Cardinal Health™ Kendall™ Fetal Spiral Electrode System
Internal Fetal Heart Rate Monitoring During Labour
The Cardinal Health™ Kendall™ Fetal Spiral Electrode (FSE) System is an internal fetal monitoring system designed to measure fetal heart rate during labour when external monitoring methods are no longer effective.
The system is designed to collect the fetal heart rate signal and transmit it to a compatible fetal monitoring system, helping healthcare professionals evaluate fetal well-being during the delivery process.
The complete system consists of three separate but integral components: the fetal spiral electrode, FSE attachment pad and reusable FSE cable.
Key Features
- Internal Fetal Monitoring: Designed to obtain fetal heart rate signals during labour
- Single Helix Electrode: Electrode attaches to the fetal scalp according to the manufacturer’s placement procedure
- One-Step Drive and Guide Tube Removal: Designed to simplify placement and removal
- Recessed Spiral: Designed to reduce the risk of needlestick injury
- Safety Cap: Helps protect the electrode lead wires from damage
- Secure Attachment: Compatible attachment pad anchors the external portion of the FSE
- Self-Adhesive Grounding Electrode: Attachment pad provides simple and secure fixation without requiring orientation
- Reusable Cable Options: Compatible cables are available for selected HP®, Philips™ and GE® fetal monitoring systems
- Multiple Attachment Pad Sizes: Small and large disposable attachment pads are available
About the Kendall™ FSE System
The Kendall™ Fetal Spiral Electrode System is intended for internal fetal heart rate monitoring during labour.
It may be used when healthcare professionals are unable to obtain an adequate fetal heart rate tracing using external monitoring or when external monitoring becomes difficult.
Situations described by the manufacturer include maternal body habitus and frequent movement of the mother or fetus that may interfere with external fetal heart rate monitoring.
Three-Part Monitoring System
The Kendall™ FSE System is composed of three main components:
- Kendall™ Fetal Spiral Electrode: Obtains the fetal heart rate signal
- Kendall™ FSE Attachment Pad: Secures the external portion of the electrode system to the mother
- Cardinal Health™ Reusable FSE Cable: Connects the attachment pad to the compatible fetal monitoring system
How the System Works
- Fetal Spiral Electrode Placement:
The FSE is inserted through the vagina and cervix and attached to the fetal scalp according to the manufacturer’s Instructions for Use. - Secure External Attachment:
The external portion of the FSE is anchored on the mother’s thigh or lower abdomen using a compatible Kendall™ FSE Attachment Pad. - Connection to Fetal Monitor:
A compatible Cardinal Health™ reusable FSE cable connects the attachment pad to the fetal monitoring system.
When the Kendall™ FSE System May Be Used
According to the manufacturer, the system is used to collect fetal heart rate signals during the delivery process to help evaluate fetal well-being.
Clinical circumstances described in the brochure include:
- Inability to obtain an adequate fetal heart rate tracing using external monitoring
- External fetal heart rate monitoring that is difficult due to maternal body habitus
- Frequent maternal movement
- Frequent fetal movement
- Patients considered at risk of adverse perinatal outcomes
One-Step Drive and Guide Tube Removal
The Kendall™ Fetal Spiral Electrode incorporates a one-step drive and guide tube removal design.
This feature is intended to make electrode placement and removal more convenient for trained healthcare professionals.
Recessed Spiral Design
The spiral electrode is recessed within the device design.
According to Cardinal Health, the recessed spiral helps reduce the risk of needlestick injuries during handling.
Safety Cap for Lead Wires
A dedicated safety cap is incorporated around the lead-wire system.
The safety cap helps protect the lead wires from damage during handling and use.
Kendall™ FSE Attachment Pads
Proper positioning of the external portion of the fetal spiral electrode is important during internal fetal monitoring.
Kendall™ FSE Attachment Pads provide a self-adhesive grounding electrode and leg plate for secure external attachment.
The attachment pad does not require a specific orientation and is available in two sizes.
| Code | Description | Pack Size |
|---|---|---|
| 31481396 | FSE Attachment Pad, Small – 4.8 × 4.8 cm, Disposable | 50 ea/cs |
| 50000095 | FSE Attachment Pad, Large – 9.5 × 4.8 cm, Disposable | 50 ea/cs |
The attachment pads identified by the manufacturer are not made with natural rubber latex and not made with DEHP.
Fetal Spiral Electrode Ordering Information
| Code | Description | Pack Size |
|---|---|---|
| 31479549 | Kendall™ Fetal Spiral Electrode Single Helix | 50 ea/cs |
Reusable FSE Cable Options
Cardinal Health provides several reusable FSE cable options designed for connection to compatible fetal monitoring systems.
| Code | Cable | Compatibility / Description | Pack Size |
|---|---|---|---|
| 31479754 | HP® FCB 100 | FCB 100 connection | 1 ea/cs |
| 31479846 | Philips™ FCB 300 | For most Philips™ monitors – 2 ft. | 1 ea/cs |
| 50000331 | Philips™ FCB 308 | For most Philips™ monitors – 8 ft. | 1 ea/cs |
| 31479812 | GE® FCB 400 | Monitors with round connector | 1 ea/cs |
| 50000107 | GE® FCB 700 | Monitors with rectangular connector | 1 ea/cs |
Product Information
- Product: Internal Fetal Heart Rate Monitoring System
- Product Name: Kendall™ Fetal Spiral Electrode System
- Brand: Cardinal Health™ Kendall™
- Electrode Type: Single Helix Fetal Spiral Electrode
- System Components: Fetal Spiral Electrode, Attachment Pad and Reusable FSE Cable
- Application: Internal fetal heart rate monitoring during labour
- Attachment Pad Options: Small 4.8 × 4.8 cm and Large 9.5 × 4.8 cm
- Reusable Cable Options: FCB 100, FCB 300, FCB 308, FCB 400 and FCB 700
- Malaysia Medical Device Registration: GB7747025-211009