1. The HALO³⁶⁰ Energy Generator - 1100C-115B

Proprietary 300 watt RF energy generator automates the sizing procedure, sets the ablation parameters, and supplies energy to the ablation catheter.

Accessories included with the purchase of the energy generator:

• The HALO³⁶⁰ Footswitch - FS-100B
  Hands-free activation of sizing and energy delivery functions
• The HALO³⁶⁰ Output Cable - CCC-001B
  Connection cable for the sizing balloon and the ablation catheter to the energy generator

2. HALO³⁶⁰ Energy Generator Modification

• Optimizing the generator to work with the lower inflation pressure (4.5 psi) of the polyurethane balloon of the HALO³⁶⁰⁺ Ablation Catheter
• Aligning the automated sizing algorithm to ensure that the smallest appropriate sized HALO³⁶⁰⁺ Ablation Catheter is recommended for each range of esophageal inner diameter values
• Enhancing ease-of-use with respect to troubleshooting and operating code communication during sizing and ablation procedures
• Enabling the HALO³⁶⁰ Energy Generators to operate with the 18 mm HALO³⁶⁰⁺ Ablation Catheter (32041-18)

NOTE: HALO³⁶⁰ Energy Generators that include the new modification will not work with 34 mm HALO³⁶⁰ Ablation Catheters or the 34 mm HALO³⁶⁰⁺ Ablation Catheters

All HALO³⁶⁰ Energy Generators sold after March 2009 will come with the HALO³⁶⁰ Energy Generator Modification.

3. The HALO³⁶⁰ Sizing Balloon - 3441B

Works with HALO³⁶⁰ Energy Generator to measure the esophageal inner diameter.

• Diameter of balloon: 33.7 mm
• Balloon length: 4 cm

4. The HALO³⁶⁰⁺ Ablation Catheter

360 degrees electrode array delivers a short burst (< 1 sec) of ablative energy circumferentially to the esophagus.

• Balloon length: 4 cm
• Electrode length: 3 cm
• Available Diameter Sizes:




18 mm....32041-18*	22 mm....32041-22
25 mm....32041-25	28 mm....32041-28
31 mm....32041-31

* Anticipated Availability Summer 2009

5. The HALO³⁶⁰ Filter FL-200B

Disposable and single-use 0.45 µm hydrophobic filter to be used with both the Ablation Catheter and the sizing balloon

Warnings and Indications