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HeartSine samaritan SAM 350P - User Manual

HeartSine samaritan SAM 350P
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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

  • N
    Nathaniel BrewerAug 1, 2025
    What to do if HeartSine samaritan SAM 350P Medical Equipment warns 'Low Battery'?
    • J
      Jennifer PriceAug 2, 2025
      If your HeartSine Medical Equipment displays a 'Low Battery' warning, while this message does not indicate a fault, replace the battery as soon as possible and order a new Pad-Pak as soon as possible.
  • R
    Richard GarciaAug 6, 2025
    What to do if the HeartSine samaritan SAM 350P Medical Equipment shows a red status indicator and beeping while on?
    • K
      Kimberly FranklinAug 6, 2025
      If your HeartSine Medical Equipment is showing a red status indicator and beeping while on, it means there is insufficient battery capacity to deliver a shock. You should immediately replace the Pad-Pak or seek an alternative defibrillator. If neither is available, the device will continue to analyze the patient’s heart rhythm and advise when CPR is needed, but it won't be able to deliver a shock.
  • E
    evan70Aug 10, 2025
    What does 'Device service required' warning mean on HeartSine samaritan SAM 350P Medical Equipment?
    • C
      Carmen ThompsonAug 10, 2025
      If your HeartSine Medical Equipment displays a 'Device service required' warning, seek an alternative defibrillator immediately. Do not attempt to service the device, as no modification of this equipment is possible. Contact HeartSine Technologies or your Authorized Distributor immediately.
  • V
    Victoria LoveAug 14, 2025
    What to do if HeartSine samaritan SAM 350P has a flashing red status indicator or is continually beeping?
    • R
      Robert RobertsAug 14, 2025
      If your HeartSine Medical Equipment has a flashing red status indicator, is continually beeping, or has no status indicator light lit, check the expiration date on your Pad-Pak. If the expiration date has passed, immediately replace the Pad-Pak. If the expiration date has not passed, press the On/Off Button to turn on the device and listen for the voice prompt 'Call for medical assistance'. Then press the On/Off Button again to turn off the device. If these actions do not correct the problem, contact your Authorized Distributor or HeartSine Technologies immediately.
  • W
    Wendy BrownAug 19, 2025
    Why does my HeartSine samaritan SAM 350P Medical Equipment beep three times when turned off?
    • C
      christopher36Aug 19, 2025
      The HeartSine Medical Equipment beeps three times when turned off because the device has sensed that the ambient temperature is outside the specified operating range. Return your device to the specified operating conditions of 32°F to 122°F/0°C to 50°C, in which your device, with its battery and electrodes is designed to operate, and verify that the beeping has stopped.
  • J
    Jacob McguireAug 23, 2025
    What does the 'Disarming' prompt mean on HeartSine samaritan SAM 350P?
    • J
      Joseph SuttonAug 23, 2025
      The 'Disarming' prompt on your HeartSine Medical Equipment means that the AED has converted to a decision to not shock after it has initially decided to shock. This message does not indicate a fault, continue to follow the device prompts.
  • C
    Christopher FreemanAug 27, 2025
    What does 'You have pressed the off button' warning mean on HeartSine Medical Equipment?
    • J
      Jamie BoydAug 27, 2025
      The 'You have pressed the off button' warning on your HeartSine Medical Equipment means that you have pressed the On/Off button while the AED is being used to treat a patient. If you are sure you want to turn off the AED, quickly press On/Off again.

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 350 P Device Layout

Controls, Indicators, and Pad-Pak Details

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

SAM 360 P Device Layout

Controls, Indicators, and Audio Output

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

SAM 450 P 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.

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

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