ELAN 4 electro motor cable with hand lever GA804, ELAN 4 electro motorcable with hand control GA805, ELAN 4 electro Motor cable for footcontrol GA806

1

2 3

GA806

4

5 6

GA805 GA804

7

8

9

GA804

GA806

B

A GA805

C

D

en

Aesculap® ELAN 4 electro motor cable with hand lever GA804, ELAN 4 electro motor cable with hand control GA805, ELAN 4 electro Motor cable for foot control GA806 Legend 1 2 3 4 5 6 7 8 9

CE mark according to Regulation (EU) 2017/745

Socket for applied part Visual field “Off” at release button Visual field “On” at release button Connector for motor cable Release button Lug Hand lever (lever) Hand control (slide) Finger support

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 Two-dimensional machine readable 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 order 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

2

Medical device

Contents 1. 1.1 1.2 2. 2.1 2.2 2.3 2.4 2.5 3. 4. 4.1 4.2 4.3 5. 6. 6.1 6.2 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 13.

About this document... Scope... Warnings... General information... Intended use... 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... Functional test... Validated reprocessing procedure... General safety notes... General information... Reusable products... Preparations at the place of use... Preparation before cleaning... Cleaning/disinfection... Manual cleaning and wipe 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 . . Basic data, information about standards... Ambient conditions... Disposal...

3 3 3 3 3 3 3 3 3 3 4 4 4 4 4 4 5 5 5 5 5 5 5 5 6 6 7 8 8 8 8 8 8 8 8 8 8 9 9 9

en 1.

About this document

1.1

Scope

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

Name

GA804

ELAN 4 electro motor cable with hand lever

GA805

ELAN 4 electro motor cable for hand control

GA806

ELAN 4 electro motor cable for foot control

► 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.

2.

General information

2.1

Intended use

GA804/GA805 The ELAN 4 electro motor cable with hand switch GA804 and the ELAN 4 electro motor cable with hand control GA805 are accessories of the ELAN 4 electro motor system. They are used to connect the ELAN 4 electro applied parts to the control unit, provided they do not have a fixed cable. The control element on the motor connector is used to alter the speed of the applied part. GA806 The ELAN 4 electro motor cable for foot control GA806 is an accessory of the ELAN 4 electro motor system. It is used to connect the ELAN 4 electro applied parts to the control unit, provided they do not have a fixed cable. The use of this motor cable requires the usage of an ELAN 4 electro foot control.

2.2

Application Environment

Application in the sterile and unsterile area Sterile separation is carried out at the control unit.

2.3

Indications

The type and area of application depend on the applied parts and tools selected.

2.4

Absolute contraindications

2.5

Relative contraindications

The safe and effective use of the products greatly depends on influences which can only be controlled by the user. The user has to decide himself which combination of applied part and motor cable is most useful for him. 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. The ELAN 4 electro motor cable with hand switch GA804 and the ELAN 4 electro motor cable with hand control GA805 are not suitable for tapping and screwing in/unscrewing screws, as there is no option for changing the direction of rotation.

3.

Safe handling

DANGER 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. ► 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. ► Sterilize applied parts and motor cable before use. ► When using the Aesculap holder systems observe the relevant instructions for use TA009721, see B. Braun eIFU at 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.

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

3

en 4.

Product description

4.1

Scope of supply

Art. no.

Name

GA804

ELAN 4 electro motor cable with hand lever –or–

GA805

ELAN 4 electro motor cable with hand control –or–

GA806

ELAN 4 electro motor cable for foot control

GB600860

ELAN 4 electro oil spray adapter

TA014407

Instructions for use for ELAN 4 electro motor cable GA806 (leaflet)

4.2

Components required for operation

■ ELAN 4 electro control unit GA800, see TA014401 ■ ELAN 4 electro foot control GA808/GA810 (only in conjunction with GA806)

■ ELAN 4 electro applied part ■ Tool Note The operation of the ELAN 4 electro motor cable with manual control GA804/GA805) on the ELAN 4 electro control unit GA800 is only possible with software versions from 2.00. The installed software version is displayed in the system settings menu of the control unit in the sub-point device information. For further information, see instructions for use of ELAN 4 electro control unit GA800 (TA014401). To update the control unit to the current software version, contact the national B. Braun/Aesculapcustomer service center, see Technical Service.

4.3

Operating principle

The motor cables GA804, GA805 or GA806 can optionally be connected to both motor connection sockets on the ELAN 4 electro control unit. The motor cables are connected and disconnected to/from the applied part in two steps. The current position is indicated by a gold marking in one of the two visual fields 2/3 on the motor cable. Note For applied parts having slides for releasing the tool, the socket for the applied part at the motor cable blocks the slide in the 'on' position. The tools can therefore only be uncoupled in the 'off' position. For applied parts having releasing sleeves, the socket for the applied part at the motor cable blocks the releasing sleeve in the 'on' position. As a result, the attachments or shafts can only be uncoupled in the 'off' position. For applied parts not having slides for releasing tools it is possible to couple/decouple tools in the 'on' position, but due to the risk of injury arising from the applied part being activated accidentally, this may not be done. ELAN 4 electro motor cable with hand lever GA804 The motor cable having the hand lever GA804 has an integrated control element in the form of a lever 7. The lever can be raised for better access when coupling and when switching from the 'on' to the 'off' position or vice versa. The speed of a coupled and activated ELAN 4 electro applied part can be controlled by actuating the control element. The ELAN 4 electro motor cable with hand lever is preferably intended for so-called two-hand operation. During application, one hand is used to hold the ELAN 4 and the other hand is used to hold the lever for speed control.

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The direction of rotation cannot be altered using the ELAN 4 electric motor cable with hand lever. The direction of rotation for the ELAN 4 electro applied part can only be adjusted at the ELAN 4 electro Control unit. ELAN 4 electro motor cable with hand control GA805 The motor cable with hand control GA805 has an integrated control element in the form of a slider 8 having a finger rest 9. The speed of a coupled and activated ELAN 4 electro applied part can be controlled by actuating the control element. The ELAN 4 electro motor cable with hand control is preferably provided for the so-called one-hand operation of the ELAN 4 electro applied parts that are held like a pen. When using the ELAN 4 electro applied part, one finger is placed on the finger rest and pressed against the shaft. The speed is controlled by moving the finger rest along the surface of the applied part towards the cable. The direction of rotation cannot be altered using the ELAN 4 electric motor cable with hand control. The direction of rotation for the ELAN 4 electro applied part can only be adjusted at 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.

6.

Working with the product

WARNING Risk of infection and contamination! Applied parts and motor cables are supplied in an unsterile condition! ► Sterilize applied 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). WARNING Damage to the product if dropped! ► Use the products only if they are in perfect technical condition, see Function check WARNING Damage to the product due to incorrect handling! ► Do not kink, jam, crush, or pull on the motor cable, and do not damage it using sharp objects. WARNING Risk of injury and/or malfunction! ► Perform functional tests before every use.

en Note The motor cables with hand control/hand lever are fitted with a magnetic sensor system as sensor signal. To prevent an inadvertent activation of the applied part in the On position, the motor cables must not be exposed to any magnetic fields (e.g. magnetic instrument pads). If the applied part is in the Off position, it is in a safe state and inadvertent activation is avoided.

6.1

System set-up

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.

6.2

Functional test

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

ing order. ► Check the secure connection of all devices to be used. ► Operate applied part for a short time at its maximum permissible rota-

tional speed. ► Do not use a damaged or defective product. Immediately set aside any

damaged products!

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.

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

► 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 the ECCOS holder GB073R and ECCOS holder GB072R in a suitable screen basket (e.g. JF222R). ► Place the product in the correct position in the ECCOS holder GB073R, see Fig. A to Fig. D and arrange the cable around the ECCOS holders GB072R.

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.

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en 7.6

Cleaning/disinfection ► Do not exceed the maximum temperature of 60 °C during chemical

Product-specific safety instructions for the reprocessing procedure

cleaning and/or disinfection.

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 maximum temperature of 96°C during thermal dis-

infection 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.

7.7

Manual cleaning and wipe disinfection

Phase

Step

T [°C/°F]

t [min]

Conc. [%]

Water quality

Chemicals

I

Cleaning

RT (cold)

-

-

D–W

-

II

Drying

RT

-

-

-

-

III

Wipe disinfection

-

>1

-

-

Meliseptol HBV wipes 50 % Propan-1-ol

IV

Final rinse

RT (cold)

0.5

-

FD–W

-

V

Drying

RT

-

-

-

-

D–W: FD–W: RT:

Drinking water Fully desalinated water (demineralized, low microbiological contamination: drinking water quality at least) Room temperature

► Do not clean the product in a ultrasonic bath and do not immerse the

product in any fluids. To avoid the risk of corrosion/malfunctioning, allow any fluid that has entered the product to drain out immediately. Phase I ► Clean the product under running faucet water, using a suitable clean-

ing brush until all visible residues have been removed from the surfaces. ► Move non-rigid components (such as unlocking buttons, levers, sliders) during cleaning. Phase II ► Dry the product in the drying phase with suitable equipment (e.g. cloth,

compressed air), . Phase III ► Wipe all surfaces of the product with a single-use disinfecting wipe.

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Phase IV ► After the specified exposure time (at least 1 min), rinse the disinfected surfaces under running FD water. ► Drain any remaining water fully. Phase V ► 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.

en 7.8

Mechanical cleaning/disinfection with manual pre-cleaning

Note The cleaning and disinfection device 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 device 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)

1

–

D–W

–

D–W: RT:

Drinking water Room temperature

► Do not clean the product in a ultrasonic bath and do not immerse the

product in any fluids. To avoid the risk of corrosion/malfunctioning, allow any fluid that has entered the product to drain out immediately. Phase I

Phase II ► Rinse the entire product (all accessible surfaces) under running water. ► Move non-rigid components (such as unlocking buttons, levers, sliders) during cleaning.

► If necessary, clean the product with a suitable cleaning brush until all

discernible residues have been removed. ► Move non-rigid components (such as unlocking buttons, levers, sliders) during cleaning.

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

Step

T [°C/°F]

t [min]

Water quality

Chemicals

I

Pre-rinse

<25/77

3

D–W

-

II

Cleaning

55/131

10

FD–W

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

■ 0.5 % working solution – pH ~ 11* III

Intermediate rinse

>10/50

1

FD–W

-

IV

Thermal disinfection

90/194

5

FD–W

-

V

Drying

max. 120/248

min. 10

-

–

D–W: Drinking water FD–W: Fully desalinated water (demineralized, low microbiological contamination: drinking water quality at least) *Recommended: BBraun Helimatic Cleaner alkaline

► Place the product in the correct position in the ECCOS holder GB073R

and arrange the cable around the ECCOS holders GB072R. ► After machine cleaning/disinfection, check visible surfaces for residue

and repeat the cleaning/disinfection process as required.

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en 7.9

Inspection, maintenance and checks

10. Technical Service

► Allow the product to cool down to room temperature.

Note Aesculap additionally recommends the occasional spraying of moving parts (such as knobs, couplings) with the Aesculap STERILIT Power Systems oil spray.

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.

► Inspect the product after each cleaning and disinfecting cycle to be

sure it is: clean, functional, and undamaged. ► Set aside the product if it is damaged.

7.10 Packaging ► Follow the instructions for use of the packagings 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 GB073R,

see Fig. A to Fig. D and arrange the cable around the ECCOS holders GB072R. ► Pack trays appropriately for the sterilization process (e.g. in Aesculap sterile containers). ► Ensure that the packaging will prevent a recontamination of the product.

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

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.

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.

11. Accessories/Spare parts Art. no.

Name

GB072R

ECCOS winding aid for cables and hoses

GB073R

ELAN 4 electro ECCOS holder for motor cable GA804/GA805/GA806

GB600

STERILIT Power Systems oil spray

TA014406

Instructions for use ELAN 4 electro motor cable GA804/GA805/GA806 (A4 for folder)

TA014407

Instructions for use for ELAN 4 electro motor cable GA804/GA805/GA806 (leaflet)

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

a dry, dark, temperature-controlled area.

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.

9.

Troubleshooting

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

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

Designation

Class

GA804

ELAN 4 electro motor cable with hand lever

I

GA805

ELAN 4 electro motor cable with hand control

I

GA806

ELAN 4 electro motor cable for foot control

I

en 12.2 Basic data, information about standards Weight: GA804 GA805 GA806

374 g ±10 % 369 g ±10 % 270 g ± 10 %

Dimensions (L)

4m±5%

Applied part

Type BF

EMC

IEC/DIN EN 60601-1-2

Conforming to standard

IEC/DIN EN 60601-1

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

12.3 Ambient conditions Operation

Transport and storage

Temperature

10 °C to 27 °C

-10 °C to 50 °C

Relative humidity

30 % to 75 %

10 % to 90 %

Atmospheric pressure

700 hPa to 1 060 hPa

500 hPa to 1 060 hPa

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

9