FKD Esophageal Ｍonitoring System (Catheter)
This product is connected to a transesophageal external cardiac electrophysiology test pacemaker or similar device to perform temporary cardiac pacing and cardiac electrophysiology tests via the esophagus. It is also used as a monitoring system by connecting it to a temperature measurement device to continuously measure the temperature in the esophagus when performing percutaneous catheter cardiac ablation.
Description of product and components
Catheter
Catheter for continuous measurement of temperature in the esophagus
Controlled medical device Electrodes for transesophageal external cardiac pacemakers
JMDN code: 41474000
Medical device approval number: 22800BZX00224000
Ring type catheter
6Fr flat electrode specification
Accessory
Extension cable for pacing
Cable for extending the connection between catheter and transesophageal external pacemaker, etc.
Features
- 7 temperature sensors placed to reduce catheter manipulation
- Temperature sensors spaced 3mm apart for temperature measurement closer to the cauterization site
- Highly reliable temperature measurement from -20°C to +75°C
- Ring-shaped catheter with 6Fr flat electrode specification that reduces patient burden during insertion
Specifications/Packaging
Catheter
| Number of temperature sensors | 7 |
|---|---|
| Pacing electrode | 4pole |
| Electrode length | 5mm |
| Electrode spacing | 3-3-3-3-3-3 (FKD-SP-3F)* |
| 10-3-3-3-3-3-3-10 (FKD-SP-3) | |
| Catheter diameter | 6Fr |
| Max. electrode diameter | 6Fr (FKD-SP-3F) |
| 10Fr (FKD-SP-3) | |
| Effective length | 750mm |
| Electrode material | SUS303 |
| Marker | 50mm 55mm from tip (FKD-SP-3F only) |
| Stylet | Diameter 0.35mm (blue soft) |
| Diameter 0.40mm (white, hard) | |
| Connector | Black Connector for temperature connection (connect to Esophageal temperature connection cable） |
| Blue Connector for pacing (connect to Pacing extension cable) |
*20mm (between electrode and tip) is excluded
Accessory
| Pacing extension cable | FKD-PC-100 FKD-PC-200 FKD-PC-300 |
|---|
Concomitant medical devices
Fe-po esophageal monitoring system (temperature measurement device)
Device for continuous measurement and digital display of temperature in esophagus by catheter
Controlled medical device Continuous measurement electronic thermometer
JMDN code: 14032020
Specified maintenance control medical device
Medical device approval number: 22800BZX00223000
Manufacturer
J-Sol Medical Co., Ltd.
