ELAN 4 electro reciprocating saw GA832 and reciprocating saw shaftsGP559R, GP569R

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Aesculap® ELAN 4 electro reciprocating saw GA832 and reciprocating saw shafts GP559R, GP569R Legend

Manufacturer’s serial number

1 2 3

Manufacturer’s article number

Shaft holder Connector for motor cable Symbol of the application part type in the display of the ELAN 4 electro control unit 4 Blade of reciprocating saw 5 Shaft release 6 ELAN 4 disposable spray nozzle for saws 7 Tube connector on spray nozzle 8 Oil spray adapter GB600860 9 Reciprocating saw shaft 10 Tool coupling 11 Bridge on saw blade for tool release

Temperature limits during transport and storage

Air humidity limits during transport and storage

Atmospheric pressure limits during transport and storage According to US federal law, this product may only be sold by a physician or on the orders of a physician CE mark according to Regulation (EU) 2017/745

Symbols on product and packages 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 Machine-readable, two-dimensional 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 with inner protective packaging Non-sterile medical device

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

Do not use if packaging is damaged

Manufacturer batch ID

2

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 7. 7.1 7.2 7.3 7.4

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... Description... Scope of delivery... Components required for operation... Operating principle... Preparation... Working with the product... Preparation... Functional test... Operation... Validated processing procedure... General safety notes... General information... Reusable products... Preparations at the place of use...

3 3 3 3 3 3 3 3 3 3 4 4 4 4 4 4 4 5 5 5 6 6 6 6 6 7 7

en 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.

Preparation before cleaning... Cleaning/disinfection... Manual cleaning with immersion disinfection - application part/reciprocating saw shafts... Machine cleaning/disinfection including manual pre-cleaning application part/reciprocating saw shafts... Mechanical cleaning/disinfecting with manual pre-cleaning tools... Inspection, maintenance and testing... Packaging... Steam sterilization... Storage... Maintenance and repair... Troubleshooting... Technical Service... Accessories/spare parts... Technical data... Classification in accordance with Regulation (EC) 2017/745. . Performance data, information on standards... Tool speed/Setting... Short-time intermittent operation... Ambient conditions... Disposal...

1.

About this document

1.1

Scope

7 7

2.

General information

2.1

Intended use

8

The ELAN 4 electro reciprocating saw GA832 is an accessory of the ELAN 4 electro the motor system. The reciprocating saw is connected by an ELAN 4 electro motor cable to the control unit. The reciprocating saw is used to drive reciprocating saw blades and bone rasps, partially in combination with shanks for reciprocating saw.

9 10 11 12 12 12 12 12 12 12 13 13 13 13 13 13 13

2.2

Performance characteristics

Oscillation frequency min. 0 rpm to max. 20 000 rpm Short-time intermittent operation ■ 30 second application, 60 second pause ■ 3 repetitions at 16 000 rpm ■ 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. Warming 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 user against possible injury. The user shall be responsible for the implementation and adherence to the interval sequence described.

2.3

Application Environment

These instructions for use apply to the products listed below:

Application in the sterile area

Art. no.

Name

2.4

GA832

ELAN 4 electro reciprocating saw

GP559R GP569R

Reciprocating saw shaft for reciprocating saw blade GC615R/GC633R

Modes of application Separating, resecting and shaping hard tissue, cartilage, similar and bone substitute materials

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

Indications

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.

3

en 3.

Safe handling

WARNING If this product is not used as intended injury and material damage may result! ► Use the product only as intended. WARNING Improper handling of the product can result in injury and material damage! This product is an accessory of the ELAN 4 electro control unit GA800. ► Observe the instructions for use of the ELAN 4 electro control unit GA800 (TA014401). ► Observe the instructions for use of all products used.

■ General risks of surgical interventions are not described in these instructions for use.

■ The surgeon shall be responsible for the proper execution of the surgical intervention.

■ The surgeon must be proficient in both the practical and theoretical aspects of the recognized surgical techniques. ► Clean brand-new product after removal of the transport packaging and

before the first sterilization (manually or mechanically). ► Check the functionality and proper condition before using the product. ► To prevent damage caused by improper setup or operation, and to not

compromise the manufacturer warranty and liability: – Use product only in accordance with these instructions for use. – Observe safety information and maintenance instructions. – Combine only Aesculap products. ► Product and accessories to be operated and applied only by people who have the requisite training, knowledge or experience. ► Keep instructions for use accessible to the user. ► Comply with all valid standards. ► The electrical installation of the room has to comply with the requirements of IEC/DIN EN. ► Do not use the control unit and application part in potentially explosive environments. ► Sterilize application parts, reciprocating saw shafts 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 sterilized by irradiation and sterile packaged. ► Product and accessories to be operated and applied only by people who have the requisite training, knowledge or experience. ► Read, observe and store the instructions for use for tools TA012787. ► Do not use any product from open or damaged sterile packaging. ► Prior to every use, visually inspect the product for loose, bent, broken, cracked or fractured components. ► Do not use a damaged or defective product. Immediately reject damaged products! ► Do not use product after its expiration date. Note For further information, refer to the instructions for use for tools TA012787.

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Disposable products DANGER Reuse can cause infections in patients and/or users, and impairment of product functionality. 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. Contamination and/or impaired function of the products may result in injury, illness and death! ► Do not reprocess the product. The product is sterilized by irradiation and sterile packaged. ► Do not reuse the product. ► Product and accessories to be operated and applied only by people who have the requisite training, knowledge or experience. ► Read the instructions for use, comply with them and keep them in a safe place. ► Use the product only in accordance with its intended use. ► Do not use any product from open or damaged sterile packaging. ► Prior to every use, visually inspect the product for loose, bent, broken, cracked or fractured components. ► Do not use a damaged or broken product. Immediately reject damaged products! ► Do not use product after its expiration date.

4.

Description

4.1

Scope of delivery

Art. no.

Name

GA832

ELAN 4 electro reciprocating saw

TA014425

Instructions for use for ELAN 4 electro reciprocating saw GA832 (leaflet)

4.2

Components required for operation

■ Ready-to-use ELAN 4 electro control unit GA800, see TA014401 ■ Reciprocating saw blade or bone file – or – Reciprocating saw shaft with reciprocating saw blade

4.3

Operating principle

The ELAN 4 electro sagittal saw can be used to drive saw blades or bone files. The reciprocating saw is used with ELAN 4 electro foot controls or manual controls. The oscillation frequency can be adjusted infinitely using the foot/manual control. No wrenches are required for coupling/uncoupling the tool shafts and tools.

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! Application parts, reciprocating saw shafts and motor cables are delivered non-sterile! ► Sterilize application parts, reciprocating saw shafts 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

Preparation

WARNING Coupling/uncoupling tools and reciprocating saw shafts in the "On" position can cause injuries if the application part is accidentally activated! ► Couple/uncouple tools and reciprocating saw shafts only in the off position. WARNING Small parts entering the surgical field can cause injuries! ► Do not couple/uncouple tools and reciprocating saw shafts above the surgical field.

Note Control elements on the system components of the ELAN 4 electro motor system are labeled by 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. Coupling the tool or reciprocating saw shaft to the application part ► Lock application part (off position), see instructions for use for ELAN 4 electro control unit GA800 (TA014401). ► Insert the connector end of the tool 4 or the reciprocating saw shaft 9

into the bore of tool holder 1, see FigA. The tool clicks into place. ► To check for a secure coupling, pull on the tool 4 or the reciprocating saw shaft 9, see Fig. B. Uncoupling the tool or reciprocating saw shaft from the application part ► Lock application part (off position), see instructions for use for ELAN 4 electro control unit GA800 (TA014401). ► Gently press the shaft release button5 downwards and keep pressed

down, see Fig. B. ► Pull the tool 4 out of the tool holder 1.

Couple the reciprocating saw blade GC615R/GC633R to the reciprocating saw shaft GP559R/GP569R ► If the reciprocating saw shaft is coupled to the application part: Lock application part (off position), see instructions for use for ELAN 4 electro control unit GA800 (TA014401). ► Insert the saw blade 4 into the tool holder 10, see Fig A. The saw blade clicks into place. ► To check for a secure coupling, pull on the saw blade 4. Uncouple the reciprocating saw blade GC615R/GC633R from the reciprocating saw shaft GP559R/GP569R ► If the reciprocating saw shaft is coupled to the application part: Lock application part (off position), see instructions for use for ELAN 4 electro control unit GA800 (TA014401). ► Lift piece on saw blade for tool release 11 and pull from tool holder 10, see Fig A. Install spray nozzle and tube set The ELAN 4 disposable 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 the ELAN 4 micro saws GA836, GA837. ■ The large retainer clip is only for use in conjunction with the big ELAN 4 saw GA832. ► Connect tube set GA395SU to the pump of the ELAN 4 electro control unit GA800, see instructions for use of the ELAN 4 electro control unit GA800 TA014401. ► Remove the small front retainer clip from the spray nozzle 6. ► Push the tube end directed at the area of application onto the tube connector 7 of the spray nozzle.

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en ► Clip the spray nozzle 6 onto the black handle area of the application

part and push/turn into the desired position, see Fig. C. ► Push the large front retainer clip into position and clip onto the application part. – or – Remove the large 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

Functional test

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

ing order. ► Check the secure connection of all devices to be used. ► Check that the reciprocating saw shaft is coupled properly: Pull at the reciprocating saw shaft. ► 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. ► Operate application part for a short time at maximum rotational speed. ► Do not use a damaged or defective product. Immediately reject damaged products!

6.3

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.

The operation of the application part and the changing of the setting parameters on the control unit, are only possible if: ■ the application part is connected to the control unit, ■ there is no second application part activated ("On" position) at the same time and ■ the application part type 3 is shown on the display of the control unit. Note For further information, see instructions for use for the ELAN 4 electro control unit GA800 (TA014401).

7.

Validated processing 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.

7.2 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 Unintentionally releasing the tool/reciprocating saw shaft can cause injuries! ► Do not press the bridge at the saw blade for releasing the tool or the shaft during operation. ► Check that the tool/reciprocating saw shaft is securely seated after each change of tools/the reciprocating saw shaft. 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. 6

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.

en 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

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

► 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 cleaning and disinfection within 6 hours.

7.5

Preparation before cleaning

Application part ► Prior to first mechanical cleaning/disinfection: Install the ECCOS holder GB087R in a suitable tray (e.g. JF222R). ► Place the product in the correct position in the ECCOS holder GB087R, see Fig. D.

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 procedures Product

Validated procedure

Reference

Application parts and reciprocating saw shafts

Manual cleaning with immersion disinfection

see Manual cleaning with immersion disinfection - application part/reciprocating saw shafts

Manual pre-cleaning with brush and subsequent alkaline machine cleaning and thermal disinfection

see Machine cleaning/disinfection including manual pre-cleaning - application part/reciprocating saw shafts

Manual pre-cleaning with ultra-sound and brush and subsequent alkaline machine cleaning and thermal disinfection

see Mechanical cleaning/disinfecting with manual pre-cleaning tools

Tools ► Thoroughly rinse the product with running, cold water. ► Place the product in the correct position in the ECCOS holder GB729R,

see Fig. F. Reciprocating saw shafts ► Prior to first mechanical cleaning/disinfection: Install the ECCOS holder

GB729R in a suitable tray (e.g. JF222R).

Cleaning/disinfection

Tools

► Push the reciprocating saw shaft into its proper position in the ECCOS

holder GB729R and engage with the contour, see Fig. F.

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en 7.7

Manual cleaning with immersion disinfection - application part/reciprocating saw shafts

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 from aldehydes, phenols and QACs, pH ~ 9**

V

Final rinse

RT (cold)

-

-

D–W

-

VI

Drying

RT

-

-

-

-

D–W: Potable water RT: Room temperature *Recommended: BBraun Helizyme **Recommended: BBraun Stabimed fresh

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

adapter TA014447 or TA014448. ► Do not clean the application part in an ultrasonic bath. Phase I ► Clean the application part and the reciprocating saw shafts under run-

ning water, using a suitable cleaning brush until all visible residues have been removed from the surfaces. ► Move non-rigid components, such as unlocking buttons, unlocking sleeves, etc., during cleaning. ► Rinse the application part using the rinsing adapter GB698R at least 3x for 5 s using the pressurized water gun. Phase II ► Use the rinsing adapter GB698R with a disposable syringe to fill clean-

ing solution into the inside of the application part. ► Immerse the application part with the connected rinsing adapter and reciprocating saw shafts at least 5 min in an enzymatic cleaning solution. Phase III ► Rinse the entire application part and reciprocating saw shafts (all

accessible surfaces) under running water. ► Move non-rigid components, such as unlocking buttons, unlocking

sleeves, etc., during rinsing. ► Rinse the application part using the rinsing adapter GB698R at least 3x

for 5 s using the pressurized water gun. Phase IV ► Prior to manual disinfection, let rinsing water drain off the application

part and the reciprocating saw shafts sufficiently and use compressed air to blow all liquid out of the application part through the rinsing adapter GB698R to prevent the disinfecting solution from becoming diluted. ► Use the rinsing adapter GB698R with a disposable syringe to fill disinfectant solution into the inside of the application part. ► Immerse the application part with the connected rinsing adapter and reciprocating saw shafts at least 5 min in disinfecting solution. Phase V ► Rinse the entire application part and reciprocating saw shafts (all

accessible surfaces) under running water. ► Move non-rigid components, such as unlocking buttons, unlocking sleeves, etc., during cleaning. ► Rinse the application part using the rinsing adapter GB698R at least 3x for 5 s using the pressurized water gun. 8

Phase VI ► Use suitable equipment (e.g. cloth, compressed air) to dry the application part and the reciprocating saw shafts in the drying phase. ► After manual cleaning/disinfection, check visible surfaces for residue and repeat the cleaning/disinfection process as required.

en 7.8

Machine cleaning/disinfection including manual pre-cleaning - application part/reciprocating saw shafts

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

Step

T [°C/°F]

t [min]

Conc. [%]

Water quality

Chemical

I

Brushing

RT (cold)

–

–

D–W

-

II

Rinse

RT (cold)

5

-

D–W

-

D–W: RT:

Potable water Room temperature

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

adapter TA014447 or TA014448. ► Do not clean the application part in an ultrasonic bath.

Phase I ► Clean the application part and the reciprocating saw shafts under run-

ning water, using a suitable cleaning brush until all visible residues have been removed from the surfaces. ► Move non-rigid components, such as unlocking buttons, unlocking sleeves, etc., during cleaning. Phase II ► Connect connector of motor cable 2 to the 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

9

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

DI–W

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

■ Working solution 0.5 % – pH ~ 11* III

Intermediate rinse

>10/50

1

DI–W

-

IV

Thermal disinfection

90/194

5

DI–W

-

V

Drying

max. 120/248

min. 10

-

–

D–W: Potable water DI–W: De-ionized water (demineralized, microbiological at least in compliance with potable water regulations) *Recommended: BBraun Helimatic Cleaner alcaline

► Insert reciprocating saw shafts 9 in the ECCOS holder GB729R, see

Fig. F. ► Connect connector of motor cable 2 to the 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 any remaining rinsing water from the application parts and shafts, see the instructions for use ELAN 4 for rinsing system and rinsing adapter TA014447 or TA014448. – Visually check for residue on visible surfaces and repeat the cleaning/disinfection process if necessary.

7.9

Mechanical cleaning/disinfecting with manual pre-cleaning - tools

Note The cleaning and disinfection device must have a certified efficacy (e.g.,FDA approval or CE mark in accordance with EN ISO 15883). Note The cleaning and disinfection device used has to 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

Rinse

RT (cold)

–

–

D–W

–

III

Ultrasound cleaning

55/131

>15

2

D–W

Concentrate free from aldehydes, phenols and QACs, pH ~ 9**

IV

Brush cleaning

RT (cold)

–

–

D–W

–

D–W: Potable water RT: Room temperature *Recommended: BBraun Helizyme **Recommended: BBraun Stabimed fresh 10

en Phase I ► Fully immerse the product in enzymatic cleaning solution for at least 30 min. Ensure that all accessible surfaces are wetted. 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 min. Make sure all accessible surfaces are wetted and acoustic shadows are prevented. Phase IV ► Clean the product using a suitable cleaning brush until no residue is

visible on the surface. 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

DI–W

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

■ Working solution 0.5 % – pH ~ 11* III

Intermediate rinse

>10/50

1

DI–W

–

IV

Thermal disinfection

90/194

5

DI–W

–

V

Drying

max. 120/248

min. 10

–

–

D–W: Potable water DI–W: De-ionized water (demineralized, microbiological at least in compliance with potable water regulations) *Recommended: BBraun Helimatic Cleaner alcaline

► Place the product in the correct position in the ECCOS holder GB729R,

see Fig. F. ► After machine cleaning/disinfection, check visible surfaces for residue

and repeat the cleaning/disinfection process as required.

7.10 Inspection, maintenance and testing ► Allow product to cool to room temperature. ► Connect the ELAN 4 electro oil spray adapter GB600860 8 (grey) 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. E. 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:

cleanliness, damage, function, abnormal operation noise, excessive heat or strong vibration. ► Inspect tools for broken, damaged or blunt edges. ► Immediately reject damaged products!

11

en 7.11 Packaging

10. Technical Service

► 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

GB087R, see Fig. D. ► Place the reciprocating saw shafts and the tools in the correct position

in the ECCOS holder GB729R, see Fig. F.

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.

► Pack the trays properly in accordance with sterilization process (e.g.

Aesculap sterile Containers). ► Ensure that the packaging will prevent a recontamination of the product.

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

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.

8.

Maintenance and repair

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

e.g. 2016-07 Please contact your national B. Braun/Aesculap representative, see Technical Service if you require such services. Tools and reciprocating saw shafts No maintenance necessary for tools and reciprocating saw shafts. ► Do not modify or repair reciprocating saw shafts. ► Do not modify, re-sharpen or repair tools.

9.

Troubleshooting

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

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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.

11. Accessories/spare parts Art. no.

Name

GA258SU

ELAN 4 disposable spray nozzle for saws

GA395SU

ELAN 4 electro disposable tube set

GB087R

ELAN 4 ECCOS holder for reciprocating saw GA832

GB600

STERILIT Power Systems oil spray

GB600860

ELAN 4 electro oil spray adapter

GB692R

ELAN 4 electro rinsing device

GB698R

ELAN 4 electro rinsing adapter

GB729R

ECCOS holder for 2 reciprocating saw shafts

GP559R

Reciprocating saw shaft for reciprocating saw blade GC615R/GC633R

GP569R

Reciprocating saw shaft long for reciprocating saw blade GC615R/GC633R

TA012787

Instructions for use Tools for Aesculap motor systems

TA014424

Instructions for use for ELAN 4 electro reciprocating saw GA832 (A4 for folder)

TA014425

Instructions for use for ELAN 4 electro reciprocating saw GA832 (leaflet)

en 12. Technical data

13. Disposal

12.1 Classification in accordance with Regulation (EC) 2017/745

WARNING Risk of infection from contaminated products! ► Observe national regulations when disposing of or recycling the product, its components, and their packaging.

Art. no.

Name

Class

GA832

ELAN 4 electro reciprocating saw

IIa

GP559R

Reciprocating saw shaft for reciprocating saw blade GC615R/GC633R

IIa

GP569R

Reciprocating saw shaft long for reciprocating saw blade GC615R/GC633R

IIa

12.2 Performance data, information on standards Max. power

approx. 180 W

Max. oscillation frequency

20 000 rpm

Weight

238 g ±10 %

Dimensions (∅ x L)

22.8 mm x 195 mm ±5 %

Application part

Type BF

EMC

IEC/EN 60601-1-2

Compliance with standards

IEC/EN 60601-1

After 350 processing cycles, the manufacturer tested the product and it passed.

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 processing 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.

12.3 Tool speed/Setting Adjustable maximum speed range limit (oscillation frequency)

8 000 rpm to 20 000 rpm

Increment of the upper speed range limit

1 000 rpm

Default factory setting of upper speed range limit

16 000 rpm

12.4 Short-time intermittent operation

■ 30 second application, 60 second pause ■ 3 repetitions at 16 000 rpm ■ 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

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