Biom5 Instruction Manual G 55400 0413 en PDF
Biom5 Instruction Manual G 55400 0413 en PDF
Biom5 Instruction Manual G 55400 0413 en PDF
INSTRUCTION MANUAL
Binocular Indirect Ophthalmo-Microscope
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.
Table of Contents
1 Scope of Delivery
BIOM® 5c
Component Order No
BIOM® 5c
Version BIOM® 5c 55400
Version BIOM® 5cl 55403
Sterilizable drive belts (10 pcs)
Sterilizable cable duct
BIOM® 5m
Version BIOM® 5m 55462
Version BIOM® 5ml 55463
Instruction Manual G/55400/xxx/en
Box with cover
Sterilization Information G/55185/xxx/en
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.
1 2
3
6 4
5
3 Safety Instructions
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-
☞
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.
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.
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.
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.
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.
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.
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
BIOM® 5c
1 Reduction lens
(not supplied with the BIOM®)
1 2 Housing with swivel mechanism
3 Lens receptacle
4 Focus adjustment wheel
5 Control mark
6 Lensholder with safety rod
2 7 Front lens
(not supplied with the BIOM®)
8 Drive module
Fig. 5-1: Device overview BIOM® 5c with reduction lens and ophthalmoscopy lens
BIOM® 5m
1 Reduction lens
(not supplied with the BIOM®)
1 2 Adjuster, housing with swivel mechanism
3 Lens receptacle
4 Focus adjustment wheel
5 Control mark
6 Lens holder with safety rod
2 7 Front lens
(not supplied with the BIOM®)
Fig. 5-2: Device overview BIOM® 5m with reduction lens and ophthalmoscopy lens
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.
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.
For more information, refer to the Instruction Manual for the adapter.
☞
8 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.
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
Use the appropriate reduction lens for the surgical microscope’s objec-
tive.
Select the appropriate front lens for the surgery.
Lens 53603 Lens 53606 Lens 53604 Lens 53602 Lens 53601
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.
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.
BIOM® 5m Components
3
1 Housing with swivel mechanism 3 Front lens
2 Adapter plate 4 Reduction lens
Fig. 9-2: BIOM® 5m Components
BIOM® 5c Components
2
7
6
4 3
1 Housing with swivel mechanism 5 Cable duct
2 Adapter plate 6 Reduction lens
3 Drive belt 7 Cable connector
4 Front lens
Fig. 9-3: BIOM® 5c Components
1 2
Insert the reduction lens. Plug in the adapter plate. You must thereby over-
come the detent that secures the connection.
Risk of injury to the patient if the BIOM® 5 is inserted
incorrectly
Attention 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.
3 4
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.
5 6
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
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.
#
1 2
control
marking
Turn the BIOM® 5 towards the adapter plate. Make Slide the safety rod of the lens mount up and down
sure that the housing body can be shifted without several times to check that it moves smoothly. The
resistance. control marking must be visible all times.
3
Check that the knob turns easily and shorten the Check whether all fastening screws are present
total length until the adjuster is at the uppermost (e.g. screws at the feather key of the safety rod).
position.
Fig. 9-6: Test the Safety Functions
Caution
Patient hazard caused by incorrect installation
Never mount the BIOM® 5 above a patient.
1 2
Push the sterile cap onto the knurled screw. Slide the adapter plate with the BIOM® 5 into the
dovetail mount at the microscope.
For the BIOM® 5c, you must connect the control cable to the SDI® 4c.
Fig. 9-8: Connect the control cable without touching the unsterile microscope parts
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.
During extra-ocular surgery phases, swing the BIOM® out of the beam
path into the parked position.
When swinging out the BIOM®, push in the safety rod, including the
front lens, with you finger, until the rod reaches the limit stop.
Lift up the safety rod and move to the endposition. Then release the
☞
safety rod.
Focusing on the BIOM® 5m is done manually with the adjusting wheel and
can also be done by a sterile assistant, who follows the surgery via a co-
observer viewer.
Note
Adjust the ophthalmoscopy lens upwards for hyperopic eyes and
downwards for myopic eyes.
Attention
Risk of eye injury due to poor visibility conditions
If the surgeon works under poor visibility conditions, the use of intraocular
instruments can result in injury to the patient’s eyes.
When focusing the BIOM® 5, heed the following instructions.
Make sure that the microscope remains at this position (height) after
the surgical steps have been conducted at the anterior segment and
outside of the eye.
Before swinging it to the operating position, make sure that the BIOM®
5 has been set to the shortest overall length.
Before you begin to focus the BIOM® 5, check the distance from the
front lens to the patient’s eye.
Monitor the distance between the front lens and the eye while focus-
ing the BIOM® 5.
Make sure that the front lens does not come into contact with the eye.
Do not adjust the working height of the microscope while focusing the
BIOM® 5.
Do not use the microscope’s focusing function while focusing the BI-
OM® 5.
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 to
adjust the height.
Do not adjust the height of the stand arm over the surgical field,
either by motor or manually.
Do not change the patient’s position by adjusting the height of the
operating table.
After all preparations for surgery in the posterior eye segment have been
completed, proceed as follows, without changing the microscope position!
Use a suitable endoillumination.
Swivel the BIOM® 5 into the beam path of the microscope. Lift up
safety rod and only release it again when the swung-in end position
has been reached.
The lens slides down to its designated position. This position has been
reached when the control marks are fully visible.
Turn off the microscope illumination.
Activate the SDI® to right the complete image reversal.
Attention
Risk of eye injury if the surgeon works under poor visibility conditions.
During the entire process, ensure that the front lens cannot touch the
cornea, as otherwise the image may be impaired.
Keep the cornea moist with a suitable fluid to protect the cornea and
to gain a clear view of the fundus.
Attention
Risk of eye injury as a result of uncontrolled head movements of the
patient.
Take suitable measures to suppress uncontrolled head movements of
the patient during the surgery.
Note
Adjust the ophthalmoscopy lens upwards for hyperopic eyes and
downwards for myopic eyes.
Swiveling the BIOM® 5c out of the beam path automatically deactivates the
SDI® 4c.
Caution
Patient hazard caused by incorrect removing
Never dismount the BIOM® 5 above a patient.
BIOM® 5m
BIOM® 5c
1 2
Pull the plug of the BIOM® 5c out of the coupler at Detach the cable holder from the plug.
the SDI® 4c housing. To do this, grip the plug at the
sleeve and unlock it.
3
Note
Risk of damage to the device if the connector is pulled incorrectly.
If you pull on the cable, you could damage it and the complete drive module
would then have to be exchanged.l
Always grasp the plug connector of the BIOM® 5c at the sleeve to
release the locking mechanism.
9.11 Dismantle
10 Troubleshooting
Attention
If an error occurs which you are unable to correct by following the instruc-
tions below, label the device as “out of order” and contact our service de-
partment. (Address: sect. 14.2, page 34).
Never put a damaged BIOM® 5 into operation.
Loose adapter The locking screws are Tighten the locking screws by
loose hand
Dovetail mount wobbles Screws are loose Tighten the screws with a suit-
able screwdriver
Cropped or The SDI®, other attachments Correct the assembly
decentered image or the BIOM® 5 adapter have
been mounted crookedly
The magnifying lens clip is Carefully bend the magnifying
bent or mechanically damaged lens clip back into shape or re-
place it
Fundus view is too narrow Too much distance between Carefully reduce the distance
the ophthalmoscopy lens and using the microscope fine
the eye adjustment mechanism
Magnification of the Reduce magnification of the
microscope system to high microscope
The eye or the lens reflect strongly The microscope light is on Turn the light off, illuminate
only intraocular
The BIOM® 5 cannot be detached The BIOM® 5 has not been Swivel out the BIOM® 5 for
from the adapter swiveled out detachment
Vacuum has developed be- Place the BIOM® 5 and adapter
tween the BIOM® 5 and the into an ultrasound bath (for
adapter, or there are deposits approx. 5 min)
on the connecting parts
No function whatsoever when the The combination control unit Establish the connection to the
combination control unit is actuated is not connected to the SDI® SDI® 4c
4c Establish the connection to the
The SDI® 4c is not connected 6V-15V power supply
to the 6V-15V power supply
Condition the BIOM® 5 and all BIOM® components before the first and
every subsequent use so that they are sterile.
Fig. 12-1: Specially designed insert for sterilization containers. Loaded with the BIOM® 5c setup
Attention
Risk of infection if reconditioning is done incorrectly.
Please heed the separate Conditioning Manual.
Note
The sterilization tray from the company OCULUS Optikgeräte GmbH (Art.
No. 55185) can also be used for cleaning the BIOM® components.
The BIOM® 5, the adapter and the optics can be cleaned in a dishwasher
with a mild alkaline cleaning agent and can be cleaned and disinfected in
the disinfector (refer to the Conditioning Manual).
Due to the special surface finish required for sterilizability of the BIOM® 5,
structural patterns may become visible. This unavoidable minor blemish
does not in any way adversely affect the function, handling and sterilization
of the unit.
All of the components of the BIOM® 5 listed in sect. 16.1, page 36, the
adapter and the presently available reduction lenses and front lenses,
except for the disposable lens sets, can be steam-autoclaved (134°C).
Maintenance
Attention
Risk of function impairment in association with the use of mineralized
water
If you use mineralized water, mineral deposits can form on the device and
impair its function.
Use only demineralized, filtered water for steam sterilization.
Risk of damage to the device if STERRAD® is used for sterilization
The use of STERRAD® for sterilization purposes can damage the BIOM® 5.
Do not use STERRAD® for sterilization purposes.
BIOM® 5c
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 either on or inside the BIOM® 5 that require
maintenance or repair by the user. If assembly work, modifications,
adjustments, repairs, changes or service is performed by unauthorized
personnel, or if the BIOM® 5 is improperly maintained or handled, then
any liability by OCULUS is voided.
Exeption: Replacing the drive unit of the BIOM® 5.
If the above-referenced work is performed by authorized persons,
request a certification of the scope and type of repair, and, if
necessary, the changes to the standard values or to the operating
range from the service technician. This certification must contain the
date of performance and statement of the performing company, with
signature.
If requested, OCULUS will provide the service technician with a list of
spare parts and additional descriptive material for this purpose.
Make certain that only original OCULUS parts are used.
USA:
OCULUS, Inc.
17721 59th Avenue NE
Arlington
WA 98223-1337
Tel. +1 425-670-9977
Fax +1 425-670-0742
e-mail: [email protected]
http://www.oculususa.com
15 Declaration of Conformity
Binokulares-Indirektes-Ophthalmo-Mikroskop /
Antriebsmodul zum Biom
Name / nom / name / nome / nombre
Binocular Indirect Ophthalmomicroscope /
Motor unit for Biom
allen Anforderungen der Richtlinie 93/42/EWG inkl. Änderungen durch 2007 / 47 / EG entspricht.
meets all the provisions of the Directive 93/42/EEC included the changes 2007 / 47 / CE which apply to him.
remplit toutes les exigences de la 93/42/EEC y compris les modifications 2007 / 47 / CE qui le concernait
tutti i requisiti della direttiva 93/42/CEE, comprese le modifiche, entro il 2007 / 47 / CE
todos los requisitos de la Directiva 93/42/CEE, incluidas las enmiendas de 2007 / 47 / CE
Wetzlar, 19.04.2013
Basic Unit
BIOM® 5m 55462
Ophthalmoscopy lenses
17 Technical Data
Dimensions BIOM® 5m and BIOM® 5c
Weight
Ophthalmoscopy lens (only the lenses listed in this manual) Steam auto-
clave, 134°C
Zeiss:
OPMI 1/6
OPMI CS with Retrolux /CS
OPMI CS with Retroskop /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 / M620
M650 / M690
M820 / M822 / M840 / M841 / M844
Moeller:
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