AED Leader Heartsine Samaritan PAD-350P Manual

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This manual for Heartsine Samaritan PAD-350P is brought to you

by AED Leader, a leading distributor of automated external

defibrillators and original manufacturer accessories.

Phone: 855-888-2771

Website: https://www.aedleader.com

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Page 1 This manual for Heartsine Samaritan PAD-350P is brought to you by AED Leader, a leading distributor of automated external defibrillators and original manufacturer accessories. Phone: 855-888-2771 Website: https://www.aedleader.com...
Page 2: Table Of Contents
Contents Contents Paediatric-Pak Indications for Use Service and Maintenance Indications for use Tracking Requirements Contraindications for use Data Management Intended users Troubleshooting Warnings and Cautions Status indicator flashing red Introduction Low battery warning The SAM 350P Memory full warning Sudden cardiac arrest (SCA) Audible warnings Ventricular fibrillation Device service required...
Page 3 Symbols used in this manual Do not expose to high heat or open flame. Do not incinerate Warning: Risk of death or Does not contain natural rubber latex serious injury Non-sterile Recyclable Caution: Risk of injury Non- rechargeable battery Do not short circuit battery Do not crush battery Notice: Risk of damage to data or material...
Page 4: Indications For Use
Indications for Use Indications for use Intended users The SAM 350P is intended for use by The HeartSine samaritan ® ® personnel who have been trained in its 350P is indicated for use on victims of operation. Users should have received cardiac arrest who are exhibiting the training in basic life support / AED, following signs:...
Page 5: Warnings And Cautions
Warnings and Cautions Risk of electric shock Warning The SAM 350P delivers therapeutic electrical shocks that can cause serious Patients suitable for treatment harm to either operators or bystanders. The SAM 350P has been designed to Take care to ensure that nobody touches work on unconscious, nonresponsive the patient when a shock is to be patients.
Page 6 Warnings and Cautions Avoid explosive or flammable Caution gases It has been determined that the SAM Correct placement of the electrode 350P is safe to use with oxygen mask pads delivery systems. However, to avoid Proper placement of the SAM 350P the risk of an explosion, it is strongly electrode pads is critical.
Page 7 Do not use if the pouch containing Notice the electrodes is not sealed The Pad-Pak is a single-use item and you Susceptibility to electromagnetic must replace it after each use or if the interference pouch that seals defibrillation pads has To safeguard against interference, you been broken or compromised in any way.
Page 8 Warnings and Cautions Prolonging battery life Further Information Do not turn on the device unnecessarily as this may reduce the standby life of Use of this manual the device. It is important that you read this manual Standby storage outside the range of 0 ºC carefully before using the SAM 350P.
Page 9 Operator training Compliance with local regulations The SAM 350P is intended for use by Check with the relevant local government personnel who have been trained in its health department for information about operation. Users should have received any requirements associated with training in basic life support / AED, ownership and use of a defibrillator in the advanced life support or a physician-...
Page 10: Introduction
Introduction The SAM 350P The use of an external defibrillator within the first few minutes of collapse can The SAM 350P is a semi-automatic greatly improve patient’s chances of external defibrillator designed to quickly survival. Heart attack and SCA are not deliver a defibrillation shock to victims of the same, though sometimes a heart sudden cardiac arrest (SCA).
Page 11: Recommended Training
Recommended training CPR metronome SCA is a condition requiring immediate During CPR the SAM 350P will play emergency medical intervention. Due an audible beep and flash the “Safe To to the nature of the condition, this Touch” indicator at a rate compliant with intervention can be performed before 2015 AHA/ERC guidelines.
Page 12: Sam 350P Overview
SAM 350P Overview Attach pads icon Status indicator Data port The action arrows around this When the indicator is icon will flash to instruct you flashing green the SAM to attach the electrode pads to 350P is ready for use. Shock button the patient as indicated.
Page 13: Preparation
Preparation Unpacking Checks before putting into service Check that the contents include the User 1. Check the expiry date (year/month) Manual, soft case, Pad-Pak, Warranty on the rear of the Pad-Pak (see Card and Emergency User Guide. the illustration below). If the expiry date has passed, you must replace A Pad-Pak is a single-use removable the Pad-Pak.
Page 14 Preparation 2. Unpack the Pad-Pak. Retain the 4. Turn on the SAM 350P by pressing packaging in case you need to return on the front panel to check that the Pad-Pak to HeartSine. Place the the device is operating correctly. SAM 350P on a flat surface.
Page 15: Preparation Checklist
Preparation checklist 6. Place the SAM 350P in its supplied soft carry case. Store the SAM Step 1. Check the Pad-Pak expiry date. 350P in an unobstructed, secure location in a clean, dry environment Step 2. Install the Pad-Pak. specifically where it will be seen and Step 3.
Page 16: Using The Sam 350P
Using the SAM 350P When to use Using the SAM 350P The SAM 350P is indicated for use on Refer to the separate Emergency User victims of sudden cardiac arrest who are Guide. During use the SAM 350P will give exhibiting the following signs: extensive voice prompts.
Page 17: After Use
After use Do not dispose of the SAM 350P or Pad-Pak in the normal waste. 1. Turn off the SAM 350P by pressing Dispose of it at an appropriate on the front panel. recycling facility according to local requirements. Alternatively return 2.
Page 18 5. Check the SAM 350P for damage. If the SAM 350P is damaged, replace it immediately. 6. Install a new Pad-Pak. Before installing, check the Pad-Pak expiry date (see ‘Preparation’ on page 13). After installation check the status indicator is blinking green.
Page 19: Paediatric-Pak
Paediatric-Pak Using the Paediatric-Pak Electrode Placement: For paediatric patients there are two The Paediatric-Pak is intended to provide options for electrode placement: therapy for paediatric (child) victims of SCA between the ages of 1 and 8 years a. If a child’s chest is small it may be old who are: necessary to place one pad on the child’s BARE chest in the centre, and the other...
Page 20 b. If a child’s chest is large enough to Warning: Defibrillation permit a 2.5cm (1 inch) gap between the electrodes must be at least approx 2.5 cm (1 inch) apart pads, pad placement can be used similar to adult placement. Place one pad on and should never be touching child’s BARE upper right chest above one another.
Page 21: Service And Maintenance
Service and Maintenance HeartSine recommends users perform Check the expiry date of the SAM 350P regular maintenance checks. The Pad-Pak (see ‘Preparation’ on page recommended maintenance checks are: 13 for the location of the date). If the date has expired, or is near expiry, Weekly replace with a new Pad-Pak or contact your local HeartSine distributor for a...
Page 22: Tracking Requirements
Tracking Requirements Medical Devices Regulations require If there is a change in the information you us to track the location of all medical have provided to us, such as a change of devices sold. address or a change in ownership of your SAM 350P, contact us with the updated It is important that you complete the information.
Page 23: Data Management
Data Management The HeartSine Saver EVO™ software 2. Connect the USB cable to a PC. is an optional accessory. Contact your 3. Launch the HeartSine Saver authorised distributor or HeartSine EVO utility. Technologies directly about the after-use data management service. Notice: The SAM 350P should only be connected to an 1.
Page 24: Troubleshooting
Troubleshooting Status indicator flashing red Memory full warning If the status indicator is flashing red or If the device plays the message ‘memory if the device is emitting a ‘beep’, check full’, then the memory can record no the expiry date on your Pad-Pak (see further ECG data or events.
Page 25: Device Service Required
Device service required Warranty exclusion If the device plays the message ‘device HeartSine or its authorised distributors service required’, then it has detected a are not obliged to replace or repair under fault. Contact your authorised distributor or warranty if one or more of the following HeartSine directly for further instruction.
Page 26: Technical Data
Technical Data Physical parameters (with Pad-Pak installed) Size: 20 cm x 18.4 cm x 4.8 cm (8.0 in x 7.25 in x 1.9 in) Weight: 1.1 kg (2.4 lbs) Environmental Operating temperature: 0 °C to 50 °C (32 °F to 122 °F) Standby temperature: 0 °C to 50 °C (32 °F to 122 °F) Transport temperature:...
Page 27 Pad-Pak and Paediatric-Pak Weight: 0.2 kg (0.44 lbs) Battery type: Disposable single-use combined battery and defibrillation electrode cartridge (lithium manganese dioxide (LiMnO ) 18V) Battery capacity (new): >60 shocks or 6 hours of continuous monitoring Battery capacity (4 years): >10 shocks Standby life: See the expiry date on the Pad-Pak.
Page 28 Technical Data User Interface Visual prompts: Attach pads, stand clear, perform CPR, shock now, self test pass - ready state Audible prompts: Extensive voice prompts guide the user through the operation sequence (see ‘List of Voice Prompts’ on page 38). Languages: Contact your HeartSine authorised distributor.
Page 29 Event recording Type: Internal memory Memory: 90 minutes of ECG (full disclosure) and event/ incident recording Review: Custom USB cable directly connected to a PC and Saver EVO Windows-based data review software Electromagnetic compatibility EMC: IEC60601-1-2 Radiated emissions: IEC55011 Electrostatic discharge: IEC61000-4-2 (8 kV) RF immunity: IEC61000-4-3 80 MHz –...
Page 30 Technical Data SCOPE Biphasic Waveform 2000 The SAM 350P delivers a Self 1000 Compensating Output Pulse Envelope (SCOPE) biphasic waveform. This Volts waveform automatically optimises the waveform pulse envelope (amplitude, slope, and duration) for a wide range of patient impedances, from 20 ohms to 1000 -1 0 230 ohms.
Page 31 Arrhythmia analysis algorithm Waveform Waveform Voltages Duration The SAM 350P uses the HeartSine Energy Resistance (volts) (ms) samaritan ECG arrhythmia analysis (ohms) (joules) Tilt algorithm. This algorithm will evaluate the patient’s ECG to ascertain if a therapeutic 47.5 55.6 shock is appropriate. If a shock is required, 51.3 50.4 the SAM 350P will charge and advise the...
Page 32 Technical Data The SAM 350P ECG arrhythmia analysis algorithm performance is summarised in the table below: ECG Test 90% One- Required Sample Performance Sided Lower Rhythm Class Performance Size Results (%) Confidence Specifications (seconds) Limit Shockable Rhythm: 14538 Sensitivity > 90% 97.03 95.31 Ventricular Fibrillation (VF)
Page 33 Guidance and manufacturer’s declaration – electromagnetic emissions The SAM 350P is intended for use in the electromagnetic environment specified below. The customer or user of the SAM 350P must assure that it is used in such an environment. Emissions test Compliance Electromagnetic environment –...
Page 34 Technical Data Guidance and manufacturer’s declaration – electromagnetic immunity The SAM 350P is intended for use in the electromagnetic environment specified below. The customer or user of the SAM 350P must assure that it is used in such an environment. Immunity test IEC 60601 test level Compliance...
Page 35 Guidance and manufacturer’s declaration – electromagnetic immunity The SAM 350P is intended for use in the electromagnetic environment specified below. The customer or user of the SAM 350P must assure that it is used in such an environment. IEC 60601 Compliance Immunity test Electromagnetic environment –...
Page 36 Technical Data Guidance and manufacturer’s declaration – electromagnetic immunity ... compliance level in each frequency range. Interference may occur in the vicinity of equipment marked with the following symbol: Note 1: At 80 MHz and 800 MHz, the higher frequency range applies. Note 2: These guidelines may not apply in all situations.
Page 37 Recommended separation distances between portable and mobile RF communication equipment and the SAM 350P The SAM 350P is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the SAM 350P can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the SAM 350P as recommended below, according to the maximum output power of the communications equipment.
Page 38: List Of Voice Prompts
List of Voice Prompts If a shock is not required… Listed below are the voice prompts used by the SAM 350P. Read the voice prompts “No shock advised” in advance of use to be familiar with the “Begin CPR” types of instructions given. “It is safe to touch the patient”...
Page 39 Notes...
Page 40 Authorised Distributor w w w . h e a r t s i n e . c o m i n f o @ h e a r t s i n e . c o m EMEA/APAC US/Americas 0120 HeartSine Technologies, Ltd.