Barrx Radiofrequency Ablation System Quick Reference Guide

Barrx™ radiofrequency ablation system

Quick reference guide The following information is intended as a quick reference. For full details, please refer to this product's Instructions For Use (IFU). Contact customer service or your sales representative for the most in–to–date revision of the package insert. Task

Review

Basic Troubleshooting

Problem: No RF Power Output

• Energy Generator not plugged in • Energy Generator not turned on

• Energy Generator in STANDBY mode • Energy Generator in FAULT mode

• Energy Generator still in ABLATION COMPLETE mode • Fault in accessory or Footswitch

• Output Cable not connected to the Energy Generator

• No Ablation Catheter Connected • Defective Ablation Catheter

• Energy Density Parameter Not Set • Internal Energy Generator failure

• Balloon Inflation Error. The pressure in the Balloon Based Ablation Catheter or Barrx 360 Express RFA Balloon Catheter is less than the target pressure

Operational and Fault Codes

If a fault condition occurs, the System Status display on the front panel will display an operational code, and all others will be blank. The interpretation of the operational, error and fault codes, as well as possible causes and solutions are listed in Tables 3.A, 3.B, 3.C and 3.D. In the event of an operational /error or fault code, endoscopic visualization must be used to verify complete balloon deflation if using a Balloon Based Ablation Catheter, Barrx 360 Express RFA Balloon Catheter, or Sizing Balloon. If the Energy Generator displays an E95 operational code when using a Balloon Based Ablation Catheter, Barrx 360 Express RFA Balloon Catheter, or Sizing Balloon, this is probably due to an air leak within the system. In such situations verify the following connections are secure: • The pneumatic connector between the Energy Generator and the Output Cable; • The pneumatic connector between the Output Cable and the Barrx filter; • The connection between the filter and the Ablation Catheter.

If the E95 operational code is observed again, there may be an air leak in the Ablation Catheter. Under endoscopic visualization, confirm that the balloon is fully deflated and then remove the Ablation Catheter. If the balloon is not deflated by depressing the DEFLATE control button or by depressing the Auto Inflation Foot Pedal, then manually deflate the balloon using a syringe via the pneumatic connector. Remove and replace the Ablation Catheter. Complaint Filing

1. Complete the field and technical report form (which includes the information below) 2. Details must be included:

• Date Medtronic employee was first notified of the event/problem

• Initial Reporter: Who informed the sales representative or tech support of the event

• List of all products involved

• Accurate description of the problem

• Issues that the Device problem directly resulted into 3. Retain defective product for return

Barrx™ radiofrequency ablation system

Quick reference guide Troubleshooting Codes

Table 3.A. Post Faults (Unrecoverable) Error code

Description

System status messages

Auto deflate function active on error for balloon based catheters

P01

POST CPU Configuration Operational Code

Disconnect Catheter P01 – Cycle Power

N/A

P02

POST ROM Test Operational Code

Disconnect Catheter P02 – Cycle Power

N/A

P03

POST RAM Test Operational Code

Disconnect Catheter P03 – Cycle Power

N/A

P04

POST Power Operational Code

Disconnect Catheter P04 – Cycle Power

N/A

P05

POST Impedance Operational Code

Disconnect Catheter P05 – Cycle Power

N/A

P06

POST Voltage Operational Code

Disconnect Catheter P06 – Cycle Power

N/A

P07

POST Current Operational Code

Disconnect Catheter P07 – Cycle Power

N/A

P08

POST Reference Voltage Operational Code

Disconnect Catheter P08 – Cycle Power

N/A

P09

POST Watchdog Test Operational Code

Disconnect Catheter P09 – Cycle Power

N/A

P010

POST Output Transformer Impedance Operational Code

Disconnect Catheter P10 – Cycle Power

N/A

P011

POST Pressure Sensor Offset Operational Code

Disconnect Catheter P11 – Cycle Power

N/A

P012

POST Pressure Reference Voltage Operational Code

Disconnect Catheter P12 – Cycle Power

N/A

P015

POST Real Time Clock Test Operational Code

Disconnect Catheter P15 – Cycle Power

N/A

P016

POST Real Time Clock Date Operational Code

Disconnect Catheter P16 – Cycle Power

N/A

P017

POST Switch Closed Operational Code

Disconnect Catheter P17 – Cycle Power

N/A

Barrx™ radiofrequency ablation system

Quick reference guide Table 3.B. Software/Hardware Faults (Unrecoverable) Error code

Description

System status messages

Auto deflate function active on error for balloon based catheters

H10

COP Operational Code

Disconnect Catheter H10 – Cycle Power

Yes

H11

Illegal CPU Instruction

Disconnect Catheter H11 – Cycle Power

Yes

H12

Duplicate Variable Operational Code

Disconnect Catheter H12 – Cycle Power

Yes

H13

Software Operational Code

Disconnect Catheter H13 – Cycle Power

Yes

H15

Reference Voltage Operational Code

Disconnect Catheter H15 – Cycle Power

Yes

H16

Vrms Offset Operational Code

Disconnect Catheter H16 – Cycle Power

Yes

H17

Irms Offset Operational Code

Disconnect Catheter H17 – Cycle Power

Yes

H18

Pmes Offset Operational Code

Disconnect Catheter H18 – Cycle Power

Yes

H19

RF ON Synch Operational Code

Disconnect Catheter H19 – Cycle Power

Yes

H20

Pressure Out of Range Operational Code

Disconnect Catheter H20 – Cycle Power

Yes

H22

Output Transformer Channel Set Operational Code

Disconnect Catheter H22 – Cycle Power

Yes

H23

Duplicate Pressure Operational Code

Disconnect Catheter H23 – Cycle Power

Yes

Barrx™ radiofrequency ablation system

Quick reference guide Table 3.C. Catheter Errors (Recoverable) Error code

Description

System status messages

Auto deflate function active on error for balloon based catheters

C50

EEPROM CRC Code

C50 – Reconnect or Discard Catheter

No

C51

Invalid Catheter ID Code

C51 – Reconnect or Discard Catheter

No

C52

Expired Catheter Code

C52 – Max Time Reached Discard Catheter

Yes

Sizing Balloon: Discard Catheter C53 – Max Use Reached nnmm Recommended Barrx 360 RFA Balloon Catheter: Discard Catheter C53 – Max Use Reached

C53

Catheter Use Exceeded Code

nnn% nnn% nnn% Energy Delivered Barrx 360 Express RFA Balloon Catheter: Discard Catheter C53 – Max Use Reached

Yes

Energy Delivered Non Balloon Based Ablation Catheter: Discard Catheter C53 – Max Use Reached nn% Energy Delivered C55

Catheter Type Code

C55 – Reconnect or Discard Catheter

Yes

C56

Filter Blocked Code

C56 – Filter Blocked Remove Filter Deflate with Syringe Discard Catheter

No

C57

EEPROM Setting Code

Unusable Catheter C57 – Discard Catheter

No

Barrx™ radiofrequency ablation system

Quick reference guide Table 3.D. Application Operational Codes (Recoverable) Error Code

E71

Description

System Status Messages

Handpiece Communication Loss

Barrx 360 Express RFA Balloon Catheter: E71 – Catheter Communication Error

Auto deflate function active on error for balloon based catheters

Require Reset Button

Yes

Yes

Yes

N/A, catheter must be disconnected and discarded

Yes

N/A, catheter must be disconnected and discarded

Yes

No

Press Reset

E72

E73

IO Expander Readback Error

Barrx 360 Express RFA Balloon Catheter: E72 – Catheter Electronics Fault

MOSFET Stuck Error

Barrx 360 Express RFA Balloon Catheter: E73 – Catheter Electronics Fault

Replace Catheter

Replace Catheter Barrx 360 RFA Balloon Catheter: E81 – Catheter Too Big Check Sizing Results Consider Smaller Ablation Catheter nnn% nnn% nnn% Energy Delivered E81

Low Impedance Error

Barrx 360 Express RFA Balloon Catheter: E81 – Clean Electrode Low Energy Delivered Non Balloon Based Ablation Catheter: E81 – Clean Electrode nn% Energy Delivered n Ablations

Barrx™ radiofrequency ablation system

Quick reference guide Table 3.D. Application Operational Codes (Recoverable) Error Code

Description

System Status Messages

Auto deflate function active on error for balloon based catheters

Require Reset Button

Yes

No

Yes

No

Barrx 360 RFA Balloon Catheter: E82 – Clean Electrode or Poor Elec Contact nnn% nnn% nnn% Energy Delivered

E82

High Impedance Error

Barrx 360 Express RFA Balloon Catheter: E82 – Clean Electrode or Poor Elect Contact Low Energy Delivered Non Balloon Based Ablation Catheter: E82 – Clean Electrode or Poor Elec Contact nn% Energy Delivered n Ablations Barrx 360 RFA Balloon Catheter: E83 – Clean Electrode or Poor Elec Contact nnn% nnn% nnn% Energy Delivered

E83

Voltage Limit Error

Barrx 360 Express RFA Balloon Catheter: E83 – Clean Electrode or Poor Elect Contact Low Energy Delivered Non Balloon Based Ablation Catheter: E83 – Clean Electrode or Poor Elec Contact nn% Energy Delivered n Ablations

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