PENTAX MEDICAL C2 CryoBalloon Ablation System Instruction Manual

PENTAX MEDICAL C2 CryoBalloon Ablation System

Description

The C2 CryoBalloon™ Ablation System is used to eliminate unwanted tissue by application of extreme cold. The balloon probe comes in contact with the wall of target tissue. Upon activation by a physician using the Foot Pedal, the balloon probe at the end of the Catheter is simultaneously cooled and inflated with nitrous oxide, which ablates the unwanted tissue. Nitrous oxide is fully contained within the balloon and the system. The nitrous oxide gas exits through the proximal end of the Catheter. The C2 CryoBalloon Ablation System is designed for use in conjunction with a therapeutic endoscope (3.7 mm working channel ID, 105 cm maximum working length). The System is comprised of the following main components:

• C2 CryoBalloon™ Catheter (see Figure 1) connects to the Controller, which controls the operation of the Catheter such as diffuser (sprayer) positioning and ablation (nitrous oxide release). C2 CryoBalloon Catheter consists
  of proximal Connector, Catheter Connector Cap, Catheter Shaft, balloon probe, and protective sheath. The Catheter is supplied sterile and is available in three balloon configurations and is disposable after single patient use. Refer to Catheter IFU for diffuser types. Note: Interior of catheter within the balloon utilizes a series of printed dots and dashes on the Hypotube for positioning as shown below. Dots are aligned to the diffuser outlet and dashes are 180° on opposite side.

• C2 CryoBalloon™ Controller (see Figure 2) contains the cartridge heater and the cryogen delivery valve, which is controlled with the Foot Pedal. The Controller contains diffuser radial and axial positioning features that are controlled by the Foot Pedal. The Controller is powered by 12VDC through the Foot Pedal and is supplied non- sterile and is reusable. An LCD touch screen on the Controller communicates system status and allows dosimetry input.

• C2 CryoBalloon™ Cartridge (see Figure 2) containing 36 grams of nitrous oxide. The Cartridge is installed into the Controller and replaced as required per procedure. The Cartridge is supplied non-sterile for single patient use.

• C2 CryoBalloon™ Foot Pedal communicates the user input to the Controller such as diffuser positioning, ablation, and balloon deflation. The Foot Pedal is powered by mains with an input voltage of 90 to 264VAC, 50-60Hz at 2A. The Foot Pedal is supplied non- sterile and is reusable.

Indications for Use

The C2 CryoBalloon™ Ablation System is used endoscopically to ablate unwanted tissue in the gastrointestinal tract, including treatment of Barrett’s oesophagus and squamous dysplasia, by application of extreme cold.

Directions for Use

This device should only be used by a medical professional authorized to perform endoscopy and only at a medical facility.

Contraindications

There are no known contraindications for use of this device. Reported contraindications for endoscopic use of cryosurgical ablation devices include:

• Pregnancy
• Significant ulceration of the target tissue
• Narrowing of the access oesophagus lumen that precludes advancing the C2 CryoBalloon Catheter to the site of ablation
• Target tissue varices at risk for bleeding
• Prior Heller myotomy

Warnings

• The C2 CryoBalloon™ Catheter is intended for single patient use only. Do not resterilize or reuse. Resterilization or reuse may compromise device performance and increase the risk of cross contamination due to inappropriate reprocessing, resulting in damage to the device or patient injury.
• Known risks related to endoscopic cryoblation are:
  • Dysphagia
  • Stricture
  • Bleeding
  • Perforation/Oesophageal Tear
  • Mucosal Laceration
  • Pain
• If there is resistance during manipulation of the Catheter, determine the cause of the resistance before proceeding.
• Use the device prior to the Use By date specified on the package.
• If the Catheter shaft is bent or kinked, discard and replace the device. Do not use or attempt to straighten. This may result in damage to the device or patient injury.
• Use only the C2 CryoBalloon™ Cartridge. Device operation will be impaired if other refrigerants or gases are used.
• The pressure inside the C2 CryoBalloon™ Cartridge is 50 atm. Carefully remove the Cartridge to avoid unintended release of residual cryogenic fluid from the Controller. The cryogenic fluid may freeze the skin.
• Do not inhale nitrous oxide from the cryogen Cartridge. Inhalation may be dangerous to your health.
• If using the Pear balloon, do not ablate tissue adjacent to the larger balloon diameter that is not clearly visualized
• WARNING: No modification of this equipment is allowed.
• WARNING: To avoid risk of electric shock, this equipment must only be connected to a supply mains with protective earth.
• Long term (≥ 2yrs) safety and effectiveness of the cryoablation of the esophageal dysplasia as an intervention to prevent development into esophageal carcinoma remains uncertain.

Precautions

• A thorough understanding of the principles, clinical applications and risks associated with ablation of unwanted tissue is necessary before using this product.
• Use of the C2 CryoBalloon™ Ablation System for procedures other than those indicated in these instructions is not recommended.
• Multiple ablations at the same site may result in deeper than intended ablation. In the event that adjacent ablations are desired, wait until visible ice is no longer present near the adjacent ablation area.
• The C2 CryoBalloon™ Ablation System is designed to be used in patients with oesophageal lumen diameters measuring 20 mm to 30 mm. Ablation in larger or smaller oesophageal lumens is not recommended.
• Do not use if package is open or damaged.
• Prior to use, examine for defects such as breaks, tears, bends or kinks. Do not use if defects are found.
• Do not pre-inflate or pre-test balloon prior to introduction through endoscope.
• Do not attempt to refold balloon into the protective sheath.
• If the Control Panel on the C2 CryoBalloon™ Controller does not illuminate after it is plugged into the Foot Pedal interconnect cable, replace the Controller.
• After the procedure, straighten the distal end of the endoscope as much as possible prior to removing the C2 CryoBalloon™ Catheter from the endoscope. Any excess bends of the endoscope will increase the resistance during withdrawal. If there is excessive resistance, remove the endoscope and Catheter as a unit.
• Under normal use, the balloon probe is the only element of the C2 CryoBalloon™ Ablation System that will be 0oC or colder. If any of the user accessible components are excessively cold, discontinue use.
• The C2 CryoBalloon™ Controller heater assembly contains a thermal protector to protect against temperatures in excess of 100°C. If this temperature is reached, the thermal protector will render the Controller unusable.
• The C2 CryoBalloon™ Controller is considered IPX0 (no protection, do not immerse in liquids) for ingress protection against liquids.
• The C2 CryoBalloon™ Foot Pedal meets IPX6 (protection against water rinsing, do not immerse in liquids) for ingress protection against liquids.
• The C2 CryoBalloon™ Controller should not be used in the presence of flammable anesthetics.
• In the event that the C2 CryoBalloon Controller is dropped, discard and replace it.

Foot Pedal Preparation

1. Open the Foot Pedal package and remove the Power Cable and Foot Pedal.

2. Plug the Power Cable into the Foot Pedal power supply.

3. Plug the Power Cable plug into the mains power source.

4. Position the Foot Pedal at the desired location.
   Controller Preparation

5. Open the Controller package and remove the Controller and Controller Cap. Open the Cartridge package and remove a Cartridge.

6. Plug the Interconnect Cable of the Foot Pedal into the Controller to power it on. Confirm the cable is securely attached. (Figure 4) Note: Upon initial start-up, language selection is required.

7. Insert the round end of the Cartridge into the Controller Cap (press firmly).
   Caution: Use only C2 CryoBalloon™ Cartridges.

8. Insert the Controller Cap and Cartridge into the Controller and rotate the Controller Cap clockwise until it stops. This action breaks the seal on the Cartridge.
   Catheter Insertion

9. Open the package and remove the Catheter.
   Caution: Do not remove the Catheter Connector Cap (proximal) or Protective Sheath (distal) until instructed.

10. Remove the biopsy valve cap and insert the Catheter Balloon Probe constrained within the Protective Sheath into the biopsy valve of the endoscope (3.7 mm ID minimum; 105 cm length maximum).
    Caution: Do not pre-inflate or pre-test the balloon. Do not attempt to refold the balloon into the Protective Sheath. If the balloon is not constrained within the Protective Sheath prior to use, discard and replace the Catheter.

11. Grasp the Catheter close to the endoscope and advance the Catheter through the Protective Sheath and through the biopsy valve (Figure 5).

12. Continue advancing the Catheter until the balloon exits the endoscope.
    Caution: Visualize the Catheter tip as it exits the endoscope.

13. Withdraw the Protective Sheath from of the biopsy valve and slide proximally onto the Catheter shaft (Figure 6). Catheter Positioning

14. Position the distal end of the endoscope approximately 2 to 3 cm proximal to the ablation site.

15. Advance the Catheter out of the endoscope until the black Catheter shaft (proximal to the balloon) is visible. Retract the Catheter into the endoscope until there is slight resistance (balloon contacting endoscope).

16. Remove and discard the Catheter Connector Cap.

17. Insert the Catheter Connector into the Controller. An audible “click” will be heard. Lightly tug on the Connector and Controller to confirm a secure connection.

18. After the Catheter has been connected, press CLICK ICON to  verify that a Catheter has been connected.
    Ablation Dosimetry Selection

19. Using the Controller Control Panel, select the desired ablation dosimetry. Refer to specific dosimetry information in the Catheter Instructions For Use (IFU). The System is ready for ablation after the ablation dosimetry has been selected.
    Balloon Pre-Inflation and Ablation

20. When the Cartridge is at operational pressure, the orange Standby Icon will change to a blue Ready Icon , and an audible beep will sound.

21. Hold the Controller upright with the Controller Cap pointing vertically (towards the ceiling). Ablation will be disabled if the Controller orientation is incorrect.

22. To pre-inflate the balloon, perform a “puff” by depressing and quickly releasing the Blue Ablation Foot Pedal (circled below). Each puff releases a small amount of cryogen. Note: This will deliver a small amount of cryogen that inflates the balloon so that it is in contact with the tissue. Caution: Do not occlude the exhaust ports during ablation.

23. Visualize the ablation site through the balloon. Retract or advance the Catheter for optimal positioning.
    Warning: If using the Pear balloon, do not ablate tissue adjacent to the larger balloon diameter that is not clearly visualized.
    Note: If using the Pear balloon in a treatment zone lumen that has different diameters, such as in the gastroesophageal junction or the proximal margin of a hiatal hernia, position the proximal (smaller) balloon diameter in the smaller proximal lumen and the distal (larger) balloon diameter in the larger distal lumen (Figure 7).

24. To visualize the target tissue area, perform another puff. While the balloon is inflated, the cryogen from each puff will momentarily freeze the targeted tissue area, turning it white.
    Note: Markings on the nitrous oxide delivery Hypotube aide visualization of the rotation and translation of the diffuser. The nitrous oxide exit hole on the diffuser are aligned to the circle markings and dash markings are on the opposite side.

25. To reposition the balloon proximally or distally press the Deflate button on the Foot Pedal (circled below), or deflation and inflation of the balloon can be achieved by attaching a 30 mL syringe to the Luer Activated Valve on the Catheter Connector. Reposition the balloon and repeat step 22 through step 24 to confirm the position.

26. To Rotate the diffuser, select the Rotation mode with the Mode Select Button on the Foot Pedal (circled below), and use the grey pedals to rotate the diffuser clockwise or counter clockwise. The rotational arrows will illuminate to indicate to user is in Rotation mode.

27. To adjust the Axial position of the diffuser, select the Translate mode on the Foot Pedal with the Mode Select Button, and use the grey pedals to move the diffuser distally or proximally. The axial arrows will illuminate to indicate to user that Foot Pedal is in Translate mode.

28. Repeat Step 24 to verify position.
    Note: During ablation, the inflated balloon remains stationary. Note: During ablation, the Focal catheter diffuser remains stationary for the duration of the selected dosimetry time. The diffuser for all other catheter configurations travels proximally at the selected dosimetry rate.

29. To perform ablation, press and hold the Blue Ablation Foot Pedal. Cryogen is continuously delivered from the diffuser for the entire ablation duration. During ablation, the Control Panel will
    Caution: To stop the flow of cryogen during ablation prior to the full ablation duration, release the Ablation pedal. indicate that Ablating is in process, and a beep sounds every second.

30. Cryogen flow will automatically stop after the user selected duration has elapsed.

31. An extended audible sound signals when ablation is complete. Release the ablation pedal.
    Note: The balloon inflates to approximately 4.5 psig (0.3 ATM). The balloon pressure cannot be altered by the user.
    Exchange Cartridge

32. Additional ablations can be performed with the current Cartridge until the Exchange Cartridge prompt appears.

33. To exchange the Cartridge, slowly rotate the Controller Cap counterclockwise approximately 90 degrees, then allow a few seconds in that position followed by completely unscrewing the cartridge slowly. Any remaining nitrous will escape. Dispose of the used Cartridge.

34. Install a new Cartridge by following Steps 7 to 8.

35. Perform additional ablation by following Steps 20 to 31.
    Catheter Withdrawal

36. Prior to withdrawal, return the diffuser to the distal most position and straighten the distal end of the endoscope. Any excess bend on the endoscope will increase the resistance during withdrawal of the Catheter.

37. Follow one of the two techniques to withdraw the Catheter into the endoscope:

    • a) Press and hold the Deflate button on the Foot Pedal and withdraw the Catheter into the endoscope. Release the button when the Catheter has been fully withdrawn into the endoscope. Or,
    • b) Attach a 30mL syringe to the luer-activated valve that is attached to the Catheter. Draw a vacuum to fully deflate the balloon. Maintain the vacuum and slowly retract the Catheter into the endoscope.
      Caution: If there is excessive resistance, remove the endoscope and Catheter as a unit.

38. With the balloon outside the scope, press on the Control Panel to detach the Catheter from the Controller. Dispose of the Catheter according to standard hospital guidelines for the disposal of medical waste.

39. When the procedure has been completed, remove the Cartridge from the Controller and dispose of the Cartridge.

40. Clean/disinfect Controller and clean Foot Pedal and store as desired.

Troubleshooting

If a fault condition occurs, the LCD touch screen on the Controller will display an Error Description with recommended Corrective Action. If the Corrective Action displayed does not resolve the fault condition, do not use the system. Contact PENTAX Medical.

Cleaning and Disinfection

The reprocessing instructions are based on recommendations found in the “Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008” by the USA Centers for Disease Control (CDC).
This section provides guidelines for cleaning and disinfecting the C2 CryoBalloon™ Controller. The Controller has a reuse life of 1 year. Use EPA- registered disinfectant wipes and provided brushes/swabs wetted by EPA- registered disinfectant spray.
Caution: The Controller is rated for IPX0 (it has no protection against ingress of liquids) – do not allow any fluid to enter the Controller.

1. Remove the Controller Cap and soak it in warm water for at least 5 minutes.

2. Wipe all accessible surfaces on the Controller and the Cap. Repeat until visible soils are removed.

3. Spray the Controller to adequately wet the external surfaces. Brush all the external surfaces and swab the inner exhaust ports.
   Caution: Do not spray liquid disinfectant directly into the catheter insertion port, the receptacle for the Cartridge, and the cable receptacle.

4. Leave the Controller undisturbed for at least 4 minutes.

5. Wipe the Cap and all accessible surfaces on the Controller. Use multiple wipes.

6. Allow the Controller assembly to dry prior to use.

This section provides guidelines to clean the C2 CryoBalloon™ Foot Pedal. The Foot Pedal has a reuse life of 3 years.
Caution: The Foot Pedal is rated for IPX6 (protection against splashing of liquids; no protection against submersion) – do not fully submerge the Foot Pedal.

1. Clean any visible soils with a mild soap and water solution if necessary. Wipe clean.
2. Allow the Foot Pedal to dry prior to use.

Operation, Storage and Disposal

Operate and store the C2 CryoBalloon™ Ablation System as follows:

• Controlled room temperature environment with ambient temperature from +10°C to +40°C
• Relative humidity from 30% to 75%
• Atmospheric pressure from 700 to 1060 hPa

Dispose of the C2 CryoBalloon™ System components in accordance with standard hospital guidelines and local codes for the disposal of medical waste and electronic waste.

EMC Compliance and Warning Statement

This equipment has been tested and found to comply with the limits of the standard for medical devices, IEC 60601-1-2. The limits are designed to provide reasonable protection against harmful interference in a typical medical installation. This equipment generates, uses and can radiate radio frequency energy, and, if not installed and used in accordance with the manufacturer’s instructions may cause harmful interference to other devices in the vicinity. However, there is no guarantee that interference will not occur in a particular installation. If this equipment causes interference with other devices, which may be determined by turning the equipment off and on, the user should notify the hospital safety personnel and try to correct the interference by one or more of the following measures:

• Reorient or relocate the device receiving the interference.
• Increase the separation between the equipment.
• Consult the manufacturer for help.

FCC/IC Compliance and Warning Statement

Changes or modifications not expressly approved by the manufacturer could void the user’s authority to operate the equipment.
NOTE: This equipment has been tested and found to comply with the limits for a Class A digital device, pursuant to part 15 of the FCC Rules and Canada ICES-003. These limits are designed to provide reasonable protection against harmful interference when the equipment is operated in a commercial environment. This equipment generates, uses, and can radiate radio frequency energy and, if not installed and used in accordance with the instruction manual, may cause harmful interference to radio communications. Operation of this equipment in a residential area is likely to cause harmful interference in which case the user will be required to correct the interference at their own expense.

EMC Guidance and Declaration

The CryoBalloon Ablation System is intended for use in the electromagnetic environments described in the tables below. The customer or user of the system should assure that is used in such an environment.

ELECTROMAGNETIC IMMUNITY

Immunity Test| 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%
Power Frequency (50/60 Hz)

magnetic field

IEC 61000-

4-8

|

3 A/m

|

3 A/m

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

Radiated RF

IEC 61000-

4-3

|

3 V/m

80 MHz

to 2.5 GHz

|

3 V/m

80 MHz to 2.5 GHz

| Portable and mobile RF communications equipment should be used no closer to any part of the CryoBalloon Ablation Controller, than the recommended separation distance calculated from the equation applicable to the frequency of the

transmitter.

ELECTROMAGNETIC IMMUNITY

Immunity Test| Test Level| Compliance Level| Electromagnetic environment guidance
 |  |  | Therecommended separation distances calculations can be calculated as follows:

= 1.2√ ( < 800Mhz)

= 2.3√ ( ≥ 800Mhz) Field strengths fromfixed 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 ofthe equipment marked with the followingsymbol:

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

b Over the frequency range 150kHz to 79MHz, field strength should be less than 3 V/m.

ELECTROMAGNETIC EMISSION

Emission Test| Compliance| Electromagnetic environment guidance

RF Emissions CISPR 11

|

Group 1

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

equipment.

Class B

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

The C2 CryoBalloon™ Ablation System is intended for use in an electromagnet environment in which radiated RF disturbances are controlled. The Controller part of the system is the only electronic component of the system; therefore, the distances described below only apply to the Controller. The customer or user of the system can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Controller as recommended below, according to the maximum output power of the communications equipment.

Recommended separation distances between portable and mobile

communications systems and the CryoBalloon Ablation Controller

Rated Max Output of Transmitter (watts)| Separation distance according to frequency of the transmitter (meters)
150kHz-79Mhz d=1.2 √| 80MHz-799Mhz

d=1.2 √

| 800MHz-2.5GHz

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 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 according to the transmitter manufacturer.

NOTE: These guidelines may not apply in all situations. Electromagnetic

propagation is affected by absorption and reflection from structures, objects, and people.

Labeling Symbol Key

PENTAX Medical
A Division of PENTAX of America, Inc.
303 Convention Way, Suite 1 Redwood City, CA 94063 Tel.: +1 866 979 5022
Fax: +1 866 584 8523
PENTAX Europe GmbH Julius-Vosseler-Straße 104 22527 Hamburg, Germany Tel.: +49 40 561 92-0 Fax: +49 40 560 42 13

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