Related Manuals for HeartSine Samaritan PAD 300
Summary of Contents for HeartSine Samaritan PAD 300
- Page 1 Samaritan® PAD USER INSTRUCTIONS For using Model SAM 300 With Software Version complaint with AHA/ERC Guidelines 2000 and 2005 2006 VERSION H017-001-006-2...
- Page 2 Information in this document is subject to change without notice and does not represent a commitment on behalf of HeartSine Technologies. No part of this manual may be reproduced or transmitted in any form or by any means, electrical or mechanical, including photocopying and recording for any purpose without the express written permission of HeartSine Technologies.
- Page 3 150J – 150J – 200J 150J – 150J – 200J HeartSine Technologies provides you with a fully configureable samaritan PAD system to allow you to comply with your chosen SCA treatment protocol. Our current devices can be configured to be compliant with the 2000 or 2005 version of the AHA/ERC guidelines on Cardiopulmonary Resuscitation (CPR) and Emergency Cardiovascular Care (ECC).
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Page 4: Table Of Contents
What does the samaritan PAD do?..............25 What is heart rhythm?..................26 ® How does the samaritan PAD work? ............. 26 What is biphasic? .................... 27 Escalating energy protocol................28 Biphasic waveform specifications..............28 How is impedance measured?................. 29 © Heartsine Technologies... - Page 5 ® UNDERSTANDING THE SAMARITAN PAD INTERFACE....... 30 Understanding visual indicators ............... 30 Status Indicator....................30 Defibrillation Pads Connection Indicator............31 Shock Button Indicator..................31 Rescuer Action Indicators ................32 Audible prompting.................... 33 Audible indications................... 33 Voice prompting....................33 ® RECORDING THE SAMARITAN PAD’S USAGE........
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Page 6: Introduction, Regulatory Requirements
Who is required to report and what events are considered a reportable event can be found in the U.S. Federal Regulations, 21 CFR 803. If you are unsure of what to do, always report any samaritan® malfunctions or failures to HeartSine Technologies. -
Page 7: Warnings
WARNINGS This section provide you with important warnings while using the PAD. The samaritan® PAD has the capability to deliver therapeutic electrical shocks. The electrical shock can cause serious harm to either operators or bystanders. Caution must be taken to ensure that neither the operators or bystanders touch the patient when a shock is to be delivered. - Page 8 If damage is suspected the Pad-Pak™ or Ped-Pak™ must be replaced immediately. * Not available this user manual was written. Ask HeartSine or your authorised distributor for more details. This device is to be used by a person trained in the use of the product.
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Page 9: Overview Of The Samaritan® Pad
3.1 Indications for Use 3.2 The samaritan® PAD Controls 3.3 Samaritan® PAD Symbols Indications for Use: The HeartSine samaritan® PAD is indicated for use on victims of cardiac arrest who are exhibiting the following signs: Unconscious Not Breathing Without Circulation The samaritan®... - Page 10 Saver™ data management software for the samaritan® PAD must be installed on your PC in order to review the event data. NEW Guideline version AHA/ERC 2000 or AHA/ERC 2005. Figure 1 – samaritan® PAD Controls © Heartsine Technologies...
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Page 11: Samaritan® Pad Symbols
® Samaritan PAD Symbols The samaritan® PAD device and Pad-Pak use certain symbols to represent warnings. Depending on the type of danger apparent, different symbols are used. The table below provides an outline of the different symbols used: Symbol Meaning This symbol appears on the samaritan®... - Page 12 It has not been configured to take a Ped-Pak* *Older devices will not display these labels. These older samaritan PAD will have been configured to the AHA/ERC 2000 Guidelines with an escalating energy protocol of 100J-150J-200J. © Heartsine Technologies...
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Page 13: Preparing The Samaritan
® PREPARING THE SAMARITAN PAD FOR USE This chapter contains the following sub-sections: 4.1 Quick list. 4.2 Understanding the Pad-Pak™. ® 4.3 Ensuring the samaritan PAD is working correctly. ® 4.4 Where to place the samaritan PAD. It is imperative that the samaritan® PAD is always prepared for operational use, since it is designed for use in emergency situations. -
Page 14: Ensuring The Samaritan Pad Is Working Correctly
If the Status Indicator is not flashing the device is not working correctly. If the Status Indicator is not flashing a problem has been detected. You should refer to troubleshooting in this manual and/or contact HeartSine Technologies or your local HeartSine distributor for technical support © Heartsine Technologies... -
Page 15: Where To Place The Samaritan Pad
® Where to Place the samaritan The samaritan® PAD should be placed in an easily accessible location when in use. The Status Indicator must be clearly visible. ® The samaritan PAD must be stored with a Pad-Pak™ installed. ® The samaritan PAD must not be used or stored in the presence of flammable agents or oxygen enriched atmospheres. -
Page 16: Preparing The Patient
It is essential that the disposable defibrillation pads are connected correctly to the patient. It is these pads that monitor the heart and deliver the therapeutic shock treatment. To connect the pads to the patient, you: Pull out defibrillation pads pouch. Open the pouch and remove the defibrillation pads. © Heartsine Technologies... - Page 17 Peel pads one at a time from the protective backing, firmly place the pads sticky side down on the patient’s bare chest and ensure the pads are completely adhered to the skin. Place one pad just below the right collarbone and place the other pad over the patient’s ribs in line with the armpit and below the left breast.
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Page 18: Using The Samaritan Pad
Follow audio guidance. If directed, administer therapy by pressing the Shock button. Useful Hints Don’t worry! The samaritan® PAD will provide audio prompts during the entire procedure. Good contact between the defibrillation pads and the patient is essential. © Heartsine Technologies... -
Page 19: Step-By-Step Instructions
If activated an audible tone will be given to aid the CPR rhythm applied to the patient. Your HeartSine dealer should have given you training on the specific configuration and use of your samaritan PAD. In all cases you should follow the audible and visual prompts given by your samaritan PAD. - Page 20 The samaritan® PAD will continue with audio prompts: “Peel pads from Liner.” “Apply pads to patient’s bare chest as shown in picture.” “Press pads firmly to patient’s bare skin.” © Heartsine Technologies...
- Page 21 Refer to section 5.2 Placing Pads on the Patient for further details on placing the pads on the patient. The Pads Connection Indicator indicates if the pads are attached to the patient. If the pads are not attached to the patient, you will hear the audio prompts: “Check Pads.”...
- Page 22 After a successful shock or after the configured number of shocks have been delivered, the samaritan® PAD will enter either “Check Patient” or “CPR” mode: Check Patient Mode (Version 2000): “It is safe to touch the patient.” “Check Airway.” “Check Breathing.” “Check for circulation.” “If needed begin CPR.” © Heartsine Technologies...
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Page 23: Understanding Check Patient Mode
CPR Mode (Version 2005): “It is safe to touch the patient.” “Begin CPR.” The Check Patient mode will last 60 and the CPR mode will last 120 seconds. The mode used by your device depends on how your samaritan PAD has been configured. The voice prompts should be followed at all times. - Page 24 PAD properly as described in the Cleaning and Maintenance section of this manual. ® Insert a new Pad-Pak™ in the samaritan PAD. Check the Status Indicator. ® Position the samaritan PAD in a suitable and pre-arranged location. Your notes © Heartsine Technologies...
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Page 25: Understanding The Samaritan® Pad
PAD should not be used on children less than 8 years of age with a PAD-Pak™ installed. For treatment of children under 8 years of age a PAED-Pak™ * should be installed in the samaritan PAD. * Not yet available. Ask HeartSine or your authorised distributor. ® What does the samaritan PAD do? The samaritan®... -
Page 26: What Is Heart Rhythm
How does the samaritan PAD work? HeartSine and Academia have spent several years researching the analysis of heart rhythms to identify the optimal technique of applying the lowest possible amount of electrical energy, in order to resuscitate a victim of SCA. -
Page 27: What Is Biphasic
A biphasic shock has been found to be as effective as higher energy monophasic shocks. HeartSine have developed the samaritan® PAD using SCOPE biphasic technology. The Self-Compensating Output Pulse Envelope Waveform is incorporated in the samaritan®... -
Page 28: Escalating Energy Protocol
The samaritan® PAD charges the internal storage capacitors to a selected level. The output pulse phase is adjusted to ensure delivery of the selected level of energy. Phase A and Phase B of the output pulse envelope are always of the same duration. © Heartsine Technologies... -
Page 29: How Is Impedance Measured
How is impedance measured? An impedance measurement is performed when the samaritan® PAD is switched on. This measurement is important for the following reasons: It checks the integrity of the electrode-patient contact and of the electrode leads. If the impedance is too high, electrode-patient contact is poor. -
Page 30: Understanding The Samaritan Pad Interface
If the Status Indicator is not flashing, the samaritan® PAD is either still performing the self-test, or the self-test has detected one or more errors. ® Do not use the samaritan PAD if the Status Indicator is not flashing. © Heartsine Technologies... -
Page 31: Defibrillation Pads Connection Indicator
Defibrillation Pads Connection Indicator The Defibrillation Pads Connection Indicator is a diagram illustrating a patient and defi- brillation pads. If the arrows and defibrillation pads on this diagram are illuminated the defibrillation pads are not yet attached or are not attached correctly. If the defibrillation pads are attached then only the pads located on the patient’s torso in this diagram are illuminated. -
Page 32: Rescuer Action Indicators
The Rescuer Action Indicators are two diagrams located just below the shock button, illustrating a rescuer and a patient. The Rescuer Action Indicator is illustrated below: “Stand clear” “It’s OK to touch the patient” When illuminated When illuminated Figure 7 – Rescuer Action Indicator © Heartsine Technologies... -
Page 33: Audible Prompting
Audible prompting The samaritan® PAD employs two types of audible prompting: Audible indications, such as a short tone to indicate that the device has powered on. Voice prompting, such as instructions or warnings. Audible indications An audible indication is used to alert you when the device has been powered up. When the On/Off button is pressed, the samaritan®... -
Page 34: Recording The Samaritan Pad's Usage
Events Log The samaritan® PAD recording system can record events that take place during the therapy session. The time and date is stored with each event. The types of events that can be recorded are: buttons pressed © Heartsine Technologies... -
Page 35: Other Information Recorded
Power up Monitoring Charging Therapy delivery Charge disarm Self-test Shut down Error codes – the error code associated with any error messages. Other information recorded Other information specific to the particular samaritan® PAD and battery pack is recorded for reference. The types of specific information stored are: Time Date samaritan®... -
Page 36: Maintaining The Samaritan Pad
The following procedure should be followed each time the samaritan® PAD is used: 1. Dispose of the existing Pad-Pak™ 2. Use Saver to download information about the therapy performed and erases memory. 3. Install a new Pad-Pak™ 4. Check the Status Indicator © Heartsine Technologies... -
Page 37: Monthly Checks To Perform
If the Status Indicator is not flashing a problem has been detected. You should refer to troubleshooting in this manual and/or contact HeartSine Technologies or your local HeartSine distributor for technical support. Check supplies, accessories and spares for damage or expiration and replace immediately if any damage or expiration is found. -
Page 38: Storing The Device
The battery lifetime can be up to 6 hours monitoring or 30 shocks (or a combination of both). Your battery and electrode cartridge have an expiration date. Please ensure that you do not exceed this limit as performance of the product beyond this date cannot be guaranteed. © Heartsine Technologies... -
Page 39: Selected Accessories For The Samaritan® Pad
Trainer Pads (set of 10) TNR-PAK-04 Trainer Pads (set of 25) TNR-ACC-01 AHA Instructor Guidelines 2005 TNR-ACC-03 AHA Provider Guidelines 2005 (x10) TNR-ACC-05 Barrier Mask (x5) *This item is not currently available. Contact your HeartSine distributor for further information. PAD User Manual... -
Page 40: Troubleshooting
PAD-Pak™ – before the expiration date printed on the Pad-Pak™ has been exceeded. Typically 3 years from production date. HeartSine is responsible for extensions of the warranty period only when specifically agreed between HeartSine Technologies and the distributor. HeartSine Technologies or the distributor are not obliged to carry out service under warranty if: Unauthorized modifications have been made to the device. - Page 41 The distributor, before carrying out service under warranty, may require evidence of purchase. The product must be used in accordance with the user manual and for the purpose that it was intended. If you have a query please contact support@HeartSine.com for assistance. PAD User Manual...
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Page 42: Appendix
Appendix This chapter contains the following sub-sections: ® samaritan PAD technical specifications. SCOPE™ Biphasic™ waveform specifications. ECG analysis detection system description. ECG arrhythmia analysis algorithm performance. SCOPE™ Biphasic waveform Clinical Summary. © Heartsine Technologies... - Page 43 PAEDIATRIC* 1. Shock 2. Shock 50J 3. Shock 66J *Not currently available. Ask Heartsine Technologies or your authorised distributor. Charging Time: 150J in < 8 seconds. 200J in < 12 seconds. 200J from a SA message with new Pad-Pak™. Controls: Shock, On/Off.
- Page 44 Voice and icon prompts: Extensive voice and icon prompts guide the user through the operation sequence Languages: Contact your HeartSine dealer. ENVIRONMENTAL Operating Temperature: 0˚C to 50˚C (+32˚F to +122˚F) Storage Temperature: -10˚C to 50˚C (+14˚F to +122˚F)
- Page 45 Playback Capabilities: Custom USB cable directly connected to PC and SAVER® windows-based data review software. Pad-Pak™ Shelf Life: Check Expiration Date (typically 3years from manufacture) Weight: 0.44 lbs (0.2kg) Size: 3.93in x 5.24in x .94in (10cm x 13.3cm x 2.4cm) BATTERY Type: Lithium Manganese Dioxide (LiMnO2) 18V, 0.8 Amp Hrs...
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Page 46: Scope™ Biphasic Waveform Specification
SCOPE™ BIPHASIC WAVEFORM SPECIFICATIONS The HeartSine samaritan® PAD delivers a Self Compensating Output Pulse Envelope (SCOPE) biphasic waveform. This waveform automatically optimizes the waveform pulse envelope (amplitude, slope and duration) for a wide range of patient impedances, from 20 ohms to 230 ohms. The delivered waveform to the patient is an optimized impedance compensated biphasic truncated exponential waveform that incorporates an escalating energy protocol of 150 J, 150 J, 200 J. -
Page 47: Ecg Analysis Detection System Description
Ventricular Tachycardia – consisting of a heart rate 180 BPM, and a QRS duration equivalent to > 0.14 seconds. The HeartSine Samaritan® ECG Analysis Detection System has been designed to prov- ide a No-Shock Advised decision for ECG Arrhythmias consisting of but not limited to: Normal Sinus Rhythm (NSR). -
Page 48: Ecg Arrhythmia Analysis Algorithm Performance
The HeartSine samaritan® ECG Arrhythmia Analysis Algorithm Performance has been extensively evaluated by using the American Heart Association’s (AHA) Database and the Massachusetts Institute of Technology MIT – NST database. The HeartSine samaritan® ECG Arrhythmia Analysis Algorithm Sensitivity and Specificity meets the AAMI DF80a 2003 requirements and AHA recommendations. -
Page 49: Scope™ Biphasic Clinical Summary
SCOPE BIPHASIC WAVEFORM CLINICAL SUMMARY The HeartSine SCOPE Biphasic waveform has been clinically tested in a three phase validation program. Numerous animal studies have been conducted to compare the efficacy of the SCOPE biphasic to other defibrillation waveforms. Results of these studies have been published. - Page 50 25.0 16.6 SUMMARY The initial results from the Human Clinical trial shows that the HeartSine SCOPE biphasic waveform is at least as effective as the other marketed, constant energy biphasic waveform system. For more literature contact HeartSine or your authorised distributor.
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Page 51: Glossary
SCOPE SCOPE stands for Self-Compensating Output Pulse Envelope Waveform. This is the biphasic technology developed by HeartSine that is incorporated into the samaritan® PAD. Sinus Rhythm Sinus Rhythm is the normal electrical rhythm by which the heart muscle contracts and expands to create blood flow around the body.
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