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Related Manuals for Instramed EazyPro
Summary of Contents for Instramed EazyPro
- Page 1 User manual AUTOMATED EXTERNAL DEFIBRILLATOR WITH MANUAL FUNCTION...
- Page 2 For information about warranty or technical assistance, please contact Instramed’s technical support. Copyright © 2017 Instramed. The Eazy PRO, Instramed and its respective logos are trademarks of Instramed Indústria Médico Hospitalar Ltda. The internal software of this product is Instramed’s intellectual property, being protected under international copyright laws.
- Page 3 (see battery specifications in chapter 8). When the device presents a drop in battery performance, with low autonomy, please request a new unit from Instramed’s technical assistance. The batteries are rechargeable Lithium-Ion (Li-ion). The battery can be removed...
- Page 4 Optional Item: • A pair of disposable child size adhesive pads Replacement parts: You can ask Instramed for replacements of the following items (consult Instramed for prices. Shipping costs may be applied): • Batteries replacement • Adult/child adhesive pads replacement...
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Page 5: Table Of Contents
Index Introduction Characteristics ......................09 Purpose ........................10 Principle ........................10 Use criteria ....................... 11 Qualified users ......................11 About the manual ..................... 11 Safety Information Warnings ........................12 Adverse effects ......................14 Standards ......................... 14 Device care ....................... 14 Cleaning and disinfection .................. - Page 6 User manual | Index Sides ......................... 24 1 - Speaker ......................25 2 - Battery power supply connector ..............25 3 - Battery compartment ..................25 4 - USB Connector ....................25 5 - Disposable pads compartment ............... 25 6 - Disposable pads connector ................26 7 - Cabinet recess ....................
- Page 7 User manual | Index Use in children Using the Eazy PRO on children under 8 years old ..........43 PC Connection Introduction ....................... 44 Requirements ......................44 SoftDEA Installation ....................45 Connecting the Eazy PRO to a PC ................45 Operating SoftDEA Startup screen ......................
- Page 8 User manual | Index Other buttons ......................51 1- Back ........................ 51 2- Exit ........................52 Precautions, restrictions and warnings Electromagnetic Compatibility (warnings and notices) ..........53 Electromagnetic emissions ..................54 Electromagnetic immunity - ................55 General Electromagnetic immunity - ........
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Page 9: Introduction
Introduction The Eazy PRO is a new generation Semi-Automated External Defibrillator (AED). Using Neural Network technology, the Eazy PRO guides by voice, makes the diagnosis, considers clinical variables and applies treatment safely with the touch of only a single button. Designed for emergency care, it is compact, light, resistant and easy to use. -
Page 10: Purpose
User manual | Introduction Purpose The defibrillator is a device used for treating cardiac arrhythmias, situations in which the heart loses the ability of keeping steady heartbeats, blood stops being pumped and oxygen and nutrients do not get to the organs, starting a degenerative process known as biological death. -
Page 11: Use Criteria
The information contained in this manual belongs to Instramed and cannot be used fully, or in part, without expressed written consent. Instramed has the right to make any changes to improve this guide and the product without prior notice. This guide is a part of the Eazy PRO and must be kept for further reference. -
Page 12: Safety Information
THE EQUIPMENT. WARNING: NOT RECOMMENDED FOR PATIENTS YOUNGER THAN ONE (01) YEAR OLD. WARNING: THIS PRODUCT IS PORTABLE, BUT INSTRAMED DOES NOT RECOMMEND ITS USE IN AMBULANCES. WARNING: EAZY PRO CAN BE USED BY PATIENTS OVER 01 (ONE) YEAR OLD, REGARDLESS OF THEIR WEIGHT. - Page 13 User manual | Safety Information NOTICE: EACH AND EVERY REPAIR TO THE EQUIPMENT CAN ONLY BE DONE BY INSTRAMED’S AUTHORIZED TECHNICAL ASSISTANCE CENTERS. NOTICE: THE USE OF THE EAZY PRO IS RESTRICTED TO ONE PATIENT AT A TIME. NOTICE: THE APPLIED PARTS ARE PROTECTED AGAINST DEFIBRILLATION DISCHARGE;...
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Page 14: Adverse Effects
Or equivalent IECs. The current versions of technical standards can be verified on the Product Conformity Certificate, available at www.instramed.com.br. Device care Do not place the equipment where it may fall on the patient. Do not lift the equipment by its cables or connections. -
Page 15: Cleaning And Disinfection
User manual | Safety Information Cleaning and disinfection Instramed recommends cleaning and disinfecting the equipment and its accessories every three months, or shorter periods whenever excessive dirt or contamination is noticed. Equipment: • Disconnect the unit from the mains before cleaning. -
Page 16: Disposing Of The Device
User manual | Safety Information Disposing of the device Avoid contamination of the environment, humans, or other equipment by making sure to properly sterilize and decontaminate the equipment before disposing of it. Refer to local regulations for the proper disposal of trash in your area. For countries that follow European Guidelines, refer to 2002/96/CE. -
Page 17: Classification And Symbols
User manual | Safety Information Classification and Symbols Symbol Standard Description IEC 60601-1 Follow the instructions for use IEC 60601-1 General warning symbol IEC 60601-1 Warning: dangerous voltage IEC TR 60878 Power supply connector IEC TR 60878 Non-ionizing radiation USB connector ISO 780 This side up ISO 780... -
Page 18: The Equipment
The Equipment Front Panel AUTOMATED EXTERNAL DEFIBRILLATOR (AED) MANUAL OVERRIDE FUNCTION 1. Touch screen: presents operational 2. Operational status indicator. information and allows for manual 3. Start button. interaction with the device. On the next pages you will find the detailed description of each component of the front panel. -
Page 19: Touch Screen
User manual | The Equipment 1 - Touch screen A) IN AUTOMATIC MODE As default, the device starts operating in AUTOMATIC MODE. In this configuration, the Eazy PRO presents the following items on the screen when connected to the patient: BPM 080 CPR 00:00 Analyzing... - Page 20 User manual | The Equipment B) IN MANUAL MODE If the user decides to switch to manual mode, the equipment will function as a standard defibrillator. In this situation, it will be necessary to select the appropriate charge according to the type of patient without the Eazy PRO’s intervention or orientation.
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Page 21: Operational Status Indicator
User manual | The Equipment 2 - Operational status indicator The Eazy PRO performs a full auto-test weekly, allowing the user to know the operational status of the device. This status is informed by a visual indicator (see picture below), voice messages and sound signals. The automatic test is also performed when the device is switched on. - Page 22 User manual | The Equipment ATTENTION: remember to check the status of the operational status indi- cator at least every 30 days. SOUND INDICATOR Along with visual indication, the Eazy PRO emits electronic beeps which can be identified by the user from a distance and can also be interpreted according to the frequency, as in the table below: Number of beeps Failure description...
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Page 23: Start Button
User manual | The Equipment 3 - Start button The Eazy PRO offers exclusive technology which allows to operate the device completely safely with a single button. Início Start Switch on Analyze Deliver shock press press The start button has the functions of: •... -
Page 24: Sides
User manual | The Equipment Sides 1. Speaker 5. Disposable pads compartment 2. Battery power supply connector 6. Disposable pads connector 3. Battery compartment 7. Cabinet recess 4. USB connector... -
Page 25: Speaker
ATTENTION: in case of battery replacement, use original replacements from Instramed supplied by its authorized distributors. 4 - USB Connector Used for connecting the equipment to a PC (see chapter 5). -
Page 26: Disposable Pads Connector
User manual | The Equipment ATTENTION: only use original pads provided by Instramed. Not following this observation may prevent the equipment from working. 6 - Disposable pads connector Used for connecting disposable pads to the Eazy PRO. ATTENTION: whenever the pads set is replaced, remember to keep a new pair already connected to the equipment. -
Page 27: Operating In Aed Mode
Operating in AED mode When in AED mode (Automated External Defibrillator), the Eazy PRO identifies arrhythmias and selects the energy charge automatically. Eazy PRO, on AED mode, is in accordance with American Heart Association 2015 Guidelines. Below you will find a simplified introduction to how the Eazy PRO operates. Be sure to carefully memorize the detailed guide on the next pages before operating the equipment. -
Page 28: Step 1
User manual | Operating in AED mode Step 1 Before starting the operation, please call the emergency service. If the disposable pads have not been connected to the Eazy PRO yet, attach the connector to the plug on the right side of the equipment. After disposing of used pads, always leave a replacement pair already connected to the equipment, avoiding having to replace them at the mo- ment of the emergency. -
Page 29: Step 2
User manual | Operating in AED mode Step 2 Remove pads from their wrapping and peel off the film protecting the adhesive. Place pads on the patient according to the picture above, keeping adhesive area in contact with the skin. This position allows the electric current to circulate from one pad to the other, thus reaching the whole thoracic cage. -
Page 30: Step 3
ATTENTION: the pads are disposable and can be used in only one patient at a time. Remember to always keep extra ones with the equipment. For replacements, please contact Instramed. -
Page 31: Step 4
User manual | Operating in AED mode Step 4 Treatment recommended. Don’t touch the patient! Push the flashing button to treat the patient. If the need for shock is detected, the shock symbol will blink and the device will ask the user to press the start button again. -
Page 32: Simplified Diagram Of Procedure In Adults
User manual | Operating in AED mode Simplified diagram of procedure in adults Healthcare professional Unconscious - Conscious Check patient’s condition - Panting Not breathing Wait for emergency Call emergency team service No pulse Place victim on a dry, flat and steady area - Place pads - Activate the Eazy PRO... - Page 33 User manual | Operating in AED mode Simplified diagram of procedure in adults User without a degree in medicine, with previously training in the use of automatic defibrillators (AED) and CPR techniques. Unconscious Call emergency service - Conscious Check patient’s condition - Panting Not breathing Wait for emergency...
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Page 34: Operating In Manual Mode
Operating in manual mode The Eazy PRO enables manual mode operation, as a conventional defibrillator. In this situation, the device does not interfere with the treatment, and the user is responsible for choosing the energy, charging the charge and delivering the shock. After confirming the mode change, the Eazy PRO ceases to emit sound and visual orientation, in addition to the automatic safeguards against shocks. -
Page 35: Step 1
User manual | Operating in manual mode Step 1 Before starting the operation, please call the emergency service. If the disposable pads have not been connected to the Eazy PRO yet, attach the connector to the plug on the right side of the equipment. After disposing of used pads, always leave a replacement pair already connected to the equipment, avoiding having to replace them at the mo- ment of the emergency. -
Page 36: Step 2
User manual | Operating in manual mode Step 2 Remove pads from their wrapping and peel off the film protecting the adhesive. Place pads on the patient according to the picture above, keeping adhesive area in contact with the skin. This position allows the electric current to circulate from one pad to the other, thus reaching the whole thoracic cage. -
Page 37: Step 3
User manual | Operating in manual mode Step 3 Analyzing heart rhythm... Press “START” button. Press the MANUAL button on the device’s screen. Confirm this choice on the following screen. The Eazy PRO will switch to manual mode. Follow the instructions: Place pads on the patient. -
Page 38: Step 4
User manual | Operating in manual mode Step 4 BPM 080 CPR 00:00 Charge: Charge Cancel buttons to select the desired charge. button to store the charge. Charge Press Início The shock will be delivered. ATTENTION: the user must not touch the patient or conductive surfaces in contact with him/her during the shock delivery, under risk of suffering a powerful electric discharge. -
Page 39: Simplified Diagram Of Procedure In Adults
User manual | Operating in manual mode Simplified diagram of procedure in adults Healthcare professional Unconscious - Conscious Check patient’s condition - Panting Not breathing Wait for emergency Call emergency team service No pulse Place victim on a dry, flat and steady area - Place pads - Activate the Eazy PRO... - Page 40 User manual | Operating in manual mode Simplified diagram of procedure in adults User without a degree in medicine, with previously training in the use of automatic defibrillators (AED) and CPR techniques. Unconscious Call emergency service - Conscious Check patient’s condition - Panting Not breathing Wait for emergency...
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Page 41: Applying Cpr
Applying CPR 2 min. CPR (cardiopulmonary resuscitation) is a technique which consists in mechanical stimulation of the lungs and heart. Through simple actions, it aims to maintain the oxygenation of the brain, avoiding irreversible damage. 1) Lay the victim on his back on a hard flat surface. 2) Run your fingers from the center of the victim’s thorax, descending until finding a bone that comes to a tip in the middle of the chest (Sternum), right above the stomach. - Page 42 User manual | Applying CPR • Place one hand on the back of the victim’s neck and lift it; place your other hand on the victim’s forehead and force the head back, in order to let the air through. • Close the victim’s nostrils with the fingers which are on the forehead. •...
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Page 43: Use In Children
Use in children Using the Eazy PRO on children under 8 years old The Eazy PRO can be used on children from the age of one year onwards. However, on patients from one year of age to eight years of age or patients who weigh less than 25kg, some precautions must be taken: •... -
Page 44: Pc Connection
PC Connection Introduction The Eazy PRO can be connected to a PC, allowing the user access to new functions as: • View, save in external media or print list of the last 100 events. • View, save in external media and print ECG activity of the last two hours. •... -
Page 45: Softdea Installation
• After the installation connect the device through the USB cable given. • The location of the device drivers to be installed will be required. They can be found in this folder: C:\Program Files\Instramed\SoftDEA\DRIVERS. • Start the SoftDEA application. • On the language selection screen, choose among Spanish, English or Portuguese. -
Page 46: Operating Softdea
Operating SoftDEA Startup screen 1 - Graphic display button Click this button to display the ECG waveforms and event list stored on the device. The displayed interval corresponds to the user-defined time frame (see item 7 on page 47 of this manual). -
Page 47: Graphic Display Screen
User manual | Operating Soft DEA Graphic display screen 1 - Download The set of information that is currently being viewed can be saved on the PC by clicking this button. A window will open enabling the user to select the desired location in which to store the file. download 2 -Open Click this button to open a ".dea"... -
Page 48: Print
User manual | Operating Soft DEA 3 - Print Click this button to print the set of information that is currently displayed on the screen. Use the printer driver dialog box to set printing options. print 4 - PDF Click this button to generate a file showing the set of information that is currently displayed on the screen in pdf format. - Page 49 User manual | Operating Soft DEA • INTERNAL DISCHARGE - Power discharged internally due to pressing the start button for an excessive amount of time. • TREATMENT PERFORMED - A shock was delivered to the patient. • SHOCK INDICATED - Shock indicated due to the patient's ventricular fibrillation or ventricular tachycardia pattern.
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Page 50: Adjustments
User manual | Operating Soft DEA Adjustments Click the settings button to access the screen that allows you to update the clock and set the sound level emitted by the speaker on the equipment. In order to make changes, the Eazy/Eazy PRO device must be turned on and connected to the PC running SoftDEA, via the supplied USB cable. -
Page 51: Changing Languages
User manual | Operating Soft DEA Changing languages • Under the "in the SoftDEA" option: Change the language of the software interface. Does not require a device to be connected. • Under the "in the device" option (when an Eazy/Eazy PRO device is connected): Change the language of voice prompts emitted by the speaker on the device to the selected language. -
Page 52: 2- Exit
User manual | Operating Soft DEA 2- Exit Click this button to close SoftDEA 3. -
Page 53: Precautions, Restrictions And Warnings
• USB cable WARNING: using cables and accessories different from the ones specified above, except for cables and accessories sold by Instramed as replacement pieces, may result in emission gain or immunity decrease of the equipment. The Eazy PRO must not be used too close to or piled over other equipment. -
Page 54: Electromagnetic Emissions
User manual | Precautions, restrictions and warnings Electromagnetic emissions Directives and manufacturer declaration - electromagnetic emissions The Eazy PRO is intended for use in the specific electromagnetic environment below. The customer or user of the defibrillator is advised to ensure that it is used in such an environment. Tests Compliance Electromagnetic environment - directives... -
Page 55: Electromagnetic Immunity - General
User manual | Precautions, restrictions and warnings Electromagnetic immunity - General Directives and declaration of the manufacturer - electromagnetic emissions The Eazy PRO is intended to be used in the specific electromagnetic environment below. The user or customer of the defibrillator should ensure that it is used in such an environment. -
Page 56: Electromagnetic Immunity - Equipment With Life Support Functions
User manual | Precautions, restrictions and warnings Electromagnetic immunity - Equipment with life support functions Advisable separation distances between mobile and portable RF communications equipment and the Eazy PRO The Eazy PRO is intended to be used in the electromagnetic environment specified below. The customer or user of the defibrillator should ensure that it is used in such an environment. - Page 57 User manual | Precautions, restrictions and warnings Electromagnetic immunity - Life support function equipment Advisable separation distances between mobile and portable RF communications equipment and the Eazy PRO The Eazy PRO is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or user of the defibrillator can help to prevent electromagnetic interference by maintaining a minimum distance between the mobile and portable RF communications equipment (transmitters) and the Eazy PRO as recommended below, according to the maximum output power of the communication equipment.
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Page 58: Ecg Analysis Algorithm
User manual | Precautions, restrictions and warnings ECG analysis algorithm Databases used for the VF/VT recognition algorithm tests: • MIT-BIH Arrhythmia Database. • MIT-BIH Atrial Fibrillation Database. • MIT-BIH Supraventricular Arrhythmia Database. • European Society of Cardiology Arrhythmia Database. • Creighton University Arrhythmia Database. Test report: •... - Page 59 User manual | Precautions, restrictions and warnings Sensitivity is the equipment’s percent ability to correctly identify a shockable rhythm. Specificity is the equipment’s percent ability to correctly identify a nonshockable rhythm. A = True Positive B = False Positive C = False Negative D = True Negative A true positive (A) is the equipment’s ability, in measurement units, to correctly identify a shockable rhythm.
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Page 60: Types Of Arrhythmia Analyzed
User manual | Precautions, restrictions and warnings Types of arrhythmia analyzed Nonshockable: • Sinus Rhythm/ Sinus Tachycardia/ Sinus Bradycardia; • Atrial Tachycardia; • Atrial Fibrillation; • Atrial Flutter; • Supraventricular Tachyarrhythmia; • Normal Rhythm with Extrasystoles; • Sinus Rhythm with Pacemaker; •... -
Page 61: Specifications
Specifications General specifications Dimensions: 22 cm (8.7 in ) (L) 13 cm (5.1 in) (W) 29 cm (11.4 in) (H) Weight: Equipment – 2.90 Kg (6.38 lbs) Internal rechargeable battery: Type: Li-ion, 14,4VDC 4,0 A/h Life: 10 hours in cardiac rhythm recognition mode (new fully charged battery), or a minimum of 200 shocks at 200 Joules. -
Page 62: Environmental Specifications
User manual | Specifications Electrical Isolation: CF Type Operating Mode: Continuous operation Maximum time from rhythm analysis beginning to discharge readiness: Maximum time from rhythm analysis beginning to full discharge readiness: Isolating Method from Mains Power Supply: Flexible cable with a mains plug. Non-frequent use equipment: Comply with the requirements for non- frequent use equipment as specified in... -
Page 63: Defibrillator
User manual | Specifications Defibrillator Waveform: Biphasic truncated exponential. Wave shaped parameters adjusted according to the patient’s impedance Shock application: By means of multifunctional adhesive pads Commands: Front panel button: on/off. Touchscreen: allows for the selection of manual mode and defining energy scales. Scales for defibrillation: Adult: 150 to 270 J. -
Page 64: Precision Of Applied Energy
User manual | Specifications Pads cable length: 2 meters Maximum output voltage: 2000V Maximum output current: 80A (25Ω) Precision of applied energy Impedance Selected Accuracy energy 49,0 52,0 53,0 52,5 51,5 48,0 45,5 ±15% 143,0 151,5 155,0 153,0 148,0 141,0 137,0 ±15% 191,5 201,5... - Page 65 User manual | Specifications Values on the Y axis refer to voltage (volts) and values on the X axis refer to time (milliseconds). 200J of energy at 25R impedance. 200J of energy at 50R impedance. 200J of energy at 75R impedance.
- Page 66 User manual | Specifications 200J of energy at 100R impedance. 200J of energy at 125R impedance. 200J of energy at 150R impedance.
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Page 67: Alarm System
User manual | Specifications 200J of energy at 175R impedance. Alarm system Eazy PRO’s alarm system is made of a single alarm, as shown in the table below: ALARM CONDITION The device is ready to apply the shock treatment to the patient using the energy previously established by either the algorithm (AED mode) or the operator (manual override mode), waiting only for the operator to press the button. -
Page 68: Information Signals
User manual | Specifications Verifying if the alarm system is functional: It is possible to verify if the alarm signals are functional with an ECG simulator capable of generating ventricular fibrillation signals. It is recommended that the verification be made by a qualified technician, during the preventive maintenance (see chapter “Inspection and maintenance”). - Page 69 User manual | Specifications The device also has verbal information signals. They differ from the verbal alarm signal in two manners: Sound Level: The verbal information signals will always be at least 6dB(A) lower than the previously configured level for verbal alarm signals. Verbal Content: The verbal information signals have the following messages: •...
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Page 70: Inspection And Maintenance
Remember to check the status of the operational status indicator at least every 30 days (see page 20 - operational status indicator). Corrective Maintenance If the equipment needs repair, this can only be done by INSTRAMED or its authorized representative, otherwise this Warranty certificate may no longer be valid. -
Page 71: Warranty Certificate
This also applies in case of alterations made to this contract, the fiscal receipt, or to the equipment’s serial number. Instramed Indústria Médico Hospitalar Ltda. is not responsible for the improper use of this equipment, by people who are not familiar with its function or the techniques recommend for its proper use. - Page 72 AUTOMATED EXTERNAL DEFIBRILLATOR WITH MANUAL FUNCTION www.instramed.com.br +55 (51) 3073 8200...
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