ELAN 4 air transversal saw GA733 and transversal saw shafts GP580R,GP582R, GP586R, GP590R

2

1

A

90°

105°

7 180°

8 6 5

B

3

4

C

90°

4

7

270° 0°

5 3

6

D

6

5 6

6 5

5

4 4

4

1

2

9

2

14

13

12

15

11 10

F

E

6

7

G

H

16 17

18 3

16 18

19

I

3

17

en

Aesculap® ELAN 4 air transversal saw GA733 and transversal saw shafts GP580R, GP582R, GP586R, GP590R Legend 1 Shaft holder 2 Connection for motor hose 3 Transversal saw blades (S/M/L) 4 Bridge on transversal saw blade for tool release 5 Tool coupling 6 ELAN 4 transversal saw shaft 7 Shaft release 8 Plug connection 9 Connection for applied part 10 Field of vision “On“ on the motor coupling 11 Field of vision “Off“ on the motor coupling 12 Release button 13 Nib on motor hose 14 Groove on connection for motor hose 15 Oil spray adapter GB600850

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

Do not use if packaging is damaged

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

Air humidity limits during transport and storage ELAN 4 ECCOS general holder for saw blades GB720R 16 Side handles 17 Tool coupling 18 Holding nibs 19 Tab

Atmospheric pressure limits during transport and storage

Symbols on product and packages

CE mark according to Regulation (EU) 2017/745

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

2

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

Medical device

en 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 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. 11.1 12. 12.1 12.2 12.3 12.4 13.

About this document... Scope... Warnings... General information... Intended use... Application Environment... Indications... Absolute contraindications... Relative contraindications... Safe handling... Sterile ELAN 4 tools... Product description... Scope of supply... Components required for operation... Operating principle... Preparation... Working with the product... System set-up... Function checks... Safe operation... 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/transversal saw shafts... Machine cleaning/disinfection including manual pre-cleaning application part/transversal 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... ELAN 4 shafts for transversal saw blade... Technical data... Classification in accordance with Regulation (EC) 2017/745. . Performance Data... Short-time interval operation... Ambient conditions... Disposal...

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

1.

About this document

1.1

Scope

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

Designation

GA733

ELAN 4 air transversal saw

GP580R

ELAN 4 shaft for saw blade S transversal 65 mm

GP582R

ELAN 4 shaft for saw blade M transversal 65 mm

GP586R

ELAN 4 shaft for saw blade M transversal 95 mm

GP590R

ELAN 4 shaft for saw blade L transversal 30 mm

► 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.

8

2.

General information

9

2.1

Intended use

11 12 12 12 12 12 12 12 13 13 13 13 13 13 13 13

The ELAN 4 air transversal saw GA733 is an accessory of the ELAN 4 air motor system. The transversal saw is connected by an ELAN 4 air motor hose GA705R to the ELAN 4 air foot control GA708 or to an ELAN 4 air motor hose with hand control GA706R or GA707R. The transversal saw is used to drive transversal saw blades in combination with ELAN 4 shanks for transversal saw.

2.2

Application Environment

Application in the sterile area

2.3

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 transversal saw shaft and tool selected.

2.4

Absolute contraindications

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

3

en 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.

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 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 hand control (TA014481). ► 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. ► read, follow, and keep the instructions for use. ► Always adhere to applicable standards. ► Do not operate the applied part in explosion-hazard areas. ► Sterilize application parts, transversal saw shafts and motor hose before use. ► Observe the relevant instructions for use TA009721 when handling the Aesculap holder systems, see B. Braun eIFU under eifu.bbraun.com ► Use the applied parts and tools within the specified pressure range only. 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

3.1

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 keep 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 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 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.

4.

Product description

4.1

Scope of supply

Art. no.

Designation

GA733

ELAN 4 air transversal saw

TA014468

Instructions for use for ELAN 4 air transversal saw GA733 (flyer)

4.2

Components required for operation

■ ELAN 4 air wall adapter GA710R, GA712R, GA713R or GA715R ■ ELAN 4 air foot/hand 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 ■ ELAN 4 transversal saw shaft (S/M/L) ■ ELAN 4 transversal saw blade (S/M/L)

4.3

Operating principle

The ELAN 4 air transversal saw can be used to drive transversal blades. The transversal saw is used with ELAN 4 air foot controls or hand controls. The oscillation frequency is infinitely variable by means of the foot/hand control. The tool shafts and tools are coupled / uncoupled without a key. The tool shafts can be coupled in four different positions (0° / 90° / 180° / 270°). The S and M tools can be coupled in the associated tool shaft in two different alignments (90°/105°).

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, transversal saw shafts and the motor hose will be delivered non-sterile! ► Sterilize application parts, transversal saw shafts and motor hose before use in accordance with the instructions for use. 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). WARNING Risk of injury and material damage due to inappropriate use of tools! ► Always follow the safety advice and information given in the instructions for use. ► When coupling/uncoupling, handle tools with cutting edges with care. ► Do not use tools for spreading or levering. WARNING Risk of burns to skin and tissue due to blunt tools/insufficient maintenance of the application part and broken transversal saw shafts! ► Only use tools or transversal saw shafts that are in perfect condition. ► Replace blunt tools. ► Ensure correct maintenance of the applied part, see Maintenance. WARNING Damage to the product if dropped! ► Use the products only if they are in perfect technical condition, see Function check

6.1

System set-up

WARNING Coupling/uncoupling tools and transversal saw shafts in the "On" position can cause injuries if the application part is accidentally activated! ► Couple/uncouple tools and transversal saw shafts only in the 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. Remove ECCOS universal holder for saw blades GB720R from tray The insert of the ECCOS holder can be removed from the tray together with the tools. ► Pull the tab 19 and remove the insert of the holder, see Fig. I. ► Lift up tool holder 17. Connecting the applied part to the motor hose ► Attach the connection for motor hose of the applied part 2 to the con-

nection for applied part 9 of the motor hose, see Fig. F. When doing so, ensure that the nib 13 on the motor hose is aligned with the groove on the connection for motor hose 14. The applied part engages. When the field of vision is “Off” 11 on the motor hose, a gold-colored marking is visible. Note The applied part attached to this motor hose is only ready for operation when the release button is in "On" 10 position. Coupling the tool to the transversal saw shaft ► If the transversal saw shaft is coupled to the application part: Lock the

application part ("Off" position) see Locking the applied part ("Off" position). ► Make sure that the S, M, L tool connection identifiers on the transversal shaft and saw blade match. Note Size S and M saw blades 3 can be coupled in the transversal saw shaft in two different alignments; see Fig. A. This results in the saw blade having an angle of either 90° or 105°. ► Insert saw blade 3 in slot in tool holder 5, see Fig. B. When doing so,

make certain that the lateral stops of the saw blade are resting on the tool holder, see fig. C. The saw blade engages. ► Pull on the attachment 3 to ensure a secure fit. Uncoupling the tool from the transversal saw shaft ► If the transversal saw shaft is coupled to the application part: Lock the application part ("Off" position), see Locking the applied part ("Off" position). ► Gently press the gold piece on saw blade for tool release 4 downwards and keep pressed down, see Fig. C. ► Remove the saw blade 3 from the tool holder 5.

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 air motor system are labeled with a gold marking.

5

en Coupling the transversal saw shaft to the application part Note The transversal saw shaft can be inserted into the application part in four different positions (0°/90°/180°/270°), see Fig. D. ► Lock the applied part ("Off" position), see Locking the applied part

("Off" position). Note The shaft release button 7 does not have to be pressed when coupling the transversal saw shaft. ► Push the transversal saw shaft 6 into the shaft holder 1 to the limit

stop. While doing so, hold the transversal saw shaft horizontally and ensure that the shaft release 7 is in the horizontal, folded position. ► Make sure that the connector plug 8 is properly seated in the shaft holder 1: Move the transversal saw shaft 6 slightly back and forth. The transversal saw shaft 6 engages. ► To check for a secure coupling, pull on the transversal saw shaft 6.

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.

Uncoupling the transversal saw shaft from the application part ► Lock the applied part ("Off" position), see Locking the applied part

("Off" position).

WARNING Risk of injury when using the product beyond the field of view! ► Apply the product only under visual control.

► Push the shaft release button 7 downwards and pull the transversal

saw shaft 6 out of the shaft holder 1. Releasing the applied part for operation ("On" position) ► Activate the release button 12 on the motor hose and push the connection for applied part 9 onto the applied part, see Fig. E. The applied part engages. When the field of vision is “On” 10 on the motor hose, a gold-colored marking is visible. Locking the applied part ("Off" position) ► Activate the release button 12on the motor hose and remove the connection for applied part see E. The applied part engages. When the field of vision is “Off” 11 on the motor hose, a gold-colored marking is visible.

WARNING Risk of injury if the tool comes loose accidentally! ► Do not press the saw blade tool release or shaft release during operation. ► Check that the tool/transversal saw shaft is securely seated after each change of tools/the transversal saw shaft. Operation of the applied part is only possible if: ■ the applied part is released, ■ a foot control or hand control is connected.

7.

Validated reprocessing procedure

Disconnecting the applied part from the motor hose

7.1

General safety notes

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

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

("Off" position). ► Activate the release button 12 on the motor hose and pull at the con-

nection for applied part 9 to disconnect the motor hose from the applied part, see Fig. E.

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 transversal saw shaft is coupled securely: Pull on the

transversal 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. ► 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

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.

en 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

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

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

Tools ► Thoroughly rinse the product with running, cold water. ► Prior to the first mechanical cleaning/disinfection process, mount the bottom part of the ECCOS fixation GB720R in a suitable tray (e.g. JF222R). ► Insert transversal saw blade (S/M/L) 3 in tool holder 17 of ECCOS fixation GB720R in correct position; see Fig. I. ► Engage the fixation in the bottom part. When doing so, ensure that the holding lugs 18 on the insert are inserted in the recesses in the bottom part. ► Lift and fold down the tool holder 17 using the two side handles 16.

7.6

Cleaning/disinfection

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/transversal saw shafts

Manual cleaning with immersion disinfection

see Manual cleaning with immersion disinfection application part/transversal saw shafts

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

see Machine cleaning/disinfection including manual pre-cleaning - application part/transversal 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

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

Applied part ► Prior to first mechanical cleaning/disinfection: Install ECCOS holder GB068R in a suitable tray (e.g. JF222R). ► Place the product in the correct position in the ECCOS holder GB068R, see Fig. G. Transversal saw shafts

Tools

► Before the first automatic cleaning/disinfection: attach ECCOS fixation

GB730R in a suitable tray (e. g. JF222R). ► Fold out shaft release 7. ► Push transversal saw shaft 6 into its proper position in the ECCOS

holder GB730R until it engages in the contour, see Fig. H.

7

en 7.7

Manual cleaning with immersion disinfection - application part/transversal 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, QUAT-free, 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 transversal 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. ► Immerse the application part with the connected rinsing adapter and

transversal saw shafts at least 5 min in an enzymatic cleaning solution. Phase III ► Rinse the entire application part and transversal saw shafts (all acces-

sible 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. Phase IV ► Prior to manual disinfection, let rinsing water drain off the application

part and the transversal 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 with the connected rinsing adapter and transversal saw shafts at least 5 min in disinfecting solution.

8

Phase V ► Rinse the entire application part and transversal 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 ► In the drying phase, dry the application part and the crosscut saw shafts 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/transversal 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 transversal 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

► Place the transversal saw shafts 6 in the ECCOS holder GB730R, see

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

device GB691R. ► Place the rinsing device in a wire suitable basket 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 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.

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 surfactants

■ 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: 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

for cleaning. ► 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 15 (purple) to

connector for motor hose 2 and spray through the application part for approx. 2 s using STERILIT Power Systems oil spray GB600, see Fig. F. ► Oil any moving parts of the transversal saw shafts using STERILIT Power Systems oil spray GB600. 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). ► Place the application part in the correct position in the ECCOS holder

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 transversal saw shafts No maintenance required for tools and transversal saw shafts. ► Do not modify or repair transversal saw shafts. ► Do not modify, re-sharpen or repair tools.

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).

GB068R, see Fig. G. ► Place the transversal saw shafts 6 in the correct position in the ECCOS

holder GB730R, see Fig. H. ► Fold out shaft release 7. ► Place the transversal saw blades in the correct position in the ECCOS holder GB720R, see Fig. I. ► Pack trays appropriately for the sterilization process (e.g. in Aesculap sterile containers). ► Ensure that the packaging will prevent a recontamination of the product.

7.12 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.

12

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.

en 11. Accessories/Spare parts

12.3 Short-time interval operation

Art. no.

Designation

GB068R

ELAN 4 air ECCOS holder for saws GA731/GA733

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

GB720R

ECCOS universal fixation for saw blades

GB730R

ECCOS fixation for transversal saw shafts

Saw operation with transversal saw shaft GP580R, GP582R, GP586R at 8 bar: ■ 120 second application, 30 second pause ■ 5 repetitions ■ 30 min cooling time ■ Max. Temperature 48 °C Saw operation with transversal saw shaft GP590R at 8 bar: ■ 60 second application, 60 second pause ■ 4 repetitions ■ 30 min cooling time ■ Max. Temperature 48 °C

TA012787

Instructions for use tools for Aesculap motor systems

12.4 Ambient conditions

TA014467

Instructions for use for ELAN 4 air transversal saw GA733 (A4 for folder)

Application part

TA014468

Instructions for use for ELAN 4 air transversal saw GA733 (flyer)

Operation

Transport and storage

Temperature

10 °C to 27 °C

-10 °C to 50 °C

11.1 ELAN 4 shafts for transversal saw blade

Relative humidity

30 % to 75 %

10 % to 90 %

Art. no.

Designation

Atmospheric pressure

700 hPa to 1 060 hPa

500 hPa to 1 060 hPa

GP580R

ELAN 4 shaft for saw blade S transversal 65 mm

GP582R

ELAN 4 shaft for M transversal saw blade 65 mm

GP586R

ELAN 4 shaft for M transversal saw blade 95 mm

GP590R

ELAN 4 shaft for L transversal saw blade 30 mm

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

Designation

Class

GA733

ELAN 4 air transversal saw

IIa

GP580R

ELAN 4 shaft for saw blade S transversal 65 mm

IIa

GP582R

ELAN 4 shaft for saw blade M transversal 65 mm

IIa

GP586R

ELAN 4 shaft for saw blade M transversal 95 mm

IIa

GP590R

ELAN 4 shaft for saw blade L transversal 30 mm

IIa

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.

12.2 Performance Data Max. power

approx. 75 W at 8 bar

Max. oscillation frequency

approx. 21 000 rpm at 8 bar

Weight

200 g ±10 %

Dimensions (∅ x L)

23 mm x 115 mm ±5 %

Tool connection

Saw blade transversal S/M/L

Shaft connection

ELAN 4 transversal

Pressure range

8 bar ±2 bar

13