Instramed Dualmax User Manual

Cardioverter/biphasic defibrillator monitor
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Cardioverter/Biphasic Defibrillator Monitor

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Summary of Contents for Instramed Dualmax

  • Page 1 User manual Cardioverter/Biphasic Defibrillator Monitor...
  • Page 2 For information about warranty or technical assistance, please contact Instramed’s technical support. Copyright © 2019 Instramed. The DualMax, 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 ATTENTION: observe the battery charge maintenance instructions. First use Before using the DualMax for the first time, the equipment must receive a full battery charge. In order to do this, the equipment needs to be connected to an electric current for at least eught hours.
  • Page 4 Package contents Included items • 1 Dualmax and accessories listed in Accessories chapter. Optional items Optional items listed in Accessories chapter. • Consult availability.
  • Page 5 Replacement parts You can call Instramed for replacements of consumable items, parts and accessories. Consult Instramed for prices. Shipping may apply. To request parts and services, contact your local representative (the list can be found at www.instramed.com.br) or directly contact Instramed by telephone at: +55 (51) 3073 8200.
  • Page 6: Table Of Contents

    Index Introduction Purpose and application ................... 20 Characteristics ......................20 Optional items ......................21 About the manual ..................... 21 Safety information Warnings ........................22 Adverse or side effects ..................... 24 Classification and symbols ..................25 Standards ......................... 26 Device care ....................... 27 Grounding .........................
  • Page 7 User manual | Index 8 - Capnography connector ................. 33 9 - NIBP connector ....................33 10 - SpO connector .................... 33 11 - CPR Maestro connector ................33 12 - P1 connector ....................34 13 - P2 connector ....................34 14 - Defibrillation electrodes (pads) connector: ..........
  • Page 8 User manual | Index AED mode screen - Variation B (with CPR) ............44 Defibrillator mode screen – Variation A (with CPR) ..........45 Defibrillator mode screen – Variation B (without CPR) ..........46 Pacemaker mode screen ..................47 Charge auto-sequencing mode screen – Variation A (with CPR) ......48 Charge auto-sequencing mode screen –...
  • Page 9 Use criteria ....................... 80 Qualified users ......................80 Operation ........................81 Applying CPR ......................85 Using the DualMax on children under 8 years old ............ 87 Alarm system ......................88 Information signals ....................88 CPR Maestro Using the CPR Maestro .................... 90 Feedback ........................
  • Page 10 User manual | Index Demand mode (synchronous) .................. 97 Operating in pacemaker mode ................. 98 Starting stimulation ....................99 Fixed stimulation ....................... 99 Under demand stimulation ..................100 Defibrillation ......................100 Monitor mode - ECG Physics principle used .................... 101 Warnings ........................
  • Page 11 User manual | Index 8 - Back/Exit ...................... 108 Monitor mode - NIBP Physics principle used .................... 110 Warnings ........................ 110 Monitoring Non-Invasive Pressure ................111 Measurement modes ....................112 NIBP numeric indicator ................... 113 NIBP setup - Principal .................... 113 1 - Manual measurement ..................
  • Page 12 User manual | Index 2 - SpO response ..................... 120 3 - Sensitivity ..................... 120 4 - Next page ..................... 120 5 - Back/Exit ...................... 121 SpO2 configurations – Alarm .................. 121 1 - Alarm sound ....................121 2 - Maximum limit ....................121 3 - Minimum limit ....................
  • Page 13 User manual | Index Warnings ........................ 128 Respiration monitoring .................... 129 Respiration numeric indicator ................. 130 Respiration setup ....................131 1 - Respiration monitoring On/Off ..............131 2 - Respiratory frequency .................. 131 3 - Respiration amplitude .................. 131 4 - Apnea alarm ....................131 5 - Next page .....................
  • Page 14 User manual | Index 5 - Maximum limit (temperature 2) ..............136 6 - Minimum limit (temperature 2) ..............137 7 - Previous page ....................137 8 - Back/Exit ...................... 137 Invasive pressure monitoring Physics principle used .................... 138 IP numeric indicator ....................139 Invasive pressure configuration ................
  • Page 15 User manual | Index 1 - IP alarms 2 ....................145 2 - Maximum limit - Systole ................145 3 - Minimum limit - Systole ................145 4 - Maximum limit - Diastole ................145 5 - Minimum limit - Diastole ................145 6 - Maximum limit - Average ................
  • Page 16 Functional test General ........................163 Performing the functional test ................. 163 RTC - Real Time Check General ........................165 RTC Operation on DualMax ................... 165 1 - Number of daily tests ................... 165 2 - Test 1 time ....................165...
  • Page 17 PC connection Introduction ......................168 Requirements ......................168 SoftDEA installation ....................169 Connecting the DualMax to a PC ................169 Startup screen ......................170 1 - DualMax services initialization button ............170 SoftDEA language selection screen ............... 171 1 - Buttons of SoftDEA language selection ............171 Graphics generated by AED mode display screen ..........
  • Page 18 User manual | Index 2 - Reading log of the equipment ..............179 3 - Options ......................181 4 - Backup ......................183 5 - Information ....................183 Receiving data ......................184 Closing the application ................... 184 Care and maintenance Preventive maintenance ..................
  • Page 19 User manual | Index AED mode (optional) ....................204 ECG analysis algorithm ..................206 External pacemaker (optional) ................210 ECG ........................211 NIBP - Non-Invasive Arterial Pressure (optional) ........... 214 BCI (optional) ....................215 Respiration ......................215 Capnography (optional) ..................216 Printer (opcional) ....................
  • Page 20: Introduction

    The RESP/Monitor mode displays the respiratory rate measured by ECG electrodes or by the capnograph. Characteristics The DualMax is a modern, practical, lightweight, compact and portable device that can be used in emergency situations. The DualMax offers the following parameters and/or characteristics (some parameters are optional): •...
  • Page 21: Optional Items

    About the manual This guide explains the functioning of the DualMax defibrillator/monitor series , alerting the user to possible safety risks. This manual is part of the DualMax 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 22: Safety Information

    Excessive hair or wet skin in the application area of the electrodes. • Pieces of clothing between skin and pads. DualMax does not have support system and its carrying handle must not be used for this purpose. This equipment does not have reminder signals.
  • Page 23 It must be accompanied by constant analysis of the patient’s clinical status and symptoms. WARNING: The use of the DualMax is restricted to one patient at a time. NOTICE: the applied parts (electrodes, sensors, armbands, etc.) are protected against defibrillation discharge;...
  • Page 24: Adverse Or Side Effects

    User Manual | Safety information Adverse or side effects Superficial burns may occur on the patient’s skin in the area in contact with the electrodes. To minimize the effect of the disposable paddles, apply them directly after removal from the protection envelope and attach them firmly to the patient’s skin. The skin must be dry, or electric current leakage may occur, increasing the burn’s area and reducing the efficiency of the treatment.
  • Page 25: Classification And Symbols

    User Manual | Safety information Classification and symbols Symbol Description Equipment and its isolated defibrillation proof applied parts of CF type. Follow the instructions for use. General warning symbol. Warning: dangerous voltage. Terminal for equalization of potential. Terminal for general ground. Disconnects the equipment.
  • Page 26: Standards

    Lot code. Catalog number. Date after which the product cannot be used. Standards DualMax was designed following performance and safety national and international standards. Among them are: • NBR IEC 60601-1 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance.
  • Page 27: Device Care

    Or equivalent IECs. The current versions of the Standards can be verified in the Certificate of Conformity of the product, 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 28: Electromagnetic Compatibility

    For disposal of products from Instramed, contact us by the telefone numbers available on the website www.instramed.com.br or by the e-mail qualidade@instramed.com.br.
  • Page 29: The Equipment

    The equipment Front panel 1. Touch screen. 6. Disarm: disarms the stored charge. 2. Indication of AC Mains, battery 7. Sync: activates synchronization. charging and product operation status 8. Selector key: turns the equipment on (see item “Indication of AC Mains, and off;...
  • Page 30: Screen

    “Screen and operation” section. e-Jog control The e-Jog control is used to access all of the DualMax's functions, such as set alarms, define information displayed on the screen, alter parameters, etc. ROTATE: rotating allows the user to select or change information and navigate all menus.
  • Page 31: Quick Access Buttons

    2. Battery charging: when the LED is on, it indicates that the battery is charging. OBS: when the equipment is connected to an electric current, the LEDs will light up indicating the beginning of charging, even if the DualMax is inoperative.
  • Page 32: Side View

    Printer for thermosensitive paper. It prints electrocardiograms and events. For more information view the “Printing” chapter. 2 - Pads The pads accompanying the DualMax must be placed on top of the equipment and must be properly connected to the adult adapter. 3 - Transport handle Handle used to carry the equipment.
  • Page 33: Temperature Connector

    User manual | The equipment 5 - Temperature connector Temperature connector YSI 400 standard (channel 2). 6 - ECG connector Connector for ECG cables. Depending on the parameters present in the equipment, it may be available in the following settings: •...
  • Page 34 User manual | O equipamento 12 - P1 connector Invasive pressure connector (channel 1). 13 - P2 connector Invasive pressure connector (channel 2). 14 - Defibrillation electrodes (pads) connector: Multifunctional: adhesive pads for desfibrillation, pacemaker and monitoring. Adult/child external pads: accompany the equipment, may be used in adults and children.
  • Page 35 User manual | O equipamento 1 - Removable battery 1 The battery can be easily replaced by simply pressing both side tabs one against the other. The battery will unlock and automatically detach itself from the equipment. NOTE: do not remove the battery when the equipment is operating in battery mode.
  • Page 36 User manual | The equipment 7 - USB connector USB connector for access to data stored by the AED mode. It can be plugged directly to a Windows PC. 8 - LAN connector Connector for wired network connection. 9 - USB host connector Connector for pendrive connection.
  • Page 37 Screen and operation Turning on and operating Use selector switch (1) for turning DualMax on and off. When turning on, the operator must immediately select an operation mode. 1 - Selector switch Turn clockwise or counter-clockwise to select the operation mode. On "Off" position the equipment is turned off.
  • Page 38 (adhesive) are connected to the equipment. 4 - Turns equipment off In this position, the DualMax is turned off. After the device is turned off, only the circuit that charges the battery remains in operation. (This is indicated by a green LED in the base of the equipment’s front).
  • Page 39 User manual | Screen and operation Operating e-Jog control To access the configuration menus and equipment operation use the rotating e-Jog control as indicated below: STEP 1 ROTATE: rotate the button to the desired item observing the highlighted icons on the equipment screen. STEP 2 PRESS: press to select the highlighted item.
  • Page 40 User manual | Screen and operation Information bar The information bar is present in all operating modes of the equipment. In it are present the following information: 1. Time. 6. Date. 2. Patient status. 7. Patient data. 3. Alarms total number. 8.
  • Page 41 User manual | Screen and operation Monitor mode screen – Variation A (with curves exhibition) 1. Information bar. 7. ECG data. 2. Graphic area for parameter curves 8. SpO data. exhibition. 9. Invasise Pressure data. 3. RESP data. 10. Capnography data. 4.
  • Page 42 User manual | Screen and operation Monitor mode screen – Variation B (without curves exhibition) 1. Information bar. 8. ST segment data. 2. ECG data. 9. RESP data. 3. SpO data. 10. ∆T value. 4. Invasive pressure 1 data. 11. Temperature 1 data. 5.
  • Page 43 User manual | Screen and operation AED mode screen - Variation A (without CPR) 1. Information bar. 8. Charges selected for the first, second and third shocks. 2. Graphic area for parameter curves exhibition. 9. Illustrative image of the treatment stage.
  • Page 44 User manual | Screen and operation AED mode screen - Variation B (with CPR) 1. Information bar. 8. Number of applied shocks. 2. Graphic area for ECG curves 9. Type of pads selected and exhibition. defibrillation mode. 3. ST segment data. 10.
  • Page 45 User manual | Screen and operation Defibrillator mode screen – Variation A (with CPR) 1. Information bar. 9. Treatment duration. 2. Graphic area for parameter curves 10. Indication of active synchronism. exhibition. 11. Number of applied shocks. 3. ST segment data. 12.
  • Page 46 User manual | Screen and operation Defibrillator mode screen – Variation B (without CPR) 1. Information bar. 8. NIBP data. 2. Graphic area for parameter curves 9. Treatment duration. exhibition. 10. Number of applied shocks. 3. ST segment data. 11. Type of pads selected (adult/child). 4.
  • Page 47 User manual | Screen and operation Pacemaker mode screen 1. Information bar. 8. NIBP data. 2. Graphic area for parameter curves 9. Pacemaker operating status. exhibition. 10. Pacemaker operating mode. 3. ST segment data. 11. BPM measure value. 4. ECG data. 12.
  • Page 48 User manual | Screen and operation Charge auto-sequencing mode screen – Variation A (with CPR) 1. Information bar. 9. Treatment duration. 2. Graphic area for parameter curves 10. Number of applied shocks. exhibition. 11. Type of pads selected (adult/child). 3. ST segment data. 12.
  • Page 49 User manual | Screen and operation Charge auto-sequencing mode screen – Variation B (without CPR) 1. Information bar. 9. Treatment duration. 2. Graphic area for parameter curves 10. Number of applied shocks. exhibition. 11. Type of pads selected (adult/child). 3. ST segment data. 12.
  • Page 50 ECG - Asistoly - The DualMax cannot detect valid heartbeats for over 4 seconds. SDP - Shock Indicated - When the DualMax identifies a rhythm that is liable to shock. RESP - Apnea - When the DualMax identifies lack of respiration for a period of time longer than that set in the Adjustments menu.
  • Page 51 Min. 50 mmHg Technical alarm (medium priority) Sound and visual signals indicate that the DualMax is not able to accurately monitor the patient's status. The technical alarm indications are shown in the information bar (see item "Information bar"). In addition to the technical alarm conditions indicated in the information bar, the are two more conditions: "bad contact"...
  • Page 52 If the equipment has different alarm priorities simultaneously occurring, the high priority alarm will overlap the medium priority. The DualMax maintains the previous alarm settings in case of shutdown for a period of 30 seconds or less. After this time, the equipment returns automatically to the...
  • Page 53 HIGH PRIORITY When the BPM is below the value set on the below the limit. alarm configuration. Asystole. HIGH PRIORITY DualMax cannot detect valid beats for more than 4 seconds. Shock Indicated. HIGH PRIORITY Ventricular fibrillation/ventricular tachycardia(VF/VT) was identified. Pacemaker detected - Represented by a white vertical line at the point of the ECG curve, where the pacemaker pulse is detected.
  • Page 54 User manual | Alarms and limits (↑) RESP - RPM HIGH PRIORITY When the RPM is above the value defined on above the limit. the alarm configuration. (↓) RESP - RPM HIGH PRIORITY When the RPM is below the value defined on below the limit.
  • Page 55 - Artifact. MEDIUM PRIORITY Yellow Muscle tremor detected. Weak signal. MEDIUM PRIORITY Yellow DualMax cannot identify the signal. Weak signal, possibly patient with low perfusion. Loss of pulse. HIGH PRIORITY Patient without heartbeats for more than 4 seconds. (↑) SPO...
  • Page 56 User manual | Alarms and limits (↑) NIBP - Mea HIGH PRIORITY Mean pressure value is above the value set in above the limit. the alarm setting. (↓) NIBP - Mea HIGH PRIORITY Mean pressure value is below the value set in below the limit.
  • Page 57 Adhesive pads - DualMax detected adhesive pads connected. Adult pads - DualMax detected adult pads connected. Children pads - DualMax detected paddles connected, but the adult electrode is disconnected. The same message is also exhibited when DualMax detects children adhesive pads.
  • Page 58 User manual | Alarms and limits Pacemaker Alarm Priority Color Possible cause Connect MEDIUM PRIORITY YELLOW Adhesive paddles are disconnected. adhesive pads. Informative message PM: Pause - The outbreak of pacemaker pulses is paused. PM: On - The outbreak of pacemaker pulses is on. Mode: Asynch - The pacemaker is in asynchronous mode.
  • Page 59 "audio paused" icon in all parameters. Configuration of alarm limits The DualMax maintains the previous alarm settings, in case of turning off for a period of 30 seconds or less. After this time, the device automatically returns to the...
  • Page 60 User manual | Alarms and limits To change the alarm limits, the user must select the "ALARMS" menu. Then must press the "Edit" button to access the desired parameter.
  • Page 61 User manual | Alarms and limits After editing an alarm, to return to the alarms menu, only select the button present on the alarm configuration screens of each parameter. Minimum / Maximum limits adjustment The adjustment of minimum and maximum values is done individually on each parameter by using the e-Jog Control.
  • Page 62 User manual | Alarms and limits : it is possible to adjust the minimum CO alarm to levels between 18 and 96 mmHg, with intervals of 3 mmHg in "adult" mode and intervals of 1 mmHg in "neo" mode. It is possible to set the maximum CO alarm to levels between 21 and 99 mmHg, with intervals of 3 mmHg in "adult"...
  • Page 63 User manual | Alarms and limits Physiological alarm test To perform the alarm test do the following steps: 1 - Turn on the equipment, with the electrodes properly connected. Verify the BPM value on the equipment screen and that there are no alarms. 2 - Through the e-Jog Control key on the panel, navigate to: PARAMETER CONFIGURATION >...
  • Page 64 Shock). These impulses are used to eliminate arterial, ventricular fibrillation, and ventricular disturbances. Warnings The DualMax has a patient impedance meter that delivers shocks in 25 to 300 Ohms impedances. If a cable or conductor is suspected of being ruptured, avoid using the equipment due to possible risk to the operator.
  • Page 65 User manual | Defibrillator mode Use criteria In defibrillation mode, the DualMax must only be used if the following circumstances, as a whole, are presented: 1 - Unconscious victim. 2 - No breathing. 3 - No pulse. Other important considerations regarding the use of the DualMax: 1 - Not recommended for children under one year old.
  • Page 66 Defibrillator mode External pads use 1 - Verify if the pads are connected to DualMax. If they are not, connect the defibrillation cable to the pads socket located on the equipment’s side. (according to the image). Press the quick release connector.
  • Page 67 User manual | Defibrillator mode The electrodes must be placed in a position which will maximize the current that passes through the myocardium. The standard position is: a) Electrode identified as “STERNUM” on the right second intercostal space, mid- clavicular line. b) Electrode identified as “APEX”...
  • Page 68 About shock delivery Aligning the pressure of the pads and the conductive material applied to the electrodes, different patient impedances are obtained. The table below indicates the conditions in which the DualMax offers or inhibits the delivery of energy. Patient's...
  • Page 69 2 - Pull the pads base forward to remove them. 3 - This exposes the smaller electrode for children. Adult Child The DualMax will automatically identify that it is operating in pediatric mode. Energy is limited to 50 J in the pediatric mode.
  • Page 70 User manual | Defibrillator mode Using multifunction pads The use of the multifunction pads (disposable) requires that the operator uses the adapter provided (extension cable) in order to connect them to the standard socket of the external pads, as described below: 1 - Connect the AED/pacemaker extension cable to the equipment.
  • Page 71 Press the “Charge” button (green) in the front panel or use the charge button in the external pads (orange). While the DualMax is charging, a sound will be emitted and the measurement of the charged energy will appear on the display.
  • Page 72 Follow steps 1-2-3 for defibrillation. IMPORTANT: Keep key 3 (shock) or the two shock pads’ buttons pressed until the next “R” wave is identified. The DualMax will deliver the shock when the next “R” wave is identified. IMPORTANT: If DualMax does not identify a valid QRS it will not trigger the shock! For this reason, do not use the cardioversion in Ventricular Fibrillation rhythms.
  • Page 73 User manual | Defibrillator mode Disarm key Disarm the stored charge. Charge may be disarmed at any time, whether the charge is ready or not. Defibrillation display: 1 - Elapsed time Indicates how long the equipment has been used for. The marker returns to zero if the equipment is turned off.
  • Page 74 User manual | Defibrillator mode During the equipment's charging cycle, the value of the energy that has already been stored is displayed in RED. When the charge is complete the numbers are displayed in RED and blink, indicating the equipment is ready and the shock can be delivered.
  • Page 75 User manual | Defibrillator mode Defibrillation setup 1 - Internal discharge time Determines how long the equipment keeps the charge ready before discharging it internally. 2 - Back/Exit “BACK” to configuration menu or “EXIT” to go to the monitoring screen.
  • Page 76 User manual | Defibrillator mode Auto-sequencing configurations 1 - First shock Sets energy levels for the first shock of the Auto Seq mode. The user can select energy levels from 10 to 360 J. Preset values are 150 J for the first shock and 200 J for the next shocks.
  • Page 77 User manual | Defibrillator mode 3 - Third shock Sets energy levels for the third shock of the Auto Seq mode. The user can select energy levels from 10 to 360 J. Preset values are 150 J for the first shock and 200 J for the next shocks.
  • Page 78 Given the complexity of clinical variables involved, for many years only doctors and experienced paramedics could use defibrillators to reverse a cardiac arrest. Nowadays, however, with the evolution of artificial intelligence (AI), the DualMax, using its Neural Network Technology, is capable of assessing, via sophisticated sensors, the patient’s state, consider the clinical variables and deliver automatically...
  • Page 79 Shock). These impulses are used to eliminate arterial, ventricular fibrillation, and ventricular disturbances. Warnings The DualMax has a patient impedance meter that delivers shocks in 25 to 300 Ohms impedances. If a cable or conductor is suspected of being ruptured, avoid using the equipment due to possible risk to the operator.
  • Page 80 User manual | AED mode Use criteria In defibrillation mode, the DualMax must only be used if the following circumstances, as a whole, are presented: 1 - Unconscious victim. 2 - No breathing. 3 - No pulse. Other important considerations regarding the use of the DualMax: 1 - Not recommended for children under one year old.
  • Page 81 Before starting the operation, call the emergency service. Step 1 - Connect disposable pads to the DualMax If the disposable pads have not been connected to the DualMax yet, attach the connector to the plug on the right side of the equipment.
  • Page 82 User manual | AED mode Step 2 – Apply pads to patient Sternum Apex 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 83 Analyzing heart rhythm... Rotate the selector switch to the "AED" position. The DualMax will automatically enter cardiac rhythm analysis mode and will start giving vocal instructions clearly and pausedly, so that the user can perfectly understand them. ATTENTION: the patient must be on a steady surface. Any movement during the process of clinical analysis will result in mistaken scans.
  • Page 84 For adult electrodes: 1st shock is 150 J and the following are 200 J; for child electrodes, all shocks are 50 J. If clinical scans show that defibrillation is not recommended, the DualMax will announce: “TREATMENT NOT RECOMMENDED”. Check if there was no movement of the patient during the analysis. If so, restart the process.
  • Page 85 User manual | AED mode Step 5 - Start CPR 2 min After the shock, start the CPR procedure. 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.
  • Page 86 6) Keep your arms stretched. Put pressure on the victim’s thorax, compressing the chest and then releasing it. Follow the BEEPS emitted by the DualMax, which mark the rhythm of the compressions. Every 30 compressions, apply 2 mouth-to-mouth ventilations.
  • Page 87 Using the DualMax on children under 8 years old The DualMax 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 40 Kg, some precautions must be taken: •...
  • Page 88 It is recommended that this check is done by a qualified technician, during preventative maintenance (see "Inspection and maintenance"). Information signals DualMax AED mode has information signals that can be visual, audio and verbal. VISUAL INFORMATION SIGNAL DESCRIPTION Patient BPM Number of heart beats per minute of the patient detected by the equipment.
  • Page 89 User manual | AED mode AUDITIVE INFORMATION SIGNAL (BEEP) DESCRIPTION Metronome for CPR compressions The equipment beeps at a frequency of 100 beeps per minute, helping the user in performing the cardiac compressions. The equipment also has verbal information signals. The differentiation of verbal information signals and verbal alarm signal is given in two ways: Sound power Verbal information signals will always be at least 6 dB(A) below the set to the alarm...
  • Page 90 To turn off the equipment, simply press the ON/OFF button for 3 seconds. The parameter will be automatically turned off on the DualMax screen. Using the CPR Maestro 1 – Connect the CPR Maestro to DualMax, using the input indicated below, located on the side of the equipment.
  • Page 91 User manual | CPR Maestro 2 – Place the device on the patient’s chest, according to the image below. This step is important and must always be followed. When the equipment is initialized, the CPR sensors are calibrated, enabling the evaluation of the compressions.
  • Page 92 User manual | CPR Maestro patient's chest, where the compressions will be performed. If yes, press the ON/ OFF button again and start the compressions. Feedback The user receives CPR feedback in the following ways: Message and CPR image on DualMax screen.
  • Page 93 User manual | CPR Maestro 1. CPR indicative graphic. 2. Messages. • CPR indicative graphic on the CPR Maestro screen. • Audio message.
  • Page 94 User manual | CPR Maestro Messages The following messages can be displayed during the CPR Maestro use: Compress harder: the rescuer did not reach the minimum depth required which is of 50 mm. Allow full chest expansion: the rescuer is not allowing the patient's chest to return to total relief position.
  • Page 95 User manual | CPR Maestro 3. Chest full expansion indicator: when 7. Frequency indicative bar: indicated filled with the color green indicates that the frequency of the compressions. the chest returned to the initial position When aligned with the red rectangles, of the compressions.
  • Page 96 (mA). The pacemaker works in two modes: fixed or on demand (synchronous). Warnings The DualMax has a patient impedance meter that delivers shocks in 25 to 300 Ohms impedances. If a cable or conductor is suspected of being ruptured, avoid using the equipment due to possible risk to the operator.
  • Page 97 PPM number defined by the user. Demand mode (synchronous) In this mode the DualMax assesses the patient's heart rate, applying the PPM number selected in the panel only when the heart rate is lower than the PPM value indicated.
  • Page 98 User manual | Pacemaker mode Operating in pacemaker mode Place the selector switch on pacemaker mode. The screen below will appear. With the e-Jog, navigate on the yellow area to configure the pacemaker's parameters. 1. Changes between “PAUSE” and “ON” in the Pacemaker mode. In “PAUSE” mode, it does not emit any stimulation.
  • Page 99 User manual | Pacemaker mode Starting stimulation 1 - If it not yet connected, connect the adhesive pads cable to the DualMax. 2 - Check if the multifunction adhesive pads package is intact and within the expiration date. 3 - Insert the adhesive pads connector into the equipment's extension cable.
  • Page 100 The stimulated pulses will be applied in the asynchronous mode if there is a connection problem with the ECG monitoring electrodes or if the DualMax does not identify a valid QRS. Defibrillation If defibrillation is necessary, turn the switch to defibrillation mode. The DualMax automatically inhibits the pacemaker's stimulation pulse.
  • Page 101 “R” waves. Using this measurement, it is possible to determine the beats per minute (BPM). Warnings Use only original Instramed cables and conductors. Other ECG cables may impede defibrillation or not work correctly. If you suspect a cable or conductor is ruptured, avoid its use due to possible risk to operator.
  • Page 102 User manual | Monitor mode - ECG Monitoring ECG 1 - Connect the ECG cable into the ECG socket in the equipment's side panel. 2 - Select the electrodes to be used on the patient. Use only one kind or brand of electrode.
  • Page 103 LA - (LL+RA) LL - (LA+RA) C (V1 - V6) C - (RA+LA+LL) Color patterns There are two color patterns for ECG cables. The DualMax uses the IEC pattern. See the table below. Position IEC (European) AHA (American) Right Arm...
  • Page 104 User manual | Monitor mode - ECG Operating in monitor mode - ECG Turn the selector switch to the Monitor mode. All ECG and SpO alarms will be enabled. The next screen will be displayed. 1. ECG numeric value and BPM 5.
  • Page 105 User manual | Monitor mode - ECG ECG Setup - Principal 1 - ECG response Select the ECG numeric update response. You can select from “SLOW, “NORMAL” and “FAST” responses. NORMAL: used for most patients, this mode uses 16 beats to define the average. FAST: used when the operator needs faster responses.
  • Page 106 User manual | Monitor mode - ECG 3 - Detect pacemaker Enables to turn the pacemaker detection mode on or off. When on, the equipment indicates on the screen the pacemaker’s pulse moment. Detect pacemaker mode must only be used on patients with pacemaker. 4 - Amplitude Selects the gain of the ECG amplification stage.
  • Page 107 User manual | Monitor mode - ECG ECG configurations - Alarm 1 - Alarm sound Selection of ECG alarm status: active sound and disabled sound. 2 - Maximum limit Selection of ECG alarm maximum limit. 3 - Minimum limit Selection of ECG alarm minimum limit. 4 - Alarm sound Selection of ST alarm status: active sound and disabled sound.
  • Page 108 Monitor Mode, the DualMax will freeze 1/3 of the screen and will keep displaying, in real time, the curves on the rest of the space. Additionally, the DualMax will calculate the intervals QT, QTc, QRS, BPM and PR to help the cardiologist.
  • Page 109 User manual | Monitor mode - ECG NOTE For better calculation of ECG complex intervals, ECG electrodes must be positioned correctly, also avoiding noise. The COMPLEX key will be disabled in MODE 12 DERIVATIONS, or when there is a LOOSE ELECTRODE, or when using the 3-lead CABLE. If the clinical operator intentionally disconnects the ECG, SpO defibrillation module, it will appear the message ECG: COMMUNICATION ERROR, SpO...
  • Page 110 Do not place armband on limb or extremity which is being used for intravenous infusion, or in any area where circulation is compromised. The DualMax shows the results of the last NIBP measurement until a new measurement is obtained. If the patient’s conditions change between measurements, the monitor will not detect it.
  • Page 111 User manual | Monitor mode - NIBP Monitoring Non-Invasive Pressure 1 - Connect the end of the extension hose to the equipment’s non-invasive pressure connector. 2 - Measure the limb in which the armband will be applied to and select an adequate type.
  • Page 112 1, 2, 3, 4, 5, 10, 15, 30, 60, 90 minutes. Interrupting NIBP measurements: to cancel an ongoing pressure measurement, press “NIBP MANUAL MEASUREMENT”, located in the equipment’s front panel. The DualMax does not offer a short-term automatic measurement option.
  • Page 113 User manual | Monitor mode - NIBP NIBP numeric indicator 1. Numeric values for systolic/diastolic 3. Maximum and minimum alarm values. and mean pressures. 2. Icon “BELL” - Indicates if audio is active, paused or turned off. NIBP setup - Principal...
  • Page 114 1 - Manual measurement Start a NIBP manual measurement. 2 - NIBP On/Off Enables or disables the DualMax’s NIBP function. 3 - Automatic measurement Starts the NIBP automatic measurement mode. When selecting this function, a measurement is immediately exerted. Posterior measurements will be exerted in the time set by the user.
  • Page 115 User manual | Monitor mode - NIBP NIBP configurations - Alarm 1 - Alarm Selection of alarm status: active sound and disabled sound. 2 - Maximum limit - Systole Selection of systole alarm maximum limit. 3 - Minimum limit - Systole Selection of systole alarm minimum limit.
  • Page 116 User manual | Monitor mode - NIBP 6 - Maximum limit – Average Selection of average pressure maximum limit. 7 - Minimum limit – Average Selection of average pressure minimum limit. 8 - Previous page Returns to previous page on NIBP menu. 9 - Back/Exit “BACK”...
  • Page 117 Monitor mode - SpO Physics principle used The DualMax measures oxygen saturation on arterial blood by the passage of two light wavelengths through the body tissue, a red one and an infrared one which are detected by a photo-sensor. The oximeter processes these signals, separating invariable parameters (thickness...
  • Page 118 User manual | Monitor mode - SpO Factors which affect the SpO measurement’s precision • Incorrect use of the sensor. • Anemia. • Use of vasoactive drugs. • Patient in shock or cardiac arrest. • Significant number of dysfunctional hemoglobins. •...
  • Page 119 User manual | Monitor mode - SpO Operating in monitor mode - SpO Select the selector switch to Monitor mode. All ECG and SpO alarms will be enabled. The following screen will be displayed. 1. SpO numeric value. 6. Perfusion - Measurement value in percentage.
  • Page 120 User manual | Monitor mode - SpO setup - Principal 1 - SpO (On/Off) Allows to turn the parameter monitoring on or off. 2 - SpO response Selects the SpO numeric update response. You can select among the SLOW, NORMAL and FAST options. NORMAL: used for most patients.
  • Page 121 User manual | Monitor mode - SpO 5 - Back/Exit “BACK” to the configuration menu or “EXIT” to monitoring screen. SpO2 configurations – Alarm 1 - Alarm sound Selection of alarm status: active sound and disabled sound. 2 - Maximum limit Selection of BPM and SpO saturation alarm maximum limit.
  • Page 122 The microstream method is used in intubated or non-intubated patients. A sample of the gas exhaled by the patient is collected by cannulas and sent to the Microstream chamber and sensor inside the DualMax. CO measurement is based on the characteristics of laser absorption by CO molecules.
  • Page 123 “auto- zero”, which is necessary for the proper functioning of the equipment. During this procedure, no measurements are exerted. The DualMax can monitor EtCO in intubated or non-intubated patients. To do so, you just need to change the following accessories.
  • Page 124 User manual | Monitor mode - Capnography Sampling line The sampling line collects a sample of the gas released by the patient. In intubated patients the sampling line is directly connected into the circuit via the “T” connector. In non-intubated patients the sampling line is connected to the cannula and positioned on the patient.
  • Page 125 User manual | Monitor mode - Capnography EtCO setup - Principal 1 - CO On/Off Turns the CO module on or off. When on, the sampling pump is also operating. The numeric values, graphs and CO alarms will be activated. 2 - Units Selects the measuring units of the CO values.
  • Page 126 User manual | Monitor mode - Capnography 4 - Calibration The equipment is calibrated using a known gas sample, thus configuring its measuring curve. IMPORTANT: calibration must be performed when the equipment shows a message requiring this procedure during initialization. Calibration must be performed by QUALIFIED TECHNICAL PERSONNEL.
  • Page 127 User manual | Monitor mode - Capnography EtCO2 configurations – Alarm 1 - Alarm sound Selection of alarm status: active sound and disabled sound. 2 - Maximum limit Selection of EtCO alarm maximum limit. 3 - Minimum limit Selection of EtCO alarm minimum limit.
  • Page 128 Monitor mode - Respiration Physics principle used The respiration waveform is generated by the measurement of the patient’s bioimpedance. By means of a high frequency signal, which is applied to two electrodes (RA and LA), the thoracic impedance variation caused by the effort of breathing is detected and displayed on the monitor, in graph and numeric forms.
  • Page 129 User manual | Monitor mode - Respiration Respiration monitoring The breathing signal is obtained by ECG electrodes. For more information o connections see the “ECG monitoring” chapter. In order to improve breathing performance, you can change the position of the ECG electrodes, opting for alternative places.
  • Page 130 User manual | Monitor mode - Respiration Respiration numeric indicator 1. Numeric value of the respiration, 3. Maximum and minimum alarm values. measured in rpm. 2. Icon “BELL” - Indicates if audio is active, paused or turned off.
  • Page 131 User manual | Monitor mode - Respiration Respiration setup Using the e-Jog select the respiration function in the setup menu to access the respiration setup sub-menu. 1 - Respiration monitoring On/Off When turned off, all visual and sound alarms will be inhibited and there will be no numeric indication for respiration.
  • Page 132 User manual | Monitor mode - Respiration 6 - Back/Exit “BACK” to Configuration menu or “EXIT” to monitoring screen. Respiration configurations – Alarm Using the e-Jog, select the function respiration on the configuration menu to have access to thesubmenu of repiration configurations. 1 - Alarm Selection of alarm status: active sound and disabled sound.
  • Page 133 Temperature monitoring Physics principle used The temperature is determined by measuring the resistance of the temperature sensor - a device called a thermistor whose impedance varies according to temperature. The sensor signal is picked up by the input circuit that processes the signal and converts to values expressed as degrees Celsius (°C) or Fahrenheit (°F).
  • Page 134 User manual | Temperature monitoring Monitoring temperature The DualMax uses YSI 400 standard temperature sensors. The sensors can be for esophagus, rectum, skin, surface or temperature in the airways. In each type of sensor are found instructions for its proper use and maintenance.
  • Page 135 User manual | Temperature monitoring Temperature configurations – Principal 1 - Temperature 1 Turns the channel 1 temperature monitoring on or off. When turned off, all visual and sound alarms are disabled e there is no numeric indication for this parameter. 2 - Temperature 2 Turns the channel 2 temperature monitoring on or off.
  • Page 136 User manual | Temperature monitoring Temperature configurations – Alarms 1 - Temperature 1 alarm Selection of channel 1 temperature alarm status: active sound and disabled sound. 2 - Maximum limit (temperature 1) Selection of channel 1 temperature alarm maximum limit. 3 - Minimum limit (temperature 1) Selection of channel 1 temperature alarm minimum limit.
  • Page 137 User manual | Temperature monitoring 6 - Minimum limit (temperature 2) Selection of channel 2 temperature alarm minimum limit. 7 - Previous page Returns to the previous page of the temperature menu. 8 - Back/Exit “BACK” to the configuration menu or “EXIT” to monitoring screen.
  • Page 138 Invasive pressure monitoring Physics principle used The most accurate way to measure blood pressure is through the invasive method. This method is performed by means of a catheter inserted into the artery, which is connected to a liquid column. The pressure measurement is obtained through a pressure transducer.
  • Page 139 User manual | Invasive pressure monitoring IP numeric indicator 1. Channel P1 invasive pressure 4. Channel P2 invasive pressure numeric value. SYSTOLE/DIASTOLE numeric value. SYSTOLE/DIASTOLE (AVERAGE). (AVERAGE). 2. Channel P1 “BELL” Icon - Indicates if 5. Channel P2 “BELL” Icon - Indicates if audio is active, paused or off.
  • Page 140 User manual | Invasive pressure monitoring IP configuration - Principal 1 - 60 Hz filter Selection of mains interference filter for both pressure channels. 2 - Channel 1 On/Off Turns the channel 1 invasive pressure on or off. 3 - Channel 1 scale Changes the scale of the channel 1 invasive pressure.
  • Page 141 User manual | Invasive pressure monitoring 6 - Channel 2 On/Off Turns the channel 2 invasive pressure on or off. 7 - Channel 1 scale Changes the scale of the channel 1 invasive pressure. 8 - Channel 1 clear transducer Clears the channel 1 invasive pressure transducer.
  • Page 142 User manual | Invasive pressure monitoring e. Measuring blood pressure in the arm on the same side of a mastectomy can cause measurements to be inaccurate. In this case, use the contralateral arm. f. Pressurization of the ARMBAND may cause temporary loss of function of the equipment being used on the same limb.
  • Page 143 User manual | Invasive pressure monitoring IP configurations – P1 alarms 1 - IP alarms 1 Selection of channel 1 alarm status: active sound and disabled sound. 2 - Maximum limit - Systole Selection of systole alarm maximum limit for channel 1. 3 - Minimum limit - Systole Selection of systole alarm minimum limit for channel 1.
  • Page 144 User manual | Invasive pressure monitoring 7 - Minimum limit - Average Selection of average alarm minimum limit for channel 1. 8 - Previous page Returns to the previous page of the IP menu. 9 - Next page Displays the next screen of the IP menu. 10 - Back/Exit “BACK”...
  • Page 145 User manual | Invasive pressure monitoring IP configurations – P2 alarms 1 - IP alarms 2 Selection of channel 2 alarm status: active sound and disabled sound. 2 - Maximum limit - Systole Selection of systole alarm maximum limit for channel 2. 3 - Minimum limit - Systole Selection of systole alarm minimum limit for channel 2.
  • Page 146 User manual | Invasive pressure monitoring 7 - Minimum limit - Average Selection of average alarm minimum limit for channel 2. 8 - Previous page Returns to the previous page of the IP menu. 9 - Back/Exit “BACK” to the configuration menu or “EXIT” to monitoring screen.
  • Page 147 User manual | Invasive pressure monitoring Transducer connection and calibration accessories ATTENTION: before monitoring the pressure, the system must be reset. CAUTION: before connecting, make sure the connectors are dry and free of contaminated substances. Assemble the transducer connections and the disposable kit in the operating position, with the zero-adjustment tap at the patient level, according to the rules or procedures of the hospital.
  • Page 148 ST segment Relation between ST elevation and myocardial infarction Acute myocardial infarction is a necrosis process of part of the cardiac muscle due to the interruption of blood flow in the coronary arteries. Early diagnosis is a key factor in reducing mortality and possible sequelae for the patient. One of the most precise forms for this diagnosis is the identification of anomalies on ST elevation, which can be identified in the electrocardiogram (ECG) evaluation.
  • Page 149 User manual | ST segment ST elevation characterization The waves recorded on the ECG are identified by the points ranging from P to T, as shown in figure 1. The ST segment begins at the point at which the set Q-R-S ends, presenting upward curve in a normal situation.
  • Page 150 ST segment ST levels detection The DualMax has internal algorithms for measuring ST levels. It will be measured seven ST segments of DI, DII, DIII, aVR, aVL, aVF and C derivations. These 7 ST gradients will be shown on the screen at the right end of each curve.
  • Page 151 User manual | ST segment Turning ST segment on and off The ST segment monitoring can be turned on or off through the item “ST” on the ECG configurations screen (see item “ECG configurations - principal”). 1. Turns the ST segment monitoring on or off.
  • Page 152 User manual | ST segment ST configurations – Alarms 1 - ST alarms Selection of ST alarm status: active sound and disabled sound. 2 - Maximum limit Selection of ST alarm maximum limit. 3 - Minimum limit Selection of ST alarm minimum limit. 4 - Previous page Returns to the previous page of the ECG menu.
  • Page 153 Event and data storage Data storage The DualMax creates an event list for each patient observing the following criteria: Automatically - If DualMax stays turned off for 30 seconds more. Manually - Via the events setup menu. The equipment stores data from up to 100 patients and 800 generated events. In each event it will be stored the ECG curve 12 seconds before and 12 seconds after the event generation.
  • Page 154 User manual | Event and data storage Patient configurations 1 - Insert new patient Manual generation of a new patient. 2 - Patient number Value between 1 and 100 automatically generated for each new patient. 3 - Name Allows to change the patient's name through the keyboard displayed on screen. See item "Keyboards"...
  • Page 155 User manual | Event and data storage 6 - Register number Allows to edit the patient’s register number, using the keyboard displayed on screen. 7 - Back/Exit “BACK” to the configuration menu or “EXIT” for the monitoring screen. Mark events The "Mark events"...
  • Page 156 User manual | Event and data storage PERSONALIZED EVENTS Allows to mark or edit up to 10 personalized events. VIEW EVENTS Allows to view, print and transfer the generated events.
  • Page 157 User manual | Event and data storage 1 - Patient selected Allows to select the patient whose events will be displayed. 2 - Transfer patient data Tranfers the stores events data to a pendrive. 3 - Print Prints data regarding the selected event or a list of all events of the patient selected. The printing will show 12 seconds of curve before the event and 12 seconds after the event.
  • Page 158 User manual | Event and data storage Keyboards Personalizable information from the events menu (such as patient name, age and personalized events) are edited with the help of the keyboards below, according to the selected field:...
  • Page 159 Instant printing When the print button is pressed for LESS than three seconds, the DualMax prints a fast report. The fast report prints the same curves being displayed at the moment. The numeric indicators for the following parameters are: date/time, trace speed and number of shocks.
  • Page 160 Instant printing Continuous printing When the print button is pressed for MORE than three seconds, the DualMax prints a continuous report for an indeterminate period of time or until printing is interrupted. The data in the continuous report is identical to the data in the quick printing.
  • Page 161 2 - Shock printing When the shock printing option is enabled (in the printing setup menu), the DualMax prints an instant report whenever the equipment identifies shock delivery. In this report you can see the equipment’s operation mode at the moment of the defibrillation: MANUAL mode, SYNC mode and AED mode.
  • Page 162 User manual | Printing 3 - Paper size Shows the selected size of the report to be printed. Large = length 30 m. Medium = length 23 m. Small = length 14 m. 4 - Electrocardiograph function To print a 7-lead electrocardiogram use the print Electro function, in the printing setup menu.
  • Page 163 Functional test General The functional test must be executed daily in order to guarantee that the equipment is in working order and ready to use. Performing the functional test To perform the functional test, simply click on the TEST shortcut, or go to the menu and select the "TEST FUNC"...
  • Page 164 NOTE: the option of printing the test results will only be available in the DualMax units equipped with printer. NOTE: the DualMax indicates failure in the functional test when there is a failure in one of the 4 steps of the functional test or when the power delivered has an energy exceeding that allowed by standards.
  • Page 165 This function allows you to program up to three different times for the device to carry out a self-diagnosis of defibrillation, battery level, connected paddles, and verification of the device's connection to the power outlet. RTC Operation on DualMax The configurations for the RTC function can be accessed through the menu CONFIGURATION > RTC.
  • Page 166 Automatic test To perform the automatic test, the equipment should be turned off at the programmed time. At the configured time, the DualMax will automatically turn on and begin the test, composed of the following steps: • Test of the connection with the ECG board.
  • Page 167 10 seconds. After this procedure, the device will save the collected data and return to the mode defined by the rotating switch on the DualMax. Error BEEPS When there is an error in the last RTC test, the equipment emits three beeps in sequence, which can be identified by the user from a distance.
  • Page 168 PC connection Introduction The DualMax can be connected to a PC, allowing the user access to new functions • 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 169 If the autorun does not start automatically, find the “softdeasetup.exe” file in the CD and double-click it. • Follow the installation instructions which will show up on the screen. Connecting the DualMax to a PC • Connect the equipment only after installing SoftDEA. •...
  • Page 170 User manual | PC connection Startup screen 1 - DualMax services initialization button Press this button to initialize the device’s configuration screen and display of ECG curves and stored events on the device.
  • Page 171 User manual | PC connection SoftDEA language selection screen 1 - Buttons of SoftDEA language selection Click on the language option chosen. A warning message will appear, confirm clicking “OK”. Wait for the program to be closed and reopen it.
  • Page 172 User manual | PC connection Graphics generated by AED mode 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.
  • Page 173 PDF of all events. 6 - Event viewer window After downloading the information contained in the DualMax memory, the list of events stored by the device will be displayed in this area in chronological order.
  • Page 174 Information regarding the analyzed patient. 2 - Event view window After downloading the information contained in the DualMax memory, this area will display the list of events stored by the device, in chronological order. To view an event on the main screen, double-click it.
  • Page 175 The RTC software runs in the background, with the minimized system awaiting a device to communicate with the "Real Time Check Control Center". The DualMax can be configured to perform self tests at times specifically configured by the user. The device will send the results of the following tests to the RTC system: •...
  • Page 176 User manual | PC connection To see the software's main window, just click on the heart icon. This window will also be shown when receiving data via USB. 1 - E-mail configurations Click on this icon to open the e-mail configurations screen. On this screen, it is possible to configure the sender, recipient and enable or disable sending e-mails when the software receives equipment tests.
  • Page 177 User manual | PC connection "E-mail to send" tab A. Selected tab. F. Confrms and saves the completed data. B. Opens the sender data tab. G. Cancels changes and closes the e-mail C. Field for entering the recipient's confgurations window. address.
  • Page 178 User manual | PC connection "Sender Data" tab A. Opens the "E-mail to send" tab. G. Select if the server requires an encrypted connection (SSL) or not. B. Selected tab. H. Confirms and saves the completed C. Field for entering the sender's address. data.
  • Page 179 User manual | PC connection 2 - Reading log of the equipment Click on this icon to check the test logs stored in the system. A. Filter selection area. Allows you to D. Log display area. This contains select the criteria for displaying logs. information about the tests conducted with the filters applied.
  • Page 180 User manual | PC connection Log details Double-clicking on any line of the log will open a second window with more details. Report To open this screen, click on the "Report" button. A complete report of the selected log will be generated. It is possible to save the content in Word or Excel, as well as print it.
  • Page 181 User manual | PC connection 3 - Options Click to open the options screen. On this screen, it is possible to change the RTC software language and program the device communication check. NOTE: the system should be restarted for the changes to take effect. "Language"...
  • Page 182 User manual | PC connection "Check device communication" tab. A. Opens the "Language" tab. D. Confirms and saves the configurations. B. Selected tab. E. Cancels changes and closes the window. C. Field for entering the time to perform the device communication check. The system will perform a check at the selected time.
  • Page 183 User manual | PC connection 4 - Backup Click on this icon to select between the options "Save data files" and "Restore data files." If a data file is lost, it is possible to restore the information from the last saved file. When restoring, all of the data obtained after the last backup file was saved will be lost.
  • Page 184 User manual | PC connection Receiving data When the DualMax performs the RTC test, the results will be sent to the control center and shown on the screen, along with the MAC ID code of the device. Closing the application...
  • Page 185 Functional tests must 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 representative, otherwise this Warranty certificate may no longer be valid. No internal parts are to be fixed by the user.
  • Page 186 User manual | Care and maintenance • Keep the cable plugs dry, since a wet plug may cause some kind of failure. For the SPO sensor and cable: • The cleaning process is specified in the accompanying instructions. For the NIBP armband: •...
  • Page 187 If this procedure is not performed, there is a risk of draining the battery and consequently being unable to use the DualMax in its portable configuration (not connected to the electric current). To recharge the battery, connect the monitor to charge the battery, connect the monitor to an AC power source (110 or 220 V outlet) or a DC power source.
  • Page 188 User manual | Care and maintenance Removable battery replacement The battery will automatically detach itself from the equipment as shown in the picture below. 1 - Press the side tabs to unlock the removable battery. 2 - Manually remove the battery from the equipment. 3 - Correctly position the new battery.
  • Page 189 User manual | Care and maintenance Replacing the thermal paper 1 - Press the button to open the printer door. 2 - Remove the old paper bobbin,monitor well. 3 - Place the new bobbin, The bobbin must be positioned as shown in the picture above.
  • Page 190 Care and maintenance Repairs If it is necessary to send the DualMax for repairs or to clarify other doubts, contact Instramed at +55 (51) 30738200 or by the e-mails: assistencia@instramed.com. br and suporte@instramed,com,br. Please, be prepared to inform the equipment’s serial number.
  • Page 191 Instramed as replacement pieces, may result in emission increase or immunity decrease of the equipment. The DualMax must not be used too close to or piled over other equipment. When the equipment is used in a surgical procedure simultaneously with an...
  • Page 192 User manual | Care and maintenance The essential performance of the DualMax is understood as the ANALYSIS of the patient's heart rate, the DEFIBRILLATION, CARDIOVERSION and PACEMAKER applied to the patient, and the monitoring of the PATIENT in electrocardiogram, oximetry, non-invasive pressure, respiration, and invasive pressure, The performance of the DualMax is designed and verified for the absence of an unacceptable risk.
  • Page 193 Electromagnetic immunity - General Directives and declaration of the manufacturer - Electromagnetic emissions The DualMax 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 194 RF transmitters, it is advisable to consider an electromagnetic site survey, If the measured field strength in the site where the DualMax is used exceeds the level of RF compliance used above, the DualMax should be observed to check if operation is normal, If abnormal performance is observed, additional procedures may be required, such as reorienting or repositioning the DualMax.
  • Page 195 Advisable separation distances between mobile and portable RF communications equipment and the DualMax The DualMax 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 DualMax as recommended below, according to the maximum output power of the communication equipment.
  • Page 196 The DualMax was designed to provide basic safety with RF equipment by the following table: Testing specifications for cabinet interface immunity to RF wire communications equipment The DualMax was designed to provide basic security with RF equipment by the following table: Testing Band...
  • Page 197 Troubleshooting Symptom Probable cause Probable solution - Check connections:the DualMax/Power Cable/ The DualMax does not turn on. There is no electricity. Plug. - Check if is adult pads are connected to the Does not select energy > 50 J. Adult pads identification .
  • Page 198 Quantity Description Code Mains supply power cable (3 pins)*. 5550 Removable battery. 12883 CD of Instramed's manuals and softwares. 25277 Pads set for adult and child external defibrillation paddles. 13202 Quick guide. 13237 When Pacemaker or AED is present Quantity...
  • Page 199 User manual | Accessories When Non-Invasive Blood Pressure (NIBP) is present Quantity Description Code Adult armband (cuff) *. 25900 Description: adult cuff. Armband (cuff) extensor*. 25671 Description: adult cuff extensor. When Invasive Blood Pressure is present Quantity Description Code Utah Medical invasive blood pressure accessories kit*, 79181 consisting of: Organizer.
  • Page 200 User manual | Accessories When PRINTER is present Quantity Description Code White thermosensitive paper bobbin 58 mm x 15 m x 40 mm* 11858 Optional items Disposable adult ECG electrodes*. Description: package (check quantity availability per package) with adult non reusable ECG 21669 electrode.
  • Page 201 Specifications and safety General specifications Dimension with pads: 31 cm (W). 24 cm (D). 30 cm (H). Weight: Device - 5.15 kg (11.35 lbs). Li-Ion battery - 0.60 kg (1.32 lbs). External pads - 0.85 kg (1.87 lbs). Complete set (Li-Ion battery) - 6.60 Kg (15.66 lbs)* *except NIBP, IP, EtCO2, printer and accessories.
  • Page 202 User manual | Specifications and safety RTC - Real Time Check: Defibrillation self-test, battery level, connected pads, power source connection check. Check is performed 3 times which are set in advance. This information is wirelessly transmitted to a PC with RTC System software installed and within range of the network.
  • Page 203 Storage: 10 to 95% RH, without condensation. Altitude: Recommended to use in altitudes lower than 2000 meters. WARNING: if the DualMax is used outside these conditions, 15 through 30 minutes will be required to stabilize the system so that functioning failures do not occur.
  • Page 204 Multifunctional for pacemaker, monitoring and defibrillation (optional). Multifunction extension (optional). NOTE: the adhesive pads provided by Instramed have a biocompatibility certificate in accordance with ISO 10993. External pads size: Adult = 10.3 cm x 8.5 cm (contact area = 81.9 cm²).
  • Page 205 User manual | Specifications and safety Waveform: Truncated exponential biphasic pulse. Waveform parameters adjusted according to the patient’s impedance. Shock delivery: By means of multifunctional pads (adhesive) or defibrillation pads. Defibrillation scales: Adult: 150 and 200 J. Child: 50 J. Adult/children’s selection: Automatic due to the size of the pads.
  • Page 206 Ventricular Tachycardia with several QRS amplitudes and widenings. • Ventricular Fibrillation with several amplitudes. Rhythm classes Specifications Shock - VF The DualMax meets IEC 60601-2-4 requirements for sensitivity > 90%. Shock - VT The DualMax meets IEC 60601-2-4 requirements for sensitivity > 75%. Nonshockable rhythms.
  • Page 207 User manual | Specifications and safety Precision of applied energy: Energy Impedance Accuracy selected 0.8 ±1J 1.9 ±1J 3.2 ±2J 3.9 ±2J 4.9 ±3J 6.0 ±3J 7.0 ±3J 7.7 ±3J 8.8 ±3J 10.2 10.4 10.3 10.2 9.8 ±3J 19.0 20.5 21.0 21.0 20.5...
  • Page 208 User manual | Specifications and safety Values on the Y axis refer to voltage (volts) and values on the X axis refer to time (milliseconds). 360 J of energy at 25 R impedance. 360 J of energy at 50 R impedance.
  • Page 209 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 210 User manual | Specifications and safety 360 J of energy at 150 R impedance. 360 J of energy at 175 R impedance. External pacemaker (optional) Waveform: Single-phase rectangular pulse. Modes: Demand or fixed. Amplitude: Between 5 mA to 200 mA (resolution of 5 mA), precision 10%.
  • Page 211 User manual | Specifications and safety Frequency: Between 30 ppm to 180 ppm (increments of 5 ppm), precision ± 2%. Refractory period: 340 ms (between 30 to 80 ppm). 240 ms (between 90 to 180 ppm). Maximum output voltage: 350 V. Input: ECG patient cable and the corresponding derivations: - 03 leads (optional): DI, DII and DIII.
  • Page 212 User manual | Specifications and safety Electrode error: NO ELECTRODES and a trace line will appear on the display if there is a disconnected cable or electrode. Low ECG amplitude or The “Searching for ECG Signal” message will appear on the saturated ECG signal: screen or printer (electrocardiograph mode) when the ECG 10mm/mV amplitude is less than 2.4 mm peak-to peak (or...
  • Page 213 User manual | Specifications and safety Time to re-establish the ECG ≤ 3 seconds. baseline after defibrillation: Loose electrode: Identified and shown with low level alarm. ECG amplifiers impedance 4.7 MOhms (Mega Ohms). input: ST segment analysis: Performs the ST elevation measurement. Pacemaker rejection Pacemaker Stimuli with width between 0.1 ms and 2 ms, stimulus:...
  • Page 214 User manual | Specifications and safety Tachycardia alarm time: 206 BPM (1 mV): 5 seconds. 206 BPM (0.5 mV): 5 seconds. 206 BPM (2 mV): 5 seconds. 195 BPM (2 mV): 5 seconds. 195 BPM (1 mV): 5 seconds. 195 BPM (4 mV): 5 seconds.
  • Page 215 User manual | Specifications and safety BCI (optional) range: 0 to 100%. Pulse range: 30 to 250 BPM. 's precision: ± 2% (70 to 100%). ± 3% (50 to 69%). Pulse precision: ± 2 BPM. Scan speed: 12.5, 25 and 50 mm/s. Physiological alarm: Alarm not locked.
  • Page 216 User manual | Specifications and safety Capnography (optional) Weight: 160 gr. measurement interval: 0 - 99 mmHg. Precision: ± 2 mmHg (0 - 38 mmHg). ± 5% + 0.08% for each 1 mmHg above 38 mmHg (39 – 99 mmHg). Calibration: 2 points.
  • Page 217 User manual | Specifications and safety CPR Maestro (optional) Accessory for cardiac massage feedback, it presents visual and audible messages guiding the rescuer in relation to the speed and depth of the massage, providing a cardiac massage with greater efficiency. CPR Maestro precision: Depth: ±...
  • Page 218 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 219 (51) 3073 8200...

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