BIOM 5 and Accessories Conditioning Instructions Nov 2016

Notes on this Instruction Manual This instruction manual explains how to condition the BIOM® 5. It is valid for all reusable 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 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 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 depict 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.

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Conditioning Instructions BIOM® 5 (G/55185/1116/en)

Table of Contents

Table of Contents 1

Applicability...1

2

Safety Instructions...1 2.1 2.2

About this Manual ...1 2.1.1 Used Graphic Symbols...2 Safety Instructions for Use ...2

3

Conditioning Procedure...3

4

Components of the BIOM® 5 to be Conditioned ...4

5

Cleaning and Disinfection ...5 5.1 5.2 5.3

5.4 5.5 6

Preparation: Dismantle the BIOM® 5 ...5 Pre-Cleaning ...7 Cleaning/Disinfection by Machine ...8 5.3.1 Information About Cleaning/Disinfection by Machine ...8 5.3.2 Cleaning and Disinfecting by Machine...9 Manual Cleaning/Disinfection ... 12 Cleaning in an Ultrasonic Bath (Optional) ... 13

Steam Sterilisation ... 14 6.1

6.2

Prior to Steam Sterilisation ... 14 6.1.1 Function Check Prior to Steam Sterilisation... 14 6.1.2 Lubrication... 17 6.1.3 Packaging... 18 Steam Sterilisation... 18

7

Storage... 19

8

Disposal... 19

9

Guarantee and Service... 19 9.1

Manufacturer and Service Address ... 20

10 Overview: Permitted Sterilisation Method – List of Articles ... 21 11 Consumables and Sterilisable Accessories... 24 12 Appendix... 24

Conditioning Instructions BIOM® 5 (G/55185/1116/en)

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Table of Contents

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Conditioning Instructions BIOM® 5 (G/55185/1116/en)

1 Applicability

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 21. Example: Symbols on the BIOM® 5 sterilisation insert 1 4 3 2

1 Company logo + manufacturer 3 Article number 2 Name of device 4 CE marking Fig. 1–1: Symbols on the BIOM® 5 sterilisation insert

2

Safety Instructions

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.

Conditioning Instructions BIOM® 5 (G/55185/1116/en)

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2 Safety Instructions

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.

2.2

Denotes important information about the product and its use, which require special attention.

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 

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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.

Conditioning Instructions BIOM® 5 (G/55185/1116/en)

3 Conditioning Procedure

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.

 





3

Conditioning Procedure 



Cleaning/Disinfection  Preparation  Cleaning/disinfection by machine or  Manual cleaning/disinfection Sterilising  Preparation for sterilisation  Steam sterilisation

Conditioning Instructions BIOM® 5 (G/55185/1116/en)

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4 Components of the BIOM® 5 to be Conditioned

4

Components of the BIOM® 5 to be Conditioned BIOM® 5c/cl 1

2 6 5

4

3

1 BIOM® 5cl 2 Adaptor plate 3 Drive belt 4 Ophthalmoscopy magnifying loupe Fig. 4–1: Components of the BIOM® 5cl

BIOM® 5m/ml 1

5 6

Cable duct Reduction lens

2

3

4

5 1 Adaptor plate 2 Housing with swivel mechanism 3 Reduction lens Fig. 4–2: Components of the BIOM® 5ml

4 5

Safety rod Front loupe

A list of other conditionable components and other conditioning accessories is given in sect. 11, page 24.

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Conditioning Instructions BIOM® 5 (G/55185/1116/en)

5 Cleaning and Disinfection

Cleaning and Disinfection

☞

5

5.1

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.

Preparation: Dismantle the BIOM® 5 You must dismount the BIOM® 5 before you condition it.

1



2



Take out the reduction lens and put it down onto the soft pad.

Pull the BIOM® 5 off the adaptor plate. To do so, swing out the BIOM® 5

3



Pull off the front loupe and put it down onto the soft pad.

Fig. 5–1: Dismounting the components

Conditioning Instructions BIOM® 5 (G/55185/1116/en)

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5 Cleaning and Disinfection

For BIOM® 5c and BIOM® 5cl only:

1



Detach the cable duct from the plug.

3

2

1 

Take off the drive belt.

Before sterilising, check that the drive module is secure. If it is loose, tighten the Allen screw, 2 mm, (1) at the drive module, or call in your hospital technician

Fig. 5–2: Remove additional components of the BIOM® 5c or BIOM® 5cl

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Conditioning Instructions BIOM® 5 (G/55185/1116/en)

5 Cleaning and Disinfection

5.2

Pre-Cleaning Cleaning tools  

Cold water Water pistol

Procedure 

Place the BIOM® 5 in cold water for five minutes. The BIOM® 5 must be fully covered.  Flush the gaps, joints and cavities (the marked locations) for 15 seconds with the water pistol.

Fig. 5–3: Pre-cleaning

You can now clean the components either by machine (sect. 5.3, page 8) or manually (sect. 5.4, page 12).

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5 Cleaning and Disinfection

5.3 5.3.1

Cleaning/Disinfection by Machine Information About Cleaning/Disinfection by Machine Cleaning/Disinfection Unit (CDU) 

Make sure that the CDU meets the following criteria.

It must have been tested for efficiency (e.g. DGHM I or FDA approval, or CE marking, in conformity with DIN EN ISO 15883-1 )  Use a tested disinfection programme (at least 5 minutes at 90°C) for thermal disinfection, as with chemical disinfection, there is a risk of disinfectant residues being left on the products. The A0 value=3000 must be reached.  Use water of a quality that meets the requirements of DIN EN 285 (including demineralised water with an electrical conductivity of approx. 15S/cm).  Use air that meets the compressed air requirements in a hospital, for drying purposes.  Make sure that the detergent and the disinfectant do not react with each other. 

Also see “Appendix” on page 24 

Regularly inspect and service the CDU in accordance with in-house specifications.

Detergents and Disinfectants 

Make sure that the detergents and disinfectants meet the following criteria.

The detergent (e.g. neodisher MediClean concentration 0.5 %, Dr. Weigert, Hamburg) must:   

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Be suitable for cleaning the products. Be compatible with the disinfectant that is used. Be listed with the DGHM (German Society for Hygiene and Microbiology)

Conditioning Instructions BIOM® 5 (G/55185/1116/en)

5 Cleaning and Disinfection

Note Risk of malfunctions and surface damage if alkaline detergents are used. If you use alkaline detergents: 

Properly neutralise after use in accordance with the manufacturer’s specifications.  Check whether the chemicals that are used are compatible with the products. Alkaline detergents can attack the surfaces of the products and lead to malfunctions. If thermal disinfection (at least 5 minutes at 90°C) is not performed, the disinfectant must: Be of a proven efficiency (e.g. have DGHM or FDA approval, or CE marking).  Be compatible with the detergent that is used.  Always adhere to the detergent and disinfectant concentrations specified by the manufacturer. 

Cleaning method The following cleaning method was used for validation of the steamautoclavability of the BIOM optics:

☞

See sect. 12, page 24

5.3.2

Use the cleaning method that meets the requirements of your national standards.

Cleaning and Disinfecting by Machine     



Check whether the components have been pre-cleaned, sect. 5.2, page 7. Place the components of the BIOM® 5 into the disinfector basket or into a sterilisation tray. Secure the loupes in the tray with the holders provided for that purpose. Loose loupes could get scratched. To ensure that the effectiveness of the cleaning/disinfection is not impaired, make sure that the components do not touch each other. Place the disinfector basket or the sterilisation tray with the components in the CDU. For stackable disinfection baskets or sterilisation trays, heed the manufacturer’s instructions. To prevent water stains on the optics, keep the loupes and reduction lenses as vertical as possible during the cleaning process.

Conditioning Instructions BIOM® 5 (G/55185/1116/en)

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5 Cleaning and Disinfection



☞

Start the cleaning programme, see sect. 12, page 24, e.g.:  3 Minute pre-wash cycle with cold water  Empty  Clean for 5 minutes at 55°C with cleaning detergent  Empty  3 Minute rinse cycle with cold, demineralised water  Empty  2 Minute rinse cycle with demineralised water  Empty  At the end of the programme: Remove the disinfector basket or the sterilisation tray from the disinfector.  Check whether the BIOM® 5 needs to be dried with compressed air. 

Conduct a function test before you sterilise the BIOM® 5 with steam, sect. 6.1.1, page 14.

For more information about these jobs, refer to sect. 12, page 24.

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Conditioning Instructions BIOM® 5 (G/55185/1116/en)

5 Cleaning and Disinfection

OCULUS Sterilisation Insert You can use the specially designed sterilisation insert, OCULUS Art. No. 55185 for the BIOM® 5 and its accessories.

Fig. 5–4: Components of the BIOM® 5 on the sterilisation insert

Dimensions of the OCULUS sterilisation insert Width

240 mm

Depth

245 mm

Height

53 mm

Total height, loaded

80 mm

One adaptor plate, the BIOM® 5, one reduction lens, at least one front loupe, 2 rubber drive belts, sterile cap for the knurled screw, SDI® control knob belong together. These components can be put into the special insert and placed into a suitable sterilisation container for sterilisation in the steam autoclave.

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5 Cleaning and Disinfection

5.4

Manual Cleaning/Disinfection

☞

The method described below has been validated for manual cleaning/ disinfection:

If you clean and disinfect your equipment manually, you must verify your procedure independently and validate it specific to the product and the method.

Cleaning tools 



Cleaning solution with 0.8% detergent (Cidezyme/Enzol from Johnson & Johnson) Water

☞

Procedure



Perform a manual disinfection in accordance with the requirements of the VAH or the applicable standards.



Check that the components have no visible signs of soiling, sect. 5.2, page 7.  Place the components in the cleaning solution for 5 minutes at 40°C. The BIOM® 5 must be fully covered.  Rinse the components for 5 seconds under running water (static pressure 4.2 bar).

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Conditioning Instructions BIOM® 5 (G/55185/1116/en)

5 Cleaning and Disinfection

5.5

Cleaning in an Ultrasonic Bath (Optional) Note If the fluid in the ultrasonic bath is too dirty, the cleaning effectiveness will be impaired and there is a risk of corrosion. The criterion is a visibly dirty fluid. 

Change the cleaning solution based on the operating conditions. This must be changed regularly, at least once a day.



When cleaning with ultrasound, adhere to the soaking times (at least 3 minutes) and concentrations specified by the manufacturer of the cleaning additive.  Use the quantity of fluid specified by the manufacturer of the ultrasonic bath.  Heed the following instructions:  Insert the BIOM® 5 in its unfolded state, with the swivel head of the BIOM® 5 at an angle.  The loupe holder of the BIOM® 5 must be fully pulled out to the stop

Fig. 5–5: Cleaning in an ultrasonic bath 

 

The products must always be completely submerged in the cleaning solution Place the products on trays only To ensure the effectiveness of the ultrasonic bath and to prevent damage to the optics, attach the loupes to specially designed holders.

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6 Steam Sterilisation

6

Steam Sterilisation

6.1

Prior to Steam Sterilisation Attention Improper cleaning/disinfection is a health risk. 

After cleaning/disinfecting the components, check whether they are macroscopically clean, i.e. free from visible soiling, corrosion or damage.  If impurities are found: Clean/disinfect the components again.  If corrosion or damage is found: Do not use corroded or damaged components again for a surgical procedure.

6.1.1

Function Check Prior to Steam Sterilisation You must check the moving parts of the BIOM® 5 prior to packaging and steam-sterilising them to ensure their function. 

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Check all moving parts of the BIOM® 5.

Conditioning Instructions BIOM® 5 (G/55185/1116/en)

6 Steam Sterilisation



Pay particular attention to the following:  Smooth movement of the articulated joint  Function of the safety rod of the front loupe  Function of the focussing knob

1

2

Control mark



Flip the BIOM® 5 towards the adaptor plate. Make sure that the housing body can be shifted without resistance.



Slide the safety rod of the loupe holder up and down several times to check that it runs smoothly. After the test, the rod must be pulled fully down to the stop.

3

1



Check that the knob turns easily and shorten the total length until the adjuster is at the uppermost position.



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.

Fig. 6–1: Test the safety functions

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6 Steam Sterilisation

Attention Risk of injury if components are damaged 

If a component does not pass the function test, do not use that component for a surgical procedure.  Send the components to OCULUS Service or an authorized dealer. Before sending: Clean, disinfect and sterilise the components. Comply with hospital regulations and all applicable national regulations and laws.

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Conditioning Instructions BIOM® 5 (G/55185/1116/en)