Braun Aesculap ELAN 4 Manual

Aesculap®
Aesculap Power Systems
USA Instructions for use/Technical description
ELAN 4 electro remote foot control GA810
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Aesculap®
ELAN 4 electro remote foot control GA810
Legend
1Transport brace
2Function button
3Pedal
4Rotational direction button for motor
5Maximum speed button
6Holding receptacle for transport brace
7Guide pins for pedal
Symbols on product and packages
Contents
1. About this document. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
1.1 Scope . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
1.2 Safety instructions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
2. General information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
2.1 Intended use. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
2.2 Application Environment. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
2.3 Indications for Use. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
3. Safe handling. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
4. Product description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
4.1 Scope of supply . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
4.2 Components required for operation. . . . . . . . . . . . . . . . . . . . . . . 3
4.3 Operating principle . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
5. Preparation and setup. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
5.1 First use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
6. Working with the product. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
7. Disassembling the pedal for cleaning . . . . . . . . . . . . . . . . . . . . . 4
8. Mounting the pedal (after cleaning) . . . . . . . . . . . . . . . . . . . . . . 4
9. Processing procedure. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
9.1 General safety notes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
9.2 Reusable products . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
9.3 Preparation before cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
9.4 Cleaning/disinfection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
9.5 Wiper disinfection for electrical equipment . . . . . . . . . . . . . . . . 5
9.6 Manual cleaning including immersion disinfection
(recommended for heavily soiled objects) . . . . . . . . . . . . . . . . . . 5
9.7 Inspection, maintenance and checks . . . . . . . . . . . . . . . . . . . . . . 5
10. Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
11. Troubleshooting list. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
12. Technical Service . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
13. Accessories/Spare parts. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
14. Technical data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
14.1 Classification according to Regulation (EU) 2017/745 . . . . . . . 6
14.2 Basic data, information about standards. . . . . . . . . . . . . . . . . . . 6
14.3 Ambient conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
15. Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
16. Distributor in the US/Contact in Canada for product information
and complaints . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Caution
Observe important safety information such as warnings
and precautions in the instructions for use.
Follow the instructions for use
Manufacturer
Date of manufacture
Manufacturer serial number
Manufacturer's batch name
Manufacturer order number
Delivery quantity
Non-sterile medical product
CE mark according to Regulation (EU) 2017/745
Temperature limits during transport and storage
Atmospheric pressure limits during transport and stor-
age
Air humidity limits during transport and storage
Preselection of motor rotation direction
SN
LOT
REF
QTY
Pump setting
Change maximum speed
Device Class AP according to IEC/DIN EN 60601-1
Labeling of electrical and electronic devices according
to directive 2012/19/EU (WEEE), see Disposal
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1. About this document
Note
General risk factors associated with surgical procedures are not described
in these instructions for use.
1.1 Scope
These instructions for use apply to the ELAN 4 electro remote foot control
GA810.
►For article specific instructions for use and material compatibility, see
B. Braun eIFU at eifu.bbraun.com
1.2 Safety instructions
Safety instructions specify the dangers to patient, user and/or product that
can occur during the use of the product. Safety instructions are labeled as
follows:
DANGER
Indicates a potential hazard. If not avoided, death or serious injury
may result.
WARNING
Indicates a potential hazard. If not avoided, minor or moderate injury
may result.
CAUTION
Indicates a potential threat of material damage. If not avoided, the
product may be damaged.
2. General information
2.1 Intended use
The ELAN 4 electro remote foot control GA810 is an accessory for the
ELAN 4 electro motor system.
With the remote foot control:
■the user activates the motor of the applied part and selects the rota-
tional direction,
■the user activates/deactivates the coolant pump,
■the user can change the maximum speed of the motor.
Note
The ELAN 4 electro remote foot control GA810 cannot be used if a manually
controlled applied part or a cable-connected foot control is used.
2.2 Application Environment
Application in the unsterile area
Remote foot controls are Class AP devices. The foot control circuit is igni-
tion-safe and approved for operation in medical environments according
to IEC /DIN EN 60601-1. The housing is constructed according to Protec-
tion Type IPX8.
2.3 Indications for Use
The ELAN 4 Electro Motor System is intended for high speed cutting, saw-
ing, and drilling of bone in the fields of Spine, ENT, Neuro, and Maxillofa-
cial Surgery.
3. Safe handling
CAUTION
Federal law restricts this device to sale by, or on order of a physician!
WARNING
Risk of injury and material damage if this product is not used as
intended!
►Use the product only according to its intended use.
WARNING
Risk of injury and damage to property due to improper handling of the
product!
This product is an accessory for 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 tech-
niques.
►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.
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
4.2 Components required for operation
■ELAN 4 electro control unit GA800
■ELAN 4 electro motor cable for foot control GA806
■ELAN 4 electro applied part
■Tool
Location Floors
Art. no. Designation
GA810 ELAN 4 Electro remote foot control
TA014411 Instructions for use of remote foot control GA810 (bro-
chure)
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4.3 Operating principle
With the ELAN 4 electro remote foot control GA810 the active applied
part is connected to the control unit without manual control. The coolant
pump is activated or deactivated and the maximum speed and direction of
the applied part is changed.
Function button 2:
Rotational direction button for motor 4: Selection of right or left rotation.
Pedal 3: The pedal serves as the actuator for the speed setting of the con-
trol unit. Depending on the actuating path, the speed of the motor can be
selected continuously from 0 to the maximum speed set.
Maximum speed button 5: The maximum speed button is for step-by-step
changes to the set maximum speed on the control device GA800 with full
operation of the pedal.
5. Preparation and setup
Non-compliance with the following instructions will preclude all respon-
sibility 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 regulations on fire and explosion protection.
5.1 First use
Assembling/disassembling the transport brace
►Insert transport brace 1on one side into the holding receptacle for
transport brace 6, see Fig. A2.
►Widen the transport brace 1and insert it into the other holding recep-
tacle for transport brace 6. Make certain that the transport brace is
correctly mounted.
Note
Disassembly is carried out in the reverse order.
6. Working with the product
How to work with the ELAN 4 electro system and its accessory compo-
nents is described in the instructions for use of the ELAN 4 electro control
unit GA800, see TA014401.
7. Disassembling the pedal for cleaning
►Lift the pedal 3upwards, see Fig. B.
►Remove pedal 3from the guide bolts for pedal 7.
►Remove the pedal 3in an upward direction, see Fig. C.
8. Mounting the pedal (after cleaning)
►Insert pedal 3onto guide bolts for pedal 7, see Fig. B.
►Fold pedal 3down.
9. Processing procedure
9.1 General safety notes
Note
Adhere to national statutory regulations, national and international stan-
dards and directives, and local, clinical hygiene instructions for reprocess-
ing.
Note
For patients with Creutzfeldt-Jakob disease (CJD), suspected CJD, or possi-
ble 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.
9.2 Reusable products
The life time of the product is limited due to damage, normal wear and
tear, type and duration of use, in addition to the handling, storing and
transporting of the product.
Careful visual and functional testing prior to next use is the best way to
identify a malfunctioning product.
9.3 Preparation before cleaning
►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.
Note
The pedal can be removed for cleaning, see Disassembling the pedal for
cleaning.
9.4 Cleaning/disinfection
Product-specific safety instructions for the reprocessing procedure
CAUTION
Damage to, or destruction of the product caused by mechanical clean-
ing/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 clean-
ing. Follow the manufacturer’s instructions for the respective
cleaning/disinfecting agent.
Note
If the product is heavily soiled, Aesculap recommends manual cleaning
including immersion disinfection.
Short actuation Activation/deactivation of the coolant pump.
The pump only works when a motor is running.
Prolonged Pressing Flush function
The pump operates until activation is ended.
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9.5 Wiper disinfection for electrical equipment
RT: Room temperature
*Recommended: Meliseptol® Wipes sensitive (B. Braun)
►Disassemble pedal for cleaning, see Disassembling the pedal for clean-
ing.
Phase I
►Remove any visible residues with a disposable disinfectant wipe.
Phase II
►Wipe all surfaces of the optically clean product with a fresh, disposable
disinfectant wipe.
►Observe contact time requirements (at least 1 min).
9.6 Manual cleaning including immersion disinfection (recommended for heavily soiled objects)
P–W: Potable water
DI-W: de-ionized water (demineralized, microbiological at least in compliance with potable water regulations)
RT: Room temperature
*Recommended: BBraun Stabimed
►Disassemble pedal for cleaning, see Disassembling the pedal for clean-
ing.
Phase I
►Immerse product at least 15min completely in the actively cleaning
disinfecting solution. Ensure that all accessible surfaces are wetted.
►Clean the product in the solution using a suitable cleaning brush until
no residue is visible on the surface.
Phase II
►Rinse product completely (all accessible surfaces) under running water.
►Allow sufficient time for water to drip off.
Phase III
►Completely immerse the product in the disinfectant solution.
Phase IV
►Rinse/flush product completely (all accessible surfaces).
►Allow sufficient time for water to drip off.
Phase V
►During the drying phase dry the product using the appropriate equip-
ment (e.g. wipes, compressed air).
9.7 Inspection, maintenance and checks
►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.
►Change battery when the energy level is low:
– Remove the 4 screws on the bottom of the device with a screwdriver
(Torx TX20).
– Remove the cover of the battery compartment. Replace batteries
(3x) (battery type D / LR20 / Mono).
– Note the polarity of the batteries.
– Replace the battery compartment cover and secure with 4 screws.
10. Maintenance
To ensure reliable operation, the product must be maintained at least once
a year.
For technical service, please contact your national B. Braun/Aesculap
agency, see Technical Service.
Phase Step T
[°C/°F]
t
[min]
Conc.
[%]
Water quality Chemical
I Cleaning RT 1 - - 17 % Propan-1-ol,
0.23 % Didecyldimethylammonium chloride*
II Wipe disinfection RT ≥1 - - 17 % Propan-1-ol,
0.23 % Didecyldimethylammonium chloride*
Phase Step T [°C/°F] t [min] Conc. [%] Water quality Chemicals
I Disinfecting cleaning RT (cold) >15 2 P–W Concentrate free from aldehydes, phenols and QAV, pH
~ 9*
II Intermediate rinse RT (cold) 1 - P–W -
III Disinfection RT (cold) 15 2 P–W Concentrate free from aldehydes, phenols and QAV, pH
~ 9*
IV Final rinse RT (cold) 1 - DI-W -
V Drying RT - - - -
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11. Troubleshooting list
Note
For further information, see instructions for use of ELAN 4 electro control
unit GA800 (TA014401).
12. Technical Service
DANGER
Danger to life of patients and users if the product malfunctions and/or
protective measures fail or are not used!
►Do not perform any servicing or maintenance work under any cir-
cumstances while the product is being used on a patient.
►Do not modify the product.
Modifications carried out on medical technical equipment may result in
loss of guarantee/warranty rights and forfeiture of applicable licenses.
►For service and repairs, please contact your national B. Braun/Aesculap
agency.
Service addresses
Aesculap Technischer Service
Am Aesculap-Platz
78532 Tuttlingen / Germany
Phone: [phone]
Fax: [phone]
E-Mail: [email protected]
Or in the US:
Aesculap Inc.
Attn. Aesculap Technical Services
615 Lambert Pointe Drive
Hazelwood
MO, 63042 USA
Aesculap Repair Hotline
Phone: [phone]
Fax: [phone]
Other service addresses can be obtained from the address indicated above.
13. Accessories/Spare parts
14. Technical data
14.1 Classification according to Regulation (EU)
2017/745
14.2 Basic data, information about standards
14.3 Ambient conditions
Art. no. Name
TA014411 Instructions for use of the ELAN 4 electro remote foot
control GA810 (brochure)
Art. no. Designation Class
GA810 ELAN 4 electro remote foot control I
For connection to ELAN 4 electro control unit GA800
Degrees of protection in
accordance with IEC/ DIN EN
60601-1
AP
Housing protection class
according to IEC/DIN 60529
IPX8
Weight 3810 g ±10 %
Dimensions (L x W x H) with-
out transport bracket
271 mm x 266 mm x 85 mm ±10 %
Dimensions (L x W x H) with
transport bracket
271 mm x 310 mm x 200 mm ±10 %
Compliance with standards IEC/DIN EN 60601-1
EMC IEC/DIN EN 60601-1-2
Battery type D / LR20 / Mono (3x)
Radio standards ETSI EN 300 440
ETSI EN 301 489-1
ETSI EN 301 489-3
IEC/DIN EN 62311
ISM band 2 403 MHz to 2 480 MHz
CISPR11 Class A
Operation Storage and transport
Temperature 10 °C to 40 °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
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15. Disposal
WARNING
Risk of infection due to contaminated products!
►Adhere to national regulations when disposing of or recycling the
product, its components and its packaging.
Note
The user institution is obliged to process the product before its disposal, see
Processing procedure.
►Detailed information concerning the disposal of the product is avail-
able through your national B. Braun/Aesculap agency, see Technical
Service.
16. Distributor in the US/Contact in Canada
for product information and complaints
Aesculap Inc.
3773 Corporate Parkway
Center Valley, PA, 18034,
USA
The recycling pass can be downloaded from the
Extranet as a PDF document under the respective arti-
cle number. (The recycling pass includes disassembling
instructions for the product, as well as information for
proper disposal of components harmful to the environ-
ment.)
Products carrying this symbol are subject to separate
collection of electrical and electronic devices. Within
the European Union, disposal is taken care of by the
manufacturer as a free-of-charge service.
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Aesculap AG | Am Aesculap-Platz | 78532 Tuttlingen | Germany
Phone [phone] | Fax [phone] | www.aesculap.com
Aesculap®– a B. Braun brand SOP-AIC-5002243 (TA014410)
2019-10 Rev. 1
Document No.: TA014410 - Version: 1.0 - Document ID: SOP-AIC-5002243 Date/Time Printed/Viewed: 2022-04-13 16:00 (CET)
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