Skin mesh dermatome BA720R

en 2.

Safe handling

4.

CAUTION Federal law restricts this device to sale by, or on order of a physician!

WARNING

The operation and reprocessing instructions for the skin mesh dermatome may differ from these instructions for use! These instructions for use describe only the operation and reprocessing of the skin mesh dermatome as of series number 4000. ► For upgrades, please contact your national B. Braun/Aesculap agency.

Preparation

Non-compliance with the following instructions will preclude all responsibility and liability in this respect on the part of Aesculap. ► Prior to use, inspect the skin mesh dermatome BA720R and its accessories for visible damage. ► Only use the skin mesh dermatome BA720R and its accessories if they are in perfect condition. ► Be certain that the skin mesh dermatome is set up on a sufficiently stable support (e.g. table, equipment cart, etc.).

5.

Working with the skin mesh dermatome BA720R

5.1

System set-up

► Remove the transport packaging and clean the new product, either

manually or mechanically, prior to its initial sterilization. ► Prior to use, check that the product is in good working order. ► To prevent damage caused by improper setup or operation, and in order

not to compromise warranty and manufacturer liability: – Use the product only according to these instructions for use. – Follow the safety and maintenance instructions. – Only combine Aesculap products with each other. ► Ensure that the product and its accessories are operated and used only by persons with the requisite training, knowledge, or experience. ► Keep the instructions for use accessible for the user.

3.

Product description

3.1

Scope of supply

Designation

Art. no.

Skin mesh dermatome, complete with hand ratchet

BA720R

Carrier plate for expansion factor 1.5; sterile

BA721

Carrier plate for expansion factor 3; sterile

BA722

Carrier plate for expansion factor 6; sterile

BA723

3.2

Intended use

WARNING

► Slide hand ratchet 12 on shaft 10 so that it clicks into position.

5.2

Function checks

Carry out a trial run of the skin mesh dermatome BA720R prior to each use: ► Verify that gearwheel transmission 7 is moved when turning hand ratchet 12. ► Make certain that setting wheel 6, once engaged, can be easily rotated through the range of scale 18. ► Only use the device if it is in perfect condition.

5.3

Safe operation

WARNING

Operating principle

The cutting cylinder 2 is turned anticlockwise with hand ratchet 12. The carrier plate 5 transports the skin graft between cutting cylinder 2 and counter cylinder 3. During this transport, the skin graft is cut. The cutting depth is set with setting wheel 6, using scale 18. The staggered slits in the skin graft allow expanding the graft to rhombic skin mesh. The skin mesh can be used for covering defects of up to six times the size of the grafting site.

Risk of injury and/or malfunction! ► Always carry out a function check prior to using the product.

Setting the cutting cylinder

The skin mesh dermatome BA720R is used for the cutting of skin grafts in general, burns and plastic surgery.

3.3

Risk of infection and contamination! The device and its accessories are delivered in unsterile condition. ► Sterilize the device and accessories before use.

CAUTION

Damage to the cutting cylinder! The cutting cylinder can only be set when running freely. ► Make certain that the carrier plate is not engaged under the cutting cylinder.

► Slightly pull out setting wheel 6 until it disengages. ► Turn setting wheel 6 to the required position.

Skin graft cutting Possible settings at the setting wheel

Scale symbols

extremely thick skin graft normal setting for cutting reserve setting for cutting

► Slightly push in setting wheel 6 until it engages.

3

en Processing the skin graft Note Only place individual carrier plates on the insertion tray, one after the other. For long skin grafts, sequentially insert several carrier plates.

► Open upper part 17, see Fig. 2.

17

Coiling of the skin graft! The skin graft can be lifted off from carrier plate as soon as it has been cut into by the cutting cylinder! ► Press the skin graft onto the carrier plate, using fine tweezers, directly behind the cut-in line. ► If the cutting cylinder has been turned too far already, turn back the cutting cylinder, using the screwdriver end of the ratchet.

CAUTION

► Position the required carrier plate 5, with the grooved surface facing

up, on insertion tray 16. ► Position the skin graft on carrier plate 5. ► Push carrier plate 5 between guide strips 15 under cutting cylinder 2

until the cutting cylinder engages. ► Turn hand ratchet 12 anticlockwise. The carrier plate is transported. ► Keep turning hand ratchet 12 until the complete carrier plate 5 is in position on removal tray 9. This completes the processing of the skin graft.

14

Fig. 2 ► Hold down lock 8 and, at the same time, pull at shaft 10 to decouple

cutting cylinder 2, see Fig. 3.

Changing the cutting cylinder Note The cutting cylinder cannot be sharpened. Dismounting the cutting cylinder Cuts on hands or other body parts, caused by sharp edges on the cutting cylinder! ► Touch the cutting cylinder only at the shaft.

WARNING

10

► Turn cutting device 4 upside down so that the four screws 11 are vis-

ible, see Fig. 1.

8

11

Fig. 3

11

Fig. 1 ► Loosen screws 11 by hand or, if they are difficult to turn, with the

screwdriver end 13 of hand ratchet 12. ► Return cutting device 4 to its upright position.

4

en ► Turn cutting cylinder 2 while pulling it out of bearings 20, see Fig. 4.

This completes the dismounting of cutting cylinder 2. 2

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. The recommended chemistry was used for validation.

20

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

20

Note For up-to-date information about reprocessing and material compatibility, see also the Aesculap Extranet at https://extranet.bbraun.com The validated steam sterilization procedure was carried out in the Aesculap sterile container system.

6.2

Fig. 4

Single-use products

WARNING

Mounting the cutting cylinder Note To prevent transport damage, cutting cylinder 2 is protected by a piece of cardboard on delivery. Remove the cardboard protection only after cutting cylinder 2 has been mounted completely.

Infection hazard for patients and/or users and impairment of product functionality due to reuse. Risk of injury, illness or death due to contamination and/or impaired functionality of the product! ► Do not reprocess the product!

Designation

Article no.

Carrier plate

BA721

► Insert the cutting cylinder 2 into the two bearings 20, see Fig. 4.

BA722

► Hold cutting cylinder 2 at shaft 10 and press it into bearings 20 until

it clicks into position, see Fig. 3. ► Turn shaft 10 and check cutting cylinder 2 for correct seating. ► Close upper part 17 on lower part 14, see Fig. 2. ► Turn cutting device 4 upside down so that the four screws 11 are visible, see Fig. 1. ► Tighten screws 11 by hand. ► Return cutting device 4 to its upright position. ► Remove the piece of cardboard from cutting cylinder 2. This completes the mounting of cutting cylinder 2.

6.

Validated reprocessing procedure

WARNING

6.1

The reprocessing instructions for the skin mesh dermatome may differ from these instructions for use! These instructions for use describe only the operation and reprocessing of the skin mesh dermatome as of series number 4000. ► For upgrades, please contact your national B. Braun/Aesculap agency.

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.

BA723

6.3

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 precleaning 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.

5

en ► Do not use metal cleaning brushes or other abrasives that would dam-

age 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 Publications, Red Brochure – Proper maintenance of instruments.

6.4

CAUTION

Preparations at the place of use

► 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.

6.5

Preparation before cleaning

► Carry out non-fixating/NaCl-free pre-cleaning immediately after use.

6.6

Cleaning/disinfection

Product-specific safety instructions for the reprocessing procedure

CAUTION

Damage to the product due to inappropriate cleaning/disinfecting agents! ► Only use cleaning/disinfecting agents approved for surface cleaning. Follow the manufacturer’s instructions for the respective cleaning/disinfecting agent.

Damage to the product due to inappropriate cleaning/disinfecting agents and/or excessive temperatures! ► Use cleaning and disinfecting agents according to the manufacturer’s instructions which – are approved for plastic material and highgrade steel, – do not attack softeners (e.g. in silicone). ► Observe specifications regarding concentration, temperature and exposure time. ► Do not exceed the maximum permitted cleaning temperature of 60 °C.

► Dry the product for at least 10 minutes at a maximum of 120 °C.

Note The indicated drying temperature is a guide temperature only. It must be checked taking into account the specific conditions (e.g. load) and if applicable adjusted.

Validated cleaning and disinfection procedure Validated procedure

Special features

Reference

Manual cleaning and wipe disinfection

■ When cleaning products with movable hinges, ensure that these are in

Chapter Manual cleaning/disinfecting and subsection:

an open position and, if applicable, move the joint while cleaning.

■ Drying phase: Use a lint-free cloth or compressed air for medical pur- ■ Chapter Manual cleaning and wipe disinfectposes

ing

■ Ensure that the product is positioned in such a way that water will not enter the product e.g. through coupling interfaces. (Immediately remove any fluid that entered the product inadvertently.)

■ To avoid damage to cutting cylinder 2, clean the cutting cylinder with a soft brush. Mechanical alkaline cleaning and thermal disinfecting

■ Install Eccos holder GB688R in a suitable wire basket (e.g. JF214R). ■ Insert the product in its proper position in Eccos holder GB682R.

Chapter Mechanical cleaning/disinfecting and subsection:

■ Chapter Mechanical alkaline cleaning and thermal disinfecting

6.7

Manual cleaning/disinfecting

► Prior to manual disinfecting, allow water to drip off for a sufficient

length of time to prevent dilution of the disinfecting solution. ► After manual cleaning/disinfection, check visible surfaces visually for residues. ► Repeat the cleaning/disinfection process if necessary.

6

en Manual cleaning and wipe disinfecting Phase

Step

T [°C/°F]

t [min]

Conc. [%]

Water quality

Chemical

I

Cleaning

RT (cold)

-

-

D–W

-

II

Drying

RT

-

-

-

-

III

Wipe disinfection

-

>1

-

-

Meliseptol HBV wipes 50 % Propan-1-ol

IV

Final rinse

RT (cold)

0.5

-

FD-W

-

V

Drying

RT

-

-

-

-

D–W: FD–W: RT:

Drinking water Fully desalinated water (demineralized, low microbiological contamination: drinking water quality at least) Room temperature

Phase I ► Clean the product under running faucet water, using a suitable cleaning brush until all visible residues have been removed from the surfaces. ► Mobilize non-rigid components, such as set screws, links, etc. during cleaning. Phase II ► Dry the product in the drying phase with suitable equipment (e.g. cloth,

compressed air), see Validated cleaning and disinfection procedure. Phase III ► Wipe all surfaces of the product with a single-use disinfectant wipe.

Phase V ► Dry the product in the drying phase with suitable equipment (e.g. cloth, compressed air), see Validated cleaning and disinfection procedure.

6.8

Mechanical cleaning/disinfecting

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.

Phase IV ► After the specified exposure time (at least 1 min), rinse the disinfected

surfaces under running FD water. ► Drain any remaining water fully.

Mechanical alkaline cleaning and thermal disinfecting Machine type: single-chamber cleaning/disinfection device without ultrasound Phase

Step

T [°C/°F]

t [min]

Water quality

Chemical/Note

I

Prerinse

<25/77

3

D–W

-

II

Cleaning

55/131

10

FD-W

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

■ 0.5 % working solution – 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

D–W: Drinking water FD–W: 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/disinfect-

ing.

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en 6.9

Inspection, maintenance and checks

► When sterilizing several products at the same time in a steam sterilizer,

ensure that the maximum load capacity of the steam sterilizer specified by the manufacturer is not exceeded.

► Allow the product to cool down to room temperature. ► Inspect the product after each cleaning and disinfecting cycle to be

sure it is: clean, functional, and undamaged. ► Set aside the product if it is damaged.

6.12 Sterilization for the US market

■ Aesculap advises against sterilizing the device by flash sterilization or chemical sterilization.

6.10 Packaging ► Follow the instructions for use for the applied packaging and storage

systems (e.g. instructions for use TA009721 for Aesculap Eccos storage system). ► Insert the product in its proper position in the Eccos holder, or put it on a tray in such a way that the product is protected against damage. Ensure that all cutting edges are protected. ► Pack trays appropriately for the sterilization process (e.g. in Aesculap sterile containers). ► Ensure that the packaging will prevent a recontamination of the product.

■ Sterilization may be accomplished by a standard prevacuum cycle in a steam autoclave. To achieve a sterility assurance level of 10-6, Aesculap recommends the following parameters: Aesculap Orga Tray/Sterile container (perforated bottom) Minimum cycle parameters* Sterilization method

Temp.

Time

Minimum drying time

Prevacuum

270 °F/275 °F

4 min

20 min

6.11 Steam sterilization Note The carrier plates BA721, BA722 and BA723 are gamma-sterilized singleuse products. These products must not be steam-sterilized and are intended for single use only. Note The product may only be sterilized with the upper part 17 open and the cutting cylinder 2 removed.

*Aesculap has validated the above sterilization cycle and has the data on file. The validation was accomplished in an Aesculap sterile container cleared by FDA for the sterilization and storage of these products. Other sterilization cycles may also be suitable, however individuals or hospitals not using the recommended method are advised to validate any alternative method using appropriate laboratory techniques. Use an FDA cleared accessory to maintain sterility after processing, such as a wrap, pouch, etc.

► Sterilize the skin mesh dermatome immediately after cleaning.

6.13 Storage

► Store the skin mesh dermatome in a suitable wire basket (e.g. JF214R).

► Store sterile products in germ-proof packaging, protected from dust, in

a dry, dark, temperature-controlled area.

► 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 – Disassemble the product – Steam sterilization through fractionated 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

8.

7.

Maintenance

In order to ensure reliable operation, the product must be maintained after 300 reprocessing cycles or at least once a year. For technical service, please contact your national B. Braun/Aesculap agency, see Technical Service.

Troubleshooting list

Malfunction

Detection

Cause

Remedy

Cutting cylinder 2 fails to rotate

Foreign body in device

Cutting cylinder jammed

Remove foreign body

–

Hand ratchet 12 not engaged

Engage hand ratchet 12

Excessive axial slack of cutting cyl- Cutting cylinder loose inder

Engage cutting cylinder and secure with lock 8

Cutting cylinder 2 stiff

Strong force required on hand ratchet 12

Defective bearing

Repair by manufacturer

Skin not cut through completely

Incorrect symbol on fine adjustment scale 18

Incorrect setting

Select the required fine adjustment, see Safe operation

–

Screws 11 loose

Tighten screws by hand or with screwdriver 13

Cutting tips shiny, hand ratchet 12 stiff

Cutting cylinder 2 worn

Replace cutting cylinder 2, see Safe operation

Cutting tips broken off

Cutting cylinder 2 defective

Replace cutting cylinder 2, see Safe operation

8

en 9.

Technical Service

11.1 Ambient conditions Operation

Risk of injury and/or malfunction! ► Do not modify the product.

Storage and transport

Temperature

WARNING ► For

service and repairs, please contact your national B. Braun/Aesculapagency. Modifications carried out on medical technical equipment may result in loss of guarantee/warranty rights and forfeiture of applicable licenses. Service addresses Aesculap Technischer Service Am Aesculap-Platz 78532 Tuttlingen / Germany Phone: +49 (7461) 95 -1601 Fax: +49 (7461) 14 -939 E-Mail: [email protected] Or in the US: Attn. Aesculap Technical Services 615 Lambert Pointe Drive Hazelwood MO, 63042 USA Aesculap Repair Hotline Phone: +1 (800) 214 -3392 Fax: +1 (314) 895 -4420 Other service addresses can be obtained from the address indicated above.

10. Accessories/Spare parts Art. no.

Designation

BA725R

Replacement cutting cylinder

BA721

Carrier plate factor 1.5

BA722

Carrier plate factor 3

BA723

Carrier plate factor 6

BA726R

Hand ratchet

BA727R

Basket storage aid

GB688R

Eccos holder

TA008023

Instructions for use BA720R

Relative humidity

Atmospheric pressure

12. Disposal Note The user institution is obliged to process the product before its disposal, see Validated reprocessing procedure. The skin mesh dermatome BA720R is made of stainless steel. ► Dispose of the device with other recyclable metals. ► Detailed information concerning the disposal of the product is avail-

able through your national B. Braun/Aesculap agency, see Technical Service.

13. Distributor in the US/Contact in Canada for product information and complaints Aesculap Inc. 3773 Corporate Parkway Center Valley, PA, 18034, USA

11. Technical data Classification acc. to Directive 93/42/EEC Art. no.

Designation

Class

BA720R

Skin mesh dermatome

IIa

Dimensions (H x W x D)

150 mm x 195 mm x 105 mm

Weight

4 800 g

Length of carrier plate 220 mm Width of carrier plate

75 mm

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