Model ASU2 and ASU3 Users Manual Rev G

USER’S MANUAL

European Representative: Herbert Köntges Köntges SPRL Avenue Hellevelt 35 B-1180 Brussels Belgium Tel: +32 2 375 51 63 FAX: +32 2 375 89 06 email: [email protected]

Table of Contents 1.

GETTING STARTED ...3 1.1. 1.2. 1.3. 1.4. 1.5.

2.

THE ATRICURE ABLATION AND SENSING UNIT (ASU)...11 2.1. 2.2. 2.3.

3.

Transporting the ASU ... 16 Adjusting the Viewing Angle ... 16 Preparing the ASU For Use ... 16 Power Cord ... 16 Connecting and Disconnecting the Handpiece... 17 Installing the Footswitch ... 17

INSTRUCTIONS FOR USE ...19 4.1. 4.2. 4.3. 4.4.

5.

Device Description ... 11 ASU Front Panel – Illustration and Nomenclature ... 11 ASU Rear Panel – Illustration and Nomenclature ... 14

INSTALLING THE ASU ...16 3.1. 3.2. 3.3. 3.4. 3.5. 3.6.

4.

System Description ... 4 Unpacking ... 4 Warnings and Precautions ... 4 EMC Guidance and Manufacturer’s Declaration ... 7 Responsibility of the Manufacturer ... 10

Powering Up the ASU ... 19 Operating Modes ... 20 Audio Tones ... 21 Delivering RF Energy ... 22

TROUBLESHOOTING ...25 5.1. 5.2. 5.3.

No RF Power Output ... 25 Error Codes ... 25 Electromagnetic or Other Interference ... 26

6.

SYMBOLS USED ...28

7.

TECHNICAL SPECIFICATIONS ...30 7.1. 7.2. 7.3. 7.4. 7.5. 7.6. 7.7. 7.8.

8.

RF Output ... 30 Mechanical Specifications... 30 Environmental Specifications ... 30 Electrical Specifications ... 31 Fuses ... 31 Footswitch Specifications ... 31 Power and Voltage Output Restrictions ... 31 Equipment Type / Classification ... 31

PREVENTIVE MAINTENANCE AND CLEANING OF ASU ...34 8.1.

Preventive Maintenance ... 34

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8.2. 9.

Cleaning and Disinfecting ... 35

DISPOSAL ...35

10. ACCESSORIES ...35 10.1. ASB3, Switch Matrix Accessory ... 36 11. ACCESSORIES AND CABLES...38

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1. Getting Started This manual, and the equipment, it describes are for use only by qualified medical professionals trained in the particular technique and surgical procedure to be performed. Federal Law (US) restricts this device to sale by or on the order of a physician. Please read all information carefully. Failure to properly follow the instructions may lead to serious surgical consequences. Important: This manual is designed to provide instructions for use of the AtriCure Ablation and Sensing Unit (ASU) with the AtriCure Bipolar Handpiece (Isolator clamp, Isolator Transpolar pen, or CoolRail linear pen) and AtriCure Accessory Devices (ASB 3). It is not a reference to surgical technique. The AtriCure ASU produces and delivers RF energy, in a bipolar mode, at a frequency of approximately 460 kHz, with a maximum output power ranging from 22.8 Watts up to 28.5 Watts for the Isolator clamps, 12.0 Watts up to 30.0 Watts for the Isolator Transpolar pen or CoolRail linear pen devices depending on the mode of operation The AtriCure ASU is capable of producing a maximum output power of 32.5 Watts under a 100 Ohm load, although no current AtriCure Bipolar Handpiece uses power above 30 Watts. The operating mode is a function of the handpieces or pen and is set by the ASU. The AtriCure ASU is designed to operate only with an AtriCure Bipolar Handpiece, AtriCure Isolator Pen, or AtriCure CoolRail linear pen. The Footswitch is the input device used to activate RF energy delivery. Please refer to the handpiece and pen Instructions for Use for complete description of the indications and use of these devises. For the user’s convenience, the AtriCure Ablation and Sensing Unit will be referred to in this User’s Manual as the “ASU”. The AtriCure Bipolar Handpiece will be referred in this User’s Manual as the “Handpiece”. This User’s Manual provides a description of the ASU, its controls, displays, indicators, tones and a sequence for its operation with the Handpiece. This User’s Manual also supplies other information of importance to the user. This manual is intended as a User’s Manual only. Do not operate the ASU before thoroughly reading this manual.

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1.1. System Description As shown in Figure 1, the system is comprised of the following: •

AtriCure Bipolar Handpiece with integral cable (not shown)

•

AtriCure Ablation and Sensing Unit (ASU)

•

Footswitch

•

Power cord.

Accessory devices are described in paragraph 10.

Figure 1 – ASU, Footswitch, and Power Cord 1.2. Unpacking Lift the ASU, Footswitch, and Power Cord from the box and remove the protective wrapping. It is recommended that the original shipping box and protective wrapping be saved for future storing and/or transporting of the device. 1.3. Warnings and Precautions The safe and effective use of RF energy is highly dependent upon factors under the control of the operator. There is no substitute for a properly trained operating room staff. It is important that the operating instructions supplied with the ASU be read, understood and followed before use.

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1.3.1. WARNINGS •

Do not operate the ASU before thoroughly reading this manual.

•

Do not use electrosurgical equipment unless properly trained to use it in the specific procedure being undertaken. This manual, and the equipment, it describes are for use only by qualified medical professionals trained in the particular technique and surgical procedure to be performed.

•

Do not use this device in the presence of flammable anesthetics; other flammable gases; near flammable fluids such as skin prepping agents and tinctures; flammable objects; or with oxidizing agents. Observe appropriate fire precautions at all times.

•

Do not use this device in oxygen-enriched atmospheres, nitrous oxide (N2O) atmospheres, or in the presence of other oxidizing agents.

•

Fire Hazard: Electrosurgical accessories that are activated or hot from use can cause a fire. Do not place them near or in contact with flammable materials (such as gauze or surgical drapes). Avoid igniting endogenous gases.

•

Fire Hazard: Do not use extension cords.

•

Fire Hazard: To avoid igniting cleaning agents, use only non-flammable agents to clean and disinfect the ASU. If flammable agents are inadvertently used on the ASU, allow these substances to evaporate completely before operating.

•

Contact of the Handpiece with any metal (such as hemostats, clamps, staples, etc.) can result in unintended burn injuries.

•

When not using the Handpiece, place it in a clean, dry nonconductive, and highly visible area not in contact with the patient. Inadvertent contact by an active Handpiece with the patient may result in burns.

•

When the ASU is activated, the conducted and radiated electrical fields may interfere with other electrical medical equipment. Refer to Section 5 for more information regarding potential electromagnetic or other interference, and advice regarding avoidance of such interference.

•

Electrosurgery should be used with caution in the presence of internal or external pacemakers. Interference produced with the use of electrosurgical devices can cause devices such as a pacemaker to enter an asynchronous mode or can block the pacemaker entirely. Consult the pacemaker manufacturer or hospital Cardiology department for further information when use of electrosurgical appliances is planned in patients with cardiac pacemakers.

•

Trip Hazard: Standard care should be used to reduce the risk of tripping on the Footswitch cable.

•

The use of accessories, transducers and cables other than those specified in accordance with the instructions or supplied by AtriCure, may result in increased emissions or decreased immunity of the equipment.

•

The ASU should not be used adjacent or stacked with other equipment, except for intended stacking with AtriCure’s equipment in accordance with the instructions. The ASU normal use configuration should be observed to verify normal operation.

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•

The voltage selector is factory set and should not be changed by the user. The voltage selector and the power entry module must be set to the same voltage setting to prevent ASU malfunction and potential instrument damage.

•

Electric Shock Hazard: Connect the ASU Power Cord to a properly grounded receptacle. Do not use power plug adapters.

•

Electric Shock Hazard: Do not connect wet accessories to the generator.

•

Electric Shock Hazard: Ensure that the Handpiece is correctly connected to the ASU and that no wires are exposed from the cable, connector or Handpiece.

1.3.2. PRECAUTIONS •

Use only with the AtriCure Handpieces intended for use with the ASU.

•

Do not activate the ASU until the Handpiece is properly positioned in the patient.

•

The activation tone and indicator are important safety features. Do not obstruct the activation indicator. Ensure that the activation tone is audible to personnel in the operating room prior to use. The activation tone alerts personnel when the Handpiece is active. Do not disable the audible tone.

•

Do not remove the cover of the ASU as there is a potential for electrical shock. Refer to authorized personnel for service.

•

Use only the Footswitch provided with the ASU.

•

The Power Cord of the ASU must be connected to a properly grounded receptacle. Extension cords and/or adapter plugs must not be used.

•

Do not wrap instrument cable around metal objects. Wrapping cables around metal objects may induce hazardous currents.

•

To avoid shock, do not allow patients to come into contact with earth metal parts of the ASU. The use of antistatic sheeting is recommended.

•

Studies have shown that smoke generated during electrosurgical procedures can be potentially harmful to surgical personnel. These studies recommend using surgical masks and adequately ventilating the smoke by using a surgical smoke evacuator or other means.

•

When the ASU and Handpiece are used on a patient simultaneously with physiological monitoring equipment, ensure that the monitoring electrodes are placed as far as possible from the surgical electrodes. Be sure to position the Handpiece cables so that they do not come in contact with the patient or the other leads.

•

Needle monitoring electrodes are not recommended for use when operating the ASU and Handpiece.

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•

Monitoring systems that incorporate high frequency current-limiting devices are recommended for use with the ASU and Handpiece.

•

Failure of the ASU and Handpiece could result in unintended power output increases.

1.4. EMC Guidance and Manufacturer’s Declaration 1.4.1. Electromagnetic Requirements The AtriCure Ablation and Sensing Unit (ASU) has been tested and found to comply with the limits for medical devices in IEC 60601-1-2:2007. These limits are designed to provide reasonable protection against harmful interference in a typical medical installation. The ASU can radiate radio frequency energy and, if not installed, used, and serviced in accordance with electromagnetic compatibility information provided in the instructions, may cause harmful interference to other devices in the vicinity. Portable and mobile RF communications equipment can also affect ASU performance and care should be taken to minimize such interference. However, there is no guarantee that interference will not occur in a particular installation. If the ASU does cause harmful interference to other devices, which can be determined by turning the ASU off and on, the user is encouraged to try to correct the interference by one or more of the following measures: •

Reorient or relocate the receiving device.

•

Increase the separation between the ASU and the other devices.

•

Connect the ASU into an outlet on a circuit different from that to which the other device(s) are connected.

•

Contact the AtriCure service representative for help.

1.4.2. Electromagnetic Emissions Guidance and manufacturer’s declaration – electromagnetic emissions The AtriCure Ablation and Sensing Unit (ASU) is intended for use in the electromagnetic environment specified below. The customer or the user of the ASU unit should assure that it is used in such an environment. Emissions test RF emissions CISPR 11

Compliance

Electromagnetic environment – guidance

Group 1

The ASU unit uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.

RF emissions CISPR 11

Class A

Harmonic emissions IEC 61000-3-2

Class A

Voltage fluctuations/ flicker emissions IEC 61000-3-3

Complies

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The ASU unit is suitable for use in all establishments other than domestic and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.

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1.4.3. Electromagnetic Immunity Guidance and manufacturer’s declaration – electromagnetic immunity The AtriCure Ablation and Sensing Unit (ASU) is intended for use in the electromagnetic environment specified below. The customer or the user of the ASU unit should assure that it is used in such an environment. IMMUNITY test Electrostatic discharge (ESD) IEC 61000-4-2 Electrical fast transient/burst IEC 61000-4-4

Surge IEC 61000-4-5

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

Power frequency (50/60 Hz) magnetic field IEC 61000-4-8 NOTE:

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IEC 60601 test level

Compliance level

± 6 kV contact

± 6 kV contact

± 8 kV air

± 8 kV air

± 2 kV for power supply lines

± 2 kV for power supply lines

± 1 kV for input/output lines

± 1 kV for input/output lines ± 1 kV differential mode

± 1 kV line(s) to line(s) ± 2 kV line(s) to earth <5 % UT (>95 % dip in UT) for 0,5 cycle

± 2 kV common mode <5 % UT (>95 % dip in UT) for 0,5 cycle

40 % UT (60 % dip in UT) for 5 cycles

40 % UT (60 % dip in UT) for 5 cycles

70 % UT (30 % dip in UT) for 25 cycles

70 % UT (30 % dip in UT) for 25 cycles

<5 % UT (>95 % dip in UT) for 5 s

<5 % UT (>95 % dip in UT) for 5 s

3 A/m

3 A/m

Electromagnetic environment – guidance Floors should be wood, concrete, or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30 %. Mains power quality should be that of a typical commercial or hospital environment. Mains power quality should be that of a typical commercial or hospital environment.

Mains power quality should be that of a typical commercial or hospital environment. If the user of the ASU unit requires continued operation during power mains interruptions, it is recommended that the ASU unit be powered from an uninterruptible power supply or a battery.

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

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

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1.4.4. EMC Guidance and Manufacturer’s Declaration Guidance and manufacturer’s declaration – electromagnetic immunity The AtriCure Ablation and Sensing Unit (ASU) is intended for use in the electromagnetic environment specified below. The customer or the user of the ASU should assure that it is used in such an environment. IMMUNITY test

IEC 60601 TEST LEVEL

Compliance level

Electromagnetic environment – guidance Portable and mobile RF communications equipment should be used no closer to any part of the ASU, 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

Radiated RF IEC 61000-4-3

3 V/m 80 MHz to 2.5 GHz

3 Vrms

d = 1.2 √P

d = 1.2 √P 80 MHz to 800 MHz 3 V/m 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: a

b

These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people. 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 ASU is used exceeds the applicable RF compliance level above, the ASU should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the ASU. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

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1.4.5. Recommended Separation Distance Recommended separation distances between portable and mobile RF communications equipment and the AtriCure Ablation and Sensing Unit The AtriCure Ablation and Sensing Unit (ASU) is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the ASU can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the ASU as recommended below, according to the maximum output power of the communications equipment. Rated maximum output power of transmitter W

Separation distance according to frequency of transmitter m 150 kHz to 80 MHz d = 1.2 √P

80 MHz to 800 MHz d = 1.2 √P

800 MHz to 2.5 GHz d = 2.3 √P

0.01

0.12

0.12

0.23

0.1

0.38

0.38

0.73

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 power 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.

1.5. Responsibility of the Manufacturer AtriCure is responsible for safety, reliability, and performance of the equipment only if: • Installation procedures in this manual are followed. •

Persons authorized by AtriCure carry out modifications or repairs.

•

The electrical installation of the relevant room complies with local codes and regulatory requirements such as IEC and BSI.

•

The equipment is used in accordance with the AtriCure User’s Manual.

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2. The AtriCure Ablation and Sensing Unit (ASU) This section provides a detailed description of the ASU including its function and operating features. 2.1. Device Description The AtriCure ASU produces and delivers RF energy, in a bipolar mode, at a frequency of approximately 460 kHz, with a maximum output power ranging from 12 Watts up to 30 Watts depending on the operating mode. The AtriCure ASU is capable of producing a maximum output power of 32.5 Watts under a 100 Ohm load although no current AtriCure Bipolar Handpiece uses power above 30 Watts. The operating mode is a function of the handpiece and is set by the ASU. The AtriCure ASU is designed to operate with the AtriCure Handpiece. The ASU and Handpiece are designed for use without a neutral electrode. The Footswitch is the input device used to activate RF energy delivery. 2.2. ASU Front Panel – Illustration and Nomenclature An illustration of the ASU front panel is shown in Figure 2, below.

Figure 2 – ASU Front Panel 1.

Tissue Conductance/ Power Graph Display

6.

Transmurality Indicator

2.

Ready Indicator

7.

Fault Indicator

3.

RF ON Indicator

8.

Power Indicator

4.

Temperature Display

9.

Handle

5.

Handpiece Receptacle

10. Handle Adjustment Knobs

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Front Panel Displays There are two displays on the front panel of the ASU: the Tissue Conductance / Power Graph Display and the Temperature Display. These two displays are described below. Display

Description Tissue Conductance Graph Display – Isolator clamp (Default): During the ablation cycle the ASU displays a graph of tissue conductance (Current/Voltage) versus Time. The y-axis is Tissue Conductance and the x-axis is Time. When the Footswitch is disconnected or reconnected, the display of the tissue conductance graph is not affected. Refer to Section 4.4.3. Power Graph Display – Isolator Transpolar pen or CoolRail™ linear pen: During the ablation cycle the ASU displays a graph of power (Current  Voltage) versus Time. The y-axis is Power and the x-axis is Time. When the Footswitch is disconnected or reconnected, the display of the power graph is not affected. Refer to Section 4.4.3. Temperature Display – This 3-digit LED display shows the temperature at the thermocouple, located near the outer edge of the upper jaw 1.3 mm from the electrode. Temperature is measured and displayed in real-time, whenever the Isolator clamp is connected. Functionality can be quickly verified when the handpiece is plugged in by confirming that the temperature reading is of room temperature. When the Isolator clamp or the footswitch is disconnected the temperature display becomes blank. Refer to Section 4.3. If a Handpieces does not have a thermocouple, the temperature display will only show “- - -”.

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Front Panel Indicators Indicator

Description POWER Indicator – A Green LED indicates that the AC power is present and the ASU has been switched on. FAULT Indicator – This Red lamp indicates that a fault has occurred and requires that the power be cycled. READY Indicator – This Green lamp indicates that the Footswitch and Handpiece are connected and the ASU is ready for use RF ON Indicator – A Blue LED indicates that RF power is being output to the Handpiece. The RF power output is initiated by pressing the Footswitch. TRANSMURALITY Indicator – A Blue flashing LED indicates that the Transmurality Algorithm has been satisfied indicating that the user may terminate the ablation cycle.

Front Panel Receptacle Receptacle

Description HANDPIECE or ASU Accessory Receptacle This 12-pin receptacle accepts the AtriCure Handpiece or connection cable to an accessory device. This connection is patient-isolated.

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2.3. ASU Rear Panel – Illustration and Nomenclature An illustration of the ASU rear panel is shown in Figure 3, below.

Product Labeling

Figure 3 – ASU Rear Panel

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1. Data Port

5. Equipotential Ground Stud

2. Speaker Volume Control

6. Input Voltage Selector Switch

3. Power Entry Module

7. Footswitch Receptacle

4. Fuse Box

8. Service Access

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Rear Panel Functions Graphic

Description Equipotential Ground Stud – Provides a means of securely linking the earth grounds of the AtriCure ASU to other grounded equipment. Data Port – For manufacturing and test purposes.

Power Entry Module – This module contains both the ON/OFF switch and the fuses. The voltage is selected by the orientation of the fuse drawer as marked. Fuse Box – The Fuse Box contains fuses selected for the input voltage. See Technical Specifications in Section 7 of this manual. Input Voltage Selector Switch – The input voltage selector switch is pre-set at the factory to either 110V or 220V and should not be adjusted by the operator. This setting should only be adjusted by the manufacturer or by an authorized service representative. Speaker Volume Control – The audible volume level is adjustable via a rotary dial. The ASU includes a speaker for producing audible feedback to the user.

Footswitch Receptacle – This receptacle accepts the Footswitch connector. The single momentary actuation pedal provides for the activation of RF power output.

Service Access – For manufacturing and test purposes.

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3. Installing the ASU Inspect the ASU for any signs of physical damage to the front panel, chassis or cover. NOTE: If any physical damage is found, DO NOT USE THE UNIT. CONTACT AtriCure for a replacement. All returns must be approved by AtriCure. 3.1. Transporting the ASU The handle may be used to carry the ASU. To change the positioning of the handle, depress both handle adjustment knobs simultaneously and move the handle to the desired location. Do not change the handle position when a Handpiece or Accessory Device is connected to the Handpiece receptacle. 3.2. Adjusting the Viewing Angle To change the viewing angle of the ASU Conductance Graph Display, adjust the handle position using the directions in Section 3.1., above. 3.3. Preparing the ASU For Use The ASU may be placed on a mounting cart or on any sturdy table or platform. It is recommended that carts have conductive wheels. Refer to hospital procedures or local codes for detailed information. Provide at least four to six inches of space around the sides and top of the ASU for convection cooling. Under continuous use for extended periods of time, it is normal for the top and rear panel to be warm. 3.4. Power Cord The ASU is shipped with an approved hospital grade power cord. Plug the ASU into a grounded receptacle. NOTE: Do not use extension cords or three-prong to two-prong adapters. The Power Cord assembly should be periodically checked for damaged insulation or connectors.

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3.5. Connecting and Disconnecting the Handpiece Connect the Handpiece directly to the ASU. Insert the Handpiece cable connector into the receptacle on the front panel of the ASU, ensuring that the arrow symbol on the connector is facing upward and oriented to the arrow symbol on the ASU receptacle. NOTE: Typically, you will connect the Handpiece to the ASU when the ASU has been powered up and is in STANDBY operating mode (see Section 4.2 regarding the STANDBY mode). However, the Handpiece may be connected when powered up, or prior to powering up the ASU. NOTE: Once you have connected the Handpiece, it cannot be disconnected from the ASU by pulling on the cable. To disconnect the Handpiece, pull back on the cable connector body and remove it from the ASU receptacle. NOTE: Refer to the Handpiece instruction sheet for more detailed information about connecting the Handpiece to the ASU in a sterile environment. 3.6.Installing the Footswitch 3.6.1. Inspect the Footswitch Inspect the Footswitch for any signs of physical damage to the cable and connector. If physical damage is found or the Footswitch does not perform within specification, notify AtriCure. All returns must have approval from AtriCure. 3.6.2. Connecting and Disconnecting the Footswitch With the connector alignment arrow in the 12 o’clock position, push the Footswitch Connector into the Footswitch Receptacle on the rear panel of the ASU, shown in the Figure 4. NOTE: Typically, you will connect the Footswitch to the ASU when the ASU has been powered up and is in STANDBY operating mode (see Section 4 regarding the STANDBY mode). However, the Footswitch may be connected when powered up, or prior to powering up the ASU.

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Product Labeling

Figure 4 – Connecting the Footswitch to the ASU

3.6.3. Preparing the Footswitch for Use The Footswitch should be placed on a flat floor. It is recommended that the area near the Footswitch be kept dry to reduce the risk of slippage. Appropriate precautions should be taken to ensure that the cable connecting the Footswitch to the ASU does not create a hazard in the operating room.

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