OCULUS BIOM 4 User manual

INSTRUCTION MANUAL
Binocular Indirect OphthalmoMicroscope

i / ii
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 re-
spect 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 and 13485, setting high standards of
quality where development, manufacture, quality assurance and service regarding the
entire range of products are concerned.

Table of Contents
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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
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

Table of Contents
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1 Scope of Delivery
Instruction manual BIOM 4 (G/54400/1011/en) 1 / 34
1ScopeofDelivery
BIOM 4m
BIOM 4c
Supplementary components needed for BIOM 4c and 4m
Please read the special packing notice included with the adapter and accessories.
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.
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 devel-
opment.
Component
BIOM 4m
Instruction manual
Box with cover
Conditioning manual
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
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

2 Safety Instructions
2 / 34 Instruction manual BIOM 4 (G/54400/1011/en)
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 im-
portant safety-related information.
Attention
Do not operate the unit until you have read and fully understood the entire instruction
manual.
Make sure to keep this instruction manual in a safe place and available to operating
personnel at all times.
Observe the legal regulations with regard to accident prevention.
The unit must not be used if a fault occurs that you cannot rectify. Get in touch with
our service personnel.

2 Safety Instructions
Instruction manual BIOM 4 (G/54400/1011/en) 3 / 34
Attention
Heed unconditionally the instruction manual and safety advice of the operating micro-
scope 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 famil-
iarized with it by an Oculus Optikgeräte GmbH representative or an authorized dealer.
Attention
No modifications may be made to this device without the permission of the manufactur-
er.
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-operation-
al and get in touch with our service personnel.
The BIOM and all sterilizable BIOM components must be sterilely condi-
tioned 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".

2 Safety Instructions
4 / 34 Instruction manual BIOM 4 (G/54400/1011/en)
Attention
After the BIOM 4 has been swung in into the working position, the following must not be
performed during the proper use:
to use the rough adjustment mechanism of the microscope support under any
circumstances (since the mechanism is not designed for precisely controlled
movement)
to change the height position of the microscope support by mechanical or
motorized means whilst above the operating area
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.

3 Proper Usage
Instruction manual BIOM 4 (G/54400/1011/en) 5 / 34
3 Proper Usage
This binocular indirect ophthalmomicroscope (BIOM 4) is used for non-contact observa-
tion of surgeries in the posterior segment of the eye.
The BIOM 4 should be used only by physicians and OP personnel who have been corre-
spondingly trained and who have the training, knowledge, and practical experience to en-
sure appropriate handling.
The BIOM 4 is intended for use with compatible designed operating microscopes in hos-
pitals, 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 de-
vice is in technically correct working order.
Please note carefully all safety information in this manual.
4 Transport of the BIOM 4
Avoid shock/vibration when transporting the BIOM 4 and the optical modules to a
different location.
Check the unit and its accessories for damage after every transport.

5 Device Description
6 / 34 Instruction manual BIOM 4 (G/54400/1011/en)
5 Device Description
5.1 Overview of device components
fig. 5-1: BIOM 4m with reduction lens and ophthalmoscopy front lens
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
1 Reduction lens
(not supplied with the BIOM)
5 Ophthalmoscopy lens - so called front 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
6
7
8
1
2
3
4
5

5 Device Description
Instruction manual BIOM 4 (G/54400/1011/en) 7 / 34
conditions. The BIOM 4 works as an indirect ophthalmomicroscope without corneal con-
tact 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 re-
duced.
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.

6 Operation
8 / 34 Instruction manual BIOM 4 (G/54400/1011/en)
6Operation
6.1 First-time operation
Please remove the BIOM 4 and its accessories from the packaging and dispose of the lat-
ter 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 han-
dled 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 mount-
ing fixture for any reason, please proceed as shown on the assembly diagram pro-
vided 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.
Therefore, after each conversion, check that all retaining elements (e.g. locking
screws) are present and are tight.

7 Use of the BIOM 4
Instruction manual BIOM 4 (G/54400/1011/en) 9 / 34
7 Use of the BIOM 4
7.1 Prior to each use
Under sterile conditions: Perform a safety function test
Make sure that all components are present and are sterile.
Flip the BIOM 4 towards the adapter plate. It is equipped with a swivel mechanism
for 90° and a detent for this purpose.
Make sure that the housing body can be swiveled without resistance.
fig. 7-1: Moving Components of the BIOM
Check that the safety slider for the lens holder runs smoothly by sliding it in and out
several times by hand.
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.

7 Use of the BIOM 4
10 / 34 Instruction manual BIOM 4 (G/54400/1011/en)
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 assem-
bled under sterile conditions.
Choose the appropriate optics
Use the appropriate reduction lens for the operating microscope’s objective.
Select the appropriate front lens for the surgery.
fig. 7-2: Surgical Ophthalmoscopy lenses (front lenses)
Currently available front lenses:
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

7 Use of the BIOM 4
Instruction manual BIOM 4 (G/54400/1011/en) 11 / 34
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.
53604 90D lens, very good resolution; standard lens for most applications; maxi-
mum field of view with this lens is approx. 90º, whereas the working distance is ap-
prox. 8 mm.
The outside diameter of the lens mount is 19 mm.
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.
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 (image similar)
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).
For detailed information please see the instructions for use for the "Disposable
BIOM Wide Field Lens-Set" attached to this instruction manual.

7 Use of the BIOM 4
12 / 34 Instruction manual BIOM 4 (G/54400/1011/en)
7.3 Preparing the BIOM 4 for use
Put together the complete BIOM setup from the sterile components.
fig. 7-4: Necessary components of the BIOM 4c
Insert the reduction lens into the lens holder so that the side lugs sit in the recesses.
Turn the reduction lens clockwise until the bayonet catch engages. It is thus held at
that position.
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:
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 guaran-
teed. When inserting the belt, begin at the groove at the bottom end of the adjusting
wheel; this will make handling easier.
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.
1 Adapter plate 4 Drive belt
2 Reduction lens 5 Front lens
3BIOM4c
1
2
3
4
5

7 Use of the BIOM 4
Instruction manual BIOM 4 (G/54400/1011/en) 13 / 34
7.3.1 Under sterile conditions:
Perform a safety function test
Make sure that all components are present and are sterile.
Flip the BIOM against the adapter plate. It is equipped with a swivel mechanism for
90° and a detent for this purpose.
Make sure that the housing body can be shifted without resistance.
fig. 7-5: Moving Components of the BIOM 4m
Check that the safety insertion for the lens holder runs smoothly by sliding it in and
out several times by hand.
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.

7 Use of the BIOM 4
14 / 34 Instruction manual BIOM 4 (G/54400/1011/en)
7.3.2 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.

7 Use of the BIOM 4
Instruction manual BIOM 4 (G/54400/1011/en) 15 / 34
Fit the cable duct at the end of the plug (2) first.
Then fit the other semi-open part (1) over the cable.
Proceed in reverse order prior to conditioning.
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.
1
2

7 Use of the BIOM 4
16 / 34 Instruction manual BIOM 4 (G/54400/1011/en)
7.3.3 Swing the BIOM 4 to the parked position
During extra-ocular surgery phases, swing the BIOM out of the beam path into the
parked position.
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
Make the basic settings at the microscope in accordance with the manufacturer’s
specifications.
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:
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 ad-
justed, nor must the focusing function of the microscope be used.