Product Manual

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C O R P O R A T I O N
R
E L E C T R O S U R G E R Y
TM
2
0123
C O R P O R A T I O N
R
E L E C T R O S U R G E R Y
TM
2
0123
C O R P O R A T I O N
R
E L E C T R O S U R G E R Y
TM
English
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.
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 62-9658 REV C 5/13
Laparoscopic ABC© Probes™ - Single Patient Use
REF 130342 - 10mm Footswitching (28cm)
REF 160655 - 5mm Footswitching (28cm)
REF 160656 - 5mm Handswitching (28cm)
REF 160636 - 5mm Handswitching (36cm)
REF 160644 - 5mm Handswitching (44cm)
Sterility guaranteed unless package has been opened, damaged or compromised.
Description:
The Laparoscopic Argon Beam Coagulation (ABC©) Extended Probe is a single patient use
product, provided sterile. This argon gas enhanced monopolar electrosurgical device is intend-
ed to be used through a laparoscopic trocar sleeve.
Indications:
Use the Laparoscopic ABC© Extended Probe only in situations where you would normally use
monopolar energy.
For use with CONMED© Electrosurgical Generators with ABC© and ABC© Modules.
Maximum generator voltage 6.5KV peak @ 3% duty cycle.
Contraindications
• Do not use this device in situations where conventional monopolar electrosurgery is inap-
propriate or unsafe.
• Do not use this argon gas enhanced device in procedures where the risk of gas embolism
exists (such as inside the uterus).
• Do not direct the nozzle into open vessels or bury the nozzle into tissue. Intra-abdominal
pressure should not exceed 18 millimeters of Hg. Discontinue use of this device if intra-
abdominal pressure exceeds this value. Failure to follow these warnings and instructions
(i.e. maximum flow rate of 4 liters per minute of argon and 18mm Hg intra-abdominal
pressure) could increase risk of embolism.
• Do not use in the presence of flammable anesthetics, disinfecting agents, oxygen-rich
environments or other combustible materials.
Warnings:
• This device should be used only in conjunction with an electronic insufflator and venting
trocar to control the intra-abdominal pressure.
• This is a monopolar, active instrument. Before use, a dispersive electrode (i.e. grounding
pad) must be applied to the patient as recommended by the manufacturer.
• Do not directly secure the handpiece cord to surgical drapes with metal instruments.
Activation of the handpiece in contact with metal instruments may cause burns at the tis-
sue/instrument interface.
• Isolate the handpiece in an accessory holster when not in use. This will prevent inadvertent
contact with fluids, the patient, or surgical personnel.
• Question unusual requests for increased power output settings. Such requests should initi-
ate a check of integrity/condition of all cords, connections, and electrodes including the
dispersive electrode (ground pad) before a power increase is made.
• Care should be taken during surgery to prevent inadvertent contact of the handpiece/
probe tip with tissue.
• Do not activate the electrosurgical unit, if the tip of the instrument is not in a position to
deliver energy (fulguration) to target tissue. Doing so may cause inadvertent burns to
patient.
• 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, neurostimula-
tors or other active implants. High frequency energy may damage or adversely affect
active implants. Ventricular fibrillation may occur.
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.Improper operation of this device may
compromise device safety.
• Use of the handpiece without gas flow may cause severe tip damage. Make certain the
ABC© connector is fully seated into the gas supply receptacle and make sure the gas sup-
ply hose does not become kinked or crimped. (Always test for gas flow prior to surgical use
by activating the handpiece and directing the active tip toward pooled fluid. Appropriate
gas flow will result in fluid dispersion prior to establishment of Argon Beam.)
• Before use, inspect the cord insulation and handpiece integrity and condition. If dam-
aged, chipped, cut, or nicked, do not use the handpiece/probe.
• Do not immerse, or pour fluids over, the handpiece.
• Do not pull or stretch the cord.
• Keep the handpiece and cord away from sharp objects that may cause damage to insu-
lation.
• Do not test the generator by sparking the active electrode to the dispersive electrode
(ground pad) or other objects.
• Argon Beam Coagulation should be used only by surgeons experienced in, and aware of,
Argon Beam techniques and safety.
• A complete understanding of the principles of monopolar electrosurgical technique is
necessary to avoid shocks and burns and the potential for gas embolism to the patient.
System Set-Up Procedure:
1. Use aseptic technique when removing the Handpiece from the package.
2. Remove tip protector from end of probe prior to use.
3. Inspect the probe for any damage. Do not use if you suspect any damage is present.
Notify the manufacturer immediately.
4. Attach the Laparoscopic ABC© Probe to the ABC© connector and (if using a hand-control
Probe being used) the Beam/monopolar hand-control connector on the front panel of
the CONMED Electrosurgical Generator with Argon Beam coagulation (integrated units) or
ABC© module.
5. Turn on the main power switch.
6. Select "Endo" gas flow.
Warning:
Gas Flow Rate should not exceed 4 LPM during laparoscopic procedures.
7. Select desired ABC© power level.
8. Set Gas Flow Rate to 4 liters per minute (LPM).
Recommendedforusewithadisposabletrocar,inordertominimizepotentialprobedam-
age.
Handpiece/ProbeActivation:
FootControl:
To activate Argon Beam Coagulation, depress ABC© footswitch.
HandControl:
To activate Argon Beam Coagulation, depress the blue button.
Note:
Handswitching Probes when used with an ABC© footswitch (REF 130146), can also be foot-
switch activated.
Handpiece/ProbeOperation:
1. Insert ABC© probe through the appropriate trocar by manually opening the valve and
inserting the probe.
2. Actively vent in order to prevent high insufflation pressures in the abdominal cavity during
laparoscopic use of this device, completely open the trocar stopcock on the trocar con-
taining the ABC© probe prior to and during the activation of the ABC© probe.
3. Depress ABC© button on handpiece or depress ABC© footswitch. Argon gas will begin to
flow.
4. Initiation (firing) of the Argon Beam Coagulator will occur as the Probe is advanced to
within 1 to 3 centimeters of the tissue.
5. Continuously monitor the abdominal pressure and the patient during use of this device. Do
not rely exclusively on the trocar stopcock to maintain the intra-abdominal pressure below
18mm Hg. Every effort should be made to not exceed the 18mm Hg maximum pressure.
If, except for very short transient events, the pressure exceeds this value, discontinue use
of the Laparoscopic ABC© Probe and allow excess gas to escape. Once pressure has
dropped below 18mm Hg you may continue use of the probe.
6. Move the activated Probe within 1-3cm slowly back and forth across the tissue surface in a
gentle motion.
7. When adequate hemostasis or tissue effect is achieved, deactivate the beam by releasing
the switch, then remove the Laparoscopic ABC© Probe and close the trocar stopcock.
Important:
Arc initiation is dependent on several variables such as ESU type, energy level used, handpiece
angle to the target area, and tissue type. It is recommended that the handpiece be held at
a 45 degree angle to the tissue for optimum performance and visibility. To initiate the arc, it is
recommended that the handpiece tip be brought to a distance within 1cm to the patient tis-
sue, once initiated the handpiece tip may be retracted for a more comfortable position and
arc length.
Do not touch the nozzle directly to tissue or otherwise bury the nozzle tip in tissue or fluids which
obscure visualization of the handpiece/probe tip.
AfterUse:
1. When finished using the handpiece/probe, disconnect it by unplugging the handpiece
connectors from the generator and argon gas unit.
2. After disconnection, this product may be a potential biohazard. Handle and disperse of
the handpiece as required by hospital policy and applicable law. Do not resterilize.
CAUTION:FederalLaw(U.S.A.)restrictsthisdevicetosalebyorontheorderof
aphysician.