Acculan 3Ti Dermatome GA670

en

Aesculap® Acculan 3Ti Acculan 3Ti Dermatome GA670 Note Store the instructions for use for Acculan 3Ti in a folder!

Symbols on product and packages Caution Observe important safety information such as warnings and precautions in the instructions for use.

Legend 1 Dermatome 2 Nut 3 Sliding surfaces 4 Trigger (for controlling the oscillation frequency) 5 Safety catch 6 Blade cover 7 Clamping lever 8 Sliding surfaces 9 Blade guide peg 10 Pusher dog 11 Flap tabs 12 Flaps 13 Surface 14 Setting lever 15 Lock (of setting lever) 16 Dial wheel 17 Roll pin 18 Flap rod 19 Guide slots 20 Sterile funnel 21 Cover 22 Cover release button 23 Battery 24 Dermatome blade 25 Battery removal device 26 Coding

YYYY-MM

Maintenance label Indication of the next maintenance appointment (Date: YearMonth) Machine-readable, two-dimensional code The code contains a unique serial number which can be used for electronic tracking of the individual instrument. The serial number is based on the global standard sGTIN (GS1). Date of manufacture

Follow the instructions for use

Labeling of electrical and electronic devices pursuant to directive 2002/96/EG (WEEE)

Classification Type BF

2

en Motor speed control

Rotational direction for loosening the nut

Direction of rotation to tighten the nut

Alignment of flaps on the flap rod

LOT

Manufacturer’s batch designation

SN

Manufacturer’s serial number

REF

Manufacturer’s article number Non-sterile medical product Temperature limits during transport and storage

Air humidity limits during transport and storage

Atmospheric pressure limits during transport and storage

S9

Operating mode

Contents 1. 1.1 1.2 1.3 1.4 1.5 2. 3. 3.1 3.2 3.3 4. 5. 5.1 5.2 5.3 6. 6.1 6.2 6.3 6.4 6.5 6.6 6.7 6.8 6.9 6.10 6.11 6.12 6.13 7. 8. 9. 10. 11. 11.1 11.2 12.

General information... 4 Intended use... 4 Main functions and design characteristics . . 4 Indications... 4 Absolute contraindications... 4 Relative contraindications... 4 Safe handling... 4 Product description... 5 Scope of supply... 5 Components required for operation... 5 Operating principle... 5 Preparation... 5 Working with the Acculan 3Ti Dermatome. . 6 System set-up... 6 Function checks... 12 Safe operation... 13 Validated reprocessing procedure... 14 General safety information... 14 General notes... 15 Preparation at the place of use... 15 Dismantling prior to carrying out the reprocessing procedure... 15 Preparation before cleaning... 15 Single-use products... 16 Cleaning/disinfection... 16 Manual cleaning with wipe disinfection... 17 Automatic cleaning/disinfection with manual pre-cleaning... 18 Inspection, maintenance and checks... 19 Packaging... 20 Steam sterilization... 20 Storage... 20 Maintenance... 20 Troubleshooting list... 21 Technical Service... 21 Accessories/Spare parts... 22 Technical data... 22 Operating mode... 23 Ambient conditions... 23 Disposal... 23

3

en 1. 1.1

General information

1.4

Intended use

The product is not licensed for use on the central nervous system or central circulatory system.

Task/Function The dermatome GA670, combined with dermatome blade, is used for split skin removal in adjustable depth. Application Environment The product fulfills the requirements for type BF pursuant to IEC/DIN EN 60601-1 and is used in operating rooms in sterile environments of explosion risk areas (such as areas with pure oxygen or anesthesia gases).

1.2

Main functions and design characteristics

Oscillation frequency

min. 0 min-1 to max. 6 500 min-1

Operating mode

Operation with non-periodic load and speed changes (type S9 pursuant to IEC EN 60034-1)

1.5

Absolute contraindications

Relative contraindications

The safe and effective use of the product greatly depends on influences which can only be controlled by the user. Therefore the specifications provided represent framework conditions only. Clinically successful use of the product is dependent on the knowledge and experience of the surgeon. The surgeon must decide which structures it is sensible to treat and take into account the safety and warning information contained in these instructions for use.

2.

Safe handling

WARNING

Risk of injury and material damage if this product is not used as intended! ► Use the product only for its intended purpose.

WARNING

Risk of injury and damage to property due to improper handling of the product! ► Follow the instructions for use of all products used.

■ 60 second application, 60 second pause

■ 10 repetitions ■ 30 min cooling time ■ Max. Temperature 48 °C Electrical systems generally heat up during continual operation. It is advised to give the system a break after use to cool down, as listed in the table on operating mode. Heating depends on the tool used and the load. After a certain number of repetitions, the system should cool down. This procedure prevents the system overheating as well as possible injury to the patient or user. The user is responsible for the use and adherence to the pause sequence described.

1.3

Indications

The type and area of application depend on the tool selected.

4

► 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. ► See “Information on electromagnetic compatibility (EMC) for Acculan components" TA022450; see Aesculap Extranet at https://extranet.bbraun.com

en ► 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. ► Use product and accessories in surgery and/or in the framework of emergency medical treatment. ► Keep the instructions for use accessible for the user. ► Always adhere to applicable standards. ► Follow the instructions for use for the Acculan 3Ti charger TA022160.

3.

Product description

3.1

Scope of supply

3.2

Components required for operation

Designation

Art. no.

STERILIT Power Systems dripping oils (50 ml)

GA059

Acculan 3Ti Dermatome

GA670

Cover

GA675

Sterile funnel

GA678

Battery (rechargeable, charged)

GA666 (NiMH) or GA346 (Li-Ion)

Charger

GA677

Dermatome blade

GB228R

STERILIT Power Systems oil spray (300 ml)

GB600

3.3

Operating principle

In the Acculan 3Ti, the rotational speed of the motor is converted, through reduction gearing and an eccentric drive unit, directly and with minimum loss into oscillating movement of the dermatome blade.

Designation

Art. no.

Acculan 3Ti Dermatome

GA670

Cover

GA675

4.

Sterile funnel

GA678

NiMH battery

GA666

Instructions for use

TA013000

Instructions for use for battery GA666

TA011867

Non-compliance with the following instructions will preclude all responsibility and liability in this respect on the part of Aesculap. ► Check the Acculan 3Ti Dermatome and its accessories for visible damage before use. ► Use Acculan 3Ti Dermatomes and accessories only if they are in perfect condition.

Preparation

5

en 5.

Working with the Acculan 3Ti Dermatome

WARNING

WARNING

WARNING

WARNING

WARNING

6

Risk of infection and contamination! Product is delivered unsterilized! ► Sterilize the product before use pursuant to the operating instructions. Risk of injury and material damage due to accidental activation of the product! ► Products which are not being actively used must be secured against accidental activation (position OFF). Risk of injury and material damage due to inappropriate use of tools! ► Always follow the safety advice and information given in the instructions for use. ► When coupling/uncoupling, handle tools with cutting edges with care. Damage to the product if dropped! ► Use the products only if they are in perfect technical condition, see Function check. Risk of injury and/or malfunction due to unrecognized change to cutting setting! The basic adjustment of the cutting setting can change if the product falls on the floor, for example. ► Do not use product. ► Have the manufacturer inspect the product.

WARNING

5.1

Risk of burns to skin and tissue through blunt tools or if product has not been maintained properly! ► Use tools only if they are in perfect condition. ► Replace blunt tools. ► Maintain the product properly, see maintenance guide.

System set-up

Connecting the accessories

DANGER

Risk of injury due to unapproved configuration using additional components! ► For all applied components, ensure that their classification matches that of the application component (e.g. Type BF or Type CF) of the respective device.

Combinations of accessories that are not mentioned in the present instructions for use may only be employed if they are specifically intended for the respective application, and if they do not compromise the performance and safety characteristics of the products. ► Please address your B. Braun/Aesculap partner or Aesculap Technical Service with any inquiries in this respect; for a contact address, see Technical Service.

en Installing the flap rod of the Acculan 3Ti Dermatome

► Engage safety catch 5.

► Attach flaps 12 on flap rod 18 down to the onset

arrows. Blade cover 6 is now unlocked. ► Open blade cover 6 in the direction of the arrow. ► Safely insert the dermatome blade 24 into the pusher dog 10 and blade guide peg 9, see Fig. 2. ► Close blade cover 6. ► Cock both clamp levers 7 so that the roll pin 17 grips into the recess of the clamp lever 7.

of the rear surface. Observe the symbol on the face of the thread. ► Screw the nut 2 counterclockwise onto the thread of flap rod 18 (left-handed thread). ► Turn the nut 2 up to the edge of the visible surface. ► Insert and twist the complete flap rod 18 in its guide slots 19 on the side surfaces. ► Push the flap rod 18 laterally all the way so that the cross pin of the flap rod 18 comes to rest in the guide slot 19. ► Tighten nut 2 by turning it counterclockwise.

► Push both clamp levers 7 in the direction of the

Removing the dermatome blade ► Release both clamp levers 7. ► Open blade cover 6. ► Remove the dermatome blade 24 from the pusher

dog 10 and blade guide peg 9, see Fig. 2.

2

19

24

12

18 Fig. 1

19

Mounting the flap rod

6 9

Inserting the dermatome blade

DANGER

DANGER

Risk of infection and contamination due to torn or cut surgical gloves! ► Avoid contact with the cutting edge when inserting the dermatome blade.

7 Fig. 2

Safe insertion and removal of the dermatome blade

Risk of injury and material damage due to inadvertent activation of the dermatome while inserting the dermatome blade! ► Prior to inserting the blade, engage the safety catch.

7

en Inserting the battery

CAUTION

Damage to, or destruction of the batteries due to processing! ► Do not sterilize batteries.

► Hold dermatome 1 so that the battery compart-

► Get a helper to insert a battery 23 (unsterile)

through the sterile funnel 20 into the battery compartment (observe coding 26), see Fig. 4.

23

ment is facing upwards. ► Set the sterile funnel 20 in place, see Fig. 3.

20 26 20 1

Fig. 4

Fig. 3

Installing the sterile funnel

Installing the sterile funnel in the battery compartment

Note Once the battery is in the battery compartment, a series of acoustic blips will signal that the dermatome is ready for operation. Note The color code on the floor of the battery compartment must match the color code at the bottom of the battery.

8

en ► Once the battery has been inserted, have a helper

remove sterile funnel 20 (unsterile), see Fig. 5.

► Mount cover 21 (sterile) in such a way that it

engages at both cover release buttons 22, see Fig. 6.

20

Fig. 5

22

21

Removing the sterile funnel Fig. 6

Mounting the cover

Note Sterility of the unit is ensured only if the cover is mounted correctly.

9

en Removing the battery

► Hold dermatome 1 with the battery compartment

pointing upward.

WARNING

CAUTION

CAUTION

Risk of injury from hot battery! Battery may be hot after use in the machine. ► Let the battery cool in the machine and then remove. – or – ► Remove the battery with the battery removal device and let it cool.

► Press both cover release buttons 22 on the

cover 21 simultaneously and remove cover 21. ► With one hand, completely envelope the battery

compartment at its lower end, see Fig. 7.

Damage to the battery caused by knocking it against hard objects! ► Only remove battery by tapping the product on the palm of the hand. Damage to, or destruction of the batteries due to processing! ► Do not sterilize batteries.

Note The battery must be removed after the surgical operation and prior to processing. Note If necessary, the battery removal device can be used to facilitate removal of the battery, see Fig. 9!

Fig. 7

10

Tapping the dermatome

en ► Remove battery 23 from the battery compartment

by knocking the unit against the palm of the hand, see Fig. 8.

The battery removal device is used for intraoperative battery changes ensuring that sterile conditions are safely maintained. ► Hold dermatome 1 with the battery compartment upward and remove cover 21. ► Mount sterile battery removal device 25, see Fig. 9.

25

1

Fig. 8

Removing the battery

Intraoperative battery change

WARNING

Risk of injury from hot battery! Battery may be hot after use in the machine. ► Remove the battery with the battery removal device and let it cool.

Note The function checks must be carried out prior to each surgical application of the unit and after each intraoperative battery change!

Fig. 9

Using the battery removal device

► Slightly shake dermatome 1 with battery removal

device 25 mounted and the battery compartment facing downward. Rechargeable battery 23 will slip smoothly into battery removal aid 25. ► Hand battery removal device 25 containing the discharged battery 23 to an unsterile helper. ► Insert charged battery 23, see Inserting the battery.

11

en Protection against inadvertent activation To prevent inadvertent activation of dermatome 1 while replacing the dermatome blade, trigger 4 must be locked. ► To lock trigger 4: Move safety catch 5 to its OFF position, see Fig. 10. Trigger 4 is locked. Dermatome 1 cannot be activated. ► To unlock trigger 4: Move safety catch 5 to its ON position, see Fig. 10. Trigger 4 is unlocked. Dermatome 1 can be activated.

► Engage safety catch 5 against inadvertent activa-

tion, see Protection against inadvertent activation. ► Fold back the clamp of the ECCOS holder. ► Place dermatome 1 in the ECCOS holder, see

Fig. 11.

4 1 5

Fig. 11 Store the dermatome ready for operation in the ECCOS holder

5.2

Function checks

Fig. 10 Engaging the safety catch

Note The function checks must be carried out prior to each surgical application of the unit and after each intraoperative battery change!

Intraoperative storage

► Follow the advisories/procedure for inspection,

Note The Eccos holder can be used for intraoperative storage. The dermatome can not be processed in this position. For the correct position, see Automatic cleaning/disinfection with manual pre-cleaning!

maintenance and checks, see Inspection, maintenance and checks. ► Ensure that a dermatome blade is correctly seated in the dermatome. ► Make certain that a battery has been installed. ► Check that the roll pin is securely seated. ► Check that the dermatome blade is securely seated. ► Briefly activate the dermatome at maximum oscillation frequency.

12

en 5.3

Safe operation

WARNING

WARNING

WARNING

Risk of infection or injury due to aerosol formation or particles! ► Use suitable protection (such as waterproof protective clothing, face mask, safety gases, suction). Risk of injury and/or malfunction! ► Always carry out a function check prior to using the product. Risk of injury due to application of the product outside the field of view! ► Only use the product under vision.

Note The motor found within this Acculan 3Ti hand piece is powered by a magnetic system. To ensure that the motor of this powered instrument does not inadvertently activate, do not allow the hand piece to come in contact with any magnetic sources (i.e. magnetic instrument pads). Please note that having the safety switch in the locked position does not assure that the motor will not run inadvertently.

Adjust the cutting width of the Acculan 3Ti Dermatome

WARNING

Risk of injury/cuts by the dermatome blade if the flaps are opened incorrectly! ► Always use the flap tabs for lifting the flaps.

Note The width of the skin graft will be approx. 2 mm less than the cutting width set by the flaps! ► Set the required cutting width by opening the

appropriate number of flaps 12. ► Safely lift flaps 12 by pressing flap tabs 11, see

Fig. 12.

12

11

Fig. 12 Safely lifting the flaps ► Completely open flaps 12 until they engage in their

end positions (flap width = 8 mm).

Adjust the cutting depth of the Acculan 3Ti Dermatome Note The skin condition (e.g. due to age) of the patient must be considered when adjusting the cutting depth (graft thickness)! ► Adjust the cutting thickness with the setting

lever 14. Lock 15 of setting lever 14 prevents inadvertent changes of the cutting depth setting. ► Read the cutting depth (graft thickness) on dial wheel 16 (1/10 mm gradation). ► Follow the troubleshooting advisories/procedure, see Troubleshooting list.

13

en Operate Acculan 3Ti Dermatome

6.

Note The low howling noise heard during startup of the Acculan 3Ti Dermatome is normal for this product!

Validated reprocessing procedure

6.1

General safety information

► Press trigger 4.

The saw runs at the continuously controlled oscillation frequency.

Taking skin grafts To familiarize with the operation of the Acculan 3Ti Dermatome prior to its first surgical application, the user should carry out some test cuts on a specimen. ► Stretch flabby skin. ► With the cutting surface in contact with the skin to be cut, smoothly push forward the dermatome 1, applying gentle pressure. Be careful not to cant dermatome 1. ► For very thin grafts, use a forceps, from time to time, to lay up the resected portion of the graft on surface 13. ► Turn off the motor and pull the freshly cut skin graft out of the device - or ► Lower the handle and cut off the skin graft with dermatome 1.

Note Adhere to national statutory regulations, national and international standards and directives, and local, clinical hygiene instructions for reprocessing. 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 It should be noted that successful reprocessing of this medical device can only be guaranteed following prior validation of the reprocessing method. The operator/reprocessor is responsible for this. The recommended chemical was used for validation. Note If there is no final sterilization, then a virucidal disinfectant must be used. Note For the latest information on 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.

14

en 6.2

General notes

Dried or affixed surgical residues can make cleaning more difficult or ineffective and lead to corrosion. Therefore, no more than 6 hours should be left between use and preparation, pre-clean temperatures >45 °C liable to fusing should not be employed and disinfectants liable to fusing (aldehyde or alcohol-based) should not be used. Excessive neutralizing agents or basic cleaners may result in a chemical attack and/or fading and the laser marking becoming unreadable either visually or by machine in case of non stainless steel. On stainless steel, residues containing chlorine or chloride (such as surgical residues, drugs, saline solutions in water for cleaning, disinfection and sterilization) may lead to corrosion (pitting corrosion, tensile corrosion) and thus to the destruction of the product. These must be removed by rinsing thoroughly with demineralized water and then drying. Perform 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 reprocessing the product. All the chemical manufacturer's application specifications must be strictly observed. Failure to do so can result in the following problems: ■ Visual material changes (such as fading or color changes in titanium or aluminum). For aluminum, the application/process solution only needs to be pH >8 to cause visible surface changes. ■ Material damage (such as corrosion, cracks, breaks, premature aging or swelling). ► Do not use metal cleaning brushes or other abrasives that would damage the product surface and could cause corrosion. ► Further detailed advice on hygienically safe and material-/value-preserving reprocessing can be found at www.a-k-i.org, section Publications, Red Brochure – Proper maintenance of instruments.

6.3

Preparation at the place of use

► Remove all attached components from the product

(dermatome blade, battery, accessories). ► Remove any visible surgical residues as much as

possible with a damp, lint-free cloth. ► Place the dry product in a sealed waste container

and forward it on for cleaning and disinfection within 6 hours.

6.4

Dismantling prior to carrying out the reprocessing procedure

► Remove battery 23 from the product 1, see

Removing the battery. ► Open the clamping levers 7 to remove the derma-

tome blade 24, see Removing the dermatome blade. ► Disassemble the product 1 immediately after use, according to instructions.

Removing the flap rod of the dermatome ► Loosen nut 2 by turning it clockwise (left-handed

thread). ► Screw the nut 2 back to the end of the visible sur-

face. ► Press on nut 2 and push flap rod 18 approx. 4 mm

to one side. ► Twist flap rod 18 until it can be removed. ► Remove flap rod 18. ► Slide off the flaps 12 from flap rod 18.

The flap rod 18 has been dismantled.

6.5

Preparation before cleaning

► Prior to the first mechanical cleaning/disinfection

process, mount the ECCOS fixations in a suitable tray (e.g. JC254R) or use the ECCOS tray GB256R with fixations equipped. ► Insert the product in its proper position in the ECCOS fixations, see Fig. 11.

15

en 6.6

Single-use products

Dermatome blade GB228R

WARNING

6.7

Risk of infection 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 dermatome blade GB228R.

Cleaning/disinfection

Product-specific safety instructions for the reprocessing procedure

CAUTION

16

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 – be approved for plastic material and highgrade steel, – do not attack softeners (e.g. in silicone). ► Do not use cleaning agents that contain acetone. ► Observe specifications regarding concentration, temperature and exposure time. ► Do not exceed the maximum temperature of 60 °C during chemical cleaning and/or disinfection. ► Do not exceed the maximum temperature of 96 °C during thermal disinfection with FD water. ► Dry the product for at least 10 minutes at a maximum of 120 °C.

CAUTION

Damage or destruction of the batteries due to processing! ► Protect battery from moisture.

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

en 6.8

Manual cleaning with wipe disinfection

Phase

Step

D [°C/°F]

t [min]

Conc. [%]

Water quality

Chemistry

I

Pre-cleaning

RT (cold)

≥2

-

DW

until visually clean

II

Cleaning with enzyme solution

RT (cold)

≥2

0.8

DW

pH-neutral*

III

Intermediate rinse

RT

≥5

-

DW

–

IV

Drying

RT

-

-

-

-

V

Wipe disinfection

-

>1

-

-

Meliseptol HBV wipes 50 % Propan-1-ol

VI

Final rinse

RT (cold)

0.5

-

FD–W

-

VII

Drying

RT

-

-

-

-

DW: FD–W: RT: *

Drinking water Fully desalinated water (demineralized, microbiological, at least of drinking water quality) Room temperature validated with enzyme cleaner “Cidezyme Johnson & Johnson”

► Do not clean the product in a ultrasonic bath and

do not immerse the product in any fluids. Let any fluid incursions drain out immediately, otherwise there is a danger of corrosion and loss of function. Phase I ► Mobilize non-rigid components during cleaning. ► Clean the product under running water, using a

suitable cleaning brush until all visible residues have been removed from the surfaces. ► Brush difficult to access surfaces with a suitable plastic cleaning brush for at least 1 min. Note For details on difficult to access surfaces, see Acculan pre-cleaning and care information TA016000 (available in Aesculap Extranet at https://extranet.bbraun.com). Phase II ► Follow the operating instructions of the enzyme

cleaner with regard to correct concentration, dilution, temperature and water quality. ► Spray products with a pH neutral enzyme solution, let soak in for at least 2 minutes and then wipe off.

Phase III ► Mobilize non-rigid components during cleaning. ► Rinse product under running tap water for at least 5 minutes. ► Follow the operating instructions of the enzyme cleaner with regard to correct concentration, dilution, temperature and water quality. ► Contamination should be removed with a lint-free cloth or soft brush moistened with enzyme cleaner. ► Flexible components should be rinsed for 20 seconds with the water pistol (cold water, at least 2.5 bar). ► After manual cleaning, check visible surfaces and areas of flexible components for residues. ► If necessary, repeat the cleaning process (phase 1 to 3). Phase IV ► Dry the product in the drying phase with suitable equipment (such as lint-free cloths, pressurized air). Phase V ► Wipe all surfaces of the product with a single-use disinfecting wipe.

17

en Stage VI ► Rinse disinfected surfaces after the prescribed reaction time for at least 1 minute under running demineralized water. ► Drain any remaining water fully.

6.9

Stage VII ► Dry the product in the drying phase with suitable equipment (such as lint-free cloths, pressurized air).

Automatic cleaning/disinfection with manual pre-cleaning

Note The cleaning and disinfection device must fundamentally have a tested efficacy (such as FDA approval or CE label pursuant to DIN EN ISO 15883).

Note The washer-disinfector machine used for processing must be serviced and checked at regular intervals.

Manual pre-cleaning with brush Phase

Step

D [°C/°F]

t [min]

Conc. [%]

Water quality

Chemistry/Note

I

Rinsing

RT (cold)

-

-

DW

until visually clean

II

Brushes

RT (cold)

-

-

DW

until visually clean

DW: RT:

Drinking water Room temperature

► Do not clean the product in a ultrasonic bath and

do not immerse the product in any fluids. Let any fluid incursions drain out immediately, otherwise there is a danger of corrosion and loss of function. Phase I ► Dismantle the flap rod 18 for cleaning. Store flap

rod 18, flaps 12 and nut 2 separately in tray. ► Mobilize non-rigid components during cleaning. ► Thoroughly clean the product under running water.

Phase II ► Mobilize non-rigid components during cleaning. ► Brush difficult to access surfaces with a suitable

plastic cleaning brush for at least 1 min. ► After manual preparation, check visible surfaces for

residue and repeat the pre-cleaning process as needed. Note For details on difficult to access surfaces, see Acculan pre-cleaning and care information TA016000 (available in Aesculap Extranet at https://extranet.bbraun.com).

18

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

Step

D [°C/°F]

t [min]

Water quality

Chemistry/Note

I

Pre-rinse

<25/77

3

DW

-

II

Cleaning

55/131

10

FD–W

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

■ working solution 0.5% – pH ~ 11* III

Intermediate rinse

> 10/50

1

FD–W

-

IV

Thermal disinfection

90/194

5

FD–W

-

V

Drying

-

-

-

mind. 10 min at max. 120 °C

DW: Drinking water FD–W: Fully desalinated water (demineralized, microbiological, at least of drinking water quality) *Recommended: BBraun Helimatic Cleaner alcaline ► Insert the product in its proper position in the

ECCOS fixation. Insert the battery compartment over the clamp and swivel device into the ECCOS fixation so that the trigger 4 points upwards. ► Ensure that the blade cover 6 is kept open through the entire processing procedure. ► Dismantle the flap rod 18 for cleaning. Store flap rod 18, flaps 12 and nut 2 separately in tray. ► After automatic cleaning/disinfection, check visible surfaces for residues and repeat the cleaning/disinfection process as needed.

6.10 Inspection, maintenance and checks Note Aesculap recommends lubricating the flap rod, flaps, sliding surfaces and other moving parts, (e.g. trigger, cover lids) with STERILIT-Power-Systems oil spray GB600 or the STERILIT-Power Systems drip lubricator GA059 prior to every sterilization. Remove excess oil with a lint-free wipe. ► Allow the product to cool down to room tempera-

ture. ► Inspect the product after each cleaning and disin-

fecting cycle to be sure it is: clean, functional, and undamaged. ► Check the product for any damage, abnormal running noise, overheating or excessive vibration. ► Set aside the product if it is damaged.

19

en 6.11 Packaging

6.13 Storage

► Always follow the instructions for use of the

► Store sterile products in germ-proof packaging,

respective packaging and storage devices (e.g. instructions for use TA009721 for Aesculap-ECCOS fixation system). ► Insert the product in its proper position in the ECCOS fixations, see Fig. 11. ► Pack trays appropriately for the sterilization process (e.g. in Aesculap sterile containers). ► Ensure that the packaging will prevent a recontamination of the product.

protected from dust, in a dry, dark, temperaturecontrolled area. ► Store sterile single-use GB258R product in germproof packaging in a dry, dark and temperaturecontrolled room.

6.12 Steam sterilization

CAUTION

7.

Maintenance

To ensure reliable operation, maintenance must be performed once annually pursuant to the maintenance label, see Fig. 13, for example July 2010.

Damage or destruction of the batteries due to processing! ► Do not sterilize the rechargeable battery.

Note The product may be only sterilized with the blade, battery lid and battery removed and placing the blade cover in the open position. Note The product can be sterilized with a mounted flap tab and flaps in the open position. ► 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). ► Use a validated sterilization method: – Steam sterilization using fractional vacuum process – Steam sterilizer DIN EN 285 and validated pursuant to DIN EN ISO 17665 – Sterilization using fractionated vacuum process at 134 °C/holding time 5 min When sterilizing multiple products in one steam sterilizer: ► Ensure that the maximum permitted load specified by the manufacturer for the steam sterilizer is not exceeded.

20

Fig. 13 Acculan 3Ti Dermatome maintenance label For technical service, please contact your national B. Braun/Aesculap agency, see Technical Service.