Oculus Biom 5 User manual

OCULUS BIOM® 5

INSTRUCTION MANUAL

Binocular Indirect Ophthalmo-Microscope

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.

i / iii Instruction Manual BIOM® 5 (G/55400/0215/en)

Table of Contents

1 Scope of Delivery........................................................................................................................1

2 BIOM® 5 Symbols .......................................................................................................................2

3 Structure of the Documentation.......................................................................................... 3

4 Safety Instructions.....................................................................................................................3

5 Intended Use.................................................................................................................................6

6 Device Description......................................................................................................................7

7 Transport and Storage.............................................................................................................. 8

8 Initial Operation ..........................................................................................................................9

9 Use of the BIOM® 5 ...................................................................................................................9

10 Troubleshooting ........................................................................................................................20

11 Change the Drive Module .....................................................................................................23

12 Cleaning, Sterilisation and Maintenance........................................................................23

13 Disposal of Used Devices.......................................................................................................24

14 Guarantee and Service ...........................................................................................................25

15 Declaration of Conformity....................................................................................................27

16 Order Information, Accessories and Replacement Parts..........................................28

17 Technical Data............................................................................................................................30

Table of Contents

4.1 About this Manual ......................................................................................................3

4.1.1 Used Graphic Symbols.........................................................................3

4.2 Safety Instructions for Use ..................................................................................... 4

4.2.1 Instructions for Use ..............................................................................5

6.1 Mode of Operation of the BIOM® 5.....................................................................8

8.1 Before Initial Operation ............................................................................................9

8.2 Before First Use............................................................................................................9

9.1 Choose the Appropriate Optics..............................................................................9

9.2 Mounting the BIOM® 5...........................................................................................10

9.3 Under Sterile Conditions: Test the Safety Functions..................................13

9.4 Connect the BIOM® 5 to the Microscope........................................................14

9.5 Swing the BIOM® 5 to the Parked Position....................................................16

9.6 Make the Basic Settings at the Microscope ...................................................16

9.7 Instructions for Focussing the BIOM® 5m/ml...............................................17

9.8 During the Surgery ...................................................................................................18

9.9 After the Surgery.......................................................................................................18

14.1 Assumption of Liability for Functions and Damage ...................................25

14.2 Manufacturer and Service Address....................................................................26

16.1 Components for the BIOM® 5..............................................................................28

16.2 Sterilisation Components.......................................................................................30

16.3 Image Reversal Systems.........................................................................................30

Instruction Manual BIOM® 5 (G/55400/0215/en) ii / iii

Table of Contents

iii / iii Instruction Manual BIOM® 5 (G/55400/0215/en)

1Scope of Delivery

BIOM® 5c

Component Order no.

BIOM® 5c

 Version BIOM® 5c
 Version BIOM® 5cl
 Sterilisable drive belts (10 of)
 Sterilisable cable duct (1 of)

BIOM® 5m

1 Scope of Delivery

55400

55403

 Version BIOM® 5m
 Version BIOM® 5ml

 Instruction Manual
 Conditioning Instructions

 Box with cover

G/55400/xxx/en

G/55185/xxx/en

55462

55463

Additional components needed for BIOM® 5

Needed Supplementary Components see

Reduction lens and front loupe sect. 9.1, page 9

Adaptor for surgical microscope (if necessary,

sect. 16.1, page 28

with additional adaption modules).

Stereoscopic diagonal inverter for erecting the

sect. 16.3, page 30

image

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.

Instruction Manual BIOM® 5 (G/55400/0215/en) 1 / 32

2 BIOM® 5 Symbols

1

2

3

7

6

4

5

1

2

3

7

10

8

94

5

7

2BIOM® 5 Symbols

1 Company logo + manufacturer 6 Device type
2 Serial number of the device 7 Name of device
3 Matrix 8 Applied part of the type B (BIOM® 5c and BIOM® 5cl only)
4 Heed Instruction Manual 9 Disposal with household waste is prohibited (BIOM® 5c and

BIOM® 5cl only)

5 CE marking 10 Protection class (BIOM® 5c and BIOM® 5cl only)

Fig. 2–1: Examples: BIOM® 5ml and BIOM® 5 symbols:

2 / 32 Instruction Manual BIOM® 5 (G/55400/0215/en)

3 Structure of the Documentation

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

4.1 About this Manual

 Carefully read through the instruction manual.
 Keep the instruction manual in good condition, near to the device.
 Observe the legal requirements for accident prevention.
 Please read the separate operating instructions for the SDI® 4 and

accessories.

 Please read the special packing notice included with the adaptor 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.

4.1.1 Used Graphic Symbols

Attention

Denotes a potentially hazardous situation which can easily result in minor
physical injury or property damage.

Instruction Manual BIOM® 5 (G/55400/0215/en) 3 / 32

4 Safety Instructions

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.

4.2 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.

Transport and storage instructions

Refer to the notes in sect. 7, page 8.

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.

Installation 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.

4 / 32 Instruction Manual BIOM® 5 (G/55400/0215/en)

4 Safety Instructions

 BIOM® 5c and BIOM® 5cl: Do not use excessive force to connect the

electrical connectors to the OCULUS SDI® 4c.
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.

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 path),
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, sect. 9.7, page 17.

More information can be found in the Application tips: BIOM® 5 and
can be downloaded from the OCULUS website.

Instruction Manual BIOM® 5 (G/55400/0215/en) 5 / 32

5 Intended Use

Troubleshooting

 If a fault occurs that you cannot rectify with the help of the trouble-

shooting table (page 21), 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.

EMC and electrical safety information

The BIOM® 5c, a connected SDI® 4c and a microscope form a medical
electrical system (ME system) according to 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

5 Intended Use

This binocular indirect ophthalmomicroscope (BIOM® 5) is used for non­contact 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.

 Make certain that the following connection types are used for the

power supply:

6 / 32 Instruction Manual BIOM® 5 (G/55400/0215/en)

6 Device Description

8

1

2

3

4

5

6

7

BIOM® 5c BIOM® 5m

6 Device Description

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

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

(not supplied with the BIOM®)

Instruction Manual BIOM® 5 (G/55400/0215/en) 7 / 32

7 Transport and Storage

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.

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 re-

quirements, the applicable national regulations and the regulations of
your hospital. See also sect. 17, page 30

8 / 32 Instruction Manual BIOM® 5 (G/55400/0215/en)

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, sect. 12, page 23.

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

8 Initial Operation

9 Use of the BIOM® 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.

The following front loupes can be steam-autoclaved:

53603
Wide-field high definition loupe

53606
Hi-res loupe

53602
Wide-field (E) loupe

53601
Wide-field loupe for deep-set eyes

53604
90D loupe

Instruction Manual BIOM® 5 (G/55400/0215/en) 9 / 32

9 Use of the BIOM® 5

6

1

2

4

5

3

Disposable Loupe Sets

Objective
Lens

for f=175 mm BIOM® 5m (55462)

BIOM® Model BIOM® Optic Set

HD Professional 54411

BIOM® 5c (55400)

for f=200 mm BIOM® 5ml (55463)

HD Professional 54412

BIOM® 5cl (55403)

for f=200 mm BIOM® 5m (55462)

HD Flex 54415

BIOM® 5c (55400)

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

10 / 32 Instruction Manual BIOM® 5 (G/55400/0215/en)



1

2

3

4

Insert the reduction lens. Then turn the reduction
lens clockwise until it reaches the stop.

9 Use of the BIOM® 5

 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

Instruction Manual BIOM® 5 (G/55400/0215/en) 11 / 32

9 Use of the BIOM® 5

5

6

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

12 / 32 Instruction Manual BIOM® 5 (G/55400/0215/en)

9 Use of the BIOM® 5

1

2

3

1

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.

 Flip the BIOM® 5 towards the adaptor plate. Make

sure that the housing body can be shifted without
resistance.

 Check that the knob turns easily and shorten the

total length of the BIOM® 5 until the adjuster is at
the fully up position.

Fig. 9–4: Test the safety functions

 Slide the safety rod of the loupe holder up and

down several times to check that it runs smoothly.

 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.

Instruction Manual BIOM® 5 (G/55400/0215/en) 13 / 32

9 Use of the BIOM® 5

1

2

3

 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.

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

14 / 32 Instruction Manual BIOM® 5 (G/55400/0215/en)

9 Use of the BIOM® 5

For BIOM® 5c/cl only

For the BIOM® 5c/cl, you must connect the control cable with the SDI® 4c.

Fig. 9–6: BIOM® 5c/cl: Connecting the control cable

 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.

 Connect the cable at the SDI® 4c. The connector locks into place

automatically.

Instruction Manual BIOM® 5 (G/55400/0215/en) 15 / 32

9 Use of the BIOM® 5

9.5 Swing the BIOM® 5 to the Parked Posi-

tion

 During extra-ocular surgery phases, swing the BIOM® 5 out of the

beam path into the parked position.

 When swinging out the BIOM, push in the safety rod, including the

front loupe, with you finger, until the rod reaches the limit stop.

Fig. 9–7: BIOM® 5cl in the working position Fig. 9–8: BIOM® 5cl at parked position

When swinging into the beam path:

 Lift up safety rod and only release it again when the swung-in end

position has been reached.

9.6 Make the Basic Settings at the

Microscope

 Adjust the microscope to the anterior eye segment and perform the

surgery steps under microscope illumination, including starting the
infusion.

16 / 32 Instruction Manual BIOM® 5 (G/55400/0215/en)

9 Use of the BIOM® 5

9.7 Instructions for Focussing the BIOM®

5m/ml

Focussing on the BIOM® 5m is done manually with the adjusting knob, and
on the BIOM® 5c/cl, also by means of a foot pedal.

Fig. 9–9: Focussing with the adjusting knob

Attention

Risk of eye injury due to poor visibility conditions

The use of intraocular instruments in poor visibility conditions for the
surgeon can result in injury to the patient’s eyes.

 When focussing with the BIOM® 5, heed the following instructions.

 Before you begin to focus the BIOM® 5, check the distance from the

ophthalmoscopy magnifying loupe to the patient’s eye.

 When focussing the BIOM® 5, make sure that:

 The microscope is left at this position (height) after the surgical

steps have been performed at the anterior section.

 The BIOM® 5 has been set to the shortest length before you swing

it into the working position.

 The ophthalmoscopy loupe does not touch the eye.
 You do not adjust the height of the microscope.
 You do not use the microscope’s focussing function.

Instruction Manual BIOM® 5 (G/55400/0215/en) 17 / 32

9 Use of the BIOM® 5

Special Case „Air-filled eye“

 During the fluid-air-exchange: Turn the focussing knob of the BIOM®

5 until the front lens reaches the highest position.

 Use the microscope’s fine focus to enlarge the image section.

For the BIOM

®

5c/cl only (focussing with electric motor):

Focussing of the BIOM® 5c/cl is done by the surgeon by means of the
combination foot switch while observing through the microscope.

 Only use the BIOM® 5c/cl’s motorized focussing function when the

front loupe is far enough away from the patient’s eye.

 The surgeon may only use the motorized focussing function when the

distance between the ophthalmoscopy loupe and the eye is
simultaneously monitored.

 It must be ensured that the surgeon can stop the motorized focussing

function at any time.

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 path),
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.

9.8 During the Surgery

 Make sure that the cornea is sufficiently moistened with a suitable

solution.

9.9 After the Surgery

After the surgery, you must remove the BIOM® 5 from the microscope.

You must bring the BIOM® 5 and its components to the conditioning
station immediately after the surgery.

18 / 32 Instruction Manual BIOM® 5 (G/55400/0215/en)

9 Use of the BIOM® 5

Attention

Incorrect detaching is hazardous to the patient

 Never detach the BIOM® 5 over the patient.

 To dismount the das BIOM® 5, swing it to its standby position.

BIOM® 5m/ml

 Pull the BIOM® 5 off the adaptor plate.
 Loosen the knurled screw, Fig. 9–5, page 14, Fig. 3.
 Pull the adaptor plate off the dovetail mount.

Fig. 9–10: Pull off the adaptor plate

 Bring the BIOM® 5 and its components to the conditioning station

immediately.

®

BIOM

Fig. 9–11: BIOM® 5c/cl: Disconnect the plug-in connectors

5c/cl

Pull the plug of the BIOM® 5c/cl out of the coupler at the SDI® 4c housing.
To do so, take hold of the connector at the sleeve to unlock the connector.

Instruction Manual BIOM® 5 (G/55400/0215/en) 19 / 32

10 Troubleshooting

Note

Risk of damage to the unit if the plug is pulled incorrectly

If you pull on the cable, you could damage it and the complete drive module
would then have to be exchanged.

 Always grip the plug of the BIOM® 5c/cl at the sleeve, in order to

release the lock.

 Pull the BIOM® 5 off the adaptor plate
 Loosen the knurled screw, Fig. 9–5, page 14, Fig. 3.
 Pull the adaptor plate out of the dovetail mount, Fig. 9–10, page 19.
 Bring the BIOM® 5 and its components to the conditioning station

immediately.

10 Troubleshooting

Attention

If a fault occurs which you are unable to correct by following the
instructions below, label the device as “out of order” and contact our service
department. (Address: sect. 14.2, page 26).

 Never operate a damaged BIOM® 5.
 Before returning to OCULUS: Condition the BIOM® 5 and its

components in accordance with the conditioning instructions.

20 / 32 Instruction Manual BIOM® 5 (G/55400/0215/en)

Troubleshooting guide – BIOM® 5

Fault Possible cause Remedy

10 Troubleshooting

The safety rod of the BIOM® 5 is
stuck

BIOM® 5 must not be used in this
state!

Loose adaptor

Dovetail mount wobbles

 Deposits on the BIOM® 5 due to

inadequate sterilisation

 Foreign body in safety rod

extension channel

 Safety rod is bent

 The locking screws are loose
 Screws are loose

 Carefully mechanical cleaning

and change to a better

demineralised water, clean the

BIOM® 5 ultrasonically

 Careful mechanical cleaning and

removal of the foreign body

 Clean the BIOM® 5 in the ultra-

sound bath

 Treat the rod with a suitable,

silicone oil-free lubricant prior

to the next sterilisation

 Send the BIOM® 5 to OCULUS

Service

 Tighten the locking screws by

hand

 Tighten the screws with a

suitable screwdriver

Image is cropped or out-of-center  The SDI®, other components, or

the BIOM® 5 adaptor are
incorrectly mounted at an angle

 The magnifying lens clip is bent

or mechanically damaged

Unclear image  Soiled glass surfaces

 The glass surfaces have been

damaged during sterilisation

 The glass surfaces have been

mechanically damaged

 Ophthalmoscopy loupe is

touching the eye

 Dry patient cornea

 Correct the assembly

 Send the loupe to

OCULUS Service for

readjustment

 Clean the glass surfaces



Change the sterilisation method,

replace lenses if necessary

 Greater care in use and storage

of lenses; replace if necessary

 Choose the correct work

distance, clean the loupe

 Moisten the cornea regularly

with a suitable solution

Instruction Manual BIOM® 5 (G/55400/0215/en) 21 / 32

10 Troubleshooting

Fault Possible cause Remedy

Unfocussed image  Incorrect adjustment of the

BIOM® 5

 Focus the BIOM® 5 in

accordance with the
instructions

 A reduction lens is not being

used

 The reduction lens is not

compatible with the
microscope objective

Fundus view is too narrow  Too much distance between

the ophthalmoscopy lens and
the eye

 Magnification of the

microscope system to high

 Use a reduction lens
 Check the engraving on the

reduction lens and exchange
the reduction lens, if necessary
(see sect. 9.1, page 9

 Carefully reduce the distance

using the microscope fine
adjustment mechanism

 Reduce magnification of the

microscope

The eye or the lens reflects strongly  The microscope light is on  Turn the light off, illuminate

only intraocular

The BIOM® 5 cannot be detached
from the adaptor

 BIOM® 5 has not been tilted to

the side

 Mineral deposits on the con-

necting components of the

 Tilt the BIOM® 5 to the side
 Place the BIOM® 5 and adaptor

into an ultrasound bath (for
approx. 5 min)

BIOM® 5 and adaptor

No function whatsoever when the
combination control unit is actuated

 The combination control unit

is not connected to the SDI®
4c

 The SDI® 4c is not connected

to the 6V-15V power supply

 Power failure or power socket

is not active

 These are not active when the

sockets at the microscope
stand are in use

 Establish the connection to the

SDI® 4c

 Establish the connection to the

6V-15V power supply

 Inform the in-house

electrician

 Use the 6V-15V plug

transformer

 Use the mechanical adjusting

element or adjusting wheel

 Activate the sockets in

accordance with the
instructions for the stand

 Contact the microscope

manufacturer for assistance

22 / 32 Instruction Manual BIOM® 5 (G/55400/0215/en)

11 Change the Drive Module

Fault Possible cause Remedy

Malfunction when using the
combination control unit

 5-pole plug has been forcibly

plugged in the wrong way
round

Motorized focussing not possible with
the

BIOM® 5c/cl when using the

combination control unit

 BIOM® 5c/cl connector not

plugged into the SDI® 4c
properly

 Defective drive belt

 Drive belt missing

 Connecting cable damaged

 Defective drive module

11 Change the Drive Module

 Plug it in the right way round

(pay attention to the lug and
slot of the polarity reversal
protection)

 Plug in the connector correctly

 Install a new, sterile drive belt,

or focus
manually using the focussing
knob at the BIOM® 5c/cl

 Install a sterile drive belt
 Exchange the drive module
 Exchange

 Proceed in the manner described in the assembly instructions for the

drive module.

12 Cleaning, Sterilisation and Maintenance

Attention

Risk of infection due to improper reconditioning

 Bring the BIOM® 5 and its components to the conditioning station im-

mediately after the surgery.

 Pay attention to the separate conditioning instructions.

Instruction Manual BIOM® 5 (G/55400/0215/en) 23 / 32

13 Disposal of Used Devices

13 Disposal of Used Devices

 Dispose of the BIOM® 5 in compliance with the corresponding legal

requirements. Comply with the hygiene and disposal regulations of
the hospital or clinic.

®

BIOM

In accordance with Directive 2002/96/EC of the European Parliament and of
the Council dated 27 January 2003, and also the Law of the Federal Republic
of Germany on the Commercialization, Recall and Environmentally
Compatible Disposal of Electrical and Electronic Equipment, old electrical
and electronic equipment must be sent out for recycling and may not be
disposed in household trash.

5c

24 / 32 Instruction Manual BIOM® 5 (G/55400/0215/en)

14 Guarantee and Service

Please note the following guarantee provisions:

 Prior to and while operating the device, it is important that you heed

the instruction manual and safety instructions.

 The BIOM® 5 carries a guarantee to which you are entitled in

accordance with the legal provisions.

 If modifications are made to the BIOM® 5 by unauthorized persons, all

guarantee claims shall be voided. Improper modifications and repairs
may result in considerable hazards to users and patients.

 Any transport damage must be reported immediately to the shipping

company. Have the transport damage noted on the bill of lading so
that complaint handling and compensation of damages can proceed
in an orderly manner.

 In general, our Business and Shipping Terms applicable on the date of

purchase shall apply.

14 Guarantee and Service

14.1 Assumption of Liability for Functions and Damage

OCULUS will only accept responsibility for the safety, reliability and
serviceability of the BIOM® 5 if the unit is used in compliance with the
following terms:

 Only use the equipment in conformance with this instruction manual.
 There are no parts on the BIOM® 5 that require maintenance or repair

by the user. If assembly work, modifications, adjustments, repairs,
changes or service are performed by unauthorized personnel, or if the
BIOM® 5 is improperly maintained or handled, then any liability by
OCULUS is voided.
Exception: Exchange of the BIOM® 5 drive module

 If the above-mentioned work is performed by authorized persons, then

a certification of the work shall be requested from the service
technician in which any changes to factory defaults or to operating
ranges shall be stated. This certification must contain the date of
performance and statement of the performing firm, with signature.

 If requested, OCULUS will provide to the service technician a list of

spare parts and additional descriptive material for this purpose.

 Make certain that only original OCULUS parts are used.

Instruction Manual BIOM® 5 (G/55400/0215/en) 25 / 32

14 Guarantee and Service

14.2 Manufacturer and Service Address

Supplemental information is available from our Service Department or from
our authorized representatives. Manufacturer and Service Address:

Germany:

OCULUS Optikgeräte GmbH

Münchholzhäuser Straße 29

35582 Wetzlar

Germany

Tel.: [phone]

Fax: [phone]

E-mail: [e-mail]

www.oculus.de

USA:
OCULUS, Inc.
17721 59th Avenue NE
Arlington
WA 98223-1337
Tel. [phone]
Fax [phone]
e-mail: [e-mail]
web: http://www.oculususa.com

26 / 32 Instruction Manual BIOM® 5 (G/55400/0215/en)

15 Declaration of Conformity

15 Declaration of Conformity

Instruction Manual BIOM® 5 (G/55400/0215/en) 27 / 32

16 Order Information, Accessories and Replacement Parts

16 Order Information, Accessories and

Replacement Parts

16.1 Components for the BIOM® 5

Basic unit

Component Order no.

BIOM® 5c 55400

BIOM® 5cl 55403

BIOM® 5m 55462

BIOM® 5ml 55463

Accessories for the BIOM

Component Order no.

Drive belts (pack of 10) 54176

Cable duct (pack of 5) 54178

Optical components for BIOM

Component Order no.

Reduction lens for f = 175 mm 55401

Reduction lens for f = 200 mm 55405

Optical components for BIOM

Component Order no.

Reduction lens for f = 200 mm 55404

®

5c / BIOM® 5cl

®

5m/BIOM® 5c

®

5ml/BIOM® 5cl

Ophthalmoscopy loupes (autoclavable loupes)

Component Order no.

Wide-field lens, diameter 12 mm for BIOM® 5 53601

Wide-field (enhanced) lens for BIOM® 5 53602

Wide-field, high definition loupe for BIOM® 5 53603

90 D lens for BIOM® 5 53604

Hi-res loupe for BIOM® 5 53606

28 / 32 Instruction Manual BIOM® 5 (G/55400/0215/en)

16 Order Information, Accessories and Replacement Parts

Adaption components for BIOM® 5

Component Order no.

For Alcon LuxOR

 Adaptor plate

For Alcon LuxOR

 Adaptor plate
 Dovetail mount

Adaptor plate for Kaps SOM 55423

Adaptor for Leica M500/M501/M620 55445

Adaptor for Leica M650/M690 55446

Adaptor for Leica M822 55447

Adaptor for Leica M820/ M841/ M844 55448

TM

with Q-Vue

TM

without Q-Vue

55423

55423
54856

Adaptor for Möller Ophtamic 900/ Hi-R 900/EOS 900/

55440

Allegra 900

Adaptor for Takagi OM 8/OM 18 55418

Adaptor for Topcon OMS 600/OMS 610/ OMS 650/

55441
OMS 710/
OMS 800 Pro/ OMS 800 Standard/
OMS 850 Pro/ OMS 850 Standard

Adaptor plate for Zeiss:

55423
OPMI VISU 150/160
OPMI VISU 200/210
Lumera® 700
Lumera® T
Lumera® i
OPMI CS with Retrolux /CS
OPMI CS with Retroscope CS
OPMI MDI/MDO/MDU

Adaptor plate for Zeiss OPMI 1/6 55424

Dovetail for Zeiss OPMI VISU/Lumera® 54511

Spacer for ring support objective on Zeiss OPMI 6 54535

Adaption part for 0° co-observation holder on Zeiss OPMI 6 54536

Dovetail for Zeiss OPMI 1/6 54537

Dovetail for Zeiss MDO/Retrolux CS 54538

Spacer Zeiss OPMI MD 54539

Spacer for Möller Ophtamic 900 mit 20°-illumination unit 54639

Instruction Manual BIOM® 5 (G/55400/0215/en) 29 / 32

17 Technical Data

16.2 Sterilisation Components

Component Order no.

Sterilisation container with insert for BIOM5 and accessories

Insert for sterilisation container

Paper filters for sterilisation container (100 pcs/box)

16.3 Image Reversal Systems

Component Order no. Component Order no.

SDI® 4c (6-15 V, 0.5 A) 54320 SDI® 4eli (6-15 V, 0.5 A) Leica 54332

SDI® 4e (6-15 V, 0.5 A)) 54300 SDI® 4m (mechanical) 54302

SDI® 4c (6-15 V, 0.5 A) Leica 54330 SDI® 4m (mechanical) Leica 54312

SDI® 4e (6-15 V, 0.5 A) Leica 54310 SDI® 4b (mechanical) 54301

SDI® 4cli (6-15 V, 0.5 A) Leica 54331 SDI® 4b (mechanical) Leica 54311

17 Technical Data

55180

55185

55190

Dimensions of the BIOM® 5

BIOM® 5m and BIOM® 5c BIOM® 5ml and BIOM® 5cl

Dimensions (W x D x H) 63 x 112 x 110-145 mm 63 x 112 x 124-160 mm

Total height approx. 123-158 mm approx. 137-173 mm

Travel of safety rod approx. 29 mm

approx. 29 mm

Weight

Product Weight Product Weight

BIOM® 5m

BIOM® 5ml

BIOM® 5c

approx. 186 g

approx. 190 g

approx. 250 g

BIOM® 5cl

Reduction lens

Front loupe: depending on the
model

approx. 260 g

approx. 30 g

approx. 3 — 10 g

30 / 32 Instruction Manual BIOM® 5 (G/55400/0215/en)

Ambient Conditions, Transport and Storage Requirements for Optics

17 Technical Data

Temperature

Humidity

Air pressure

Operating conditions Transport requirements for BI-

OM® 5c and BIOM® 5cl, in acc.

with DIN EN 60601-1

+10°C to +40°C -40°C to +70°C -10°C to +55°C

30% to 70% 10% to 95% 10% to 95%

700 hPa to 1060 hPa 500 hPa to 1060 hPa 700 hPa to 1060 hPa

Storage requirements for BI-

OM® 5c and BIOM® 5cl, in
acc. With DIN EN 60601-1

These values apply to all BIOM® versions.

Sterilization and Disinfection Procedures

BIOM® 5

Reduction lens (only the reduction lenses listed in this manual) Steam autoclave, 134°C

Ophthalmoscopy loupe (only the loupes listed in this manual) Steam autoclave, 134°C

Adaptor Steam autoclave, 134°C

Drive belt Steam autoclave, 134°C

Steam autoclave, 134°C

BIOM® 5c and BIOM® 5cl: Classification according to IEC 60601 - 1

Type of protection against electric shock

Protection class 2

Degree of protection against electric shock Type B

Degree of protection against harmful penetration of water IPX8

Power supply via SDI® 4

Miscellaneous

Expected service life 4 years

Instruction Manual BIOM® 5 (G/55400/0215/en) 31 / 32

17 Technical Data

The unit can be attached to the following microscopes:

Manufac­turer

Alcon LuxOR

Zeiss: OPMI 1/6

Microscope

TM

OPMI CS with Retroscope 1/3 /CS

OPMI CS with Retroscope T/CS

OPMI MDI/MDO/MDU

OPMI VISU 150/ VISU 160

OPMI VISU 200 / VISU 210

OPMI Lumera

OPMI Lumera i

OPMI Lumera T

OPMI Lumera 700

Leica M500 / M501 /

M820 / M822 / M840 / M841 M844

M620 / M650 / M690

Möller Ophtamic 900 Hi-R 900 EOS 900 Allegra 900

Takagi OM 8 OM 18

Topcon OMS 600 / OMS 610 / OMS 650 OMS 110

OMS 710

OMS 800 Standard
OMS 800 Pro

OMS 850 Standard
OMS 850 Pro

Kaps SOM

32 / 32 Instruction Manual BIOM® 5 (G/55400/0215/en)