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HeartSine samaritan SAM 350P User Manual

HeartSine samaritan SAM 350P
60 pages
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USER MANUAL
HeartSine
®
samaritan
®
PAD
SAM 350P Semi-Automatic Debrillator
SAM 360P Fully Automatic Debrillator
SAM 450P Semi-Automatic Debrillator

Questions and Answers:

HeartSine samaritan SAM 350P Specifications

General IconGeneral
Device TypeAutomated External Defibrillator (AED)
IP RatingIP56
Operating Temperature0°C to 50°C (32°F to 122°F)
Storage Temperature-20°C to 60°C (-4°F to 140°F)
PacingNo
Voice PromptsYes
Visual IndicatorsYes
CPR AdvisorYes
Warranty8 years
Battery Life4 years
Energy Output150 Joules
Waveformbiphasic
Energy LevelsFixed 150 J
Self-TestingAutomatic self-testing daily, weekly and monthly

Summary

Indications for Use

Contraindications and Caution

Defines when not to use the PAD and legal restrictions on sale.

Warnings and Precautions

Patient Safety and Operational Guidelines

Covers patient suitability, treatment delay, electric shock, repair, flammable gases, and patient contact.

Specific Device Warnings and Precautions

Operational Safety and Interference

Addresses automatic shock, CPR advisor restrictions, electrode placement, and interference.

Device Specifications and Usage Advice

Maintenance, Disposal, and Regulatory Compliance

Covers ingress protection, battery life, training, maintenance, disposal, and regulations.

Overview of Sudden Cardiac Arrest

Understanding SCA and AED Treatment Basics

Explains SCA, heart rhythms (VF/VT), and the role of AEDs in treatment.

Introduction to HeartSine samaritan PAD

Models, Features, and CPR Guidance

Introduces PAD models, their purpose, and CPR metronome/advisor features.

Training and Safety Data Reference

Recommended Training and Effectiveness Data

Advises on training needs and references Safety/Effectiveness data in Appendix E.

SAM 350P Device Layout

Controls, Indicators, and Pad-Pak Details

Details buttons, indicators, ports, Pad-Pak, green tab, and audio output.

SAM 360P Device Layout

Controls, Indicators, and Audio Output

Details buttons, indicators, ports, Pad-Pak, green tab, and audio output.

SAM 450P Device Layout

Controls, CPR Advisor, and Pad-Pak Details

Details buttons, indicators, CPR advisor, Pad-Pak, green tab, and audio output.

Setting Up the samaritan PAD

Unpacking and Pad-Pak Selection

Covers verifying contents and choosing between adult and pediatric Pad-Paks.

Putting the PAD into Service

Pad-Pak Installation and Initial Testing

Guides on checking expiration, inserting Pad-Pak, and performing self-tests.

Final Setup and Registration

Preparation Checklist and Registration Process

Lists final setup steps, storage, registration, and service schedule creation.

Using the samaritan PAD: Initial Steps

Patient Assessment and Safety Precautions

Covers patient assessment, moving to safety, and avoiding electromagnetic interference.

Using the samaritan PAD: Pad Application

Electrode Pad Placement and Verification

Details applying pads firmly, checking placement criteria, and ensuring proper contact.

Using the samaritan PAD: Chest Preparation

Chest Preparation and Electrode Removal

Covers exposing bare chest, drying, shaving, and removing electrode pads.

Using the samaritan PAD: Shock Delivery

Shockable Rhythm Analysis and Delivery Protocol

Explains rhythm analysis, standing clear, pressing shock button, or automatic shock delivery.

Using the samaritan PAD: CPR and Completion

CPR Guidance and Rescuer Actions

Provides CPR instructions, metronome use, and actions upon emergency services arrival.

Pediatric-Pak Usage

Pediatric Patient Treatment and Placement

Details use on children (1-8 yrs, <55 lb), magnetic warning, and placement options.

Pediatric Electrode Placement

Anterior-Lateral vs. Anterior-Posterior Placement

Describes anterior-lateral and anterior-posterior electrode placement for pediatric patients.

After Using the samaritan PAD

Cleaning and Pad-Pak Management

Covers device cleaning, Pad-Pak removal, and disposal of used electrodes.

Event Data Management

Downloading and Submitting Event Information

Explains using Saver EVO software and USB cable to manage event data.

Device Disposal and Compliance

Proper Disposal of Pad-Pak and Device

Details proper disposal of Pad-Paks (lithium batteries) and the device.

Tracking and Registration Requirements

Device Tracking and User Registration Methods

Outlines tracking regulations and registration via online tool or email.

Service and Maintenance Schedule

Regular Maintenance Checks and Procedures

Details weekly and monthly checks for status indicator, damage, and Pad-Pak expiration.

Appendix A: Symbols Used

Manual and Device Symbol Explanations

Provides definitions for symbols used in the manual and on the samaritan PAD.

Appendix B: Troubleshooting Common Issues

Status Indicators and Warning Prompts

Explains troubleshooting for flashing red status, low battery, memory full, and temperature warnings.

Appendix B: Troubleshooting Device Warnings

Device Service Warnings and Disarming Prompts

Troubleshoots 'device service required', 'off button' warnings, and 'disarming' prompts.

Appendix B: Obtaining Support

Support Contact and Warranty Exclusions

Guides on contacting support and lists conditions for warranty exclusion.

Appendix C: Technical Data - Specifications

Physical and Environmental Specifications

Details size, weight, temperatures, humidity, enclosure, altitude, shock, and vibration.

Appendix C: Technical Data - Interface

Pad-Pak, Analysis, and User Interface Data

Covers Pad-Pak specs, analysis method, sensitivity, prompts, and controls.

Appendix C: Technical Data - Performance

Defibrillator Performance and Waveform

Details charging time, shock delivery, impedance, waveform type, energy, and event recording.

Appendix C: Technical Data - Waveform Details

SCOPE Biphasic Waveform Specifications

Explains SCOPE waveform and provides voltage/duration specs for Pad-Pak.

Appendix C: Technical Data - Algorithms

Pediatric Waveform and Motion Detection

Provides pediatric waveform specs and details the SAM 360P motion detection algorithm.

Appendix C: Technical Data - Analysis

Arrhythmia Analysis Algorithm Performance

Summarizes algorithm performance for various rhythm classes.

Appendix C: Technical Data - CPR Advisor

CPR Rate Advisor Guidance

Details visual (LED) and audio guidance for CPR rate feedback on SAM 450P.

Appendix C: Technical Data - Pediatric Restrictions

CPR Rate Advisor Pediatric Use Restrictions

Explains why CPR Rate Advisor is restricted to adults and disabled with Pediatric-Pak.

Appendix C: Electromagnetic Emissions

Emissions Guidance and Compliance

Provides guidance on RF emissions, harmonic emissions, and voltage fluctuations.

Appendix C: Electromagnetic Immunity

Immunity Test Levels and Compliance

Details immunity tests for ESD, transients, surge, voltage variations, magnetic fields, and RF.

Appendix C: Separation Distances

RF Equipment Separation Guidance

Recommends minimum distances for RF equipment to prevent interference.

Appendix D: Voice Prompts

Voice Prompts for All Patients

Lists common voice prompts used by the samaritan PAD devices for all patients.

Appendix D: Voice Prompts - CPR and Shock

Prompts for CPR Advisor and Shock Scenarios

Details voice prompts for CPR advisor, no shock, and shock required scenarios.

Appendix E: Safety and Effectiveness Data

Potential Adverse Effects and Safety Summary

Lists potential adverse effects and summarizes preclinical lab and animal study results.

Appendix E: Animal Study Results

Animal Study Findings on Waveform and Algorithms

Presents results from animal studies on waveform, refibrillation, bra interference, and algorithm accuracy.

Appendix E: Clinical Study Summary

Overall Effectiveness Summary and Published Data

Summarizes effectiveness from bench, animal, and clinical studies, including published data.

Appendix E: Clinical Data Analysis

Clinical Data on Shock Success and Survival

Analyzes clinical data regarding shock success rates and patient survival to hospital admission.

Appendix E: Shock Success by Model

Shock Success and Survival Comparison Across Models

Compares shock success and survival rates for different HeartSine PAD models.

Appendix E: Postmarket Data Summary

Postmarket Data on Performance and Usability

Summarizes postmarket data on arrhythmia detection, waveform effectiveness, and overall usability.

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