OCULUS BIOM 5c User manual

Instruction Manual BIOM® 5 (GA/55400/0313/en – YYYY-MM-DD) 1 / 1
OCULUS BIOM
®
5
INSTRUCTION MANUAL
Binocular Indirect Ophthalmo-Microscope

i / iii Instruction Manual BIOM® 5 (G/55400/0413/en)
Notes on this
Instruction Manual
The BIOM® 5 was manufactured and tested under strict quality criteria. You
have selected a modern and well-engieered product.
The Binocular Indirect Ophthalmo-Microscope, BIOM® 5, is further stage of
development of the BIOM®.
The BIOM® 5 combines an ophthalmoscope with a surgical microscope. It
enables the vitreous cavity to be viewed under stereoscopic conditions with
optimal image quality, with up to 125° non-contact observation of the fun-
dus.
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. Pay particular atten-
tion 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 iden-
tical 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 man-
ual 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.

Table of Contents
Instruction Manual BIOM® 5 (G/55400/0413/en) ii / iii
Table of Contents
1 Scope of Delivery........................................................................................................................ 1
2 Graphic Symbols on the Equipment ...................................................................................2
3 Safety Instructions..................................................................................................................... 2
3.1 About this Manual ...................................................................................................... 2
3.1.1 Pictograms Used in this Manual...................................................... 3
3.2 Safety Instructions for Use ..................................................................................... 3
3.2.1 Instructions for Use .............................................................................. 5
4 Proper Use ..................................................................................................................................... 5
5 Device Description...................................................................................................................... 6
5.1 Function of the BIOM® 5 .........................................................................................7
6 Transport and Storage.............................................................................................................. 8
7 Connect the BIOM® 5c to the SDI® 3c...............................................................................9
8 Initial Operation .......................................................................................................................... 9
8.1 Prior to Initial Operation ..........................................................................................9
8.2 Prior to Start-Up.......................................................................................................... 9
9 BIOM® 5 in Use..........................................................................................................................11
9.1 Choose the Appropriate Optics............................................................................11
9.2 Assembly.......................................................................................................................12
9.3 Under Sterile Conditions: Test the Safety Functions..................................16
9.4 Connect the BIOM® 5 to the Microscope........................................................17
9.5 Swivel the BIOM® 5 to its Parked Position.....................................................19
9.6 Make the Basic Settings at the Microscope ...................................................19
9.7 Instructions for Focusing the BIOM® 5m........................................................20
9.8 Instructions for Visualization of the Posterior Eye Segment..................21
9.9 Practical Information for Use...............................................................................23
9.9.1 End Operation of the BIOM® 5.......................................................24
9.10 Remove the BIOM® 5 from the Microscope...................................................24
9.11 Dismantle......................................................................................................................26
10 Troubleshooting ........................................................................................................................26
11 Change the Drive Module .....................................................................................................29
12 Cleaning, Sterilization and Maintenance........................................................................29
12.1 Condition Components...........................................................................................29
13 Disposal of Used Devices.......................................................................................................32
14 Warranty and Service..............................................................................................................33
14.1 Assumption of Liability for Functions and Damage ...................................33
14.2 Manufacturer and Service Address....................................................................34
15 Declaration of Conformity....................................................................................................35

Table of Contents
iii / iii Instruction Manual BIOM® 5 (G/55400/0413/en)
16 Order Information, Accessories and Replacement Parts..........................................36
16.1 Components for the BIOM® 5..............................................................................36
16.2 Sterilization Components for the BIOM® 5....................................................38
16.3 Stereoscopic Diagonal Inverter Systems for the BIOM® 5.......................38
17 Technical Data............................................................................................................................38

1 Scope of Delivery
Instruction Manual BIOM® 5 (G/55400/0413/en) 1 / 40
1ScopeofDelivery
BIOM®5c
Supplementary components required for BIOM® 5c
We reserve the right to change the scope of delivery in line with ongoing
technical development.
If you find transport damage upon delivery, immediately file a claim
with the transport company.
Have the damages noted on the bill of lading, so that your claim for
damages can be handled properly.
Component Order No
BIOM® 5c
Version BIOM® 5c
Version BIOM® 5cl
Sterilizable drive belts (10 pcs)
Sterilizable cable duct
55400
55403
BIOM® 5m
Version BIOM® 5m
Version BIOM® 5ml
55462
55463
Instruction Manual G/55400/xxx/en
Box with cover
Sterilization Information G/55185/xxx/en
Needed Supplementary Components
Reduction lens and ophthalmoscopy lens
Adapter for surgical microscope (if necessary,
with additional adaption modules).
Stereoscopic Diagonal Inverter for erecting the
image

2 Graphic Symbols on the Equipment
2 / 40 Instruction Manual BIOM® 5 (G/55400/0413/en)
2 Graphic Symbols on the Equipment
3 Safety Instructions
3.1 About this Manual
Carefully read through the Instruction Manual.
Keep the Instruction Manual in good condition near the device.
Observe the legal regulations with regard to accident prevention.
Read the separate operating instructions for the SDI® 4 and accesso-
ries.
Read the special packing notice included with the adapter and acces-
sories.
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.
1 Company logo + Manufacturer 4 Country of manufacture
2 CE marking 5 Device number
3 Serial number 6 Device name
Fig. 2-1: Graphic Symbols on the Equipment BIOM® 5
1
3
4
6
5
2

3 Safety Instructions
Instruction Manual BIOM® 5 (G/55400/0413/en) 3 / 40
3.1.1 Pictograms Used in this Manual
Attention
Identifies a potentially dangerous situation which may cause minor injury
or material damage.
Note
Denotes situations which could result in incorrect findings, denotes user in-
structions and useful or other important information.
☞
Identifies important information about the product and its use, which re-
quire special attention.
3.2 Safety Instructions for Use
Attention
Personal injury or material damage due to improper operation
Observe the following safety instructions.
Personal injury or material damage due to equipment modifications that
could jeopardize safety
No modifications may be made to this device without the permission
of the manufacturer.
Instructions for Operating Personnel
Ensure that the BIOM® 5 is only used by duly trained physicians and
OR-personnel, who, based on their qualifications or their knowledge
and practical experience, can guarantee proper handling of the device.

3 Safety Instructions
4 / 40 Instruction Manual BIOM® 5 (G/55400/0413/en)
Instructions for Setup and Connection
Also 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 or dismount the BIOM® 5 above a patient.
Assembly and instruction in the use of the BIOM® 5 and its accessories will
be done by an OCULUS employee or by a person authorized by OCULUS.
Instructions for Operation and Maintenance
Prior to use: Let OCULUS or an authorized dealer train you in the op-
eration of the BIOM® 5.
Never put a damaged BIOM® 5 into operation.
Only operate the BIOM® 5 with the original accessories supplied by us
and only when the unit is in a technically perfect condition.
Only operate the device if you have understood the operating instruc-
tions.
The BIOM® 5 and all sterilizable BIOM® 5 components must be sterilely
conditioned
prior to the first use
after every use
It is imperative that you heed the cleaning, disinfection and steriliza-
tion instructions given in the Conditioning Manual.

4 Proper Use
Instruction Manual BIOM® 5 (G/55400/0413/en) 5 / 40
3.2.1 Instructions for Use
Attention
Risk of eye injury if the working distance of the BIOM® 5 to the patient is
changed
When swiveling the BIOM® 5 into the work position (into the beam path)
you must comply with the following instructions:
Do not use the coarse adjustment knob at the microscope stand.
Do not adjust the height of the stand arm over the surgical field, ei-
ther by motor or manually.
Do not change the patient’s position by adjusting the height of the
operating table.
Heed the focusing instructions, sect. 9.7, page 20.
Heed the instructions for visualisation of the posterior segment of the
eye, sect. 9.8, page 21.
Heed the practical information for use of the BIOM® 5, sect. 9.9,
page 23.
Troubleshooting
If a fault occurs that you cannot rectify with the help of the trouble-
shooting table (Page 27), 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
Dispose of the device according to legal regulations. Comply with the
hygiene and waste disposal regulations in force in the hospital or
clinic.
4 Proper Use
This Binocular Indirect OphthalmoMicroscope (BIOM® 5) is used for non-
contact observation of surgeries in the posterior segment of the eye.
The BIOM® 5 is intended for use with compatible designed surgical micro-
scopes in hospitals, clinics or other institutions for human medicine.
Use only surgical microscopes named by OCULUS Optikgeräte GmbH as
adaptable for the OCULUS.
Only operate the device using original accessory parts supplied by us, and
when the device is in technically correct working order.
Heed the safety instructions listed above.

5 Device Description
6 / 40 Instruction Manual BIOM® 5 (G/55400/0413/en)
5Device Description
BIOM®5c
1 Reduction lens
(not supplied with the BIOM®)
2 Housing with swivel mechanism
3 Lens receptacle
4 Focus adjustment wheel
5 Control mark
6 Lensholder with safety rod
7 Front lens
(not supplied with the BIOM®)
8 Drive module
Fig. 5-1: Device overview BIOM® 5c with reduction lens and ophthalmoscopy lens
8
1
3
6
4
7
5
2

5 Device Description
Instruction Manual BIOM® 5 (G/55400/0413/en) 7 / 40
BIOM®5m
5.1 Function 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.
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 with-
out corneal contact during the surgery.
1 Reduction lens
(not supplied with the BIOM®)
2 Adjuster, housing with swivel mechanism
3 Lens receptacle
4 Focus adjustment wheel
5 Control mark
6 Lens holder with safety rod
7Frontlens
(not supplied with the BIOM®)
Fig. 5-2: Device overview BIOM® 5m with reduction lens and ophthalmoscopy lens
1
3
6
4
7
5
2

6 Transport and Storage
8 / 40 Instruction Manual BIOM® 5 (G/55400/0413/en)
The patient’s eyeball 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 125° in total.
The optical system of the BIOM® 5 consists of the reduction lens and the
front lens. The reduction lens ensures that the distance between the pa-
tient’s eye and the surgical microscope remains more or less the same when
the BIOM® 5 is swiveled in and out. Individually adjusted to the respective
surgical microscope, the microscope objective’s focal distance is reduced.
The position of the reduction lens with respect to the surgical microscope
is preset.
The height adjustment of the front lens is used for focusing the BIOM® im-
age. The distance between the surgical microscope and the front lens is set
using the adjusting wheel at the BIOM® 5.
For BIOM® 5c 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® 5 is used, optimal use
is only guaranteed in conjunction with a SDI®. The SDI® rights the complete
image reversal and can be switched on and off as required.
6 Transport and Storage
The following values apply for a period of 6 months at most in the shipping
container.
The transport and storage conditions according to DIN EN ISO 601-1 are:
Attention
Risk of damage to the device due to improper transport and storage
Transport the BIOM® 5 carefully.
Store the BIOM® 5 under proper storage conditions.
An ambient temperature range of -40°C to +70°C
A relative humidity range of 10% to 100%,
including condensation
An air pressure range of 5o kPa to 106 kPa

7 Connect the BIOM® 5c to the SDI® 3c
Instruction Manual BIOM® 5 (G/55400/0413/en) 9 / 40
7ConnecttheBIOM
®5c to the SDI®3c
You need an adapter (Art. No. 54406) to connect the BIOM® 5c (4-pole) to
an SDI® 3c (2-pole).
Plug in the unsterile adapter at the 2-pole SDI® housing.
Carefully connect the sterilized plug of the BIOM® 5c to the adapter
plug, taking care to maintain the sterility.
To disconnect after use, take hold of the outer sleeve of the BIOM® 5c
plug and unlock the connection.
☞
For more information, refer to the Instruction Manual for the adapter.
8 Initial Operation
8.1 Prior to Initial Operation
Remove the BIOM® 5 and its accessories from the packaging and dis-
pose of the latter in the proper manner.
Clean, disinfect and sterilize the BIOM® prior to initial use, fig. 12,
page 29.
Assembly and instruction in the use of the BIOM® 5 and its accessories will
be done by an OCULUS employee or by a dealer authorized by OCULUS.
8.2 Prior to Start-Up
An adapter is needed for attachment of the BIOM® 5. Check whether
it adapted to the respective surgical microscope type.
If necessary, extend the adapter.
A part of the mounting fixture generally remains installed at the mi-
croscope.
Clean, disinfect and sterilize the detachable adapter plate for the
BIOM® 5 prior to use, see sect. 12, page 29.
If, however, you do have to remove the mounting fixture for any
reason, proceed as shown on the assembly diagram provided with the
adapter.
Clean, disinfect and sterilize the BIOM® 5 prior to every use, sect. 12,
page 29.

8 Initial Operation
10 / 40 Instruction Manual BIOM® 5 (G/55400/0413/en)
Check and Mount the Dovetail Connections:
First visually check the connection for correct mounting.
Check this by gently rocking the connection before you begin mount-
ing any of the other attachments.
Attention
Risk of injury to the patient if the BIOM® 5 drops.
Loose connections can pose a hazard if you mount the adapter plate incor-
rectly.
Therefore, after each conversion, check that all retaining elements (e.g.
locking screws) are present and are tight.

9 BIOM® 5 in Use
Instruction Manual BIOM® 5 (G/55400/0413/en) 11 / 40
9BIOM
®5in Use
9.1 Choose the Appropriate Optics
Use the appropriate reduction lens for the surgical microscope’s objec-
tive.
Select the appropriate front lens for the surgery.
Currently available front lens:
53603 Wide field, high definition lens with very good resolution in all
areas; can be used with maximum microscope magnification. With this
lens, the maximum field of view is approx. 60° to 125°. The outside di-
ameter of the lens mount is 20 mm.
53606 Hi Res lens with very good resolution, can be used with maxi-
mum microscope magnification; with this lens, the maximum field of
view is approx. 60º and the working distance between the cornea and
front lens (bottom surface) is approx. 10 mm. The outside diameter of
the lens mount is 19 mm.
53604 90D lens with very good resolution; standard lens suitable for
most cases; with this lens, the maximum field of view is approx. 90º,
and the working distance is approx. 8 mm. The outside diameter of the
lens mount is 19 mm.
53602 Wide field (E)-lens with good resolution, large depth of focus;
lens with a maximum field of view of approx. 120º, and a working dis-
tance of approx. 3-4 mm. The outside diameter of the lens mount is 19
mm.
53601 Wide field lens for deepset eyes; with this lens the maximum
field of view is approx. 70°, and the working distance is approx. 3-4
mm. The outside diameter of the lens mount is 12 mm.
Note
Sterilize the front lenses in the steam autoclave.
Lens 53603 Lens 53606 Lens 53604 Lens 53602 Lens 53601

9 BIOM® 5 in Use
12 / 40 Instruction Manual BIOM® 5 (G/55400/0413/en)
Disposable lens Sets
In addition to the re-sterilizable lenses, disposable sterile BIOM® Optic Sets
can also be used on the BIOM® 5.
The sets consist of a wide-angle front lens and a reduction lens, which can
be used for a microscope length of f=175 mm or f= 200 mm.
The maximum field of view is approx. 125° and the working distance is
approx. 3-4 mm.
The disposable lens sets can be combined with models BIOM® 5:
9.2 Assembly
Make sure that all components are present and are sterile.
Fig. 9-1: Disposable lenses (similar to those shown here)
Objekctiv
lens
Model BIOM® BIOM® Optic Set
for f=175 mm BIOM® 5m (55462)
BIOM® 5c (55400)
HD Professional 54411
for f=200 mm BIOM® 5ml (55463)
BIOM® 5cl (55403)
HD Professional 54412
for f=200 mm BIOM® 5m (55462)
BIOM® 5c (55400)
HD Flex 54415

9 BIOM® 5 in Use
Instruction Manual BIOM® 5 (G/55400/0413/en) 13 / 40
BIOM®5m Components
BIOM®5c Components
1 Housing with swivel mechanism 3 Front lens
2 Adapter plate 4 Reduction lens
Fig. 9-2: BIOM® 5m Components
1 Housing with swivel mechanism 5 Cable duct
2 Adapter plate 6 Reduction lens
3 Drive belt 7 Cable connector
4Frontlens
Fig. 9-3: BIOM® 5c Components
4
1
2
3
6
1
2
4
5
3
7

9 BIOM® 5 in Use
14 / 40 Instruction Manual BIOM® 5 (G/55400/0413/en)
Insert the reduction lens. Plug in the adapter plate. You must thereby over-
come the detent that secures the connection.
Attention
Risk of injury to the patient if the BIOM® 5 is inserted
incorrectly
If you do not insert the BIOM® 5 correctly, you will get
a decentered fundus image.
Make sure that the BIOM® 5 has been slipped on up to
the limit stop.
Insert the front lens. The BIOM® 5ml is fully assembled.
Fig. 9-4: Component assembly
1
2
3
4

9 BIOM® 5 in Use
Instruction Manual BIOM® 5 (G/55400/0413/en) 15 / 40
Additionally for the BIOM®5:
You must insert the drive belt and put on a cable duct. The purpose of the
cable duct is to keep the connecting cable of the drive unit at the BIOM® 5c
(also fits the previous model) away from the unsterile microscope parts. The
cable duct and the drive belt can be steam autoclaved and are conditioned
in the same way as the other BIOM® 5 components.
Install the drive belt. First fasten the cable holder to the
connector
Then fit the other side over the cable.
Fig. 9-5: Installation of the drive belt and cable duct
5
6

9 BIOM® 5 in Use
16 / 40 Instruction Manual BIOM® 5 (G/55400/0413/en)
9.3 Under Sterile Conditions:
Test the Safety Functions
Attention
Risk of injury in the event of malfunction
Only use the BIOM® 5 after the following functions have been tested
and are in perfect working order.
#
Turn the BIOM® 5 towards the adapter plate. Make
sure that the housing body can be shifted without
resistance.
Slide the safety rod of the lens mount up and down
several times to check that it moves smoothly. The
control marking must be visible all times.
Check that the knob turns easily and shorten the
total length until the adjuster is at the uppermost
position.
Check whether all fastening screws are present
(e.g. screws at the feather key of the safety rod).
Fig. 9-6: Test the Safety Functions
1
2
control
marking
3