Oculus BIOM 4 User manual
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
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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.
Table of Contents
1 Scope of Delivery......................................................................................................................................1
2 Safety Instructions...................................................................................................................................2
2.1 Pictogram definitions ...............................................................................................................2
2.2 Safety instructions concerning organisation .................................................................2
2.3 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 Overview of device components ..........................................................................................6
5.2 Mode of operation of the BIOM 4.......................................................................................6
5.3 To use a BIOM 4c on SDI 3c...................................................................................................7
6 Operation.....................................................................................................................................................8
Table of Contents
6.1 First-time operation ..................................................................................................................8
6.2 Daily operation ............................................................................................................................8
7 Use of the BIOM 4....................................................................................................................................9
7.1 Prior to each use.........................................................................................................................9
7.2 Assembly and handling..........................................................................................................10
7.3 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
7.4 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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1Scope of Delivery
BIOM 4m
Component
BIOM 4m
Instruction manual
Box with cover
Conditioning manual
BIOM 4c
Component
BIOM 4c
1 Scope of Delivery
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 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.
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) 1 / 34
☞
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.
2 / 34 Instruction manual BIOM 4 (G/54400/0109/en)
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.
2.3 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 Safety Instructions
☞
Attention
No modifications may be made to this device without the permission of the manufacturer.
Î Only operate the device using original accessory parts supplied by us, and when the
device is in technically correct working order.
Î Do not use the unit if it is damaged; in this case, get in touch with your supplier.
Î Observe the legal regulations with regard to accident prevention.
Î Also comply with the legal provisions in force in your country, and with the hygiene
and waste disposal regulations of the hospital or clinic.
Î 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-operation-
al and get in touch with our service personnel.
Î The BIOM and all sterilizable BIOM components must be sterilely condi-
tioned prior to the first, and every subsequent use.
Î 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) 3 / 34
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):
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.
4 / 34 Instruction manual BIOM 4 (G/54400/0109/en)
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.
3 Proper Usage
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) 5 / 34
5 Device Description
5 Device Description
5.1 Overview of device components
1
8
2
7
6
fig. 5-1: BIOM 4m with reduction lens and ophthalmoscopy front lens
1 Reduction lens
(not supplied with the BIOM)
2 Lens receptacle 6 Focus adjustment wheel
3 Control mark 7 Bridge
4 Lens holder with safety slider 8 Housing with swivel mechanism
5 Ophthalmoscopy lens - so called front lens
(not supplied with the BIOM)
3
4
5
5.2 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
6 / 34 Instruction manual BIOM 4 (G/54400/0109/en)
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.
5 Device Description
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) 7 / 34
6 Operation
6Operation
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 op-
erating 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 Therefore, after each conversion, check that all retaining elements (e.g. locking
screws) are present and are tight.
8 / 34 Instruction manual BIOM 4 (G/54400/0109/en)
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.
7 Use of the BIOM 4
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) 9 / 34
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