® 5c is swung into the vertical working position, a position switch on the BIOM® 5c activates the SDI® 4c. The SDI® 4c is automatically deactivated when the BIOM® 5c is swung out of the beam path. Respectively, you can control the SDI® 4c with the combination foot switch. SDI® 4m Image inversion with the SDI® 4m can take place only by mechanical adjustment with the star knob. You can recognize the position of the optical system by the indicator in the transparent glass. It is centrally located on the front of the SDI® 4m, just to the left of the star knob. If the sight glass is completely yellow, the image erection is not active.

Instruction Manual SDI® 4 (G/54320/EN 0220 Rev01)

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7 Initial Operation

7

Initial Operation

Attention Risk of incorrect use due to improper training 

7.1

Preliminary Steps   





7.2

Before initial operation: Let OCULUS or an authorized dealer train you in the operation of the SDI® 4.

Remove the plastic carrying case from its packing and dispose of the packing properly. Make sure that the sterilisable rubber cap has been cleaned, disinfected and sterilised before the first and every subsequent use. Keep the plastic case and the transport lock for the star knob. If you want to store the SDI® 4 for a longer period of time or if you want to transport it, or if you have to return it for service or repair, this can only be optimally done in the plastic case with special insert and with the transport lock for the star knob. Like the operation microscope, the SDI® 4 is part of an optical unit. Handle the equipment with care. Do not expose the equipment to vibrations, knocks, soiling and high temperatures (above 35°C). Before assembling the unit, remove both protective dust covers and the transporting lock for star knob. Keep the two dust covers for proper dust protection later, in case you have to dismantle the SDI® 4 at some point.

Attach the SDI® 4 to an Operation Microscope

1

1 Locking screw Fig. 7–1: Before the installation of the SDI® 4



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Always take care when mounting or removing the SDI® 4 that none of the optics in the beam path become soiled.

Instruction Manual SDI® 4 (G/54320/EN 0220 Rev01)

7 Initial Operation

 







 

Whilst protecting the binocular tube from falling down, please unscrew the locking screw on the main body of the microscope (1). The SDI® 4 is generally mounted below the beam splitter. To do so, remove the binocular tube, including the beam splitter from the body of the microscope. On some microscopes, the beam splitter is fully integrated into the microscope, in which case you then have to mount the SDI® 4 above the beam splitter. Place the flange of the SDI® 4 into the dovetail receptacle of the main body of the microscope. Check that the SDI® 4 is properly seated before carefully tightening the locking screw of the main body of the microscope. When properly mounted, the SDI® 4 should not wobble. Make sure of this before attaching the other microscope components. Proceed in the same manner when mounting the beam splitter, the binocular eyepiece and other components of the microscope; Carefully tighten the hexagon socket set screw of the SDI® 4 (Fig. 7– 2, page 12, pos. 2) in the same way with the included hexagon screw driver and then make sure that each component is correctly seated. Before connecting the electrical versions of the SDI® 4 to the power supply, check to see whether the power supply voltage is within the voltage range given on the rating plate. This is guaranteed if the plug-in power supply unit provided by OCULUS is used. Make sure that the voltage supply in the mains socket is within the voltage range of the plug-in power supply unit. When connecting the hand or foot switch, please do not join the electrical plug-and-socket connections by excessive force. After inserting the plugs into the corresponding sockets (Fig. 7–2, page 12, items 3 and 4), lock them in place by turning the threaded connector (milled sleeve).

Instruction Manual SDI® 4 (G/54320/EN 0220 Rev01)

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7 Initial Operation

Connector SDI® 4c     

Make sure that the plugs are plugged into the appropriate jacks or sockets. Plug the plug for the foot switch into the 5-pole jack (3). Plug the power supply plug (6V-15V) into the 3-pole jack (4). After plugging in the plug, secure it by turning the screw connectors (knurled bushings). If you want to connect the SDI® 4 to a BIOM® 5c: Plug the BIOM® 5c plug into one of the rotating, 4-pole jacks (2).

Caution The SDI® 4c is connected to the BIOM® 5c solely via the 4-pole jacks (2).

4 1 2 3

1 Set screw of the SDI® 4 3 Plug for the combination foot switch 2 Connection jack for the BIOM® 5 4 Connection jack for power supply Fig. 7–2: Example: SDI® 4c at the microscope

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Instruction Manual SDI® 4 (G/54320/EN 0220 Rev01)

8 Operation

8

Operation

8.1

Prior to each Use Before each use, check that the unit is in technically perfect condition  all connections and fasteners that can be loosened are properly tightened and are in a safe condition  all cables and plugs are free of damage  the unit is connected to a proper power supply (SDI® 4c and SDI® 4e).  All electric functions are operational: - SDI® 4 on/off (SDI® 4e and 4c) - BIOM®-focussing up, BIOM®-focussing down (SDI® 4c)  the rubber covering for the adjustment button of the SDI® 4c is supplied and sterile.  Adjust the binocular tube to as comfortable a position as possible. 

8.2

Practical Tips for Use 

To adjust the optical system of the SDI® 4: Briefly press the foot switch. The optic system then moves to its other position.  Always activate the SDI® 4 if you are using optical inversion, e.g. BIOM® or an indirect vitrectomy lens. When the unit is activated, the indicator lamp at the SDI® 4c and SDI® 4e lights up. The indicator remains empty on the SDI® 4m.  If you are using non-inverting optics, usch as e.g. a Kilp contact lens, or if you have swung out the BIOM®, you must deactivate the inverting optics of the SDI® 4. The indicator light of the SDI® 4c and SDI® 4e is not illuminated in this case, and is yellow on the SDI® 4m and shows “0“.

Instruction Manual SDI® 4 (G/54320/EN 0220 Rev01)

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9 Care and Maintenance

9

Care and Maintenance Cleaning of the SDI® 4 is described in this chapter. Disinfection is not necessary. Sterilisation of the SDI® is not possible; only the rubber cap of the star knob on the SDI® 4 can be sterilised. 

9.1

Heed the product descriptions and instruction manuals of products and equipment you use to care for, clean, and disinfect the unit and/ or its accessories.

Removing the Accessories 

Pull the rubber cap off the star knob.  When disconnecting electrical connections: Do not pull on the cable, but pull the respective plug or loosen the screw connectors. To do so, take hold of the respective plug.  To disconnect the hand or foot switch: Loosen the screw connector of the plug at the connecting cable and pull the plug out of the jack.

9.2

Cleaning Attention Risk of electric shock if the SDI® 4 is not completely disconnected from the power supply for these jobs. 

Before cleaning the SDI® 4, disconnect it from the power supply.

Required Materials 

Damp cloth (distilled water)

Cleaning intervals Whenever necessary Cleaning the Housing 

☞

Clean only the exterior surfaces of the unit with a damp cloth.  Do not clean the SDI® 4 with aggressive, chlorine-containing, abrasive or sharp cleaning agents.

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If the protective glasses are dirty, contact OCULUS Service or an authorized dealer.

Instruction Manual SDI® 4 (G/54320/EN 0220 Rev01)

10 Transport and Storage

9.3

Sterilization of the Rubber Cap If you are using the rubber cap for the star knob, it must be sterilised first. The rubber cap for the star knob of the SDI® 4 can be autoclaved with steam (max. 134°C); also refer to the Conditioning Manual.

10 Transport and Storage

Attention Equipment damage due to improper transport and storage 

Transport the SDI® 4 with care.  Store the SDI® 4 in compliance with the transport and storage conditions, the national regulations and the regulations of your hospital. Also see sect. 15, page 20. 

Avoid impacts when moving the SDI® 4 to another location, since this can have an adverse affect on the adjustments.  With the use of the transporting lock for star knob you position the optical system of the SDI® 4 in the rest position. Only then the position is fixed.  Check the unit and its accessories for damage after every transport.

11 Troubleshooting

Attention If a fault occurs which you are unable to correct by following the instructions below, label the device as “out of order” and contact our service department. (Address: sect. 12.2, page 18). 

Never operate a damaged SDI® 4.

Instruction Manual SDI® 4 (G/54320/EN 0220 Rev01)

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11 Troubleshooting

Fault list - SDI® 4 Fault

Possible cause

No function when the hand switch / foot switch is pressed



(hand-held pushbutton for SDI® 4c only optional)







Remedy

The hand switch / foot switch is not connected to the SDI® 4e/c no connection of the SDI® 4e/ c to the power supply Power failure or power socket is not active These are not active if the sockets of the stand are being used.



Establish the connection to the SDI® 4e/c



Establish the connection to the power supply Inform the in-house electrician Use the plug transformer Switch the SDI® 4 mechanically Activate the sockets in accordance with the instructions for the stand Ask the microscope manufacturer for assistance



 





The image is cropped





Unclear image



The SDI® 4 or other components are incorrectly mounted at an angle The optics of the SDI® 4 are not in operating position (locking position)



Correct the assembly



Turn it on or off again with the switch

The SDI® 4 or the optic of the BIOM® 5 are dirty



Clean the glass surface of the BIOM® 5 loupe



If the SDI® 4 optics are dirty, contact OCULUS Service or your authorized dealer.

The SDI® 4 or its fixtures wobble



The locking screws are loose



Tighten the locking screws

Fundus view is too narrow



Distance between ophthalmoscopic lens and eye too large (only when using



Carefully reduce the distance using the microscope fine adjustment mechanism

BIOM® 5)

Pronounced reflections on BIOM®loupe or contact lens

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

Magnification of the microscope system to high



Reduce magnification of the microscope



The microscope light is on Bright ceiling illumination



Turn the light off, illuminate only intraocular



Instruction Manual SDI® 4 (G/54320/EN 0220 Rev01)