ELAN 4 air reciprocating saw GA732 and reciprocating saw shaftsGP559R, GP569R

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Aesculap® ELAN 4 air reciprocating saw GA732 and reciprocating saw shafts GP559R, GP569R Legend

Manufacturer batch ID

1 Shaft holder 2 Connection for motor hose 3 Blade of reciprocating saw 4 Shaft release 5 Connection for applied part 6 Field of vision “On“ on the motor coupling 7 Field of vision “Off“ on the motor coupling 8 Release button 9 Nib on motor hose 10 Groove on connection for motor hose 11 Oil spray adapter GB600850 12 Reciprocating Saw Shaft 13 Tool coupling 14 Bridge on saw blade for tool release

Manufacturer’s serial number Manufacturer’s article number 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

Medical device

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

2

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

About this document... Scope... Warnings... General information... Intended use... Application Environment... Indications... Absolute contraindications... Relative contraindications... Safe handling... Sterile ELAN 4 tools... Product description... Package includes... Components required for operation... Operating principle... Preparation... Working with the product... System set-up... Function check... Operation...

3 3 3 3 3 3 3 3 3 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 13.

Validated reprocessing procedure... General safety notes... General information... Reusable products... Preparations at the place of use... 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 checks... Packaging... Steam sterilization... Storage... Maintenance... Troubleshooting list... Technical Service... Accessories/Spare parts... Technical Data... Classification in accordance with Regulation (EC) 2017/745. . Performance Data... Short interval operation... Ambient conditions... Disposal...

1.

About this document

1.1

Scope

6 6 7 7 7 7 7 8

Designation

GA732

ELAN 4 air reciprocating saw

GP559R GP569R

Reciprocating saw shaft for reciprocating saw blade GC615R/GC633R

General information

2.1

Intended use

The ELAN 4 air reciprocating saw GA732 is an accessory of ELAN 4 air the motor system. A ELAN 4 air motor hose GA705R is used to connect the reciprocating saw to the ELAN 4 air foot control GA708 or the reciprocating saw is connected to a ELAN 4 air motor hose with manual control GA706R or GA707R. The reciprocating saw is used to drive reciprocating saw blades and bone files (rasps), partly in conjunction with reciprocating sawing shafts.

9

2.2 11 12 12 12 12 12 12 12 12 13 13 13 13 13 13

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

2.

Application Environment

Application in the sterile area

2.3

Indications

Application types Separation, removal and modeling of hard tissue, cartilage, etc. and bone replacement material Surgical category/applications Neurosurgery, ENT-surgery and CMF-surgery, orthopedics and trauma surgery Note The type and area of application depend on the tools selected.

2.4

Absolute contraindications

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

2.5

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.

► 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.

3

en 3.

Safe handling

WARNING Risk of injury and material damage if this product is not used as intended! ► Use the product only as intended. WARNING Risk of injury and damage to property due to improper handling of the product! This product is part of the ELAN 4 air motor system. ► Follow the general safety advice given in the instructions for use of ELAN 4 air foot control GA708, ELAN 4 air wall hoses, ELAN 4 air wall adapters (TA014450) and/or instructions for use of ELAN 4 air motor hose with manual control (TA014481). ► Follow the instructions for use of all products used.

■ General risk factors associated with surgical procedures are not

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 TA012787 for tools. ► 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, 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. Single-use products

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. ► Sterilize reusable application parts, reciprocating saw shafts and motor hose before use. ► Observe the relevant instructions for use TA009721 when using the Aesculap holder systems, see B. Braun eIFU under eifu.bbraun.com ► Use the applied parts and tools within the specified pressure range only.

DANGER Risk of patient and/or user infection and impairment of the functionality of the products through re-use. Contamination and/or impaired function of the products may result in injury, illness and death! ► Do not reprocess the product.

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.

4.3

4

4.

Product description

4.1

Package includes

Art. no.

Designation

GA732

ELAN 4 air reciprocating saw

TA014466

Instructions for use for ELAN 4 air reciprocating saw GA732 (leaflet)

4.2

Components required for operation

■ ELAN 4 air wall adapter GA710R, GA712R, GA713R or GA715R ■ ELAN 4 air Foot control/manual control: – ELAN 4 air wall hose GA702R or GA703R, ELAN 4 air foot control GA708 and ELAN 4 air motor hose GA705R or – ELAN 4 air motor hose with manual control GA706R or GA707R ■ Reciprocating saw blade or bone file or reciprocating saw shaft with reciprocating saw blade

Operating principle

The ELAN 4 air reciprocating saw can be used to drive saw blades and bone files. The reciprocating saw is used with ELAN 4 air foot control or manual controls. The foot/manual control can be used to control the oscillation frequency in an infinitely variable manner. The tool shafts or tools are coupled / uncoupled without a key.

en 5.

Preparation

6.1

System set-up

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.

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.

6.

WARNING Risk of injury due to small parts that could enter the surgical field! ► Do not couple/uncouple tools and reciprocating saw shafts above the surgical field.

Working with the product

WARNING Risk of infection and contamination! Application parts, reciprocating saw shafts and the motor hose are delivered non-sterile! ► Sterilize application parts, reciprocating saw shafts and motor hose prior to use in accordance with the instructions for use.

Note Operating elements on the system components of the ELAN 4 air motor system are labeled with a gold marking.

WARNING Risk of injury and material damage due to inadvertent activation of the applied part! ► Secure application parts that are not actively used against inadvertent activation (off position).

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.

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.

Connecting the applied part to the motor hose ► Attach the connection for motor hose of the applied part 2 to the connection for applied part 5 of the motor hose, see Fig. E. When doing so, ensure that the nib 9 on the motor hose is aligned with the groove on the connection for motor hose 10. The applied part engages. When the field of vision is “Off” 7 on the motor hose, a gold-colored marking is visible.

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

Note The applied part attached to this motor hose is only ready for operation when the release button is in "On" 6 position. Coupling the tool or reciprocating saw shaft to the application part ► Lock the applied part ("Off" position), see Locking the applied part

("Off" position). ► Insert the connector end of the tool 3 or the reciprocating saw shaft

12 into the opening of tool holder 1, see FigA. The tool engages. ► To check for a secure coupling, pull on the tool 3 or the reciprocating saw shaft 12, see Fig. B. Releasing the applied part for operation ("On" position) ► Activate the release button 8 on the motor hose and push the connection for applied part 5 onto the applied part, see Fig. E. The applied part engages. When the field of vision is “On” 6 on the motor hose, a gold-colored marking is visible. Locking the applied part ("Off" position) ► Activate the release button 8 on the motor hose and detach the motor hose from the applied part, see Fig. E. The applied part engages. When the field of vision is “Off” 7 on the motor hose, a gold-colored marking is visible.

5

en Uncoupling the tool or reciprocating shaft from the application part ► Lock the applied part ("Off" position), see Locking the applied part ("Off" position). ► Gently press the shaft release button4 downwards and keep pressed down, see Fig. B. ► Remove the tool 3 from 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 the application part ("Off" position) see Locking the applied part ("Off" position). ► Insert the saw blade 3 into the tool holder 13, see Fig A. The saw blade clicks into place. ► To check for a secure coupling, pull on the saw blade 3.

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 if the saw blade is unintentionally released! ► Do not press the leaf spring for releasing the tool or the shaft during operation. ► Check that the tool/reciprocating saw shaft is securely seated after each change of the tool/reciprocating saw shaft.

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 the application part ("Off" position) see Locking the applied part ("Off" position). ► Lift bridge on saw blade for tool release 14 and pull from tool holder 13, see Fig A.

Operation of the applied part is only possible if: ■ the applied part is released, ■ a foot control or manual control is connected.

Disconnecting the applied part from the motor hose

Note Adhere to national statutory regulations, national and international standards and directives, and local, clinical hygiene instructions for reprocessing.

► Lock the applied part ("Off" position), see Locking the applied part

("Off" position). ► Activate the release button 8 on the motor hose and pull at the con-

nection for applied part 5 to disconnect the motor hose from the applied part, see Fig. E.

6.2

Function check

► 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 saw shaft is coupled properly: Pull at the reciprocating

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. ► Briefly run the applied parts at maximum speed. ► Do not use the product if it is damaged or defective. Set aside the product if it is damaged.

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.

6

7.

Validated reprocessing procedure

7.1

General safety notes

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

Reusable products

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

► 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

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

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

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

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

see Mechanical cleaning/disinfecting with manual pre-cleaning tools

Preparations at the place of use

► Separate the products from each other immediately after use.

Validated procedure

Application Manual cleaning with part/reciprocat- immersion disinfection ing saw shaft

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

Tools

Preparation before cleaning

Applied part ► Prior to first mechanical cleaning/disinfection: Install ECCOS holder GB067R in suitable tray (e.g. JF222R). ► Place the product in the correct position in the ECCOS holder GB067R, see Fig. C. 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 ECCOS holder

GB729R in suitable tray (e.g. JF222R). ► Place the product in the correct position in the ECCOS holder GB729R,

see Fig. F.

7

en 7.7

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

Phase

Step

T [°C/°F]

t [min]

Conc. [%] Water quality

Chemicals

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: BBraun Stabimed fresh

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

ing adapters TA014447 and TA014448. ► Do not clean the applied part in an ultrasound bath. ► Never place the applied part in liquid without an ELAN 4 air rinsing adapter GB697R connected. To avoid the risk of corrosion/malfunctioning, allow any fluid that has entered the product to drain out immediately. ► Leave the rinsing adapter GB697R on the applied part for the entire cleaning process. 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. ► Mobilize non-rigid components, such as release button, unlocking sleeve, etc. during cleaning. ► Rinse the applied part through the rinsing adapter GB697R 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 GB697R. ► Place the applied part, with rinsing adapter connected, fully in enzy-

matic cleaning solution for 5 minutes. ► Immerse the application part with the connected rinsing adapter 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. ► Mobilize non-rigid components, such as release button, unlocking

sleeve, etc. during rinsing. ► Rinse the applied part through the rinsing adapter GB697R at least

3 times for 5 seconds with a water gun.

8

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 GB697R to prevent the disinfecting solution from becoming diluted. ► Using a disposable syringe, fill the inside of the applied part with disinfectant solution through the rinsing adapter GB697R. ► Immerse the application part including the connected rinsing adapter for at least 5 min in disinfecting solution. ► Fully immerse the reciprocating saw shafts in disinfecting solution for at least 5 min. Phase V ► Rinse the entire application part and reciprocating saw shafts (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 GB697R at least 3 times for 5 seconds with a water gun. Phase VI ► Dry application part and jigsaw shafts in the drying phase with suitable aids (e.g. cloths, compressed air). ► 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 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 with a brush Phase

Step

T [°C/°F]

t [min]

Conc. [%]

Water quality

Chemicals

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 applied part in an ultrasound bath. ► Never place the applied part in liquid without an ELAN 4 air rinsing

adapter GB697R connected. To avoid the risk of corrosion/malfunctioning, allow any fluid that has entered the product to drain out immediately. 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. ► Mobilize non-rigid components, such as release button, unlocking sleeve, etc. during cleaning. Phase II ► Connect the connection for motor hose 2 with ELAN 4 air rinsing

device GB691R. ► Rinse the applied part:

– For 5 min with a tap/hose or – 3 times for 5 seconds with a water gun

9

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

Step

T [°C/°F]

t [min]

Water quality

Chemicals

I

Pre-rinse

<25/77

3

D–W

-

II

Cleaning

55/131

10

FD–W

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

■ 0.5 % working solution – 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

► Insert reciprocating saw shafts 12 in theECCOS holder GB729R, see

Fig. F. ► Connect the connection for motor hose 2 with ELAN 4 air rinsing

device GB691R. ► Place the rinsing device on a wire basket suitable for cleaning. ► Connect the rinsing device to the rinsing connection 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.

10

en 7.9

Mechanical cleaning/disinfecting with manual pre-cleaning - tools

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 with ultrasound and brush Phase

Step

T [°C/°F]

t [min]

Conc. [%]

Water quality

Chemicals

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, QUATfree, pH ~ 9**

IV

Cleaning with brush

RT (cold)

–

–

D–W

–

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

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 the entire product (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 with a suitable cleaning brush until all discernible residues have been removed.

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

Step

T [°C/°F]

t [min]

Water quality

Chemicals

I

Pre-rinse

<25/77

3

D–W

–

II

Cleaning

55/131

10

FD–W

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

■ 0.5 % working solution – 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

► 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. 11

en 7.10 Inspection, maintenance and checks ► Allow the product to cool down to room temperature. ► Connect the ELAN 4 air oil spray adapter GB600850 11 (purple) to

motor hose 2 and spray through the application part for approx. 2 s using STERILIT Power Systems oil spray GB600, see Fig. D. 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. ► 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). ► Insert the application part in the correct position in the ECCOS holder

GB067R, see Fig. C. ► Insert the reciprocating saw shafts and the tools in the correct position

in the ECCOS holder GB729R, see Fig. F ► Pack trays appropriately for the intended sterilization process (e.g. in

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

uct.

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

exposed to the sterilizing agent.

9.

Troubleshooting list

Note For further information, see instructions for use for ELAN 4 air foot control GA708, ELAN 4 air wall hoses, ELAN 4 air wall adapter (TA014450) or instructions for use for ELAN 4 air motor hose with manual control (TA014481).

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 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.

► 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

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

e.g. 2016-07 For technical service, please contact your national B. Braun/Aesculap agency, see Technical Service. 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.

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11. Accessories/Spare parts Art. no.

Designation

GB067R

ELAN 4 air ECCOS holder for reciprocating saw GA732

GB600

STERILIT Power Systems oil spray

GB600850

ELAN 4 air oil spray adapter

GB691R

ELAN 4 air rinsing device

GB697R

ELAN 4 air 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

TA014465

Instructions for use for ELAN 4 air reciprocating saw GA732 (A4 for folder)

TA014466

Instructions for use for ELAN 4 air reciprocating saw GA732 (leaflet)

en 12. Technical Data 12.1 Classification in accordance with Regulation (EC) 2017/745 Art. no.

Designation

Class

GA732

ELAN 4 air reciprocating saw

IIa

GP559R

Reciprocating saw shaft for reciprocating saw blade GC615R/GC633R

IIa

GP569R

Reciprocating saw shaft long for reciprocat- IIa ing saw blade GC615R/GC633R

12.2 Performance Data Max. power

approx. 75 W at 8 bar

Max. oscillation frequency

approx. 21 000 rpm at 8 bar

Weight

250 g ±10 %

Dimensions (∅ x L)

23 mm x 180 mm ±5 %

Pressure range

8 bar ±2 bar

12.3 Short interval operation

■ 30 s application, 60 s pause ■ 3 repetitions ■ 30 min cooling time ■ Max. temperature 48 °C

12.4 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. Note The operator must process the product before disposal, see Validated reprocessing procedure. ► In case of questions regarding the disposal of the product, contact your

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

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