OCULUS BIOM 5 Manual de usuario
OCULUS BIOM
®
5
CONDITIONING INSTRUCTIONS
BIOM® 5 and Accessories
i / iii Conditioning Instruction BIOM® 5 (G/55185/0818/en)
Notes on this Instruction Manual
This instruction manual explains how to condition the BIOM® 5. It is valid for all re-
usable components and accessories of the BIOM® 5 that must be sterile for use.
To ensure safe operation, it is essential that you use the device correctly. For this rea-
son, you should thoroughly familiarize yourself with the contents of this instruction
manual before operating the device. In particular, pay attention to the safety instruc-
tions.
This instruction manual describes how to condition the following BIOM® 5 models:
BIOM 5c and 5cl (long version)
BIOM 5m and 5ml (long version)
Due to ongoing development, the diagrams shown in the instruction manual may de-
pict minor changes to the devices delivered.
If you have any questions or would like additional information about your device,
please do not hesitate to contact us by phone, 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
Conditioning Instruction BIOM® 5 (G/55185/0818/en) ii / iii
Table of Contents
1 Applicability..................................................................................................................................1
2 Safety Instructions......................................................................................................................1
2.1 About this Manual .........................................................................................................1
2.1.1 Used Graphic Symbols.................................................................................2
2.2 Safety Instructions for Use..........................................................................................2
3 Conditioning Procedure.............................................................................................................4
4 Components of the BIOM® 5 to be Conditioned ...............................................................5
5 Cleaning and Disinfection ........................................................................................................6
5.1 Preparation: Dismantle the BIOM® 5 .......................................................................6
5.2 Pre-Cleaning ....................................................................................................................8
5.3 Cleaning/Disinfection by Machine ............................................................................9
5.3.1 Information About Cleaning/Disinfection by Machine......................9
5.3.2 Cleaning and Disinfecting by Machine................................................ 10
5.4 Manual Cleaning/Disinfection ................................................................................. 13
5.5 Cleaning in an Ultrasonic Bath (Optional)........................................................... 14
6 Steam Sterilisation .................................................................................................................. 15
6.1 Prior to Steam Sterilisation ...................................................................................... 15
6.1.1 Function Check Prior to Steam Sterilisation...................................... 15
6.1.2 Lubrication................................................................................................... 18
6.1.3 Packaging..................................................................................................... 19
6.2 Steam Sterilisation...................................................................................................... 19
7 Storage........................................................................................................................................ 20
8 Disposal....................................................................................................................................... 20
9 Guarantee and Service............................................................................................................ 20
9.1 Manufacturer and Service Address ........................................................................ 21
10 Overview: Permitted Sterilisation Method – List of Articles ....................................... 22
11 Consumables and Sterilisable Accessories........................................................................ 25
12 Appendix..................................................................................................................................... 25
Table of Contents
iii / iii Conditioning Instruction BIOM® 5 (G/55185/0818/en)
1 Applicability
Conditioning Instruction BIOM® 5 (G/55185/0818/en) 1 / 26
1 Applicability
These conditioning instructions explain how to condition the BIOM® 5.
They apply for all models and accessories of the BIOM® 5. A list of exactly
which these are is given in sect. 10, page 22.
Example: Symbols on the BIOM® 5 sterilisation insert
2SafetyInstructions
2.1 About this Manual
Carefully read through the conditioning instructions.
Keep the conditioning instructions in a safe place. You must have
access to these during the conditioning process.
Observe the legal requirements for accident prevention.
Heed the supplementary conditioning information supplied with
certain products.
The current version of this manual can be downloaded at www.oculus.de,
or you can request a copy from OCULUS Optikgeräte GmbH, Wetzlar.
1 Company logo + manufacturer 3 Article number
2 Name of device 4 CE marking
Fig. 1–1: Symbols on the BIOM® 5 sterilisation insert
1
4
3
2
2 Safety Instructions
2 / 26 Conditioning Instruction BIOM® 5 (G/55185/0818/en)
2.1.1 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.
2.2 Safety Instructions for Use
Attention
Risk of injury or material damage if the conditioning procedure is done
incorrectly
Observe the following safety instructions.
Risk of personal injury or property damage due to equipment
modifications that could jeopardize safety
The BIOM® 5 sterilisation insert must not be modified without the
manufacturer’s permission.
Information about the Conditioning Personnel
Ensure that the conditioning is done by duly trained personnel only,
who due to their qualifications or knowledge and practical
experience, can guarantee proper handling.
2 Safety Instructions
Conditioning Instruction BIOM® 5 (G/55185/0818/en) 3 / 26
Conditioning Information
Attention
Risk of injury if the BIOM® 5 is not sterile
If the patient or his bodily fluids come into contact with the BIOM® 5, it
can become contaminated, e.g. when putting it away.
Make sure that the BIOM® 5 is cleaned, disinfected and sterilised.
Condition the BIOM® 5 before the first and every subsequent use.
Comply with the legal provisions in force in your country, and with
the hygiene and waste disposal regulations of the hospital or clinic.
Condition the BIOM® 5 only after you have fully understood this
instruction manual.
The BIOM® 5 and all sterilisable components of the BIOM® 5 must
be cleaned, disinfected and sterilised prior to initial use and prior to
every subsequent use. To do so, take the BIOM® 5 out of the
packaging.
Make sure that only validated device and product-specific
procedures are used for cleaning/disinfection and sterilisation and
that the validated parameters are observed for each cycle.
Use a machine (disinfector) for cleaning/disinfection purposes. This
is much more effective.
Notes on returning
Attention
Personal injury caused by contaminated BIOM® and components
Before returning the product to OCULUS: Prepare the BIOM® and
sterilisable components according to this treatment instructions.
Send only visibly prepared OCULUS products back to OCULUS
3 Conditioning Procedure
4 / 26 Conditioning Instruction BIOM® 5 (G/55185/0818/en)
3 Conditioning Procedure
Cleaning/Disinfection
Preparation
Cleaning/disinfection by machine
or
Manual cleaning/disinfection
Sterilising
Preparation for sterilisation
Steam sterilisation
4 Components of the BIOM® 5 to be Conditioned
Conditioning Instruction BIOM® 5 (G/55185/0818/en) 5 / 26
4 Components of the BIOM®5 to be Conditioned
A list of other conditionable components and other conditioning
accessories is given in sect. 11, page 25.
BIOM®5c/cl
1 BIOM® 5cl 5 Cable duct
2 Adaptor plate 6 Reduction lens
3Drivebelt
4 Ophthalmoscopy magnifying loupe
Fig. 4–1: Components of the BIOM® 5cl
BIOM®5m/ml
1 Adaptor plate 4 Safety rod
2 Housing with swivel mechanism 5 Front loupe
3 Reduction lens
Fig. 4–2: Components of the BIOM® 5ml
6
1
2
4
5
3
1
3
2
5
4
5 Cleaning and Disinfection
6 / 26 Conditioning Instruction BIOM® 5 (G/55185/0818/en)
5 Cleaning and Disinfection
☞
Recommendation:
Clean or disinfect the BIOM® 5 by machine, as this is much more
effective.
Start pre-conditioning immediately after receiving the equipment in
the conditioning station.
5.1 Preparation: Dismantle the BIOM®5
You must dismount the BIOM® 5 before you condition it.
Pull the BIOM® 5 off the adaptor plate. To do so,
swing out the BIOM® 5
Take out the reduction lens and put it down onto
the soft pad.
Pull off the front loupe and put it down onto the
soft pad.
Fig. 5–1: Dismounting the components
1
2
3
Este manual sirve para los siguientes modelos
4
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