Acculan 3Ti drill and reamer GA672

en

Aesculap® Acculan 3Ti Acculan 3Ti drill and reamer GA672 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 Drill attachment with quick-action chuck adapter 2 Drill attachment with Jacobs chuck 3 Reamer attachment with quick-action chuck adapter 4 Kirschner wire attachment 5 Rotating sleeve 6 drill and reamer 7 Button for counterclockwise rotation 8 Rotational speed control button 9 Safety catch 10 Locking pin 11 Cover 12 Cover release button 13 Battery 14 Sterile funnel 15 Kirschner wire protection sleeve 16 Coding 17 Adapter (for Kirschner wire protection sleeve and rinsing adapter) 18 Battery removal device 19 Drill attachment (for radiolucent angle transmission) 20 Adapter (AO large to DHS/DCS) 21 Sagittal saw attachment

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 R

L

Reverse button clockwise/counterclockwise rotation + oscillation mode switch

Motor speed control

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 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... 5 Product description... 5 Scope of supply... 5 Components required for operation... 5 Operating principle... 6 Preparation... 6 Working with the Acculan 3Ti drill and reamer 6 System set-up... 7 Function checks... 13 Safe operation... 13 Validated reprocessing procedure... 14 General safety information... 14 General notes... 15 Preparation at the place of use... 15 Preparation before cleaning... 15 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... 21 Technical data... 22 Operating mode... 22 Ambient conditions... 22 Disposal... 23

3

en 1.

General information

1.1

Intended use

Task/Function The drill and reamer GA672, combined with the relevant attachment and tool, is used for processing hard tissue, cartilage and the like, as well as bone replacement material, to screw bone pins in and out and to set transfixion wires. 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

Speed

min. 0 min-1 to max. 26 000 min-1

Rotational direction

Right and left rotation

Operating mode

Operation with non-periodic load and speed changes (type S9 pursuant to IEC EN 60034-1) Drilling (clockwise/counterclockwise rotation): ■ 60 second application, 60 second pause

■ 20 repetitions ■ 30 min cooling time Reaming (clockwise/counterclockwise rotation): ■ 30 second application, 30 second pause

■ 8 repetitions ■ 30 min cooling time Saw mode with GB660R:

■ 30 second application, 60 second pause

■ 3 repetitions ■ 30 min cooling time

4

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.

1.4

Absolute contraindications

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

1.5

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.

en 2.

Safe handling

WARNING

WARNING

Risk of injury and material damage if this product is not used as intended! ► Use the product only for its intended purpose. Risk of injury and damage to property due to improper handling of the product! ► Follow the instructions for use of all products used.

► 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 ► 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. ► Observe the instructions for use of Acculan 3Ti charger TA022160.

3.

Product description

3.1

Scope of supply

Designation

Art. no.

drill and reamer

GA672

Kirschner wire protection sleeve

GA672207

Rinsing adapter

GA672211

Cover

GA675

Battery

GA676

Sterile funnel

GA678

STERILIT Power Systems adapter

GB600840

Cleaning brush

TA011944

Instructions for use for GA676

TA011867

Instructions for use for GA672

TA011869

Instructions for use for Acculan 3Ti attachments

TA011936

3.2

Components required for operation

Designation

Art. no.

drill and reamer

GA672

Battery (rechargeable, charged)

GA676

Charger

GA677

Drill and reamer attachments

see TA011936 (Acculan 3Ti) and/or TA014540 (Acculan 4)

Cover

GA675

Sterile funnel

GA678

5

en 3.3

Operating principle

In the drill and reamer 6, the electric motor is supplied with voltage by a battery and the speed output is electronically controlled. The speed can be adjusted continuously by pressing rotational speed control trigger 8. The direction of rotation can be changed especially for tapping and for loosening of bone screws. To change the direction of rotation, fully press down button for counterclockwise rotation 7. The drill and reamer 6 is fitted with a spindle cannulation to insert guide skewers or similar devices with a diameter of up to 4.0 mm. Some attachments are fitted with a cannulation of a smaller diameter.

4.

Preparation

Non-compliance with the following instructions will preclude all responsibility and liability in this respect on the part of Aesculap. ► Do not use products from open or damaged sterile packaging. ► Prior to use, inspect the product and its accessories for any visible damage. ► Use the products and their accessories only if they are in perfect technical condition.

5.

Working with the Acculan 3Ti drill and reamer

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 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.

en 5.1

System set-up

Inserting the battery

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.

CAUTION

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

► Turn drill and reamer 6 so that the battery com-

partment points upward; position sterile funnel 14 (sterile), see Fig. 1.

14

6

Fig. 1

7

en ► Have a second person guide battery 13 (unsterile)

into the battery compartment, see Fig. 2. Observe coding 16 when doing this.

13

14

► Once the battery has been inserted, have a helper

remove sterile funnel 14 (unsterile), see Fig. 3.

14

16

Fig. 2 Note The coding on the floor of the battery compartment of the unit must match the coding at the bottom of the battery. Note After insertion of the battery, a series of acoustic blips will indicate that the drill and reamer is ready for operation.

8

Fig. 3

en ► Mount cover 11 (sterile) in such a way that it

Removing the battery

engages at both cover release buttons 12, see Fig. 4. WARNING

11 12

CAUTION

CAUTION

Fig. 4 Note Sterility of the unit is ensured only if the cover is mounted correctly.

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. 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.

The battery must be removed after the operation and prior to processing of the unit. Note If necessary, the battery removal device can be used to facilitate removal of the battery, see Fig. 7!

9

en ► Hold drill and reamer 6 with the battery compart-

► In this position, remove battery 13 from the battery

ment pointing upwards. ► Simultaneously press both cover release buttons 12 at cover 11 and remove cover 11. ► Hold the battery compartment at its lower end, with the first two fingers and the thumb encompassing the compartment and the ring finger and small finger protruding as a cushion, see Fig. 5.

compartment by knocking the unit against the palm of the hand, see Fig. 6.

Fig. 6

Fig. 5

10

en 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.

The battery removal device is used for intraoperative battery changes ensuring that sterile conditions are safely maintained. ► Turn drill and reamer 6 so that the battery compartment points upward and remove cover 11. ► Mount sterile battery removal device 18, see Fig. 7.

Coupling and uncoupling of attachments on the drill and reamer ► Secure drill and reamer 6 against inadvertent acti-

vation with the safety catch 9. Note For further information about the attachments for the drill and reamer, see TA011936 (Acculan 3Ti) and/or TA014540 (Acculan 4). To apply drilling wires we recommend using the special Kirschner wire chuck. This quick-action chuck adapter allows quick and easy tensioning of drilling wires. To protect against injuries when using long drilling wires, screw in the Kirschner wire protection sleeve supplied with the product. ► Screw Kirschner wire protection sleeve 15 into adapter 17, see Fig. 8.

18

17

6

15

8 Fig. 8

Fig. 7 ► Slightly shake drill and reamer 6 with battery

removal device 18 mounted and the battery compartment held pointing downward. The battery slides smoothly into battery removal device 18. ► Hand over battery removal device 18 containing the discharged battery to an unsterile person. ► Insert a charged battery, see Inserting the battery.

11

en Coupling ► Push the attachment onto drill and reamer 6 until it engages with a click, see Fig. 9.

6

Protection against inadvertent activation The rotational speed control button can be locked to prevent inadvertent activation of the drill and reamer during a tool change. ► To lock rotational speed control button 8: Turn safety catch 9 to its OFF position, see Fig. 11. The speed control knob 8 is blocked and the drill and reamer 6 cannot be operated. ► To unlock rotational speed control button 8: Turn safety catch 9 to its ON position, see Fig. 11. The speed control knob 8 is unlocked and the drill and reamer 6 can be operated.

Fig. 9 Uncoupling ► Turn rotating sleeve 5 in the direction of the arrow

(clockwise when viewed from the rear end of drill and reamer 6). ► Remove the attachment from drill and reamer 6.

7 8

5

9 6 6

Fig. 10 Fig. 11

Coupling tools in the tool chuck adapter Note The coupling of tools is described in instructions for use TA011936 (Acculan 3Ti) and/or TA014540 (Acculan 4).

12

en 5.2

Function checks

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

WARNING

► Make certain that a battery has been installed. ► Make certain that the attachment is securely

Risk of injury when attaching/removing attachments/tools in the ON position through inadvertent activation of the product! ► Only attach/remove attachments/tools in the OFF position.

seated. ► Check that the tool is seated properly. ► Briefly run the drill and reamer at maximum speed

in clockwise and counterclockwise mode. ► Make certain that the rotational direction is correct

WARNING

in each case.

Risk of injury due to application of the product outside the field of view! ► Only use the product under vision.

► Only use the device if it is in perfect condition.

5.3

Safe operation

WARNING

WARNING

WARNING

Coagulation of patient tissue or risk of burns for patients and user through hot product! ► Cool the tool during operation. ► Keep product/tool out of the reach of patients. ► Let the product/tool cool down. ► Use a cloth to protect against burns when changing the tool. Risk of infection or injury through aerosol formation or particles ejected from the tool! ► Use suitable protection (such as waterproof protective clothing, face mask, safety gases, suction).

WARNING

Risk of injury and damage to the tool/system! The rotating tool may get caught in drapes (such as textiles). ► Do not let the tool come into contact with drapes (such as textiles) during operation.

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. Note The low whistling noise at startup of the drill and reamer 6 is normal!

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

13

en To run drill and reamer 6 in clockwise mode: ► Press rotational speed control button 8. The drill and reamer 6 is continuously adjusted to the correct speed for the attachment coupled to the unit. To run drill and reamer 6 in counterclockwise mode: ► Fully press/actuate first the button for counterclockwise rotation 7 and press speed control button 8, see Fig. 12. The drill and reamer 6 is continuously adjusted to the correct speed for the attachment coupled to the unit.

6.

Validated reprocessing procedure

6.1

General safety information

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.

7 8 9 6

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.

Fig. 12

14

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.

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

(tool an 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

Preparation before cleaning

► Prior to the first mechanical cleaning/disinfection

process, mount the ECCOS fixations in a suitable tray (e.g. GB243800). ► Insert the product in its proper position in the ECCOS fixations.

15

en 6.5

Cleaning/disinfection

Product-specific safety instructions for the reprocessing procedure

CAUTION

CAUTION

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. 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.

16

en 6.6

Manual cleaning with wipe disinfection

Phase

Step

D [°C/°F]

t [min]

Conc. [%]

Water quality

Chemistry

I

Pre-cleaning

RT (cold)

≥2

-

D–W

until visually clean

II

Cleaning with enzyme solution

RT (cold)

≥2

0.8

D–W

pH-neutral*

III

Intermediate rinse

RT

≥5

-

D–W

–

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

-

-

-

-

D–W: 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 plastic cleaning brush until all visible residues have been removed from the surfaces. ► Brush cannulation with cleaning brush TA011944 and 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 (such as sleeves) and cannulations 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.

6.7

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)

-

-

D–W

until visually clean

II

Brushes

RT (cold)

-

-

D–W

until visually clean

D–W: 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 ► Mobilize non-rigid components during cleaning. ► Thoroughly clean the product under running water.

Phase II ► Mobilize non-rigid components during cleaning. ► Brush cannulation with cleaning brush TA011944

and 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

D–W

-

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

D–W: 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. ► Screw the rinsing adapter (GA672211) on the prod-

uct in the mount 17. ► Then connect the interior rinse device and connect

to the rinse connector of the cleaning/disinfection device/rinse cart. ► Attach the Kirschner wire protection sleeve 15 to a rinse hose. ► After automatic cleaning/disinfection, check visible surfaces for residues and repeat the cleaning/disinfection process as needed.

6.8

Inspection, maintenance and checks

► 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. ► Spray product after every cleaning and disinfection with oil spray adapter GB600840 (black) approx. 2 sec with Aesculap STERILIT-Power-Systems GB600 oil spray, see Fig. 13.

Fig. 13 Note Aesculap additionally recommends occasional spraying of moving parts (such as knobs, couplings, cover lids) with the Aesculap STERILIT-Power-Systems oil spray. ► Check the product for any damage, abnormal run-

ning noise, overheating or excessive vibration. ► Set aside the product if it is damaged.

19

en 6.9

Packaging

► Always follow the instructions for use of the

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

7.

Maintenance

To ensure reliable operation, the product must be maintained as indicated on the maintenance label once per year, see Fig. 14, e.g. in February 2012.

6.10 Steam sterilization

CAUTION

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

Note Remove all attached components from the product (tools, accessories) before 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). ► 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.

6.11 Storage ► Store sterile products in germ-proof packaging,

protected from dust, in a dry, dark, temperaturecontrolled area.

20

Fig. 14 For technical service, please contact your national B. Braun/Aesculap agency, see Technical Service.