RF Footswitch
Operator’s Manual
34-109-1
RF Footswitch
Operator’s Manual
34-109-1
EN
EN
Copyright and
Trademarks
Disclaimer
© 2019 Medtronic. All rights reserved. Medtronic, Medtronic logo and Further, Together
are trademarks of Medtronic. All other brands are trademarks of a Medtronic company.
No part of this publication may be reproduced, transmitted, transcribed, stored in retrieval
systems, or translated into any form, or by any means: electronic, mechanical, magnetic,
optical, or otherwise, without the prior written permission of Medtronic Navigation, Inc.
826 Coal Creek Circle, Louisville, CO 80027, United States of America.
Medtronic reserves the right to change its products and services at any time to incorporate
the latest technological developments. This guide is subject to change without notice.
Federal (USA) law restricts this device to sale by or on the order of a physician.
Customer Service Telephone Numbers:
US +1 800 595 9709
Intl. +1 720 890 3160
Contents
1. Preface
Indications for Use ................................................................................................................................................................................. 1-1
Device Description ....................................................................................................................................................................... 1-1
Safety .......................................................................................................................................................................................................... 1-1
General Use ..................................................................................................................................................................................... 1-1
Denitions of Terminology ................................................................................................................................................................. 1-2
Warnings and Cautions ........................................................................................................................................................................1-3
2. The RF Footswitch
The RF Footswitch ..................................................................................................................................................................................2-1
Channel/Coding ............................................................................................................................................................................ 2-1
3. Operation
The RF Footswitch ..................................................................................................................................................................................3-1
EN
4. Cleaning and Maintenance
Transmitter ............................................................................................................................................................................................... 4-1
Receiver ..................................................................................................................................................................................................... 4-1
5. Specications
RF Footswitch .......................................................................................................................................................................................... 5-1
General .............................................................................................................................................................................................. 5-1
Dimensions and Weight .............................................................................................................................................................. 5-1
Certication ..................................................................................................................................................................................... 5-2
Electromagnetic Interference ................................................................................................................................................... 5-2
6. Limited Express Warranty and Disclaimers
Limited Express Warranty....................................................................................................................................................................6-1
Disclaimer of Implied Warranties and Consequential Damages .......................................................................................... 6-1
7. Symbols
Symbols ..................................................................................................................................................................................................... 7-1
RF Footswitch Operator’s Manual i
EN
List of Figures
Figure 2-1. AEX™ Generator, RF Footswitch ................................................................................................................................2-1
Figure 2-2. Receiver Front View .......................................................................................................................................................2-2
Figure 2-3. Receiver Rear View .........................................................................................................................................................2-3
Figure 2-4. Transmitter .......................................................................................................................................................................2-3
Figure 3-1. Wireless Receiver ............................................................................................................................................................3-1
Figure 4-1. Transmitter Battery Replacement ............................................................................................................................ 4-2
Table 7-1. Symbols ................................................................................................................................................................................7-1
ii
1. Preface
Indications for Use
The RF Footswitch is an accessory that is indicated for use to provide foot switch input control to the AEX™
Generator (40-405-1).
Device Description
The RF Footswitch is an accessory to the AEX™ Generator. The foot switch provides input control to the AEX™
Generator which utilizes a switch closure (on/o) to activate Medtronic monopolar and bipolar disposable
electrosurgical handpieces. Use of the optional wireless foot switch in conjunction with the wireless receiver
(connected to the AEX™ Generator) provides CUT & COAG power to Medtronic monopolar and bipolar
handpieces.
EN
Safety
The information presented in this section is important for the safety of both the patient and the operator
and also serves to enhance equipment reliability. This section describes how the terms Warning, Caution,
Important, and Note are used throughout the manual.
General Use
If the foot switch is cold to the touch or below ambient temperature, allow it to stabilize before use.
The use of accessory equipment not complying with the equivalent safety requirements of this equipment
may lead to a reduced level of safety of the resulting system.
Consideration relating to the choice shall include:
• use of the accessory in the patient vicinity
• evidence that the safety certication of the accessory has been performed in accordance
to the appropriate IEC 60601-1 and/or IEC 60601-1-2 harmonized national standard.
Periodically, whenever the integrity of the switch is in doubt, test all functions.
RF Footswitch Operator’s Manual 1-1
EN
Denitions of Terminology
Four types of special notice are used throughout this manual. They are: Warning, Caution, Important, and
Note. The warnings and cautions in this safety section relate to the equipment in general and apply to all
aspects of the foot switch. Be sure to read the other chapters because there are additional warnings and
cautions, which relate to specic features of the foot switch.
▲ WARNING: A warning indicates a hazardous condition that may result in injury or death if not corrected
or avoided.
◆ CAUTION: A CAUTION indicates a potentially hazardous situation which, if not avoided, may result in
minor or moderate injury. Cautions are also used to avoid damage to equipment.
■ IMPORTANT: An IMPORTANT notice indicates an emphasized note. It is something you should be
particularly aware of, something not readily apparent.
● NOTE: A NOTE indicates a particular point of information, something on which to focus your
attention.
1-2 Preface
Warnings and Cautions
The warnings and cautions presented in this manual should be read, understood and followed for safety
purposes.
▲ Warning for Accidental Spills: In the event that uids are accidentally spilled on the receiver, take the
receiver out of operation and inspect for damage.
▲ Warning for Electric Shock Hazard. To reduce the risk of electrical shock do not remove any covers.
Refer servicing to qualied personnel.
▲ Warning for Explosion Hazard: Do not use this equipment in the presence of ammable anesthetics.
EN
▲ Warning for Interfacing to Equipment: Foot switches must be interfaced with other equipment.
Be certain to consult manufacturer’s specications to maintain safe operation.
◆ Caution for Annual Servicing: For continued safety and performance of the switch, it is recommended
that the functionality and electrical safety of the switch be veried on an annual basis.
◆ Caution for Daily Testing: It is essential that the foot switch be inspected every day or before use.
◆ Cautions for Performance:
• The wireless foot switch system operates in the Frequency range of 2.405 to 2.408 GHz. It should be tested
to assure compatibility with any device it is connected to or environment in which it is working.
• Report all problems experienced with the foot switch. If the foot switch is not working properly, contact
your service representative for service. The foot switch should not be used if it is not working properly.
RF Footswitch Operator’s Manual 1-3
EN
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1-4 Preface
2. The RF Footswitch
The RF Footswitch
The RF Footswitch is one component of the (Medtronic/AEX™) Surgery System. The Generator provides radio
frequency (RF) energy to disposable electrosurgical handpieces.
Figure 2-1. AEX™ Generator, RF Footswitch
EN
AEX™ Generator
RF Footswitch
Channel/Coding
The radio frequency foot switch has fteen distinct channel capabilities. This allows multiple channels to be
used in the same area simultaneously. The channel is identied in the serial number of the units. See example
below. The channel also appears on a label on top of the units.
XXXXXXXX T001
In addition to the fteen channels, each manufacturer has its own code encryption. This assures that dierent
manufacturers with the same channel marking can be used in the same area simultaneously with no
interference. The manufacturer’s code is embedded into the model number as shown below. It also appears
on a label on the top of the units.
Alpha digit designates transmitter or receiver
SP-9970214-XXX XXXXXX
Last digit designates channel
These three digits denote the manufacturer’s code.
Example A :
UNIT LABEL: The rst two or three digits denote the manufacturer code; the last digit is the channel.
RF Footswitch Operator’s Manual 2-1
XXX
EN
Receiver Front View
Figure 2-2. Receiver Front View
A B C
Name Description
A Power On indicator The Power On indicator lights green to indicate the unit is powered
B Switch function
Indicators
C Low battery
indicator foot
switch
LED’s will light when switch(es) are actuated.
Red LED will ash when the batteries are close to the end of their life. The LED will
ash for 3-4 hours. When LED stays on constantly there is 3-4 hours of battery life
remaining. However batteries should be replaced immediately.
2-2 The RF Footswitch
Receiver Rear View
Description
EN
Figure 2-3. Receiver Rear View
J5 Output Connector: For connection of interface cable to the Medtronic/AEX™ Generator.
Transmitter
Figure 2-4. Transmitter
A
Description
A Primary switches
Single or Dual Function
RF Footswitch Operator’s Manual 2-3
EN
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2-4 The RF Footswitch
3. Operation
The RF Footswitch
● NOTE: The wireless foot switch is only compatible with enabled handpieces.
1. Plug the wireless receiver into the foot switch connector on the back of the Medtronic/AEX™ Generator
using the appropriate interface cable. While using a foot switch, RF power will be delivered via the
handpiece.
2. Turn on the Medtronic/AEX™ Generator and ensure that the wireless receiver’s power-on LED is green,
indicating that the receiver is powered on.
Figure 3-1. Wireless Receiver
EN
Power-On
▲ WARNING: Ensure that the foot switch is not inadvertently depressed to prevent the device from being
unintentionally activated. Place the foot switch in a location that requires deliberate action in order to
activate the unit.
▲ WARNING: Only the primary surgeon using the handpiece should operate the foot switch. Unintentional
activation may occur if the foot switch is activated by a separate user, which may result in patient or user injury.
LED Indicator
RF Footswitch Operator’s Manual 3-1
EN
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3-2 Operation
4. Cleaning and Maintenance
The following cleaning instructions are provided.
◆ CAUTIONS:
• ABRASION: Do not use abrasive cloth, sharp objects, or abrasive cleaners.
• DISCONNECTION: Detach the interconnect cables from the receiver.
• IMMERSION: Do not immerse the receiver, cables or connectors under running water.
Transmitter
The transmitter is IP68 rated and can be completely immersed briey.
EN
Dampen a non-abrasive cloth with one of the following products; then wring out until slightly wet and gently
rub soiled area until clean.
• Isopropyl alcohol
• Soap and water
• Cidex
• Sodium Hypochlorite 5.25% (Bleach) diluted 10:1
Receiver
◆ CAUTION: The receiver is IPX1 rated and cannot be immersed.
Dampen a non-abrasive cloth with one of the following products; then wring out until slightly wet and gently
rub soiled area until clean.
• Isopropyl alcohol
• Soap and water
• Cidex
• Bleach Sodium Hypochlorite 5.25% (Bleach) diluted 10:1
Wipe any uids from the surface of the receiver.
RF Footswitch Operator’s Manual 4-1
EN
Battery Replacement
Figure 4-1. Transmitter Battery Replacement
2X LOCKING TABS
BATTERY COVER
SLOTTED DRIVE
1/4 TURN FASTENER
“O” RING SEAL
RECESSED AREA FOR COVER REMOVAL
(GENTLY PRY FLAT TIP DEVISE TO
REMOVE COVER)
3X “AA” BATTERIES
3X BATTERY POLARITY INDICATOR
ON BOTTOM FACE OF HOLDER
Replace the batteries in the transmitter with high quality “AA” size Alkaline batteries as shown.
◆ CAUTIONS:
• Never mix manufacturers when replacing the batteries.
• Never mix old and new batteries.
• Care must be taken when replacing the batteries not to damage the o-ring seal on the battery cover.
• The o-ring seal should be replaced whenever it is damaged or its integrity is in question.
• Medtronic Navigation, Inc. recommends the seal should be replaced at the minimum every third time batteries
are replaced. When replacing the seal lubricate it with petroleum jelly.
• Battery Leakage: If the transmitter will not be used for an extended period of time, remove the batteries to
prevent damage due to possible battery leakage.
• Battery Disposal: Follow the battery manufacturer’s recommendations or your hospital policy for the
disposal of used batteries.
4-2 Cleaning and Maintenance
5. Specications
RF Footswitch
All specications are subject to change without notice.
General
EN
Range:
Switch functions:
Latency:
Power consumption
(transmitter):
Power requirements
(receiver):
Receiver output:
Communication:
Frequency:
Encryption:
Transmitter:
Receiver:
Dimensions and Weight
Typically 30 feet (9.14 m)
Maximum of 2
Typically 100 milliseconds
Stand-by 2ua
6VDC @ 200ma
SPST relay, 0.5 amp contacts
IEEE802.15.4 Compliant
2.4 GHz
None - Only sensor data transferred
EN 60529 Degree of protection IP68
EN 60529 Degree of protection IPX1
Transmitter
Width:
Length:
Height:
Weight:
14.0 in (35.5 cm)
10.0 in (25.4 cm)
2.63 in (6.68 cm)
5.5 lbs (2.49kg) w/batteries
Receiver
Width:
Length:
Height:
Weight:
5.0 in (12.7 cm)
3.5 in (8.89 cm)
2.2 in (5.72 cm)
0.45 lbs (0.204kg)
RF Footswitch Operator’s Manual 5-1
EN
Certication
IEC/UL 60601-1
CAN/CSA C22.2 No. 60601-1
Classied to IEC/UL 60601-1 Medical electrical equipment by
Underwriter’s Laboratories, Inc. with respect to re, shock, and
mechanical hazards.
Classied with respect to electric shock, re, mechanical, and
other specied hazards only.
Electromagnetic Interference
This device has been tested and found to comply with the limits for medical devices to the EN 60601-1-2
(2002), Medical Device Directive 93/42/EEC. These limits are designed to provide reasonable protection
against harmful interference in a typical medical installation.
However, because of the proliferation of radio-frequency transmitting equipment and other sources of
electrical noise in the health-care and home environments it is possible that high levels of such interference
due to close proximity or strength of a source, may result in disruption of performance of this device.
This equipment generates, uses, and can radiate radio frequency energy and, if not installed and used
in accordance with these instructions, may cause harmful interference with other devices in the vicinity.
Disruption or interference may be evidenced by erratic or incorrect functioning. If this occurs, the site of use
should be surveyed to determine the source of this disruption, and actions taken to eliminate the source.
The user is encouraged to try to correct the interference by one of the following measures:
• Turn equipment in the vicinity o and on to isolate the oending equipment.
• Reorient or relocate the other receiving device.
• Increase the separation between the interfering equipment and this equipment.
• If assistance is required, contact your Medtronic Navigation, Inc. Representative.
5-2 Specifications
6. Limited Express Warranty and Disclaimers
Limited Express Warranty
For one (1) year from the date of shipment from Medtronic Navigation, Inc., if an RF Footswitch is found,
to Medtronic Navigation, Inc.’s satisfaction, to be inoperable during normal and proper use in accordance
with applicable instructions, Medtronic Navigation, Inc. will repair or replace the product, at its sole option,
provided the product is returned, freight prepaid, in accordance with all return packaging and shipping
instructions. A product repaired or replaced under this warranty will be warranted for the remainder of the
original warranty period.
Disclaimer of Implied Warranties and Consequential Damages
MEDTRONIC NAVIGATION, INC. MAKES NO OTHER WARRANTIES WITH RESPECT TO THE
PRODUCT AND EXPRESSLY DISCLAIMS ALL OTHER WARRANTIES, EXPRESS OR IMPLIED, AS
TO MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE OR ANY OTHER MATTER. IN NO
EVENT SHALL MEDTRONIC NAVIGATION, INC. BE LIABLE FOR ANY CONSEQUENTIAL DAMAGES.
THE ABOVE WARRANTY IS VOID ON ANY PRODUCT WHICH HAS BEEN MODIFIED OR REPAIRED
OTHER THAN BY MEDTRONIC NAVIGATION, INC. OR AN AUTHORIZED REPRESENTATIVE,
IMPROPERLY INSTALLED, USED, MAINTAINED OR STORED, OR SUBJECT TO ABUSE, MISUSE,
NEGLECT OR ACCIDENT. MEDTRONIC NAVIGATION, INC. IS NOT RESPONSIBLE FOR DAMAGE OR
ANY OTHER LOSS DURING RETURN SHIPMENT.
EN
RF Footswitch Operator’s Manual 6-1
EN
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6-2 Limited Express Warranty and Disclaimers
7. Symbols
Symbols
The following symbols are used on the product and/or packaging.
Symbol Description
EN
Tab le 7-1. Symbols
Attention: Consult accompanying documents
Power ON: To indicate connection to voltage mains
IPX1
IP68
Low battery
Follow instructions for use
Has passed IEC 60529, IPX1 water-ingress testing (Receiver)
Has passed IEC 60529, IP68 water-ingress testing (Transmitter)
Date of manufacture
Separate collection of waste at end of life as required by European Directives.
Dispose of in accordance with the applicable country regulation.
Axed in accordance with European Council Directive 93/42/EEC.
Classied by UL to IEC/UL 60601-1
Manufacturer
Non-ionizing electromagnetic radiation
RF Footswitch Operator’s Manual 7-1
EN
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7-2 Symbols
La pédale de contrôle RF
Manuel d’utilisation
34-109-1
FR
FR
Copyright et marques
commerciales
Clause de non-
responsabilité
© 2019 Medtronic. Tous droits réservés. Medtronic, le logo Medtronic et Further, Together
sont des marques commerciales de Medtronic. Toutes les autres marques sont des marques
commerciales d’une société Medtronic.
Aucune partie de cette publication ne peut être reproduite, transmise, transcrite, enregistrée
dans des systèmes d’archivage ou traduite sous quelque forme que ce soit, ni d’aucune
manière: électronique, mécanique, magnétique, optique ou autre, sans l’autorisation
préalable par écrit de Medtronic Navigation, Inc. 180International Drive, Portsmouth,
NH03801, États-Unis d’Amérique.
Medtronic se réserve le droit de modier ses produits et ses services à tout moment pour y
incorporer les derniers développements technologiques. Ce manuel est susceptible d’être
modié sans préavis.
Selon la législation fédérale (États-Unis), ce dispositif est strictement réservé à la vente par un
médecin, ou sur ordonnance.
Numéros de téléphone du service clientèle:
US +1 800 595 9709
Intl. +1 720 890 3160
Table des matières
1. Préface
Indications ................................................................................................................................................................................................ 1-1
Description du dispositif ............................................................................................................................................................ 1-1
Sécurité ...................................................................................................................................................................................................... 1-1
Utilisation générale ...................................................................................................................................................................... 1-1
Dénition de termes ............................................................................................................................................................................. 1-2
Mises en garde et avertissements .................................................................................................................................................... 1-3
2. La pédale de contrôle RF
La pédale de contrôle RF .....................................................................................................................................................................2-1
Canaux/Codage ............................................................................................................................................................................. 2-1
3. Fonctionnement
La pédale de contrôle RF .....................................................................................................................................................................3-1
FR
4. Nettoyage et entretien
Transmetteur ........................................................................................................................................................................................... 4-1
Récepteur ..................................................................................................................................................................................................4-1
5. Caractéristiques techniques
La pédale de contrôle RF .....................................................................................................................................................................5-1
Générales ......................................................................................................................................................................................... 5-1
Dimensions et poids .................................................................................................................................................................... 5-1
Certication ..................................................................................................................................................................................... 5-2
Interférence électromagnétique ............................................................................................................................................. 5-2
6. Garantie expresse limitée et clauses de non-responsabilité
Garantie expresse limitée ...................................................................................................................................................................6-1
Exclusion de garanties implicites et des dommages consécutifs ........................................................................................6-1
7. Symboles
Symboles ...................................................................................................................................................................................................7-1
La pédale de contrôle RF Manuel d’utilisatio i
FR
Liste des gures
Figure2-1. Générateur AEX™, La pédale de contrôle RF ........................................................................................................2-1
Figure2-2. Vue avant du récepteur ............................................................................................................................................... 2-2
Figure2-3. Vue arrière du récepteur ............................................................................................................................................. 2-3
Figure2-4. Transmetteur ................................................................................................................................................................... 2-3
Figure3-1. Récepteur sans l ........................................................................................................................................................... 3-1
Figure4-1. Remplacement des piles du transmetteur ........................................................................................................... 4-2
Tableau7-1. Symboles ........................................................................................................................................................................ 7-1
ii
1. Préface
Indications
La pédale de contrôle RF est un accessoire indiqué dans l’utilisation d’un interrupteur à pédale permettant de
contrôler le générateur AEX™ (40-405-1).
Description du dispositif
La pédale de contrôle RF est un accessoire du générateur AEX™. Cette commande au pied permet de contrôler
le générateur AEX™ qui utilise un contact de fermeture (marche/arrêt) an d’activer les pièces à main
électrochirurgicales monopolaires et bipolaires jetables Medtronic. L’utilisation de la commande au pied sans
l en option, associé au récepteur sans l (connecté au générateur AEX™), fournit la puissance COAG/CUT
nécessaire aux pièces à main monopolaires et bipolaires Medtronic.
FR
Sécurité
Les informations présentées dans cette section sont importantes pour la sécurité du patient et de l’utilisateur.
Elles permettent en outre d’améliorer la abilité du matériel. Cette section indique comment les termes Mise
en garde, Avertissement, Important et Remarque sont utilisés dans ce manuel.
Utilisation générale
Si la commande au pied est froide au toucher ou au-dessous de la température ambiante, laissez-la se
stabiliser avant de l’utiliser.
L’utilisation de matériel accessoire non conforme aux exigences de sécurité de cet équipement est susceptible
d’augmenter les risques liés à la sécurité.
Lors du choix de matériel accessoire, il convient de prendre en compte les points suivants:
• l’utilisation de l’accessoire à proximité du patient
• la preuve que la certication de sécurité de l’accessoire a bien été eectuée en accord avec la norme
nationale harmonisée CEI60601-1 et/ou CEI60601-1-2.
Périodiquement, chaque fois qu’il peut y avoir des doutes sur le bon état de marche de l’interrupteur, testez
toutes les fonctions.
La pédale de contrôle RF Manuel d’utilisatio 1-1
FR
Dénition de termes
Quatre types de recommandations particulières sont utilisées dans ce manuel, à savoir: Mise en garde,
Avertissement, Important et Remarque. Les mises en garde et les avertissements contenus dans cette
section relative à la sécurité se rapportent à l’équipement en général et s’appliquent à tous les aspects de la
commande au pied. Veillez à lire consciencieusement les autres chapitres, car ils contiennent des mises en
garde et des avertissements liés à des fonctions spéciques de la commande au pied.
▲ MISE EN GARDE: Une mise en garde indique une situation dangereuse susceptible d’entraîner des
blessures ou la mort, si elle n’est pas corrigée ou évitée.
◆ AVERTISSEMENT: Un AVERTISSEMENT indique une situation potentiellement dangereuse
susceptible d’entraîner des blessures légères ou modérées si elle n’est pas évitée.
Lesavertissements sont également utilisés pour éviter d’endommager le matériel.
■ IMPORTANT: Le terme IMPORTANT permet de mettre l’accent sur un point particulier. Il s’agit d’un
point auquel vous devez prêter une attention particulière et qui n’apparaît pas de
manière évidente.
● REMARQUE: Une REMARQUE indique une information particulière à laquelle vous devez
porterattention.
1-2 Sécurité La pédale de contrôle RF Manuel d’utilisatio 1-31-2 Préface