Instramed - InMax - Manual do Usuario 07-2009 - Inglês
Contents
1. C Time reference Time of start and end of graph plotting time 2 Navigation on the Trending Graphic Area 20 og Screen 1 20 Interval 4h A 12h Scale 1 2 1 User s Manual Tendencies A Returns to positions in graphic lt Goes to the beginning of graphic 4 OBS On the left there are the oldest memory data and on the right the latest ones B Interval Configurable to 4h 6h and 12h and adjusts the viewable window size on graphic axle X C Scale Configurable to 1 all parameter scale or 1 2 most significant half axle Y D Position The red bar indicates amount of memory used The white dash and numbers below that inform the viewing position E Goes to positions in graphic gt Goes to the end of graphic P 3 Erases memory Erases all InMax trending memory 4 Screen Continues or returns on Screen 1 ECG and SpO2 Screen 2 NIBP and TEMP Screen 3 P1 and P2 Screen 4 EtCO2 and RESP 81 Printing General The optional thermal printer allows the printing of two kinds of printing reports instantaneous and continuous The equipment s front panel is activated by the printing button Instant printing lt 3 secs When printing button is pressured for LESS than three seconds InMax prints a FAST REPORT which corresponds to the curve selected by the user All monitored parameters numeric values are indicated on the fast report date t2. 72 hours non volatile 25 seconds A graphic per vital sign 350mW 20g 50 and 60 Hz 99mmHg to 310 mmHg 70mmHg 1 1 digit whichever is higher 5uV V mmHg disposable or reusable Graphic and tabular 72 hours non volatile 25 seconds A graphic per vital sign Thermal 0 4 Kg 50 mm 98 Accessories Accessories accompanying equipment Basic e One professional network cable 3 pins code 555 0 B e One auxiliary cable for grounding and equalization of potential code 549 5 C e One operations manual code 18805 ECG e One 5 way ECG cable code 18376 SpO2 e One Oximetry sensor 3044 code 12556 D e One expansion for Oximetry code 18627 H Temperature e One adult superficial temperature sensor code 18384 A NIBP e One adult clamp mitten code 18562 F e One expansion for mitten code 12432 G PI e One Medex MX960 Transducer e One interconnection cable MX961Z14 e One support for transducer MX261 e One Medex MX9604A monitoring kit Capnography e One low humidity sample line EtcO2 e One adult pediatric T for sample line 99 User s Manual Accessories Optionals e Support MX 262 for two transducers e 3 way ECG code 18376 e Extra large clamp mitten code 18945 e Pediatric 2 clamp mitten code 18929 e Pediatric 2 clamp mitten code 18937 e Newly born O clamp mitten code 1302 e Newly born 1 clamp mitten code 1891 1 e Oximetry sensor Type Y 3043 code 12475 e Gullet
3. User s Manual Alarms and Limits MINIMUM MAXIMUM LIMIT ADJUSTMENT 160 The adjustment of minimum and maximum values is independent per parameter By means of the e Jog Control m i the operator must select the limit and the parameter to be modified and press it Following the desired value must be 40 adjusted and e Jog pressed again SCALES It is possible to adjust ECG minimal alarm to levels between 30 and 100 BPMs with 5 BPMs interval It is possible to adjust ECG maximum alarm to levels between 100 and 250 BPMs with 5 BPMs interval It is possible to adjust SpO2 minimal alarm to levels between 40 and 95 with 5 interval It is possible to adjust SoO2 maximum alarm to levels between 45 and 100 with 5 interval It is possible to adjust NIBP minimum alarm levels between 50 and 290 mmHg to Systolic Diastolic and average pressure with 5mmHg intervals It is possible to adjust NIBP maximum alarm levels between 60 and 300 mmHg to Systolic Diastolic and average pressure with 5mmHg intervals It is possible to adjust RESP minimal alarm to levels between 6 and 147 BPMs with 3 RPMs intervals It is possible to adjust RESP maximum alarm to levels between 6 and 150 BPMs with 3 RPMs intervals It is possible to adjust Minimum TEMP alarm between 15 and 30 C with 0 2 C intervals It is possible to adjust TEMP maximum alarm to levels between 30 2 and 45 C with 0 2 C intervals It is possible to adjust CO2 minim
4. or 10 4 Traces 6 simultaneous traces maximum Protection Class Class According to NBR IEC601 1 Type CF According to NBR IEC601 1 Electrical Internal Battery Type NiMH 4 Amperes hour Life 3 5 h full charged battery without printer AC 85 to 265 VAC 50 60 Hz 120 VA External DC 10 to 16 VDC 5A Environmental Temperature Operational O to 50 C Storage O to 70 C Humidity Operational 10 to 95 RH non condensing Storage 10 to 100 RH non condensing 95 ECG Electromagnetic compatibility Range Precision Sensibility ECG Cable Filter Derivations Pacemaker detection Electrode Off Defibrillator discharge Sweeping Respiration Technical Range Precision Sensibility Electrodes Sweeping User s Manual Specifications Irradiated and conducted CISPR1 1 15 to 250 BPM 1 BPM trom 30 to 250 BPM 5 10 20 and 40 mm mV 3 or 5 vias 35 Hz and 60Hz DI DII DIII aVL aVR aVF and V Rejects pacemaker pulse for double counting dentified and displayed with low level alarm lt 5 seconds according to EC 601 2 27 12 5 25 and 50 mm s Transthorax impedance 3 to 150 breath min 3 resp min 1 2 3 4 5 and 6X RA LA 6 25 12 5 and 25 mm s NIBP Non Invasive Arterial Pressure Technical Adult range Systolic Moderate Diastolic Newly born range Systolic Moderate Diastolic Oscillometric 30 to 2
5. Invasive Pressure Channel P2 72 User s Manual Invasive Pressure Configuration Using the e Jog select Invasive Pressure function in the Configuration Menu to have access to Invasive Pressure configuration sub menu Configuration gt PI On Off A On On off 0n 120 80 25 0 300 0 ii Offe On 120 80 25 0 300 0 120 80 100 sis dia med lt 3 120 20 1 Filter 60Hz Selection of network interference filter for the two pressure channels 73 User s Manual Invasive Pressure Monitoring PI 2 P1 On Off Turns on and off invasive pressure channel 1 3 Scale Alters invasive pressure channel 1 scale 4 Reset Transducer Resets invasive pressure channel 1 Transducer OBS This procedure must be followed in every new procedure First position the transducer then select Reset transducer 5 P2 On Off Turns on and off invasive pressure channel 2 6 Scale Alters invasive pressure channel 2 scale 7 Reset Transducer Resets invasive pressure channel 1 Transducer 74 User s Manual Invasive Pressure Monitoring PI OBS This procedure must be followed in every new procedure First position the transducer then select Reset transducer 8 Alarm Bell icon indicates if alarm sound is on or off Configuration of MINIMUM and MAXIMUM alarm limits 9 Exit return Return t
6. Manual NIBP Monitoring 2 Verity the proper clamp size for the chosen place according to the previous table 3 Make sure the limb is firmly positioned to guarantee the clamp is at the heart s level Due to the hydrostatic effect the positioning above or below the heart s level may cause incorrect measurement 4 Make sure the ARTERY mark is on the brachial artery Measuring modes 1 Manual On this mode InMax makes an instant measurement of Systolic Diastolic and Average pressure To activate the manual mode just press NIBP MANUAL MEASUREMENT on the front panel or on the NIBP Configuration Menu select Manual Measurement When pressing the NIBP MANUAL MEASUREMENT while the monitor is measuring NIBP it immediately discontinues the measurement 2 Automatic On this mode InMax makes automatic measurements of Systolic Diastolic and Average pressure The measurements are automatically repeated according to the time established by the operator To activate the automatic mode select the desired time on the NIBP configuration menu in the numeric area The interval between measurements can be selected as follows 1 2 3 4 5 10 15 30 60 90 minutes 3 STAT On this mode InMax makes automatic measurements of Systolic Diastolic and Average pressure during 5 minutes During this period the measurements are made automatically by the device so we have the highest number of measurements in 5 minutes 47 User s
7. Manual NIBP Monitoring To activate the STAT mode press NIBP MANUAL MEASUREMENT button in the front panel for 3 more seconds Discontinuing NIBP measurements To cancel an on going Pressure measurement press the NIBP MANUAL MEASUREMENT button located in the equipment s front panel NIBP Numeric Indicator 1 Systolic diastolic and 3 Bell icon indicates alarm or average pressure numeric alarm disarmed voles 4 Time interval between 2 Number of measurements measurements used in made used in automatic automatic measurements measurements 48 User s Manual NIBP Configuration Using the e Jog select NIBP function in the Configuration Menu to have access to NIBP configuration sub menu Configuration gt NIBP Manual Measurement Automatic Measurement 3 Off 90 Initial Pressure 140 60 240 BEOU e 120 80 100 mmHg 120 80 100 mmHg 200 150 170 120 a HAWA GA 80 vV 90 80 50 4 100 sis dia med c 120 20 00DA 1 Manual measurement Starts a NIBP manual measurement 49 User s Manual NIBP Monitoring 2 Automatic Measurement It starts the NIBP measurement automatic mode when selecting the item a measurement is made immediately later measurements will occur as configured Time selection off 1 3 4 5 10 15 30 60 90 minutes 3 Initial pressure It allows the selection of init
8. Monitoring Temperature Monitoring InMax may use temperature sensors YSI 400 The sensors may be for gullet rectum skin surface or temperature in air ways Every sensor accompanies proper instructions of maintenance and use Temperature Numeric Indicator 1 Temperature numeric value selected between C or F 2 Measurement unit may be 62 User s Manual Temperature Configuration Using the e Jog select Temperature function in the Configuration Menu to have access to Temperature configuration sub menu Configuration gt TEMP Units ee 1 Units Measurement unit selection for monitoring temperature select between C Celsius or F Fahrenheit 63 User s Manual Temperature Monitoring 2 Alarm Bell Icon indicates if sound alarm is on or off Configuration of minimum and maximum alarm limits 3 Exit return Return to Configuration Menu or Exit to monitoring screen 64 Capnography Monitoring Physical Principle Used Capnography is a non invasive measurement and graphic presentation due to the CO2 curve time function Sidestream method is used in intubated and or not intubated patients The gas is exhaled from the patient a sample is collected by the tubes and sent to InMax The sidestream camera and sensor are located inside the monitor The CO2 measurement is based on the IR characteristics of CO2 molecules absorption Capnogra
9. Monitoring Non Invasive Pressure Measuring modes NIBP Numeric Indicator NIBP Configuration 8 SpO2 Monitoring Physical Principle Used Warnings Factors affecting SoO2 measurement accuracy SpO2 Numeric Indicator SpO2 Configuration 9 Respiration Monitoring Physical Principle Used Warnings Respiration Monitoring User s Manual Index Respiration Numeric Indicator Respiration Configuration 10 Temperature Monitoring Physical Principle Used Temperature Monitoring Temperature Numeric Indicator Temperature Configuration 11 Capnography Monitoring Physical Principle Used Capnography Monitoring Capnography Numeric Indicator Capnography Configuration 12 Invasive Pressure Monitoring PI Physical Principle Used IPI Numeric Indicator Invasive Pressure Configuration Transducer connection 13 Tendencies Data storage Trending Graph Selection 14 Printing General Instant printing Continuous printing Stop printing Printing in alarm Electrocardiographer Function Printing Configuration User s Manual Index 58 59 User s Manual Index 15 Care and Maintenance 86 Preventive Maintenance 86 Corrective Maintenance 86 Cleaning 86 Internal Battery 87 Replacement of printer thermal paper 87 Return of components 88 16 Precautions Restrictions and Warnings 89 ECG 89 SpO2 89 Electromagnetic Compatibility 90 Warning 90 Electromagnetic emissions 9 Electromagnetic Immunity Overview 92 Electromagn
10. aper Size Small Small Large Print Electro ECG ms 70 O P1 O P2 er 120 80 100 O ETCO2 mmHg O RESP pa 120 80 100 mmHg BOUCHE 1 Print size e On the small mode it prints small for economy e Normal and Large modes are for more detailed exams 84 User s Manual Printing 2 Electrocardiographer function Electro cardiographer Function used to print a 7 derivation electrocardiogram 3 Printing curve Selects the curve to be printed on the report 4 Exit return Return to Configuration Menu or Exit to monitoring screen 85 Care and Maintenance Preventive Maintenance Instramed recommends InMax is verified by a qualified technician every 12 months We recommend you contact the manufacturer to have information about qualitied and trained personnel to make preventive maintenance It is recommended that periodic inspections should be done to the equipment s power source cable cables and connectors observing possible isolation or internal conductors ruptures Corrective Maintenance Whenever it is necessary to repair the equipment it can only be made by Instramed or authorized representative or the warranty certificate will no longer be valid No internal parts can be fixed by the user Cleaning Instramed recommends the equipment and its accessories are cleaned every three months or shorter periods whenever it is clearly dirty or
11. by Oximetry pulse amplitude sensor 4 SpO2 numeric value 2 Bell icon indicates if alarm is on off or disarmed 53 User s Manual Sp02 Monitoring pO2 Configuration Using the e Jog select SpO2 function in the Configuration Menu to have access to SoO2 configuration sub menu Response SPO2 Slow Fast E 0 0 dll 20 mm mV BPM BECOOOO0 pr 120 80 100 re 120 80 100 voa 1K00 85 1 Response SpO2 1 Select SoO2 numeric update response you may select Slow Normal and Fast e Normal Used for most patients 54 User s Manual Sp02 Monitoring e Fast It is used when the user needs faster responses very affected by patient s movements e Slow It is less affected by the patient s movements however you must pay attention to the SpO2 variation slow response 2 Alarm Bell icon indicates if alarm is on off or disarmed Configuration of MINIMUM and MAXIMUM alarm limits 3 Exit return Return to Configuration Menu or Exit to monitoring screen 55 Respiration Monitoring Physical Principle Used The Respiration wave shape is generated by the patient s bioimpedance measurement Where a high frequency signal is applied to the electrodes RA and LA and the thorax impedance variation caused by the breathing effort is detected and represented in the monitor screen in a graphic and in numbers WARNINGS In case of cable
12. is recommended that the InMax client or user makes sure it is used in such environment Immunity Rehearsal NBR IEC 60601 Compliance Electromagnetic Environment Guidelines ABNT Level Rehearsal Level Electrostatic Discharge 6 kVby 6 kV by Floor must be wooden concrete or ceramic If flooring ESD contact contact is synthetic relative humidity must be of at least 30 IEC 61000 4 2 8 kV by air 8 kV by air Fast electric Transitory 2 kVon 2kVon Power supply quality must be typical of a hospital or Burst supply lines supply lines commercial environment IEC6 1000 4 4 Surges 1 kV line by 1 kV line by Power supply quality must be typical of a hospital or IEC 61000 4 5 line line commercial environment 2 kV line by 2 kV line by line line Power surges short lt 5 Ur lt 5 Ur Power supply quality must be typical of a hospital or interruptions and tension drop from gt drop from gt commercial environment In case the InMax user oscillations on supply 95 on 95 on demands continuous operation during power surge it input lines U to0 5cycle U to0 5 is recommended that InMax is supplied by a UPS or IEC 61000 4 11 40 Ur cycle battery drop from gt 40 Ur 60 on drop from gt Ux to 5 cycles 60 on 70 Ur U to 5 cycles drop from gt 70 Ur 30 on drop from gt U to25cycles 30 on lt 5 Ur Ur to 25 drop from gt cycles 95 on lt 5 Ur Ux to cycle of 5 drop from gt seconds 95 on Ur to c
13. or conductors rupture avoiding using them InMax is a breathing rhythm monitor It must NOT be used to detect apnea only when on CO2 mode Excessive patient s movements may cause inaccurate measurements 56 User s Manual Respiration Monitoring Respiration Monitoring Respiration signal is captured by the ECH electrodes For further information about connection see chapter Monitoring ECG To improve breathing pertormance it is possible to change the ECG electrodes positioning choosing alternative places RA and LA must be repositioned in a way they are under the nipples level as the picture shows ALERT When repositioning electrodes the wave form and the ECG amplitude may change ALERT Only Respiration numeric value is captured by the CO2 module Waveform is not Capnography Monitor may also show breathing frequency calculated by the Capnography module For that you just have to configure the function in the Configuration Menu MENU gt RESP gt RESP FREQ 57 User s Manual Respiration Monitoring Respiration Numeric Indicator 1 Respiration symbol and blue Capnography color it measurement unit Respiration indicates the respiration Per Minute frequency source is 2 The Bell icon indicates opno sound alarm ON or OFF 4 Indicates respiration ve frequency is being detected by o Respiration numeric value CO2 module this option is When yellow it indicates the
14. 2 P cCoO2 NIBP RESP TEMP Alarms Date and Time Configurations Tabular Trend Graphic Trending 1 ECG SpO2 PI CO2 NIBP RESP TEMP Menus Allows individual configuration of each parameter 2 Alarm Menu Allows contiguration of maximum and minimum alarm limits individually by parameter See Alarm 25 User s Manual Screen and Operation 3 Date and Time Menu Allows adjustment of date and time 4 Configuration Item Allows for modification of the following equipment operational items e Speed Allows for ECG speed configuration in mm s e CO2 Speed Allows for EtCO2 speed configuration in mm s e QRS Volume It allows modifying the BIP volumes that show the moment the R wave peak was detected giving the cardiac frequency mark You may select OFF 1 2 3 4 5 6 7 8 9 and 10 e Alarm Volume It allows modifying the ALARM volumes to 1 2 3 4 5 6 7 8 9 and 10 e Heart Frequency Allows for configuration of heart frequency origin may be from electrocardiogram or Oximetry SpO2 e Instraserv Address Future Use e Mode Enables internal modules to adult pediatric or neonatal modes e Screen Auto adjust When on off mode InMax is started showing previous screen configuration When on On mode InMax is started showing most common parameters e VGA video output Enables VGA output to an external video through a connector behind the equipment e Langua
15. 55 mmHg 20 to 235 mmHg 15 to 110 mmHg 30 a 135 mmHg 20a 125 mmHg 15a 110 mmHg 96 User s Manual Specifications Over pressure limit by software Adult Newly born 290 mmHg max 145 mmHg max Over pressure limit by hardware Adult Newly born Resolution Manual Mode Automatic Mode STAT mode Sp02 SpO2 Range Pulse Range SpO2 Precision Pulse Precision Sweeping Temperature Technical Range Resolution Capnography Weight CO2 measurement Interval Precision 300 mmHg 150 mmHg 1 mmHg One medication 1 2 3 4 5 10 15 30 60 and 90 Interval minutes Maximum of consecutive measurements in 5 minutes O to 100 30 to 250 BPM 2 from 70 to 100 3 from 50 to 69 2 BPM 12 5 25 and 50 mm s Thermistor series YSI 400 15 to 45 C 59 to 113 F 0 1 C 160 gr 0 99 mmHg 2mmHg of 0 38 mmHg 5 0 08 to each 1mmHg over 38 mmHg 39 99 mmHg 97 Calibration Start Consumption Shape Memory Data interval Graphic Shape Invasive Pressure Consumption Weight Filter Measurement interval Resetting interval Precision Transducer Trending Shape Memory Data interval Graphic shape Printer Type Weight Paper Width User s Manual Specifications Two points 10 seconds to begin CO2 curve Less than 3 minutes for full functioning 1 5 W Graphic and Tabular
16. FOR ELECTRICAL INSTALLATIONS NBR 13534 1995 Besides the network cable with a plug and 3 pin connector a cable with a banana pin on one side and an alligator type clasp 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 must be done in the potential equalization connector and general grounding in the rear panel 11 User s Manual Security Discarding Monitor To avoid contaminating or infecting employees the environment or other equipment make sure the monitor has been properly disinfected and decontaminated before discarding it Discard must be done according to national laws for electrical content and electronic parts To discard parts and accessories follow local regulations about hospital garbage For lead acid battery discard follow local regulations about safe lead disposal Precautions Danger of EXPLOSION Do not use InMax in presence of flammable anesthetic Risk of ELECTRICAL SHOCK Never take the equipment caps off when necessary it must be done by qualified personnel AN Do not use the monitor in presence of magnetic resonance devices This monitor was designed for providing resistance to electromagnetic interference However this equipment performance can be affected in presence of stron
17. G F2A GLASS equalizer RUSE 4 External DC Input For connecting battery or an external DC source with operating range from 10 to 16 VDC Printer InMax offers as an option a thermal printer embedded to the equipment hence the user may print the patient s electrocardiogram as well as the present monitored values See Printing 20 User s Manual The Equipment Support and transportation accessories In the lower part the equipment there are three preparations for fixating the optional support modules or accessories for transportation and fixating For more information contact the manufacturer 21 Screen and Operation Screen Setup The screen below is an example of a patient s monitoring featuring all InMax parameters 120 80 100 mmHg 1 Graphic Area The area to the left is called Graphic Area and shows several divisions where the physiological parameters or the trending data are presented The unit presents only parameter curves monitored at the moment 22 User s Manual Screen and Operation enhancing information view by offering a cleaner reading However the operator may set the view to trend curve form or value table 2 Configuration Menu Icon Any motion of e Jog rotating or pressing activates the Contiguration Menu screen Therein it is possible to set the equipment internal functions and parameter operation For detailed information about this funct
18. User s Manual INMAX Multiparametric Vital Sign Monitor INSTRAMED Manufacturer Instramed Industria M dico Hospitalar Ltda Address Beco Jos Paris 339 Pavilh o 19 91140 310 Porto Alegre RS Brasil Phone Fax 55 51 3334 4199 Email comercial instramed com br Website www instramed com br For information about warranty or technical assistance contact Instramed Technical Support Copyright 2009 Instramed InMax User s manual 09 2009 English RO1 Index 1 Introduction Purpose About the Manual Configurations 2 Safety Information General Warnings Classification and Symbols Norms Device care Connection with other devices Grounding Discarding Monitor Precautions 3 The Equipment Front Panel 8 4 model Front Panel 10 4 model Screen e Jog Control Alarm Display Hot Keys Power Indicators Connectors interlinking the patient Side view Rear connectors Printer Support and transportation accessories 4 Screen and Operation Screen Setup Configuration Menu e Jog Configuration Menu Options Smart Screen Parameter viewing ouwN 5 Alarms and Limits General Priority Visual Indicators Sound Indicators Contiguration of alarm limits Automatic configuration of alarm limits AUTOSET 6 ECG Monitoring Physical Principle Used Warnings ECG Monitoring Derivations Color patterns ECG numeric indicator ECG setup 7 NIBP Monitoring Physical Principle Used Warnings
19. ac defibrillator is used to patient there may be a brief pressure measurement change To minimize undesired effects keep pressure transducer cables as far as possible from defibrillation cables 76 User s Manual Invasive Pressure Monitoring PI Transducers disposable systems must not be reused They must be replaced according to hospital norms and procedures T7 Tendencies Data storage The Trending data are stored for all parameters where the last 40 seconds average is calculated except for NIBP where the measured values and stored Along with the parameter data time and date are stored InMax is capable to store up to 72 monitoring hours when data exceed this time it will substitute the later data for the latest ones allowing the visualization of most recent information 78 User s Manual Tendencies Trending Graph Selection When selecting Graphic Trend in Configuration Menu InMax will show the graphic trend of all parameters in four of them two parameters per screen dil A 20 mmimv er 120 80 100 iC mmHg OO 45 13 p 120 80 100 Screen 1 20 mmHg Interval 4h 12h 120 Scale 1 2 lt 1 80 100 Screen 1 4 N 0 2 Menu i 79 User s Manual Tendencies 1 Trending Graphic Area A Graphic vertical scale superior and interior limits on the parameter measurement unit B Trending Graphic Area
20. al alarm to levels between 18 and 96 mmHg with 3 mmHg intervals It is possible to adjust CO2 maximum alarm to levels between 21 and 99 mmHg with 3 mmHg intervals It is possible to adjust Pl minimum alarm levels between O and 290 mmHg to Systolic Diastolic and average pressure with 5mmHg intervals It is possible to adjust PI maximum alarm levels between 10 and 300 mmHg to Systolic Diastolic and average pressure with 5mmHg intervals 35 User s Manual Alarms and Limits Automatic configuration of alarm limits AUTOSET The AUTOSET function configures alarm limits considering physiological parameter values instantly measured on the patient calculating a deviation for minimum and maximum limits See table below Parameter Minimum Maximum NIBP Sistole x 0 7 10 x 0 9 40 NIBP Diastole x0 7 6 x 0 9 34 NIBP Average x0 7 6 x0 9 35 Temperature C 0 5 TOS Temperature F SpO2 Connection standard Connection standard Respiration x 0 5 x 1 5 ECG x 0 8 x6 For instance if the patient registers 60 BPM as a cardiac frequency when selecting function AUTO ADJUSTMENT will be Minimum 48 and Maximum 96 Alarm Test When turning on the equipment with no cable or sensor connected it shall indicate low priority alarm 1 Press ALARM SILENCE button for 1sec and verify on the Tp screen the disarmed alarm indication for all parameters HB Beep sound shall be suspended Wait for 60 secs the alarm will turn
21. al disaster wrong connection to power source different use from that described by the user s guide or under irregular working conditions Any attempt to violate adjust or repair this equipment by individuals not authorized by Instramed will automatically cancel the warranty The same will happen in case of adulterations made to this contract or to the purchase fiscal receipt or to the equipment series number Instramed Industria M dico Hospitalar Ltda is not responsible for the inadequate use of this equipment by people who are not familiar with its work or techniques which recommend its use EQUIPMENT SERIAL NUMBER DATE OF PURCHASE FISCAL RECEIPT NUMBER 101 INMAX Multiparametric Vital Sign Monitor INSTRAYE D www instramed com br 55 51 3073 8200
22. and rectal YSI 401 adult temperature sensor code 18970 e Gullet and rectal YSI 402 Pediatric temperature sensor code 18988 Oral and rectal YSI 423 pediatric temperature sensor code 18996 e Adult superficial YSI 409B temperature sensor code 18384 e Adult superficial YSI 409AC temperature sensor sterilizable by autoclave code 19003 e Pediatric superficial YSI 427 temperature sensor code 7781 Oral and rectal YSI 403 adult temperature sensor code 1901 1 Cable for synchronization with defibrillator code 10626 e Cable for external DC interconnection code 19020 Consult factory for order specifications e Cable for interconnection with PC code 16411 Capnography sampling line to high humidity yellow with two filters Capnography sampling line to medium humidity yellow with one filter e Software for PC control code 19038 100 Warranty Certificate Instramed guarantees the equipment describes in this certificate for 12 twelve months counting from the delivery date This warranty covers manufacturing or material defects that impede its correct functioning according to the specifications stated herein as long as the conditions presented by this certificate are respected During the warranty period Instramed or its representative will repair or replace defective parts on its own expenses free of charges for the equipment owner The present warranty will no longer be valid in case of damage because of accident natur
23. configured in Configuration respiration frequency originates Seow from the ECG cable and when 58 User s Manual Respiration Configuration Using the e Jog select Respiration function in the Configuration Menu to have access to Respiration configuration sub menu Configuration gt RESP Resp Off On On Off On Frequency Resp ECG ECG C02 Sensibility e 120 80 100 mmHg 120 80 100 mmHg 1 Turns On and Off Respiration monitoring When off all visual and sound alarms will be turned off and ther is no numeric indication of breathing values 59 User s Manual Respiration Monitoring 2 Respiration Frequency It configures if the frequency shown on the device is captured by the thorax impedance ECG cable or by Capnography CO2 3 Sensibility Select 1 2 3 4 5 and 6 4 Alarm The BELL icon indicates sound alarm ON or OFF Configuration of MINIMUM and MAXIMUM alarm limits 5 Exit return Return to Configuration Menu or Exit to monitoring screen 60 Temperature Monitoring Physical Principle Used The temperature is determined by the temperature sensor resistance measurement a device called thermistor whose impedance varies according to temperature The sensor signal is captured by the entry circuit that processes the signal and converts into values expressed in C or F 61 User s Manual Temperature
24. contaminated Below you will see cleaning and sterilization procedure EQUIPMENT EXTERNAL PARTS e Turn off the device from the power source before cleaning e Clean the equipment s external parts with a wet cloth and neutral soap e Never immerse it in liquids 86 User s Manual Care and Maintenance CABLES e Clean them with a cloth wet in warm water and neutral soap e Never immerse it in liquids e Do not sterilize it Internal Battery If InMax has not been used for a long time the battery will have to be recharged To charge the battery connect the monitor to an AC source 110 or 220V outlet or a DC source The rechargeable batteries contained in Instramed equipment must be replaced only by qualified technical personnel from Instramed In case of power shortage the battery guarantees the equipment stability for approximately 2 hours according to technical characteristics Replacement of printer thermal paper Thermal printer module P Button to open the printer port and eject paper TIN 87 User s Manual Care and Maintenance REPLACING PAPER 1 Press the button to open the printer port 2 Previous Figure If the port does not open completely pull it to your direction 2 Remove the old paper bobbin di Return of components If it is necessary to return InMax for repair call Instramed for shipping instructions To facili
25. derivation you can select dl dll dlll aVR aVL aVF and V 4 Sensibility Select the ECG amplification phase gain You can select 5 10 15 20 30 40 mm mV 5 50 60 HZ filter Filter selection for network interference On or Of 6 35 HZ filter Filter selection for muscular trembling On or Off 43 User s Manual ECG Monitoring Alarm It configures MINIMUM and MAXIMUM ALARM limits 8 Exit return Return to Configuration Menu or Exit to monitoring screen 44 NIBP Monitoring Physical Principle Used InMax uses the oscilometric method for calculating Non Invasive Arterial Pressure A mitten is used to send arterial pressure changes caused by blood flow The mitten is insufflated up to a pressure higher than the systolic pressure so to occlude the blood flow in extremities The mitten pressure is reduced slowly generating small pulses and oscillations The average pressure is the least pressure in the mitten where the detected oscillation peaks are of larger amplitude The systolic pressure is found when the oscillation increases fast and the diastolic when the oscillation decreases by the same intensity According to the oscillometric method the average pressure is the most precise one WARNINGS AN Use only original Instramed mittens and conductors Other brands may risk the equipment s precision In case of suspicions of cable or conductor rupture avoid use under possibility
26. disemoglobine such as carboxihemoglobin due to carbon monoxide poisoning or 89 User s Manual Precautions Restrictions and Warnings methemoglobin due to sulphonamide treatment may affect SPO2 measurement accuracy Electromagnetic Compatibility InMax Monitor installation requires special precaution as to electromagnetic compatibility according to information contained in this manual Mobile and portable RF communication equipment such as mobile phones may affect InMax performance Warning The use of accessories transducers and cable not as specified except for transducers and cables sold by Instramed as replacement parts for internal components may result in higher emission or decrease of equipment immunity Maximum length of cables to comply with electromagnetic compatibility requirements 5 way ECG cable code 18376 2 5m SpO2 finger sensor cable code 12556 Extension of SpO2 sensor code 18627 2 5m Adult superficial Temperature Sensor code18384 2 5m Interlink cable MX961Z14 code 39709 2 5m InMax must not be used too close or on top of other equipment 90 User s Manual Precautions Restrictions and Warnings Electromagnetic emissions Manufacturer s guidelines an d statement electromagnetic emissions InMax is destined for use in electromagnetic environment as described below It is recommended that the InMax client or user makes sure it is used in such en
27. e Equipment Power Indicators Network When the Led is on it indicates the equipment is operating on 85 to 265 alternate power network or External Battery Battery When the Led is on it indicates the equipment is CI operating on the internal battery Connectors interlinking the patient The connectors for measuring the patients vital signs are positioned to provide more practicality to the user and are located in the back and side of the equipment control log InMax 8 Model v C O InMax 10 Model 1 1 ECG RESP 3 or 5 way 3 SpO2 Oximetry connector ECG AAMI Standard Connector BCI standard 2 NIBP Fast Clutch connector 4 TEMP Temperature for Non invasive pressure connector YSI400 standard 17 User s Manual The Equipment Side view InMax 8 Model and InMax 10 Model 1 P1 Invasive Pressure 3 CO Capnography Connector CHANNEL 1 Connector CO 2 P2 Invasive Pressure Connector CHANNEL 2 Rear panel InMax 8 Model and InMax 10 Model User s Manual The Equipment 1 Handle for transportation For eas
28. e mouse buttons do Alarm Display The alarm display is lit according to the ALARM origin PRIORITY as in the table below Alarm Category Display Low Priority Not lit Moderate Priority It blinks every second High Priority It blinks every 2 seconds 15 Hot Keys User s Manual The Equipment The hot keys were designed to allow the user instant access to functions that need to be fast V 8 V 10 ON Stand By Adjusts the equipment to Stand By mode partly on low consumption or turns the equipment on Freeze t makes it possible to freeze the screen graph signs for a more detailed exam Volume It allows along with e Jog Control the sound alarm adjust Manual NIBP and STAT mode measurement When pressing the button just once the monitor makes a manual and instant measurement of non invasive arterial pressure When pressed for over 3 seconds it measures on STAT mode where the monitor makes the most NIBP measurements in 5 minutes Print When the button in pressed once the equipment prints a 10 seconds report For continuous printing just press the button for 3 seconds for more information check the section Printing Alarm silence When rapidly pressing the button it blocks ALL sound indications for a period pre determinate by the operator or when pressed by 3 seconds they are blocked for an UNDETERMINATE period for more information check Alarms and Limits 16 User s Manual Th
29. es and conductors Other ECG cables may be risky for defibrillation or have a bad performance In case of suspicions of cable or conductor rupture avoid use under possibility of risk to the operator In cases where the patient has a pacemaker do not rely only on InMax alarms Keep the patient under observation 38 User s Manual ECG Monitoring ECG Monitoring 1 Connect ECG cable to the ECG input in the equipment front panel 2 Select the electrodes to be used on the patient Use only one kind or brand or electrode The electrodes must follow AAMI norm for electrode performance 3 Prepare the application place according to the manufacturer s instructions 4 Apply the electrodes according to the images below following the color pattern 5 Connect the ECG patient s cable to the electrodes Way Cable Way Cable 3 derivations 7 derivations 39 User s Manual ECG Monitoring Derivations Derivation Electrode Differential Reference DI LA RA LL DII LL RA LA DIII LL LA RA aVR RA LL LA RL aVL LA LL RA RL aVF LL LA RA RL V V RA LA LL RL Color patterns There are two color patterns for ECG cables InMax uses IEC pattern See table below Position IEC European AHA American Right Arm R Red RA White Left Arm L Yellow LA Black Left Leg F Green LL Red Right Leg N Black RL Green Thorax C White V Brown 40 User s Manual ECG Moni
30. etic Immunity Equipment with no Life support functions 93 17 Specifications 95 General 95 Electrical 95 Environmental 95 ECG 96 Respiration 96 NIBP 96 SpO2 97 Temperature 97 Capnography 97 Invasive Pressure 98 Trending 98 Printer 98 18 Accessories 99 Accessories accompanying equipment 99 Optionals 100 19 Warranty Certificate 101 Introduction Purpose A InMax is a configurable Vital Signs Monitor produced by Instramed for vital signs monitoring of adult pediatric and neonatal patients The parameters monitored by the InMax monitors are ECG and heart frequency e Respiration by Bioimpedance e Non invasive arterial pressure systolic diastolic and average arterial pressure Functional Arterial Oxygen Saturation SpO2 e Temperature e Capnography Carbon dioxide breathed out at the end of breathing EtCO2 Invasive Arterial Pressure InMax is a light and compact equipment with a sharp design and proper for use in hospitals and similar institutions Pertect for transportation within hospitals or in ambulances WARNING InMax must be used only as a complement in assessing the patient s physiological conditions It must be used along with patient s symptoms and clinical signs About the Manual This manual is to explain the InMax monitor series functioning alerting the user about safety risks The information contained herein belongs to Instramed and cannot be partly or totally used withou
31. g sources of electromagnetic interference or radio frequency such as mobile phones radio communicators etc If the measurements accuracy seems to be incorrect check first the patient s vital signs and later InMax performance 12 The Equipment Front Panel 8 4 model l INSTRAMED INMAX JE ENO es Liquid Cristal Display 5 Basic connectors for patient interlinkin Alarm Indication g Hot Keys Bh OU N E Jog Control equipment configuration overview User s Manual The Equipment Front Panel 10 4 model 1 Liquid Cristal Display 5 Basic connectors for patient pear interlinking 2 Alarm Indication 3 Hot Keys 4 E Jog Control equipment configuration overview 14 User s Manual The Equipment Screen InMax LCD screen shows graphic and numeric information used in ECG breathing SoO2 NIBP and temperature monitoring For more information about the configurations and screen information check chapter screen and operations e Jog Control e Jog Control is used to operate all functions available on InMax it may configure alarms change screen information etc ROTATE When rotated it allows the user to select or change information It allows navigation throughout the equipment as a computer mouse PRESS It selects the option chosen also as th
32. ges Allows selection of the following languages Portuguese English and Spanish e Restores original configuration Returns equipment to factory configurations 26 User s Manual Screen and Operation 5 Tabular Trend item Displays table with last 72 hours Trending 6 Graphic Trending Menu Displays graph with last 72 hours Trending IMPORTANT Some menu items may be deactivated when the parameter does not exist or is unavailable for that the item is in a different configuration 27 User s Manual Screen and Operation Smart Screen InMax always presents the best on screen available space parameter number relationship InMax offers the smart screen feature which automatically adjusts to the number of present parameters When a parameter is not being used the equipment turns odd the specific alarm for such function and inhibits visualization of curve and numeric values making characters and curves in use bigger what allows for better viewing 28 User s Manual Screen and Operation Parameter viewing ECG Parameter always active regardless of any use condition SpO2 Parameter always active regardless of any use condition NIBP On equipment startup this parameter will be inactive To activate select a Manual or an Automatic measurement After that the function shall be active until the equipment is turned off See NIBP TEMP The parameter is automatically activated whenever t
33. he Temperature sensor is connected to equipment It deactivates when sensor is removed See TEMP CO2 To start CO2 module operation usage the function CO2 On Off in the Configuration Menu This enables disables the module operation as well as numeric values and graphic See Capnography PI To start Pl module operation usage the function PI On Off in the Contiguration Menu This enables disables the module operation as well as numeric values and graphic See Invasive Pressure RESP To start Respiration function operation usage RESP On Off in the Configuration Menu This enables disables the module operation as well as numeric values and graphic See Respiration 29 Alarms and Limits General InMax gets to alarm state when it identifies other monitoring condition than normal The monitor has 3 types of alarm priority that help the operator the monitor responses in alarm state are e Alarm Visual Indication e Sound Alarm Indication e Printing Optional Priority For prompt assistance InMax features 3 different types of alarm which ditfer in priority High Average or Low The higher priority alarms substitute the lower priorities HIGH PRIORITY e Assistoly Monitor cannot identity valid heart beatings for over 4 seconds e Loss of SpO2 pulse Oximetry pulse loss and no ECG valid signal MODERATE PRIORITY MAXIMUM and MINIMUM limits violated When the breathing Oximetry ECG Non invasive pressure
34. ial pressure in which the mitten will be insufflated 4 Alarm Bell icon indicates the sound alarm is on or off And MINIMUM and MAXIMUM ALARM limits configuration 5 Exit return Return to Configuration Menu or Exit to monitoring screen 50 SpO2 Monitoring Physical Principle Used InMax measures the oxygen saturation in arterial blood by the passage of two light waves lengths through the body tissue a red and an infrared one which are detected by a photo sensor The oxymeter processes these signals separating the invariable parameters tissue thickness skin color light intensity and venon blood of variable parameters arterial volume and SpO2 to identify the pulse frequency and calculate the oxygen saturation The oxygen saturation calculation is necessary because the oxygen saturated blood absorbs less the red light than the oxygen containing less oxygen InMax measures the functional saturation not detecting significant dystunctional hemoglobin quantities such as carboxyhemoglobin or methemoglobin WARNINGS i Use only original SpO2 sensors supplied by Instramed Other sensors may cause inadequate performance In case of cable or conductors rupture avoiding using them Before using a sensor read the instructions carefully Any condition that may restrict the blood circulation such as the arterial pressure device mitten or systemic vascular resistance extremes may affect the pulse and SpO2 frequency
35. ime and speed of printing in mm s When the ECG curve is printed the corresponding derivation and amplitude are printed too ECG 120 BPM SpO2 98 NIBP 120 80 96 mmHg RESP 23 RPM TEMP 37 2 C adadad 08 04 03 14 32 dll 25 0 mm s 20 mm mV Continuous printing gt 3 secs When the printing button located on the front panel is pressed for MORE than 3 seconds InMAx prints a CONTINUOUS report for indeterminate time or untilthe printing is interrupted The report data are identical to the instant report 82 User s Manual Printing Stop printing To interrupt continuous or instant printing press the printing button on the frompanel at the moment the report is being printed Printing in alarm When the option Printing in Alarm on the Alarm menu is selected as On InMax prints an instant report whenever the equipment is on high or moderate priority alarm Printing shall happen every time an alarm limit is violated Electrocardiographer Function To print a 7 derivation electrocardiogram use the electrocardiographer function on the Configuration Menu When selecting this function the equipment starts monitoring and printing the derivations starting by dl At the end of printing the monitor returns to monitoring normal mode OBS To stop printing press printing key on the equipment front panel 83 User s Manual Printing Configuration Configuration gt Printing
36. ion check the Configuration Menu 3 Status Indicator and Battery Charge This indicator monitors the device s internal battery performance showing through 5 grades the battery charge level 4 Time Indicator It indicates the equipment internal time 5 Numeric Area It shows the numeric value corresponding to the parameter shown in waveform in the graphic area In this area the value of parameters not represented in waveform are also presented when available in InMax 23 User s Manual Screen and Operation 6 Date Indicator It indicates the equipment internal date 7 Status Message Area Important information about the equipment operation besides alarm messages such as loosen electrode pacemaker detected sensor disconnected among others In case of more than one simultaneous message the information displayed alternates every three seconds Configuration Menu e Jog To access configuration and equipment operation menus use the e Jog button as follows ROTATE Rotate the button to the item to be changed observing the highlighted icons on the equipment screen STEP 2 PRESS Press to select the highlighted item The chosen function menu appears 24 STEP 3 ROTATE In the Item menu rotate the button to the corresponding desired value STEP 4 PRESS Press to confirm the new value selected User s Manual Screen and Operation Configuration Menu Options ECG SpO
37. itter as determined through an electromagnetic inspection at the place should be lower than the compliance level on each frequency range There may be interference around the equipment marked with the following symbol a Note 1 At 80MHz and 800MHz the highest frequency range is applied Note 2 These guidelines may not be applicable in all situations Electromagnetic propagation is affected by structure object and people absorption and reflection a Field intensities established by fixed transmitters such as base radio stations telephones wireless cellular phone terrestrial mobile radios amateur radio AM and FM radio transmission cannot be accurately forecast To evaluate electromagnetic environment due to fixed RF transmitters it is recommended an electromagnetic inspection at the place If the local field intensity measure where InMax is used exceeds the applicable compliance level used above InMax must be observed to verify if operation is normal Incase an abnormal behavior is observed additional procedure may be necessary such as reorientation or relocation of InMax P Above 150KHz to 80MHz range field intensity must be smaller than 3 V m User s Manual Precautions Restrictions and Warnings Electromagnetic Immunity Equipment with no Life support functions Recommended separation distances between portable and mobile RF communication equipment and InMax InMax is destined for use in electromagnetic e
38. measurement reading accuracy 51 User s Manual Sp02 Monitoring Factors affecting SpO2 measurement accuracy Incorrect use of sensor anemia use of vasoactive drugs patient in shock or having a heart attack significant levels of dysfunctional hemoglobin intravascular contrasts as indocain green and methylene blue exposure to light in excess and arterial occlusion next to the sensor Sensor selection Choose the appropriate sensor in the following table In the sensor instructions see how it must be applied Patient Adult gt 45Kg Pediatric 15 45kg Children 3 15kg Children lt 3kg Place Finger hand Finger or toe hand or foot Ear Finger hand Finger or toe hand or foot Ear Hand or foot Finger hand Finger or toe Hand or foot Hand or foot Description 3044 3444 3043 1300 3078 3044 3444 3043 1300 3078 3043 3025 1303 B02 3026 52 Sensor adult Sensor adult Sensor Y Universal Sensor disposable adult finger Sensor ear Sensor adult Sensor adult Sensor Y Universal Sensor disposable child finger Sensor ear Sensor Y Universal sensor overlay children Sensor disposable children Sensor disposable newly born Sensor overlay newly born User s Manual Sp02 Monitoring Sp0O2 Numeric Indicator 1 2 2 4 1 Patient s pulse frequency 3 Digital bargraph indicates value captured
39. nvironment where radiated RF disturbance is controlled InMax client or user may help preventing electromagnetic interference by minimum clearance between portable and mobile RF communication equipment transmitters and InMax according to what is recommended below as per the communication equipment output maximum power Transmitter output nominal Separation distance according to transmitter frequency maximum power meters W 150 kHz to 80 MHz 80 MHz to 800 800 MHz to 2 5 MHz GHz a 1 2 P d 1 2 P d 2 3JP For transmitters whose output nominal power is not listed above recommended separation distance D in meters m may be determined by use of applicable equation for transmitter frequency where P is the transmitter output maximum nominal power in Watts W according to the transmitter manufacturer Note 1 At 80MHz and 800MHz the separation distance for the highest frequency range is applied Note 2 These guidelines may not be applicable in all situations Electromagnetic propagation is affected by structure object and people absorption and reflection 94 Specifications General Size 231 x 295 x 190 mm 8 4 model or 260 x 340 x 185 mm 10 4 model Weight 5 4 Kg excluding accessories 8 4 model or 5 9 Kg excluding accessories 10 4 model Screen Type LCD Screen Backlight TFT Thin Film Transistor Active Matrix Size 170 x 128 mm 8 4 model or 211 2 x 158 4 mm 10 4 model Diagonal 8 4
40. o Configuration Menu or Exit to monitoring screen Transducer Connection Attention Before monitoring pressure set the system to zero CAUTION Before connection check if connectors are dry and free of contaminated substances Assemble the transducer connection and the disposable kit in the operational position keep the zero adjust tap top on patient s level according to norms or hospital procedure Expose transducer to atmospheric pressure by turning zero adjust the tap so OFF point to patient Adjust monitor to zero channel transducer used in the Monitor Invasive Pressure Configuration Menu 75 User s Manual Invasive Pressure Monitoring PI Warning When reusable cable connectors are not in use keep them in the holder PRECAUTIONS Air bubbles in the system may result in significant distortion of pressure waveform Check the monitoring system for bubbles Lightly hit the non visible areas to locate any occult bubbles Slowly hit the sampling place to remove all bubbles from the reservoir The operator must avoid conductive connection between the applied part and equipment and accessory metal parts When monitoring along with high frequency surgical equipment one shall avoid the transducer and cables touch high frequency equipment conductive connections to protect patient from burns Transducer pressure system is resistant to cardiac defibrillator discharge effects During monitoring in case a cardi
41. of risk to the operator The mitten must not be applied to the same limb or extremity as the SpO2 sensor When inflating the mitten SpO2 monitoring may be affected Do not position the mitten in limb or extremity being used for intravenous infusion or in any area where circulation is damaged InMax shows results of last NIBP measurement until a new one is made If patient condition changes between the measurements the monitor will not detect that Excessive motion of the patient may cause inaccurate measurement 45 User s Manual NIBP Monitoring Monitoring Non Invasive Pressure 1 Connect the extension hose extremity to the equipment s front panel 2 Measure the limb where the clamp will be applied in the patient and select the proper clamp See table below 3 Position the clamp according to the item Positioning the clamp in the patient 4 Connect the clamp to the extension hose 5 Select a measurement mode Manual Automatic or Stat CLAMP SELECTION Clamp mitten Limb circumference arm leg Children 10 to 19 cm Pediatric 18 to 26 cm Adult 25 to 35 cm Extra Large 33 to 4 cm CLAMP POSITIONING 1 Select the measurement place Choose a place where the blood circulation is good the skin is Q healthy and where the clamp will not harm the patient Both for convenience and normative values to be based on this place it is preferable to use the upper arm I 46 User s
42. on again The suspended alarm signal is off and the alarm sound is back one beep every ten seconds 36 User s Manual Alarms and Limits The period the alarm is off can be adjusted on the menu Alarm gt Silence ee 2 Press ALARM SILENCE button for 3 secs and verify on the screen if the alarm indication is permanently off To turn it back on press ALARM SILENCE button for 1 sec The parameter alarm sounds can be individually turned on and off in the option Alarm gt Configuration Menu The low priority parameter alarm sounds can be individually turned on and off in the option Alarm gt Configuration Menu 37 ECG Monitoring Physical Principle Used ECG is the measurement of electrical potential generated by the depolarization and re polarization of heart cells activity that generates the bioelectrical impulse responsible for heart contraction Heart impulses are detectable on body s surface by means of electrode s application Each electrode potential is amplitied and processed by the heart monitor which presents the signal on the screen and calculates the heart frequency BPM A cardiac cycle period is the time between a certain point during the ECG cycle until the next cycle corresponding point for instance the interval R R is the time run between two successive R waves From this time measurement it is possible to determine the beating per minute BPM WARNINGS uN Use only original Instramed cabl
43. phy involves measurement and registry of carbon dioxide breathed out at the end of exhaling EtCO2 Capnographer is a CO2 analyzer that shows its concentration or partial pressure both digitally or in a graph The most important information coming from the capnographer include partial CO2 pressure breathed out at the end of exhaling EtCO2 breathing frequency and capnogram 65 User s Manual Capnography Monitoring Capnography Monitoring To start EtCO2 measurement navigate on the Configurations Menu CO2 and set to ON item CO2 On Off Right after start EtCO2 module executes a procedure called autozero which is necessary for the equipment to work well During this startup no measurement will be performed InMax can monitor EtCO2 in patients intubated or not by only changing accessories Connect accessories in sequence e Intubated Patient Water Trap Sample Line and T connector e Not Intubated Patient Water Trap Sample Line with nasal tube Sample Line Sample Line Not Intubated Patient Intubated Patient 66 User s Manual Capnography Monitoring Sample Line Sample Line is used to get a sample from the gas exhaled by the patient In intubated patients the line is connected directly to the circuit by mean of a T for connection In patients who are not intubated the sample is connected to the tube and positioned on the patient T for connection Use to connect the
44. quipment Part 1 General Safety Prescription e NBR EC 60601 2 Electromedical Equipment Part 1 General Safety Prescription Part 2 collateral norm Electromagnetic Compatibility Prescriptions and rehearsals e NBR EC 60601 2 27 Electromedical Equipment Part 2 Particular prescriptions for equipment safety for electrocardiogram monitoring e NBR automa e NBR direct b EC 60601 2 30 Electromedical Equipment Part 2 Equipment for tic and cyclic monitoring of indirect blood pressure non invasive EC 60601 2 34 Electro medical Equipment Part 2 Equipment for lood pressure monitoring e NBR p EC 60601 2 49 Electro medical Equipment Part 2 49 Particular escriptions for equipment safety for patient s multiparametric monitoring e NBR IEC 61000 3 2 Limits for harmonic current emissions e NBR IEC 61000 3 3 Voltage fluctuations and flicker e NBR IEC 61000 4 2 Electrostatic discharge immunity tests e NBR IEC 61000 4 3 Radiated radio frequency electromagnetic field immunity test e NBR e NBR e NBR IEC 61000 4 4 Electrical fast transient burst immunity test IEC 61000 4 5 Surge immunity test IEC 61000 4 6 Immunity to conducted disturbances induced by radio frequency fields variatio e NBR method e NBR IEC 61000 4 11 Voltage dips short interruptions and voltage ns immunity tests e NBR IEC 61000 4 8 Power freq
45. s Similar to the visual alarms the sound alarm indicators have different tones for different kinds of priorities See table below Priority Sound High 880 Hz 2 times every second Moderate 440 Hz 1 time every second Low off Silence Disarm Alarm When pressing ALARM SILENCE button with a FAST touch HB shorter than 3 seconds ALL alarm sound indications are silenced for a period pre determined by the operator Your visual indication is the alarm silence icon in all parameters When pressing ALARM SILENCE button with a LONG touch A longer than 3 seconds ALL alarm sound indications are silenced for an INDETERMINATE period Your visual indication is the disarmed alarm icon in all parameters IMPORTANT No kind of sound alarm will occur when the alarm is disarmed 33 User s Manual Alarms and Limits Configuration of alarm limits To alter alarm limits the user must select the ALARM menu on the Configuration screen Even after being turned off InMax keeps memory of latest limits and configurations set by user Autoset Silence Print Alarm LIMITS Sy ey 8 NIALAIS 120 80 100 mmHg 120 80 100 mmHg TURNS ON OFF SOUND ALARM For each parameter the user can TURN ON OFF the sound alarm The bar above the symbol indicates the parameter sound alarm is off On the screen above we have for instance the breathing parameters off other parameters are still on 34
46. sample line to the ventilation main circuit Sample lines are disposable and not washable 67 User s Manual Capnography Monitoring Capnography Numeric Indicator 1 EtCO2 exhaling numeric 4 Measurement unit of CO2 value Informs in mmHg or the values May be in mmHg CO2 value measured at the end mercury millimeters or of exhaling percentage related to the value measured in mmHg divided by the environment pressure in mmHg 2 Bell Icon indicates if sound alarm is on or off 3 Numeric value of inhaled CO 68 User s Manual Capnography Configuration Using the e Jog select EtCO2 function in the Configuration Menu to have access to EtCO2 configuration sub menu Configuration gt CO2 EOOOO00 ENON P1 120 80 O N20 Desflurano gt 12 P2 120 80 100 mmHg 100 mmHg o z a 120 80 100 lt 5120 20 1 CO2 On Off Turns on and off CO2 module When on the sample pump will be on the numeric values graphs and CO2 alarms will be active 69 User s Manual Capnography Monitoring 2 Units Selects a measurement unit of CO2 values May be in mmHg mercury millimeters or percentage related to the value measured in mmHg divided by the environment pressure in mmHg 3 Scale Changes CO2 graph gain on screen 4 Calibration From a known gas sample the equipment is calibrated and sets i
47. t a written authorization Instramed has the right to make any changes to improve this manual as well as the product without prior notice User s Manual Introduction Configurations InMax can be present the following configurations InMax Mono InMax Color ECG resp Analogic BCI Oximetry Digital BCI Oximetry Non Invasive Pressure Temperature Invasive Pressure 1 Invasive Pressure 2 Capnography Thermal Printer xX Display FSTN 7 4 X Display TFT 8 4 Display TFT 10 4 X x XxX XxX XxX X xX XxX X X X XXX X x Safety Information General Warnings IMPORTANT This equipment must be operated only by qualified technical people Before use read this manual carefully Before installing the equipment verify if there is any abnormality or damage caused by improper impact or handling during transportation WARNING InMax must be used only as a complement in assessing the patient s physiological conditions It must be used along with patient s symptoms and clinical signs Classification and Symbols 9 Type CF equipment isolated defibrillation proof Attention Use only as instructed by this manual Warning High Voltage Terminal for potential equalization Terminal for general grounding ON Standby button Grg p es o Non ionizing radiation User s Manual Security Norms InMax was designed according to Safety and Performance norms such as e NBR IEC 60601 1 Electromedical E
48. tate assistance be prepared to inform the equipment series number If possible use the original equipment package In case it is not possible use an appropriate box and protect the monitor well 88 Precautions Restrictions and Warnings InMax is built according to the NBR and IEC norms providing full safety to the patient and operator even when used along with defibrillator and pacemaker However all safety items must be followed as described below Monitor s operation can be affected by the presence of electromagnetic power sources such as electrosurgical equipment and computer tomography CT ECG 1 To guarantee protection against the effects of a defibrillation use only the patient cable that is provided with the equipment 2 When the monitor is used simultaneously with electroscapel position the ECG electrodes as far as possible from the RF current route between the surgical field and the neutral card Do dot use needle type ECG electrode during surgical procedure p02 1 This equipment s operation can be affected by the presence of electromagnetic power sources such as electrosurgical equipment and computer tomography CT It can be damaged by strong light presence In case it is necessary protect the sensor area for example a surgical towel 2 Any coloring introduced to the blood such as methilen blue indocain green and fluorescein may affect the reading accuracy of SPO2 Presence of
49. temperature Capnography or invasive pressure maximum or minimum alarm limits are not within the pre established range for the device 30 User s Manual Alarms and Limits LOW PRIORITY e ECG Loosen Electrode Loosen ECG electrode or bad contact between electrode and skin or ECG conductor is broken e ECG Pacemaker detected Indicates pacemaker pulse was detected on ECG s signal e SpO2 No finger in sensor Sensor is connected to equipment and finger is not detected in sensor e SpO2 Searching Signal Monitor is searching for SoO2 valid signal e SpO2 Sensor disconnected SpO2 sensor or extension disconnected or sensor is badly positioned e SpO2 Artifact Muscular trembling detected e SpO2 Weak Signal It cannot identity signal Weak signal patient possibly has low perfusion e SpO2 Pulse Loss No heart beating for over 4 seconds e PI Transductors were not zeroed The measurements have started but the transductor has not been zeroed See Chapter Invasive Pressure PI Cable P1 disconnected The Invasive Pressure Channel Cable 1 is disconnected e PI Cable P2 disconnected The Invasive Pressure Channel Cable 2 is disconnected e NIBP Mitten Problems Mitten is badly positioned or measurement circuit is leaking NIBP Weak Signal Pulse captured for pressure measurement is too weak for NIBP measurement Check mitten positioning and fastening e NIBP Excessive Moving Noise d
50. toring ECG numeric indicator 100 dil A 20 mm mV 1 ECG symbol the ICG icon silenced alarm or alarm is represented by a heart that disarmed expands indicating ECG s R wave ae Seon 2 ok 4 ECG numeric value and BPM measurement unit Indicates the derivation that ieecloctad Indicates the ECG input amplifier gain 3 Bell icon indicates the alarm 41 User s Manual ECG setup Using the e Jog select ECG function in the Configuration Menu to have access to ECG configuration sub menu Configuration gt ECG ECG Response Normal Slow Fast Detect Pacemaker Off Off On ee ee Sensibility 10 5 40 Filter 50 60 Hz On OA Le or 120 80 100 P1 mmHg po 120 80 100 mmHg S 120 80 100 E co 120 Y 20 10000 1 ECG setup Selection for ECG numeric update may select Slow Normal and Fast e Normal Used for most patients 42 User s Manual ECG Monitoring e Fast It is used when the user needs faster responses very affected by patient s movements e Slow It is less affected by the patient s movements however you must pay attention to the SpO2 cardiac variation 2 Pacemaker Detector Select if the pacemaker detector circuit is operating The visual indication will appear in the status menu with the message pacemaker detected 3 Derivation It indicates the ECG module
51. ts measurement curve IMPORTANT Calibration must be performed whenever the equipment displays the message requesting such procedure during startup Calibration must be performed by QUALIFIED TECHNICIAN 5 Alarm The BELL icon indicates sound alarm ON or OFF Configuration of MINIMUM and MAXIMUM alarm limits 6 Exit return Return to Configuration Menu or Exit to monitoring screen 70 Invasive Pressure Monitoring PI Physical Principle Used The most precise way to measure arterial pressure is the invasive method This method uses a tube that connects the artery to the pressure transducer The invasive technique is largely used in intensive care medicine anesthesia and research The invasive arterial pressure measurement is done by a catheter inside the artery which is connected to a liquid column The pressure measurement is obtained by a pressure transducer that makes the reading By this method numeric values and curves that correspond to the arterial pressure measure are observed The invasive technique is regularly used in intensive care medicine anesthesiology and research 71 User s Manual Invasive Pressure Monitoring PI PI Numeric Indicator 1 120 80 100 2 e 120 80 100 mmHg 4 1 Numeric Value of Invasive SYSTOLE DIASTOLE Pressure Channel P1 MODERATE SYSTOLE DIASTOLE 3 Measurement unit mmHg mercury millimeters MODERATE 2 Numeric Value of
52. ue to patient s movements e NIBP Long Measurement Pressure measurement is too long and may be imprecise 31 User s Manual Alarms and Limits TEMP Temperature Sensor disconnected Temperature sensor is disconnected or defective e Printer without paper No paper in printer or it is badly positioned e Printer port is open Printer port is open making printing not possible e InMax Printing Equipment printing e EtCO2 No Watertrap Capnography sampling line is not connected e EtCO2 Occlusion No air passage EtCO2 sensor Watertrap change nor sampling line e EtCO2 Starting Sensor EtCO2 module is heating internal sensors this happens while Capnography is started and lasts no longer than 15 seconds Visual Indicators InMax has a luminous indicator on top of equipment to help operator identity alarm Messages are also presented on the Status Message Area see image on page 25 In the event of simultaneous messages they are managed according to priority In case of same priority messages they will intertwine When a medium priority alarm of an off limit parameter occur the numeric value to that related and the bell icon flash in the frequency of medium priority of equipment monitor When an Assistoly high priority alarm occurs the numeric value and bell icon flash An Assistoly message appears cancelling any other message 32 User s Manual Alarms and Limits Sound Indicator
53. uency magnetic field immunity test IEC CISPR 11 Electromagnetic disturbance characteristics Limits and s of measurement e ANSI AAMI EC13 2002 Cardiac Monitors heart rate alarms and alarms 10 User s Manual Security Device care Do not put the monitor in position that may fall on the patient and do not lift the equipment by cables or connections to the patient Allocate the cables connected to the patient in a way that restricts the possibility to cause strangulation Keep the equipment in dry places avoiding the possibility to spill liquids on the monitor Do not use the equipment if it is wet or excessively humid Keep the equipment and its accessories always clean and in good conservation state In case of suspicion of fall or external damage do not use the equipment Connection with other devices When connecting InMax to any instrument check the equipment correct operation before its clinical use The equipment or accessories connected to the equipment must be certified according to the IEC 950 standard for data processing equipment or according to the NBR IEC 60601 1 1 of IEC for medical equipment Grounding GROUNDING IS ESSENCIAL FOR THE PROTECTION OF THE OPERATOR AND PATIENT AGAINST ELECTRICAL DISCHARGE ACCIDENTS IN THE ABSENCE OF AN ADEQUATE GROUNDING DANGEROUS CURRENTS MY CIRCULATE FROM THE EQUIPMENT BOX IN CASE OF AN INTERNAL ELECTRICAL DEFECT GROUNDING MUST BE DONE ACCORDING TO ABNT NORMS
54. vironment Rehearsals Compliance ABNT NBR IEC Group 1 CISPR11RF EMISSIONS ABNT NBR IEC Class A CISPR11 RF EMISSIONS IEC 61000 3 2 Class A harmonic emissions al Emissions due to Compliant tension scintillation flotation IEC 61000 3 3 Electromagnetic environment Guidelines InMax uses RF power only for its internal functions However its RF emissions are very low and itis not likely that they generate any interference in electronic equipment nearby InMaxis proper for use in all establishment which are not domestic and may be used in residential establishments and in those directly connected to public low power distribution supplying domestic buildings as long as the following warning is understood Warning This equipment is destined for health care professional use only This equipment may cause radio interference or interrupt operation of equipment nearby It may be necessary to adopt mitigation procedure such as reorientation or relocation of InMax or place screening NOTE It is critical that the RF screening real efficacy and RF filter real lessening of screened place are verified to guarantee they fulfil or exceed the specified minimum values 91 User s Manual Precautions Restrictions and Warnings Electromagnetic Immunity overview Manufacturer s guidelines and statement electromagnetic emissions InMax is destined for use in electromagnetic environment as described below It
55. y transportation InMax features an embedded handle it also offers an external accessory for accommodation in stretchers and beds 2 ID tags ID tags present information about manufacturer equipment characteristics local health authority registration serial number and production date 3 Ventilation Ventilation outputs must be clear and facilitate air circulation The ventilation outputs are designed to prevent water insertion in case of liquid spills or leakage However the unit must not be exposed to excessive humidity rain or dipped in liquids 4 Rear Connectors The connectors on the rear part of the unit allow connection of InMax to peripherals and power supply For detailed information about this panel check Rear Connectors 5 Speakers output The speaker output is designed to prevent water insertion in case of liquid spills or leaking 19 User s Manual The Equipment Rear connectors InMax 8 Model and InMax 10 Model FUSIVEL 1A Trey 260 50 60Hz 20 VA Qe 1 RS 232 output for central 5 External battery fuse 5A and interconnection with PC 20mm 20AG FSA GLASS FUSE 2 Console Output for 6 Internal battery fuse 5A defibrillator 1 V mV output 20mm 20AG F5A GLASS FUSE nurse alarm output and programming cable for software update input 7 3 pin network connector 85 to 265 VAC input with central pin for grounding 2A fuse 3 Grounding and potential 20mm 20A
56. ycle of 5 seconds Magnetic field on supply Magnetic fields on supply frequency must be at frequency 50 60 Hz characteristic levels as of a typical hos pital or IEC 610004 8 commercial environment NOTE Uris the c a supply tension before application at rehearsal level 92 User s Manual Precautions Restrictions and Warnings Electromagnetic Immunity Equipment with no Life support functions Recommended separation distances between portable and mobile RF communication equipment and InMax InMax is destined for use in electromagnetic environment as described below Itis recommended that the InMax client or user makes sure it is used in such environment Immunity NBR IEC 60601 Compliance Electro magnetic Environment Guidelines Re hear sal ABNT Rehearsal Level Level Conduced RF 3 Vrms Portable and mobile RF communication equipment must not IEC 61000 4 150 kHz to 80 be used near any InMax part including cables closer than the 6 MHz recommended distance calculated from the applicable equation to transmitter frequency RADIATED 3 V m Recommended Separation Distance RF 80 MHz to 2 5 IEC 610004 MHz d 1 2VP 3 d 1 2VP 80 MHz to 800 MHz d 2 3 P 800 MHzto2 5 Ghz Where P is the maximum nominal trans mitter output power measured in Watts W according to transmitter manufacturer and D is the separation distance recommended in meters m It is recommended that field intensity established by RF transm
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