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Instramed CardioMax, User Manual

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Instramed CardioMax User Manual Download Page 191

User manual | 

Specifications and safety

191

Sensitivity is the equipment’s percent ability to correctly identify a shockable rhythm.
Specificity is the equipment’s percent ability to correctly identify a nonshockable 

rhythm.

A

 = 

True positive.

B

 = 

False positive.

C

 =

 False negative.

D

 = 

True negative.

A true positive (A) is the equipment’s ability, in measurement units, to 

correctly

 

identify a 

shockable

 rhythm.

A false positive (B) is the equipment’s ability, in measurement units, to 

wrongly

 

recognize a 

shockable

 rhythm.

A false negative (C) is the equipment’s ability, in measurement units, to 

wrongly 

recognize a 

nonshockable

 rhythm.

A true positive (D) is the equipment’s ability, in measurement units, to 

correctly 

recognize a 

nonshockable

 rhythm.

Values measured with the AED using the specified database:

VF/VT

Nonshockable 

rhythms

Shock INDICATED

329

23

NO shock INDICATED

10

454

Sensivity     =  

97.05%

Specificity   =  

95,18%

Summary of Contents for CardioMax

Page 1: ...User manual Cardioverter Biphasic Defibrillator Monitor ...

Page 2: ...device attempts of repair not provided by authorized technical assistance centers operation by unqualified personnel use of defective device or use of accessories and parts not supplied by the manufacturer 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 In...

Page 3: ...ry charge If this procedure is not performed there is a risk of draining the battery and consequently being unable to use the CardioMax in its portable configuration not connected to the electric current Storage The battery must be removed from the equipment in case it is stored or not used Replacement Every battery has a determined lifetime which is the possible quantity of full charge and discha...

Page 4: ...the NIBP optional parameter is present Adult armband Armband extensor When the Oximetry optional parameter is present Oximetry sensor Oxymetry sensor extensor When the Printer optional parameter is present Paper bobbin for the printer When the CO2 optional parameter is present Sampling line When the Pacemaker AED parameter is present MP trunk cable Multifunction adhesive pads SoftDEA installation ...

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: ...or side effects 23 Classification and symbols 24 Standards 25 Device care 26 Connection to other equipment 27 Disposing of the device 27 The equipment 28 Front panel 28 Screen 29 e Jog Control 29 Selector switch 29 Quick access buttons 30 Power and battery charging indications 30 Side view 31 1 SpO2 connector 31 2 USB connector 31 3 NIBP connector 31 ...

Page 7: ...33 2 Removable battery 33 3 Identification tags 33 4 Ventilation 33 Rear connectors 34 1 3 pin power connector 34 2 External DC socket 34 3 Grounding and potential equalizer 34 4 RS 232 output 34 Screen and operation 35 Turning on and operating 35 1 Selector switch 35 2 Defibrillator mode 35 3 Auto Seq mode 36 4 Monitor mode 36 5 Turns equipment off 36 6 AED mode 36 7 Pacemaker mode 36 Operating t...

Page 8: ...creen variation C all parameters present 43 Pacemaker mode screen 44 AED mode screen 45 Defibrillator mode variation A ECG SpO2 and NIBP present 46 Defibrillator mode variation B ECG SPO2 and EtCO2 present 47 Configuration menu 48 1 ECG 48 2 SpO2 48 3 NIBP 49 4 CO2 49 5 Defibrillator mode 49 6 RESP 49 7 Functional test 49 Configuration menu 50 1 Physiological Alarm 50 2 Technical Alarm 50 2 Time a...

Page 9: ...uto set 65 Silence 65 Minimum maximum limit 66 Technical alarms settings 67 Technical alarm test 67 Physiological alarm test 68 Defibrillator mode 69 Physics principle used 69 Use criteria 70 Qualified users 70 External pads use 71 About shock delivery 73 Child pads use 74 Using multifunction pads 75 Defibrillation 76 Synchronism Synchronized discharge Cardioversion 77 Disarm key 78 ...

Page 10: ...Defibrillation setup 81 1 Internal discharge time 81 2 Sudden Death Prevention SDP 81 3 Charge Auto Sequencing 81 4 Back Exit 82 Functional test 82 Result screens for functional tests 83 AED mode 84 Introduction 84 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 Informa...

Page 11: ...timulation 99 Under demand stimulation 100 Defibrillation 100 Monitor mode ECG 101 Physics principle used 101 Warnings 101 Monitoring ECG 102 Leads 103 Color patterns 103 Operating in monitor mode ECG 104 ECG Setup 105 1 ECG response 105 2 ECG cable 105 3 Sensitivity 106 4 Frequency bandwidth selection 106 5 Mains supply filter 106 6 Detect pacemaker 106 7 ST segment 106 8 Alarm 106 ...

Page 12: ...NIPB monitoring 110 Physics principle used 110 Warnings 110 Monitoring Non Invasive Pressure 112 Measurement modes 113 NIBP numeric indicator 114 NIBP setup 114 1 Manual measurement 115 2 NIBP ON OFF 115 3 Automatic measurement 115 4 Initial pressure 115 5 Alarm 115 6 Back Exit 115 Monitor mode SpO2 116 Physics principle used 116 Factors which affect the SpO2 measurement s precision 117 Sensor sel...

Page 13: ...ings 120 Capnography monitoring 121 EtCO2 numeric indicator 123 EtCO2 setup 124 1 CO2 ON OFF 124 2 Units 124 3 Scale 124 4 Calibration 125 5 EtCO2 alarm 125 6 Back Exit 125 Monitor mode Respiration 126 Physics principle used 126 Warnings 126 Respiration monitoring 127 Respiration numeric indicator 128 Respiration setup 129 1 Respiration monitoring On Off 129 2 Respiratory frequency 129 ...

Page 14: ...ing events 132 1 Patient 133 2 Print list 133 3 Delete memory used memory 133 4 New patient 134 5 Events list 134 6 Printing icon 134 Printing 135 General 135 Instant printing 135 Continuous printing 136 Stop printing 137 Configurations 137 1 Alarm printing 137 2 Shock printing 138 3 Paper size 139 4 Electrocardiograph function 139 5 Number of leads 139 6 Back Exit 139 ...

Page 15: ...IPS 144 RTC Operation on the CardioMax 8 without transmitter 145 CPR Maestro 146 Using the CPR Maestro 146 Feedback 148 Messages 149 CPR Graphic 149 PC connection 151 Introduction 151 Requirements 151 SoftDEA Installation 152 Connecting the CardioMax to a PC 152 Startup Screen 153 1 Graphic display button 153 Graphic display screen 154 1 Download 154 2 Open 154 3 Print 155 4 PDF 155 ...

Page 16: ... Exit 158 RTC software installation 158 RTC software operation 158 1 E mail configurations 159 2 Reading log of the equipment 162 3 Options 164 4 Backup 166 5 Information 166 Warning 167 Receiving data 167 Closing the application 167 Care and maintenance 168 Preventive maintenance 168 Corrective maintenance 168 Cleaning 168 Removable battery replacement 171 Replacing the thermal paper of the GSI P...

Page 17: ...ility 175 Electromagnetic emissions 176 Electromagnetic immunity General 178 Electromagnetic immunity Equipment with life support functions 179 Troubleshooting 182 Accessories 183 Basic 183 Defibrillator 183 ECG 183 NIBP 183 SpO2 183 Pacemaker 184 List of optional accessories 184 Parts 184 Specifications and safety 185 General specifications 185 Environmental specifications 187 Defibrillator 187 A...

Page 18: ... Index XVIII ECG analysis algorithm 190 Pacemaker 196 ECG 197 NIBP Non Invasive Arterial Pressure 199 SpO2 200 CPR Maestro 201 GSI Printer 201 Bixolon Printer 202 Respiration 202 Capnography 202 Warranty Certificate 204 ...

Page 19: ...ed by a Non Invasive method on the screen The SpO2 Monitor mode measures the oxygen saturation of blood by a Non Invasive method The EtCO2 Monitor mode presents the partial pressure of exhaled CO2 at the end of expiration as well as inhaled value The RESP Monitor mode displays the respiratory rate measured by ECG electrodes or by the capnograph Characteristics The CardioMax is a modern practical l...

Page 20: ...ibrillation therapy or as a complement in assessing the patient s physiological conditions It must be accompanied by constant analysis of the patient s clinical status and symptoms 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 T...

Page 21: ...ardioversion pacing and AED modes we do not recommend the use in patients under 01 one year old For monitoring modes such as ECG SpO2 NIBP and EtCO2 it s use is possible with suitable accessories to these patients WARNING CardioMax can be used by patients over 01 one year old regardless of their weight WARNING risk of explosion if the equipment is operated in the presence of flammable liquids or g...

Page 22: ...ax must only be used as a complement to assess the patient s physiological conditions 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 during discharge there may be baseline variation...

Page 23: ...easing the burn s area and reducing the efficiency of the treatment Possibility of reddish skin at the defibrillation electrodes exposition place due to the high voltage applied Possibility of superficial skin burns To minimize the effect in the case of adhesive pads apply them immediately after removal of the protective envelope and securely attach to the patient s skin The patient s skin must be...

Page 24: ...ic pressure Minimum and maximum relative humidity Recyclable paper 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 DISCOMFORT or COMPLICAT...

Page 25: ...nd ISO 15223 are used as reference to the symbols Compulsório Segurança Inmetro conformity identification labelling Protected against water drops falling vertically Do not reuse Non sterile Do not use if the packaging is damaged Keep away from sunlight Adhesive pads operation temperature limits Check instructions for use LOT Lot code REF Catalog number Date after which the product cannot be used S...

Page 26: ...ipment Part 2 27 Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment NBR IEC 80601 2 30 Medical electrical equipment Part 2 30 Particular requirements for the basic safety and essential performance of automated non invasive sphygmomanometers NBR IEC 60601 2 49 Medical electrical equipment Part 2 49 Particular requirements for the basi...

Page 27: ...ICAL DEFECT GROUNDING MUST BE PERFORMED ACCORDING TO ABNT NORMS FOR ELECTRICAL INSTALLATIONS NBR 13534 1995 The potential equalization is performed by the Mains Supply cable connector with 3 pins accompanying the product and or with the earthing cable optional The installation of the CardioMax requires special precautions concerning Electromagnetic Compatibility in compliance with the information ...

Page 28: ...the equipment on and off Selects the operation mode see following chapters 4 Quick access buttons see quick access buttons in this chapter 5 E Jog Control equipment general configuration 6 Power and battery charging indicators see power and charging indicators in this chapter 1 4 5 2 3 6 ...

Page 29: ...mputer mouse PRESS works similarly to the enter button on a computer confirming the selection Selector switch Monitor Energy OFF Seq Auto Pacemaker Scale from 1 to 360 J allows the user to select the desired energy charge Monitor mode used to monitor ECG SpO2 NIBP EtCO2 and RESP parameters as in a multiparametric monitor Pacemaker mode enables external pacemaker Off turns off the equipment AED Pos...

Page 30: ... information see the Alarms and limits section NIBP when available starts or suspends the functionality of the Non Invasive Blood Pressure Measurement When the NIBP optional parameter is not present in the device this button has no function Freeze Freezes graphic screen signals for a closer examination same Cancel button Power and battery charging indications 1 Power Connected when the LED is on i...

Page 31: ...epending on the parameters present in the equipment it may be available in the following settings 3 or 5 wire AAMI standard Protected against defibrillation 10 wire optional allows up to 12 simultaneous leads This connector substitutes the standard connector and is not compatible with the 3 or 5 wire cables The photos in this manual are merely illustrative The connections are placed correctly acco...

Page 32: ...defibrillation electrodes pads Multi functional adhesive pads for defibrillation pacemaker and monitoring Adult child external included with the equipment may be used on adults and or children Cannot be used in pacemaker mode 8 Capnography exhaust connector Connector used for the removal of the gases collected by capnography For more information see chapter 12 Capnography 9 Capnography connector C...

Page 33: ... when the equipment is operating in battery mode Connect it to an electric current first 3 Identification tags The identification tags have important information about the product such as the model serial number and manufacturer information This information may be requested if technical assistance is needed Therefore do not remove or damage the identification tags 4 Ventilation Do not block ventil...

Page 34: ...ing 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 3 Grounding and potential equalizer Potential equalization and general grounding connector 4 RS 232 output Cable socket for updating software reserved for authorized technical personnel ...

Page 35: ...ect an operation mode defibrillator monitor or pacemaker 1 Selector switch Turn clockwise or counter clockwise to select the operation mode On Off position the equipment is turned off 2 Defibrillator mode Enables to set the time of the automated internal discharge of the energy stored in the device Monitor Energy OFF Seq Auto Pacemaker 1 2 4 5 6 7 3 35 ...

Page 36: ...ation This is indicated by a green LED in the base of the equipment s front 6 AED mode Enables the Automated External Defibrillator AED In this situation the CardioMax is capable of assessing through sophisticated sensors the patient s state consider the clinical variables and apply automatically the most indicated shock therapy At the same time the device guides the user by verbal commands and sc...

Page 37: ...cated 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 The menu for the chosen function will appear STEP 3 ROTATE Rotate the button to the corresponding value desired in the selected item s menu STEP 4 PRESS Press to confirm the new selected value ...

Page 38: ...d runs accordingly Fail Parameter has been installed but failure is detected Contact Instramed assistance Not present Parameter has not been originally installed or has been removed from device Software versions for each internal module are also presented ECG Resp DEA PMS 12D SPO2 NIBP Defibrillator Pacemaker Printer EtCO2 OK OK OK OK OK OK not present Firmware Version CPU Firmware Version ECG Fir...

Page 39: ...configurations 2 Time date battery and mode status 3 ECG ECG measurements and ECG alarms 4 Pacemaker or defibrillation modes area for the defibrillation or pacemaker modes 5 Infocenter Information on the equipment and its operation This is how the device communicates with the user 6 SpO2 Oximetry measurements and oximetry alarms 7 Access icons for event and configuration functions check it on the ...

Page 40: ... Configuration menu in this chapter 3 Alarms menu shortcut configures ECG and SpO2 alarms 4 Printer menu shortcut prints and configures the printing parameters The equipment screen will display different segments and parameters according to the mode defined using the selector switch See examples on the following pictures Access icons for events and configuration functions 1 4 3 2 ...

Page 41: ... 4 5 6 1 ECG ECG measurements and ECG alarms 2 Time date battery and mode status 3 Graph area for oximetry ECG and EtCO2 waveforms Also used for configurations 4 Infocenter information on the equipment and its operation This is how the device communicates with the user 5 SpO2 oximetry measurements and oximetry alarms 6 Access icons for event and configuration functions ...

Page 42: ...2 Oximetry measurements and oximetry alarms 4 Graph area for oximetry ECG and EtCO2 waveforms Also used for configurations 5 Time date battery and mode status 6 Infocenter information on the equipment and its operation This is how the device communicates with the user 7 Access icons for event and configuration functions 09 44 07 10 12 I N F O C E N T E R BPM 80 dII S P O 2 Mode Adult NIBP mmHg 73 ...

Page 43: ...ve Blood Pressure 5 SpO2 oximetry measurements and oximetry alarms 6 Graph area for oximetry ECG and EtCO2 waveforms Also used for configurations 7 Time date battery and mode status 8 Infocenter information on the equipment and its operation This is how the device communicates with the user 9 Access icons for event and configuration functions 17 00 11 12 12 I N F O C E N T E R BPM 80 dII S P O 2 E...

Page 44: ...ion on the equipment and its operation This is how the device communicates with the user 5 Information on the pacemaker mode 6 NIBP measurement values for systolic diastolic and mean Non Invasive Blood Pressure 7 SpO2 Oximetry measurements and oximetry alarms 8 Access icons for event and configuration functions PPM mA 180 200 Mode Adult ON DEMAND 07 10 12 74 5 leads NIBP mmHg 73 104 57 98 dII S P ...

Page 45: ...ximetry ECG and EtCO2 waveforms Also used for configurations 4 Visual representation of the instruction given by the CardioMax to the user when in AED mode 5 Transcription of the instruction given by the CardioMax to the user when in AED mode 5 leads 07 10 12 P a d s AED Don t touch the patient Analyzing the rhythm Child pads Mode Neo 1 2 3 4 5 ...

Page 46: ...ocenter Information on the equipment and its operation This is how the device communicates with the user 5 Information on the defibrillation mode 6 NIBP measurement values for systolic diastolic and mean Non Invasive Blood Pressure 7 SpO2 oximetry measurements and oximetry alarms 8 Access icons for event and configuration functions Defibrillator 100 J 1 45 04 Adult 0 Mode Adult 07 10 12 5 leads 80...

Page 47: ...n the defibrillation mode 6 Infocenter Information on the equipment and its operation This is how the device communicates with the user 7 SpO2 oximetry measurements and oximetry alarms 8 Access icons for event and configuration functions Defibrillator mode variation B ECG SPO2 and EtCO2 present 17 00 11 12 12 I N F O C E N T E R dII S P O 2 E t C O 2 Mode Adult 98 Defibrillator 100 J 2 30 Adult 0 ...

Page 48: ...onitor mode ECG 2 SpO2 Enables manual configuration of SpO2 parameters See Monitor mode SpO2 chapter exit 07 10 12 EtCO2 mmHg rpm NIBP mmHg PPM mA 70 30 PAUSE DEMAND PARAMETER SETUP GENERAL SETUP ECG SPO2 NIBP CO2 Functional Test Resp Defibrillation Physiological Alarm Technical Alarm Date and Time General Setup Printer Curves RTC Events 7 5 6 4 3 2 1 ...

Page 49: ...itor 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 respiration chapter 7 Functional test Enables to perform the CardioMax s functional test See the Defibrillator mode chapter ...

Page 50: ...lows you to turn on or off different technical alarms see section Alarms and limits Configuration menu General setup exit 07 10 12 EtCO2 mmHg rpm NIBP mmHg PPM mA 70 30 PAUSE DEMAND PARAMETER SETUP GENERAL SETUP ECG SPO2 NIBP CO2 Functional Test Resp Defibrillation Physiological Alarm Technical Alarm Date and Time General Setup Printer Curves RTC Events 7 5 6 4 3 2 1 8 ...

Page 51: ...e this information will appear on all printed reports You can adjust the time and the date using the e Jog Control 3 General setup The General setup menu allows you to configure four items and perform two actions GENERAL SETUP BIP Volume Off 10 Alarm Volume 1 10 Defibrillator Volume 1 10 Language Port Span Mode Neo Adult Cardiac Freq SpO2 Auto Restore original setup Off 1 1 Port Adult ECG exit bac...

Page 52: ...tomatic mode In the automatic mode priority is given to ECG electrodes Restores original setup Restores original factory settings 4 Printer Print and configure printing parameters See the Printing chapter 5 Events View and manage events saved in the CardioMax See the Events chapter 6 Waveforms In this menu you may select which waveform will be presented on the screen ECG SpO2 EtCO2 or RESP wavefor...

Page 53: ...ff Pads dII Waveform 3 Off EtCO2 Off Waveform 2 Off SPO2 Off ECG SPO2 speed 12 5 50 0 25 0 12 lead ECG Off On Off Initial derivation Monitor dII Pads dII Initial derivation Def dII Pads Pads 8 RTC Allow access to RTC function configurations see the chapter RTC Real Time Check ...

Page 54: ... are not within the equipment s preset range The visual indications of physiological alarms will occur in any mode except on AED mode as well as audible indication FEATURES ECG SpO2 NIBP RESP or EtCO2 except AED mode Alarm indicator numerical value in white alternating with a red arrow The direction of the arrow indicates up or down which limit has been exceeded Maximum alarm delay includes the de...

Page 55: ...in 85 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 SpO2 No finger on sensor sensor connected to the device but cannot ...

Page 56: ...ling line is not connected EtCO2 Occlusion there is no airflow in the EtCO2 sensor Change the sampling line Filterline EtCO2 Starting sensor the EtCO2 module is heating up its internal sensors this occurs during the beginning of capnography and lasts about 15 seconds RESP Apnea alarm the alarm will emit a sound when a suspension of breathing is detected apnea in the specified times of 5 10 15 20 2...

Page 57: ...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 Alarm Priority Alarm description or audible alert Alarm Volume or audible ale...

Page 58: ...ow the value defined on the alarm configuration SpO2 ALARM PRIORITY COLOR POSSIBLE CAUSE No finger on the sensor MEDIUM PRIORITY Yellow Connected sensor on the equipment but without detection of patient s finger Searching signal MEDIUM PRIORITY Yellow The monitor is searching for valid SpO2 signal SpO2 Disconnected Sensor MEDIUM PRIORITY Yellow Sensor or SpO2 extension disconnected or incorrectly ...

Page 59: ...iguration Pressure Systolic Diastolic or Medium Low HIGH PRIORITY RED The pressure is below the value defined on the alarm configuration EtCO2 ALARM PRIORITY COLOR POSSIBLE CAUSE No Filterline MEDIUM PRIORITY YELLOW The capnography sampling line is not connected Occlusion MEDIUM PRIORITY YELLOW There is no airflow in the EtCO2 sensor Change the sampling line Filterline Starting sensor MEDIUM PRIOR...

Page 60: ...delivered The energy was delivered to the patient Shock disarmed The energy was canceled by the operator Shock disarmed Automatic internal discharge The energy was automatically canceled because the shock button was not pressed before the internal discharge time selected by the operator Shock disarmed Contact Bad The energy was canceled because the impedance of the patient is not satisfying the ap...

Page 61: ...ment or area it means if it is changed for each patient or it is different for more than one equipment Confirm that the alarm limits are appropriate for the patient each time there is a new case of patient Do not set alarm limits to such extreme values that make the alarm system useless Bad contact Informs when the patient s impedance measurement does not satisfy the necessary shock delivery condi...

Page 62: ...g if the battery has been inserted 80 charged Enables approximately 2 hours and 50 minutes of monitoring 60 charged Enables approximately 1 hour and 40 minutes of monitoring 40 charged Enables approximately 1 hour and 10 minutes of monitoring 20 charged Enables approximately 40 minutes of monitoring battery status when the AC power supply cable is not connected ...

Page 63: ... battery OK CardioMax will turn off shortly Warning Connect Multifunctional Paddles 100 100 35 100 See the indication for low battery above 1 One red battery bar and four white bars 2 Dialogue box shows low battery When you see these indications on screen this means the equipment will turn off shortly 1 2 ...

Page 64: ...d alarms are silenced for a period pre determined by the operator 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: ...7 6 X 0 9 34 NIBP Mean X 0 7 6 X 0 9 35 Respiration Default Default EtCO2 Default Default For instance if a patient registers a cardiac frequency of 60 BPM the values for the AUTO ADJUSTMENT function will be Minimum 48 and Maximum 96 Silence It allows the silence time of the physiological and technical alarms to be adjusted with times between 30 and 180 seconds When the Alarm Silenced indication i...

Page 66: ... to levels between 41 and 100 BPMs with intervals of 5BPMs in adult mode and intervals of 1 BPMs in neo mode NIBP It is possible to adjust the minimum NIBP alarm to levels between 50 and 290 mmHg to systolic diastolic and mean pressure with intervals of 5 mmHg It is possible to adjust the maximum NIBP alarm to levels between 60 and 300 mmHg to systolic diastolic and mean pressure with intervals of...

Page 67: ...m the alarm test do the following steps 1 Turn the equipment on without cables or sensors connected It should occur indication of technical alarm text messages in Infocenter disconnected sensor 2 After confirming the visual indication connect the sensor correctly If the indication disappears the alarm is working properly Otherwise change the sensor and repeat the test If the result is the same the...

Page 68: ...o that the initially measured value is outside the range Then go back to the main screen 3 Having done this the alarm should sound If it does not the alarm is probably defective 4 Repeat this procedure for the other modules remembering to test with their respective sensor and parameters 5 With the indication of an active technical alarm press the button PAUSE AUDIO for 1s and check on screen the s...

Page 69: ...ative impulse of adjustable intensity Truncated Exponential Biphasic 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 Ensu...

Page 70: ...garding the use of the CardioMax 1 Not recommended for children under one year old 2 Pacemakers may affect the device s efficiency 3 Medicines in adhesive form must be removed before starting defibrillation 4 Hypothermic patients may not respond well to defibrillation 5 Once the removal of the patient is started the defibrillation must be interrupted Qualified users Shall be considered qualified u...

Page 71: ...x If they are not connect the defibrillation cable to the pads socket located on the equipment s side as show in the image below 2 Take both pads from their base pulling them up and out 3 Apply the conductive material to the pads electrodes 4 Place pads as shown in the image below A B A Sternum B Apex ...

Page 72: ...pace midaxillary line ENSURE that the electrodes are away from each other DO NOT apply paste or gel to the thorax between the pads or the current may follow a superficial route along the thorax wall and not reach the heart 5 Check contact with the patient The STERNUM pad has a patient contact indicator The indicator goes from BAD contact red flashing LED to GOOD contact at least one LED on Make su...

Page 73: ...on bargraph Short circuit Shock inhibited Bad contact All LEDs blinking 25 Ohm Shock inhibited Bad contact All LEDs blinking 25 Ohm e 300 Ohm Shock delivered and the waveform is adjusted according to the patient s impedance No message LEDs lit up indicating contact level 300 Ohm Shock inhibited Bad contact Only the red LED is blinking Short open Shock inhibited Bad contact Only the red LED is blin...

Page 74: ... front of the adult external pads 2 Pull the pads base forward to remove them 3 This exposes the smaller electrode for children 1 2 3 The CardioMax will automatically identify that it is operating in pediatric mode Energy is limited to 50 J in the pediatric mode Adult Child ...

Page 75: ...cket of the external pads as described below 1 Connect the AED pacemaker extension cable to the equipment 2 Connect the adhesive multifunction pads to the extension cable 3 Remove the multifunction pads protective film and apply them to the patient using the same positions recommended for the external pads Sternum and Apex ATTENTION The pads are disposable and for single use cannot be reused under...

Page 76: ...s 200 J is recommended for adult use Step 2 Charge Monitor Energy OFF Seq Auto Pacemaker 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 The energy selected can be increased or decreased at any time just by rotating the s...

Page 77: ...ter the shock is delivered Monitor the patient with 3 or 5 leads ECG cables or with the defibrillation electrodes Press the Sync button in the front panel Ensure that the synchronization marker is red and lined up with the R wave and the SYNC indication is displayed next to the selected energy value Follow steps 1 2 3 for defibrillation IMPORTANT Keep key 3 shock or the two shock pads buttons pres...

Page 78: ...n or off When it is turned on the symbol blinks indicating the function is activated 2 Elapsed time Indicates how long the equipment has been used for The marker returns to zero if the equipment is turned off 3 Defibrillation electrode type Shows which defibrillation electrode is connected to the equipment ADULT adult external pads CHILD child external pads or ADHESIVE Defibrillator Sync 1 2 3 4 5...

Page 79: ...lected and charged energy The energy SELECTED by the user is shown in this display area in BLACK numbers 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 80: ...ode energy levels available after the delivery of the third shock If child pads are used the equipment will automatically limit the charge value to 50 J Auto Sequencing 50 J 100 J 200 J 50 45 Adult 0 The energy to be charged is indicated in red Auto Sequencing 50 J 100 J 200 J 50 45 Adult 1 After shock delivery the energy is updated with the next energy level Monitor Energy OFF Seq Auto Pacemaker ...

Page 81: ...lectrodes monitoring the equipment sets off the alarm and shows Shock Indicated if ventricular fibrillation ventricular tachycardia VF VT is identified 3 Charge Auto Sequencing Sets energy levels for the Auto Seq mode The user can select energy levels of 10 to 360 J for the first second and third shocks Preset values are 150 J for the first shock and 200 J for the next shocks If child pads are use...

Page 82: ...in order to guarantee that the equipment is in working order and ready to use Put the Paddles on the support Select 100J Press CHARGE Press SHOCK FUNCTIONAL TEST exit back X Step 1 Place pads on their base located on top of the equipment Step 2 Select 100 J of energy Step 3 Press the charge key and wait until the equipment sends the charge ready signal Step 4 Press the shock key ...

Page 83: ...l 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 health standards Put pads on the base Select 100J Press CHARGE Press SHOCK Passed test FUNCTIONAL TEST print OK Functional test Passed test exit back Put pads on the base Selecit 100J Press CHARGE Press SHOCK Failed test FUNCTIONAL TEST print OK Functional...

Page 84: ...er automatically the most indicated shock therapy This allows any individual with adequate training to perform assistance to a victim in fibrillation process facilitating and multiplying lifesaving possibilities Characteristics Artificial Intelligence accurate diagnosis of the patient s conditions indicating shock delivery or not Safety safeguards avoids accidental use in cases in which shock trea...

Page 85: ...he myocardium is briefly depolarized by a strong positive and negative impulse of adjustable intensity Truncated Exponential Biphasic 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 av...

Page 86: ...ng the use of the CardioMax 1 Not recommended for children under one year old 2 Pacemakers may affect the device s efficiency 3 Medicines in adhesive form must be removed before starting defibrillation 4 Hypothermic patients may not respond well to defibrillation 5 Once the removal of the patient is started the defibrillation must be interrupted Qualified users Shall be considered qualified users ...

Page 87: ...he plug on the right side of the equipment After disposing of used pads always leave a replacement pair already connected to the equipment avoiding having to replace them at the moment of the emergency ATTENTION this device has electronic safeguards and will not operate in inadvisable situations Check patient s condition Only use the equipment if the patient is not breathing NOTE When using child ...

Page 88: ...ive 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 ATTENTION the area in contact with the pads must be dry he presence of too much hair in the contact area may affect scanning In this case shave hair ATTENTION the pads must be applied directly over the skin DO NOT place pads over clothes Sternum A...

Page 89: ... 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 ATTENTION the pads are disposable and can be used in only one patient at a time Remember to always keep extra ones with the equipment For replacements please contact Instramed Monitor Energy OFF Seq Auto Pacemaker Analy...

Page 90: ...uffering a powerful electric discharge NOTE The energy delivered is pre adjusted The user cannot alter this protocol 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 a...

Page 91: ...brain avoiding irreversible damage Applying CPR 1 Lay the victim on his back on a hard flat surface 2 Run your fingers from the center of the victim s thorax descending until finding a bone that comes to a tip in the middle of the chest Sternum right above the stomach 3 Keep two fingers right below this point 4 Place the palm of your other hand above the two fingers that indicate the base of the S...

Page 92: ...ur other hand on the victim s forehead and force the head back in order to let the air through Close the victim s nostrils with the fingers which are on the forehead Take a deep breath and place your open mouth on the victim s mouth if it is a child also cover the nose with your mouth Force air inside the victim s lungs until the thorax inflates as in normal breathing Allow the person to release t...

Page 93: ...s 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 Use child pads If the pads cannot be placed within the minimal distance of 4 centimeters between them place one of them on the child s chest and another on his back Chest Back Smaller than 4 cm Larger than 4 cm ...

Page 94: ...operator to pause or disable the alarm signals to the device ALARM CONDITION Alarm Checking You can check the operation of alarm signals using an ECG simulator device capable of generating signals of ventricular fibrillation 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 i...

Page 95: ... ways Sound power Verbal information signals will always be at least 6dB A below the set to the alarm signal Messages content Verbal information signals have the following messages Analyzing heart rhythm Perform CPR for two minutes Treatment recommended do not touch the patient Shock is not recommended Put the paddles on the patient s chest Energy is being discharged internally Don t touch the pat...

Page 96: ...tant system center the atrium ventricular node also located in the right atrium which transmits the potential to the ventricles through the atrium ventricular and its branches The pacemaker uses electrical stimulation to reproduce or regulate the heart s rhythm Its function is to supply pulses in order to stimulate the heart These pulses have two characteristics that must be adjusted The number of...

Page 97: ...e 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 It must be within at least 5 BPM the security margin for the pacemaker to work In this mode the pacemaker uses the ECG signal captured by the electrodes patient cable synchronizing the pulses in order to prevent the heart s vulnerable phase ...

Page 98: ...w area to configure the pacemaker s parameters 1 PPM selection of the pacemaker s stimulation frequency The user alters the Pulses Per Minute PPM value 2 Changes between PAUSE and ON in the Pacemaker mode In PAUSE mode it does not emit any stimulation 3 Allows the change between FIXED and DEMAND modes 4 mA alters the stimulation current in milliamperes 218 BPM dII SPO2 70 PPM mA 30 II PAUSE FIXED ...

Page 99: ... Rotate the dial to the pacemaker mode The pacemaker starts in PAUSE without stimulation pulses The mode must be changed to FIXED 2 Select the leads for ECG viewing 3 With the e Jog adjust the initial current and frequency PPM values see the previous page The current value must be as low as possible 4 Go to ON with the e Jog in order to start stimulation A message in the Infocenter will inform the...

Page 100: ...on current until cardiac capture occurs The capturing is indicated by the presence of a QRS straight after the pacemaker marker NOTES There may be spontaneous beatings not related to the application of stimulation If the patient s heart frequency is above the pulse s frequency the stimulation pulses will not be applied and the stimulation markers will not appear Stimulation will not start if there...

Page 101: ...ECG cycle to the corresponding point in the next cycle For example the interval R R is the time between two successive 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 poss...

Page 102: ... follow AAMI standards for electrode performance 3 Prepare the application area according to the manufacturer instructions 4 Apply the electrodes according to the images below following the color pattern on the table on the following page 5 Connect the patient s ECG cable to the electrodes R RA L LA F LL N RL C 10 wire cable 12 leads C1 C2 C3 C4 C5 C6 R RA L LA F LL 3 wire cable 3 leads R RA L LA ...

Page 103: ...RL aVL LA LL RA RL aVF LL LA RA RL C V1 V6 C RA LA LL RL 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 R Red RA White Left Arm L Yellow LA Black Left Leg F Green LL Red Right Leg N Black RL Green Thorax C White V Brown ...

Page 104: ...switch to the Monitor mode All ECG and SpO2 alarms will be enabled The next screen will be displayed 205 BPM 1 ECG Symbol The ECG icon represents an expanding heart that indicates that the ECG s R wave peak has been detected 2 ECG numeric value and BPM measuring unit 3 The BELL Icon Indicates audio in pause or off 1 2 3 ...

Page 105: ... 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 It is affected by the patient s movements using 8 beats to define the average SLOW less affected by the patient s movements However you must pay attention to the slow response of the heart rate variation This mode uses 32 beats to define the aver...

Page 106: ...r 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 7 ST segment Enables disables the presentation of the ST segment The visual indication will occur in the column at the end of the parameter curves before the numerical values 8 Alarm The BELL icon indi...

Page 107: ...for this diagnosis is the identification of anomalies on ST elevation which can be identified in the electrocardiogram ECG evaluation When a ST elevation bigger than 2 mm is detected the patient may be suffering the acute phase of a myocardial infarction When a ST depression of more than 2 mm is detected the patient may be suffering from myocardial ischemia malnutrition of a certain part of the my...

Page 108: ...nt at which the set Q R S ends presenting upward curve in a normal situation The indication of possible acute myocardial infarction is an evident decrease of the ST segment represented by the decrease or inversion of the concavity of this region of the curve other figures ST T ST elevation ST T ST depression ST T ST depression P Q R S T Time 1s Milivolts 0 1 2 1 2 Normal ST segment Fig 1 ...

Page 109: ...able 3 wire 10 wire 5 wire Detect Pacemaker Off On Off Segmento ST Off On Off Sensitivity 5 40 20 Frequency bandwith Diag Monitor Monitor Mains supply filter Off On On 40 160 ECG ECG SETUP back exit 4 4 10 0 ST 1 2 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 limit...

Page 110: ...or is When inflating the armband SpO2 monitoring may be affected 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 Patient s excess...

Page 111: ...pment being used on the same limb In patients where the measurement is FREQUENT it must be checked if there is a prolonged reduction of blood circulation in the patient For a blood pressure measurement with greater precision it is necessary Patient at rest User adjust pressure reduction rate when necessary Patient must be Comfortably seated With legs uncrossed With feet flat on the floor With the ...

Page 112: ...iatric 18 to 26 cm Adult 25 to 35 cm Extra Large 33 to 47 cm PLACING THE ARMBAND 1 Select the measurement place Choose a place with good blood circulation without skin problems and in which armband use does not harm the patient Because of convenience and because of the fact that standard values are based on this location give preference to the upper arm 2 Check the armband s appropriate size for t...

Page 113: ...ately interrupt the measurement 2 Long term automatic Automatic measurements of systolic diastolic and mean pressures Measurements are automatically repeated during the time set by the operator To activate the automatic mode select the desired time in the Configuration Menu NIBP Interval between measurements can be selected to 1 2 3 4 5 10 15 30 60 90 minutes Interrupting NIBP measurements To canc...

Page 114: ...rted used in automatic measurements 3 Time interval between measurements 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 Manual Measurement NIBP On Off Off On Off 90 Initial pressure 60 240 On On 60 NIBP SETUP exit back 80 300 75 300 80 300 sys dia mean 5 Automatic Measurement 1 4 3 2 5 6 ...

Page 115: ...ng this function a measurement is immediately exerted Posterior measurements will be exerted in the time set by the user Time can be selected to OFF 1 2 3 4 5 10 15 30 60 90 minutes 4 Initial pressure Select the initial pressure for the armband s insufflation 5 Alarm The BELL icon indicates audio OFF ON or PAUSED Alarm limits configuration MINIMUM and MAXIMUM 6 Back Exit BACK to configuration menu...

Page 116: ...sensors manufactured by Instramed Other sensors may cause inadequate performance If you suspect a cable or conductor is ruptured avoid using the equipment due to possible risk to the operator Before using the sensor carefully read instructions which accompany it Do not wet the SpO2 sensor When handling the SpO2 cable be careful not to strangle the patient The SpO2 sensor should be repositioned eve...

Page 117: ... precision Incorrect use of the sensor Anemia Use of vasoactive drugs Patient in shock or cardiac arrest Significant number of dysfunctional hemoglobins Intravascular contrasts such as indocyanine green and methylene blue Arterial occlusion next to the sensor Sensor selection Choose an appropriate sensor in the chart below Check the instructions which accompany the sensor for application instructi...

Page 118: ...elect the selector switch to Monitor mode All ECG and SpO2 alarms will be enabled The following screen will be displayed 1 The BELL Icon Indicates audio in pause or off 2 Digital scale indicating pulse amplitude 3 SpO2 numeric value 4 Patient s pulse frequency value obtained by the oximetry sensor 4 3 2 1 ...

Page 119: ...MAL Used for most patients FAST Used when the operator needs faster answers The response is affected by the patient s movements SLOW Less affected by the patient s movements However you must pay attention to the SpO2 slow response variations 2 Alarm The BELL icon indicates audio OFF ON or PAUSED Alarm limits configuration MINIMUM and MAXIMUM 3 Back Exit BACK to the Configuration menu or EXIT to th...

Page 120: ...molecules Capnography consists of measuring and registering the carbon dioxide released at the end of expiration EtCO2 The capnograph is an EtCO2 analyzer which displays its concentration or partial pressure both digitally and in graph record The main information given by the capnograph are the exhaled CO2 partial pressure at the end of expiration respiratory frequency and the capnogram Warnings N...

Page 121: ...ch is necessary for the proper functioning of the equipment During this procedure no measurements are exerted The CardioMax can monitor EtCO2 in intubated or non intubated patients To do so you just need to change the following accessories Connect the following accessories Intubated patient sampling line and T connector Non intubated patient sampling line and nasal cannula Nonintubated patient Int...

Page 122: ...t 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 T connector Connects the sampling line into the main ventilation circuit The sampling lines are disposable and non washable ...

Page 123: ...is informed in mmHg or percents 2 EtCO2 measuring units They can be displayed in mmHg mercury millimeters or the relative percent of the value measured in mmHg divided by the atmospheric pressure in mmHg 3 Inspiration numerical value Informs in mmHg or percentage the value of CO2 measured at the end of inspiration 4 The BELL Icon Indicates audio in pause 1 2 3 4 ...

Page 124: ...ng The numeric values graphs and CO2 alarms will be activated 2 Units Selects the measuring units of the CO2 values They can be displayed in mmHg mercury millimeters or the relative percent of the value measured in mmHg divided by the atmospheric pressure in mmHg 3 Scale Alters the CO2 gain graph on the screen On mmHg 100 CO2 On Off Units CALIBRATION On Off mmHg Scale 40 40 Calibration EtCO2 SETUP...

Page 125: ...ICAL PERSONNEL 5 EtCO2 alarm The BELL icon indicates audio OFF ON or PAUSED Alarm limits configuration MINIMUM and MAXIMUM Is it possible to adjust the EtCO2 minimum alarm to levels between 18 and 96 mmHg with a 3 mmHg interval when in Adult mode and a 1 mmHg interval when in Neo mode It is possible to adjust the EtCO2 maximum alarm to levels between 21 and 99 mmHg with a 3 mmHg interval when in A...

Page 126: ...l 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 Warnings If you suspect a cable or conductor is ruptured avoid using them The respiratory rhythm must be used to detect apnea Patient s excessive movements may cause imprecise measurements 126 ...

Page 127: ...ve places You must reposition RA and LA in a way so that they are applied bellow the nipples as shown in the picture below R RA L LA F LL WARNING When repositioning the electrodes the ECG waveform and amplitude may change WARNING Only the respiration numeric value is obtained by the CO2 module The waveform is not Capnography The monitor can also show the respiratory frequency calculated by the Cap...

Page 128: ...suring unit respirations per minute Yellow indicators show that the respiratory frequency is originated via ECG cable blue indicators show that the respiratory frequency is originated via capnography If the EtCO2 and respiration are on in the defibrillator and pacemaker modes the respiration numeric indicator will be shown in the EtCO2 window with the same color indications check picture below EtC...

Page 129: ...ion monitoring On Off When turned off all visual and sound alarms will be inhibited and there will be no numeric indication for respiration 2 Respiratory frequency Determines if the frequency shown by the equipment will be obtained by thoracic impedance ECG cable or by capnography CO2 3 Apnea alarm The alarm emits a sound when a suspension of breathing is detected apnea in the specified times of 5...

Page 130: ...User manual Monitor mode Respiration 130 5 Back Exit BACK to Configuration menu or EXIT to monitoring screen ...

Page 131: ...mits events prior to 100 will be replaced with new information CardioMax does not store patient s personal data and does not allow the entrance of external data The CardioMax does not record occurrences of ALARM CONDITIONS Events stored The CardioMax stores date time heart frequency and saturation of the following events Pads change Charge values Number of shocks Turn equipment on off Loose electr...

Page 132: ...dioMax off CardioMax on Change pads Adult Endotracheal access back exit Viewing and managing events Event setting works on defibrillator monitor and pacemaker mode and allows you to manually mark the following items Events Endotracheal Access Intravenous Access Adrenaline Epinephrine Lidocaine Atrophine Morphine Nitroglycerin and Aspirin To view manage and print stored events use the e Jog control...

Page 133: ...oMax off CardioMax on Change pads Adult CardioMax off CardioMax on Change pads Adult Endotracheal access back exit 1 Patient Indicates the number of the active patient and enables changing patients 2 Print list Prints a list of events associated with a specific patient including related events and the moment when each event occurred 3 Delete memory used memory Deletes every event from the memory I...

Page 134: ...icon indicates that printing the ECG waveform associated with that event is available 15 seconds of an ECG curve are stored for each event which displays this icon To print the curve the table must be selected by browsing the table of events using the e Jog Control After selecting an event quickly press the printing button in the front panel to print it 15 seconds of the ECG wave related to the se...

Page 135: ...r use the e Jog control to enter the printing menu e Jog 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 In the ECG report the leads and corresponding amplitud...

Page 136: ...Sensitivity 20 mm mV Date 03 07 19 Time 12 25 Pads 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 See the instructions below for more informat...

Page 137: ...figurations ELETRO Print Electro Number of Leads 3 1 3 PRINTER SETUP Alarm printing Shock printing Paper size Off On Small Off Off Small On On Large back exit 1 2 3 4 6 5 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: ...never 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 See the pictures below Report GSI printer ECG 60 bpm SpO2 96 Shocks 0 Time 01 26 Speed 25 0 mm s Sensitivity 20 mm mV Date 03 07 16 Time 12 25 MODO SYNC Pads Report Bixolon printer ...

Page 139: ...inting the leads starting by the DI lead At the end of printing it returns to its normal monitoring mode 5 Number of leads Select the number of leads to be printed simultaneously in the electrocardiograph function The DI DII DIII AVR AVL AVF and C leads will be printed sequentially individually or in groups in this same sequence according to the defined value The C lead is always printed individua...

Page 140: ...ns screen of the RTC function allows you to define the number of automatic daily tests to be performed configurable in values from 1 to 3 tests It is also possible to configure the time for each of these daily tests carry out a manual test or check the status of the last test carried out Daily tests quantity 3 06 00 12 00 20 00 First Schedule Second Schedule Third Schedule Perform test manually La...

Page 141: ...ed time the CardioMax will automatically turn on and begin the test composed of the following steps Test of the connection with the ECG board Test of the defibrillator module Check of the battery level Check of the connection with the power outlet WARNING RTC AUTO TEST PRESS E JOG TO CANCEL Communication with the ECG Defibrillation 30J Battery level Connected to the main power It is possible to in...

Page 142: ...vice will save the collected data and turn off automatically WAIT 98 WARNING RTC AUTO TEST Test completed Sending data to the Central Wait Communication with the ECG Defibrillation 30J Battery level Connected to the main power Note The test of the defibrillator module will not be carried out if The equipment is connected to the computer by USB cable The paddles are not on the support or are discon...

Page 143: ...k on next to start the test Or click on cancel to close the dialog box and return to the RTC menu Once started the manual test goes through the following steps Test of the connection with the ECG board Test of the defibrillator module Check of the battery level Check of the connection with the power outlet WARNING RTC MANUAL TEST 98 Test completed Sending data to the Central Wait Communication wit...

Page 144: ...ode defined by the rotating switch on the CardioMax Status of the last test To see the data from the last test performed access CONFIGURATION GENERAL CONFIGURATIONS RTC STATUS OF THE LAST TEST In this window the information regarding the last test is available including possible failures OK Communication with the ECG Defibrillation 30J Battery Level Connected to the main power 98 Failure in the co...

Page 145: ...y 3 06 00 12 00 20 00 First Schedule Second Schedule Third Schedule Perform test manually Last test status exit RTC no transmitter 1 Number of automatic daily tests It can be configured with values of 1 to 3 tests daily 2 Time for performing the first daily test Configured by the user 3 Time for performing the second daily test Configured by the user This item will be disabled when the number of d...

Page 146: ... the CPR Maestro Note Because it is an accessory it can not be used by itself Only connected to CardioMax The CPR Maestro parameter must work on DEFRIBRILLATION CHARGE AUTO SEQUENCE and AED modes On AED mode the messages on screen and the audible ones will only be presented after the orientation Perform CPR for 2 minutesˮ To turn off the equipment simply press the ON OFF button for 3 seconds The p...

Page 147: ... with the device out of the recommended position may cause incorrect evaluations CAUTION For long lasting CPR in naked chest place a gauze between the skin and the CPR MAESTRO to avoid risk of skin abrasion ATTENTION Do not use CPR Maestro in NEONATES The reccomended for NEONATES is the resuscitation maneuver using 2 fingers without the use of CPR Maestro accessory 3 Press the ON OFF button on the...

Page 148: ...ress 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 100 J 1 45 04 Adult 0 Mode Adult 07 10 12 5 leads 80 NIBP mmHg 73 104 57 Compress faster CPR P a d s 1 2 1 CPR indicative graphic 2 Messages CPR indicative graphic on the CPR Maestro screen Audio message ...

Page 149: ... rescuer exceeded the limit of chest compression which is of 60 mm Compress faster the rescuer is performing the compressions at a frequency below the ideal limit which is of 100 to 120 compressions per minute Compress slower the rescuer is performing the compressions at a frequency beyond the limit Good compressions the rescuer is performing a perfect massage Start CPR the rescuer stopped doing t...

Page 150: ...m depth indicator When filled with the color green indicates that the compression reached the ideal depth When filled with the color red indicates too hard compression 7 Frequency indicative bar Indicated the frequency of the compressions When aligned with the red rectangles indicates need of frequency adjustments 8 Frequency indicators The red rectangles indicate very low on the left or very high...

Page 151: ...quipment only for authorized technical personnel Requirements The CardioMax can be connected to a computer through the installation of two pieces of software The SoftDEA application and the RTC application This software is found on the CD that comes with the device To install the SoftDEA application and or the RTC application observe the following requirements Windows XP Windows Vista or Windows 7...

Page 152: ...e equipment only after installing SoftDEA After the installation connect the device through an USB cable The location of the device drivers to be installed will be required They can be found in this folder C Program Files Instramed SoftDEA DRIVERS Start the SoftDEA application On the language selection screen choose among Spanish English or Portuguese You only have to select a language the first t...

Page 153: ...3 Startup Screen 1 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: ...t 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 2 Open Click this button to open a dea file that was previously saved on the computer download open ...

Page 155: ...the file 5 Amplitude selection Allows the user to vary the ECG amplitude from 0 5 mV to 3 0 mV 6 Time frame Allows the ECG to be viewed in time frames from 1 second to 60 seconds 7 Time frame scroll Allows the ECG to be viewed throughout its time scale 8 Amplitude scroll Allows the ECG to be viewed throughout its amplitude scale 9 Event viewer window After downloading the information contained in ...

Page 156: ...unt of the electrocardiogram pattern not requiring a shock ANALYZING AED Analyzing heart rhythm ASYSTOLE Asystole detected PADS DISCONNECTED The pads were disconnected CHILD PADS Child pads were connected to the device ADULT PADS Adult pads were connected to the device TURNED ON The equipment was turned on CPR Equipment indicating the CPR procedure Settings Volume and clock adjustments via SoftDEA...

Page 157: ...pts 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 However if the voice prompts emitted by the CardioMax device show signs of degradation or defects this function can be used to restore the equipment s speech synthesis...

Page 158: ...itter installed will not have communication with the central station installed on the PC RTC software operation 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 ...

Page 159: ...xt 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 This window will also be shown when receiving data via USB 1 2 3 4 5 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 soft...

Page 160: ... discarded by the system after the third attempt E mail to send Tab A B F G C D E A Selected tab B Opens the sender data tab C Field for entering the recipient s address D Field for entering the carbon copy recipients addresses E Enables or disables sending of the e mail when new tests are received F Confirms and saves the completed data G Cancels changes and closes the e mail configurations windo...

Page 161: ...ntering the sender s address D Field for entering the SMTP address E Field for entering the e mail server password F Field for entering the sending portal G Select if the server requires an en crypted connection SSL or not H Confirms and saves the completed data I Cancels changes and closes the e mail configurations window ...

Page 162: ... ID area Allows you to limit the log display to a time period and or specific equipment C Opens a new screen with a detailed report of the selected log D Log display area This contains infor mation about the tests conducted with the filters applied A double click on the content of a log will open a new screen with detailed information E Closes the equipment reading log window Note The equipment co...

Page 163: ...cking 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: ... software language and program the device communication check Note The system should be restarted for the changes to take effect Language tab A B D E C A Selected tab B Opens the Check device communication tab C Selects the software language D Confirms and saves the configurations E Cancels changes and closes the window ...

Page 165: ... for entering the time to perform the device communication check D Confirms and saves the configurations E Cancels changes and closes the window The system will perform a check at the selected time If a device has not communicated with the control center for more than 24 hours a notification will be shown on the screen ...

Page 166: ... 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 ATTENTION It is the full responsibility of the final user to make data file backups 5 Information Click to see version and software developer information ...

Page 167: ...ng to 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 To close the RTC software access the initial program screen and type S ...

Page 168: ...ed or its authorized representative otherwise this Warranty certificate may no longer be valid No internal parts are to be fixed by the user Cleaning Instramed recommends cleaning and disinfecting the equipment and its accessories every three months or shorter periods whenever excessive dirt or contamination is noticed CLEANING THE EQUIPMENT Disconnect the equipment from the mains supply before cl...

Page 169: ...s For the CPR MAESTRO Moisten a cloth with clean water and neutral detergent and clean the device until all dirty is removed Use a second dry cloth to remove excess of liquid and or foam Moisten a third cloth with Alcohol 70o and pass lightly on the product IMPORTANT RECOMMENDATIONS Never immerse in liquid and never spill liquid of any kind on any part of the equip ment Do not use any other cleani...

Page 170: ...to the electric current To recharge the battery connect the monitor to 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 Every battery has a determined lifetime which is the possible quantity of full charg...

Page 171: ...nt 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: ...ry 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 1 2 Remove the old paper bobbin monitor well ...

Page 173: ...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 6 Close the printer door The printer is ready for use Replacing the Thermal Paper of the Bixolon Printer 1 Pull the lever to open the printer door 1 2 Remove the old paper roll ...

Page 174: ...r 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 Repairs Please contact Instramed at 55 51 3073 8200 or at assistencia instramed com br or suporte instramed com br in case of repair...

Page 175: ...sitivo pode ser afetada pela presença de fontes de en ergia eletromagnética tais como equipamentos eletrocirúrgicos ou de computação tomográfica CT Pode ser prejudicada pela presença de luz ambiente forte Sendo necessário proteja a área do sensor por exemplo com uma toalha cirúrgica 2 Any dyes injected into the blood stream such as methylene blue indocaine green indigo carmine and fluorescein may ...

Page 176: ...in the specific electromagnetic environment below The customer or user of the defibrillator is advised to ensure that it is used in such an environment Tests Compliance Electromagnetic environment directives RF Emissions ABNT NBR IEC CISPR11 Group 1 The CardioMax only uses RF power for its internal functions Nevertheless its RF emissions are very low and are not likely to cause any interference in...

Page 177: ...f the patient s heart rhythm and the DEFIBRILLATION applied to the patient depending on the result of the analysis The performance of the Ion PRO is designed and veri fied for the absence of an unacceptable risk User manual Precautions restrictions and warnings If performance is lost or degraded due to electromagnetic disturbances the ECG signal may be interfered with and cardiac rhythm analysis m...

Page 178: ...000 4 5 1 KV differential mode phase phase 2 KV common mode phase ground 1 KV differential mode phase phase 2 KV common mode phase ground The quality of the power supply should be that of a typical commercial or hospital environment Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 5 UT 95 dip in UT for 0 5 cycle 40 UT 60 dip in UT for 5 cycles 70 U...

Page 179: ...ves may not be applicable in all situations Electromagnetic transmission is affected by the absorption and reflection of structures objects and people a ISM bands industrial medical and scientific between 150 KHz and 80 MHz are 6 765 MHz to 6 795 MHz 13 553 Mhz to 13 567 MHz 26 957 MHz to 27 283 MHz and 40 66 MHz to 40 70 MHz b The compliance levels in the ISM frequency bands between 150 KHz and 8...

Page 180: ... 35 120 12 23 For transmitters with a maximum output power not listed above the advisable separation distance d in meters m can be determined by using the equation applicable to the frequency of the transmitter where P is the maximum output power of the transmitter in watts W according to the transmitter manufacturer NOTE 1 At 80 MHz and 800 MHz the separation distance for the highest frequency ra...

Page 181: ... 930 1720 1700 1990 GSM 1800 CDMA 1900 GSM 1900 DECT Band LTE 1 3 4 25 UMTS Modulação de pulsob 217 Hz 2 0 3 28 1845 1970 2450 2400 2570 Bluetooth WLAN 802 11 b g n RFID 2450 Band LTE 7 Pulse modulationb 217 Hz 2 0 3 28 5240 5100 5800 WLAN 802 11 a n Pulse modulationb 217 Hz 0 2 0 3 9 5500 5785 NOTE If necessary to reach the IMMUNITY TEST LEVEL the distance between the transmitting antenna and the...

Page 182: ...stable since last shutdown Restore initial configuration Low battery autonomy Defective battery Turn off battery No QRS audio indication BEEP volume Turn on BEEP s volume in the configuration menu No alarm sound indications Operation mode Alarm indications are only active in the monitor mode No SpO2 curve SpO2 curve turned off Turn on SpO2 curve in Waveform setup Pacemaker does not start Multifunc...

Page 183: ...ser manual 22619 Defibrillator Quantity Description Code 01 A set of adult child external defibrillation pads 79001 ECG Quantity Description Code 01 5 lead ECG cable 79005 NIBP Quantity Description Code 01 Adult armband 25671 01 Armband extensor 25900 SpO2 Quantity Description Code 01 Oximetry sensor 12556 01 Oximetry sensor extensor 21176 183 ...

Page 184: ...ge 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 EtCO2 set including 79032 Tracheal sample line adult 22686 Tracheal sample line children 22687 Nasal sample line adult 22688 CPR Maestro 11066 Parts Description Code Oridion capnography board EtCO2 22684 W...

Page 185: ...e new fully charged battery 3 hours in monitor mode without the printer or a minimum of 140 shocks at 360 J or a minimum of 200 shocks at 200 J Time to fully charge the battery when fully depleted 4h 30min Maximum consumption AC 400 W Battery 15 A Fuse Location Marking Nominal current Action Rated voltage Breaking current External mains supply Fuse 5 A Normal 250 V AC 100 A External mains supply F...

Page 186: ...ce 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 Protection index IPX1 Classification Class I Electrical insulation of the equipment and its applied parts CF Type Operating mode Continuous operation Screen Size 128 2 mm x 170 9 mm Diagonal 8 4 inches Type col...

Page 187: ...haped parameters adjusted according to the patient s impedance Shock application By means of multifunction pads or external adult child pads Scales for adult external defibrillation 1 2 3 4 5 6 7 8 9 10 20 30 50 80 100 150 200 250 300 and 360 J Maximum energy limited to 50 J with child pads Charge auto sequencing When enabled it charges power previously set by the user for the first second and thi...

Page 188: ...ds 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 Maximum output voltage 2000 V Maximum output electric current 70 A 25 Ω AED mode Waveform Truncated exponential biphasic pulse Waveform parameters adjusted according to the patient s impedance Shock delivery By means of multifuncti...

Page 189: ...Maximum time from rhythm analysis beginning to discharge readiness 20 s Maximum time from beginning of defibrillator operation to discharge readiness in maximum energy 30 s The rhythm detector and recognizer does not continue analyzing ECG after a shockable rhythm is detected Size of adhesive pads Adult area 82 cm2 Child area 30 cm2 ...

Page 190: ... the files were acquired via internet through the MIT BIH database and used via computer ECG rhythm sources MIT BIH on http ecg mit edu Rhythm selection criteria rhythms were chosen according to notes present in the MIT BIH database Criteria and annotation methods the rhythms were recognized and annotated in a separate file Later they were recognized and compared for sensitivity and specificity ca...

Page 191: ...nt units to correctly identify a shockable rhythm A false positive B is the equipment s ability in measurement units to wrongly recognize a shockable rhythm A false negative C is the equipment s ability in measurement units to wrongly recognize a nonshockable rhythm A true positive D is the equipment s ability in measurement units to correctly recognize a nonshockable rhythm Values measured with t...

Page 192: ...xtrasystoles Sinus Rhythm with Pacemaker Asystole Shockable 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 Nonshockable rhythms The CardioMax meets IEC ...

Page 193: ... 20 5 19 5 19 0 15 30 27 5 30 0 31 0 31 5 31 0 29 5 27 5 15 50 49 0 52 0 53 0 52 5 51 5 48 0 45 5 15 80 77 5 81 5 82 5 83 0 80 5 76 5 74 5 15 100 96 0 101 0 102 5 103 5 101 0 96 5 92 0 15 150 143 0 151 5 155 0 153 0 148 0 141 0 137 0 15 200 191 5 201 5 205 5 206 0 203 5 192 0 177 0 15 250 240 0 250 5 256 5 256 0 254 0 241 5 224 0 15 300 284 0 302 0 305 5 306 0 305 0 290 0 270 0 15 360 344 0 363 0 ...

Page 194: ...er manual Specifications and safety 194 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 195 360 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: ...ce 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 Frequency Between 30 ppm to 180 ppm increments of 5 ppm precision 2 ...

Page 197: ... ECG amplitude or saturated ECG signal The Searching for ECG Signal message will appear on the screen or printer electrocardiograph mode when the ECG 10 mm mV amplitude is less than 2 4 mm peak to peak or sensitivity proportional Multifunction pads error If an adhesive pad is disconnected a trace line will appear on the display Range Precision 15 to 350 BPM 1 BPM of 15 to 350 BPM Rejection in comm...

Page 198: ...idth between 0 1 ms and 2 ms and amplitude between 2 mV e 700 mV are rejected in the heart beat counting Regarding the overshoot it meets the method A of the AAMI EC13 2002 standard In the range of 15 BPM the 350 BPM the pacemaker pulses are rejected 50 102 15 standard of IEC 60601 2 27 heart rate range accuracy and QRS detection range To maintain accuracy at low heart rate and high heart rate the...

Page 199: ...ectrode 3 Remove the film from the electrode and put it in place by pressing firmly PRECAUTIONS Do not open the packaging before use Do not apply the electrodes on the nipples bony protuberance cuts lesions scars only on intact skin Store at temperatures between 15 C and 40 C Non sterile single use product Discard after use ECG gel It is recommended the use of a gel suitable for medical procedure ...

Page 200: ...x Neonatal 145 mmHg max Overpressure protection by hardware Adult 300 mmHg Neonate 150 mmHg Resolution Manual mode Automatic mode 1 mmHg One measurement 1 2 3 4 5 10 15 30 60 and 90 minutes STAT mode Maximum of consecutive measurements in 5 minutes Armband Use only armband that has connector according to norm ISO 594 1 SpO2 SpO2 range Pulse range 0 to 100 30 to 250 BPM SpO2 s precision Pulse preci...

Page 201: ...und indication function Silence sound indication function Technical alarm Alarm not locked Visual indication Sound indication Suspend sound indication function Silence sound indication function CPR Maestro Precision Depth 2 Frequency 16 Minimum number of uses 100 uses GSI Printer Type Weight Speed Paper size Thermal 0 4 Kg 12 5 25 or 50 mm s 48 mm width 30 m length ...

Page 202: ...h Respiration Technique Transthoracic impedance Range Precision 3 to 150 breaths per minute 3 breaths per minute Sensitivity 1 2 3 4 5 and 6 X Electrodes RA LA Scan speed 6 25 12 5 and 25 mm s The impedance frequency of the breathing detector signal is of 150 15 KHz at 82 microamps RMS rectangular wave at 100 Ohms Capnography Weight 160 gr ...

Page 203: ...mHg Calibration 2 points Start 10 seconds to start the CO2 curve Less than a minute for full functioning Consumption 1 5 W Format Graphic Memory 72 hours Non volatile Data Interval 25 seconds Graph format A graph per vital sign WARNING If the patient s physiological signs are below the specified in the manual the results presented may be imprecise ...

Page 204: ...tion to a power source use distinct from that described in the User manual or irregular working conditions Any attempt to violate adjust or repair this equipment by individuals not authorized by Instramed Indústria Médico Hospitalar Ltda will automatically invalidate this warranty This also applies in case of alterations made to this contract the fiscal receipt or to the equipment s serial number ...

Page 205: ...www instramed com br 55 51 3073 8200 2460 Biphasic Monitor Defibrillator ...

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