BBraun
ELAN 4 air foor control GA708, ELAN 4 air wall hose GA702R GA703R,ELAN 4 air wall adapter GA710R to GA715R
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Aesculap®
Aesculap Power Systems
en
USA
Instructions for use/Technical description ELAN 4 air foor control GA708, ELAN 4 air wall hose GA702R/GA703R, ELAN 4 air wall adapter GA710R to GA715R Note for U.S. users This Instructions for Use is NOT intended for United States users. Please discard. The Instructions for Use for United States users can be obtained by visiting our website at www.aesculapusa.com. If you wish to obtain a paper copy of the Instructions for Use, you may request one by contacting your local Aesculap representative or Aesculap's customer service at 1800-282-9000. A paper copy will be provided to you upon request at no additional cost.
de
Gebrauchsanweisung/Technische Beschreibung ELAN 4 air Fußsteuerung GA708, ELAN 4 air Wandschläuche GA702R/GA703R, ELAN 4 air Wandadapter GA710R bis GA715R
fr
Mode d’emploi/Description technique Commande au pied ELAN 4 air GA708, ELAN 4 air tuyaux muraux GA702R/GA703R, ELAN 4 air adaptateur mural GA710R à GA715R
es
Instrucciones de manejo/Descripción técnica Mando de pedal ELAN 4 air GA708, tubos de pared ELAN 4 air GA702R/GA703R, ELAN 4 air adaptadores de pared GA710R a GA715R
it
Istruzioni per l’uso/Descrizione tecnica Comando a pedale ELAN 4 air GA708, tubi a parete ELAN 4 air GA702R/GA703R, connettori a parete da ELAN 4 air GA710R a GA715R
pt
Instruções de utilização/Descrição técnica Comando a pedal ELAN 4 air GA708, tubos de parede ELAN 4 air GA702R/GA703R, adaptador de parede ELAN 4 air GA710R até GA715R
nl
Gebruiksaanwijzing/Technische beschrijving ELAN 4 air voetbediening GA708, ELAN 4 air wandslangen GA702R/GA703R, ELAN 4 air wandadapter GA710R tot GA715R
sv
Bruksanvisning/Teknisk beskrivning ELAN 4 air fotstyrning GA708, ELAN 4 air väggslangar GA702R/GA703R, ELAN 4 air väggadapter GA710R till GA715R
ru
Инструкция по примению/Техническое описание Блок ножного управления ELAN 4 air GA708, ELAN 4 ai rшланги к воздушной розетке GA702R/GA703R, ELAN 4 air переходники к воздушной розетке GA710R – GA715R
cs
Návod k použití/Technický popis Nožní ovládání ELAN 4 air GA708, vzduchová hadice ELAN 4 air GA702R/GA703R, nástěnný adaptér ELAN 4 air GA710R až GA715R
pl
Instrukcja użytkowania/Opis techniczny Sterownik nożny ELAN 4 air GA708, węże ścienne ELAN 4 air GA702R/GA703R, adapter ścienny ELAN 4 air GA710R do GA715R
sk
Návod na použitie/Technický opis Nožné ovládanie ELAN 4 air GA708, nástenné hadice ELAN 4 air GA702R/GA703R, nástenné adaptéry ELAN 4 air GA710R až GA715R
tr
Kullanım Kılavuzu/Teknik açiklama ELAN 4 air ayak kumandası GA708, ELAN 4 air duvar hortumları GA702R/GA703R, ELAN 4 air duvar adaptörü GA710R ila GA715R
4 1
5
GA708
5 3
6
2 GA705R
8
GA702R/GA703R 9
7 11
11
11 10
GA712R
GA710R
10
10
GA715R
GA713R 10
12 6
17
A
16
11
15
14 13
en
Aesculap® ELAN 4 air foor control GA708, ELAN 4 air wall hose GA702R/GA703R, ELAN 4 air wall adapter GA710R to GA715R Legend ELAN 4 air foot control GA708 1 Pedal 2 Connection for wall hose 3 Connection for motor hose 4 Bracket 5 Adapter for bracket ELAN 4 air motor hose for foot control GA705R 6 Connection for applied part 7 Connection for foot control ELAN 4 air wall hose GA702R/GA703R 8 Connection for wall adapter 9 Connection for foot control ELAN 4 air wall adapter GA710R/GA712R/GA713R/GA715R 10 Connection for compressed-air source 11 Connection for wall hose Coupling ELAN 4 air applied part with ELAN 4 air motor hose for foot control GA705R 12 Connection for motor hose of applied part 13 Field of vision “On“ 14 Field of vision “Off“ 15 Release button 16 Nib on motor hose 17 Groove on connection for motor hose
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 CE mark according to Regulation (EU) 2017/745
Medical device
2
en 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. 5.1 5.2 5.3 5.4 6. 6.1 6.2 6.3 7. 7.1 7.2 7.3 7.4 7.5 7.6 7.7 8. 8.1 8.2 9. 10. 11. 12. 12.1 12.2 12.3 12.4 12.5 12.6 12.7 12.8 12.9 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... Compressed air supply/compressed air hoses... Operation with central gas supply according to DIN EN ISO 5359... Operation with compressed-gas cylinders according to DIN EN ISO 11117... First use of foot control... Working with the product... System set-up... Function checks... Safe operation... Processing procedure... General safety notes... General information... Reusable products... Preparations at the place of use... Cleaning/disinfection... Wipe disinfection... Inspection, maintenance and checks... Maintenance... ELAN 4 air foot control, ELAN 4 air wall adapter... ELAN 4 air wall hose... Troubleshooting list... Technical Service... Accessories/Spare parts... Technical data... Classification in accordance with Regulation (EC) 2017/745. . ELAN 4 air foot control GA708... ELAN 4 air wall hose 3m GA702R... ELAN 4 air wall hose 5m GA703R... ELAN 4 air wall adapter Aesculap-Dräger GA710R... ELAN 4 air wall adapter Schrader with diffuser GA712R... ELAN 4 air wall adapter DIN with diffuser GA713R... ELAN 4 air wall adapter Synthes GA715R... Ambient conditions... Disposal...
3 3 3 3 3 3 3 3 4 4 4 4 4 4 5 5 5 5 5 5 5 6 6 6 6 7 7 7 7 7 7 7 7 7 8 10 10 10 10 10 10 10 10 10 10 10 11 11
1.
About this document
1.1
Scope
These instructions for use apply to the products listed below: Art. no.
Designation
GA708
ELAN 4 air foot control
GA702R
ELAN 4 air wall hose, 3m
GA703R
ELAN 4 air wall hose, 5m
GA710R
ELAN 4 air Wall adapter Aesculap Dräger
GA712R
ELAN 4 air wall adapter Schrader with diffuser
GA713R
ELAN 4 air wall adapter DIN with diffuser
GA715R
ELAN 4 air wall adapter Synthes
► 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
The ELAN 4 air foot control GA708, the ELAN 4 air wall hoses GA702R and GA703R, ELAN 4 air wall adapters GA710R, GA712R, GA713R and GA715R are accessories of the ELAN 4 air motor system. The foot control is used by the user to control the motor speed of the connected ELAN 4 air applied part, provided that a hand control is not being used. The ELAN 4 air wall hose connects the ELAN 4 air foot control to the ELAN 4 air wall adapters. The ELAN 4 air wall adapters connect the ELAN 4 air wall hose to the compressed air supply unit.
2.2
Application Environment
The product is used in non-sterile areas. Location of foot control: On the floor
2.3
Indications
The type and area of application depend on the applied parts and tools selected.
2.4
Absolute contraindications
The product is not licensed for use on the central nervous system or central circulatory system.
3
en 2.5
Relative contraindications
The safe and effective use of the products greatly depends on influences which can only be controlled by the user. Therefore the specifications provided represent framework conditions only. The clinically successful use of the product is dependent on the knowledge and experience of the surgeon. The surgeon must decide on which bodily structures to use the product and take into account the safety and warning information contained in these instructions for use.
3.
Product description
4.1
Scope of supply
ELAN 4 air foot control Art. no.
Name
GA708
ELAN 4 air foot control
TA014450
Instructions for use for ELAN 4 air foot control GA708, ELAN 4 air wall hoses GA702R/GA703R, ELAN 4 air wall adapters GA710R to GA715R
TA014782
Supplement ELAN 4 air motor system
Safe handling
DANGER Danger of fire and explosion when operating devices that run on oxygen! ► Never operate the pneumatic motor with oxygen! ► Only use compressed air or nitrogen to power pneumatic motors. WARNING Risk of injury and material damage if this product is not used as intended! ► Use the product only for its intended purpose. WARNING Risk of injury and damage to property due to improper handling of the product! This product is part of the ELAN 4 air motor system. ► Follow the 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. ► Clean the new product after removing its transport packaging. ► 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. ► Use the product within the specified pressure range only. Note The user agrees to report all serious incidents occurring in connection with the product to the manufacturer and to the competent authority of the country in which the user is registered.
4
4.
ELAN 4 air wall hose Art. no.
Name
GA702R
ELAN 4 air wall hose, 3 m – or– ELAN 4 air wall hose, 5m
GA703R TA014454
Instructions for use for ELAN 4 air foot control GA708, ELAN 4 air wall hoses GA702R/GA703R, ELAN 4 air wall adapters GA710R to GA715R (leaflet)
ELAN 4 air wall adapter Art. no.
Name
GA710R GA712R GA713R GA715R
One of the following wall adapters: ELAN 4 air wall adapter Aesculap Dräger ELAN 4 air wall adapter Schrader with diffuser ELAN 4 air wall adapter DIN with diffuser ELAN 4 air wall adapter Synthes
4.2
Components required for operation
4.3
Operating principle
■ ELAN 4 air wall adapter GA710R, GA712R, GA713R or GA715R ■ ELAN 4 air wall hose GA702R or GA703R ■ ELAN 4 air foot control GA708 ■ ELAN 4 air motor hose GA705R ■ ELAN 4 air applied part ■ Tool ELAN 4 air foot control By activating the pedal 1 of the ELAN 4 air foot control, the user controls the motor speed of the connected ELAN 4 air applied part. The pedal activates a valve of the ELAN 4 air foot control. When the pedal is in its initial position, the valve is closed and the motor of the applied part does not run. When the pedal is in its end position, the valve is open and the motor of the applied part runs at maximum speed. When the pedal is released, the ELAN 4 air motor hose is vented. ELAN 4 air wall hoses and ELAN 4 air wall adapters The ELAN 4 air wall hoses and ELAN 4 air wall adapters guide compressed air from the compressed-air source to the foot control. The wall hoses and wall adapters have a fast-lock coupling. This coupling prevents the escape of compressed air during detachment of the parts. The wall hoses have an exit-air recycling system. The supply hose is embedded in an additional exit air hose, which takes the exit air away from the operating field.
en There are two exit air recycling systems: ■ Aesculap-Dräger and Synthes wall adapters with complete exit-air recycling: The exit air is channeled back from the O.R. into the central gas supply system. In this way, air turbulences and adverse effects on the climate and hygiene in the O.R. are avoided. ■ Schrader and DIN wall adapters without complete exit-air recycling: The exit air enters the O.R. through a diffuser on the wall adapter.
5.
Preparation
Non-compliance with the following instructions will preclude all responsibility and liability in this respect on the part of Aesculap. ► When setting up and operating the product, adhere to – national regulations for installation and operation, – national legal regulations pertaining to compressed air supply, – National regulations on fire and explosion protection ► Before using the product and its accessories, check to be sure that neither are damaged. ► Use the products and their accessories only if they are in perfect technical condition.
5.1
Compressed air supply/compressed air hoses
WARNING Damage to persons and/or property due to the placing of the hose! The user may injure the patient with an unintentional movement due to shock. ► Be careful not to damage the compressed-air hose. ► Ensure annual repair. WARNING Operating pressures in excess of 10bar will damage the motor system! ► Set an operating pressure of between 6 bar and 10 bar. CAUTION Impaired performance of the pneumatic motor/bursting of damaged compressed-air hoses! ► Lay compressed-air hoses only through unobstructed areas. ► Do not squeeze or block open hose ends or diffusers. ► Do not coil up compressed-air hoses to tightly (minimum coil diameter 20cm). ► Do not kink, squeeze or clamp compressed-air hoses. ► Verify that the compressed-air hoses are not damaged (e.g. by scalpels) or squeezed with sharp objects (e.g. cloth clips).
5.2
Operation with central gas supply according to DIN EN ISO 5359
The gas supply must provide clean, dry air and must be set as follows: Nominal operating pressure
8 ±2 bar
Maximum permissible operating pressure
10 bar
For exhaust air recirculation, the maximum per- 0.5bar to 0.7 bar missible velocity pressure in the exhaust line during motor operation Minimum gas-supply delivery
300 l/min
5.3
Operation with compressed-gas cylinders according to DIN EN ISO 11117
The following conditions must be met: ■ Compressed air or nitrogen is used ■ An adequate stock of full gas cylinders is in place ■ Cylinder pressure reduced to operating pressure of 6 bar to 10 bar through a pressure reducer (e.g., GA099) ■ Operating pressure has been read from the scale on the device and set with the T-screw. Note If the system is operated with compressed gas cylinders, the exit air is not removed from the O.R. It emerges from the ELAN 4 wall adapter, away from the operating field.
5.4
First use of foot control
Mounting/dismounting the bracket ► Insert bracket 4 on one side into the adapter for bracket 5. ► Widen the bracket 4 and insert it fully into the other adapter for bracket 5. ► Disassembly: Press bracket 4 together by the two lower horizontal ends and remove bracket 4 from the adapters for bracket 5.
6.
Working with the product
WARNING Risk of injury and/or malfunction! ► Always carry out a function check prior to using the product. WARNING Risk of injury and material damage due to inadvertent activation of the applied part! ► Secure application parts that are not actively used against inadvertent activation (off position). WARNING Dropping may damage the product! ► Use the products only if they are in a flawless technical condition, see function check
6.1
System set-up
Note Operating elements on the system components of the ELAN 4 air 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. Connecting wall adapter to compressed-air source ► Couple connection for compressed-air source 10 of the wall adapter with the compressed-air source. Connecting the wall adapter to the foot control ► Attach the connection for wall adapter 8 of the wall hose to the connection for wall hose 11 of the wall adapter and couple the bayonet lock.
5
en Connecting the wall hose to the foot control ► Attach the connection for foot control 9 of the wall hose to the connection for wall hose 2 on the foot control and couple the bayonet lock. Connecting the motor hose to the foot control ► Attach the connection for foot control 7 of the motor hose to the connection for motor hose 3 on the foot control and couple the bayonet lock.
6.2
Function checks
► Check the ELAN 4 air motor system with a trial run prior to each appli-
cation. ► Make certain that the applied part and foot control are in good working
order. ► Make certain that all compressed-air hoses and the wall adapter are
correctly connected and leak-tight. ► Check the secure connection of all products used. ► Make certain that the applied part runs at maximum speed when the
Connecting the applied part to the motor hose ► Attach the connection for motor hose of the applied part 12 to the connection for applied part 6 of the motor hose, see Fig. A. When doing so, ensure that the nib 16 on the motor hose is aligned with the groove 17 on the connection for motor hose 12. The applied part engages. When the field of vision is “Off” 14 on the motor hose, a gold-colored marking is visible. Note The applied part attached to this motor hose is only ready for operation when the release button is in "On" position. Releasing the applied part for operation ("On" position) ► Activate the release button 15 on the motor hose and push the con-
nection for applied part 6 onto the applied part, see Fig. A. The applied part engages. When the field of vision is “On” 13 on the motor hose, a gold-colored marking is visible. Locking the applied part ("Off" position) ► Activate the release button 15 on the motor hose and detach the motor
hose from the applied part. The applied part engages. When the field of vision is “Off” 14 on the motor hose, a gold-colored marking is visible. Disconnecting the applied part from the motor hose ► Activate the release button 15 on the motor hose and pull at the con-
nection for applied part 6 to disconnect the motor hose from the applied part. Disconnecting the motor hose from the foot control ► Disconnect the bayonet lock of the connection for foot control 7 of the
motor hose and detach motor hose from foot control. Disconnecting the wall hose from the foot control ► Disconnect the bayonet lock of the connection for foot control 9 of the
wall hose and detach wall hose from foot control. Disconnecting the wall hose from the wall adapter ► Turn the connection for wall adapter 8 of the wall hose into the middle
position of the bayonet lock to ensure pressure equalization and prevent any loud bangs. ► Disconnect the wall hose fully from the wall adapter. Disconnecting the wall adapter from the compressed-air source ► Uncouple the connection for compressed-air source 10 of the wall
adapter from the compressed-air source.
6
foot control pedal is pushed all the way down. ► Do not use a damaged or broken product. Immediately set aside any
damaged products!
6.3
Safe operation
Operation of the applied part is only possible if: ■ the applied part is released ("On" position) ■ a foot control or hand control is connected. Activating the applied part via foot control ► Press the pedal 1 on the ELAN 4 air foot control. The motor of the applied part runs. ► Adjusting speed: Press down on the pedal 1 to a greater or lesser extent. ► To select maximum speed: Press down on the pedal 1 as far as it will go.
7.
Processing 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 It should be noted that successful reprocessing of this medical device can only be guaranteed following prior validation of the reprocessing method. The operator/reprocessing technician is responsible for this. Note If there is no final sterilization, then a virucidal disinfectant must be used. Note See also B. Braun eIFUs at eifu.bbraun.com for up-to-date information on processing and material compatibility The validated steam sterilization procedure was carried out in the Aesculap sterile container system.
en 7.2
General information
7.3
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".
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. ► Carry out non-fixating/NaCl-free pre-cleaning immediately after use. ► Send the product in a dry condition for cleaning and disinfection within 6 hours.
7.5
Cleaning/disinfection
Product-specific safety instructions for the reprocessing procedure CAUTION Damage to, or destruction of the product caused by mechanical cleaning/disinfection! ► Only clean and disinfect the product manually. ► Do not sterilize the product under any circumstances. CAUTION Damage to the product due to inappropriate cleaning/disinfecting agents! ► Only use cleaning/disinfecting agents approved for surface cleaning. Follow the manufacturer’s instructions for the respective cleaning/disinfecting agent.
7.6
Wipe disinfection
Phase
Step
T [°C/°F]
t [min]
Conc. [%]
Water quality
Chemicals
I
Wipe disinfection
RT
≥1
-
-
17 % Propan-1-ol, 0.23 % Didecyldimethylammonium chloride*
RT: Room temperature * Meliseptol® wipes sensitive (BBraun) are recommended
Phase I ► Remove any visible residues with a disposable disinfectant wipe. ► Wipe all surfaces of the optically clean product with a fresh, disposable disinfectant wipe. ► Observe the specified application time (1 min minimum). ► After manual cleaning/disinfection, check visible surfaces for residue and repeat the cleaning/disinfection process as required.
8.
Maintenance
8.1
ELAN 4 air foot control, ELAN 4 air wall adapter
7.7
8.2
Inspection, maintenance and checks
► Inspect the product after each cleaning and disinfecting cycle to be
sure it is: clean, functional, and undamaged. Note Aesculap additionally recommends the occasional spraying of moving parts (such as knobs, couplings) with the Aesculap STERILIT Power Systems Oil spray.
To ensure reliable operation, the product must be maintained at least once every two to three years. For technical service, please contact your national B. Braun/Aesculap agency, see Technical Service.
ELAN 4 air wall hose
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.
► Set aside the product if it is damaged.
7
en 9.
Troubleshooting list
Fault
Cause
Detection
Remedy
Applied part not running
No compressed air
Motor coupling in “off” position
Activate applied part for operation ('on' position).
Hoses and wall adapters not correctly coupled
Check the coupling points.
No compressed air at the wall out- Check the building technology let
Disconnecting/connecting the applied part from/with the motor hose not possible (change from "On" to "Off" position and vice versa)
Gas cylinder empty (pressure gauge set to "0")
Change cylinder.
Valve on cylinder closed
Open valve.
Applied part defective
Tool not moving
Replace applied part.
Foot control defective
Pedal not moving
Replace foot control.
Do not disengage the release but- Coupling processes cannot be perton on the motor hose between formed connection/separation and activation/locking of the applied part
Disengage the release button on the motor hose between connection/separation and activation/locking of the applied part and re-actuate.
Motor coupling defective
Replace applied part and motor hose.
Applied part runs without activat- Foot control defective ing the foot control
Applied part runs without being activated by the foot control
Replace foot control.
Insufficient power
Cutting edge worn
Use a new tool.
Cutting edge is clogged up, e.g. due to insufficient rinsing
Use a new tool.
The craniotome burr is not centrally aligned with the dura guard hook
Dura guard bracket bent Poor progress during craniotomy
Use new dura guard, follow instructions for use (TA014473/TA014474).
Applied part defective
Insufficient performance of applied part
Follow instructions for use of the applied part (processing, maintenance).
Blunt tool
Replace applied part. Steep rise in temperature after a short period of time
Follow instructions for use of the applied part (processing, maintenance). Replace applied part.
Air resistance in hoses and wall adapter too high
Air supply too low
Accessory broken
8
Use of extension hoses
Only use one wall hose.
Hoses bent or squashed
Lay hoses only through unobstructed areas.
No free exhaust air outlet at the diffuser
Free up the openings on the diffuser.
Operating pressure too low
Adjust the operating pressure to min. 6 bar.
Pressure regulator on the cylinder defective
Check pressure regulator.
Leaks in the hose/hose coupling
Replace hose.
Large amount of heat generated after a short time
Observe the instructions for use of accessories. Replace accessory.
en Fault
Cause
Detection
Remedy
Applied part is getting hot
Excessive use
The applied part becomes hot Loud operating noise/vibration
Follow instructions for use of the applied part (interval operation).
High speed applied part vibrates excessively
Improper processing
Follow instructions for use of the applied part (reprocessing, maintenance)
Shaft of applied part bent
Replace applied part.
Applied part defective
Replace applied part.
Accessory defective
Observe the instructions for use of accessories. Replace accessory.
Shaft of applied part bent Applied part defective
Excessive running noises, vibrations
Reprocessing carried out incorrectly Tool cannot be coupled or uncoupled
Attachment for GA749 (craniotome) cannot be coupled or uncoupled
Replace applied part. Replace applied part. Follow instructions for use of the applied part (processing, maintenance).
ELAN 4 air Highspeed: Automatic tool lock blocked
Highspeed tool doesn't engage
Activate slide for tool lock and hold, then couple tool.
ELAN 4 air Highspeed: Slider for tool lock locked
Applied part released for operation ("On" position)
Block applied part ('off' position).
Incompatible tool
Incorrect tool
Select an appropriate tool according to the instructions for use of the applied part.
Tool connection or coupling deformed, defective
Tool is difficult to couple/uncouple or cannot be coupled/uncoupled
Use a new tool.
Automatic attachment lock blocked
Attachment does not click into place
Pull back unlocking sleeve and hold, then couple the attachment.
Unlocking sleeve blocked
Applied part released for operation ("On" position)
Lock the applied part ("Off" position).
Attachment coupling defective
Attachment is difficult to couple/uncouple or cannot be coupled/uncoupled
Use a new attachment.
Attachment is difficult to couple or cannot be coupled
Clean the attachment or use a new attachment.
Attachment coupling is dirty
Replace applied part.
Replace applied part.
Clean the applied part. Rotary dura guard GB947R hard to turn
Bearing dirty or worn
Rotary dura guard is hard to move Follow the instructions for use (TA014473/TA014474) (reprocessing, maintenance). Replace rotary dura guard.
Hoses/wall adapter/foot control cannot be coupled or uncoupled
Hoses/wall adapters/foot control not compatible
Hoses/wall adapter are difficult to couple/uncouple or cannot be coupled/uncoupled
Hose coupling deformed, defective Rinsing adapter cannot be adapted Rinsing adapter not compatible
Oil spray adapter cannot be attached
Select an appropriate hose/wall adapter/foot control according to the instructions for use. Replace hose/wall adapter/foot control.
Rinsing adapter cannot be adapted Use matching rinsing adapter
Port on applied part deformed
Replace applied part.
Screw thread on rinsing adapter deformed/defective
Replace rinsing adapter.
Oil spray adapter not compatible
Oil spray adapter cannot be attached
Use the matching oil spray adapter.
9
en 10. Technical Service
12. Technical data
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.
12.1 Classification in accordance with Regulation (EC) 2017/745
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.
Art. no.
Designation
Class
GA708
ELAN 4 air foot control
I
GA702R
ELAN 4 air wall hose, 3m
I
GA703R
ELAN 4 air wall hose, 5m
I
GA710R
ELAN 4 air wall adapter Aesculap-Dräger
I
GA712R
ELAN 4 air wall adapter Schrader with diffuser
I
GA713R
ELAN 4 air Wall adapter DIN with diffuser
I
GA715R
ELAN 4 air Wall adapter Synthes
I
12.2 ELAN 4 air foot control GA708 Weight
2.1 kg ±5 %
Dimensions (L x W x H)
235 mm x 105 mm x 60 mm ±5 % For mounted bracket: 235 mm x 160 mm x 192 mm ±5 %
11. Accessories/Spare parts
12.3 ELAN 4 air wall hose 3m GA702R
Art. no.
Name
Weight
0.7 kg ±10 %
GA099
Pressure reducer with quick-locking coupling
Dimensions (∅ x L)
26 mm x 3 000 mm ±5 %
GA708203
Bracket
12.4 ELAN 4 air wall hose 5m GA703R
GA702R
ELAN 4 air wall hose, 3m
Weight
1.06 kg ±10 %
GA703R
ELAN 4 air wall hose, 5m
Dimensions (∅ x L)
26 mm x 5 000 mm ±5 %
GA705R
ELAN 4 air motor hose 3m for foot control
GA710R
ELAN 4 air wall adapter Aesculap Dräger
GA712R
ELAN 4 air wall adapter Schrader with diffuser
GA713R
ELAN 4 air wall adapter DIN with diffuser
GA715R
ELAN 4 air wall adapter Synthes
GB600
STERILIT Power Systems oil spray
TA014450
ELAN 4 air foot control GA708, ELAN 4 air wall hoses GA702R/GA703R, ELAN 4 air wall adapters GA710R to GA715R (A4 for folder)
Weight
154 g ±10 %
Dimensions (∅ x l)
26 mm x 126 mm ±5 %
ELAN 4 air foot control GA708, ELAN 4 air wall hoses GA702R/GA703R, ELAN 4 air wall adapters GA710R to GA715R (leaflet)
12.7 ELAN 4 air wall adapter DIN with diffuser GA713R
TA014454
12.5 ELAN 4 air wall adapter Aesculap-Dräger GA710R Weight
290 g ±5 %
Dimensions (∅ x L)
37 mm x 121 mm ±5 %
12.6 ELAN 4 air wall adapter Schrader with diffuser GA712R
Weight
156 g ±10 %
Dimensions (∅ x l)
26 mm x 121 mm ±5 %
12.8 ELAN 4 air wall adapter Synthes GA715R
10
Weight
150 g ±10 %
Dimensions (∅ x L)
26 mm x 110 mm ±5 %
en 12.9 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 operator must process the product before disposal, see Processing procedure. ► In case of questions regarding the disposal of the product, contact your
local B. Braun/Aesculap representative, see Technical Service.
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