Acculan 3Ti reciprocating saw GA674

en

Aesculap® Acculan 3Ti Acculan 3Ti reciprocating saw GA674 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 Opening (at support foot) 2 Marking (at support foot) 3 Locking sleeve (to couple the support foot) 4 Support foot 5 Centering pins 6 Saw blade 7 Cleaning template 8 Saw blade coupling 9 Rotating sleeve 10 Cut-outs (for centering pins) 11 Safety catch 12 Rotational speed control button 13 Reciprocating saw 14 Locking pin 15 Cover 16 Cover release buttons 17 Sterile funnel 18 Battery 19 Battery removal device 20 Coding 21 Rinse adapter with Luer Lock connector 22 Inspection hole (for floor of the saw blade coupling)

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 Oscillation frequency control

Locking sleeve open/closed

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... 4 Product description... 5 Scope of supply... 5 Components required for operation... 5 Operating principle... 5 Preparation... 5 Working with the Acculan 3Ti reciprocating saw... 6 System set-up... 6 Function checks... 11 Safe operation... 12 Validated reprocessing procedure... 13 General safety information... 13 General notes... 13 Preparation at the place of use... 14 Preparation before cleaning... 14 Cleaning/disinfection... 14 Manual cleaning with wipe disinfection... 15 Automatic cleaning/disinfection with manual pre-cleaning... 17 Inspection, maintenance and checks... 18 Packaging... 19 Steam sterilization... 19 Storage... 19 Maintenance... 19 Troubleshooting list... 20 Technical Service... 21 Accessories/Spare parts... 21 Technical data... 22 Operating mode... 22 Ambient conditions... 22 Disposal... 23

3

en 1. 1.1

General information

1.3

Intended use

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

Indications

Task/Function The reciprocating saw GA674, combined with the relevant tool and with corresponding support foot as required, is used for processing hard tissue, cartilage and the like, as well as for bone replacement materials.

1.4

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).

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.

1.2

Main functions and design characteristics

Oscillation frequency

min. 0 min-1 to max. 15 000 min-1

Operating mode

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

■ 30 second application,

Absolute contraindications

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

1.5

2.

Relative contraindications

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.

30 second pause

■ 5 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.

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

Designation

Art. no.

Reciprocating saw

GA674

Rinsing adapter

GA674890

Cover

GA675

Battery

GA676

Sterile funnel

GA678

Cleaning template

GB440215

Instructions for use for GA674

TA011474

Instructions for use for GA676

TA011867

3.2

Components required for operation

Designation

Art. no.

Reciprocating saw

GA674

Battery (rechargeable, charged)

GA676

Charger

GA677

Cover

GA675

Sterile funnel

GA678

Support foot according to indication

GB436R

Saw blade according to indication

-

3.3

Operating principle

Reciprocating saw 13 incorporates an electric motor powered by a rechargeable battery 18 and electronic circuitry for controlling the rotational speed of the motor. The motor speed can be adjusted continuously by pressing rotational speed control trigger 12. Reciprocating saw 13 converts the motor rotation into oscillation of saw blade 6. The bone is separated by the oscillating movement of saw blade 6. No key or wrench is required for inserting the saw blades. Support foot 4 of reciprocating saw 13 and saw blade 6 can be fixed in two different positions offset by 180° from each other. This allows either pulling or pushing incisions.

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

en 5.

Working with the Acculan 3Ti reciprocating saw

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.

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 contact your B. Braun/Aesculap partner or Aesculap Technical Service (address: see Technical Service) with any inquiries in this respect.

en Inserting the battery

CAUTION

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

► Hold reciprocating saw 13 with the battery com-

partment upwards and insert funnel 17 (sterile), see Fig. 1.

17

► Have a second person guide battery 18 (unsterile)

into the battery compartment, see Fig. 2. Observe coding 20 when doing this.

18

17

20

13

Fig. 2

Fig. 1

Note The coding on the floor of the battery compartment of the unit must match the coding at the bottom of the battery. Note Once the battery is in the battery compartment, a series of acoustic blips will signal that the Acculan 3Ti reciprocating saw is ready for operation.

7

en ► After insertion of battery 18 have another person

remove funnel 17 (unsterile), see Fig. 3.

► Mount cover 15 (sterile) in such a way that it

engages at both cover release buttons 16, see Fig. 4.

17 16

15

Fig. 4 Fig. 3

8

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

en Removing the battery

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. 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.

Rechargeable battery 18 must be removed after each surgical procedure and prior to processing of the device.

Fig. 5 ► Remove battery 18 from the battery compartment

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

Note If necessary, the battery removal device can be used to facilitate removal of the battery, see Fig. 7! ► Hold reciprocating saw 13 with the battery com-

partment pointing upward. press both cover release buttons 16 at the cover and remove cover 15. ► Hold the battery compartment at its lower end, with the first two fingers are protruding, see Fig. 5. ► Simultaneously

Fig. 6 9

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.

Coupling the saw blade ► Secure reciprocating saw 13 against inadvertent

activation by engaging safety catch 11. ► Turn rotating sleeve 9 as far as it will go against the

direction indicated by the arrow. ► Insert saw blade 6 for pulling or pushing incision in

saw blade coupling 8, see Fig. 8. Saw blade 6 clicks into position.

6

The battery removal device is used for intraoperative battery changes ensuring that sterile conditions are safely maintained. ► Hold reciprocating saw 13 with the battery compartment upward and remove cover 15. ► Mount sterile battery removal device 19, see Fig. 7.

13 11

89

12

Fig. 8

Uncoupling the saw blade

19

► Secure reciprocating saw 13 against inadvertent

activation by engaging safety catch 11. ► Turn rotating sleeve 9 as far as it will go in the

direction indicated by the arrow. ► Remove the saw blade 6 from the saw blade cou-

13

pling 8, see Fig. 9.

6

13 11

89

Fig. 7 ► Mildly shake reciprocating saw 13 with battery

removal device 19 mounted and the battery compartment facing downward. Rechargeable battery 18 will slip smoothly into battery removal aid 19. ► Hand over battery removal aid 19 containing the discharged battery 18 to an unsterile person. ► Insert charged battery 18, see Inserting the battery.

10

Fig. 9

12

en Coupling the support foot

11

► Secure reciprocating saw 13 against inadvertent

activation by engaging safety catch 11. ► Open locking sleeve 3 at support foot 4. Marking (at support foot) 2 points to symbol "open". ► Pull back and hold locking sleeve 3 towards support foot 4. ► Push the support foot 4 all the way over the rotating sleeve 9 of the saw blade coupling 5 so that the saw blade 6 grips into the opening (on the support foot) 1 and the centering pins 5 sit in the cutouts 10. The teeth of saw blade 6 must point away from support foot 4. ► Release and turn locking sleeve 3 until marking (at support foot) 2 points to symbol “closed”. Support foot 4 is locked now.

Uncoupling the support foot.

12

13

Fig. 10

► Secure reciprocating saw 13 against inadvertent

activation by engaging safety catch 11. ► Open locking sleeve 3 at support foot 4.

Support foot 4 is unlocked now. ► Push the support foot 4 in the direction of the

reciprocating saw 13 and withdraw from the reciprocating saw 13 on the locking sleeve 3.

Protection against inadvertent activation Rotational speed control trigger 12 can be locked to prevent inadvertent activation of reciprocating saw 13 during a tool change. ► To lock rotational speed control button 12: Turn safety catch 11 to its OFF position, see Fig. 10. Rotational speed control trigger 12 is blocked and reciprocating saw 13 cannot be operated. ► To unlock rotational speed control button 12: Turn safety catch 11 to its ON position, see Fig. 10. Rotational speed control trigger 12 is unlocked and reciprocating saw 13 can be operated.

5.2

Function checks

Note These function checks must be carried out prior to each surgical application of the unit and after each intraoperative battery change! ► Make certain that rechargeable battery 18 has

been inserted. ► To check for secure coupling of the tool: Pull at saw

blade 6. ► To check for secure coupling of support foot 4: Ver-

ify that locking sleeve 3 is closed. ► Verify that saw blade 6 can freely move in support

foot 4. ► Briefly run reciprocating saw 13 at maximum

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

11

en 5.3

Safe operation

DANGER

WARNING

WARNING

WARNING

WARNING

12

Risk of injury from an incorrectly coupled support foot! ► Make certain that the support foot is coupled correctly and the marking point to symbol “closed”. 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). Risk of injury and/or malfunction! ► Always carry out a function check prior to using the product. Risk of injury when attaching/removing sawblades or support foot in the ON position through inadvertent activation of the product! ► Only attach/remove saw blades or support foot in the OFF position.

WARNING

WARNING

CAUTION

Risk of injury due to application of the product outside the field of view! ► Only use the product under vision. Risk of injury and damage to the tool/system! The tool may get caught in drapes (such as textiles). ► Do not let the tool come into contact with drapes (such as textiles) during operation. The saw blade will be damaged if the support foot is deformed! ► Never use a damaged support foot.

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 when reciprocating saw 13 starts running is a normal feature of this product! ► To run the reciprocating saw: Press rotational speed

control button 12. The saw runs at the continuously controlled oscillation frequency. ► Be careful not to cant support foot 4 a saw blade 6 during the cutting procedure.

en 6. 6.1

Validated reprocessing procedure 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. 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.

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.

13

en 6.3

Preparation at the place of use

► Remove all attached components from the product

(tool and 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

6.5

Cleaning/disinfection

Product-specific safety instructions for the reprocessing procedure

CAUTION

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 1 in its proper position in the ECCOS fixation.

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.

14

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

-

DW

until visually clean

II

Cleaning with enzyme solution

RT (cold)

≥2

0.8

D–W

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

► Use rinsing adapter 21 to clean the inside of the

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. ► Push the saw blade coupling 8 towards the housing as far as it will go.

saw blade coupling 8: – Fit rinsing adapter 21 onto rotating sleeve 9. ► Using an appropriate syringe, rinse slot manually with 100 ml tap water. ► Remove rinsing adapter.

Phase I ► Mobilize non-rigid components during cleaning,

e.g. pull locking sleeve 3 back from the support foot 4. ► Clean the product under running water, using a suitable plastic cleaning brush until all visible residues have been removed from the surfaces. ► Use cleaning template 7 to clean the slot of the saw blade coupling 8. Insert cleaning template into the slot and carefully push out the debris through the slot or the inspection holes at least 5 times in both directions. Turn template 180° in order to do so. ► 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 ► Pull back locking sleeve 3 on support foot 4, push cleaning template 7 between sleeve and support foot and release locking sleeve 3. ► 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.

15

en Phase III ► Rinse product under running tap water for at least 5 minutes. ► Flexible components (such as sleeves) will move during cleaning. ► 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) 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). ► Remove cleaning template 7 from support foot 4. 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. Stage VI ► Rinse disinfected surfaces after the prescribed reaction time for at least 1 minute under running demineralized water. ► Drain any remaining water fully. Stage VII ► Dry the product in the drying phase with suitable

equipment (such as lint-free cloths, pressurized air).

16

en 6.7

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

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. ► Push the saw blade coupling 8 towards the housing as far as it will go.

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 I ► Mobilize non-rigid components during cleaning,

e.g. pull locking sleeve 3 back from the support foot 4. ► Thoroughly clean the product under running water. ► Use cleaning template 7 to clean the slot of the saw blade coupling 8. Insert cleaning template into the slot and carefully push out the debris through the slot or the inspection holes at least 5 times in both directions. Turn template 180° in order to do so. ► Manually clean the contact sites of the rinsing adapter GA674890 and the rotating sleeve 9 thoroughly. Phase II ► Mobilize non-rigid components during cleaning,

e.g. pull locking sleeve 3 back from the support foot 4. ► 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.

17

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

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. ► Pull back locking sleeve 3 on support foot 4, push cleaning template 7 between sleeve and support foot and release locking sleeve 3. ► Then connect the rinsing adapter GA674890 to the rotating sleeve 9 and connect to the rinse connector of the cleaning/disinfection device/rinse cart. ► Check visible surfaces for residues after mechanical cleaning/disinfecting. ► Remove cleaning template 7 from support foot 4. ► Check the floor of the saw blade coupling 8 slit (open inspection holes 22) for cleanliness. ► Repeat the cleaning/disinfection process if necessary.

18

6.8

Inspection, maintenance and checks

Note Aesculap recommends occasional spraying of moving parts (such as knobs, couplings, cover lids) with the Aesculap STERILIT-Power-Systems oil spray. ► 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. ► Inspect the saw blades for broken, damaged or blunt cutting edges. ► Set aside the product if it is damaged.

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 AesculapECCOS fixation system). ► Insert the product 1 in its proper position in the ECCOS fixation. ► 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 once per year as indicated on the maintenance label, see Fig. 11, 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.

Fig. 11 For technical service, please contact your national B. Braun/Aesculap agency, see Technical Service.

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

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

19

en 8.

Troubleshooting list

Malfunction

Detection

Cause

Remedy

Saw blade not moving

Loud running noise from motor

Defective gearings

Have repaired by manufacturer

Insufficient cutting performance of the saw blade

Saw blade worn

Blunt saw blade

Replace saw blade

Battery too weak

Insufficient motor power/speed

Charge battery

-

Battery not fully charged

Recharge the battery in the battery charger.

Symbol "Battery replacement recommended" illuminated on the charger

End of service life of battery

Have battery repaired by the manufacturer

-

Motor defective

Have motor repaired by the manufacturer

No acoustic signal on insertion of the battery

Battery defective

Have battery repaired by the manufacturer

Debris on the saw blade or in the coupling

Debris

Clean saw blade/coupling with cleaning template 7

Coupling components or saw blades deformed

Deformation

Have repaired by manufacturer

-

Incompatible saw blade

Insert a fitting Aesculap saw blade, see Accessories/Spare parts

Saw blade cannot be locked and can be pulled out during function check

Saw blade can be pulled out without rotating sleeve action

Rotating sleeve in incorrect position (not returning automatically to rest position)

Clean the coupling if it is dirty If damaged, have device repaired by the manufacturer

Saw blade cannot be uncoupled

-

Rotating sleeve in incorrect position

Turn rotating sleeve 180° in direction of the arrow, see Uncoupling the saw blade

Saw blade coupling warped or bent saw blade

Mechanical damage

Have repaired by manufacturer

Battery worn out or defective Symbol "Battery replacement recommended" illuminated on the charger Insufficient power output

Motor not running

The saw blade cannot be coupled

20

Replace battery