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5 - Information

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Summary of Contents for DUALMAX

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

Page 2: ...ce 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 DualMax Instramed and its respective logos are trademarks of Instrame...

Page 3: ...quently being unable to use the DualMax 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 discharge cycles without loss of performance When the appliance has a drop in performance of the batte...

Page 4: ...Included items 1 Dualmax and accessories listed in Accessories chapter Optional items Optional items listed in Accessories chapter Consult availability IV Package contents ...

Page 5: ...ed for prices Shipping may apply To request parts and services contact your local representative the list can be found at www instramed com br or directly contact Instramed by telephone at 55 51 3073 8200 The items already included may be acquired for replacement as extra items V Replacement parts ...

Page 6: ...dards 26 Device care 27 Grounding 27 Electromagnetic compatibility 28 Disposing of the device 28 The equipment 29 Front panel 29 Screen 30 e Jog control 30 Selector switch 30 Quick access buttons 31 Power and battery charging indications 31 Side view 32 1 Printer 32 2 Pads 32 3 Transport handle 32 4 Temperature connector 32 5 Temperature connector 33 6 ECG connector 33 7 Capnography exhaust connec...

Page 7: ... connector 35 6 Grounding and potential equalizer 35 7 USB connector 36 8 LAN connector 36 9 USB host connector 36 Screen and operation 37 Turning on and operating 37 1 Selector switch 37 2 Defibrillator mode 37 3 AED mode 38 4 Turns equipment off 38 5 Pacemaker mode 38 6 Monitor mode 38 7 Auto Seq mode 38 Operating e Jog control 39 Information bar 40 Quick access bar 40 Monitor mode screen Variat...

Page 8: ...y 50 Technical alarm medium priority 51 Battery charge level 59 Pause audio 59 Configuration of alarm limits 59 Minimum Maximum limits adjustment 61 Technical alarm test 62 Physiological alarm test 63 Defibrillator mode 64 Physics principle used 64 Warnings 64 Use criteria 65 Qualified users 65 External pads use 66 About shock delivery 68 Child pads use 69 Using multifunction pads 70 Defibrillatio...

Page 9: ...k 76 2 Second shock 76 3 Third shock 77 4 Back Exit 77 AED mode 78 Introduction 78 Characteristics 78 Physics principle used 79 Use criteria 80 Qualified users 80 Operation 81 Applying CPR 85 Using the DualMax on children under 8 years old 87 Alarm system 88 Information signals 88 CPR Maestro 90 Using the CPR Maestro 90 Feedback 92 Messages 94 CPR graphic 94 Pacemaker mode 96 Physics principle use...

Page 10: ...s 103 Color patterns 103 Operating in monitor mode ECG 104 ECG Setup Principal 105 1 ECG response 105 2 ECG cable 105 3 Detect pacemaker 106 4 Amplitude 106 5 Frequency bandwidth selection 106 6 Mains supply filter 106 7 ST 106 8 Sudden Death Prevention SDP 106 9 Next page 106 10 Back Exit 106 ECG configurations Alarm 107 1 Alarm sound 107 2 Maximum limit 107 3 Minimum limit 107 4 Alarm sound 107 ...

Page 11: ...ressure 114 5 Next page 114 6 Back Exit 114 NIBP configurations Alarm 115 1 Alarm 115 2 Maximum limit Systole 115 3 Minimum limit Systole 115 4 Maximum limit Diastole 115 5 Minimum limit Diastole 115 6 Maximum limit Average 116 7 Minimum limit Average 116 8 Previous page 116 9 Back Exit 116 Monitor mode SpO2 117 Physics principle used 117 Factors which affect the SpO2 measurement s precision 118 S...

Page 12: ... Capnography 122 Physics principle used 122 Warnings 122 Capnography monitoring 123 EtCO2 numeric indicator 124 EtCO2 setup Principal 125 1 CO2 On Off 125 2 Units 125 3 Scale 125 4 Calibration 126 5 Calibration status 126 6 Next page 126 7 Back Exit 126 EtCO2 configurations Alarm 127 1 Alarm sound 127 2 Maximum limit 127 3 Minimum limit 127 4 Previous page 127 5 Back Exit 127 Monitor mode Respirat...

Page 13: ...rm 132 2 Maximum limit 132 3 Minimum limit 132 4 Previous page 132 5 Back Exit 132 Temperature monitoring 133 Physics principle used 133 Monitoring temperature 134 Temperature numeric indicator 134 Temperature configuration 134 Temperature configurations Principal 135 1 Temperature 1 135 2 Temperature 2 135 3 Unit 135 4 Next page 135 5 Back Exit 135 Temperature configurations Alarms 136 1 Temperat...

Page 14: ...Channel 1 scale 140 4 Channel 1 clear transducer 140 5 Channel 1 reset status 140 6 Channel 2 On Off 141 7 Channel 1 scale 141 8 Channel 1 clear transducer 141 9 Channel 1 reset status 141 10 Next page 141 11 Back Exit 141 IP configurations P1 alarms 143 1 IP alarms 1 143 2 Maximum limit Systole 143 3 Minimum limit Systole 143 4 Maximum limit Diastole 143 5 Minimum limit Diastole 143 6 Maximum lim...

Page 15: ...ries 147 ST segment 148 Relation between ST elevation and myocardial infarction 148 ST elevation characterization 149 ST levels detection 150 ST segment configuration 150 Turning ST segment on and off 151 ST configurations Alarms 152 1 ST alarms 152 2 Maximum limit 152 3 Minimum limit 152 4 Previous page 152 5 Back Exit 152 Event and data storage 153 Data storage 153 Events stored 153 Patient conf...

Page 16: ... 157 Keyboards 158 Printing 159 General 159 Instant printing 159 Continuous printing 160 Stop printing 160 Configurations 161 1 Alarm printing 161 2 Shock printing 161 3 Paper size 162 4 Electrocardiograph function 162 5 Number of leads 162 6 Back Exit 162 Functional test 163 General 163 Performing the functional test 163 RTC Real Time Check 165 General 165 RTC Operation on DualMax 165 1 Number of...

Page 17: ...tion 169 Connecting the DualMax to a PC 169 Startup screen 170 1 DualMax services initialization button 170 SoftDEA language selection screen 171 1 Buttons of SoftDEA language selection 171 Graphics generated by AED mode display screen 172 1 Download 172 2 Open 172 3 Print 173 4 PDF 173 5 Select all 173 6 Event viewer window 173 Events graphics display screen 174 1 Patient data window 174 2 Event ...

Page 18: ...he thermal paper 189 Repairs 190 Precautions restrictions and warnings 190 1 ECG 190 2 SpO2 190 3 Electromagnetic compatibility 191 Electromagnetic immunity General 193 Electromagnetic immunity Equipment with life support functions 194 Electromagnetic immunity Equipment with life support functions 195 Troubleshooting 197 Accessories 198 Included items 198 Optional items 200 Specifications and safe...

Page 19: ...206 External pacemaker optional 210 ECG 211 NIBP Non Invasive Arterial Pressure optional 214 SpO2 BCI optional 215 Respiration 215 Capnography optional 216 Printer opcional 216 CPR Maestro optional 217 Temperature 217 Invasive pressure optional 217 Warranty certificate 218 ...

Page 20: ... 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 DualMax is a modern practical lightweight compact and portable ...

Page 21: ...d professionals on patients who need defibrillation 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 DualMax defibrillator monitor series alerting the user to possible safety risks This manual is part of the DualMax and ...

Page 22: ...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 DualMax 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 gas...

Page 23: ... patient at a time NOTICE the applied parts electrodes sensors armbands etc are protected against defibrillation discharge during discharge there may be baseline variation WARNING when the DualMax is operated in monitor mode it can be used with other electromedical equipment simultaneously connected to the patient provided that the other equipment are in compliance with the safety standards WARNIN...

Page 24: ...al leakage Possibility of erythematous skin at the pacemaker electrodes exposition place especially during prolonged use Possibility of discomfort and pain with the use of high levels of pacemaker current In case of high levels of current it is recommended that the patient is anesthetized or unconscious Possibility of eczematous skin due to the use of non biocompatible electrodes Always use access...

Page 25: ...is side upwards Fragile equipment Maximum stacking of 4 units Maintain protected from the rain Storage temperature limits The norms EN 60601 1 IEC 60601 1 and ISO 15223 are used as reference for the symbols Operation temperature limits The norms EN 60601 1 IEC 60601 1 and ISO 15223 are used as reference for the symbols Minimum and maximum atmospheric pressure Minimum and maximum relative humidity ...

Page 26: ...basic safety and essential performance Collateral standard Electromagnetic compatibility Requirements and test NBR IEC 60601 1 4 Medical electrical equipment Part 1 4 General requirements for the safety Collateral Standard Programmable electrical medical systems NBR IEC 60601 1 6 Medical Electrical Equipment Part 1 6 General requirements for basic safety Collateral Standard Usability NBR IEC 60601...

Page 27: ...bles connected to the patient in order to restrict the possibility of strangulation Keep the defibrillator in a dry environment avoiding places that allow liquids to spill over the monitor Do not use the defibrillator if it is wet or excessively humid Always keep the equipment and its accessories clean and well maintained If you suspect a fall or external damage do not use the equipment Grounding ...

Page 28: ...eferred to the manufacturer for the final destination thus preserving the natural resources and contributing to the conservation of the environment For disposal of products from Instramed contact us by the telefone numbers available on the website www instramed com br or by the e mail qualidade instramed com br Avoid contamination of the environment humans or other equipment by making sure to prop...

Page 29: ... Jog control access to the equipment s general settings and menu navigation 5 Quick access buttons see item Quick access buttons forward in this chapter 6 Disarm disarms the stored charge 7 Sync activates synchronization 8 Selector key turns the equipment on and off selects the operation mode see following chapters 9 Charge charges the electrodes with the selected charge 10 Shock applies shock 11 ...

Page 30: ... similarly to a computer mouse PRESS works similarly to the enter button on a computer confirming the selection Selector switch 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 position enables extern...

Page 31: ...MINATE period For more 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 Power and battery charging indications OBS when the equipment is connected to an electric current the LEDs will light up indicating the b...

Page 32: ...trocardiograms and events For more information view the Printing chapter 2 Pads The pads accompanying the DualMax must be placed on top of the equipment and must be properly connected to the adult adapter 3 Transport handle Handle used to carry the equipment 4 Temperature connector Temperature connector YSI 400 standard channel 1 ...

Page 33: ... 12 simultaneous leads This connector substitutes the standard connector and is not compatible with the 3 or 5 wire cables 7 Capnography exhaust connector Connector used for the removal of the gases collected by capnography For more information see chapter 12 Capnography 8 Capnography connector Connector for the capnography sampling line 9 NIBP connector Connector for direct use with the armband 1...

Page 34: ...vasive pressure connector channel 2 14 Defibrillation electrodes pads connector Multifunctional adhesive pads for desfibrillation pacemaker and monitoring Adult child external pads accompany the equipment may be used in adults and children Cannot be used for pacemaker mode Rear panel 1 2 3 5 4 9 6 7 8 ...

Page 35: ...equipment NOTE do not remove the battery 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 identificatio...

Page 36: ...36 7 USB connector USB connector for access to data stored by the AED mode It can be plugged directly to a Windows PC 8 LAN connector Connector for wired network connection 9 USB host connector Connector for pendrive connection ...

Page 37: ...n the operator must immediately select an operation mode 1 3 4 2 6 5 7 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 37 ...

Page 38: ...equipment 4 Turns equipment off In this position the DualMax is turned off After the device is turned off only the circuit that charges the battery remains in operation This is indicated by a green LED in the base of the equipment s front 5 Pacemaker mode Enables the external pacemaker The external pacemaker will only work if the multifunction pads adhesives are connected to the equipment 6 Monito...

Page 39: ...ted 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 40: ... access bar is present in all operating modes of the equipment In it are present access buttons to different functions NOTE the available functions may vary according to the parameters installed and according to the operating mode selected The buttons shown below are only an example and may vary 1 2 3 4 5 6 7 1 Button to access the configuration menu 2 Operating mode active 3 Changes the number of...

Page 41: ...es exhibition 1 Information bar 2 Graphic area for parameter curves exhibition 3 RESP data 4 Temperature 1 data 5 Temperature 2 data 6 ST segment data 7 ECG data 8 SpO2 data 9 Invasise Pressure data 10 Capnography data 11 NIBP data 12 Quick access bar 7 8 9 11 10 2 1 3 4 5 12 6 ...

Page 42: ...curves exhibition 1 Information bar 2 ECG data 3 SpO2 data 4 Invasive pressure 1 data 5 Invasive pressure 2 data 6 Capnography data 7 NIBP data 8 ST segment data 9 RESP data 10 T value 11 Temperature 1 data 12 Temperature 2 data 13 Quick access bar 2 3 4 6 1 5 7 13 8 9 10 11 12 ...

Page 43: ...T segment data 4 ECG data 5 Treatment duration 6 Number of applied shocks 7 Type of pads selected and defibrillation mode 8 Charges selected for the first second and third shocks 9 Illustrative image of the treatment stage 10 Quick access bar and treatment stage information 11 Automated External Defibrillator AED volume 4 2 1 8 9 10 11 3 5 6 7 ...

Page 44: ...ent data 4 ECG data 5 Value of energy to be applied 6 Illustrative image of the treatment stage 7 Treatment duration 8 Number of applied shocks 9 Type of pads selected and defibrillation mode 10 CPR indicative graphic 11 Quick access bar and treatment stage information 12 Automated External Defibrillator AED volume 4 2 10 1 11 12 3 7 8 9 6 5 ...

Page 45: ...ves exhibition 3 ST segment data 4 ECG data 5 SpO2 data 6 Invasive pressure data 7 Capnography data 8 NIBP data 9 Treatment duration 10 Indication of active synchronism 11 Number of applied shocks 12 Type of pads selected adult child 13 Selected charge 14 CPR indicative graphic 15 Quick access bar 4 5 6 8 7 2 1 13 14 15 3 10 9 11 12 ...

Page 46: ...or parameter curves exhibition 3 ST segment data 4 ECG data 5 SpO2 data 6 Invasive pressure data 7 Capnography data 8 NIBP data 9 Treatment duration 10 Number of applied shocks 11 Type of pads selected adult child 12 Indication of active synchronism 13 Selected charge 14 Quick access bar 4 5 6 8 7 2 1 13 14 3 9 10 11 12 ...

Page 47: ...ic area for parameter curves exhibition 3 ST segment data 4 ECG data 5 SpO2 data 6 Invasive pressure data 7 Capnography data 8 NIBP data 9 Pacemaker operating status 10 Pacemaker operating mode 11 BPM measure value 12 mA measure value 13 Quick access bar 4 5 6 8 7 2 1 11 12 13 3 9 10 ...

Page 48: ...ST segment data 4 ECG data 5 SpO2 data 6 Invasive pressure data 7 Capnography data 8 NIBP data 9 Treatment duration 10 Number of applied shocks 11 Type of pads selected adult child 12 Indication of auto sequencing active 13 Charges selected for the first second and third shocks 14 CPR indicative graphic 15 Quick access bar 4 5 6 8 7 2 1 13 14 15 3 9 10 11 12 ...

Page 49: ... ECG data 5 SpO2 data 6 Invasive pressure data 7 Capnography data 8 NIBP data 9 Treatment duration 10 Number of applied shocks 11 Type of pads selected adult child 12 Indication of auto sequencing active 13 Charge selected for the first shock 14 Charge selected for the second shock 15 Charge selected for the third shock 16 Quick access bar 4 5 6 8 7 2 15 14 13 1 16 3 11 9 12 10 ...

Page 50: ...rms will occur in any mode Sound indications will only occur in monitor mode In other modes the sound indications will be disabled and the symbol beside here will be shown with the text Sound alarm off 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 exceed...

Page 51: ...x 100 Min 10 mm SPO2 Min 85 Pulse Max 160 IP channels 1 and 2 Pulse Min 40 Systole Max 200 mmHg Systole Min 90 mmHg Temperature channels 1 and 2 Diastole Max 150 mmHg Max 38 0 C Diastole Min 50 mmHg Min 30 0 C Average Max 170 mmHg Average Min 50 mmHg Technical alarm medium priority Sound and visual signals indicate that the DualMax is not able to accurately monitor the patient s status The technic...

Page 52: ...rm indicates the physiological changes of the patient and will be triggered when the value measured by the equipment exceeds the minimum or maximum limits set previously on the machine by the operator Medium Priority alarm Technical alarm indicates that the equipment is not able to monitor the patient s condition Information messages they are displayed on equipment screen in white or cyan colors T...

Page 53: ...the BPM is above the value set on the alarm configuration ECG BPM below the limit HIGH PRIORITY RED When the BPM is below the value set on the alarm configuration Asystole HIGH PRIORITY RED DualMax cannot detect valid beats for more than 4 seconds Shock Indicated HIGH PRIORITY RED Ventricular fibrillation ventricular tachycardia VF VT was identified Pacemaker detected Represented by a white vertic...

Page 54: ...ected MEDIUM PRIORITY Yellow Temperature sensor disconnected or defective TEMP T1 above the limit HIGH PRIORITY RED Temperature is above the value defined in the alarm configuration TEMP T1 below the limit HIGH PRIORITY RED Temperature is below the value defined in the alarm configuration TEMP T2 above the limit HIGH PRIORITY RED Temperature is above the value defined in the alarm configuration TE...

Page 55: ...n the alarm configuration NIBP Alarm Priority Color Possible cause Excessive pressure MEDIUM PRIORITY YELLOW The cuff s maximum pressure has been exceeded Cuff problems MEDIUM PRIORTY YELLOW The cuff is misplaced or there is leakage on measure circuit Weak signal MEDIUM PRIORITY YELLOW Pulse too weak for NIBP measurements Check the cuff s position and tightening Excessive movement MEDIUM PRIORITY ...

Page 56: ...e is above the value set in the alarm setting IBP P1 Dia below the limit HIGH PRIORITY RED Diastolic pressure port 1 value is below the value set in the alarm setting IBP P1 Mea above the limit HIGH PRIORITY RED Mean pressure port 1 value is above the value set in the alarm setting IBP P1 Mea below the limit HIGH PRIORITY RED Mean pressure port 1 value is below the value set in the alarm setting I...

Page 57: ...sible cause Connect pads MEDIUM PRIORITY YELLOW Pads are not connected Informative messsage Adhesive pads DualMax detected adhesive pads connected Adult pads DualMax detected adult pads connected Children pads DualMax detected paddles connected but the adult electrode is disconnected The same message is also exhibited when DualMax detects children adhesive pads Charging The load is not yet complet...

Page 58: ... Asynch The pacemaker is in asynchronous mode Mode Dem The pacemaker is in demand mode Printer Informative message Without paper Printer is out of paper 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 Confirm that the alar...

Page 59: ...tery status when the AC power supply cable is not connected Pause audio By pressing the Pause Audio button RAPIDLY less than 3 seconds ALL sound 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 The DualMax maintains the previous alarm settings in case of turning off for a period of 30 seco...

Page 60: ...User manual Alarms and limits 60 To change the alarm limits the user must select the ALARMS menu Then must press the Edit button to access the desired parameter ...

Page 61: ...tervals of 1 BPMs in neo mode It is possible to adjust the maximum ECG alarm to levels between 100 and 250 BPMs with intervals of 5 BPMs in adult mode and intervals of 1 BPMs in neo mode SpO2 it is possible to adjust the minimum SpO2 alarm to levels between 40 and 99 BPMs with intervals of 5 BPMs in adult mode and intervals of 1 BPMs in neo mode It is possible to adjust the maximum ECG alarm to le...

Page 62: ...ors 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 alarm will probably be defective 3 Repeat this procedure for the other modules rememb...

Page 63: ...d check on screen the suspended alarm indication for all parameters Wait for 60 s and the alarm will activate On the screen the suspended alarm signal disappears indicating the return of the alarm sound The time the alarm stays turned off is 60 s 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 ...

Page 64: ...gative impulse of adjustable intensity Truncated Exponential Biphasic Shock These impulses are used to eliminate arterial ventricular fibrillation and ventricular disturbances Warnings The DualMax has a patient impedance meter that delivers shocks in 25 to 300 Ohms impedances If a cable or conductor is suspected of being ruptured avoid using the equipment due to possible risk to the operator Ensur...

Page 65: ...garding the use of the DualMax 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 use...

Page 66: ... connect the defibrillation cable to the pads socket located on the equipment s side according to the image Press the quick release connector 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 67: ...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 GOOD BAD The STERNUM pad has a patient contact indicator The indicator goes from BAD contact red flashing LED to GOOD contact at least one LED o...

Page 68: ...rgraph Short circuit Shock inhibited Bad contact All LEDs blinking 25 Ohms Shock inhibited Bad contact All LEDs blinking 25 Ohms and 300 Ohms Shock delivered and the waveform is adjusted according to the patient s impedance No message LEDs lit up indicating contact level 300 Ohms Shock inhibited Bad contact Only the red LED is blinking Short open Shock inhibited Bad contact Only the red LED is bli...

Page 69: ...e front of the adult external pads 1 2 Pull the pads base forward to remove them 2 3 This exposes the smaller electrode for children 3 Adult Child The DualMax will automatically identify that it is operating in pediatric mode Energy is limited to 50 J in the pediatric mode ...

Page 70: ...ibed 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 after opening the wrapping the pads should be used within 24 hours ATTENTION in case of use for lon...

Page 71: ...Charge button green in the front panel or use the charge button in the external pads orange While the DualMax is charging a sound will be emitted and the measurement of the charged energy will appear on the display The energy selected can be increased or decreased at any time just by rotating the selector switch to the new charge To cancel the shock press Disarm When the charge is complete the dev...

Page 72: ...after 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 pr...

Page 73: ... of shocks Shows number of shocks delivered The counter is set to zero when 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 4 Synchronism Indicates if the synchronism is on beige When turned on the symbol flashes indicating the activation of the function 5 ...

Page 74: ...lation AUTO SEQUENCING CHARGE See Defibrillation setup below There are three sequential energy levels being that from the third shock on all subsequent shocks will use the same discharge value of the latter The preset sequence will be interrupted in the following conditions Equipment shutdown Auto Seq mode exit Reconfiguration of the Auto Sequencing mode energy levels available after the delivery ...

Page 75: ... mode 75 Defibrillation setup 1 2 1 Internal discharge time Determines how long the equipment keeps the charge ready before discharging it internally 2 Back Exit BACK to configuration menu or EXIT to go to the monitoring screen ...

Page 76: ...s will be recovered The charge and shock delivery processes are operated manually and after every delivery the energy levels are updated 2 Second shock Sets energy levels for the second shock of the Auto Seq mode The user can select energy levels from 10 to 360 J Preset values are 150 J for the first shock and 200 J for the next shocks In case child pads are used the equipment will automatically l...

Page 77: ...e next shocks In case child pads are used the equipment will automatically limit the charge to 50 J When there is use of child pads followed by the use of adult pads the last configured values for adult pads will be recovered The charge and shock delivery processes are operated manually and after every delivery the energy levels are updated 4 Back Exit BACK to configuration menu or EXIT to go to t...

Page 78: ...ed 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 treatment is not indicated or in heal...

Page 79: ... adjustable intensity Truncated Exponential Biphasic Shock These impulses are used to eliminate arterial ventricular fibrillation and ventricular disturbances Warnings The DualMax has a patient impedance meter that delivers shocks in 25 to 300 Ohms impedances If a cable or conductor is suspected of being ruptured avoid using the equipment due to possible risk to the operator Ensure that the defibr...

Page 80: ...ng the use of the DualMax 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 th...

Page 81: ... 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 pa...

Page 82: ...ve 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 The 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 83: ...ng 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 ATTENTION the pads are disposable and can be used in only one patient at a time Remember to always keep extra ones with the equipment For replacements please contact Instramed ...

Page 84: ...very under risk of suffering 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 DualMax will announce TREATMENT NOT RECOMMENDED Check if there was no movement of the pa...

Page 85: ...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 86: ...r 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 the air by removing your mouth 8 At every interval to perform mouth to ...

Page 87: ...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 Larger than 4 cm Chest Back Smaller than 4 cm ...

Page 88: ... 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 DualMax AED mode has in...

Page 89: ...ways Sound power Verbal information signals will always be at least 6 dB 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 90: ... because it is an accessory it can not be used by itself Only connected to DualMax 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 parameter will be automa...

Page 91: ... 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 on patients under 8 years old or under 25 Kg 3 Press the ON OFF button on the side of the equipment At this moment the equipment is not ready to be used yet 4 A...

Page 92: ...2 patient s chest where the compressions will be performed If yes press the ON OFF button again and start the compressions 1 Feedback The user receives CPR feedback in the following ways Message and CPR image on DualMax screen ...

Page 93: ...User manual CPR Maestro 93 1 2 1 CPR indicative graphic 2 Messages CPR indicative graphic on the CPR Maestro screen Audio message ...

Page 94: ...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 th...

Page 95: ...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 96: ...so 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 pulses per minute PPM and the strength of the cu...

Page 97: ...de the DualMax assesses the patient s heart rate applying the PPM number selected in the panel only when the heart rate is lower than the PPM value indicated 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: ...igure the pacemaker s parameters 1 Changes between PAUSE and ON in the Pacemaker mode In PAUSE mode it does not emit any stimulation 2 Allows the change between FIXED and DEMAND modes 3 Type of pads selected adhesive 4 PPM selection of the pacemaker s stimulation frequency The user alters the Pulses Per Minute PPM value 5 mA alters the stimulation current in milliamperes 1 2 4 3 5 ...

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: ...tion 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 the...

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 pos...

Page 102: ... The electrodes must 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 RA C 5 wire cable 3 leads R L LA F LL L LA F LL R RA N RL 3 wire cable 7 to 12 leads C1 C...

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 DualMax 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: ...l The ECG icon represents an expanding heart that indicates that the ECG s R wave peak has been detected 3 Number of ECG leads selected 4 The BELL Icon Indicates audio in pause or off 5 Maximum and minimum alarm values 6 mm mV value 7 Pacemaker detector symbol Represents a pacemaker generator that flashes when a pulse is detected In case the symbol is overlaid by a red X it means that the pacemake...

Page 105: ... 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 average 2 ECG cable It allows selecting the ECG monitoring by cable with 3 lead 5 lead or 10 lead Using the 3 wire ECG cable ...

Page 106: ...ion for power interference Diag or Monitor 6 Mains supply filter Enables to turn filter on or off to reduce mains supply interference with the ECG signal 7 ST Turns on or off the ST segment monitoring 8 Sudden Death Prevention SDP Allows to turn on or off the Sudden Death Prevention mode When turned on in monitoring through the adhesive pads or electrodes the equipment alarms and indicates shock i...

Page 107: ...lection of ECG alarm status active sound and disabled sound 2 Maximum limit Selection of ECG alarm maximum limit 3 Minimum limit Selection of ECG alarm minimum limit 4 Alarm sound Selection of ST alarm status active sound and disabled sound 5 Maximum limit Selection of ST alarm maximum limit ...

Page 108: ...CG menu 8 Back Exit BACK to the configuration menu or EXIT to monitoring screen When pressing the key only in Monitor Mode the DualMax will freeze 1 3 of the screen and will keep displaying in real time the curves on the rest of the space Additionally the DualMax will calculate the intervals QT QTc QRS BPM and PR to help the cardiologist ...

Page 109: ...MPLEX key will be disabled in MODE 12 DERIVATIONS or when there is a LOOSE ELECTRODE or when using the 3 lead CABLE If the clinical operator intentionally disconnects the ECG SpO2 and defibrillation module it will appear the message ECG COMMUNICATION ERROR SpO2 COMMUNICATION ERROR DEF COMMUNICATION ERROR and the ALARM SIGNALS will be automatically disabled ...

Page 110: ...sor 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 DualMax shows the results of the last NIBP measurement until a new measurement is obtained If the patient s conditions change between measurements the monitor will not detect it Patient s excessi...

Page 111: ...9 cm Pediatric 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 si...

Page 112: ...mediately 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 ...

Page 113: ...NIBP 113 NIBP numeric indicator 1 Numeric values for systolic diastolic and mean pressures 2 Icon BELL Indicates if audio is active paused or turned off 3 Maximum and minimum alarm values 1 2 3 NIBP setup Principal 1 2 3 5 6 4 ...

Page 114: ...rement mode When selecting 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 Next page Displays the next screen of the NIBP menu 6 Back Exit BACK to configuration menu or EXIT to monitoring s...

Page 115: ...m status active sound and disabled sound 2 Maximum limit Systole Selection of systole alarm maximum limit 3 Minimum limit Systole Selection of systole alarm minimum limit 4 Maximum limit Diastole Selection of diastole alarm maximum limit 5 Minimum limit Diastole Selection of diastole alarm minimum limit ...

Page 116: ...imit Average Selection of average pressure maximum limit 7 Minimum limit Average Selection of average pressure minimum limit 8 Previous page Returns to previous page on NIBP menu 9 Back Exit BACK to configuration menu or EXIT to monitoring screen ...

Page 117: ...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 every 4 hours alternating its location Any condition that may restrict blood circulation such as the armband of the arterial pressure device or extremes of system...

Page 118: ...ntravascular contrasts such as indocyanine green and methylene blue Exposure to excessive lighting 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 instructions Patient Place Description Adult Pediatric Finger hand Finger or toe hand or foot Sensor adult Sensor Y universal Child ...

Page 119: ...l scale indicating pulse amplitude 3 Patient s pulse frequency value obtained by the oximetry sensor 4 Icon BELL saturation Indicates if audio is active paused or turned off 5 Maximum and minimum alarm values for saturation measurement 6 Perfusion Measurement value in percentage 7 Icon BELL pulse Indicates if audio is active pause dor turned off 8 Maximum and minimum alarm values for pulse frequen...

Page 120: ...the SLOW NORMAL and FAST options NORMAL 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 3 Sensitivity Allows to set the parameter sensitivity to normal or high 4 Next page Displays the next page of the SpO2 men...

Page 121: ... Alarm sound Selection of alarm status active sound and disabled sound 2 Maximum limit Selection of BPM and SpO2 saturation alarm maximum limit 3 Minimum limit Selection of BPM and SpO2 saturation alarm minimum limit 4 Previous page Returns to the previous page of the SpO2 menu 5 Back Exit BACK to the configuration menu or EXIT to monitoring screen ...

Page 122: ...O2 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 Warning...

Page 123: ...ich is necessary for the proper functioning of the equipment During this procedure no measurements are exerted The DualMax 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 Intu...

Page 124: ...o the cannula and positioned on the patient T connector Connects the sampling line into the main ventilation circuit EtCO2 numeric indicator 1 Numeric value for the EtCO2 expiration The value of the EtCO2 measured at the end of expiration is informed in mmHg or percents 2 Numeric value for the FiCO2 inspiration It informs in mmHg or percentage the value of CO2 measured at the end of the inspiratio...

Page 125: ...pling pump is also operating 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 ...

Page 126: ...performed when the equipment shows a message requiring this procedure during initialization Calibration must be performed by QUALIFIED TECHNICAL PERSONNEL 5 Calibration status Displays the date of the last calibration or the current stage of calibration 6 Next page Displays the next screen of the EtCO2 menu 7 Back Exit BACK to Configuration menu or EXIT to monitoring screen ...

Page 127: ...ction of alarm status active sound and disabled sound 2 Maximum limit Selection of EtCO2 alarm maximum limit 3 Minimum limit Selection of EtCO2 alarm minimum limit 4 Previous page Returns to the previous page of the EtCO2 menu 5 Back Exit BACK to the configuration menu or EXIT to monitoring screen ...

Page 128: ...ignal 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 ...

Page 129: ...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 130: ... Monitor mode Respiration 130 Respiration numeric indicator 1 Numeric value of the respiration measured in rpm 2 Icon BELL Indicates if audio is active paused or turned off 3 Maximum and minimum alarm values 1 2 3 ...

Page 131: ...hibited 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 Respiration amplitude Selectable in 1 2 3 4 5 and 6 4 Apnea alarm The alarm emits a sound when a suspension of breathing is detected apnea in the specified times of 5 10 15 20 25 30 35 or ...

Page 132: ...e configuration menu to have access to thesubmenu of repiration configurations 1 2 3 5 4 1 Alarm Selection of alarm status active sound and disabled sound 2 Maximum limit Selection of RESP alarm maximum limit 3 Minimum limit Selection of RESP alarm minimum limit 4 Previous page Returns to the previous page of the RESP menu 5 Back Exit BACK to the configuration menu or EXIT to monitoring screen ...

Page 133: ...ce of the temperature sensor a device called a thermistor whose impedance varies according to temperature The sensor signal is picked up by the input circuit that processes the signal and converts to values expressed as degrees Celsius C or Fahrenheit F OBS temperature sensor not included with product 133 ...

Page 134: ...nnel 1 temperature numeric value 2 Channel 1 BELL Icon Indicates if audio is active paused or off 3 Channel 1 Maximum and minimum alarm values 4 Channel 2 Temperature numeric value 5 Channel 2 BELL Icon Indicates if audio is active paused or off 6 Channel 2 Maximum and minimum alarm values 7 ΔT numeric value 1 2 3 7 4 5 6 Temperature configuration Using the e Jog select the function Temperature on...

Page 135: ...on for this parameter 2 Temperature 2 Turns the channel 2 temperature monitoring on or off When turned off all visual and sound alarms are disabled e there is no numeric indication for this parameter 3 Unit Selection of the measurement unit for the temperature monitoring selectable in C Celsius or F Fahrenheit 4 Next page Displays the next screen of the temperature menu 5 Back Exit BACK to the con...

Page 136: ...nd disabled sound 2 Maximum limit temperature 1 Selection of channel 1 temperature alarm maximum limit 3 Minimum limit temperature 1 Selection of channel 1 temperature alarm minimum limit 4 Temperature 2 alarm Selection of channel 2 temperature alarm status active sound and disabled sound 5 Maximum limit temperature 2 Selection of channel 2 temperature alarm maximum limit ...

Page 137: ...ing 137 6 Minimum limit temperature 2 Selection of channel 2 temperature alarm minimum limit 7 Previous page Returns to the previous page of the temperature menu 8 Back Exit BACK to the configuration menu or EXIT to monitoring screen ...

Page 138: ...lood pressure measurement are observed The invasive technique is regularly employed in intensive care medicine anesthesiology and for research purposes Warnings The following situations may cause inaccuracy or failure in the invasive pressure measurement Cracked luer lock connections Air bubbles in sampling line Faulty infusion pump Defective reusable transducer interface cable Wrong readings caus...

Page 139: ...d minimum alarm values 4 Channel P2 invasive pressure numeric value SYSTOLE DIASTOLE AVERAGE 5 Channel P2 BELL Icon Indicates if audio is active paused or off 6 Channel P2 Maximum and minimum alarm values 1 3 2 4 6 5 Invasive pressure configuration Using the e Jog select the function Invasive Pressure on the Configuration menu to have access to the submenu of invasive pressure configurations See i...

Page 140: ...nnel 1 invasive pressure on or off 3 Channel 1 scale Changes the scale of the channel 1 invasive pressure 4 Channel 1 clear transducer Clears the channel 1 invasive pressure transducer OBS this operation must be performed in every new procedure First position the transducer and then select Start 5 Channel 1 reset status Displays the date of the last reset or the current reset step of the channel 1...

Page 141: ...transducer 10 Next page Displays the next screen of the IP menu 11 Back Exit BACK to the configuration menu or EXIT to monitoring screen WARNING a Harmful injury to the patient may be caused by the continuous pressure of the ARMBAND and resulting from twists in the connecting tubing b Very frequent measurements of blood pressure can cause injury to the patient because of interference with blood fl...

Page 142: ... pressure reduction rate when necessary c Patient must be Comfortably seated With legs uncrossed With feet flat on the floor With the back and arms propped up With the middle of the ARMBAND in the right atrium level of the heart Patient relaxed and avoiding speaking It is recommended that there be a 5 minute pause before the first reading is taken Operator position in NORMAL USE d Any reading of b...

Page 143: ...limit Systole Selection of systole alarm maximum limit for channel 1 3 Minimum limit Systole Selection of systole alarm minimum limit for channel 1 4 Maximum limit Diastole Selection of diastole alarm maximum limit for channel 1 5 Minimum limit Diastole Selection of diastole alarm minimum limit for channel 1 6 Maximum limit Average Selection of average alarm maximum limit for channel 1 ...

Page 144: ...m limit Average Selection of average alarm minimum limit for channel 1 8 Previous page Returns to the previous page of the IP menu 9 Next page Displays the next screen of the IP menu 10 Back Exit BACK to the configuration menu or EXIT to monitoring screen ...

Page 145: ...mit Systole Selection of systole alarm maximum limit for channel 2 3 Minimum limit Systole Selection of systole alarm minimum limit for channel 2 4 Maximum limit Diastole Selection of diastole alarm maximum limit for channel 2 5 Minimum limit Diastole Selection of diastole alarm minimum limit for channel 2 6 Maximum limit Average Selection of average alarm maximum limit for channel 2 ...

Page 146: ...re monitoring 146 7 Minimum limit Average Selection of average alarm minimum limit for channel 2 8 Previous page Returns to the previous page of the IP menu 9 Back Exit BACK to the configuration menu or EXIT to monitoring screen ...

Page 147: ...on of the pressure waveform Inspect the monitoring system in search for bubbles Tap gently on areas that are not visible to locate any hidden bubbles Tap slowly on the spot sample to remove all bubbles from the reservoir The operator must avoid a conductive connection between the part applied and the metallic parts of the equipment and accessories When monitoring in conjunction with a high frequen...

Page 148: ... 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 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 malnutrit...

Page 149: ...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 150: ...DI DII DIII aVR aVL aVF and C derivations These 7 ST gradients will be shown on the screen at the right end of each curve 1 1 ST segment values exhibition area ST segment configuration Using the e Jog in the main menu select the ECG parameter and in its submenu the ST Segment function to turn on or off this analysis function See figure on next page ...

Page 151: ...t 151 Turning ST segment on and off The ST segment monitoring can be turned on or off through the item ST on the ECG configurations screen see item ECG configurations principal 1 1 Turns the ST segment monitoring on or off ...

Page 152: ...f ST alarm status active sound and disabled sound 2 Maximum limit Selection of ST alarm maximum limit 3 Minimum limit Selection of ST alarm minimum limit 4 Previous page Returns to the previous page of the ECG menu 5 Back Exit BACK to the configuration menu or EXIT to monitoring screen ...

Page 153: ... mode the equipment stores in its memory the last two ECG hours Events stored The DualMax stores the date time and ECG curve of the following situations Defibrillation cardioversion Stimulation Pacemaker On Off Pause audio key activation Shock failure Internal discharge Manual event marking Indicated shock or asystole for equipment with SDP Values out of the the alarm limits Change of pads The eve...

Page 154: ... Value between 1 and 100 automatically generated for each new patient 3 Name Allows to change the patient s name through the keyboard displayed on screen See item Keyboards in this chapter 4 Age Allows to change the patient s age using the keyboard displayed on screen See item Keyboards in this chapter 5 Gender Allows selection of patient s gender ...

Page 155: ...ation menu or EXIT for the monitoring screen Mark events The Mark events menu allows the user to manually add pre set events or configure personalized events This menu is divided into two screens PRE SET EVENTS Allows to manually mark the following events Generic Endotracheal access Intravenous access Adrenaline Lidocaine Atropine Morphine Nitroglycerin Aspirin Epinephrine ...

Page 156: ...User manual Event and data storage 156 PERSONALIZED EVENTS Allows to mark or edit up to 10 personalized events VIEW EVENTS Allows to view print and transfer the generated events 1 2 7 4 3 5 6 ...

Page 157: ...w 12 seconds of curve before the event and 12 seconds after the event 4 Visualize curve associated with event Allows to visualize 8 5 of curve before an event and 8 5 seconds after a generated event For it to be possible to view the curve it is necessary that the selected event has the indication of associated curve 5 Events list Displays the events of the selected patient 6 Roll list Allows to se...

Page 158: ...Event and data storage 158 Keyboards Personalizable information from the events menu such as patient name age and personalized events are edited with the help of the keyboards below according to the selected field ...

Page 159: ...nt panel or use the e Jog control to enter the printing menu eJOG Instant printing When the print button is pressed for LESS than three seconds the DualMax prints a fast report The fast report prints the same curves being displayed at the moment The numeric indicators for the following parameters are date time trace speed and number of shocks In the ECG report the leads and corresponding amplitude...

Page 160: ... button is pressed for MORE than three seconds the DualMax prints a continuous report for an indeterminate period of time or until printing is interrupted The data in the continuous report is identical to the data in the quick printing See the instructions below for more information on use Stop printing To interrupt continuous printing or instant printing press the print key again ...

Page 161: ...hen the shock printing option is enabled in the printing setup menu the DualMax prints an instant report whenever the equipment identifies shock delivery In this report you can see the equipment s operation mode at the moment of the defibrillation MANUAL mode SYNC mode and AED mode See the pictures below ECG 60 bpm SpO2 96 Shocks 0 Time 01 26 Speed 25 0 mm s Sensitivity 20 mm mV Date 03 07 19 Time...

Page 162: ...ng 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 individually In case the ECG cab...

Page 163: ... menu and select the TEST FUNC option following the instructions shown on the screen as follows Using the button Perform functional test it is possible to start the test which takes place in a new window opened on the screen By using the Print last test report button it is possible to print the details and status of the last test performed Using the Show last test report button it is possible to v...

Page 164: ...one of the 4 steps of the functional test or when the power delivered has an energy exceeding that allowed by standards The report is shown using the same pattern of images when the test is in progress ie all test steps are shown and next to each of them there is a checkbox showing its status As well as it is possible to view the date and time data and the final result of the last test performed B...

Page 165: ...ATION RTC The configurations 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 Imprimir relatorio ultimo teste 1 2 3 8 9 5 4 7 6 1 Number of daily tests Sets the am...

Page 166: ...t performed or the current step when a test is running 7 Show last test report Shows the results of the last test performed 8 Print last test report Prints the results of the last test performed 9 Back Exit BACK to the configuration menu or EXIT to the monitoring screen Automatic test To perform the automatic test the equipment should be turned off at the programmed time At the configured time the...

Page 167: ...est Follow the instructions on screen to start the test Or click cancel to cancel the test 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 It is not possible to interrupt the manual test After completing the test the equipment will send t...

Page 168: ...agnosis of defibrillation battery level connected pads and verification of the device s connection to the mains supply Requirements The DualMax 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 obse...

Page 169: ... 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 ti...

Page 170: ...manual PC connection 170 Startup screen 1 1 DualMax services initialization button Press this button to initialize the device s configuration screen and display of ECG curves and stored events on the device ...

Page 171: ...ection 171 SoftDEA language selection screen 1 1 Buttons of SoftDEA language selection Click on the language option chosen A warning message will appear confirm clicking OK Wait for the program to be closed and reopen it ...

Page 172: ... 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 2 Open Click this button to open a dea file that was previously saved on the computer ...

Page 173: ...rom the list this way it is possible to easily print or generate PDF of all events 6 Event viewer window After downloading the information contained in the DualMax memory the list of events stored by the device will be displayed in this area in chronological order Double click on an event to view it on the main screen Definition of events displayed in AED mode ANALYZING Analyzing heart rhythm SHOC...

Page 174: ... were connected to the device Events graphics display screen On the events screen the open files will be extension ev 1 2 1 Patient data window Information regarding the analyzed patient 2 Event view window After downloading the information contained in the DualMax memory this area will display the list of events stored by the device in chronological order To view an event on the main screen doubl...

Page 175: ...he Real Time Check Control Center The DualMax can be configured to perform self tests at times specifically configured by the user The device will send the results of the following tests to the RTC system 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 Upon receiving the test results the RTC softwar...

Page 176: ...n to open the e mail configurations screen On this screen it is possible to configure the sender recipient and enable or disable sending e mails when the software receives equipment tests 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 at...

Page 177: ... 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 Confrms and saves the completed data G Cancels changes and closes the e mail confgurations window ...

Page 178: ...entering 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 encrypted connection SSL or not H Confirms and saves the completed data I Cancels changes and closes the e mail configurations window ...

Page 179: ...t 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 information 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 180: ...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 181: ... 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 182: ... 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 183: ... 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 184: ... When the DualMax performs the RTC test the results will be sent to the control center and shown on the screen along with the MAC ID code of the device Closing the application To close the RTC software access the initial program screen and type S ...

Page 185: ...d 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 cleaning it Wipe the external part of the device with a cloth moistened with water almost dry and neutral liquid soap until the e...

Page 186: ...e DEFIBRILLATION PADDLES set Dampen a cloth with clean water and mild detergent and wipe any accessories until all dirt is removed Use a second dry cloth to remove excess liquid and or foam Moisten a third cloth with 70º alcohol and lightly wipe the product IMPORTANT RECOMMENDATIONS Never immerse in liquid and never spill liquid of any kind on any part of the equipment Do not use any other cleanin...

Page 187: ...to the electric current To recharge the battery connect the monitor to charge the battery connect the monitor to an AC power source 110 or 220 V outlet or a DC power source There are no restrictions or limitations for using the DualMax 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 charge and...

Page 188: ...ill 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 4 Push the new battery until it firmly locks into the cabinet ...

Page 189: ...on to open the printer door 1 2 Remove the old paper bobbin monitor well 3 Place the new bobbin The bobbin must be positioned as shown in the picture above 4 Pull to unroll about 10 cm of paper 5 Align paper with the printer door 6 Close the printer door The printer is ready for use ...

Page 190: ...graphy CT 1 ECG 1 To guarantee protection against the effects of a defibrillation use only the patient cable that accompanies the equipment 2 If the monitor is used simultaneously with an electric scalpel position the ECG electrodes as far as possible from the RF current route between the surgical field and the neutral card Do not use needle type ECG electrode during surgical procedures 2 SpO2 1 T...

Page 191: ...s different from the ones specified above except for the ones sold by Instramed as replacement pieces may result in emission increase or immunity decrease of the equipment The DualMax must not be used too close to or piled over other equipment When the equipment is used in a surgical procedure simultaneously with an electric scalpel there is a risk of burnouts if a defect in the connection of the ...

Page 192: ...e The performance of the DualMax is designed and verified for the absence of an unacceptable risk If performance is lost or degraded due to electromagnetic disturbances The ECG signal may be interfered with and cardiac rhythm analysis may be compromised as long as electromagnetic disturbances persist The SPO2 curve can be disturbed besides the possibility of alteration in the measured value Non in...

Page 193: ... 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 UT 30 dip in UT For 25 cycles 5 UT 95...

Page 194: ...ncy ranged Interference can occur around equipment marked with the following symbol NOTE 1 at 80 MHz and 800 MHz the highest frequency range is applied NOTE 2 these directives 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 ...

Page 195: ...8 3 8 3 8 7 3 100 12 12 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 high...

Page 196: ...850 Band LTE 5 Pulse modulationb 18 Hz 2 0 3 28 870 930 1720 1700 1990 GSM 1800 CDMA 1900 GSM 1900 DECT Band LTE 1 3 4 25 UMTS Pulse modulationb 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 ...

Page 197: ...able 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 Multifuncti...

Page 198: ...functional adhesive pads Description non reusable adhesive pads for monitoring pacing cardioverting and defibrillating 20637 When 7 derivations ECG is present Quantity Description Code 1 5 lead shielded ECG cable Description 5 leads ECG cable to monitor up to 7 derivations 79005 When 12 derivations ECG is present Quantity Description Code 1 10 lead shielded ECG cable Description 10 leads ECG cable...

Page 199: ...vide strangulation of sampling line limiting pressure 22713 1 Electrical cable Description cable connecting the transducer to the device 25134 1 Sampling line Description sampling line for blood pressure system 39708 1 Transducer Description transducer that converts pressure to electrical signal 80015 When Capnography EtCO2 is present Quantity Description Code 1 Oridion capnography accessories kit...

Page 200: ...3 Cuff kit with 5 neonatal units Description neonate size cuff 79029 Extra large cuff Description extra large size cuff 24500 USB A B shielded cable Description USB cable to use for data transmition 10985 Transport bag Description transport bag to use for transport the device with all accessories 13878 Thermosensitive printer paper Description 58 mm width printer paper 11858 CPR Maestro Descriptio...

Page 201: ...DC 4 4 A h Life new fully charged battery 7 hours in monitor mode without the printer or a minimum of 280 shocks at 360 J or a minimum of 400 shocks at 200 J Time to fully charge the battery when fully depleted 4 hours Maximum consumption AC 400 W Battery 15 A Fuse Mains supply 5 A Battery storage Storing the battery for a long period of time in temperatures higher than 40 C will reduce its capaci...

Page 202: ...mode Continuous operation Isolating method from mains power supply Flexible cable with a MAINS PLUG Equipment lifetime 10 years excluding battery and adhesive pads NOTE each accessory has its own useful lifespan specified by the manufacturers by the number of uses Adhesive pads lifetime 2 years Display Battery level indication Yes Diagonal 10 4 Size Screen 10 4 210 43 mm x 157 82 mm Resolution 102...

Page 203: ...rs 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 Energy option delivered limited to 200 J Maximum energy limited to 50 J with child pads Charge auto sequencing When enabled it charges power previously set by the user f...

Page 204: ...nsion optional NOTE the adhesive pads provided by Instramed have a biocompatibility certificate in accordance with ISO 10993 External pads size Adult 10 3 cm x 8 5 cm contact area 81 9 cm Children 4 5 cm x 4 cm contact area 18 cm Pads cable length 2 meters Cardioversion 60 ms Maximum output voltage 2000 V Maximum output electric current 70 A 25 Ω AED mode optional Functional characteristics Voice ...

Page 205: ...ze of the pads Charge command Automatic after identifying an arrhythmia Shock command Frontal panel button shock Maximum charge time with 100 of the minimum specified voltage 200 J 6 s 150 J 4 s 50 J 2 s 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...

Page 206: ...inus Bradycardia Atrial Tachycardia Atrial Fibrillation Atrial Flutter Supraventricular Tachyarrhythmia Normal Rhythm with Extrasystoles 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 DualMax meets IEC 60601 2 4 requirements for sensitivity 9...

Page 207: ... 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 208: ...er manual Specifications and safety 208 Values on the Y axis refer to voltage volts and values on the X axis refer to time milliseconds 360 J of energy at 25 R impedance 360 J of energy at 50 R impedance ...

Page 209: ...User manual Specifications and safety 209 360 J of energy at 75 R impedance 360 J of energy at 100 R impedance 360 J of energy at 125 R impedance ...

Page 210: ...0 J of energy at 150 R impedance 360 J of energy at 175 R impedance External pacemaker optional Waveform Single phase rectangular pulse Modes Demand or fixed Amplitude Between 5 mA to 200 mA resolution of 5 mA precision 10 Pulse width 20 ms 1 ms ...

Page 211: ...drogel and silver sensor Ag AgCl latex free USE INSTRUCTIONS 1 Shave hairs clean the spot and dry with gauze 2 Before removing the protective film attach the ECG wire to the electrode 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 int...

Page 212: ... 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 common mode Higher than 90 dB measurement in compliance with the AAMI standards for heart monitors EC 13 Sensitivity 5 10 15 20 30 and 40 mm mV Scan speed 12 5 25 or 50 mm s Filter 35 Hz or 60 Hz ECG response frequency Diagnostic mode 0 05 100 Hz Monitor mode 1 40 Hz Patient i...

Page 213: ...re rejected Maximum amplitude of the T wave It meets the minimum recommended value of 1 2 mV for the T wave amplitude rejection Accuracy of cardiac frequency in irregular rhythms It complies with the AAMI standard for Ventricular bigeminy FC 40 BPM Slow alternating ventricular bigeminy FC 30 BPM Fast alternating ventricular bigeminy FC 120 BPM Bidirectional systoles FC 45 BPM Input dynamic range a...

Page 214: ...ector according to norm ISO 594 1 Automatic mode 1 2 3 4 5 10 15 30 60 e 90 minutes Manual mode One measurement Adult range Systolic 40 to 260 mmHg Mean 26 to 220 mmHg Diastolic 20 to 200 mmHg Pediatric range Systolic 40 160 mmHg Mean 26 133 mmHg Diastolic 20 120 mmHg Neonatal range Systolic 40 to 130 mmHg Mean 26 to 110 mmHg Diastolic 20 to 100 mmHg Overpressure limit per software Adult 290 mmHg ...

Page 215: ... 25 and 50 mm s Physiological alarm Alarm not locked Minimum level 40 95 Maximum level 45 100 Visual indication Sound indication Technical alarm Alarm not locked Visual indication Sound indication Respiration Technique Transthoracic impedance Range Precision 3 to 150 breaths per minute 3 breaths per minute Sensitivity 1 2 3 4 5 and 6 Electrodes RA LA Scan speed 6 25 12 5 and 25 mm s ...

Page 216: ... each 1 mmHg above 38 mmHg 39 99 mmHg Calibration 2 points Start 10 seconds to start the CO2 curve Less than a minute for full functioning Consumption 1 5 W Compensation BTPS N2 O O2 Printer opcional Type Thermal Weight 0 2 Kg Speed 12 5 25 or 50 mm s with precision of 5 Paper size White thermosensitive paper 58 mm x 15 m x 40 mm of exernal diameter ...

Page 217: ...ion Depth 2 Frequency 16 Minimum number of uses 100 uses Temperature Technique Thermistor serie YSI 400 Range 0 to 50 C 32 to 122 F Precision 0 1 C Temperature sensor It must be used reusable temperature sensor adult or child type YSI 400 25ºC 2 252 K Ohms Invasive pressure optional Consumption 350 mW Weight 20 g Filter 50 and 60 Hz Measures interval 99 mmHg to 310 mmHg Clearing interval 70 mmHg P...

Page 218: ... 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 Inst...

Page 219: ...www instramed com br 51 3073 8200 ...

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