ELAN 4 electro perforator driver GA822

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2

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Hudson

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B

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Aesculap® ELAN 4 electro perforator driver GA822 Legend 1 2 3 4 5 6

Medical device

HUDSON tool coupling Pull back unlocking sleeve Connector for motor cable HUDSON tool shaft Symbol of the applied part type in display of ELAN 4 electro control unit Oil spray adapter GB600860

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

YYYY-MM

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

Date of manufacture

Non-sterile medical device

Manufacturer batch ID 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 EAC symbol of the Eurasian Economic Union

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Contents 1. 1.1 1.2 2. 2.1 2.2 2.3 2.4 2.5 2.6 3. 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 8. 9. 10. 11. 12. 12.1 12.2 12.3 12.4 12.5 13.

About this document... Scope... Warnings... General information... Intended use... Performance characteristics... Application Environment... Indications... Absolute contraindications... Relative contraindications... Safe handling... 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... Mechanical cleaning/disinfection with manual pre-cleaning . . Inspection, maintenance and checks... Packaging... Steam sterilization... Storage... Maintenance and repair... Troubleshooting... Technical Service... Accessories/Spare parts... Technical data... Classification in accordance with Regulation (EC) 2017/745 . . Performance data, information about standards... Tool speed/Setting... Short interval operation... Ambient conditions... Disposal...

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en 1.

About this document

2.4

1.1

Scope

Modes of application Cranial trepanation

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

Name

GA822

ELAN 4 electro perforator driver

► 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.

Indications

Surgical discipline/areas of application Neurosurgery Note The operator shall be responsible for the compatibility and proper, safe use of the tools used with this application part.

2.5

Absolute contraindications

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

2.6

Relative contraindications

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

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

3.

2.

General information

2.1

Intended use

WARNING Risk of injury and material damage if this product is not used as intended! ► Use the product only as intended.

The ELAN 4 electro perforator driver GA822 is an accessory of the ELAN 4 electro motor system. The perforator driver is connected by an ELAN 4 electro motor cable to the control unit. The perforator driver is used to drive cranial perforators with HUDSON connection.

2.2

Performance characteristics

Speed min. 0 rpm to max. 1 200 rpm Direction of rotation Right and left rotation Short-time intermittent operation ■ 1 min application, 3 min rest ■ 3 repetitions ■ 30 min cooling time ■ Max. temperature 48 °C Electrical systems generally heat up during continual operation. It is advisable to give the system a break after use to cool down, as indicated below. Heating depends on the tool used and the load. After a certain number of repetitions, the system should be allowed to cool down. This procedure prevents the system from overheating and protects the patient or users against possible injury. The user shall be responsible for the implementation and adherence to the interval sequence described.

2.3

Application Environment

Application in the sterile area

Safe handling

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 to not compromise the manufacturer warranty and liability: – Use product only in accordance with these instructions for use. – Observe safety information and maintenance instructions. ► Ensure that the product and its accessories are operated and used only by persons with the requisite training, knowledge, or experience. ► Keep the instructions for use accessible for the user. ► Always adhere to applicable standards. ► Ensure that the electrical installations at the premises where the device is to be used meet all requirements acc. to IEC/DIN EN. ► Do not use the control unit and applied part in potentially explosive areas.

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en ► Sterilize application parts and motor cable before use. ► Observe the relevant instructions for use Aesculap when handling the

TA009721 holder systems, see B. Braun eIFU under eifu.bbraun.com ► Operate the applied parts and tools only at the recommended speeds.

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.

Product description

4.1

Scope of supply

Art. no.

Name

GA822

ELAN 4 electro perforator driver

TA014419

Instructions for use for ELAN 4 electro perforator driver GA822 (leaflet)

4.2

Operating principle

The ELAN 4 electro perforator driver can be used to drive trepanning instruments. The tools are coupled/uncoupled without a key (HUDSON coupling). The perforator driver is used with the ELAN 4 electro foot control or manual control. The rotating speed is continuously variable by means of the foot/manual control. The recommended speed for trepanning using Aesculap tools is 1 200 rpm. If tools from other manufacturers are used, the manufacturer's instructions for use must be followed and, if applicable, the tools must be adjusted to the ELAN 4 electro control unit.

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.

4

Working with the product

WARNING Malfunction can cause injuries! ► Keep alternative treatment method or replacement system available. WARNING Risk of infection and contamination! Application parts and motor cables are delivered non-sterile! ► Sterilize application parts and motor cables prior to use in accordance with the instructions for use. WARNING Risk of injury and material damage due to inadvertent activation of the application part! ► Secure applied parts that are not actually used against inadvertent activation ("Off" position), see instructions for use for ELAN 4 electro control unit GA800 (TA014401).

Components required for operation

■ Operation-ready ELAN 4 electro control unit GA800, see TA014401 ■ Cranial perforator with HUDSON connector 4.3

6.

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. WARNING Risk of burns to skin and tissue due to blunt tools/ lack of maintenance of the applied part! ► Use tools only if they 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

en 6.1

System set-up

WARNING Risk of injury when coupling/uncoupling tools in the "On" position due to accidental activation of the applied part! ► Only couple/uncouple tools in the "Off" position. WARNING Risk of injury due to small parts that could enter the surgical field! ► Do not couple/uncouple tools over the operation site. 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. The combination of accessories used must not adversely affect performance and safety requirements. ► Observe the instructions for use of individual accessories. ► In case of questions please contact your B. Braun/Aesculap Partner or the Aesculap Technical Service, Address see Technical Service. Coupling the tool to the applied part ► Lock applied part ("Off" position), see instructions for use of

ELAN 4 electro control unit GA800 (TA014401). ► Pull back unlocking sleeve 2 on the applied part and push tool shaft 4

in the correct position as far as it will go into the tool coupling 1. ► Release unlocking sleeve 2. ► Pull at tool shaft 4 to check that it is securely coupled.

Uncoupling the tool from the applied part ► Lock applied part ("Off" position), see instructions for use of

ELAN 4 electro control unit GA800 (TA014401). ► Pull back unlocking sleeve 2 on the applied part and remove tool by the

tool shaft 4 from the tool coupling 1.

6.2

6.3

Safe operation

DANGER Improper use can result in injury to the dura mater and brain tissues! ► Apply special care when using perforator drivers. ► Make certain that the user is familiar with the skull trepan and its mode of operation. ► Only use sharp tools. WARNING Coagulation of patient tissue or risk of burns for patients and users from hot applied part/tool! ► Cool the tool during use. ► Put down the applied part/tool beyond reach of the patient. ► Let the application part/tool cool down. ► Use a cloth to protect against burns when changing the tool. WARNING Risk of infection from aerosol formation! Risk of injuries caused by particles peeling off the tool! ► Take appropriate protective measures, e.g. watertight protective clothing, face mask and protective goggles, extraction system. WARNING Risk of injury and/or malfunction! ► Perform functional tests before every use. 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 applied part released ("On" position) at the same time and ■ the applied part type 5 is shown in the display of the control unit. Note For further information, see instructions for use of ELAN 4 electro control unit GA800 (TA014401).

Function checks

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

ing order. ► Check the secure connection of all products to be used. ► Check that the tool is coupled properly. To do this, pull on the tool. ► Check that the cutting edges of the tools are not showing any mechan-

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

uct if it is damaged.

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en 7.

Validated reprocessing procedure

7.1

General safety notes

Note Adhere to national statutory regulations, national and international standards and directives, and local, clinical hygiene instructions for reprocessing. Note For patients with Creutzfeldt-Jakob disease (CJD), suspected CJD, or possible variants of CJD, observe the relevant national regulations concerning the reprocessing of products. Note Mechanical reprocessing should be favored over manual cleaning as it gives better and more reliable results. Note It should be noted that successful reprocessing of this medical device can only be guaranteed following prior validation of the reprocessing method. The operator/reprocessing technician is responsible for this. Note If there is no final sterilization, then a virucidal disinfectant must be used. Note See also B. Braun eIFUs at eifu.bbraun.com for up-to-date information on processing and material compatibility The validated steam sterilization procedure was carried out in the Aesculap sterile container system.

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".

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7.3

Reusable products

The service life of the product is limited by damage, normal wear, type and duration of the application, handling, storage and transportation of the product. Careful visual and functional testing prior to next use is the best way to identify a malfunctioning product.

7.4

Preparations at the place of use

► Separate the products from each other immediately after use. ► Remove any visible surgical residues as much as possible with a damp,

lint-free cloth. ► Place the dry product in a sealed waste container and forward it on for

cleaning and disinfection within 6 hours.

7.5

Preparation before cleaning

► Prior to first mechanical cleaning/disinfection: Install ECCOS holder

GB076R in a suitable tray (e.g. JF222R). ► Place the product in the correct position in the ECCOS holder GB076R,

see Fig. A.

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.

en 7.7

Manual cleaning with immersion disinfection

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 product under running water, using a suitable cleaning brush

Phase VI ► Dry the product in the drying phase with suitable equipment (e.g. cloth, compressed air). ► After manual cleaning/disinfection, check visible surfaces for residue and repeat the cleaning/disinfection process as required.

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. ► Place the applied part, with rinsing adapter connected, fully in enzy-

matic cleaning solution for 5 minutes. Phase III ► Rinse the entire product (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 GB698R at least

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

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

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

3 times for 5 seconds with a water gun.

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en 7.8

Mechanical cleaning/disinfection with manual pre-cleaning

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

Brushes

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 product with a suitable cleaning brush until all discernible

residues have been removed. ► Mobilize non-rigid components, such as release button, unlocking

sleeve, etc. during cleaning. Phase II ► Connect the connector for motor cable 3 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

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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

► Connect the connector for motor cable 3 with ELAN 4 electro rinsing

7.11 Steam sterilization

device GB692R. ► 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, 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.

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

7.9

Inspection, maintenance and checks

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.

► Allow the product to cool down to room temperature. ► Connect the ELAN 4 electro oil spray adapter GB600860 6 (gray) to the

connector for the motor cable 3 and use the STERILIT Power Systems oil spray GB600 to spray through the application part for approx. 2 s, see Fig. B.

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

a dry, dark, temperature-controlled area.

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.

7.10 Packaging ► Observe the instructions for use of the packaging and holders used (e.g.

instructions for use TA009721 for Aesculap ECCOS holder system). ► Place the product in the correct position in the ECCOS holder GB076R,

see Fig. A. ► Pack trays appropriately for the sterilization process (e.g. in Aesculap

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

uct.

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en 8.

Maintenance and repair

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.

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

Name

Class

GA822

ELAN 4 electro perforator driver

IIa

12.2 Performance data, information about standards

9.

Troubleshooting

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

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.

Max. power

approx. 180 W

Max. torque

approx. 2.5 Nm

Max. motor speed

1 200 rpm

Weight

410 g ±10 %

Dimensions (∅ x L)

35 mm x 166 mm ±5 %

Application part

Type BF

EMC

IEC/DIN EN 60601-1-2

Compliance with standards

IEC/EN 60601-1

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

12.3 Tool speed/Setting Adjustable direction of motor rotation

Clockwise/counterclockwise

Adjustable maximum speed setting

100 rpm to 1 200 rpm

Step width for maximum speed setting

100 rpm

Default factory setting of upper speed range limit

1 200 rpm , clockwise

Reduction gear

33.2: 1

Tool connection

HUDSON

12.4 Short interval operation

11. Accessories/Spare parts Art. no.

Name

GB076R

ELAN 4 electro ECCOS holder for perforator driver GA822

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

TA014418

Instructions for use for ELAN 4 electro perforator driver GA822 (A4 for folder)

TA014419

10

Instructions for use for ELAN 4 electro perforator driver GA822 (leaflet)

■ 1 min application, 3 min rest ■ 3 repetitions ■ 30 min cooling time ■ Max. temperature 48 °C

12.5 Ambient conditions Application part Operation

Transport and storage

Temperature

10 °C to 27 °C

-10 °C to 50 °C

Relative humidity

30 % to 75 %

10 % to 90 %

Atmospheric pressure

700 hPa to 1 060 hPa

500 hPa to 1 060 hPa

en 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 user institution is obliged to process the product before its 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. ► Detailed information concerning the disposal of the product is avail-

able through your national B. Braun/Aesculap agency, see Technical Service.

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