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Instramed apolus User Manual

Biphasic defibrillator
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User Manual
Biphasic Defibrillator

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Summary of Contents for Instramed apolus

  • Page 1 User Manual Biphasic Defibrillator...
  • Page 2 For information about warranty or technical assistance, please contact Instramed’s technical support. Copyright © 2016 Instramed. Apolus, 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 20 days, and with the power switch at the position on, it is advisable to execute a full battery charge. If this procedure is not performed, there is a risk of draining the battery and consequently being unable to use the Apolus in its portable configuration (not connected to the electric current).
  • Page 4 You can call Instramed for replacements of consumable items, parts and accessories. Consult Instramed for prices. Shipping may apply. To request pieces and services please contact the representative of your region (the list may be found on www.instramed.com.br ) or directly Instramed by the telephone +55 51 3073-8200.

  • Page 5: Table Of Contents

    Index Introduction Purpose and application ................... 08 Characteristics ......................08 About the Manual ..................... 08 Safety Information Attention ........................09 Warnings ........................09 Adverse effects ......................10 Classification and symbols ..................11 Standards ......................... 12 Device care ....................... 12 Connection to other equipment ................12 Grounding .........................
  • Page 6 User manual | Index Warnings ........................20 Use criteria ....................... 20 Qualified users ......................20 External pads use ..................... 21 Considerations for shock delivery ................23 Child pads use ......................24 Defibrillation ......................25 Synchronism - Synchronized discharge - Cardioversion .......... 26 Disarm key ........................
  • Page 7 User manual | Index Troubleshooting Accessories List of basic accessories ................... 40 List of optional accessories ..................40 Specifications and safety General specifications ....................41 Environmental specifications ..................42 Defibrillator ....................... 42 Warranty Certificate...

  • Page 8: Introduction

    About the Manual This manual explains the functioning of the Apolus defibrillators series, alerting the user to safety risks. This manual is part of the Apolus and must be kept for further reference. The information contained in this manual belongs to Instramed and cannot be copied fully, or in part, without expressed written consent.

  • Page 9: Safety Information

    ATTENTION: always check the general state of the equipment and its accessories before using it. Before installing the equipment verify if there are any abnormalities or damage caused by mishandling during transportation. WARNING: The use of the Apolus is restricted to one patient at a time.

  • Page 10: Adverse Effects

    WARNING: In general, the parts of the EQUIPMENT and ACCESSORIES of the Apolus defibrillator intended to come into contact with biological tissues, cells or fluids are tested and analyzed according to the directives and principles of ISO 10993-1, which deals exclusively with the biocompatibility test of the applied parts.

  • Page 11: Classification And Symbols

    User manual | Safety information Classification and symbols Symbol Standard Description IEC TR 60878 Defibrillation proof insulated CF type equipment IEC 60601-1 Follow the instructions for use IEC 60601-1 General warning symbol IEC 60601-1 Warning: dangerous voltage IEC TR 60878 Terminal for equalization of potential IEC TR 60878 Terminal for general ground...

  • Page 12: Standards

    If you suspect a fall or external damage, do not use the equipment. Connection to other equipment When connecting the Apolus to any device, ensure that the equipment is operating correctly before clinical use. The equipment or accessories connected to the device must be certified according to the IEC 950 standard for data processing equipment or according to the IEC 60601-1-1 for medical equipment.

  • Page 13: Grounding

    For disposal of products from Instramed, contact us by the telephone numbers available on the website www.instramed.com.br or by the e-mail qualidade@instramed.com.br.

  • Page 14: The Equipment

    The equipment Front panel Selection of energy delivered Joules 50 1 - Selector switch: turns the equipment on and off; selects the energy 2 - LCD display 3 - Power, battery charge and QRS indications 4 - Operation buttons 5 - Transport handle...

  • Page 15: Selector Switch

    Joules 50 2 - LCD Display The LCD screen of the Apolus shows numeric information related to the defibrillation process, as well as the battery level indicator (5 levels). For further information, see chapter “Defibrillation operation”. Battery charge level: •...

  • Page 16: Power, Battery Charge And Qrs Indications

    User manual | The equipment 3 - Power, battery charge and QRS indications A - Power connected: when the LED is on, it indicates that the equipment is connected to a power source or an external battery. B - Battery charging: when the LED is on, it indicates that the battery is charging. C –...

  • Page 17: Side View

    User manual | The equipment Side view 1 - Connector for defibrillation electrodes (pads) Adult/child external: included with the equipment, may be used on adults and/or children. Internal: Used in surgeries.

  • Page 18: Rear Pannel

    User manual | The equipment Rear pannel 1. ECG signal socket: ECG input connector (1V/mV) for synchronized defibrillation. 2. Grounding and potential equalizer: potential equalization and general grounding connector. 3. External DC socket: for battery connection or external DC source in a range of 11 to 16 VDC.

  • Page 19: Defibrillation Operation

    (applying the capacitor discharge directly to the heart, with with an open chest and during a surgical procedure). The Apolus uses biphasic shock technology, which is characterized by a current liberated in one direction and, after a brief period of time, reverted in the opposite direction.

  • Page 20: Warnings

    Ensure that the patient does not come into contact with any metallic parts. Use criteria The Apolus, in defibrillation mode, must only be used if the following circumstances, as a whole, are presented: 1 - Unconscious victim 2 - No breathing...

  • Page 21: External Pads Use

    Defibrillation operation External pads use 1 - Check if the pads are connected to the Apolus. If they are not, connect the defibrillation cable to the pads socket located on the equipment’s side (as show in the image below). Turn the screw all the way.
  • Page 22 User manual | Defibrillation operation ENSURE that the electrodes are away from each other. DO NOT apply paste or gel to the thorax between the pads or the current may follow a superficial route along the thorax wall and not reach the heart. 5 - Check contact with the patient.

  • Page 23: Considerations For Shock Delivery

    Considerations for shock delivery Combining the pressure of the pads with the conductive material applied to the electrodes, different patient impedances are obtained. The table below indicates the conditions in which the Apolus offers or inhibits the delivery of energy. Patient’s...

  • Page 24: Child Pads Use

    2 - Pull the pads base forward to remove them. 3 - This exposes the smaller electrode for children Adult Child The Apolus will automatically identify that it is operating in pediatric mode. Energy is limited to 50 Joules in the pediatric mode.

  • Page 25: Defibrillation

    Joules 50 Joules. In most cases, 200 Joules is recommended for adult use The Apolus automatically identifies that it is operating with internal pads. Energy in internal pads mode is limited to 50 Joules. Step 2 – Charge Press the “Charge” button (green) in the front panel or use the charge button in the external pads (orange).

  • Page 26: Synchronism - Synchronized Discharge - Cardioversion

    1 V/mV is required. 1 - Using a sync cable, connect the ECG input ( ), located on the rear panel of the Apolus, to the 1 V / mV ECG output of your cardiac monitor. 2 - Press the “Sync” button on the panel for two seconds.

  • Page 27: Disarm Key

    User manual | Defibrillation operation Disarm key Disarm the stored charge. Charge may be disarmed at any time, whether the charge is ready or not Pantalla de desfibrilación 1. Energy selected: from 5 to 360J. 2. Type of defibrillation electrode: adult pad, internal pad, adhesive pad or disconnected pad.

  • Page 28: Functional Test

    Functional test ATTENTION: The functional test must be performed daily, which ensures that the equipment is working perfectly and in a state of readiness. Selection of energy delivered Joules 50 Step 1 Put the selector switch in the functional test position. Step 2 In case the pads are not connected, the display will show the message: CONNECT THE PADS ON THE EQUIPMENT.

  • Page 29: Indication Of The Functional Tests Results

    Equipment passed functional test Equipment failed functional test ATTENTION: If Apolus fails the functional test, contact technical support immediately. NOTE: the Apolus indicates failure in the functional test when the energy delivered presents an error higher than the allowed by standards...

  • Page 30: Care And Maintenance

    It is recommended that functional tests be performed at the beginning of every work shift. Corrective maintenance If the equipment needs repair, this can only be done by Instramed or its authorized representa-tive, otherwise this Warranty certificate may no longer be valid. No internal parts are to be fixed by the user.

  • Page 31: Battery

    Battery If Apolus is not used for a long period of time, the battery will need to be recharged. To recharge the battery, connect the monitor to an AC power source (110 or 220V outlet) or a DC power source.
  • Page 32 Instramed as replacement pieces, may result in emission increase or immunity decrease of the equipment. The Apolus must not be used too close to or piled over other equipment. The actions to be taken to prevent adverse events to the patient and operator due to electromagnetic disturbances during the equipment’s useful life are:...

  • Page 33: Electromagnetic Emissions

    Electromagnetic emissions Directives and manufacturer declaration - electromagnetic emissions The Apolus 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.

  • Page 34: Electromagnetic Immunity - General

    Electromagnetic immunity - General Directives and declaration of the manufacturer - electromagnetic emissions The Apolus 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 35: Electromagnetic Immunity - Equipment With Life Support Functions

    Advisable separation distances between mobile and portable RF communications equipment and the Apolus The Apolus is intended to be used in the electromagnetic environment specified below. The customer or user of the Apolus should ensure that it is used in such an environment.
  • Page 36 In order to evaluate the electromagnetic environment due to fixed RF transmitters, it is advisable to consider an electromagnetic site survey. If the measured field strength in the site where the Apolus is used exceeds the level of RF compliance used above, the Apolus should be observed to check if operation is normal.
  • Page 37 Advisable separation distances between mobile and portable RF communications equipment and the Apolus The Apolus is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or user of the Apolus can help to prevent electromagnetic interference by maintaining a minimum distance between the mobile and portable RF communications equipment (transmitters) and the Apolus as recommended below, according to the maximum output power of the communication equipment..
  • Page 38 User manual | Care and maintenance Apolus was designed to provide basic security with RF equipment as per the following table: Testing specifications for cabinet interface immunity to RF wire communications equipment Testing Band Service Modulation Maximum Distance Immunity frequency...

  • Page 39: Troubleshooting

    - Check connections: the Apolus/Power Cable/ The Apolus does not turn on There is no electricity Plug. - Check if the Apolus is equipped with adult Does not select energy > 50J Adult pads identification pads and if adult electrodes are properly connected.

  • Page 40: Accessories

    Quantity Description Code Power supply cable 5550 A set of adult/child external defibrillation pads 79001 Quick guide 26173 CD with Instramed’s manuals and softwares 25277 List of optional accessories Description Code Auxiliary grounding cable 5495 External DC connection cable 79004...

  • Page 41: Specifications And Safety

    Specifications and safety General specifications Dimension with pads: 44.5 cm (W). 24.5 cm (D). 20.0 cm (H). Weight: Device - 3.90 Kg. External set - 0.85 Kg. Complete set - 4.75 Kg. Power: AC: 100 to 240 VAC, 50/60 Hz. DC external: 11 to 16 VDC.

  • Page 42: Environmental Specifications

    Operational: 10 to 95% RH, without condensation Storage: 10 to 95% RH, without condensation WARNING: if the Apolus is used outside these conditions, 15 through 30 minutes will be required to stabilize the system so that functioning failures do not occur.
  • Page 43 User manual | Specifications and safety Command keys: Charge, Shock, Disarm and Sync (Synchronism) Charge command: CHARGE button in fron panel, button in external pads. Shock command: SHOCK button in front panel, buttons in external pads. Disarm command: DISARM button in front panel. Synchronized command: SYNC button in front panel.
  • Page 44 User manual | Specifications and safety Precision of applied energy: Energy Impedance Accuracy selected 4,9 ±3J 10,2 10,4 10,3 10,2 9,8 ±3J 13,4 16,0 16,7 17,2 17,5 17,7 17,2 ±3J 19,0 20,5 21,0 21,0 20,5 19,5 19,0 ±15% 27,5 30,0 31,0 31,5 31,0...
  • Page 45 User manual | Specifications and safety Values on the Y axis refer to voltage (volts) and values on the X axis refer to time (milliseconds). 360J of energy at 25R impedance. 360J of energy at 50R impedance.
  • Page 46 User manual | Specifications and safety 360 J of energy at 75 R impedance. 360 J of energy at 100 R impedance. 360 J of energy at 125 R impedance.
  • Page 47 User manual | Specifications and safety 360 J of energy at 150 R impedance. 360 J of energy at 175 R impedance.

  • Page 48: Warranty Certificate

    This also applies in case of alterations made to this contract, the fiscal receipt, or to the serial number of the equipment. 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 49 Biphasic Defibrillator www.instramed.com.br (51) 3073 8200...

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