GMX Monitor User Manual
Contents
1. 6 2 tnnt totg uenientes 16 ON OFF Indicator 16 Chapter 4 Assembly 17 Flow sensor connection 1 1 kk kk kk kk kk k k 18 Chapter 5 Operation 19 iniia 0 19 EMEN ROM DN E TALI n 20 Initial SCreen EEE 21 Ke m 22 S orco essa Er MEE 22 ocu c M M 23 Parameters Screen usce een on ren eX EXEXERER EREEEERER PARERE 23 Menu Screen iret ridere Lester KARKIR KK 23 Configuring graphical onde 24 Loop scale SCr GIT xu dkan dl diella dipe da dada dakan kakil ka ka kaya anan 25 TAME scale SCHEIN a s k l ls sla ela lelak H ka Ha kaka kas i HUE 25 NOUNS CN aioe Dr E 25 Flow scale Screen i kilk k kllelseslka bikele allen EE iEn E 26 Pressure scale screen vce 27 Configuring trend graphical scales 27 INTERMED Inter GMX Slim Operation Manual code 806 00223 Rev 07 Table of Contents 5 PEEP 29 PIP me E 29 I fer E E TEE 29 30 COSTA 30 MSN INN NIMM NNNM ME M MEUM 31 Configuring Date and Time E keke2. FRONT PANEL Figure 3 1 Inter GMX Slim Front Panel INTERMED Inter GMX Slim Operation Manual code 806 00223 Rev 07 CONTROLS Chapter 3 Controls and Indicators 15 FREEZE STAND BY This key enables freezing stop the graphic drawing If itis momentarily pressed a single touch the drawing will remain frozen Press it again to return the graphic monitoring SCREEN SCROLL FORWARD SCREEN SCROLL BACKWARD These keys enable selecting the monitoring screens available in the Intere GMX Slim CONFIRM This key enables confirming the option or adjustment selected POSITION These keys control the up down left and right cursor movement in order to adjust the monitoring screen MENU This key accesses the selection menu task bar When the menu is accessed the movement across the various options must be made by the position keys PRINT not applicable for the Inter e GMX Slim model This key enables printing the selected screen INTERMED Inter GMX Slim Operation Manual code 806 00223 Rev 07 16 Chapter 3 Controls and Indicators GRAPHICAL DISPLAY The Intere GMX Slim graphical display presents the control and monitoring screens Type Liquid Crystal Display of active matrix TFT Visible area 115 x 86 mm Resolution 320 x 240 points ON OFF INDICATOR POWER ON POWER OFF In the center top of the Intere GMX Slim graphical monitor front panel there is the indicator green led that w
3. INTERMED Inter GMX Slim Operation Manual code 806 00223 Rev 07 40 Chapter 6 Troubleshooting PROBLEM The screen displays the message TRANSMISSION OFF The screen displays the message DISCONNECTED SENSOR Monitor does not update therespiratory parameters Monitor does not displayflow and or pressurecurves Monitor displaysflow and or pressurecurves distortedand or attenuated The indicated values of flow and or curves exceeded the scale limits INTERMED 1 Monitor disconnected ofthe ventilator 2 Electronic failure 1 Misconnected or disconnected flow sensor in the ventilator 1 Flow sensor disconnected from the patient circuit 2 Leakage in patient s circuit 3 Leakage in the flow sensor connection 4 Flow sensor tube blocked secretion accumulation on the flow sensor or within the sensor tube 5 Defective flow sensor 6 Electronic problem 1 Improper selection of the neonatal pediatric flow sensor 2 Secretion accumulation on the sensor PROBABLE CAUSE CORRECTIVE ACTION 1 Checkthe connection fitting 2 Contact the Authorized Technical Service 1 Connect the appropiate flow sensor in the ventilator 1 Connect the sensor in the patient s circuit 2 Remove the circuit leakage 3 Reconnect the sensor in the monitor replace the sensor 4 Remove the blocking and or clean the flow sensor tube 5 Replace the flow senso
4. This Chapter Contains Caution Warning Notes Intere GMX Slim shall be handled and operated by qualified and trained personnel under the direct supervision of a licentiate physician You must READ THE OPERATION MANUAL COMPLETELY BEFORE using the Intere GMX Slim on patients The use of this equipment before its characteristics and functions are fully understood may result in risk conditions to the operator the patient and the equipment itself All paragraphs preceded by the following terms deserve special attention CAUTION Indicates those conditions that may adversely affect the operator or the patient N WARNING Indicates those conditions that may affect and or damage the equipment or its accessories NOTE Indicates additional information for a better understanding of equipment operation INTERMED Inter GMX Slim Operation Manual code 806 00223 Rev 07 10 Chapter 2 Precautions and Notes CAUTION INTERMED Before the first utilization and after using on every patient or more frequently if required clean the monitor and sterilize the sensor according to Chapter 7 DO NOT use the equipment in the presence of flammable anesthetic gases because there is RISK OF EXPLOSION ELECTRIC SHOCK HAZARD do not disassemble the equipment cabinet In case of doubts call Intermed or the Authorized Technical Service For safety the screws used for closing are SEALED OFF Breaking this seals by unaut
5. 32 Configuring patient data 33 Configuring Oz Analyzer RN RR 34 Installation of O2 Cell 35 Preparation for 35 Cell Calibration NN Rs 36 Configuring analyzer 37 E 38 Erasing data in Memory u s eere kk kk kk 38 Chapter 6 Troubleshooting eese 39 Chapter 7 Cleaning and Sterilization 43 Intere GMX Slim MONItTOT MET 44 Oxyg n Cells e a qala 45 FOW SENSON 45 rta NT 46 Chemical Disinfection by Immersion 46 Chemical Sterilization by Immersion 46 ETO Ethylene Oxide BO assasias iri i RERERLE keke 47 Chapter 8 Accessories and Parts 49 Chapter 9 Preventive Maintenance 51 Functional VerificationTest 52 PLS CUMS IE CUMING TA MNT 53 Initial Ss IV INN NAS cra 53 Test Sequence Neonatal sensor 54 Test S
6. according to the scale LOW from 18 to 99 concentration HIGH from 19 to OFF 3 Press the MENU key in the monitor command to finish NOTE The O analyzer alarm is presented by a visual indication in the monitor graphical display and by an audible signal in the ventilator medium priority signal from 18 to 100 O concentration high priority signal O concentration equal or less than 18 To silence an alarm caused by the O analyzer press SILENCE RESET in the ventilator MESSAGES AREA During the alarms calibration and configuration processes the following information can be displayed in the message area OK Indicates correct calibration ERROR Calibration out of the defined parameter ABORT Calibration aborted MUST BE BELOW Indicates that the minimum O alarm cannot HIGH ALARM be equal or greater than the maximum O alarm MUST BE ABOVE Indicates that the minimum O alarm cannot LOW ALARM be equal or greater than the minimum O alarm Cell disconnected Indicates that the O cell is not connected Inter GMX Slim Operation Manual code 806 00223 Rev 07 38 Chapter 5 Operation MONITORING O The Oz monitoring is displayed in the parameter screen of the Intere GMX Slim graphical monitor The set alarms are indicated by the symbol in the lower right corner of the working screens When an alarm is triggered the letters L LOW or H HIGH will flash in the left side of the O2 value
7. and until select O ANALYZER 018 100 3 Use the direction key to access the calibration and adjustment screen 4 Check the PRESS ENTER TO START CALIBRATION message in the information frame 5 Press the CONFIRM key to start the calibration 6 Adjust 21 in the ventilator blender and press the CONFIRM key Wait until the end of the visualization bar course in the monitor This time will be of approximately 1 min and 30 sec after which the message will be displayed 7 Now adjust 100 in the ventilator blender and repeat the operation The calibration is done AN NOTE The following failure conditions may occur during the calibration ERROR Error occurrence due to wearing or O Cell defect CELL Operation not feasible due to O Cell disconnection Disconnected When you press MENU the calibration operation is aborted In ABORT this case the calibration will be kept with the data of the last calibration performed or the factory default INTERMED Inter GMX Slim Operation Manual code 806 00223 Rev 07 Chapter 5 Operation 37 CONFIGURING Oz ANALYZER ALARMS INTERMED 1 Still in the calibration screen select the SET ALARM function using the direction keys 4 or P In the monitor central command adjust the LOW low saturation and HIGH high saturation alarms 2 Once the alarm is chosen use the direction keys or V to select the alarm value for LOW and HIGH
8. SET TIME option in order to configure date and time and open the configuration window 3 Adjust each field year month day hour and minutes using the direction key A 4 Pressthe CONFIRM key to change field and to return to the previous menu The time can be configured in the formats 12 hour AM PM 24 hour default Move the cursors 4 and to select each field Move the cursors A and V to change them Keeping the or W keys pressed values changed more quickly The date can be configured in the formats month in the numeric format 01 to 12 default months abbreviated in English JAN January FEB February MAR March APR April MAY May JUN June JUL July AUG August SEP September OCT October NOV November DEC December INTERMED Inter GMX Slim Operation Manual code 806 00223 Rev 07 Chapter 5 Operation 33 The exhibition order can be presented in the following options mm dd yyyy dd mm yyyy Where dd day 2 digits mm month 2 digits yyyy year 4 digits To leave the configuration screen press the MENU key or the FORWARD or BACKWARD keys CONFIGURING PATIENT DATA 1 Press the MENU key on the control panel to activate the menu on the monitor screen 2 Press the directional key A to select the SET UP option 3 Press the direction keys j and A to select the PATIENT option patient data configuration 4
9. and an audible alarm in the ventilator will be activated until it is disabled by the SILENCE RESET key in the ventilator When the alarm is silenced the x symbol will appear and the letters L LOW or H HIGH will stop flashing when the alarm Cause is removed Press SILENCE RESET in the ventilator to erase the signal ERASING DATAIN MEMORY 1 Press the MENU key on the control panel to activate the menu on the monitor screen 2 To erase the data stored in the memory as patient data and TREND select the CLEAR DATA option using the direction key A and press CONFIRM 3 Then the DELETE DATA YES NO confirmation request will appear With the direction key gt select YES to erase data NO to return to the main menu without erasing data 4 When the YES option is pressed the monitor will present the respiratory parameters monitoring screen with the default configuration AN NOTE The time and date data are not affected but they return to the default exhibition format 24 hour time format and date in the numeric format dd mm yyyy INTERMED Inter GMX Slim Operation Manual code 806 00223 Rev 07 Chapter 6 Troubleshooting 39 Chapter 6 Troubleshooting This Chapter Contains Troubleshooting array Some problems can be solved by the user WARNING Whenever a problem cannot be solved by the operator stop using the equipment and contact Intermede 0800 770 3357
10. in system memory for 24 hours Open the trend graph by moving the 4 or P directional keys Use the A or W keys to open or close the time window of the trend graph intended INTERMED Inter GMX Slim gt Operation Manual code 806 00223 Rev 07 28 Chapter 5 Operation 1 Press the MENU key on the control panel to activate the functions 2 Press the directional key A to select the TREND SCALE function 3 Press the direction key J to open the scale options menu ERASE PEEP PIP VTe CSTAT or RR 4 Press the directional key A to select the parameter to be configured 5 Press the CONFIRM key to confirm the selected scale 6 Adjust the other scales following the steps above for every function of item 2 using the direction keys 4 and or A in order to select when selected INTERMED Inter GMX Slim Operation Manual code 806 00223 Rev 07 Chapter 5 Operation 29 PEEP Positive End Expiratory Pressure The PEEP function enables adjusting the expiratory pressure scale visualization mode in 10 20 or 50 hPa The PIP function enables adjusting the inspiratory pressure scale visualization mode in 20 40 or 120 hPa VTe Total Expiratory Volume The VTe function enables adjusting the Total Expiratory Volume scale visualization mode according to the sensor used Neonatal Sensor Pediatric Sensor Adult Sensor 80 mL 500 mL 2000 mL 40 mL 200 mL 1
11. neonatal pediatric or adult Sensor Patient Neonatal Clearance 0 8mL Flow 0 2 to 9 L min Pediatric Clearance 0 8mL Flow 2 to 24 L min Adult Clearance 7mL Flow 6 to 120 L min 3 Connect the sensor to an Intere Plus system ventilator and to the Y connection of the patient circuit according to Figures 4 3 or 4 5 contained in the Assembly Chapter of the Manual for this equipment 4 Power on the ventilator according to the instructions in the Operation Manual CAUTION a The equipment must be handled and operated by qualified and trained personnel under the direct supervision of a licentiate physician The use of this equipment before its characteristics and functions are fully understood may result in risk conditions for the operator the patient and the equipment itself Inter GMX Slim Operation Manual code 806 00223 Rev 07 Chapter 5 Operation 21 INITIAL SCREEN INTE es E When the equipment is powered jam on the initial screen informs the 7 software revision the flow sensor reno connection condition and the type used with the following information DISCONNECTED SENSOR Indicates that there is no sensor connected to the monitor NEONATAL SENSOR CONNECTED Indicates that the neonatal sensor is connected to an Inter Plus system ventilator In this case the monitor assumes the calibration configurations and the neonatal range scale PEDIATRIC SENSOR CONNECTED In
12. of data Respiratory Rate Inspiratory Resistance Compliance Power Supply 12 V Direct Current 0 25 A Dimensions and Weight INTERMED Intere GMX Slim Operation Manual code 806 00223 Rev 07 Chapter 10 Technical Description 63 Accessory O Concentration Sensor Type of sensor Galvanic Cell Measurement Range from 0 to 100 Response Time Above the range of 2 0 Accuracy of full scale operating temperature At constant temperature and pressure 1 0 0 to 40 C Operating Temperature 32 to 104 F 15 to 50 C 5 to 122 F Operating Humidity non condensed 0 to 95 Storage Temperature Stability above 8 hours of use at constant temperature and pressure Electromagnetic Emission GMX is designed for use an electromagnetic environment as specified below The GMX client or user must assure that it is used in such environment Emission Test Compliance Guidelines Electromagnetic Environment GMX uses RF energy only for its internal functions This RF emission is very low and must not cause any interference in electronic devices close to it RF emission places including domestic places IEC 61000 3 2 short tension public power main Eid supplying energy for domestic ension Fluctuation Flickers emission urposes P RF emission CISPR 11 INTERMED Inter GMX Slim gt Operation Manual code 806 00223 Rev 07 64 Chapter 10 Technical Description Electromagn
13. ventilator 6 Adjust the alarm thresholds compatible with the parameters adjusted in the ventilator Change the parameters adjusted in the ventilator in order to generate alarm conditions checking their actuation in the monitor INTERMED Inter GMX Slim Operation Manual code 806 00223 Rev 07 Chapter 9 Preventive Maintenance 57 ROUTINE PREVENTIVE MAINTENANCE INTERMED Daily or prior to using 1 Check the integrity of flow sensor sensor tubes and power cable and their proper connection as per described in the Chapter 4 2 Check the integrity of the patient circuit eliminate possible leakages due to the assembly or replace the circuit if necessary 3 Check the equipment s general status so as to ensure that it did not suffer any falls or damages that might compromise its safe working request for Intermede or Authorized Technical Service technical support in case of doubts or problems 4 Check the equipment s cleaning status proceeding in accordance with Chapter 7 5 Sterilize the patient s circuit according to Chapter 7 and or the institution s procedures Monthly Conduct the Functional Verification Test FVT requesting technical support from Intermede 0800 770 3357 in case of problems Annually Request for the Annual Preventive Maintenance APM including verification adjust and calibration of the equipment to Intermede or the Authorized Technical Service Inter GMX Slim gt Operation
14. 000 mL 20 mL 100 mL 500 mL INTERMED Inter GMX Slim gt Operation Manual code 806 00223 Rev 07 30 Chapter 5 Operation RISNP Inspiratory Resistance The RISNP function enables adjusting the inspiratory resistance scale visualization mode according to the sensor used Neonatal Sensor Pediatric Sensor Adult Sensor 200 hPa L s 200 hPa L s 100 hPa L s 100 hPa L s 100 hPa L s 50 hPa L s 50 hPa L s 50 hPa L s 20 hPa L s CSTAT Static Compliance The CSTAT function enables adjusting the static compliance scale visualization mode according to the sensor used Neonatal Sensor Pediatric Sensor Adult Sensor 5mL hPa 5mL hPa 20 mL hPa 10 mL hPa 10 mL hPa 50 mL hPa 20 mL hPa 20 mL hPa 100 mL hPa INTERMED Inter GMX Slim Operation Manual code 806 00223 Rev 07 Chapter 5 Operation 31 RR Respiratory Rate The RR function enables adjusting the respiratory rate scale visualization mode in 30 60 or 180 1 To view the trend screens press the page FORWARD or BACKWARD keys until the following screens are displayed PEEP and CSTAT trend screen VTe and RR trend screen PIP and RINSP trend screen INTERMED Inter GMX Slim Operation Manual code 806 00223 Rev 07 32 Chapter 5 Operation CONFIGURING DATE AND TIME 1 Press the MENU key and use the direction key to select the SET UP option 2 Press the direction key to access the
15. 223 Rev 07 Chapter 10 Technical Description 59 Chapter 10 Technical Description This Chapter Contains Classification Always use the Flow Sensors Operation Manual as reference INTERMED Monitors Alarms Graphics Power Supply Dimensions and Weight CLASSIFICATION According to the type of protection Class against electric shock Internally Energized Equipment According to the type of protection Type B applied part against electric shock According to the type of protection IP24 against noxious dripping water According to the operation mode Continuous Operation Equipment not suitable for use in the presence of a flammable anesthetic mixture with air oxygen or nitrous oxide NBR IEC 60601 1 1994 A1 1997 NBR IEC 60601 1 2 2006 NBR IEC 60601 2 12 2004 EN 60601 1 1990 A1 1993 A2 1995 EN 60601 1 2 2001 A1 2004 EN 60601 2 12 2006 CEE 93 42 Medical Device Class IIb rule 9 NOTE All measured values are expressed in BTPS Body Temperature and Pressure Saturated Inter GMX Slim Operation Manual code 806 00223 Rev 07 60 Chapter 10 Technical Description FLOW SENSORS Range Tolerance Neonatal 0 2 to9 5 or 0 2 L min Clearance internal volume 0 8mL Pediatric 2 to 24 5 or 0 5 L min Clearance internal volume 0 8mL Adult 6 to 120 5 or 2 L min Clearance internal volume 7mL Maximum deviation according to gas composition lt 4 at 100 O calibrate
16. 42 Medical Device IIb rule 9 NBR IEC 60601 1 1994 and 1997 amendment NBR IEC 60601 1 2 2006 NBR IEC 60601 2 12 2004 EN 60601 1 1990 A1 1993 A2 1995 and EN 60601 1 2 2001 A1 2004 EN 60601 2 12 2006 Equipment Class Internally energized Type B applied part IP24 Continuous Operation Equipment not appropriate for utilization in the presence of a flammable anesthetic mixture with air oxygen or nitrous oxide Technical Responsibility Legal Responsibility Eng Jorge Bonassa Milton Rubens Salles CREA 137 189 D INTERMED Inter GMX Slim gt Operation Manual code 806 00223 Rev 07 4 Table of Contents Table of Contents Chapter 1 Introduction 7 Description 8 Chapter 2 Precautions and Notes 9 Chapter 3 Controls and Indicators 13 Front Panel 14 iege met NOR TUM DERE 15 15 SCREEN SCROLL FORWARD 15 SCREEN SCROLL 15 POSITION dcum oia n aa 15 CONFIRM ceninin ingone aaa 15 MENU Tec H 15
17. E USED Contact Intermed amp 0800 770 3357 NEVER TRUST the equipment maintenance to NON AUTHORIZED PERSONNEL Contact Intermed 0800 770 3357 in case of any problem or difficulty INTERMED Inter GMX Slim gt Operation Manual code 806 00223 Rev 07 Chapter 9 Preventive Maintenance 53 REQUIRED EQUIPMENT For the FVT conduction the following equipment required Intermede ventilator model Intere Plus Intermede Lung Simulator model LS2000 or similar WARNING In order to assure the accuracy of the measures taken it is required that the ventilator used is calibrated by traceable measurement equipment under metrological standards worldwide recognized and in compliance with the requirements of the ISO 9001 2008 Quality system rules In case of doubts please contact Intermede 0800 770 3357 INITIAL CONDITIONS INTERMED 1 The Intere GMX Slim graphical monitor and the ventilator must be properly assembled according to Chapter 4 2 The monitor and the ventilator must be disconnected from the patient 3 Assemble the patient circuit in the ventilator 4 Connect the ventilator to the power mains under the proper voltage and to the grounding system for protection 5 Connect the ventilator to the proper pneumatic pipeline Air and oxygen pressure at 350 kPa Inter GMX Slim gt Operation Manual code 806 00223 Rev 07 54 Chapter 9 Preventive Maintenance TESTS SEQUENCE NEONATAL SE
18. FECTION is a process capable of destroying pathogenic microorganisms BUT IT CANNOT destroy the spores The spores are only destroyed by STERILIZATION INTERMED Inter GMX Slim Operation Manual code 806 00223 Rev 07 Chapter 7 Cleaning and Sterilization 45 OXYGEN CELL WARNING Use ONLY a clean and dry rag for the oxygen cell cleaning NEVER use any substance for the cell cleaning because it can be damaged FLOW SENSOR Neonatal Sensor code 136 00347 Silicone Polycarbonate L D EQ ETO Pediatric Sensor code 136 00311 Silicone Polycarbonate L D EQ ETO Adult Sensor code 136 00310 Silicone Polycarbonate L D EQ ETO Caption L Washing D Chemical Disinfection by Immersion EQ Chemical Sterilization by Immersion ETO Ethylene Oxide INTERMED Inter GMX Slim Operation Manual code 806 00223 Rev 07 46 Chapter 7 Cleaning and Sterilization WASHING BEFORE performing any disinfection or sterilization process washing by immersion should be carried out in a neutral solution with enzymatic detergent at a temperature between 35 C and 65 C for approximately 10 minutes Rinse with distilled or filtered water to eliminate the high concentrations of chemical substances used Leave to dry in a clean environment before proceeding with the disinfection or sterilization AN WARNING DO NOT USE Phenol gt 5 Chlorinated Hydrocarbons Formaldehyde Inorganic Acids Hyp
19. Manual code 806 00223 Rev 07 58 Chapter 9 Preventive Maintenance ANNUAL PREVENTIVE MAINTENANCE APM The Annual Preventive Maintenance APM is an exclusive service provided by Intermede in order to assure the safe operation of the equipment in compliance with the original specifications and requirements of the NBR IEC 60601 1 1994 and 1997 amendment NBR IEC 60601 2 12 2004 EN 60601 1 1990 A1 1993 A2 1995 and EN 60601 2 12 2006 rules The APM consists basically of the check of all equipment functions replacement of defective parts or components that present wear or deterioration due to use and adjustment and calibration of the equipment The calibration is performed with traceable measurement equipment under metrological standards worldwide recognized and in compliance with the requirements of the ISO 9001 2008 Quality System rules The following conditions are applied 1 The customer should send the equipment for APM to Intermedeor Intermede Authorized Service after using the equipment for 12 months In case of doubts please contact Intermede 0800 770 3357 2 The APM should be performed at Intermede or Intermede Authorized Service facilities with the customer being responsible for freight 3 When performed within the WARRANTY period the conditions established in Chapter 11 will be applicable 4 APM is limited to the equipment accessories are not included INTERMED Inter GMX Slim Operation Manual code 806 00
20. NSOR 1 Connect the neonatal sensor to the ventilator and to the patient s circuit between the lung simulator and the circuit s Y connection according to Chapter 4 2 Power on the ventilator Check if the sensor ID on the Intere GMX Slim initial screen is correct NEONATAL SENSOR CONNECTED Access the monitoring screen 3 Adjust the simulator to 50 hPa cmH2O L s of resistance and 20mL hPa cmH2O of compliance Adjust the following ventilator parameters Mode Controlled Time Cycle Assisted Controlled Inspiratory Flow 6 L min Expiratory Flow 2 L min Inspiratory Time 1 00 sec Respiratory Rate 30 min Resulting Ratio 1 2 PEEP 0 hPa cmH2O Inspiratory Pressure threshold 80 hPa cmH20 maximum 4 Check on the Intere GMX Slim monitor if the indicated values for Inspiratory Pressure Peak PEEP Airways Average Pressure MEAN Inspiratory Flow Peak Pif Respiratory Rate RATE Inspiratory Time Tinsp and Ratio RATIO are in compliance with the values programmed and indicated in the ventilator 5 Check if the values for Vol insp and Vol exp displayed on the Intere GMX Slim monitor are 100ml 10ml 6 Check if the pressure flow and volume curves are compatible with the ventilation parameters and the ventilation mode selected in the ventilator 7 Adjust the alarm thresholds compatible with the parameters adjusted in the ventilator Change the parameters adjusted in the ventilator in order to
21. Open the data entry screen with the direction key gt To enter data in the fields select the characters to compose words or numbers using the direction keys and confirm their entry with the CONFIRM key NAME up to 25 characters AGE upto 03 characters SEX M male or F female with the directional keys WEIGHT up to 03 characters INTERMED Inter GMX Slim gt Operation Manual code 806 00223 Rev 07 34 Chapter 5 Operation INTERMED Special characters amp spaces between words in the same field backward movement to any field gt forward movement to any field Reset clears all information Confirm the option with the CONFIRM key NOTE Keeping the W keys pressed the values are changed more quickly Press the CONFIRM key to go to the next field Press the MENU key to return to main menu CONFIGURING THE O ANALYZER The Intere GMX Slim presents an Oz analyzer This operation is made together with the ventilator controls and will only be performed when using the Cell optional NOTE For the perfect operation of this mode install the O Cell and proceed according to the Operation Assembly and Calibration instructions described in this section In order to operate correctly the ventilator blender must be fed by one 100 oxygen gas supply and one 21 oxygen medical air supply Inter GMX Slim Operation Manual code 806 00223 Rev 07 IN
22. Operation Manual desde INTERMED GRAPHICAL MONITOR The Intermed and inter names and logotypes are registered trademarks of Intermed Equipamento M dico Hospitalar Ltda Sao Paulo Brazil 2011 MOP Code 806 00223 Operation Manual INTER GRAPHICAL MONITOR 1 CAUTION Read this manual completely before using Intere GMX Slim on patients This equipment can be changed without any previous notice to the user INTERMED Inter GMX Slim Operation Manual code 806 00223 Rev 07 Foreword 3 Foreword This Operation Manual presents the information required for the correct utilization of Intermede ventilation graphical monitor model Intere GMX Slim Always use the Operation Manual as reference Manufacturer Intermed Equipamento M dico Hospitalar Ltda Rua Santa M nica 980 Cotia SP Brazil CEP 06715 865 55 11 5670 1300 55 11 4615 9300 Fax 55 11 4615 9310 website www intermed com br Email contato intermed com br CNPJ 49 520 521 0001 69 I E 278 188 774 118 After Sales 0800 770 3357 55 11 5670 1300 or by the website OBELIS s a Boulevard G n ral Wahis 53 1030 Brussels BELGIUM Tel 32 2 732 59 54 Fax 32 2 732 60 03 E Mail mail obelis net ANVISA Product Registration Technical name Ventilation Monitor Business Name Graphical Monitor Intere GMX Slim Registration Nr 10243240040 Product Classification CEE 93
23. RE FLOW VOLUME TIME or LOOP H RS 3 Press the direction key 4 Press CONFIRM key to validate to select the scale the selected scale 20 40 or 120 hPa 5 Adjust the other scales following the steps above for every function of item 2 using the direction keys 4 and or in order to select and j when selected INTERMED Intere GMX Slim Operation Manual code 806 00223 Rev 07 Chapter 5 Operation 25 LOOP SCALE SCREEN This screen enables to select the loop scale defining the period after which the loop is updated It can be at every 1 cycle 2 cycles 4 cycles Select the desired scale and press CONFIRM key In order to view the graphic d Pod Wr nau ra screen press FORWARD or Tu BACKWARD keys until this screen appears Bog 209200 027 TIME SCALE SCREEN This screen enables to select the time scale defining the window scanning period that can be 5 sec 10 sec 20 sec This configuration is applicable to Pressure vs Flow and Pressure vs Volume graphics As lower the scanning time is greater the graphic reading resolution will be VOLUME SCREEN This screen enables to select the proper volume scale in order to assure a better graphic visualization The values depend on the sensor used Neonatal Sensor Pediatric Sensor Adult Sensor 20 mL 100 mL 500 mL 40 mL 200 mL 1000 mL 80 mL 500 mL 2000 mL Select the desired scale and pr
24. STALLATION Cell Chapter 5 Operation 35 Install the Oz Cell according to the drawing below Figure 5 1 Fitting diagram of PREPARATION FOR O ANALYZER USE INTERMED NOTE 1 Connect the cable terminal in the O2 Cell entry located in the ventilator rear panel 2 Connect the Cell in the ventilator side panel fitting the female side in the Inspiratory branch output before connecting the Insp tube of the patient circuit 3 Fit the Insp tube of the patient circuit in the male side of the O2 Cell Keep the circuit disconnected from the patient 1 Connect the O2 Cell cable in the ventilator according to previous description 2 Make sure that the gas supplies are connected and under the working pressures described in the ventilator s Operation Manual 3 Obstruct the patient circuit Y 4 Power on the ventilator with the Intere GMX Slim connected and set the following parameters in the commands Mode Sensitivity by pressure Insp Time Flow Resp Rate P Limit 5 The ventilator starts to cycle Time Cycle A C Exp Flow 1 00 sec 30 L min 30 min 20 hPa cmH2O Inter GMX Slim gt Operation Manual code 806 00223 Rev 07 36 Chapter 5 Operation CELL CALIBRATION Fi02 ANALYZER 1 In the Intero GMX Slim graphical monitor press the MENU key and select the SET UP mode using the direction key A A j 2 Use the direction keys
25. ation Manual code 806 00223 Rev 07 70 Chapter 11 Warranty INTERMED Inter GMX Slim Operation Manual code 806 00223 Rev 07 Annex Symbols and Terminology 71 Annex A Symbols and Terminology Symbols 1 The meaning of standard symbols printed on the equipment is given below 60601 1 1994 Dip proof when bent up to 15 and Symbol n protected against penetration of 529 solid particles of 12 5mm diameter 60601 1 1994 Warning Consult Symbol No 348 ATTACHED DOCUMENTS IEC60601 1 1994 Equipment with Symbol Type B part applied No 878 02 02 IEC60601 1 1994 Symbol No Hazardous electrical voltage 878 03 01 INTERMED Inter GMX Slim Operation Manual code 806 00223 Rev 07 72 Annex Symbols and Terminology 2 The meaning of standard symbols printed on the equipment package is given below INTERMED ISO 780 1997 E Symbol No 1 ISO 780 1997 E Symbol No 3 ISO 780 1997 E Symbol No 4 ISO 780 1997 E Symbol No 6 ISO 780 1997 E Symbol No 14 ISO 780 1997 E Symbol No 17 ISO 7000 1998 E F Symbol No 0505 FRAGILE The package s contents are fragile therefore shall be handled with care THIS SIDE UP Indicates the package s upside position PROTECT AGAINST DIRECT SUNLIGHT The package shall remain sheltered from direct sunlight PROTECT AGAINST RAIN The package shall remain sheltered from rain MAXIMUM PILING Indicates the max
26. com br E mail contato intermedbr com br Suggestions questions or claims After Sales 0800 770 3357 or by the website
27. d at will be necessary to the power supply place magnetic shields frequency 50 60 Hz The magnetic field must IEC 61000 4 8 be measured in the place intended for the placement and it must be assured that it is weak enough INTERMED Intere GMX Slim Operation Manual code 806 00223 Rev 07 Chapter 10 Technical Description 65 NOTE FOR ELECTROMAGNETIC COMPATIBILITY This equipment was developed tested and certified in accordance with the thresholds established in NBR IEC 60601 1 2 2006 and EN 60601 1 2 2001 A1 2004 for Class Internally Powered electromedical equipment and CEE 93 42 Medical Device Class rule 9 following CISPR 11 normative conditions The thresholds are intended to offer protection against prejudicial interferences in its installation and operation according to the immunity levels defined for electromagnetic interferences for the equipment connected on patient as per technical description and use in conformity with this manual When exposed to situations adverse to its specification this equipment can produce or suffer electromagnetic interference In order to prevent prejudicial interferences it is mandatory to Observe the distances between this equipment and other possible EMI emitters Only connect the equipment to a grounded outlet for protection Never disable the grounding terminal on the power cable plug of the equipment ventilator In case of doubts always contact Inter
28. d sensor to 21 O Maximum deviation according to gas temperature See the graph below NOTE Flow sensors are accessories of the Intere Plus model Volume Temperature Ratio 5 1 04 gt 102 2 5 1 00 1 gt lt P 0 98 4 E 0 96 r gt gt 0 94 T 2 092 4 7 E an 0 90 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 Temperature 5 INTERMED Inter GMX Slim Manual code 806 00223 Rev 07 INTERMED Chapter 10 Technical Description 61 Maximum Inspiratory Pressure Peak Plateau Pressure Plateau Mean Airway Pressure 20 Inspiratory Peak Flow Expiratory Peak Flow Pef Tidal Inspiratory Volume Vol insp Tidal Expiratory Volume Vol exp Minute Volume Vol min Respiratory Rate Rate Inspiratory Time Tinsp Ratio Ratio Inspiratory Resistance Rinsp Expiratory Resistance Rexp Dynamic Compliance Cdyn Static Compliance Cstat Weaning Index RSBI Negative Inspiratory Pressure NIP Ventilation Work ventilator WOBvent O Analyzer Visual signalling on the monitor and medium priority audible alarm in the ventilator Low oxygen concentration Low 0 18 to 99 High oxygen concentration High 0 19 to OFF Inter GMX Slim Operation Manual code 806 00223 Rev 07 62 Chapter 10 Technical Description Graphics Curves Pressure vs Time 24 hours maximum period
29. dicates that the pediatric sensor is connected to an Inter Plus system ventilator In this case the monitor assumes the calibration configurations and the pediatric range scale ADULT SENSOR CONNECTED Indicates that the adult sensor is connected to an Inter amp Plus system ventilator In this case the monitor assumes the calibration configurations and the adult range scale not applicable to Inter amp 3 Plus NEO ventilators TRANSMISSION OFF Indicates that there is no signal between the Inter GMX Slim ventilator and monitor Contact Intermed or the authorized technical service If the sensor is connected the monitor will leave the initial screen after 5 seconds and will start the Cleaning and Auto Zero resources INTERMED Inter GMX Slim gt Operation Manual code 806 00223 Rev 07 22 Chapter 5 Operation INTERMED NOTE After exhibiting the initial screen the equipment presents the last screen displayed before it has been powered off CLEANING At every 5 minutes the equipment eliminates eventual liquids existing within both sensor measurement duct paths CAUTION Perform the cleaning of the sensor duct when there are solid residues inside it in order to prevent that the sensor accuracy is affected AUTO ZERO At every 5 minutes the equipment repositions the flow zero indication in order to assure the accuracy during the monitoring period NOTE During the Cleaning and Auto Zer
30. equence Pediatric 55 Test Sequence Adult 56 Routine Preventive Maintenance 57 Annual Preventive Maintenance 58 INTERMED Inter GMX Slim gt Operation Manual code 806 00223 Rev 07 6 Table of Contents INTERMED Chapter 10 Technical Description 59 Classification mM I 59 Flow Sensors M 60 MONON MR RN E ERR HR RE kn k 61 Alan de 61 go TT 62 Power Supply TT 62 Dimensions and 62 Accessory O concentration Sensor 63 Electromagnetic levels of 63 Chapter 11 Warranty 69 Annex A Symbols and Terminology 71 Inter GMX Slim Operation Manual code 806 00223 Rev 07 Chapter 1 Introduction 7 Chapter 1 Introduction This Chapter Contains Always use the Description Operation Manual as reference INTERMED Inter GMX Slim Operation Manual code 806 00223 Rev 07 8 Chapter 1 Introduction Description Inter GMX Slim is a microprocessor based graphical monitor coupled and integrated to the Inter Plus ventilation sys
31. ess the CONFIRM key INTERMED Inter GMX Slim Operation Manual code 806 00223 Rev 07 26 Chapter 5 Operation In order to view the graphic screen press FORWARD or BACKWARD keys until the presented screen appears Pressure vs Volume graphic screen FLOW SCALE SCREEN This screen enables to select the most suitable flow scale in order to assure a better graphic visualization The values depend on the sensor used Neonatal Sensor Pediatric Sensor Adult Sensor 3 L min 8 L min 40 L min 6 L min 16 L min 80 L min 9 L min 24 L min 120 L min Select the desired scale and press the CONFIRM key In order to view the graphic screen press FORWARD or BACKWARD keys until the screen aside appears Pressure vs Flow graphic screen INTERMED Inter GMX Slim Operation Manual code 806 00223 Rev 07 Chapter 5 Operation 27 PRESSURE SCALE SCREEN This screen enables to select the most suitable pressure scale in order to assure a better graphic visualization 20 hPa 40 hPa or 120 hPa Select the desired scale and press the CONFIRM key In order to view the graphic screen press FORWARD or BACKWARD keys until the screen aside appears Pressure vs Volume graphic screen CONFIGURING TREND GRAPHICAL SCALES ZOOM Feature The trend graphs may be presented in scales from 15 minutes 1 2 4 8 12 up to 24 hours by using the ZOOM function If the gathered data is not erased it remains
32. etic Immunity GMX is designed for use in an electromagnetic environment as specified below The GMX client or user must assure that it is used in such environment Immunity Test Test Level IEC 60601 Compliance Level bilia eem The floor must be made t6kV 6kV of wood concrete or Electrostatic Discharge 5 d IEC 61000 4 2 material the relative 8kV 8kV humidity must be 30 at least 2 kV for power supply 2 kV for power supply The power mains quality Electric Transient line line must be standard for Fast Surge 61000 4 4 1 kV for inlet and outlet 51 kV for inlet and commercial or hospital line line environment 1kV from line to line 1kV Diferential Mode The power mains quality Surge must be standard for IEC 61000 4 5 2kV from line to commercial or hospital lt 5 U gt 95 dip at lt 5 U gt 95 dip at U for 0 5 for 0 cycle 40 U 60 dip at U 40 U 60 dip at U The power mains quality for 5 cycles for 5 cycles must be standard for 70 U 30 dip at U 70 U 30 dip at U commercial or hospital for 25 cycles for 25 cycles environment 5 U gt 95 dip at U 5 U gt 95 dip at U for 5 seconds for 5 seconds Tension Dips Short Tension interruptions and differences in the power mains inlet tension IEC 61000 4 11 distortion occurs GMX may need to be positioned far from the magnetic sources or it Electromagnetic fiel
33. generate alarm conditions checking their actuation in the monitor INTERMED Inter GMX Slim Operation Manual code 806 00223 Rev 07 Chapter 9 Preventive Maintenance 55 TESTS SEQUENCE PEDIATRIC SENSOR 1 Connect the pediatric sensor to the ventilator and to the patient s circuit between the lung simulator and the circuit s Y connection according to Chapter 4 2 Power on the ventilator Check if the sensor ID on the Intere GMX Slim initial screen is correct PEDIATRIC SENSOR CONNECTED Access the monitoring screen 3 Adjust the simulator to 50 hPa 2 1 5 of resistance and 20mL cmH O of compliance Adjust the following ventilator parameters Mode Controlled Time Cycle Assisted Controlled Inspiratory Flow 15 L min Expiratory Flow 5 L min Inspiratory Time 1 00 sec Respiratory Rate 20 min Resulting I E Ratio 212 5 hPa cmH2O Inspiratory Pressure threshold 120 hPa cmH2O maximum 4 Check on the Intere GMX Slim monitor if the indicated values for Inspiratory Pressure Peak PEEP Airways Average Pressure MEAN Inspiratory Flow Peak Pif Respiratory Rate RATE Inspiratory Time Tinsp and Ratio RATIO are in compliance with the values programmed and indicated in the ventilator 5 Check if the values for Vol insp and Vol exp displayed on the Intere GMX Slim monitor are 250mL 25mL 6 Check if the pressure flow and volume curves are compatible with the ventilation parame
34. horized personnel may result in the equipment WARRANTY lost The equipment must be perfectly coupled to a ventilator of Inter Plus system ALWAYS USE the equipment INCOMPLIANCE WITH THE SPECIFICATIONS included in the manual In case of doubts call Intermed or the Authorized Technical Service NEVER trust the equipment MAINTENANCE to NON AUTHORIZED TECHNICAL PERSONNEL Contact Intermed or the Authorized Technical Service in case of any problem or difficulty In case of replacement always use ORIGINAL ACCESSORIES COMPONENTS AND PARTS otherwise you can impair equipment performance patient and operator s safety and the warranty validity When Inter amp GMX Slim and the respiratory circuit are connected to the patient a QUALIFIED PROFESSIONAL must be READY to take the required actions whenever an alarm or problem occurs An ALARM indicates a situation that requires operator attention and SHALL NEVER BE IGNORED Inter GMX Slim Operation Manual code 806 00223 Rev 07 Chapter 2 Precautions Notes 11 WARNING Perform the FUNCTIONAL VERIFICATION TEST FVT specified in the Chapter 9 Preventive Maintenance BEFORE THE FIRST UTILIZATION and at least ONCE A MONTH or always there are DOUBTS on the equipment operation In case of problems during the FVT stop the equipment utilization and request corrective maintenance by an authorized technician Do not sterilize the Inter GMX Slim The internal component
35. ill remain lit while the equipment is connected to a power supply INTERMED Inter GMX Slim Operation Manual code 806 00223 Rev 07 Chapter 4 Assembly 17 Chapter 4 Assembly This Chapter Contains m Connection of the flow sensors to an Inter Plus system The correct ventilator assembly of Intere GMX Slim is essential for the perfect equipment operation N WARNING The assembly and the operation start up of this equipment must be performed by an Intermede qualified technician or by the Authorized Technical Service AN NOTE The correct operation of Intere GMX Slim depends on the perfect connection of flow sensors in an Intere Plus system ventilator INTERMED Inter GMX Slim Operation Manual code 806 00223 Rev 07 18 Chapter 4 Assembly FLOW SENSOR CONNECTIONS Figure 4 1 Detail of the flow sensors connection on the side panel of an Intere Plus system ventilator INTERMED Inter GMX Slim Operation Manual code 806 00223 Rev 07 Chapter 5 Operation 19 Chapter 5 Operation This Chapter Contains m Introduction Follow correctly Initial Screen the instructions included this 8 Operation manual to achieve the best equipment performance INTERMED Inter GMX Slim Operation Manual code 806 00223 Rev 07 20 Chapter 5 Operation INTRODUCTION INTERMED 1 Clean the monitor and sterilize the sensor according to Chapter 7 2 Select the proper flow sensor
36. imum number of identical package allowed to be superposed TEMPERATURE LIMIT It indicates the limit temperature for storage and handlling the package as cargo in transportation RELATIVE HUMIDITY Indicates the relative humidity for storage and handling the package as cargo in transportation Inter GMX Slim Operation Manual code 806 00223 Rev 07 Annex Symbols and Terminology 73 BS EN 980 2008 Symbol No 4 6 BS EN 980 2008 Symbol No 5 2 BS EN 980 2008 CE Mark of Conformity MANUFACTURING DATE It indicates the date when equipment was manufactured MANUFACTURER It indicates the the manufacturer of the equipment LEGAL REPRESENTATIVE It indicates the Authorised Representative in the European Community CE CONFORMITY Its indicates that the system is in compliance with the European Council Directive 93 42 for Medical Devices The xxxx is the certification number of the Notified Body used by equipment manufacturer INTERMED Inter GMX Slim gt Operation Manual code 806 00223 Rev 07 74 Annex A Symbols and Terminology TERMINOLOGY The main terms used in this manual defined by NBR IEC 60601 1 1994 and 1997 amendment and EN 60601 1 1990 1 1993 A2 1995 standards are given below 1 ACCOMPANYING DOCUMENTS Documents accompanying the equipament or on acessory and that contain all information that is important to the equipment user operator and installer or assembler mai
37. me will depend on the care in its utilization and handling Do not use sensors that have damage or deterioration signals Inter GMX Slim Operation Manual code 806 00223 Rev 07 48 Chapter 7 Cleaning and Sterilization INTERMED Inter GMX Slim Operation Manual code 806 00223 Rev 07 Chapter 8 Accessories and Parts 49 Chapter 8 Accessories and Parts This Chapter Contains Accessories Components and Parts Always use original accessories and parts AN CAUTION Incase of replacement always use ORIGINALACCESSORIES AND PARTS otherwise you can impair the equipment performance patient and or user s safety and warranty validity INTERMED Inter GMX Slim Operation Manual code 806 00223 Rev 07 50 Chapter 8 Accessories and Parts Accessories and Parts The accessories and parts of Intere Plus model ventilators used with the Intere GMX Slim graphical monitor are listed below code eseription o 151 00000 Inter GMX Slim Graphical Monitor 151 00900 O sensor cable and oxygen cell p LLL eS TT TN NOTE The accessories required for the Inter amp GMX Slim operation are connected to the ventilator INTERMED Inter GMX Slim Operation Manual code 806 00223 Rev 07 Chapter 9 Preventive Maintenance 51 Chapter 9 Preventive Maintenance This Chapter Contains Functional Verification Test FVT Always use original Routine Preventive Maintenance accessories Annual Pre
38. mede or the Authorized Technical Service Restrictions The non authorized modification of any elements or components which operation can be affected by electromagnetic fields voids the product warranty and can produce adverse operating results Do not operate the equipment out of the described conditions and in a magnetic resonance environment or near to high frequency surgical equipment defibrillators or short wave therapy equipment The electromagnetic interference may impair this equipment operation INTERMED Inter GMX Slim gt Operation Manual code 806 00223 Rev 07 66 Chapter 10 Technical Description Manufacturer s guidelines and statement electromagnetic immunity GMX is designed for use an electromagnetic environment as specified below The GMX client or user must assure that it is used in such environment IEC 60601 TEST Compliance a Immunity test LEVEL Electromagnetic environment guidelines Portable and mobile RF communication equipment must not be used close to any GMX component including cables with distance lower than that recommended calculated from the equation applicable to the transmitter frequency Recommended Separation Distance 10 Vrms 1 25 150 kHz up to 80 MHz 10 Vrms ISM bands RF Radiated 10 V m 10 V m 1 25 80 MHz up to 800 MHz IEC 61000 4 3 80 MHz up to 2 5 GHz 2 35 800 MHz up to 2 5 GHz where P is the maximum outlet nominal strength of the
39. n and TV transmission cannot be accurately predicted To evaluate the electromagnetic environment due to fixed RF transmitters it is recommended to consider an electromagnetic inspection of the place If the field intensity measurement at the place where GMXG is used exceeds the above applicable RF compliance level the observation of is recommended to check if the operation is Normal If an unusual performance is observed additional procedures may be necessary such as a new orientation or new positioning of GMX Above the frequency range from 150 kHz to 80 MHz the field intensity is recommended to be lower than 3 V m INTERMED Intere GMX Slim Operation Manual code 806 00223 Rev 07 Chapter 10 Technical Description 67 Recommended separation distance between mobile and portable RF communication equipment and GMX GMX is designed for use an electromagnetic environment in which RF disturbances are controlled The GMX client or user may help preventing electromagnetic interference by keeping a minimal distance between mobile and portable RF communication equipment transmitters and GMX as recommended below according to the maximum outlet strength of the communication equipment Separation distance according to the transmitter frequency m Transmitter maximum 150 kHz up to 80 150 kHz up to 80 outlet strength MHz out of ISM MHz in the ISM bands bands 80 MHz up to 800 800 MHz up to 2 5 GHz For transmitters wi
40. nly related to safety procedures 2 CLASS EQUIPMENT Equipment in which the protection against electric shock is not based on its basic insulation but rather incorporates an additional safety precaution consisting of a protection feature as to the equipment connection to a grounding conductor for protection belonging to fixed installation wiring to prevent accessible metallic parts from being energized in the event of a failure occuring in the basic insulation 3 TYPE B APPLIED PART Applied part in compliance with the provisions specified in standard NBR IEC 60601 1 1994 and 1997 amendment to provide protection against electric shocks particularly in connection with the admissible leakage current and marked by the 878 02 02 NBR IEC 60601 1 1994 and 1997 amendment symbol 4 PROTECTIVE GROUNDING TERMINAL A terminal connected the conductive parts of a class equipment for safety purposes and intended to be connected to an external protective grounding system through a grounding conductor for protection INTERMED Inter GMX Slim Operation Manual code 806 00223 Rev 07 INTERMED Inter GMX Slim Operation Manual code 806 00223 Rev 07 INTERMED since 1082 Intermede Equipamento M dico Hospitalar Lida Rua Santa M nica 980 Cotia SP Brazil CEP 06715 865 After Sales 55 11 5670 1340 55 11 4615 9300 Sales Center 55 11 5112 1300 55 11 4615 9300 Fax 55 11 4615 9310 Web site www intermed
41. o routine 25 seconds an interval in the monitoring occurs Inter GMX Slim Operation Manual code 806 00223 Rev 07 Chapter 5 Operation 23 OPERATION Parameter Screen Press FORWARD or BACKWARD keys to display the parameter change screen This screen displays all information related to the patient in terms of the respiratory mechanics as well as the indication of the oxygen alarm cause low or high concentration Respiratory parameter screen Menu Screen Press the MENU key to start the access to the controls and screens available in the Intere GMX Slim SET UI The menu screen presents the ba led hes available control functions CALE EI Ee FUNCTION DESCRIPTION SET UP Enables configuring date and time the digital visualization of the flow and pressure for calibration purposes the patient data and data cleaning TREND SCALE Enables configuring the trend graphical scales GRAPH SCALE Enables configuring the pressure flow volume and time scales and the loop of graphics displayed on the screens INTERMED Inter GMX Slim Operation Manual code 806 00223 Rev 07 24 Chapter 5 Operation 24 Press the direction keys to access each command gt Press the center key inthe command area CONFIRM to select the commands CONFIGURING GRAPHICAL SCALES 1 Press the MENU key to 2 Press the direction key gt to activate the function to open the scale options PRESSU
42. ochlorite Ammonium Quaternary Compounds These solutions may cause cracks on polysulfone components or disintegration of silicone tubes Do not use these solutions in washing processes that precede sterilization in autoclave and pasteurization since they can accelerate materials deterioration CHEMICAL DISINFECTION BY IMMERSION Chemical disinfection by immersion can be performed using a 2 Glutaraldehyde solution Cidexe for a period of 40 MINUTES Rinse with distilled and sterilized water to eliminate the high concentrations of chemical substances used Let it dry in a clean environment CHEMICAL STERILIZATION BY IMMERSION Chemical sterilization by immersion can be performed using a 296 Glutaraldehyde solution Cidexe for a period of 12 HOURS Rinse with distilled and sterilized water to eliminate the high concentrations of chemical substances used Let it dry in a clean environment INTERMED Inter GMX Slim Operation Manual code 806 00223 Rev 07 INTERMED Chapter 7 Cleaning and Sterilization 47 ETHYLENE OXIDE C2H O The sterilization using Ethylene Oxide gas must comply with EN ISO 11135 1 2007 standard WARNING After sterilizing in Ethylene Oxide await from 24 to 48 hours before using the material in order to enable aeration and exit of gas residues NOTE Components submitted to sterilization suffer natural degradation due to the characteristics of the processes used The sensor lifeti
43. or assistance from the authorized representative INTERMED Intermed Equipamento M dico Hospitalar Ltda products are warranted against material and manufacturing defects and meet the published characteristics The warranty and technical assistance are assured by Intermed Equipamento M dico Hospitalar Ltda and its Authorized Service throughout Brazilian territory and in countries where the Authorized Service is instituted The responsibility for the warranty is limited to replacement repair and labor at the manufacturer s discretion for components presenting defect or not meeting the characteristics published during the warranty period The warranty does not cover defects caused by accident improper use use conditions improper installation or sterilization service installation operation or alteration performed by non authorized or unqualified personnel For safety the screws used for closing are SEALED OFF Breaking this seals by unauthorized personnel may result in the equipment WARRANTY lost Components subject to normal wear or degradation through use adverse use conditions negligent use or accidents are not covered by the WARRANTY The established warranty period is of 12 months for the equipment and 60 days for accessories provided that their original characteristics are maintained counted as of the equipment s delivery date or according to specific contractual conditions agreed upon Inter GMX Slim Oper
44. r 6 Stop using the equipment and contact the Authorized Technical Service 1 Replace the sensor for the pediatric adult model 2 Clean the flow sensor Inter GMX Slim Operation Manual code 806 00223 Rev 07 PROBLEM Exhaled volume less than the inspired volume The pressure and or flow curves present noises Expiratory Flow Volume and Peak flashing Inspiratory Flow Volume and Peak flashing Fail Calibration INTERMED Chapter 6 Troubleshooting 41 PROBABLE CAUSE CORRECTIVE ACTION 1 Endotracheal tube leakage 2 Water and or secretion accumulation on the flow sensor and or within the sensor tube 3 Miscalibrated flow sensor 4 Defective self cleaning system 5 Miscalibrated monitor 1 Water and or secretion accumulation within the patient s circuit 2 Secretion accumulation within the endotracheal tube 1 Flow limit exceeded e g using the neonatal pediatric sensor 1 Calibration out of the 10 6 range 1 Remove leakages 2 Clean the flow sensor and or the sensor tube 3 Replace the flow sensor 4 Contact IntermedG or the Authorized Technical Service 5 Contact Intermed or the Authorized Technical Service 1 Remove the water from the circuit clean secretions 2 Aspirate the secretions from the endotracheal tube 1 Reduce the work flow 2 Replace the neonatal pediatric sensor by the pediatric adult sensor 1 Contac
45. s are not compatible with sterilization techniques Follow correctly the instructions for cleaning and sterilizing the components Sterilizing agents containing phenol ammonium chloride dimethyl and solutions with a glutaraldehyde concentration higher than 2 can damage the plastic components Inter GMX Slim maintenance must be performed only by Intermed or the Authorized Technical Service AN NOTES The circuit diagrams component lists technical descriptions adjustment and calibration instructions and other required information for the equipment maintenance can be supplied to the customer upon request Inter GMX Slim is a medical equipment that must be used by specialized personnel under the direct supervision of a physician The use of Inter GMX Slim in Inter Plus and Inter 5 Plus models require optional up grade in this equipment For further information please contact Intermed 0800 770 3357 INTERMED Inter GMX Slim Operation Manual code 806 00223 Rev 07 12 Chapter 2 Precautions Notes INTERMED Inter GMX Slim Operation Manual code 806 00223 Rev 07 Chapter 3 Controls and Indicators 13 Chapter 3 Controls and Indicators This Chapter Contains Front Panel person Manualas Controls uda Graphical Display a ON OFF Indicator Power ON Power OFF INTERMED Inter GMX Slim gt Operation Manual code 806 00223 Rev 07 14 Chapter 3 Controls and Indicators
46. t Intermed or the Authorized Technical Service Inter GMX Slim gt Operation Manual code 806 00223 Rev 07 42 Chapter 6 Troubleshooting INTERMED Inter GMX Slim Operation Manual code 806 00223 Rev 07 Chapter 7 Cleaning and Sterilization 43 Chapter 7 Cleaning and Sterilization This Chapter Contains Monitor The Flow sensor components durability Oxygen and the patient safety depend on the proper cleaning and sterilization N WARNING Before using the equipment for the first time and after its use on every patient or more frequently when required clean the equipment and sterilize the flow sensor After the sterilization rinse and dry properly the flow sensor order to eliminate any residual chemical substances INTERMED Inter GMX Slim gt Operation Manual code 806 00223 Rev 07 44 Chapter 7 Cleaning Sterilization INTERe GMX SLIM MONITOR Cleaning and disinfection of the monitor outer parts except for the control panel may be done with an appropriate germicidal or bactericidal agent The control panel may be cleaned with a gauze humidified with 70 Isopropyl Alcohol N WARNING NEVER sterilize the monitor NEVER place the monitor in a liquid solution NEVER use abrasives on the monitor surface NEVER allow liquid to enter inside the monitor NEVER use alcohol for the rear panel cleaning because the lettering can be damaged THE DISIN
47. tem ventilators for use on neonatal pediatric and adult patients It is recommended for the monitoring of the respiratory mechanics on patients under mechanical ventilation or breathing spontaneously Inter amp GMX Slim uses a high contrast liquid crystal graphical display enabling excellent visualization both on monochromatic and colorful versions nter amp GMX Slim measures the flow and pressure respiratory parameters by a pneumotachograph with fixed orifice From the measured signals of flow and pressure many other relevant parameters are calculated including inspired and exhaled volumes airways resistance weaning rate negative inspiratory pressure among others nter amp GMX Slim incorporates an automatic system to prevent water condensation within pneumotachograph tubes A self calibration routine is periodically performed to enable its continuous utilization Inter GMX Slim presents the graphical and digital monitoring of the ventilation parameters Pressure Flow and Volume Curves due to Time Pressure vs Volume Flow vs Volume and trend curves facilitate the ventilation monitoring and optimization Inter GMX Slim also presents an O analyzer Its operation depends on the ventilator controls and cell utilization and on the optional O sensor cable INTERMED Inter GMX Slim Operation Manual code 806 00223 Rev 07 Chapter 2 Precautions and Notes 9 Chapter 2 Precautions and Notes
48. ters and the ventilation mode selected in the ventilator 7 Adjust the alarm thresholds compatible with the parameters adjusted in the ventilator Change the parameters adjusted in the ventilator in order to generate alarm conditions checking their actuation in the monitor INTERMED Inter GMX Slim gt Operation Manual code 806 00223 Rev 07 56 Chapter 9 Preventive Maintenance TEST SEQUENCE ADULT SENSOR 1 Connect the adult sensor to the ventilator and to the patient s circuit between the lung simulator and the circuit s Y connection according to Chapter 4 2 Power on the ventilator Check if the sensor ID in the Intere GMX Slim initial screen is correct ADULT SENSOR CONNECTED Access the monitoring screen Adjust the simulator to 20 hPa cmH2O L s of resistance and 50mL cmH O of compliance Adjust the following ventilator parameters Mode Controlled Volume Cycle Assisted Controlled Volume 500mL Inspiratory Flow 30 L min Respiratory Rate 15 min PEEP 5 hPa cmH2O 4 Check on the Intere GMX Slim monitor if the indicated values for Inspiratory Pressure Peak PEEP Airways Average Pressure MEAN Inspiratory Flow Peak Pif Respiratory Rate RATE Volume Exp and Ratio E RATIO are in compliance with the values programmed and indicated in the ventilator 5 Check if the pressure flow and volume curves are compatible with the ventilation parameters and the ventilation mode selected in the
49. th a maximum outlet nominal strength not listed above the recommended separation distance d in meters m may be determined by using the equation applicable to the transmitter frequency where P is the transmitter maximum outlet nominal strength in watts W according to the transmitter manufacturer NOTE 1 In 80 MHz and 800 MHz the separation distance for the highest frequency range is applied NOTE 2 The ISM bands industrial medical and scientific between 150 kHz and 80 MHz are 6 765 MHz up to 6 795 MHz 13 553 MHz up to 13 567 MHz 26 957 MHz up to 27 283 MHz and 40 66 MHz up to 40 70 MHz An additional 10 3 factor is used to calculate the distance separation recommended to transmitters in the NOTE 3 ISM bands between 150 kHZ and 80 MHz and in the frequency range between 80 MHz up to 2 5 GHz to reduce the probability of mobile and portable communication equipment to cause interference if brought inadvertently to the patient environment NOTE 4 These guidelines may not be applied to all situations The electromagnetic propagation is affected by the absorption and reflection of structures objects and people INTERMED Inter GMX Slim gt Operation Manual code 806 00223 Rev 07 68 Chapter 10 Technical Description INTERMED Inter GMX Slim Operation Manual code 806 00223 Rev 07 Chapter 11 Warranty 69 Chapter 11 Warranty Read the warranty conditions attentively In case of doubts or problems always request f
50. transmitter in watts w according to the manufacturer s transmitter and d is the recommended separation distance in meters m is recommended that the field intensity from the RF transmitter as determined by electromagnetic inspection at the to be lower than the compliance level in each frequency range Interference may occur close to the equipment marked with the following symbol Co NOTE 1 In 80 MHz and 800 MHz the highest frequency range must be applied These guidelines may not be applied to all situations The electromagnetic propagation is affected by the NOTE absorption and reflection of structures objects and people The ISM bands industrial medical and scientific between 150 kHz and 80 MHz are 6 765 MHz up to 6 795 MHz 13 553 MHz up to 13 567 MHz 26 957 MHz up to 27 283 MHz and 40 66 MHz up to 40 70 MHz The compliance level in the ISM frequency bands between 150 kHZ and 80 MHz and in the frequency range between 80 MHz up to 2 5 GHz is intended to reduce the probability of mobile and portable communication equipment to cause interference if brought inadvertently to the patient environment Therefore an additional 10 8 factor is used to calculate the distance separation recommended to transmitters in those frequency ranges The field intensity established by fixed transmitters such as base radio station telephone mobile wireless land mobile radios amateur radio AM and FM radio transmissio
51. ventive Maintenance and parts WARNING order to prevent premature equipment wear and to achieve a safe performance within the required specifications the following should be made Routine Preventive Maintenance It must be carried out DAILY or before each use according to this chapter instructions Functional Verification Test It must be performed at least MONTHLY or in case of doubts on the equipment operation Annual Preventive Maintenance APM Request the equipment checking adjustment and calibration ANNUALLY performed by Intermed eor by Authorized Service INTERMED Inter GMX Slim gt Operation Manual code 806 00223 Rev 07 52 Chapter 9 Preventive Maintenance FUNCTIONAL VERIFICATION TEST FVT The FVT is atest that enables to verify if the equipment is operating in accordance with specifications The FVT must be performed by the operator at least once a month or in case of doubts on the ventilator operation When detecting problems during the FVT the equipment must be removed for corrective maintenance Contact Intermede 0800 770 3357 The analyzer calibration must be done at every patient change and must follow the conditions established in Chapter 5 Operation CAUTION The equipment must be DISCONNECTED FROM THE PATIENT for FCT conduction The equipment that is not operating IN ACCORDANCE TO THE SPECIFICATIONS CONTAINED IN THE MANUAL SHOULD NOT B
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