Breathe LIFE2000 Instructions For Use Manual Download Page 143

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CHAPTER 12: COMPLIANCE AND IEC CLASSIFICATION

IEC COMPLIANCE:

EN/IEC 60601-1-2 4th edition: 2014 (Medical electrical equipment Part 1-2: General

requirements for basic safety and essential requirements - Collateral standard: Electromagnetic disturbances

- Requirements and tests) defines the RF emissions limits and minimum RF immunity requirements for different

types of medical electrical equipment. The following tables include the RF emissions limits and RF immunity

requirements for, and results of tests upon, the Breathe Technologies® Life2000® Ventilation System.
The Breathe Technologies® Life2000® Ventilation System requires special precautions regarding electromagnetic

compatibility (EMC) and needs to be installed and put into service according to the EMC information provided in

this

Instructions for Use

The use of accessories or cables other than those specified by Breathe Technologies® may result in increased

emissions or decreased immunity of the Breathe Technologies® Life2000® Ventilation System.

GUIDANCE AND MANUFACTURER’S DECLARATION: ELECTROMAGNETIC EMISSIONS

The Breathe Technologies® Life2000® Ventilation System is intended for use in the electromagnetic

environment specified below. The customer or user of the ventilation system should ensure that it is used in

such an environment.

Emission Test

Compliance

Electromagnetic Environment - Guidance

RF emissions CISPR 11

Group 1

The Breathe Technologies® Life2000® Ventilation System

RF emissions are within CISPR 11 guidelines and are not

likely to cause interference in nearby electronic equipment.

RF emissions CISPR 11

Class B

The Breathe Technologies® Life2000® Ventilation System

is suitable for use in all establishments, including domestic

establishments and those directly connected to the public

power supply network that supplies buildings used for

domestic purposes.

Harmonic emissions IEC 61000-3-2

Complies

Voltage fluctuations/flicker emissions

IEC 61000-3-3

Complies

Summary of Contents for LIFE2000

Page 1: ...BREATHE TECHNOLOGIES LIFE2000 VENTILATION SYSTEM Instructions for Use 0 100 ...

Page 2: ..._____________ 18 Connecting an Interface to the Compressor____________________________________________________ 19 The Outlet Fitting in Stationary Configuration____________________________________________________ 19 Powering On Sequence in Stationary Configuration______________________________________________ 20 Checking the Compressor s Internal Battery Status_____________________________________...

Page 3: ...ing the Ventilator Battery Charge________________________________________________________45 Ventilator Battery Charge Icons Meaning and Approximate Time Remaining____________________________45 Assembling the Ventilator Battery Charger and Charging the Ventilator________________________________46 Securing the Ventilator____________________________________________________________________47 Belt Clip...

Page 4: ..._____________________64 Setting Ventilation Parameters in Assist Control Ventilation Mode___________________________________ 66 Setting Ventilation Parameters in Assist Ventilation Mode__________________________________________68 Setting Alarm Limits for Breath Rate and PIP____________________________________________________ 71 Setting Breath Timeout Apnea Backup Ventilation Mode _________________...

Page 5: ..._______ 108 Alarm Checks__________________________________________________________________________ 109 Cleaning and Disinfecting the Ventilation System________________________________________________ 109 Cleaning for Single Patient Use_____________________________________________________________ 110 Cleaning for Multi Patient Use_______________________________________________________________ 111 C...

Page 6: ...__________________134 General Overview_______________________________________________________________________ 134 Stationary Configuration Operation Summary and Pneumatic Diagram________________________________ 134 Extended Range Configuration Operation Summary and Pneumatic Diagram___________________________ 134 Stand Alone Configuration Operation Summary and Pneumatic Diagram____________________...

Page 7: ...or ambulance or air transportation WARNING Use the Breathe Technologies Life2000 Ventilation System only for patients who meet the Indications for Use If the ventilation system is used for patients that do not meet the Indications for Use patients may not receive appropriate respiratory therapy SYMBOLS AND CONVENTIONS The following symbols and conventions are used throughout this manual THIS MEANS...

Page 8: ...oxygen sources or near the ventilation system and do not place oxygen sources or the ventilation system near any source of direct heat or open flame because flammable materials burn more readily in the presence of oxygen Do not submerge the ventilation system in liquids or pour liquids on it Liquids may cause components in the system to malfunction Do not use the Breathe Technologies Life2000 Vent...

Page 9: ...erapy If using the ventilator with an alternate gas source in Stand Alone Configuration and the ventilator is not used with a regulator capable of 41 PSI to 87 PSI nominal 50 PSI with greater than 40 LPM capability patients may not receive appropriate respiratory therapy To prevent risk of cross contamination clean and disinfect the ventilation system before using it on a new patient and use a new...

Page 10: ...ows Interface Do not use a Breathe Pillows Interface or Breathe Universal Circuit connector that is cracked odorous broken or kinked If a damaged interface is used the patient may not receive adequate respiratory therapy 70 isopropyl alcohol may damage the touch screen When cleaning external surfaces of the ventilation system with 70 isopropyl alcohol avoid contact with the touch screen Keep in a ...

Page 11: ... Can be used with a variety of commercially available invasive interfaces such as ET tubes or non invasive masks such as full face nasal and pillows masks Enables clinicians to define three prescriptions based on patient need Allows for an adjustable PEEP setting for each prescription Allows for an adjustable trigger sensitivity for each prescription Includes the ability to set various critical al...

Page 12: ...ressor is an electropneumatic power unit that provides the ventilator with a continuous pressure source and is a charging station for the ventilator Belt clip for ventilator The belt clip is used to secure the ventilator when it is used in wearable configurations Battery charger and AC power cord for the ventilator The battery charger and AC power cord connect the ventilator to an AC power source ...

Page 13: ...facturer s use only FRONT Touch screen Activity buttons High Activity button Medium Activity button Low Activity button Power button for ventilator Power indicator light Alarm speaker Backup alarm buzzer Breath indicator light SIDE 13 Belt clip sockets BOTTOM 11 Interface connection 12 Gas inlet connection 2 3 1 4 5 6 7 8 10 9 11 12 13 ...

Page 14: ... indicator light Locking knob Unlocked icon Battery charge status button Battery charge indicator lights and battery charge scale SIDE Interface connection Outlet fitting BACK 11 Handle 12 Air inlet and filter 13 Cooling filter cover Cooling vents Condensation tray Power supply connection and cover SIDE Alarm buzzer internal Silence Alarm button 0 100 10 9 2 3 1 7 6 5 8 4 OutletAirOnly OutletAirOn...

Page 15: ...tion see the following chapter Chapter 2 Stationary Configuration EXTENDED RANGE WEARABLE CONFIGURATION The ventilator is connected to the compressor with a gas supply hose to enable the activities of daily living For information about how to setup the ventilation system in this configuration see Chapter 3 Extended Range Configuration on page 26 STAND ALONE WEARABLE CONFIGURATION The ventilator is...

Page 16: ...nto the compressor see page 18 TIP Check to make sure the ventilator is locked in the compressor Connect an interface to the compressor see page 19 NOTE For information about the interface on the patient side see Chapter 5 Connecting an Interface on page 51 Power on the compressor see page 20 Power on the ventilator see page 20 Check the compressor s battery charge status see pages 21 22 Check the...

Page 17: ...eved when sourced by the Life2000 Compressor due to increases in altitude near or above 2500 feet Consult the table to ensure that the compressor can meet the ventilator settings The tidal volume delivered to the patient includes the ventilator set volume entrainment volume from patient interface supplemental oxygen volume if used For additional information see page 152 WARNING Do not use the vent...

Page 18: ...and pull to release the cord from the compressor To isolate the compressor from the supply mains AC power source unplug the compressor s AC power cord from the AC power source TIP The compressor s power supply connection is equipped with a protective cover to prevent ingress of water and debris Use the cover to keep the power supply connection covered when not in use WARNING The interface source g...

Page 19: ...e inadvertently changed if the ventilator is not powered off before docking To dock the ventilator into the compressor make sure the locking knob is in the unlock position as shown Position the ventilator into the compressor cradle as shown Push the ventilator into the compressor in the direction indicated by the arrow until it clicks into place Gently push the top of the ventilator in the area in...

Page 20: ...ilator Battery Charge on page 23 NOTE For undocking instructions see Undocking the Ventilator from the Compressor on page 29 VENTILATOR CHARGING BY COMPRESSOR WHEN DOCKED AND LOCKED Compressor ON Compressor OFF AC CONNECTED to Compressor Ventilator charging Ventilator charging AC DISCONNECTED from Compressor Ventilator charging Ventilator DOES NOT charge NOTE The ventilator will not charge when th...

Page 21: ...ble tones to test the ventilator s alarm speaker During the ventilator s start up sequence the ventilator will perform a self test During the test all ventilator indicator lights should briefly flash and an audible alarm should briefly sound This self test can take up to 15 seconds to complete If you do not hear tones when you turn on the ventilator contact your Breathe Technologies service repres...

Page 22: ...hts surrounding the power button are illuminated in orange the compressor is running on its internal battery The battery charge indicator lights and battery charge scale surround the battery charge status button and indicate the compressor s current battery charge level Consult the charts on the following page to determine the approximate amount of charge on the compressor s internal battery TIP W...

Page 23: ...and running on its internal battery the indicator lights surrounding the compressor s power button are illuminated in orange BATTERY CHARGE SCALE 0 100 0 100 0 100 0 100 0 100 0 100 APPROX CHARGE AMOUNT 0 1 20 21 50 51 70 71 90 91 100 The compressor s low battery alarm will sound when its internal battery charge drops to 20 or less WHEN THE COMPRESSOR IS CONNECTED TO AC POWER When the compressor i...

Page 24: ... the ventilator Refer to the chart below to determine the approximate amount of ventilator battery charge When the ventilator is properly docked the ventilator battery charge icon should display either the charging icon or the icon for 100 charged NOTE There may be a 5 10 second delay before the Ventilator Battery Charge icon appears on the touch screen VENTILATOR BATTERY CHARGE ICONS MEANINGS AND...

Page 25: ...larm and is not silenced after 60 seconds the alarm will continue with an additional buzzer Resolve the condition that triggered the alarm For help resolving alarms see the alarm and troubleshooting tables in Chapter 7 Alarms Alerts and Troubleshooting for possible causes of an alarm and options to resolve it If an alarm silence button is pressed but the condition that triggered the alarm is not r...

Page 26: ...hree seconds until a confirmation screen appears To continue to power off the ventilator choose OK NOTE If a selection is not made within 20 seconds or if the BACK button is selected the previous screen will be displayed and the ventilation status will not be affected NOTE To isolate the compressor from the supply mains AC power source unplug the compressor s AC power cord from the AC power source...

Page 27: ...t the compressor to an AC power source using the compressor s external power supply and AC power cord see page Undock the ventilator from the compressor see page 29 Connect the compressor and the ventilator with an oxygen hose see page 30 Connect an interface to the ventilator see page 31 NOTE For information about the interface on the patient side see Chapter 5 Connecting an Interface on page 51 ...

Page 28: ...hieved when sourced by the Life2000 Compressor due to increases in altitude near or above 2500 feet Consult the table to ensure that the compressor can meet the ventilator settings The tidal volume delivered to the patient includes the ventilator set volume entrainment volume from patient interface supplemental oxygen volume if used For additional information see page 152 WARNING Do not use the ve...

Page 29: ...d and pull to release the cord from the compressor To isolate the compressor from the supply mains AC power source unplug the compressor s AC power cord from the AC power source TIP The compressor s power supply connection is equipped with a protective cover to prevent ingress of water and debris Use the cover to keep the power supply connection covered when not in use WARNING The interface source...

Page 30: ...be encountered and or the selected Activity Button might be inadvertently changed if the ventilator is not powered off before undocking Turn the locking knob counterclockwise to the unlocked position until the compressor ejects the ventilator NOTE Some tension will be encountered while turning the knob during ejection Pull the ventilator in the direction shown by the arrow to separate it from the ...

Page 31: ...outlet fitting on the compressor NOTE The outlet fitting is to be used only for connecting the compressor to the Life2000 Ventilator with a Breathe Technologies Source gas supply hose or during the purging of a Breathe Technologies interface For more information about the purging process see Purging the Breathe Universal Circuit Connector and Breathe Pillows Interface on page 113 Connect the other...

Page 32: ... Circuit connector into the interface port on the bottom of the ventilator until it clicks For more information about wearing interfaces see Chapter 5 Connecting an Interface on page 51 NOTE Ensure that the Breathe Pillows Interface or Breathe Universal Circuit connector is connected to the ventilator in Extended Range Configuration and Stand Alone Configuration ...

Page 33: ...larm speaker During the ventilator s start up sequence the ventilator will perform a self test During the test all ventilator indicator lights should briefly flash and an audible alarm should briefly sound This self test can take up to 15 seconds to complete If you do not hear tones when you turn on the ventilator contact your Breathe Technologies service representative When the Home Screen is dis...

Page 34: ...ights surrounding the power button are illuminated in orange the compressor is running on its internal battery The battery charge indicator lights and battery charge scale surround the battery charge status button and indicate the compressor s current battery charge level Consult the charts on the following page to determine the approximate amount of charge on the compressor s internal battery TIP...

Page 35: ...n and running on its internal battery the indicator lights surrounding the compressor s power button are illuminated in orange BATTERY CHARGE SCALE 0 100 0 100 0 100 0 100 0 100 0 100 APPROX CHARGE AMOUNT 0 1 20 21 50 51 70 71 90 91 100 The compressor s low battery alarm will sound when its internal battery charge drops to 20 or less WHEN THE COMPRESSOR IS CONNECTED TO AC POWER When the compressor...

Page 36: ...attery charge level for the ventilator Refer to the chart below to determine the approximate amount of ventilator battery charge and the approximate time remaining NOTE The Ventilator Battery Charge icon is always displayed on the touch screen during normal operation VENTILATOR BATTERY CHARGE ICONS MEANINGS AND APPROXIMATE TIME REMAINING BATTERY CHARGE ICON APPROX CHARGE AMOUNT Charging 5 15 15 35...

Page 37: ...e icon on the touch screen to see the ventilator s current battery charge status NOTES When charging the battery there may be a 5 10 second delay before the Ventilator Battery Charge icon appears on the touch screen The ventilator performance is the same regardless of power source internal battery or AC WARNING The interface source gas supply hose and power cords should be positioned to avoid rest...

Page 38: ...e ventilator the ventilator may fall and be damaged Always secure the ventilator to prevent it from falling or becoming damaged Use only the Breathe Technologies approved belt clip with the ventilator Position the clip over the belt and push down until it is secure Line up the belt clip with the belt clip sockets on the ventilator Push in the ventilator towards the belt clip until the ventilator a...

Page 39: ... high priority alarm and is not silenced after 60 seconds the alarm will continue with an additional buzzer Resolve the condition that triggered the alarm For help resolving alarms see the alarm and troubleshooting tables in Chapter 7 Alarms Alerts and Troubleshooting for possible causes of an alarm and options to resolve it If a Silence Alarm button is pressed but the condition that triggered the...

Page 40: ...fected To power off the compressor press the compressor s power button NOTE To isolate the compressor from the supply mains AC power source unplug the compressor s AC power cord from the AC power source DISCONNECTING EXTENDED RANGE CONFIGURATION Power off the ventilator Disconnect the oxygen hose from the ventilator by pulling back on the knurled ring on the quick connect end of the oxygen hose un...

Page 41: ... for ensuring compatibility of the ventilator and the parts used to connect to the patient before use STAND ALONE CONFIGURATION SETUP CHECKLIST Refer to the chapter contents for full instructions warnings and cautions Test the ventilator before using it on a new patient if in multi patient environment see page 41 Undock the ventilator from the compressor see page 41 Connect the ventilator to an ox...

Page 42: ...off before undocking Turn the locking knob counterclockwise to the unlocked position until the compressor ejects the ventilator NOTE Some tension will be encountered while turning during ejection Pull the ventilator in the direction shown by the arrow to separate it from the compressor cradle Power off the compressor NOTE For docking instructions see Docking the Ventilator into the Compressor on p...

Page 43: ... an adequate supply of oxygen for the intended duration of the therapy Otherwise the patient may not receive appropriate therapy Do not allow smoking near oxygen sources or near the ventilation system and do not place oxygen sources or the ventilation system near any source of direct heat or open flame because flammable materials burn more readily in the presence of oxygen Do not use the ventilato...

Page 44: ...and regulator the instructions below are provided as an example NOTE If using a cylinder with a built in regulator skip to step 9 Ensure that the regulator is preset to 50 PSI or adjust the regulator pressure to 41 PSI to 87 PSI 50 PSI nominal Slide the regulator over the neck of the cylinder and line up the pins on the regulator with the holes in the cylinder neck Tighten the tee screw on the reg...

Page 45: ... contact your Breathe Technologies service representative When the Home Screen is displayed the touch screen is ready to use NOTE Ventilation will not begin until an Activity Button is selected on the ventilator For more information see Choosing an Activity Button Patient Selectable to Begin Ventilation on page 74 1 2 CONNECTING AN INTERFACE TO THE VENTILATOR IN STAND ALONE CONFIGURATION Plug the ...

Page 46: ...ttery charge level for the ventilator Refer to the chart below to determine the approximate amount of ventilator battery charge and the approximate time remaining NOTE The Ventilator Battery Charge icon is always displayed on the touch screen during normal operation VENTILATOR BATTERY CHARGE ICONS MEANING AND APPROXIMATE TIME REMAINING BATTERY CHARGE ICON APPROX CHARGE AMOUNT Charging 5 15 15 35 3...

Page 47: ... icon on the touch screen to see the ventilator s current battery charge status NOTES When charging the battery there may be a 5 10 second delay before the Ventilator Battery Charge icon appears on the touch screen The ventilator performance is the same regardless of power source internal battery or AC WARNING The interface source gas supply hose and power cords should be positioned to avoid restr...

Page 48: ...tor If the clip is not securely fastened to the belt and the ventilator the ventilator may fall and be damaged Always secure the ventilator to prevent it from falling or becoming damaged Use only the Breathe Technologies approved belt clip with the ventilator Position the clip over the belt and push down until it is secure Line up the belt clip with the belt clip sockets on the ventilator Push in ...

Page 49: ...d be damaged Always secure the ventilator to prevent it from falling or becoming damaged Use only the Breathe Technologies approved belt clip and pole mount with the ventilator Position the pole mount around the pole in the correct orientation Turn the knob on the pole mount until the pole mount is securely attached to the pole Slide the belt clip for the ventilator into the hole on the top of the...

Page 50: ...high priority alarm and is not silenced after 60 seconds the alarm will continue with an additional buzzer Resolve the condition that triggered the alarm For help resolving alarms see the alarm and troubleshooting tables in Chapter 7 Alarms Alerts and Troubleshooting for possible causes of an alarm and options to resolve it If a Silence Alarm button is pressed but the condition that triggered the ...

Page 51: ...s the Ventilator Power button for three seconds until a confirmation screen appears To continue to power off the ventilator choose OK NOTE If a selection is not made within 20 seconds or if the BACK button is selected the previous screen will be displayed and the ventilation status will not be affected 1 ...

Page 52: ...ects directly to a Breathe Technologies ventilator or compressor NOTES For information about ordering accessories and replacement parts see Accessories and Replacement Parts on page 133 Before using an interface visually inspect it for damage CONNECTING AN INTERFACE TO THE COMPRESSOR IN STATIONARY CONFIGURATION Plug the Breathe Pillows Interface or Breathe Universal Circuit connector into the inte...

Page 53: ...rilized prior to first use Compressor or ventilator connector Interface tubing Entrainment ports Breathe Universal Circuit connector patient side Sense tube WARNING Breathe interfaces are designed for single patient use To prevent risk of cross contamination use a new Breathe Universal Circuit connector for each new patient For the third party mask or tube refer to the user guide provided by the m...

Page 54: ...ask endotracheal tube or tracheostomy tube ensuring that the sense tube does not become kinked or pinched NOTE Your mask or tube connection may differ a full face mask connection is shown below as an example Ensure that the entrainment ports are clear of any obstruction and are not covered by any clothing or bedding EXAMPLES OF PATIENT MASK AND TUBE CONNECTIONS The Breathe Universal Circuit connec...

Page 55: ...Interface tubing Compressor or ventilator connector WARNING Properly secure the patient interface to the face and route tubing around the ears to avoid strangulation Breathe interfaces are designed for single patient use To prevent risk of cross contamination use a new Breathe Pillows Interface for each new patient The interface source gas supply hose and power cords should be positioned to avoid ...

Page 56: ...st the tubing length under the chin so that the interface is secured snugly and comfortably CHECKING THE BREATHE PILLOWS INTERFACE POSITIONING The interface is placed correctly when The interface pillows rest snugly inside the nostrils as shown The fit is comfortable The interface does not make breathing difficult Air does not flow to the eyes cheeks or lips Entrainment ports are not obstructed If...

Page 57: ...lume displayed on the Home Screen during ventilation The Flip Button flips the screen 180 Peak Inspiratory Pressure PIP cmH2 O indicator displayed on the Home Screen during ventilation Current breath rate Breath min or BPM displayed on the Home Screen during ventilation Average gas flow in liters per minute Air LPM or O2 LPM based on prescription and patient s current breath rate displayed on the ...

Page 58: ...d total operating time or go back to the Home Screen To get to the Menu screen touch the Wrench button from any screen Screen title Touch to go to the Home Screen Touch to go to the Settings Screen for Trigger Sensitivity Clinician s Settings and Utilities Touch to go to the Information Screen 20 0 7 5 15 500 ml Air LPM PIP cmH2 O Breath min 10 11a Fri Jun 12 2015 1 2 10 11a Fri Jun 12 2015 2 3 4 ...

Page 59: ...creen Touching the screen again will reactivate it and display the Home Screen DEFINING CLINICAL SETTINGS ACCESSING THE SETTINGS MENU On any screen touch the Wrench button On the Menu screen touch Settings 20 0 7 5 15 500 ml Air LPM PIP cmH2 O Breath min 10 11a Fri Jun 12 2015 1 2 10 11a Fri Jun 12 2015 Values displayed on the screen are for illustrative purposes only ...

Page 60: ... menu to prevent unintended changes to the programmed clinical settings AUTOMATIC TIMEOUT An Automatic Timeout disables access to the Clinician s Settings menu after five minutes of inactivity in the Clinician s Settings menu The password must be re entered to regain access to the Clinician s Settings menu NOTE Automatic Timeout begins after the Touch Screen Energy Save Mode For more information s...

Page 61: ...ting screen is used to return to the Settings Menu screen TIP The ventilator is shipped with factory set default values Be sure to adjust the Prescription Settings based on a physician s order The Activity Icon at the top of the screen indicates which prescription is being edited For each of the three prescriptions that may be made available to the patient the Low Activity Icon is shown for illust...

Page 62: ...tive Activating checking a Prescription Setting button makes that Activity Button available to the patient for selection on the ventilator In the example below the Low Activity Prescription Setting is activated for patient selection on the ventilator using the Low Activity button NOTE Making a Prescription Setting button active checked does not begin ventilation therapy an Activity button must als...

Page 63: ... Sensitivity Trigger Sensitivity 4 BR Breath Rate 12 BPM Ventilation mode Assist Control ventilation mode Alarm Limits High BR Breath Rate alarm limit 50 BPM Low BR Breath Rate alarm limit 5 BPM High PIP Peak Inspiratory Pressure alarm limit 20 cmH2O Low PIP Peak Inspiratory Pressure alarm limit 1 cmH2O Breath Timeout Breath Timeout Period 60 seconds Breath Timeout Action 12 BPM Source Gas Source ...

Page 64: ...t s effort and volume delivery is controlled by the prescribed volume setting and inspiratory time VENTILATION MODES The ventilation system delivers an inspired tidal volume to the patient according to the clinical settings volume breath rate trigger sensitivity PEEP and inspiratory time Three different volume control modes are available Control Assist Control Assist VENTILATION SETTINGS AND MODES...

Page 65: ...y breaths A mandatory breath is delivered according to the breath setting BPM This also means that a breath will not be triggered based on patient s inspiratory effort Flow Time 3 seconds 3 seconds 3 seconds Mandatory Breath Mandatory Breath Mandatory Breath I Time Volume Pressure Time 3 seconds 3 seconds 3 seconds PEEP Mandatory Breath Mandatory Breath Mandatory Breath ...

Page 66: ...sing and holding an arrow button will continue to increase or decrease the value Repeat steps 2 and 3 for each setting you want to change and then press OK In the message asking if the settings are OK touch CONFIRM NOTE Changes to settings only take effect when you touch CONFIRM 10 11a Fri Jun 12 2015 Clinician s Settings Ventilation Settings Alarm Limits Breath Timeout Source Gas 1 10 11a Fri Jun...

Page 67: ...nded when the Inspiratory Time setting has been met A mandatory breath is delivered if the patient does not breathe within the prescribed Breath Rate setting This ensures that the patient receives a minimum number of breaths per minute Flow Time 3 seconds 3 seconds 3 seconds Assisted Breath Mandatory Breath Assisted Breath I Time Volume Pressure Time 3 seconds 3 seconds 3 seconds Assisted Breath A...

Page 68: ...e it Pressing and holding an arrow button will continue to increase or decrease the value Repeat steps 2 and 3 for each setting you want to change and then press OK In the message asking if the settings are OK touch CONFIRM NOTE Changes to settings only take effect when you touch CONFIRM 10 11a Fri Jun 12 2015 Clinician s Settings Ventilation Settings Alarm Limits Breath Timeout Source Gas 1 10 11...

Page 69: ... has been met If the ventilation system does not detect breaths during the allotted time as defined by the Breath Timeout parameter the ventilation system will deliver breaths or a continuous flow of gas based on the Timeout Action parameter setting Flow Time 3 seconds 3 seconds 3 seconds Assisted Breath Assisted Breath Assisted Breath I Time Volume Pressure Time 3 seconds 3 seconds 3 seconds Assi...

Page 70: ...essing and holding an arrow button will continue to increase or decrease the value Repeat steps 2 and 3 for each setting you want to change and then press OK In the message asking if the settings are OK touch CONFIRM NOTE Changes to settings only take effect when you touch CONFIRM 10 11a Fri Jun 12 2015 Clinician s Settings Ventilation Settings Alarm Limits Breath Timeout Source Gas 1 10 11a Fri J...

Page 71: ...orter than set if additional time is required to deliver the set volume The actual delivery time may also be longer or shorter than set to maintain a minimum delivered peak gas flow rate of 8 40 LPM range PEEP Positive End Expiratory Pressure PEEP can be adjusted as per the prescription PEEP values can be set from 0 10 cmH2O Sensitivity Trigger Sensitivity Specifies the minimum negative pressure t...

Page 72: ...u want to change and then press OK In the message asking if the settings are OK touch CONFIRM NOTE Changes to settings only take effect when you touch CONFIRM ALARM LIMITS SETTINGS SUMMARY ALARM DEFAULT MINIMUM MAXIMUM INCREMENT High Breath Rate Alarm Limit BPM 50 5 120 1 Low Breath Rate Alarm Limit BPM 5 0 119 1 High PIP Alarm Limit cmH2O 20 5 40 1 Low PIP Alarm Limit cmH2O 1 1 15 1 TIP The breat...

Page 73: ...sing and holding an arrow button will continue to increase or decrease the value Repeat steps 2 and 3 for each setting you want to change and then press OK In the message asking if the settings are OK touch CONFIRM NOTE Changes to settings only take effect when you touch CONFIRM BREATH TIMEOUT SETTINGS SUMMARY PARAMETER DEFAULT ALTERNATE Timeout Period 60 seconds 20 seconds Timeout Action 12 BPM 3...

Page 74: ...Range Configuration O2 On the Clinician s Setting screen touch Source Gas On the Source Gas screen touch the appropriate check box for the source gas prescribed by the physician Touch OK to confirm your selection In the message asking if the settings are OK touch CONFIRM NOTE Changes to settings only take effect when you touch CONFIRM SOURCE GAS SETTINGS SUMMARY DEFAULT ALTERNATE Air O2 Oxygen Cli...

Page 75: ...ator is powered on Ensure a pressure source the compressor an oxygen cylinder or an oxygen wall source is connected to the ventilator and turned on Press and hold an Activity Button until you hear a tone that indicates it is active The touch screen will display the Home Screen and the ventilator will begin delivering therapy Confirm the selected Activity Icon is displayed at the bottom of the touc...

Page 76: ...py when selecting an Activity Button with a different source gas a message will appear as a reminder to connect or disconnect oxygen as appropriate After connecting or disconnecting oxygen touch OK to begin ventilating using the prescription represented by the new Activity Button For more information see Selecting the Source Gas on page 73 This Prescription Setting is not active 10 11a Fri Jun 12 ...

Page 77: ...ntrol Mode Sensitivity is OFF ACCESSING THE TRIGGER SENSITIVITY SCREEN On any screen touch the Wrench button On the Menu screen touch Settings On the Settings Menu screen touch Trigger Sensitivity NOTE A grayed out Trigger Sensitivity button indicates that this feature is not available for one of the following reasons An Activity Button has not been chosen the ventilator is not currently ventilati...

Page 78: ...the value NOTE The lower the number the more sensitive the setting When you are finished touch OK In the message asking if the settings are OK touch CONFIRM NOTE Changes to settings only take effect when you touch CONFIRM This Trigger Sensitivity setting will be saved as part of the currently ventilating prescription 1 1 10 11a Fri Jun 12 2015 2 3 Trigger Sensitivity 10 11a Fri Jun 12 2015 Values ...

Page 79: ...f audible alarms and set alarms to vibrate mode On any screen touch the Wrench button On the Menu screen touch Settings On the Settings Menu screen touch Utilities 20 0 7 5 15 500 ml Air LPM PIP cmH2 O Breath min 10 11a Fri Jun 12 2015 1 2 10 11a Fri Jun 12 2015 3 10 11a Fri Jun 12 2015 Values displayed on the screen are for illustrative purposes only ...

Page 80: ...n will continue to increase or decrease the value Repeat steps 2 and 3 for each box you want to change and then touch OK In the message asking if the settings are OK touch CONFIRM NOTE Changes to settings only take effect when you touch CONFIRM 1 10 11a Fri Jun 12 2015 2 10 11a Fri Jun 12 2015 3 3 10 11a Fri Jun 12 2015 4 5 10 11a Fri Jun 12 2015 Values displayed on the screen are for illustrative...

Page 81: ...s with a vibration alarm with no delay On the Utilities Menu screen touch Set Vibration On the Set Vibration screen touch ON or OFF When you are finished touch OK In the message asking if the settings are OK touch CONFIRM NOTE Changes to settings only take effect when you touch CONFIRM Check that the Vibrate icon appears indicating the ventilator is in vibrate mode VIBRATION SETTINGS SUMMARY DEFAU...

Page 82: ...n will continue to increase or decrease the value You can choose a loudness level between 1 and 5 with 5 being the loudest and 1 the quietest When you are finished touch OK In the message asking if the settings are OK touch CONFIRM NOTE Changes to settings only take effect when you touch CONFIRM LOUDNESS SETTINGS SUMMARY DEFAULT MINIMUM MAXIMUM INCREMENT 5 1 5 1 1 10 11a Fri Jun 12 2015 2 2 10 11a...

Page 83: ... to increase or decrease the value You can choose a brightness level between 1 and 5 with 5 being the brightest and 1 the dimmest When you are finished touch OK In the message asking if the settings are OK touch CONFIRM BRIGHTNESS SETTINGS SUMMARY DEFAULT MINIMUM MAXIMUM INCREMENT 3 1 5 1 10 11a Fri Jun 12 2015 1 2 2 10 11a Fri Jun 12 2015 3 4 10 11a Fri Jun 12 2015 Values displayed on the screen ...

Page 84: ...en displays software version serial number and total operating time 20 0 7 5 15 500 ml Air LPM PIP cmH2 O Breath min 10 11a Fri Jun 12 2015 1 2 10 11a Fri Jun 12 2015 Software Version Life2000 Ventilation System Software Version BT V5 xx xx xx xx CRC xxxxxxxx Serial Number xxxxxxxx xxx Operating Time 12 hrs 42 mins 10 11a Fri Jun 12 2015 Values displayed on the screen are for illustrative purposes...

Page 85: ...on mode Alarm Limits High BR Breath Rate alarm limit 50 BPM Low BR Breath Rate alarm limit 5 BPM High PIP Peak Inspiratory Pressure alarm limit 20 cmH2O Low PIP Peak Inspiratory Pressure alarm limit 1 cmH2O High PEEP Positive End Expiratory Pressure Pressure alarm limit 7 cmH2O above PEEP setting High PEEP Pressure alarm limit is automatically set and cannot be adjusted Breath Timeout Breath Timeo...

Page 86: ...lty in hearing alarms and might affect ventilator performance Do not cover or block the compressor s internal alarm buzzer with any object Covering the buzzer may make it difficult for a patient or caregiver to hear alarms which may result in inadequate respiratory therapy There are two types of notifications provided by the Life2000 Ventilation System VENTILATOR ALARMS Ventilator alarms are visua...

Page 87: ...own arrows to scroll through the list Touch the Active Alarms button to display the alarm list Alarm icon Use the Scroll Down Arrow to view additional active alarms Use the Scroll Up Arrow to go to the beginning of the list of active alarms Alarm message alternates between each occurring alarm Alarm Silenced icon Alarm Silenced icon is displayed at the bottom of the touch screen when all alarms ar...

Page 88: ...ed after 60 seconds the alarm will continue with an additional buzzer Resolve the condition that triggered the on screen alarm For help resolving alarms see the alarm tables that follow for possible causes of an alarm and options to resolve it If a Silence Alarm button is pressed but the condition that triggered the alarm is not resolved the alarm will sound again after 60 seconds After resolving ...

Page 89: ... 7 5 High PEEP Pressure Interface may be blocked Inspect and clean the interface per the instructions for cleaning the interface High PIP Pressure 10 11a Fri Jun 12 2015 12 Breath min Air LPM PIP cmH2 O 13 2 3 4 High PIP Pressure Peak Inspiratory Pressure PIP exceeds the set limit Check the interface or tubing for any obstruction Check all connectors for possible damage Re adjust volume setting fo...

Page 90: ...Ensure the ventilator is properly docked into the compressor Inspect and clean the interface per the instructions for cleaning the interface Check the interface or tubing for any obstruction Check all connectors for possible damage Re adjust volume setting for the active prescription Ensure the ventilator is properly docked into the compressor Check the interface or tubing for any obstruction Chec...

Page 91: ...r battery charger and an AC power source to recharge the battery OR Dock the ventilator back into the compressor to recharge the battery Ensure that the locked icon on the compressor illuminates to indicate the ventilator is charging Ensure the compressor is powered on If the battery does not recharge place the patient on an alternate means of ventilation if necessary and contact your Breathe Tech...

Page 92: ... to indicate the ventilator is charging Ensure the compressor is powered on If the battery does not recharge place the patient on an alternate means of ventilation if necessary and contact your Breathe Technologies service representative Ensure the ventilator is properly docked and locked into the compressor and the locked icon is illuminated to indicate the ventilator is charging Ensure the compr...

Page 93: ... depending on the setting Patient is not breathing Patient is breathing through the mouth while using the Breathe Pillows Interface Breaths are too shallow to trigger ventilation change the trigger sensitivity to a lower setting higher sensitivity Ensure patient interface is not leaking at patient side Inspect and clean the interface per the instructions for cleaning the interface High Breath Rate...

Page 94: ...sure patient interface is not leaking at patient side Inspect and clean the interface per the instructions for cleaning the interface Patient is not breathing Patient is breathing through the mouth while using the Breathe Pillows Interface Breaths are too shallow to trigger ventilation change the trigger sensitivity to a lower setting higher sensitivity Ensure patient interface is not leaking at p...

Page 95: ...rm is not resolved power off the ventilator and contact your Breathe Technologies service representative Low Breath Rate 10 11a Fri Jun 12 2015 13 Breath min Air LPM PIP cmH2 O 1 5 4 1 Low Breath Rate Respiratory rate falls below set limit Patient is breathing through the mouth while using the Breathe Pillows Interface Breaths are too shallow to trigger ventilation change the trigger sensitivity t...

Page 96: ... Alone Configuration Power off the compressor and contact your Breathe Technologies service representative Check that the interface is connected to the ventilator not the compressor Patient is breathing through the mouth while using the Breathe Pillows Interface Breaths are too shallow to trigger ventilation change the trigger sensitivity to a lower setting higher sensitivity Ensure patient interf...

Page 97: ...SI nominal regulator with a minimum outlet flow of 40 LPM at 41 PSI Ensure the gas source e g cylinder has a sufficient supply of gas e g check that the cylinder is not empty If using a cylinder as the gas source ensure the cylinder valve is fully open Connect the ventilator to the compressor in Extended Range or Stationary Configuration or connect the ventilator to another gas source oxygen cylin...

Page 98: ...rm should resolve itself within 60 seconds Ventilation is still provided while the ventilator is alarming A 50 foot source gas supply hose may require changing to a 20 foot source gas supply hose for volumes greater than 350ml Verify that the compressor is powered on Ensure the ventilator is properly docked into the compressor Ensure that the purge tube connector is not connected to the compressor...

Page 99: ... 13 Breath min Air LPM PIP cmH2 O 0 0 4 3 Low PIP Pressure Peak Inspiratory Pressure PIP below set limit Ensure patient interface is not leaking at patient side Switch to another active Activity Button If the alarm persists contact your physician System Fault 10 11a Fri Jun 12 2015 Breath min O2 LPM PIP cmH2 O System Fault Press OK to restart system System Fault Internal fault detected during oper...

Page 100: ...the alarm persists contact your physician Ensure patient interface is not leaking at patient side Ensure the ventilator is properly docked into the compressor Switch to another active Activity Button If the alarm persists contact your physician If a system fault occurs in the message on the touch screen to reboot touch OK the ventilator will turn itself off and then on again Restart ventilation by...

Page 101: ...fications to be silenced there is no Silence Alarm button for alerts originating from the compressor NOTIFICATION CAUSE STAND ALONE CONFIGURATION Low Battery Alert Intermittent buzzer Compressor battery capacity drops to 20 or less N A Constant Audible Alert Compressor stops operating Multiple causes high motor temperature high electronics temperature electronic circuit error or motor stall N A ...

Page 102: ...e the patient on an alternate means of ventilation if necessary or connect the ventilator to an alternate pressure source oxygen cylinder or wall source in Stand Alone Configuration If running on battery check the compressor s battery charge status If the status is less than two indicator lights connect the compressor to an AC power source Power off the compressor and power it on again If the aler...

Page 103: ... have built up on the interface blocking the sense port Inspect and clean the interface per the instructions for cleaning the interface Patient is breathing faster than 40 BPM It is normal for the ventilator to limit breath rate to 40 BPM No volume output Compressor and or ventilator is not on Turn the ventilator on An Activity Button has not been pressed to start therapy Press an Activity Button ...

Page 104: ...face per the instructions for cleaning the interface Inspect and clean the interface per the instructions for cleaning the interface It is normal for the ventilator to limit breath rate to 40 BPM It is normal for the ventilator to limit breath rate to 40 BPM Ensure both the compressor and the ventilator are on Ensure both the compressor and the ventilator are on Press an Activity Button on the ven...

Page 105: ... than 40 BPM Secretions have built up on the interface Inspect and clean the interface per the instructions for cleaning the interface Patient interface is not connected or is leaking Verify that the interface is properly connected to the ventilator and is not leaking at patient side Ventilator is triggering during exhalation Secretions have built up on the interface Inspect and clean the interfac...

Page 106: ...ct and clean the interface per the instructions for cleaning the interface Verify that the interface is properly connected to the ventilator not the compressor and is not leaking at patient side Verify that the interface is properly connected to the compressor and is not leaking at patient side Inspect and clean the interface per the instructions for cleaning the interface Inspect and clean the in...

Page 107: ...reathe Technologies service representative The source gas supply hose does not connect to the gas source An incorrect source gas supply hose is being used Ensure that a Breathe Technologies oxygen hose is connected An incompatible regulator is being used Ensure the gas regulator is 42 87 PSI with a standard DISS fitting For any issues with the regulator contact the regulator manufacturer Cylinder ...

Page 108: ...ventilator charging indicator light the locked icon on the compressor is illuminated when the compressor is on Connect the ventilator to the ventilator battery charger and an AC power source or dock the ventilator back into the compressor and power on the compressor to recharge the battery If the issue is not resolved contact your Breathe Technologies service representative Connect the compressor ...

Page 109: ... if necessary For more information see Checking and Replacing the Condensation Tray on page 115 Essential Performance Absence of system fault alarms Unintended change of settings and modes Absence of false alarms No interruption of operation without alarms If damage is discovered discontinue use of the ventilation system or do not begin using the ventilation system For instructions on servicing or...

Page 110: ...stem with petrochemical or oil based materials Clean the touch screen with a soft microfiber cloth and disinfect with PDI Super Sani Cloth Germicidal Disposable Wipes as necessary After allowing for the manufacturer s suggested wait time wipe the screen with clean cloth to remove any residual cleaner CAUTION 70 isopropyl alcohol may damage the touch screen When cleaning external surfaces of the ve...

Page 111: ...compressor s cooling filter assembly and replace if necessary For more information see Checking and Replacing the Cooling Filter Assembly on page 117 OXYGEN HOSES If dirt is visible on the outside of the hose use a clean cloth and mild detergent such as dishwashing soap to remove it Replace every six months WARNING Do not subject Breathe source gas supply hoses to heat sterilization hot water past...

Page 112: ... to a new patient VENTILATION SYSTEM Follow the instructions in Cleaning and Disinfecting the Ventilation System on page 109 Replace the compressor s condensation tray For more information see Checking and Replacing the Condensation Tray on page 115 Replace the compressor s air inlet filter For more information see Checking and Replacing the Air Inlet Filter on page 116 Replace the compressor s co...

Page 113: ...FACE Submerge the patient side of the Breathe Pillows Interface or the patient side of the Breathe Universal Circuit connector in a clean container of mixed warm water suitable for drinking and a mild detergent e g dishwashing soap and agitate the patient side of the interface to clean it Rinse the patient side of the interface thoroughly with warm water PURGE THE INTERFACE Perform a purge immedia...

Page 114: ...rbed outlet of the purge tube connector by twisting on until secure NOTE Ensure that the purge tube is not twisted or kinked Power on the compressor Firmly press and hold the smaller end of the purge tube over one of the interface ports that connects the interface to the compressor NOTE Take care not to slide the tube over the O ring of the port Hold the purge tube over the interface port until al...

Page 115: ...eathe Technologies or an authorized service center Trained personnel and authorized service centers are provided with the proper documentation to maintain the ventilation system When shipping the ventilation system use proper packaging for protection NOTE The compressor contains a lithium ion battery Before shipping the compressor contact your transportation carrier for information TIP The ventila...

Page 116: ...ray from the compressor and empty the water thoroughly Squeeze the attached condensation tray sponge to remove as much water as possible some remaining dampness is normal NOTE Do not try to remove the sponge from the condensation tray Ensure that the overflow hole is not blocked Inspect the condensation tray and replace it if it has any damage or if the sponge shows signs of degradation contaminat...

Page 117: ...ilter if it is blocked by dirt or dust or is otherwise contaminated If replacing the filter obtain a replacement filter from Breathe Technologies For more information about purchasing replacement filters refer to Accessories and Replacement Parts on page 133 If the filter is clean return it to the back of the compressor NOTES Reusing contaminated filters is not recommended Dispose of used filters ...

Page 118: ...ct the used cooling filter Replace the cooling filter assembly if the filter is blocked by dirt or dust or is otherwise contaminated If replacing the cooling filter assembly obtain a replacement from Breathe Technologies For more information about purchasing replacement parts refer to Accessories and Replacement Parts on page 133 Replace the cooling filter assembly on the back of the compressor by...

Page 119: ...eck of the equipment and test alarms If the device is used in a clinical setting refer to PL 20 0011 Life2000 Performance Verification Testing for more information VERIFYING POWER ON SELF TEST ALARMS Press the Power button to turn on the ventilator Verify that there are audible tones while powering on the ventilator VERIFYING BACKUP ALARM BUZZER With the ventilator powered on and no source gas con...

Page 120: ... Alarms Alerts and Troubleshooting on page 85 As long as the alarm you are testing for is listed the test may be considered complete If the alarm is not listed turn off the ventilator and turn it back on Check that the test settings are correct and repeat the test EQUIPMENT REQUIRED FOR TESTING A Life2000 Ventilator An adjustable gas source connected to an adjustable regulator to test the High Gas...

Page 121: ...OK High BR 40 Low BR High PIP min cmH2O 0 40 cmH2O Low PIP 1 Touch OK and then CONFIRM Set the Breath Timeout to Breath Timeout 20 Sec 12 BPM 10 11a Fri Jun 12 2015 Touch OK and then CONFIRM Set the Source Gas to whatever source gas is being used for testing Connect the adjustable source gas supply to the ventilator using an adjustable regulator set to 50 PSI Turn on the source gas supply to 50 PS...

Page 122: ... displayed before the High Gas Pressure alarm increase the volume in the Ventilation Settings until the Low PIP Pressure alarm clears Changes to the Ventilation Settings take effect only after selecting the OK and CONFIRM buttons If a low or medium priority alarm occurs while the ventilator is in vibration mode and the alarm is not resolved within 60 seconds an audible alarm occurs After verifying...

Page 123: ...PRIORITY Begin by ventilating using the Low Activity button Allow the ventilator to ventilate for a few breaths using the current settings As soon as the breath indicator light shows a breath being delivered by the ventilator quickly pinch the interface tubing near the ventilator connection The top of the touch screen should display the High Delivery Pressure High Del Pressure alarm in yellow and ...

Page 124: ... to display the active alarms window the Low Del Pressure alarm should be listed in the list of alarms NOTE If a low or medium priority alarm occurs while the ventilator is in vibration mode and the alarm is not resolved within 60 seconds an audible alarm occurs After verifying the correct alarm notifications reconnect the interface to the ventilator The alarms should resolve themselves once the i...

Page 125: ...IP Pressure alarm in red and you should hear a sequence of two sets of five tones indicating a high priority alarm NOTE For a high priority alarm an audible tone immediately occurs with a vibration alarm with no delay After verifying the correct alarm notifications for the High PIP Pressure alarm release the interface and allow the alarm to resolve itself Using the Clinician s Settings Menu naviga...

Page 126: ...ouch screen should display the High Circuit Pressure High Crct Pressure alarm in red and you should hear a sequence of two sets of five tones indicating a high priority alarm NOTE For a high priority alarm an audible tone immediately occurs with a vibration alarm with no delay After verifying the correct alarm notifications for the High Circuit Pressure alarm release the interface tubing and allow...

Page 127: ...ch screen should display the High Breath Rate alarm in yellow and you should hear a sequence of three tones indicating a medium priority alarm or vibrate NOTE If a low or medium priority alarm occurs while the ventilator is in vibration mode and the alarm is not resolved within 60 seconds an audible alarm occurs After verifying the correct alarm notifications release the interface tubing The High ...

Page 128: ... alarm in yellow and you should hear a sequence of three tones indicating a medium priority alarm or vibrate NOTE If a low or medium priority alarm occurs while the ventilator is in vibration mode and the alarm is not resolved within 60 seconds an audible alarm occurs Using the Clinician s Settings Menu navigate to Alarm Limits and return the Low BR alarm limit to 0 min Select OK and CONFIRM The L...

Page 129: ...or will continue to alarm for the Battery Low alarm until the Very Low Battery alarm occurs 15 battery charge When the Very Low Battery alarm occurs the screen should display the Very Low Battery alarm in red and you should hear a sequence of two sets of five tones indicating a high priority alarm NOTE For a high priority alarm an audible tone immediately occurs with a vibration alarm with no dela...

Page 130: ... displays an alarm message when the battery has less than 25 of its charge and then again when it has less than 15 CHAPTER 9 ACCESSORIES COMPRESSOR BATTERY SPECIFICATIONS SPECIFICATION DESCRIPTION Type Lithium ion rechargeable not user replaceable Ampere hour rating 10200 mAh Maximum current 10 A Operating Voltage 28 8 V internal Duration 1 hour Compressor If the battery performance degrades to un...

Page 131: ...b 0 115 kg VENTILATOR POWER CORD SPECIFICATIONS 6 ft IEC 320 E7 compliant cord COMPRESSOR POWER SUPPLY AND POWER CORD SPECIFICATIONS COMPRESSOR POWER SUPPLY SPECIFICATIONS CATEGORY SPECIFICATION Input AC voltage 100 240 VAC Input AC frequency 50 60 Hz Input AC current 5 A max at 100 VAC 2 5 A max at 240 VAC Output DC voltage 24 VDC Output DC current 12 5 A Insulation class Class II Ingress protect...

Page 132: ...efer to the manufacturer s instructions The Tee Adapter will be connected between the Breathe Universal Circuit connector and the patient mask NOTE The clinician shall ensure that the patient is getting sufficient oxygen EXHALATION VOLUME MONITOR WARNING To monitor minute volume use an external exhaled volume monitor Recommended flow monitors Ohmeda 5420 Respironics NM3TM Datex Ohmeda CardiocapTM ...

Page 133: ...00 84 140 234 327 468 702 1075 1640 500 86 143 238 334 477 715 1050 990 300 87 146 243 340 486 729 1025 320 100 89 149 248 347 495 743 1000 370 110 91 152 253 354 505 758 975 1060 320 93 155 258 361 516 773 950 1770 540 95 158 263 369 527 790 925 2500 760 97 161 269 377 538 807 900 3240 990 99 165 275 385 550 826 875 4000 1220 101 169 282 394 563 845 850 4780 1460 104 173 288 404 577 865 825 5580 ...

Page 134: ...55 0003 Oxygen Hose 6 ft BT 55 0004 Oxygen Hose 10 ft BT 55 0005 Oxygen Hose 20 ft BT 55 0033 CombO2 Hose 10 ft BT 55 0034 CombO2 Hose 20 ft BT 55 0035 CombO2 Hose 50 ft Power Supply and Charger MS 03 1506 Compressor External Power Supply MS 03 1511 Compressor AC Power Cord MS 02 0178 Ventilator Battery Charger MS 03 0019 Ventilator Charger AC Cord Cleaning and Purging BT 80 0005 Life2000 Compress...

Page 135: ...L OVERVIEW The Life2000 Ventilation System utilizes an electromechanical pneumatic system under the control of a microprocessor to deliver patient ventilation The following descriptions and diagrams illustrate the major components of the ventilation system in each configuration STATIONARY CONFIGURATION OPERATION SUMMARY AND PNEUMATIC DIAGRAM Ambient air enters through an inlet filter on the compre...

Page 136: ...d to the safety valve and then to the flow valve which controls all inspiratory gas flow to the patient A flow sensor is also provided to measure delivered flow to the patient and the closed loop control system ensures the delivery of the required flow to the patient A pressure sensor is also used to measure the pressure at the patient connection to ensure patient safety The electromechanical pneu...

Page 137: ...programmable Prescription Settings can provide different volume outputs as prescribed by the physician Each setting is clinician definable between 50 ml to 750 ml Volume output adjustment Volume output may be adjusted by patient as prescribed by physician using the available programmable prescription settings Inspiratory Time I Time Range 0 15 sec to 3 00 sec Resolution 0 05 sec Accuracy 0 05 sec ...

Page 138: ...nspiratory pressure relief Pressure is relieved through the patient s mouth or through the patient interface Expiratory resistance at patient connection Breathe Pillows Interface Extra Small Small Medium Large 1 9 cmH2O at 30 LPM 1 1 cmH2O at 30 LPM 1 0 cmH2O at 30 LPM 0 96 cmH2O at 30 LPM 4 6 cmH2O at 50 LPM 3 5 cmH2O at 50 LPM 3 3 cmH2O at 50 LPM 2 5 cmH2O at 50 LPM Breathe Universal Circuit con...

Page 139: ...xygen hose Stand Alone use with cylinder or alternate gas source Ventilator Battery Specifications Type Lithium ion rechargeable not user replaceable Ampere hour rating 1800 mAh Maximum current 450 mA Operating Voltage 7 4 V internal Duration Approximately 4 hours If the battery performance degrades to unacceptable levels before the scheduled 2 5 year replacement contact your Breathe Technologies ...

Page 140: ...ure Interface pressure during delivery exceeds the maximum expected High Gas Pressure Source gas pressure exceeds the allowable limit 95 PSI Low Breath Rate Respiratory rate falls below the set limit Low Delivery Pressure Interface pressure during delivery fails to exceed the minimum expected Low Gas Pressure Source gas pressure drops below the allowable limit 35 PSI Low PIP Pressure PIP below set...

Page 141: ...II Electrical safety approvals UL 60601 1 EN 60950 EN 60601 1 EN 60335 2 29 Dimensions 3 55 x 1 77 x 1 26 90 x 45 x 32 mm Weight 0 25 lb 115 g Ventilator Power Cord Specifications Cord length 6 ft Compliance IEC 320 E7 Compressor Power Supply Specifications Input AC voltage 100 240 VAC Input AC frequency 50 60 Hz Input AC current 5 A max at 100 VAC 2 5 A max at 240 VAC Output DC voltage 24 VDC Out...

Page 142: ...essor can meet the ventilator settings The tidal volume delivered to the patient includes the ventilator set volume entrainment volume from patient interface supplemental oxygen volume if used For additional information see page 152 Physical Features Ventilation system weight 16 lb Ventilation system size 12 1 x 8 7 x 8 6 Ventilator weight 1 1 lb Ventilator size 3 2 x 7 7 x 1 0 Compressor weight 1...

Page 143: ...by Breathe Technologies may result in increased emissions or decreased immunity of the Breathe Technologies Life2000 Ventilation System GUIDANCE AND MANUFACTURER S DECLARATION ELECTROMAGNETIC EMISSIONS The Breathe Technologies Life2000 Ventilation System is intended for use in the electromagnetic environment specified below The customer or user of the ventilation system should ensure that it is us...

Page 144: ...kV for input output lines 2 kV for power supply lines Not applicable Mains power quality should be that of a typical household or hospital environment Surge IEC 61000 4 5 1 kV line s to line s 2 kV line s to earth 1 kV line s to line s 2 kV line s to earth Mains power quality should be that of a typical household or hospital environment Voltage dips short interruptions and voltage variations on po...

Page 145: ...on distance in meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol Radiated RF IEC 61000 4 3 Shall withstand test frequencies amplitudes and conditions specified in Table 9 of IEC 60601 1 2 4th ed Teste...

Page 146: ...ut power of transmitter W Separation distance according to frequency of transmitter m 150 kHz to 80 MHz d 1 17 P 80 MHz to 800 MHz d 0 35 P 800 MHz to 2 5 GHz d 0 7 P 0 01 0 17 0 035 0 070 0 1 0 37 0 11 0 22 1 1 17 0 35 0 70 10 3 69 1 1 2 2 100 11 70 3 5 7 0 NOTE 1 At 80 MHz and 800 MHz the separation distance for the higher frequency range applies NOTE 2 These guidelines may not apply in all situ...

Page 147: ...n silenced Ventilator touch screen Displayed on touch screen Touching the Wrench button displays the Menu screen Ventilator touch screen Displayed on touch screen Touching the Flip button rotates the touch screen 180 Ventilator touch screen Displayed on touch screen if ventilator is in vibrate mode h Ventilator label and compressor label Indicates catalog number and denotes the location of the par...

Page 148: ...en Displayed on touch screen if ventilator battery charge has approximately 80 100 of its charge remaining Ventilator touch screen Displayed on touch screen if battery is charging Ventilator label and compressor label Indicates BF type equipment Device isolates the patient from any live voltage in the equipment Ventilator label compressor label ventilator battery charger label and compressor exter...

Page 149: ...label and compressor external power supply Indicates product meets US standards for use with medical electrical equipment i Ventilator battery charger label Consult Instructions for Use Ventilator label compressor label and documentation Documentation includes important information that must be read before using device Ventilator battery charger label Indicates indoor use only and denotes that it ...

Page 150: ...creen if the ventilator is set to the Low Activity Prescription Setting Ventilator and ventilator touch screen On the ventilator the Medium Activity Button delivers prescription parameters set by a clinician in the Clinician s Settings menu Displayed on the Prescription Settings screen as a label for the Medium Activity Prescription Setting parameters set by a clinician Displayed on the touch scre...

Page 151: ...0 5 0 5 0 4 0 4 500 0 5 0 4 0 3 0 3 0 3 0 2 0 2 0 2 0 2 750 0 3 0 3 0 2 0 2 0 2 0 2 0 2 0 1 0 1 CYLINDER SIZE D 425 LITERS M15 BREATHS PER MINUTE BPM 12 14 16 18 20 22 24 26 28 Volume ml Duration in hours 50 11 8 10 1 8 9 7 9 7 1 6 4 5 9 5 4 5 1 100 5 9 5 1 4 4 3 9 3 5 3 2 3 0 2 7 2 5 150 3 9 3 4 3 0 2 6 2 4 2 1 2 0 1 8 1 7 200 3 0 2 5 2 2 2 0 1 8 1 6 1 5 1 4 1 3 250 2 4 2 0 1 8 1 6 1 4 1 3 1 2 1 ...

Page 152: ...When the source gas cylinder needs to be replaced Place the patient on an alternate means of ventilation if necessary Power off the ventilator NOTE Alarms might be encountered and or the selected Activity Button might be inadvertently changed if the ventilator is not powered off before replacing the cylinder Turn off the oxygen supply according to the regulator and gas supply manufacturers instruc...

Page 153: ...he amount of supplemental oxygen if any that is injected into the patient interface It is further influenced by the patient s resistance compliance and effort As a result the potential patient volume will be higher than the ventilator set volume NOTE This graph uses a PEEP value of 0 cmH2O 0 100 200 300 400 500 600 700 800 900 1 000 1 100 1 200 1 300 1 400 1 500 1 600 1 700 1 800 1 900 2 000 50 15...

Page 154: ...it 3 Unauthorized modifications or repairs to the unit 4 Use of the unit with unauthorized accessories e g external battery or AC adapter 5 Operation of the unit outside the specified environment 6 Fire flood earthquake acts of war or terrorism or acts of God The foregoing limited warranty is in lieu of and specifically excludes and replaces to the maximum extent permitted by applicable law all ot...

Page 155: ...or applicable US and Foreign Patent Coverage see www breathetechnologies com All other products or services mentioned in this manual are identified by the trademark or service marks of their respective companies or organizations Breathe Technologies Inc disclaims any responsibility for specifying which marks are owned by which companies or organizations The Breathe Technologies Life2000 Ventilatio...

Page 156: ...ies CombO2 Life2000 and Universal Circuit are trademarks of Breathe Technologies Inc Breathe Technologies Inc 15091 Bake Pkwy Irvine CA 92618 USA Technical Support and Customer Service United States 1 877 698 1325 info breathetechnologies com www breathetechnologies com ...

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