miaspas Instruments

en ®

Aesculap miaspas Instruments Legend 1 2 3 4 5 6 7 8

Instrument that cannot be taken apart, without cover tube Instrument that cannot be taken apart, with cover tube Instrument that can be taken apart Feed spindle Handle Base tube Cover tube Working end

1.

About this document

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

1.1

Scope

These instructions for use apply for the following products:

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 Art. no.

Designation

BT070R

miaspasTL exploration hook, medium, narrow

BT096R to BT099R

miaspasTL exploration hook short

BT450R to BT451R BT466R to BT469R

miaspas miniALIF retractor(s)

BV935R to BV936R

miaspasTL two-bladed speculum

Product specific safety information

Any endoscopic use of the instruments requires detailed knowledge of spinal surgery and of the biomechanical conditions of the spine. ► To avoid damage to the working end: Carefully insert the product through the working channel (e.g. trocar). ► Only use the product under visual control.

2.2.3

Sterility

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

2.3

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.

EJ340R

miaspasTL dilator rod

FF335R/FF337R/ FF339R/FF340R

miaspasTL dissector

FF422R/FF423R

miaspas miniTTA Hockey dissector

FF894R/FF895R

miaspas miniALIF impactor

FG044R

miaspasTL bone graft holder

FG045R

miaspasTL bone graft measuring instrument

FK380R

miaspasTL rib elevator

FK389R

miaspasTL rib head resector

FK392R

miaspasTL rib raspatory

FK779R to FK781R FK789R to FK792R

miaspasTL scoop

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.

FL079R

miaspasTL sliding tube

Note Mechanical reprocessing should be favored over manual cleaning as it gives better and more reliable results.

FL080R to FL082R

miaspasTL impactor

FL450R/FL451R

miaspasTL osteotome

PL671R

miaspasTL dissection and lung spatula

Note The applicable CE mark for the product can be found on the label or packaging of the product. ► For article specific instructions for use and material compatibility and lifetime information, see B. Braun eIFU at

eifu.bbraun.com

1.2

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. 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

miaspas instruments are designed for use in endoscopic spinal surgery both on the thoracic spine (thoracoscopic) and on the lumbar spine (laparoscopic). miaspas instruments are used for cutting, dissecting, removing, exploring and working on bone tissue and intervertebral disk tissue, depending on the design of the working ends.

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. For indications, see Intended use.

2.1.3

Contraindications

No known contraindications.

Instruments for endoscopic spinal surgery can be used in conjunction with the Aesculap trocars. ► Before the start of surgery, make sure that – the instruments have been processed, see Validated reprocessing procedure. – all required instrument parts are present. ► When inserting it into the trocar, snap the cover tube 7 into the forward position thereby covering the working end 8, see Fig. 2 (top).

3.

Validated reprocessing procedure

3.1

General safety information

Note Adhere to national statutory regulations, national and international standards and directives, and local, clinical hygiene instructions for sterile processing.

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.a-k-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 option to determine if a product 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

Preparing for cleaning

► Disassemble the product prior to cleaning, see Disassembly.

3.6

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

Disassembly

infection procedure.

Note Do not use tools during disassembling or assembling to prevent damage.

3.6.1

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.

Instrument that cannot be taken apart, with cover tube

► Disengage the cover tube 7 and push it forward, see Fig. 1.

3.6.2

Instrument that can be taken apart

► Unscrew the feed spindle 4 and pull out towards the rear, see Fig. 3. ► Detach the handle 5 and the working end 8 from the base tube 6, see Fig. 4 ► Disengage the cover tube 7 and push it forward, see Fig. 5.

3.7

Cleaning/Disinfection

3.7.1

Product-specific safety information on the reprocessing method

Hazardous to patients! The product FG045R may not be processed manually. ► Process FG045R only by mechanical cleaning preceded by manual pre-cleaning. Damage to or destruction of the product due to inappropriate cleaning/disinfecting agents and/or excessive temperatures! ► Use cleaning agents and disinfectants according to the manufacturer's instructions. ► Observe specifications regarding concentration, temperature and exposure time. ► Do not exceed the maximum allowable disinfection temperature of 95 °C. ► For wet disposal use suitable cleaning agents/disinfectants. To prevent foam from forming and reduced effec-

tiveness of the process chemicals: Prior to mechanical cleaning and disinfection, rinse the product thoroughly under running water

3.7.2

Validated cleaning and disinfection procedure

Validated procedure

Specific requirements

Reference

Manual cleaning with immersion disinfection

■ Use a suitable cleaning brush. ■ 20 ml disposable syringe ■ Keep working ends open for clean-

Chapter Manual cleaning/disinfection and sub-sections:

■ All products except for BV935R, BV936R

■ Chapter Manual cleaning with immersion disinfection

ing purposes.

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.

3.8.2

Manual cleaning with ultrasound and immersion disinfection

Phase

Step

T [°C/°F]

t [min]

Conc. [%]

Water quality

Chemical

I

Ultrasonic 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

-

V

Drying

RT

-

-

-

-

■ Drying phase: Use lint free cloth or medical compressed air Manual cleaning using ultrasound and immersion disinfection

■ Disposable syringe 20ml ■ Keep working ends open for clean-

■ BV935R ■ BV936R

■ Drying phase: Use a lint-free cloth

Chapter Manual cleaning/disinfection and subsection:

■ Chapter Manual cleaning

ing purposes.

with ultrasound and immersion disinfection

or medical compressed air

■ Place product on a sterile screen

Alkaline machine cleaning and thermal disinfection

Chapter Machine cleaning/disinfection and sub-sections:

basket suitable for cleaning (make sure all areas will be reached by water jets).

■ All products except for BT098R, BT099R, BV935R, BV936R, FG045R and FL079R

■ Chapter Mechanical alkaline cleaning and thermal disinfection

■ To flush the lumens/channels: Use flush lances or flush sleeves in the injector cart.

D–W: FD–W:

■ Keep working ends open for cleaning purposes.

■ Use a suitable cleaning brush. ■ Disposable syringe 20ml ■ Put jaw protecting cap on the prod-

Manual pre-cleaning with brush and subsequent mechanical alkaline cleaning and thermal disinfection

■ BT098R ■ BT099R ■ BV935R ■ BV936R ■ FL079R

Chapter Mechanical cleaning/disinfection with manual pre-cleaning and sub-sections:

■ Chapter Manual pre-cleaning

uct.

with a brush

■ Place the product on a tray that is

■ Chapter Mechanical alkaline

suitable for cleaning (avoid rinsing blind spots).

cleaning and thermal disinfecting

■ To flush the lumens/channels: Use flush lances or flush sleeves in the injector cart.

■ Keep working ends open for cleaning purposes. Manual pre-cleaning using ultrasound and brush and subsequent alkaline machine cleaning and thermal disinfection

■ FG045R

■ 20 ml disposable syringe ■ Put jaw protecting cap on the prod-

Chapter Mechanical cleaning/disinfection with manual pre-cleaning and subsection:

uct.

■ Chapter Manual pre-cleaning

■ Place product on a screen basket

with ultrasound and brush

suitable for cleaning (make sure all areas will be reached by water jets).

■ Chapter Mechanical alkaline cleaning and thermal disinfecting

■ Keep working ends open for cleaning purposes.

3.8

Manual cleaning/disinfection

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

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

Drinking water Fully desalinated water (demineralized, low microbiological contamination: drinking water quality at least) RT: Room temperature *Recommended: BBraun Stabimed fresh ► Note the information on appropriate cleaning brushes and disposable syringes, see Validated cleaning and dis-

infection procedure. Phase I ► Clean the product in an ultrasonic cleaning bath (frequency 35 kHz) for at least 15 min. Ensure that all accessible surfaces are immersed and acoustic shadows are avoided. ► 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 five times at the beginning of the exposure time with an appropriate disposable syringe. Ensure that all accessible surfaces are moistened. Phase IV ► Rinse/flush the product thoroughly (all accessible surfaces) under running water. ► 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.

3.8.1

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*

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).

II

Intermediate rinse

RT (cold)

1

-

D–W

-

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

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

-

V

Drying

RT

-

-

-

-

D–W: FD–W:

3.9

Drinking water Fully desalinated water (demineralized, low microbiological contamination: drinking water quality at least) RT: Room temperature *Recommended: BBraun Stabimed fresh

Machine cleaning/disinfection

3.9.1

Mechanical alkaline cleaning and thermal disinfection

3.10.3 Mechanical alkaline cleaning and thermal disinfecting

Machine type: single-chamber cleaning/disinfection device without ultrasound

Machine type: single-chamber cleaning/disinfection device without ultrasound

Phase

Step

T [°C/°F]

I

Pre-rinse

<25/77

II

Cleaning

55/131

t [min]

Water quality

Chemical/Note

Phase

Step

T [°C/°F]

t [min]

Water quality

Chemical

3

D–W

-

10

FD-W

I

Prerinse

<25/77

3

D–W

-

II

Cleaning

55/131

10

FD-W

■ Concentrate, alkaline:

■ Concentrate, alkaline:

– pH = 13 – <5 % anionic surfactant

– pH ~ 13 – <5 % anionic surfactant

■ 0.5 % working solution

■ working solution 0.5%

– pH = 11*

– pH = 11*

III

Intermediate rinse

>10/50

1

FD-W

-

III

Intermediate rinse

>10/50

1

FD-W

-

IV

Thermal disinfecting

90/194

5

FD-W

-

IV

Thermal disinfecting

90/194

5

FD-W

-

V

Drying

-

-

-

According to the program for cleaning and disinfection device

V

Drying

-

-

-

In accordance with the program for the cleaning and disinfecting machine

D–W: FD–W:

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

D–W: FD–W:

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

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

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

3.10 Mechanical cleaning/disinfection with manual pre-cleaning

3.11 Inspection

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).

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

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

► Ensure that all soiling has been removed. In particular, pay attention to mating surfaces, hinges, shafts, recessed

3.11.1 Visual inspection areas, drill grooves and the sides of the teeth on rasps. ► 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

3.10.1 Manual pre-cleaning with a brush Phase

Step

T [°C/°F]

t [min]

Conc. [%]

Water quality

Chemical

I

Disinfectant cleaning

RT (cold)

>15

2

D–W

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

II

Rinsing

RT (cold)

1

-

D–W

-

scratched and fractured components. ► Check the product for missing or faded labels. ► Check products having long, narrow geometries (in particular rotating instruments) for deformations. ► Check the cutting edges for continuity, sharpness, nicks and other damage. ► 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.

D–W: Drinking water RT: Room temperature *Recommended: BBraun Stabimed fresh

3.11.2 Functional test

► 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.

3.10.2 Manual pre-cleaning with ultrasound and brush

CAUTION The product may become damaged (metal pitting/fretting corrosion) if not sufficiently oiled! ► Oil any moving parts (e.g. joints, spool parts and threaded rods) prior to the functional test using oil suitable for the applied sterilization process (e.g. STERILIT® I oil spray JG600 for steam sterilization or STERILIT® Idrip-feed lubricator JG598). ► Assemble disassembled products, see Assembly. ► Check that the product functions correctly. ► Check that all moving parts are working property (e.g. hinges, locks/latches, sliding parts etc.). ► Check for compatibility with associated products. ► Immediately put aside inoperative products and send them to Aesculap Technical Service, see Technical service.

3.12 Assembly Note Do not use tools during disassembling or assembling to prevent damage.

3.12.1 Instrument that cannot be taken apart, with cover tube ► Carefully push the cover tube 7 (against the direction of the arrow Fig. 1) over the working end 8 and lock it in

the desired position, see Fig. 2.

3.12.2 Instrument that can be taken apart

Phase

Step

T [°C/°F]

t [min]

Conc. [%]

Water quality

Chemical

I

Ultrasonic cleaning

RT (cold)

>15

2

D–W

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

II

Rinsing

RT (cold)

1

-

D–W

-

D–W: Drinking water RT: Room temperature *Recommended: BBraun Stabimed fresh ► Note the information on appropriate cleaning brushes and disposable syringes, see Validated cleaning and dis-

infection procedure. Phase I ► Clean the product in an ultrasonic cleaning bath (frequency 35 kHz) for at least 15 min. Ensure that all accessible surfaces are immersed and acoustic shadows are avoided. ► 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.

► Attach the handle 5 and the working end 8 to the base tube 6. ► Insert feed rod 4 and screw together. ► Carefully push the cover tube 7 over the working end 8 and lock in the desired position.

3.13 Packaging ► Appropriately protect products with fine working tips. ► Place the product in its holder or on a suitable tray. Ensure that sharp edges are covered. ► 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.

3.14 Steam sterilization Note BT098R and BT099R: The product can be sterilized in both a disassembled and an assembled state. ► 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.

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

4.

Technical service

CAUTION Modifications of medical equipment may result in the voiding of any guarantee/warranty claims and any approvals. ► 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.

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. WARNING Risk of injury from sharp and/or pointed products! ► When disposing of or recycling the product, make sure the packaging prevents injuries from the product. Note The user institution is obliged to reprocess the product before its disposal, see Validated reprocessing procedure. TA009288

2020-10

V6

Change No. 63402