Mallets having replaceable metal or plastic end caps Instructions for Use

en ®

Aesculap Mallets / mallets having replaceable metal or plastic end caps 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 to the products listed below: Normal mallets Art. no.

Designation

DF112R

Mallet, head-∅ 22.5 mm, length 165 mm

DF114R

Mallet, 218 g, head-∅ 25 mm, length 190 mm

FL038R

Mallet COTTLE, 320 g, head-∅ 30 mm, length 185 mm

FL039R

Mallet, 234 g

FL044R

Mallet HAJEK, 210 g, length 220 mm

FL055R

Mallet BERGMANN, 490 g, head-∅ 30 mm, length 235 mm

FL057NR

Mallet, 380 g

FL059R

Mallet, 750 g, head-∅ 30/42mm, length 245 mm

FL060R

Mallet BERGMANN, 655 g, head-∅ 45 mm, 245 mm

FL066NR

Mallet, 580 g

FL066R

Mallet OMBREDANNE, 900 g, head-∅ 40 mm, length 240 mm

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

2.2.3

FL068R

Mallet HEATH, 850 g head-∅ 40 mm, length 240 mm Mallet, 780 g

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

FL069NR

Product

Product-specific safety information ► Do not tap a metal instrument or metal object using a mallet having plastic end caps. ► Do not tap a plastic handle using a mallet having metal end caps. ► Check calibration point before every use, see Inspection. ► Immediately single out the defective product and send it to the Aesculap Technical Service, see Technical service.

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.

FL069R

Mallet HEATH, 1 160 g, head-∅ 45 mm, length 240 mm

3.

Validated reprocessing procedure

FL070S

Mallet 600 g, head-∅ 27/13.5 mm, length 235 mm

3.1

General safety information

FL072K

Mallet 180 g, head-∅ 11.5/20 mm, length 230 mm

KH113NR

Slotted mallet, 680 g

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

MB630R

Orthopedic mallet, head-∅ 30 mm

MB631NR

Mallet, 660 g

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.

MB631R

Orthopedic mallet, head-∅ 38 mm

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

OG209R

Metal mallet HEERMANN, hollow handle

Mallets having replaceable end caps

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.

Art. no.

Designation

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

DX545R

ERGOPLANT mallet, 135 g, head-∅ 25 mm, length 200 mm

FL035R

Mallet MEAD, 350 g, length 190 mm

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.

FL036R

Mallet 210 g, head-∅ 25 mm, length 185 mm

3.2

FL045R

Malle 340t g, head-∅ 30mm, length 235 mm

FL046NR

Mallet, 330 g

FL062

Mallet WAGNER 690 g, head-∅ 35 mm, length 240 mm

FL062NR

Mallet, 530 g

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".

► 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 potential hazard. 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

Mallets are used to hammer, knock or tap on chisels, osteotomes, insertion and removal instruments for implants and their rasp handles and tampers.

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

Currently no known contraindications.

3.3

General information

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

Preparing for cleaning

► Disassemble the product prior to cleaning, see Disassembly.

3.6

Disassembly

► For FL062, FL062NR, FL045R and FL046NR: Unscrew the end caps using wrench FL062206 and process them sep-

arately. ► In case of other mallets having replaceable end caps: Unscrew the end caps by hand or on the vise and process

separately.

3.7

Cleaning/Disinfection

3.9

3.7.1

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! ► 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

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

3.7.2

Validated cleaning and disinfection procedure

Validated procedure

Specific requirements

Reference

Manual cleaning with immersion disinfection

■ Suitable cleaning brush ■ Drying phase: Use a lint-free

Chapter Manual cleaning/disinfection and subsection:

cloth or medical compressed air Mechanical alkaline cleaning and thermal disinfection

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

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

3.9.1

Mechanical alkaline cleaning and thermal disinfection

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

■ Chapter Manual cleaning with

– pH = 13 – <5 % anionic surfactant

immersion disinfection

■ 0.5 % working solution

Chapter Mechanical cleaning/disinfection and subsection:

■ Chapter Mechanical alkaline cleaning and thermal disinfection

3.8

Mechanical cleaning/disinfection

Manual cleaning/disinfection

– pH = 11* 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

► 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.

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*

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

-

-

-

-

D–W: FD–W:

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

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

3.10.1 Visual inspection ► Make sure all contamination has been removed. In particular, pay attention for instance to mating surfaces,

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 ► 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.

shafts, recessed areas and drilled grooves. ► If the product is dirty: repeat the cleaning and disinfection process. ► Check the product for damage, in particular:

– Cracks and holes, in particular in the shaft and handle area – Bending or breakage of the mallet handle – Massive deformation of the mallet head, resulting in risk of chipping ► 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 Technical service.

3.10.2 Functional test ► Assemble disassembled products, see Assembly. ► 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.

3.11 Assembly ► For FL062, FL062NR, FL045R and FL046NR: Screw end caps to the mallet head using wrench FL062206 . ► In case of other mallets having replaceable end caps: screw end caps to the mallet head by hand or using the vise.

3.12 Packaging ► Allocate product to dedicated storage or place on suitable screen basket. ► 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.

3.13 Steam sterilization Note FL062NR: The product can be sterilized in both a disassembled and an assembled state. ► Make certain that all external and internal surfaces of the product will be exposed to the sterilizing agent. ► Validated sterilization process

– Steam sterilization in the fractionated vacuum process – Steam sterilizer in accordance with DIN EN 285 and validated in accordance with DIN EN ISO 17665 – Sterilization in the 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.

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

4.

Technical service

CAUTION Modifications carried out on medical technical equipment may result in loss of guarantee/warranty rights and forfeiture of applicable licenses. ► 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

Accessories/spare parts for

DX545204

Plastic end caps convex

DX545R

DX545205

Plastic end caps plane

DX546

Pair of spare plastic end caps

FL034

Pair of spare plastic end caps

FL037

Pair of spare end caps

FL036R

FL047

Pair of spare plastic end caps, plane and convex

FL045R

FL046211

Metal end caps, convex

FL046NR

FL046212

Plastic end caps convex

FL046213

Metal end caps, plane

FL046214

Plastic end caps, plane

FL062211

Metal end caps, convex

FL062212

Plastic end caps convex

FL062213

Metal end caps, plane

FL062214

Plastic end caps, plane

FL064R

Pair of spare metal end caps, plane and convex

FL065

Pair of spare plastic end caps, plane and convex

FL062206

Wrench

6.

FL035R

FL062NR

FL062

FL046NR/FL062NR/FL062/ FL045

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 due to sharp-edged and/or pointed products! ► When disposing of or recycling the product, ensure that the packaging prevents injury by the product. Note The user institution is obliged to reprocess the product before its disposal, see Validated reprocessing procedure. TA015666

2021-01

V6

Change No. 64152