Product Manual

English
European Authorized Representative
MDSS GmbH
Schiffgraben 41
D - 30175 Hannover
Germany
For International orders or inquiries, please contact
CONMED International Sales
[phone] • FAX [phone]
P/N 62-7533-001 REV B 3/13
European Authorized Representative
MDSS GmbH
Schiffgraben 41
D - 30175 Hannover
Germany
For International orders or inquiries, please contact
CONMED International Sales
[phone] • FAX [phone]
525 French Road • Utica, NY 13502-5994 USA
[phone] • FAX [phone]
Customer Service (USA) 1-800-448-6506
e-mail: [e-mail]
http://www.conmed.com
© CONMED Corporation, Printed in U.S.A.
525 French Road • Utica, NY 13502-5994 USA
[phone] • FAX [phone]
Customer Service (USA) 1-800-448-6506
e-mail: [e-mail]
http://www.conmed.com
© CONMED Corporation, Printed in U.S.A.
ABC
®
Bend-A-Beam
®
Single Function Handpieces:
REF 134003 = 3” Malleable ABC
®
Handpiece.
134006 = 6” Malleable ABC
®
Handpiece.
134009 = 9” Malleable ABC
®
Handpiece.
Sterility guaranteed unless package has been opened, damaged or compromised.
Description:
Malleable Single Function Handcontrol Disposable Handpiece, hand switch activated, 10 foot (3.05m) cable, 3 sizes.
Handpiece is intended for use with the CONMED
®
ABC
®
Electrosurgical Generator for non-contact superficial ablation and hemostasis at the operative site The handpiece is designed for
Monopolar ABC
®
Coagulation only
Intended Use:
The ABC Bend-A-Beam Single Function handpieces have applications in open electrosurgical procedures to provide a means of coagulation.
Maximum generator voltage 6,500V @ 3% duty cycle.
Contraindications:
These devices should never be used when:
• Thereisvisibleevidenceofdamagetotheexteriorofthedevice,suchascracks,cuts,punctures,nicks,abrasions,discolorationorconnectordamage.
• Whereconventionalmonopolarelectrosurgeryisinappropriateorunsafe,suchasforsmallappendages,incircumcisionorfingersurgery.
• Inthepresenceofflammablegases,flammableprepsolutionsordrapes,oxidizinggases,suchasNitrousOxide,orinoxygen-enrichedenvironments.
Warning:
• VenousgasembolimaybeproducedwhileutilizingArgonBeamCoagulation.Tolowertheriskofgasemboli,donotuseArgonBeamCoagulationforprolongedperiods,donotallowargon
gas flow to make direct contact with open vessels, set the gas flow to the lowest setting capable of achieving the desired clinical effect, do not allow argon gas to flow for more than 5 sec-
onds without cutting or coagulating tissue.
• Donotdirectlysecurethecablewithmetalinstrumentstosurgicaldrapes.Activationofthedeviceincontactwithmetalinstrumentsmaycauseburnsatthetissue/instrumentinterface.
• Donotpermitcablesconnectedtoassociatedelectrosurgicalaccessoriestobeparalleltoorincloseproximitytotheleadsofotherelectricaldevices.
• Toavoidburnsneverallowcableassociatedwiththisdevicetobeincontactwithskinofpatientortouchingoperator.
• Topreventburns,donotactivatetheelectrosurgicalunitifthetipofthemalleabletubeisnotinapositiontodeliverenergytotargettissue.
• Prolongeduseofthehandpiececausesthetiptobecomeveryhotandthetipremainshotforaperiodafteruse.Donotallowthetiptocomeincontactwiththepatientorothersafteracti-
vation to avoid burns.
• MODIFICATIONOFTHEDEVICEBYTHEUSER:CONMED
®
warns explicitly against modifying the device, e.g., cutting off the tip of the malleable tube. Any modification voids warranty and
exempts CONMED
®
from all liability.
• Electrosurgeryispotentiallyhazardousforpatientswithpacemakers,AICDs,neurostimulatorsorotheractiveimplants.Highfrequencyenergymaydamageoradverselyaffectactiveimplants.
Ventricular fibrillation may occur.
• Alwaysplacehandpieceinasafeinsulatedlocationwhennotinuse,toavoidburns.
Precautions:
• RefertoCONMED
®
ABC
®
Generator operator manual and CONMED
®
ABC
®
Handpiece instructions prior
to use.
• SINGLEPATIENTUSE.DONOTRESTERILIZE.Theabilitytoeffectivelycleanandre-sterilizethisdevicehas
notbeenestablishedandsubsequentre-usemayadverselyaffecttheperformance,safetyand/or
sterility of the device.
• Donotbendthemalleableshaftover60°.Donotbendwithinaninchofthehandle,orwithin1.5
inches of the tip. Do not bend shaft repeatedly. Bend gently using only thumb and forefinger.
• Useofthehandpiecewithinsufficientargongasflowmayseverelydamagethetip.
• Donotimmerseorsaturatehandcontrolpencilorcordinfluid.
• Donotpullonorstretchthehandpiececord.
• DonottesttheCONMED
®
ABC
®
Electrosurgical Generator by sparking the active electrode to the
patient plate or other objects.
• UselowestpossiblepowersettingontheCONMED
®
ABC
®
Electrosurgical Generator capable of achiev-
ing the desired surgical effect.
• UseshortesteffectiveABC
®
activation time necessary.
• Afterpatientuse,thisproductshouldbeconsideredapotentialbiohazardanddisposedofperbyhospitalpolicyandapplicablelaw.
• TheCONMED
®
ABC
®
ElectrosurgicalGeneratorshouldbeusedonlybysurgeons/healthcarepractitionersexperiencedinArgonBeamelectrosurgicaltechniquesandsafety.
Inspection:
These devices should be inspected before use. Visually examine the devices for obvious physical damage and do not use if found:
• Cracked,brokenorotherwisedistortedplasticparts;
• Brokenorsignificantlybenthandle,shaftorconnectorcontacts;
Instructions for Use:
1. Before turning on generator power, insert the round connector end of the handcontrol pencil cord into the “Argon Beam Coagulator” receptacle of the ABC
®
Electrosurgical Generator and turn
clockwise until tight.
2. Plugthree-prongedendconnectorintothe“BeamHandcontrol”receptacleoftheABC
®
electrosurgical generator.
3. Removetipprotectorpriortoactivation.
4. Turn on generator power. To activate the argon beam, depress blue button on the handpiece. Argon gas will continue to flow approximately four seconds after button is released.
5. Turnoffgeneratorpowerbeforedismantling/disposingofhandpiece.
USA Federal law restricts this device to sale by or on the order of a physician.
Assembled in Mexico