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GE iVent 201 1.4, User'S Reference Manual

Introducing the GE iVent 201 1.4 - a cutting-edge medical device designed to enhance patient care. Access the comprehensive User's Reference Manual effortlessly on our website - download it now, absolutely free! Explore the ins and outs of this remarkable product, available exclusively at manualshive.com.

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IV 

 

5

 

ADAPTIVE BI-LEVEL ........................................................................................................................................ 129

 

Introduction ..................................................................................................................................................................................... 131

 

About Adaptive Bi-Level............................................................................................................................................................. 131

 

Guide to Adaptive Bi-Level ....................................................................................................................................................... 131

 

Indications and Warnings ......................................................................................................................................................... 132

 

Indications ........................................................................................................................................................................................ 132

 

Warnings ........................................................................................................................................................................................... 132

 

Setup ................................................................................................................................................................................................... 132

 

Adaptive Bi-Level Alarm Settings .......................................................................................................................................... 134

 

Other Alarm Options .................................................................................................................................................................... 134

 

Adjusting Adaptive Bi-Level Parameters ........................................................................................................................... 134

 

Adaptive Bi-Level Window ........................................................................................................................................................ 135

 

Easy Exhale ...................................................................................................................................................................................... 137

 

Optimizing the Patient Ventilator Interface ...................................................................................................................... 137

 

Resolving Patient Ventilator Dysynchrony ........................................................................................................................ 137

 

Excessive Ventilation ................................................................................................................................................................... 137

 

Excessive Leak ............................................................................................................................................................................... 137

 

Non-Triggered Breaths (Inspiratory Trigger Failure) ..................................................................................................... 138

 

Excessive Triggering (auto cycling): ...................................................................................................................................... 138

 

I:E Cycling Dysynchrony ............................................................................................................................................................. 138

 

Premature I:E Cycling .................................................................................................................................................................. 138

 

6

 

ALARMS ............................................................................................................................................................ 141

 

Introduction ..................................................................................................................................................................................... 143

 

How Alarms Work ......................................................................................................................................................................... 143

 

Responding to an Alarm ............................................................................................................................................................ 143

 

Alarm settings ................................................................................................................................................................................ 144

 

Changing Individual Alarm Settings ..................................................................................................................................... 145

 

Setting the Respiratory Rate Alarm ...................................................................................................................................... 146

 

Setting the Minute Volume Alarm ........................................................................................................................................................ 147

 

Setting the Pressure Alarm ...................................................................................................................................................................... 148

 

Setting the Apnea Time Alarm ............................................................................................................................................................... 149

 

Setting the FiO2 Alarm .............................................................................................................................................................................. 150

 

Setting the Leak Alarm .............................................................................................................................................................................. 151

 

Auto Settings ................................................................................................................................................................................... 152

 

Alarm Options ................................................................................................................................................................................. 153

 

Setting the Alarm Volume ........................................................................................................................................................................ 154

 

Setting the Inverse I:E Ratio Alarm ....................................................................................................................................................... 154

 

Setting the Tidal Volume Not Delivered Alarm ............................................................................................................................... 155

 

Disabling or Enabling the Patient Circuit Disconnect Alarm .................................................................................................... 156

 

Guide to Alarm Definitions and Priorities ........................................................................................................................... 158

 

Summary of Contents for iVent 201 1.4

Page 1: ...GE Healthcare iVentTM201 User s Reference Manual Revision 13 ...

Page 2: ...VersaMed a General Electric Company doing business as GE Healthcare ...

Page 3: ...r support is necessary Model Number Serial Number Customer Service If you have a ventilator problem you cannot solve and you purchased your ventilator directly from GE call US number 800 345 2700 Customer Service If you have a ventilator problem that you cannot solve and you purchased your ventilator from an authorized GE distributor please contact your distributor directly to report the problem ...

Page 4: ......

Page 5: ...nd Controlled Parameters 17 Pulse Oximetry Specifications 18 Standards and Safety Requirements 19 User Adjustable Alarms 22 Additional Alarms and Indicators 23 Waveforms and Diagnostics Packages 23 Intended Use 25 Use of the iVentTM201 With MRI 25 MRI Conditional Tests Specifications 29 2 SETTING UP 31 Introduction 32 Power Connection 32 External Power 32 Internal Battery 35 Oxygen Supply 38 High ...

Page 6: ...and Power Up 52 The Front Panel 52 Silence 52 Manual Breath 53 Hold 53 Clear 53 LED Indicators 53 The Screen 54 3 OPERATING THE IVENTTM201 SETTING MODES AND PARAMETERS 57 Introduction 59 Operation of the iVentTM201 59 Power Up and Weight Selection 59 O V T 60 Standby and Patient Ventilation 61 Changing Ventilation Mode 62 Common Parameters 64 Changing Ventilation Paramters Overview 65 The Selectio...

Page 7: ...5 Alarm Messages 96 Low Monitoring Option 97 Low Option 97 None Option 98 Adaptive Peak Flow 98 Humidifier Setting 99 Pulse Oximetry 100 Pneumatic Nebulizer 102 Set Time and Date 103 Restore Default Settings 105 Default parameters Settings 106 Show Graphs 108 Browse Waveforms 108 Select Range 110 Show Trends 112 Selecting Trends To Display 114 Browsing Trends 115 Show Loops 117 Show Mechanics 119 ...

Page 8: ...ger Failure 138 Excessive Triggering auto cycling 138 I E Cycling Dysynchrony 138 Premature I E Cycling 138 6 ALARMS 141 Introduction 143 How Alarms Work 143 Responding to an Alarm 143 Alarm settings 144 Changing Individual Alarm Settings 145 Setting the Respiratory Rate Alarm 146 Setting the Minute Volume Alarm 147 Setting the Pressure Alarm 148 Setting the Apnea Time Alarm 149 Setting the FiO2 A...

Page 9: ...ification tests 179 Required Equipment and Supplies 180 Starting the VVT 181 The Alarm Sound Test 181 Pressure Tests 182 Flow Tests 182 O2 Tests 182 Battery Test 183 Watchdog Timer Tests 183 VVT Completion 183 Configuration Screen 184 Choosing a Different Startup Screen 184 Setting the Startup Weight 185 Default FiO2 Setting 185 VersaMed Service Functions 186 Communication Port 186 Communication R...

Page 10: ...ggering 213 Breath Types 214 Adaptive Flow and Adaptive I Time 215 Mandatory Volume Control Breath 216 Pressure Control Breath 217 Manual Mandatory Breath 218 Patient Pressure Support Breath 218 Patient Spontaneous Breath 219 Summary 220 APPENDIX E VENTILATION MODES 223 Assist Control Mode 225 Definition 225 Available Breath Types 225 Description 225 Parameters Setting 226 Synchronized Intermitten...

Page 11: ...8 RR Vt Ratio 239 APPENDIX G ACCESSORIES 241 Disposable Breathing Circuit 243 Instructions for Use 244 Instructions for Use With a Pneumatic Nebulizer 245 Reuseable Patient Breathing Circuit 245 Contents 245 Warnings and Cautions 245 Sterilization and Duration of Use 246 Phthalates 246 Instructions for use 247 Instructions for use with the humidifier 247 Cleaning and Sterilization 248 Reassembly 2...

Page 12: ...rm for Breathing Circuit 261 connecting the Patient circuit to the Support Arm 261 Roll Stand 262 Mounting the iVentTM201 On The Roll Stand 262 Dismounting the iVentTM201 From The Roll Stand 262 Connecting the optional Battery Holder Accessory P N M1162050 263 APPENDIX H REMOTE ALARM PINOUT 265 APPENDIX I PART NUMBERS AND ACCESSORIES 269 INDEX 275 ...

Page 13: ...1 1 INTRODUCTION This chapter contains the following sections Introduction Page 3 Specifications Page 13 Intended Use Page 25 Use of the iVentTM201 With MRI Page 25 ...

Page 14: ......

Page 15: ...termittent Mandatory Ventilation SIMV o Volume Controlled SIMV Vctrl SIMV o Pressure Controlled SIMV Pctrl SIMV Continuous Positive Airway Pressure CPAP Pressure Support Ventilation PSV NOTE Certain modes are optional features and may not be operational in some iVentTM201 models In addition the iVent 201 has the following advanced features Quick setup enabled by Preset Parameters according to Pati...

Page 16: ...with the iVent 201 in close proximity along with a patient circuit preferably with a test lung and Rp20 resistor Become comfortable with the Control Knob and the front panel buttons The user interface consists of three primary screens menus The Main Screen The Main Menu The Mode Menu Almost every function or operation of the iVent 201 is accessible through one of the Main screen menus Be aware of ...

Page 17: ...NG AT THE IVENT 201 Figure 1 Front View of the iVent 201 Item Number Description 1 Display 2 Keypad 3 Control Knob 4 Exhalation valve luer inlet 5 Ventilator outlet 6 Sensor line luer inlets 7 Nebulizer outlet 1 2 3 4 5 6 7 ...

Page 18: ...nector 3 Remote alarm connector 4 External screen connector 5 LAN connector Do not remove connector cap This connection port is not in use 6 AC cable clip 7 RS 232 connectors COM1 and COM2 8 On off switch with cover 9 High pressure oxygen inlet connector 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 ...

Page 19: ...he airflow provided by the iVentTM201 The iVentTM201 must not be operated immediately following storage or transport outside the recommended operation condition The iVentTM201 internal battery contains lead and must be disposed of in accordance with local ordinances and environmental regulations Do not connect the O2 supply when equipment is not in use The remote alarm should be considered seconda...

Page 20: ...le it is in use Make sure that the iVentTM201 is positioned so that its inlet ports and cooling vents are open to freely circulating air SYMBOLS AND LABELS Symbol Meaning Indicates that you should Refer to documentation for further information Refer to manual per IEC 601 1 Potential equalization Ground point Direct Current DC and Alternating Current AC Type BF equipment per IEC 601 1 MR conditiona...

Page 21: ...r Inlet Cooling Fan Connector DC Fuse Device ID Device Product Ethernet Connector not on all units External Display Connector AC IN 100 240V 50 60Hz 1 6A 2xT3 15AL 250V INLET AIR FILTER DO NOT OBSTRUCT COOLING FAN DO NOT OBSTRUCT DC IN 12 15V 8 5A T15A 250V ...

Page 22: ...10 High Pressure Oxygen Inlet Keyboard Connector Power Pack Fuse Power Switch Remote Alarm Connector Serial Communication Connector T15A 250V ON OFF REMOTE ALARM RS 232 ...

Page 23: ...11 Power Pack inside VersaMed Caution This Power Pack contains a sealed Lead Acid Battery Disposal of this unit should be according to Environmental Safety Requirements for Lead Acid batteries POWER PACK P N 503A0012 ...

Page 24: ...or Adaptive I Time sec 10 Y Y 80 Peak Flow up to 120 or Adaptive Flow L min 10 Y Y 74 Peak Flow Spontaneous up to 180 L min 10 Y Y 74 Oxygen Mix FiO2 21 to 100 10 of the set value or 3 absolute whichever is greater Y Y 73 PEEP 0 to 40 cmH2O 1 or 10 whichever is greater Y Y 78 Trigger sensitivity 1 to 20 off 0 5 to 20 off L min cmH2O Y Y 79 PSV 0 to 60 cmH2O 10 Y Y 76 Positive Pressure relief valve...

Page 25: ...to 150 min Exhale tidal volume Range 0 to 5000 mL Resolution 1 mL Accuracy 10 mL or 15 whichever is greater for 0 to 300 mL 10 for 300 to 5000 mL Exhaled Minute Volume Range 0 to 99 9L Resolution 0 1 L Accuracy 10 Peak flow Range 0 to 140 L min Resolution 1 L min Accuracy 10 PIP Peak Inspiratory Pressure Range 0 to 99 cmH2O Resolution 1 cmH2O Accuracy 2 5 of reading cm H2O Inspiratory time Range 0...

Page 26: ... cmH2O Resolution 0 1 ml cmH2O Accuracy 2 20 of actual value ml cmH2O RR Vt Rapid Shallow Breathing Index RSBI Range 0 200 min L Resolution 1 min L Accuracy 5 20 of actual value min L Static compliance Range 0 to 99 ml cmH2O Resolution 1 ml cmH2O Accuracy 2 20 of actual value ml cmH2O Auto PEEP Range 0 to 99 cmH2O Resolution 1 cmH2O Accuracy 2 5 of reading cmH2O Plateau Pressure Range 0 to 99 cmH2...

Page 27: ...t 24 5 lb 11 1 kg Overall Weight with extended Battery 27 8 lb 12 6 kg VENTILATION MODES Assist Control A C o Volume Controlled A C o Pressure Controlled A C Synchronized Intermittent Mandatory Ventilation SIMV o Volume Controlled SIMV Vctrl o Pressure Controlled SIMV Pctrl Continuous Positive Airway Pressure CPAP with Pressure Support Ventilation PSV NOTE Certain modes are optional and might not ...

Page 28: ...l External Sound Level 40 45 dBa at one meter POWER SUPPLY Parameter External AC 100 to 240 V 50 60 Hz max 1 6 A External DC Battery 12 to 15 V max 8 5 A Internal Battery Sealed Lead Acid 12 V 8 Ah rechargeable Recharge Time Over 8 hours 1 Ampere Operating Time internal battery Up to 2 hours varies with ventilation parameters Extended Battery Sealed Lead Acid 12 V 12 Ah rechargeable Extended Batte...

Page 29: ...le Tidal volume Measurement 15 above 100 mL from actual reading or 10 cc below 100 mL Inspiratory Pressure Limit 5 to 80 5 cmH2O Inspiratory Time Adaptive TimeTM or 0 2 to 3 10 sec Peak Flow PIF Adaptive FlowTM or to 120 10 L min Spontaneous to 180 10 L min Oxygen Mix FiO2 21 to 100 10 of the set value or 3 absolute whichever is greater PEEP 0 to 40 1 cmH2O or 10 whichever is greater Trigger Sensi...

Page 30: ... 300 BPM adult pediatrics Motion 40 240 BPM adult pediatrics Low Perfusion 40 240 BPM adult pediatrics 3 digits 3 digit 3 digits Operating Temperature 0 C to 50 C 32 F to 122 F Storage Temperature 20 C to 50 C 4 F to 122 F Power Consumption 60mW typical operation Dimensions 2 1 x 0 8 x 0 6 53 x 201 x 15mm Weight 75g including 6 and connector Shock Ruggedness Immersion Per IEC 86 2 27 Vibration Rug...

Page 31: ...tibility requirements and tests EN IEC 60601 1 6 General requirements for basic safety and essential performance Collateral standard Usability EN IEC 60601 2 12 Medical Electrical Equipment Particular Requirements for the Safety of Lung Ventilators Critical Care Ventilators UL 60601 1 Medical Electrical Equipment part1 General Requirements for Safety ASTM F1246 Standard Specification for Electrica...

Page 32: ...tivity Values Triggers Pressure and Flow cmH2O LPM Pressure Support Ventilation PSV cmH2O Flow termination Esens Rise time drive Alarm Pressure Limit Pressure cmH2O Positive End Expiratory Pressure PEEP cmH2O Exhaled Minute Volume L Peak Inspiratory Pressure cmH2O Pressure Flow Wave Forms Electrical Power Source Ext Int SpO2 Heart rate Bmp In Adaptive Bi Level Mode IPAP Ins Pressure cmH2O EPAP Exp...

Page 33: ...ction 21 Parameter Unit of Measure Set Displayed Sigh Breath Setting Humidifier Setting purge cycle Nebulizer Settings time Hr min In SW version 19 18 01 estimated leak in adaptive Bi Level mode is presented in ...

Page 34: ...ressure High 4 80 cmH2O Low 1 77 cmH2O Apnea 5 120 seconds FiO2 High 22 100 Low 21 99 Leak 0 100 Low Tidal Volume Delivered Off or 15 85 Volume Limit Reached 100 2000 mL Inverse I E Ratio ON OFF Patient Circuit Disconnect AB Level mode for other modes optional ON OFF Alarm Volume 1 10 SpO2 High 60 100 Low 59 99 Heart Rate High 50 175 Low 40 150 ...

Page 35: ... Disconnect Patient Disconnect Service Notice High PEEP Need Cal Calibration Patient Circuit Failed SpO2 Patient Disconnect SpO2 Sensor Disconnect SpO2 Reading Failed The following table shows additional Indicators and Icons Indicators Battery Charge Alarm Silence Icon Timer Work Hour Counter Date and Time LEDs ON Charge Alarm Power Source Icon Breath Type Mandatory Spontaneous Assist Hold or Sigh...

Page 36: ... Package includes the following Real Time Pressure and Flow Waveforms Waveform History Browsing Trending of Monitored Data Respiratory Diagnostics Software Package Pressure Flow and Volume Loops Lung Mechanics Compliance static and dynamic Resistance Mean Airway and Plateau Pressure ...

Page 37: ...asive monitoring of oxygen saturation and pulse rate and is suitable for use in all above mentioned areas excluding MR environments The iVent 201 MR Conditional ventilator is a restricted medical device intended for use by qualified trained personnel under the direct supervision of a physician USE OF THE IVENTTM201WITH MRI The iVent 201 ventilator serial number 15 000 and higher is classified as M...

Page 38: ...ine on the floor with a durable tape VersaMed Gauss line warning floor label Versamed P N 350C0323 01 GE P N M1218236 shown in Figure 3 below can be used to emphasize the location of the 100 Gauss line Figure 3 100 Gauss Line Warning Floor Label Figure 4 MRI Warning Card ...

Page 39: ...n 100 Gauss field line of the MR magnet If there is a risk of personnel moving the ventilator it should be tethered to the wall or placed within a retaining box affixed to the floor The SpO2 option is not intended for use in the MR environment Use of the ventilator other than as instructed may cause the ventilator to malfunction and may cause permanent damage to the ventilator NOTE To avoid degrad...

Page 40: ...pecifications refer to MRI Conditional Tests Specifications below The outcomes of the test results were There was no detectable magnetic attraction of the ventilator when placing the iVentTM201 close to the 100 Gauss line The operation of the ventilator was not affected when adhering to the instructions as described above The ventilator demonstrated minor visible RF interference zipper interferenc...

Page 41: ...coil for transmitting receiving signals Field Strength 3 Tesla Spatial gradient 0 12 mT m dB dt 200mT m ms RF 13 231 Watts SAR 0 2 92 2 Spin echo SE 2D Time of echo TE 20 ms Time of repetition TR 1000 ms Field of view FoV 400 x 400mm Matrix 256 x 256 pixel FoV phase 100 Flip angle 90 Bandwidth Pixel 100 Hz Slice thickness 5 mm No of slices 1 Slice orientation Coronal No of averages 1 Phase encodin...

Page 42: ......

Page 43: ...g sections Introduction Page 32 Power Connection Page 32 Oxygen Supply Page 38 Patient Circuit Page 40 Other Connections Page 44 Patient Connection Page 49 Filters Page 49 Operational Case Page 51 The iVentTM201 User Interface Page 51 Controls and Power Up Page 52 ...

Page 44: ... Packing the unit in its optional transportation case POWER CONNECTION EXTERNAL POWER The iVentTM201 can use either external alternating current AC or direct current DC power Both AC and DC inputs are located on the back panel of the ventilator see Figure 5 A hospital grade AC power cord is supplied CAUTION Before connecting the ventilator to an AC or DC outlet verify that the external power suppl...

Page 45: ... prevent accidental disconnection of the AC power cord secure it with the cable clip WARNING If the power cord is damaged worn or frayed replace it immediately NOTE Before you turn off the iVentTM201 change the mode to Standby mode Page 61 When the ventilator is in operation icons at the bottom section of the screen indicate the power state Figure 6 ...

Page 46: ...om the DC power supply the screen shows No EXT in black CAUTION If the screen flashes EXT in red the external battery voltage is low Replace the battery at once Ensure adequate power is immediately available If the external battery connector is removed from the iVentTM201 IT MUST REMAIN DISCONNECTED FOR 40 SECONDS before plugging it back in NOTE The iVentTM201 is designed to switch off the externa...

Page 47: ...nal battery can supply approximately 3 to 4 hours of power under typical conditions and settings CAUTION The iVentTM201 should only be used with a properly functioning battery The battery is automatically charged when attached to an external power source whether the ventilator is operating in Standby mode or switched off Batteries should undergo a full recharge procedure Prior to initial use After...

Page 48: ...rs NOTE If the Extended battery is in use charge the unit for at least 24 hours 3 Switch on the ventilator When the Weight Selection window appears select the 70kg patient weight setting 4 Set the pressure alarm to 60 cmH20 5 Connect the ventilator with a patient circuit to the Rp20 resistor and test lung 6 Press Start on the ventilator See page 59 for directions on starting the iVentTM201 7 Adjus...

Page 49: ...2 With a 1 Phillips head screwdriver remove all four screws from the battery pack plate Figure 7 Figure 8 Figure 7 Unscrewing the Battery Pack Figure 8 Unscrewing the Extended Battery Pack 3 Using the handle pull the Battery Pack out Figure 9 Removing the Battery Pack Figure 10 Removing the Extended Battery Pack 4 Carefully slide the new battery pack into the chassis Be sure it is properly aligned...

Page 50: ... ensure that the correct type of oxygen source is selected in Advanced Settings Main Screen Menu Advanced Settings Oxygen Supply Pressure See page 94 The factory default is High pressure WARNING The O2 system must be calibrated every 6 months We recommend calibration every 3 months to ensure the O2 system integrity For instructions for performing the O2 calibration see O2 Calibration Page 177 HIGH...

Page 51: ...er LOW PRESSURE OXYGEN SUPPLY Connecting a low pressure O2 supply Adapter requires a low pressure O2 filter adapter fitted with a 22mm female port To connect the low pressure oxygen supply 1 Remove the air inlet filter by turning it counterclockwise Then install the Low Pressure O2 filter adapter with a clockwise turn 2 You are now ready to connect the Low Pressure O2 Supply Adapter to the air inl...

Page 52: ...s easily blocked When the Low M option is the selected in the Advanced Settings window the measured FiO2 level is displayed in the Main window of the screen PATIENT CIRCUIT There are three ways to connect a patient circuit to the iVentTM201 using a disposable patient circuit a reusable patient circuit or a dual limb patient circuit Consult a physician and an authorized VersaMed dealer for the appr...

Page 53: ...piratory limb onto the ventilator outlet The connector should fit snugly 2 Connect the Flow Sensor tubing the clear tubes to their connectors Ensure correct connection of the Male and Female luer connectors on the flow sensor tubing 3 Connect the external Exhalation Valve control tube the blue tube to its connector marked with a blue dot 4 Ensure that all connections are secure and airtight Perfor...

Page 54: ...is connected to external Exhalation valve which is then connected to the iVentTM201 To connect a dual limb patient circuit 1 Connect the Exhalation valve and its accessories to the ventilator 2 Connect the Tubing NOTE The instructions provided below only refer to devices in which the Transport Mounting plate P N M1169908 is installed For additional information regarding Transport Mounting plate re...

Page 55: ...igure 1 item number 5 4 Connect the patient circuit inspiratory limb to the one way valve sitting on the ventilator patient outlet and the expiratory limb to the exhalation valve 5 If appropriate fit the patient wye to the inspiratory and expiratory patient circuit tubes 6 Secure the flow sensor to the patient wye and connect the 2 sensor lines to the ventilator sensor line luer inlets see figure ...

Page 56: ...e the ventilator s Patient Disconnect alarm detection Do not use any filter that appears to be discolored or filled with water NOTE Adding attachments components or sub assemblies to the iVentTM201 breathing circuit may increase the pressure gradient MDI To administer medication install an adapter for MDI treatment between the flow sensor and the patient connection USING THE IVENTTM 201 WITH HEATE...

Page 57: ...cuit 5 Connect the Male and Female clear sensor tubing connectors to the Male and Female luer inlets on the front of the iVent201 as described above in Patient Circuit page 40 6 Connect the blue Expiratory Sensor tube to the luer connector marked with a blue dot on the front of the ventilator Figure 15 The iVentTM201 shown connected to a Fisher and Paykel Heated Humidifier Model MR850 Figure 16 He...

Page 58: ... enable the nebulizer operation To activate the nebulizer you need to select the High option under Oxygen Supply in the advance menu See page 95 To connect a nebulizer device 1 Connect the Nebulizer tube to the Nebulizer outlet on the front panel The Nebulizer icon is still displayed in gray at the lower bar of the display showing that the nebulizer is connected but not activated Figure 17 Figure ...

Page 59: ...oute cables and connections to reduce the possibility of entanglement and strangulation The SpO2 device do not meet defibrillation proof requirement per IEC 60601 1 Do not sterilize the SpO2 device Refer to the cleaning instructions included in the sensor instruction Do not use the pulse oximeter in the MRI environment To connect the pulse oximeter to the iVentTM201 ventilator 1 Remove the Pulse O...

Page 60: ...232 connector to the RS 232 port COM1 or COM2 located on the right side of the device Figure 20 Figure 20 iVentTM201 Rear Panel You can connect the RS 232 to any communication port The iVentTM201 sets the communication automatically To configure the communication port see page 186 Keyboard Connector RS 232 Connectors COM1 COM2 Remote Alarm LAN Connector ...

Page 61: ...times SENSOR LINE MAINTENANCE The iVentTM201 monitors the sensor lines and periodically sends pressurized air through the lines to clear them of any accumulated material It is possible for secretions and or condensation to accumulate Should this occur 1 Do not attempt to clean sensor lines while a patient is connected to the iVentTM201 2 Disconnect the sensor lines from the connectors on the iVent...

Page 62: ...s contamination of the patient circuit components and prevents bacteria excessive humidity and liquids from entering the iVentTM201 WARNING Failure to use an adequate bacterial filter may cause severe damage to internal pressure and flow sensors which may result in ventilator failure CHEMICAL BIOLOGICAL RADIOLOGICAL AND NUCLEAR FILTER In the event of environmental contamination by hazardous or tox...

Page 63: ...ch as rain or snow Padding and protected ventilation ports enable full function in a variety of situations Figure 23 Soft Case THE IVENTTM201 USER INTERFACE It is important to invest time to acquaint yourself with the iVentTM201 and how the Control Knob is integrated with the screen and the operation of the iVentTM201 Connect a test lung with an Rp20 resistor and patient circuit Switch on the unit...

Page 64: ...spin button or counter in increments calibrated precisely along the full range of values In some settings menus one press of the knob is enough to instantly select or confirm a value which thereafter immediately returns you to the previous screen Five dedicated keys are positioned below the LCD Figure 24 Figure 24 the iVentTM201 Front Panel Silence Silence is used to immediately mute the audible a...

Page 65: ...tory hold maneuver which allows the calculation of intrinsic PEEP For more details see page 235 Clear Clear has several functions Press it to perform the following Clear the screen of its current selection and return the operator to the previous screen or menu selection just like the Escape key on a computer keyboard Minimize any red alarm warning pop up window and mute the alarm sound for 30 seco...

Page 66: ...ssure below a digital readout of the last peak inspiratory pressure value On the top left of the screen a large shows the total measured respiratory rate in breaths per minute in large blue numbers The selected default respiratory rate is shown in smaller black numbers below Proceed to the Respiratory Rate option to enable and change the number of breaths per minute Beside the Respiratory Rate opt...

Page 67: ...The Main Screen If a pulse oximeter is connected to the iVentTM201 the SpO2 levels and Heart rate are displayed on the lower right side of the screen Figure 27 Figure 27 The Main Screen With the Pulse Oximetry Monitoring Window ...

Page 68: ...56 Notes ...

Page 69: ...tTM201 Setting Modes and Parameters 57 3 OPERATING THE IVENTTM201 SETTING MODES AND PARAMETERS This chapter contains the following sections Introduction Page 59 Operation of the iVentTM201 Page 59 Common Parameters Page 64 ...

Page 70: ......

Page 71: ... values OPERATION OF THE IVENTTM201 The following section describes the various functions and capabilities for operating the iVentTM201 POWER UP AND WEIGHT SELECTION If you have installed a patient circuit then you are ready to begin operating the iVentTM201 To turn on the power press the green ON OFF switch on the rear panel When power is turned on the software performs a self test Once the boot ...

Page 72: ...esistance it sounds an alarm and begins ventilating in SIMV pressure control mode at a rate of 15 breaths per minute P INSP 20 and a PEEP of 5 If the iVentTM201 detects no airway resistance it enters Standby mode During this state if flow is detected in the patient circuit the iVentTM201 performs an auto start O V T The patient circuit must be tested each time it is connected so if you are reconne...

Page 73: ...sfully completed the O V T the patient circuit and ventilator are ready for use If the O V T fails 1 Verify that both Flow Sensor tubes are properly and snugly connected to the correct luer ports on the front of the iVentTM201 Note Remember that two lines go to the patient Wye connectors and the blue line goes to the Expiratory Valve Control connector Repeat the test 2 If the O V T fails once agai...

Page 74: ...the knob until Standby is selected and press Then select the Yes option in the Confirmation window and press the knob The ventilator suspends operation NOTE Always return the iVentTM201 to Standby mode before powering down CHANGING VENTILATION MODE The Mode Selection option is on the top right side of the LCD display Figure 30 Figure 30 The Mode Selection Menu Selected To change the mode turn the ...

Page 75: ...meters or change any of them For example to change to SIMV pressure control mode from SIMV volume control mode 1 Make sure that you start from the Main screen NOTE To return to the Main screen press the clear key on the keypad below the display This returns you to all previous screens until you return to the Main screen 2 From the Main screen turn the Control Knob to select the Mode Selection opti...

Page 76: ...l Parameters Screen 5 Note that Accept is automatically selected which makes it possible to accept the default parameters immediately and go directly into patient ventilation This is after you have verified that the patient settings are correct NOTE The user must press Accept to change both the mode and the parameters COMMON PARAMETERS This section details how to change Breath rate ...

Page 77: ... adjustment When you have set each parameter you can accept all of them at once To change ventilation parameters through the Main Screen 1 Return to the Main screen if you are not already there press the Clear button until you return to it 2 Turn the Control Knob to select the parameter you want to adjust 3 Press the Control Knob 4 Adjust the setting to the required value 5 Press the Control Knob ...

Page 78: ...ation about restoring defaults See page 105 Restore Default Settings THE SELECTION INTERFACE Most of the quantitative parameters are presented in the form of an oval dial with black numerals in the iVentTM201 black numbers represent Set values on solid teal Turning the Control Knob increases or decreases the selected value as indicated by the black numerals inside the oval A dark blue ribbon indic...

Page 79: ...osen value press the Clear button To return the selection of ALL ventilation parameters to their default levels for a given patient weight see page 105 ADJUSTING THE BREATH RATE The following procedures explain how to adjust the breath rate which is measured in breaths per minute To adjust the breath rate during the ventilation 1 From the top most left side of the Main screen select the Respirator...

Page 80: ...me change automatically 4 After setting a new value press the Control Knob to confirm and accept the settings NOTE Certain modes and values described in this section are not operational in all iVentTM201 models When the setting for Inspiratory Time is Adaptive the value to reach I E ratio 1 2 is displayed Once this value reaches 2 seconds it does not change since the Adaptive Respiratory algorithm...

Page 81: ...o adjust the tidal volume 1 Select the Tidal Volume or in Pressure Control select Volume Limit setting from the top middle section of the Main screen Figure 38 Figure 38 Tidal Volume Selected on the Main Screen Or select Tidal Volume in the Parameters screen Figure 39 Figure 39 Tidal Volume Selected on the Parameters Screen 2 Press the Control Knob to display the Tidal Volume pop up window Figure ...

Page 82: ...taneous and mandatory peak flows are displayed and cannot be changed Breath Types The following section describes the various breath types which are each represented by their own specific icon The Tidal Volume portion of the Main screen indicates the Exhale Minute Volume MV on the left side of the window Figure 41 The Tidal Volume Window With the Breath Type Icon Displayed The upper left corner of...

Page 83: ... sensors are measuring accurately Blue P Purge sensor lines function activated Periodically the iVentTM201 sends a puff of high pressure air through the sensor lines to clean them You can set the purging interval through the Advanced Menu Humidifier Settings See page 99 This icon indicates that the Purge System is now activated ADJUSTING PRESSURE The pressure setting depends on the ventilation mod...

Page 84: ...en Or select the Pressure option in the Mode Parameters screen Figure 43 Figure 43 Pressure Limit Selected on the Mode Parameters Screen 2 Press the Control Knob to display the Set Pressure pop up window Figure 44 Figure 44 The Set Pressure Pop Up Window ...

Page 85: ...on see page 148 4 Press the Control Knob to confirm and save the settings ADJUSTING FIO2 The O2 percentage delivered to the patient is adjustable NOTE Adjusting FiO2 can be performed only when the Oxygen Supply High option is selected in the Advanced Setting menu For more information see page 95 To adjust the FiO2 1 Select the FiO2 setting from the top left of the Main screen Figure 45 Figure 45 F...

Page 86: ...ng the FiO2 percentage automatically changes the O2 alarm based on a default margin of 20 10 O2 The O2 alarm parameters can also be adjusted from the Alarm Settings See page 150 ADJUSTING PEAK FLOW In volume control ventilation modes you can adjust the peak flow You can also set the ventilation to adaptive peak flow which matches the flow to the patient spontaneous flow To adjust the peak flow 1 S...

Page 87: ...ters 75 Figure 48 Peak Flow Selected on the Main Screen Or select the Peak Flow on the Mode Parameters screen Figure 49 Figure 49 Peak Flow Selected on the Mode Parameters Screen 2 Press the Control Knob to display the Peak Flow pop up window Figure 50 ...

Page 88: ...s selected a blue icon with a black circled A is displayed on the Main screen Figure 51 Figure 51 Adaptive Flow Icon If a Manual Peak Flow is set a transparent icon with a black circled M is displayed on the Main screen Figure 52 Figure 52 Manual Peak Flow Icon ADJUSTING PRESSURE SUPPORT VENTELATION The Pressure Support Ventilation PSV during the ventilation is adjustable To adjust the PSV 1 Selec...

Page 89: ...SV Selected on the Main Screen Or select the PSV option in the Mode Parameters screen Figure 54 Figure 54 PSV Selected on the Mode Screen 2 Press the Control Knob The PSV pop up window appears Figure 55 The PSV Pop up Window 3 Turn the Control Knob to adjust the PSV level ...

Page 90: ...EEP The PEEP level of the patient is adjusted to a set value during the ventilation To adjust the PEEP 1 Select PEEP from the second row on the Main screen Figure 56 Figure 56 PEEP Selected on the Main Screen Or select the PEEP option in the Mode Parameters screen Figure 57 Figure 57 PEEP Selected on the Mode Screen 2 Press the Control Knob The set PEEP pop up window appears ...

Page 91: ...er than P limit PSV or a maximum value of 40 cmH2O 4 Press the Control Knob to confirm and accept the settings ADJUSTING TRIGGER SENSITIVITY When the patient s breathing is measured and above the adjustable value then it is identified as spontaneous breath To adjust the triggers sensitivity 1 Select the Triggers option from the bottom left section of the Main screen Figure 59 Figure 59 Triggers Se...

Page 92: ...s the Control Knob to confirm the pressure settings and select the Flow gauge 5 Dial to select the required Flow settings 6 Press the Knob to confirm and accept the settings ADJUSTING INSPIRATORY TIME The inspiration time is the time between the start of the inspiration until the exhalation is started To adjust the inspiratory time 1 Select the Inspiratory Time setting from the middle of the lower...

Page 93: ...y Time Selected on the Main Screen Or select the Inspiratory Time option on the Mode Parameters screen Figure 63 Figure 63 Inspiratory Time Selected on the Mode Parameters Screen 2 Press the Control Knob The I Time pop up window appears Figure 64 Figure 64 The I Time Pop Up Window ...

Page 94: ...gure 65 Manual I Time Figure 66 Adaptive I Time If a manual I time is set that does not allow for a 1 1 I E Ratio or does not allow the set volume to be delivered within the set I time then the display flashes during the ventilation ADJUSTING RISE TIME The iVentTM201 provides four possible values for Rise Time drive Mid High Max or Auto These options refer to the speed of the engine acceleration d...

Page 95: ...r select the Rise Time option in the Mode Parameters screen Figure 68 Figure 68 Rise Time Selected on the Mode Parameters Screen NOTE The Rise Time option is located in the top left of the Mode Parameters screen for Adaptive Bi Level mode 2 Press the Control Knob The Rise Time pop up window appears Figure 69 ...

Page 96: ...lect the required value 4 Press the Control Knob to confirm and accept the settings ADJUSTING FLOW TERMINATION ESENS The iVentTM201 terminates the pressure support breath delivery after flow drop detection to an adjustable percentage of the peak flow The flow termination exhale sensitivity can be set between 10 to 90 percentages of the peak flow To adjust the flow termination 1 Select the Esens op...

Page 97: ...Mode Parameters screen Figure 72 Figure 72 The Esens Option Selected on the Mode Parameters Screen 2 Press the Control Knob The Set Flow Term pop up window appears Figure 73 Figure 73 The Set Flow Term Pop Up Window 3 Turn the Control Knob to change Flow termination percentages 4 Press the Control Knob to confirm and accept the settings ...

Page 98: ...86 Notes ...

Page 99: ...igating the Main Menu Page 89 Alarm Settings Page 90 Advanced Settings Page 91 Restore Default Settings Page 105 Show Graphs Page 108 Show Trends Page 112 Show Loops Page 117 Show Mechanics Page 119 Pulse Oximetry Screen Page 120 Show Log Book Page 123 Display Page 124 O V T Page 127 Maintenance Page 127 ...

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Page 101: ...try window Display a Log Book showing all adjustments and recent history of i iVentTM201 use Select the display type Perform an Operational Verification Test Access the Maintenance menu NOTE Depending on which model iVentTM201 you are using not all of these features may be available NAVIGATING THE MAIN MENU The following procedures explain how to navigate the options provided in the Main Menu To n...

Page 102: ...the function you have selected To return to the Main Screen from anywhere in the Main Menu either Press the Clear button on the keypad until you return or Use the Control Knob to select Display on the Main Menu and press the Control Knob then select Main and press the Control Knob ALARM SETTINGS Do not change any Alarm setting without reading Chapter 6 Alarms For changing the alarm settings see Ch...

Page 103: ...1 Select and press the Menu option in the Main screen to access the Main Menu Figure 75 2 Turn the Control Knob to select the second item on the Main Menu list Advanced Settings 3 Press the Control Knob The Advanced Settings menu appears Figure 76 Figure 76 the Advanced Settings Menu To exit from the Advance Setting menu select Close on the bottom and press the Control Knob SIGH BREATH In Volume c...

Page 104: ...h Breath Every The current interval is shown in the right column of the screen Figure 77 Figure 77 Sigh Breath Selected in the Advanced Settings Screen 3 Press the Control Knob A pop up window appears with the values 25 50 75 100 125 150 and Off Figure 78 Figure 78 The Sigh Breath Selection Pop Up Window 4 Turn the Control Knob to select the required value 5 Press the Control Knob to confirm and a...

Page 105: ...o enable or disable the Easy Exhale 1 From the Main screen select Menu Advanced Settings 2 In the Advanced Settings screen select Easy Exhale The current status is shown in the right column of the screen Figure 79 Figure 79 Easy Exhale Selected in the Advanced Settings Screen 3 Press the Control Knob A pop up window appears with the values On and Off Figure 80 Figure 80 The Easy Exhale Selection P...

Page 106: ...cription below To set the oxygen supply pressure 1 From the Main screen select Menu Advanced Settings 2 In the Advanced Settings screen select Oxygen Supply Pressure The current option is shown in the right column of the screen Figure 81 Figure 81 Oxygen Supply Selected in the Advanced Settings Screen 3 Press the Control Knob A pop up window appears with the options High Low M Low and None Figure ...

Page 107: ...173 High Option The High option is used for high pressure supply either from a wall outlet or a compressed canister both of which use the internal O2 mixer The High option is the factory default setting for the oxygen supply type NOTE The nebulizer can be activated only when the High Option is selected When the High option is selected the set value is displayed in the FiO2 field on the iVentTM201 ...

Page 108: ...e two options for the FiO2 setting are 21 or 100 After this value is changed to 21 or 100 the new settings are displayed with a yellow background Figure 83 Alarm Message O2 Sensor Failed For 12000 14999 devices When the O2 sensor alarm message is activated the O2 alarm messages such as High O2 or Low O2 are not activated The O2 alarm settings bar and the O2 readings are disabled A small red icon i...

Page 109: ...reen shows the measured FiO2 the FiO2 delivered to the patient as in the Alarm screen Menu Alarm Settings All O2 related alarms are enabled If the O2 sensor fails the following alarm message is displayed Figure 85 Low Monitoring O2 Sensor Failed Alarm Message NOTE You cannot close this alarm using the Clear button When the O2 sensor alarm message is activated the O2 alarm messages such as High O2 ...

Page 110: ...hen this option is selected all the O2 related alarms are disabled The alarm settings and readings are also disabled and the FiO2 field displays If the O2 sensor fails no alarm is displayed ADAPTIVE PEAK FLOW The rate for Adaptive Peak Flow can be adjusted with the Advanced Settings menu For information about Adaptive Peak Flow see Appendix D To change the Adaptive Peak Flow setting 1 From the Mai...

Page 111: ...ated sensor purging NOTE This is an optional feature not available in all units Possible values are Heated purge every 1 minute HME purge every 10 minutes and Off The factory setting is HME There are no default settings for the Humidifier The iVentTM201 retains the last settings even if a new patient is selected The factory settings are used only when new software is installed or the memory data i...

Page 112: ...ted heart rate and a graphical display of the blood flow past the probe plethysmograph A pulse oximeter can be connected to the iVentTM201 ventilator allowing the operator to continuously monitor patient s oxygenation saturation on the iVentTM201 screen CAUTION The accuracy of the SpO2 measurement can be affected if the total cable length including extension cables is greater than 3 meters The pul...

Page 113: ...xhibits an allergic reaction to the adhesive material To enable the Pulse Oximetry function 1 From the Main screen select and press Menu Advance Setting 2 In the Advanced Settings screen select SpO2 enable The current setting is shown in the right column of the screen Figure 89 Figure 89 SpO2 Enabled 3 Press the Control Knob A pop up window appears with the Enable and Disable options Figure 90 Fig...

Page 114: ...uring nebulization the flow is synchronized with the inspiratory phase of each breath Note that the Nebulizer works during the inspiratory phase only For proper installation of the Nebulizer see page 46 CAUTION The nebulizer is operational for all tidal volumes greater than 200ml Do not activate the nebulizer if the set tidal volume is below 200ml To set the Nebulizer 1 From the Main screen select...

Page 115: ...isplayed at the bottom of the screen and is depicted by a thick gray line You can set more nebuliziation time while the nebulizer is activated The new set time is the sum of the time you have added and the elapsed time 5 Press the dial to activate the nebulizer and accept the settings During the nebulization process you can re enter the Nebulizer screen and view the elapsed time Note that the rema...

Page 116: ...r make sure the hour is selected then press the Control Knob Turn the dial to adjust the clock clockwise to set the clock to a later hour counterclockwise to set it earlier 5 Press the Control Knob to confirm and accept the setting 6 Turn the Control Knob to select the minute day month and year fields Press the Control Knob and turn the knob to adjust the time and date 7 Turn the dial to select OK...

Page 117: ...up state use Restore Defaults The factory startup default state is based on a patient weight of 70 kg SIMV Volume Control mode WARNING Restoring Defaults resets all parameters and settings to their default To restore the defaults settings 1 Select the Menu option in the Main screen to display the Main Menu 2 In the Main Menu select Restore Defaults Figure 95 Figure 95 Restore Defaults Selected 3 P...

Page 118: ...again The iVentTM201 s settings return to their defaults and the Main screen is displayed DEFAULT PARAMETERS SETTINGS The following tables summarize the default parameters and alarm values for the iVentTM201 by patient weight Table 1 Default Start Parameters for Volume Ventilation for 10 kg to 70 kg Patient Weight bpm Rate Tidal Volume Max Pressure PLimit Kg lb bpm mL cMH2O 10 22 30 70 18 15 33 25...

Page 119: ...arameters for Pressure Ventilation for 10 kg to 70 kg Patient Weight RATE PInsp above PEEP I Time Volume Limit kg lb bpm cmH2O sec mL 10 22 30 20 0 6 200 15 33 25 20 0 8 300 20 44 20 20 1 0 400 30 66 18 20 1 1 600 40 88 16 20 1 2 800 50 110 14 20 1 4 1000 60 132 12 20 1 7 1100 70 154 12 20 1 7 1200 Alarm Parameter Weight kg 10 15 20 30 40 50 60 70 High Pressure cmH2O 23 25 30 33 35 40 40 40 High R...

Page 120: ...ults to displaying the waveform graphs while ventilating The Main Menu allows the operator to choose to display only the waveform graphs default or to split the view between waveform graphs and Trends Loops or Mechanics To access the graphs 1 Select Menu on the Main screen to view the Main Menu 2 In the Main Menu select the Show Graphs option and press the control knob The Graphs are displayed as ...

Page 121: ...hat the Select bar of either is chosen Figure 97 Figure 97 The Flow Waveform Selected 2 Press the Control Knob to display the Graph Choice bar 3 From the Graph Choice bar select Browse with the Control Knob and press the Control Knob A pop up window appears Figure 98 time stamped at the moment you pressed Browse Figure 98 The Browse Pop Up Window ...

Page 122: ... display waveforms based on the selected ventilation parameters If you wish to change the view scale of Pressure or Flow waveforms use the Range function To change the waveform range 1 From the Main screen choose either the Pressure waveform or the Flow waveform by rotating the dial so that the Select bar of either is chosen Figure 97 2 Press the Control Knob to display the Graph Choice bar Figure...

Page 123: ... 90 60 L minute and Auto the default Turn the dial to select the required value and press to accept the new range Figure 101 Flow Ranges If you select the Flow graph the choices are 210 150 120 90 60 L minute and Auto the default Figure 101 Turn the knob to select the required value and press to accept the new range 5 Turn the dial until Close is selected on the Graph Choice bar and press the dial...

Page 124: ...e Mandatory Rate Spontaneous Rate Mandatory Volume Spontaneous Volume Spontaneous inspiratory time Mandatory inspiratory time I E Ratio Mean Airway Pressure Resistance Compliance Up to three trends at a time can be displayed To view trends 1 Select and press the Menu option in the Main Screen to view the Main Menu 2 Turn the Control Knob until Show Trends is selected then press to select Figure 10...

Page 125: ...Figure 103 Figure 103 Trends Pop Up Window in Standby Mode If the ventilator is in operation the three displayed Trends appear in a window beside the waveforms Figure 104 Figure 104 Trends Pop Up Window During Ventilation To turn OFF trends display 1 Select and press Menu in the Main Screen to view the Main Menu 2 Turn the Control Knob until Display is selected then press to select 3 In the Displa...

Page 126: ...Selected 2 Press the Control Knob The Trends Choice window appears 3 Turn the Control Knob to Select then press A pop up window appears with a choice of parameters and diagnostic variables Figure 106 Figure 106 The Trends Selections Pop Up I E Ratio Has Been Selected 4 Dial to select one then press to make your selection The selected parameter is displayed in the Trends Graph window Figure 107 ...

Page 127: ...e BROWSING TRENDS You can recall trend information over a 72 hour period using the Browse feature To browse the trends 1 Turn the Control Knob to select the Select bar of the Trend graph you want to browse Figure 104 Press the Control Knob to display the Trends Choice option Figure 108 2 Dial the Control Knob to select Browse and then press the dial Figure 108 The Trends Choice Bar with Browse Sel...

Page 128: ...al clockwise moves the time cursor indicator forward Rotating the dial counterclockwise moves the indicator backwards along the timeline 5 You can change the scale of the time coordinate on which the Trends display Select any of the graphs and press the Control Knob to display the Trends Choice pop up window Select Zoom Figure 110 Figure 110 The Trends Choice Pop Up Window with Zoom Selected ...

Page 129: ... the Show Graphs option and press the Control Knob The Trends pop up window closes and only the graphs are displayed SHOW LOOPS You can view Loops in four ways Volume Flow Pressure Flow Pressure Volume All three You can select one Loop to display or show all three Loops at once To display loops 1 Select and press the Menu option in the Main screen to view the Main Menu Figure 111 Figure 111 Show L...

Page 130: ...sample of a Pressure Volume Loop is displayed below Figure 113 Figure 113 A Pressure Volume Loop Each new loop is drawn in blue and turns to dark gray once the inspiratory cycle begins The display retains the previous two loops Note that when in single loop display the Loop window has two selection buttons marked Freeze and Free Figure 114 ...

Page 131: ...ted then press As soon as the current breath is completed the frozen loop disappears and the display resumes its default behavior drawing each new loop in blue and displaying the two previous loops in black To switch back to the default pressure flow graph view 1 Select and press the Menu option in the Main screen to view the Main Menu 2 Select the Show Graphs option and press the Control Knob The...

Page 132: ...ected 3 Press the Control Knob The right section of the screen shows the selection of numeric values Figure 116 The Mechanics Pop Up Window PULSE OXIMETRY SCREEN The Pulse Oximetry screen Figure 117 displays the following measurements ...

Page 133: ...surements are displayed in blue The plethysmography waveform is displayed on the screen lower section Figure 118 Figure 118 The Pulse Oximetry screen To display the Pulse Oximetry screen 1 Select and press the Menu option in the Main screen to view the Main Menu 2 Turn the Control Knob until Pulse Oximetry is selected then press to select The Pulse Oximetry screen is active even when the iVentTM20...

Page 134: ...llowing alarms are the pulse oximetry alarms They are activated only when the Pulse Oximetry screen is enabled SpO2 reading failed SpO2 Patient disconnect SpO2 Sensor disconnect Low SpO2 High SpO2 High Heart Rate Low Heart Rate You can set the alarms for the high and low ranges for the SpO2 and Heart Rate alarms To set the alarms 1 From the Pulse Oximetry screen use the Control Knob to select Alar...

Page 135: ...press the Control Knob for acceptance 5 Select Accept and press the Control Knob for confirming and accepting the settings SHOW LOG BOOK Beginning each time it is powered up every time the ventilator enables a setting sounds an alarm or an operator makes an adjustment to the iVentTM201 an entry is noted in the Log Book The iVentTM201 retains up to 1500 events in its memory of which up to 500 can b...

Page 136: ...og of events Rotating the dial clockwise advances the log book forward in time DISPLAY You can choose from among three displays Main Monitoring and Home Care NOTE Depending on which iVentTM201model you have purchased determines which display is available On the Display Choices menu Brightness is not active The Main display is most commonly used The Monitoring display features a scaled down menu wi...

Page 137: ...ntilation parameters The Pulse SpO2 pop up window can be viewed on the Monitor display To display the SpO2 pop up window on the monitoring screens select and press the SPO2 option on the lower left side of the screen The SpO2 pop up window appears on right side of the screen Figure 123 Figure 123 The Pulse Oximetry Pop Up Window in the Monitor Display The Home Care display only shows the essential...

Page 138: ...elect and press the SPO2 option on the lower left side of the screen The SpO2 pop up window appears on right side of the screen Figure 125 Figure 125 The Pulse Oximetery Option in the Home Care Display To access settings from the Monitoring or the Home Care screen rotate the Control Knob to select the required option Press the Knob to accept your selection ...

Page 139: ...ay 3 The Display menu pop up window appears Select the display you require and press the Control Knob O V T The O V T Operational Verification Test tests the patient circuit and the alarm sound It must be performed every time a new circuit is connected In Monitor and Home Care displays you can access the O V T only through the Main menu In the Main screen you can activate the O V T from the O V T ...

Page 140: ...128 Notes ...

Page 141: ... Adaptive Bi Level Page 131 Guide to Adaptive Bi Level Page 131 Indications and Warnings Page 132 Setup Page 132 Adjusting Adaptive Bi Level Parameters Page 134 Adaptive Bi Level Window Page 135 Easy Exhale Page 137 Optimizing the Patient Ventilator Interface Page 137 Resolving Patient Ventilator Dysynchrony Page 137 ...

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Page 143: ...breaths GUIDE TO ADAPTIVE BI LEVEL Adaptive Bi Level is a support mode of ventilation where spontaneous breathing efforts are pressure supported at a high inspiratory and low expiratory pressure In the absence of spontaneous breathing efforts the ventilator provides mandatory breaths at a rate indicated by the respiratory rate setting The default setting should be lower than the spontaneous breath...

Page 144: ...tients exhibiting an altered level of consciousness requiring intubation for mechanical ventilation inability to tolerate facemask ventilation injury burn etc or severe decompensated respiratory failure requiring intubation should not be treated with a face mask SETUP To set up and apply facemask ventilation 1 Power up the ventilator 2 Select Patient Weight based on ideal body weight 3 Select the ...

Page 145: ...pply a facemask to the patient Connect the ventilator breathing circuit to the facemask 6 Adjust the ventilator parameters for optimal ventilator patient synchrony and adequate ventilation See page 134 7 Select suitable patient alarms by proceeding to the Main Menu and selecting the Alarm Settings option Enter the appropriate alarms according to facility protocol NOTE Adaptive Bi Level provides a ...

Page 146: ...pnea Time is 20 seconds FiO2 Default for High FiO2 is 20 from set value Default for Low FiO2 is 21 or 10 from set value Leak Default for Leak is 100 NOTE Auto Settings are disabled in Adaptive Bi Level OTHER ALARM OPTIONS In addition to the Alarm Settings the operator can disable the Inverse I E Ratio alarm and the patient circuit disconnect alarm Inverse I E Ratio ON OFF option default set to OFF...

Page 147: ... P Low 2 EPAP 0 to IPAP minus 2 or Maximum 30 cmH2O Esens 10 to 90 I Time 0 2 to 3 seconds with CAUTION indication at 2 0 seconds or when rate setting I E ratio reaches 1 4 NOTE If I Time flashes inspiration is terminated when the set I Time is reached When breath termination occurs due to decreased flow the I Time display is steady NOTE Apnea Back Up ventilation operates in the same manner as in ...

Page 148: ...elow the Tidal Volume field of the display The Leak Estimate value is measured in lpm See Figure 129 Figure 129 Leak Estimated Value in LPM In SW version 19 18 01 estimated leak in adaptive Bi Level mode is presented in See Figure 130 Estimates Vti Vte Inhale Exhale tidal volume ratio are disregarded at leaks above 40 Liters minute Figure 130 Leak Estimated Value as Shown in Version 19 18 01 ...

Page 149: ...s discretion See page 93 OPTIMIZING THE PATIENT VENTILATOR INTERFACE Setting up the Patient Ventilator interface is straightforward Either a nasal CPAP mask or a full facemask can be used If the mask incorporates an anti asphyxia device make sure that it closes on pressurizing the mask and does not require continuous uni directional flow to remain closed Connect the facemask to the circuit using a...

Page 150: ...ssure alarms or obvious ventilator patient dysynchrony and breath stacking Intervention Increase the percent of peak flow termination value Esens from the menu Additionally consider decreasing I time An air leak can lead to inspiratory hang up This can be corrected by adjusting the full facemask or if a nasal mask is used consider switching to a facemask To exclude the presence of breath stacking ...

Page 151: ...o pressure release Table 9 Recommended Masks Part Number Description Nasal Masks All Types chin strap may be required for mouth breathers Respironics Image 3 SE disposable version Resmed Mirage 2 reusable version no vent holes M1162031 Koo Medical Equipment Bluestar Plus NIV Face Mask Kit Ultra Large KM 310 M1162032 Koo Medical Equipment Bluestar Plus NIV Face Mask Kit Large KM 311 M1162033 Koo Me...

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Page 153: ... sections Introduction Page 143 How Alarms Work Page 143 Alarm settings Page 144 Guide to Alarm Definitions and Priorities Page 158 Alarms Test Page 167 The Sensor Failure Alarm Page 169 Patient Disconnect Alarm Page 170 Patient Circuit Failed Alarm Page 170 ...

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Page 155: ...ays a pop up window on the LCD screen After the alarm is minimized using the Silence or Clear key it is minimized to the bottom left of the screen In that position it performs the following Appears red as long as the alarm condition persists Turns green if the alarm condition resolves itself without user intervention RESPONDING TO AN ALARM To silence an alarm 1 Rectify the condition which causes t...

Page 156: ...ted the minimized alarm appears red with a text message that describes the alarm condition If the alarm condition is not resolved within two minutes the alarm pop up window maximizes and sounds an audible alert WARNING Rectify all alarm conditions immediately Always make sure that the patient is safe An alternate means of ventilation must be available at all times NOTE If more than one alarm condi...

Page 157: ...p window in the Main screen whereas the other alarms are set from the Alarm Settings screen Audio Alarm Volume Inverse I E Ratio Alarm Tidal Volume not delivered Patient Circuit Disconnect Enable Disable On Off The following alarms are always operational A C Power disconnect High PEEP Low Battery Low O2 pressure Battery Empty Check Sensor Over Temperature Sensor Disconnect Patient Circuit Failed A...

Page 158: ... numerals to the left of each gauge show the absolute maximum or minimum allowed alarm setting The larger blue numbers to the left of each gauge are displayed only during ventilation showing each parameter s current operative value NOTE To save any alarm change the Accept button must be selected Exiting the alarm screen by any other means cancels all changes that have been made SETTING THE RESPIRA...

Page 159: ...t the alarm rate for the lower limit in Breaths per Minute Note that adjusting the lower limit higher than the currently selected higher limit moves the higher limit up 8 Press the Control Knob to confirm the alarm settings 9 The Alarm Setting screen is re displayed You can dial and select an additional alarm setting to adjust or dial and select Accept to accept all the alarm settings and return t...

Page 160: ...lected bright blue Turn the dial to adjust the alarm for the lower limit in liters per minute Note that adjusting the lower limit higher than the currently selected higher limit moves the higher limit up 8 Press the Control Knob to confirm the settings 9 The Alarm Setting screen is re displayed You can dial and select an additional alarm setting to adjust or dial and select Accept to accept all th...

Page 161: ...right blue Turn the dial to adjust the alarm for the lower limit in cmH2O Note that adjusting the lower limit higher than the currently selected higher limit moves the higher limit up 8 Press the Control Knob to confirm the settings 9 The Alarm Setting screen is re displayed You can dial and select an additional alarm setting to adjust or dial and select Accept to accept all the alarm settings and...

Page 162: ...played You can dial and select an additional alarm setting to adjust or dial and select Accept to accept all the alarm settings and return to the Main screen Setting the FiO2 Alarm To set the FiO2 alarm upper and lower limits 1 Select the Menu option in the Main screen to view the Main Menu 2 Select the first item on the Main Menu Alarm Settings 3 In the Alarm Settings screen dial the Control Knob...

Page 163: ...9 The Alarm Setting screen is re displayed You can dial and select another alarm setting to adjust or dial and select Accept to accept all the alarm settings and return to the Main screen Setting the Leak Alarm To set the leak percentage limit 1 Select the Menu option in the Main screen to view the Main Menu 2 Select the first item on the Main Menu Alarm Settings 3 In the Alarm Settings screen dia...

Page 164: ...UTION The factory default setting for Leak Alarm is set to OFF You must manually set the leak alarm to enable it NOTE The Auto settings option is available only when the iVentTM201 is ventilating To choose auto settings 1 Select the Menu option in the Main screen to view the Main Menu 2 Select the first item on the Main Menu Alarm Settings 3 In the Alarm Settings screen dial the Control Knob until...

Page 165: ...larm Enable or disable the Patient Circuit Disconnect alarm To access the Alarm Options menu 1 From the Main screen select Menu Alarm Settings The Alarm Settings screen is displayed Figure 141 2 Select Options and press the knob Figure 141 The Options Selection Selected on the Alarm Settings Screen 3 The Alarm Options screen appears Figure 142 Figure 142 The Alarm Options Screen ...

Page 166: ...ple of the level If you set the level under 2 or over 8 a Caution pop up window appears 5 Press the Control Knob to confirm the settings 6 You are returned to the Alarm Settings screen Dial and select Accept to accept the Alarm Options settings Setting the Inverse I E Ratio Alarm WARNING The default setting for Inverse I E Ratio Alarm is ON Before disabling any alarms ensure that you are operating...

Page 167: ... The default setting for Tidal Volume Not Delivered Alarm is 85 Before disabling or adjusting any alarms be sure that you are operating in accordance with facility policy and patient needs NOTE This option is not available in Adaptive Bi Level ventilation mode To set the low Vt Alarm Range 1 From the Main screen select Menu Alarm Settings Option The Alarm Option screen is displayed 2 Turn the Cont...

Page 168: ...sconnect Alarm WARNING The default setting for the Patient Circuit Disconnect Alarm is ON It should be shut off under medical discretion ONLY if necessary Be sure that you are operating in accordance with facility policy and patient needs NOTE This option is available in Adaptive Bi Level mode only To disable the patient disconnect alarm 1 From the Main screen select Menu Alarm Settings Options Th...

Page 169: ... The Patient Circuit Disconnect Alarm Off Warning 6 Press Yes by using the Control Knob to confirm 7 You are returned to the Alarm Settings screen Dial and select Accept to accept the Alarm Options settings 8 When the Patient Disconnect Alarm is turned OFF the Main Screen displays a warning in the bottom left corner Figure 148 Figure 148 The Patient Circuit Disconnect Alarm Off Icon ...

Page 170: ... Mid Triple beep every 5 secs Alarm pop up is removed Message is removed Log is updated Low Single beep No pop up Message is removed Log is updated Table 11 below shows alarm definitions and guides you through troubleshooting procedures which include the following Set Count or Time of Condition shows the number of occurrences or amount of time breath cycles or minutes during which the condition ex...

Page 171: ...te Verify patient is adequately ventilated Check changes in patient symptoms and vital signs Correct setting Battery Empty 10 min operating time left Internal battery is nearly depleted operating time is dependent on ventilation parameters High Ventilator operating with internal battery only Battery Charging detected Connect unit to external power source AC or DC Recharge battery Leak 1 breath del...

Page 172: ... concentration with external analyzer Refer unit to qualified service technician for calibration of O2 sensor High Heart Rate 2 breath delay The heart rate exceeds the upper rate limit Mid Clinical Condition Heart rate is lower than the alarm settings for 1 breath Check the patient s condition High Minute Volume 4 breath delay 20 with setting change Minute volume exceeds high alarm setting High Cl...

Page 173: ... patient clinical condition decreasing the FiO2 level or increasing the SpO2 alarm settings Inverse I E Ratio for Volume Control modes only 20 mandatory breaths delay The I E ratio has changed to an inverse ratio Low Improper setting of Tidal Volume Breath Rate P limit Peak Flow Trigger settings and or Inspiratory Time Inverse I E ratio corrected for 5 breaths Correct setting s Low Battery Approx ...

Page 174: ...T Alarm set too high No or low oxygen flow to system Calibration required High variability in patient breathing FiO2 is higher than alarm setting for 2 breaths Check oxygen supply Verify delivered O2 concentration with an external analyzer Refer unit to qualified service technician for calibration Decrease alarm settings Change from Adaptive Flow to fixed manual flow Low O2 Pressure 10 seconds aft...

Page 175: ...atient clinical condition increasing the FiO2 concentration or decreasing the SpO2 alarm setting Auto Start Patient is connected but the unit is in Standby mode High Mid User enters Standby mode unintentionally User connects the ventilator to the patient but fails to press Start N A Clear the alarm and set the required ventilation parameters Service Notice Technical irregularity needs Technical Su...

Page 176: ... clean Remove or protect unit from external heat source Remove unit for inspection and servicing by qualified service personnel Patient Disconnect 2 breaths delay Loss of patient resistance detection Loss of exhaled volume High LT Patient has been disconnected Leak in patient circuit or in endotracheal tube Improper settings Reconnection of patient detected Reconnect patient Correct leak Correct s...

Page 177: ...t firmly connected The signals from the SpO2 sensor return to normal values Check if the sensor is placed correctly on the patient try to find a better place for connecting the patient Reconnect the patient to the SpO2 sensor SpO2 Sensor disconnect No signal is received from the SpO2sensor Mid The SpO2sensor is not connected to the iVent although the patient might be connected to the sensor the po...

Page 178: ...patient Reduce Inspiratory pressure Increase volume limit High PEEP Alarm 2 breath delay Actual PEEP value more than 10 cmH2O from set value High Exhalation Valve occlusion Improper parameter setting PEEP pressure decrease to set value 10 for 1 breath Check exhalation valve Check parameter setting Low Minute Volume 2 breath delay 20 with setting change Minute volume lower than low alarm setting Hi...

Page 179: ...ee page 60 5 Attach a 2L test lung with Rp20 resistance to the patient circuit through an HME filter and start ventilation 6 Tube Disconnect alarm test Wait for at least 30 seconds after the ventilation starts and disconnect the patient circuit from the ventilator outlet port Verify that the Tube Disconnect alarm is activated during the first inhale after disconnection Reconnect the patient circui...

Page 180: ...p window and restore the alarm setting to its default value 13 High O2 alarm test Press Menu and open the Alarm Settings screen Set the High O2 alarm setting to a value below the measured value for FiO2 in blue in the alarm setting bar and press Accept Verify that the High O2 alarm is activated on the twentieth breath after Accept was pressed Close the Alarm pop up window and restore the alarm set...

Page 181: ...ble wait approximately 10 breaths sometimes coughing can cause Check Sensor or Sensor Disconnect alarms If the ventilator does not automatically return to the previous mode and setup press the Restore option in the Backup Mode Activated message and check the setting values PEEP Rise Time auto WARNING If the Check Sensor alarm persists repeatedly provide an alternative source of ventilation Then re...

Page 182: ... settings when one full breath is detected NOTE During ventilation under high leak conditions e g non inflated cuff of the endotracheal tube a Patient Disconnect alarm is activated if the exhaled tidal volume criteria is not met In this case ventilating the patient in Bi Level mode See Appendix D is recommended To disable the Patient Disconnect alarm see page 156 An irregular ventilation condition...

Page 183: ...n Page 173 Cleaning and Maintenance Page 173 Planned Maintenance Page 174 Storage Planned Maintenance Page 176 The O V T Page 176 The Maintenance Screen Page 176 Ventilator Verification tests Page 179 Configuration Screen Page 184 VersaMed Service Functions Page 186 Localization Page 186 Total Operating Hours Page 188 ...

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Page 185: ... mild detergent Air Inlet Filter Replace every 500 hours or 1 month of operation or as necessary Do not attempt to clean or reuse the air inlet filter Cooling Vents Cooling Inlet Filter Clean every 1500 hours or 3 months of use or as necessary Use vacuum device to clean the vents and cooling air inlet filter Battery Pack Recharge after every three months of storage Replace every year or as necessa...

Page 186: ...nclosure Wipe clean the exterior Patient tubing Replace and perform O V T Cooling air filter and vents Clean and replace air filter as needed O2 sensor Replace the O2 sensor Every 500 hours or 1 month or whichever comes first Air Inlet Filter Remove the used air inlet filter and replace it with a new inlet filter 1500 hours or 3 months of use O2 System O2 Calibration Battery Charge the battery Ven...

Page 187: ...ibration It is good practice to perform O2 calibration every 3 months Perform VVT Perform safety checks Replace listed parts by an authorized VersaMed Service Technician Every 2 years O2 sensor Replace the O2 sensor Every 15000 hours or every 4 years whichever is first Pneumatic Assembly Replace parts by authorized VersaMed Service Technician ...

Page 188: ...lator Perform VVT Annually Battery Replace the battery Ventilator Full calibration Perform VVT Every 2 years O2 sensor Replace O2 sensor THE O V T O V T Operational Verification Test should be performed each and every time a new patient circuit is used The O V T procedure is covered in detail on page 60 THE MAINTENANCE SCREEN WARNING Never attempt to access ANY Maintenance Screen functions while t...

Page 189: ... another for 21 oxygen NOTE You are required to perform O2 calibration every 6 months To calibrate the O2 1 Turn the control knob on the Main screen to select Menu Maintenance A caution pop up window appears which warns that the menu is a restricted maintenance area and is for service personnel only 2 Select Yes The Maintenance screen is displayed Figure 151 Figure 151 Maintenance Screen 3 Select ...

Page 190: ...sealed by any component 6 Remove the inlet filter on the side of the ventilator and install the O2 calibration cover Figure 154 Figure 154 O2 Calibration Filter Cover 7 In the O2 System Calibration screen select Start to proceed This calibration takes approximately 30 seconds during which the message working is displayed on screen After the calibration is completed the O2 System Calibration for 21...

Page 191: ...creen VENTILATOR VERIFICATION TESTS The Ventilator Verification Test VVT is a set of simple self tests designed to confirm ventilator functionality It is designed as a troubleshooting procedure to check the operation of a multitude of functions A series of simple user prompts guides the user through each step NOTE The Ventilator Verification Test should be performed quarterly or whenever a Call Se...

Page 192: ... measurement and pressure performance Blower pressure measurement Transducer tubes leak Motor speed measurement Positive relief valves Solenoid valves two Flow performance Flow zeroing accuracy 21 FiO2 Pressure switch status at 21 Demand Valve leak 100 FiO2 Pressure Switch status at 100 Battery status Motor watchdog safety device PC watchdog safety device Required Equipment and Supplies Plug for b...

Page 193: ... performing the VVT the unit must be in a warm condition Connect the breathing circuit to a test lung and operate the ventilator for at least 15 minutes 4 Proceed to the Main Menu from the Main screen 5 From the Main menu select Maintenance 6 A caution pop up window appears Select Yes to proceed 7 Dial the Control Knob to select Ventilator Verification Test and press 8 The Ventilator Verification ...

Page 194: ...ed The unit automatically proceeds through a number of tests for approximately 30 seconds The VVT instruction pop up window appears Flow Tests The following procedures explain how to perform an O2 Tests To perform O2 tests 1 A pop up window appears and instructs you to unblock the patient circuit Remove the stopper and then select and press OK 2 The test is completed in approximately six 6 seconds...

Page 195: ...is off and that the AC plug icon at the bottom of the LCD display is crossed out 3 Press OK Once the test has completed which takes approximately 20 seconds the VVT Instruction pop up window appears Watchdog Timer Tests The following procedures explain how to perform Watchdog Timer Tests To perform watchdog timer tests 1 Reconnect the AC power cable when the VVT screen prompts you to do so 2 Selec...

Page 196: ...ow appears Select Yes 3 The Maintenance menu appears Select Configuration Screen WARNING Several functions on the Configuration Screen are designed only as service indicators and are not accessible Do not attempt to change any settings on the iVentTM201 unless you are certain of the options you intend to alter Make sure settings are in accordance with standard protocol within the hospital or patie...

Page 197: ...ht selected When the iVentTM201 is restarted the first screen appears with the weight you have selected now selected NOTE Note that the weight selection does not take effect until the ventilator is restarted If you need to change or restore the currently select weight use Restore Defaults un the Main Menu See page 105 DEFAULT FIO2 SETTING Use the Default FiO2 setting option if you need to change t...

Page 198: ... need and press the knob to confirm COMMUNICATION RATE The iVentTM201 has a serial port installed for remote communication with other devices The default data transfer rate is 115 200 bps Ordinarily there should be no reason to change this setting To change the communication rate 1 From the Service screen dial the Control Knob to select Communication Rate then press 2 A pop up window appears offer...

Page 199: ...ng Pop Up Window 2 Select Yes and press the Control Knob The Localization screen appears 3 Make sure Language is selected and press the Control Knob A pop up window appears with a choice of several languages Figure 162 Figure 162 Language Choices 4 Dial the Control Knob to select the language you require When you press to confirm your selection the machine restarts in the language you selected ...

Page 200: ...e character that separates the day month and year can also be selected by choosing the Date Interfield Character menu This character can be either a forward slash a colon or a period TOTAL OPERATING HOURS The Maintenance screen also shows the total number of hours the ventilator has been turn on Figure 163 Figure 163 Total Operating Hours Screen ...

Page 201: ...7 Care Maintenance and Tests 189 Notes ...

Page 202: ......

Page 203: ...Appendix A Glossary 191 APPENDIX A GLOSSARY ...

Page 204: ......

Page 205: ... level at which a high pressure alarm occurs Apnea Apnea occurs when the patient fails to receive or perform a breath during a period of 20 seconds or as set Apnea Mode A ventilation mode that automatically starts when a patient apnea is detected Assist Breath patient initiated mandatory breath Any positive pressure breath that is initiated by the patient and controlled and terminated by the venti...

Page 206: ...pressure is applied throughout the breath cycle Easy Exhale When active this feature relieves the exhalation valve diaphragm of pressure immediately at the end of inspiration Exhalation Phase The part of the breath cycle in which the ventilator does not perform mandatory inspiration Exhalation Time The time required for the patient to exhale Exhaled Tidal Volume The exhaled volume measured by the ...

Page 207: ...e airway pressure throughout the breath cycle Minimum Exhalation Time A period of time starting at the beginning of the exhalation phase during which any type of breath cannot be initiated Nebulizer Nebulizer is a pneumatic device that uses compressed gas to deliver aerosolized medication that can be inhaled by patients During nebulization the flow is synchronized with the inspiratory phase of eac...

Page 208: ...ing cycle may be chosen through the Advanced Menu Pressure Support Breath A patient breath in which the ventilator elevates the inspiratory pressure above the baseline i e PEEP Available in SIMV and CPAP PSV modes Pressure Trigger A method of initiating a breath in response to patient effort by measuring a decrease in airway pressure below the baseline O2 Oxygen Rise Time The acceleration of press...

Page 209: ...ute period measured in liters Transducer Sensor A device used to measure pressure and flow Ventilator Breath A ventilator delivered breath that is initiated controlled and terminated by the ventilator Available in Assist Control and SIMV modes Volume Controlled Ventilation A type of ventilation in which the ventilator breath is controlled by flow and terminated by volume as long as airway pressure...

Page 210: ...198 Notes ...

Page 211: ...Appendix B Warranty 199 APPENDIX B WARRANTY ...

Page 212: ......

Page 213: ...ility or fitness for a particular purpose In no event shall the Supplier be liable for any damages including loss of profits incidental or consequential damages arising out of or in connection with the use or inability to use the Products Subject to the following the Purchaser shall send Products with defects that are covered by this warranty to the Supplier repair center The Purchaser shall reque...

Page 214: ...ithout the prior written consent of the Supplier nor shall this Warranty or any rights of the Purchaser inure to the benefit of any trustee in bankruptcy receiver creditor trustee or successor of the Purchaser s business or its property whether by operation of law or otherwise or to a purchaser or successor of the business or of any of the assets of the Purchaser without the written consent of the...

Page 215: ...Appendix C Operating Theory 203 APPENDIX C OPERATING THEORY ...

Page 216: ......

Page 217: ...logical and Nuclear CBRN filter LOW PRESSURE O2 ADAPTER AND FILTER OPTIONAL An optional configuration that enables the usage of low pressure O2 sources such as concentrators to provide O2 enrichment AIR OXYGEN BLENDING SYSTEM The blending system consists of an air entrainment port and a PSV Proportional Solenoid Valve High Pressure O2 Enrichment Valve The ventilator software controls both the port...

Page 218: ... release pressure in the patient circuit An air path from the patient breathing circuit to the manifold and air inlet filter is present OVER PRESSURE RELIEF VALVE If the control system fails to limit the turbine pressure to a maximum level of 80 cmH2O this valve relieves at 80 cmH2O AIRWAY FLOW AND PRESSURE SENSORS A differential pressure transducer is attached to the patient breathing circuit at ...

Page 219: ...Appendix C Operating Theory 207 ...

Page 220: ......

Page 221: ...Appendix C Operating Theory 209 Notes ...

Page 222: ......

Page 223: ...Appendix D Theory of Breath Delivery 211 APPENDIX D THEORY OF BREATH DELIVERY ...

Page 224: ......

Page 225: ...llows the patient to exhale 2 An exhalation phase in which air flows out from the patient s lungs and pressure returns to the baseline pressure The baseline pressure may be either the ambient pressure curve 1 or a higher positive end expiratory pressure PEEP curve 2 The ventilator s control system accomplishes the ventilation cycle by a mechanism which Initiates inspiration Controls the flow or pr...

Page 226: ...r patient safety it is not possible to disable flow or pressure triggering when using the Adaptive Bi level Mode BREATH TYPES The ventilator delivers two primary breath types 1 Mandatory Breath A breath in which the ventilator controls and terminates phase This breath type is divided into three secondary types according to the method by which the inspiratory phase is initiated Ventilator breath in...

Page 227: ...E ratio of 1 2 In the absence of sufficient spontaneous patient efforts Adaptive Flow and Adaptive I Time work together in volume control modes SIMV and A C When used together The default state for SIMV Volume Control mode these two features seek to achieve an I E ratio of 1 2 As close as possible within clinical limitations such as Pressure Limit and Alarm Pressure Cutoff settings as well as mini...

Page 228: ...flow rate that the ventilator uses is depicted by a circled M symbol next to the peak inspiratory flow value NOTE When setting a manual inspiratory flow during low flow conditions this flow target may briefly over shoot as the ventilator controls the flow to the patient However the average flow is maintained at the set value If the target flow is set higher than the ventilator is able to provide d...

Page 229: ... initiated both by the ventilator ventilator pressure control breath and by the patient assist pressure control breath The inspiratory phase is terminated by the ventilator when inspiration time is elapsed or set limit for tidal volume is delivered prior to the end of the inspiratory phase The figure below demonstrates how pressure and flow behave when the ventilator delivers a pressure control br...

Page 230: ...ing to the default volume control for the specified patient weight PATIENT PRESSURE SUPPORT BREATH A patient pressure support breath is a positive pressure patient breath in which the ventilator maintains an elevated target pressure during inspiration The Pressure Support setting is a pressure above PEEP when PEEP is in use Pressure Support breaths are always initiated and terminated by the patien...

Page 231: ...hs is that the spontaneous breath pressure is maintained at the PEEP level PSV 0 during the inspiratory phase Flow is regulated by the ventilator to meet the patient s inspiratory flow demand and to maintain airway pressure at the PEEP level An inspiratory phase in this breath type continues until The flow decreases to a set value of the peak flow Esens or The airway pressure exceeds a value 5 cmH...

Page 232: ...By Ventilator time trigg Pressure Level Volume By Ventilator Inspiratory Time is elapsed Assist Pressure Control By Patient pt trigg Pressure Level Volume By Ventilator Inspiratory time is elapsed Manual By Operator Volume or Pressure Level Pressure Volume or Time By Ventilator Set VT is delivered or Inspiratory time is elapsed Breath Type Initiation Controlled parameters Limiting parameters Termi...

Page 233: ...Appendix D Theory of Breath Delivery 221 Notes ...

Page 234: ......

Page 235: ...Appendix E Ventilation Modes 223 APPENDIX E VENTILATION MODES ...

Page 236: ......

Page 237: ...Figure 170 Breath Pattern in Assist Control Mode At the beginning of the breath cycle event a the ventilator delivers a ventilator breath After the ventilator breath is delivered the patient does not attempt to trigger an assist breath The ventilator then waits for the normal breath period 60 bpm to elapse and delivers another ventilator breath event b An insufficient inspiratory effort event c ha...

Page 238: ...ceive a set number of mandatory breaths All breath types are available in this mode This mode is identical to Assist Control mode except for the following Patient spontaneous breaths are allowed between mandatory breaths Although mandatory breaths are synchronized with the patient s inspiration the breath period is not reset when the patient initiates an assist breath therefore average mandatory b...

Page 239: ... period an Assist window opens and the ventilator either waits for the next patient effort or delivers the next mandatory breath at the end of the Breath window Mandatory breaths terminate when The set tidal volume is delivered The level of High pressure Alarm is reached The I E ratio reaches 1 2 1 when an inspiratory time is not manually set PARAMETERS SETTING The following parameters can be set ...

Page 240: ... 172 illustrates how breaths are delivered in this mode Figure 172 Pressure During CPAP Mode for Spontaneous Breaths and Pressure Support Breath Patient triggering results in the delivery of a patient breath spontaneous or pressure support The ventilator maintains airway pressure as in Figure 172 during the inspiratory phase at PEEP level If pressure support is selected the ventilator maintains an...

Page 241: ...l Volume for CPAP mL bpm mL 50 90 30 70 91 120 25 105 121 175 20 140 176 245 18 210 246 315 16 280 316 385 14 350 386 455 12 420 456 12 490 The ventilator remains in apnea backup ventilation until the patient initiates 3 consecutive breaths within a 1 minute time period and then returns to the previous mode automatically The unit does not exit from apnea ventilation during the first minute The ope...

Page 242: ...imit Ventilation is based on the average measured inhaled volume similar to apnea ventilation See Table 16 above Pressure is measured via an internal pressure sensor Upon the restoration of normal conditions the unit automatically restores the previous ventilation parameters after 2 3 proper breaths are detected The user is prompted to restore the previous ventilation parameters manually at any ti...

Page 243: ...Appendix E Ventilation Modes 231 Notes ...

Page 244: ......

Page 245: ...Appendix F Hold Function and Static Mechanics Measurements 233 APPENDIX F HOLD FUNCTION AND STATIC MECHANICS MEASUREMENTS ...

Page 246: ......

Page 247: ...ng end inspiratory hold and Auto PEEP using end expiratory hold Due to the fact there is resistance in airways there is a delay to the equilibration of pressure throughout the respiratory system In order to characterize tissue properties of the respiratory system independently of airway resistance it is necessary to stop airflow for a period of time long enough for the pressure in the respiratory ...

Page 248: ...xhalation valve closed until a plateau pressure is reached The following pop up window Figure 175 appears on the screen of the ventilator Figure 175 Inspiratory Hold Popup The ventilator automatically terminates the hold maneuver if the pressure continues to rise once the exhalation valve is closed signifying a patient is trying to breathe against the exhalation valve Similarly the ventilator also...

Page 249: ...window with the appropriate time when the respective hold maneuvers are performed See page 238 Reviewing Static Mechanics and Intrinsic PEEP Measurements CLINICAL CONSIDERATIONS The clinician should note that the use of static hold maneuvers may distress the patient as it prolongs the inspiratory phase of the breath which delays exhalation Active breathing during the hold maneuver affects the meas...

Page 250: ...place the end expiratory hold is suspended Figure 175 Note that if the patient is conscious and breathing rapidly it may not be possible to perform an end expiratory hold maneuver If the ventilator senses a negative pressure excursion during the end expiratory hold maneuver that exceeds the current pressure trigger setting it suspends the end expiratory hold maneuver and delivers a breath REVIEWIN...

Page 251: ...hanical ventilation One of the most popular and easiest methods of predicting this success is through the use of the RR Vt ratio or Rapid Shallow Breathing Index RSBI It is the relationship between the patients spontaneous breathing rate with the exhaled tidal volume Literature suggests there is a strong relationship between fast and shallow breathing high RR Vt indexes with patients that fail spo...

Page 252: ...240 Notes ...

Page 253: ...Appendix G Accessories 241 APPENDIX G ACCESSORIES ...

Page 254: ......

Page 255: ... Phthalates Risks and Precautionary Measures related to Phthalates This instruction pertains to the phthalate symbol marked on the device or its packaging If this device is used for the treatment of children or treatment of pregnant or nursing women please note that the following types of procedures may increase the risk of exposure to phthalates Exchange transfusion in neonates total parenteral n...

Page 256: ...nal exhalation valve E Flow sensor F Wye connector G Nebulizer 1 Connect the Inspiratory limb Figure 177 to the iVentTM201 outlet NOTE If using a humidifier see Other Connections page 44 See manufacturer s instructions for the correct use and application of the humidifier 2 Connect the flow sensor tubing clear tubes B in Figure 177 to their ports The male and female luer connectors on the flow sen...

Page 257: ...t the free end of the nebulizer tube to the respective nebulizer port 4 For instructions on activating the Nebulizer see page 102 REUSEABLE PATIENT BREATHING CIRCUIT These instructions refer to the following reusable circuits Breathing Circuit REF Patient Circuit for adult M U 620B0008 02 M1161145 Breathing Circuit W Trap M U 620B0023 02 M1162028 Breathing Circuit Heated W M U 620B0024 02 M1162029...

Page 258: ...halates This instruction pertains to the phthalate symbol marked on the device or its packaging If this device is used for the treatment of children or treatment of pregnant or nursing women please note that the following types of procedures may increase the risk of exposure to phthalates Exchange transfusion in neonates total parenteral nutrition in neonates multiple procedures in sick neonates h...

Page 259: ... Connect opposite end of tubing to humidifier inlet and connect 22 mm tubing with the installed watertrap between humidifier outlet and Y connector Figure 178 F 4 If using Patient circuit with heated wire Connect full length tubing with heated wire to Y connector Figure 178 F Note The P N of the circuit with the heated wire configuration is M1161732 5 Connect the Exhalation valve Figure 178 D to t...

Page 260: ...tubing assembly Cleaning and Sterilization Disassembly 1 Detach the one way valve from the Y Connector and the long inspiratory corrugated tube Note Do not remove the tube holders that support the sensor tubes from the corrugated tube 2 Disassemble the exhalation valve as follows open the top cover together with its control tube and GENTLY remove the internal membrane Note do A Ventilator outlet B...

Page 261: ...titutes for washing purposes Wash according to preset washing cycles and use different adapters to pass cleaning solution through the thin tubes 2 Remove the patient circuit components from the solution and rinse the components with distilled or sterile water Pass water through the small diameter tubing by using syringe or connect to flow source of automatic washing equipment Patient circuit compo...

Page 262: ...e upper and lower parts exhalation valve together 6 Check that the groove in the cap mates with the pin in the valve housing in the same orientation 7 Check that all tube holders on corrugated tube are firmly supported See that all other connections are stable and that there are no loose ends 8 Check that all tube holders on corrugated tube are firmly supported See that all other connections are s...

Page 263: ... increased risk of exposure conclusive evidence of human health risks has not been established As a precautionary measure to reduce the potential for unnecessary exposures to phthalates the product must be used in accordance with the instructions for use and practitioners should refrain from using this product beyond the period of time the product is medically necessary or needed INSTALLATION Thes...

Page 264: ...arb fitting of the exhalation valve and the other end to the barb fitting of the reusable Luer fitting 2 Connect the assembled PEEP pressure line by securing the luer lock fitting to the Exhalation valve luer inlet which is marked with a blue dot on the front panel of the ventilator see Figure 183 item D 3 Secure the multi use One way valve to the ventilator patient outlet see Figure 183 item C 4 ...

Page 265: ...Appendix G Accessories 253 Figure 181 Attaching the Exhalation Valve Adapter Figure 182 Mounting the Exhalation Valve Adapter Figure 183 Tubing Connectors on the iVentTM201 ...

Page 266: ...TTERY 1 Make sure that the iVentTM201 is turned off 2 Disconnect the iVentTM201 from external power 3 Remove all four screws from the power pack using a 1 Phillips screwdriver as shown in the Figure 185 4 Using the handle pull the battery pack out as shown in Figure 186 5 Open the power pack package remove the foam protecting the extended battery and take out the extended battery as shown in Figur...

Page 267: ... sure that the female connectors of the battery are in place 8 You can pack the regular battery in the extended battery package placing back the foam inverted Charge the extended battery for at least 24 hours See Full Recharge Procedure page 36 Figure 185 Battery Screw Locations Figure 186 pulling the Battery Pack Out Figure 187 Unpacking the Battery Figure 188 Sliding the Battery In ...

Page 268: ... or nursing women please note that the following types of procedures may increase the risk of exposure to phthalates Exchange transfusion in neonates total parenteral nutrition in neonates multiple procedures in sick neonates haemodialysis in peripuberal males male foetus and male infant of pregnant women and lactating women and massive blood infusion into trauma patients Although these procedures...

Page 269: ...Appendix G Accessories 257 Duration of use should be determined by the appropriate personnel based on accepted infection control procedures but no more than 30 days ...

Page 270: ...e Exhalation valve luer inlet 5 Connect the open male side of the 22 mm Extension Tube to the female side of the Patient Circuit 6 On the open side connect the two transparent Channel Flow Sensor luer connectors to the respective luer connectors the Flow Sensor in the Patient circuit 7 Connect the open Exhalation Control Tube with luer connector blue tube to its respective Exhalation Valve luer co...

Page 271: ...n old model with an old mounting plate VersaMed P N 325A0162 A3 GE P N M1161827 is attached to the ventilator release the 4 screws that hold the old model of the Mounting plate and remove it See Figure 190 3 For Disaster Preparedness models only Screw the four spacers item no 5 into place using a 6mm socket wrench See Figure 191 4 Lay the Transport mounting plate item no 1 on the ventilator see Fi...

Page 272: ...ation on the HS Ventilator Figure 192 Positioning the Mounting Plate Figure 193 Inserting Screws into Flat Washer and Spring Washer NOTE The iVentTM201 MRI Transport Mounting Plate is an MR conditional accessory which poses no known hazards in all MR environments as per F 2503 05 ...

Page 273: ...ARM 1 Place the Support Arm base on the roll stand frame as shown in Figure 194 2 Turn the lower screw A in Figure 195 to fasten the Support Arm to the roll stand CAUTION The side screw B in Figure 195 fastens the Support Arm to its base Do not open this screw Do not over tighten the screws as this might cause damage to the Support Arm Figure 194 The Support Arm based on Roll Stand frame Figure 19...

Page 274: ... as per F 2503 05 MOUNTING THE IVENTTM 201 ON THE ROLL STAND WARNING Make sure that the patient is not connected to the ventilator and that the device is in Standby mode or shut down 1 Verify that the standard Transport Mounting Plate M1169908 Figure 198 1 1A or a Plate Cart Adapter M1161827 Figure 198 1 1B is connected to the ventilator 2 Lock all roll stand casters using the casters breaks 3 Pul...

Page 275: ...oll Stand CONNECTING THE OPTIONAL BATTERY HOLDER ACCESSORY P N M1162050 1 Fasten the Battery Holder mount screws to the post using a Philips screwdriver See Figure 199 2 Using the Adjustment screw at the end of the Battery holder tighten or loosen the screw to the required degree as to provide optimal support to the External Battery size 3 Peel the transparent layer of both 2 of the pair strips at...

Page 276: ...264 5 Fasten the external battery using the strap belt Figure 199 Connecting the Optional Battery Bag ...

Page 277: ...Appendix H Remote Alarm Connector 265 APPENDIX H REMOTE ALARM CONNECTOR ...

Page 278: ......

Page 279: ...tor provides access to a relay that is normally activated but deactivates when an alarm status occurs or the main power is turned off In Normal mode the N O contact to common is disconnected while the N C contact to common is connected The N C 51K is connected to common through a 51K ohm resistor required by some alarm systems In Alarm mode the N O contact to common is connected while the N C and ...

Page 280: ......

Page 281: ...Appendix I Part Numbers and Accessories 269 APPENDIX I PART NUMBERS AND ACCESSORIES ...

Page 282: ......

Page 283: ...T DISPOSABLE 4M M1198077 iVentTM201 PATIENT CIRCUIT W TRAP MULTI USE QTY 15 Mechanical M1199141 PATIENT CIRCUITS HW MU QTY 1 Breathing Circuits Components M1161015 319G0040 A0 FLOW SENSOR Y PIECE REUSABLE M1161016 319G0020 A0 FLOW SENSOR Y PIECE DISPOSABLE M1161029 50801020 A0 DISPOSABLE EXHALATION VALVE M1161030 50801030 A0 MULTI USE EXHALATION VALVE M1173617 620B0019 01 MRI PATIENT CIRCUIT M1162...

Page 284: ...NDER HOLDER MRI CONDITIONAL M1174996 Suko Roll Stand Caster Kit Oxygen M1162017 620B0002 01 OXYGEN SUPPLY HOSE 15FT LENGTH DISS FITTINGS M1162020 Adapter For Low Pressure O2 SpO2 M1176366 611A0005 02 NONINVASIVE SPO2 FOR iVentTM201 M1162015 611A0005 02 SPO2 KIT INCL CABLE AND DISPOSABLE PROBE Remote Alarm M1192088 375HC021 01 REMOTE ALARM BOX M1161989 507A0052 C0 NORMALLY CLOSED NC 51K CONNECTOR M...

Page 285: ...664 AC Cable 3pin 180 cm Brazil M1212963 EU AC CORD L 2M Batteries M1161011 504A0051 A0 EXTERNAL BATTERY KIT M1171502 900K0011 01 EXTENDED POWER PACK KIT M1171503 900K0011 02 H S EXTENDED POWER PACK KIT M1161022 503A0012 SP POWER PACK REVISION 1 4 ASSY iVentTM201 M1161960 DHHS POWER PACK ASSY 1 4 5 SN GT 20 000 Ventilator Cases M1161822 PVC COVER NOT COMPATIBLE WITH DHHS UNITS M1161882 375B0003 01...

Page 286: ...274 ...

Page 287: ... cycle 194 Breath type 13 breathing circuit 32 44 60 133 180 181 193 206 Compliance dynamic 14 DC 7 8 16 23 27 32 33 34 159 161 206 Delivered O2 13 disposable patient circuit 40 41 dual limb patient circuit 40 42 Easy Exhale 93 137 Exhalation Valve 41 42 43 166 170 Exhale tidal volume 13 Exhaled Minute Volume 13 Extended Battery 16 filters 7 32 201 FiO2 12 17 20 107 162 Flow Leak 14 Home Care 19 I...

Page 288: ... 236 Plateau Pressure 14 119 pneumatic nebulizer 32 245 pressure alarm 193 Pressure control breath 215 PSV 12 17 20 196 Purging cycle 196 Purging Cycle 17 Resistance dynamic 14 Respiratory Rate 12 13 17 20 22 54 66 67 68 133 144 146 147 168 193 respiratory volume 12 reusable patient circuit 40 41 42 Rise Time 20 196 safety mode 193 229 SIMV 3 15 60 61 63 64 66 71 105 193 194 195 196 197 216 226 22...

Page 289: ...Index 277 ...

Page 290: ... Medical Systems Israel LTD a General Electric Company doing business as GE Healthcare Manufacturer VersaMed Medical Systems Ltd P O B 5011 Ornat Bldg Hasharon Ind Park Kadima 60920 Israel 0473 Obelis s a Av de Tervuren 34 Bte 44 B 1040 Brussels Belgium Tel 32 2 7325954 Fax 32 2 7326003 mail obelis net iVentTM 201 User s Reference Manual English USA M1162064 DOC0899695 March 2011 ...

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