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APPENDIX A

OPRHT50NA B0908

A-5

HT50 Ventilator Quick Check

Pass / Fail Check-Off Sheet

Preparation for Use Tests

Indicate result for each test

Pre-Test Inspection Check

Pass _____ Fail ______

Power Switchover Alarm Check

Pass _____ Fail ______

Alarm & Indicators Check

Pass _____ Fail ______

High

▲

Paw Alarm

Pass _____ Fail ______

Low

▼

Paw Alarm

Pass _____ Fail ______

Humidifier Alarm (HT50-H,HT50-HB only)

Pass _____ Fail ______

Paw Monitor / Pressure Meter Check

Pass _____ Fail ______

Volume/Frequency Monitor Check

Pass _____ Fail ______

Internal Battery Check

Pass _____ Fail ______

The ventilator is ready for operation when all tests have been completed

successfully.

Note any comments on inspection of unit, corrective action taken, or recommendations for

further action.

Completed by:

Date:

Facility:

Serial #:

Unit hours:

Содержание Newport HT50

Страница 1: ...NA Rev B September 2008 Exclusively Distributed by Newport Medical Instruments Inc 1620 Sunflower Ave Costa Mesa CA 92626 USA Tel 800 451 3111 US only 714 427 5811 Fax 714 427 0489 Customer Service ext 282 Technical Service ext 500 www NewportNMI com email Customers NewportNMI com ...

Страница 2: ...ES EFFECTED September 2007 A New release for dual internal battery updates from OPRHT50B rev D 2 2 2 3 2 4 2 5 2 6 3 12 3 13 6 8 7 2 7 3 7 7 A 7 September 2008 B Updated to include additional dual internal battery data update intended use statement refine cleaning and sterilization section ...

Страница 3: ...xygen Entrainment Mixer Specifications Oxygen Blending Bag Kit Specifications Section 3 DESCRIPTION OF CONTROLS INDICATORS ALARMS CONNECTORS Front Panel Overview Front Panel Controls Indicators Front Panel Alarms Front Panel Message Display Window Left Side Connectors Right Side Connectors Optional Accessories User Set Up Section 4 THEORY OF OPERATION General System Overview A CMV Mode Assist Cont...

Страница 4: ...ional Accessory Section 6 CLEANING MAINTENANCE Cleaning Disinfecting Maintenance General Warnings Section 7 TROUBLESHOOTING Introduction Table 7 1 Alarms Table 7 2 Built in Humidifier Table 7 3 General Clinical Table 7 4 Setting Limitation Messages Appendix A QUICK CHECK PROCEDURE Introduction Set Up Standard Test Settings Quick Check Procedure Pass Fail Check Off Sheet Abbreviated Check Procedure...

Страница 5: ...S RESPONSIBILITY Operator s Responsibility for Patient Safety 1 1 Limitation of Liability 1 2 Warranty 1 2 Definitions 1 3 Typing Conventions 1 3 Warnings and Cautions 1 3 Factory Maintenance or Repair 1 7 Contact Information 1 7 ...

Страница 6: ...regiver has received training and has demonstrated competency in all equipment functions A specific written care plan must be established by the attending physician Transport of patients with the HT50 requires that medical staff have a good working knowledge of the ventilator s use and problem resolution Proper emergency back up equipment must be immediately available during transport HT50 operato...

Страница 7: ...ries from NEWPORT due to such situations WARRANTY The Newport HT50 Ventilator is guaranteed to be free of defects for a period of two 2 years from date of delivery The following are exceptions to this warranty 1 Defects caused by misuse mishandling tampering or by modifications not authorized by Newport Medical Instruments Inc NEWPORT or its representatives 2 Rubber and plastic components and mate...

Страница 8: ...ion of actual condition Service Measures required to maintain a specified condition Repair Measures required to restore a specified condition Maintenance Required inspection service and repair of the device Preventive Maintenance Maintenance performed at regular intervals to keep the device in good working condition TYPING CONVENTIONS Within the text of this manual controls alarms and indicators a...

Страница 9: ...her humidification device should be used until the unit is connected to A C power at which time the built in humidifier can be used Do not use electrically conductive patient circuits Always use a clean patient circuit Always use an inline filter p n HT6004701 or equivalent at the Airway Pressure Connector to protect the internal transducers from moisture or other contaminants Always use appropria...

Страница 10: ...r sources contact Newport Medical Instruments Inc When the HT50 is used for transport applications ensure that the internal battery system is fully charged prior to use When the Battery Empty audible alarm sounds continuously only a limited time of internal battery power remains and an alternate power source should be found immediately Frequent deep discharge of the internal battery system will de...

Страница 11: ... These limits are designed to provide reasonable protection against harmful interference in a typical medical installation The equipment generates uses and can radiate radio frequency energy and if not installed and used in accordance with these instructions may cause harmful interference to other devices in the vicinity However there is no guarantee that interference will not occur in a particula...

Страница 12: ... Manual and Theory of Operation Section 4 of this manual before using the ventilator NOTE Use the tools and equipment specified in this manual to perform specific procedures Batteries contain materials that can harm the environment Do not discard them in an incinerator or force them open Batteries cannot be disposed of with normal waste Factory Maintenance or Repair Scheduled maintenance or repair...

Страница 13: ...Service 282 Technical Service 500 24 hour pager activated after Technical Service department hours Clinical Support 123 24 hour pager Corporate Office Monday through Friday 8 00 am to 5 00 pm hours USA Pacific Time Technical Service Monday through Friday 7 00 am to 4 00 pm hours USA Pacific Time HT50s distributed internationally have CE authorization HT50 H HT50 H1 and are represented by Obelis s ...

Страница 14: ... Use 2 1 Symbols Labeling Table 2 1 Controls Alarms Monitors 2 2 Hardware Requirements 2 5 Miscellaneous Specifications 2 5 Humidifier Specifications 2 7 Air Oxygen Entrainment Mixer Specifications 2 7 Oxygen Blending Bag Kit Specification 2 8 ...

Страница 15: ...t control SIMV and SPONT modes of ventilation The HT50 is suitable for use in hospital sub acute emergency room home care environments as well as for transport and emergency response applications Front panel controls allow trained operators to select between a number of operational modes pressure support and volume or pressure control A comprehensive alarm system is built in to alert the user to v...

Страница 16: ...ar Pressure Safety Valve 12 Manual Inflation 3 sec maximum While button is pushed the ventilator closes the exhalation valve and delivers a operator controlled breath to the patient 13 Humidifier Optional 19ºC to 39ºC 14 Airway Pressure Meter 10 to 100 cmH2O 10 to 98 mbar 15 Alarm Silence Reset Button Pressing button silences an audible alarm violation for 60 Indicator seconds and resets a latched...

Страница 17: ...ing V I Insp Min Volume 1 1 to 50 0 L min V I Insp Min Volume 0 1 to 49 0 L min Check Prox Line Prox Paw does not match machine Paw during inspiration Humidifier 5 messages Humidifier malfunction disconnection Power Switchover External power to internal battery switchover alert Battery Low Minimum of 30 minutes battery time remains until shutdown Battery Empty Minimum of 15 minutes battery time re...

Страница 18: ...I High Insp Min Volume Red LED indicates high inspiratory minute volume alarm limit is violated V I Low Insp Min Volume Red LED indicates low inspiratory minute volume alarm limit Back Up Vent is violated Misc Indicators Silence Reset Yellow LED indicates that the audible alarm is silenced for 60 seconds Auto Lock On Green LED indicates that the panel is currently locked On Standby Green LED indic...

Страница 19: ...internal battery should be replaced 27 RS 232C Interface Remote 8 pin SEMCONN connector Operates at 19 200 baud Allows Alarm Output put for interfacing with central alarms systems 28 Pneumatics Gas delivery system requires no external air compressor Miscellaneous Description 29 Operating Temperature 18ºC to 50ºC NOTE For proper operation at low range temperatures 18 C the HT50 must be started in a...

Страница 20: ...pecifications for Ventilators Intended for Critical Care Use ASTM F 1246 91 1991 Standard Specifications for Electrically Powered Home Care Ventilators Part 1 Positive Pressure Ventilators and Ventilator Circuits DO 160D Environmental Conditions and Test Procedures for Airborne Equipment 34 Storage Temperature 40ºC to 65ºC 35 Storage Humidity 0 to 95 non condensing 36 Height includes handle 10 inc...

Страница 21: ...as not been tested and approved by Newport Medical for use with the HT50 HT50 H HT50 HB Humidifier Specifications operates on A C power only Set Target Temperature Range 19ºC to 39ºC Operating Water Volume 300 mL Usable Volume of Water Bottle 265 mL Compliance at Minimum Water Level Refill Line 0 5 mL cmH2O mbar 23ºC Compliance at Maximum Water Level Full Line 0 33 mL cmH2O mbar 23ºC Intended Use ...

Страница 22: ... is required for patient safety The HT50 does not have a built in alarm system to notify user of a failure or disconnect of the oxygen source optional Oxygen Blending Bag Kit Specifications Pneumatic Requirements Oxygen 0 10 L min calibrated Air Atmospheric pressure FIO2 Control FIO2 indirectly adjusted from 0 21 up to 1 00 via oxygen flow L min WARNING Continuous oxygen monitoring is required for...

Страница 23: ...ATORS ALARMS CONNECTORS Front Panel Overview 3 1 Front Panel Controls and Indicators 3 5 Front Panel Alarms 3 14 Front Panel Message Display Window 3 23 Left Side Connectors 3 24 Right Side Connectors 3 25 Optional Accessories 3 26 User Set Up 3 27 ...

Страница 24: ...ifferently in Setting and On conditions Setting Condition Press the A CMV SIMV or SPONT button The LED on the selected Mode will light green to confirm the selection On Condition Press the A CMV SIMV or SPONT button The LED on the selected Mode will blink green and the Message Display Window will read PRESS AGAIN Press the button again within 5 seconds to confirm the mode change or the previously ...

Страница 25: ...he parameter by pressing the labeled button i e ƒ P trig etc The parameter s numeric display will blink Adjust the numeric value with the Up Down buttons Accept the value by either pressing the selected button again or by pressing another button to select a new parameter for adjustment or by waiting 5 seconds without making a change Enabling Disabling Auto Panel Lock Auto Panel Lock can be enabled...

Страница 26: ...SECTION 3 OPRHT50NA B0908 3 3 Figure 3 1 HT50 Ventilator Front Panel model HT50 H1 HT50 H1B ...

Страница 27: ...DESCRIPTION OF CONTROLS INDICATORS ALARMS CONNECTIONS 3 4 OPRHT50NA B0908 Figure 3 2 Newport HT50 H HT50 HB with built in humidifier ...

Страница 28: ...o second delay in going from Standby to Setting condition During this time the HT50 performs a self test and will light all displays on the front panel During Setting condition all adjustable LEDs are lit This allows the operator to preset and adjust controls prior to ventilation The On Standby indicator is not lit The Message Display Window shows Press ON to Vent suggesting that the On Standby bu...

Страница 29: ... the set ƒ frequency of mandatory breaths NOTE If the Ptrig setting is not adjusted to a level that allows the patient s inspiratory effort to be detected A CMV mode performs as CMV control mode SIMV Synchronized Intermittent Mandatory Ventilation In SIMV the user may choose to pressure or volume control mandatory breaths In either case all mandatory breaths delivered to the patient whether time v...

Страница 30: ...or 2 the user selects a different parameter or 3 five seconds elapses Pressing a parameter button without pressing either the Up or Down control button within 5 seconds causes the parameter to retain its current value NOTE If in the On condition and switching between Volume Control and Pressure Control the value adjustment for the new breath type selected Volume or Pressure will be accepted as not...

Страница 31: ...selector button The user is alerted to tI settings which result in an inverse I E Ratio by an audible beep and an Inverse I E message in the Message Display Window Attempts to continue increasing the value after this alert are permitted up to an I E Ratio of 3 1 If the inspiratory time setting causes the flow rate to reach the maximum or minimum level of the flow specification adjustment of tI cea...

Страница 32: ...rol is first initiated or the setting is changed the first few breaths may cycle off early until slope rise is optimized If early cycling off continues re evaluate the breathing circuit configuration and lengthen the tubing as necessary Pressing this control button followed by pressing the Up Down controls allows the adjustment of the target airway pressure setting Target pressure is referenced to...

Страница 33: ... PEEP CPAP Range 0 to 30 cmH2O mbar The PEEP CPAP setting establishes airway pressure in the patient circuit during the exhalation phase It is also referred to as base or baseline pressure The set PEEP CPAP value is displayed in the adjacent window NOTE In Pressure Control ventilation PEEP CPAP cannot be set higher than 5 cmH2O mbar below the set Pressure Control setting NOTE The value of PEEP CPA...

Страница 34: ...this button displays the set target temperature in the adjacent window While the display is blinking use the Up Down controls to adjust the target temperature When temperature adjustment is complete and 1 five seconds have elapsed without touching the control 2 the Humidifier On button is pressed again or 3 another parameter is selected for adjustment the display stops blinking and the measured te...

Страница 35: ... 3 1 I E Ratio shares a numeric display window with V I E LED is illuminated green when I E Ratio is displayed I E Ratio is determined by the ƒ and tI settings If expiratory time is longer than inspiratory time the display format is 1 X X If expiratory time is shorter than tI the display format is X X 1 When the I E Ratio is inverse the I E Ratio indicator illuminates once every breath I E Ratio d...

Страница 36: ...t and Int Battery Test are locked preventing accidental changes Press and hold the Push to Unlock button for at least one second to unlock the panel and enable the activation of all touch buttons for adjustment An audible beep sounds and the LED is extinguished When 30 seconds have elapsed without pressing any buttons the Auto Lock is automatically activated again NOTE Auto Panel Lock is factory p...

Страница 37: ...gh Paw and Low Paw Alarm Control and Display airway pressure Range Paw 10 to 100 cmH2O 98 mbar High Paw Alarm 4 to 99 cmH2O 97 mbar Low Paw Alarm 3 to 98 cmH2O 96 mbar The Paw button allows the selection of the high peak airway pressure alarm setting The Paw button allows the selection of the low peak airway pressure alarm setting To adjust either alarm press the desired button once The value in t...

Страница 38: ...es not function in SPONT mode The Paw alarm limit does not apply to spontaneous breaths in SIMV mode High V I and Low V I Alarm Control and Display inspiratory minute volume Range V I 0 to 99 0 L min High V I Alarm 1 1 to 50 0 L min Low V I Alarm 0 1 to 49 0 L min This window displays the inspiratory minute volume in liters and is automatically updated every 10 seconds The V I window always displa...

Страница 39: ...V i BUV if back up ventilation is active The Low Insp Minute Volume Alarm is activated when delivered inspiratory minute volume falls below the Low V I alarm limit setting WARNING The Insp Minute Volume Alarms are based on the delivered volume from the ventilator The actual minute volume in the patient lungs may be significantly different in cases such as circuit leak disconnection and pneumothora...

Страница 40: ... until the condition is corrected The alarm resets when airway pressure falls to within 15 cmH2O mbar of baseline at which point breath delivery is resumed Occlusion Alarm Device automatic Audible Alarm Intermittent beep Visual Alarm Paw indicator blinks red at the high priority rate and Device Alert indicator blinks Message Window OCCLUSION An Occlusion alarm is activated when airway pressure is ...

Страница 41: ...s alarm is activated The alarm resets when airway pressure is 3 cmH2O mbar below baseline Check Prox Line Alarm automatic Audible Alarm Intermittent beep Visual Alarm Paw Apnea indicator blinks red Message Window CHECK PROX LINE The Check Prox Line Alarm is activated when during inspiration the pressure measurement of the proximal pressure sensing line is significantly different from the internal ...

Страница 42: ...T50 built in humidifier When an alarm condition is detected the humidifier heater shuts down There are five humidifier alarms Message Display Window Cause of Alarm Check Humidifier Bottle removed or not clamped properly when trying to activate the humidifier Temp Probe not connected or missing when trying to activate the humidifier Humidifier Fail Bottle removed while humidifier is On Failure of t...

Страница 43: ... a minimum of 15 minutes of operating power remains in the dual internal battery An alternate power source must be located immediately This alarm can only be temporarily silenced as long as the alarm condition continues The alarm is reset when A C or external D C power is connected to the HT50 NOTE The actual time remaining depends on the battery condition and the ventilator settings used NOTE Fre...

Страница 44: ...xternal power to the dual internal battery due to disconnection from the power cord or a power interruption Pressing the Silence Reset button will 1 cancel the audible alarm 2 cancel the No ext power message 3 cancel the Ext Power LED and 4 cause the Int Battery LED to change to non blinking yellow indicator If external power is connected within 60 seconds following internal battery operation the ...

Страница 45: ...present The format for the time is H MM SS The SYSTEM ERROR message will always be displayed with full text NOTE If the cause of the SYSTEM ERROR does not allow the HT50 to display the alarm message and the Device Alert indicator to light the ventilator will shut down and the Shut Down Alert Alarm will activate Upon the next power up of the unit the SYSTEM ERROR message will be displayed If the ca...

Страница 46: ... a 60 sec rolling average NOTE Monitoring Messages cannot be accessed during alarm violations There are 3 selections available VT V i f Paw P M B H S L or Q Press the Up button to scroll through the lines Three seconds after selecting a line the relevant operating parameters are displayed Following are the parameters for each line Line 1 VT xxx V i xx f xx VT Tidal volume in mL V i Insp Minute Vol...

Страница 47: ...0 PC Peep Too Low Pressure Control value minus PEEP is less than 5 cmH2O mbar 앖 PEEP Too Low High Pressure alarm limit minus PEEP is less than 5 cmH2O mbar The following messages are provided as prompts or reminders Panel Locked notifies user that the front panel buttons are now locked PRESS AGAIN notifies user that a second press on the same button is required in order to confirm change requested...

Страница 48: ...te system failure Air intake opening pressure is approximately 3 cmH2O 3 mbar WARNING Do not obstruct the Emergency Air Intake Any impediment could result in patient suffocation WARNING HOME CAREGIVERS Should a complete failure of the ventilator occur the Emergency Air Intake allows the patient to breath from room air through the intake valve Blockage of the valve could result in suffocation Check...

Страница 49: ...tric potential equalization Power Cord Ferrite Use of the Power Cord Ferrite ensures that the HT50 meets EMC requirements Anytime the HT50 is operating on A C power the ferrite should be attached to the power cord Operating from D C power does not require the use of the ferrite NOTE Always use the A C power cord supplied with the HT50 OPTIONAL ACCESSORIES Air Oxygen Entrainment Mixer The Air Oxyge...

Страница 50: ... must be established before the HT50 is used for ventilation NOTE HOME CAREGIVERS The User Set Up parameters should be defined in conjunction with your physician or Homecare Dealer Once established these parameters are kept in memory and will be in affect each time the ventilator is powered on until the operator enters User Set Up and makes changes NOTE To enter User Set Up the HT50 must be in the...

Страница 51: ... Save function is suspended for 2 minutes The Power Save feature can extend battery operating time by as much as 30 Pressure Units Selects between cmH2O and mbar as the unit used on the pressure meter and the various front panel controls The HT50 is factory set to cmH2O Use the Up Down controls to toggle to the mbar setting NOTE For consistency particularly in medical record keeping it is recommen...

Страница 52: ... ventilator is powered on Default parameters are listed on pg 2 6 NOTE HOME CAREGIVERS This parameter should always be set to USER for home use to ensure that when the HT50 is powered off and on the physician directed ventilation settings remain in place Auto Panel Lock This setting allows the user to enable turn on or disable turn off the Auto Panel Lock feature For a complete description of Auto...

Страница 53: ... Control Mandatory Ventilation 4 2 SIMV Mode Synchronized Intermittent Mandatory Ventilation 4 3 SPONT Mode Spontaneous Ventilation 4 3 Psupport Pressure Support 4 4 Pressure Control Pressure Control Ventilation 4 4 Volume Control Volume Control Ventilation 4 5 Back Up Ventilation 4 5 ...

Страница 54: ...ring of inspiratory tidal volume every breath inspiratory minute volume total respiratory rate peak pressure mean pressure and baseline PEEP pressure Real time patient circuit pressure is displayed at all times on the airway pressure gauge on the face panel The user sets variable alarm settings for High Pressure Low Pressure High Inspiratory Minute Volume and Low Inspiratory Minute Volume with Bac...

Страница 55: ... plan must be established by the attending physician NOTE Transport of patients with the HT50 requires that medical staff have a good working knowledge of the ventilator s use and problem resolution Proper emergency back up equipment must be immediately available during transport A CMV MODE Assist Control Mandatory Ventilation In A CMV mode time activated mandatory breaths are delivered in accorda...

Страница 56: ...never the patient triggers a mandatory breath This limits the number of mandatory breaths time triggered or patient triggered the patient receives in 60 seconds to the ƒ b min setting As with all HT50 operating modes Back up Ventilation is activated if the Low V I alarm limit is violated SPONT MODE Spontaneous Ventilation In SPONT mode mandatory breaths are not delivered but the user can adjust bo...

Страница 57: ...ath s peak flow rate or 2 the target airway pressure is exceeded by 3 cmH2O mbar or 3 after 3 seconds of inspiration PRESSURE CONTROL Pressure Control Ventilation The HT50 targets and maintains patient airway pressure at the set pressure control level throughout inspiration Breath termination occurs when 1 the set tI elapses or 2 Paw exceeds the Pressure Control setting by 8 cmH2O mbar NOTE The ta...

Страница 58: ...n that activates when the delivered inspiratory minute volume V I falls below the Low V I alarm limit setting During Back up Ventilation the Low V I Back up Vent alarm indicator blinks an audible alarm sounds and Low V i BUV is displayed in the Message Display Window The ventilation settings employed by Back up Ventilation are displayed on the front panel Back up Ventilation is functional in all m...

Страница 59: ...sure 15 cmH2O mbar above set PEEP and inspiratory time tI 1 0 sec Cancellation of Back up Ventilation User Cancelled If during Back up Ventilation the user adjusts any ventilation parameter Back up Ventilation is suspended for one minute and all user selected ventilation parameters are employed Another 60 seconds must pass after parameter adjustments before a V I alarm violation will result in Bac...

Страница 60: ...5 1 Assembling the Ventilator 5 1 Ventilator Set Up Procedure with Exhalation Valve Calibration 5 2 Patient Set Up Procedure 5 8 Built in Humidifier 5 10 Air Oxygen Entrainment Mixer Optional Accessory 5 13 Oxygen Blending Bag Kit Optional Accessory 5 14 ...

Страница 61: ...iarize yourself with the various components Remove all of the items from the shipping box and inspect each part and component for completeness and to verify that there is no shipping damage Complete the Order Review Form and Warranty Card and process as per the instructions The complete assembly consists of the following parts HT50 Ventilator Select one HT50 H HT50 HB home care hospital use with b...

Страница 62: ...0 has the Power Cord Ferrite attached between the adapter box and the ventilator If utilizing external power plug the ventilator s electric cord into a properly grounded outlet If using internal battery ensure that battery is fully charged Power Cord Ferrite WARNING Always use the A C power cord supplied with the HT50 that has the Power Cord Ferrite attached between the adapter box and the ventila...

Страница 63: ...tion located below the Gas Output on the HT50 See Figure 5 1 h When using the HT50 built in humidifier model HT50 H HT50 HB plug the temperature probe electrical connector into the Temp Probe connection on the left side of the HT50 Attach the short wire plug into the elbow outlet on top of the humidifier Attach the long wire plug into the exhalation valve port See Figure 5 2 Exhalation Valve Calib...

Страница 64: ...ils the calibration procedure try another circuit exhalation valve or use an alternate method of ventilation WARNING Some disposable breathing circuit exhalation valve assemblies are not compatible with the HT50 Ventilator due to the requirements of the ventilator s sophisticated servo controlled pressure management system If your disposable circuit fails consistently switch to a Newport approved ...

Страница 65: ... Side Panel Connections DETAIL A Exhalation Valve Gas Output Connection Single Limb Breathing Circuit with proximal line Exhalation Valve Proximal Line Connector Exhalation Drive Line Connector Proximal Inline Filter with tubing Exhalation Drive Line Proximal Line Cap on Temp Probe Port ...

Страница 66: ...er Humidifier Circuit Single Limb Breathing Circuit with proximal line Temperature Probe Port on Exhalation Valve Humidifier Temperature Probe Electrical Connector Figure 5 2 HT50 H HT50 HB with built in humidifier Set Up Assembly Figure 5 3 HT50 H HT50 HB with Prox Line Tee d into Dry Side of Humidifier ...

Страница 67: ... with Third Party Humidifier Set Up and Prox Line Tee d into Dry Side Figure 5 5 HT50 H1 HT50 H1B with HME and Prox Line Tee d into Patient Side Humidifier Outlet Humidifier Inlet Prox Line Tee Adapter Exh Valve Drive Line Prox Line Tee Adapter Prox Line HME ...

Страница 68: ...is placed on a new patient and when the breathing circuit exhalation valve is changed NOTE HOME CAREGIVERS Initial set up and verification of the ventilator operation should be done by the caregiver in conjunction with the Homecare Dealer or hospital provided clinician 3 Press the On Standby button located on the lower right side of the ventilator s front panel The ventilator performs a brief self...

Страница 69: ...ate ventilation The On indicator illuminates 15 Connect the ventilator breathing circuit to the patient interface 16 Reassess High and Low Paw alarm settings and adjust to appropriate levels 17 Verify that the Ptrig indicator blinks each time the patient initiates a spontaneous inspiratory effort Readjust Ptrig as necessary 18 Reassess High and Low V I alarm settings and adjust to appropriate leve...

Страница 70: ...riate actions such as using an HME should be taken to prevent significant humidity deficit in the patient WARNING When a humidifier malfunction is detected or a humidifier alarm exists the humidifier turns OFF The user is alerted by both an audible alarm and a change in the LED from green to blinking yellow The nature of the alarm is displayed in the message window Pressing the Silence Reset butto...

Страница 71: ...emperature probes must be placed firmly in the patient circuit opening for proper humidifier operation WARNING It is unsafe to configure the HT50 humidifier with accessories that are not specified for use with the humidifier NOTE Remove the plastic packaging from the humidifier bottle and heat sink before use 1 Ensure that the patient circuit and humidifier are assembled correctly Refer to Figure ...

Страница 72: ...e starting ventilation 5 When the humidifier water level reaches the REFILL line refill with sterile distilled water The humidifier must be restarted afterward by pressing the Humidifier On button 6 The absorbent paper in the humidifier should be replaced with each cleaning weekly during use or sooner if it becomes torn NOTE Humidifier specifications may be found on pg 2 7 NOTE For cleaning disinf...

Страница 73: ...HT50 is in User Setup or Settings Condition Installation Instructions WARNING Make sure to monitor and when necessary replace the air inlet filter to ensure that it is clean when using the Mixer The Air Oxygen Entrainment Mixer attaches into the inlet port on the Filter Cover located on the right side of the ventilator NOTE Before attaching the Air Oxygen Entrainment Mixer make sure that the three...

Страница 74: ...gen Blending Bag Kit p n HT600044 allows the user to ventilate patients with oxygen enriched gas of up to 100 oxygen WARNING The Oxygen Blending Bag Kit is designed to operate with hospital grade O2 supply The supply should not exceed 10 L min flow to the oxygen blending bag NOTE Before attaching the Oxygen Blending Bag make sure that the three hold down screws on the Filter Cover are tight If the...

Страница 75: ...ivery with an oxygen monitor Installation Instructions The Oxygen Blending Bag Kit attaches into the Fresh Gas Intake port on the Filter Cover located on the right side of the HT50 1 Remove the three thumb screws from the Filter Cover 2 Open the Cover and inspect the filter Replace it if it is dirty 3 Close the Filter Cover ensuring that the three thumb screws are tight 4 Press the 30 mm O D outle...

Страница 76: ...monitor positioned in the inspiratory limb of the patient circuit near the airway to verify the level of oxygen enrichment The information in these graphs should be used as a reference only To use the graphs 1 Select the appropriate graph determined by whether you are ventilating with or without PEEP 2 Select the Desired of Oxygen Enrichment listed at the bottom of the graph 3 Follow your selectio...

Страница 77: ...without PEEP and Table 5 2 in the presence of PEEP Data in Table 5 2 are taken at an I E ratio of 1 2 Different I E ratios may slightly affect the Desired of Oxygen Enrichment when PEEP is in use Table 5 1 Oxygen Supply Flow for Desired of Oxygen Enrichment Without PEEP Table 5 2 Oxygen Supply Flow for Desired of Oxygen Enrichment With PEEP ...

Страница 78: ...OPRHT50NA B0908 6 CLEANING MAINTENANCE Sterilization Cleaning 6 1 Maintenance 6 9 General Warnings 6 11 ...

Страница 79: ...ide EtO is toxic All accessories MUST be completely dry prior to packaging for ethylene oxide sterilizing After sterilizing they must be properly aerated to dissipate residual gas absorbed by the material Follow the EtO manufacturer s recommendations for the specific aeration periods required Caution Ethylene Oxide may cause superficial crazing of plastic components and will accelerate the aging o...

Страница 80: ...rubber bag between patients and replace with a new bag Caution Avoid touching the rubber valves which are inserted in the plastic body Do not attempt to clean the inside of the rubber bag keep it dry Disinfect Use the following disinfecting methods Soak plastic and metal parts in a solution of one part white vinegar to two parts of water thirty 30 minutes rinse thoroughly with sterile distilled wa...

Страница 81: ...ly Figure 6 1 Humidifier Assembly Disassemble Remove the humidifier bottle from the HT50 Open the humidifier bottle and remove the heat sink Remove the absorbent paper from the heat sink and discard Wash off any residual paper that remains on the heat sink with running water Clean Wash both halves of the bottle and the heat sink in a warm detergent solution using a soft brush Rinse thoroughly with...

Страница 82: ... twice per week while in use Probe Clean and sterilize between patients Disassemble Remove the temperature probes from the patient breathing circuit humidifier outlet and exhalation valve then unplug the electrical connector from the side of the ventilator by pressing the release tab and pulling gently Caution The electrical connector that plugs into the ventilator must stay dry at all times Clean...

Страница 83: ...permanent breathing circuit please refer to manufacturer s instructions for cleaning Disassemble Remove the entire circuit from the ventilator Remove the exhalation valve proximal inline filter if attached and temperature probe if used from the circuit Disassemble the circuit to expose all surfaces for cleaning Caution The NEWPORT breathing circuit is manufactured from a Polyester Elastomer high t...

Страница 84: ...ervice to assure that the circuit will perform correctly Reusable Exhalation Valve Clean and sterilize between patients and twice per week p n HT600039 while in use NOTE The older revision prior to February 2003 of the Newport Exhalation Valve does not disassemble The new revision of the valve can be cleaned as assembled or it can be disassembled for thorough cleaning Figure 6 2 Exhalation Valve A...

Страница 85: ...tter Wash the exhalation valve with a soft brush Rinse thoroughly with sterile distilled water Shake off excess water and place it on a clean towel to air dry Do not heat or blow dry Disinfect Any of the following disinfecting methods are suitable for the NEWPORT exhalation valve p n HT600039 Soak in one part white vinegar to one part of water for 2 hours and rinse thoroughly with sterile distille...

Страница 86: ...nd affect ventilator performance Perform a successful exhalation valve calibration to verify proper valve assembly HT50 Air Inlet Particle Filter WARNING NEVER operate the HT50 without a clean inlet particle filter in place WARNING NEVER reverse inlet particle filter when dirty The air inlet particle filter located on the right side of the ventilator behind the Filter Cover keeps dirt and particle...

Страница 87: ...cluded the primary indication for this would be a Low Pressure Alarm indication with the message CHECK PROX LINE Should this happen replace the filter NOTE NEWPORT strongly recommends that extra Prox Inline Filters be available at all times when using the HT50 ventilator Caution Do not wash or sterilize the Prox Inline Filter MAINTENANCE Preventive Maintenance The Air Inlet Filter located behind t...

Страница 88: ...ccessory p n HT460085 4 It is recommended that you keep a Battery Use Time Log so that you know when it is time to have your primary internal battery LA replaced Use Time is the time from when you unplug your ventilator from A C and power it on internal battery until it indicates a Battery Low alarm 10 000 Hour Maintenance A comprehensive maintenance should be performed after 10 000 hours of opera...

Страница 89: ...and accessories in accordance with established hospital procedures physician prescription or Homecare Dealer instructions Certain components of the ventilator such as the exhalation valve and the front panel consist of materials that are sensitive to some organic solvents used for cleaning and disinfection e g phenols halogen releasing compounds oxygen releasing compounds and strong organic acids ...

Страница 90: ...OPRHT50NA B0908 7 TROUBLESHOOTING Introduction 7 1 Table 7 1 Alarms 7 2 Table 7 2 Built in Humidifier 7 6 Table 7 3 General Clinical 7 6 Table 7 4 Setting Limitation Messages 7 12 ...

Страница 91: ...s a guide NOTE HOME CAREGIVERS Contact your Homecare Dealer physician or Newport if you have questions or concerns about the performance of the HT50 ventilator WARNING Non medical home caregivers must have complete training and demonstrate competency in proper set up use troubleshooting and maintenance of the HT50 prior to use They must have a planned response to emergencies and must comply with a...

Страница 92: ...ient Pressure transducer is improperly calibrated or defective Change proximal line filter and re route proximal line to a connector on the inlet dry side of the humidifier Insert approved proximal filter Reconnect proximal line or un kink line Reconnect circuit to patient Call NEWPORT Technical Service Dept Apnea Alarm Paw Apnea LED blinks red audible alarm sounds Patient did not trigger a breath...

Страница 93: ...proper Ptrig setting Unblock occluded area Re calibrate exhalation valve Evaluate patient and make necessary adjustments to ventilation parameters Fix leak and re adjust Ptrig as needed High V I Alarm V I LED blinks red audible alarm sounds Increased spontaneous patient breathing Increase in trach airway leak Increased minute volume due to ventilator auto triggering from a Leak b Ptrig setting too...

Страница 94: ...elow set Pbase due to airway or circuit leak or fluid pooled in tubing Verify all circuit connections are secure and leak free and that all fluid is cleared from tubing Low Paw Alarm cont d A CMV or SIMV modes Paw LED blinks red audible alarm sounds Ptrig setting too low most common with single patient use exhalation valve Loose expiratory drive line or proximal tubing connections loose Circuit di...

Страница 95: ...d ventilator down b External power cord is disconnected internal battery is discharged c External power source and or internal battery system failure a Push the Silence Reset button b Reinsert power cord and recharge internal battery c Use an alternate external power sourrce If none is available ventilate the patient with a manual resuscitator or alternate ventilator system until problem is correc...

Страница 96: ...atedly contact NEWPORT Technical Service Dept See page 1 6 and 1 7 for contact information Check Temp Probe Alarm Red LED humidifier function terminated Temperature probe is disconnected Faulty temperature probe Insert temperature probe into port Press Humidifier On to restart Replace temperature probe Press Humidifier On to restart High Prox Temp Alarm Red LED humidifier function terminated Set h...

Страница 97: ...re that the green Ext Power LED is lit when connected to an AC or DC power source it can take up to two minutes If LED is not lit check connections and resolve any problems Enter User Setup and turn Power Save ON Press Alarm Silence Reset to clear latched alarm indicators At your ventilator settings note the battery use time until the first Battery Low alarm sounds A minimum of 30 minutes of opera...

Страница 98: ...not titrated directly into the breathing circuit Use the Oxygen Blending Bag Kit or Air Oxygen Entrainment Mixer to provide oxygen enrichment Use an exhalation valve that is approved for use with the HT50 ventilator Circuit disconnect no alarm sounds Breathing circuit is disconnected from patient but there is no alarm Proximal line is not appropriately placed in circuit Low Paw alarm is not approp...

Страница 99: ...al inflation If a higher inflation pressure is needed increase the High Paw alarm limit setting to a safe but appropriate level Otherwise decrease flow rate or manual inflation time Manual Inflation Button Can t generate adequate rise in pressure Mandatory flow is set too low Gross leak in patient breathing circuit Faulty exhalation valve Pressure Control mode Evaluate ventilation settings If appr...

Страница 100: ...uating Water in breathing circuit tubing Leak in patient breathing circuit Leak in the exhalation valve Bounce rebound from test lung Drain tubing Perform exhalation valve calibration leak check eliminate any leaks found Replace the exhalation valve Use a test lung with more physiologic performance Pressure Not Rising Ventilator sounds like it is delivering breaths but pressure is not rising durin...

Страница 101: ...ntil the ventilator auto triggers then slowly increase the Ptrig setting until the auto triggering stops Check ventilation settings re adjust if necessary Check ventilation settings re adjust if necessary Manage airway leak fix circuit leak Evaluate patient Trigger Problem Patient double triggers the ventilator patient has trouble exhaling because second breath is being delivered In volume control...

Страница 102: ...iratory time tI or decrease frequency ƒ to resolve Reached Max I E Inverse I E Ratio has reached 3 1 Decrease inspiratory time tI or decrease frequency ƒ to resolve PEEP PS Too High Set PEEP Psupport is higher than 60 Adjust PEEP or Psupport to resolve PC PEEP Too Low Pressure Control value minus PEEP is less than 5 cmH2O mbar Adjust PEEP or Pressure Control to resolve 앖 PEEP Too Low High Pressure...

Страница 103: ...chnical Service Dept Oxygen leaks out of Mixer when connected to 50 psig oxygen gas source Mixer diaphragm is leaking Contact Newport Technical Service Dept TABLE 7 5 AIR OXYGEN ENTRAINMENT MIXER PROBLEM POTENTIAL CAUSE SUGGESTED CORRECTIVE ACTION Monitored FIO2 is lower than set FIO2 by 08 when using Air Oxygen Entrainment Mixer Filter cover is loose Filter cover needs to be replaced Tighten filt...

Страница 104: ...OPRHT50NA B0908 APPENDIX A QUICK CHECK PROCEDURE Introduction A 1 Set Up A 1 Standard Test Settings A 2 Quick Check Procedure A 2 Pass Fail Check Off Sheet A 5 Abbreviated Check Procedure A 6 ...

Страница 105: ...er Replace the filter if it is dirty Re install screws 2 A 500 mL test lung with restrictor LNG500A is required to perform this procedure Examine the test lung and patient circuit to ensure that there are no holes that will cause leaks 3 Verify that the condition of the A C power cord is acceptable e g no frays or breaks Set Up 1 Connect the A C power cord to an A C power source 2 Connect an adult...

Страница 106: ...mH2O mbar Psupport 0 cmH2O mbar Humidifier Off QUICK CHECK PROCEDURE 1 Power Switchover Alarm Check Disconnect the A C power cord Verify that there is an audible beep Power Switchover alarm The Ext Power Charging indicator turns red and the Int Battery indicator blinks to indicate that the ventilator is on battery power The Message Display Window displays No ext power Reconnect the A C power cord ...

Страница 107: ...ad the temperature displayed in the humidifier temperature window Press the Humidifier On button once and use the Down control to lower the set humidifier temperature by 5º Verify that an audible alarm sounds and the Message Display Window reads High Prox Temp and the humidifier is powered off Press the Silence Reset button to clear the alarm Press the Humidifier On button and adjust the set tempe...

Страница 108: ...e PEEP CPAP to zero Select Pressure Control and set pressure at 20 cmH2O mbar Verify that both the Paw meter and the Message Display Window read a peak pressure that is within 3 cmH2O mbar of each other Place the ventilator in Volume Control by pressing the Volume Control button twice 4 Volume Frequency Monitor Check Press the Up control until VT V i f is displayed Verify that VT 450 550 V i 6 9 a...

Страница 109: ...s _____ Fail ______ Low Paw Alarm Pass _____ Fail ______ Humidifier Alarm HT50 H HT50 HB only Pass _____ Fail ______ 3 Paw Monitor Pressure Meter Check Pass _____ Fail ______ 4 Volume Frequency Monitor Check Pass _____ Fail ______ 5 Internal Battery Check Pass _____ Fail ______ The ventilator is ready for operation when all tests have been completed successfully Note any comments on inspection of ...

Страница 110: ...cause leaks 4 Verify that the condition of the A C power cord is acceptable i e no frays Connect the power cord to A C power source Exhalation Valve Calibration NOTE Each time an exhalation valve is maintained or replaced by another such as when the complete circuit is changed it must be recalibrated The valve must pass the calibration procedure before it is used 1 Connect the HT50 patient breathi...

Страница 111: ...attery Test button Observe the needle indicator on the Paw meter If the battery charge level is medium to full charge the needle will read in the blue area If the battery charge is low the needle will read in the red area Reconnect to A C power NOTE The HT50 should not be used on internal battery unless the battery is charged to its full level If the internal battery system charge level is low con...

Страница 112: ...OPRHT50NA B0908 APPENDIX B HT50 ACCESSORIES HT50 Ventilator Parts and Accessories B 1 ...

Страница 113: ... heated single limb with exh valve 13 10862 701 Patient breathing circuit disposable pediatric 20 case 8 2 4m non heated single limb with exh valve 14 10855 855 Patient breathing circuit disposable ped adult 20 case 8 2 4m non heated J circuit with exh valve 15 10856 H08 Patient breathing circuit disposable ped adult 20 case 8 2 4m heated wire J circuit with exh valve 16 HT600047 Patient breathing...

Страница 114: ...500A Adult test lung 500 mL with R20 restrictor 1 28 V24 00900 60 Electrical power cord A C with Ferrite 1 29 HT460400 Power cord ferrite 1 30 HT460085 Automobile 12 V accessory power cord 1 31 OPRHT50NA Operating manual for HT50 1 32 SERHT50NA Service manual for HT50 1 33 HT6004701 Prox inline filters disposable 5 ea 34 BAT3300A External Batttery Pack Assy 1 35 CHG3313P Battery Charger for BAT330...

Страница 115: ...OPRHT50NA B0908 APPENDIX C HT50 HELP GUIDE Questions and Answers C 1 ...

Страница 116: ...ugh the proximal tubing The filter provides a contamination barrier 3 Can I use a single patient use breathing circuit on the HT50 Yes There are several good single use breathing circuits available from Newport Medical and other suppliers A good quality circuit is important in controlling PEEP patient trigger sensitivity and patient comfort You can access a list of circuits that have been tested f...

Страница 117: ...priate for the patient The continuous flow generated by the HT50 when PEEP 0 will exit the exhalation valve prior to the HME 7 How do I obtain hours of operation Press the Up arrow until the information is displayed The Message Display Window displays the following H xxxxx Sxxxx L or Q Where H is hours of operation S is Software revision and L or Q is alarm loudness setting Loud or Quiet 8 Why doe...

Страница 118: ...50 H HT50 HB 5 6 HT50 H HT50 HB Humidifier 6 3 Oxygen Blending Bag Kit 5 15 Auto Lighter Cable 3 27 Auto Panel Lock 3 29 Enabling Disabling 3 2 B Back Up Ventilation 4 5 A CMV and SIMV 4 5 Activation 4 5 Cancellation 4 6 Spont 4 6 Battery Empty Alarm 3 20 Battery Fault Alarm 3 21 Battery Low Alarm 3 20 Breathing Circuit Cleaning 6 5 Part numbers B 1 BUV See Back up Ventilation Buzzer Volume 3 13 3...

Страница 119: ...0 Prep For Use 5 11 Set Up And Operation 5 12 Specifications 2 7 Warnings Precautions 5 11 Humidifier Fail Alarm 3 19 Humidifier On Button 3 11 I I E Ratio 3 12 Inlet Filter See Air Inlet Particle Filter Inspiratory Minute Volume 3 15 3 23 Inspiratory Time See tI Intended Use 2 1 Internal Battery Dual Alarms 3 20 3 21 Charge Level Meter 3 13 General Warnings 1 5 Maintenance 6 10 Recharge Time 3 20...

Страница 120: ...ximal Line See Assembly Diagram Psupport Pressure Support 3 10 4 4 Ptrig Sensitivity 3 10 Push to Unlock Button 3 13 Q Quick Check Procedure A 1 to A 4 Quick Check Procedure Check Off Sheet A 5 R Reached Max I E Message 3 24 Reached Max V Message 3 24 Reached Min V Message 3 24 Respiratory Frequency See ƒ Right Side Connectors 3 25 RS 232 Interface Comm Port 3 25 S Sensitivity See Ptrig Set Up Use...

Страница 121: ...Unlock Panel See Auto Panel Lock Up and Down Control 3 7 User Set Up 3 27 Exiting 3 29 How to access 3 27 Parameters 3 28 V V Mandatory Flow 3 12 V Unavailable Message 3 24 Ventilator Set Up See Set Up Use Volume Control 3 8 4 5 Switch To Pressure Control 3 1 3 9 W General Warnings 1 4 Warranty 1 2 Water Trap See Breathing Circuits ...

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