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1. Maximum output electric current AED mode Waveform Shock delivery Defibrillation scales Adult children s selection Charge command Shock command Maximum charge time with 100 of the minimum specified voltage Maximum time from rhythm analysis beginning to discharge readiness Maximum time from beginning of defibrillator operation to discharge readiness in maximum energy User manual Specifications and safety 70A 25 Q Truncated exponential biphasic pulse Waveform parameters adjusted according to the patient s impedance By means of multifunction adhesive paddles Adult 150 and 200J Child 50J Automatic due to the size of the pads Automatic after identifying an arrhythmia Frontal panel button shock 200J lt 6s 150J lt 4s 50J lt 2s 20s 30s The rhythm detector and recognizer does not continue analyzing ECG after a shockable rhythm is detected Size of adhesive pads Adult area 82 cm Child area 30 cm 150 User manual Specifications and safety ECG analysis algorithm Databases used for the VF VT recognition algorithm tests e MIT BIH Arrhythmia Database e MIT BIH Atrial Fibrillation Database e MIT BIH Supraventricular Arrhythmia Database e European Society of Cardiology e Creighton University Test report e Recording methods the files were acquired via internet through the MIT BIH database and used via computer e
2. 20 charged Enables approximately 40 minutes of monitoring battery status when the AC power supply cable is not connected 55 User manual Alarms and limits SPO2 CardioMax will turn off shorily INFOCENTER 09 44 Connect 07 10 12 Multifunctional Paddles See the indication for low battery above 1 Five white battery bars 2 Dialogue box shows low battery When you see these indications on screen this means the equipment will turn off shortly 56 User manual Alarms and limits Silence disarm alarm A When pressing the ALARM SILENCE button with a FAST touch shorter than 3 seconds ALL alarm audio indications will be silenced for a period of time predetermined by the operator Your visual indication is the Alarm Silenced icon in all parameters Suspend Alarm Ka When pressing the ALARM SILENCE button with a LONG touch longer than 3 seconds ALL alarm audio indications are silenced for an INDETERMINATE period of time Your visual indication is the Alarm Disarmed icon in all parameters IMPORTANT No audio alarm will emit a sound when the alarm is disarmed 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 ep Ess 57 User manual Alarms and limits Auto set Silence ECG tech
3. b Electrode identified as APEX positioned on the left sixth intercostal space 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 sure to adjust the pressure and the pads placement to optimize contact with the patient so that AT LEAST ONE GREEN LED remains on 64 User manual Defibrillator mode About shock delivery Aligning the pressure of the pads and the conductive material applied to the electrodes different patient impedances are obtained The table below indicates the conditions in which the CardioMax offers or inhibits the delivery of energy Patient s Message on screen after Values indicated on impedance Charge key pressed bargraph Short circuit Shock inhibited Bad contact All LEDs blinking Shock inhibited Bad contact All LEDs blinking Shock delivered gt 25 ohme ano dee dios D N LEDs lit up indicating contact lt 300 ohm adjuste according o message ieval to the patient s impedance gt 300 ohm Shock inhibited Bad contact Only the red LED is blinking Short open Shock inhibited Bad contact Only the red LED is blinkin
4. o SH a Es I Cal W EE N I OT gt 25 Ohms AND lt 300 Ohms Shock delivered with a waveform adjusted to the patient s impedance gt 300 Ohms Shock inhibited 154 User manual Specifications and safety Values on the Y axis refer to voltage volts and values on the X axis refer to time milliseconds 360J of energy at 25R impedance 360J of energy at 50R impedance 155 User manual Specifications and safety 360J of energy at 75R impedance GN soov Pi4 00ms 360J of energy at 100R impedance GT soov 4 P O Oms 360J of energy at 125R impedance ail soov Pl10 0ms User manual Specifications and safety 360J of energy at 150R impedance P10 0ms 360J of energy at 175R impedance SI 500v 4 P 10 0ms Pacemaker Wave form 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 1ms Frequency Between 30 ppm to 180 ppm increments of 5 ppm precision 2 157 Refractory period Maximum output voltage ECG Input Electrode error Low ECG amplitude or saturated ECG signal Multifunction pads error Range Precision Rejection in common mode Sensitivity CA line filter ECG response frequency User manual Specifications and safety 340 ms between 30 to 80 ppm 240 ms be
5. Maximum consumption AC 400W Battery 15A Fuse 5A power supply Battery storage Storing the battery for a long period of time in temperatures higher than 40 C will reduce its capacity and shelf life 147 Memory RTC Real Time Check available when equipped with Li lon optional battery Protection Index Classification Functioning mode Screen Scan Speed User manual Specifications and safety Capacity 2 Mbytes Patients stored gt 150 patients ECG recording of 2 continuous hours of the ECG curve when the AED mode is on Storage 15 seconds of ECG when in shock physiological alarm and panel events Defibrillation self test battery level connected pads power source connection check Check is performed 3 times which are set in advance This information is wirelessly transmitted to a PC with RTC System software installed and within range of the network IPX1 Class I CF Type Continuous operation Size 128 2 mm x 170 9 mm Diagonal 8 4 inches Type color LCD TFT Resolution 640 x 480 pixels VGA 12 5 25 and 50 mm s Environmental specifications Temperature Humidity Operational 0 to 50 C Storage 20 to 50 C Operational 10 to 95 RH without condensation Storage 10 to 95 RH without condensation WARNING If the CardioMax is used outside these conditions 15 through 30 minutes will be required to stabilize the system so that functioning failures do not o
6. 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 35 User manual Screen and operation Startup screen The startup screen is displayed whenever the device is turned on It displays a list of all parameters available to CardioMax by showing the corresponding status next to each item OK Parameter has been installed and runs accordingly 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 IN ST RAJE D CARDIO MAX bi phasic ECG Resp AED SPO2 NIBP Defibrillator Pacemaker Printer EtCO2 not present Firmware Version CPU SWCPUH CM123R1 Firmware Version ECG SWECGDSP CM305 Firmware Version CTBF SWCTBFARM7 CM315 36 User manual Screen and operation Parameters visualization screen INFOCENTER 09 44 Shock OK 07 10 04 1 Graph area for oximetry ECG and 5 Infocenter Information on the equip EtCO waveforms Also used for con ment and its operation This is how the figurations device communicates with the user 2 Time date battery and mode status 6 SpO Oximetry m
7. User manual Defibrillator mode Use criteria In defibrillation mode the CardioMax must only be used if the following circumstances as a whole are presented 1 Unconscious victim 2 No breathing 3 No pulse Other important considerations regarding the use of the CardioMax 1 Not recommended for children under one year old 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 those who have a degree in Medicine 62 User manual Defibrillator mode External pads use 1 Check if the pads are connected to the CardioMax If they are not connect the defibrillation cable to the pads socket located on the equipment s side as show in the image below LR 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 Sternum B Apex 63 User manual Defibrillator mode The electrodes must be placed in a position which will maximize the current that passes through the myocardium The standard position is a Electrode identified as STERNUM on the right second intercostal space mid clavicular line
8. 20 to 100 mmHg Adult 290 mmHg max Neonatal 145 mmHg max 1 mmHg One measurement 1 2 3 4 5 10 15 30 60 and 90 minutes Maximum of consecutive measurements in 5 minutes 0 to 100 30 to 250 BPM 160 SpO s precision Pulse precision Scan Physiological alarm Technical Alarm Printer Type Weight Speed Paper size Respiration Technique Range Precision User manual Specifications and safety 2 70 to 100 3 50 a 69 2 BPM 12 5 25 e 50 mm s Alarm not locked Minimum level 40 95 Maximum level 45 100 Visual indication Sound indication Suspend sound indication function Silence sound indication function Alarm not locked Visual indication Sound indication Suspend sound indication function Silence sound indication function Thermal 0 4 Kg 12 5 25 or 50 mm s 5 accuracy 48 mm width 30 m length Transthoracic impedance 3 to 150 breaths per minute 3 breaths per minute 161 Sensitivity Electrodes Scans Capnography Weight CO measurement interval Precision Calibration Start Consumption Format Memory Data Interval Graph format User manual Specifications and safety 1 2 3 4 5 and 6 X RA LA 6 25 12 5 and 25 mm s 160 gr 0 99 mmHg 2 mmHg 0 38 mmHg 5 0 08 for each 1mmHg above 38 mmHg 39 99mmHg 2 points 10 seconds to start the CO curve Less than
9. Pacemaker Quantity Description 01 Trunk cable 01 Multifunctional pads List of optional accessories Description Internal defibrillation electrode adult Internal defibrillation electrode child Cable for internal electrodes adult and child Y 3043 type oximetry sensor Y 3043 type oximetry sensor holder Cable for external DC connection Thermal printer paper 146 Specifications and safety General specifications Dimension with pads 30 0 cm L 21 5 cm P 28 0 cm A Weight Device 5 15 kg 11 35 Ibs NiMH battery 1 10 kg 2 43 Ibs Li lon battery 0 60 kg 1 32 Ibs External pads 0 85 kg 1 87 lbs Complete set NiMH battery 7 10 kg 15 66 Ibs except NIBP Complete set Li lon battery 6 60 kg 15 66 Ibs except NIBP Power AC 100 TO 265 VAC 50 60 Hz DC external 11 to 16 VDC Removable rechargeable battery Type NiMH 14 4V DC 4 5 A h Life 3 hours fully charged battery without the printer or a minimum of 140 shocks at 360 joules or a minimum of 200 shocks at 200 joules Time to fully charge the battery when fully depleted 8 hours Optional battery Type Li lon 14 8 VDC 4 4 A h Life 3 hours fully charged battery in monitor mode without printer or a minimum of 140 shocks at 360 Joules or a minimum of 200 shocks at 200 joules Time to fully charge the battery when fully depleted 8 hours Consult availability
10. 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 87 User manual Pacemaker mode Operating in pacemaker mode Place the selector switch on pacemaker mode The screen below will appear With the e Jog navigate on the yellow area to configure the pacemaker s parameters Monitor Pacemaker mA TNT FIXED 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 88 User manual Pacemaker mode Starting stimulation 1 If it not yet connected connect the adhesive pads cable to the CardioMax 2 Check if the multifunction adhesive pads package is intact and within the expiration date 3 Insert the adhesive pads connector into the equipment s extension cable 4 Put the adhesive pads on the patient according to package instructions 5 In case of demand mode stimulation apply ECG monitoring electrodes Fixed stimulation 1 Rotate the dial to the pacemaker mode The pacemaker starts in PAUSE without stimulati
11. EEE 70 VAN Elapsed iMenso EE E 70 3 Defibrillation electrode fvpe ENEE ENEE 70 4 Number of shocks ae ekenandg dd 71 5 Selected and charged energy c cssssscecsseecssesnesesessesesesestecenesenerseennenseess 71 Charge Auto Sequencing mode Auto Gen 72 Defibrillation setup EE 73 1 Internal discharge TEE 73 2 Sudden Death Prevention SDP siscnupsutashentianaicneiiaramaeewnaunes 73 3 Charge AUt0 Seque ning wiscssescccsscasscussessseeseseeeeetstneenestanentteessennnstarsaannaneneneet 73 Ee E 74 PUNCH OMe VCS E 74 Result screens for functional feste 75 AED mode 76 La eener EE 76 OE ee EE ose E E aE AES EEEE 76 Physics principle used BE T7 KEE 78 Eelere EE EE 78 Go EEE EE NE REE ENE 79 User manual Index Applying Ee 83 Using the CardioMax on children under 8 years old 85 Pacemaker mode 86 Physics principle used EE 86 2100 EE NE EE 86 EE 87 Demand mode synchronous E 87 Operating in pacemaker MOde EEN 88 Starting 111400 Eg EE EE 89 Feld vasene Banat benker 89 Under demand samul ton navnemeananensennne dunkle sinnets 90 Kei MOA EE EE area 90 Monitor mode ECG 91 Physics principle used EE EEE ES NE nen nnnn neee 91 LE 0110 eier eege 91 EE 92 Leads SP 93 Color EE ee 93 Operating in monitor mode ECG ccecseseceesseseseseseeseeeseeseseeeeseseeesesnesnseeeeseneeees 94 EEE EE EET ENE EE 95 1 ECG WS OSG EEE EE 95 ZEISS CAG EE 96 FN EE 96 4 Frequency bandwidth selechon EEN 96
12. 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 93 RL Green User manual Monitor mode ECG Operating in monitor mode ECG Turn the selector switch to the Monitor mode All ECG and Spo alarms will be enabled The next screen will be displayed Pacemaker 1 ECG Symbol The ECG icon 3 BELL icon indicates that the represents an expanding heart that alarm has been activated inhibited or indicates that the ECG s R wave peak suspended has been detected 4 Indicates the selected lead 2 ECG numeric value and BPM measuring unit 94 User manual Normal Slow emm 3 wire 3 wire enn Sensitivity Frequency bandwidth Mains supply filter Detect Pacemaker 1 ECG response Select the ECG numeric update response You can select from SLOW NORMAL and FAST responses NORMAL used for most patients this mode uses 16 beats to define the average FAST used when the operator needs faster responses 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 95 User manual Monitor mode ECG 2 ECG cable Enabl
13. Graph area for oximetry ECG and EtCO waveforms Also used for con figurations 4 Infocenter information on the equip ment and its operation This is how the device communicates with the user 42 5 7 8 Information on the pacemaker mode NIBP measurement values for systol ic diastolic and mean Non Invasive Blood Pressure SpO Oximetry measurements and oximetry alarms Access icons for event and configura tion functions User manual AED mode screen BPM 09 44 07 10 12 AED Mode Ned j Child pads 0000 1 ECG ECG measurements and ECG 4 Visual representation of the instruction alarms given by the CardioMax to the user when in AED mode 2 Time date battery and mode status 5 Transcription of the instruction given 3 Graph area for oximetry ECG and by the CardioMax to the user when in EtCO waveforms Also used for con AED mode figurations 43 User manual Screen and operation Defibrillator mode variation A ECG SpO and NIBP present VET wer H sPo2 100 J 91 45 04 70 09 44 07 10 12 1 ECG ECG measurements and ECG alarms 2 Time date battery and mode status 3 Graph area for oximetry ECG and EtCO waveforms Also used for con figurations 4 Infocenter Information on the equip ment and its operation This is how the device communicates with the user 44 8 Information on the defibrillation mod
14. 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 30738200 or at assistencia instramed com br or suporte instramed com br in case of repairs or further doubts In order to help us assist you please be ready to inform the equipment s serial number In case you send us the equipment for repairs try to use its original packaging If it is not possible use proper packaging and protect the monitor well 137 User manual Care and maintenance Precautions Restrictions and Warnings AN The CardioMax is a device built according to NBR and IEC standards and therefore offers total safety for patient and operator However all safety precautions described below must be followed The monitor s operation can be affected by the presence of electromagnetic power sources such as electrosurgical equipment and computer tomography 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 SpO 1 The device s operation may be affected by the pre
15. a minute for full functioning 1 5 W Graphic 72 hours Non volatile 25 seconds Agraph per vital sign 162 Warranty Certificate Instramed Industria M dico Hospitalar Ltda warrants the equipment described in this Certificate for 12 twelve months starting from the delivery date This warranty covers manufacturing or material defects that prevents proper functioning according to the specifications stated herein as long as the conditions presented in this Certificate are respected During the warranty period Instramed Industria M dico Hospitalar Ltda or its representative will repair or replace defective parts at no expense to the equipment s owner This warranty will no longer be valid if any damage occurs due to accident natural disaster improper connection 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 Industria M dico 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 Instramed Industria M dico Hospitalar Ltda is not responsible for the improper use of this equipment by people who are not familiar with its function or the techniques recommend for its proper use EQUIPMENT SERIAL NUMBER PURCHASE DATE FISCAL RECEIP
16. calculating a deviation of the minimum and maximum limits See the table on the following page 59 User manual Alarms and limits Parameter Minimum Maximum SpO Connection standard Connection standard NIBP Systole X 0 7 10 X 0 9 40 NIBP Diastole X 0 9 34 NIBP Mean X0 9 35 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 Alarm Test To carry out an alarm test proceed as follows 1 Turn the equipment on without cables and with no sensors connected A technical alarm indication a text message in the Infocenter must be displayed 2 Press the SILENCE ALARM button for 1 second and check if the alarm disarmed indication appears on the screen for all parameters Wait 60 seconds and the alarm will self activate The alarm disarmed indication will disappear from the screen and the sound alarm will return You can adjust the duration of the alarm disarmed function in the Alarm Silence menu 3 Press the ALARM SILENCE button for 3 seconds On the screen you will see the permanent alarm disarmed indication The audio alarm parameters can be individually turned on and off in the alarm menu as well as in the individual parameter menus The audio intensity of the alarm indications can be adjusted in the Configuration Alarm volume menu 60 D
17. connector of the internal pad set which is connected to the equipment should not be immersed with the entire length of this accessory ATTENTION NEVER sterilize any parts of the equipment or its accesso ries using dry heat sterilization such as when using an autoclave This will damage the mechanical structure and compromise functioning Removable battery Even when disconnected stand by the CardioMax executes internal routines checking the status of the equipment In spite of this procedure entailing a low power consumption the battery charge may be consumed Therefore whenever the device has not been connected to an electric current for more than 20 days it is advisable to execute a full battery charge If this procedure is not performed there is a risk of draining the battery and consequently being unable to use the CardioMax in its portable configuration not connected 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 220V 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 shelf life which is the possible quantity of full charge and discharge cycles without loss of performance see battery specifications in chapter 8 If the equipment presents a loss in battery performance pl
18. 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 cuffs etc are protected against defibrillation discharge during discharge there may be baseline variation WARNING When the CardioMax 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 WARNING The conductive parts of the electrodes and connectors associated with the applied parts including the neutral electrode must not come into contact with other conductive parts including the ground wire NOTICE Avoid connecting the patient to several items of equipment at the same time The limits of current leakage may be exceeded NOTICE The applied parts intended to come into contact with the patient have been evaluated and comply with the directives and principles of ISO 10993 1 NOTICE When removing the equipment from its package carefully verify if there is any abnormality or visible damage in the device or its accessories caused by impact or mishandling during transportation In case of irregularities please contact Instramed NOTICE Disposable accessories and any other components must be disposed of according to the norms of hospital waste disposal Adverse effects
19. rotating allows the user to select or change information and navigate all menus It operates 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 Joules allows the user to select the desired energy charge Monitor mode used to monitor ECG SpO NIBP EtCO and RESP parameters as in a multiparametric monitor Pacemaker mode enables external pacemaker Off turns off the equipment AED Position enables external automatic defibrillator mode Auto Seq Mode enables charge auto sequencing monitor Pacemaker NOTE The equipment does not defibrillate in pacemaker and monitor modes The pacemaker will only work in pacemaker mode Check your equipment s configuration This item is optional and may not be op present in all commercialized equipment 27 User manual The equipment Quick access buttons Fast Lead Change enables quick alarms for a previously programmed Ge access to change ECG leads period of time Press for 3 seconds to deactivate ALL sound alarms for Fast Sensitivity Change enables an INDETERMINATE period For quick change of ECG sensitivity more information see the Alarms and limits section Print press once to print a quick report For continuous printing NIBP when available starts simply press the button for 3 or suspends the functionality of seconds For further in
20. 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 81 User manual AED mode Step 4 Deliver shock Press shock button If the need for shock is detected the shock symbol will blink and the device will ask the user to press the shock button again Press SHOCK button again The shock will be delivered ATTENTION the user must not touch the patient or conductive surfaces in contact with him her during shock delivery 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 Joules and the following are 200 Joules for child electrodes all shocks are 50 Joules If clinical scans show that defibrillation is not recommended the CardioMax will announce TREATMENT NOT RECOMMENDED Check if there was no movement of the patient during the analysis If so restart the process If not remove pads and start the CPR cardiopulmonary resuscitation procedure Details on the next section 82 User manual AED mode Step 5 Start CPR After the shock start the CPR procedure C
21. transmitter manufacturer NOTE 1 At 80MHz and 800MHz the separation distance for the highest frequency range is applied NOTE 2 The ISM industrial medical and scientific frequency bands between 150kHz and 80MHz are 6 765MHz to 6 795MHz 13 553 MHz to 13 567MHz 26 957MHz to 27 283MHz and 40 66MHz to 40 70MHz NOTE 3 An additional factor of 10 3 is used in calculating the advisable separation distance for transmitters in the ISM frequency bands between 150kHz and 80MHz and in the frequency range 80MHz to 2 5GHz to reduce the likelihood of interference that mobile portable communications equipment could cause if taken inadvertently to patient areas NOTE 4 These directives may not be applicable in all situation Electromagnetic transmission is affected by the absorption and reflection of structures objects and people 143 Troubleshooting Symptom Probable cause Probable solution The CardioMax does not turn on There is no electricity Check connections the CardioMax Power Cable Plug Does not select energy gt 50J Adult pads identification Check if is adult pads are connected to the equipment and if adult electrodes are properly connected Does not deliver shock Impedance measuring Check the graph bar for the patient s impedance indication Does not capture ECG via electrodes Lead selection Select a lead other than the pads lead No tracing Unstabl
22. use Monter ander The CardioMax limits the energy to the internal pads to 50 Joules Step 2 Charge Press the Charge button green in the front panel or use the charge button in the external pads orange 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 selector switch to the new charge To cancel the shock press Disarm When the charge is complete the device sends a sound signal and displays Charge Ready on the screen 68 User manual Defibrillator mode Step 3 Shock SI After the Charge Ready warning press the Shock 3 button orange in the front panel or use the two buttons orange in the external paddles It is only possible to defibrillate using the pad buttons with the adult child external pads N CAUTION Make sure nobody is touching the patient Tell passersby to stand clear of the patient The number of shocks and length of operation are indicated on the screen Synchronism Synchronized discharge Cardioversion Remember The function Synchronized Shock is disabled after the shock is delivered Sync 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 li
23. 5 Mains supply filter enee 96 User manual Index 6 Detect NA 96 TE To EE NE 96 FRP 96 NIPB monitoring 97 Physics principle used ss ssssssessissiesrisstssterteststittttttnttntetntattntnntnrnnannnnnn tennene ena 97 AI 97 Monitoring Non Invasive Pressure Luagsseaaamusnmsmnp edeeduad 98 Measurement ue 99 NIBP age 100 NIBP E 100 1 Manual measurement svsicacnssecnsacatcxedaasacsdarieasecadaacnsvstsascevedbasndstesasicecaastsetviny 101 2 DBP ONO 101 3 Automatic measurement nonesrsrsrrrverrrrrrrrrrrrsrnrrreresrssresrseneresenenenenenrnrnennn 101 4 Initial ss EE 101 S PAM E 101 EE EEE ON 101 Monitor mode SpO 102 EECHER ee eege 102 Factors which affect the SpO measurement s precision en 103 TEN 103 Operating in monitor mode SPO csseccacicertsnatanrcastdacatamesceetiottaxtedstdeatieeentsnien 104 SPO SEP nananana T RE iannis 105 THOTT SS 105 EE EEE 105 9 Back EEE EE EE 105 User manual Index Monitor mode Capnography 106 AER 106 Capnography monitoring E 107 EtCO numerie N GAR O rnin nnnc unnannnannen anaa 109 ED Pad 110 EE EE EE EE 110 Eeer 110 TEE 110 8 Ge 10 TE NE EN TER 111 EN Mee 111 FRP 111 Monitor mode Respiration 112 Physics principle HEEN 112 VI EE 112 KST elsk 0 ALe 00 deeg 113 Respiration date TE 114 KER 1116 Es EE EE 115 1 Respiration monitoring On ENEE 115 2 Respiratory ENEE scsacedencersloisicatensoestadvanaceadansnsneddaasescdasseieltasticea
24. 85 The adjustment of minimum and maximum values is done individually on each parameter by using the e Jog Control The operator must first select the limit and the parameter to be modified and then press it Next the desired value must be adjusted and then pressed again ECG It is possible to adjust the minimum ECG alarm to levels between 30 and 100 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 levels between 100 and 250 BPMs with intervals of 5 BPMs in adult mode and intervals of 1 BPMs in neo mode SpO It is possible to adjust the minimum SpoO 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 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 5 mmHg Automatic configuration of alarm limits AUTO SET The AUTO SET function configures alarm limits taking into account the physiological parameter values that are instantly measured on the patient by
25. ECG rhythm sources MIT BIH on http ecg mit edu e Rhythm selection criteria rhythms were chosen according to notes present in the MIT BIH database e Criteria and annotation methods the rhythms were recognized and annotated in a separate file Later they were recognized and compared for sensitivity and specificity calculations Rhythms Shock INDICATED AB NOshockINDICATED Ir 0 Sensitivity g r Specificity B D D 151 User manual Specifications and safety Sensitivity is the equipment s percent ability to correctly identify a shockable rhythm Specificity is the equipment s percent ability to correctly identify a nonshockable rhythm A True positive B False positive C False negative D True negative 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 NO shock INDICATED Sensitivity 97 05 Specificity 95 18 152 User manual Specifications and safety Types of A
26. PR cardiopulmonary resuscitation is a technique which consists in mechanical stimulation of the lungs and heart Through simple actions it aims to maintain the oxygenation of the brain avoiding irreversible damage 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 Sternum bone This is the correct spot for the massage CONTINUES gt 83 User manual AED mode 5 Put one palm on top of the other keeping your fingers curled up without touching the thorax In small children however use only your fingers Apply force according to the victim s size 6 Keep your arms stretched Put pressure on the victim s thorax compressing the chest and then releasing it Follow the BEEPS emitted by the CardioMax which mark the rhythm of the compressions Every 30 compressions apply 2 mouth to mouth ventilations 7 Performing mouth to mouth breathing Place one hand on the back of the victim s neck and lift it place your 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 bre
27. R OPEN THE DEVICE Each and every repair must be performed by Instramed s authorized technical centers WARNING THE PATIENT MUST BE PLACED ON NON CONDUCTIVE SURFACES DO NOT USE WET OR METALLIC SURFACES AND IF NECESSARY DRY THE CHEST BEFORE APPLYING THE SHOCK WARNING DO NOT TOUCH THE PATIENT THE EQUIPMENT THE ACCESSORIES NOR ANY METALLIC OR CONDUCTIVE SURFACE WHICH IS IN CONTACT WITH THE PATIENT DURING THE DEFIBRILLATION WARNING THE PATIENT MUST BE COMPLETELY STILL DURING THE CARDIAC RHYTHM ANALYSIS PHASE AED MODE DO NOT GIVE CARDIAC MASSAGE AT THIS POINT Do not use the equipment in the presence of magnetic resonance devices This equipment was projected to offer resistance to electromagnetic interferences However the functioning of this device can be affected in the present of strong sources of electromagnetic interference or radio frequency such as mobile phones communicator radios etc If the precision of measurements seems to be incorrect first check the vital signs of the patient and then check the functioning of the CardioMax WARNING always check the general state of the equipment the battery and 20 User manual Safety information the accessories before using it Before installing the equipment verify if there are any abnormalities or damage caused by mishandling during transportation NOTICE The CardioMax must only be used as a complement to assess the patient s physiological conditions It
28. Superficial burns may occur on the patient s skin in the area in contact with the electrodes To minimize the effect of the disposable paddles apply them directly after removal from the protection envelope and attach them firmly to the patient s skin The skin must be dry or electric current leakage may occur increasing the burn s area and reducing the efficiency of the treatment 21 User manual Safety information Classification and symbols Symbol Standard Description Je IEC TR 60878 Defibrillation proof insulated CF type equipment A IEC TR 60878 Attention only use as per the instructions of this manual A IEC TR 60878 Careful dangerous high electric voltage ed IEC TR 60878 Terminal for equalization of potential L IEC TR 60878 Terminal for general ground Off Disconnects the equipment DO IEG TR 60878 Alternate current ae ae IEC TR 60878 Direct current a te IEC TR 60878 Non ionizing radiation lt gt IEC TR 60878 Input and output connection t t ISO 780 Maintain this side upwards ISO 780 Fragile equipment ISO 780 Maximum stacking of 4 units SE ISO 780 Maintain protected from the rain EE Minimum and maximum temperature ISO 780 Ei ISO 7000 Minimum and maximum atmospheric pressure eg ISO 7000 Minimum and maximum relative humidity OY BE IEC TR 60878 Recyclable paper X Directive 2002 96 CE Remains of electrical and e
29. T NUMBER 163 CARDIOMAX Biphasic Monitor Defibrillator bi phasic SHOCK IN STRAED www instramed com br 55 51 3073 8200
30. User manual CARDIOMAX Cardioverter Biphasic Defibrillator Monitor INSTRAMED Manufacturer Instramed Industria M dico Hospitalar Ltda ra Industrial unity Rua Beco Jos Paris 339 Pavilh o 19 Postal code 91140 310 Porto Alegre RS Brasil Phone fax number 51 3073 8200 E mail comercial instramed com br Website www instramed com br ANVISA 10242950009 European representative Obelis S A Bd G n ral Wahis 53 1030 Brussels Belgium Phone 32 2 732 59 54 Fax 32 2 732 60 03 E mail mail obelis net 0499 ATTENTION Instramed assumes no responsibility for any damage caused to individuals or property brought by failure to use this product in accordance with the information recommendations and warnings presented in the user manual alterations made in the 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 2015 Instramed The CardioMax Instramed and its respective logos are trademarks of Instramed Industria M dico Hospitalar Ltda The internal software of this product is Instramed s intellectual property being protected under international copyright laws It is provided exclusively to be used with this present
31. an V V m 142 User manual Care and maintenance Electromagnetic immunity Equipment with life support functions Advisable separation distances between mobile and portable RF communications equipment and the CardioMax The CardioMax is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or user of the defibrillator can help to prevent electromagnetic interference by maintaining a minimum distance between the mobile and portable RF communications equipment transmitters and the CardioMax as recommended below according to the maximum output power of the communication equipment Maximum output power of the transmitter W Distance of separation according to the frequency of the transmitter m 150 kHz to 80 MHz outside ISM bands d gt VP V 150 kHz to 80 MHz outside ISM bands d VP V 80 MHz to 800 MHz a 2 VP E 800 MHz to 2 5 GHz d vP E 0 01 0 35 1 2 0 12 0 23 0 1 1 1 3 8 0 38 0 73 1 3 5 12 1 2 2 3 10 11 38 3 8 7 3 100 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
32. and 25 0mm s for EtCO and RESP waveforms OBS if all waveforms are disabled simultaneously the CardioMax will automatically select the DII lead The EtCO curve will only be enabled if the module is on See the picture on the next page 50 User manual Screen and operation ECG waveform SPO2 waveform RESP EtCO2 waveform ECG SPO2 speed RESP EtCO2 speed 51 Alarms and limits The CardioMax has audio and visual indications of physiological and technical alarm conditions Physiological Alarm There are two ways to enable the physiological alarm indications Asistoly the CardioMax cannot detect valid heartbeats for over 4 seconds Violation of MAXIMUM or MINIMUM limits When the Oximetry ECG NIBP EtCO or RESP maximum or minimum alarm limits are not within the equipment s preset range Physiological alarm visual indications will be given in either mode but the audio indications will only be given when the equipment is in the monitoring mode FEATURES ECG SpO NIBP EtCO or RESP defibrillator mode white numerical value of 2 cm x 2 cm e ECG SpO NIBP EtCO or RESP monitor mode white numerical value of 3 cm x 1 8 cm Alarm indicator blinking bell sine numerical value of 7 mm x 7 mm e Visual frequency 2Hz Sound frequency 440Hz at intervals of 150ms Technical alarm Sound and visual signals indicate that the CardioMax is not able to accurately monitor the patient s s
33. and events For more op information view the Printing chapter 29 User manual The equipment 6 Connector for 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 Internal Used in surgeries 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 30 User manual The equipment Rear panel 1 Pads The pads accompanying the CardioMax must be placed on top of the equipment and must be properly connected to the adult adapter 2 Removable battery The battery can be easily replaced by simply pressing both side tabs one against the other The battery will unlock and automatically detach itself from the equipment NOTE Do not remove the battery when the equipment is operating in battery mode 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 ven
34. art 2 Particular Requirements for the Safety of Electrocardiogram Monitoring Equipment IEC 60601 2 27 2005 Medical Electric Equipment Part 2 27 Particular Requirements for Safety including essential development of Electrocardiographic Monitoring Equipment NBR IEC 60601 2 30 1997 IEC60601 2 30 1995 Medical Electric Equipment Part 2 30 Particular Requirements for the Safety of Automatic and Cyclic Monitoring of Indirect Blood Pressure Non Invasive Equipment IEC 60601 2 30 1999 Medical Electric Equipment Part 2 30 Particular Requirements for the Safety of Automatic Cycling Non Invasive Blood Pressure Monitoring Equipment NBR IEC 60601 2 49 2003 IEC 60601 2 49 2001 Electrical Medical Equipment Part 2 Particular Requirements for the of Multiparametric Patient Monitoring equipment ANSI AAMI EC13 2002 Cardiac monitors heart rate alarms and alarms NBR IEC CISPR11 1995 Electromagnetic Compatibility Radiated and Conducted NBR IS09919 1997 1S09919 1992 Pulse Oximeter for Medical Use 23 User manual Safety information Requirements e ISO 9919 2005 Medical Electrical Equipment Particular Requirements for the Safety and Essential Development of Pulse Oximeters for Medical Use Device care Do not place the equipment where it may fall on the patient Do not lift the equipment by its cables or connections e Place cables connected to the patient in order to restrict the possibility of stran
35. ath 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 mouth breathing check if the patient s pulse is back The massage and ventilation cycle must be done for two minutes If the patient s pulse does not return restart shock procedure with the CardioMax After the third complete CPR and shock cycle chances of the patient s resuscitation are very slim 84 User manual AED mode Using the CardioMax on children under 8 years old The CardioMax can be used on children from the age of one year onwards However on patients from one year of age to eight years of age or patients who weigh less than 40kg some precautions must be taken e Use child pads e Ifthe 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 Smaller than 4 cm Chest Back 85 Pacemaker mode Physics principle used The external pacemaker applies a squared waveform of variable frequency and intensity to the heart in order to stimulate heartbeats In a normal heart the heart beats as follows the sinoatrial node located in the right atrium stimulates the heart s contraction It is controlled by
36. ax 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 defibrillation electrodes of the CardioMax are at an appropriate distance from other electrodes so that the power applied does not flow through these electrodes Disconnect all equipment devoid of protection against the discharge of defibrillators Ensure that the patient does not come into contact with any metallic parts 77 User manual AED mode Use criteria In defibrillation mode the CardioMax must only be used if the following circumstances as a whole are presented 1 Unconscious victim 2 No breathing 3 No pulse Other important considerations regarding the use of the CardioMax 1 Not recommended for children under one year old 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 those who have a degree in Medicine 78 User manual AED mode Operation Before starting the operation call the emergency service Step 1 Connect disposable pads to the CardioMax If the disposable pads have not
37. been connected to the CardioMax yet attach the connector to the 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 mo ment 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 pads the shock will be set in 50 Joules 79 User manual AED mode Step 2 Apply pads to patient Stern rs Remove pads from their wrapping and peel off the film protecting the adhesive Place pads on the patient according to the picture above keeping adhesive area in contact with the skin This position allows the electric current to circulate from one pad to the other thus reaching the whole thoracic cage 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 User manual AED mode Step 3 Select AED Analyzing cardiac rhythm Monitor l Pacemaker Rotate the selector switch to the AED position The CardioMax will automatically enter cardiac rhythm analysis mode and will start giving vocal instructions clearly and pausedly
38. below 3 Place the armband according to the Placing the armband item 4 Connect the armband to the extension hose 5 Select one of the measurement modes manual automatic or stat ARMBAND SELECTION Armband cuff Limb circumference arm leg Child 10 to 19 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 cuffs appropriate size for the chosen area according to the previous chart 3 Make sure the limb is supported to guarantee that the armband is at the heart s level Due to the hydrostatic effect placement above or below the heart s level may cause incorrect measurements 4 Ensure the ARTERY Mark is above the Se brachial artery 98 User manual NIPB monitoring Measurement modes 1 Manual Instantaneous measurement of systolic diastolic and mean pressure To activate the manual mode press NIBP MANUAL MEASUREMENT in the front panel or in the NIBP Menu Setup select the Manual Measurement item When pressing the NIBP MANUAL MEASUREMENT button while the mon itor is exerting the NIBP measurement it will immediately interrupt the measurem
39. cale 8 Amplitude scroll Allows the ECG to be viewed throughout its amplitude scale 9 Event viewer window After downloading the information contained in the CardioMax memory the list of events stored by the device will be displayed in this area in chronological order Double click on an event to view it on the main screen Definition of events displayed in AED mode 129 User manual PC connection INTERNAL DISCHARGE Power discharged internally due to pressing the start button for an excessive amount of time TREATMENT PERFORMED A shock was delivered to the patient SHOCK INDICATED Shock indicated due to the patient s ventricular fibrillation or ventricular tachycardia pattern SHOCK NOT INDICATED Shock not indicated on account 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 2 INSTRAMED oe ADJUST Q update clock Ge volume level UW P OM Hk GI Volume and clock adjustments via Soft DEA are only available for Isis Isis PRO and Isis PRO training equipment In CardioMax these adjust ments are made via the device s own settings menu as described on pag
40. ccur 148 Defibrillator Waveform Shock application Scales for adult external defibrillation Charge Auto Sequencing Commands Energy selection Charge command Shock command Synchronized command Charge Indicators Maximum charge time in maximum energy External pads size Cardioversion Maximum output voltage User manual Specifications and safety Biphasic truncated exponential Wave shaped parameters adjusted according to the patient s impedance By means of multifunction pads or external adult child pads 1 2 3 4 5 6 7 8 9 10 20 30 50 80 100 150 200 250 300 and 360 Joules Maximum energy limited to 50J in internal or child pads When enabled it charges power previously set by the user for the first second and third shocks with no need to manually adjust the selector On off charge shock sync key Selector switch in front panel Button in front panel buttons in external pads Button in front panel buttons in external pads Sync key in front panel Audio indication of equipment being charged audio indication of charge completed LED on external pads and charge level indicated on display lt 6s with 90 to 100 of the minimum specified voltage lt 6s with a full charge lt 13s from equipment initialization Adult 10 3 cm x 8 5 cm contact area 81 9 cm Children 4 5 cm x 4 cm contact area 18 cm lt 60 ms after the QRS peak 2000V 149
41. d Visual indication Sound indication Suspend sound indication function Silence sound indication function lt 3 seconds 4 7 Mohms Mega ohms Pacemaker stimuli with widths between 0 1ms and 2ms and amplitude between 2mV and 700mV are rejected in the counting of heartbeats Concerning the overshoot it complies with method A of the AAMI EC13 2002 standard It meets the minimum recommended value of 1 2mV for the T wave amplitude rejection 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 80 to 120 bpm maximum of 7 seconds 80 to 40 bpm maximum of 11 seconds 159 Tachycardia alarm time User manual Specifications and safety 206 bpm 1 mV 5 seconds 206 bpm 0 5 mV 5 seconds 206 bpm 2 mV 5 seconds 195 bpm 2 mV 5 seconds 195 bpm 1 mV 5 seconds 195 bpm 4 mV 5 seconds NIBP Non Invasive Arterial Pressure Technique Adult range Pediatric range Neonatal range Overpressure limit per software Resolution Manual mode Automatic mode STAT mode Sp SpO range 2 Pulse range Oscillometric Systolic 40 to 260 mmHg Mean 26 to 220 mmHg Diastolic 20 to 200 mmHg Systolic 40 to 160 mmHg Mean 26 to 133 mmHg Diastolic 20 to 120 mmHg Systolic 40 to 130 mmHg Mean 26 to 110 mmHg Diastolic
42. d by the Capnography module In order to this set the function in the Configuration Menu Menu gt RESP gt RESP Freq 113 User manual Monitor mode Respiration Respiration numeric indicator 1 Respiration symbol 3 Respiration numeric value 2 Apnea alarm displayed when 4 Measuring unit respirations per breathing suspension is detected minute Yellow indicators show that the respiratory frequency is originated via ECG cable blue indicators show that the respiratory frequency is originated via capnography If the EtCO and respiration are on in the defibrillator and pacemaker modes the respiration numeric indicator will be shown in the EtCO window with the same color indications check picture below 114 User manual Monitor mode Respiration Respiration setup Using the e Jog select the respiration function in the setup menu to access the respiration setup sub menu Resp On Off Respiratory Frequency Apnea Alarm Sensitivity 1 Respiration monitoring On Off When turned off all visual and sound alarms will be inhibited and there will be no numeric indication for respiration 2 Respiratory frequency Determines if the frequency shown by the equipment will be obtained by thoracic impedance ECG cable or by capnography CO 3 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 40 s
43. device identified by the serial number and may not be in whole or in part evaluated recompiled or altered in any way cardiomax user manual eng r8 6 2015 08 10 Battery use ATTENTION Observe the battery charge maintenance instructions First use Before using the CardioMax for the first time the equipment must receive a full battery charge In order to do this the equipment needs to be connected to an electric current for at least eight hours Occasional use Even when disconnected stand by the CardioMax executes internal routines checking the status of the equipment In spite of this procedure entailing a low power consumption the battery charge may be consumed Therefore whenever the device has not been connected to an electric current for more than 20 days it is advisable to execute a full battery charge If this procedure is not performed there is a risk of draining the battery and consequently being unable to use the 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 shelf life which is the possible quantity of full charge and discharge cycles without loss of performance check out the specifications of the battery in chapter 15 When the appliance has a drop in performance of the battery with low autonomy request a new unit from Instramed
44. e NIBP Measurement values for systol ic diastolic and mean Non Invasive Blood Pressure SpO Oximetry measurements and oximetry alarms Access icons for event and configura tion functions User manual Screen and operation Defibrillator mode variation B ECG SPO and EtCO present Met H I BPM POS Defibrillator SPO2 innen FOCENTE 1 ECG ECG measurements and ECG 5 Information on the defibrillation mode alarms 6 Infocenter Information on the equip 2 EtCO EtCO measurements and ment and its operation This is how the alarms device communicates with the user 3 Time date battery and mode status 7 SpO Oximetry measurements and oximetry alarms 4 Graph area for oximetry ECG and EtCO waveforms Also used for con 8 Access icons for event and configura figurations tion functions 45 User manual Screen and operation Configuration menu Parameter setup IIPAUSE DEMAND PARAMETER SETUP GENERAL SETUP ECG Alarm SPO2 Date and Time NIBP General Setup CO2 Printer Defibrillation Events Resp Functional Test 1 ECG Enables manual configuration of ECG parameters See Monitor mode ECG chapter 2 SpO Enables manual configuration of SpO parameters See Monitor mode SpO op chapter 46 User manual Screen and operation 3 NIBP Enables manual configuration of NIBP parameters See Monitor mode NIBP op chapt
45. e 49 in the Screen and operation chapter 130 User manual PC connection Changing languages SoMDEA 3 22 INSTRAMED LANGUAGES 2 in the SoftDEA in the device languages Portugu s Portugu s English English Espan l Espan l Pycckuii Isis Only T rk e Isis Only All CardioMax Only e Under the in the SoftDEA option Change the language of the software interface Does not require a device to be connected e Under the in the device option when an Isis Isis PRO device is connected Change the language of voice prompts emitted by the speaker on the device to the selected language e 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 files Other buttons 1 Back Click this button to return to the previous page menu 131 User manual PC connection 2 Exit Click this button to close Soft DEA 3 132 Care and maintenance Preventive maintenance Instramed recommends that the CardioMax be examined by a qualified technician every 12 months We recommend that you contact the manufacturer for more information about qualified and trained personnel in your area to perform preventive mai
46. e 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 will be printed E gt lt 3 seconds 121 User manual Printing Quick printing ECG ECG 171 bom SPO2 100 Shock 3 Time 05 17 D a Q gd 3 2 E 5 ES E E Oo Oo UD UD 10 25 04 18 19 51 dll 25 mm s 30 mm mV 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 information on use gt gt 3 seconds Stop printing To interrupt continuous printing or instant printing press the print key again 122 User manual Printing Configurations Alarm printing Shock printing Paper size Print Electro Number of Leacs 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 2 Shock printing When the shock printing option is enabled in the printing setup menu the CardioMax prints an instant report whenever the equipment identifies shock delivery In this report you can see the equipment s operation mode at the moment
47. e 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 SpO curve SpoO curve turned off Turn on SpO curve in Waveform Setup Pacemaker does not start Multifunction Adhesive pads Check if multifunction pads are connected Check if there is a bad contact message Check gel in multifunction pads Does not print Printer makes noises and does not print No paper in the printer Too much paper on roll 144 Check if there is paper in the printer Check if paper is positioned properly Change roll s size Accessories Accessories accompanying the equipment Basic Quantity Description 01 Power cable 3 pins 01 Auxiliary cable for grounding and potential equalization 01 Removable battery 01 User manual Defibrillator Quantity Description 01 A set of adult child external defibrillation pads ECG Quantity Description 01 5 lead ECG cable NIBP Quantity Description 01 Armband adult cuff 01 Cuff extensor Quantity Description 01 Oximetry sensor 01 Oximetry sensor extensor 145 User manual Accessories
48. ease request a new set to Instramed s technical assistance To request pieces and services please contact Instramed at 55 51 3073 8200 The battery s shelf life is at least 500 cycles full charges and discharges 134 User manual Care and maintenance Removable battery replacement The battery will automatically detach itself from the equipment as shown in the picture below 1 Press the side tabs to unlock the removable battery 2 Manually remove the battery from the equipment 3 Correctly position the new battery as shown in the picture below 135 User manual Care and maintenance 4 Push the new battery until it firmly locks into the cabinet Thermal paper replacement 1 Press the button to open the printer door see picture below If the door does not open completely pull it in your direction 2 Remove the old paper bobbin 136 User manual Care and maintenance 3 Place the new bobbin between side clasps The bobbin must be positioned as shown in the picture above with the thermal sensitive side measurements in millimeters 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 Returning components If CardioMax must be returned for repair call Instramed for shipping instructions To facilitate assistance be prepared to provide the equipment s series number
49. easurements and oximetry alarms 3 ECG ECG measurements and ECG alarms 7 Access icons for event and configu ration functions check it on the next 4 Pacemaker or defibrillation modes page area for the defibrillation or pacemaker modes 37 User manual Screen and operation Access icons for events and configuration functions e O ee G 1 Events menu views events stored in the CardioMax 2 Configuration menu enables the configuration of all the parameters of the equip ment See the Configuration menu in this chapter 3 Alarms menu shortcut configures ECG and SpO 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 38 User manual Screen and operation Monitor mode screen variation A ECG and SpO present OG BPM SPO2 07 10 12 Mode Adul 1 ECG ECG measurements and ECG 4 Infocenter information on the equip alarms ment and its operation This is how the device communicates with the user 2 Time date battery and mode status 5 SpO oximetry measurements and 3 Graph area for oximetry ECG and oximetry alarms EtCO waveforms Also used for con figurations 6 Access icons for event and configura tion functions 39 User manual Screen and operati
50. eatings not related to the application of stim ulation 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 is a problem with the multifunction ad hesive paddles or contact with the patient The stimulated pulses will be applied in the asynchronous mode if there is a connection problem with the ECG monitoring electrodes or if the Car dioMax does not identify a valid QRS Defibrillation If defibrillation is necessary turn the switch to defibrillation mode The CardioMax automatically inhibits the pacemaker s stimulation pulse 90 Monitor mode ECG Physics principle used ECG is the measurement of electrical potential generated by the depolarization and re polarization of heart cells generating the bioelectrical impulse responsible for the heart s contraction Heart impulses are detectable on the body surface by applying electrodes Each electrode s potential is amplified and processed by the heart monitor displayed on the screen and then used to calculate the heart s frequency BPM The heart cycle period is the elapsed time from any point in the 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 N Warnings Use on
51. eces may result in emission increase or immunity decrease of the equipment The CardioMax 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 neutral electrode of the high frequency equipment matches a defect in the CardioMax s ECG socket This type of accident will only occur when the defects occur simultaneously as the CardioMax s ECG socket is electrically protected against risks of burnouts being completely insulated Electromagnetic emissions Directives and manufacturer declaration electromagnetic emissions The CardioMax is intended for use in the specific electromagnetic environment below The customer or user of the defibrillator is advised to ensure that it is used in such an environment Tests Compliance Electromagnetic environment directives The CardioMax only uses RF power for its internal RF Emissions ABNT NBR IEC functions Nevertheless its RF emissions are very low CISPR11 and are not likely to cause any interference in nearby electronic equipment RF Emissions ABNT NBR IEC CISPR11 de The CardioMax is suited for use in any establishment Harmonics emissions IEC This includes residential establishments and those 61000 3 2 Class A directly connected to the public network of distribution of low voltage electricity which supply domestic
52. eck and update firmware version of the equipment only for authorized technical personnel Requirements Connecting the CardioMax to a PC requires installation of the Soft DEA application in the computer to which a connection will be made This software is in the CD which accompanies the equipment To install Soft DEA observe the following requirements Windows XP Windows Vista or Windows 7 operating system CPU of 300 MHz or faster 02 GB free hard disk space Minimum 512 MB RAM 1 GB recommended CD or DVD ROM reader unit For physical connection to the PC An available USB port 125 User manual PC connection Soft DEA Installation Insert the program CD in the CD DVD ROM drive If the autorun does not start automatically find the softdeasetup exe file in the CD and double click it Follow the installation instructions which will show up on the screen Connecting the CardioMax to a PC Connect the equipment only after installing Soft DEA After the installation connect the device through the USB cable given The location of the device drivers to be installed will be required They can be found in this folder C Program Files Instramed Soft DEA DRIVERS Start the Soft DEA application On the language selection screen choose among Spanish English or Portuguese You only have to select a language the first time you start the software Start the list of events and ECG waveform display following the step
53. econds 4 Respiration sensitivity You can select among the following values 1 2 3 4 5 and 6 115 User manual Monitor mode Respiration 5 Back Exit BACK to Configuration menu or EXIT to monitoring screen 116 Event and data storage Data storage The CardioMax creates an event list for each patient observing the following criteria Automatically a new patient is identified every time the equipment is turned on Manually via the events setup menu The quantity of events the equipment can store will vary according to how long each patient has used the equipment and the type of therapy used The CardioMax has a 2 Mb memory The last two hours of continuous ECG will be stored in the equipment s memory ATTENTION Whenever the internal memory capacity reaches its limits events prior to 100 will be replaced with new information Events stored The CardioMax stores date time heart frequency and saturation of the following events e Pads change pacemaker monitoring e Charge values Stimulation pacemaker on off e Number of shocks e Silent alarm key activation e Turn equipment on off Shock failure Loose electrode bad contact in Internal discharge the pads e Physiological alarm activation e Failure in module initialization Event setting key activation e Functional test stimulation Suge e Printing synchronism e Low battery equipment turning off Operati
54. efibrillator mode Physics principle used The biphasic cardiac defibrillator is an instrument that delivers energy previously stored in a capacitor to a patient The defibrillation can be external when the capacitor s discharge is delivered through the patient s thorax or internal applying the capacitor s discharge directly to the heart with an open thorax and during surgical procedure The CardioMax uses biphasic shock technology which is characterized by a current liberated in one direction and after a brief period of time reverted in the opposite direction During the defibrillation the 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 big phasic SHOCK 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 Ensure that the defibrillation electrodes of the CardioMax are at an appropriate distance from other electrodes so that the power applied does not flow through these electrodes Disconnect all equipment devoid of protection against the discharge of defibrillators Ensure that the patient does not come into contact with any metallic parts 61
55. ency value obtained by the oximetry sensor 2 Digital scale indicating pulse amplitude 104 User manual Monitor mode SpO SpO setup SPO2 SETUP SPO2 response Normal Slow mellem Fast L if d 85 HYEN 1 SpO response Selects the SpO numeric update response You can select among the SLOW NORMAL and FAST options NORMAL Used for most patients FAST Used when the operator needs faster answers The response is affected by the patient s movements SLOW Less affected by the patient s movements However you must pay attention to the SpO slow response variations 2 Alarm BELL icon indicates sound alarm ON or OFF gt Configures MINIMUM and MAXIMUM ALARM limits 3 Back Exit BACK to the Configuration menu or EXIT to the monitoring screen 105 Monitor mode Capnography Physics principle used D Capnography is a Non Invasive measurement usually presented by a graph of expiratory CO plotted against time The Microstream method is used in intubated or non intubated patients A sample of the gas exhaled by the patient is collected by cannulas and sent to the Microstream chamber and sensor inside the CardioMax CO measurement is based on the characteristics of laser absorption by CO molecules Capnography consists of measuring and registering the carbon dioxide released at the end of expiration EtCO The capnograph is an EtCO analyzer which displays its concentra
56. ent 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 gt NIBP Interval between measurements can be selected to 1 2 3 4 5 10 15 30 60 90 minutes Interrupting NIBP measurements To cancel an ongoing pressure mea surement press NIBP MANUAL MEASUREMENT located in the equip ment s front panel The CardioMax does not offer a short term automatic measurement option 99 User manual NIPB monitoring NIBP numeric indicator 1 Numeric values for systolic diastolic used in automatic measurements and mean pressures 3 Time interval between measurements 2 Number of measurements exerted used in automatic measurements NIBP setup Using the e Jog select the NIBP function in the setup menu to access the NIBP setup sub menu NIBP SETUP Manual Measurement 300 300 300 NIBP On Off Lig Automatic Measurement ig i i dh 80 75 80 Initial pressure so sys dia mean ee 100 User manual NIPB monitoring 1 Manual measurement Start a NIBP manual measurement 2 NIBP ON OFF Enables or disables the CardioMax s NIBP function 3 Automatic measurement Starts the NIBP automatic measurement mode When selecting this function a measurement is immediately exerted Poste
57. er 4 CO Enables manual configuration of CO parameters See Monitor mode op 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 47 User manual Configuration menu General setup PARAMETER SETUP GENERAL SETUP ECG Alarm SPO2 Date and Time NIBP CO2 Defibrillation Resp Functional Test 09 44 07 10 12 1 Alarm Adjust the ECG and SpO alarm values See the Alarms and limits chapter 48 User manual 2 Time and date TIME AND DATE SETUP Date 08 02 07 Time 08 45 The Time and date menu adjusts the CardioMax s calendar and time You can opt for international or North American standards of date and time It is very important to keep time and date well adjusted because this information will appear on all printed reports You can adjust the time and the date using the e Jog Control 3 General setup GENERAL SETUP BIP Volume 10 Alarm Volume 10 Defibrillator Volume 10 Language Span Mode Adult Cardiac Freq Auto Restore original setup The General setup menu allows you to co
58. er an optional characteristic is mentioned WARNING the CardioMax must be used by qualified 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 CardioMax defibrillator monitor series alerting the user to possible safety risks This manual is part of the CardioMax and must be kept for further reference The information contained in this manual belongs to Instramed and cannot be copied fully or in part without expressed written consent Instramed has the right to make any changes to improve this guide as well as the product without prior notice 19 Safety information ATTENTION A The following factors can cause ECG misinterpretation e Wrongly placed pads e Patient s movements e Pacemaker it may lessen the precision of the cardiac arrest detector e Radio frequency interference including mobile phones e Excessive hair or wet skin in the application area of the electrodes e Pieces of clothing between skin and pads Warnings IMPORTANT This device must only be operated by qualified technical personnel Before using read the manual attentively WARNING risk of explosion if the equipment is operated in the presence of flammable liquids or gases ELECTRICAL SHOCK Hazard NEVE
59. es the selection of ECG monitoring by 3 wire or 5 wire cables Using the 3 wire ECG cable in the SDP Sudden Death Prevention makes it functional only in the DII lead 3 Sensitivity Select the ECG amplification gain You can select from 5 10 15 20 30 or 40 mm mV 4 Frequency bandwidth selection Filter selection for power interference Diag or Monitor 5 Mains supply filter Enables to turn filter on or off to reduce mains supply interference with the ECG signal 6 Detect pacemaker Enables to turn the pacemaker detection mode on or off When on the equipment indicates on the screen the pacemaker s pulse moment Detect pacemaker mode must only be used on patients with pacemaker 7 Alarm BELL icon which indicates sound alarm ON or OFF Configuration of MINIMUM and MAXIMUM alarm limits 8 Back Exit Back to Configuration menu and Exit to monitoring screen 96 NIPB monitoring Physics principle used D CardioMax uses oscillometric mode to calculate Non Invasive blood pressure A cuff is used to convey arterial pressure changes caused by blood flow The cuff is insuflated to a pressure higher than systolic pressure in order to occlude blood flow in extremities Gradually cuff pressure is reduced generating little pulses or oscillations Mean pressure is the lowest pressure in the cuff in which detected oscillation peaks have higher amplitude Sy
60. event occurred 3 Delete memory used memory Deletes every event from the memory It Indicates the percentage of memory that has already been used 2Mb limit NOTE When 100 of the memory has been used the contents of the event memory must be deleted 119 User manual Event and data storage 4 New patient Creates a new patient and initiates a new table of events 5 Events list Presents the selected patient s events 6 Printing icon When present next to an event this icon indicates that printing the ECG waveform associated with that event is available 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 selected event will be printed 5 seconds before the event and 10 seconds after the event 120 Printing General The thermal printer optional item allows you to manually or automatically print events shock or electrocardiogram reports To activate the printer press the print button located in the equipment s front panel or 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 th
61. formation the Non Invasive Blood Pressure see the Printing section Measurement When the NIBP optional parameter is not present Alarm silence press the button in the device this button has no quickly to deactivate ALL sound function Power and battery charging indications 1 Power Connected when the LED is on it indicates that the equipment is connected to a power source or an external battery 2 Battery Charging when the LED is on it indicates that the battery is charging O 30 en OBS When the equipment is connected to an electric current the LEDs will light up indicating the beginning of charging even if the CardioMax is inoperative 28 User manual The equipment Side view 1 SpO connector BCI standard oximetry connector Adult and child oximetry sensors 2 USB connector USB connector for access to data stored by the AED mode It can be plugged directly to a Windows PC 3 NIBP connector Connector for direct use with the cuff 4 ECG connector Connector for ECG cables Depending on the parameters present in the equipment it may be available in the following settings e 3 or 5 wire AAMI standard Protected against defibrillation e 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 5 Printer Printer for thermosensitive paper It prints electrocardiograms
62. g When all LEDs blink simultaneously the pads have a short circuit and shock delivery will not be permitted When only the RED LED is blinking shock delivery will not be allowed 65 User manual Defibrillator mode Child pads use 1 Fasten the lock in the front of the adult external pads 2 Pull the pads base forward to remove them 3 This exposes the smaller electrode for children i o gt 3 The CardioMax will automatically identify that it is operating in pediatric mode Energy is limited to 50 Joules in the pediatric mode 66 User manual Defibrillator mode Using multifunction pads The use of the multifunction pads disposable requires that the operator uses the adapter provided extension cable in order to connect them to the standard socket of the external pads as described below 1 Connect the AED pacemaker extension cable to the equipment 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 User manual Defibrillator mode Defibrillation Follow the steps 1 2 3 Step 1 Select energy Rotate the selection switch until you reach the energy desired Energy options go from 1 to 360 Joules In most cases 200 Joules is recommended for adult
63. gulation 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 e If you suspect a fall or external damage do not use the equipment Connection to other equipment When connecting the CardioMax to any device ensure that the equipment is operating correctly before clinical use The equipment or accessories connected to the device must be certified according to the IEC 950 standard for data processing equipment or according to the IEC 60601 1 1 for medical equipment Grounding GROUNDING IS ESSENTIAL TO PROTECT THE OPERATOR AND PATIENT AGAINST ELECTRICAL DISCHARGE ACCIDENTS IN THE ABSENCE OF ADEQUATE GROUNDING DANGEROUS CURRENTS MAY CIRCULATE FROM THE EQUIPMENT BOX IF THERE IS AN INTERNAL ELECTRICAL DEFECT GROUNDING MUST BE PERFORMED ACCORDING TO ABNT NORMS FOR ELECTRICAL INSTALLATIONS NBR 13534 1995 In addition to the power cable with a plug and 3 pin connector there is a cable with a banana pin on one side and an alligator clip on the other for potential equalization The potential equalization must be done when the patient is connected to the monitor and directly or indirectly to another device for instance monitoring a child in an incubator This interconnection should be made with the potential equalization connector and ge
64. ith a 3 mmHg interval when in Adult mode and a 1 mmHg interval when in Neo mode 6 Back Exit BACK to Configuration menu or EXIT to monitoring screen 111 Monitor mode Respiration Physics principle used The respiration waveform is generated by the measurement of the patient s bioimpedance By means of a high frequency signal which is applied to two electrodes RA and LA the thoracic impedance variation caused by the effort of breathing is detected and displayed on the monitor in graph and numeric forms VAN 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 112 User manual Monitor mode Respiration Respiration monitoring The breathing signal is obtained by ECG electrodes For more information o connections see the ECG monitoring chapter In order to improve breathing performance you can change the position of the ECG electrodes opting for alternative places You must reposition RA and LA in a way so that they are applied bellow the nipples as shown in the picture below WARNING When repositioning the electrodes the ECG waveform and amplitude may change WARNING Only the respiration numeric value is obtained by the CO module The waveform is not Capnography The monitor can also show the respiratory frequency cal culate
65. jects and people CONTINUA gt 141 User manual Care and maintenance a ISM bands industrial medical and scientific between 150kHz and 80MHz are 6 765MHz to 6 795MHz 13 553Mhz to 13 567MHz 26 957MHz to 27 283MHz and 40 66MHz to 40 70MHz gt The compliance levels in the ISM frequency bands between 150kHz and 80MHz and in the frequency range between 80MHz and 2 5GHz are intended to reduce the likelihood of mobile and portable communications equipment causing interference if inadvertently brought into the patient areas Therefore an additional factor of 10 3 is used in calculating the advisable separation distance for transmitters in these frequency ranges Field strengths established by fixed transmitters such as base stations for radio telephones cell phone wireless mobile land radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with any accuracy In order to evaluate the electromagnetic environment due to fixed RF transmitters it is advisable to consider an electromagnetic site survey If the measured field strength in the site where the CardioMax is used exceeds the level of RF compliance used above the CardioMax should be observed to check if operation is normal If abnormal performance is observed additional procedures may be required such as reorienting or repositioning the CardioMax 4 Over the frequency range 150kHz to 80MHz the field intensity should be less th
66. lectronic equipment separate disposal from other objects NN Directive 93 42 EEC Mark of compliance with European Community ul EN 980 Manufacturer ee EN 980 Manufacturing date co ner EN 980 European representative SN EN 980 Serial number 22 User manual Safety information Standards The CardioMax was designed according to safety and performance standards such as NBR IEC 60601 1 2010 IEC 60601 1 1995 Medical Electric Equipment Part 1 General Requirements for Safety NBR IEC 60601 1 2 2006 IEC 60601 1 2 2004 Medical Electric Equipment Part 1 2 Requirements for Safety Collateral standard Electromagnetic Compatibility Requirements and Tests IEC 60601 1 2 2007 Medical Electric Equipment Part 1 2 General rules for basic safety requirements and essential development Collateral standard Electromagnetic Compatibility Requirements and Tests NBRIEC60601 1 4 2004 IEC60601 1 4 1999 Medical Electric Equipment Part 1 4 General Requirements for Safety Collateral standard Programmable electrical medical systems NBR IEC 60601 2 4 2005 IEC 60601 2 4 2002 Medical Electric Equipment Part 2 Particular Requirements for the Safety of Cardiac Defibrillators NBR IEC 60601 2 25 2001 IEC 60601 2 25 1999 Medical Electric Equipment Part 2 Particular Requirements for the Safety of Electrocardiographs NBR IEC 60601 2 27 1997 IEC 60601 2 27 1994 Medical Electric Equipment P
67. line Filterline EtCO Starting sensor the EtCO 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 25 30 35 or 40 seconds set in Menu gt RESP gt Apnea Alarm NOTE These indications will only be enabled when the CardioMax is in monitoring mode Sound signals are emitted at intervals of 6 seconds whenever there is a technical alarm situation 53 User manual Alarms and limits In addition to the technical alarm conditions indicated in the Infocenter there are two other situations that may occur Bad contact Informs when the patient s impedance measurement does not satisfy the necessary shock delivery conditions This information is presented in the Infocenter Bad Contact INFOCENTER S 09 44 Connect 07 10 12 Multifunctional Paddles 54 Battery charge level User manual Alarms and limits Indication Battery status 100 charged Device operating conditions Enables approximately 3 hours of monitoring if the battery has been inserted 80 charged Enables approximately 2 hours and 50 minutes of monitoring 60 charged 40 charged Enables approximately 1 hour and 40 minutes of monitoring Enables approximately 1 hour and 10 minutes of monitoring BO
68. ly original Instramed cables and conductors Other ECG cables may impede defibrillation or not work correctly If you suspect a cable or conductor is ruptured avoid its use due to possible risk to operator If the patient has a pacemaker do not rely solely on the equipment alarms Keep the patient under observation The cardiac frequency measurement can be affected in the presence of a transcutaneous pacemaker 91 User manual Monitor mode ECG Monitoring ECG 1 Connect the ECG cable into the ECG socket in the equipment s side panel 2 Select the electrodes to be used on the patient Use only one kind or brand of electrode 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 3 wire cable 5 wire cable 3 leads 7 12 leads 92 Leads DI Electrode differential LA RA User manual Monitor mode ECG Reference LL DII LL RA LA DIII LL LA RA aVR RA LL LA RL aVL LA LL RA VF LL RL RL a LA RA V V1 V6 V 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
69. ned 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 pressed until the next R wave is identified The CardioMax will deliver the shock when the next R wave is identified A IMPORTANT If the CardioMax does not identify a valid QRS it will not deliver the shock 69 User manual Defibrillator mode Disarm key Disarm Disarm the stored charge Charge may be disarmed at any time whether the charge is ready or not Defibrillation display Defibrillator 1 Synchronism Indicates if sync is on 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 INTERNAL internal pads or ADHESIVE 70 User manual Defibrillator mode 4 Number of shocks Shows number of shocks delivered The counter is set to zero when the equipment is turned off 5 Selected and charged energy The energy SELECTED by the user is shown in this display area in BLACK numbers During the equipment s charging cycle the value of the energy that has alread
70. neral grounding in the rear panel Electromagnetic compatibility The installation of the CardioMax requires special precautions concerning Electromagnetic Compatibility in compliance with the information contained in this manual see the chapter Care and maintenance 24 User manual Safety information Disposing of the device Avoid contamination of the environment humans or other equipment by making sure to properly sterilize and decontaminate the equipment before disposing of it Refer to local regulations for the proper disposal of trash in your area For countries that follow European Guidelines refer to 2002 96 CE 25 The equipment Front panel 09 44 07 06 13 Mode Adit 1 LCD screen 5 E Jog Control equipment general configuration 2 Transport handle 6 Power and battery charging indicators on and off Selects the operation mode this chapter see following chapters 4 Quick access buttons see quick ac cess buttons in this chapter 26 User manual The equipment Screen The LCD screen displays graphic and numeric information used in ECG and SpO defibrillation and others For more information about the configurations and screen information see the Screen and operation section e Jog Control The e Jog Control is used to access all of the CardioMax s functions such as set alarms define information displayed on the screen alter parameters etc ROTATE
71. nfigure four items and perform two actions 49 User manual Screen and operation BEEP Volume turns off or adjusts BEEP volume BEEP is the audio indication of QRS Alarm Volume alarm volume adjustment Defibrillator Volume adjusts the volume of the defibrillator s audio information charge charge ready shock disarmed and shock delivered Language choose the language in which menus will be displayed Mode enables to select Non Invasive pressure monitoring in adult pediatric or neona tal patients In neonatal mode the cuffs initial pressure is limited to 60mmHg and in pediatric mode the cuff s initial pressure is limited to 140mmHg Cardiac Frequency enables to select the heart rate by the SpO sensor ECG elec trodes or automatic mode In the automatic mode priority is given to ECG elec trodes 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 SpO EtCO or RESP waveforms or you may view up to 3 waveforms the EtCO and RESP waveforms cannot be shown at the same time It is also possible to select the waveform scan speed The possible speeds are 12 5mm s 25 0mm s e 50 0mm s for ECG and SpO and 6 25mm s 12 5mm s
72. nical alarm SPO2 technical alarm EtCO2 technical alarm 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 is ON the silence time adjustment is blocked until the indication is back to normal ECG technical alarm It allows the enabling or disabling of the sound indications of the ECG technical alarms When this option is enabled and there is a technical alarm situation in the ECG parameter the equipment will send sound warnings at intervals of approximately 6 seconds Sp technical alarm It allows the enabling or disabling of the sound indications of the SpO technical alarms When this option is enabled and there is a technical alarm situation in the SpO parameter the equipment will send sound warnings at intervals of approximately 6 seconds EtCO technical alarm It allows the enabling or disabling of the sound indications of the EtCO technical alarms When this option is enabled and there is a technical alarm situation in the EtCO parameter the equipment will send sound warnings at intervals of approximately 6 seconds 58 User manual Alarms and limits Turn audio alarm ON OFF OR For each parameter the user can turn the audio alarm ON or OFF An X on top of the bell symbol indicates the audio alarm for that particular parameter is off Minimum maximum limit 100
73. ntenance It is recommended that periodic inspections be performed on the equipment s power supply charger cables and connectors in order to determine possible isolation or internal conductor ruptures Functional tests must be performed at the beginning of every work shift Corrective maintenance If the equipment needs repair this can only be done by Instramed or its authorized representative otherwise this Warranty certificate may no longer be valid No internal parts are to be fixed by the user Cleaning and disinfection Instramed recommends cleaning and disinfecting the equipment and its accessories every three months or shorter periods whenever excessive dirt or contamination is noticed Equipment Remove the equipment from the electric current before cleaning it e Wipe the external part of the equipment with a cloth dampened with water and neutral soap or isopropyl alcohol Accessories e Use a cloth dampened with isopropyl alcohol e Rub the surface for about 10 minutes 133 User manual Care and maintenance Sterilization Instramed recommends that the set of internal pads and their adult electrodes be sterilized using the cold sterilization method making correct use of chemical compounds such as ethylene oxide activated Glutaraldehyde solution or more modern processes provided that quality is guaranteed and the sterilization process and handling is performed by specialized professionals However the
74. of the defibrillation MANUAL mode SYNC mode and AED mode See the picture below 123 User manual Printing 3 Paper size Informs the equipment of the paper size be used for printing Large 30 m length Medium 23 m length Small 14 cm length 4 Electrocardiograph function To print a 7 lead electrocardiogram use the print Electro function in the printing setup menu When this function is selected the equipment begins monitoring and printing 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 individually In case the ECG cable used is a 3 wire one it is not possible to print more than one lead simultaneously 6 Back Exit Back to configuration menu or EXIT to go to the monitoring screen 124 PC connection Introduction The CardioMax can be connected to a PC allowing the user access to new functions as View save in external media or print list of the last 100 events View save in external media and print ECG activity of the last two hours Change the operational configurations of the CardioMax only for authorized technical personnel Ch
75. on Monitor mode Screen variation B ECG SpO and NIBP present ESESESESSN INFOCENTER 09 44 07 10 12 Mode Aglult 1 ECG ECG measurements and ECG device communicates with the user alarms 5 NIBP measurement values for systol 2 Time date battery and mode status ic diastolic and mean Non Invasive Blood Pressure 3 Graph area for oximetry ECG and EtCO waveforms Also used for con 6 SpO Oximetry measurements and figurations oximetry alarms 4 Infocenter information on the equip 7 Access icons for event and configura ment and its operation This is how the tion functions 40 User manual Screen and operation Monitor mode screen variation C ECG EtCO and SPO present Y BPM EtCO2 SPO2 mmHg lusuauauauauauiiunt INFOCENTER 17 00 11 12 12 1 ECG ECG measurements and ECG device communicates with the user alarms 5 EtCO EtCO measurements and 2 Time date battery and mode status alarms 3 Graph area for oximetry ECG and 6 SpO oximetry measurements and EtCO waveforms Also used for con oximetry alarms figurations 7 Access icons for event and configura 4 Infocenter information on the equip tion functions ment and its operation This is how the 41 Pacemaker mode screen User manual Screen and operation INFOCENTER PM ON Mod Dem 1 ECG ECG measurements and ECG alarms 2 Time date battery and mode status 3
76. on mode monitor e Pacemaker stimulus change 117 User manual 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 Events Intravenous Access Adrenaline Endotracheal Access Epinephrine Lidocaine Atrophine Intravenous Access Morphine Nitroglycerin and Aspirin Adrenaline Epinephrine To view manage and print stored 8 events use the e Jog control to select Lidocaine the e icon in the main screen s Atrophine configuration menu Morphine Also use the e jog to navigate through events and available settings Nitroglycerin Aspirin LUU J eae Visualizing events is also Patient Events gt y possible by accessing e a the Events option in the 32 CardioMax off configuration menu CardioMax on wW Clear Change pads Adult Memory j CardioMax off e CardioMax on i Change pads Adult List Endotracheal access 3 118 User manual e GE Patient 3 New Change pads Adult Patient CardioMax off CardioMax on Change pads Adult CardioMax off 13 02 Change pads Adult 13 02 Endotracheal access r ees back exit INFOCENTER ape 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
77. on 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 pacemaker is active 5 Check if the pacemaker s pulse meter appears on the screen 6 Increase the stimulation current until the heart rate is captured This is indicated by the presence of the QRS complex Q R and S waveforms right after the pacemaker marker 89 User manual Pacemaker mode Under demand stimulation 1 Rotate the selector switch to the pacemaker mode The pacemaker starts in PAUSE without stimulation pulses 2 Select the leads for viewing the ECG Check if the R wave indicators mark every R wave present on the screen If not change the derivation 3 Adjust the initial current values and frequency PPM with the e jog The current value must be as low as possible 4 With the e Jog go to ON to start stimulation A message in the Infocenter will warn that the pacemaker is active 5 Check if the pacemaker s pulse meter appears on the screen 6 Increase the stimulation 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 b
78. onment specified below The customer or user of the defibrillator should ensure that it is used in such an environment Test Level of ABNT Compliance Immunity Test NBR IEC 60601 Level Electromagnetic Environment Directive Portable and mobile RF communications equipment should not be used near any part of the CardioMax including cables with a separation distance less than the one advised calculated using the equation applicable to the frequency of the transmitter Advisable distance of separation Conducted RF 3 Vrms DEN IEC 61000 4 6 150 kHz up to 80 MHz outside bands ISM 12 d v VP 10Vrms 150 kHz up to 80 MHz outside bands ISM 12 ai P a 80 MHz to 800 MHz Conducted RF 10V m e d Ka VP IEC 61000 4 6 80MHz up to 2 5GHz i 80 MHz to 2 5 GHz Where P is the maximum output power of the transmitter in watts W according to the transmitter manufacturer and d is the advisable separation distance in meters min Field strengths established by RF transmitters as determined by an electromagnetic site survey should be less than the compliance level in each frequency range 4 Interference can occur around equipment marked with the following symbol 9 NOTE 1 At 80MHz and 800MHz 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 ob
79. perator Before using the sensor carefully read instructions which accompany it Any condition that may restrict blood circulation such as the cuff of the arterial pressure device or extremes of systemic vascular resistance may affect the precision of the pulse frequency and SpO readings 102 User manual Monitor mode SpO Factors which affect the SpO measurement s precision Incorrect use of the sensor Anemia Use of vasoactive drugs Patient in shock or cardiac arrest Significant number of dysfunctional hemoglobins 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 instructions Patient Place Description Adult Pediatric Finger hand 12556 Sensor adult Ref 3044 Finger or toe hand or foot 12475 Sensor Y universal Ref 3043 Finger or foot 12475 Sensor Y universal Ref 3043 103 User manual Monitor mode SpO Operating in monitor mode SpO Select the selector switch to Monitor mode All ECG and Go alarms will be enabled The following screen will be displayed Monitor Pacemaker III 1 BELL icon displaying alarm 3 SpO numeric value inhibited alarm or suspended alarm indications 4 Patient s pulse frequ
80. reens for functional tests FUNCTIONAL TEST Put pads on the base Select 100J Press CHARGE Press SHOCK Passed test Passed test FUNCTIONAL TEST Put pads on the base Selecit 100J Press CHARGE Press SHOCK Failed test Failed test Contact technical support Equipment failed functional test Remember If CardioMax fails the functional test contact technical support IMMEDIATELY NOTE printouts of test results will only be available in the CardioMax units equipped with a thermal printer NOTE the CardioMax indicates failure in the functional test when there is a failure in one of the 4 steps of the functional test or when the power delivered has an energy exceeding that allowed by health standards 75 AED mode Automatic External Defibrillator Introduction Given the complexity of clinical variables involved for many years only doctors and experienced paramedics could use defibrillators to reverse a cardiac arrest Nowadays however with the evolution of artificial intelligence Al the CardioMax using its Neural Network Technology is capable of assessing via sophisticated sensors the patient s state consider the clinical variables and deliver automatically 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 A J J J Neural Netwo
81. rior 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 cuff s insufflation 5 Alarm BELL icon indicates if the sound alarm is on or off Sets the minimum and maximum alarm limits 6 Back Exit BACK to configuration menu or EXIT to monitoring screen 101 Monitor mode SpO Physics principle used D The CardioMax measures oxygen saturation on arterial blood by the passage of two light wavelengths through the body tissue a red one and an infrared one which are detected by a photo sensor The oximeter processes these signals separating invariable parameters thickness of tissue skin color light intensity and venous blood from the variable parameters arterial volume and SpO in order to identify pulse frequency and calculate oxygen saturation Calculation of oxygen saturation is precise due to the fact that blood saturated with oxygen absorbs less red light than blood with less oxygen The CardioMax measures functional saturation not detecting significant quantities of dysfunctional hemoglobins such as carboxyhemoglobin or methemoglobin VAN Warnings Use only original SpO 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 o
82. rk Technology JO 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 healthy people Voice orientation and screen indications Internal recording of events PC connection via USB Connection software data download and management via PC Biphasic Shock Automatic self test Use in hospital or extra hospital environments including rescue emergency units 76 User manual AED mode Physics principle used The biphasic cardiac defibrillator is an instrument that delivers energy previously stored in a capacitor to a patient The defibrillation can be external when the capacitor s discharge is delivered through the patient s thorax or internal applying the capacitor s discharge directly to the heart with an open thorax and during surgical procedure The CardioMax uses biphasic shock technology which is characterized by a current liberated in one direction and after a brief period of time reverted in the opposite direction During the defibrillation the 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 bi g phasic SHOCK Warnings The CardioM
83. rrhythmia analyzed Nonshockable Sinus Rhythm Sinus Tachycardia Sinus 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 CardioMax meets IEC 60601 2 4 requirements for sensitivity gt 90 Shock VT The CardioMax meets IEC 60601 2 4 requirements for sensitivity gt 75 Nonshockable rhythms The CardioMax meets IEC 60601 2 4 requirements for specificity gt 95 153 User manual Specifications and safety Precision of applied energy Energy Impedance Accuracy ee Caas on Pat 36 eof ss 9 0 7 0 3J zl 7 7 33 SECHER ej 72 vs 09 7s esf sof eo 0 woo 205 mo o 205 195 of s 490 so so szs sis of sf eo s es es ao mos ves 7a5 15 oo sof oro 1025 voss 110 ves mofese 450 vo srs 1550 1590 m80 uro Trofense mo ors 2015 2055 2050 2035 1920 1770 15 C z 2400 2505 2565 2550 2540 215 2200 15 Patient s impedance response table Patient Impedance Shock o Short circuit Shock inhibited lt 25 Ohms Shock inhibited wf ms sl SS of ss sef sef eo so so SS D D 1 D D 1 3 125 60 20 103
84. s ECG SpO NIBP EtCO and RESP In this position the CardioMax works as a multiparametric monitor ECG and Spo limit alarms continue operating ECG and SpO messages are enabled 5 Turns equipment off In this position the CardioMax is turned off After the device is turned off only the circuit that charges the battery remains in operation This is indicated by a green LED in the base of the equipment s front 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 screen indications which can be warnings instructions or status messages The CardioMax s Automated External Defibrillator will only function if the multifunctional pads adhesive are connected to the equipment 7 Pacemaker mode OP Enables the external pacemaker The external pacemaker will only work if the multifunction pads adhesives are connected to the equipment 34 User manual Screen and operation Operating the e Jog Control To access the configuration menus and equipment operation use the rotating e Jog Control as indicated below STEP 1 ROTATE Rotate the button to the desired item observing the highlighted icons on the equipment screen CG
85. s in the next section 126 User manual PC connection Startup Screen SoftDEA show graphics INSTRAQMJED 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 127 User manual PC connection Graphic display screen Sg ELECTROCARDIOG RAM r r e 1 Download The set of information that is currently being viewed can be saved on the PC by clicking this button A window will open enabling the user to select the desired location in which to store the file download 2 Open Click this button to open a dea file that was previously saved on the computer 128 User manual PC connection 3 Print Click this button to print the set of information that is currently displayed on the screen Use the printer driver dialog box to set printing options 4 PDF Click this button to generate a file showing the set of information 3 that is currently displayed on the screen in pdf format The user must select the desired directory in which to save 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 s
86. sanunetesie 115 EE TE 115 4 Respiration Sensitivity NEEN EEN 115 EN 116 Event and data storage 117 Data storage EEE EE NE 117 ET este E 117 User manual Index Viewing and managing SES Eeer eelere 118 KE E 119 gl 119 3 Delete memory used memory ENEE 119 4 New patient EEE EE 120 EEE EEN 120 EE 120 Printing 121 ETL RE EE 121 WEED 121 EOS OTANI DE 122 Stop 1 EN NE EE EEE 122 ANTE NOUS EE EEE EE ee 123 Erol EE EE RET E 123 STI 123 PE Edessa 124 4 Electrocardiograph EHS 124 5 Number 5 EE EE nnn tnnannnne nenn 124 ee 124 PC connection 125 dur eier ES NE EE 125 KE 1 10 EEE 125 SEELEN 126 Connecting the CardioMax to a PC oi cess cos csnsvscstescsxcteassesossentnnestinncosedeewnacdhaneermneee 126 XIV User manual Index NN NN 127 1 Graphic display button EEN 127 Graphic display screen E 128 12 Downoad EE 128 0 EE EE EN EE 128 PIN ee 129 4 un 129 5 Amplitude selection x sasacanaiasticbacasiaacna cod eantasnasacdnaoesrnnstsiunsnesiavrssanadheaeatsendained 129 Ps TIME FN deeg 129 7 Time 00 EEE REN 129 8 Amplitude scroll E 129 9 Event viewer WINKOW EEE 129 SENGS NE EN ET 130 Changing languages 2 4arvrvj4v4v4749p4rrsRe 131 Other BEIENEE 131 EE 131 EE 132 Care and maintenance 133 Preventive maintenance EE 133 Corrective ire FEC an een nets Rate Dee oer ee 133 leet TE 133 SE ete E 134 Removable battery repnlacement NEEN 135 Thermal paper replacement E 136 Returning Componen
87. sence of strong sources of electromagnetic energy such as electrosurgical equipment or computed tomography equipment CT Operation may also be harmed by the presence of strong lights If it is necessary protect the area of the sensor using for example a surgical towel 2 Any dyes injected into the blood stream such as methylene blue indocaine green indigo carmine and fluorescein may affect the SpO reading precision The presence of dyshemoglobin such as carboxyhemoglobin in consequence of carbon monoxide poisoning or methemoglobin in consequence of sulfonamide s treatment may affect the SpO reading precision 3 Electromagnetic compatibility Warning Installing the CardioMax requires special precautions concerning electromagnetic compatibility according to the information contained in this manual Mobile and portable RF communications equipment such as mobile phones can affect the CardioMax s functioning Maximum length of accessories cables in compliance with electromagnetic compatibility requirements 138 User manual Care and maintenance ECG cable 5 leads code 7900 5 2 5m Set of external defibrillation pads code 79001 2 5m Spo finger sensor cable code 12556 SpO finger cable extensor code21176 2 5m I Pacemaker cable code 79023 2 5mWARNING Using cables transducers and accessories different from the ones specified above except for the ones sold by Instramed as replacement pi
88. sification and symbols A SEENEN EE Connection to other equipment ccccececsesesesesestetetseeeeeeees 611111 1 enee Electromagnetic compatibility rornrnrnrnrnrrrrrrrnrnrrrrrnnnrnnnnnnn Disposing Of the device c cscccscccscicecsseccvescesestenssenneeeenenseaneententens The equipment 54 101 EE So ES PE NE e Jog Control REE ee Selector switch NE ne Quick ES NN NS Power and battery charging mdcetons AAA Te EEE ENE User manual Index 1500 ET rene 29 2 USB PE anda TEE a i a 29 NEPPE aent 29 EN 29 SD MMU EE EE 29 6 Connector for defibrillation electrodes pads AAA 30 7 Capnography exhaust connector s wescanaiesusomaeninnsiariamuneardaesubuaniie 30 8 Capnography connector sicisacsas uc scnaunavicansossaraidnedunscaautstensndataibanmsnitcieateesdatalacs 30 Eeer 31 FP 31 2 Removable battery EE 31 3 Identification CC 31 4 TEE 31 le EE 32 1 3 pin power GOE E 32 2 External DC socket een EE 32 3 Grounding and potential equalizer ENEE 32 TR MM ee 32 Screen and operation 33 Turning and operating E 33 1 Selector switch EE 33 2 Defibrillator EE 33 E Dn 34 4 Monitor EE 34 5 Turns equipment off EE EE ETER 34 User manual Index En EE 34 T Pacemaker mode sec ctatcssnieiaascesncasstiadsvaideadhanlapaecuatdescaasdhstagasasdsatendncneasaaddaccaass 34 Operating the e Jog Control NEE 35 Startup NRS 36 Parameters visualization screen 37 Access icons for events and configura
89. sive pads OP or electrodes 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 Joules for the first second and third shocks Preset values are 150J for the first shock and 200 J for the next shocks In case child or internal pads are used the equipment will automatically limit the charge to 50 Joules When there is use of internal or child pads followed by the use of adult pads the last configured values for adult pads will be recovered 73 User manual Defibrillator mode The charge and shock delivery processes are operated manually After every delivery the energy levels are updated 4 Back Exit BACK to configuration menu or EXIT to go to the monitoring screen Functional test WARNING The functional test must be executed daily in order to guarantee that the equipment is in working order and ready to use FUNCTIONAL TEST Put the Paddles on the support v Select 100J Press CHARGE Press SHOCK Step 1 Place pads on their base located on top of the equipment Step 2 Select 100J of energy Step 3 Press the charge key and wait until the equipment sends the charge ready signal Step 4 Press the shock key 74 User manual Defibrillator mode Result sc
90. stolic pressure occurs when oscillation increases quickly and diastolic pressure occurs when oscillation decreases in the same intensity As a characteristic of oscillometric mode mean pressure is the most precise one VAN Warnings If you suspect a cable or conductor is ruptured avoid using the equipment due to possible risk to the operator The cuff must not be applied on the same limb or extremity where the SpO sensor is When inflating the cuff SpO monitoring may be affected Do not place cuff 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 excessive movements may cause imprecise measurements During NIBP monitoring avoid compression or restriction of the pressure tubes The NIBP connection is protected against defibrillation discharges It is not necessary to remove the cuff from the patient or disconnect it in case of defibrillation In case the equipment is accidentally wet dry it with a clean cloth 97 User manual NIPB monitoring Monitoring Non Invasive Pressure 1 Connect the extremity of the extension hose to the equipment s front panel 2 Measure the limb in which the armband will be applied to and select an adequate type See the chart
91. tatus 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 SpO No finger on sensor sensor connected to the device but cannot detect the patient s finger SpO Searching for signal monitor searching for valid SpO signal SpO Disconnected sensor the SpO sensor or extension is disconnected or badly placed 52 User manual Alarms and limits Spo Artifact muscular spasm detected Spo Weak signal the CardioMax cannot identify the signal Weak signal means the patient probably has low perfusion SpoO Lost pulse no beats for more than 4 seconds Printer Printer without paper printer out of paper Printer Printer door open printer door is not properly closed NIBP Excessive pressure the armband s maximum pressure has been exceeded NIBP Cuff problems the cuff has been wrongly placed or has a leak in its measurement circuit NIBP Weak signal pulse too weak for NIBP measurements Check the cuff s position and tightening NIBP Excessive movement there is noise due to the patient s moving NIBP Long measurement the pressure measurement is too long and possibly inaccurate EtCO No Filterline the capnography sampling line is not connected EtCO Occlusion there is no airflow in the EtCO sensor Change the sampling
92. technical assistance The battery can be replaced following the procedures described on the chapter Care and maintenance The battery s shelf life is at least 500 cycles full charges and discharges Package contents Included Items When opening the package please check whether all items below are present The CardioMax Monitor Cardioverter Biphasic Defibrillator e Instruction Manual e 3 pin Professional Power cable e Grounding and potential equalization auxiliary cable e Removable battery e USB Cable e External defibrillation pads adult and child e 5 lead ECG cable When the NIBP optional parameter is present e Armband adult cuff e Cuff Extensor When the Oximetry optional parameter is present e Oximetry sensor e Oxymetry sensor extensor When the Printer optional parameter is present e Paper bobbin for the printer When the CO optional parameter is present e Sampling line When the Pacemaker AED parameter is present e MP trunk cable e Multifunction adhesive pads e Soft DEA installation CD 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 Index Introduction Purpose and Eiter OG 2 10 1 EE EE Optional AUSTIN REE EE een About the Manual EE EO EE EEE Safety information NM eet Adverse E Clas
93. the parasympathetic system that by freeing acetylcholine performs a depressor effect while a sympathetic innervation when stimulated produces noradrenaline which accelerates the rhythm This potential is then propagated through the atrial myocardium and then reaches the second most important 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 pulses per minute PPM and the strength of the current mA The pacemaker works in two modes fixed or on demand synchronous VAN 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 86 User manual Pacemaker mode Fixed mode In this mode the pacemaker does not consider the patient s heart frequency and applies the PPM number defined by the user Demand mode synchronous In this mode the CardioMax assesses the patient s heart rate applying the PPM number selected in the panel only when the heart rate is lower than the PPM value indicated It must be within at least
94. tilation slots Keep the equipment positioned in order to facilitate airflow These slots are raised to reduce the accidental entry of liquids as well as to prevent against spills or drips 31 User manual The equipment Rear connectors 1 3 pin power connector Input of 100 to 265 VAC with central pin for grounding 5A fuse 20mm 20AG 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 32 Screen and operation Turning and operating Use selector switch 1 for turning CardioMax on and off When turning on the operator must immediately select an operation mode defibrillator monitor or pacemaker Monitor 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 33 User manual Screen and operation 3 Auto Seq mode In this mode it is possible to deliver shocks in a sequence of energy levels preset by the user See the Defibrillator mode chapter 4 Monitor mode Used to monitor the patient
95. tion Tunchone A 38 Monitor mode screen variation A ECG and SpO present e 39 Monitor mode Screen variation B ECG SpO and NIBP present sesees 40 Monitor mode screen variation C ECG EtCO and SPO present 41 Pacemaker mode NS 42 AED mode screen E 43 Defibrillator mode variation A ECG SpO and NIBP presen 44 Defibrillator mode variation B ECG SPO and EtCO present 45 Configuration Menu EE cecetlnt Oke seep cece te Sen bate ca danas 46 E 0 E 46 EE eene ea eee 46 SUE 47 0 EE ER reer ee eer TE NT 47 5 Defibrillator ue CR 47 E 47 Functional ES E 47 EE 48 ES E EE 48 2 MUNG ANC KO Te eee A 49 RE 0 a NER 49 PN 50 User manual Index a GE 50 6 WG TONING EE EE 50 Alarms and limits 52 Physiological TER ENE 52 Technical NWN EEE EE ea EERE ARE EE Ee 52 BOT 54 Battery charge lev l vvs 55 Silence disarm alarm E 57 Suspend AE EE EE 57 Configuration of alarm limits ass vage enst sndeenr 57 BONN TE EE EE cst edecscesmenmeeem nhac 58 EK GH TEE E 58 E E 58 EtGO EN sved 58 Tum BUGIS alarm ON OFF scesa ere 59 Minimum maximum mt 59 Automatic configuration of alarm limits AUTO GET 59 ETT er 60 Defibrillator mode 61 SPEL 61 JE MA SS 62 ET EE 62 EIERE 63 About shock delivery EE EE 65 El Ke 66 User manual Index Using multifunction Eeer 67 Kell 68 Synchronism Synchronized discharge Cardoveraon 69 Disarm EEE cats see a eens ce ste 70 Kell eut E 70 EEE 6 10 REE TE
96. tion or partial pressure both digitally and in graph record The main information given by the capnograph are the exhaled CO partial pressure at the end of expiration respiratory frequency and the capnogram 106 User manual Monitor mode Capnography Capnography monitoring To start the EtCO measurement navigate through the Configuration Menu CO and set the CO On Off item to ON Right after the start the EtCO module performs a procedure called au to zero which is necessary for the proper functioning of the equipment During this procedure no measurements are exerted The CardioMax can monitor EtCO in intubated or non intubated patients To do so you just need to change the following accessories Connect the following accessories e intubated patient sampling line and T connector e Non intubated patient sampling line and nasal cannula Sampling line Sampling line Nonintubated patient Intubated patient 107 User manual Monitor mode Capnography Sampling line The sampling line collects a sample of the gas released by the patient In intubated patients the sampling line is directly connected into the circuit via the T connector In non intubated patients the sampling line is connected to the cannula and positioned on the patient T connector Connects the sampling line into the main ventilation circuit The sampling lines are disposable and non
97. ts The ECG Monitor mode shows the ECG signal and the heart rate value on the screen The NIBP Monitor mode indicates the blood pressure value measured by a Non Invasive method on the screen The SpO Monitor mode measures the oxygen saturation of blood by a Non Invasive method The EtCO Monitor mode presents the partial pressure of exhaled CO 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 lightweight and compact device that can be used in emergency situations and transported within hospitals or in ambulances The CardioMax offers the following parameters and or characteristics some parameters are optional e Exhaled carbon dioxide CO monitoring e Respiratory rate monitoring RESP e ECG and cardiac frequency monitoring e Functional artery oxygen saturation monitoring SpO e Non Invasive pacemaker e Pressure monitoring Non Invasive method NIBP e Biphasic Defibrillator e Automatic defibrillator mode AED 18 User manual Introduction e Sudden Death Prevention Mode SDP e Charge Auto Sequencing mode CAS e Printer e Removable Battery Optional items A This manual refers to all of CardioMax s functions however some of them are optional and may not be present in your equipment The icon beside will appear next to the text whenev
98. ts eeben 137 User manual Index E 137 Precautions Restrictions and Wamimgs 138 E Ce ane erent eee EE ote RP Ua ee ee ee ea 138 Ber OOO AE 138 3 Electromagnetic compatbltv ENEE 138 Electromagnetic SMISSIONS E 139 Electromagnetic immunity SEENEN 140 Electromagnetic immunity Equipment with life support funchons 141 Troubleshooting 144 Accessories 145 EE 145 BL Teo EE TE 145 ee 145 UPP 145 Eeer 145 Ee ER NR EN ES 146 List of EEN 146 Specifications and safety 147 General specifications EE 147 Environmental specifications gege uinacisunecenidenlebedi 148 ell REE ER 149 AED TONG Vane 150 ECG analysis E 151 Ee bt EE ege EAE A E EER 157 User manual Index Eeer 158 NIBP Non Invasive Arterial Pressure ccccssesesseseseeeesensseseseesecetnsnetetetens 160 00 ntsc atin Sadar EEE EE 160 Ee 161 PRES 0 1110 EE 161 OG 01119101 EE E S EN 162 Warranty Certificate 163 XVII Introduction Purpose and application The CardioMax uses electrical defibrillation and cardioversion therapy to reverse ventricular fibrillation arrhythmia or ventricular tachycardia without a pulse in adult and pediatric patients Cardioversion of arrhythmias is also used when necessary In the external pacemaker mode the CardioMax uses monophasic electrical stimulation in order to reproduce or regulate the cardiac rhythm The equipment is also used for monitoring vital signs in adult pediatric and natal patien
99. tween 90 to 180 ppm 350 V 3 or 5 lead ECG cable 10 lead ECG cable optional External pads Multifunctional pads Supports up to 12 simultaneous derivations when equipped with optional cable NO ELECTRODES and a trace line will appear on the display if there is a disconnected cable or electrode The Searching for ECG Signal message will appear on the screen or printer electrocardiograph mode when the ECG 10mm mV amplitude is less than 2 4 mm peak to peak or sensitivity proportional If an adhesive pad is disconnected a trace line will appear on the display 15 to 350 BPM 1 BPM of 15 to 350 BPM Higher than 90 dB measurement in compliance with the AAMI standards for heart monitors EC 13 5 10 15 20 30 e 40 mm mV 60 Hz or 50 Hz Diagnostic mode 0 05 100 Hz Monitor mode 1 40 Hz 158 Patient isolation s defibrillation proof Physiological alarm Technical alarm Time to re establish the ECG baseline after defibrillation ECG amplifiers impedance input Pacemaker rejection stimulus Maximum amplitude of the T wave Accuracy of cardiac frequency in irregular rhythms Cardiac frequency response time User manual Specifications and safety ECG CF type SpO CF type Alarm not locked Minimum level 30 100 Maximum level 100 250 Visual indication Sound indication Suspend sound indication function Silence sound indication function Alarm not locke
100. use buildings Voltage fluctuations flicker emissionslEC 61000 3 3 Complies NOTE It is of paramount importance that the true efficacy of the RF shielding and the true attenuation of the RF filter of the shielded location are checked to ensure that they meet or exceed the minimum values specified 139 User manual Care and maintenance Electromagnetic immunity General Directives and declaration of the manufacturer electromagnetic emissions The CardioMax is intended to be used in the specific electromagnetic environment below The user or customer of the defibrillator should ensure that it is used in such an environment Immunity Test Test Level ABNT NBR IEC 60601 Compliance Level Electromagnetic Environment Directives Electrostatic discharge ESD IEC 61000 4 2 Electrical fast transient Burst IEC61000 4 4 6 kV contact 8 KV air 2 kV for power supply lines 1 KV for input output lines 6 kV contact 8 KV air 2 kV for power supply lines 1 KV for input output lines Floors should be made of wood concrete or tiles If floors are covered with synthetic material the relative humidity should be at least 30 The quality of the power supply should be that of a typical commercial or hospital environment Surge IEC 61000 4 5 Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 Power frequenc
101. washable 108 User manual Monitor mode Capnography EtCO numeric indicator 109 User manual Monitor mode Capnography EtCO setup Using the e Jog select the EtCO function in the setup menu to access the EtCO setup sub menu CO2 On Off Units Scale Calibration 1 CO ON OFF Turns the CO module on or off When on the sampling pump is also operating The numeric values graphs and CO alarms will be activated 2 Units Selects the measuring units of the CO values 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 CO gain graph on the screen 110 User manual Monitor mode Capnography 4 Calibration The equipment is calibrated using a known gas sample thus configuring its measuring curve IMPORTANT Calibration must be performed when the equipment shows a message requiring this procedure during initialization Calibration must be performed by QUALIFIED TECHNICAL PERSONNEL 5 EtCO alarm BELL icon indicates if the sound alarm is on or off Sets the minimum and maximum alarm limits Is it possible to adjust the EtCO 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 EtCO maximum alarm to levels between 21 and 99 mmHg w
102. y 50 60 Hz magnetic field IEC 61000 4 8 1 kV differential mode phase phase 2 kV common mode phase ground lt 5 UT gt 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 lt 5 UT gt 95 dip in UT for cycle of 5 seconds 1 kV differential mode phase phase 2 kV common mode phase ground lt 5 UT gt 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 lt 5 UT gt 95 dip in UT for cycle of 5 seconds The quality of the power supply should be that of a typical commercial or hospital environment The quality of the power supply should be that of a typical commercial or hospital environment If the user of the defibrillator requires continued operation during power interruption it is advisable that the CardioMax is supplied by an uninterrupted power source or a battery Power frequency magnetic fields should be at characteristic levels of a typical commercial or hospital environment NOTE U is the ac mains voltage prior to application of the test level 140 User manual Care and maintenance Electromagnetic immunity Equipment with life support functions Advisable separation distances between mobile and portable RF communications equipment and the CardioMax The CardioMax is intended to be used in the electromagnetic envir
103. y 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 71 User manual Defibrillator mode Charge Auto Sequencing mode Auto Seq In the Auto Seq mode the shock energy levels will follow the order previously set by the user in Defibrillation gt Auto Sequencing Charge See Defibrillation setup below Monitor Pacemaker 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 e Equipment shutdown Auto Seq mode exit e Reconfiguration of the Auto Sequencing mode energy levels available after the delivery of the third shock In case child or internal pads are used the equipment will automatically limit the charge to 50 Joules The energy to be charged is indicated in red After shock delivery the energy is updated with the next energy level User manual Defibrillation setup DEFIBRILLATION SETUP Internal discharge time Sudden Death Prev First Shock Second Shock Third Shock Wa 1 Internal discharge time Determines how long the equipment keeps the charge ready before discharging it internally 2 Sudden Death Prevention SDP Turn on or off the Sudden Death Prevention mode When on adhe

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