Acculan 4 GA334 Reciprocating Saw Instructions for Use Oct 2020

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Aesculap® Acculan 4 Reciprocating saw GA334 Legend

Classification Type BF

1 Product (reciprocating saw) 2 Trigger (for oscillation frequency control) 3 Safety catch 4 Battery bay 5 Locking pin 6 Sterile funnel 7 Battery 8 Lid 9 Lid release element 10 Battery removal device 11 Saw blade 12 Rotating sleeve 13 Cut-outs (for centering sleeve) 14 Saw blade coupling 15 Cleaning template 16 Support foot 17 Rinsing adapter 18 Opening (at support foot) 19 Marking (at support foot) 20 Locking sleeve (to couple the support foot) 21 Centering pins 22 Inspection hole (for the bottom of the slot of the saw blade coupling)

Manufacturer’s batch designation Manufacturer serial number Manufacturer order number Temperature limits during transport and storage

Air humidity limits during transport and storage

Atmospheric pressure limits during transport and storage

S9

Operating mode According to US federal law, this product may only be sold by a physician or by the order of a physician CE mark according to Regulation (EU) 2017/745 Medical device

The depictions are schematic only.

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

YYYY-MM

Maintenance label Indication of the next maintenance appointment (Date: Year-Month) Two-dimensional machine readable code The code contains a unique serial number that can be used for electronically tracking single instruments. The serial number is based on the worldwide standard sGTIN (GS1). Manufacturer

Date of manufacture

Follow the instructions for use

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

2

Oscillation frequency control

Locking sleeve open/closed

en Contents 1. 1.1 1.2 2. 2.1 2.2 2.2.1 2.3 2.4 2.5 3. 4. 4.1 4.2 4.3 5. 6. 6.1 6.1.1 6.1.2 6.1.3 6.1.4 6.1.5 6.1.6 6.2 6.3 6.3.1 7. 7.1 7.2 7.3 7.4 7.5 7.6 7.7 7.8 7.8.1 7.8.2 7.9 7.10 7.11 7.12 8. 9. 10. 11. 12. 12.1 12.2 12.3 12.4 13.

About this document... Scope... Warnings... General information... Intended use... Main functions and design characteristics... Operating mode... Indications... Absolute contraindications... Relative contraindications... Safe handling... Product description... Scope of supply... Components required for operation... Operating principle... Preparation... Working with the device... System set-up... Connecting the accessories... Inserting the rechargeable battery... Intraoperative battery change... Removing the rechargeable battery... Protection against inadvertent activation... Attaching and detaching the saw blade... Function checks... Safe operation... Operating the product... Validated reprocessing procedure... General safety notes... General information... Reusable products... Preparations at the place of use... Preparation before cleaning... Product-specific safety instructions for the processing procedure... Manual cleaning with wipe disinfection... Automatic cleaning/disinfection with manual pre-cleaning . . Manual pre-cleaning with a brush... Mechanical alkaline cleaning and thermal disinfection... Inspection, maintenance and checks... Packaging... Steam sterilization... Storage... Maintenance... Troubleshooting list... Technical Service... Accessories/Spare parts... Technical data... Classification according to Regulation (EU) 2017/745... Performance data, information about standards... Nominal operating mode... Ambient conditions... Disposal...

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1.

About this document

1.1

Scope

These instructions for use apply to the products listed below: Art. no.

Name

GA334

Reciprocating saw

► For instructions for use of specific items and information on material

compatibility, see B. Braun eIFU at eifu.bbraun.com

1.2

Warnings

Warnings indicate risks to patients, users, and/or the product that could develop while using the product. Warnings are marked as follows: DANGER Indicates a potential danger. If it is not prevented, death or severe injuries may result. WARNING Indicates a potential danger. Minor or moderate injuries may result if this is not prevented. CAUTION Indicates a potential damage to property. The product may become damaged if it is not prevented.

2.

General information

2.1

Intended use

Task/Function When combined with the appropriate tool, and where required with the corresponding protection guide, the Reciprocating saw GA334 is used to work on hard tissue, cartilage and related materials, as well as bone replacement materials. 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).

2.2

Main functions and design characteristics

Oscillation frequency

min. 0 rpm to max. 15 000 rpm

2.2.1 Operating mode Operation with non-periodic load and speed changes (type S9 pursuant to IEC EN 60034-1) ■ 30 second application, 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.

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en 2.3

Indications

Type and area of application depend on the selected tool.

2.4

Absolute contraindications

The product is not approved for use in the central nervous system or central circulatory system.

2.5

Relative contraindications

The safe and effective use of the product depends greatly on factors that only operators themselves can control. The information provided therefore only represents general conditions. The clinically successful use of the product depends on the knowledge and experience of the surgeon. They must decide which structures can be sensibly treated and must take the safety information and warnings in the instruction for use into account.

3.

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.

■ General risk factors associated with surgical procedures are not described in this documentation.

■ It is the operating surgeon's responsibility to ensure that the surgical procedure is performed correctly.

■ The operating surgeon must have a thorough understanding of both the hands-on and conceptual aspects of the established operating techniques. ► Remove the transport packaging and clean the new product, either manually or mechanically, prior to its initial sterilization. ► Check the functionality and proper condition before using the product. ► Observe "Guidance on Electromagnetic Compatibility (EMC) for Acculan Components" TA022450, see B. Braun eIFU at eifu.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. ► Keep the instructions for use accessible for the user. ► Comply with valid standards. ► Ensure that the electrical installation of the room is consistent with the requirements of IEC/DIN EN. ► Do not operate the product in explosion-hazard areas. ► Sterilize product before use. ► When using ECCOS holder systems, observe relevant instructions for use TA009721, see B. Braun eIFU at eifu.bbraun.com Note The user must report all serious incidents occurring in connection with the product to the manufacturer and to the competent authority of the country in which the user is registered.

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4.

Product description

4.1

Scope of supply

Art. no.

Designation

GA334

Reciprocating saw

GA674890

Rinsing adapter installed

GA678

Sterile funnel

GB440215

Cleaning template

TA014545

Instructions for use of reciprocating saw GA334 (flyer)

4.2

Components required for operation

4.3

Operating principle

■ NiMH battery long GA676 (charged) ■ Sterile funnel GA678 ■ Lid GA675 ■ Support foot GB436R (as required) ■ Saw blade

The product 1 contains an electric motor, which is powered by a replaceable battery 7. The charged non-sterile battery 7 is inserted into the product 1 via the sterile funnel 6 and sealed with the lid 8 so that it is sterile. The oscillation frequency is controlled electronically and can be continuously regulated with the trigger 2. The product 1 has a coupling 14, which allows for the attachment of various saw blades 11. These saw blades 11 lock automatically when attached to the product 1. The saw blade 11 can be removed by activating a rotating sleeve 12. The product 1 has an interface, which allows for the attachment of support foot 16.

5.

Preparation

Aesculap assumes no liability if the following rules are not followed: ► 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.

6.

Working with the device

WARNING Risk of infection and contamination! Product is delivered unsterilized! ► Sterilize the product before use pursuant to the operating instructions. WARNING 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).

en WARNING 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. WARNING Damage to the product if dropped! ► Use the products only if they are in perfect technical condition, see Function check WARNING 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.

6.1.3

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 replacing the battery during surgery while ensuring that sterile conditions are maintained. ► Turn the product 1 with the battery shaft 4 upwards. ► Press both safety catches 9 on the lid 8 at the same time and remove the lid 8. ► Attach the sterile battery removal device 10, see Fig. B. ► Gently shake the product 1 with the attached battery removal device 10 with battery compartment 4 facing downwards. The battery 7 slides easily into the battery removal device 10. ► Hand battery removal device 10 including dead battery 7 to a nonsterile person. ► Insert a charged battery 7, see Inserting the rechargeable battery.

6.1

System set-up

6.1.4

6.1.1

Connecting the accessories

WARNING 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.

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. All configurations must fulfill the fundamental standard IEC/DIN EN 60601-1. The person connecting the devices with each other is responsible for the configuration and must ensure that the fundamental standard IEC/DIN EN 60601-1 or relevant national standards. ► Follow the instructions for use of individual accessories. ► In case of questions, contact your B. Braun/Aesculap partner or Aesculap Technical Service, address see Technical Service. 6.1.2

Inserting the rechargeable battery

CAUTION The product does not function when using the wrong battery! ► Do not use battery GA666 (with red base) or GA346. ► Product 1 with the battery shaft 4 must be turned upwards and the

sterile funnel 6 (sterile) attached, see Fig. A. ► Battery 7 (non-sterile) is inserted into the battery shaft 4 by a second (non-sterile) person, see Fig. A. Note After the battery has been inserted, multiple signals will sound, which indicate that the product is ready to use. ► After insertion of the battery, have the sterile funnel 6 (non-sterile)

removed by a second person. ► Attach the lid 8 (sterile) in such a manner that it clicks into place with

both release catches 9. Note The sterility of the product is only guaranteed with a correctly placed lid.

Removing the rechargeable battery

CAUTION Damage to the battery caused by knocking it against hard objects! ► Only remove battery by tapping the product on the palm of the hand. CAUTION Damage to, or destruction of the batteries due to processing! ► Do not sterilize batteries. Rechargeable battery must be removed after each surgical procedure and prior to processing of the device. Note The battery removal device can be used for easier battery removal, see Fig. B. ► Turn the product 1 with the battery shaft 4 upwards. ► Press both safety catches 9 on the lid 8 at the same time and remove

the lid 8. ► Tightly grasp the battery shaft 4 at the lower end. ► Tap the battery shaft 4 on the palm of the hand until the battery 7 slides out of the battery shaft 4 and can be removed. 6.1.5 Protection against inadvertent activation To prevent inadvertent activation of the product during tool change, the trigger can be locked. To lock trigger: ► Twist the safety catch 3 to position OFF. The trigger 2 is blocked and the product 1 cannot be operated. To unlock trigger: ► Twist the safety catch 3 to position ON. The trigger 2 is unlocked and the product 1 can be operated.

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en 6.1.6

Attaching and detaching the saw blade

WARNING 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. Coupling the saw blade ► Secure product 1 against inadvertent activation with the safety

catch 3.

6.3

Safe operation

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.

► Turn rotating sleeve 12 as far as it will go against the direction indi-

cated by the arrow. ► Insert saw blade 11 for pulling or pushing incision in saw blade coupling 14. Saw blade 11 engages. Uncoupling the saw blade ► Secure product 1 against inadvertent activation with the safety

catch 3. ► Turn rotating sleeve 12 180° as far as it will go in the direction indicated by the arrow. ► Pull out saw blade 11 from the saw blade coupling 14. Coupling the support foot ► Secure product 1 against inadvertent activation with the safety catch 3. ► Open locking sleeve 20 at support foot 16. Marking (on support foot) 19 points to symbol "open." ► Pull back and hold locking sleeve 20 towards support foot 16. ► Push the support foot 16 all the way over the rotating sleeve 12 of the saw blade coupling 14 so that the saw blade 11 grips into the opening (on the support foot) 18 and the centering pins 21 sit in the cut-outs 13. The teeth of saw blade 11 must point away from support foot 16. ► Release and turn locking sleeve 20 until marking (at support foot) 19 points to symbol “closed.” The support foot 16 is locked in place. Uncoupling the support foot ► Secure product 1 against inadvertent activation with the safety catch 3. ► Open locking sleeve 20 at support foot 16. The support foot 16 is unlocked. ► Push the support foot 16 in the direction of the product 1 and pull the locking sleeve 20 from the product 1.

6.2

Function checks

The function checks must be carried out prior to each use and after each intraoperative battery change. ► Make certain there is a battery in the battery compartment. ► Ensure that the lid has completely clicked into place. ► Pull on the saw blade to check that it is securely coupled. ► Check that the cutting edges of the saw blade do not exhibit any mechanical damage. ► Check secure seating of the support foot: ensure locking sleeve is closed. ► Release product for use (ON position). ► Briefly operate product at maximum oscillation frequency. ► Do not use the product if it is damaged or defective. ► Set aside the product if it is damaged.

6

WARNING Risk of infection from aerosol formation! Risk of injuries caused by particles coming loose from the tool! ► Use suitable protection (such as waterproof protective clothing, face mask, safety gases, suction). WARNING Risk of injury and/or malfunction! ► Always carry out a function check prior to using the product. WARNING Risk of injury when using the product beyond the field of view! ► Apply the product only under visual control. WARNING 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. Note The product drive motor is operated using a magnetic sensor system. In order to prevent inadvertent activation of the motor, the product may not be exposed to any magnetic fields (such as magnetic instrument pads). 6.3.1 Operating the product Note The slight whistling noise when the product is starting up is due to the construction. ► Activate trigger 2.

The oscillation frequency of the product 1 is continuously variable.

en 7.

Validated reprocessing procedure

7.1

General safety notes

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/reprocessing technician is responsible for this. Note If there is no final sterilization, then a virucidal disinfectant must be used. Note See also B.Braun eIFU at eifu.bbraun.com for current information on processing and compatibility of material The validated steam sterilization procedure was carried out in the Aesculap sterile container system.

7.2

General information

Dried or affixed surgical residues can make cleaning more difficult or ineffective and lead to corrosion. Therefore the time interval between application and processing should not exceed 6 h; also, neither fixating precleaning temperatures >45 °C nor fixating disinfecting agents (active ingredient: aldehydes/alcohols) should be used. Excessive 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. 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 processing the product. All the chemical manufacturer's application specifications must be strictly observed. Failure to do so can result in the following problems: ■ 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 link to "AKIBrochures", "Red brochure".

7.3

Reusable products

The service life of the product is limited by damage, normal wear, type and duration of the application, handling, storage and transportation of the product. Careful visual and functional testing prior to next use is the best way to identify a malfunctioning product.

7.4

Preparations at the place of use

► Remove all attached components from the product (tool an accesso-

ries). ► 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.

7.5

Preparation before cleaning

► Prior to first mechanical cleaning/disinfection: Assemble ECCOS hold-

ers in a suitable basket (e.g. GB243800). ► Insert product 1 in the correct position into the ECCOS holders, see

Fig. B.

7.6

Product-specific safety instructions for the processing procedure

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 – are approved for plastic material and high-grade steel, – and which do not affect softeners (e.g., in silicone). ► Do not use cleaning agents that contain acetone. ► Observe information concerning concentration, temperature and exposure time. ► Do not exceed the maximum temperature of 60 °C in chemical cleaning and/or disinfection. ► Do not exceed maximum temperature during thermal disinfection using 96 °C DI 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 drying time listed is only indicative. It has to be checked taking into account the specific conditions (e.g. load) and adjusted if necessary.

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en 7.7

Manual cleaning with wipe disinfection

Phase

Step

T [°C/°F]

t [min]

Conc. [%]

Water quality

Chemical

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 with 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, low microbiological contamination: drinking water quality at least) Room temperature Suitable enzyme solution: Helizyme, Cidezyme (the latter used for validation purposes)

► 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 14 towards the housing as far as it will go. Phase I ► Mobilize non-rigid components during cleaning, e.g. pull locking

sleeve 20 back from the support foot 16. ► 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 15 to clean the slot of the saw blade coupling 14. 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. ► Use rinsing adapter 21 to clean the inside of the saw blade coupling 14: – Fit rinsing adapter 21 onto rotating sleeve 12. ► Using an appropriate syringe, rinse slot manually with 100 ml tap water. ► Remove rinsing adapter. 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 20 on support foot 16, push cleaning

template 15 between sleeve and support foot and release locking sleeve 20. ► 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. ► 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. 8

Phase III ► Rinse product under running tap water for at least 5 minutes. ► Flexible components (such as sleeves) will move during cleaning. ► If necessary, repeat the cleaning process (phase 1 to 3). ► Remove cleaning template 15 from support foot 16. 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. Phase 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).

en 7.8

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). 7.8.1

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

Manual pre-cleaning with a brush

Phase

Step

T [°C/°F]

t [min]

Conc. [%]

Water quality

Chemistry/Note

I

Rinse

RT (cold)

–

–

D–W

Until visually clean

II

Brush

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

Phase II ► Mobilize non-rigid components during cleaning, e.g. pull locking sleeve 20 back from the support foot 16. ► 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.

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 14 towards the housing as far as it will go. Phase I ► Mobilize non-rigid components during cleaning, e.g. pull locking

sleeve 20 back from the support foot 16. ► Thoroughly clean the product under running water. ► Use cleaning template 15 to clean the slot of the saw blade coupling 14. 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 12 thoroughly.

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).

7.8.2 Mechanical alkaline cleaning and thermal disinfection Type of device: Single-chamber cleaning/disinfection device without ultrasound Phase

Step

T [°C/°F]

t [min]

Water qual- Chemicals ity

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

max. 120/248

min. 10 min –

–

D–W: Drinking water FD–W: Fully desalinated water (demineralized, low microbiological contamination: drinking water quality at least) *Recommended: BBraun Helimatic Cleaner alkaline

► Insert the product in its correct position into the ECCOS holder.

► Check visible surfaces for residues after mechanical cleaning/disinfect-

► Pull back locking sleeve 20 on support foot 16, push cleaning

ing. ► Remove cleaning template 15 from support foot 16. ► Check the floor of the saw blade coupling 14 slit (open inspection holes) for cleanness. ► Repeat the cleaning/disinfection process if necessary.

template 15 between sleeve and support foot and release locking sleeve 20. ► Then connect the rinsing adapter GA674890 to the rotating sleeve 12 and connect to the rinse connector of the cleaning/disinfection device/rinse cart.

9

en 7.9

Inspection, maintenance and checks

► Allow the product to cool down to room temperature.

Note Aesculap additionally recommends the occasional spraying of moving parts (such as knobs, connections) with STERILIT Power Systems oil spray. ► Inspect the product after every cleaning and disinfecting cycle for:

cleanliness, damage, function, abnormal operation noise, excessive heat or strong vibration. ► Inspect the saw blades for broken, damaged or blunt cutting edges. ► Set aside the product if it is damaged.

7.10 Packaging ► Observe the instructions for use of the respective packaging and hold-

ers (e.g. Instructions for use TA009721 for Aesculap ECCOS holder system). ► Insert product 1 in the correct position in the ECCOS holders, see Fig. B. ► Pack trays appropriately for the sterilization process (e.g. in Aesculap sterile containers). ► Ensure that the packaging will prevent a recontamination of the product.

7.11 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 in fractionated vacuum process – Steam sterilizer in accordance with DIN EN 285 and validated in accordance with DIN EN ISO 17665 – Sterilization in fractionated vacuum process at 134°C, holding time 5 min When sterilizing multiple products in one steam sterilizer: ► Ensure that the maximum permissible load of the steam sterilizer according to the manufacturer's specifications is not exceeded.

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

a dry, dark, temperature-controlled area.

10

8.

Maintenance

To ensure reliable operation, the product must be maintained in accordance with the maintenance labeling or at least once a year.

YYYY-MM For technical service, please contact your national B. Braun/Aesculap agency, see Technical Service.

en 9.

Troubleshooting list

► Have defective products repaired by Aesculap Technical Service, see Technical Service.

Fault

Cause

Detection

Remedy

Product not running

No battery

No battery in the battery shaft

Insert battery.

Battery not charged

No signal tone when inserting the battery

Charge battery in charger.

Battery broken

No signal tone when inserting the battery

Have the manufacturer repair the battery.

Product in secured OFF position

Safety catch is in OFF position

Turn the safety catch into the ON position.

Product defective

Product not running

Have the manufacturer repair the product.

Excessive use

Product heating

Observe instructions for use (nominal operating mode).

Reprocessing/maintenance carried out incorrectly

Product heating

Observe instructions for use (processing, care). Preventive measure: Oil product before every sterilization.

Fall damage, product defective

Product heating

Have the manufacturer repair the product.

Blunt tool

Tool and product become hot

Change tool.

Product broken

Insufficient product performance

Observe instructions for use (processing, care). Preventive measure: Oil product before every sterilization. Have the manufacturer repair the product.

Steep rise in temperature after a short period of time

Observe instructions for use (nominal operating mode). Have the manufacturer repair the product

Blunt tool

Tool blades worn

Change tool.

Loud running noise

Broken gearing/ball bearings of the product

Loud, perceptible noise during operation

Follow operating instructions (preparation, care). Preventative: lubricate product before every sterilization. Have the manufacturer repair the product

Lid cannot be attached/removed

Lid not compatible

Lid does not click into place

Use the compatible lid for GA334.

Lid deformed/broken

Lid is difficult or cannot be mounted/removed

Have the manufacturer repair the lid.

Connection on product deformed/broken

Lid is hard or impossible to install/remove

Have the manufacturer repair the product.

Battery not compatible

Battery cannot be completely inserted into the battery compartment

Use the compatible battery for GA334.

Battery deformed/broken

Battery is hard or impossible to insert/remove

Have the manufacturer repair the battery.

Battery shaft to product deformed/defective

Battery is difficult or cannot be mounted/removed

Have the manufacturer repair the product

Sterile funnel or battery removal device not compatible

Sterile funnel or battery removal Use suitable sterile funnel or battery removal device not attachable to the bat- device for GA334. tery shaft

Sterile funnel or battery removal device deformed/broken

Sterile funnel or battery removal Change sterile funnel or battery device. device difficult or not attachable

Battery compartment at product deformed/broken

Sterile funnel or battery removal device is hard or impossible to attach

Product becomes too hot

Insufficient power

Battery cannot be inserted/removed

Sterile funnel or battery removal device cannot be attached

Have the manufacturer repair the product.

11

en Fault

Cause

Detection

Remedy

Speed control knob cannot be actuated

Product in locked OFF position

Safety catch is in OFF position

Turn the safety catch to the ON position.

Speed control knob sticks/is defective

Speed control knob cannot be actuated

Have the manufacturer repair the product.

Saw blade does not move Noisy motor

Broken gearings

Have product repaired by the manufacturer

Insufficient cutting performance of the saw blade

Saw blade teeth worn

Blunt saw blade

Replace saw blade

Battery power is low

Power/speed of drive inadequate Charge battery

Battery empty/broken Symbol "Battery replacement recommended" illuminated on the charger The saw blade cannot be coupled

Debris on the saw blade or in the coupling

Replace battery

Debris

Clean saw blade/coupling with cleaning template 7

Deformed coupling parts/saw blades Deformation

Have product repaired by the manufacturer

-

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

Incompatible saw blade

Saw blade cannot be Saw blade can be pulled out without locked and can be pulled rotating sleeve action out during function check

Rotating sleeve in incorrect Clean clutch if soiled position (not returning automat- If damaged, have device repaired by the manufacically to rest position) turer

Saw blade cannot be uncoupled

-

Rotating sleeve in incorrect position

Turn rotating sleeve 180° in direction of the arrow, see Attaching and detaching the saw blade

Saw blade coupling warped or bent saw blade

Mechanical damage

Have repaired by manufacturer

Support foot cannot be coupled

Saw blade bent

Replace saw blade

Support foot cannot be coupled

Support foot bent

Have support foot repaired by the manufacturer

Marking on support foot points to “Closed” symbol.

Locking sleeve is closed

Open locking sleeve, see Coupling the support foot.

Support foot cannot be coupled

10. Technical Service DANGER Danger to life of patients and users in case of malfunctions and/or failure of protective measures! ► Do not perform any servicing or maintenance work under any circumstances while the product is being used on a patient. CAUTION Modifications of medical devices may result in a loss of potential guarantee/warranty claims and forfeiture of applicable licenses. ► Do not modify the product. ► Contact national B. Braun/Aesculap representative for service and repair. Service addresses Aesculap Technischer Service Am Aesculap-Platz 78532 Tuttlingen / Germany Phone: +49 (7461) 95 -1601 Fax: +49 (7461) 14 -939 E-Mail: [email protected] Other service addresses can be obtained from the address indicated above.

12

en 11. Accessories/Spare parts

12.4 Ambient conditions

Art. no.

Name

GA674890

Rinsing adapter

GA675

Lid

GA676

NiMH battery long

GA678

Sterile funnel

GA679

Battery removal device

GB243R GB244R

ECCOS basket with holder for Acculan 4

GB600

STERILIT Power Systems oil spray

GB436R

Support foot

GB440215

Cleaning plate

GB495R

ECCOS holder for machine

GB487R

ECCOS holder for lid

GB488R

ECCOS holder for sterile funnel

GB489R

ECCOS holder for battery removal device

GB686R

ECCOS support foot holder

TA014544

Instructions for use of reciprocating saw GA334 (A4 for ring binder)

TA014545

Instructions for use of reciprocating saw GA334 (flyer)

Operation

Transport and storage

Temperature

10 °C to 27 °C

-10 °C to 50 °C

Relative humidity

30 % to 75 %

10 % to 90 %

Atmospheric pressure

700 hPa to 1 060 hPa

500 hPa to 1 060 hPa

13. Disposal WARNING Risk of infection from contaminated products! ► Observe national regulations when disposing of or recycling the product, its components, and their packagings. Note The operator must process the product before disposal, see Validated reprocessing procedure. The recycling pass can be downloaded from the Extranet as a PDF document under the respective article number. (The recycling pass includes disassembling instructions for the product, as well as information for proper disposal of components harmful to the environment.) Products carrying this symbol are subject to separate collection of electrical and electronic devices. Within the European Union, disposal is taken care of by the manufacturer as a free-of-charge service. ► For questions regarding the disposal of the product, please contact your

12. Technical data

local B. Braun/Aesculap representative, see Technical Service.

12.1 Classification according to Regulation (EU) 2017/745 Art. no.

Designation

Class

GA334

Reciprocating saw

IIa

12.2 Performance data, information about standards Max. power

approx. 250 W

Max. oscillation frequency

15 000 rpm

Weight (operational)

1.54 Kg ±10 %

Dimensions (L x W x H, ready for operation)

207 mm x 180 mm x 55 mm ±5 %

Application part

Type BF

EMC

IEC/DIN EN 60601-1-2

Conforming to standard

IEC/DIN EN 60601-1

After 500 processing cycles, the manufacturer tested the product and it passed.

12.3 Nominal operating mode Operation with non-periodic load and speed changes (type S9 pursuant to IEC EN 60034-1) ■ 30 second application, 30 second pause ■ 5 repetitions ■ 30 min cooling time ■ Max. Temperature 48 °C 13