Harmony Clinical Manual
Contents
1. 6 2 Supplemental Oxygen Concentrations Figures 6 2 and 6 3 illustrate the potential range of oxygen concentration available to the patient at a given tidal volume supplemental oxygen flow and pressure setting These figures represent bench test results without inadvertent mask leaks when O is administered at the mask Substantial leaks around the mask may reduce the expected oxygen concentration to below the levels shown in Figures 6 2 and 6 3 This guideline may be used as a starting point for initiating oxygen therapy Oxygen flow should be gradually adjusted until the patient s oxygen needs are adequately met Supplemental O Flows AH 2 L min 10 L min r 15 L min 100 7 90 F 80 F AAA EBEN y gz 70 Pp o 60 F 8 50 5 40 30 F m 20 107 0 10 5 20 5 30 5 IPAP EPAP Settings 600 cc Tidal Volume Respiratory Rate 20 BPM Figure 6 2 Oxygen Concentration for 600cc Tidal Volume Supplemental O2 Flows 2 Lmin Oo 10 L min m 15 L min 100 90 F 80 F g 707 3 50 a j 8 5 40 F 6 30 F Bm E 207 107 0 10 5 20 5 30 5 IPAP EPAP Settings 1000 cc Tidal Volume Respiratory Rate 20 BPM Figure 6 3 Oxygen Concentration for 1000cc Tidal Volume BiPAR 5 Harmony S T Clinical Manual 7 1 Chapter 7 Cleaning and Routine Maintenance This chapter provides guidelines for the cleaning and maintenance procedures 7 1 Cleaning the Harmony S T Ventilator To avo2. AC Inlet DC Inlet A o DC Cord Filter Access Retainer Panel 3 3 1 PATIENT ALARM This panel is removed to adjust the patient disconnect alarm delay time See Access PANEL Chapter 4 for details 3 3 2 AC INLET The AC inlet is where the AC power cord 100 to 240 Vac is inserted 3 3 3 DC INLET The DC inlet is where the DC power cord 12 Vdc is inserted 3 3 4 FILTER CCESS This panel is removed to access the inlet air filters See Chapter 7 for details PANEL 3 3 5 DC Corp RETAINER The DC cord retainer provides strain relief for the DC power cord Harmony S T Clinical Manual Ventilatory Support System 3 4 Oxygen Valve and Air Vent 3 4 Optional Oxygen Valve The Harmony S T ventilator optional oxygen valve is mounted to the side of the unit as shown in Figure 3 2 The valve must be used if low flow oxygen is to be titrated into the breathing circuit of the Harmony S T ventilator See Chapter 6 for instructions Figure 3 2 Location of Oxygen Valve 3 5 Air Vent The air vent located on the bottom of the unit allows the excess air that is vented from the internal control valve to leave the unit Harmony S T Clinical Manual Ventilatory Support System 4 1 Chapter 4 Setting Up and Starting the Harmony S T Ventilator 4 1 Setting Up the Harmony S T Ventilator 4 1 1 INSTALLING THE FILTERS The Harmony S T ventilator uses two removable filters at the air inlet You must install these filters befo
3. R Rear Panel 3 3 AC Inlet 3 3 DC Cord Retainer 3 3 DC Inlet 3 3 Filter Access Panel 3 3 Patient Alarm Access Panel 3 3 S Setting Patient Disconnect Alarm Delay 4 4 Patient Parameters 4 3 Specifications 9 1 Accuracy 9 2 Electrical 9 1 Environmental 9 1 Physical 9 1 Pressure 9 1 Supplemental Oxygen Concentrations 6 4 Oxygen Valve 6 2 Symbol Key 1 4 T Time at Pressure Display 3 2 Trigger Sensitivity 9 2 W Warnings 2 1 Warnings Cautions and Notes 2 1 2 4 BiPAR En s E Harmony S T Clinical Manual Limited Warranty Respironics Inc warrants that the BiPAP Harmony S T ventilator shall be free from defects of workmanship and materials and will perform in accordance with the product specifications for a period of one 1 year from the date of sale by Respironics Inc to the dealer If the product fails to perform in accordance with the product specifications Respironics Inc will repair or replace at its option the defective material or part Respironics Inc will pay custom ary freight charges from Respironics Inc to the dealer location only This warranty does not cover damage caused by accident misuse abuse alteration and other defects not related to material or workmanship Respironics Inc disclaims all liability for economic loss loss of profits overhead or consequential damages which may be claimed to arise from any sale or use of this product Some states do not allow the exclusion or l
4. The functioning of the Harmony S T ventilator can be adversely affected by electromagnetic interference exeeding the level of 10 V m in the test conditions of EN 60601 1 2 Always use the recommended inlet filter when the Harmony S T ventilator is operating If the External Battery Discharged Alarm is activated disconnect the external battery immediately A discharged battery may be damaged if it continues to be connected to the ventilator The Inspiratory Positive Airway Pressure IPAP and Expiratory Positive Airway Pressure EPAP controls are coupled The unit will not deliver an EPAP level that is higher than the set IPAP level Additional Warnings Cautions and Notes are located throughout this manual rmoOony S T Clinical Manual Ventilatory Support System 2 4 Intended Use Contraindications and Patient Precautions 2 4 Intended Use 2 5 Contraindications 2 6 Patient Precautions AR TM armorny s T Clinical Manual The Harmony S T ventilator is a noninvasive pressure support ventilator used to augment the breathing of adult patients gt 30 kg suffering from acute or chronic respiratory insufficiency or to maintain airway patency and provide ventilatory support to patients who experience obstructive sleep apnea The Harmony S T is not intended to provide the total ventilatory requirements of the patient The Harmony S T is intended for use in the home hospital or alternate care The use of the
5. AC amp DC LEDs off System LED on Continuous Internal critical error Shutdown Service unit Continuous Loss of input power Shutdown Check power source Internal power Shutdown Service unit supply failure System LED on Continuous Check inlet filters or service unit Pressure regulation System LED on High Priority low Operates Pressure regulation high System LED on High Priority Outlet overpressure System LED on High Priority Motor fault Shutdown Service unit System LED on High Priority Shutdown Service unit System LED on High Priority Outlet pressure low Operates Service unit DC Power Alarms Switchover to DC Reconnect AC and power from AC Operates restart or disconnect power AC and restart on DC Warning 30 Flashing DC second repeat External battery Low external battery Operates failure imminent seek alternate power source Warning 15 Flashing DC second repeat Replace external Shutdown battery or seek alternate power source External battery System LED on Continuous discharged Patient Alarm Check for excessive Operates leak or replace mask reconnect circuit Patient disconnect Patient LED on High Priority excessive flow Audible Alarm Indicators e Continuous Alarm is always on e High Priority Alarm sounds three beeps followed by two beeps repeats after a short pause then repeats the ten beep pattern every five seconds Warning
6. ROWER INDICATORS a e e Bine a A es Ess 3 2 SE TEA T eA A A NIBI OINO SE LE E E ATE E SEEN pu 3 2 391 27 DTPA A AN 3 2 3 2 Patient Circuit Connection cccccccccessssscecececeeeesenssecececececsessnseseceseceeeseessasececeseeseseeetsaaeeaeeeeees 3 3 A O 3 3 3 301 PATIENT ATARM ACCESS PANEL ti nas 3 3 3 3 2 ACI A e A 3 3 ID DECANO A e e a a o 3 3 3 34 FILTER ACCESS LANE dai 3 3 3 30 DE CORD RETAINER EEEE A a 3 3 3 4 Optional Oxygen Valve esse Rem 3 4 II ATAS E e Ms A 3 4 4 1 Setting Up the Harmony S T Ventilator a2 RE BE 4 1 A T 1INSTALEING THEIFTIHTERS ae ek een essen Cases AE ridad aida das Ei oe 4 1 4 1 2 ASSEMBLING THE PATIENT CIRCUIT cccscccccecesssceceecsssscececesessaecececenssssecececessaaeececeessaececcecseeeeceecsesaeeecesersaaeeeecenes 4 2 4 2 Selling the ds A O od lols Bids 4 3 4 21 SETTING THE PATIENT PARAMETERS pedara a A EE dt as tias 4 3 4 2 2 SETTING THE PATIENT DISCONNECT ALARM DELAY ccccccesssssceececesssceceecsesscececesessaecececessaasecececessaaeceeceensusseeceenenees 4 4 4 3 Operating the Harmony S T Ventilator 2 44 2 nice EL 4 5 ASA GAC OPERATION GAS Essen A TE SWS Loss 4 5 4 3222 DEOBRRATION G O a is EERO Ea AIG SB 4 5 4 3 3 CONNECTING THE PATIENT scsscccccecessccsccscessenccescessensceseeceenseececessnseneeescensnneeescscenncessescesnseseecessssnuecsecesenseesecs conse 4 6 BiPAR ay N Jar nony S T Clinic al M anual 11 Chapter 5 Alas ic citas 5 1 Chapter 6
7. STEP 5 Set the patient s prescription see Section 4 2 before applying the patient interface to the patient Figure 4 10 Plugging in the DC Cord BiPAP en Harmony S T Clinical Manual Operating the Harmony S T System 4 3 3 CONNECTING THE PATIENT NOTE Before placing the patient interface on the patient check the integrity of the patient circuit and the exhalation port NOTE During normal operation the IPAP and EPAP controls should illuminate steadily during the appropriate breathing phase The Rate control should illuminate steadily only when a machine triggered breath is delivered STEP 1 Place the interface device on the patient STEP 2 If oxygen is being used turn on the oxygen flow Always turn the Harmony S T ventilator on before turning on the oxygen and always turn the oxygen off before turning off the Harmony S T ventilator STEP 3 Place the Start Stop switch in the START position The Harmony ventilator initiates a self test All LED indicators light momentarily and the audible alarm beeps twice to verify that the audible alarm is functioning If the indicators do not light or the audible alarm does not beep twice the unit requires service STEP 4 After the self test the unit begins operation If any control LED is blinking a parameter is set incorrectly e Blinking IPAP and EPAP controls mean that the IPAP has been set at a value lower than EPAP The unit will deliver CPAP at the
8. 4 rs 444 054 KAN Alarm om Indicators IPAP EPAP f T MO Em BPM E JE 7 o x e m ia IPAP Rise Time Bilermow sr Control Time at Pressure Display Figure 3 1 The Harmony S T Control Panel Figure 3 1 illustrates the Harmony S T control panel The control panel includes e device controls slide controls with LED indicators e pressure bar graph indicator e Time at Pressure display e Start Stop switch e power indicators AC and DC e alarm indicators System and Patient e IPAP Rise Time control The device controls are inaccesible to the patient To access the controls you must use a tool to unlatch and open the door See Section 4 2 1 When the door is closed the pressure bar graph and the IPAP and EPAP slide controls can be viewed through a window in the door BiPAR EN Harmony S T Clinical Manual 3 2 Control Panel 3 1 1 DEVICE CONTROLS Values are set with illuminated slide controls The top edge of the control indicates the value of the parameter on the adjacent scale IPAP Control NOTE The IPAP value should not e Adjusts the pressure level for the inspiratory phase be set lower than the EPAP value If e Range 4 to 30 em H O you attempt to set IPAP lower than e Steady illumination during IPAP phase EPAP the unit will only deliver e Blinking illumination if IPAP is set lower than EPAP pressure at the IPAP level EPAP Control e Adjusts the baseline expiratory pressure PEEP e Range 4 to 15 cm
9. Chart 3 provides the approximate total volume of each of the patient interface accessories that can be used with the BiPAP Harmony S T Respironics Patient Interface Volume EEE A Mouthpiece Adapter includes extension tube Chart 3 NOTE For comparison purposes testing for Charts 1 and 2 were conducted using a medium mask BiPAR a 7 Harmony S T Clinical Manual 10 1 Chapter 10 Performance Verification The performance verification allows the home care provider or clinician to verify that the Harmony S T ventilator is functioning properly Performance verification should be completed before each new patient setup Step 1 Step 2 Step 3 Step 4 Step 5 Step 6 Step 7 Step 8 Step 9 Connect the patient circuit to the Harmony S T as described in Chapter 3 of this manual Connect a water column or digital manometer to one of the mask ports Open the control panel door on the front of the Harmony S T see section 4 2 1 Set the patient controls as follows e IPAP 10cmH O EPAP 4cmH O e Rate 6 BPM e Timed Inspiration 1 5 sec e IPAP Rise Time Slow Connect the AC inlet to the Harmony S T and connect the AC line to the appropriate power source The AC power LED should be illuminated Simulate a breathing pattern by occluding and opening the patient outlet Verify that the IPAP LED is illuminated during the inspiratory phase and that the EPAP LED is illuminated during the expira
10. Access Panel STEP 3 Set the switch to the desired delay setting e 60 sec u e 15sec Three Position e Disabled Slide Switch See Chapter 5 for an explanation of the Patient Disconnect alarm 15 sec Disabled Figure 4 8 Patient Disconnect Alarm Delay Settings STEP 4 Replace the access panel BiPAR en 5 Harmony S T Clinical Manual AC amp DC Operation 4 5 4 3 Operating the Harmony S T Ventilator 4 3 1 AC OPERATION Follow the procedure in section 4 1 2 Assembling the Patient Circuit Plug the electrical cord into the AC inlet in the back of the Harmony S T unit Verify that the Start Stop switch is in the STOP position then plug the electrical cord into an outlet that is not controlled by a wall switch STEP 4 Set the patient s prescription see Section 4 2 before applying the patient interface to the patient NOTE The use of an electrical adaptor or extension cord is not recommended Figure 4 9 Plugging in the AC Cord 4 3 2 DC OPERATION STEP 1 Follow the procedure in section 4 1 2 Assembling the Patient Circuit CAUTION Only use a Respironics supplied DC cord STEP 2 Plug the DC cord connector into the rear of the Harmony S T ventilator STEP 3 Leaving a small amount of slack in the cord press the cord into the DC cord retainer STEP 4 Connect the DC cord to the appropriate DC source Refer to the DC cord instruction sheet for recommended DC power sources
11. Alarm sounds three beeps and repeats every 15 or 30 seconds depending on cause of alarm Table 5 1 Harmony S T Alarm Conditions and Corrective Actions BiPAR en 5 Harmony S T Clinical Manual 6 1 Chapter 6 Adding Supplemental Oxygen You may add supplemental oxygen directly to the patient circuit This chapter describes the method of oxygen delivery and shows the oxygen concentrations attained at various IPAP and EPAP settings and oxygen flow rates WARNING Oxygen should be administered only on the order of a physician WARNING Oxygen supports combustion Oxygen should not be used while smoking or in the presence of an open flame BiPAR ES x Harmony S T Clinical Manual 6 2 Adding Supplemental Oxygen 6 1 Adding Supplemental Oxygen Low flow oxygen may be added to the patient circuit at the air outlet or at the mask WARNING If supplemental The delivered oxygen concentration varies with changes in flow in the circuit oxygen is added to the breathing The following may impact oxygen concentration circuit the optional oxygen valve must be installed and used as shown in e Pressure settings Figure 6 1 If the Harmony S T air e Patient Tidal Volume flow stops the valve automatically e Peak Inspiratory Flow closes preventing high levels of e TIE Ratio oxygen concentration from entering e Respiratory rate the unit case e Circuit leak rate e Oxygen flow rate e Site where oxygen is added to the c
12. Assembling the Patient Circuit 4 2 C Cautions 2 3 Circuits and Accessories 8 3 Cleaning Filters 7 1 Ventilator 7 1 Connections Patient Circuit 3 3 Contraindications 2 4 Controls Alarm Indicators 3 2 Device 3 2 Front Panel 3 1 IPAP Rise Time 3 2 Power Indicators 3 2 Pressure Bar Graph 3 2 Start Stop Switch 3 2 Time at Pressure 3 2 Controls and Displays 3 1 D DC Cord Retainer 3 3 DC Operation 4 5 E Electrical Specifications 9 1 Environmental Specifications 9 1 Exhalation Ports 8 3 F Filter Access Panel 3 3 Filters Installing 4 1 Replacing Cleaning 7 1 BiPAR Ha Index H Humidifier 8 3 I Indicator Pressure Bar Graph 3 2 Indicators Alarm 3 2 Power 3 2 Intended Use 2 4 M Maintenance 7 1 Manual Overview 1 3 Masks and Related Accessories 8 3 N Notes 2 3 O Operating the Harmony S T Ventilator 4 5 AC Operation 4 5 DC Operation 4 5 Optional Oxygen Valve 3 4 Overview Front Panel 3 1 Manual 1 3 Vision 1 1 Oxygen Valve 3 4 6 2 P Panels Filter Access 3 3 Patient Alarm Access 3 3 Patient Alarm Access Panel 3 3 Patient Circuit 4 2 Patient Circuit Connection 3 3 Patient Disconnect Alarm Delay 4 4 Patient Parameters 4 3 Patient Precautions 2 4 Performance Verification 10 1 Physical Specifications 9 1 Plugging the Ventilator in 4 5 Power Indicators 3 2 Prescription 4 3 Pressure Bar Graph 3 2 Pressure Specifications 9 1 Product Support 1 5 Y S T Clinical Manual 1 2
13. H O e Steady illumination during EPAP phase e Blinking illumination if IPAP is set lower than EPAP NOTE The Rate control and the Timed Inspiration Control are linked Rate Control so that the inspiratory time is never longer than the expiratory time or e Adjusts the frequency of timed breaths greater than 3 seconds If the Rate is e Range 4 to 30 BPM increased to a value that would exceed e Steady illumination during timed breath a 1 1 I E ratio the Timed Inspiration e Blinking illumination if settings cause inspiratory time to exceed control would be automatically expiratory time reduced to maintain a 1 1 I E ratio Timed Inspiration Control NOTE The blinking illumination is re e Adjusts the duration of the inspiratory phase of a timed breath used to indcate gross inspiratory time e Range 0 4 to 3 0 seconds e Blinking illumination if settings cause inspiratory time to exceed expiratory time mismatches only Do not use the blinking illumination to set the inspiratory time 3 1 2 PRESSURE BAR The Pressure Bar Graph indicator changes height in response to the pressure output level It is used to show the change between IPAP and EPAP It is not GRAPH INDICATOR intended to be used for pressure measurement 3 1 3 TIME AT PRESSURE The Time at Pressure display is an LCD time meter that indicates the accumu DISPLAY lated hours of patient therapy in 0 1 hour increments The display can be reset by inserting a pi
14. Harmony S T ventilator is contraindicated on patients without a spontaneous respiratory drive The use of the Harmony S T ventilator for noninvasive positive pressure therapy may be contraindicated on patients unable to maintain a patent airway or adequately clear secretions at risk for aspiration of gastric contents with acute sinusitis or otitis media with a history of allergy or hypersensitivity to the mask materials where the risk from allergic reaction outweighs the benefit of ventilatory assistance with epistaxis causing pulmonary aspiration of blood or with hypotension Advise the patient to immediately report any unusual chest discomfort shortness of breath or severe headache Tf skin irritation or breakdown develops from the use of the mask refer to the mask instructions for appropriate action The following are potential side effects of noninvasive positive pressure therapy Ear discomfort Conjunctivitis Skin abrasions due to noninvasive interfaces Aerophagia gastric distention 3 1 Chapter 3 Controls This chapter describes the panel controls and displays the patient circuit connections and the rear panel connections and controls 3 1 Control Panel Device Start Stop Controls N Vy Switch 30 4 30 3 04 319 e Pressure 24 20 gt 3 Bar Graph e cm E op Power Indicator NAH AH ee OF Indicators
15. and cycle to EPAP Expiration During setup it is important to ensure that the ventilator is in synchrony with the patient s ventilatory needs and breathing pattern 4 1 2 ASSEMBLING THE PATIENT CIRCUIT STEP 1 Assemble the patient circuit according to the configurations presented in Chapter 8 fa Patient vg hienas STEP 2 If required connect a bacteria filter to the Patient Interface Port Port shown in Figure 4 3 and connect the patient tubing to the outlet of aa ee the bacteria filter If the bacteria filter is not required connect the patient tubing directly to the Patient Interface Port Figure 4 3 Patient Interface Port If oxygen is to be used connect it now according to Chapter 6 A completed assembly is shown below Patient Interface ct typical ya Exhalation E Port Circuit Oxygen Bacteria Valve Filter Optional Optional Figure 4 4 An example of a Respironics approved circuit Harmony S T Clinical Manual Ventilatory Support System Setting the Prescription 4 3 4 2 Setting the Prescription 4 2 1 SETTING THE PATIENT PARAMETERS STEP 1 Use a small flat blade screwdriver to unlatch the parameter door Figure 4 5 Opening the Parameter Door STEP 2 Slide the patient setting controls to the prescribed settings IPAP EPAP Rate Timed Inspiration When the unit is started if 4to30cmH20 4to1Bc
16. higher than room temperature Caution should be exercised if the room temperature is greater than 40 C 104 F When the Harmony S T ventilator is used with a humidifier always position the humidifier lower than both the ventilator and the patient When administering supplemental oxygen a controlled method of setting and measuring inspired oxygen concentrations cannot be accomplished At a fixed flow of supplemental oxygen the inspired oxygen concentration will vary depending on the IPAP and EPAP settings patient breathing pattern and the leak rate Substantial leaks around the mask may reduce the inspired oxygen concentration to less than the expected concentrations shown in Chapter 6 Continuous patient monitoring is recommended while administering supplemental oxygen Patient monitoring should consist of as a minimum patient observa tion and pulse oximetry Arterial blood gas measurements should be used when necessary When using supplemental oxygen the oxygen line flow meter should be compensated i e flow reads zero if there is an occlusion after the flow meter Also the oxygen supply should be observed after each use to ensure that the gas contents have been reduced These measures will indicate if the Respironics oxygen valve fails in the closed position which would stop oxygen flow from reaching the patient BiPAR En s E Harmony S T Clinical Manual Warnings Cautions Notes 2 3 Warnings continued 2 2
17. patient circuit and adjusts its output to assist in inhalation and exhalation This assistance is provided by the administration of two levels of positive pressure During exhalation pressure is variably positive or near ambient During inspiration pressure is variably positive and always higher than the expiratory level The Harmony S T ventilator responds reliably to patient flow rates that indicate movement to inhalation or exhalation even in the presence of most normal leaks in the patient circuit Automatic adjustment of this trigger threshold in the presence of leaks makes the system ideal for mask applied ventilation assistance The ventilator operates in the Spontaneous Timed S T mode The S T mode is introduced in Section 1 2 Figure 1 1 The BiPAP Harmony S T Ventilator Harmony S T Clinical Manual 1 2 S T Mode 1 2 S T Mode The ventilator s S T mode delivers pressure support with Positive End Expira tory Pressure PEEP The unit triggers Inspiratory Positive Airway Pressure IPAP in response to spontaneous inspiratory effort and cycles to Expiratory Positive Airway Pressure EPAP during exhalation The level of pressure support PS delivered is determined by the difference between the IPAP and EPAP settings PS IPAP EPAP The S T mode ensures that patients will receive a minimum number of breaths per minute if their spontaneous breathing rate drops below the Rate setting If the patient fails to i
18. Adding Supplemental Oxygen cccsssssssscssssssssssccsscsssssssccsssssees 6 1 6 1 Addins Supplements 6 2 6 2 Supplemental Oxygen Concentrations uses 6 4 Chapter 7 Cleaning and Routine Maintenance scssssssssssssnsnssnssnnsnnsnnnnssnnnnnsnne 7 1 7 1 Cleaning the Harmony S T Ventilator ito tdci 7 1 7 2 Cleaning Replacing the Inlet Filters au teas ncag ied poe aeanedcugeasy dasysendudeotde sem sananesiens aeekanetins 7 1 Chapter 8 Circuits and Accessories ccccssssssscccssssscssscccssssssssscccssssssssscecssssees 8 1 8 Siem CONASUTAONS er ri 8 1 8 2 CIECUILS and ACCESSOTIE Srei mosa calida 8 3 8 3 Masks Exhalation Ports and Related Accessories cuuaanaseeeeeeeeeennnnnnensnseeneennnnnnnnnnnnennenennnenenn 8 3 8 4 IMSS RA aaa 8 3 Chapter 9 Specifications o cence 9 1 Chapter 10 Performance Verification ssssssssssessnnnsnssnssnsnnnsnsnnssnsnnssnssnsnnsnnnse 10 1 BiPAR En armony s T Clinical Manual 1 1 Chapter 1 Introduction 1 1 Harmony S T The Harmony S T ventilator shown in Figure 1 1 is a low pressure electri Overview cally driven ventilator system with electronic pressure control The unit s pressure controls are adjusted to deliver pressure support for patient ventilatory assistance The Harmony S T ventilator is intended to augment patient breathing by supplying pressurized air through a patient circuit It senses the patient s breathing effort by monitoring airflow in the
19. BiPAR ArMONY S T Ventilatory Support Syste Clinical Manual EN RESPIRONIG BiPAP systems are the subject of one or more of U S Patents 5148802 5239995 5313937 5433193 Canadian Patent 2 024 477 European Patent AEP0425092 German Patent 46902 1681 5 08 and other pending U S and foreign patents BiPAP Harmony Plateau Whisper Swivel Comfort Flap Spectrum Monarch Softcap Ouick Clip Oasis and Auto Trak Sensitivity are registered trade marks of Respironics Inc O 2000 Respironics Inc All rights reserved Table of Contents Chapter 1 Introduction nes Lara EOS ea id ins 1 1 TO 1 2 PERO Blei 1 3 E Sy TANI Bey OO 1 4 1 I Produet SUD POU than ci ls od Medea csi 1 5 Chapter 2 Warnings Cautions and Notes sscccsssssssssccsssssssssscccsssssssssecsssees Zul Ze Ve WY APTI SS EE geass vasneusssaaesaaneneasts A E AS 2 1 DD Me AU LIONS e E A ETE E EE oT 2 3 DES SIN OLS as costs siete dd eo o teca ill end 2 3 2 2 Intended SCs ses e TAR SMCs Ss A o 2 4 22 COMUPAIIGIC AUIONS areas asado ais 2 4 26 Patient Pre UI A tere leerer 2 4 Chapter 3 Controls urn Oe COMO Pane ler O A BEE SE 3 1 31 1 TIEVICE CONTROLS a Areas A E EE E 3 2 3 1 2 PRESSURE BAR GRAPH INDICATOR ccccccesssscceeceessaececescesecececesescecececessaaeecececesueseccecsessaeseecsesaesecesensaaseeecensnsaaeess 3 2 31 3 TIME ATPRESSURE DISPLAY 882 a AE EE EEA ta 3 2 IEA STARTS TOP SWITCH ani dt dali 3 2 3 Ale
20. Cautions 2 3 Notes If you detect any unexplained changes in the performance of the Harmony S T ventilator seek the assistance of Respironics Inc or an authorized service center Repairs and adjustments must be performed by Respironics Inc or an authorized service center Service done by inexperienced unqualified personnel or installation of unauthorized parts could cause injury invalidate the warranty or result in costly damage Electrical cords and cables should be periodically inspected for damage or signs of wear To avoid electrical shock unplug the Harmony S T unit before cleaning it If the Harmony S T ventilator is dropped or mishandled the unit must be checked by a qualified technician Avoid exposing the Harmony S T ventilator to non ionizing radiation e g x ray CT and to magnetic fields e g MRI Inspect the patient circuit before each use to verify that the patient circuit is not occluded The patient must be capable of removing the mask in the event of a problem with the Harmony S T ventilator Avoid exposure of the Harmony S T ventilator to temperatures at or near the extremes of those specified in Chapter 9 If exposure to such temperatures has occurred the unit should be allowed to come to room temperature before being turned on For proper operation the unit must be placed on its base with its cooling and exhaust vents unoccluded Do not operate the Harmony S T ventilator in direct sunlight
21. IPAP setting e Blinking Timed Inspiration and Rate controls mean that the Inspiratory time exceeds the Expiratory time The unit will not allow the I E ratio to exceed 1 1 for a machine triggered breath See Chapter 5 for alarm information See Chapter 6 if you are administering oxygen to the patient Harmony S T Clinical Manual 5 1 Chapter 5 Alarms This chapter describes the Harmony S T alarms and lists possible corrective actions for the alarm conditions The Harmony S T ventilator provides two alarm levels high priority and warning High priority alarms require immediate attention and consist of a System or Patient LED on and an audible alarm that is either continuous or sounds a pattern of three beeps followed by two beeps which is repeated after a short pause the ten beep pattern is repeated every five seconds Warning alarms are less critical and consist of a flashing LED and an audible alarm that sounds three beeps every 15 or 30 seconds depending on the cause of the alarm 3 0 25 2 07 System Alarm ee LED 1 0 2 0 5 E ei Patient Alarm 5 LED Figure 5 1 System and Patient Alarm LEDs BiPAP T 3 Harmony S T Clinical Manual 5 2 Alarm Conditions and Corrective Actions Table 5 1 lists the alarm indicators the possible conditions for each alarm and the corrective action for each alarm Audible Machine LED Indicator Indicator Action Corrective Action System Alarms System LED on
22. Support 1 5 1 5 Product Support You may contact Respironics Inc with any questions or for product support at O RESPIRONICS INC 1001 Murry Ridge Lane Murrysville Pennsylvania 15668 8550 U S A RESPIRONICS Deutschland Gewerbestrasse 17 82211 Herrsching Germany BiPAR a c Harmony S T Clinical Manual BiPAR En s E Harmony S T Clinical Manual 2 1 Chapter 2 Warnings Cautions and Notes WARNING Indicates the possibility of injury to the patient or the operator CAUTION Indicates the possibility of damage to the device NOTE Places emphasis on an operating characteristic 2 1 Warnings This manual serves as a reference The instructions in this manual are not intended to supersede the institution s protocol regarding the use of the BiPAP Harmony S T ventilator The Harmony S T provides positive pressure ventilation and is indicated for assisted ventilation This system does not provide ventilation with guaranteed tidal volume delivery Patients requiring ventilation at predetermined tidal volumes are not candidates for pressure support ventilation The Harmony S T requires an intentional leak port exhalation port instead of an actively controlled exhalation valve to remove exhaled gases from the circuit Some Respironics masks have integrated exhalation ports and do not require the use of a separate exhalation device If the mask or flexible tubing does not have an integrated exhalation port an exh
23. Whisper Swivel or Disposable Exhalation Port and a Plateau Exhalation Valve at various IPAP EPAP settings Volume of Volume of CO CO Rebreathed Rebreathed per per breath breath Whisper Swivel Plateau Disposable Exhalation Exhalation Valve Port AAA ae ise Tose are ore 0 6 cc 8 cm H O 800 cc 1 3 cc 12 cm H O 800 cc 1 400 20 cm H O 800 cc 0 5 cc 20 cm H O 800 cc 0 1 cc 30 cm H O 800 cc 0 3 cc 30 cm H O 800 cc Chart 1 0 1 cc NOTE The information in Chart 1 was generated from laboratory testing using a constant respiratory rate of 20 BPM 1 2 ratio It does not account for the many variables that can affect the amount of CO rebreathing in actual use e g leak 9 3 Chart 2 compares the volume of CO rebreathed per breath for a Whisper Swivel or Disposable Exhalation Port and a Plateau Exhalation Valve at various inspiration times Harmony S T Clinical Manual Ventilatory Support System 9 4 Specifications Volume of Volume of CO CO Rebreathed Rebreathed per breath per breath Whisper Swivel Plateau Inspiration Disposable Exhalation Time Exhalation Valve Port 2 2 Chart 2 a NOTE The information in Chart 2 was generated from laboratory testing using a constant respiratory rate of 20 BPM with varying I E ratios It does not account for the many variables that can affect the amount of CO rebreathing in actual use e g leak
24. ainst harmful ingress of water Modes of Operation Electromagnetic Compatibility Fuses PRESSURE Output Dynamic Regulation Maximum Achievable Pressure Under Single Fault Condition 20 C to 60 C 15 to 95 Relative Non condensing 50 to 102 kPa 5 C to 40 C 15 to 95 Relative Non condensing 76 7 to 102 kPa 29 cmx 18 cm x 14cm 2 9 kg 100 to 240 V 50 60 Hz 12V 1 25 A maximum 5 5 A maximum Class II Device Type BF Applied Part Ordinary Equipment IPXO Continuous The BiPAP Harmony S T Ventilatory Support System meets the requirements of EN 60601 1 2 There are no user replaceable fuses 4 to 30 cm H O 5 cm H O 40 cm H O Har mony S T Clinical Manual Ventilatory Support System 92 Specifications CONTROL ACCURACY Rate 10 1 BPM of the set point TRIGGER SENSITIVITY Spontaneous Trigger Shape Trigger Volume 6 cc above V Flow Reversal leak Spontaneous Cycle Spontaneous Expiratory Threshold SET Shape Cycle IPAP maximum of 3 0 sec Control Ranges and Increments CONTROL PARAMETER RANGE TOLERANCE IPAP 4 to 30 cm H O 2 10 EPAP 4 to 15 cm H O 2 10 Timed Inspiration 0 5 to 3 0 sec 0 1 10 IPAP Rise Time 600 300 100 msec BiPAR en 5 Harmony S T Clinical Manual Specifications CO Rebreathing Charts Chart 1 compares the volume of CO rebreathed per breath for a
25. alation device must be added to the circuit The pressurized air from the Harmony S T causes a continuous flow of air to exhaust from the leak port flushing exhaled gas from the circuit The machine should be turned on and the intentional leak port should be checked before application The continuous flow of air through the leak port flushes exhaled gases from the circuit The ability to completely exhaust exhaled gas from the circuit is dependent upon the EPAP setting and I E ratio At low EPAP pressures or with short expiratory times i e high breathing rates the leak rate through the intentional leak port may be inadequate to clear all exhaled gas from the circuit Some rebreathing may occur If the patient is using a full face mask with the Harmony S T ventilator an entrainment valve must be used in the patient circuit to minimize the possibility of rebreathing CO The Harmony S T ventilator is intended for use with a Respironics Inc patient circuit only See Chapter 8 for approved patient circuit configurations and accessories Proper operation of the Plateau Exhalation Valve or any other exhalation port used with the Harmony S T must be regularly verified by inspection during use Occlusion or partial occlusion of the exhalation port may result in asphyxia To reduce the risk of contamination a low resistance main flow bacteria filter may be placed in line between the unit and the patient If the bacteria filter is used ver
26. ation ports or Respironics interface with separate exhalation device e heated humidifier Additional accessories may be added to the circuit to meet specific needs Every time changes are made to the circuit configuration the delivered pressures must be monitored with the unit operating Respironics circuit connectors comply with ISO 5356 1 or 5356 2 The BiPAP Harmony S T ventilator requires an intentional leak port either built into the mask or on a separate exhalation device e g Whisper Swivel II Plateau Exhalation Valve or Disposable Exhalation Valve to remove exhaled air from the circuit Therefore specific masks and circuits using an intentional leak port are required for normal operation The pressurized air from the Harmony S T ventilator causes a continuous flow of air to exhaust from the leak port to flush the exhaled air from the circuit The machine should be turned on and the intentional leak port should be checked before using the unit BiPAR En x Harmony S T Clinical Manual 8 2 Respironics interface with integrated exhalation port u or Respironics interface with separate exhalation device OOOO Bacteria 1 8 m Smooth Harmony S T i Filter Inner Lumen Ventilator Tubing Figure 8 1 Harmony S T Standard Circuit o pirani morana wih integrated exnalation por A T z _ or i Respironics interface with separate
27. d provides troubleshooting guidelines for mask discomfort Chapter 6 Provides information for adding oxygen to the Harmony S T patient circuit Chapter 7 Provides cleaning instructions and routine maintenance procedures Chapter 8 Describes the accessories and circuits to be used with the Harmony S T Chapter 9 Lists the Harmony S T specifications Chapter 10 Describes the Harmony S T performance verification NOTE Illustrations are for reference only Occasionally cosmetic changes may be made to the product that do not affect the performance or specifications of the product These kinds of changes do not warrant a reprinting of this manual so the illustrations may differ slightly from your unit Har mMony S T Clinical Manual Ventilatory Support System 1 4 Symbol Key 1 4 Symbol Key The following symbols are used on the Harmony S T ventilator Symbol Meaning N Attention consult accompanying documents Jo AC Power Indicator DC Power Indicator Alarms Patient Disconnect Alarm Disabled System Alarm Indicator START STOP Time at Pressure E E m Patient Alarm Indicator D de A Rise Time control patient comfort f Breaths Per Minute setting Ti Inspiratory Time Setting Type BF Applied Part 0 Class Il for Protection Against Electric Shock O X Oxygen Valve Inlet Optional Oxygen Valve gt Outlet Optional Oxygen Valve BiPAR a 7 Harmony S T Clinical Manual Product
28. exhalation device Harmony S T A Bacteria 45 7 cm Smooth 1 8 m Smooth Ventilator Filter Inner Lumen Inner Lumen Tubing Tubing Low Resistance ____ HC 100 Heated Humidifier Figure 8 2 Harmony S T Circuit with Heated Humidifier BiPAR en 5 Harmony S T Clinical Manual 8 3 8 2 Circuits and Accessories The following accessory items may be used with the BiPAP Harmony System Reusable or Disposable Circuit Reusable 1 8 m smooth inner lumen tubing exhalation port Accessories 15 2 cm disposable circuit tubing 45 7 cm disposable circuit tubing 1 8 m disposable tubing O enrichment attachment bacteria filter 8 3 Masks Exhalation Ports and Related Accessories Masks Respironics mask with built in exhalation ports or Respironics mask with separate exhalation device Accessories Disposable headgear Reusable headgear Chin strap Softcap Slip on spacers Quick Clip Comfort Flap mask accessory 8 4 Humidifiers Fisher amp Paykel HC 100 Heated Humidifier Har MONY S T Clinical Manual Ventilatory Support System BiPAR En s E Harmony S T Clinical Manual Chapter 9 Specifications ENVIRONMENTAL Operating Storage Temperature Humidity Atmospheric Pressure PHYSICAL Dimensions Weight ELECTRICAL AC Voltage DC Voltage AC Current DC Current Protection against electric shock Degree of protection against electric shock Degree of protection ag
29. id electric shock always switch the Harmony S T ventilator Start Stop Switch to the STOP position and disconnect the unit from the power source before cleaning or performing any routine maintenance CAUTION Do not immerse the Harmony S T ventilator or allow any liquid to enter the case or the inlet filter NOTE The following guidelines for cleaning refer to the Harmony S T ventilator only To clean the circuit accessories refer to each accessory s instruction sheet STEP 1 Clean the front panel as needed by wiping with a cloth dampened with water or 70 Isopropyl Alcohol only STEP 2 Clean the exterior of the enclosure as needed by wiping with an anti bacterial agent but do not allow liquid to enter the inside of the ventilator STEP 3 Allow the unit to dry completely before reconnecting power 7 2 Cleaning Replacing the Inlet Filters The Harmony S T ventilator uses two removable filters at the air inlet The gray pollen filter is washable and reusable The optional white ultra fine filter is disposable Filters may be obtained from the medical device supplier On a monthly basis clean the gray pollen filter replace the optional white ultra fine filter if necessary Always inspect the filters and replace them if they are damaged CAUTION Dirty inlet filters may cause high operating temperatures and may affect ventilator performance Examine the inlet filters for integrity and cleanliness monthly or sooner depending on the o
30. ify its proper operation Occlusion or partial occlusion can result in reduced air flow rmony S T Clinical Manual Ventilatory Support System 2 2 Warnings Warnings continued All patient settings must be determined via appropriate assessment and monitoring as determined by the prescribing physician The Harmony S T ventilator is not suitable for use in the presence of a flammable anesthetic mixture with air or with oxygen or nitrous oxide Oxygen supports combustion Oxygen should not be used while smoking or in the presence of an open flame If supplemental oxygen is added to the breathing circuit the optional oxygen valve must be installed and used as shown in Chapter 6 The valve automatically stops the flow of oxygen if the Harmony S T power is off The functionality of this machine may be adversely affected by the operation of high frequency diathermy equipment defibrillators or short wave therapy equipment in the general vicinity Do not use antistatic or electrically conductive hoses or tubing with the Harmony S T system In the event of a power failure an audible visual alarm will activate Disconnect the Harmony S T ventilator from the patient immediately As in most ventilators with passive exhalation ports when power is lost sufficient air will not be provided through the circuit and exhaled air may be rebreathed The air flow for breathing produced by this device can be as much as 10 C 18 F
31. imitation of incidental or consequential damages so the above limitation or exclusion may not apply to you This warranty is given in lieu of all other express warranties In addition any implied warranties including any warranty of merchantability or fitness for the particular purpose are limited to one year Some states do not allow limitations on how long an implied warranty lasts so the above limitation may not apply to you This warranty gives you specific legal rights and you may also have other rights which vary from state to state To exercise your rights under this warranty contact your local authorized Respironics Inc dealer or contact Respironics Inc at 1001 Murry Ridge Lane Murrysville Pennsylvania 15668 8550 1 412 731 2100 Har mMony S T Clinical Manual Ventilatory Support System BiPAR En s E Harmony S T Clinical Manual RESPIRONICS INC RESPIRONICS 1001 Murry Ridge Lane Deutschland Murrysville Pennsylvania Gewerbestrasse 17 15668 8550 U S A 82211 Herrsching Germany Ce 0123 1009763 LG 2 7 02
32. ircuit To add oxygen to the circuit a controlled low flow source is needed An oxygen source governed by a compensated flow meter assembly should be used Testing has shown that the performance of the system is not affected by the addition of a low flow up to 15 L min oxygen source to the patient circuit Step 1 As shown in Figure 6 1 attach oxygen tubing from the oxygen source to the rear oxygen valve port a From Oxygen A Source Circuit Tubing Oxygen Tubing from Oxygen Valve Oxygen Oxygen Enrichment Valve Attachment Figure 6 1 Methods of Adding Oxygen to the Patient Circuit Step 2 Connect a section of oxygen tubing to the front valve port then to one of the sample ports on the mask or to an O enrichment adaptor positioned in the patient circuit Step 3 Turn the Harmony S T ventilator on Step 4 Turn the oxygen flow to the desired setting BiPAR en 5 Harmony S T Clinical Manual Adding Supplemental Oxygen 6 3 NOTE When adding supplemental oxygen to the patient circuit the flow is gradually adjusted until the patient s oxygenation needs are ad equately met Patient monitoring should consist of patient observation and oximetry or arterial blood gas measurement as directed by the physician If adequate oxygenation cannot be achieved an alternate method of delivery should be considered Har MONY S T Clinical Manual Ventilatory Support System 6 4 Supplemental Oxygen Concentrations
33. mH20 41030 BPM 0 510 3 0 sec IPAP is set lower than EPAP both control LEDs flash and the pressure output is set to the IPAP level el To e When the unit is started if op the Rate or Timed Inspiration OFA have values that would cause the I E ratio to be greater than oe ai 1 1 both control LEDs flash ro me f y and the I E ratio is set to 1 1 5 _ i IE a O Beres Figure 4 6 Patient Settings The control LEDs are used to indicate gross inverse I E ratios Do not use the control LEDs to set the inspiratory time STEP 3 Close the parameter door and be sure it latches Before placing the patient interface on a patient verify the output pressures with a manometer connected at the patient interface Harmony S T Clinical Manual Ventilatory Support System 4 4 Setting the Patient Disconnect Alarm Delay 4 2 2 SETTING THE PATIENT DISCONNECT ALARM DELAY WARNING Always disconnect the Harmony S T from the power source Patient Disc nn ct before opening the access panel Alarm Delay Access Panel STEP 1 Disconnect the Harmony S T from the power source STEP 2 Pry open the access panel with a small screwdriver di open 77 a a NOTE Always verify that the Patient Disconnect Alarm functions properly when the patient circuit is connected Figure 4 7 Opening the
34. n through the hole in the control panel 3 1 4 START STOP Switcu The Start Stop rocker switch starts and stops the unit 3 1 5 POWER INDICATORS The power indicators show the presence and source of power connected to the Harmony S T unit The top indicator illuminates for AC power the bottom indicator illuminates for DC power 3 1 6 ALARM INDICATORS Two Alarm Indicators are included System and Patient The System Alarm Indicator lights when an internal error is detected or power is lost The Patient Alarm Indicator lights when a patient disconnect is detected See Chapter 5 for an explanation of all alarms 3 1 7 IPAP Rise TIME The IPAP Rise Time control varies the rate of change slow to fast of pressure during the transition from EPAP to IPAP The IPAP Rise Time control is intended as a patient comfort control Harmony S T Clinical Manual Ventilatory Support System Patient Circuit Connection and Rear Panel 3 3 3 2 Patient Circuit Connection The patient circuit is connected to the Patient Interface port Patient Interface Port Optional amp Oxygen Valve The Patient Interface port accepts a 22 mm I D tubing or an optional 22 mm I D bacteria filter 3 3 Rear Panel The rear panel contains e Patient Disconnect Alarm Delay access panel e AC inlet e DC inlet e Filter access panel Patient Disconnect Alarm Delay Access Panel
35. nitiate an inspiration within the interval determined by the Rate control the unit triggers a timed breath resulting in a pressure control pressure limited time cycled breath at the set IPAP level The rate of timed breaths can be adjusted from 4 to 30 BPM and the duration of each breath is controlled by an Inspiratory Time control See Figure 1 2 for an example of patient triggered and machine triggered breaths Example IPAP 14 cm H O EPAP 6 cm H O Rate 10 BPM PS 8cm H O Time Interval Exceeds Rate Setting 20 P ccm H20 approx 6 sec i rt gt o 4m tt 6 12 18 21 sec 15007 Vol m 1000 500 1 1 Spontaneously triggered pressure support breaths 2 Time triggered pressure limited time cycled breath Figure 1 2 Example of Patient Triggered and Machine Triggered Breaths Harmony S T Clinical Manual Ventilatory Support System Manual Overview 1 3 1 3 Manual Overview This manual describes the Harmony S T ventilator and its operation Chapter 1 Introduces the Harmony S T ventilator Chapter 2 Lists the Warnings Cautions Notes and Contraindications for the Harmony S T Also contains information concerning rebreathing Chapter 3 Provides an overview of the controls connections and outputs Chapter 4 Provides the set up start up and operating procedures for the Harmony S T and details the operation of the S T mode Chapter 5 Describes the alarms and alarm conditions an
36. perating environment STEP 1 Turn the Harmony S T ventilator Start Stop Switch to the STOP position and disconnect the unit from the power source Remove the filter cap by pressing down on the top of the cap to release the tabs then swinging the cap out from the unit s body Harmony S T Clinical Manual Ventilatory Support System Remove the filters from the enclosure The top filter is the reusable gray pollen filter The bottom filter is the optional disposable white ultra fine filter Examine the filters for cleanliness and integrity Reusable Pollen Fil Wash the pollen filter in warm soapy water Rinse thoroughly to remove all soap residue Allow the filter to completely dry before _ Disposable Ultra fine reinstalling it If the pollen filter is torn replace it Filter STEP 6 If the ultra fine filter is dirty or torn replace it STEP 7 Replace the filters with the ultra fine filter on the bottom STEP 8 Replace the filter cap BiPAR en 5 Harmony S T Clinical Manual 8 1 Chapter 8 Circuits and Accessories This chapter details the Respironics approved breathing circuits and accessories 8 1 Circuit Configurations The Harmony S T ventilator is intended for use with Respironics approved patient circuits as illustrated in Figures 8 1 and 8 2 The configuration components are e bacteria filter e 22 mm tubing with a smooth inner lumen e Respironics interface with integrated exhal
37. re operating the Harmony S T ventilator The gray pollen filter is washable and reusable The optional white ultra fine filter is disposable STEP 1 Place the pollen filter on top of the ultra fine filter STEP 2 Slide the filters into the air inlet at the rear of the unit as shown in Figure 4 1 Disposable Ultra fine Filter Inlet Filter Cover Figure 4 1 Installing the Air Filters STEP 3 Place the bottom of the inlet filter cover into the bottom of the air inlet opening making sure that the catches engage the lip of the opening STEP 4 Swing the top of the cover into place and press down on the cover to engage the catches in the air inlet opening Figure 4 2 Replacing the Filter Cover Harmony S T Clinical Manual Ventilatory Support System 4 2 Patient Circuit WARNING The exhalation port e g the Whisper Swivel II is designed to exhaust CO from the patient circuit Do not block or seal the gas vents on the exhalation port WARNING The oxygen valve must be installed and used if oxygen is to be titrated to the patient circuit See Chapter 6 for complete details NOTE Each time changes are made to the circuit configuration confirm the set and delivered pressures NOTE When setting up a patient on the Harmony device please ensure that in addition to following the setup guidelines detailed in this manual you have the patient when breathing spontaneously trigger the ventilator to IPAP Inspiration
38. tory phase Verify the IPAP and EPAP pressures with the manometer When you have established an IPAP EPAP pattern occlude the patient circuit Wait for the Harmony S T to establish a breathing pattern according to the settings of Step 4 e Verify that the Rate LED is illuminated in the Timed mode e Use a stopwatch to verify the accuracy of the Rate setting Reset the patient controls as follows e IPAP 25cmH O EPAP 15 cm H O e Rate 30 BPM e Timed Inspiration 3 0 sec e IPAP Rise Time Fast Step 10 Repeat steps 6 and 7 BiPAR Er X Harmony S T Clinical Manual 10 2 e Ifall of the parameters are within the stated operating specifications the system is ready for patient application e Adjust the settings to the appropriate level for patient application prior to placing the circuit on the patient Step 11 With the START STOP switch in the START position disconnect the power cord at the wall outlet Verify that a continuous alarm sounds for at least two minutes WARNING Ifthe Harmony S T ventilator fails to perform within the stated specifications have the system serviced by a qualified Respironics approved service facility Harmony S T Clinical Manual Ventilatory Support System I 1 A AC Inlet 3 3 AC Operation 4 5 Access Panel 4 4 Accessories Circuits 8 3 Exhalation Ports 8 3 Humidifiers 8 3 Masks 8 3 Accuracy Specifications 9 2 Air Vent 3 4 Alarm Indicators 3 2 Alarms 5 1
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