OCULUS BIOM 4 Manual de usuario
INSTRUCTION MANUAL
Binocular Indirect OphthalmoMicroscope
i / ii
Notes on this instruction manual
Thank you for your purchase and the trust you have placed in this OCULUS product. The
BIOM 4 has been manufactured and tested according to strict quality criteria. You have
selected a modern and well-engineered product.
The Binocular Indirect Ophthalmomicroscope, BIOM 4, is an advancement of the BIOM.
It successfully combines an ophthalmoscope with an operating microscope. Without
corneal contact, it provides an optimum image of the vitreous space under stereoscopic
conditions with a panoramic, up to 120° view of the fundus.
To ensure safe operation, it is essential that you use the device correctly. For this reason
you should familiarise yourself thoroughly with the contents of this instruction manual
before operating the device. In particular, pay attention to the safety instructions.
This operating manual describes the following BIOM 4 models:
BIOM 4c and 4cl (long version)
BIOM 4m and 4ml (long version)
Except for the difference in length, the respective long version is identical with re-
spect to handling and features. The long version should be used on microscopes with
focal length of 200 mm or more.
Due to ongoing development, the diagrams shown in the instruction manual may depict
minor changes to the actual device delivered.
If you have any queries or would like additional information about your device, do not
hesitate to call or send us a fax. Our service team will gladly assist.
OCULUS Optikgeräte GmbH
OCULUS is certified according to DIN EN ISO 9001 and 13485, setting high standards of
quality where development, manufacture, quality assurance and service regarding the
entire range of products are concerned.
Table of Contents
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Table of Contents
1 Scope of Delivery......................................................................................................................................1
2 Safety Instructions...................................................................................................................................2
2.1 Pictogram definitions...............................................................................................................2
2.2 Safety instructions concerning organisation .................................................................2
2.3 Safety instructions for use of the BIOM 4.......................................................................3
2.3.1 Safety instructions for focusing the BIOM 4 ..............................................4
3 Proper Usage..............................................................................................................................................5
4 Transport of the BIOM 4........................................................................................................................5
5 Device Description ...................................................................................................................................6
5.1 Overview of device components..........................................................................................6
5.2 Mode of operation of the BIOM 4.......................................................................................6
5.3 To use a BIOM 4c on SDI 3c...................................................................................................7
6 Operation.....................................................................................................................................................8
6.1 First-time operation..................................................................................................................8
6.2 Daily operation............................................................................................................................8
7 Use of the BIOM 4....................................................................................................................................9
7.1 Prior to each use.........................................................................................................................9
7.2 Assembly and handling..........................................................................................................10
7.3 Preparing the BIOM 4 for use .............................................................................................12
7.3.1 Under sterile conditions: Perform a safety function test ....................13
7.3.2 Connect the BIOM 4 to the microscope......................................................14
7.3.3 Swing the BIOM 4 to the parked position..................................................16
7.4 Practical application tips for the BIOM 4.......................................................................21
8 Troubleshooting......................................................................................................................................22
9 Exchanging the BIOM 4c Drive Module........................................................................................24
10 Care and Maintenance.........................................................................................................................24
11 Disposal of Used Devices ....................................................................................................................27
12 Warranty and Service ...........................................................................................................................27
12.1 Warranty......................................................................................................................................27
12.2 Assumption of liability for functions and damage ....................................................27
12.3 Manufacturer’s and service addresses ............................................................................28
13 Declaration of Conformity .................................................................................................................28
14 Order Information, Accessories and Replacement Parts........................................................29
15 Technical Data .........................................................................................................................................32
Table of Contents
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1 Scope of Delivery
Instruction manual BIOM 4 (G/54400/1011/en) 1 / 34
1ScopeofDelivery
BIOM 4m
BIOM 4c
Supplementary components needed for BIOM 4c and 4m
Please read the special packing notice included with the adapter and accessories.
If you have also selected our company’s Stereoscopic Diagonal Inverter (SDI 4), you
will find this unit and its accessories in a lined plastic carrying case.
Please read the separate operating instructions for the SDI 4 and accessories.
☞
Note
We reserve the right to change the scope of delivery in line with ongoing technical devel-
opment.
Component
BIOM 4m
Instruction manual
Box with cover
Conditioning manual
Component
BIOM 4c
Sterilizable drive belts (10 of)
Sterilizable cable duct
Drive unit as spare part (item no. 54405)
Instruction manual
Box with cover
Conditioning manual
Needed supplementary components
Reduction lens and ophthalmoscopy front lens
Adapter for operating microscope (if necessary, with additional adaption
modules).
Stereoscopic diagonal inverter for erecting the image
2 Safety Instructions
2 / 34 Instruction manual BIOM 4 (G/54400/1011/en)
2 Safety Instructions
2.1 Pictogram definitions
Attention
Indicates a potentially hazardous situation that can result in injury or material damage.
Note
Instructions for use and useful or important information.
☞
Note
Identifies important information about the product or on how to use it, which requires
special attention.
2.2 Safety instructions concerning organisation
The law requires that the manufacturer expressly informs the user about safety aspects
concerning the handling of the device. This chapter contains a summary of the most im-
portant safety-related information.
Attention
Do not operate the unit until you have read and fully understood the entire instruction
manual.
Make sure to keep this instruction manual in a safe place and available to operating
personnel at all times.
Observe the legal regulations with regard to accident prevention.
The unit must not be used if a fault occurs that you cannot rectify. Get in touch with
our service personnel.
2 Safety Instructions
Instruction manual BIOM 4 (G/54400/1011/en) 3 / 34
Attention
Heed unconditionally the instruction manual and safety advice of the operating micro-
scope and of the additional equipment. Familiarize yourself with all safety features and
devices before you put the unit into initial operation.
2.3 Safety instructions for use of the BIOM 4
☞
Note
Before putting this instrument into operation for the first time, the user must be famil-
iarized with it by an Oculus Optikgeräte GmbH representative or an authorized dealer.
Attention
No modifications may be made to this device without the permission of the manufactur-
er.
Only operate the device using original accessory parts supplied by us, and when the
device is in technically correct working order.
Do not use the unit if it is damaged; in this case, get in touch with your supplier.
Observe the legal regulations with regard to accident prevention.
Also comply with the legal provisions in force in your country, and with the hygiene
and waste disposal regulations of the hospital or clinic.
If a fault occurs that you cannot rectify with the help of the troubleshooting table
(sect. 8, page 22), the unit must not be used. Clearly mark the unit as non-operation-
al and get in touch with our service personnel.
The BIOM and all sterilizable BIOM components must be sterilely condi-
tioned prior to the first, and every subsequent use.
It is imperative that you heed the cleaning, disinfection and sterilization instructions
given in the "conditioning manual".
2 Safety Instructions
4 / 34 Instruction manual BIOM 4 (G/54400/1011/en)
Attention
After the BIOM 4 has been swung in into the working position, the following must not be
performed during the proper use:
to use the rough adjustment mechanism of the microscope support under any
circumstances (since the mechanism is not designed for precisely controlled
movement)
to change the height position of the microscope support by mechanical or
motorized means whilst above the operating area
to change the patient´s position by raising/lowering the OP-table
2.3.1 Safety instructions for focusing the BIOM 4
Attention
The following points must be heeded when focusing the BIOM 4:
The BIOM 4 is only needed for visualization of the posterior segment of the eye.
After performing the operation steps at the anterior segment of the eye and outside
of the eye, the microscope should be remaining at this position (height).
Before swinging it to the operating position, make sure that the BIOM has been set
to the shortest overall length.
Before you begin to focus the BIOM 4, check the distance from the ophthalmoscopy
front lens to the patient’s eye.
Monitor the distance between the front lens and the eye while focusing the BIOM 4.
Make sure that the ophthalmoscopy front lens does not come into contact with
the eye.
The microscope must not be adjusted in height, nor must the focusing function of
the microscope be used while the BIOM is being focused.
For BIOM 4c only (focusing done by electric motor):
Only use the motorized BIOM focusing function when the ophthalmoscopy lens is
far enough away from the eye.
The motorized focusing function of the BIOM 4c may only be used by the surgeon,
when this distance is simultaneously monitored.
It must be ensured that the operator can stop the motorized focusing function at
any time.
3 Proper Usage
Instruction manual BIOM 4 (G/54400/1011/en) 5 / 34
3 Proper Usage
This binocular indirect ophthalmomicroscope (BIOM 4) is used for non-contact observa-
tion of surgeries in the posterior segment of the eye.
The BIOM 4 should be used only by physicians and OP personnel who have been corre-
spondingly trained and who have the training, knowledge, and practical experience to en-
sure appropriate handling.
The BIOM 4 is intended for use with compatible designed operating microscopes in hos-
pitals, clinics or other institutions for human medicine.
Use only operating microscopes named by OCULUS Optikgeraete GmbH as adaptable for
the BIOM 4.
Only operate the device using original accessory parts supplied by us, and when the de-
vice is in technically correct working order.
Please note carefully all safety information in this manual.
4 Transport of the BIOM 4
Avoid shock/vibration when transporting the BIOM 4 and the optical modules to a
different location.
Check the unit and its accessories for damage after every transport.
5 Device Description
6 / 34 Instruction manual BIOM 4 (G/54400/1011/en)
5 Device Description
5.1 Overview of device components
fig. 5-1: BIOM 4m with reduction lens and ophthalmoscopy front lens
5.2 Mode of operation of the BIOM 4
The BIOM 4 is used in conjunction with an SDI (Stereoscopic Diagonal Inverter) to erect
the image for non-contact, wide-angle observation of the fundus and vitreous body.
The combination of operating microscope and the optical components of the BIOM 4
allows examination of the vitreous body in the posterior chamber under stereoscopic
1 Reduction lens
(not supplied with the BIOM)
5 Ophthalmoscopy lens - so called front lens
(not supplied with the BIOM)
2 Lens receptacle 6 Focus adjustment wheel
3 Control mark 7 Bridge
4 Lens holder with safety slider 8 Housing with swivel mechanism
6
7
8
1
2
3
4
5
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