FAQs About HeartSync Defibrillator Pads

Find answers to common questions about HeartSync defibrillator electrodes, including compatibility, usage, and storage.

 

HeartSync Multifunction Disposable Single-Use Defibrillator Pads are designed for defibrillation, external pacing, cardioversion, and monitoring applications. They are designed to be the interface between specific defibrillators and the patient. When used with an external defibrillator, the electrodes can help treat many varieties of electrical arrhythmias by delivering electrical therapy through an external defibrillator and facilitate monitoring of the patient

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 only a shadow in X-rays).

HeartSync can be used with an external defibrillator to address various heart conditions and rhythms via Defibrillation, Cardioversion, External Pacing and Monitoring.

  • HeartSync Multifunction Disposable Single-Use Defibrillator Pads are reliable, easy-to-use electrodes that  can facilitate fast, life-saving responses in sudden cardiac arrest emergencies. HeartSync includes multiple models that are compatible for use in adult and pediatric patients, The adult HeartSync models are compatible with various Defibrillators and AED models. Pediatric Defibrillator Pads are not intended for AED use, but are designed for use with manual defibrillation only. Please review the compatibility chart before use.

 

  • The 36-month extended shelf-life can reduce cost and waste for healthcare facilities.

  • The 60-78-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 offers a “Leads Out” packaging configuration,  which allows for pre-connecting the electrodes to the defibrillation device without having to open the package. This can  save multiple seconds when they count.

  • With an extended shelf life, long lead wire, and the leads-out feature, HeartSync supports preparedness for what could be critical moments in healthcare facilities. In addition, the user-friendly design contains pictograms and instructions on the pouch to provide clear visual cues, making them an ideal choice for clinical staff.

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

The HeartSync Multifunction electrodes are single-use, non sterile, disposable pads that are intended to be used in external pacing, cardioversion, defibrillation, and monitoring applications. 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 these documents.

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

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

Manual Defibrillator:  Adult pads can be used on patients greater than 10 kg or 22 pounds.

Pediatric Multifunction Defibrillator Pads are also intended to be used for external pacing, defibrillation, cardioversion, and monitoring applications.  Note Pediatric HeartSync Models are not intended for AED use, but rather with manual defibrillation only. Please review the compatibility chart before use.

The HeartSync Multifunction Disposable Single-Use Defibrillator Pads are compatible with many defibrillators available on the market and are comparable to many defibrillator pads offered by these OEM defibrillator manufacturers.

For Zoll, Physio Control, and Cardiac Science, non-clinical studies have shown comparable performance of HeartSync to the OEM electrodes. Based on pre-clinical and non-clinical benchtop testing, design verification, and post market surveillance performed by Nissha HeartSync Defibrillator Pads are safe and effective and can be considered comparable to many OEM Electrodes.

Some of the Equivalent OEM Models are:

HeartSync Model OEM Equivalent Model
T100AC-Physio, T100LOAC-Physio Quick-Combo (11996-000091)
C100AC-Physio, C100AC-Physio RTS Quick-Combo (11996-000090)
T100-CS Powerheart G3 AED (9131-001)
T100AC-Zoll, T100LOAC-Zoll Pro-Padz (8900-4004
C100AC-Zoll, C100LOAC-Zoll Pro-Padz Radiolucent (8900-4006)

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

To know more, check the video below:

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

Defib-Leads-Out.png

To know more, check the video below:

Premarket approval (PMA) is the US Food and Drug Safety Administration’s (FDA) most stringent process for marketing approval for high-risk Class III medical devices in the United States.  This includes a scientific and regulatory review to evaluate the safety and effectiveness of the 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.

As part of the PMA application process, we submitted extensive information and data pertaining to:

  • The device's design, manufacturing process, performance, and intended use. 
  • Results of Clinical Testing
  • Risk Analysis
  • Demonstrate a robust Quality Management System (QMS)

 
If you want to learn about our journey to get the FDA PMA approval, please refer the blog here.

US Adult Pads, the Compatible Models are:  

Physio Control: LifePak-15, LifePak-20/20e, LifePak -1000;  

Zoll Medical: R-Series, X-Series; 
*Not Compatible with Zoll AED Plus or Zoll AED Pro 

Cardiac Science: PowerHeart AED G3 Plus, PowerHeart AED G3 Pro 

 

US Pediatric Pads 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.

 

Rest of the World Adult Pads Compatible Model:

Philips Medical: HeartStart Intrepid, HeartStart MRx (plug style connector), HeartStart XL, HeartStart Forerunner 

Physio Control: LifePak CR Plus Series, LifePak-20 / 20e, LifePak-500, LifePak-1000, LifePak-15, LifePak-12  

Zoll Medical: M-Series, E-Series, R-Series, X-Series, Powerheart G3, Propaq MD  

Cardiac Science: PowerHeart AED G3 Plus, PowerHeart AED G3 Pro  

Schiller: FRED easy, DG4000,DG5000,DG6002, SKITY, OBLS300, OBLS300A  

Nihon Kohden: TEC-5500 Series, TEC-7700 Series, TEC-5600 Series, TEC-8300 Series, TEC-7600 Series 

 

Rest of World Pediatric Pads Compatible Models:

Philips Medical: HeartStart Intrepid, HeartStart MRx (plug style connector), HeartStart XL, HeartStart XL+, HeartStart XLT

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

 The US FDA regulations require that only defibrillators that have Pre-Market Approval can be listed as compatible with our HeartSync Products.  This is the reason there are less devices listed for use in the US versus the rest of the world.

Note: If your defibrillator device is not listed here that means, it’s not compatible with our current HeartSync Multifunction Disposable Single-Use Defibrillator Pad models. 

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

The pads should be applied firmly to clean, dry, intact skin on bare chest and/ or back, refer to Instructions for Use (IFU) for detailed instructions for more details for proper pad placement.

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

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

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 for patients that meet the guidelines provided on the label/labeling, IFU, and the American Heart Association Guidelines.

To identify if the patient is an adult or pediatric, the following guidelines can be found on the IFUs and packaging:

  • AED or AED Mode: 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.

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 defibrillation pads compatible with non-PMA approved devices in the United States, including the Philips AED devices.

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.

In addition, Philips has decided to discontinue several Philips defibrillators, they are no longer eligible for sale and support. The following compatible Adult HeartSync brand defibrillation pads are no longer available in the United States:

Part # Description
6600015H HeartSync C100AC-PHILIPS (D311)
6600021H HeartSync C100LOAC-PHILIPS
6600091H HeartSync T100AC-PHILIPS (D309)
6600099H HeartSync T100LOAC-PHILIPS (D317)

 

These products are still available in our European markets.

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.

Label Change on models previously labeled for use on Adult/Child: The product labeling has been revised from “Adult/Child Defibrillation Electrodes” to “Adult Defibrillation Electrodes”. It’s important to note that while the labeling has changed, the pads can still be used 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 may receive product with either label on the pouch.  We appreciate your patience and understanding during this time. Once the transition is complete, you'll see only the new packaging.

OldvsNew-Defib-Packaging.png

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.

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