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- Defibrillation - Cardioversion - Noninvasive Pacing - ECG Monitoring - CPR Feedback For use with ZOLL® Defibrillators, such as: - R Series - X Series Trained Personnel only, Including: - Physicians - Nurses - Paramedics - Emergency Medical Technicians - Cardiovascular Laboratory Technicians The OneStep Pediatric CPR electrodes are indicated for use on a patient less than 8 years of age or weighing less than 55 lbs (25kg).

As with the currently marketed OneStep Pediatric CPR Multi-Function Electrode (reviewed and cleared with K120907), the modified OneStep Pediatric CPR Multi-Function Electrode (MFE) is intended for use with ZOLL R Series and ZOLL X Series defibrillators for ECG Monitoring, Defibrillation, External Noninvasive Pacing, Cardioversion and CPR Feedback for use on patient less than 8 years of age or weighing less than 55lbs (25kg) in either the hospital environment. The currently marketed OneStep Pediatric CPR MFE provides users with accurate depth compression feedback when CPR is performed on a firm surface – a known recommended practice. A recent publication by the AHA acknowledges that "accelerometers are insensitive to mattress compression" and stresses the need for "continued development of optimal and widely available CPR monitoring." So. with the current submission. we are proposing to modify the OneStep Pediatric CPR MFE to incorporate a second motion sensor on the posterior electrode thereby allowing rescuers to obtain accurate depth compression feedback when CPR is performed on soft/ compressible surfaces. Dual sensor technology, utilized in the proposed OneStep Pediatric CPR MFE. has been reviewed and cleared by the agency with OneStep CPR II MFE (K133441). As with the predicate device, the proposed electrode and wire harness with a ZOLL proprietary connector will have a pre-connect feature that enhances the user's ability to deliver immediate therapy. And like the predicate device, the OneStep Pediatric CPR electrode is also designed to support the defibrillator's self test and expiration date identification. Each electrode pad is structurally comprised of a solid hydrogel with a pure tin electrical conductive element having a polyethylene terephtalate (PET) backing with an adhesive perimeter suitable for coupling to patient skin during rescue and/or treatment.

- Defibrillation - ECG Monitoring - Cardioversion ● - CPR Feedback ● The CPR Dura-padz Reusable Defibrillation Electrode is used in conjunction with Dura-padz Gel, and for use with the following ZOLL Biphasic-only defibrillators with max. energy setting of 200 Joules: - AED Pro - M Series ● - E Series ● - R Series ● The device will be used in pre-hospital, alternate care and hospital settings by trained personnel only, including: - . Physicians - Nurses - Paramedics - Emergency Medical Technicians ● - Cardiovascular Laboratory Technicians - First Responders The CPR Dura-padz Reusable Defibrillation Electrodes are not for use with ZOLL AED Plus and/or any Public Access Defibrillators. The CPR Dura-padz Reusable Defibrillation Electrodes are not indicated for use on a patient less than 8 years of age or weighing less than 55 lbs (25kg).

As with the cleared predicate device (K100565), the CPR Dura-padz Reusable Defibrillation Electrode is intended for use with the following ZOLL biphasic-only defibrillators: AED Pro, E Series, R Series and M Series for ECG monitoring, defibrillation and cardioversion. The addition of a CPR sensor (cleared per K110742) to the subject device will enable CPR feedback. As with the currently marketed predicate device (K100565), the CPR Dura-padz electrode is intended for use in conjunction with Dura-padz Gel on adult patients, and the electrode is reusable up to 100 patient uses.

- Defibrillation ● - Cardioversion ● - Noninvasive Pacing o - ECG Monitoring ● - CPR Sensor . For use on adult patients with ZOLL® R Series® defibrillator by trained personnel only, including: - Physicians - Nurses - Paramedics ● - Emergency Medical Technicians ● - Cardiovascular Laboratory Technicians ● The OneStep CPR II Adult Electrodes are not indicated for use on a patient less than 8 years of age or weighing less than 55 lbs (25kg).

As with the cleared predicate device (K110742), the OneStep CPR II MFE is intended for use with ZOLL R Series defibrillators for ECG Monitoring, Defibrillation, External Noninvasive Pacing, Cardioversion and CPR Feedback for adult patients in either the hospital or pre-hospital environment. The currently marketed OneStep CPR MFE provides users with accurate depth compression feedback when CPR is performed on a firm surface - a known recommended practice. A recent publication by the AHA acknowledges that "accelerometers are insensitive to mattress compression" and stresses the need for "continued development of optimal and widely available CPR monitoring". The proposed device incorporates a second motion sensor on the posterior electrode which will allow rescuers to obtain accurate depth compression feedback when CPR is performed on soft/ compressible surfaces. The dual sensor technology works by detecting motion in the posterior sensor and communicating it to the anterior sensor to allow for compensation for a compressible surface underneath the patient. The accelerometers in each CPR sensor work in series to provide a signal to the defibrillator which interprets that signal to determine actual chest compression depth when compressions are performed on a compressible surface. The dual sensor technology can also be used on a solid surface as the design of the posterior sensor is not influenced by lack of movement. As with the predicate device, the proposed electrode and wire harness with a ZOLL proprietary connector will have a pre-connect feature that enhances the user's ability to deliver immediate therapy. And like the predicate device. the OneStep CPR II electrode will also have the ability to perform a defibrillation self test and expiration date identification with the ZOLL R Series Defibrillator. Each electrode pad is structurally comprised of a solid hydrogel with a pure tin electrical conductive element having a polyethylene terephtalate (PET) backing with an adhesive perimeter suitable for coupling to patient skin during rescue and/or treatment.

To assist users in the performance of effective CPR on a victim 8 years or older.

PocketCPR™ is a device that uses voice prompts and visual indicators to assist rescuers in the performance of cardiopulmonary resuscitation (CPR). PocketCPR is designed to be used by a rescuer to perform CPR. PocketCPR provides rescuers with real-time feedback during the administration of CPR. PocketCPR has two operating modes: Normal and Silent Operating Mode which allows the rescuer to perform CPR in any type of environmental condition. In Normal Operating Mode, PocketCPR operates with all sounds, including voice prompts and metronome beeping. In Silent Operating Mode, PocketCPR operates with visual flashing metronome and chest compression lights "only". The PocketCPR directly measures acceleration through the use of an integrated accelerometer and The Fookers' It allocaly model is not compressing the chest at least 1.5 inches Instantal. Books are will instruct them to increase compression depth. The rate of compression is (comm), the Fooketer ( will morable non signal, encouraging the rescuer to keep pace with the prompled by the ace of a fiten 30 compressions or about 18 seconds of chest compressions, PocketCPR will instruct the rescuer to give breaths.

The BIO-DETEK Electrode Adapter is indicated for use with ZOLL CPR-D, stat-padz™ and statepadz II™ Electrodes for connection with Medtronic Physio-Control Defibrillator and data: LIFEPAK 9, LIFEPAK 10C, LIFEPAK 11, LIFEPAK 12, and LIFEPAK 20, all fitted with QUIK-COMBO Therapy Cable.

The BIO-DETEK Electrode Adaptor is made of rigid thermoplastic and conductive material. The adaptor will be provided as a reusable stand-alone accessory to be used in conjunction with ZOLL CPR-D, Stat*padz, and Stat*padz II Electrodes.

The pedirpadz™ Radiolucent MFE's are intended to be used on pediatric patients, 0-8 years of age at <55 lbs/25kg weight, for defibrillation, non-invasive pacing, cardioversion, and ecg monitoring in conjunction with ZOLL Pacemaker/Defibrillator equipment.

The pediepadz™ Radiolucent Pediatric Multi-Function Electrodes consist of a pair of liquid gel electrodes with permanently attached lead wires that join together at a proprietary ZOLL connector. The connector interfaces with ZOLL the Pacemaker/Defibrillator multifunction cable.

The BIO-DETEK Modified Adult Multi-Function Electrode with Connector is indicated for use with Medtronic Physio-Control Defibrillator Models: LIFEPAK 9, LIFEPAK 10C, LIFEPAK 11, LIFEPAK 500, LIFEPAK 12, and LIFEPAK 20, all fitted with QUIK-COMBO Therapy Cables, for defibrillation, cardioversion, non-invasive pacing, and electrocardingraph monitoring.

The BIO-DETEK Modified Adult Multi-Function Electrodes with Connector is indicated for use with Medtronic Physio-Control Defibrillator Models: LIFEPAK 9, LIFEPAK 10C, LIFEPAK 11, LIFEPAK 12, and LIFEPAK 20, all fitted with QUIK-COMBO Therapy Cable, for defibrillation, cardioversion, non-invasive pacing, and electrocardiograph monitoring.

ZOLL Superpadz Adult Multi-Function Electrodes will be used for the following clinical applications: - Defibrillation . - Cardioversion . - Noninvasive Pacing . - Electrocardiograph Monitoring . In conjunction with these devices: - ZOLL PD™ 1200 Pacemaker/Defibrillator . - ZOLL PD™ 1400 Pacemaker/Defibrillator . - ZOLL PD™ 2000 Pacemaker/Defibrillator . - ZOLL D 900 Defibrillator . - ZOLL D 1400 Defibrillator . - ZOLL D 2000 Defibrillator . - ZOLL 1600 Pacemaker/Defibrillator . - ZOLL 1700 Pacemaker/Defibrillator . - ZOLL NTP 1000 Noninvasive Temporary Pacemaker . - ZOLL M Series .

Superpadz Adult Multi-Function Electrodes

ZOLL First Responder Padz Adult Defibrillation Electrodes will be used for the following clinical applications: - Defibrillation - Electrocardiograph Monitoring In conjuction with these devices: - ZOLL PD™ 1200 Pacemaker/Defibrillator - ZOLL PD™ 1400 Pacemaker/Defibrillator - ZOLL PD™ 2000 Pacemaker/Defibrillator - ZOLL D 900 Defibrillator - ZOLL D 1400 Defibrillator - ZOLL D 2000 Defibrillator - ZOLL 1600 Pacemaker/Defibrillator - ZOLL 1700 Pacemaker/Defibrillator - ZOLL 1700 Facemanen sive Temporary Pacemaker - ZOLL M Series

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