ScalpFix Scalp Clip System

2.2.2

en ®

Aesculap ScalpFix Scalp Clip System Legend 1 2 3 4 5 6 7 8 9

Trigger lever Cartridge securing pin Hook Cartridge Lock pusher Clip applicator Transit slider Scalp clip Cartridge opening

1.

Art. no.

Name

FF007P

ScalpFix Plastic Applicator

FF012R

ScalpFix Aluminum Applicator

FF014R

ScalpFix Application and Removal Forceps

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

About this document

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

1.1

Sterility

Non-sterile packaged products

Art. no.

Name

FF013P

ScalpFix Scalp Clips sterile

The product is EtO sterilized and wrapped in sterile packaging. ► Do not use any product from open or damaged sterile packaging. ► Do not use product after expiration date. ► Do not reuse the product.

Scope

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

Designation

Processing the product will impair its functionality. Contamination and/or impaired function of the products may result in injury or illness and death. ► Do not reprocess the product.

FF007P

ScalpFix Plastic Applicator

2.3

FF012R

ScalpFix Aluminum Applicator

FF014R

ScalpFix Application/Removal Forceps

FF013P

ScalpFix Scalp Clips sterile

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.

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

Application

CAUTION Scalp clip will be ejected when the pulled trigger lever is released! ► Pull the trigger lever only if the scalp bracket is actually required.

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

The cartridge 4 is equipped with a transit slider 7 for the scalp clips. The transit slider 7 must be removed in the direction of the arrow before the cartridge 4 can be installed. ► Pull and hold the trigger lever 1 as far as it will go. The scalp clip 8 is pushed out of the cartridge 4 and opened. ► Place the open scalp clip 8 at the edge of the wound. ► Slowly release the trigger lever 1. The scalp bracket 8 closes and detaches from the cartridge. ► Use the ScalpFix application/removal forceps FF014R to remove the clips. ► Apply forceps to the clip, compress and force the clip open. Only compress the forceps up to the last catch but not beyond. ► Remove the clip.

2.

Clinical use

3.

Validated reprocessing procedure

2.1

Areas of use and limitations of use

3.1

General safety information

2.1.1

Intended use

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

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.

The scalp clip system consists of a clip applicator FF007P or FF012R, the cartridge FF013P and the removal forceps FF014R. The scalp clamp system is used in cranial surgery to place sterile scalp clips on the wound edges of the scalp. This temporarily prevents blood from seeping around the edges of the wound.

2.1.2

Indications

Temporary hemostasis of the scalp during cranial surgery

2.1.3

Absolute contraindications

■ Hemostasis of other anatomical regions not listed in the indication ■ Material intolerances against polyoxymethylene 2.1.4

Relative contraindications

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.

It is recommended not to apply the scalp clips when the skull is open, as there is a possibility that a clip might fall into the operating field. The conditions listed below, may, individually or combined, result in delayed healing or jeopardize the success of the operation: ■ Medical or surgical conditions that might prevent the success of the operation, e.g. excessively thin scalp or laceration caused by the scalp clip. In the presence of relative contraindications, the user decides individually regarding the use of the product.

Note If there is no final sterilization, then a virucidal disinfectant must be used.

2.2

Safety information

2.2.1

Clinical user

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".

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.

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

3.3

General information

Single use products

Art. no.

Name

FF013P

ScalpFix Scalp Clips sterile

► Do not reuse product.

Processing the product will impair its functionality. Contamination and/or impaired function of the products may result in injury or illness and death. ► Do not reprocess the product.

3.4

Reusable products

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.

Art. no.

Name

FF007P

ScalpFix Plastic Applicator

FF012R

ScalpFix Aluminum Applicator

FF014R

ScalpFix Application/Removal Forceps

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.

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.

3.5

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.

3.6

Preparing for cleaning

► Do not disassemble anchoring screws/bolts that permanently connect the various components. ► Disassemble the product prior to cleaning, see Disassembly.

3.7

Disassembly

► Slide the lock pusher 5 in the direction of the arrow. ► Rotate the cartridge 4 in the direction of the arrow. ► Remove the hook 3 from the cartridge securing pin 2 and lift out the cartridge, see Fig. C.

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.

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

3.10.1 Mechanical alkaline cleaning and thermal disinfection

3.8

Cleaning/Disinfection

3.8.1

Product-specific safety information on the reprocessing method

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

Hazardous to patients! The product must not be manually processed. ► FF007P, FF012R: Only reprocess the product using machine cleaning. Damage to or destruction of the product due to inappropriate cleaning/disinfecting agents and/or excessive temperatures! ► Use cleaning agents and disinfectants in accordance with the manufacturer's instructions. ► Observe specifications regarding concentration, temperature and exposure time. ► Do not exceed the maximum allowable disinfection temperature of 95 °C.

Phase

Step

T [°C/°F]

t [min]

Water quality

Chemical/Note

I

Pre-rinse

<25/77

3

D–W

-

II

Cleaning

55/131

10

FD-W

■ Concentrate, alkaline: – pH = 13 – <5 % anionic surfactant

■ 0.5 % working solution

► Do not use oxidizing chemicals (e.g.H2O2) on PVD coated products, as the former can cause bleaching or layer

loss. ► Use suitable cleaning/disinfectants for wet disposal. To prevent foam from forming and reduced effectiveness of the process chemicals: Prior to mechanical cleaning and disinfection, rinse the product thoroughly under running water

3.8.2

III

Intermediate rinse

>10/50

1

FD-W

-

IV

Thermal disinfecting

90/194

5

FD-W

-

V

Drying

-

-

-

According to the program for cleaning and disinfection device

Validated cleaning and disinfection procedure

Validated procedure

Specific requirements

Reference

Manual cleaning with immersion disinfection

► Drying phase: Use lint free

Chapter Manual cleaning/disinfection and subsection:

cloth or medical compressed air

■ FF014R

■ Chapter Manual cleaning with immersion disinfection ► Place product on a screen bas-

Alkaline machine cleaning and thermal disinfection

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

■ FF014R

Neutral or mildly alkaline machine cleaning and thermal disinfection

► Place the product on a clean-

■ FF007P ■ FF012R

3.9

– pH = 11*

suitable screen basket (avoid flushing shadows).

D–W: FD–W:

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

Chapter Machine cleaning/disinfection and sub-sections:

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

■ Chapter Mechanical alkaline

3.10.2 Mechanical neutral or mild alkaline cleaning and thermal disinfecting

cleaning and thermal disinfection

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

Step

T [°C/°F]

t [min]

Water quality

Chemical

Chapter Machine cleaning/disinfection and sub-sections:

■ Chapter Mechanical neutral or

I

Prerinse

<25/77

3

D–W

-

mild alkaline cleaning and thermal disinfecting

II

Cleaning

55/131

10

FD-W

Neutral:

■ Concentrate: – pH neutral – <5 % anionic surfactant

Manual cleaning/disinfection

■ 0.5 %* working solution Mildly alkaline:

► 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.

■ Concentrate: – pH = 9.5 – <5 % anionic surfactant

3.9.1

Manual cleaning with immersion disinfection

Phase

Step

T [°C/°F]

t [min]

Conc. [%]

Water quality

Chemical III

Intermediate rinse

>10/50

1

FD-W

-

I

Disinfecting cleaning

RT (cold)

>15

2

D–W

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

IV

Thermal disinfection

90/194

5

FD-W

-

II

Intermediate rinse

RT (cold)

1

-

D–W

-

V

Drying

-

-

-

According to the program for cleaning and disinfection device

III

Disinfection

RT (cold)

5

2

D–W

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

D–W: FD–W:

IV

Final rinse

RT (cold)

1

-

FD-W

-

V

Drying

RT

-

-

-

-

D–W: FD–W:

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

■ 0.5 % solution

Drinking water Fully desalinated water (demineralized, low microbiological contamination: drinking water quality at least) *Recommended: BBraun Helimatic Cleaner neutral ► Check visible surfaces for residues after mechanical cleaning/disinfecting. ► Repeat the cleaning/disinfecting process if necessary.

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

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

► 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.

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

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.

3.11.2 Functional test 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® I drip-feed lubricator JG598). ► Assemble disassembled products, see Assembly. ► Check product for proper function: Actuate the trigger lever 1 and the lock pusher 5 and visually check the

sprocket of the cartridge. ► Check that all moving parts are working property (e.g. hinges, locks/latches, sliding parts etc.). ► Immediately put aside inoperative products and send them to Aesculap Technical Service, see Technical service.

3.12 Assembly ► Mount the hook 3 at an angle of approx. 60° in the cartridge securing pin 2, see Fig. A. ► Rotate the rear part of the cartridge 4 in the direction of the arrow against the lock pusher 5, see Fig. B. ► Slide the lock pusher 5 towards the cartridge 4. Be careful not to actuate the trigger lever 1.

The cartridge catches and is installed.

3.13 Packaging ► Secure products having ratchet locks fully opened or locked no further than in the first notch. ► Close the locks until the jaw tips are just in contact. ► Allocate product to associated storage or place on a suitable sterile screen basket. Ensure that any blades are

protected. ► 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 ► 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. ► Store sterile packaged single-use products in a dry, dark and evenly tempered room.

4.

Technical service

CAUTION Modifications to 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.

6.

Symbols at product and packaging Steam sterilization up to 134°C

TA010579

2021-01

V6

Change No. 64152