Accu2i pMTA applicator Instructions for Use Issue 6.0

1. TABLE OF CONTENTS 1.

TABLE OF CONTENTS

2. Accu2I pMTA APPLICATOR

2. Accu2i pMTA APPLICATOR 2

Intended Use

2

2.2.

Description

2

2.3.

Accu2i Applicators

3

2.4.

MTA Temperature Probe

3

3.

2.1.

INSTRUCTIONS FOR USE

4

3.1.

Training

4

3.2.

System Set up

4

3.3. Removal of Applicator from Packaging

4

3.4. Connection of Accu2i pMTA Applicator

4

3.5.

Connect MTA Temperature Probes 5

3.6.

Coolant System Operation

3.7. Placement of Accu2i pMTA Applicator and MTA Temperature Probes 6

3.8.

3.9. Disconnection of the Accu2i pMTA Applicator and MTA Temperature Probes 7

FIGURE 1 1.

Applicator handle

3.10. Accu2i pMTA Applicator Fault Condition

8

2.

Applicator shaft

3.

Radiating tip

4.

CONTRAINDICATIONS

8

4.

Cartridge connector

5.

HOW SUPPLIED

9

5.

Spike for coolant reservoir

6.

Umbilical cable

7.

Coolant reservoir feed/return

8.

Microwave link

System Operation

5.1. Accu2i pMTA 14cm Standard Applicator 5.2.

6

9

Accu2i pMTA 29cm Long Applicator 9

5.3. Accu2i pMTA 19cm Intermediate Applicator 6.

5

9

EXPLANATION OF SYMBOLS

9

7. EXAMPLES OF COAGULATION SIZE ACHIEVED IN EX-VIVO TISSUE

9

CAUTION Federal US law restricts this device for sale by or on the order of a physician. The Accu2i pMTA Percutaneous Applicator has not been cleared for laparoscopic use 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

2.1. Intended Use The Accu2i pMTA Applicator is intended for the coagulation of soft tissue during open, laparoscopic (except in the USA or Canada) or percutaneous procedures. 2.2. Description The Acculis* Microwave Tissue Ablation (MTA) System when configured for use with the Accu2i pMTA Applicators consists of the Sulis* VpMTA Generator, optional MTA Temperature Probes, Acculis Local Control Station (LCS) and Accu2i pMTA Applicators. The Acculis MTA System is used to deliver energy to soft tissue

for the purpose of thermal 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

•

I ntraoperative ultrasound and/or CT guided needle placement

2.3. Accu2i Applicators The Accu2i pMTA Applicators are sterile single use disposable instruments used to thermally coagulate target tissue during open, laparoscopic (except in the USA or Canada) or percutaneous procedures. Each Accu2i pMTA Applicator comprises a 1.8mm diameter stainless steel shaft tipped with a ceramic trocar microwave array. The applicator shaft is cooled with sterile saline and contains a thermocouple to monitor shaft temperature during use. The microwave delivery cable is also cooled and terminates in a single action multifunction connection cartridge which contains a disposable pump head and microwave and data connections. A two way bag spike is used to connect the applicator to a

Shaft markings each centimeter, double mark every five centimeters

3 litre sterile saline coolant reservoir. During microwave activation the temperature of the coolant is continuously monitored. During prolonged full power use the coolant temperature may rise. If the coolant temperature rises too high then the “Coolant” warning light will illuminate on the LCS. If the coolant reservoir is not changed the coolant temperature will continue to rise. If the coolant temperature exceeds its safe operating range the system will declare a fault condition and microwave energy delivery will stop. A complete failure of the coolant system during microwave energy delivery results in an immediate and rapid increase in coolant temperature. If such a condition is detected the microwave power is stopped immediately. Using ultrasound or other imaging guidance, the distal end of the applicator is placed at the centre of the target tissue where microwave energy radiates to thermally coagulate the tissue. Each applicator may be used to coagulate up to 8 separate areas of target tissue for each patient at the maximum power and time settings. If the applicator is activated

Shaded zone indicate last 23 millmeteres before emitting tip

Shaded zone should remain inserted into tissue during operation

IMPORTANT – Always advance the applicator into the target tissue using axial forces only. Avoid placing lateral forces on the applicator tip during placement or removal Manifold handle with coolant inflow and outflow chambers

Target Tissue – coagulation zone at full power and time up to 4.5 cm in diameter and 5.5 cm in length depending on tissue type

in air then it may receive an instantaneous reflected power signal which is detected by the Sulis VpMTA Generator and microwave power is stopped. The Accu2i pMTA Applicator is available in three sizes: Standard 14cm, Intermediate 19cm and Long 29cm, with usable lengths of 14 cm, 19 cm and 29 cm, respectively. The target tissue is identified with imaging (such as ultrasound or CT) and the applicator is also positioned with image guidance. The shaded zone on the applicator must be fully inserted into tissue. During procedure, the effect on the target

FIGURE 2 Coolant temperature monitored at this location inside shaft Sharp cutting trocar tip

Active Region – the microwave emission pattern around antenna tip

tissue is localised intense heating in the area immediately around the applicator and more diffused gentle heating towards the extremities of the coagulation zone for the purpose of tissue destruction. Refer to section 6 for examples of coagulation sizes. Note: for full technical specification, contact manufacturer for the MTA Technical Service Manual. 2.4. MTA Temperature Probe The MTA Temperature Probe is a singleuse, sterile, disposable instrument used to monitor temperature levels up to 70°C. Its

3

use with the Acculis MTA system is optional and is determined by the user depending on the clinical circumstances of the treatment. Using ultrasound or other imaging guidance, the MTA Temperature Probes may be placed adjacent to the geometry of the coagulation to monitor the progression of the coagulation to achieve the targeted volume. They may also be placed between the target tissue and adjacent vital structures so that the progression of the coagulation towards those structures can be monitored. The probes are to be placed at a minimum distance of 2 cm from the location of the radiating portion of the applicator tip. The temperature probes are constructed with 18 gauge (1.27 mm) stainless steel, incorporate integral 2.7 m cables, and are available in 20 cm or 33 cm lengths. They are available with either Black or Gray color coding. The Temperature Probes feature a 1.5 cm long abraded zone located proximal to the tip to allow for improved visibility using ultrasound. MTA Temperature Probe

3. INSTRUCTIONS FOR USE 3.1. Training All users must be trained in the correct use of the Acculis MTA System in accordance with the Manufacturers training programme. WARNING Use of the Acculis MTA System by untrained users could pose a safety risk to patients and users. 3.2. System Set up 3.2.1. The Acculis Microwave Tissue Ablation (MTA) System when configured for use with the Accu2i pMTA Applicators consists of the Sulis VpMTA Generator, MTA Temperature Probes and Acculis Local Control Station (LCS) 3.2.2.  Refer to the Acculis MTA System Operators Manual for details of system set-up in preparation for the use of the Accu2i pMTA Applicators.

4

3.2.3. Power on the Sulis VpMTA Generator. The LCS will automatically power on. 3.3. Removal of Applicator from Packaging Select either an Accu2i pMTA 14cm Standard, 19cm Intermediate or 29cm Long applicator. Inspect packaging and expiration date prior to use. Using appropriate aseptic techniques remove the Accu2i pMTA Applicator from the sterile packaging. WARNING DO NOT use the Accu2i pMTA Applicator or the Temperature Probes if the expiration date provided on the packaging has been exceeded. DO NOT use the Accu2i pMTA Applicator or the Temperature Probes if the sterile packaging is broken, altered or compromised. 3.4. Connection of Accu2i pMTA Applicator 3.4.1.  Remove the applicator and cartridge from the packaging. Insert the cartridge into the recess on the front of the LCS and engage the microwave connection as shown, then rotate clockwise to lock in place, engaging the pump and data connections. 3.4.2. Use a 3 litre sterile saline drip bag as the coolant reservoir. 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. 3.4.3.  Remove the coolant reservoir spike connector from the applicator packaging and insert into the coolant reservoir (saline bag) as shown. 3.4.4. 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 and the pump LED will light up green. 3.4.5. Run the pump for two minutes to prime the coolant.

When the LCS has enabled microwave generation, the LCS ready (green tick) symbol will appear in the top left corner of the Sulis VpMTA Generator user interface screen. 1. Insert cartridge into recess of LCS, engage microwave connector

4. Press Pump start/stop button to start coolant flowing

2. Rotate clockwise to lock into position

3. Insert coolant reservoir spike into coolant reservoir

5. Press Pump start/stop button again to stop coolant and prepare for disconnection of the applicator

6. Press Release button to withdraw locking pin and remove cartridge

WARNING Do not energise the applicator unless coolant flow can be observed in the applicator handle 3.4.6.  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.

5

•

T he applicator cartridge is connected to the LCS and locked in place.

•

The pump is running - Pump LED is lit.

•

There is no fault detected with the applicator (indicated by the Fault LED).

CAUTION Do not place the applicator in the patient until the applicator has been connected, successfully primed and the LCS Ready symbol is showing on the control unit. 3.5. Connect MTA Temperature Probes 3.5.1.  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 Gray. They must be connected to the corresponding color temperature probe input jacks. 3.6. Coolant System Operation 3.6.1. The cooling system utilises a recirculating coolant methodology. This means that warm coolant from the probe is recirculated back to the coolant reservoir. Hence during microwave activation the temperature of the coolant will increase over time. 3.6.2.  To maximise the thermal capacity of the coolant system a 3 litre sterile saline bag is specified as the coolant reservoir. For added themal capacity the coolant reservoir may be chilled prior to use to 50C or less. 3.6.3. If the coolant temperature rises to the point that a fresh bag is required then the LCS “Coolant“ light will illuminate and the coolant reservoir should be replaced as soon as possible and in any case before commencing the next microwave application. Use of smaller bags will result in reduced run time between coolant reservoir changes. CAUTION

5

DO NOT Clip the microwave cable directly or otherwise kink or obstruct the microwave cable as to do so may impair coolant flow and cause an Applicator Fault condition as a result of applicator over temperature. CAUTION Use only Sterile Saline for the coolant reservoir. Patient injury may occur in the event of a coolant leak if non sterile saline, water, or other liquids are used. Use of a smaller coolant reservoir will increase the rate of coolant temperature rise.

need for further port reducers. Use down larger ports may be considered to increase applicator angulation and manoeuvrability. If the desired approach path to the target tissue is not possible because of trocar positioning then consideration should be given to using a percutaneous placement of the applicator into the laparoscopic field to achieve the desired path. Applicator placement should be monitored using transcutaneous or laparoscopic ultrasound or other imaging techniques. WARNING

3.6.4. If the coolant reservoir is not changed then the coolant temperature will continue to rise and may result in an applicator fault condition occurring. Microwave energy delivery will stop and the applicator and coolant reservoir must be discarded. 3.7. Placement of Accu2i pMTA Applicator and MTA Temperature Probes 3.7.1.  Using ultrasound or other imaging guidance, the Accu2i pMTA Applicator should be fully inserted into the target tissue with the active region positioned at the centre of the targeted coagulation volume. See Figure 2 to identify the active region of the applicator. When using percutaneously the tip of the antenna may be used to puncture the skin at the point of insertion. Use the minimum force necessary to achieve this and take care not to over advance the applicator. Refer to the shaft depth markings to monitor placement depth. Care should be taken to plan the insertion path to avoid unnecessary contact with adjacent tissues and to ensure only axial forces are imparted on the applicator during insertion or withdrawal. Lateral forces on the applicator tip should be avoided both during insertion and removal. Failure to do so could result in damage to the microwave array, failure of the applicator and injury to the patient. If used laparoscopically either a 5mm diameter or a 10-11mm diameter port with a standard 5mm reducer should be used. The normal pneumo-peritoneum should be maintained without the

6

DO NOT bend the Accu2i pMTA Applicator as this may impair the function of the cooling system and may damage the microwave feedline inside the applicator. DO NOT apply lateral forces on the ceramic tip of the applicator on insertion, during use or during removal as this may cause the ceramic to break and cause injury to the patient or user. 3.7.2.  Using ultrasound or other imaging guidance place the Temperature Probes in the peripheral coagulation zone to monitor the geometry of the coagulation or to monitor adjacent tissues, vital structures, ducts, vessels and nerves. The probes are to be placed at a minimum distance of 2 cm from the location of the radiating portion of the applicator tip. When using percutaneously the tip of the Temperature Probe may be used to puncture the skin at the point of insertion. Use the minimum force necessary to achieve this and take care not to over advance the probe. WARNING 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. 3.8. System Operation 3.8.1. On the Sulis VpMTA Generator touchscreen, set the time (10 seconds to 6 minutes) and power (60 to 140 W). Use the guidance provided to select the appropriate power

and time for the coagulation volume desired. Take account of the proximity of structures to be spared and use the MTA Temperature Probes as necessary to monitor tissue temperatures at critical locations. For coagulations close to vital structures consider using lower power and longer time. This will encourage more gentle heating and enhance vessel self protection. CAUTION Output power should be switched off when the applicator is being positioned for treatment. Microwave energy should not be applied to persons wearing metallic jewellery or clothing containing metallic material (for example metallic buttons, clips or thread). Parts of the body of the PATIENT containing metallic implants (for example a medullary nail) should not be treated unless specialized medical advice is obtained. Hearing aids should be removed. PATIENTS with implanted electronic devices and/or electrodes should be excluded from treatment with microwaves and from areas where the EQUIPMENT is operated. When coagulating close to vascular structures to be spared be aware that use of the Pringle manoeuvre will inhibit blood flow in the vessel and reduce the ability of the vessel to protect itself from thermal damage. 3.8.2. Once satisfied with the placement of the Applicator in the target tissue press and hold the microwave START button on the right side of the Sulis VpMTA Generator for at least 1 second. Microwave energy will be delivered to the Applicator. 3.8.3. At the end of the coagulation, carefully remove the Accu2i pMTA Applicator and the Temperature Probe(s) from the targeted tissue. 3.8.4. If necessary the Accu2i pMTA Applicator may be energised during withdrawal to coagulate the insertion track and eradicate any unwanted cells on the insertion track. Take care to stop energy delivery once the Applicator reaches the minimum insertion depth. 3.8.5. Before commencing the next insertion and coagulation inspect the applicator

for any damage. Ensure the tip is straight and the biocompatible coating is not compromised. If any damage is observed the applicator should be discarded and replaced with a new applicator. If the applicator is undamaged then it may be reinserted and re-energised. Subject to passing inspection between utilisations the device may be used multiple times. The device is tested to withstand 8 sequential coagulations at maximum power and time. WARNING DO NOT energize the Accu2i pMTA Applicator unless the ACTIVE REGION of the applicator is fully inserted into target tissue. If the applicator is not properly located into the selected tissue, an unintended thermal injury to the user, or an unintended injury to tissues, vital structures, ducts, vessels, or nerves tissue may occur. USE CAUTION when treating close to structures to be spared. Always use the lowest power and shortest time necessary to achieve the targeted coagulation. Use the MTA Temperature Probes to monitor the temperature of the structures to be spared. Failure to do so may result in unintended thermal injury. Do not re-energise an applicator that has not been visually inspected between uses. Re-energising the applicator without visually inspecting for damage may result in unnecessary patient injury as the Accu2i pMTA Applicator may not function. Do not conduct more than 8 sequential full power and full time coagulations. The surface temperature of the Accu2i pMTA Applicator, near the distal end of the shaft, may reach 43°C if used for 8 sequential full power and full time coagulations. 3.9. Disconnection and disposal of the Accu2i pMTA Applicator and MTA Temperature Probes 3.9.1.  To disconnect the Accu2i pMTA Applicator first remove the applicator from the patient. Press the “Pump” start/ stop button on the LCS to stop the pump and park the drive piston in the correct position for cartridge release. 3.9.2.  Press the “Disconnect” button on the LCS to release the cartridge locking pin.

7

The pin will retract for 5 seconds during which the cartridge may be rotated to the right and withdrawn from the LCS. 3.9.3. Remove the coolant reservoir from the hook and invert the bag. Remove the two way spike from the bag. 3.9.4. To disconnect a Temperature Probe first remove the probe from the patient. At the control unit, pull the collar while holding the connector stationary. 3.9.5. Dispose of the Accu2i pMTA Applicator and MTA Temperature Probes according to hospital policy or state and local regulations for handling sharps and biohazardous materials. WARNING Used Accu2i pMTA Applicators and MTA temperature probes may present a biohazard. Used Accu2i pMTA Applicators and MTA temperature probes may present a sharps hazard.

3.10. Accu2i pMTA Applicator Fault Condition 3.10.1. If the thermocouple in the tip of the Accu2i pMTA Applicator registers a coolant temperature outside of its safe operating range or if a total failure of the coolant system is detected or if the thermocouple circuit itself fails then microwave power will stop and the LCS “Fault” light will illuminate. 3.10.2.  If a fault condition occurs remove the Accu2i pMTA Applicator from the patient as soon as possible. 3.10.3. If a fault condition occurs, the condition of the Applicator cannot be assured and the Applicator and Coolant Reservoir must be changed in order to progress with treatment.

WARNING Failure to remove the applicator following a fault condition could result in thermal injury to user or patient due to thermal conduction from tissue in the heated coagulation zone. Attempting to re-use an Accu2i pMTA Applicator and coolant reservoir following a Fault condition may result in unnecessary patient injury as the Accu2i pMTA Applicator may not function.

8

4. CONTRAINDICATIONS The Accu2i pMTA Applicators are contraindicated in patients with heart pacemakers and other electronic device implants Do not reuse. 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 of the equipment in accordance with the operating instructions. Do not use the Accu2i pMTA Applicator or MTA Temperature Probes if the expiration date provided on the packaging has been exceeded. DO NOT touch the Temperature Probe to the Accu2i Surgical Applicator tip as exposure to temperatures in excess of 90°C may result in failure of the probe. Read all instructions for use for the Acculis MTA System prior to use, including the Sulis VpMTA Generator Operators Manual, and the Instructions for Use for the Accu2i pMTA Applicator and MTA Temperature Probes. 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 DO NOT attempt to use the Sulis VpMTA Control Unit if the LCD screen or system controls are not operational. DO NOT attempt to repair or alter any of the Acculis MTA System components. Use only accessories or parts supplied by AngioDynamics*. Store in a cool, dry place out of sunlight.

5. HOW SUPPLIED 5.1.

Accu2i pMTA 14cm Standard Applicator Description

Qty

1

Accu2i pMTA 14cm Standard Applicator c/w coolant tubing, LCS cartridge connector and 2 way coolant spike

1

2

Instructions for Use

1

5.2. Accu2i pMTA 29cm Long Applicator Description

Qty

1

Accu2i pMTA 29cm Long Applicator c/w coolant tubing, LCS cartridge connector and 2 way coolant spike

1

2

Instructions for Use

1

5.3. Accu2i pMTA 19cm Intermediate Applicator Description

Qty

1

Accu2i pMTA 19cm Intermediate Applicator c/w coolant tubing, LCS cartridge connector and 2 way coolant spike

1

2

Instructions for Use

1

6. EXPLANATION OF SYMBOLS Refer to Instructions

9

7. EXAMPLES OF COAGULATION SIZE ACHIEVED IN EX-VIVO TISSUE FIGURE 3 COAGULATION DIMENSIONS

B

A

In the plane perpendicular to the applicator. A is the COAGULATION DIAMETER

In the plane of the applicator. B is the COAGULATION LENGTH

Note: Tables 1, 2 and 3 illustrate the coagulation size (A x B, see Figure 3) created by the Accu2i pMTA Applicator over a range of 60 to 140 W (power) and 2, 4 and 6 minutes (time). The coagulation results are from coagulations performed in ex-vivo animal tissue models. Coagulation size may vary in clinical settings. All results are in cm and presented as diameter x length. TABLE 1 LIVER

2 min

4 min

6 min

60W

2.3 x 2.7

3.3 x 3.7

3.5 x 4.0

100W

2.7 x 3.2

3.6 x 4.1

4.0 x 4.7

140W

2.9 x 3.5

4.1 x 5.2

4.5 x 5.5

Use By Date

TABLE 2

Sterilised using ethylene oxide

MUSCLE

2 min

4 min

6 min

Do not reuse

60W

2.0 x 3.5

2.9 x 4.0

3.1 x 4.2

No latex

100W

2.4 x 3.8

3.2 x 4.3

3.6 x 4.5

Do not dispose

140W

2.5 x 4.1

3.4 x 4.9

3.9 x 5.0

Do not use if package is damaged

TABLE 3

Keep dry

KIDNEY

2 min

4 min

6 min

Temperature Limit

60W

2.1 x 2.2

3.0 x 3.2

3.2 x 3.6

Keep away from sunlight

100W

2.3 x 2.5

3.6 x 3.7

3.8 x 4.0

Manufacturer

140W

2.7 x 3.0

3.9 x 4.0

4.1 x 4.3

9

The Acculis System is manufactured by AngioDynamics, Inc.

AngioDynamics, Inc. No.1 Falcon Court Parklands Business Park Denmead Hampshire PO7 6XP United Kingdom Tel: +44 (0)2392 240011 w w w.angiodynamics.com *AngioDynamics, the AngioDynamics logo, Acculis and Sulis are trademarks and/ or registered trademarks of AngioDynamics, Inc. an affiliate or a subsidiary

510-243 Issue 6.0 (CO 1069)