Hillrom Breathe LIFE2000 Instructions For Use Manual Download Page 2

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CHAPTER 1: LIFE2000® VENTILATION SYSTEM INTRODUCTION ____________________________1

CHAPTER 2: STATIONARY CONFIGURATION __________________________________________ 11

CHAPTER 3: EXTENDED RANGE CONFIGURATION ____________________________________ 20

® Hose ____________________________________________________________________ 26

Connecting a Low-Flow Oxygen Source using the CombO2® Hose __________________________________27
Powering On Sequence in Extended Range Configuration _________________________________________28

CONTENTS

NOTICE OF EMERGENCY USE OF VENTILATORS DURING THE COVID-19 PANDEMIC

The FDA issued a guidance document on March 24, 2020, Enforcement Policy for Ventilators and Accessories

and Other Respiratory Devices During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency.

During this emergency and while the policy is in effect, FDA does not intend to object to limited modifications to

the FDA-cleared indications without prior submission of a 510(k) where the modifications do not create undue

risks. Hillrom

™

does not yet have FDA 510(k) clearance on the use of The Life2000

Ventilator Software version

06.08.00.00. Hillrom

™

intends to adhere to FDA’s recommendations to market The Life2000

Ventilator with

appropriate testing and labeling while the policy is in effect but does not have specific 510(k) clearance at this

time.

Summary of Contents for Breathe LIFE2000

Page 1: ...LIFE2000 VENTILATION SYSTEM Instructions for Use 0 100 Rx Only ...

Page 2: ...___________________________________________ 17 Silence Alarm Button on the Compressor______________________________________________________ 18 Powering Off Sequence in Stationary Configuration_______________________________________________ 19 CHAPTER 3 EXTENDED RANGE CONFIGURATION_____________________________________ 20 Introduction to Extended Range Configuration__________________________________...

Page 3: ...e Screen___________________________________________________________________________49 Moving Between the Home Screen and Menu Screen____________________________________________ 50 Menu Screen__________________________________________________________________________ 50 Touch Screen Energy Save Mode_________________ _______________________________________ ___ 51 Defining Clinical Settings___________...

Page 4: ...sting Ventilator Alarms_________________________________________________________ ____________115 Testing Alarm Conditions______________________________________________________________________116 CHAPTER 9 BATTERY INFORMATION_________________________________________________ 122 Checking the Ventilator Battery Charge__________________________________________________________ 125 Ventilator Battery Ch...

Page 5: ...l ether and ethylene as they may form flammable or explosive mixtures with oxygen Do not use the ventilator with helium or helium mixtures Do not use the ventilator with nitric oxide Do not use the ventilator in a hyperbaric chamber Do not eat drink or chew gum while using the ventilation system Food or liquids that make contact with the ventilation system may cause components in the system to mal...

Page 6: ...ub assemblies to the ventilator breathing system can cause an increase in expiratory resistance at the patient connection Adding humidification or nebulization can increase the resistance of the breathing circuit The operator of the ventilation system needs to monitor the breathing system for increased resistance and blockage Ventilator accuracy can be affected by the gas added by use of a nebuliz...

Page 7: ...h Alternative to belt clip for securing the ventilator when using in wearable configurations FEATURES The Life2000 Ventilation System is a critical care volume control mechanical ventilation system designed for a broad range of applications in critical care and home settings The modular Life2000 Ventilation System system is composed of the Life2000 Ventilator ventilator and the Life2000 Compressor...

Page 8: ...ensure proper use of your system IDENTIFYING THE REF NUMBER The REF number is located on the label on the back of the ventilator see examples below Ventilator REF MS 01 0100 released prior to Sept 16 2019 Ventilator REF MS 01 0118 released after Sept 16 2019 SYSTEM COMPONENTS VENTILATOR TOP Battery charger connection Silence Alarm button Communication Port FRONT Touch screen Activity buttons High ...

Page 9: ...tilation system in this configuration see Chapter 3 Extended Range Configuration on page 20 STAND ALONE WEARABLE CONFIGURATION The ventilator is connected to an alternate pressure source such as a hospital wall source or an air or oxygen cylinder For more information about how to setup the ventilator in this configuration see Chapter 4 Stand Alone Configuration on page 34 18 11 12 13 15 14 16 17 C...

Page 10: ... cover the ventilator touch screen speaker or backup alarm buzzer with tape or any other object Covering the ventilator or any of its parts might cause difficulty in hearing alarms and might affect ventilator performance When the ventilator is in use keep it in a well ventilated area to prevent it from overheating The ventilator may overheat and be permanently damaged if it is used in an area that...

Page 11: ...ly connection on the back of the compressor until it clicks into place the lock tab on the cord will be on the top Connect the AC power cord to the compressor s external power supply and cord Connect the pronged end of the compressor s AC power cord to an AC power source Verify that the green LED indicator on the external power supply lights up to indicate the AC connection NOTES To remove the pow...

Page 12: ...ator in the compressor When the compressor is on check that the locked icon lights up green to indicate the ventilator is properly docked When the ventilator is properly docked and locked the ventilator is being charged by the compressor NOTES If the compressor is off and connected to an AC power source press the battery charge status button on the compressor to illuminate the green locked icon an...

Page 13: ...larm will sound again after 60 seconds After resolving a High Temperature High Circuit Pressure or High PEEP Pressure high priority alarm touch OK in the message that indicates the alarm has been resolved 1 500 ml High Circuit Peak Pressure has been resolved 10 11a Fri Jun 12 2015 3 Values displayed on the screen are for illustrative purposes only CHECKING THE COMPRESSOR S INTERNAL BATTERY STATUS ...

Page 14: ... an Interface on page 44 Power on the compressor Power on the ventilator Check the compressor s battery charge status Check the ventilator s battery charge and charge the ventilator if necessary Secure the ventilator using the belt clip or pole mount NOTE Ventilation will not begin until an Activity button is pressed on the ventilator For more information see Choosing an Activity Button Patient Se...

Page 15: ...e compressor make sure to use the handle keep the compressor in an upright position and protect it from falling or dropping NOTES The compressor outputs an audible sound and must be at least 3 feet 1 m away from the user during use When operating in a 40 C 104 F environment the gas output by the ventilation system may reach temperatures up to 48 C 118 4 F To reduce patient discomfort operate the v...

Page 16: ...ecommended when using a ventilator output volume greater than 350 ml Ensure the ventilator is powered off NOTE Alarms might be encountered and or the selected Activity Button might be inadvertently changed if the ventilator is not powered off The compressor may be powered off or powered on Undock the ventilator from the compressor for more information see Undocking the Ventilator from the Compress...

Page 17: ...flow oxygen from an oxygen concentrator or other low flow oxygen source WARNING The interface source gas supply hose and power cords should be positioned to avoid restricting movement causing a tripping hazard or posing a strangulation risk CAUTION Use only an approved source gas supply hose with the ventilation system If an unauthorized source gas supply hose is used with the ventilation system t...

Page 18: ...ange Configuration on page 28 NOTES 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 67 4 5 POWERING ON SEQUENCE IN EXTENDED RANGE CONFIGURATION 0 100 1 2 3 4 Power on the compressor by pressing the power button for the compressor When powered on lights surrounding ...

Page 19: ...se and power cords should be positioned to avoid restricting movement causing a tripping hazard or posing a strangulation risk CAUTION Do not place the battery charger on wet surfaces or use in wet environments Wet environments may damage the battery charger and may cause electric shock Use only the approved battery charger and cord set with the ventilator If an unauthorized battery charger or cor...

Page 20: ...ot resolved the alarm will sound again after 60 seconds After resolving a High Temperature High Circuit Pressure or High PEEP Pressure high priority alarm touch OK in the message that indicates the alarm has been resolved 1 500 ml High Circuit Peak Pressure has been resolved 10 11a Fri Jun 12 2015 3 Values displayed on the screen are for illustrative purposes only SECURING THE VENTILATOR BELT CLIP...

Page 21: ...the oxygen just before powering on the ventilator Connect an interface to the ventilator NOTE For information about the interface on the patient side see Chapter 5 Connecting an Interface on page 44 Turn on the oxygen and estimate cylinder duration see Appendix Cylinder Duration Information Power on the ventilator Check the ventilator s battery charge and charge the ventilator if necessary Secure ...

Page 22: ...on risk CAUTION Follow local regulations and NFPA 55 in the handling and use of oxygen cylinders TIPS If using a cylinder make sure your oxygen supply is sufficient for your length of use For more information about estimating oxygen usage see Cylinder Duration Information on page 148 If not connected to AC power make sure the ventilator battery has sufficient charge for your length of use Refer to...

Page 23: ...ding to the regulator and oxygen cylinder manufacturers instructions NOTE When not in use turn off the oxygen supply according to the regulator and oxygen supply manufacturers instructions NOTE For information about estimating the duration of oxygen cylinders and for cylinder replacement instructions see Cylinder Duration Information on page 148 Oxygen regulator Oxygen cylinder medical grade Oxyge...

Page 24: ...ay become loose over time WARNING The interface source gas supply hose and power cords should be positioned to avoid restricting movement causing a tripping hazard or posing a strangulation risk CAUTION Do not place the battery charger on wet surfaces or use in wet environments Wet environments may damage the battery charger and may cause electric shock Use only the approved battery charger and co...

Page 25: ...ation see Chapter 7 Alarms Alerts and Troubleshooting Silence Alarm button on ventilator Press the Silence Alarm button to temporarily silence the alarm for 60 seconds Pressing the Silence Alarm button silences only one alarm at a time in audible or vibrating alarm mode If more than one alarm occurs press the Silence Alarm button once for each alarm If the alarm is a medium or high priority alarm ...

Page 26: ...CTOR The Universal Circuit Connector is used to connect any commercially available non invasive mask full face nasal or pillows or tracheostomy tube to a Life2000 ventilator or compressor The Universal Circuit Connector is only compatible with Life2000 ventilators and compressors NOTE The interface assembly is packaged clean but not sterile The Universal Circuit Connector does not need to be clean...

Page 27: ...ONNECTIONS The Universal Circuit Connector with a full face mask The Universal Circuit Connector with an endotracheal tube The Universal Circuit Connector with a tracheal tube CONNECTING THE UNIVERSAL CIRCUIT CONNECTOR TO THE OXYGEN ADAPTER AND PATIENT MASK OR TUBE CAUTION A 90 day replacement schedule for the Universal Circuit Connector and interface accessories is recommended Do not use a Univer...

Page 28: ...e Breathe Pillows Entrainment Interface is designed for single patient use To prevent risk of cross contamination use a new Breathe Pillows Entrainment Interface for each new patient Place the interface in front of the patient with the curve of the Interface towards the patient s face and the entrainment ports facing up entrainment ports facing up Loop the interface tubing over the ears and positi...

Page 29: ...e click indicates the feature you touch is activated HOME SCREEN When the ventilator is powered on it completes a self test and then displays the Home Screen This screen indicates that the ventilator is ready for use When an Activity Button is selected on the ventilator the Home Screen will display the breath rate Breath min or BPM Peak Inspiratory Pressure PIP cmH2 O and gas flow rate Air LPM or ...

Page 30: ...e password must be re entered to access the Clinician s Settings menu DEFINING CLINICAL SETTINGS NOTE For facilities where trained healthcare professionals are the intended users the password to access clinical settings may be enabled or disabled For more information contact customer service ACCESSING THE SETTINGS MENU On any screen touch the Wrench button On the Menu screen touch Settings ACCESSI...

Page 31: ...es underneath the corresponding Activity Icon on the Prescription Settings screen Prescription Settings 10 11a Fri Jun 12 2015 Low Activity Medium Activity High Activity EDITING PRESCRIPTION SETTINGS Select the button on the Prescription Settings screen representing the prescription you want to edit NOTES The button on the Prescription Settings screen does not need to be checked to edit the prescr...

Page 32: ... parameters accordingly VENTILATION MODES SET TRIGGER SENSITIVITY TO SET BREATH RATE TO Control OFF 1 Assist Control 0 to 9 1 Assist 0 to 9 0 SETTINGS BASED ON PRESCRIPTION FACTORY DEFAULT PRESCRIPTION SETTINGS The following table lists the Life2000 factory default Prescription Settings that may be edited For a full list of factory defaults see the Summary of Factory Default Settings on page 77 DE...

Page 33: ...ttings Touch OK and then re evaluate and readjust the Volume PEEP or I Time setting in the Ventilation Settings screen For more information see Incompatible Settings Message on page 68 10 11a Fri Jun 12 2015 Clinician s Settings Ventilation Settings Alarm Limits Breath Timeout Source Gas 1 10 11a Fri Jun 12 2015 Ventilation Settings 10 11a Fri Jun 12 2015 ml FLIP CANCEL OK Volume 500 I Time PEEP B...

Page 34: ...ntilation Settings screen For more information see Incompatible Settings Message on page 68 10 11a Fri Jun 12 2015 Clinician s Settings Ventilation Settings Alarm Limits Breath Timeout Source Gas 1 10 11a Fri Jun 12 2015 Ventilation Settings 10 11a Fri Jun 12 2015 ml FLIP CANCEL OK Volume 500 I Time PEEP BR sec cmH2O min 1 00 4 20 0 9 OFF Sensitivity 4 3 3 2 4 10 11a Fri Jun 12 2015 10 11a Fri Jun...

Page 35: ...creen For more information see Incompatible Settings Message on page 68 10 11a Fri Jun 12 2015 Clinician s Settings Ventilation Settings Alarm Limits Breath Timeout Source Gas 1 10 11a Fri Jun 12 2015 Ventilation Settings 10 11a Fri Jun 12 2015 ml FLIP CANCEL OK Volume 500 I Time PEEP BR sec cmH2O min 1 00 4 0 0 9 OFF Sensitivity 4 3 3 2 4 10 11a Fri Jun 12 2015 10 11a Fri Jun 12 2015 1 FLIP OK CA...

Page 36: ...vered volume will include ventilator set volume entrained air and supplemental oxygen if applicable and therefore will be higher than the ventilator set volume For more information see Potential Tidal Volumes on page 150 NOTE Volume levels are not adjusted for altitude For more information see the Accessories and Replacement Parts on page 147 I Time Inspiratory Time The time over which the selecte...

Page 37: ...nician s Setting screen touch Breath Timeout On the Breath Timeout screen touch the Timeout Period or Timeout Action box you want to change TIP The Breath Timeout screen has two options for setting the Breath Timeout alarm You can set the time to trigger the alarm at 20 or 60 seconds and the backup ventilation mode to 3 LPM continuous flow or 12 BPM at the current volume setting Touch the Up arrow...

Page 38: ...layed on the screen are for illustrative purposes only Source gas is oxygen Stand Alone Configuration with an oxygen cylinder or a wall oxygen pressure source Source gas is air Stationary Configuration Extended Range Configuration O2 CHOOSING AN ACTIVITY BUTTON PATIENT SELECTABLE TO BEGIN VENTILATION When the ventilator is first powered on you must select an Activity Button to begin ventilation Th...

Page 39: ...nd 9 is the least sensitive setting An Activity Button must already be selected the ventilator must be currently ventilating to allow changes to the Trigger Sensitivity settings through the patient accessible Settings menu NOTE Trigger Sensitivity cannot be adjusted by patients when the currently ventilating Activity Button represents a prescription in Control Mode Sensitivity is OFF ACCESSING THE...

Page 40: ...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 purposes only Values displayed on the screen are for illustrative purposes only ACCESSING THE UTILITIES MENU With the Utilities menu you can change the time and date brightness of the touch screen volume of audible alarms and ...

Page 41: ...0 11a Fri Jun 12 2015 3 4 10 11a Fri Jun 12 2015 Values displayed on the screen are for illustrative purposes only SETTING VIBRATION MODE The Set Vibration screen lets you change alarm notifications from audible tones to a vibration However if a low or medium priority vibrating alarm occurs and is not resolved in 60 seconds an audible alarm occurs For a high priority alarm an audible tone immediat...

Page 42: ...ime These screen values are accurate to within two minutes 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 10 11a Fri Jun 12 2015 Information Life2000 Ventilator Software Version BT V5 XX XX XX XX Serial Number XXXXXXXX XXX CRC XXXXXXXX Operating Time 13 hrs 48 min High Activity Time 0 hrs 36 min Medium Activity Time 2 hrs 11 min Low Activity Time...

Page 43: ...RTS The compressor has audible alerts that are independent of the ventilator Compressor alerts must be resolved for the compressor alert notifications to be silenced as there is no button to silence alerts originating from the compressor SUMMARY OF FACTORY DEFAULT SETTINGS The following table lists the factory default settings for the ventilator CLINICIAN S MENU SETTINGS DEFAULT VALUE LOW ACTIVITY...

Page 44: ...reen are for illustrative purposes only VENTILATOR ON SCREEN ALARM SOUNDS AND MESSAGE DISPLAY When an alarm notification occurs there is a distinct sound and a display message corresponding to the priority level of the alarm The priority level of an alarm is indicated by the color and the rate at which the message flashes ACTIVE ALARMS WINDOW Multiple on screen alarms may occur at the same time To...

Page 45: ...ctive prescription High Temperature 10 11a Fri Jun 12 2015 15 Breath min Air LPM PIP cmH2 O 20 7 5 High Temperature Ventilator CPU or battery temperature is above the allowable limit Check to make sure the ventilator is Not near a heat source In a well ventilated area Not covered or enclosed Operating within the given operating environmental specifications see page 103 If the alarm persists contac...

Page 46: ...vided 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 If the alarm is not resolved place the patient on an alternate mea...

Page 47: ...played on the screens are for illustrative purposes only HIGH PRIORITY ALARMS CONTINUED NOTIFICATION CAUSE CHECKS AND POSSIBLE RESOLUTION IN EACH CONFIGURATION STAND ALONE CONFIGURATION EXTENDED RANGE CONFIGURATION STATIONARY CONFIGURATION Very Low Battery 10 11a Fri Jun 12 2015 12 Breath min Air LPM PIP cmH2 O 3 9 1 1 Very Low Battery Ventilator battery capacity drops below 15 Connect the ventila...

Page 48: ...ensitivity is set too low in Assist or Assist Control ventilation mode Verify the ventilator is syncing with patient effort and adjust trigger sensitivity higher lower sensitivity Patient is breathing faster than the rate set by the clinician Inspect and clean the interface per the instructions for cleaning the interface The ventilator may be false triggering because the trigger sensitivity is set...

Page 49: ...n Stand Alone Configuration Contact your service representative The Low Gas Pressure alarm may temporarily sound when switching from an Activity Button with a lower volume to one with a higher volume the alarm should resolve itself within 60 seconds Ventilation is still provided while the ventilator is alarming The Low Gas Pressure alarm may temporarily sound when switching from an Activity Button...

Page 50: ...ontact your service representative Power off the ventilator and power it on again If the system fault persists place the patient on an alternate means of ventilation if necessary and contact your service representative Power off the ventilator and power it on again If the system fault persists place the patient on an alternate means of ventilation if necessary and contact your service representati...

Page 51: ...tient on an alternate means of ventilation if necessary and contact your service representative Constant Audible Alert Compressor stops operating Multiple causes high motor temperature high electronics temperature electronic circuit error or motor stall N A Discontinue use of the compressor Place the patient on an alternate means of ventilation if necessary or connect the ventilator to an alternat...

Page 52: ...an the interface per the instructions for cleaning the interface Inspect and clean the interface per the instructions for cleaning the interface 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 It is normal for the ventilator to limit breath rate to 40 BPM It is nor...

Page 53: ... interface Inspect and clean the interface per the instructions for cleaning 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 Verify that the interface is properly connected to the ventilator not the compr...

Page 54: ...vice representative 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 service representative Connect the compressor to an AC power source If the issue is not resolved contact your service representative The source gas supply hos...

Page 55: ...incompatible to maintain clinical settings Touch OK and then re evaluate and readjust the Volume PEEP or I Time setting in the Ventilation Settings screen Touch OK and then re evaluate and readjust the Volume PEEP or I Time setting in the Ventilation Settings screen Touch OK and then re evaluate and readjust the Volume PEEP or I Time setting in the Ventilation Settings screen This Prescription Set...

Page 56: ...lation system from ingress of dust lint and pests Do not leave exposed to the sun or other sources of radiant heat it may overheat Do not allow children or pets to access the ventilation system it may become damaged CLEANING BEFORE FIRST USE It is not necessary to clean or sterilize the Life2000 Ventilation System before the first use DAILY CHECKS Look at the ventilation system components daily If...

Page 57: ...condensation tray and replace if necessary For more information see Checking and Replacing the Condensation Tray on page 112 Every three to six months or more often if necessary check the compressor s air inlet filter and replace if necessary For more information see Checking and Replacing the Air Inlet Filter on page 113 Every three to six months or more often if necessary check the compressor s ...

Page 58: ...uctions If mucous accumulates on the patient interface use a clean cloth to remove it If dirt is visible on the outside of the interface use a clean cloth and mild detergent such as dishwashing soap to remove it WARNING Do not subject Breathe interfaces to heat sterilization hot water pasteurization autoclaving radiation sterilization ethylene oxide gas sterilization or attempt to clean them in a ...

Page 59: ... Firmly press and hold the smaller end of the purge tube over one of the interface ports that connect 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 all the water is purged from the tube Repeat step 5 for the other interface port Firmly press the smaller end of the purge tube over the oxygen tubing ...

Page 60: ...eds to be checked and emptied will depend on the amount of humidity in the ambient air The more humidity that is in the air the more frequently the condensation tray will need to be checked emptied and replaced NOTE The compressor is shipped with a condensation tray already installed Place the patient on an alternate means of ventilation If operating in Stationary or Extended Range Configuration p...

Page 61: ...CHECKING AND REPLACING THE COOLING FILTER ASSEMBLY The cooling filter is used to filter air that enters the compressor to cool it during operation The cooling filter assembly including the cooling filter and cooling filter cover needs to be changed every three to six months or as needed NOTE The compressor is shipped with a cooling filter assembly already installed Place the patient on an alternat...

Page 62: ...ng alarm notifications occur and are correct The visual alarm appears on the touch screen and The audio alarm is audible or the ventilator vibrates if in vibration mode NOTE Other alarms and or multiple alarms may occur during the testing procedure If a different alarm occurs from the one you re testing for use the Active Alarms button on the touch screen to display the alarm list The alarm you ar...

Page 63: ... the source gas supply hose from the ventilator connection by pulling back on the knurled ring until the hose detaches The top of the touch screen should display the Low Gas Pressure 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 ...

Page 64: ...tilating using the Low Activity button Allow the ventilator to ventilate for a few breaths using the current settings Using the Clinician s Settings Menu navigate to the Low Activity Prescription Setting Alarm Limits and change the High PIP alarm limit to 10 cmH2O Select OK and CONFIRM If testing with the Universal Circuit Connector completely plug the large opening on the patient side of the inte...

Page 65: ...o 12 min Select OK and CONFIRM The Breath Timeout alarm will resolve itself once the setting is changed Ventilation Settings 10 11a Fri Jun 12 2015 ml FLIP CANCEL OK Volume 300 I Time PEEP BR sec cmH2O min 0 75 0 0 0 9 OFF Sensitivity 4 10 11a Fri Jun 12 2015 Breath min O2 LPM PIP cmH2 O 1 4 3 0 Breath Timeout 10 11a Fri Jun 12 2015 High Crct Pressure Breath min O2 LPM PIP cmH2 O 1 4 Ventilation S...

Page 66: ...he Battery Low Alarm occurs 25 battery charge The top of the touch screen should display the Battery Low 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...

Page 67: ...geable not user replaceable Ampere hour rating 1800 mAh Maximum current 450 mA Operating Voltage 7 4 V internal Duration Approximately 5 6 hours Ventilator If the battery performance degrades to unacceptable levels contact your service representative Approx Time Remaining based on the following ventilator settings BR 12 Volume 350 PEEP 0 I Time 1 0 TIPS For Ventilator REF MS 01 0118 a fully charge...

Page 68: ...n are illuminated in green TIP When the compressor s internal battery is charging the blinking indicator light shows the current level of charge BATTERY CHARGE SCALE 0 100 0 100 0 100 0 100 0 100 0 100 APPROX CHARGE AMOUNT 0 20 21 50 51 70 71 90 91 99 100 VENTILATOR BATTERY CHARGER AND POWER CORD SPECIFICATIONS VENTILATOR BATTERY CHARGER SPECIFICATIONS CATEGORY SPECIFICATION Input AC voltage 100 2...

Page 69: ...ing table shows the typical calculated volume output for several volume settings at different altitudes Check the performance of the ventilator for adequate therapy delivery in the environment s in which it will be used and adjust the volume to compensate for altitude when necessary CAUTION The actual volume output by the ventilator could be different from the calculated values shown VOLUME SETTIN...

Page 70: ...ting and terminating inspiratory phases Control ventilation mode The inspiratory phase is started and terminated by the ventilator based on set inspiratory time and respiratory rate Assist Control ventilation mode The inspiratory phase is started based on the patient s breath triggering or by the ventilator based on set inspiratory time and terminated by the set inspiratory time Assist ventilation...

Page 71: ...IP exceeds the set limit High Temperature Ventilator CPU or battery temperature is above the allowable limit Very Low Battery Ventilator battery capacity drops below 15 Battery Low Ventilator battery capacity drops below 25 Breath Timeout No breath is detected for 20 seconds or 60 seconds depending on the setting High Breath Rate Respiratory rate exceeds the set limit High Delivery Pressure Interf...

Page 72: ...Environment Operating Temperature 5 C to 40 C 41 F to 104 F Operating Humidity 10 to 95 non condensing Operating Altitude 1100 hPa to 624 hPa or 2290 ft to 8000 ft 700 m to 2439 m NOTES The performance of the compressor may degrade in high temperature high humidity or high altitude environments If degradation is seen switch to an alternate means of ventilation The ventilator settings might not be ...

Page 73: ...ent air enters through an inlet filter on the compressor The compressor pressurizes the air and then delivers it to the ventilator In the ventilator the air flows through the safety valve and then to the flow valve which controls all inspiratory air 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...

Page 74: ...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 GUIDANCE AND MANUFACTURER S DECLARATION ELECTROMAGNETIC IMMUNITY The Life2000 Ventilation System is intended for use in the electromagnetic environment specified below The customer or u...

Page 75: ... At 80 MHz and 800 MHz the higher frequency range applies Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TB broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters and electromagnetic site survey should be ...

Page 76: ...le mount label source gas supply hose label and interface labels Indicates that the product is not sterile ICON WHERE USED MEANING Ventilator touch screen Displayed on touch screen if ventilator battery status is unknown or charge is critically low 5 Ventilator touch screen Displayed on touch screen if ventilator battery has approximately 5 14 of its charge remaining Ventilator touch screen Displa...

Page 77: ...atest DOE Efficiency Level VI requirements for average efficiency and standby power ICON WHERE USED MEANING Compressor external power supply Indicates compliance with RoHS Compressor Indicates the unlocking knob is in the unlocked position Compressor When lit indicates the locking knob is in the locked position Compressor Battery Charge Status button Compressor Power on off button Ventilator Power...

Page 78: ...he volume of the cylinder and the breathing pattern of each patient which can change throughout the day Observe your daily oxygen consumption a few times before estimating typical use The following tables can be used to obtain approximate values only NOTE These tables use a PEEP value of 0 cmH2O CYLINDER SIZE B 164 LITERS M6 BREATHS PER MINUTE BPM 12 14 16 18 20 22 24 26 28 Volume ml Duration in h...

Page 79: ...m the used cylinder by turning the handle counterclockwise Slide the regulator over the neck of the new cylinder and line up the pins on the regulator with the holes in the cylinder neck Tighten the tee screw on the regulator by turning the handle clockwise The source gas supply hose should still be connected to the regulator Turn on the oxygen supply according to the regulator and gas supply manu...

Page 80: ...SURE SOURCE entrained with supplemental oxygen in the volumes LPM shown based on 0 9 sec iTime BREATHE PILLOWS ENTRAINMENT INTERFACE USING OXYGEN AS THE PRESSURE SOURCE BREATHE PILLOWS ENTRAINMENT INTERFACE USING AIR AS THE PRESSURE SOURCE entrained with supplemental oxygen in the volumes LPM shown based on 0 9 sec iTime based on 0 9 sec iTime APPENDIX FiO2 TABLES ...

Page 81: ...roduct or its associated accessories except to refer to this limited warranty The exclusive remedy with respect to any losses or damages resulting from any cause whatsoever shall be as specified above Breathe Technologies Inc shall not be liable for any consequential or incidental damages of any kind including but not limited to exemplary damages special punitive commercial loss from any cause bus...

Page 82: ...ty Road F St Paul MN 55126 Technical Support Customer Service 800 426 4224 PL 20 0028 Rev F 2020 Breathe Breathe Technologies CombO2 Life2000 and Universal Circuit are trademarks of Breathe Technologies Inc a Hillrom Company ...

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