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 CardioMax, 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 CardioMax 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 four and a half hours.
Page 4 Package contents Included items: When opening the package, please check whether all items below are present: • The CardioMax Monitor Cardioverter/Biphasic Defibrillator. • Instruction Manual. • 3-pin professional power cable. • Removable battery. • External defibrillation pads - adult and child.
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 pieces and services please contact Instramed.
Page 6: Table Of Contents
Index Introduction Purpose and application ................... 19 Characteristics ......................19 Optional items ......................20 About the Manual ..................... 20 Safety information Warnings ........................21 Adverse or side effects ..................... 23 Classification and symbols ..................24 Standards ......................... 25 Device care ....................... 26 Connection to other equipment ................
Page 7 User manual | Index 4 - ECG connector ....................31 5 - Printer ......................32 6 - CPR Maestro connector ................. 32 7 - Connector for defibrillation electrodes (pads) ..........32 8 - Capnography exhaust connector ..............32 9 - Capnography connector ................. 32 Rear panel ........................
Page 8 User manual | Index Startup screen ......................38 Parameters visualization screen ................39 Access icons for events and configuration functions ..........40 Monitor mode screen – variation A (ECG and SpO present) ........41 Monitor mode Screen – variation B (ECG, SpO , and NIBP present) ......
Page 9 User manual | Index 8 - RTC ........................ 53 Alarms and limits Physiological Alarm ....................54 Technical Alarm ......................55 Bad contact ....................... 61 Battery charge level: ....................62 Pause audio ......................64 Configuration of alarm limits ..................64 Auto set ........................65 Silence ........................
Page 10 Characteristics ......................84 Physics principle used ....................85 Use criteria ....................... 86 Qualified users ......................86 Operation ........................87 Applying CPR ......................91 Using the CardioMax on children under 8 years old ..........93 Alarm system ......................94 Information signals ....................94...
Page 11 User manual | Index Pacemaker mode Physics principle used ....................96 Warnings ........................96 Fixed mode ....................... 97 Demand mode (synchronous) .................. 97 Operating in pacemaker mode ................. 98 Starting stimulation ....................99 Fixed stimulation ....................... 99 Under demand stimulation ..................100 Defibrillation ......................
Page 12 User manual | Index 9 - Back/Exit ...................... 106 ST segment Relation between ST elevation and myocardial infarction ......................... 107 ST elevation characterization ................. 108 ST segment configuration ..................109 1 - ST segment ....................109 2 - Alarm ......................109 NIPB monitoring Physics principle used ....................
Page 13 User manual | Index Operating in monitor mode - SpO ................ 118 setup ......................119 1 - SpO response ..................... 119 2 - Alarm ......................119 3 - Back/Exit ...................... 119 Monitor mode - Capnography Physics principle used .................... 120 Warnings ........................
Page 14 User manual | Index 3 - Apnea alarm ....................129 4 - Respiration sensitivity .................. 129 5 - Back/Exit ...................... 130 Event and data storage Data storage ......................131 Events stored ......................131 Viewing and managing events ................132 1 - Patient ......................133 2 - Print list ......................
Page 15 User manual | Index RTC - Real Time Check General ........................140 RTC Operation on the CardioMax 8 with transmitter ..........140 Automatic test ......................141 Manual test ......................143 Status of the last test ....................144 Error BIPS ......................144 RTC Operation on the CardioMax 8 without transmitter .........
Page 16 User manual | Index 5 - Amplitude selection ..................155 6 - Time frame ....................155 7 - Time frame scroll ..................155 8 - Amplitude scroll .................... 155 9 - Event viewer window ..................155 Settings ........................156 Changing languages ....................157 Other buttons ......................
Page 17 User manual | Index Replacing the Thermal Paper of the Bixolon Printer ..........173 Returning components ................... 174 Repairs ........................174 Precautions, Restrictions and Warnings ..............175 1 - ECG ......................175 2 - SpO ......................175 3 - Electromagnetic compatibility ............... 175 Electromagnetic emissions ..................
Page 18 User manual | Index ECG analysis algorithm ..................190 Pacemaker ......................196 ECG ........................197 NIBP - Non-Invasive Arterial Pressure ..............199 ........................200 CPR Maestro ......................201 GSI Printer ......................201 Bixolon Printer ......................202 Respiration ......................202 Capnography ......................202 Warranty Certificate XVIII XVIII...
Page 19: Introduction
The RESP/Monitor mode displays the respiratory rate measured by ECG electrodes or by the capnograph. Characteristics The CardioMax is a modern, practical, lightweight, compact and portable device that can be used in emergency situations. The CardioMax offers the following parameters and/or characteristics (some parameters are optional): •...
Page 20: Optional Items
About the Manual This guide explains the functioning of the CardioMax defibrillator/monitor series , alerting the user to possible safety risks. This manual is part of the CardioMax 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 21: Safety Information
• Excessive hair or wet skin in the application area of the electrodes. • Pieces of clothing between skin and pads. CardioMax does not have support system and its carrying handle must not be used for this purpose. This equipment does not have reminder signals.
Page 22 It must be accompanied by constant analysis of the patient’s clinical status and symptoms. WARNING: The use of the CardioMax is restricted to one patient at a time. NOTICE: The applied parts (electrodes, sensors, armbands, etc.) are protected against defibrillation discharge;...
Page 23: Adverse Or Side Effects
User manual | Safety information WARNING: CardioMax should not be used too close to or over other equipment. If this is necessary, it is recommended that the equipment or system be observed to verify the normal operation in the configuration in which it will be used.
Page 24: Classification And Symbols
User manual | Safety information Possible DISCOMFORT and REDUCED BLOOD CIRCULATION in NIBP measuring. The operator should always ensure that the applied pressure or the quantity of measures did not effect in the blood circulation or discomfort to the user. In this case, the quantity of measures should be decreased and the arm should be changed.
Page 25: Standards
Catalog number Date after which the product cannot be used Standards CardioMax 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 26: Device Care
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 27: Connection To Other Equipment
Safety information Connection to other equipment When connecting the CardioMax 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 28: The Equipment
The equipment Front panel 1. LCD screen. 5. E-Jog Control: equipment general configuration. 2. Transport handle. 6. Power and battery charging indicators 3. Selector switch: turns the equipment (see “power and charging indicators” in on and off. Selects the operation mode this chapter).
Page 29: Screen
“Screen and operation” section. e-Jog Control The e-Jog Control is used to access all of the CardioMax'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 30: 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 CardioMax is inoperative.
Page 31: Side View
User manual | The equipment Side view The photos in this manual are merely illustrative. The connections are placed correctly according to the images. The art on the labels may be altered in accordance with the requirements of the applicable standards. 1 - SpO connector BCI standard oximetry connector.
Page 32: Printer
User manual | The equipment 5 - Printer Printer for thermosensitive paper. It prints electrocardiograms and events. For more information view the “Printing” chapter. 6 - CPR Maestro connector Connector for the CPR Maestro accessory. 7 - Connector for defibrillation electrodes (pads) Multi-functional: adhesive pads for defibrillation, pacemaker and monitoring.
Page 33: Rear Panel
The equipment Rear panel 1 - Pads The pads accompanying the CardioMax must be placed on top of the equipment and must be properly connected to the adult adapter. 2 - Removable battery The battery can be easily replaced by simply pressing both side tabs one against the other.
Page 34: Rear Connectors
User manual | The equipment Rear connectors 1 - 3-pin power connector Input of 100 to 220 VAC, with central pin for grounding. 5 A fuse (20 mm 20 AG F5A GLASS FUSE). 2 - External DC socket For battery connection or external DC source connection in a range of 11 to 16 VDC.
Page 35: Screen And Operation
Screen and operation Turning on and operating Use selector switch (1) for turning CardioMax on and off. When turning on, the operator must immediately select an operation mode (defibrillator, monitor or pacemaker). Auto Seq. Monitor Pacemaker 1 - Selector switch Turn clockwise or counter-clockwise to select the operation mode.
Page 36: Auto Seq. Mode
5 - Turns equipment off In this position, the CardioMax 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 37: Operating The E-Jog Control
User manual | Screen and operation Operating the 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 38: Startup Screen
Startup screen The startup screen is displayed whenever the device is turned on. It displays a list of all parameters available to CardioMax by showing the corresponding status next to each item: [OK] - Parameter has been installed and runs accordingly.
Page 39: Parameters Visualization Screen
User manual | Screen and operation Parameters visualization screen SPO2 % DEMAND I N F O C E N T E R 09:44 Shock OK 07/10/04 1. Graph area for oximetry, ECG and 5. Infocenter: Information on the EtCO waveforms. Also used for equipment and its operation.
Page 40: Access Icons For Events And Configuration Functions
Screen and operation Access icons for events and configuration functions 1. Events menu: views events stored in the CardioMax. 2. Configuration menu: enables the configuration of all the parameters of the equip- ment. See the “Configuration menu” in this chapter.
Page 41 User manual | Screen and operation Monitor mode screen – variation A (ECG and SpO present) SPO2 % I N F O C E N T E R 09:44 07/10/12 Mode: Adult 1. ECG: ECG measurements and ECG 5. SpO : oximetry measurements and alarms.
Page 42 User manual | Screen and operation Monitor mode Screen – variation B (ECG, SpO , and NIBP present) NIBP mmHg 104/157 ( 73) I N F O C E N T E R 09:44 07/10/12 Mode: Adult 1. ECG: ECG measurements and ECG 5.
Page 43: Monitor Mode Screen – Variation C (All Parameters Present)
User manual | Screen and operation Monitor mode screen – variation C (all parameters present) RESP ETCO2 NIBP mmHg mmHg 104/ 57 ( 73) I N F O C E N T E R 17:00 11/12/12 Mode: Adult 1. ECG: ECG measurements and ECG 6.
Page 44: Pacemaker Mode Screen
User manual | Screen and operation Pacemaker mode screen 5 leads NIBP mmHg 104/ 57 180 200 ( 73) DEMAND PM ON 07/10/12 Mode: Dem Mode: Adult 1. ECG: ECG measurements and ECG 5. Information on the pacemaker mode. alarms. 6.
Page 45: Aed Mode Screen
AED mode. 2. Time, date, battery and mode status. 5. Transcription of the instruction given 3. Graph area for oximetry, ECG and by the CardioMax to the user when in EtCO waveforms. Also used for AED mode. configurations.
Page 46 User manual | Screen and operation Defibrillator mode - variation A (ECG, SpO and NIBP present) Defibrillator 5 leads NIBP mmHg 104/ 57 100 J ( 73) 1:45:04 Adult 07/10/12 Mode: Adult 1. ECG: ECG measurements and ECG 5. Information on the defibrillation mode. alarms.
Page 47 User manual | Screen and operation Defibrillator mode - variation B (ECG, SPO and EtCO present) EtCO2 Defibrillator mmHg 100 J 2:30 Adult I N F O C E N T E R 17:00 11/12/12 Mode: Adult 1. ECG: ECG measurements and ECG 6.
Page 48: Configuration Menu
Events Functional Test Curves exit 07/10/12 1 - ECG It allows you to manually set the ECG parameters of CardioMax (see chapter "Monitor mode - ECG"). 2 - SpO Enables manual configuration of SpO parameters (See: “Monitor mode - SpO...
Page 49: Nibp
(See: “Monitor mode - capnography” chapter). 5 - Defibrillator mode Enables to set the time of the automated internal discharge of the energy stored in the CardioMax (See the “Defibrillator mode” chapter). 6 - RESP Enables manual configuration of RESP parameters (See the “Monitor mode –...
Page 50: Configuration Menu
User manual | Screen and operation Configuration menu General setup EtCO2 NIBP mmHg mmHg PAUSE DEMAND PARAMETER SETUP GENERAL SETUP Physiological Alarm SPO2 Technical Alarm NIBP Date and Time General Setup Defibrillation Printer Resp Events Functional Test Curves exit 07/10/12 1 - Physiological Alarm It allows you to set the alarm for each of the parameters (see section "Alarms and limits).
Page 51: Time And Date
The “Time and date” menu adjusts the CardioMax’s calendar and time. You can opt for international or North-American standards of date and time. It is very important to keep time and date well adjusted because this information will appear on all printed reports.
Page 52: Printer
6.25 mm/s, 12.5 mm/s and 25.0 mm/s for EtCO and RESP waveforms. OBS: if all waveforms are disabled simultaneously, the CardioMax will automatically select the “DII” lead. The EtCO curve will only be enabled if the module is on.
Page 53 User manual | Screen and operation WAVEFORMS SETUP Waveform 1 [dII Pads Waveform 2 [Off SPO2 Waveform 3 [Off EtCO2 ECG/SPO2 speed [25,0 12,5 50,0 12-lead ECG [Off Initial derivation - Monitor [dII Pads Initial derivation - Def [Pads Pads back exit 8 - RTC...
Page 54: Alarms And Limits
Physiological Alarm There are two ways to enable the physiological alarm indications: Asistoly - the CardioMax cannot detect valid heartbeats for over 4 seconds. Violation of MAXIMUM or MINIMUM limits - When the Oximetry, ECG, NIBP, EtCO RESP maximum or minimum alarm limits are not within the equipment's preset range.
Page 55: Technical Alarm
Normal 100% Technical Alarm Sound and visual signals indicate that the CardioMax is not able to accurately monitor the patient's status. The technical alarm indications are shown in the Infocenter area. See below a detailed list: ECG or RESP - Loose Electrode: loose ECG electrode, poor contact between electrode and skin, or broken ECG conductor.
Page 56 (apnea) in the specified times of 5, 10, 15, 20, 25, 30, 35 or 40 seconds (set in Menu > RESP > Apnea Alarm). These indications will be enabled when CardioMax is in any mode except in AED Mode.
Page 57 If the equipment has different alarm priorities simultaneously occurring, the high priority alarm will overlap the medium priority. The CardioMax 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 factory default settings to ensure safety in the event of patient exchange.
Page 58 HIGH PRIORITY When the bpm is below the value set on the alarm configuration. Asystole HIGH PRIORITY CardioMax cannot detect valid beats for more than 4 seconds. Shock Indicated HIGH PRIORITY Ventricular fibrillation / ventricular tachycardia(VF / VT) was identified.
Page 59 User manual | Alarms and limits NIBP ALARM PRIORITY COLOR POSSIBLE CAUSE Excessive MEDIUM PRIORITY YELLOW The cuff´s maximum pressure has been Pressure exceeded. Cuff problems MEDIUM PRIORTY YELLOW The cuff is misplaced or there is leakage on measure circuit. Weak signal MEDIUM PRIORITY YELLOW...
Page 60 Adhesive pads - CardioMax detected Adhesive pads connected. Adult pads - CardioMax detected Adult pads connected. Children pads - CardioMax detected paddles connected, but the adult electrode is disconnected. The same message is also exhibited when CardioMax detects Children Adhesive pads.
Page 61: Bad Contact
User manual | Alarms and limits Printer INFORMATIVE MESSAGES Without paper – Printer is out of paper. Open door (ONLY for GSI model printer) – The door of the printer compartment is open. Printing – Printer is printing. ATTENTION: There is a risk possibility if the alarm limits do not follow a pattern in the equipment or area, it means, if it is changed for each patient, or it is different for more than one equipment.
Page 62: Battery Charge Level
User manual | Alarms and limits Battery charge level: Indication Battery status* Device operating conditions Enables approximately 3 hours of monitoring if the battery has 100% charged been inserted. 80% charged Enables approximately 2 hours and 50 minutes of monitoring. 60% charged Enables approximately 1 hour and 40 minutes of monitoring.
Page 63 User manual | Alarms and limits SPO2 % DEMAND Low battery Warning CardioMax will turn off shortly I N F O C E N T E R 09:44 Connect 07/10/12 Multifunctional Paddles See the indication for low battery above: 1 - One red battery bar and four 2 - Dialogue box shows: “low...
Page 64: Pause Audio
Its visual indication is the "audio paused" icon in all parameters. Configuration of alarm limits Whenever the CardioMax is started, it returns to the last limits and configurations set by the user. To alter alarm limits, the user must select the ALARM menu.
Page 65: Auto Set
User manual | Alarms and limits ALARM SETUP Auto set [180 ] SPO2 Auto set The AUTO SET function configures alarm limits taking into account the physiological parameter values that are instantly measured on the patient by calculating a deviation of the minimum and maximum limits. See the table below: Parameter Minimum Maximum...
Page 66: Minimum/Maximum Limit
User manual | Alarms and limits Minimum/maximum limit The adjustment of minimum and maximum values is done individually on each parameter by using the e-Jog Control. The operator must first select the limit and the parameter to be modified and then press it. Next, the desired value must be adjusted and then pressed again.
Page 67: Technical Alarms Settings
User manual | Alarms and limits Technical alarms settings When turned on, CardioMax returns to the last limits and setting made by the user. In order to change the active technical alarms, the user must access the "Settings > Technical alarm" menu.
Page 68: Physiological Alarm Test
User manual | Alarms and limits To turn the alarm sound on again, press the PAUSE AUDIO button for 1 second. The sound of the parameters of alarm can be turned on and off individually in the "Alarm" menu and in parameter menus. Physiological alarm test To perform the alarm test do the following steps: 1 - Turn on the equipment, with the electrodes properly connected.
Page 69: Defibrillator Mode
Shock). These impulses are used to eliminate arterial, ventricular fibrillation, and ventricular disturbances. Warnings The CardioMax 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 70: Use Criteria
User manual | Defibrillator mode Use criteria In defibrillation mode, the CardioMax 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 CardioMax: 1 - Not recommended for children under one year old.
Page 71: External Pads Use
User manual | Defibrillator mode External pads use 1 - Check if the pads are connected to the CardioMax. If they are not, connect the defibrillation cable to the pads socket located on the equipment’s side (as show in the image below).
Page 72 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 73: About Shock Delivery
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 CardioMax offers or inhibits the delivery of energy. Patient's...
Page 74: Child Pads Use
2 - Pull the pads base forward to remove them. 3 - This exposes the smaller electrode for children. Adult Child The CardioMax will automatically identify that it is operating in pediatric mode. Energy is limited to 50 J in the pediatric mode.
Page 75: Using Multifunction Pads
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 76: Defibrillation
Press the “Charge” button (green) in the front panel or use the charge button in the external pads (orange). While the CardioMax is charging, a sound will be emitted and the measurement of the charged energy will appear on the display.
Page 77: Synchronism - Synchronized Discharge - Cardioversion
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 CardioMax will deliver the shock when the next “R” wave is identified. IMPORTANT: If CardioMax 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 78: Disarm Key
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 Defibrillator Sync 1 - Synchronism Indicates if sync is on or off. When it is turned on, the symbol blinks indicating the function is activated.
Page 79: Number Of Shocks
User manual | Defibrillator mode 4 - Number of shocks Shows number of shocks delivered. The counter is set to zero when the equipment is turned off. 5 - Selected and charged energy The energy SELECTED by the user is shown in this display area in BLACK numbers.
Page 80: Charge Auto-Sequencing Mode (Auto Seq)
User manual | Defibrillator mode Charge Auto-Sequencing mode (Auto Seq) In the Auto Seq mode, the shock energy levels will follow the order previously set by the user in: "Defibrillation > Auto Sequencing Charge” (See “Defibrillation setup” below). Auto Seq. Monitor Pacemaker There are three sequential energy levels, being that, from the third shock on all...
Page 81: Defibrillation Setup
User manual | Defibrillator mode Defibrillation setup DEFIBRILLATION SETUP Internal discharge time Sudden Death Prev. CHARGE AUTO-SEQUENCING First Shock Second Shock [100 ] Third Shock [200 ] back exit 1 - Internal discharge time Determines how long the equipment keeps the charge ready before discharging it internally.
Page 82: Back/Exit
User manual | Defibrillator mode 4 - Back/Exit “BACK” to configuration menu or “EXIT” to go to the monitoring screen. Functional test WARNING: The functional test must be executed daily in order to guarantee that the equipment is in working order and ready to use. FUNCTIONAL TEST Put the Paddles on the support Select 100J...
Page 83: Result Screens For Functional Tests
NOTE: printouts of test results will only be available in the CardioMax units equipped with a thermal printer. NOTE: the CardioMax 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...
Page 84: Aed Mode
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 CardioMax, using its Neural Network Technology, is capable of assessing, via sophisticated sensors, the patient’s state, consider the clinical variables and deliver automatically...
Page 85: Physics Principle Used
Shock). These impulses are used to eliminate arterial, ventricular fibrillation, and ventricular disturbances. Warnings The CardioMax 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 86: Use Criteria
User manual | AED mode Use criteria In defibrillation mode, the CardioMax 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 CardioMax: 1 - Not recommended for children under one year old.
Page 87: Operation
Before starting the operation, call the emergency service. Step 1 - Connect disposable pads to the CardioMax If the disposable pads have not been connected to the CardioMax yet, attach the connector to the plug on the right side of the equipment.
Page 88 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 89 Monitor Pacemaker Rotate the selector switch to the AED position. The CardioMax 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 90 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 CardioMax will announce: “TREATMENT NOT RECOMMENDED”. Check if there was no movement of the patient during the analysis. If so, restart the process.
Page 91: Applying Cpr
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 92 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 CardioMax, which mark the rhythm of the compressions. Every 30 compressions, apply 2 mouth-to-mouth ventilations.
Page 93: Using The Cardiomax On Children Under 8 Years Old
AED mode Using the CardioMax on children under 8 years old The CardioMax 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 94: Alarm System
It is recommended that this check is done by a qualified technician, during preventative maintenance (see "Inspection and maintenance"). Information signals CardioMax 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 95 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 infor-mation signals and verbal alarm signal is given in two ways: Sound power: Verbal information signals will always be at least 6dB(A) below the set to the alarm...
Page 96: Pacemaker Mode
(mA). The pacemaker works in two modes: fixed or on demand (synchronous). Warnings The CardioMax 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: Fixed Mode
PPM number defined by the user. Demand mode (synchronous) In this mode the CardioMax 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: Operating In Pacemaker Mode
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. Auto Seq. Monitor Pacemaker SPO2 % II PAUSE FIXED 1 - PPM: selection of the pacemaker’s stimulation frequency.
Page 99: Starting Stimulation
User manual | Pacemaker mode Starting stimulation 1 - If it not yet connected, connect the adhesive pads cable to the CardioMax. 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: Under Demand Stimulation
The stimulated pulses will be applied in the asynchronous mode if there is a connection problem with the ECG monitoring electrodes or if the CardioMax does not identify a valid QRS. Defibrillation If defibrillation is necessary, turn the switch to defibrillation mode. The CardioMax automatically inhibits the pacemaker's stimulation pulse.
Page 101: Monitor Mode - Ecg
“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: Monitoring Ecg
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: Leads
LA - (LL+RA) LL - (LA+RA) C (V1 - V6) C - (RA+LA+LL) Color patterns There are two color patterns for ECG cables. The CardioMax uses the IEC pattern. See the table below. Position IEC (European) AHA (American) Right Arm...
Page 104: Operating In Monitor Mode - Ecg
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. Auto Seq. Monitor Pacemaker 1 - ECG Symbol. The ECG icon 3 - The “BELL”...
Page 105: Ecg Setup
User manual | Monitor mode - ECG ECG Setup ECG SETUP ECG Response [Normal ] Slow Fast ECG Cable [5-wire 3-wire 10-wire 10.0 WAVEFORM -4.4 Sensitivity Frequency bandwith [Monitor ] Diag Monitor Mains supply filter Detect Pacemaker [Off Segmento ST [Off back exit...
Page 106: Sensitivity
User manual | Monitor mode - ECG 3 - Sensitivity Select the ECG amplification gain. You can select from 5, 10, 15, 20, 30 or 40 mm/mV. 4 - Frequency bandwidth selection Filter selection for power interference. “Diag” or “Monitor”. 5 - Mains supply filter Enables to turn filter on or off to reduce mains supply interference with the ECG signal.
Page 107: St Segment
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 108: St Elevation Characterization
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 109: St Segment Configuration
1 - ST segment Location of the power switch for displaying the "ST Segment" on the main screen of CardioMax. 2 - Alarm Bell icon - Indicates sound alarm off or on. Minimum and maximum alarm limits configuration both in the ECG menu and in the alarm...
Page 110: Nipb Monitoring
Do not place armband on limb or extremity which is being used for intravenous infusion, or in any area where circulation is compromised. The CardioMax 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 | NIPB monitoring Harmful injury to the patient may be caused by the continuous pressure of the ARMBAND and resulting from twists in the connecting tubing. Very frequent measurements of blood pressure can cause injury to the patient, because of interference with blood flow. Injury to the patient can be caused if the ARMBAND is positioned on top of a WOUND.
Page 112: Monitoring Non-Invasive Pressure
User manual | NIPB monitoring Monitoring Non-Invasive Pressure 1 - Connect the extremity of the extension hose to the equipment’s front panel. 2 - Measure the limb in which the armband will be applied to and select an adequate type. See the chart below. 3 - Place the armband according to the “Placing the armband”...
Page 113: Measurement Modes
NIBP. Interval between measurements can be selected to: 1, 2, 3, 4, 5, 10, 15, 30, 60, 90 minutes. Interrupting NIBP measurements: To cancel an ongoing pressure mea- surement, press “NIBP MANUAL MEASUREMENT”, located in the equip- ment’s front panel. The CardioMax does not offer a short-term automatic measurement option.
Page 114: Nibp Numeric Indicator
User manual | NIPB monitoring NIBP numeric indicator NIBP mmHg 120/80 (100) 1 - Numeric values for systolic/diastolic 3 - Time interval between measurements and mean pressures. (used in automatic measurements). 2 - Number of measurements exerted (used in automatic measurements). NIBP setup Using the e-Jog select the NIBP function in the setup menu to access the NIBP setup sub-menu.
Page 115: Manual Measurement
1 - Manual measurement Start a NIBP manual measurement. 2 - NIBP ON/OFF Enables or disables the CardioMax’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 116: Monitor Mode - Spo
Monitor mode - SpO Physics principle used The CardioMax 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 117: Sensor Selection
User manual | Monitor mode - SpO Prolonged use or the condition of the patient may require replacement of the sensor. Replace the sensor every 4 hours and often check the integrity and circulatory condition of the skin as well as the correct alignment of the sensor.
Page 118: Operating In Monitor Mode - Spo
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 Auto Seq. displayed. Monitor Pacemaker 1 - The “BELL” Icon – Indicates audio in 3 - SpO numeric value.
Page 119: Spo Setup
User manual | Monitor mode - SpO setup SPO2 SETUP ALARM SPO2 response [Normal ] Slow Fast back exit 1 - SpO response Selects the SpO numeric update response. You can select among the SLOW, NORMAL and FAST options. NORMAL: Used for most patients. FAST: Used when the operator needs faster answers.
Page 120: Monitor Mode - Capnography
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 CardioMax. CO measurement is based on the characteristics of laser absorption by CO molecules.
Page 121: Capnography Monitoring
“auto- zero”, which is necessary for the proper functioning of the equipment. During this procedure, no measurements are exerted. The CardioMax can monitor EtCO in intubated or non-intubated patients. To do so, you just need to change the following accessories.
Page 122 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 123: Etco Numeric Indicator
User manual | Monitor mode - Capnography EtCO numeric indicator 1 - Numeric value for the EtCO expiration. 3 - Inspiration numerical value. Informs, The value of the EtCO measured at the in mmHg or percentage, the value of CO end of expiration is informed in mmHg or measured at the end of inspiration.
Page 124: Etco Setup
User manual | Monitor mode - Capnography EtCO setup Using the e-Jog select the EtCO function in the setup menu to access the EtCO setup sub-menu. EtCO2 SETUP ALARM CO2 On/Off Units [mmHg] mmHg Scale [ 40 CALIBRATION Calibration back exit 1 - CO ON/OFF...
Page 125: Calibration
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 126: Monitor Mode - Respiration
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 127: Respiration Monitoring
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 128: Respiration Numeric Indicator
User manual | Monitor mode - Respiration Respiration numeric indicator RESP 1 - Respiration symbol. 3 - Respiration numeric value. 2 - Apnea alarm – Displayed when 4 - Measuring unit(respirations per breathing suspension is detected. minute). Yellow indicators show that the respiratory frequency is originated via ECG cable, blue indicators show that the respiratory frequency is originated via capnography.
Page 129: Respiration Setup
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. RESP SETUP Resp On/Off [Off ] Respiratory Frequency [ECG ] Apnea Alarm [Off ] WAVEFORM Sensitivity back...
Page 130: Back/Exit
User manual | Monitor mode - Respiration 5 - Back/Exit “BACK” to Configuration menu or “EXIT” to monitoring screen.
Page 131: Event And Data Storage
Manually - via the events setup menu. The quantity of events the equipment can store will vary according to how long each patient has used the equipment and the type of therapy used. The CardioMax has a 2 Mb memory.
Page 132: Viewing And Managing Events
DEMANDA possible by accessing Time Events Patient the Events option in the New patient Change pads - Adult configuration menu. CardioMax off Patient CardioMax on Change pads - Adult Clear Memory CardioMax off CardioMax on Change pads - Adult Print...
Page 133: Patient
User manual | Event and data storage PLAY DEMANDA Time Events Patient New patient Change pads - Adult 12:32 CardioMax off CardioMax desligado Patient 12:35 CardioMax ligado CardioMax on 12:35 Change pads - Adult Troca de pas - Adulto Clear...
Page 134: New Patient
User manual | Event and data storage 4 - New patient Creates a new patient, starting a new event table. When it is done the alarms limits are restored to the original factory values. 5 - Events list Presents the selected patient's events. 6 - Printing icon When present next to an event, this icon indicates that printing the ECG waveform associated with that event is available.
Page 135: Printing
Control Instant printing When the print button is pressed for LESS than three seconds, the CardioMax 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 136: Continuous Printing
Instant printing - Bixolon printer Continuous printing When the print button is pressed for MORE than three seconds, the CardioMax 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 137: Stop Printing
Paper size [Small] Small Large ELETRO Print Electro Number of Leads back exit 1 - Alarm printing When the “alarm printing” option is enabled (in the printing setup menu), the CardioMax prints an instant report whenever an alarm goes off.
Page 138: Shock Printing
2 - Shock printing When the shock printing option is enabled (in the printing setup menu), the CardioMax 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 139: Paper Size
User manual | Printing 3 - Paper size Shows the selected size of the report to be printed. GSI printer: • Large = 30 cm. • Medium = 23 cm. • Small = 14 cm. Bixolon printer: • Large = 30 cm. •...
Page 140: Rtc - Real Time Check
When the RTC Central module is not acquired, the equipment will not have communication with PC central, but it will be enable on the menu (details on page 142). RTC Operation on the CardioMax 8 with transmitter The configurations for the RTC function can be accessed through the menu CONFIGU- RATION >...
Page 141: Automatic Test
CONFIGURATION > GENERAL CONFIGURATIONS > RTC. To perform the automatic test, the equipment should be turned off at the programmed time. At the configured time, the CardioMax will automatically turn on and begin the test, composed of the following steps: •...
Page 142 User manual | RTC - Real Time Check After completing the test, the equipment will send the collected data to the RTC Control Center. At this time, it is not possible to turn off the device. If the connection with the RTC Control Center cannot be established, the device will cancel sending the data after 10 seconds.
Page 143: Manual Test
User manual | RTC - Real Time Check Manual test To open the dialog box for the manual test, access CONFIGURATION > GENERAL CONFIGURATIONS > RTC > PERFORM TEST MANUALLY. Manual test Put the Paddles on the support □ Select 30J □...
Page 144: Status Of The Last Test
10 seconds. After this procedure, the device will save the collected data and return to the mode defined by the rotating switch on the CardioMax. Status of the last test To see the data from the last test performed, access CONFIGURATION >...
Page 145: Rtc Operation On The Cardiomax 8 Without Transmitter
User manual | RTC - Real Time Check RTC Operation on the CardioMax 8 without transmitter The equipment that do not have RTC module installed, will not have communication with PC. The functionalities of the RTC will be the same as listed above, without performing data transmission.
Page 146: Cpr Maestro
To turn off the equipment, simply press the ON/OFF button for 3 seconds. The parameter will be automatically turned off on the CardioMax screen. Using the CPR Maestro 1 – Connect the CPR Maestro to CardioMax, using the input indicated below, located on the side of the equipment.
Page 147 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 148: Feedback
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 CardioMax screen. Defibrillator 5 leads NIBP...
Page 149: Messages
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 150 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 151: Pc Connection
PC connection Introduction The CardioMax 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 152: Softdea Installation
CD and double-click it. • Follow the installation instructions which will show up on the screen. Connecting the CardioMax to a PC • Connect the equipment only after installing SoftDEA. • After the installation connect the device through an USB cable.
Page 153: Startup Screen
User manual | PC connection 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 128 of this manual).
Page 154: Graphic Display Screen
User manual | PC connection 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 155: Print
Allows the ECG to be viewed throughout its amplitude scale. 9 - Event viewer window After downloading the information contained in the CardioMax memory, the list of events stored by the device will be displayed in this area in chronological order.
Page 156: Settings
Settings Volume and clock adjustments via SoftDEA are only available for Isis, Isis PRO and Isis PRO training equipment. In CardioMax these adjustments are made via the device's own settings menu, as described on page 49 in the "Screen and operation" chapter.
Page 157: Changing Languages
Change the language of voice prompts emitted by the speaker on the device to the selected language. • Under the "in the device" option (when a CardioMax device is connected): The CardioMax language can be changed through the device's settings menu (see page 48 - "General setup").
Page 158: Exit
The RTC software runs in the background, with the minimized system awaiting a device to communicate with the "Real Time Check Control Center". The CardioMax 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 159: E-Mail Configurations
User manual | PC connection After the program is run for the first time, the software will be configured to automatically run after Windows starts up. The RTC icon is in the shape of a heart and will be shown on the task bar, next to the clock of the operating system, as shown in the figure below: To see the software's main window, just click on the heart icon.
Page 160 User manual | PC connection ATTENTION: When sending e-mails is enabled, the system will try to send 3 times, with intervals of 15 minutes between attempts. If sending is not possible, the e-mail will be discarded by the system after the third attempt.
Page 161 User manual | PC connection "Sender Data" Tab A. Opens the "E-mail to send" tab. F. Field for entering the sending portal. B. Selected tab. G. Select if the server requires an en- crypted connection (SSL) or not. C. Field for entering the sender's address. H.
Page 162: Reading Log Of The Equipment
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 infor- select the criteria for displaying logs. mation about the tests conducted with the filters applied.
Page 163 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 164: Options
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 165 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 166: Backup
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 167: Warning
IEC 60950 for data processing equipment. Receiving data When the CardioMax 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 168: Care And Maintenance
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 169 User manual | Care and maintenance CLEANING THE ACCESSORIES: For the ECG cable: • Clean the cable, the connection box and the surfaces of contact with the patient with a soft cloth moistened with water or neutral desinfection solution, dry the cable to use again.
Page 170 To charge the battery, connect the monitor to an AC power source (110 or 220 V outlet) or a DC power source. There are no restrictions or limitations for using the CardioMax while its battery is being recharged by an AC source or DC External source.
Page 171: Removable Battery Replacement
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, as shown in the picture below.
Page 172: Replacing The Thermal Paper Of The Gsi Printer
User manual | Care and maintenance 4 - Push the new battery until it firmly locks into the cabinet. Replacing the thermal paper of the GSI Printer 1 - Press the button to open the printer door (see picture below). If the door does not open completely, pull it in your direction.
Page 173: Replacing The Thermal Paper Of The Bixolon Printer
User manual | Care and maintenance 3 - Place the new bobbin between side clasps. The bobbin must be positioned as shown in the picture above, with the thermal-sensitive side (measurements in milli- meters) facing up. 4 - Unroll about 10 cm of paper. 5 - Align paper with the printer door.
Page 174: Returning Components
6 - Close the printer door. The printer is ready for operation. Returning components If CardioMax must be returned for repair, call Instramed for shipping instructions. To facilitate assistance be prepared to provide the equipment's series number. If possible, use the original equipment’s packaging. If this is not possible, use an equivalent box that provides adequate protection for the monitor.
Page 175: Precautions, Restrictions And Warnings
User manual | Care and maintenance Precautions, Restrictions and Warnings The CardioMax is a device built according to NBR and IEC standards and therefore offers total safety for patient and operator. However, all safety precautions de- scribed below must be followed.
Page 176: Electromagnetic Emissions
Electromagnetic emissions Directives and manufacturer declaration - electromagnetic emissions The CardioMax 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 177: Accessories
• Do not use this product in conjunction with electrical scalpel. • Do not use this product in conjunction with MRI devices. The essential performance of the CardioMax is understood as the ANALYSIS of the patient’s heart rhythm and the DEFIBRILLATION applied to the patient, depending on the result of the analysis.
Page 178: General
General Directives and declaration of the manufacturer - electromagnetic emissions The CardioMax 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 179: Equipment With Life Support Functions
RF transmitters, it is advisable to consider an electromagnetic site survey. If the measured field strength in the site where the CardioMax is used exceeds the level of RF compliance used above, the CardioMax should be observed to checK if operation is normal.
Page 180: Electromagnetic Immunity
Advisable separation distances between mobile and portable RF communications equipment and the CardioMax The CardioMax 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 CardioMax as recommended below, according to the maximum output power of the communication equipment.
Page 181 User manual | Care and maintenance Testing specifications for cabinet interface immunity to RF wire communications equipment The Ion PRO was designed to provide Basic Security with RF equipment by the following table: Testing Maximum Immunity test Band (MHz) Service Modulation Distance (m) frequency (MHz)
Page 182: Troubleshooting
Troubleshooting Symptom Probable cause Probable solution - Check connections: the CardioMax/Power The CardioMax does not turn on. There is no electricity. Cable/Plug. - Check if is adult pads are connected to the Does not select energy > 50 J. Adult pads identification.
Page 183: Basic
Accessories Accessories accompanying the equipment: Basic Quantity Description Code Power cable (3 pins) 5550 Removable battery 11013 User manual 22619 Defibrillator Quantity Description Code A set of adult/child external defibrillation pads 79001 Quantity Description Code 5-lead ECG cable 79005 NIBP Quantity Description Code...
Page 184: Pacemaker
23897 Disposable adult ECG electrodes package (check quantity availability per package) 21669 GSI Printer Paper 10766 Bixolon Printer Paper 11858 Li-Ion Cardiomax external battery charger 13982 EtCO set, including: 79032 • Tracheal sample line - adult 22686 • Tracheal sample line - children 22687 •...
Page 185: General Specifications
Specifications and safety General specifications Dimension with pads: 30.0 cm (W). 21.5 cm (D). 28.0 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).
Page 186 User manual | Specifications and safety Battery storage: Storing the battery for a long period of time in temperatures higher than 40°C will reduce its capacity and lifetime. Memory: Capacity: 2 Mbytes. Patients stored: >150 patients. ECG: recording of 2 continuous hours of the ECG curve (when the AED mode is on).
Page 187: Environmental Specifications
Storage: 10 to 95% RH, without condensation. Altitude: Recommended to use in altitudes lower than 2000 meters. WARNING: If the CardioMax is used outside these conditions, 15 through 30 minutes will be required to stabilize the system so that functioning failures do not occur.
Page 188: Aed Mode
Children = 4.5 cm x 4 cm (contact area = 18 cm²). Pads cable length: 2 meters. The adhesive pads provided by Instramed have a biocompatibility certificate in accordance with ISO 10993. Cardioversion: < 60 ms after the QRS peak.
Page 189 User manual | Specifications and safety Maximum charge time 200 J: < 6 s. (with 100% of the minimum 150 J: < 4 s. specified voltage): 50 J: < 2 s. Maximum time from rhythm 20 s. analysis beginning to discharge readiness: Maximum time from 30 s.
Page 190: Ecg Analysis Algorithm
User manual | Specifications and safety 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. • Creighton University. Test report: •...
Page 191 User manual | Specifications and safety 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.
Page 192 • Ventricular Tachycardia with several QRS amplitudes and widenings. • Ventricular Fibrillation with several amplitudes. Rhythm Classes Specifications Shock - VF The CardioMax meets IEC 60601-2-4 requirements for sensitivity > 90%. Shock - VT The CardioMax meets IEC 60601-2-4 requirements for sensitivity > 75%.
Page 193 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 194 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 195 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 196: Pacemaker
User manual | Specifications and safety 360 J of energy at 150 R impedance. 360 J of energy at 175 R impedance. Pacemaker Waveform: Single-phase rectangular pulse. Modes: Demand or fixed. Amplitude: Between 5 mA to 200 mA (resolution of 5 mA), precision 10%. Pulse width: 20 ms (tolerance of 10%).
Page 197 User manual | Specifications and safety Refractory period: 340 ms (between 30 to 80 ppm), 240 ms (between 90 to 180 ppm). Maximum output voltage: 350 V. Input: 3 or 5 lead ECG cable. 10 lead ECG cable (optional). External pads. Multifunctional pads.
Page 198 User manual | Specifications and safety Patient isolation’s ECG: CF type. (defibrillation proof): : CF type. Physiological alarm: Alarm not locked. Minimum level (30-100). Maximum level (100-250). Visual indication. Sound indication. Suspend sound indication function. Silence sound indication function. Technical alarm: Alarm not locked.
Page 199: Nibp - Non-Invasive Arterial Pressure
User manual | Specifications and safety Input dynamic range and The equipment complies with 50.102.2 standard IEC offset differential voltage: 60601-2-27. Tachycardia alarm time: 206 bpm (1 mV): 5 seconds. 206 bpm (0.5 mV): 5 seconds. 206 bpm (2 mV): 5 seconds.
Page 200 User manual | Specifications and safety Pediatric range: Systolic: 40 to 160 mmHg. Mean: 26 to 133 mmHg. Diastolic: 20 to 120 mmHg. Neonatal range: Systolic: 40 to 130 mmHg. Mean: 26 to 110 mmHg. Diastolic: 20 to 100 mmHg. Overpressure limit per Adult: 290 mmHg max.
Page 201: Cpr Maestro
User manual | Specifications and safety Physiological alarm: Alarm not locked. Minimum level (40-95). Maximum level (45-100). Visual indication. Sound indication. Suspend sound indication function. Silence sound indication function. Technical alarm: Alarm not locked. Visual indication. Sound indication. Suspend sound indication function. Silence sound indication function.
Page 202: Bixolon Printer
User manual | Specifications and safety Bixolon Printer Type: Thermal. Weight: 0.104 Kg. Speed: 25 or 50 mm/s. Paper size: 57 mm (width). 15 m (length). Respiration Technique: Transthoracic impedance. Range: 3 to 150 breaths per minute. Precision: ± 3 breaths per minute. Sensitivity: 1, 2, 3, 4, 5 and 6 X.
Page 203 User manual | Specifications and safety measurement interval: 0 - 99 mmHg. Precision: ± 2 mmHg (0 - 38 mmHg). ± 5% + 0.08% for each 1 mmHg above 38 mmHg (39 – 99 mHg). Calibration: 2 points. Start: 10 seconds to start the CO curve.
Page 204 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 205 Biphasic Monitor Defibrillator www.instramed.com.br +55 (51) 3073 8200 2460...

Instramed CARDIOMAX User Manual

Introduction

Safety Information

The Equipment

Screen and Operation

Alarms and Limits

Defibrillator Mode

Monitor Mode - ECG

ST Segment

NIPB Monitoring

Monitor Mode - Spo

Monitor Mode - Capnography

Monitor Mode - Respiration

Event and Data Storage

RTC - Real Time Check

PC Connection

Care and Maintenance

Accessories

Specifications and Safety

Troubleshooting

Quick Links

Need help?

Questions and answers

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Summary of Contents for Instramed CARDIOMAX