Instruction Manual
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INSTRUCTION MANUAL Binocular Indirect OphthalmoMicroscope
Notes on this instruction manual Thank you for your purchase and the trust you have placed in this OCULUS product. The BIOM 4 has been manufactured and tested according to strict quality criteria. You have selected a modern and well-engineered product. The Binocular Indirect Ophthalmomicroscope, BIOM 4, is an advancement of the BIOM. It successfully combines an ophthalmoscope with an operating microscope. Without corneal contact, it provides an optimum image of the vitreous space under stereoscopic conditions with a panoramic, up to 120° view of the fundus. To ensure safe operation, it is essential that you use the device correctly. For this reason you should familiarise yourself thoroughly 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 4 models:
BIOM 4c and 4cl (long version) BIOM 4m and 4ml (long version) Except for the difference in length, the respective long version is identical with respect to handling and features. The long version should be used on microscopes with focal length of 200 mm or more.
Due to ongoing development, the diagrams shown in the instruction manual may depict minor changes to the actual device delivered. If you have any queries or would like additional information about your device, do not hesitate to call or send us a fax. Our service team will gladly assist. OCULUS Optikgeräte GmbH
OCULUS is certified according to DIN EN ISO 9001:2000 and 13485:2003, setting high standards of quality where development, manufacture, quality assurance and service regarding the entire range of products are concerned.
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Table of Contents
Table of Contents 1
Scope of Delivery... 1
2
Safety Instructions... 2 2.1 2.2 2.3
Pictogram definitions ... 2 Safety instructions concerning organisation ... 2 Safety instructions for use of the BIOM 4... 3 2.3.1 Safety instructions for focusing the BIOM 4 ... 4
3
Proper Usage... 5
4
Transport of the BIOM 4... 5
5
Device Description ... 6 5.1 5.2 5.3
6
Operation... 8 6.1 6.2
7
Overview of device components... 6 Mode of operation of the BIOM 4... 6 To use a BIOM 4c on SDI 3c... 7 First-time operation ... 8 Daily operation... 8
Use of the BIOM 4... 9 7.1 7.2 7.3
7.4
Prior to each use... 9 Assembly and handling...10 Preparing the BIOM 4 for use ...12 7.3.1 Under sterile conditions: Perform a safety function test ...13 7.3.2 Connect the BIOM 4 to the microscope...14 7.3.3 Swing the BIOM 4 to the parked position...16 Practical application tips for the BIOM 4...21
8
Troubleshooting...22
9
Exchanging the BIOM 4c Drive Module ...24
10 Care and Maintenance...24 11 Disposal of Used Devices ...27 12 Warranty and Service ...27 12.1 Warranty ...27 12.2 Assumption of liability for functions and damage ...27 12.3 Manufacturer’s and service addresses ...28 13 Declaration of Conformity ...28 14 Order Information, Accessories and Replacement Parts...29 15 Technical Data ...32
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1 Scope of Delivery
1
Scope of Delivery
BIOM 4m Component
BIOM 4m
Instruction manual
Box with cover
Conditioning manual
BIOM 4c Component
BIOM 4c
Sterilizable drive belts (10 of)
Sterilizable cable duct
Drive unit as spare part (item no. 54405)
Instruction manual
Box with cover
Conditioning manual
Supplementary components needed for BIOM 4c and 4m Needed supplementary components
Reduction lens and ophthalmoscopy front lens
Adapter for operating microscope (if necessary, with additional adaption modules).
Stereoscopic diagonal inverter for erecting the image
Î
Note
We reserve the right to change the scope of delivery in line with ongoing technical development.
Instruction manual BIOM 4 (G/54400/0109/en)
☞
Please read the special packing notice included with the adapter and accessories. Î If you have also selected our company’s Stereoscopic Diagonal Inverter (SDI 4), you will find this unit and its accessories in a lined plastic carrying case. Î Please read the separate operating instructions for the SDI 4 and accessories.
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2 Safety Instructions
2
Safety Instructions
2.1
Pictogram definitions
Attention
Indicates a potentially hazardous situation that can result in injury or material damage.
Note
☞
Instructions for use and useful or important information.
Note
Identifies important information about the product or on how to use it, which requires special attention.
2.2
Safety instructions concerning organisation
The law requires that the manufacturer expressly informs the user about safety aspects concerning the handling of the device. This chapter contains a summary of the most important safety-related information.
Attention
Do not operate the unit until you have read and fully understood the entire instruction manual. Î
Make sure to keep this instruction manual in a safe place and available to operating personnel at all times. Î Observe the legal regulations with regard to accident prevention. Î The unit must not be used if a fault occurs that you cannot rectify. Get in touch with our service personnel.
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Instruction manual BIOM 4 (G/54400/0109/en)
2 Safety Instructions
Attention
Heed unconditionally the instruction manual 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.
Safety instructions for use of the BIOM 4
Note
Before putting this instrument into operation for the first time, the user must be familiarized with it by an Oculus Optikgeräte GmbH representative or an authorized dealer.
☞
2.3
Attention
No modifications may be made to this device without the permission of the manufacturer. Î Î Î Î Î
Î Î
Only operate the device using original accessory parts supplied by us, and when the device is in technically correct working order. Do not use the unit if it is damaged; in this case, get in touch with your supplier. Observe the legal regulations with regard to accident prevention. Also comply with the legal provisions in force in your country, and with the hygiene and waste disposal regulations of the hospital or clinic. If a fault occurs that you cannot rectify with the help of the troubleshooting table (sect. 8, page 22), the unit must not be used. Clearly mark the unit as non-operational and get in touch with our service personnel. The BIOM and all sterilizable BIOM components must be sterilely conditioned prior to the first, and every subsequent use. It is imperative that you heed the cleaning, disinfection and sterilization instructions given in the "conditioning manual".
Instruction manual BIOM 4 (G/54400/0109/en)
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2 Safety Instructions
Attention
After the BIOM 4 has been swung in into the working position, the following must not be performed during the proper use: Î
to use the rough adjustment mechanism of the microscope support under any circumstances (since the mechanism is not designed for precisely controlled movement) Î to change the height position of the microscope support by mechanical or motorized means whilst above the operating area Î to change the patient´s position by raising/lowering the OP-table
2.3.1
Safety instructions for focusing the BIOM 4
Attention
The following points must be heeded when focusing the BIOM 4:
The BIOM 4 is only needed for visualization of the posterior segment of the eye. After performing the operation steps at the anterior segment of the eye and outside of the eye, the microscope should be remaining at this position (height). Before swinging it to the operating position, make sure that the BIOM has been set to the shortest overall length. Before you begin to focus the BIOM 4, check the distance from the ophthalmoscopy front lens to the patient’s eye. Monitor the distance between the front lens and the eye while focusing the BIOM 4. Make sure that the ophthalmoscopy front lens does not come into contact with the eye. The microscope must not be adjusted in height, nor must the focusing function of the microscope be used while the BIOM is being focused.
For BIOM 4c only (focusing done by electric motor):
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Only use the motorized BIOM focusing function when the ophthalmoscopy lens is far enough away from the eye. The motorized focusing function of the BIOM 4c may only be used by the surgeon, when this distance is simultaneously monitored. It must be ensured that the operator can stop the motorized focusing function at any time.
Instruction manual BIOM 4 (G/54400/0109/en)
3 Proper Usage
3
Proper Usage
This binocular indirect ophthalmomicroscope (BIOM 4) is used for non-contact observation of surgeries in the posterior segment of the eye. The BIOM 4 should be used only by physicians and OP personnel who have been correspondingly trained and who have the training, knowledge, and practical experience to ensure appropriate handling. The BIOM 4 is intended for use with compatible designed operating microscopes in hospitals, clinics or other institutions for human medicine. Use only operating microscopes named by OCULUS Optikgeraete GmbH as adaptable for the BIOM 4. Only operate the device using original accessory parts supplied by us, and when the device is in technically correct working order. Please note carefully all safety information in this manual.
4
Transport of the BIOM 4
Î
Avoid shock/vibration when transporting the BIOM 4 and the optical modules to a different location. Î Check the unit and its accessories for damage after every transport.
Instruction manual BIOM 4 (G/54400/0109/en)
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5 Device Description
5
Device Description
5.1
Overview of device components
1 8
2 7
6
3 4
5 fig. 5-1: BIOM 4m with reduction lens and ophthalmoscopy front lens
1 Reduction lens (not supplied with the BIOM) 2 Lens receptacle 3 Control mark 4 Lens holder with safety slider
5.2
5 Ophthalmoscopy lens - so called front lens (not supplied with the BIOM) 6 Focus adjustment wheel 7 Bridge 8 Housing with swivel mechanism
Mode of operation of the BIOM 4
The BIOM 4 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. The combination of operating microscope and the optical components of the BIOM 4 allows examination of the vitreous body in the posterior chamber under stereoscopic
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Instruction manual BIOM 4 (G/54400/0109/en)
5 Device Description
conditions. The BIOM 4 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 view of up to 120° in total. The optical system of the BIOM 4 consists of the reduction lens and the front lens. The reduction lens provides a virtually constant distance between the patient’s eye and the operating microscope when the BIOM 4 is swung in or swung out. Individually adjusted to the respective operating microscope, the microscope objective’s focal distance is reduced. The position of the reduction lens with respect to the operating microscope is preset. The height adjustment of the front lens is used for focusing the BIOM image. The distance between the operating microscope and the front lens is set using the adjusting wheel at the BIOM 4. For BIOM 4c only:
Press the combination foot switch to focus by means of the electric motor. This height adjustment of the front lens brings the fundus image into the focal point of the microscope objective. As the image is completely reversed when the BIOM 4 is used, safe use is only guaranteed in conjunction with a stereoscopic diagonal inverter (SDI). The SDI rights the complete image reversal and can be switched on and off as required.
5.3
To use a BIOM 4c on SDI 3c
If this BIOM 4c (4-pin plug) should be used on the former SDI 3c (2-pin socket) version, a plug adapter (item no. 54406) is needed. This plug adapter should be connected with the 2-pin socket in the SDI housing. The sterile plug of the connecting cable of the BIOM 4c then needs to be connected with the adapter plug. For dismantling the BIOM 4c, grip the plug of the BIOM 4c connecting cable and pull it out of the adapter plug.
Attention
For use of a BIOM 4c, the adapter plug (item no. 54406) has to be removed from the SDI 4c housing.
Instruction manual BIOM 4 (G/54400/0109/en)
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6 Operation
6
Operation
6.1
First-time operation
Please remove the BIOM 4 and its accessories from the packaging and dispose of the latter in the proper manner. The BIOM and all sterilizable accessories must be cleaned, disinfected and sterilized prior to initial use and before each subsequent use. As part of an optical system, the BIOM 4, and the operating microscope too, must be handled with care and must not be subjected to vibrations, blows or be allowed to get dirty.
6.2
Daily operation
To mount the BIOM 4, an adapter is needed, which is customized to the type of operating microscope that is being used. If necessary, the adapter must be supplemented with an intermediate piece or a mounting fixture. Installation and instruction in the use of the BIOM 4 and its accessories will be done by an Oculus employee or by a duly authorized Oculus representative. A part of the mounting fixture generally remains installed at the microscope. Just like the BIOM 4 and its components, the detachable adapter plate must be cleaned, disinfected and sterlized prior to use. If, however, you do have to remove the mounting fixture for any reason, please proceed as shown on the assembly diagram provided with the adapter. When assembling dovetail connections, first visually check that the connection sits properly. Then tighten the knurled screw hand-tight. If the connection is correct, the dovetail connection will have no play. Check this by gently rocking the connection before you begin mounting any of the other attachments.
Attention
Detachable connections can be a source of danger if used incorrectly.
Î
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Therefore, after each conversion, check that all retaining elements (e.g. locking screws) are present and are tight.
Instruction manual BIOM 4 (G/54400/0109/en)
7 Use of the BIOM 4
7
Use of the BIOM 4
7.1
Prior to each use
Under sterile conditions: Perform a safety function test Î
Make sure that all components are present and are sterile. Î Flip the BIOM 4 towards the adapter plate. It is equipped with a swivel mechanism for 90° and a detent for this purpose. Î Make sure that the housing body can be swiveled without resistance.
fig. 7-1: Moving Components of the BIOM
Î
Check that the safety slider for the lens holder runs smoothly by sliding it in and out several times by hand. Î Check that the focus adjustment wheel can be adjusted with ease, and shorten the overall length of the BIOM until the bridge is located at the top position.
Attention
If one of these functions is not assured, the unit may not be used.
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 adapter is securely fastened at the micropscope.
Instruction manual BIOM 4 (G/54400/0109/en)
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7 Use of the BIOM 4
All fastening screws are present (e.g. screws (A) at the feather key (B) of the safety insertion)
The detachable adapter plate and the BIOM 4 have been conditioned and sterilized All needed optical components for the BIOM 4 are available and are sterile
For the BIOM 4c only:
At least one sterile drive belt is available.
7.2
Assembly and handling
All components of the BIOM 4 must be on hand and must be sterile, and must be assembled under sterile conditions. Choose the appropriate optics Î
Use the appropriate reduction lens for the operating microscope’s objective. Î Select the appropriate front lens for the surgery.
fig. 7-2: Surgical Ophthalmoscopy lenses (front lenses)
Currently available front lenses: Î 53606 Hi Res lens, excellent resolution, can be used with highest magnification of the microscope; the maximum field of view with this lens is approx. 60º, whereas the
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Instruction manual BIOM 4 (G/54400/0109/en)
7 Use of the BIOM 4
working distance between the cornea and the front lens (bottom surface) is approx. 10 mm. The outside diameter of the lens mount is 19 mm. Î 53604 90D lens, very good resolution; standard lens for most applications; maximum field of view with this lens is approx. 90º, whereas the working distance is approx. 8 mm. The outside diameter of the lens mount is 19 mm. Î 53602 Wide-Field (E)-lens, good resolution; provides the largest field of view, large depth of field; top-selling lens, first choice of experienced surgeons; the maximum field of view with this lens is approx. 120º, whereas the working distance is approx. 3-4 mm. The outside diameter of the lens mount is 19 mm. Î 53601 Wide-Field-lens for deep set eyes; the maximum field of view with this lens is approx. 70°, whereas the working distance is approx. 3-4 mm. The outside diameter of the lens mount is 12 mm.
Note
All steam autoclavable front lenses mentioned above, have a thin, amorphous carbon coating and must be sterilized in steam autoclaves.
Disposable lens set Beside the re-sterilizable lenses, there is also the possibility to use a disposable lens set for most types of microscopes.
fig. 7-3: Disposable lenses
The disposable lens set consists of wide field front lens with about 120° field of view, working distance approx. 3 - 4 mm. The included reduction lens is designed to work with microscope objectives with a focal length of 175 mm and 200 mm. These lens sets can be used with BIOM 4m and BIOM 4c (not with the long versions BIOM 4ml and BIOM 4cl). The disposable lens sets are sold sterile in a box of 6 sets and cannot be sterilized again. Î
For detailed information please see the instructions for use for the "Disposable BIOM Wide Field Lens-Set" attached to this instruction manual.
Instruction manual BIOM 4 (G/54400/0109/en)
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7 Use of the BIOM 4
7.3
Preparing the BIOM 4 for use
Put together the complete BIOM setup from the sterile components. 1
2
3
4
5 fig. 7-4: Necessary components of the BIOM 4c 1 Adapter plate 2 Reduction lens 3 BIOM 4c
4 Drive belt 5 Front lens
Î
Insert the reduction lens into the lens holder so that the side lugs sit in the recesses. Î Turn the reduction lens clockwise until the bayonet catch engages. It is thus held at that position. Î Insert the front lens into the adapter provided for that purpose. Here again, a detent prevents the lens from falling out. This detent must be overcome when inserting the lens. Make sure that the lens is properly aligned. For the BIOM 4c only: Î Mount the drive belt at the BIOM 4c. For all three pulleys, the drive belt should run
in the recesses provided for that purpose, otherwise the function cannot be guaranteed. When inserting the belt, begin at the groove at the bottom end of the adjusting wheel; this will make handling easier. Î
Now, using minimal effort, slip the BIOM 4 onto the adapter plate until it reaches the limit stop. You must thereby overcome a detent that secures the connection.
Attention
Make sure that the BIOM 4 has been slipped on up to the limit stop. That is the only way that safe handling and proper centering of the image are possible.
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Instruction manual BIOM 4 (G/54400/0109/en)
7 Use of the BIOM 4
7.3.1
Under sterile conditions: Perform a safety function test
Î
Make sure that all components are present and are sterile. Î Flip the BIOM against the adapter plate. It is equipped with a swivel mechanism for 90° and a detent for this purpose. Î Make sure that the housing body can be shifted without resistance.
fig. 7-5: Moving Components of the BIOM 4m
Î
Check that the safety insertion for the lens holder runs smoothly by sliding it in and out several times by hand. Î Check the function of the focusing wheel and shorten the overall length of the BIOM until the bridge is located at the top position.
Attention
If one of these functions is not assured, the unit may not be used.
Instruction manual BIOM 4 (G/54400/0109/en)
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7 Use of the BIOM 4
7.3.2 Î
Connect the BIOM 4 to the microscope
Slide the adapter plate with the BIOM components in compact state into the dovetail mount that is installed at the microscope. Secure the adapter into place with the knurled screw.
☞
fig. 7-6: BIOM 4c secured in the dovetail mount
Note: For BIOM 4c only
Also connect the control cable to one of the side couplers of the SDI 4c. Make sure that the cable does not touch any unsterile parts of the microscope. Suggestion: If surgery is to be done on the left eye, connect the control cable at the left hand side of the SDI. Or vice-versa if surgery is being done on the right eye.
For the BIOM 4c only: Installation of the cable duct The cable duct helps to keep the connecting cable for the drive unit at the BIOM 4c (also fits BIOM 3c) away from unsterile microscope parts. The cable duct can be sterilized in a steam autoclave and is conditioned in the same way as all other BIOM 4 components. Install the sterile cable duct at the plug and cable as shown in (fig. 7-7, page 15) and then connect the plug of the BIOM 4c with the socket on the SDI 4c housing.
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Instruction manual BIOM 4 (G/54400/0109/en)
7 Use of the BIOM 4
Î
Fit the cable duct at the end of the plug (2) first. Î Then fit the other semi-open part (1) over the cable. Î Proceed in reverse order prior to conditioning.
1 2
fig. 7-7: Installation of the cable duct at the BIOM 4c
Caution:
The cable duct must be removed before conditioning, otherwise sterilization is not possible.
Instruction manual BIOM 4 (G/54400/0109/en)
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7 Use of the BIOM 4
7.3.3
Swing the BIOM 4 to the parked position
Î
During extra-ocular surgery phases, swing the BIOM out of the beam path into the parked position. Î When swinging out the BIOM, push in the safety slider, including the front lens, with your finger, until the slider reaches the limit stop.
fig. 7-8: BIOM 4c at parked position
Make the basic settings at the microscope Î
Make the basic settings at the microscope in accordance with the manufacturer’s specifications. Î Adjust the microscope to the anterior eye segment and perform the surgery steps under microscope illumination, including insertion of the infusion.
When using the BIOM 4 focusing function, heed the following points:
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Before swinging it to the operating position, make sure that the BIOM has been set to the shortest overall length. Before starting the focusing process, check whether the ophthalmoscopy front lens is far enough away from the patient’s eye. Make sure that the front lens does not come into contact with the eye. While focusing the BIOM, the working height of the microscope must never be adjusted, nor must the focusing function of the microscope be used.
Instruction manual BIOM 4 (G/54400/0109/en)
7 Use of the BIOM 4
For BIOM 4c only (focusing done by electric motor):
Only use the BIOM 4c’s motorized focusing function when the front lens is far enough away from the patient’s eye. The surgeon may only use the motorized focusing function when the distance between the ophthalmoscopy front lens and the eye is simultaneously monitored. It must be ensured that the operator can stop the motorized focusing function at any time.
Attention
After the BIOM 4 has been swung in into the working position, the following must not be performed during the proper use: Î
to use the rough adjustment mechanism of the microscope support under any circumstances (since the mechanism is not designed for precisely controlled movement). Î to change the height position of the microscope support by mechanical or motorized means whilst above the operating area. Î to change the patient´s position by raising/lowering the OP-table.
Visualization of the posterior eye segment After all preparations for surgery in the posterior segment have been completed proceed as follows, without changing the microscope position! Î
Î
Use a suitable endoillumination. Swing the BIOM 4 into the beam path of the microscope. Lift up safety insertion and only release it again when the swung-in end position has been reached. The lens slides down to its designated position. This position has been reached when the control marks are fully visible. Turn off the microscope illumination. Activate the SDI to right the complete image reversal.
Î
For BIOM 4c and SDI 4c only:
If the BIOM 4c is swung out of the beam path the inverter function is not activated. While swinging the BIOM 4c into working position the SDI 4c is activated automatically. The position switch on board of the BIOM 4c thus operates the re-inverting function. If another status of the inverter is desired, the SDI 4c can be optionally operated via a combi foot switch.
Î Î Î
Î
At a low microscope magnification: Begin initial focusing of the BIOM 4-image by turning the BIOM 4 focus adjusting wheel. Î Magnify the image section by actuating the focus foot switch at the microscope.
Instruction manual BIOM 4 (G/54400/0109/en)
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