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
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