OCULUS BIOM 5c User manual

OCULUS BIOM
®
5
INSTRUCTION MANUAL
Binocular Indirect Ophthalmo-Microscope

i / iii Instruction Manual BIOM® 5 (G/55400/1218/en)
Notes on this Instruction Manual
The BIOM® 5 combines an ophthalmoscope with a surgical microscope. It allows the
vitreous cavity to be viewed under stereoscopic conditions, with optimal image quality,
with up to 125° non corneal-contact observation of the fundus.
The BIOM® 5 has been manufactured and tested according to strict quality criteria.
To ensure safe operation, it is essential that you use the device correctly. For this
reason, you should thoroughly familiarize yourself with the contents of this instruction
manual before operating the device. In particular, pay attention to the safety
instructions.
This operating manual describes the following BIOM® 5 models:
BIOM® 5c and 5cl (long version)
BIOM® 5m and 5ml (long version)
Except for the difference in length, the respective long version is identical with
respect to handling and features.
The long versions should be used at microscope focal lengths of f=200 mm
Due to ongoing development, the diagrams shown in the instruction manual may
depict minor changes to the actual device delivered.
If you have any questions or would like additional information about your device,
please do not hesitate to contact us by mail or fax. Our service team will gladly assist.
OCULUS Optikgeräte GmbH
OCULUS is certified according to DIN EN ISO 13485, setting high standards of quality
where development, manufacture, quality assurance and service regarding the entire
range of products are concerned.

Table of Contents
Instruction Manual BIOM® 5 (G/55400/1218/en) ii / iii
Table of Contents
1 Scope of Delivery.........................................................................................................................1
2 BIOM® 5 Symbols........................................................................................................................2
3 Structure of the Documentation ............................................................................................3
4 Safety Instructions......................................................................................................................4
4.1 About this Manual .........................................................................................................4
4.1.1 Used Graphic Symbols.................................................................................4
4.2 Safety Instructions for Use..........................................................................................5
4.2.1 Instructions for Use......................................................................................6
5 Intended Use.................................................................................................................................7
6 Device Description ......................................................................................................................8
6.1 Mode of Operation of the BIOM® 5..........................................................................9
7 Transport and Storage ............................................................................................................ 10
8 Initial Operation ....................................................................................................................... 10
8.1 Before Initial Operation............................................................................................. 10
8.2 Before First Use............................................................................................................ 10
9 Use of the BIOM® 5................................................................................................................. 11
9.1 Choose the Appropriate Optics................................................................................ 11
9.2 Mounting the BIOM® 5.............................................................................................. 12
9.3 Under Sterile Conditions: Test the Safety Functions......................................... 15
9.4 Connect the BIOM® 5 to the Microscope............................................................. 16
9.5 Swing the BIOM® 5 to the Parked Position ......................................................... 18
9.6 Make the Basic Settings at the Microscope........................................................ 18
9.7 Instructions for Focussing the BIOM® 5m/ml ..................................................... 19
9.8 During the Surgery...................................................................................................... 20
9.9 After the Surgery......................................................................................................... 20
10 Troubleshooting........................................................................................................................ 23
11 Change the Drive Module...................................................................................................... 26
12 Cleaning, Sterilisation and Maintenance.......................................................................... 26
13 Disposal of Used Devices........................................................................................................ 26
14 Guarantee and Service............................................................................................................ 27
14.1 Assumption of Liability for Functions and Damage .......................................... 27
14.2 Manufacturer and Service Address ........................................................................ 28
15 Declaration of Conformity.....................................................................................................29
16 Order Information, Accessories and Replacement Parts............................................... 30
16.1 Components for the BIOM® 5.................................................................................. 30
16.2 Sterilisation Components.......................................................................................... 32
16.3 Image Reversal Systems ............................................................................................ 32
16.4 Connection Components ........................................................................................... 32
17 Technical Data .......................................................................................................................... 33

Table of Contents
iii / iii Instruction Manual BIOM® 5 (G/55400/1218/en)

1 Scope of Delivery
Instruction Manual BIOM® 5 (G/55400/1218/en) 1 / 36
1 Scope of Delivery
BIOM®5c
Additional components needed for BIOM® 5
We reserve the right to make changes to deliverables as a part of any
technical improvements.
If transport damage is discovered from the shipment, please file a
complaint with the shipping company immediately.
Have the damage confirmed on the bill of lading so that an orderly
handling of the complaint for damages is possible.
Component Order no.
BIOM® 5c
Version BIOM® 5c
Version BIOM® 5cl
Sterilisable drive belts (10 of)
Sterilisable cable duct (1 of)
55400
55403
BIOM® 5m
Version BIOM® 5m
Version BIOM® 5ml
55462
55463
Instruction Manual
Conditioning Instructions
G/55400/xxx/en
G/55185/xxx/en
Box with cover
Needed Supplementary Components see
Reduction lens and front loupe sec. 9.1, page 11
Adaptor for surgical microscope (if necessary,
with additional adaption modules)
sec. 16.1, page 30
Stereoscopic diagonal inverter for erecting the
image
sec. 16.3, page 32

2 BIOM® 5 Symbols
2 / 36 Instruction Manual BIOM® 5 (G/55400/1218/en)
2BIOM®5Symbols
1 Company logo + manufacturer 8 Applied part of the type B (BIOM® 5c and BIOM® 5cl only)
2 CE marking 9 Power supply voltage
3 Heed Instruction Manual 10 Date of manufacture
4 UDI-Nummer 11 Serial number of the device
5 Matrix 12 Reference number
6 Disposal with household waste is prohibited (BIOM® 5c
and BIOM® 5cl only)
13 Name of device
7 Protection class (BIOM® 5c and BIOM® 5cl only)
Fig. 2-1: Examples: BIOM® 5ml and BIOM® 5 symbols
1
4
5
12
10
6
7
8
9
11
2
3
13
3
5
13
12
2
4
10
11
1

3 Structure of the Documentation
Instruction Manual BIOM® 5 (G/55400/1218/en) 3 / 36
3 Structure of the Documentation
The following documents are supplied with the BIOM® 5:
Instruction Manual: The design of the unit is described in detail in
this document. You will also find all safety-related information for
use of the BIOM® 5.
Attention
All safety-related instructions for use of the BIOM® 5 are given in the
instruction manual for the unit. It is therefore imperative that you read
and understand the whole instruction manual before you use the
BIOM® 5.
Conditioning Instructions: These conditioning instructions explain
how to condition the BIOM® 5. They apply for the various models and
accessories of the BIOM® 5. You will also find an itemized list of the
articles concerned.

4 Safety Instructions
4 / 36 Instruction Manual BIOM® 5 (G/55400/1218/en)
4SafetyInstructions
4.1 About this Manual
Carefully read through the instruction manual.
Keep the instruction manual in good condition, near to the device.
Please read the separate operating instructions for the SDI® 4 and
accessories.
Please read the special packing notice included with the adaptor and
accessories.
4.1.1 Used Graphic Symbols
Attention
Denotes a potentially hazardous situation which can easily result in minor
physical injury or property damage.
Note
Denotes situations which could result in incorrect findings, denotes user
instructions and useful or other important information.
☞
Denotes important information about the product and its use, which
require special attention.

4 Safety Instructions
Instruction Manual BIOM® 5 (G/55400/1218/en) 5 / 36
4.2 Safety Instructions for Use
Attention
Risk of personal injury or property damage due to improper operation
Observe the following safety instructions.
Risk of personal injury or property damage due to equipment
modifications that could jeopardize safety
This equipment may not be modified without the permission of the
manufacturer.
Instructions for operating personnel
Ensure that the BIOM® 5 is used only by duly trained physicians and
operating theatre personnel, who, due to their training or their knowledge
and practical experience, can guarantee proper handling of the device.
Only OCULUS or an authorized dealer is allowed to train the personnel.
Transport and storage instructions
Refer to the notes in sec. 7, page 10.
Instructions for setup and connection
Comply with the legal provisions in force in your country, and with
the hygiene and waste disposal regulations of the hospital or clinic.
Never mount and dismount the BIOM® 5 over the patient.
Assembly of the holder and instruction in the use of the BIOM® 5 and
its accessories will be undertaken by an OCULUS employee or by a
duly authorized OCULUS representative.
BIOM® 5c and BIOM® 5cl: Do not use excessive force to connect the
electrical connectors to the OCULUS SDI® 4c or BIOM® connecting
spacer.
If connection is not possible, check whether the plug fits in the
socket.
If you find damage to the plug connector, have the damage
corrected by our service department.

4 Safety Instructions
6 / 36 Instruction Manual BIOM® 5 (G/55400/1218/en)
Operation and maintenance information
Before initial operation: Let OCULUS or an authorized dealer train
you in the operation of the BIOM® 5.
Never operate a damaged BIOM® 5.
Only operate the BIOM® 5 using original accessory parts supplied by
us, and when the device is in technically perfect working order.
Only operate the equipment after your have read and understood the
instruction manual.
The BIOM® 5 and all sterilisable BIOM® 5 components must be
sterilised:
Before the first use
After every use
It is imperative that you heed the cleaning, disinfection and
sterilisation instructions given in the conditioning manual.
4.2.1 Instructions for Use
Attention
Risk of eye damage if the working distance between the BIOM® 5 and the
patient changes
When the BIOM® 5 is swung into the working position (into the beam pa-
th), the following instructions must be followed:
Do not use the coarse adjustment knob at the microscope stand to
adjust the height.
Do not adjust the height of the stand arm, either by motor or
manually, over the surgical area.
Do not change the patient’s position by adjusting the height of the
operating table.
Pay attention to the focussing instructions, sec. 9.7, page 19.
More information can be found in the Application tips: BIOM® 5 and
can be downloaded from the OCULUS website.
Troubleshooting
If a fault occurs that you cannot rectify with the help of the
troubleshooting table (page 23), the unit must not be used! Clearly
mark the unit as non-operational and get in touch with our service
personnel.
Instructions for disassembly and disposal
Dispose of the equipment in compliance with the corresponding
legal requirements. Comply with the hygiene and disposal
regulations of the hospital or clinic.

5 Intended Use
Instruction Manual BIOM® 5 (G/55400/1218/en) 7 / 36
EMC and electrical safety information
The BIOM® 5c, a connected SDI® 4c or BIOM® connecting spacer and a
microscope constitute a medical electrical system (ME system) in
accordance with DIN EN 60601-1. If you connect additional devices,
those devices become part of the ME system.
Make sure that all devices of the ME system meet the requirements
of IEC 60601-1 or IEC 60950-1.
Make certain that the SDI® 4 used for the power supply.
5 Intended Use
This binocular indirect ophthalmomicroscope (BIOM® 5) is used for non-
contact observation of surgeries in the posterior segment of the eye.
The BIOM® 5 is intended for use with compatible surgical microscopes in
hospitals, clinics or other institutions for human medicine
The surgical microscopes must be declared as adaptable by OCULUS
Optikgeräte GmbH
Only operate the device using original accessory parts supplied by us, and
when the device is in technically perfect working order.
Heed the safety instructions listed above.
Contraindication
not known

6 Device Description
8 / 36 Instruction Manual BIOM® 5 (G/55400/1218/en)
6 Device Description
BIOM®5c BIOM®5m
1 Reduction lens (not supplied with the BIOM®) 5 Control mark
2 Housing with swivel mechanism 6 Loupe holder with safety rod
3 Lens receptacle 7 Ophthalmoscopy magnifying loupe
(not supplied with the BIOM®)
4 Focus adjustment wheel 8 Drive module (BIOM® 5c and BIOM® 5cl only)
Fig. 6-1: Device Overview, BIOM® 5 with reduction lens and ophthalmoscopy loupe
8
1
2
3
4
5
6
7

6 Device Description
Instruction Manual BIOM® 5 (G/55400/1218/en) 9 / 36
6.1 Mode of Operation of the BIOM®5
The BIOM® 5 is used in conjunction with an SDI (Stereoscopic Diagonal
Inverter) to erect the image for non-contact, wide-angle observation of
the fundus and vitreous body. If the matching OCULUS SDI® is used, full
compatibility with the BIOM® 5 models is guaranteed.
The combination of surgical microscope and the optical components of
the BIOM® 5 allows examination of the vitreous chamber under
stereoscopic conditions. The BIOM® 5 works as an indirect
ophthalmomicroscope without corneal contact during the surgery.
The patient’s eye ball can be moved freely during the surgery. Peripheral
fundus portions are thus easy to examine. This combined optical system
achieves a fundus observation of approx. 125° in total.
The optical system of the BIOM® 5 consists of the reduction lens and the
front loupe. The reduction lens provides a virtually constant distance
between the patient’s eye and the surgical microscope when the BIOM®
5 is swung in or swung out. The reduction lens reduces the focal length
of the microscope objective lens.
The position of the reduction lens with respect to the surgical microscope
is preset.
The height adjustment of the front loupe is used for focussing the BIOM
image. The distance between the surgical microscope and the front loupe
is set using the adjusting wheel at the BIOM® 5.
For the BIOM® 5c/cl only:
Press the combination foot switch to focus by means of the electric
motor.
This height adjustment of the front loupe brings the fundus image into
the focal point of the microscope objective.
As the image is completely reversed when the BIOM® 5 is used, optimal
use is only guaranteed in conjunction with a stereoscopic diagnonal
inverter (SDI®). The SDI® rights the complete image reversal and can be
switched on and off as required.
If a BIOM® connecting spacer is used, this serves to focus the BIOM® 5c,
the image is erected by an inverter.

7 Transport and Storage
10 / 36 Instruction Manual BIOM® 5 (G/55400/1218/en)
7 Transport and Storage
Attention
Equipment damage due to improper transport and storage
Transport the BIOM® 5 with care.
Store the BIOM® 5 in accordance with the transport and storage
requirements, the applicable national regulations and the
regulations of your hospital. See also sec. 17, page 33
8 Initial Operation
8.1 Before Initial Operation
Remove the BIOM® 5 and its accessories from the packaging.
Clean, disinfect and sterilise the BIOM® 5 before putting it into use
for the first time, sec. 12, page 26.
Installation and instruction in the use of the BIOM® 5 and its accessories
will be undertaken by an OCULUS employee or by an OCULUS authorized
dealer.
8.2 Before First Use
Make sure that the BIOM® 5 and its components have been cleaned,
disinfected and sterilised, also refer to the conditioning instructions

9 Use of the BIOM® 5
Instruction Manual BIOM® 5 (G/55400/1218/en) 11 / 36
9UseoftheBIOM
®5
9.1 Choose the Appropriate Optics
Use the appropriate reduction lens for the surgical microscope’s
objective.
Select the appropriate front loupe for the surgery.
Disposable Loupe Sets
The following front loupes can be steam-autoclaved:
53603
Wide-field high definition loupe
53602
Wide-field (E) loupe
53606
Hi-res loupe
53601
Wide-field loupe for deep-set
eyes
53604
90D loupe
53605
Wide Field High Definition Mini
loupe
Objective
Lens
BIOM®Model BIOM®Optic Set
f=175 mm BIOM® 5m (55462)
BIOM® 5c (55400)
HD Professional 54411
f=200 mm BIOM® 5ml (55463)
BIOM® 5cl (55403)
HD Professional 54412
f=200 mm BIOM® 5m (55462)
BIOM® 5c (55400)
HD Flex 54415

9 Use of the BIOM® 5
12 / 36 Instruction Manual BIOM® 5 (G/55400/1218/en)
9.2 Mounting the BIOM®5
Make sure that all components are present and are sterile.
Example: Components of the BIOM®5cl
1 BIOM® 5cl 4 Ophthalmoscopy magnifying loupe
2 Adaptor plate 5 Cable duct (BIOM® 5c/cl only)
3 Drive belt (BIOM® 5c/cl only) 6 Reduction lens
Fig. 9-1: Components of the BIOM® 5cl
6
1
2
4
5
3

9 Use of the BIOM® 5
Instruction Manual BIOM® 5 (G/55400/1218/en) 13 / 36
Insert the reduction lens. Then turn the reduction
lens clockwise until it reaches the stop.
Plug in the adaptor plate until it reaches the stop.
Attention
Risk to the patient if the BIOM® 5 is plugged in
incorrectly
If you do not plug in the BIOM® 5 correctly, you will
get a decentred fundus image.
Insert the loupe until it reaches the stop. The BIOM® 5ml is now fully mounted.
Fig. 9-2: Mounting the components
1
2
3
4

9 Use of the BIOM® 5
14 / 36 Instruction Manual BIOM® 5 (G/55400/1218/en)
Additionally for BIOM®5c/cl:
You must insert the drive belt. You can put on a cable duct. The cable
duct is used to keep the connecting cable of the drive unit at the BIOM®
5c/cl away from unsterile parts of the microscope.
Insert the drive belt Fasten the cable duct at the connector plug first
Then push the semi-open duct part over the
cable.
Fig. 9-3: Mounting the drive belt and cable duct
5
6

9 Use of the BIOM® 5
Instruction Manual BIOM® 5 (G/55400/1218/en) 15 / 36
9.3 Under Sterile Conditions: Test the Safety Functions
Attention
Risk of injury due to improper function
Only use the BIOM® 5 when the following functions have been
checked and are in proper working order.
Before each use, check that
 The unit is in technically perfect condition.
All connections and fasteners that can be loosened are properly
tightened and are in a safe condition.
The dovetail mount for the adaptor is securely fastened at the
microscope.
Flip the BIOM® 5 towards the adaptor plate. Make
sure that the housing body can be shifted without
resistance.
Slide the safety rod of the loupe holder up and
down several times to check that it runs
smoothly.
Check that the knob turns easily and shorten the
total length of the BIOM® 5 until the adjuster is
at the fully up position.
Check whether all fastening screws are present
(e.g. screws at the feather key of the safety rod).
The control mark (1) must be below the guide.
Fig. 9-4: Test the safety functions
1
2
3
1

9 Use of the BIOM® 5
16 / 36 Instruction Manual BIOM® 5 (G/55400/1218/en)
9.4 Connect the BIOM
®
5 to the Microscope
Attention
Risk of injury to the patient if mounting is done incorrectly
Never mount the BIOM® 5 over the patient.
Push the sterile cap onto the knurled screw. Push the adaptor plate with the BIOM® 5 into the
dovetail mount at the microscope until it reaches
the stop.
Secure the adaptor into place with the knurled
screw.
Fig. 9-5: Connect the BIOM® 5 to the microscope
1
2
3