Operators Manual
50 Pages
Preview
Page 1
Acculis MTA system Operator’s Manual
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1.
TABLE OF CONTENTS
1. TABLE OF CONTENTS p2-3 2. ELECTRO-MAGNETIC COMPATIBILITY (EMC) p3 3. GUIDELINES FOR AVOIDING OR IDENTIFYING AND RESOLVING ADVERSE ELECTRO-MAGNETIC EFFECTS p3 4. ESSENTIAL PERFORMANCE p8 5. GENERAL INFORMATION p8 6. INDICATIONS FOR USE p8 7. ACCULIS* MTA SYSTEM DESCRIPTION p8 8. CONTRAINDICATIONS p8 9. HOW SUPPLIED p10 9.1. Acculis MTA System Components p10 9.2. Acculis LCS (Local Control Station) p10 9.3. Accu5i MTA Surgical Applicator p10 9.4. Accu2i pMTA Applicator p11 9.5. Accu20s MTA Surface Applicator p11 9.6. MTA Temperature Probe Kit p11 10. Sulis* VpMTA GENERATOR INSTALLATION p11 10.1. Mount the Sulis VpMTA Generator onto MTA Cart p11 10.2. Check Operating Voltage p12 10.3. Attach Power Cord p12 10.4. Transportation Position p12 11. ACCULIS LCS (LOCAL CONTROL STATION) INSTALLATION p12 11.1. Mount the articulated mounting arm onto the MTA Cart p12 11.2. Mount the LCS onto the articulated arm of the MTA Cart p12 11.3. Connect the LCS Microwave Cable and Data Cable to the Sulis VpMTA Generator p12 12. Sulis VpMTA GENERATOR FEATURES p13 12.1. Description p13 12.2. Front Panel: Display And Control Features p13 12.3. Rear Panel Features p14 12.4. Explanation Of Symbols p14 13. ACCULIS LCS (LOCAL CONTROL STATION) FEATURES p15 13.1. Description p15 14. INSTRUCTIONS FOR USE OF THE ACCULIS MTA SYSTEM p16 14.1. Sulis VpMTA Generator Setup p16
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14.2. Turn the Sulis VpMTA Generator On 14.3. Connection Of Applicators 14.4. Connect MTA Temperature Probes 14.5. Confirm Sulis VpMTA Generator Ready 14.6. Confirm The Temperature Probes Are Functional 14.7. Select desired power and time 14.8. Set The Coagulation Time 14.9. Set The Microwave Power 14.10. Confirm Settings And Connections 14.11. Confirm Proper Placement of MTA Applicator And MTA Temperature Probe(S) 14.12. Microwave Activation 14.13. Confirm Activation 14.14. Elapsed Time Display 14.15. Temperature Display 14.16. Output Power 14.17. Microwave Energy Delivery Termination 14.18. Coolant Reservoir Replacement 14.19. Disconnection of the applicator from the Acculis MTA System 14.20 Termination of the Acculis MTA System 15. Sulis VpMTA GENERATOR CARE AND MAINTENANCE 15.1. Cleaning 15.2. Storage 15.3. Maintenance And Service 15.4. End of life disposal 16. ACCULIS LCS CARE AND MAINTENANCE 16.1. Cleaning 16.2. Storage 16.3. Maintenance and Service 16.4. End of life disposal 17. TROUBLESHOOTING GUIDE 18. SPECIFICATIONS 18.1. Sulis VpMTA Generator Specifications 18.2. Acculis local Control Station (LCS) Specifications 18.3. Accu5i MTA Surgical Applicator Specifications
p16 p16 p17 p17 p17 p17 p17 p18 p18
p18 p18 p19 p19 p19 p19 p20 p20 p20 p21 p22 p22 p22 p22 p22 p23 p23 p23 p23 p23 p23 p24 p24 p25 p25
1.
TABLE OF CONTENTS
18.4. Accu2i pMTA Applicator Specifications p26 18.5. MTA Temperature Probe Specifications p26 18.6. Accu20s MTA Surface Applicator Specifications p27 19. MANUFACTURER’S WARRANTY POLICY p27 20. APPENDIX A – TEMPERATURE PROBE ERROR STATUS TABLE p28 21. APPENDIX B – Sulis VpMTA GENERATOR ON SCREEN ERROR CODES p31 22. APPENDIX C – DESCRIPTION OF Sulis VpMTA GENERATOR LCD SCREEN DISPLAYS AND ERROR MESSAGES p43
CAUTION
Within this document there is reference to the use of: • The Accu5i MTA Surgical Applicator and the Accu2i pMTA Percutaneous Applicator during laparoscopic procedures. The Accu5i Applicator and the Accu2i Applicator have not been cleared for laparoscopic use in the U.S.A. or Canada. • The Accu20s MTA Surface Applicator. The Accu20s Applicator is not yet available for sale in the U.S.A. or Canada. PLEASE NOTE: CANADA ONLY. Throughout this document any reference to “soft tissue” means tissue types: liver, kidney and muscle.
2. ELECTRO-MAGNETIC COMPATIBILITY (EMC) Medical Electrical Equipment needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided below. Portable and mobile RF (Radio Frequency) communications equipment can affect Medical Electrical Equipment. The MTA System must only be used with the applicators listed below. Failure to do so may result in increased Emissions or decreased Immunity of the MTA System: • 17 and 33 Surgical Applicators (part no’s 900-300 and 900-301). • Surface Applicator with accompanying 3.2 m cable (part no’s 900-500 and 800-107). • 14, 19 and 29 cm percutaneous Applicators (part no’s 900-600, 900-602 and 900-601) in conjunction with the Acculis LCS. The MTA System should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary the MTA System should be observed to verify normal operation in the configuration in which it will be used. 3. GUIDELINES FOR AVOIDING OR IDENTIFYING AND RESOLVING ADVERSE ELECTROMAGNETIC EFFECTS. This equipment generates, uses and can radiate radio frequency energy. If it is not installed and used in accordance with the instructions it may affect, or be affected by, other equipment. However, whilst it has been designed to comply with required standards, there is no guarantee that interference will not occur in a particular installation. Since the MTA System intentionally applies RF energy for procedure, nearby electronic equipment may be affected. If interference is suspected this can be confirmed by switching the relevant equipment off and on. Suggested methods interference are:
of
correcting
the
a. Increase the separation between the two items of equipment. b.
earrange the cables to increase the R separation between them.
c.
onnect the equipment into outlets on C different circuits.
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WARNING No modification of this equipment is allowed. Guidance and manufacturer’s declaration: Electromagnetic Emissions. The MTA System is intended for use in the electromagnetic environment specified below. The customer or the user of the MTA System should ensure that it is used in such an environment Emissions test
RF emissions CISPR 11
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Compliance
Electromagnetic environment - guidance
Group 2 (partial)
The MTA System must emit electromagnetic energy in order to perform its intended function. Nearby electronic equipment may be affected, in particular at 4.89 GHz whose emission is above the level stipulated in CISPR 11: 2003 + A1:2004 (complies at all other frequencies).
RF emissions CISPR 11
Class A
Harmonic emissions IEC 61000-3-2
Class A
Voltage fluctuations/ flicker emissions IEC 61000-3-3
Complies
The MTA System 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.
Guidance and manufacturer’s declaration: Electromagnetic Immunity. The MTA System is intended for use in the electromagnetic environment specified below. The customer or the user of the MTA System should ensure that it is used in such an environment Immunity test
IEC 60601 test level
Compliance level
Electromagnetic environment - guidance
Electrostatic 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 IEC 61000-4-4
±2 kV for power supply lines ±1 kV for input/ output lines
±2 kV for power supply lines ±1 kV for input/ output lines
Mains power quality should be that of a typical commercial or hospital environment.
Surge IEC 61000-4-5
±1 kV differential mode ±2 kV common mode
±1 kV differential mode Not applicable
Mains power quality should be that of a typical commercial or hospital environment.
Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11
<5 % UT (>95% dip in UT) for 0,5 cycle 40 % UT (60% dip in UT) for 5 cycles 70 % UT (30 % dip in UT) for 25 cycles <5 % UT (>95% dip in UT) for 5 sec
<5 % UT (>95% dip in UT) for 0,5 cycle 40 % UT (60% dip in UT) for 5 cycles 70 % UT (30 % dip in UT) for 25 cycles <5 % UT (>95% dip in UT) for 5 sec
Mains power quality should be that of a typical commercial or hospital environment. If the user of the MTA System requires continued operation during power mains interruptions, it is recommended that the MTA System be powered from an uninterruptible power supply or a battery.
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 commercial or hospital environment.
Note UT is the a.c. mains voltage prior to application of the test level.
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Guidance and manufacturer’s declaration Electromagnetic Immunity (cont’d) Immunity test
IEC 60601 test level
Compliance level
Electromagnetic environment - guidance
Conducted RF IEC 61000-4-6
3 Vrms 150 kHz to 80 MHz
3V
Radiated RF IEC 61000-4-3
3V/m 80MHz to 2,5GHz
3V/m
Portable and mobile RF communications equipment should be used no closer to any part of the MTA System, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance – d = 1.2 √ P – d = 1.2 √ P 80MHz to 800 MHz – d = 2.3 √ P 800MHz 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 metres (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 800MHz, 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.
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 MTA System is used exceeds the applicable RF compliance level above, the MTA System should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the MTA System. b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m. a
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Recommended separation distances between portable and mobile RF communications equipment and the MTA System The MTA System is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the MTA System can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the MTA System 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
80 MHz to 800 MHz d = 1.2
800 MHz to 2,5 GHz d = 2.3
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 metres (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.
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4. ESSENTIAL PERFORMANCE The essential performance of the Acculis MTA system is maintained during normal use (as defined by the Operator’s Manual and the Instructions For Use) and during electrical safety and electromagnetic compatibility testing (as defined by EN 60601-1 and other relevant collateral standards and IEC 60601-12). For each procedure cycle the MTA system must deliver the energy selected by the user at the start of each treatment cycle. The essential performance is defined as follows: a.
The user must be able to select different values of time and power
b.
The MTA system must display the Set Time and Set Power at the start of the procedure
c.
The MTA system must indicate Elapsed Time during the procedure cycle
d.
The MTA system must indicate the output power during the procedure cycle.
5. GENERAL INFORMATION The Acculis MTA system is manufactured by: AngioDynamics, Inc.* No.1 Falcon Court Parklands Business Park Denmead, Hampshire PO7 6XP UNITED KINGDOM Phone: +44 23 92 24 00 11 Fax : +44 23 92 24 00 51 E-mail: [email protected] CAUTION Federal US law restricts this device to sale by or on the order of a physician 6. INDICATIONS FOR USE The Acculis Microwave Tissue Ablation (MTA) System and Accessories are indicated for the intraoperative coagulation of soft tissue.
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7. ACCULIS MTA SYSTEM DESCRIPTION The Acculis Microwave Tissue Ablation (MTA) System may be used for intraoperative coagulation of soft tissue. Applicators are available for open, laparoscopic, percutaneous or surface application. For open and laparoscopic (except in the USA and Canada) interstitial use the system consists of the Sulis VpMTA Generator, and Accu5i MTA Surgical Applicators. For open, laparoscopic (except in the USA or Canada) or percutaneous interstitial use the system consists of the Sulis VpMTA Generator with the Accu2i pMTA Applicators and the Acculis Local Control Station (LCS). For open surface use the system consists of the Sulis VpMTA Generator and the Accu20s MTA Surface Applicator. In all configurations, the system may also be used in conjunction with the MTA Temperature Probes. The Acculis MTA System is used to deliver energy to soft tissue for the purpose of microwave coagulation. The Acculis MTA System is designed to be used by physicians who are trained in the use and application of: • Image guided ablation procedures and • Intraoperative ultrasound and/or CT guided needle placement The expected effect on the target tissue is localised intense heating for the purpose of coagulation. The Acculis MTA System has settings and displays for microwave power output and delivery time, and two temperature displays to assist the physician in monitoring and controlling the coagulation throughout the process. 8. CONTRAINDICATIONS The Accu5i MTA Surgical Applicators, Accu2i pMTA Applicators and Accu20s MTA Surface Applicator are contraindicated in patients with heart pacemakers and other electronic device implants. WARNINGS AND PRECAUTIONS Read the Operator’s Manual and the Instructions for Use for the Acculis Microwave Tissue Ablation (MTA) System and Accessories prior to its use. Safe tissue coagulation is dependent upon operation
WARNINGS AND PRECAUTIONS cont. of the equipment in accordance with the operating instructions. The Acculis MTA System is for use by qualified clinical personnel who have been instructed and trained in the correct use of the Acculis MTA System by designated AngioDynamics representatives. Operate the Acculis MTA System in environmental temperatures between 13˚C (55˚F) and 27°C (80˚F), and between 30% and 75% relative humidity (non-condensing). The Acculis MTA System is rated to operate at an altitude of 2000 metres or below. DO NOT attempt to repair or alter any of the Acculis MTA System components. Use only the Sulis VpMTA Generator, Accu5i MTA Surgical Applicators, Accu2i pMTA Applicators, MTA Temperature Probes, Accu20s MTA Surface Applicator, fuses, power cords, and parts supplied by AngioDynamics. The Accu5i Surgical Applicator and Accu2i pMTA Applicator are designated as Bipolar devices and as such the Acculis MTA System does not require the use of a neutral electrode. DO NOT allow liquids to saturate or leak inside the Sulis VpMTA Generator. DO NOT immerse the Sulis VpMTA Generator in water or liquids. DO NOT sterilize the Sulis VpMTA Generator. Clean and maintain the Sulis VpMTA Generator in accordance with the operating instructions. DO NOT use the Acculis MTA System (including the Sulis VpMTA Generator, Accu5i MTA Surgical Applicator, Accu2i pMTA Applicators and Temperature Probes or Accu20s in a Magnetic Resonance Imaging (MRI) suite. The Acculis MTA System contains ferrous materials. MTA Temperature probes should be placed as far as possible from the Accu5i Surgical Applicator or Accu2i pMTA Applicator if used simultaneously with the Acculis MTA System. DO NOT use the Accu5i MTA Surgical Applicators, Accu2i pMTA Applicators or the Temperature Probes if the expiration date provided on the packaging has expired, or the seal is broken. The Accu5i Surgical Applicator or Accu2i pMTA Applicator cable should be positioned
such that it prevents contact with the patient or with other equipment leads. When using the Accu5i MTA Surgical Applicators or Accu2i pMTA Applicators failure to locate the temperature probes and monitor the temperature levels of adjacent tissues, vital structures, ducts, vessels, or nerves could result in an unintended thermal injury. Turn the Sulis VpMTA Generator Off using the main power On/Off switch and disconnect the power cord from the AC supply before cleaning. DO NOT remove the cover of the Sulis VpMTA Generator. Refer all service to AngioDynamics. There are no userserviceable parts inside the Sulis VpMTA Generator. Warranty will be voided if the unit is opened and/or the warranty seal is broken. Allow the Accu5i MTA Surgical Applicator input connector to cool for at least 15 minutes before disconnecting from the Sulis VpMTA Generator if 30 minutes of continuous coagulation time are performed at Full Power (100 watts). All AC sourced devices require an Uninterruptable Power Supply (UPS) in order to assure continuous operation in the event that the main input power supply is interrupted. The use of flammable anaesthetics or oxidizing gases such as nitrous oxide and oxygen should be avoided if procedure is being conducted in the region of the thorax or head, unless these agents are sucked away. DO NOT use the Acculis MTA System (including the Sulis VpMTA Generator, Accu5i MTA Surgical Applicator, Accu2i pMTA Applicators, Accu20s Surface Applicator and Temperature Probes in the presence of flammable anaesthetics. There is a minimal risk of the ignition of endogenous gases when the Acculis MTA System is operating. Failure of the Acculis MTA System could result in an unintended increase of output power. DO NOT defibrillate a patient with an applicator inserted. Completely remove the applicator from the patient before defibrillation. Ensure that the Sulis VpMTA Generator and LCS are at room temperature before applying mains power. Not for use in an Oxygen-Rich environment.
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Description
Qty
6
LCS mounting nuts (M4) and shakeproof washers
4
7
Velcro cable ties
3
9. HOW SUPPLIED 9.1. Acculis MTA System Components The Acculis MTA System is supplied with the following components:
9.1.1. Sulis VpMTA Generator
The Acculis LCS provides a connection interface between the Sulis VpMTA Generator and the disposable Accu2i pMTA Applicator. It is mounted on an articulated arm alongside the coolant reservoir hanging bracket. Refer to the relevant Applicator IFU for instruction for use of the Acculis LCS.
Description
Qty
1
Acculis MTA System Operator’s Manual
1
2
Sulis VpMTA Generator
1
3
Power Cord
1
4
MTA Cart
1
5
Monitor Arm locking bracket
1
9.3.
2
Available separately from AngioDynamics, Inc.
6
M5 X 12 Screws
7
Fuse: either 5A (for operation at 200 to 240V) or 10A (for operation at 100 to 125V)
MTA Cart: Supplied with each Sulis VpMTA Generator. Supports the Sulis VpMTA Generator at a suitable operating height, allows easy local transporting of the Sulis VpMTA Generator.
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9.3.1. Accu5i MTA Surgical 17 Applicator
2
Description
Power Cord: Provides AC power to the Sulis VpMTA Generator. Various medical grade power cords are available for use with alternate voltages and receptacles in different countries.
9.2.
Accu5i MTA Surgical Applicator
1 2
Instructions for Use
Qty
1
Acculis LCS
1
2
Articulated mounting arm
1
3
Fixing bolts for LCS to brackets
2
4
Fixing nuts and bolts 4 for arm
5
Coolant reservoir Hanging bracket
1
1
To obtain more specific information, refer to the Instructions for Use of the Accu5i MTA Surgical Applicator Kit.
9.3.2. Accu5i MTA Surgical 33 Applicator Description
Qty
1
Accu5i MTA Surgical 1 33 Applicator
2
Instructions for Use
Acculis LCS (Local Control Station) Description
Qty
Accu5i MTA Surgical 1 17 Applicator
1
To obtain more specific information, refer to the Instructions for Use of the Accu5i MTA Surgical Applicator Kit. 9.4.
Accu2i pMTA Applicator
9.4.1. Accu2i pMTA 14cm Standard Applicator
Description
1
2
Accu2i pMTA 14cm Applicator c/w coolant tubing, LCS cartridge connector and 2 way coolant spike
1
Instructions for Use
1
To obtain more specific information, refer to the Instructions for Use of the Accu2i pMTA Applicator.
9.4.2. Accu2i pMTA 19cm Intermediate Applicator Description
1
2
9.6.
Accu2i pMTA 19cm Intermediate Applicator c/w coolant tubing, LCS cartridge connector and 2 way coolant spike
1
Instructions for Use
1
Description
Qty
Accu2i pMTA 29cm Long Applicator c/w coolant tubing, LCS cartridge connector and 2 way coolant spike
1
Instructions for Use
1
Accu20s MTA Surface Applicator
Available separately AngioDynamics, Inc.
Accu20s MTA Surface Applicator
1
2
Accu20s MTA Surface Applicator Cable (3.2 metre long)
1
3
Instructions for Use
1
MTA Temperature Probe Kit Description
Qty
1
MTA Temperature Probe #1 with Black Color Code, (18 gauge, 20cm or 33cm length)
1
2
MTA Temperature Probe #2 with Grey Color Code, (18 gauge, 20cm or 33cm length)
1
To obtain more specific information, refer to the Instructions for Use of the Accu5i MTA Surgical Applicator or Accu2i pMTA Applicator. 10. SULIS VpMTA GENERATOR INSTALLATION 10.1. Mount the Sulis VpMTA Generator onto MTA Cart
To obtain more specific information, refer to the Instructions for Use of the Accu2i pMTA Applicator. 9.5.
1
Qty
9.4.3. Accu2i pMTA 29cm Long Applicator
2
Qty
To obtain more specific information, refer to the Instructions for Use of the Accu20s Surface Applicator.
To obtain more specific information, refer to the Instructions for Use of the Accu2i pMTA Applicator.
1
Description
Qty
from
9.5.1. Accu20s MTA Surface Applicator
After removing the Sulis VpMTA Generator and the MTA Cart from their shipping containers, mount the generator on top of the cart as follows:
10.1.1. Lower the Sulis VpMTA Generator onto the top surface of the cart with the arm bolt holes on the left side of the generator when viewed from the rear. Position the two mounting rails on the underside of the Sulis VpMTAGenerator so that they fit in the raised flanges of the mounting plate on the top of the cart.
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to the left side of the cart (when viewed from the rear) using the holes provided.
11.1.3. Tighten the retaining nuts to secure the arm.
11.1.4. Replace the cover plate using the 2 machine screws
11.2. Mount the LCS onto the articulated arm of the MTA Cart
10.2. Check Operating Voltage
10.2.1. Make sure that the power cord is disconnected. Before use of the Sulis VpMTA Generator, it is important to check the correct operating voltage setting. The voltage selector switch is on the rear of the Sulis VpMTA Generator and should be set for the local voltage. Check that the setting is correct (either 100-125 volts or 200-240 volts) for local use and correct the setting if necessary.
11.2.1. Feed the LCS microwave cable and power/data cable through the apperture in the Coolant Hanging Bracket so as to position the Mounting Block in line with the two attachment holes in the Coolant Hanging Bracket.
11.2.2. Use the four screws provided to attach the LCS to the Coolant Hanging Bracket. Ensure the screws are tightened sufficiently to prevent any movement between the Coolant Hanging Bracket and the LCS.
11.2.3. Re-attach the Coolant Hanging Bracket to the MTA Cart Articulated Arm using the 4 nuts and shakeproof washers.
11.2.4 Use the Capping Strips to run the LCS Microwave cable and power/ data cable along the top of the arm, around the elbow and along the lower part of the arm. Use the velcro ties to positively locate the capping strips.
10.3. Attach Power Cord
10.3.1. Attach the female end of the power cord into the AC Main Power Receptacle on the back of the Sulis VpMTA Generator. 10.4. Transportation Position To transport Acculis MTA System within the hospital, ensure power cord is disconnected from supply mains. Fold the articulated mounting arm into a suitable storage position (ensure that undue stress is not applied to connectors and cables). Release both footbrakes.
11.3. Connect the LCS Microwave Cable and Data Cable to the Sulis VpMTA Generator 11.3.1. Connect the blue microwave cable from the LCS to the Sulis VpMTA Generator Applicator socket located on the front right of the generator and screw to handtighness.
11. ACCULIS LCS (LOCAL CONTROL STATION) INSTALLATION 11.1. Mount the articulated mounting arm onto the MTA Cart 11.1.1. Remove the cover plate from the arm by removing the two machine screws.
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11.1.2. Using the 4 bolts attach the arm
11.3.2. Connect the grey power/data cable of the LCS to the Sulis VpMTA Generator LCS connector located on the front right of the generator and push home.
12. MTA SULIS VpMTA GENERATOR FEATURES 12.1. Description The Sulis VpMTA Generator consists of a microwave generator that operates at 2.45 GHz. The Sulis VpMTA Generator
is specifically designed for use with Accu5i MTA Surgical Applicators, Accu2i pMTA Applicators and MTA Temperature Probes and the Accu20s MTA Surface Applicator. It has user selectable controls and displays microwave power output and time. It also has inputs for two Temperature Probes and associated temperature displays to assist the physician in monitoring and controlling the coagulation. 12.2. Front Panel: Display And Control Feature 1
Line Power Switch
Main Acculis MTA System power switch
2
Temperature Probe Input #1
Input for Temperature Probe 1 (Black Probe)
3
Temperature Probe Input #2
Input for Temperature Probe 2 (Grey Probe)
4
START
Activates microwave energy
5
STOP
Terminates microwave energy
6
FAULT INDICATOR
Red LED indicates a hardware and or software fault.
7
Applicator Input
Input for Applicator cable connector
8
SET POWER Adjustment Buttons
Up/Down buttons for setting power level
9
SET TIME Adjustment Buttons
Up/Down buttons for setting coagulation time
10
Acculis MTA System Status Information Display
Displays current state of the Acculis MTA System
11
Time SET POINT Display
Displays the setting for coagulation time
12
ELAPSED TIME Display
Displays elapsed time during coagulation
13
ON SCREEN INDICATOR LAMP
Displays current state of the Acculis MTA System
14
Power SET POINT Display
Displays the setting for power level
15
OUTPUT POWER Display
Displays actual delivered power
16
Output Power Bar Graph Display
Displays actual delivered power in bar graph
17
Temperature Probe 2 Display
Displays Temperature Probe 2 temperature reading
18
Temperature Probe 1 Display
Displays Temperature Probe 1 temperature reading
19
Local Control Station (LCS) Suppy
Provide power to LCS
NOTE: Features 2,3, 17, 18 and 19 are not applicable when using the Accu20s MTA Surface Applicator.
13
Temperature
Timer (Coagulation) Temperature Probe #1 (Black Colour Coded Probe)
12.3. Rear Panel Features 1
Fuses (2)
Fuses for AC supply
2
AC Main Power Receptacle
AC power input receptacle
3
Voltage Selector Switch
Allows selection of 100-125 Volts or 200-240 volts
12.4. Explanation of symbols Warning: Check for specific warnings or precautions Operating Instructions Warning: Dangerous Voltage
Temperature Probe #2 (Grey Colour Coded Probe) On (Main Power) Off (Main Power) Start (Coagulation) Stop (Coagulation) Protective earth Refer to instruction manual
Fuse Date of manufacture Non-Ionizing Radiation Type BF (Body Floating) Applied Part
Do not dispose Catalogue number
Microwave Power On/Off (Push - Push)
SN
Serial Number Release (Applicator) Adjust: Increase Do not Push (From this point) Adjust: Decrease
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13. ACCULIS LCS (LOCAL CONTROL STATION) FEATURES
Feature
Desc
Coolant LED
Failure to do so may result in a fault condition arising requiring the replacement of the applicator and coolant reservoir.
Fault LED
Indicates a fault with the Accu2i applicator. The user should replace the applicator and coolant reservoir with a new set.
5
Release LED
Indicates that the applicator cartridge locking mechanism has been released and the applicator can be disconnected from the LCS. The mechanism is activated by the cartridge release button (7).
6
Pump start/ stop button
Starts and stops the coolant pump. The status of the pump is indicated by the Pump LED (2).
7
Cartridge release button
Releases the applicator cartridge locking mechnism to enable the applicator to be disconnected from the LCS. Once pressed, the cartridge will be unlocked for 5 seconds, indicated by the Release LED (5).
8
Microwave connector
Connects with the microwave connector in the applicator cartridge.
9
Pump magnet
Engages with the pump magnet in the applicator cartridge.
10
Data connector
Connects with the data connector in the applicator cartridge.
Cartridge locking mechanism
Prevents the applicator being disconnected when the appicator is activated and/or when the pump is running. Released using the cartridge release button (7).
13.1. Description The Acculis LCS (Local control station) consists of a multifunction connection plate through which the disposable Accu2i pMTA Applicator is connected with the microwave feedline, coolant pump drive and applicator data connection. The Acculis LCS draws 12V electrical power from the Sulis VpMTA Generator when the Sulis VpMTA Generator is switched on. The Acculis LCS provides buttons to start/stop the pump and to release the cartridge locking mechanism. It is specifically designed for use with the Accu2i pMTA Applicators.
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8 6
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Feature
Desc
Power LED
Indicates that power (12V DC) is being supplied to the LCS.
Pump LED
Indicates that the pump is running. The pump is activated by the pump start/stop button (6).
Coolant LED
Indicates that the coolant temperature has risen and that it will shortly become ineffective in cooling the applicator shaft. The coolant reservoir should be replaced with a new bag at the earliest opportunity.
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14. INSTRUCTIONS FOR USE OF THE ACCULIS MTA SYSTEM 14.1. Sulis VpMTA Generator Setup Perform the Sulis VpMTA Generator and LCS installation as described in Section 10 and 11 of this Document. WARNING Check that the AC Voltage Selector Switch on the rear side of the Sulis VpMTA Generator is set for the correct AC line voltage. To avoid the risk of electric shock, this equipment must only be connected to a supply mains with protective earth. Do not obstruct or block air inlet or outlet fans. Ensure a clearance distance of 100mm at the rear of the Sulis VpMTA Generator. The Sulis VpMTA Generator is only to be used with the trolley supplied. CAUTION Set the wheel locks of the MTA Cart to the locked positon to prevent movement during use. The Sulis VpMTA Generator with Cart must be within 2 meters of the sterile field. Longer distances may result in excess tension being applied to the Applicator and Temperature Probe cables. To isolate the Acculis MTA System from supply mains, remove power cord from supply mains. 14.2. Turn The Sulis VpMTA Generator On Attach power cord supplys mains and turn on the Sulis VpMTA Generator using the Line Power Switch on the front of
the Sulis VpMTA Generator. When the generator is ON, the LCD Display/Control
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Panel will illuminate after 12 seconds and then briefly display the message “System Loading, Please Wait”. The power LED on the LCS will illuminate (if connected). 14.3. Connection Of Applicators Refer to the detailed Instructions for Use for the relevant applicator. Refer to specific Instuction for Use for a description of the area of intended tissue 14.3.1.Accu5i MTA Surgical Applicator Select either the Accu5i MTA Surgical 17 or Surgical 33 Applicator and attach the connector at the end of the Surgical Applicator cable to the Surgical Applicator input on the front of the Sulis VpMTA Generator and hand tighten. Make sure that the connector is fully and securely attached to the Surgical Applicator input. (Refer to Accu5i MTA Surgical Applicator Instructions for Use).
14.3.2. Accu2i pMTA Applicator
Use a standard 3 litre sterile saline (0.9% w/v of NaCl) drip bag as the coolant reservoir to achieve maximum ablation time before the Change Coolant indicator illuminates. Do not use a 3 litre saline irrigation bag with a large port as the port will be too large for the spike. Hang the coolant reservoir from the hook provided on the articulated arm of the cart. Select either the Accu2i pMTA 14cm, 19cm or 29cm applicator. Removing the applicator cartridge from the packaging, insert it into the recess on the front of the LCS to engage the microwave connection, then rotate clockwise
to lock in place, engaging the pump and data connections.
connect MTA Temperature Probes to the temperature probe input jacks on the front of the Sulis VpMTA Generator. Note that the plugs on the end of the temperature probe cables are color coded in Black or Grey. They must be connected to the corresponding color temperature probe input jacks.
Remove the coolant reservoir spike connector from the applicator packaging and insert into the coolant reservoir (saline bag). Press the pump start/stop button on the front of the LCS. This will start coolant flowing from the reservoir and around the coolant system of the applicator. Run the pump for two minutes to prime the coolant. The LCS will enable microwave generation at the Sulis VpMTA Generator once the following conditions have been met: Power is supplied to the LCS – Power LED is lit. The applicator cartridge is connected to the LCS and locked in place. The pump is running and the coolant system has been primed – Pump LED is lit. There is no fault detected with the applicator (indicated by the Fault LED). When the LCS has enabled microwave generation, the LCS Ready (green tick) symbol will appear in the top left corner of the Sulis VpMTA user interface screen.
14.3.3. Accu20s Surface Applicator
Plug the connector of the Accu20s MTA Surface Applicator cable into the Sulis VpMTA Generator and hand tighten. Place the sterile sheath over the cable and extend over the length of the cable and fix in place once fully extended. Attach the sterile Accu20s MTA Surface Applicator handpiece to the sheathed cable and hand tighten. (Refer to Accu20s MTA Surface Applicator Instructions for Use). 14.4. Connect MTA Temperature Probes When using the Accu5i MTA Surgical Applicator or Accu2i pMTA Applicator,
14.5. Confirm Sulis VpMTA Generator Ready The LCD Display/Control Panel should now appear as shown on page 18. The Sulis VpMTA Generator should indicate “SYSTEM READY”. The SET POINT indicator for TIME initially displays a setting of 0:00 (Minutes/Seconds), and the SET POINT indicator for POWER initially displays a setting of 30 (Watts) MTA and 60 (Watts) pMTA. If these settings do not appear, or if the message “SYSTEM READY” does not appear at the top of the screen refer to Section 17: TROUBLESHOOTING GUIDE and/or if an ERROR code is displayed, refer to Appendix B, MTA Sulis VpMTA Generator On Screen Error Codes., 14.6. Confirm The Temperature Probes Are Functional When using the Accu5i MTA Surgical Applicator or Accu2i pMTA Applicator confirm that the Temperature Probes are properly connected to the designated input connectors. If connected as instructed, the temperature display(s) should indicate ambient temperature. (Refer to the relevent applicator Instructions for Use for more specific information). NOTE: MTA Temperature Probes are not required when using the Accu20s MTA Surface Applicator. 14.7.
Select desired power and time Refer to the relevant applicator Instructions for Use for detailed guidance.
14.8.
Set The Coagulation Time Set the desired coagulation time using the “SET TIME” buttons on the LCD Control/Display Panel by pressing the UP arrow. Time may be adjusted by pressing and holding down either the UP or DOWN arrow. Time will be set in increments of 10 seconds up to a maximum time period of 8 minutes MTA, 6 minutes pMTA. Always set the shortest time period required to
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achieve the desired coagulation. 14.9. Set The Microwave Power Set the desired power using the “SET POWER” buttons on the LCD Control/ Display Panel. The power level may be adjusted by repeatedly pressing the UP or DOWN arrow. Power is adjustable in 10 watt increments from 30 - 100 watts MTA and 20 watt increments from 60 - 140 watts pMTA. Always set the lowest power required to achieve the desired coagulation. 14.10. Confirm Settings And Connections Prior to the delivery of microwave energy to the Accu5i MTA Surgical Applicator,
Accu2i pMTA Applicator or Accu20s MTA Surface Applicator, re-check all displays to confirm the power and time settings and confirm that the Temperature Probes, used only with the Accu5i MTA Surgical Applicator, are measuring ambient temperature. Re-check the Applicator connector to confirm that it is appropriately attached to the Applicator input connector on the Generator. Check to confirm that the message “System Ready” appears at the top of the display. NOTE: If an “ERROR” message appears at the top of the display instead of “SYSTEM READY”, refer to Appendix B . NOTE: If an audible alarm continuously sounds and/or the “FAULT” LED indicator located directly between the “START” and “STOP” buttons illuminates, the user should switch Line Power OFF and ON. If the LED indicator remains lit, contact AngioDynamics for technical support.
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14.11. Confirm Proper Placement of MTA Applicator and MTA Temperature Probe(s) Refer to the Accu5i MTA Surgical Applictor, Accu2i pMTA Applicator and Accu20s MTA Surface Applicator Instructions for Use for proper use and placement of the Applicator and Temperature Probes. CAUTION Utilize imaging techniques to confirm correct placement of the Applicator and Temperature Probe(s) before proceeding with microwave coagulation. 14.12. Microwave Activation The delivery of microwave energy is initiated by pressing the “START” Button at the right front side of the Sulis VpMTA Generator to the right of the LCD display. After pressing, the “START” button, three audible beeps are momentarily sounded and the Acculis MTA System status message “Microwave Initiating” will appear for approximately two seconds while the Acculis MTA System starts. A green indicator lamp is continuously illuminated in the top right hand corner of the display screen during “Microwave Initiating” state. Once the generator activates the delivery
TEMPERATURE IS > 70 oC
TEMPERATURE IS <5 oC
MICROWAVE INITIATING
INDICATOR LAMP IS STEADY GREEN
of microwave energy to the applicator, the Acculis MTA System will display the message “Microwave Initiating” and the output power on the display should no longer read zero. 14.13. CONFIRM ACTIVATION Confirm activation of the delivery of microwave energy by checking the status area at the top of the LCD Control/Display. When the message “Microwave Activated” appears, the green indicator lamp should be flashing and a beep sounds every five seconds. If this message does not appear at the top of the screen refer to Section 17: TROUBLESHOOTING GUIDE and/ or an ERROR code is displayed,refer to Appendix B, MTA Sulis VpMTA Generator On Screen Error Codes Section of this document 14.14. Elapsed Time Display During use the total elapsed time will be displayed. Elapsed time is defined as the total time that has elapsed since initially pressing the Start button commencing the delivery of microwave energy from the generator to the applicator.
Microwave Activated
INDICATOR LAMP IS STEADY GREEN
14.15. Temperature Display Temperature readings from the Temperature Probe(s) connected to the Sulis VpMTA Generator will be displayed at the “TEMP” area on the LCD display. NOTE: If a Temperature Probe detects a temperature that is above 70°C (158°F), the display will indicate “HIGH”. If a Temperature Probe detects a temperature that is below 5°C (41°F), the display will indicate “LOW”. See, Appendix A Temperature Probe Error Status Table, for actions to take should these messages occur. NOTE: Temperature values will only be displayed when the MTA Temperature Probes are attached.
14.16. Output Power Microwave output power will be displayed to the right of the Set Point power display. The actual Output Power may vary from the Set Point Power due to power that is reflected during energy delivery. Reflected power is continuously monitored during use. If the reflected power exceeds an internal preset limit, the microwave power supply will automatically shut off and an error message will appear on the screen (see Appendix C of this manual, Description of the Sulis VpMTA Generator LCD Displays and Screen Error Messages). If a high reflected power condition occurs, the applicator has lost efficiency and microwave energy is unable to be effectively transferred from the applicator tip into targeted tissue. (See “High Reflected Power” in the Troubleshooting Guide, section 17.) The following sequence should be completed if this problem of high reflected power persists. For the Accu5i MTA Surgical Applicator or Accu2i pMTA Applicator: • The applicator ACTIVE region may not be fully inserted in tissue or a transient gas pocket may have formed around the applicator tip. Adjust the positioning of the applicator as necessary and press and hold the microwave START button to restart the coagulation. • Check and tighten the Surgical Applicator connection to the Sulis VpMTA Generator. Press and hold the microwave START button to restart the coagulation. • If the ACTIVE region of the Surgical Applicator is fully inserted into tissue and correctly connected to the Sulis VpMTA Generator but reflected power is still a problem, then the applicator may be defective. The user should replace the applicator with a new one, re-insert the applicator and press and hold the microwave START button to restart the coagulation. • If the “High Reflected Power” condition persists, contact AngioDynamics, Inc. for technical support.
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For the Accu20s MTA Surface Applicator: • The Surface Applicator ACTIVE region may not be fully in contact with the tissue. Apply the applicator head against the target tissue and press and hold the microwave START button to restart the coagulation. • Check and tighten the Surface Applicator connection to the Sulis VpMTA Generator. Press and hold the microwave START button to restart the coagulation. • If the ACTIVE region of the Surface Applicator is fully in contact with the targeted tissue and correctly connected to the Sulis VpMTA MTA Generator but reflected power is still a problem, then the applicator may be defective. The user should replace the applicator with a new one, re-apply the applicator head on the targeted tissue and press and hold the microwave START button to restart the coagulation. • If the “High Reflected Power” condition persists, contact AngioDynamics, Inc. for technical support. A bar graph display for Output Power appears to the right of the Output Power numeric display. The bar graph displays the percentage of the maximum Sulis VpMTA Generator output power of 100 watts MTA (140 Watts pMTA) delivered to the coagulation (i.e., 99 watts as a fraction of 100 watts). A full bar would indicate 100%. NOTE: Output Power may be adjusted up or down while microwave energy is activated using the Set Power adjustment buttons. 14.17. Microwave Energy Delivery Termination Microwave energy delivery will terminate automatically after the set time has elapsed. When this condition occurs, two short beeps will sound alerting the clinician that the set time period has expired. IMPORTANT: Pressing the STOP button on the Sulis VpMTA Generator at any time will manually terminate microwave energy delivery. IMPORTANT: The LINE POWER SWITCH may also be used for emergency termination of microwave energy delivery.
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14.18. Coolant Reservoir Replacement If the coolant starts to become too warm the efficacy of the cooling system will become reduced. When this occurs the Coolant LED will illuminate, indicating that the coolant reservoir (saline bag) should be changed at the earliest opportunity and in any case before commencing the next ablation. When appropriate (i.e. the applicator is not activated and no ablation is being performed), stop the pump by pressing the pump start/stop button, remove the saline bag from the hook, invert the saline bag and remove the spike. Replace with a new 3 litre saline bag, insert the spike into the new bag, hang the bag from the hook and press the pump start/stop button. The user interface screen of the LCS should now indicate that microwave generation is enabled. Continue with the next ablation. IMPORTANT: If the coolant reservoir is not replaced the saline may become too warm to act effectively as a coolant and the LCS will disable microwave generation at the Sulis VpMTA Generator. If this occurs, the Fault LED will be lit and the condition of the applicator can’t be assured. Stop the pump and replace the applicator with a new applicator and replace the coolant reservoir as described above. 14.19. Disconnection of the applicator from the Acculis MTA System 14.19.1 Accu2i pMTA Applicator To disconnect the Accu2i pMTA Applicator from the LCS press the pump start/stop button to stop the coolant pump. Press the cartridge release button – this will release the cartridge locking mechanism for 5 seconds (indicated by the Release LED), allowing the cartridge to be rotated anticlockwise for disconnection from the LCS. Remove the coolant reservoir from the hook. Invert the coolant reservoir and remove the spike connector. Dispose of the applicator in accordance with the Accu2i Applicator Instructions For Use.