Sabre Genesis Operators Manual Rev D March 2010

LIMITED WARRANTY For a period of two years following the date of delivery, CONMED Corporation warrants the CONMED Sabre Genesis™ Electrosurgical Generator against any defects in material or workmanship and will repair or replace (at CONMED’s option) the same without charge, provided that routine maintenance as specified in this manual has been performed using replacement parts approved by CONMED. This warranty is void if the product is used in a manner or for purposes other than intended.

STERILE EO © 2010 CONMED Corporation MdSS GmbH EC

REP

525 French Road Schiffgraben 41 STERILE D-30175 Hannover Utica, NY 13502-5994 USA Germany

R

STERILE A

U.S. Patent Numbers 6,830,569 - 6,875,210 - 6,948,503 D552241 and other patents pending.

2

0123 Authorization For Technical Service or Return LOTPhone: 303-699-7600 / 1-800-552-0138 Extension 5274 Fax 303-699-1628 CUT

COAG

For Customer Service or to order parts phone: 1-800-448-6506 / 315-797-8375 / Fax 315-735-6235 or contact your CONMED Representative. EC

REP

STERILE EO

European Authorized Representative MdSS GmbH Schiffgraben 41 MDSS GmbH STERILE D-30175 Hannover Schiffgraben 41 Germany D-30175 Hannover STERILE Germany

R A

9083

The revision level of this manual is specified by~ the highest revision letter found on either theLOT inside front cover 0123 or enclosed errata pages (if any).

2

Manual Number 60-8201-ENG Rev. D 3/10 CUT

COAG

Unit Serial Number_________________________________

9083

~

Table of Contents & List of Illustrations

Section

Title

Page

1.0

General Information... 1-1

1.1

Cautions... 1-1

1.2

Specifications... 1-9

1.3

Explanation of Symbols... 1-12

1.4 1.5

Output Characteristic Curves . ... 1-13 Compatibility... 1-18

1.1.1 1.1.2 1.1.3 1.1.4 1.1.5 1.1.5.1 1.1.5.2 1.1.5.3 1.1.5.4 1.2.1 1.2.2 1.2.3 1.2.4 1.2.5 1.2.6 1.2.7 1.2.8 1.2.9 1.2.10 1.2.11 1.3.1 1.3.2 1.3.3 1.3.4

1.5.1

2.0

Cautions For Equipment Preparation... 1-1 WARNINGS For Patient Preparation... 1-2 Cautions For Use... 1-4 Cautions For Testing or Servicing... 1-5 Electromagnetic Compatibility ... 1-6 EN/IEC 60601-1-2 Table 201... 1-6 EN/IEC 60601-1-2 Table 202... 1-7 EN/IEC 60601-1-2 Table 204... 1-8 EN/IEC 60601-1-2 Table 206... 1-9

Mains Overcurrent Protection... 1-9 Mains Frequency Leakage... 1-9 Regulatory Compliance... 1-10 Operation... 1-10 Power Display Accuracy... 1-10 Line Regulation... 1-10 Environmental... 1-10 Contact Quality Monitor... 1-10 Audio Specifications... 1-10 Other Specifications... 1-10 Operating Modes and Nominal Output Parameters... 1-11 Control Panel... 1-12 Interior... 1-12 Output/Control Panel... 1-12 Rear Panel... 1-12

Compatible Active Accessories... 1-19

Installation and Operation... 2-1

2.1 2.2 2.3

Initial Inspection... 2-1 Installation... 2-1 Controls, Displays and Connectors... 2-1

2.4

Preliminary Checks... 2-6

2.3.1 2.3.2 2.3.3 2.4.1 2.4.2

Control Panel... 2-1 Output Panel... 2-3 Rear Panel... 2-4 Preliminary Functional Testing... 2-6 Preliminary Performance Testing ... 2-7

Section

Title

2.5 2.6 2.7

Set Up For Use... 2-7 Operation... 2-9 User Maintenance... 2-9

2.8

In Case of Difficulty... 2-10

2.9

Environmental Protection... 2-11

2.7.1 2.7.2 2.7.3 2.7.4 2.8.1 2.8.1.1 2.8.1.2 2.8.2 2.8.3 2.8.4

Figure/Title

Page

General Maintenance Information... 2-9 Cleaning... 2-9 Periodic Inspection... 2-10 Periodic Performance Testing... 2-10

Dispersive Electrode Alarm... 2-10 Single Dispersive Electrode Alarm... 2-10 Dual Dispersive Electrode Alarm... 2-10 Acc Codes... 2-11 Err Codes... 2-11 If All Else Fails... 2-11

Page

Figure 1.1 Monopolar Cut and Blend Output Power vs. Power Dial Setting... 1-13 Figure 1.2 Monopolar Coag Output Power vs. Power Dial Setting... 1-14 Figure 1.3 Bipolar Coag Output Power vs. Power Dial Setting... 1-14 Figure 1.4 Open Circuit Peak Voltage vs. Power Setting... 1-15 Figure 1.5 Load Regulation, Monopolar Pure Cut... 1-15 Figure 1.6 Load Regulation, Monopolar Blend... 1-16 Figure 1.7 Pulse Cut... 1-16 Figure 1.8 Pulse Blend... 1-17 Figure 1.9 Load Regulation, Bipolar... 1-17 Figure 1.10 Load Regulation, Monopolar Coag... 1-18 Figure 2.1 Sabre Genesis™ control panel... 2-2 Figure 2.2 Sabre Genesis™ output panel... 2-3 Figure 2.3 Sabre Genesis™ rear panel... 2-4 Figure 2.4 Accessory Schematics... 2-5 Figure 2.5 Active Electrode Dimensions... 2-5

General Information Section 1.0

CAUTION: FEDERAL LAW (USA) RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN. Indications for use: The CONMED Sabre Genesis™ is intended to be used by licensed practitioners as a general-purpose electrosurgical generator used in conjunction with an electrosurgical handpiece for delivery of RF (radio frequency) electrosurgical current through an accessory electrode for cutting and coagulation at the operative site. This manual provides the set up and operating instructions for the Sabre Genesis™ Electrosurgical Unit (ESU). Electrosurgery can be dangerous to patients, staff and other equipment if misused. Please understand and follow the warnings and cautions included in this manual. Technical specifications, performance characteristic curves and user maintenance instructions are also included. The Sabre Genesis™ provides a broad range of capabilities in a single, general-purpose electrosurgical generator. This ESU fulfills the operational and safety needs of the operating room by providing: • Three monopolar cutting modes: Pure, Blend and Pulse. • One monopolar coagulation mode • One bipolar mode • Radio Frequency (RF) isolated and independent outputs. • The proven Automatic Return Monitor (A.R.M.™) contact quality monitoring system. • Continuous microprocessor safety monitoring. Features include: • Dynamic Response Technology delivers optimal clinical effects in all operational modes through the continuous synchronization of current and voltage. • Automatic programming restores the ESU to the last settings used. • Ability to change power settings from the

•

• •

control panel while the ESU is activated. One combination monopolar handswitched / footswitched receptacle and a separate bipolar accessory receptacle enable multiple accessory connections. Channeled accessory receptacles direct plugs into position for easy attachment. Integrated interface for activation of smoke evacuators and similar devices.

1.1

Cautions

This equipment, in conjunction with connected accessories, is intended to produce high-frequency electrical energy for the controlled destruction of tissue. Safe and effective electrosurgery is dependent not only on equipment design, but also on factors under the control of the operator. It is important the instructions supplied with this equipment be read, understood and followed in order to ensure safe and effective use of the equipment. 1.1.1

Cautions For Equipment Preparation

•

Use only accessories that meet the requirements of Section 1.2, Section 1.4, and Figure 2.4. Use of other accessories may result in increased emissions or decreased immunity of the ESU.

•

Reusable accessory cables should be periodically function and safety tested in accordance with the original manufacturer’s instructionsfor-use.

•

Visually inspect all accessories before each use to verify the integrity of insulation and the absence of obvious defects. In particular, electrode cables and endoscopic accessories should be checked for damage to the insulation.

•

Unused accessories should be stowed in a safe, electrically insulated place such as a non-conductive holster that is isolated from

1-1

the patient. CONMED recommends accessories not be connected unless needed. •

Never connect more than one accessory at a time to any one receptacle. This does not include the dispersive electrode receptacle when the appropriate CONMED adapter is used.

•

Use the power cord provided with the unit. Replacement power cords may be obtained from ConMed. Use only a hospital grade, 3-prong, power cord rated to meet the specifications in Section 1.2 and all of the requirements for safe grounding of the ESU. The user should verify that the power receptacle with which this ESU is used is properly grounded, correctly polarized and of the proper frequency per Section 1.2. Do not use ground “cheater plugs” or extension cords.

•

• •

•

•

•

•

1-2

Do not place containers with liquid on top of the ESU. Wipe spilled liquids off the ESU immediately. To preclude inadvertent entry of liquids, do not operate this ESU except in its normal position. Do not stack other devices or equipment on top of or adjacent to the Sabre Genesis™. Confirm all accessories are properly connected to the appropriate receptacles before powering the ESU. Potentially hazardous conditions may exist when accessories of similar connector types are combined. Be certain accessories are appropriate for the type of generator output used. Use only CONMED Electrosurgery footswitches. Confirm bipolar leads are connected only to the bipolar receptacles. Connecting bipolar accessories to monopolar outputs may result in patient injury. Do not reuse disposable (single use) accessories. The ability to effectively clean and re-sterilize this single use device has not been established and subsequent re-use may adversely affect the performance, safety and/ or sterility of the device. Do not use cords as handles as damage to the insulation, increased risk of burns or other injury may result. Interference may occur between the RF signals of the Sabre Genesis™ and groundreferenced ESUs that are used simultane-

ously with the Sabre Genesis™. Do not use ground-referenced ESUs with the Sabre Genesis™. •

A failure in the ESU could cause an unintended increase in output power. Verify the ESU is functioning correctly prior to use.

•

Prior to use, verify that devices connected to the Activation Relay Connector function properly in a manner that is synchronized with ESU power delivery.

1.1.2

WARNINGS For Patient Preparation

WARNING •

Flammable agents used for cleaning or disinfecting, or as solvents of adhesives, should be allowed to evaporate before the high frequency surgical equipment is used.

•

There is a risk of pooling of flammable solutions in body depressions such as

the umbilicus and in body cavities, such as the vagina.

Any fluid pooled in

these areas should be removed before the high frequency surgical equipment is used.

•

Due to the danger of ignition of endogenous gases, the bowel should be purged and filled with nonflammable gas prior to abdominal surgery.

To

avoid the risk of tracheal fires, never use electrosurgery to enter the tra-

chea during tracheotomy procedures.

•

The use of flammable anesthetics or oxidizing gases such as nitrous oxide

(N2O) and oxygen should be avoided if a surgical procedure is carried out in

the region of the thorax or the head, unless these agents are sucked away.

•

Only non-flammable agents should be used for cleaning and disinfection.

•

Exercise care when moving the ESU to avoid electrostatic charge buildup in

the presence of flammable materials, as there is a risk of igniting these materials if a spark should occur.

•

This ESU is equipped with the Automatic Return Monitor (A.R.M.™), which monitors the quality of the dispersive electrode connection.

battery powered, insulated or isolated

WARNING When a correctly functioning single

at 50/60 Hz. The risk of burns can be reduced but not eliminated by plac-

dispersive electrode is connected to

ing the probes as far away as possible

the ESU, A.R.M.™ verifies the connec-

from the electrosurgical site and the

tions between the ESU, the dispersive electrode cable and the dispersive

dispersive electrode.

single dispersive electrode is in contact

leads may further reduce the risk of

electrode.

It DOES NOT verify that a

these burns.

with the patient.

When using a dual dispersive electrode, A.R.M.™ confirms

the total resistance is within the preset safety range.

Proper application and

visual inspection of the dispersive elec-

electrosurgical procedures.

•

equipment are used simultaneously

on the same patient, all monitoring

The use and proper placement of a dispersive electrode is a key element

electrodes should be placed as far

Follow manufacturer’s directions

dispersive electrode.

as possible from the surgical site and

and recommended practices for the

lance and removal of the dispersive

frequency current limiting devices are

electrode supplied for use with this electrosurgical unit.

Monitoring systems incorporating high

Apply the dispersive electrode over a well-vascularized muscle mass that is thoroughly clean and dry. Clean site and clip hair as necessary (per hospital policy) to provide adequate electrical connection. Avoid placement over scar tissue, bony prominences or other areas

recommended whenever possible.

•

The active electrode should not be

used in the vicinity of electrocardiograph electrodes.

•

Heat applied by thermal blankets or other sources is cumulative with the heat produced at the dispersive elec-

trode (caused by electrosurgical currents).

Choosing a dispersive electrode

site that is remote from other heat

where pressure points on small areas might develop.

sources may minimize risk of a patient

Because of the risk of burns, needles should never be used as a dispersive electrode for electrosurgery.

The

injury.

•

Electrosurgery, by its nature produces significant levels of electromagnetic interference (EMI) when the ESU is

entire area of the dispersive electrode should be placed so that the entire

activated.

conductive area is in firm contact with

impair the function of other electronic

an area of the patient’s body that has a

equipment in the operating room, espe-

good blood supply and is as close to the

cially equipment that makes contact

electrosurgical current paths should

can only be mitigated by use of equip-

be as short as possible and should run

ment specifically designed to tolerate

operative site as possible.

direction to the body, not laterally

and under no circumstances lateral to the thorax.

Dispersive electrodes and probes of

monitoring, stimulating and imaging devices can provide paths for high

This EMI may damage or

with the patient.

In general,

Adverse effects

electrosurgical interference.

either longitudinally or in a diagonal

•

Needle monitor-

ing electrodes are not recommended.

preparation, placement, use, surveil-

•

When high frequency surgical equipment and physiological monitoring

in safe and effective electrosurgery.

•

Needles should not be

used as monitoring electrodes during

trode is required for safe operation.

•

Protective imped-

ances incorporated in the monitoring

•

Other equipment in the operating room, including portable or mobile communications equipment may produce EMI, which can affect the function of the

ESU. Adverse effects can only be mitigated by use of equipment with EMI

frequency currents even if they are

1-3

WARNING

ries or illness involving the use of a medical device must be reported to

characteristics proven below recog-

the manufacturer of the device (or to

nized limits.

In the event of suspected interference from other equipment, discontinue use of the ESU until the problem can be remedied. •

the FDA if the manufacturer of the

device is not known) within 10 working days of the incident.

The patient should not be allowed to

ted directly to the FDA twice a year.

come into contact with metal items

Patient deaths related to the use of

that are grounded or have an appre-

a medical device must be reported to

ciable capacitance to earth.

Examples of this would be operating tables, supports, etc. •

the manufacturer and the FDA.

the Regulatory Affairs Department of

CONMED Electrosurgery at 800-5520138, 303-699-7600 or FAX 303-6999854.

cause localized burns if they make contact with grounded items and should

Skin to skin contacts, such as between

Do not use monopolar electrosurgery on small appendages, as in circumcision or finger surgery, as it can cause

the arm and body of a patient or

thrombosis and other unintended

use of electrosurgery.

•

•

between the legs and thighs, should be

injury to tissue proximal to the surgi-

avoided by the insertion of dry gauze.

•

cal site.

The use of electrosurgery on patients

neurostimulators or other active

apply the bipolar electrosurgical cur-

is acceptable for circumcision, do not

with cardiac pacemakers, AICDs,

rent directly to circumcision clamps.

The

implant may be irreparably damaged

1.1.3

the electrosurgical output may inter-

•

Safe and effective electrosurgery is dependent not only on equipment design, but also on factors under the control of the operator. It is important the instructions supplied with this equipment be read, understood and followed in order to ensure safe and effective use of the equipment. The Sabre Genesis™ is capable of causing physiological effects, including burns to the patient or operator.

•

Only properly qualified and trained operators should perform electrosurgery. The operator and their support personnel must be diligent in assuring the ESU is properly configured and proper settings are used. The ESU must be in a location that assures the operator or their support personnel can readily verify the settings.

•

Apparent low power output or failure of the electrosurgical equipment to provide the expected effect at otherwise normal settings may indicate faulty application of the dispersive electrode, failure of an electrical

and/or the high frequency energy of

fere with the function of the implant.

Ventricular fibrillation may occur. Precautions should be taken to ensure the patient’s well-being is maintained in the event of such interaction. The manufacturers of the implants should

be consulted for advice before operating on a patient with an implant.

These

precautions also apply to operating

room personnel with similar implants.

To minimize the possibility of cardiac

pacemaker interference, place the

dispersive electrode such that the electrosurgical current path does not intersect the path of the pacemaker or leads.

•

PLEASE NOTE: Federal law (U.S.A.) requires all health care facilities must report to the manufacturer of a medical device any death or serious injury or illness to a patient related to the use of a medical device.

1-4

Should the surgeon decide

the bipolar electrosurgical technique

implants is potentially hazardous.

•

For

further information, please contact

Jewelry and other metallic items can

be removed from the patient prior to

Summary reports

of such injuries must also be submit-

Serious inju-

Cautions For Use

lead or excessive accumulation of tissue on the active electrode. Do not increase power output before checking for obvious defects or misapplication of the dispersive electrode. Check for effective contact of the dispersive electrode to the patient anytime the patient is moved after initial application of the dispersive electrode. •

Studies have shown the smoke generated during electrosurgical procedures may be harmful to surgical personnel. These studies recommend using a surgical mask and adequate ventilation of the smoke using a surgical smoke evacuator.

the attached accessory. •

Observe all caution and warning symbols.

•

The operating room staff should never contact electrosurgical electrodes (either active or dispersive) while the RF output of the ESU is energized.

•

The electrodes of recently activated accessories may be hot enough to burn the patient or ignite surgical drapes or other flammable material.

•

Do not ignore unexpected tones. Check to determine the cause of the tone to avoid potential injury.

•

Temporarily unused active electrodes should be stored in an electrically insulated holster. The unused active electrode should never be placed on the patient. This is especially important for laparoscopic procedures.

•

Ensure the footswitches are not inadvertently depressed in order to prevent accessories from being unintentionally activated. Place footswitches in locations that necessitate deliberate action in order to activate the footswitch. Use caution when selecting the correct footswitch to activate.

•

In the event the system resets due to a power interruption or low voltage, check the contact of the dispersive electrode prior to resuming electrosurgery.

•

If a dispersive electrode or A.R.M.™ alarm is sounded intraoperatively, physically confirm proper dispersive electrode attachment to the patient and confirm the display falls within the set range. Smooth the dispersive electrode surface with hand to ensure electrode contact to patient skin. Replace the dispersive electrode if necessary.

•

The cables to the surgical electrodes (active, bipolar or dispersive electrodes) should be positioned in such a way that contact with the patient or other leads is avoided.

1.1.4 •

•

Confirm the desired electrosurgical mode is selected prior to use to ensure output characteristics are suitable for the intended procedure.

Service should not be attempted without reference to the Sabre Genesis™ Service Manual (Catalog Number 60-8202-ENG).

•

•

Confirm the desired bipolar mode is selected prior to use to ensure output characteristics are suitable for the intended procedure.

This electrosurgical unit should be tested by a Hospital Qualified Biomedical Technician on a periodic basis to ensure proper and safe operation. It is recommended that examination of the ESU be performed at least annually.

•

The output power selected should be as low as possible and activation times should be as short as possible for the intended purpose.

•

Refer all servicing to a Hospital Qualified Biomedical Technician.

•

High voltages are developed within the ESU are accessible when the top cover is removed. These voltages are potentially dangerous and should be treated with extreme caution.

•

Never remove or install any parts with the power cord connected to AC mains.

•

Always unplug the power cord before servicing the unit.

•

Avoid contact with the output leads when the ESU is activated. Periodically inspect the test leads used for the output connections for obvious defects.

•

The clinical use of electrosurgery is intermittent in nature. This ESU should not be activated continuously for extended periods of time.

•

When uncertain of the proper setting for the power level in a given procedure, start with a low setting and increase as required.

•

Avoid output power settings that may result in output voltages that exceed the rating of

Cautions For Testing or Servicing

1-5

•

Although this ESU will withstand momentary short circuits on the output, prolonged short circuits may damage the ESU. Short-circuiting the output should be avoided since it is neither necessary nor desirable.

•

As the clinical use of electrosurgical units is intermittent in nature with duty cycles on the order of 10%, this ESU is not designed to operate for extended periods of continuous output. When testing, it is recommended that duty cycles be limited to 15 seconds activation with delays of 30 seconds between activations.

•

Activating the Sabre Genesis™ in other than its normal operating position impairs the heat dissipation capability of the heat sink.

•

Ensure the two top-cover screws are tightened. Always perform a power-up check to confirm a normal power-up sequence before returning the ESU to service.

•

Improperly connecting test equipment can cause electric shock and destruction of equipment.

•

Turn unit off and wait until storage capacitors have discharged before connecting test equipment.

•

Loss of power supply isolation can cause electrical shock. When servicing the high voltage power supply, assume internal isolation is compromised until verified otherwise.

1.1.5

Electromagnetic Compatibility

Following are guidance and manufacturer’s declarations regarding electromagnetic compatibility for the Sabre Genesis™.

1.1.5.1 EN/IEC 60601-1-2 Table 201 Guidance and Manufacturer’s Declaration – Electromagnetic Emissions The Sabre Genesis™ Electrosurgical Unit is intended for use in the electromagnetic environment specified below. The customer or the end user of the Sabre Genesis™ Electrosurgical Unit should assure that it is used in such an environment.

Emissions test

Compliance

Electromagnetic environment - guidance

RF emissions CISPR 11

Group 2

The Sabre Genesis™ Electrosurgical Unit must emit electromagnetic energy in order to perform its intended function. Nearby electronic equipment may be affected.

RF emissions CISPR 11

Class A

Harmonic emissions IEC 61000-3-2

Class A

Voltage fluctuations/ Flicker emissions IEC 61000-3-3

Complies

The Sabre Genesis™ Electrosurgical Unit is suitable for use in all establishments, other than domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.

1-6

1.1.5.2 EN/IEC 60601-1-2 Table 202 Guidance and Manufacturer’s Declaration – Electromagnetic Immunity The Sabre Genesis™ Electrosurgical Unit is intended for use in the electromagnetic environment specified below. The customer or the end user of the Sabre Genesis™ Electrosurgical Unit should assure it is used in such an environment.

Immunity Test

IEC60601 test level

Compliance level

Intended Electromagnetic environment

Electromagnetic discharge (ESD) IEC 61000-4-2

±6 kV contact ±8 kV air

±6 kV contact ±8 kV air

Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%.

Electrical fast transient/ burst

±2 kV for power supply lines

±2 kV for power supply lines

Mains power quality should be that of a typical commercial or hospital environment.

IEC 61000-4-4

±1 kV for input/ output lines

±1 kV for input/ output lines

Surge

±1 kV differential mode

±1 kV differential mode

±2 kV common mode

±2 kV common mode

IEC 61000-4-5

Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11

Mains power quality should be that of a typical commercial or hospital environment.

Mains power quality should be that of a typi<5 % UT <5 % UT (>95 % dip in UT) (>95 % dip in UT) cal commercial or hospital environment. If the user of the Sabre Genesis™ Electrosurgical Unit for 0.5 cycle for 0.5 cycle requires continued operation during power 40 % UT 40 % UT mains interruptions, it is recommended that the (60 % dip in UT) (60 % dip in UT) Sabre Genesis™ Electrosurgical Unit be powfor 5 cycles for 5 cycles ered from an uninterruptible power supply or a battery. 70 % UT 70 % UT (30 % dip in UT) (30 % dip in UT) for 25 cycles for 25 cycles

<5 % UT <5 % UT (>95 % dip in UT) (>95 % dip in UT) for 5 sec for 5 sec Power frequency (50/60 Hz) magnetic field IEC 61000-4-8

3 A/m

3 A/m

Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.

NOTE UT is the a.c. mains voltage prior to application of the test level.

1-7

1.1.5.3 EN/IEC 60601-1-2 Table 204 Guidance and Manufacturer’s Declaration – Electromagnetic Immunity The Sabre Genesis™ Electrosurgical Unit is intended for use in the electromagnetic environment specified below. The customer or the end user of the Sabre Genesis™ Electrosurgical Unit should assure it is used in such an environment.

Immunity Test

IEC60601 test level

Compliance level

Intended Electromagnetic environment Portable and mobile RF communications equipment should be used no closer to any part of the Sabre Genesis™ Electrosurgical Unit, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.

Recommended separation distance Conducted RF IEC 61000-4-6

3 Vrms 150 kHz to 80 MHz

3 Vrms

d = 1.2√P

Radiated RF IEC 61000-4-3

3 V/m 80 MHz to 2.5 GHz

3 V/m

d = 1.2√P 80 MHz to 800 MHz d = 2.3√P 800 MHz to 2.5 GHz Where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey, a should be less than the compliance level in each frequency range.b Interference may occur in the vicinity of equipment marked with the following symbol:

NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. a

Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the Sabre Genesis™ Electrosurgical Unit is used exceeds the applicable RF compliance level above, the Sabre Genesis™ Electrosurgical Unit should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the Sabre Genesis™ Electrosurgical Unit.

b

Over the frequency range 150 kHz to 80 MHz, field strengths should be less than [v1] V/m.

1-8

1.1.5.4 EN/IEC 60601-1-2 Table 206 Recommended separation distances between portable and mobile RF communications equipment and the Sabre Genesis™ Electrosurgical Unit The Sabre Genesis™ Electrosurgical Unit is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The user(s) of the Sabre Genesis™ Electrosurgical Unit can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Sabre Genesis™ Electrosurgical Unit as recommended below, according to the maximum output power of the communications equipment.

Rated maximum output power of transmitter

Separation distance according to frequency of transmitter (m) 150 kHz to 80 MHz

80 MHz to 800 MHz

800 MHz to 2.5 GHz

d = 1.2√P

d = 1.2√P

d = 2.3√P

0.01

0.12

0.12

0.23

0.1

0.38

0.38

0.73

(W)

1

1.2

1.2

2.3

10

3.8

3.8

7.3

100

12

12

23

For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output rating of the transmitter in watts (W) according to the transmitter manufacturer. NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

1.2

Specifications

Input Power: 60-8200-120: 100-120V, 50/60Hz, 4.0A max, 350W max. 60-8200-230: 100-240V, 50/60Hz, 4.0A max, 350W max. 1.2.1

Mains Internal Overcurrent Protection

Two F6.3A, 250V, Type 215 by Littlefuse. 1.2.2

Mains Frequency Leakage

Designed to comply with leakage current requirements of IEC 60601-2-2:2006, 4th Edition, EN 606011:1990 +A1:1993 +A2:1995 +A13:1996, UL 60601-1 1st Edition, and CSA C22.2 No. 601.1 with Updates 1 & 2.

1-9

1.2.3

Regulatory Compliance

Designed to comply with Medical Electrical Equipment Standards (UL60601-1, IEC606011: 2005, IEC60601-1-1: 2000, IEC60601-1-2: 2005, IEC60601-1-4: 2000, IEC60601-1-6: 2004, IEC60601-1-8: 2005, IEC60601-2-2: 2006). Manufactured in an ISO 13485: 2003 Registered Facility.

1.2.8

Contact Quality Monitor

Single dispersive electrode: Two wire continuity detector, typical trip threshold is 10 ohms Dual dispersive electrode: Two wire resistance monitor, typical acceptance range 10 to 150 ohms, trip threshold typically 30% higher than initial activation. 1.2.9

Audio Specifications

Type of protection against electric shock: IEC Class 1.

Cut = 523 Hz

Degree of protection against electric shock: Type CF, Defibrillation-Proof.

Bipolar = 440 Hz

Non-Ionizing Radiation.

Dispersive Electrode Alarm = 847 Hz (pulsating)

RF Leakage: <100 mA per IEC60601-2-2: 2006 Clause 19.3.101b. 1.2.4

Operation

Coag = 440 Hz Acc Fault = 847 Hz (pulsating) Err Fault = 847 Hz (pulsating) Increase Power Level = 379 Hz Decrease Power Level = 343 Hz

Mode of operation: Intermittent 15 Sec on/30 Sec off.

(All tones are 45 dbA minimum except Alarms, which are 65 dbA minimum)

1.2.5

1.2.10 Other Specifications

Power Display Accuracy

The greater of ±10% of display or ±3 watts at rated load. 1.2.6

Line Regulation

Power Change <1% for the range of line voltages specified. 1.2.7

Environmental

Operating Conditions: 10°C to 40°C, 95% RH Non-condensing maximum at altitudes from -60 meters to 3050 meters above mean sea level. Degree of protection against Ingress of Water: IPX1 (Protection against vertically falling water drops). Mounting Restriction: 2-inch (5cm) clearance required on each side, back and above the ESU for cooling. Cooling: Natural convection, conduction, and radiation. Storage Conditions: -34°C to 65°C, at altitudes from –60 to +4500 meters above mean sea level when sealed in original poly bag, packing material and shipping carton. Prior to shipment or storage, the ESU should be enclosed and sealed in a polyethylene bag and placed in original carton using original packaging materials.

1-10

Power Cord: All units are supplied with an IEC-320 250V 10A 65°C mains inlet connector. Power cords can be ordered from CONMED Electrosurgery

Region

Specification

Description

USA, Canada

Any UL, CSA manufacturer

SJT or better

250VAC, minimum 16AWG, 3 Conductor, maxi- UL817 mum length 20 feet (6m)

Standard

Europe

Any HAR cord manufacturer

<HAR>H05WF3G1.0

Copper 1.0mm2 minimum cross sectional area, maximum length 20 feet (6m)

IEC60799

Weight: 14.65 lb. (6.65 kg) Height: 6.08 inches (15.44 cm); Width: 13 inches (33 cm); Depth: 18 inches (45.72 cm) including handle SPECIFICATIONS SUBJECT TO CHANGE WITHOUT NOTICE 1.2.11 Operating Modes and Nominal Output Parameters Mode

Max Power (watts)

Rated Load (ohms)

Typical Crest Factor*

Max Open Circuit Voltage (Peak) **

Carrier Freq. (KHz)**

Pulse Repetition Freq.(KHz)

Pure Cut

200

500

1.4–2 at 50W

924V

390-410

N/A

Blend Cut

200

500

2.2–2.9 at 50W

1,200V

390-410

24 – 26

Pulse Cut

200

500

-

924V

390-410

600mS

Pulse Blend

200

500

-

1,200V

390-410

600mS

Coag

80

500

5.6-6.6 at 50W

2,560V

485-505

38 – 42

50

50

1.4–2 at 25W

130V

390-410

N/A

Monopolar

Bipolar Coag

*Measured at rated load **Measured in the open circuit condition.

1-11

1.3

Explanation of Symbols

1.3.1

Control Panel

Note: International Sabre Genesis™ units use symbols on the Control Panel. Some symbols are replaced by words on the domestic (U.S.) units. These words are indicated by bold text in the symbol description.

USB

IOIOI IOIOI

RF Isolated: Patient connections are isolated from earth at high frequency.

Blend waveform with moderate hemostasis.

There are specific warnings or precautions associated with this device. Consult Manual prior to use. Consult accompanying documents prior to placing equipment in service.

Bipolar Coagulation

Power on: connected to the mains.

Dual[ODispersive electrode 2] Status/Alarm Indicator for dual monopolar dispersive electrodes Single Dispersive electrode Status/Alarm Indicator for single monopolar dispersive electrodes. Volume control: Activation tone.

1.3.2

Type CF: Patient connections are isolated from earth and resist the effects of defibrillator discharge.

Pure Cut waveform with minimum thermal damage and hemostasis.

Monopolar Coagulation

Single

Caution: High voltage output.

ORCC

Pulse Cut waveform

Dual

Bipolar Output: Connection for bipolar accessories.

Power off: disconnected from the mains. 1.3.4

Rear Panel Enclosure resists entry of vertically falling water.

Interior

This equipment intentionally supplies non-ionizing RF energy for physiological effect.

Protective Earth (Inlet Connector)

Explosion risk if used in the presence of flammable anesthetics.

Functional earth

Do not operate in oxygen enriched environments.

High Voltage Circuitry

Bipolar Footswitch Connector. 1.3.3

Output/Control Panel Dispersive Electrode – Connection for monopolar dispersive electrode. Hand-controlled Monopolar Output: Connection for handcontrolled monopolar accessories.

1-12

Monopolar Footswitch Connector.

[O [O22 ]]

Activation relay connector.

USB

IOIOI ORCC

IOIOI

Equipotential Ground Terminal.

UL Classifcation With Respect to electric shock, fire and mechanical hazards only in accordance with UL606011, 1st Edition, CSA C22.2 No. 601.1 with updates 1 & 2, IEC 60601-2-2:2006, 4th Edition (excluding human subject testing), EN 60601-1: 1990 + A1:1993 + A2:1995 + A13:1996.

Replace fuse only with type and rating as shown. __A ___V

Caution - High Voltage Inside - Refer servicing to qualified personnel. Keep dry

1.4

Output Characteristic Curves

Figures 1.1 - 1.3 illustrate output power delivered to rated load for each available mode. Figure 1.4 illustrates the maximum peak voltage available at a given power setting and output mode. Section 1.2 specifies rated loads and maximum power for each mode, while figures 1.5 – 1.10 illustrate output power delivered to a range of load resistances for each mode.

Dial vs Power 200

Output Power (@ 500Ω Load)

180 160 140 120 100 80 60 40 20 0 0

20

40

60

80

100

120

140

160

180

200

Displayed Power

Figure 1.1 Monopolar Cut and Blend Output Power vs. Power Dial Setting

PEAK VOLTAGE 2600 2400

1-13

Dial vs Power 80

Output Power (@ 500Ω Load)

70 60 50 40 30 20 10 0

0

10

20

30

40

50

60

70

80

Displayed Power

Figure 1.2 Monopolar Coag Output Power vs. Power Dial Setting

Dial vs Power 50

Output Power (@ 50Ω Load)

45 40 35 30 25 20 15 10 5 0 0

5

10

15

20

25

30

35

40

Displayed Power

Figure 1.3 Bipolar Coag Output Power vs. Power Dial Setting

1-14

45

50

Peak Voltage 3000

2500

Peak Voltage

2000

1500

1000

500

0 0

10

20

30

40

50

60

70

80

90

100

110

120

130

140

150

160

170

180

190

200

Power Setting

Figure 1.4 Open Circuit Peak Voltage vs. Power Setting

PURE CUT 100W, 200W 220 210 200 190 180 170 160 150 OUTPUT POWER

140 130 120 110 100 90 80 70 60 50 40 30 20 10 0 0

100

200

300

400

500

600

700

800

900

1000 1100 1200 1300 1400 1500 1600 1700 1800 1900 2000 LOAD

Figure 1.5 Load Regulation, Monopolar Pure Cut

210 200 190

BLEND 100W, 200W

1-15

0 0

100

200

300

400

500

600

700

800

900

1000 1100 1200 1300 1400 1500 1600 1700 1800 1900 2000 LOAD

BLEND 100W, 200W

210 200 190 180 170 160 150

OUTPUT POWER

140 130 120 110 100 90 80 70 60 50 40 30 20 10 0 0

100

200

300

400

500

600

700

800

900

1000 1100 1200 1300 1400 1500 1600 1700 1800 1900 2000 LOAD

Figure 1.6 Load Regulation, Monopolar Blend PULSE CUT 100W & 200W COAG 40W & 80W

220 85

PULSED PEAK 100W PULSED PEAK 200W PULSED AVG 100W PULSED AVG 200W

200 80 75

180 70 65

160 60 55

OUTPUT POWER (W)

OUTPUT POWER

140 50 45

120 40 35

100 30 25

80 20 15

60 10

5

40 0

20

0

100

200

300

400

500

600

700

800

900

1000

1100

1200

1300

1400

1500

1600

1700

1800

1900

2000

LOAD

0 0

200

400

600

800

1000

1200

RESISTANCE

BIPOLAR

55 50

1-16

45 40

Figure25W 1.7&Pulse 50W Cut

1400

1600

1800

2000