BIOM 5 Instruction Manual Oct 2017

Notes on this Instruction Manual The BIOM® 5 combines an ophthalmoscope with a surgical microscope. It allows the vitreous cavity to be viewed under stereoscopic conditions, with optimal image quality, with up to 125° non corneal-contact observation of the fundus. The BIOM® 5 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 BIOM® 5 models:  

BIOM® 5c and 5cl (long version) BIOM® 5m and 5ml (long version) Except for the difference in length, the respective long version is identical with respect to handling and features. The long versions should be used at microscope focal lengths of f=200 mm

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 contact us by mail or fax. Our service team will gladly assist. OCULUS Optikgeräte GmbH

OCULUS is certified according to DIN 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 BIOM® 5 (G/55400/1017/en)

Table of Contents

Table of Contents 1

Scope of Delivery...1

2

BIOM® 5 Symbols...2

3

Structure of the Documentation ...3

4

Safety Instructions...4 4.1 4.2

About this Manual ...4 4.1.1 Used Graphic Symbols...4 Safety Instructions for Use ...5 4.2.1 Instructions for Use...6

5

Intended Use...7

6

Device Description ...8 6.1

Mode of Operation of the BIOM® 5...9

7

Transport and Storage ... 10

8

Initial Operation ... 10 8.1 8.2

9

Before Initial Operation... 10 Before First Use... 10

Use of the BIOM® 5... 11 9.1 9.2 9.3 9.4 9.5 9.6 9.7 9.8 9.9

Choose the Appropriate Optics... 11 Mounting the BIOM® 5... 12 Under Sterile Conditions: Test the Safety Functions... 15 Connect the BIOM® 5 to the Microscope... 16 Swing the BIOM® 5 to the Parked Position ... 18 Make the Basic Settings at the Microscope ... 18 Instructions for Focussing the BIOM® 5m/ml ... 19 During the Surgery... 20 After the Surgery ... 20

10 Troubleshooting... 23 11 Change the Drive Module... 26 12 Cleaning, Sterilisation and Maintenance ... 26 13 Disposal of Used Devices... 26 14 Guarantee and Service... 27 14.1 Assumption of Liability for Functions and Damage ... 27 14.2 Manufacturer and Service Address ... 28 15 Declaration of Conformity... 29 16 Order Information, Accessories and Replacement Parts... 30 16.1 16.2 16.3 16.4

Components for the BIOM® 5... 30 Sterilisation Components... 32 Image Reversal Systems ... 32 Connection Components ... 32

17 Technical Data ... 33

Instruction Manual BIOM® 5 (G/55400/1017/en)

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Table of Contents

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Instruction Manual BIOM® 5 (G/55400/1017/en)

1 Scope of Delivery

1

Scope of Delivery BIOM® 5c Component

Order no.

BIOM® 5c    

Version BIOM® 5c Version BIOM® 5cl Sterilisable drive belts (10 of) Sterilisable cable duct (1 of)

55400 55403

BIOM® 5m  

Version BIOM® 5m Version BIOM® 5ml



Instruction Manual Conditioning Instructions



Box with cover



55462 55463 G/55400/xxx/en G/55185/xxx/en

Additional components needed for BIOM® 5 Needed Supplementary Components

see

Reduction lens and front loupe

sec. 9.1, page 11

Adaptor for surgical microscope (if necessary, with additional adaption modules)

sec. 16.1, page 30

Stereoscopic diagonal inverter for erecting the image

sec. 16.3, page 32

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

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.

Instruction Manual BIOM® 5 (G/55400/1017/en)

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2 BIOM® 5 Symbols

2

BIOM® 5 Symbols

1

2

3 13 12 11

4

10

5

8 7

9

6

1 2 3 4 5 6

Company logo + manufacturer CE marking Heed Instruction Manual UDI-Nummer Matrix Disposal with household waste is prohibited (BIOM® 5c and BIOM® 5cl only) 7 Protection class (BIOM® 5c and BIOM® 5cl only) Fig. 2-1: Examples: BIOM® 5ml and BIOM® 5 symbols

1

8 9 10 11 12 13

Applied part of the type B (BIOM® 5c and BIOM® 5cl only) Power supply voltage Date of manufacture Serial number of the device Reference number Name of device

2

13

3

12

4

11

5

10

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Instruction Manual BIOM® 5 (G/55400/1017/en)

3 Structure of the Documentation

3

Structure of the Documentation The following documents are supplied with the BIOM® 5: 

Instruction Manual: The design of the unit is described in detail in this document. You will also find all safety-related information for use of the BIOM® 5.

Attention All safety-related instructions for use of the BIOM® 5 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 BIOM® 5.



Conditioning Instructions: These conditioning instructions explain how to condition the BIOM® 5. They apply for the various models and accessories of the BIOM® 5. You will also find an itemized list of the articles concerned.

Instruction Manual BIOM® 5 (G/55400/1017/en)

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4 Safety Instructions

4

Safety Instructions

4.1

About this Manual 

Carefully read through the instruction manual.  Keep the instruction manual in good condition, near to the device.  Please read the separate operating instructions for the SDI® 4 and accessories.  Please read the special packing notice included with the adaptor and accessories.

4.1.1

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.

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

Instruction Manual BIOM® 5 (G/55400/1017/en)

4 Safety Instructions

4.2

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.

Instructions for operating personnel Ensure that the BIOM® 5 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 sec. 7, page 10. Instructions for setup and connection 

Comply with the legal provisions in force in your country, and with the hygiene and waste disposal regulations of the hospital or clinic.  Never mount and dismount the BIOM® 5 over the patient.  Assembly of the holder and instruction in the use of the BIOM® 5 and its accessories will be undertaken by an OCULUS employee or by a duly authorized OCULUS representative.  BIOM® 5c and BIOM® 5cl: Do not use excessive force to connect the electrical connectors to the OCULUS SDI® 4c or BIOM® connecting spacer. If connection is not possible, check whether the plug fits in the socket. If you find damage to the plug connector, have the damage corrected by our service department.

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4 Safety Instructions

Operation and maintenance information     



4.2.1

Before initial operation: Let OCULUS or an authorized dealer train you in the operation of the BIOM® 5. Never operate a damaged BIOM® 5. Only operate the BIOM® 5 using original accessory parts supplied by us, and when the device is in technically perfect working order. Only operate the equipment after your have read and understood the instruction manual. The BIOM® 5 and all sterilisable BIOM® 5 components must be sterilised:  Before the first use  After every use It is imperative that you heed the cleaning, disinfection and sterilisation instructions given in the conditioning manual.

Instructions for Use

Attention Risk of eye damage if the working distance between the BIOM® 5 and the patient changes When the BIOM® 5 is swung into the working position (into the beam path), the following instructions must be followed: 







Do not use the coarse adjustment knob at the microscope stand to adjust the height. Do not adjust the height of the stand arm, either by motor or manually, over the surgical area. Do not change the patient’s position by adjusting the height of the operating table. Pay attention to the focussing instructions, sec. 9.7, page 19. More information can be found in the Application tips: BIOM® 5 and can be downloaded from the OCULUS website.

Troubleshooting 

If a fault occurs that you cannot rectify with the help of the troubleshooting table (page 23), the unit must not be used! Clearly mark the unit as non-operational and get in touch with our service personnel.

Instructions for disassembly and disposal 

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Dispose of the equipment in compliance with the corresponding legal requirements. Comply with the hygiene and disposal regulations of the hospital or clinic.

Instruction Manual BIOM® 5 (G/55400/1017/en)

5 Intended Use

EMC and electrical safety information The BIOM® 5c, a connected SDI® 4c or BIOM® connecting spacer and a microscope constitute a medical electrical system (ME system) in accordance with DIN EN 60601-1. If you connect additional devices, those devices become part of the ME system. 

Make sure that all devices of the ME system meet the requirements of IEC 60601-1 or IEC 60950-1.  Make certain that the SDI® 4 used for the power supply.

5

Intended Use This binocular indirect ophthalmomicroscope (BIOM® 5) is used for noncontact observation of surgeries in the posterior segment of the eye. The BIOM® 5 is intended for use with compatible surgical microscopes in hospitals, clinics or other institutions for human medicine The surgical microscopes must be declared as adaptable by OCULUS Optikgeräte GmbH Only operate the device using original accessory parts supplied by us, and when the device is in technically perfect working order. 

Heed the safety instructions listed above.

Contraindication 

not known

Instruction Manual BIOM® 5 (G/55400/1017/en)

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6 Device Description

6

Device Description BIOM® 5c

BIOM® 5m

1

2

3

8

4

5

6

7

1 2 3

Reduction lens (not supplied with the BIOM®) Housing with swivel mechanism Lens receptacle

Control mark Loupe holder with safety rod Ophthalmoscopy magnifying loupe (not supplied with the BIOM®) 4 Focus adjustment wheel 8 Drive module (BIOM® 5c and BIOM® 5cl only) Fig. 6-1: Device Overview, BIOM® 5 with reduction lens and ophthalmoscopy loupe

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5 6 7

Instruction Manual BIOM® 5 (G/55400/1017/en)

6 Device Description

6.1

Mode of Operation of the BIOM® 5 The BIOM® 5 is used in conjunction with an SDI (Stereoscopic Diagonal Inverter) to erect the image for non-contact, wide-angle observation of the fundus and vitreous body. If the matching OCULUS SDI® is used, full compatibility with the BIOM® 5 models is guaranteed. The combination of surgical microscope and the optical components of the BIOM® 5 allows examination of the vitreous chamber under stereoscopic conditions. The BIOM® 5 works as an indirect ophthalmomicroscope without corneal contact during the surgery. The patient’s eye ball can be moved freely during the surgery. Peripheral fundus portions are thus easy to examine. This combined optical system achieves a fundus observation of approx. 125° in total. The optical system of the BIOM® 5 consists of the reduction lens and the front loupe. The reduction lens provides a virtually constant distance between the patient’s eye and the surgical microscope when the BIOM® 5 is swung in or swung out. The reduction lens reduces the focal length of the microscope objective lens. The position of the reduction lens with respect to the surgical microscope is preset. The height adjustment of the front loupe is used for focussing the BIOM image. The distance between the surgical microscope and the front loupe is set using the adjusting wheel at the BIOM® 5. For the BIOM® 5c/cl only:

Press the combination foot switch to focus by means of the electric motor. This height adjustment of the front loupe brings the fundus image into the focal point of the microscope objective. As the image is completely reversed when the BIOM® 5 is used, optimal use is only guaranteed in conjunction with a stereoscopic diagnonal inverter (SDI®). The SDI® rights the complete image reversal and can be switched on and off as required. If a BIOM® connecting spacer is used, this serves to focus the BIOM® 5c, the image is erected by an inverter.

Instruction Manual BIOM® 5 (G/55400/1017/en)

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7 Transport and Storage

7

Transport and Storage

Attention Equipment damage due to improper transport and storage 

Transport the BIOM® 5 with care.  Store the BIOM® 5 in accordance with the transport and storage requirements, the applicable national regulations and the regulations of your hospital. See also sec. 17, page 33

8

Initial Operation

8.1

Before Initial Operation 

Remove the BIOM® 5 and its accessories from the packaging.  Clean, disinfect and sterilise the BIOM® 5 before putting it into use for the first time, sec. 12, page 26. Installation and instruction in the use of the BIOM® 5 and its accessories will be undertaken by an OCULUS employee or by an OCULUS authorized dealer.

8.2

Before First Use 

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Make sure that the BIOM® 5 and its components have been cleaned, disinfected and sterilised, also refer to the conditioning instructions

Instruction Manual BIOM® 5 (G/55400/1017/en)

9 Use of the BIOM® 5

9

Use of the BIOM® 5

9.1

Choose the Appropriate Optics 

Use the appropriate reduction lens for the surgical microscope’s objective.  Select the appropriate front loupe for the surgery. The following front loupes can be steam-autoclaved: 53603 Wide-field high definition loupe

53602 Wide-field (E) loupe

53606 Hi-res loupe

53601 Wide-field loupe for deep-set eyes

53604 90D loupe

53605 Wide Field High Definition Mini loupe

Disposable Loupe Sets Objective Lens

BIOM® Model

BIOM® Optic Set

f=175 mm

BIOM® 5m (55462)

HD Professional 54411

BIOM® 5c (55400) f=200 mm

BIOM® 5ml (55463)

HD Professional 54412

BIOM® 5cl (55403) f=200 mm

BIOM® 5m (55462)

HD Flex 54415

BIOM® 5c (55400)

Instruction Manual BIOM® 5 (G/55400/1017/en)

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9 Use of the BIOM® 5

9.2

Mounting the BIOM® 5 

Make sure that all components are present and are sterile.

Example: Components of the BIOM® 5cl 1

2 6 5

4 1 BIOM® 5cl 2 Adaptor plate 3 Drive belt (BIOM® 5c/cl only) Fig. 9-1: Components of the BIOM® 5cl

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3 4 5 6

Ophthalmoscopy magnifying loupe Cable duct (BIOM® 5c/cl only) Reduction lens

Instruction Manual BIOM® 5 (G/55400/1017/en)

9 Use of the BIOM® 5

2

1



Insert the reduction lens. Then turn the reduction lens clockwise until it reaches the stop.



Plug in the adaptor plate until it reaches the stop.

Attention Risk to the patient if the BIOM® 5 is plugged in incorrectly If you do not plug in the BIOM® 5 correctly, you will get a decentred fundus image.

3



Insert the loupe until it reaches the stop.

4

The BIOM® 5ml is now fully mounted.

Fig. 9-2: Mounting the components

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9 Use of the BIOM® 5

Additionally for BIOM® 5c/cl: You must insert the drive belt. You can put on a cable duct. The cable duct is used to keep the connecting cable of the drive unit at the BIOM® 5c/cl away from unsterile parts of the microscope.

5



Insert the drive belt

6



Fasten the cable duct at the connector plug first  Then push the semi-open duct part over the cable.

Fig. 9-3: Mounting the drive belt and cable duct

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Instruction Manual BIOM® 5 (G/55400/1017/en)

9 Use of the BIOM® 5

9.3

Under Sterile Conditions: Test the Safety Functions Attention

Risk of injury due to improper function 

Only use the BIOM® 5 when the following functions have been checked and are in proper working order.

2

1



Flip the BIOM® 5 towards the adaptor plate. Make sure that the housing body can be shifted without resistance.



Slide the safety rod of the loupe holder up and down several times to check that it runs smoothly.

3

1



Check that the knob turns easily and shorten the total length of the BIOM® 5 until the adjuster is at the fully up position.



Check whether all fastening screws are present (e.g. screws at the feather key of the safety rod). The control mark (1) must be below the guide.

Fig. 9-4: Test the safety functions



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.  The dovetail mount for the adaptor is securely fastened at the microscope.

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9 Use of the BIOM® 5

9.4

Connect the BIOM® 5 to the Microscope Attention Risk of injury to the patient if mounting is done incorrectly 

Never mount the BIOM® 5 over the patient.

1



2



Push the sterile cap onto the knurled screw.

Push the adaptor plate with the BIOM® 5 into the dovetail mount at the microscope until it reaches the stop.

3



Secure the adaptor into place with the knurled screw.

Fig. 9-5: Connect the BIOM® 5 to the microscope

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Instruction Manual BIOM® 5 (G/55400/1017/en)