ELAN 4 electro micro sagittal saw GA836

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Aesculap® ELAN 4 electro micro sagittal saw GA836 Legend

Do not use if packaging is damaged

1 2 3 4

Manufacturer batch ID

5 6 7 8 9

Tool coupling Connector for motor cable Button for adjusting the tool holder Symbol of the applied part type in display of ELAN 4 electro control unit Sagittal saw blade S Piece on saw blade for tool release ELAN 4 disposable spray nozzle for saws Tube connection on spray nozzle Oil spray adapter GB600860

Manufacturer’s serial number Manufacturer’s article number Temperature limits during transport and storage

Air humidity limits during transport and storage ECCOS general holder for saw blades GB720R 10 Side handles 11 Tool coupling 12 Holding lugs 13 Tab

Atmospheric pressure limits during transport and storage

Symbols on product and packages

CE mark according to Regulation (EU) 2017/745

According to US federal law, this product may only be sold by a physician or on the orders of a physician

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

YYYY-MM

Maintenance indicator Date of the next recommended servicing (year-month) by the international B. Braun-/Aesculap agency, see Technical Service Two-dimensional machine readable code The code contains a unique serial number that can be used for electronically tracking individual instruments. The serial number is based on the worldwide sGTIN (GS1) standard. Manufacturer

Date of manufacture

Sterilization using irradiation Single Sterile Barrier System

Single sterile barrier system with inner protective packaging Non-sterile medical device

Not for reuse in intended applications as defined by the manufacturer Use by

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EAC symbol of the Eurasian Economic Union Medical device

Contents 1. 1.1 1.2 2. 2.1 2.2 2.3 2.4 2.5 2.6 3. 3.1 3.2 4. 4.1 4.2 4.3 5. 6. 6.1 6.2 6.3

About this document... Scope... Warnings... General information... Intended use... Performance characteristics... Application Environment... Indications... Absolute contraindications... Relative contraindications... Safe handling... Sterile ELAN 4 tools... Sterile ELAN 4 disposable spray nozzle for saws GA258SU... Product description... Scope of supply... Components required for operation... Operating principle... Preparation... Working with the product... System set-up... Function checks... Safe operation...

3 3 3 3 3 3 3 3 3 3 4 4 4 4 4 4 4 5 5 5 6 6

en 7. 7.1 7.2 7.3 7.4 7.5 7.6 7.7 7.8 7.9 7.10 7.11 7.12 7.13 8. 9. 10. 11. 12. 12.1 12.2 12.3 12.4 12.5 13.

Validated reprocessing procedure... 6 General safety notes... 6 General information... 7 Reusable products... 7 Preparations at the place of use... 7 Preparation before cleaning... 7 Cleaning/disinfection... 7 Manual cleaning with immersion disinfection - application part 8 Mechanical cleaning/disinfection including manual precleaning - application part... 9 Mechanical cleaning/disinfecting with manual pre-cleaning tools... 10 Inspection, maintenance and checks... 11 Packaging... 11 Steam sterilization... 11 Storage... 11 Maintenance... 12 Troubleshooting... 12 Technical Service... 12 Accessories/Spare parts... 12 Technical data... 12 Classification in accordance with Regulation (EC) 2017/745. . 12 Performance data, information about standards... 12 Tool speed/Setting... 12 Short interval operation... 13 Ambient conditions... 13 Disposal... 13

1.

About this document

1.1

Scope

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

Designation

GA836

ELAN 4 electro micro sagittal saw

► For article-specific instructions for use and material compatibility

information, see B. Braun eIFUs at eifu.bbraun.com

1.2

Warnings

Warnings indicate hazards to patients, users and/or products that may occur during the use of 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. If not prevented, minor or moderate injuries may result.

2.

General information

2.1

Intended use

The ELAN 4 electro micro sagittal saw GA836 is an accessory of the ELAN 4 electro motor system. The micro sagittal saw is connected by an ELAN 4 electro motor cable to the control unit. The micro sagittal saw is used to drive Aesculap saw blades sagittal S.

2.2

Performance characteristics

Oscillation frequency min. 0 rpm to max. 20 000 rpm Short-time intermittent operation ■ 30 second application, 60 second pause ■ 10 repetitions ■ 30 min cooling time ■ Max. temperature 48 °C Electrical systems generally heat up during continual operation. It is advisable to give the system a break after use to cool down, as indicated below. Heating depends on the tool used and the load. After a certain number of repetitions, the system should be allowed to cool down. This procedure prevents the system from overheating and protects the patient or users against possible injury. The user shall be responsible for the implementation and adherence to the interval sequence described.

2.3

Application Environment

Application in the sterile area

2.4

Indications

Modes of application Separating, resecting and shaping hard tissue, cartilage, similar and bone substitute materials Surgical discipline/areas of application Neurosurgery, ENT surgery, OMF surgery, orthopedics and trauma surgery Note The type and area of application depend on the tools selected.

2.5

Absolute contraindications

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

2.6

Relative contraindications

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

CAUTION Indicates a potential damage to property. If not prevented, the product may be damaged.

3

en 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! This product is an accessory of the ELAN 4 electro control unit GA800. ► Follow the instructions for use of the ELAN 4 electro control unit GA800 (TA014401). ► 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. ► Prior to use, check that the product is in good working order. ► To prevent damage caused by improper setup or operation, and in order not to compromise warranty and manufacturer liability: – Use the product only according to these instructions for use. – Follow the safety and maintenance instructions. – Only combine Aesculap products with each other. ► Ensure that the product and its accessories are operated and used only by persons with the requisite training, knowledge, or experience. ► Keep the instructions for use accessible for the user. ► Always adhere to applicable standards. ► Ensure that the electrical installations at the premises where the device is to be used meet all requirements acc. to IEC/DIN EN. ► Do not use the control unit and applied part in potentially explosive areas. ► Sterilize application parts and motor cable before use. ► Observe the relevant instructions for use TA009721 when handling the Aesculap holder systems, see B. Braun eIFU under eifu.bbraun.com Note The user agrees to 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.

3.1

Sterile ELAN 4 tools

The product is gamma-sterilized and supplied in sterile packaging. ► Ensure that the product and its accessories are operated and used only by persons with the requisite training, knowledge, or experience. ► Read, observe and store the instructions for use for tools TA012787. ► Do not use products from open or damaged sterile packaging. ► Prior to each use, inspect the product for: Loose, bent, broken, cracked, worn, or fractured components. ► Do not use the product if it is damaged or defective. Set aside the product if it is damaged. ► Do not use the product after its use-by date. Note For further information, see instructions for use for tools TA012787.

4

Single-use products DANGER Risk of infection for patients and/or users and impairment of product functionality due to reuse. Contamination and/or impaired function of the products may result in injury, illness and death! ► Do not reprocess the product.

3.2

Sterile ELAN 4 disposable spray nozzle for saws GA258SU

The spray nozzle is used to supply fluid for rinsing and cooling the tool or the place of application. DANGER Risk of infection for patients and/or users and impairment of product functionality due to reuse. Risk of injury, illness or death due to contamination and/or impaired functionality of the product! ► Do not reprocess the product. The product is gamma-sterilized and supplied in sterile packaging. ► Do not reuse the product. ► Ensure that the product and its accessories are operated and used only by persons with the requisite training, knowledge, or experience. ► read, follow, and keep the instructions for use. ► Use the product only in accordance with its intended use. ► Do not use products from open or damaged sterile packaging. ► Prior to each use, inspect the product for loose, bent, broken, cracked or fractured components. ► Do not use the product if it is damaged or defective. Set aside the product if it is damaged. ► Do not use the product after its use-by date.

4.

Product description

4.1

Scope of supply

Art. no.

Designation

GA836

ELAN 4 electro micro sagittal saw

TA014429

Instructions for use for ELAN 4 electro micro sagittal saw GA836 (leaflet)

4.2

Components required for operation

4.3

Operating principle

■ Operation-ready ELAN 4 electro control unit GA800, see TA014401 ■ Sagittal saw blade S The ELAN 4 electro micro sagittal saw can be used to drive saw blades. The micro sagittal saw is used with ELAN 4 electro foot controls or manual controls. The oscillation frequency can be adjusted infinitely using the foot/manual control. The saw blades 5 are coupled / uncoupled without a key. The tool holder 1 can be locked in five different positions without a key (90°/-45°/0°/45°/90°).

en 5.

Preparation

If the rules listed below are not followed, Aesculap will not accept any responsibility. ► Do not use products from open or damaged sterile packaging. ► Prior to use, inspect the product and its accessories for visible damage. ► Use the products and their accessories only if they are in perfect technical condition.

6.

Working with the product

WARNING Risk of infection and contamination! Applied parts, shafts, and motor cable are delivered unsterile! ► Sterilize application parts and motor cables prior to use in accordance with the instructions for use. WARNING Risk of injury and material damage due to inadvertent activation of the application part! ► Secure applied parts that are not actually used against inadvertent activation ("Off" position), see instructions for use for ELAN 4 electro control unit GA800 (TA014401). WARNING Injury and material damage may result from an inappropriate use of tools! ► Always follow the safety advice and information provided in the instructions for use. ► Handle tools having cutting edges with care when coupling/uncoupling. ► Do not use tools for strutting or levering. WARNING Risk of burns to skin and tissue due to blunt tools/insufficient maintenance of the application part! ► Use tools only if they are in perfect condition. ► Replace blunt tools. ► Maintain the application part properly, see maintenance. WARNING Dropping may damage the product ! ► Use the products only if they are in a flawless technical condition, see function check

6.1

System set-up

WARNING Risk of injury when coupling/uncoupling tools in the "On" position due to accidental activation of the applied part! ► Only couple/uncouple tools in the "Off" position. WARNING Risk of injury due to small parts that could enter the surgical field! ► Do not couple/uncouple tools and transversal saw shafts above the surgical field. Note Operating elements on the system components of the ELAN 4 electro motor system are labeled with a gold marking. Connecting the accessories Do not use accessories in combinations that are not mentioned in these instructions for use. ► Follow the instructions for use of individual accessories. ► Please address your B. Braun/Aesculap partner or Aesculap Technical Service with any inquiries in this respect; for a contact address, see Technical Service. Remove the ECCOS general holder for saw blades GB720R from the tray The insert of the ECCOS holder can be removed from the tray in conjunction with the tools. ► Pull at the tab 13 and remove the insert from the holder, see Fig. H. ► Fold up the tool holder 11. Coupling the tool to the applied part ► Lock applied part ("Off" position), see instructions for use of ELAN 4 electro control unit GA800 (TA014401). ► Insert connection side of saw blade 5 into the slot in the tool holder 1, see Fig. A. When doing so, make certain that the lateral stops of the saw blade are resting on the tool holder, see Fig. B. The saw blade engages. ► Pull at saw blade 5 to check that it is securely coupled. Uncoupling the tool from the applied part Note For easier uncoupling of the tool, position tool holder in the 45° position (see Fig. C) or in the 90° position (see Fig. D), see Adjusting the tool holder. ► Lock applied part ("Off" position), see instructions for use of

ELAN 4 electro control unit GA800 (TA014401). ► Gently press the gold piece on saw blade for tool release 6 downwards

and keep pressed down, see Fig. B. ► Remove the saw blade 5 from the tool holder 1.

Adjusting the tool holder ► Press and hold button for adjusting the tool holder 3 and keep pressed down, see Fig. C. ► Turn tool holder 1 to the desired position (-90°/-45°/0°/45°/90°), see Fig. C and Fig. D. ► Release button for adjusting the tool holder 3 and lock tool holder 1 by engaging it in place. If necessary, slightly move the tool holder back and forth.

5

en Mounting the spray nozzle and tube set The ELAN 4 single-use spray nozzle for sawing GA258SU is equipped with a small and large front retainer clip for optional use.: ■ The small retainer clip is only for use in conjunction with ELAN 4 micro saws GA836 GA837. ■ The large retainer clip is used only in combination with large ELAN 4 saws GA832. ► Connect tube set GA395SU to pump of ELAN 4 electro control unit GA800, see instructions for use of ELAN 4 electro control unit GA800 TA014401. ► Remove the large front retainer clip from the spray nozzle 7. ► Push the tube end directed at the area of application onto the tube connector 8 of the spray nozzle. ► Clip the spray nozzle 7 onto the black handle area of the application part and push/turn into the desired position, see Fig. E. ► Push the small front retainer clip into position and clip onto the application part. – or – Remove the small front retainer clip from the spray nozzle. Note The spray tube of the spray nozzle can be easily bent by hand and can be adapted to the requirements of the application (e.g. following the contour of the housing).

6.2

Function checks

► Prior to each use, check that all products to be used are in good work-

ing order. ► Check the secure connection of all products to be used. ► Check that the tool holder 1 is securely locked in place. Turn tool holder. ► Check that the saw blade is coupled properly. Pull at the saw blade. ► Check that the cutting edges of the saw blades are not showing any mechanical damage. ► Briefly run the applied part at maximum speed. ► Do not use the product if it is damaged or defective. Set aside the product if it is damaged.

6.3

Safe operation

WARNING Coagulation of patient tissue or risk of burns for patients and users from hot application part/tool! ► Cool the tool during operation. ► Keep product/tool out of the reach of patients. ► Allow the applied part/tool to cool down. ► When changing the tool, use a cloth as a protection against burns. WARNING Risk of infection from aerosol formation! Risk of injuries caused by particles coming loose from the tool! ► Take appropriate protective measures, e.g. watertight protective clothing, face mask and protective goggles, suction extraction. 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.

6

WARNING Risk of injury if the tool comes loose accidentally! ► Do not press the piece on saw blade for tool release during operation. ► Check for secure fixation of the tool after any tool change. Note The recommended maximum oscillation frequency for operation is 16 000 rpm. A higher oscillation frequency can cause the product to heat more quickly and adversely affect the lifetime of the product. It is only possible to operate the applied part and change the setting parameters on the control unit if: ■ the applied part is connected to the control unit, ■ no second application part is activated ("On" position) at the same time and ■ the applied part type 4 is shown in the display of the control unit. Note For further information, see instructions for use of ELAN 4 electro control unit GA800 (TA014401).

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 eIFUs at eifu.bbraun.com for up-to-date information on processing and material compatibility The validated steam sterilization procedure was carried out in the Aesculap sterile container system.

en 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. Residues containing chlorine or chlorides, e.g., in surgical residues, medicines, saline solutions, and in the service water used for cleaning, disinfection, and sterilization, will cause corrosion damage (pitting, stress corrosion) and result damage to metallic products. 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, fracturing, premature aging, or swelling. ► Do not use metal cleaning brushes or other abrasives that would damage the product surface and could cause corrosion ► For detailed information on hygienically safe and materialfriendly/careful processing, please refer to www.a-k-i.org Header "AKIBrochures", "Red brochure".

7.3

7.6

Product-specific safety instructions for the reprocessing 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, – 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 maximum temperature of 96°C during thermal disinfection using DI water. ► Dry the product for at least 10 minutes at a maximum of 120 °C. 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. Validated cleaning and disinfection procedure Product

Validated procedure

Reference

Application part

Manual cleaning with immersion disinfection

see Manual cleaning with immersion disinfection - application part

Manual pre-cleaning with brush and subsequent mechanical alkaline cleaning and thermal disinfecting

see Mechanical cleaning/disinfection including manual pre-cleaning - application part

Manual pre-cleaning with ultrasound and brush, and subsequent mechanical alkaline cleaning and thermal disinfecting

see Mechanical cleaning/disinfecting with manual pre-cleaning tools

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

Cleaning/disinfection

Preparations at the place of use

► Separate the products from each other immediately after use. ► 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

Tools

cleaning and disinfection within 6 hours.

7.5

Preparation before cleaning

Applied part ► Prior to first mechanical cleaning/disinfection: Install ECCOS holder GB086R in suitable tray (e.g. JF222R). ► Place the product in the correct position in the ECCOS holder GB086R, see Fig. F. Tools ► Thoroughly rinse the product with running, cold water. ► Prior to first mechanical cleaning/disinfection: Install the bottom part

of the ECCOS holder GB720R in a suitable tray (e.g. JF222R). ► Insert the sagittal saw blade S 5 in the correct position in the tool

holder 11 of the ECCOS holder GB720R, see Fig. H. ► Engage in the fixation in the bottom part. In doing so, make sure that

the holding lugs 12 on the insert are inserted in the recesses in the bottom part. ► Lift and fold down the tool holder 11 using the two side handles 10.

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en 7.7

Manual cleaning with immersion disinfection - application part

Phase

Step

T [°C/°F]

t [min]

Conc. [%] Water quality

Chemical

I

Pre-cleaning

RT (cold)

–

–

D–W

–

II

Cleaning

RT (cold)

>5

1

D–W

pH neutral, pH ~ 9*

III

Intermediate rinse

RT (cold)

–

–

D–W

–

IV

Disinfection

RT (cold)

>5

2

D–W

Concentrate-free, aldehyde-free, phenol-free, QUATfree, pH ~ 9**

V

Final rinse

RT (cold)

–

–

D–W

–

VI

Drying

RT

–

–

–

–

D–W: Drinking water RT: Room temperature *Recommended: BBraun Helizyme *Recommended: B. Braun Stabimed fresh

► Observe instructions for use for ELAN 4 rinsing devices and rinsing

adapter TA014447 or TA014448. ► Do not clean the applied part in an ultrasound bath. Phase I ► Clean the product under running water, using a suitable cleaning brush

until all visible residue has been removed from the surface. ► Move non-rigid components, such as unlocking buttons, unlocking

sleeves, etc., during cleaning. ► Rinse the applied part through the rinsing adapter GB698R at least

3 times for 5 seconds with a water gun. Phase II ► Using a disposable syringe, fill the inside of the applied part with clean-

ing solution through the rinsing adapter GB698R. ► Immerse the application part with the connected rinsing adapter at

least 5 minutes in an enzymatic cleaning solution. Phase III ► Rinse product completely (all accessible surfaces) under running water. ► Move non-rigid components, such as unlocking buttons, unlocking

sleeves, etc., during rinsing. ► Rinse the applied part through the rinsing adapter GB698R at least

3 times for 5 seconds with a water gun. Phase IV ► Prior to manual disinfection, allow rinsing water to drain off the prod-

uct for a sufficient length of time and use compressed air to blow all liquid out of the product through the rinsing adapter GB698R in order to prevent dilution of the disinfecting solution. ► Using a disposable syringe, fill the inside of the applied part with disinfectant solution through the rinsing adapter GB698R. ► Immerse the application part with the connected rinsing adapters in the disinfectant solution for at least 5 minutes. Phase V ► Rinse product completely (all accessible surfaces) under running water. ► Mobilize non-rigid components, such as release button, unlocking

sleeve, etc. during cleaning. ► Rinse the applied part through the rinsing adapter GB698R at least

3 times for 5 seconds with a water gun.

8

Phase VI ► During the drying phase, dry the product using the appropriate equipment (e.g. wipes, compressed air). ► After manual cleaning/disinfection, check visible surfaces for residue and repeat the cleaning/disinfection process as required.

en 7.8

Mechanical cleaning/disinfection including manual pre-cleaning - application part

Note The cleaning and disinfecting machine must be of tested and approved effectiveness (e.g. FDA approval or CE mark according to DIN EN ISO 15883). Note The cleaning and disinfection machine used for processing must be serviced and checked at regular intervals. Manual pre-cleaning using brush Phase

Step

T [°C/°F]

t [min]

Conc. [%] Water quality

Chemical

I

Brushing

RT (cold)

–

–

D–W

–

II

Rinsing

RT (cold)

5

–

D–W

–

D–W: RT:

Drinking water Room temperature

► Follow the instructions for use of the ELAN 4 rinsing devices and rins-

ing adapters TA014447 and TA014448. ► Do not clean the application part in an ultrasonic bath. Phase I ► Clean the product using a suitable cleaning brush until no residue is

visible on the surface.

Phase II ► Connect motor cable connector 2 to ELAN 4 electro rinsing device GB692R. ► Rinse application part: – For 5 min using a tap/hose or – 3 times for 5 s using a water gun

► Mobilize non-rigid components, such as release button, unlocking

sleeve, etc. during cleaning.

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

Step

T [°C/°F]

t [min]

Water quality

Chemical

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

–

–

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

► Connect motor cable connector 2 to ELAN 4 electro rinsing device

GB692R. ► Place the rinsing device in a wire basket suitable for cleaning. ► Connect the rinsing device to the rinsing port of the rinsing cart.

► After machine cleaning/disinfection process:

– Use a compressed air gun to remove the remaining rinsing water from the application parts and shafts, see the instructions for use for ELAN 4 rinsing system and rinsing adapter TA014447 or TA014448. – Visually check for residue on visible surfaces and repeat the cleaning/disinfection process if necessary. 9

en 7.9

Mechanical cleaning/disinfecting with manual pre-cleaning - tools

Note The cleaning and disinfection device must be certified (e.g., FDA approval or CE mark in accordance with DIN EN ISO 15883). Note The cleaning and disinfection device used must be serviced and tested at regular intervals. Manual pre-cleaning with ultrasound and brush Phase

Step

T [°C/°F]

t [min]

Conc. [%]

Water quality

Chemical

I

Immersion

RT (cold)

>30

50

D–W

Enzymatic detergent*

II

Rinsing

RT (cold)

–

–

D–W

–

III

Ultrasonic cleaning

55/131

>15

2

D–W

Concentrate-free, aldehyde-free, phenol-free, QUAT-free, pH ~ 9**

IV

Cleaning with brush

RT (cold)

–

–

D–W

–

D–W: Drinking water RT: Room temperature *Recommended: BBraun Helizyme *Recommended: B.Braun Stabimed fresh

► As a general rule, only perform ultrasound cleaning in the ECCOS holder

GB720R to prevent any damage to the blades. Phase I ► Fully immerse the product in enzymatic cleaning solution for at least

30 minutes. Ensure that all accessible surfaces are moistened. Phase II ► Rinse product completely (all accessible surfaces) under running water.

Phase III ► Clean the product in an ultrasonic cleaning bath (frequency 35 kHz) for

at least 15 minutes. Ensure that all accessible surfaces are immersed and acoustic shadows are avoided. Phase IV ► Clean the product using a suitable cleaning brush until no residue is

visible on the surface.

10

en Alkaline machine cleaning and thermal disinfection Type of device: Single-chamber cleaning/disinfection device without ultrasound Phase

Step

T [°C/°F]

t [min]

Water quality

Chemical

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

–

–

D–W: Drinking water FD-W: Deionized water (demineralized, microbiologically at least in compliance with potable water regulations) *Recommended: B. Braun Helimatic Cleaner alcaline

► Place product in the ECCOS holder GB720R on a wire basket suitable

7.12 Steam sterilization

for cleaning. ► After machine cleaning/disinfection, check visible surfaces for residue and repeat the cleaning/disinfection process as required.

► Make sure that all external and internal surfaces of the product are

7.10 Inspection, maintenance and checks ► Allow the product to cool down to room temperature. ► Connect the ELAN 4 electro oil spray adapter GB600860 9 (gray) to the

connector for the motor cable 2 and use the STERILIT Power Systems oil spray GB600 to spray through the application part for approx. 2 s, see Fig. G. Note Aesculap additionally recommends the occasional spraying of moving parts (such as knobs, couplings) using the Aesculap STERILIT Power Systems oil spray. ► Inspect the product after every cleaning and disinfecting cycle for:

exposed to the sterilizing agent. ► Validated sterilization process

– Steam sterilization using fractional vacuum process – Steam sterilizer according to DIN EN 285 and validated according to DIN EN ISO 17665 – Sterilization using fractionated vacuum process at 134 °C/holding time 5 min ► When sterilizing several products at the same time in a steam sterilizer, ensure that the maximum load capacity of the steam sterilizer specified by the manufacturer is not exceeded.

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

a dry, dark, temperature-controlled area.

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

7.11 Packaging ► Observe the instructions for use of the packagings and holders used

(e.g. instructions for use TA009721 for Aesculap ECCOS holder system). ► Place the application part in the correct position in the ECCOS holder

GB086R , see Fig. F. ► Insert the sagittal saw blades in the correct position in the ECCOS

holder GB720R, see Fig. H. ► Pack trays appropriately for the sterilization process (e.g. in Aesculap

sterile containers). ► Ensure that the packaging will prevent a recontamination of the prod-

uct.

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en 8.

Maintenance

Application part In order to ensure reliable operation, servicing must be performed in accordance with the maintenance labeling or at least once annually.

11. Accessories/Spare parts Art. no.

Designation

GA258SU

ELAN 4 disposable spray nozzle for saws

GA395SU

ELAN 4 electro single-use tube set

e.g. 2016-07 Please contact your national B. Braun/Aesculap representative, see Technical Service if you require such services.

GB086R

ELAN 4 electro ECCOS holder for micro sagittal saw GA836

GB600

STERILIT Power Systems oil spray

Tools No maintenance required for tools. ► Do not modify, re-sharpen or repair tools.

GB600860

ELAN 4 electro oil spray adapter

GB692R

ELAN 4 electro rinsing device

GB698R

ELAN 4 electro rinsing adapter

GB720R

ECCOS general holder for saw blades

Note For further information, see instructions for use of ELAN 4 electro control unit GA800 (TA014401).

TA012787

Instructions for use Tools for Aesculap motor systems

TA014428

Instructions for use for ELAN 4 electro micro sagittal saw GA836 (A4 for folder)

10. Technical Service

TA014429

Instructions for use for ELAN 4 electro micro sagittal saw GA836 (leaflet)

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.

12. Technical data

9.

Troubleshooting

CAUTION Modifications to medical equipment may result in loss of guarantee/warranty claims and any approvals. ► Do not modify the product. ► For service and repairs, please contact your national B. Braun/Aesculap representative. 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.

12.1 Classification in accordance with Regulation (EC) 2017/745 Art. no.

Designation

Class

GA836

ELAN 4 electro micro sagittal saw

IIa

12.2 Performance data, information about standards Max. power

approx. 180 W

Max. oscillation frequency

20 000 rpm

Weight

190 g ±10 %

Dimensions (∅ x L)

23 mm x 161 mm ±5 %

Application part

Type BF

EMC

IEC/DIN EN 60601-1-2

Compliance with standards

IEC/DIN EN 60601-1

The product was subject to a test by the manufacturer after 350 process cycles and passed.

12.3 Tool speed/Setting

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Adjustable maximum speed setting (oscillation frequency)

8 000 rpm to 20 000 rpm

Step width for maximum speed setting

1 000 rpm

Default factory setting of upper speed range limit

16 000 rpm

Tool connector

S sagittal saw blade

en 12.4 Short interval operation

■ 30 second application, 60 second pause ■ 10 repetitions ■ 30 min cooling time ■ Max. temperature 48°C 12.5 Ambient conditions Application part 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 packaging. WARNING Risk of injury from sharp and/or pointed products! ► When disposing of or recycling the product, make sure the packaging prevents injuries from the product. Note The operator must process the product before disposal, see Validated reprocessing procedure. The recycling passport can be downloaded from the extranet as a PDF document for on the individual part number. (The recycling passport contains instructions on how to disassemble the device, including information on the proper disposal of environmentally harmful components.) Any product labeled with this symbol must be disposed of separately together with electrical and electronic equipment. Within the European Union, the manufacturer will perform the disposal free of charge. ► In case of questions regarding the disposal of the product, contact your

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

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