HeartSync Defibrillation Electrodes (Defib Pads) FAQ

1. What is the HeartSync Defibrillation Electrode?

2. In which medical procedure HeartSync can be used?

3. What are the benefits of using HeartSync?

4. How to use HeartSync Defibrillation Electrodes?

5. Can HeartSync be used in manual and automatic defibrillators?

6. Is HeartSync comparable to the OEM defib pads in the market?

7. What is the difference between radiolucent and radiotransparent?

8. What is the difference between Leads In and Leads Out?

9. We got this news that HeartSync Adult defib pads are FDA PMA-approved. What is FDA PMA?

10. Are HeartSync Defib Pads compatible with all defibrillator models?

11. Are the pads reusable?

12. How should the pads be applied to the patient?

13. When should each placement method, Anterior/Posterior or Anterior/Lateral, be utilized?

14. What happens if the pads are not placed correctly?

15. The packaging says “Adult” Defibrillation Pads. Can these pads be utilized for Children as well?

16. Why is the Philip device not included in the compatibility list?

17. As of January 2025, why am I receiving a mix of different packaging?

18. Can I request custom labels?

19. Can you help me develop a defib pad that is compatible with a device not currently listed in the compatibility?

1. What is the HeartSync Defibrillation Electrode?

HeartSync Multifunction Electrodes are designed for defibrillation, pacing, cardioversion, and monitoring. They are designed to help treat many varieties of electrical arrhythmias by delivering electrical therapy through an external defibrillator.  
 

HeartSync Multifunction Electrodes consist of two electrodes, connected to a wiring Harness that plugs into the defibrillator. The HeartSync electrodes are compatible with multiple models of monophasic and biphasic defibrillators. The electrodes can be either radiotransparent (transparent in X-rays) or radio-translucent (producing a shadow in X-rays).

2. In which medical procedure HeartSync can be used?

HeartSync can be used for Defibrillation, Cardioversion, Pacing and Monitoring.

3. What are the benefits of using HeartSync?

• HeartSync is a reliable, easy-to-use defibrillation product that provides fast, life-saving responses in sudden cardiac arrest emergencies. Designed for both adult and pediatric models, HeartSync is compatible with various AED models for adult patients. Pediatric Defibrillator Pads are not AED compatible. Please review the compatibility chart before use.

• 36-month shelf-life Extended shelf life reduces cost and waste. Defibrillation electrodes in low-use areas may provide up to an additional 50% shelf life compared to other pads in the market.
  
  
• The 60-inch lead wires on each HeartSync electrode allow for a better range of motion by the medical staff and enable providers to maintain distance from the patient during treatment.
  
  
• The pads are designed to fit the natural contours of the body, ensuring optimal contact with the patient's skin. This design helps deliver effective energy transmission while reducing the risk of accidental burns.
  
  
• HeartSync has the option for a Leads Out pad which can be pre-connected to the defibrillation device that saves multiple seconds when they count.
  
  
• With a long shelf life and lead wire, leads-out feature, HeartSync ensures preparedness in critical moments. User-friendly design, clear visual cues, and durable pads make them an ideal choice for clinical staff.

For the complete list of features and benefits, refer to the document here  

4.How to use HeartSync Defibrillation Electrodes?

The HeartSync electrodes are intended to be used in external pacing, cardioversion, defibrillation, and monitoring applications as a non-sterile, disposable device for single-patient use only. The electrodes provide the conductive interface between the defibrillators and the patient’s skin. When a patient requires defibrillation, cardioversion, or external pacing, these electrodes will be applied to the patient and connected to the instrument.

For complete Instructions for Use, please refer to this document.

5. Can HeartSync be used in manual and automatic defibrillators?

Yes. These are multifunction pads and can be used with automatic or manual defibrillators for monitoring, pacing, cardioversion, as well as defibrillation. These indications are consistent with current AHA Guidelines.

When used with an external defibrillator, these electrode pads are for treating patients in cardiopulmonary arrest who are: 

• Unconscious
• Not breathing spontaneously
• Without circulation (without a pulse)

AED or AED Mode: The pads are used on patients over 8 years of age or greater than 25 Kg or 55 pounds.

Manual Defibrillator: The pads are used on patients greater than 10 kg or 22 pounds.

Pediatric Defibrillator Pads are not AED compatible. Please review the compatibility chart before use.

6. Is HeartSync comparable to the OEM defib pads in the market?

The HeartSync Multifunction Disposable Single-Use Defibrillator Pads are comparable to OEM devices that are already on the market. For Zoll, Physio Control, and Cardiac Science, our clinical studies have shown comparable performance with the OEM electrode, and it was found in the results of these studies that HeartSync is as effective as OEM Electrodes. Some of the Equivalent OEM Models are:

7. What is the difference between radiolucent and radiotransparent?

• Radiotransparent means not visible during X-Rays
• Radiolucent means slightly visible during X-Rays

To know more, check the video below:

8. What is the difference between Leads In and Leads Out?

• Leads In means Leads are inside the packaging.
• Leads Out means Leads are outside and ready to pre-connect with the device.

To know more, check the video below:

9. We got this news that HeartSync Adult defib pads are FDA PMA-approved. What is FDA PMA?

Premarket approval (PMA) is the US Food and Drug Safety Administration (FDA) process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices.  

Class III devices are those that support or sustain human life, are of substantial importance in preventing impairment of human health, or present a potential, unreasonable risk of illness or injury. View the source here.

PMA requirements are the most stringent regulatory category for medical devices. To get an FDA PMA approval for HeartSync, we had to: 

• Submit detailed information about the device's design, manufacturing process, and performance 
• Provide clinical data to demonstrate the device's safety and efficacy 
• Share results of clinical and non-clinical testing 
• Submit to facility inspections by the FDA 

 
The rigorous process proves our ability to design and develop critical life-saving devices. If you want to learn about our journey to get the FDA PMA approval, please refer the blog here.

10. Are HeartSync Defib Pads compatible with all defibrillator models?

For the US, the Compatible Models are:  

US Pediatric Compatible Models:

Physio Control: LifePak-15, LifePak-20e;  
Zoll Medical: R-Series, X-Series, Propaq MD; 
*Pediatric Defibrillation Electrodes are NOT compatible with AED’s.

For Rest of the World:

11. Are the pads reusable?

No, HeartSync Defibrillator Pads are designed for single use only.

12. How should the pads be applied to the patient?

The pads should be placed on the bare chest, ensuring proper placement is mentioned in this IFU.

13. When should each placement method, Anterior/Posterior or Anterior/Lateral, be utilized?

We recommend AHA guidelines for placing the defib pads. Click here to view the source.

14. What happens if the pads are not placed correctly?

Incorrect placement can lead to ineffective defibrillation or failure to analyze the heart rhythm properly. Always follow the instructions here to ensure proper placement for optimal results.

15. The packaging says “Adult” Defibrillation Pads. Can these pads be utilized for Children as well?

During the PMA review process for Heartsync Multifunction Defibrillation Electrodes, it was directed by the FDA that NMT revise the product labeling from “Adult/ Child Defibrillation Electrodes” to only “Adult Defibrillation Electrodes”. Although the word “Child” was removed, the pads can still be utilized consistent with their labeling and according to the American Heart Association Guidelines.

To identify if the patient is an adult or a child, the following guidelines (mentioned in IFUs and packaging) should be used:

• AED: The pads are used on patients over 8 years of age or greater than 25 Kg or 55 pounds.
• Manual: The pads are used on patients over 10 kg or 22 pounds.

16. Why is the Philip device not included in the compatibility list?

As per mandates from the US Food & Drug Administration (FDA) requiring PMA approval on both equipment and accessories, Nissha Medical Technologies no longer distributes or markets Adult HeartSync™ defibrillation pads compatible with non-PMA approved Philips AED devices in the United States.

The list of Philips devices that have not received PMA approval includes: Philips XLT, Philips MRX, Philips HeartStart XL, Philips MRX ALS, Philips HP Codemaster XL, Philips HeartStart FR2+, Philips HeartStart Forerunner.

For more information regarding PMA approval for AED devices, please consult the FDA website at this link.

Because these devices are no longer eligible for sale and support, the following compatible Adult HeartSync brand defibrillation pads are discontinued in the United States market:

These products are still available in our European markets.

17. Why am I receiving a mix of different packaging?

We made some changes to the packaging as per the US FDA PMA approval guidelines. Some major changes include:

List of Compatible Devices Added: The FDA now requires us to list compatible PMA-approved devices directly on the packaging.

Adult/Child Label Change: The product labeling has been revised from “Adult/Child Defibrillation Electrodes” to “Adult Defibrillation Electrodes” as directed by the FDA. It’s important to note that while the labeling has changed, the pads can still be used for both adults and children according to their labeling and the American Heart Association Guidelines.

These changes do not affect the performance of the device. The product's effectiveness remains unchanged.

As we are transitioning to the new packaging, you are seeing a mix of old and new pouches. We appreciate your patience and understanding during this time. Once the transition is complete, you'll see only the new packaging.

18. Can I request custom labels?

We provide Custom Labeling/Private Labeling services for products in our portfolio. With a strong emphasis on quality and cost-efficiency, we can brand and launch these products as if they were your own.

When ready, complete this form. A representative will contact you shortly.

19. Can you help me develop a defib pad that is compatible with a device not currently listed in the compatibility?

This is considered a contract manufactured device. Please Fill out this form and our Sales Representative will connect with you soon.