ELAN 4 electro transversal saw GA833 and transversal saw shaftsGP580R, GP582R, GP586R, GP590R

2

3

1

A

90°

105°

8 180°

9 7 6

B

4

5

C

90°

5

8

270° 0°

6 4

7

D

7

6 7

7 6

6

4 4

4

1

12 2

10

11

E

F

7

G

8

H

13 14

15 4

13 15

16

I

4

14

en

Aesculap® ELAN 4 electro transversal saw GA833 and transversal saw shafts GP580R, GP582R, GP586R, GP590R Legend

Use by

1 2 3

Shaft holder Connector for motor cable Symbol of the applied part type in display of ELAN 4 electro control unit 4 Transversal saw blades (S/M/L) 5 Bridge on transversal saw blade for tool release 6 Tool holder 7 ELAN 4 transversal saw shaft 8 Shaft release 9 Plug connection 10 ELAN 4 disposable spray nozzle for saws 11 Tube connection on spray nozzle 12 Oil spray adapter GB600860

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 ECCOS universal mount for saw blades GB720R 13 Side handles 14 Tool holder 15 Holding lugs 16 Tab

Atmospheric pressure limits during transport and storage

Symbols on product and packages

CE mark according to Regulation (EU) 2017/745

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

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

YYYY-MM

Maintenance indicator Date of the next recommended servicing (year-month) by the international B. Braun-/Aesculap agency, see Technical Service 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

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.

About this document... Scope... Warnings... General information... Intended use... Main functions and design characteristics... Application Environment... Indications... Absolute contraindications... Relative contraindications... Safe handling... Sterile ELAN 4 tools... Sterile ELAN 4 disposable spray nozzle for saws GA258SU... Product description... Scope of supply... Components required for operation... Operating principle... Preparation...

3 3 3 3 3 3 3 3 3 4 4 4 4 4 4 4 5 5

en 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 12.5 13.

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... Technical Service... Accessories/Spare parts... ELAN 4 shafts for transversal saw blade... Technical data... Classification in accordance with Regulation (EC) 2017/745. . Performance data, information about standards... Tool speed/Setting... Short-time intermittent operation... Ambient conditions... Disposal...

1.

About this document

1.1

Scope

5 5 6 6 6 6 7 7 7 7 7 8 9 10 11 12 12 12 12 12 12 12 12 13 13 13 13 13 13 13

These operating instructions apply to the following products: Art. no.

Designation

GA833

ELAN 4 electro transversal saw

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.

2.

General information

2.1

Intended use

The ELAN 4 electro transversal saw GA833 is an accessory of the ELAN 4 electro motor system. The transversal saw is connected by an ELAN 4 electro motor cable to the control unit. The transversal saw is used to drive transversal saw blades in combination with ELAN 4 shanks for transversal saw.

2.2

Main functions and design characteristics

Oscillation frequency min. 0 rpm to max. 20 000 rpm Short-time intermittent operation Saw operation with transversal saw shaftGP580R, GP582R, GP586R at 16 000 rpm: ■ 120 second application, 30 second pause ■ 5 repetitions ■ 30 min cooling time ■ Max. Temperature 48 °C Saw operation with transversal saw shaft GP590R at 16 000 rpm: ■ 60 second application, 60 second pause ■ 4 repetitions ■ 30 min cooling time ■ Max. Temperature 48 °C Electrical systems generally heat up during continual operation. It is advisable to give the system a break after use to cool down, as indicated below. Heating depends on the tool used and the load. After a certain number of repetitions, the system should cool down. This procedure prevents the system overheating as well as possible injury to the patient or user. The user is responsible for the use and adherence to the pause sequence described.

2.3

Application Environment

Application in the sterile area

GP580R

ELAN 4 shaft for saw blade S transversal 65 mm

GP582R

ELAN 4 shaft for saw blade M transversal 65 mm

2.4

GP586R

ELAN 4 shaft for saw blade M transversal 95 mm

GP590R

ELAN 4 shaft for saw blade L transversal 30 mm

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.

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 transversal saw shaft and tool selected.

2.5

Absolute contraindications

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

3

en 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.

Safe handling

WARNING Risk of injury and material damage if this product is not used as intended! ► Use the product only for its intended purpose. WARNING Risk of injury and damage to property due to improper handling of the product! This product is an accessory of the ELAN 4 electro control unit GA800. ► Follow the instructions for use of the ELAN 4 electro control unit GA800 (TA014401). ► Follow the instructions for use of all products used.

■ General risk factors associated with surgical procedures are not described in this documentation. ■ It is the operating surgeon's responsibility to ensure that the surgical procedure is performed correctly. ■ The operating surgeon must have a thorough understanding of both the hands-on and conceptual aspects of the established operating techniques. ► Remove the transport packaging and clean the new product, either manually or mechanically, prior to its initial sterilization. ► Prior to use, check that the product is in good working order. ► To prevent damage caused by improper setup or operation, and in order not to compromise warranty and manufacturer liability: – Use the product only according to these instructions for use. – Follow the safety and maintenance instructions. – Only combine Aesculap products with each other. ► Ensure that the product and its accessories are operated and used only by persons with the requisite training, knowledge, or experience. ► read, follow, and keep the instructions for use. ► Always adhere to applicable standards. ► Ensure that the electrical installations at the premises where the device is to be used meet all requirements acc. to IEC/DIN EN. ► Do not use the control unit and applied part in potentially explosive areas. ► Sterilize application parts, transversal saw shafts and motor cables before use. ► Observe the relevant instructions for use TA009721 when handling the Aesculap holder systems, see B. Braun eIFU under eifu.bbraun.com Note The user agrees to report all serious incidents occurring in connection with the product to the manufacturer and to the competent authority of the country in which the user is registered.

3.1

Sterile ELAN 4 tools

The product is gamma-sterilized and supplied in sterile packaging. ► Ensure that the product and its accessories are operated and used only by persons with the requisite training, knowledge, or experience. ► Read, observe and 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. Disposable products DANGER Risk of infection for patients and/or users and impairment of product functionality due to reuse. Risk of injury, illness or death due to contamination and/or impaired functionality of the product! ► Do not reprocess the product.

3.2

Sterile ELAN 4 disposable spray nozzle for saws GA258SU

The spray nozzle serves to feed fluid for rinsing and cooling the tool or point of application. 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. The product is gamma-sterilized and supplied in sterile packaging. ► Do not reuse the product. ► Ensure that the product and its accessories are operated and used only by persons with the requisite training, knowledge, or experience. ► read, follow, and keep the instructions for use. ► Use the product only in accordance with its intended use. ► Do not use products from open or damaged sterile packaging. ► Prior to each use, inspect the product for: loose, bent, broken, cracked, 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.

4.

Product description

4.1

Scope of supply

Art. no.

Designation

GA833

ELAN 4 electro transversal saw

TA014427

Instructions for use for ELAN 4 electro transversal saw GA833 (leaflet)

4.2

Components required for operation

■ Operation-ready ELAN 4 electro control unit GA800, see TA014401 ■ ELAN 4 transversal saw shaft (S/M/L) ■ ELAN 4 transversal saw blade (S/M/L)

4

en 4.3

Operating principle

The ELAN 4 electro transversal saw enables the driving of transversal saw blades. The transversal 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 key is required to couple/uncouple the tool shafts 7 and tools 4. The tool shafts 7 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°).

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 motor cables are delivered non-sterile! ► Sterilize application parts, transversal saw shafts and motor cables prior to use, in accordance with the instructions for use.

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. WARNING Small parts entering the surgical field can cause injuries! ► Do not couple/uncouple tools and transversal saw shafts above the surgical field. Note Operating elements on the system components of the ELAN 4 electro motor system are labeled with a gold marking. Connecting the accessories Do not use accessories in combinations that are not mentioned in these instructions for use. ► Follow the instructions for use of individual accessories. ► Please address your B. Braun/Aesculap partner or Aesculap Technical Service with any inquiries in this respect; for a contact address, see Technical Service. Remove ECCOS universal holder for saw blades GB720R from tray The insert of the ECCOS holder can be removed from the tray in conjunction with the tools. ► Pull the tab 16 and remove the insert of the holder, see Fig. I. ► Lift up tool holder 14. Coupling the tool to the transversal saw shaft ► If the transversal saw shaft is coupled to the application part: Lock

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 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.

application part (off position), see instructions for use for ELAN 4 electro control unit GA800 (TA014401). ► Make sure that the S, M, L tool connection identifiers on the transversal saw shaft and saw blade match. Note Size S and M saw blades 4 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 4 in slot in tool holder 6, 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 4 to ensure a secure fit.

WARNING Blunt tools/insufficient maintenance of the application part and broken transversal shafts can cause burns to skin and tissue! ► Only use tools or transversal shafts that are in perfect condition. ► Replace blunt tools. ► Ensure correct maintenance of the applied part, see Maintenance.

Uncoupling the tool from the transversal saw shaft ► If the transversal 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). ► Gently press the gold piece on saw blade for tool release 5 downwards and keep pressed down, see Fig. C. ► Remove the saw blade 4 from the tool holder 6.

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

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 applied part ("Off" position), see instructions for use of

ELAN 4 electro control unit GA800 (TA014401). 5

en Note The shaft release 8 does not have to be pressed when coupling the transversal saw shaft. ► Push the transversal saw shaft 7 into the shaft holder 1 all until the

stop. While doing so, hold the transversal saw shaft horizontally and ensure that the shaft release 8 is in the horizontal, folded position. ► Make sure that the plug connector 9 is properly seated in the shaft holder 1: Slightly move the transversal saw shaft 7 back and forth. ELAN 4 transversal saw shaft for saw blade 7 latches in place. ► To check for a secure coupling, pull on the transversal saw shaft 7. Uncoupling the transversal saw shaft from the application part ► Lock applied part ("Off" position), see instructions for use of

ELAN 4 electro control unit GA800 (TA014401). ► Push the shaft release button 8 downwards and pull the transversal

saw shaft 7 out of the shaft holder 1. Mounting the 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 pump of ELAN 4 electro control unit GA800, see instructions for use of ELAN 4 electro control unit GA800 TA014401. ► Remove the small and the big front retainer clip from the spray nozzle 7. ► Push the tube end directed at the area of application onto the tube connector 8 of the spray nozzle. ► Clip the spray nozzle 7 onto the black handle area of the application part and push/turn into the desired position, see Fig. E. Note The spray tube of the spray nozzle can be easily bent by hand and can be adapted to the requirements of the application (e.g. Following the contour of the housing).

6.2

Function checks

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

ing order. ► Check the secure connection of all products to be used. ► Check that the transversal saw shaft is coupled properly: 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.

6.3

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. 6

WARNING Risk of infection from aerosol formation! Risk of injuries caused by particles coming loose from the tool! ► Take appropriate protective measures, e.g. watertight protective clothing, face mask and protective goggles, suction extraction. WARNING Risk of injury and/or malfunction! ► Always carry out a function check prior to using the product. WARNING Risk of injury when using the product beyond the field of view! ► Apply the product only under visual control. WARNING Unintentionally releasing the tool/transversal saw shaft can cause injuries! ► 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. Note The recommended max. oscillation frequency for operation is 16 000 rpm. A higher oscillation frequency can cause the product to heat up more quickly and adversely affect the lifetime of the product. It is only possible to operate the applied part and change the setting parameters on the control unit if: ■ the applied part is connected to the control unit, ■ there is no second application part activated ("On" position) at the same time and ■ the applied part type 3 is shown on the display of the control unit. Note For further information, see instructions for use of ELAN 4 electro control unit GA800 (TA014401).

7.

Validated reprocessing procedure

7.1

General safety notes

Note Adhere to national statutory regulations, national and international standards and directives, and local, clinical hygiene instructions for reprocessing. Note For patients with Creutzfeldt-Jakob disease (CJD), suspected CJD, or possible variants of CJD, observe the relevant national regulations concerning the reprocessing of products. Note Mechanical reprocessing should be favored over manual cleaning as it gives better and more reliable results. Note It should be noted that successful reprocessing of this medical device can only be guaranteed following prior validation of the reprocessing method. The operator/reprocessing technician is responsible for this. Note If there is no final sterilization, then a virucidal disinfectant must be used.

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

Preparations at the place of use

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) 4 in tool holder 14 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 15 on the insert are inserted in the recesses in the bottom part. ► Lift and fold down the tool holder 14 using the two side handles 13.

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

Application Manual cleaning with part and trans- immersion disinfection versal saw shafts

► 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 ► Before the first automatic cleaning/disinfection: attach ECCOS fixation GB088R in a suitable tray (e. g. JF222R). ► Insert product in the correct position in the ECCOS fixation GB088R, see Fig G.

Tools

Reference 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 ultrasound and brush, and subsequent mechanical alkaline cleaning and thermal disinfecting

see Mechanical cleaning/disinfecting with manual pre-cleaning tools

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

GB730R in a suitable tray (e. g. JF222R). ► Fold out shaft release 8. ► Push transversal saw shaft 7 into its proper position in the ECCOS

holder GB730R and engage 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. 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 GB698R at least 3 times for 5 seconds with a water gun. Phase II ► Using a disposable syringe, fill the inside of the applied part with clean-

ing solution through the rinsing adapter GB698R. ► Immerse the application part with the connected rinsing adapter 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 GB698R 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 GB698R 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 GB698R. ► Immerse the application part with the connected rinsing adapter and transversal saw shafts at least 5 min in disinfecting solution. Phase V ► 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 cleaning. ► Rinse the applied part through the rinsing adapter GB698R at least

3 times for 5 seconds with a water gun.

8

Phase VI ► Use suitable equipment (e.g. cloth, compressed air) to dry the application part and the transversal 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/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.

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 connector for motor cable 2 with ELAN 4 electro rinsing

device GB692R. ► 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 7 in the ECCOS holder GB730R, see

Fig. H. ► Connect the connector for motor cable 2 with ELAN 4 electro flushing

device GB692R. ► Place the rinsing device in 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 the rinsing system and the 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 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, QUATfree, 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 10

en ► 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 surfactant

■ Working solution 0.5 % – pH ~ 11* III

Intermediate rinse

>10/50

1

FD–W

–

IV

Thermal disinfection

90/194

5

FD–W

–

V

Drying

max. 120/248

min. 10

–

–

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

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

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

and repeat the cleaning/disinfection process as required.

7.10 Inspection, maintenance and checks ► Allow the product to cool down to room temperature. ► Connect ELAN 4 electro oil spray adapter GB600860 12 (gray) to con-

nector for motor cable 2 and spray through the applied part for approx. 2 seconds with 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.

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). ► Insert applied part in correct position in ECCOS fixation GB088R,

see Fig. G. ► Place the transversal saw shafts 7 in the correct position in the ECCOS

holder GB730R, see Fig. H.

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.

► Fold out shaft release 8. ► 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 prod-

uct.

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.

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.

Designation

7.13 Storage

GA258SU

ELAN 4 disposable spray nozzle for saws

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

GA395SU

ELAN 4 electro disposable tube set

GB088R

ELAN 4 electro ECCOS holder for saws GA831/GA833

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

GB720R

ECCOS universal holder for saw blades

GB730R

ECCOS fixation for transversal saw shafts

TA012787

Instructions for use tools for Aesculap motor systems.

TA014426

Instructions for use for ELAN 4 electro transversal saw GA833 (A4 for folder)

TA014427

Instructions for use for ELAN 4 electro transversal saw GA833 (leaflet)

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 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

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

12

11.1 ELAN 4 shafts for transversal saw blade Art. no.

Designation

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

en 12. Technical data

12.5 Ambient conditions

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

Application part

Art. no.

Designation

Class

GA833

ELAN 4 electro transversal saw

GP580R

Operation

Transport and storage

Temperature

10 °C to 27 °C

-10 °C to 50 °C

IIa

Relative humidity

30 % to 75 %

10 % to 90 %

ELAN 4 shaft for saw blade S transversal 65 mm

IIa

Atmospheric pressure

700 hPa to 1 060 hPa

500 hPa to 1 060 hPa

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

12.2 Performance data, information about standards Max. power

approx. 180 W

Max. oscillation frequency

20 000 rpm

Weight

185 g ±10 %

Dimensions (∅ x L)

23 mm x 130 mm ±5 %

Applied part

Type BF

EMC

IEC/EN 60601-1-2

Compliance with standards

IEC/DIN EN 60601-1

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

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

Tool connection

Saw blade transversal S/M/L

Shaft connection

ELAN 4 transversal

WARNING Risk of infection from contaminated products! ► Observe national regulations when disposing of or recycling the product, its components, and their packaging. WARNING Risk of injury from sharp and/or pointed products! ► When disposing of or recycling the product, make sure the packaging prevents injuries from the product. Note The operator must process the product before disposal, see Validated reprocessing procedure. The recycling passport can be downloaded from the extranet as a PDF document for on the individual part number. (The recycling passport contains instructions on how to disassemble the device, including information on the proper disposal of environmentally harmful components.) Any product labeled with this symbol must be disposed of separately together with electrical and electronic equipment. Within the European Union, the manufacturer will perform the disposal free of charge. ► In case of questions regarding the disposal of the product, contact your

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

12.4 Short-time intermittent operation Saw operation with transversal saw shaft GP580R, GP582R, GP586R at 16 000 rpm: ■ 120 second application, 30 second pause ■ 5 repetitions ■ 30 min cooling time ■ Max. Temperature 48 °C Saw operation with transversal saw shaft GP590R at 16 000 rpm: ■ 60 second application, 60 second pause ■ 4 repetitions ■ 30 min cooling time ■ Max. Temperature 48 °C

13