Passive-Rigid Body FS608

en ®

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Aesculap OrthoPilot Passive-Rigid Body FS608 Legend 1 2 3 4 5 6

Passive marker Fastening pin Groove Click-lock fastener Adaption site of the instrument Impactor

1.

About this document

Note General risk factors associated with surgical procedures are not described in these instructions for use.

1.1

Assembly

2.3.1

Mounting the passive markers

CAUTION If passive markers are not fastened correctly, this will result in a false reading of the position! ► Check that the marker spheres are firmly connected to the appropriate adapters of the passive transmitters. ► Ensure that the marker spheres audibly click into place when connected. ► Slide the four passive markers 1 onto the fastening pins 2 until they click into place.

2.3.2

Mounting the Passive-Rigid Body on an instrument

CAUTION Inaccurate navigation of instruments and parts of the body due to unstable fixation of the Passive-Rigid Body on its counterpart! ► Make sure that the Passive-Rigid Body is mounted correctly on the counterpart. ► In order to affix the passive rigid body on the corresponding counterpart, push the passive rigid body with the

groove 3 onto the adaption site 5 until it clicks into place on the instrument. ► Check that the Passive-Rigid Body is fastened to the counterpart securely.

Scope

These instructions for use apply for the following products: Art. no.

Designation

FS608

Passive-Rigid Body

► For article-specific instructions for use as well as information on material compatibility and lifetime see B. Braun

eIFU at eifu.bbraun.com

1.2

2.3

Safety messages

Safety messages make clear the dangers to patient, user and/or product that could arise during the use of the product. Safety messages are labeled as follows: WARNING Indicates a possible threat of danger. If not avoided, minor or moderate injury may result.

2.4

Application

WARNING Risk of injury and/or malfunction! ► Prior to each use, inspect the product for loose, bent, broken, cracked, worn, or fractured components. ► Always carry out a function test prior to each use of the product. In order to be able to determine the position of the instruments, all 4 passive markers must be clearly and unmistakably recognized by the camera setup. ► Do not obstruct the view on the passive markers with your hand. CAUTION A bent instrument or dirty passive marker will result in a false reading of the position! ► Do not bend the instrument. ► Be sure that the passive markers do not get soiled intraoperatively. ► If the surfaces of the passive markers get soiled intraoperatively:

CAUTION Indicates a possible threat of material damage. If not avoided, the product may be damaged.

2.

Clinical use

2.1

Areas of use and limitations of use

2.1.1

Intended use

The passive transmitter serves as the interface for the defined geometric alignment between a compatible instrument and exclusively Aesculap-Passive-Marker (FS614/FS616/FS617).

2.1.2

Indications

Note The manufacturer is not responsible for any use of the product against the specified indications and/or the described applications. The indications correspond to those of the implant system used.

2.1.4

Absolute Contraindications

The absolute contraindications correspond to those of the implant system used.

2.1.5

Relative Contraindications

The relative contraindications correspond to those of the implant system used. In the presence of relative contraindications, the user decides individually regarding the use of the product.

2.2

Safety information

2.2.1

Clinical user

General safety information To prevent damage caused by improper setup or operation, and to not compromise the manufacturer warranty and liability: ► Use the product only according to these instructions for use. ► Follow the safety and maintenance instructions. ► Ensure that the product and its accessories are operated and used only by persons with the requisite training, knowledge and experience. ► Store any new or unused products in a dry, clean, and safe place. ► Prior to use, check that the product is in good working order. ► Keep the instructions for use accessible for the user. Note The user is obligated to report all severe events in connection with the product to the manufacturer and the responsible authorities of the state in which the user is located. Notes on surgical procedures It is the user's responsibility to ensure that the surgical procedure is performed correctly. Appropriate clinical training as well as a theoretical and practical proficiency of all the required operating techniques, including the use of this product, are prerequisites for the successful use of this product. The user is required to obtain information from the manufacturer if there is an unclear preoperative situation regarding the use of the product.

2.2.2

Product

Product-specific safety information ► Prior to use, mount new, sterile passive markers, see Assembly. ► When fitting the transmitter, ensure that the transmitter clicks into the end position. ► While tapping, always ensure that the transmitter is in the correct position on the impactor. ► Only mount Aesculap passive markers (art. no. FS614/FS616/FS617). ► Always put down the product in such a way that the passive markers do not get scratched. ► Make sure prior to the operation that the passive markers are undamaged and in working condition. ► Do not set up other medical devices using infrared light in proximity to the area in which the navigation system is used. ► Check the Passive-Rigid Body for correct functioning; see instructions for use for the respective application.

2.2.3

2.5

Sterility

Non-sterile packaged products The product is delivered in an unsterile condition. ► Clean the new product after removing its transport packaging and prior to its initial sterilization.

Demounting the Passive-Rigid Body from an instrument

► Withdraw the Passive-Rigid Body from its counterpart: Take instrument in both hands if necessary and use your

thumbs to press the passive rigid body of the instrument. When so doing, ensure that passive rigid body does not fall on the floor.

Operating principle

The navigation system uses the position data from the Passive-Rigid Body for the intraoperative computation of the position of instruments and parts of the body coupled to it. The position of the instruments and body parts are displayed by the navigation system. For further information, please refer to the instructions for use for the application concerned.

2.1.3

– Rinse passive markers with a sodium chloride solution. – When doing this make certain that no fluids can enter the operating field. – Dry passive markers with a dry cloth. – If the camera does not recognize the passive markers after cleaning, replace them immediately. ► Further information on using the instrument and the passive markers can be found in the instructions for use for the application concerned.

3.

Validated reprocessing procedure

3.1

General safety instructions

Note Adhere to national statutory regulations, national and international standards and directives, and local, clinical hygiene instructions for sterile processing. Note For patients with Creutzfeldt-Jakob disease (CJD), suspected CJD or possible variants of CJD, observe the relevant national regulations concerning the reprocessing of products. Note Mechanical reprocessing should be favored over manual cleaning as it gives better and more reliable results. Note Successful processing of this medical device can only be ensured if the processing method is first validated. The operator/sterile processing technician is responsible for this. Note If there is no final sterilization, then a virucidal disinfectant must be used. Note For up-to-date information about reprocessing and material compatibility, see B. Braun eIFU at eifu.bbraun.com The validated steam sterilization procedure was carried out in the Aesculap sterile container system.

3.2

General information

Dried or affixed surgical residues can make cleaning more difficult or ineffective and lead to corrosion. Therefore the time interval between application and processing should not exceed 6 h; also, neither fixating pre-cleaning temperatures >45 °C nor fixating disinfecting agents (active ingredient: aldehydes/alcohols) should be used. Excessive measures of neutralizing agents or basic cleaners may result in a chemical attack and/or to fading and the laser marking becoming unreadable visually or by machine for stainless steel. Residues containing chlorine or chlorides e.g. in surgical residues, medicines, saline solutions and in the service water used for cleaning, disinfection and sterilization will cause corrosion damage (pitting, stress corrosion) and result in the destruction of stainless steel products. These must be removed by rinsing thoroughly with demineralized water and then drying. Additional drying, if necessary. Only process chemicals that have been tested and approved (e.g. VAH or FDA approval or CE mark) and which are compatible with the product’s materials according to the chemical manufacturers’ recommendations may be used for processing the product. All the chemical manufacturer's application specifications must be strictly observed. Failure to do so can result in the following problems: ■ Optical changes of materials, e.g. fading or discoloration of titanium or aluminum. For aluminum, the application/process solution only needs to be of pH >8 to cause visible surface changes. ■ Material damage such as corrosion, cracks, fracturing, premature aging or swelling. ► Do not use metal cleaning brushes or other abrasives that would damage the product surfaces and could cause corrosion. ► Further detailed advice on hygienically safe and material-/value-preserving reprocessing can be found at www.ak-i.org, link to "AKI-Brochures", "Red brochure".

3.3

Reusable products

Influences of the reprocessing which lead to damage to the product are not known. A careful visual and functional inspection before the next use is the best opportunity to recognize a product that is no longer functional, see Inspection.

3.4

Preparations at the place of use

► If applicable, rinse non-visible surfaces preferably with deionized water, with a disposable syringe for example. ► Remove any visible surgical residues to the extent possible with a damp, lint-free cloth. ► Transport the dry product in a sealed waste container for cleaning and disinfection within 6 hours.

3.5

Disassembly

► Withdraw the passive marker 1 from the fastening pin 2 and dispose of it.

3.6

Cleaning/Disinfection

3.8

3.6.1

Product-specific safety information on the reprocessing method

Note The cleaning and disinfection device must be of tested and approved effectiveness (e.g. FDA approval or CE mark according to DIN EN ISO 15883).

Damage to or destruction of the product due to inappropriate cleaning/disinfecting agents and/or excessive temperatures! ► Following the manufacturer's instructions, use cleaning and disinfecting agents – that are approved for example, on aluminum, plastic materials, and high-grade steel, – that do not attack softeners (e.g., in silicone). ► Observe specifications regarding concentration, temperature and exposure time. ► Do not exceed the maximum allowable disinfection temperature of 95 °C. ► Use suitable cleaning/disinfecting agents if the product is disposed of in a wet condition. To prevent foaming and

Mechanical cleaning/disinfection

Note The cleaning and disinfection device used for processing must be serviced and checked at regular intervals.

3.8.1

Mechanical alkaline cleaning and thermal disinfecting

Machine type: single-chamber cleaning/disinfecting machine without ultrasound Phase

Step

D [°C/°F]

t [min]

Water quality

Chemical/Note

I

Prerinse

<25/77

3

D–W

-

II

Cleaning

55/131

10

FD-W

■ Concentrate, alkaline:

degradation of the efficacy of the process chemicals: prior to mechanical cleaning and disinfection, rinse the product thoroughly with running water.

3.6.2

Validated cleaning and disinfection procedure

Validated procedure

Specific requirements

Reference

Manual cleaning with immersion disinfection

■ Suitable cleaning brush ■ 20 ml disposable syringe ■ Drying phase: Use a lint-free

Chapter Manual cleaning/disinfection and subsection:

■ Place the product on a tray that is suitable for cleaning (avoid rinsing blind spots).

– pH = 11*

immersion disinfection III

Intermediate rinse

>10/50

1

FD-W

-

Chapter Mechanical cleaning/disinfection and subsection:

IV

Thermal disinfecting

90/194

5

FD-W

-

■ Chapter Mechanical alkaline

V

Drying

-

-

-

According to the program for cleaning and disinfection device

■ Cleaning in system-specific

cleaning and thermal disinfecting

tray holder possible; remove any template graphic from the tray before starting the cleaning cycle.

3.7

■ working solution 0.5%

■ Chapter Manual cleaning with

cloth or medical compressed air Mechanical alkaline cleaning and thermal disinfection

– pH ~ 13 – <5 % anionic surfactant

DW: FD–W:

Drinking water Fully desalinated water (demineralized, low microbiological contamination: drinking water quality at least) *Recommended: BBraun Helimatic Cleaner alcaline

Manual cleaning/disinfection

► Prior to manual disinfecting, allow water to drip off for a sufficient length of time to prevent dilution of the dis-

► Check visible surfaces for residues after mechanical cleaning/disinfecting.

infecting solution. ► After manual cleaning/disinfection, check visible surfaces visually for residues. ► Repeat the cleaning/disinfection process if necessary.

3.9

Inspection

► Allow the product to cool down to room temperature. ► Dry the product if it is wet or damp.

3.7.1

Manual cleaning with immersion disinfection

Phase

Step

T [°C/°F]

t [min]

Conc. [%]

Water quality

Chemical

I

Disinfecting cleaning

RT (cold)

>15

2

D–W

Aldehyde-free, phenol-free, and QUAT-free concentrate, pH ~ 9*

II

Intermediate rinse

RT (cold)

1

-

D–W

-

III

Disinfection

RT (cold)

5

2

D–W

Aldehyde-free, phenol-free, and QUAT-free concentrate, pH ~ 9*

IV

Final rinse

RT (cold)

1

-

FD-W

-

3.9.2

RT

-

-

► Check that the product functions correctly. ► Check for compatibility with associated products. ► Immediately put aside inoperative products and send them to Aesculap Technical Service, see Technical service.

V

Drying

D–W: FD–W: RT: *Recommended:

-

-

Drinking water Fully desalinated water (demineralized, microbiological, at least of drinking water quality) Room temperature BBraun Stabimed fresh

► Note the information on appropriate cleaning brushes and disposable syringes, see Validated cleaning and dis-

infection procedure. Phase I ► Fully immerse the product in the cleaning/disinfectant for at least 15 min. Ensure that all accessible surfaces are moistened. ► Clean the product with a suitable cleaning brush in the solution until all discernible residues have been removed from the surface. ► If applicable, brush through non-visible surfaces with an appropriate cleaning brush for at least 1 min. ► Mobilize non-rigid components, such as set screws, links, etc. during cleaning. ► Thoroughly rinse through these components with the cleaning disinfectant solution (at least five times), using a disposable syringe. Phase II ► Rinse/flush the product thoroughly (all accessible surfaces) under running water. ► Mobilize non-rigid components, such as set screws, joints, etc. during rinsing. ► Drain any remaining water fully. Phase III ► Fully immerse the product in the disinfectant solution. ► Mobilize non-rigid components, such as set screws, joints, etc. during rinsing. ► Rinse lumens at least 5 times at the beginning of the exposure time using an appropriate disposable syringe. Ensure that all accessible surfaces are moistened. Phase IV ► Rinse/flush the product thoroughly (all accessible surfaces). ► Mobilize non-rigid components, such as set screws, joints, etc. during final rinse. ► Rinse lumens with an appropriate disposable syringe at least five times. ► Drain any remaining water fully. Phase V ► Dry the product in the drying phase with suitable equipment (e.g. cloth, compressed air), see Validated cleaning and disinfection procedure.

3.9.1

Visual inspection

► Ensure that all soiling has been removed. ► If the product is dirty: repeat the cleaning and disinfection process. ► Check the product for damage, e.g. insulation or corroded, loose, bent, broken, cracked, worn or severely

scratched and fractured components. ► Check the product for missing or faded labels. ► Check the surfaces for rough spots. ► Check the product for burrs that could damage tissue or surgical gloves. ► Check the product for loose or missing parts. ► Immediately put aside damaged or inoperative products and send them to Aesculap Technical Service, see Tech-

nical service.

Functional test

3.10 Packaging ► Place the product in its holder or on a suitable tray. ► Package trays appropriately for the sterilization process (e.g. in Aesculap sterile containers). ► Ensure that the packaging provides sufficient protection against contamination of the product during storage.

3.11 Steam sterilization Note Sterilization without prior assembly of the passive markers. ► Check to ensure that the sterilizing agent will come into contact with all external and internal surfaces (e.g., by

opening any valves and faucets). ► Validated sterilization process

– Steam sterilization using fractional vacuum process – Steam sterilizer according to DIN EN 285 and validated according to DIN EN ISO 17665 – Sterilization using fractionated vacuum process at 134 °C/holding time 5 min ► If several devices are sterilized at the same time in the same steam sterilizer: Ensure that the maximum permitted load according to the manufacturers’ specifications is not exceeded.

3.12 Storage ► Store sterile products in germ-proof packaging, protected from dust, in a dry, dark, temperature-controlled area.

4.

Technical service

CAUTION Modifications to medical technology equipment result in loss of approval and can result in forfeiture of guarantee/warranty claims. ► Do not modify the product. ► For service and repairs, please contact your national B. Braun/Aesculap agency. Service addresses Aesculap Technischer Service Am Aesculap-Platz 78532 Tuttlingen / Germany Phone: +49 7461 95-1601 Fax: +49 7461 16-2887 E-Mail: [email protected] Other service addresses can be obtained from the address indicated above.

5.

Accessories / spare parts

Art. no.

Designation

FS614

Passive marker, 10 pieces

FS616

Passive marker, 3 x 4 pieces

FS617

Passive marker, 4 x 4 pieces

FS944R

PLASMACUP insertion instrument straight 305 mm

FS947R

PLASMACUP insertion instrument curved 305 mm

6.

Disposal

WARNING Risk of infection due to contaminated products! ► Adhere to national regulations when disposing of or recycling the product, its components and its packaging. Note The user institution is obliged to reprocess the product before its disposal, see Validated reprocessing procedure. TA011429

2020-04

V6

Change No. 62475