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NeoPAP Device User Manual

1. Setting ON Alarm Sound Auto Reset 5 1 0 uto Reset setting gt Auto Reset Setting Pat i Press v to change x Press to change Language Setting 4 x for menu Press to save Alarm Sound Gap 700 gt Patm 700 Auto Reset Setting gt Patm Press y to change X Press 2 to change Language Setting m Or x for menu r Press y to save MEN Y Alarm Sound Gap gt Language Setting English Language Setting English Auto Reset Setting Patm change Press to change gt Language Setting ra Or x for menu 4 Press to save 4 4 NeoPAP Neonatal CPAP User Manual Chapter 4 Setup Connecting to Air and Oxygen Supplies Connect high pressure oxygen and air supplies at the connections shown in the figure below O im O e BO oxygen supply connection S air supply connection Installing the Oxygen The NeoPAP System includes an oxygen sensor but the sensor does not come installed Sensor When setting up the system for the first time remove the sticker located inside the oxygen sensor compartment and install the oxygen sensor as described in Replacing the Oxygen Sensor in Chapter7 Maintenance Connecting a To connect a resuscitation or hyperinflation bag connect the bag s tubing connector to the Resuscitation or barb on the back panel Hyperinflation Bag resuscitation or
2. Parameter Range Resolution Accuracy 21 100 1 3 FIO in CPAP mode 5 FIO in flow mode Parameter Resolution Default Patient Pressure 2 4 cmH O 2 4 1 cmH O Alarm hPa around set CPAP to a minimum of 1 cm H O in CPAP mode as selected by the user 0 5 cmH O low 2 cmH O low pressure pressure 6 15 cmH O in Flow Mode high pressure in flow 8 cmH O high pres mode sure in Flow Mode Gas Temperature 2 5 around set 1 2 C Alarm future op temperature up to a tion maximum of 42 C Flow Alarm 2 L min Fixedat 2 L min 2 L min Gas Supply Alarms Activated when input gas pressure is below 30 psi 207 kPa or above 58 psi 400 kPa Dispose of the device and accessories in accordance with local regulations NeoPAP Neonatal CPAP User Manual Chapter 9 Accessories Use the NeoPAP System with the following Philips Children s Medical Ventures accessories Please contact your local Philips Children s Medical Ventures representative before using other accessories with the NeoPAP System Description Reorder Number NeoPAP Neonatal CPAP System USA Bonnet Extra Small Bonnet Extra Large Nasal Cannula Extra Small Nasal Cannula Small Nasal Cannula Medium Nasal Cannula Large Nasal Cannula Extra Large Mask Circuit Small Mask Circuit Large Delivery Circuit Adapter and Sizing Kit Replacement Bonnet Clips 20 pk NeoPAP Patient Interface Customer Trial Pack UK Ireland Power Cor
3. Power Supplies During Normal Operation If AC power is available the NeoPAP System runs on AC power During AC power operation the system recharges the internal battery If the system is turned with AC power connected AC appears on the message window If the system is turned off with AC power connected a battery filling icon appears on the message window indicating that charging is in progress When charging is complete a full battery icon is displayed If the internal battery has not successfully charged after 6 hours a Replace Battery alarm occurs and the battery icon flashes If AC power is not available the NeoPAP System runs on battery power NOTE A beep will sound every 10 seconds when the NeoPAP System is running on battery power The system will alarm approximately 2 minutes before full battery depletion If che battery voltage is fully depleted and AC power is not available gas delivery stops and then the system displays a shutdown message for 10 seconds before turning off 87 e o NeoPAP Neonatal CPAP User Manual 5 17 Chapter 5 5 18 This page is intentionally blank NeoPAP Neonatal CPAP User Manual Chapter 6 Alarms All alarms that occur with the NeoPAP system are treated as high priority alarms Whenever an alarm occurs an audible alarm sounds the message window displays the alarm and the alarm bar at the top front panel o
4. 8 2 DIS PO Sallis 8 2 Chapter 9 5 5 9 1 Appendix EMC 1 Appendix Elevation Settings cccsscsccccsssssssscsssssscsssssssccsssssesssssssessonsssees B 1 Appendix Maximum Leak Sensitivity by CPAP Setting C 1 DODIDpSsRuL ucils D 1 1 1 NeoPAP Neonatal CPAP User Manual al 9 5 md n This page is intentionally blank NeoPAP Neonatal CPAP User Manual Chapter 1 Introduction This chapter provides an overview of the NeoPAP device Package Contents The NeoPAP system includes the following components 1 NeoPAP Device 2 Oxygen sensor removal tool 4 3 Pole mounting bracket and cover installed 3 4 Internal battery 5 Start up part 6 User Manual CD ROM not shown 7 Fan filters installed 8 Quick start guide not shown 9 Two allen keys not shown 10 22 mm shim for use with NeoPAP IV Pole not shown The following accessories are required for operation of the system but packaged separately 1 AC Power cord 2 Airand oxygen hoses and fittings 3 Oxygen sensor not shown The following accessories are available and packaged separately 1 Remote alarm cables 2 IV Pole NeoPAP Neonatal CPAP User Manua
5. 5 3 5 4 Modes Of Operation eerte tete the 5 7 Normal Operation 5 7 Displays During Normal Operation eerte 5 7 Changing Between CPAP and Flow Mode esee 5 7 Entering Exiting Standby 5 8 Entering Resuscitation terrere 5 9 SUSPENSION of Operation titre 5 9 System Halt 5 10 DL EET HQ 5 11 System Shut DOW 5 11 ley M N 5 11 Changing CPAP 5 11 Changing Leak Sensitivity ertet 5 12 5 13 Changing Flow evel ccs tta tnit 5 13 Changing Flow Low Pressure LP and Flow High Pressure HP 5 14 Additional Menu Options 5 14 Changing MM 5 15 Changing FiO Setting from Resuscitation 5 15 Changing Settings in Standby Mode eerte 5 16 Power Supplies During Normal Operation eere 5 17 Chapter 6 Alarms rT 6
6. 2 Replace battery if necessary NeoPAP Neonatal CPAP User Manual 6 1 Chapter 6 Alarms Alarm Message Description Corrective Action Audio Visual Indicator Occlusion Possible blocked 1 Check delivery Audible Alarm delivery circuit or circuit and patient Message window patient interface interface tubing Gas delivery stops for kinks or until alarm condition occlusions is cleared O measurement is not displayed Flashing red alarm bar at top of device 2 Verify that the atmospheric pressure Patm setting in the configuration menu is within 50 hPa of ambient pressure 3 Replace delivery circuit or patient interface if necessary 4 The alarm reoccurs and gas delivery is halted if the alarm condition continues High Pressure Measured patient Check patient Audible Alarm pressure is above settings Verify that Message window the pressure alarm delivery tube or setting Alarm nasal cannula is tolerance and delay not covered or are selected in the obstructed View Alarm Settings menu Flashing red alarm bar at top of device Pressure bar Check nasal graph turns red cannula or mask tubing for water 6 2 NeoPAP Neonatal CPAP User Manual Alarm Message Description Corrective Action Audio Visual Indicator 1 Check patient and Leak Low Pressure High Flow Flow mode only Delivery circuit or patient interface disconnected is displayed Select leak delay i
7. should be even with the bottom of the infant s nose bonnet clip 2 Connect the patient interface to the delivery circuit Push the silicone plug of the patient interface securely on to the end of the delivery circuit adapter When connecting ensure that the arrow located below the exhalation port is lined up with the arrow on the a silicone plug exhalation port delivery circuit adapter patient interface pressure line silicone plug inspiratory line safety valve U e c NeoPAP Neonatal CPAP User Manual 5 5 Chapter 5 Operation b Secure the capstrap located on the patient interface connection to the delivery circuit adapter capstrap 3 Deliver CPAP by pressing the button the NeoPAP device Alarm Silence is automatically engaged for 2 minutes to accommodate patient set up After the patient interface is securely affixed to patient press the Alarm Reset button to cancel the alarm silence 4 Attach the nasal cannula or mask to the patient a Gently secure the cannula in the nose or mask over the nose b Gently pull the circuit along the face assuring a secure fit without excess tension 5 Secure the circuit tubing to the bonnet to maintain appropriate positioning at the nose a Using the detachable bonnet clips secure the circuit to the bonnet while maintaining the appropriate interface position b Reposition the bonnet
8. CPAP User Manual 6 7 Chapter 6 Alarms This page is intentionally blank 6 8 NeoPAP Neonatal CPAP User Manual Chapter 7 Maintenance Maintenance The following section contains instructions for user replaceable parts Any other service including repair and modification on this device should only be performed by qualified service technicians When returning parts for service only return the part that requires servicing ARNING To ensure correct operation perform all maintenance at the recommende Before opening the device to perform maintenance ensure Air and oxygen sup Every year or as Replace ply inlet filters needed Internal battery Every year or if the Replace Replace Battery alarm occurs Oxygen sensor Every year or as Replace and calibrate needed Device exterior As needed For external cleaning disinfection between uses wipe with a cloth or damp sponge using one of the following cleaning agents Water Hydrogen Peroxide 3 Soapy water or mild detergent 10 bleach solution 10 bleach 90 water 91 Isopropyl Alcohol Do not spray or immerse in water Do not allow liquid to penetrate the system WARNING Do not use any cleaning agents other than those listed above Patient Interface As needed For external cleaning disinfection between Exterior uses wipe with a cloth or damp sponge using one of the following cleaning agents Water 10 bleach solution 10 bleach
9. Children s Medical Ventures LLC 191 Wyngate Drive Monroeville PA 15668 USA NeoPAP Neonatal CPAP User Manual D 1 5 ES lt Warranty This page is intentionally blank D 2 NeoPAP Neonatal CPAP User Manual Index A AC Power Indicator 1 3 3 1 Air Supply Connection 3 2 4 5 Alarms High Air Supply Pressure 6 5 High 6 5 High Flow 6 4 High O Supply Pressure 6 4 High Pressure 6 2 Leak 6 3 Low Air Supply Pressure 6 5 Low Battery 6 1 Low FiO 6 6 Low Flow 6 4 Low O Supply Pressure 6 4 Low Pressure 6 4 No AC Power 6 6 No Internal battery 6 6 No O Sensor 6 4 Pressure Unstable Check Tube for Water CPAP Mode only 6 5 Occlusion Delivery Halted 6 2 Replace Battery 6 6 Unexpected Restart 6 1 Active Alarm 6 7 Alarm Reset 6 7 Alarm Silence 6 7 Alarm Pre silence 6 7 Alarm Sound Gap 4 3 Alarm Settings 5 14 Auto reset setting 4 3 Bonnet 5 3 Bonnet Clips 5 5 Capstrap 5 6 Calibration 7 5 Cautions 2 1 Configuration Menu 4 3 CPAP Level Changing 5 11 D Delivery Circuit Adapter 4 7 5 1 5 5 5 6 E EMC A 1 Enter Standby Mode 5 8 Exit Standby Mode 5 8 F Fan Filters 1 1 4 1 7 2 FiO Band 5 14 Flow Level Changing 5 13 H HP High Pressure Delay Setting 5 14 NeoPAP Neonatal CPAP User Manual 1 1 Index Internal Battery 1 1 5 16 6 6 7 1 7 2 7 3 8 1 IV Pole mounting bracket 1 1 3 2 4 1 L Light Level 5 14
10. Flow setting is now active U S e ct NeoPAP Neonatal CPAP User Manual 5 13 Chapter 5 Operation 4 Close the front door vk The Flow LP and Flow HP settings allow high and low pressure alarms to be set when the device is in flow mode This is different from CPAP mode where a pressure is set and an alarm is banded around the set pressure 1 From the current settings screen use the and V keys to scroll through the screens until Flow LP or Flow HP is displayed then press to proceed 2 Use the and V keys to adjust the value then press V to save and put the new setting into effect From both CPAP and Flow Mode the following menu setting can be selected and changed Sound Volume select this option to change the sound volume from 1 3 with 3 being the loudest Light Level select this option to set the message window to either Bright or Dim Alarm Settings The following table lists the CPAP mode menu functions To view and or change these settings scroll to the View Alarm Settings menu and press V to change a setting Menu Item Leak Delay HP Delay Setting LP Delay Setting Pressure Alarm Band FiO Band Function Selects the number of seconds 3 to 12 seconds that the leak must exceed the leak sensitivity setting before a leak alarm is activated Selects the number of seconds a high patient pressure condition must exist before an alarm is activated 0 to 10
11. Power On Off button 5 8 NeoPAP Neonatal CPAP User Manual Chapter 5 Entering Resuscitation Mode During normal operation CPAP or Flow mode resuscitation mode is available for emergency use WARNING A resuscitation or hyperinflation bag capable of operation with a 10 L min gas supply must be connected to the NeoPAP System before entering resuscitation mode 1 enter resuscitation mode press the Resuscitation mode button d located behind the door on the front of the device The message window displays this message 2 If is not pressed within 10 seconds the message window reverts to the current settings screen If proceed is pressed CPAP or Flow mode is exited and the system enters Resuscitation mode and the message window displays this message 3 During resuscitation mode the system delivers 10 L min of un humidified gas at the current FiO setting through the resuscitation port CPAP or Flow mode and pressure monitoring is suspended All alarms except the power and high and low oxygen supply alarms are disabled during resuscitation mode The system sounds a tone every 10 seconds during resuscitation mode 4 Check resuscitation mode functionality by entering resuscitation mode and verifying that gas flows into the resuscitation bag WARNING Oxygen should flow through the resuscitation port during resuscitation mode only Verify that no gas flows through the resuscitation port du
12. User Manual 2 3 Chapter 2 Warnings Cautions and Notes Operation Alarms and Messages Care and Maintenance 2 4 To reduce the risk of electric shock regularly inspect the AC power cord and verify that it is not frayed or cracked A potential hazard can exist if different alarm presets are used in the same or similar equipment in any single area e g ICU To reduce the risk of power failure monitor the battery s charge level The battery s operation time is approximate and is affected by NeoPAP settings discharge and recharge cycles battery age and ambient temperature Battery charge is reduced at low ambient temperatures or in situations where the alarm is continuously sounding CAUTIONS Ensure that any pole used to support the NeoPAP System can maintain 6 kg 13 2 lb at a height of 1 5 m 59 in at a tilt of 10 degrees to the vertical axis To prevent possible damage to the NeoPAP always secure it to its stand The NeoPAP System should not be used adjacent to or stacked with other equipment If adjacent use is necessary the NeoPAP System should be observed to verify normal operation CAUTION Never attempt to disconnect or connect the battery during operation as it has the potential to damage the device WARNING If AC power fails and the backup battery is depleted an audible and visual alarm annunciates for at least 2 minutes Immediately discontinue use and use an alternative means of respirato
13. cables Using cables other than those specified by Philips Children s Medical Ventures may result in increased magnetic emissions and or decreased electro magnetic immunity of the NeoPAP System Do not use this device close to MRI or high frequency devices such as electro surgery or diathermy equipment Do not use this device with anesthetic gases Do not use flammable disinfectants on or near this device Do not use antistatic or conductive hoses or conductive patient tubing with the device Before using the NeoPAP System on a patient allow the device to acclimate to conditions of use following transport or storage The NeoPAP CPAP device has been validated for use only with the NeoPAP patient interface and is not compatible for use with patient interfaces from other manufacturers The NeoPAP patient interface accessories have been validated for use only with the NeoPAP CPAP device and are not compatible for use with CPAP devices from other manufacturers The NeoPAP device and patient interface has been validated for use with the following humidifiers Fisher amp Paykel MR850 Humidifier and Fisher amp Paykel RT324 Breathing Circuit at NeoPAP CPAP settings of 4 to 10 cmH O and NeoPAP Flow mode settings of 5 to 7 L min Hudson RCI ConchaTherm Neptune Heater Humidifier REF 385 40 and Universal Neonatal Breathing Circuit REF 780 01 at NeoPAP CPAP settings of 2 to 10 cmH O and NeoPAP Flow mode settings of 3 to 7 L min CAUTIONS Because
14. hyperinflation bag connection NeoPAP Neonatal CPAP User Manual 4 5 Chapter 4 Setup Connecting the Before beginning the start up self test connect the start up part to the air delivery adapter and pressure barb Start up Part Connecting toa Humidifier To connect the humidifier to the NeoPAP device you will need the following accessories Delivery circuit adapter with pressure line Humidifier and delivery tubing 1 Connect the delivery tube which is connected to the humidifier to the modular air delivery adapter on the NeoPAP device The air delivery adapter accepts 15 mm outer diameter tubing fittings modular air delivery adapter delivery tube 4 6 NeoPAP Neonatal CPAP User Manual Chapter 4 Setup 2 Secure the smaller diameter pressure tube which is connected to the delivery circuit adapter to the pressure barb located on the bottom of the NeoPAP device pressure barb 3 Connect the delivery tube to the delivery circuit adapter delivery tube pressure line delivery circuit adapter 4 Connect the patient interface to the delivery circuit adapter For additional information on connecting the patient interface see Chapter 5 Operation NeoPAP Neonatal CPAP User Manual 4 7 Chapter 4 Setup 4 8 This page is intentionally blank NeoPAP Neonatal CPAP User Manual Chapter 5 Operation This chapter describes how to operate the NeoPAP System and navigate through the setting
15. message window as shown below NOTE The new CPAP setting value will flash and increase or decrease based on the direction in which the knob is moved 3 After the desired value is selected press the key The new CPAP setting is now active 4 Close the front door on the device NOTE If the V key is not pressed within 10 seconds of moving the cmH2O L min knob the message window will timeout and return to the previous screen The new CPAP setting will not be activated Changing Leak Sensitivity Leak sensitivity allows the leak alarm to be set to accommodate the estimated patient circuit leak or variations in a patient s breathing pattern Adjusting the leak sensitivity setting helps to avoid nuisance alarms Readjust leak sensitivity following any settings changes or patient interface adjustments Since the NeoPAP System automatically compensates for leaks it is not necessary to tighten the patient interface in order to reduce a leak It is preferable to adjust the leak sensitivity so that the leak does not cause nuisance alarms For example if the expected flow for a CPAP setting of 5 cmH 0 is 4 L min the actual measured flow of 8 L min would mean that the leak or estimated leak is 4 L min A leak sensitivity setting of 5 L min would mean that the leak alarm would be triggered when the total flow measured is greater than 9 L min or 5 L min above the expected flow for this setting NOTE The maximum leak sensisti
16. of the NeoPAP device by removing the four screws using one of the allen keys provided If NeoPAP IV pole 22 mm diameter is being used install the 22 mm shim to the pole to ensure proper fit If the diameter of the pole or vertical rail being used is 24 mm the 24 mm shim is needed Place the device in the desired location on the pole or rail Tighten the four screws to re install the bracket Ensure two fan filters are in place and place the pole mount cover over the mounting bracket Affix two screws and tighten in place The NeoPAP System can run AC wall or mains power or internal battery power The internal battery can run the system for two hours when fully charged 1 Install the internal battery For installation instructions see the Replacing the Internal Battery section in Chapter 7 Maintenance Plug the power cord into the bottom of the device as shown below Lock the power cord in place by tightening the screw on the power cord clamp Verify that the AC indicator is on when the power cord is connected to wall power that the battery indicator DC turns on and an alarm sounds when the AC power cord is disconnected and that the system continues to operate normally NeoPAP Neonatal CPAP User Manual Selecting Menu Items from the Configuration Menu Chapter 4 Setup The internal battery recharges when the system is connected to AC Power whether the system is turn
17. of the transmitter in watts according to the transmitter manufacturer Note 1 At 80 MHz and 800 MHz the separation distance for the higher frequency range applies Note 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people NeoPAP Neonatal CPAP User Manual Appendix Elevation Settings The table below lists the recommended device settings based on elevation Elevation meters Recommended Recommended Setting hPa Setting mmHg 803 m lt e ct 2 04 ct 5 NeoPAP Neonatal CPAP User Manual B 1 Appendix Elevation Settings This page is intentionally blank B 2 NeoPAP Neonatal CPAP User Manual Appendix Maximum Leak Sensitivity Setting by CPAP Setting CPAP Setting cmH 0 Maximum Leak Sensitivity Setting L min 4 402440008 9 M wn 4 e aS d lt e NeoPAP Neonatal CPAP User Manual C 1 Maximum Leak Sensitivity Setting by CPAP Setting This page is intentionally blank 2 NeoPAP Neonatal CPAP User Manual Appendix D Warranty Children s Medical Ventures LLC warrants the NeoPAP System to be free from defects in material and workmanship for a period of 12 months from the date of purchase provided that the un
18. on a patient familiarize yourself with this user manual particularly the safety considerations listed This manual is a reference only It is not intended to supersede your institution s protocol regarding the safe use of CPAP WARNING A warning indicates the possibility of injury to the user or operator CAUTION A caution indicates the possibility of damage to the device NOTE Emphasizes information of particular importance 5 08 2 CAUTION US federal law restricts this device to sale by or on the order of a physician General WARNINGS For optimal oxygen sensor accuracy and occlusion alarm accuracy the displayed pressure should be within 50 hPa 37 5 mmHg of ambient atmospheric pressure During startup the system displays the atmospheric pressure setting for example 1010 hPa If the setting needs adjusted use the configuration menu to enter the correct value An alternative means of respiratory support should be available whenever the is in use If a fault is detected the device disconnect the patient from it and immediately start respiratory support with such a device The NeoPAP must be removed from clinical use and serviced by Philips Children s Medical Ventures authorized service personnel All components of the patient interface are intended for single patient use only in a hospital environment do not attempt to sterilize or reuse on a different patien
19. rail mount accomodates diameter of 7 8 to 1 inch with use of shim Gas supply connections Determined by country and configuration Gas supply input pressures 50 to 70 psi 345 483 kPa Resuscitation mode output 10 L min flow Electrical Input range 100 240 50 60 Hz 2 480VA Internal battery backup Provides up to two hour of operation System automatically recharges internal battery when connected to AC power Remote alarm relay Rated current 0 5 A Rated voltage 250 V Fuse type 2 5A 250V Anti surge Type of Protection Against Class l Internally Powered Equipment Electric Shock Degree of Protection Against Type BF Applied Part Electric Shock Degree of Protection Against Drip Proof IPX1 Ingress of Water Standards Compliance This device is designed to conform to the following standards IEC 60601 1 2nd Edition Medical electrical equipment Part 1 General requirements for safety IEC 60601 1 2 2nd Edition General requirements for safety Collateral standard Electromagnetic compatibility Requirements and tests NeoPAP Neonatal CPAP User Manual 8 1 Chapter 8 Technical Specifications Pressure Control Accuracy Measured Patient Parameters Alarm Tolerances Disposal 8 2 Output 2 to 10 cmH O Parameter Range Resolution Accuracy 2 10 cmH O 1 cmH O 1 5 cmH O for peak inspiratory flow 3L min 2 3 cmH O for peak inspiratory flow 2 3L min
20. seconds 0 no delay Selects the number of seconds a low patient pressure condition must exist before an alarm is activated 0 to 10 seconds 0 no delay Selects the tolerance above or below the selected CPAP level 2 to 4 cmH O or 2 to 4 hPa beyond which a pressure alarm is activated Selects the tolerance above or below the selected FiO 5 to 10 beyond which an FiO alarm is activated 5 14 NeoPAP Neonatal CPAP User Manual Chapter 5 Changing FiO To change the FiO setting follow the steps below 1 Open the front door that covers the settings knobs The message window will read 2 Turn the O knob to adjust the setting up or down until the desired value is displayed NOTE The new FiO setting will flash and increase or decrease based on the direction in which the knob is moved 3 After the desired value is selected press new FiO setting is now active 4 Close the front door of the device NOTE If the V key is not pressed within 10 seconds of moving the O knob the message window will timeout and return to the previous screen The new FiO setting will not be activated NOTE When the knob is adjusted or after an occlusion alarm is reset extended delay of one minute will be set to allow the oxygen to settle at the new setting Changing FiO Setting from Resuscitation Mode 1 Open the front door that covers the setting knobs The d
21. 1 Active ri MU 6 7 iv NeoPAP Neonatal CPAP User Manual Allain 6 7 PAESI SIT RR 6 7 Alarm Pre silence es rettet nere 6 7 Serial Interface 6 7 Chapter 7 00 1 01 0 0 404808080 ette esee tens asset snas eset es asse essa 7 1 7 1 Recharging the 7 2 Replacing the Gas Supply Inlet Filters eee 7 2 Replacing the Fan Filters ree 7 2 Replacing the Internal Battery 7 3 Replacing the Oxygen 5 5 7 4 Calibrating the Oxygen Sensor 7 5 Chapter 8 Technical Specifications 2 4 4 41 1 1000249 1 10 9 eee eee teen nns ttn 8 1 EnV rO NEN A 2 r 8 1 A A 8 1 dg e M 8 1 Standards Combpllanee ca cerent 8 1 c 8 2 Control ursmE 8 2 Measured Patient Parameters esistere 8 2
22. 90 water Vinegar 5 acetic acid by volume WARNING Do not use any cleaning agents other than those listed above NeoPAP Neonatal CPAP User Manual 7 1 Chapter 7 7 2 Recharging the Battery To recharge the internal battery connect the system to AC power the system can be on or off for 6 hours Recharge the internal battery approximately every 3 months when storing the system for extended periods Replacing the Gas Supply Inlet Filters WARNING It is important to inspect and replace the gas supply inlet filters at the recommended intervals to avoid introducing foreign matter into the patient interface WARNING Do not disconnect the threaded adapters that are connected to the NeoPAP device as it could allow foreign matter to enter into the patient interface Inspect the gas supply inlet filters and replace every year following the instructions below 1 Disconnect the hose from the gas supply connection 2 Press the manual drain button at the bottom of the bowl to drain any water that may have accumulated in the bowl Unscrew the bowl from the connection Unscrew and remove the old filter then screw in the replacement filter Screw the bowl back into place Reconnect the gas supply connection Replacing the Fan Filters CAUTION Because some environments cause a quicker collection of lint and dust than others inspect the filters more often when
23. LP Low Pressure Delay Setting 5 14 Leak Delay 5 14 Leak Sensitivity 5 12 Language Setting 4 4 M Message Window 3 1 Modular Air Delivery Adapter 3 2 4 6 Mounting of Device 4 1 N Nasal Cannula 5 4 5 6 Nasal Mask 5 4 5 6 Oxygen Sensor 1 1 1 4 3 3 4 3 4 5 6 4 7 4 Oxygen Sensor Removal Tool 1 1 Oxygen Supply Connection 3 2 P Patm 4 4 Pressure Alarm Band 5 14 Plastic Cinch 5 6 Patient Interface Sizing 5 3 Pressure Barb 4 6 5 1 Pressure Bar Graph 3 1 Resuscitation Mode 5 7 5 9 Resuscitation Button 1 3 3 2 5 Serial Interface Remote Alarm 1 3 3 2 6 7 Settings Setting CPAP 5 11 Setting FiO 5 3 Setting Flow 5 3 Sound Volume 5 4 Standby Mode Changing Settings 5 16 Entering 5 8 Exiting 5 8 W Warnings 2 1 Warranty C 1 l 2 NeoPAP Neonatal CPAP User Manual PHILIPS Manufactured for Children s Medical Ventures LLC 191 Wyngate Drive Monroeville PA 15146 USA 1080726 HM 9 16 11
24. NOTE Gas therapy should always be started prior to placing the patient interface on the NeoPAP Patient patient Interface NOTE The patient interface includes the following Bonnet specially sized bonnet allows a secure yet non constricting fit of the nasal cannula or mask Patient circuit this circuit includes specially sized cannula or mask patient tubing and exhalation body plug Selecting Bonnet and Nasal Cannula Nasal Mask Circuit Size Bonnet 1 Measure the infant s head circumference at its largest point using the provided measuring tape 2 Select the appropriate bonnet based infant s head circumference The bonnet is available in five sizes See the sizing chart below Size Head Circumference cm Color x Patient Circuit 1 Use the measuring gauge included in the delivery circuit adapter kit to select the appropriate infant circuit mask or cannula The shaded area on the gauge represents the size of the infant s nares and the clear circles and triangles indicate the size of the uoneJedo cannula prongs and masks respectively Circuits are available in five nasal prong sizes and two mask sizes NeoPAP Neonatal CPAP User Manual 5 3 Chapter 5 Operation NOTE The NeoPAP system features Baby Trak software which allows the device to deliver the selected level of CPAP without requiring the patient interface to be fully sealed at the patient s nares o
25. NeoPAP Device User Manual PHILIPS Children s Medical Ventures For Technical Support Customer Service contact USA and Canada 1 800 345 6443 or 1 724 387 4000 Facsimile 1 724 387 5012 USA Philips Children s Medical Ventures 191 Wyngate Drive Monroeville PA 15146 Web address www philips com childmed 2011 Koninklijke Philips Electronics N V All rights reserved Table of Contents Chapter 1 1 1 Package Contents RR E TE 1 1 pA D 1 2 DIS T 1 2 dub rmt MUN 1 3 Display and Front Panel rtt tete ite reo 1 3 Rear and Side 5 enero tendi rotta 1 3 Patient e 1 4 Chapter 2 Warnings Cautions and 4 0 4 14 70 4 tnn sanno 2 1 Chapter 3 System 51 2 asas et 3 1 Front xcu Miu e 3 1 Display Control Buttons 3 1 3 1 Display Features A 3 1 NeoPAP System Setting 3 2 Bottom Panel FO atures eter 3 2 Rear Panel Fe
26. Philips Children s Medical Ventures external NeoPAP humidifier future option Pressure Flow Setting Control Adjusts the CPAP level from 2 to 10 cmH O 2 to 10 hPa in CPAP mode Adjusts the flow level from 3 L min to 7 L min in Flow mode Resuscitation Button Turns resuscitation mode on and off Power On Off and Standby Button Turns the system on and off When pressed during operation this button allows the user to select stand by mode or power off the device P Pressure line connection V Delivery tube connection Philips Children s Medical Ventures external NeoPAP humidifier cable connection future option AC Power cord connection with retaining clamp Oxygen supply connection Air supply connection Air Rear Panel Label IV Pole mounting bracket and cover Resuscitation or Hyperinflation bag connection 4 4 Serial Interface connection including remote alarm connection NeoPAP Neonatal CPAP User Manual Side Panel Features Power Sources Chapter 3 System Description 1 Internal battery compartment battery compartment oxygen sensor compartment g ei aS e 3 The NeoPAP System can access power from either an AC wall or mains power source or the internal battery internal battery supplies power to the system for two hours when AC power is not available See Connecting to Power in Chapter 4 Setup later in this manual for infor
27. allow for care procedures that require therapy to be stopped for a period of time The user can restart therapy with all previous settings by pressing the Standby Power On Off button While in Standby mode the user can change CPAP Flow and O settings and then restart therapy with the new settings by pressing the Standby Power On Off button Displays During Normal Operation The system displays either of these current settings windows during normal operation Changing Between CPAP and Flow Mode To change between CPAP and Flow mode follow the steps below 1 From CPAP mode the message window will read O 87 S e ct NeoPAP Neonatal CPAP User Manual 5 7 Chapter 5 Operation 2 Press the A key on the device until the Change Mode screen is displayed 3 Press V to change mode 4 Press until the desired mode is displayed 5 Press to save mode change The new mode is now active and the message window will show the new mode settings screen Entering Exiting Standby Mode To temporarily stop CPAP therapy to provide the patient other care procedures the NeoPAP device can be placed in Standby mode To enter Standby mode 1 Open the front door on the NeoPAP device and press the Standby Power On Off button The message window will show 2 Press the to proceed to Standby mode The device will display 3 exit out of Standby mode and resume therapy press the Standby
28. atures e 3 2 Side Panel 3 3 xo Elie 3 3 Chapter 4 Setup 4 1 WAIN Srani 4 1 DL 4 1 eee PERUENIRE PREISEN 4 1 Connecting 4 2 Selecting Menu Items from the Configuration 2 4 00 4 3 Scrolling through the Configuration Menu sss 4 4 Connecting to Air and Oxygen Supplies 4 5 Installing the Oxygen 5 4 5 Connecting a Resuscitation or Hyperinflation Bag seen 4 5 NeoPAP Neonatal CPAP User Manual al 9 gt 9 5 ct n Connecting the Start up 4 6 Connecting to 4 6 Chapter 5 5 1 5 1 Powering the Systemi Y 5 2 Connecting the NeoPAP Patient Interface 222 5 3 Selecting Bonnet and Nasal Cannula Nasal Mask Circuit Size 5 3 5 3 cures
29. clips as necessary to provide the best fit plastic cinch c Pull the plastic cinch towards the patient to secure the patient interface 6 If water begins to accumulate in the pressure line of the patient circuit unfasten the capstrap on the delivery circuit adapter until water is pushed out of the pressure line into the adapter Position the adapter to drain water out of the port Refasten the capstrap making sure it is securely in place 5 6 NeoPAP Neonatal CPAP User Manual Chapter 5 Modes of Operation Normal Operation The NeoPAP System features these operating modes e CPAP mode Provides positive pressure through nasal cannula or nasal mask The user selects the CPAP level 2 to 10 cmH O and O 21 100 Baby Trak automatic leak compensation is continuously active gt Flow mode Provides a fixed flow of gas through a nasal mask or cannula The user selects the flow 3 to 7 L min and O 21 100 e Resuscitation mode Provides 10 liters per minute L min of un humidified oxygenated air with an value between 21 100 through the resuscitation port for use with a resuscitation bag or hyperinflation bag Suspends CPAP or Flow mode and patient pressure until the user presses the resuscitation mode button again Standby Mode Allows the user to configure the device for a patient prior to patient arrival In addition from this mode the user can pause therapy to
30. ct the system to AC power and allow battery to recharge Replace battery if necessary Replace reconnect delivery tube if necessary Move system to a cooler or warmer room Turn system off and back on Provide alternate breath ing support and contact customer service Chapter 5 Settings System Shut Down 1 turn the system off press the Power On Off button The message window will read 2 Press the down arrow to select Power Off and press to turn off the device 3 If the system is connected to AC power the battery recharges To remove the system from AC power remove the AC power cord from the wall or the AC receptacle on the bottom of the NeoPAP System NOTE To prolong the life of the oxygen sensor cell run the system with 21 before shut down CPAP Mode NOTE Alarm detection is delayed following setting changes to allow new settings to take effect NOTE When using the knobs to change settings verify that the correct setting is displayed on the message window Changing CPAP level Follow these steps to change the CPAP level 1 Open the front door that covers the settings knobs The current message window displays 87 S e o NeoPAP Neonatal CPAP User Manual 5 11 Chapter 5 Operation 2 From the current settings screen turn the cmH O L min knob to adjust the setting up or down Turn the knob until the desired value is in the
31. d Denmark Power Cord Australia New Zealand Power Cord India South Africa Power Cord Italy Power Cord Argentina Power Cord Switzerland Power Cord NeoPAP IV Pole Shim 22mm NeoPAP IV Pole Shim 24mm Utility Basket for IV Pole Air Hose NIST x DIN Germany Air Hose NIST x UNI Italy Air Hose NIST x AFNOR France Air Hose NIST x NIST EU Air Hose NIST x BS UK Air Hose F DISS x DISS DV Canada Air Hose DISS HT x DISS HT U S A amp Others Air Hose NIST x AGA Scandanavia Air Hose SIS x SIS Australia gt o e 5 o NeoPAP Neonatal CPAP User Manual 9 1 Chapter 9 Accessories Description Reorder Number Fan Filter Replacement Kit Internal Battery Oxygen Sensor Tool Remote Alarm Cable Normally Closed NC Remote Alarm Cable Normally Open NO Remote Alarm Cable Open Platform OP Oxygen Sensor Door Internal Battery Door NeoPAP Carrying Case NeoPAP Dust Cover MR850 humidifier JHU Fisher amp Paykel Electrical Adapter for use with MR850 humidifier Fisher amp 1084286 Paykel MR850 Humidifier AEU Fisher amp Paykel 1084317 Pole Clamp for MR850 1084315 NeoPAP User Manual Domestic CD ROM 1080794 Philips Children s Medical Ventures continues to develop accessories for the NeoPAP System Contact your local representative for the latest accessories list 9 2 NeoPAP Neonatal CPAP User Manual Appendix A EMC Information This device is intended
32. d Buttons 4 Alarm Indicator Bar Located on the top center of the display this indicator turns red and flashes when an alarm is active whether or not alarm silence is in effect 5 Alarm Reset Removes all active and auto reset alarms from display 6 Alarm Silence Silences the audible portion of an alarm for two minutes g ei aS e 3 NOTE Each press of the SILENCE key restarts the two minute silence interval The SILENCE key indicator lights when the silence is active The SILENCE key is also used for if pressed when no alarm is active rm pre silence which provides two minutes silence Display Features 7 Pressure Bar Graph Lights to indicate measured patient pressure 8 AC Power Indicator Indicates the system is connected to AC power 9 Message Window Displays messages settings alarms and prompts 10 Battery Indicates the internal battery is installed 11 Displays the measured O of delivered gas During disconnect and occlusion alarm conditions or when the sensor is not installed the window displays NeoPAP Neonatal CPAP User Manual 3 1 Chapter 3 System Description Bottom Panel Features nu Bow M O Setting Control Adjusts the O level from 21 to 10076 Temperature Setting Control future option Adjusts the temperature of the delivered gas from 33 to 41 C when the NeoPAP is connected to a
33. ed on or off When the device is operating AC power will be displayed on the current settings screen When the device is operating using the internal battery the battery symbol will appear on the current settings screen You can use the configuration menu to select The time between alarm sound sequences Alarm auto reset or manual reset Ambient atmospheric pressure Patm setting Display Message window Language Enable Disable Philips Children s Medical Ventures Humidifer future option Follow these steps to use the configuration menu 1 Hold down the RESET key while turning the System 2 message prompts you to disconnect the patient and press to continue 3 Use the V keys to scroll through the configuration menu then press to select the menu item 4 Once you ve selected an item from the menu press to change the value or X to return to the configuration menu Use the A and V keys to scroll through the possible selections Press to select a setting or X to exit the item without making a change To resume normal operation after using the configuration menu turn the system off then back on again The following summarizes the configuration menu functions Menu item Function Alarm Sound Gap Sets the time between alarm sound sequences from 1 to 9 seconds The default setting is 7 seconds Auto Reset Setting Selects auto reset ON or manual res
34. en sensor connected Alarm tolerance is selected in the View Alarm Settings menu Internal battery may not be connected The battery icon flashes to indicate a battery fault AC mains power has just been lost Internal battery voltage depleted and cannot be recharged 1 Check that air and oxygen supplies are functional 2 Verify that the atmospheric pressure Patm setting in the configuration menu is within 50 hPa of ambient pressure 3 Recalibrate oxygen sensor 4 Replace oxygen sensor if necessary see Chapter 7 Maintenance Check internal battery connection Replace battery Check connection to AC power and ensure that AC power is functional Replace internal battery NeoPAP Neonatal CPAP User Manual Audible Alarm Message window Flashing red alarm bar at top of device FiO LED display turns red Audible Alarm Message window Flashing red alarm bar at top of device Audible Alarm Message window Battery icon illuminates at top of device and the AC icon disappears Audible Alarm Message window Flashing red alarm bar at top of device Chapter 6 Alarms Alarm When an alarm is active e The ALARM indicator bar flashes e The alarm message flashes on the message window and e The system sounds a repeating sequence of beeps The configuration menu allows you to select alarm volume and time between each sequence of beeps If an alarm auto r
35. ent alternative to shutting down the device is to put the device in Stand by mode which does not require the device to go through the start up self test 4 The NeoPAP System will then enter a self test mode During this self test the device will check for any disconnected gas or power supplies A message will display to alert the user to the items that are disconnected for example oxygen supply or AC power See Chapter 4 Setup for instructions on setting up the NeoPAP System before use NOTE Choosing to continue operation without any of these connected will disable alarms specific to the item s that is not connected As the device goes through self test the progress of the steps will be shown on the message window Once all steps are complete the device is ready for patient use 5 Once the system is ready for patient use this message appears 6 Disconnect the start up part from the bottom of the NeoPAP device 5 2 NeoPAP Neonatal CPAP User Manual Chapter 5 7 Connect the humidifier delivery tube and pressure line to the bottom of the NeoPAP device as shown in Chapter 4 Setup 8 Connect the patient interface to the delivery circuit 9 Press to deliver gas All alarms are automatically silenced for two minutes to avoid nuisance alarms during patient setup 10 Turn on the humidifier 11 The system is now ready to be connected to the patient FERE Connecting the
36. esets the ALARM indicator remains steadily lit and the alarm message is steadily displayed on the alarm screen to indicate that the alarm occurred The message window can display up to three alarm messages at a time listed in order of priority Alarm messages are not displayed on the screen if you are in the process of changing settings but audible and visual alarm indicators continue their normal operation 2 D 2 Alarm Reset Press RESET to clear audible and visual alarm indicators Pressing RESET cancels an alarm silence Al C Alarm S The SILENCE key silences the audible portion of an alarm for two minutes Pressing the SILENCE key again restarts the two minute timer The SILENCE key has no effect on the visual ALARM indicator The SILENCE key turns red when alarm silence is active The alarm silence time remaining is displayed in the message window Press the key when no alarms are active to silence any alarm that may occur in the two minutes following the key press Alarm pre silence is useful for avoiding nuisance alarms during certain procedures The alarm pre silence time remaining can be viewed by pressing the A Press the key when alarm pre silence is no longer required face Connection The serial interface connection allows the NeoPAP system to connect to a remote alarm monitoring station The connector also includes serial communications output for service purposes NeoPAP Neonatal
37. et OFF for patient pressure temperature flow and oxygen alarms All other alarms are auto reset The default setting is ON NeoPAP Neonatal CPAP User Manual 4 3 Chapter 4 Setup Menu item Function Selects the ambient atmospheric pressure setting of 800 to 1070 hPa 600 to 802 5 mmHg The system displays the current Patm setting during startup This setting allows more accurate oxygen sensor readings and does not affect the O delivered by the NeoPAP System For best accuracy use a local barometric measurement rather than published meteorological pressures which represent atmospheric pressure at sea level The default setting is 1010 hPa 757 6 mmHg Language Setting Selects the language The new selection takes effect when the system is powered off and then back on The default setting is English Humidification Enables Disables the Philips Children s Medical Ventures humidifier future option This setting should remain in the default Off mode If the setting is changed to On the heat icon on the front display will appear but it will have no impact on the safety and efficacy of the device or the external humidifier gt Alarm Sound Gap gt Alarm Sound 1 Alarm Sound Gap 1 Auto Reset Setting Patn Press change Press to change Language Setting Or x for menu Press to save t
38. f the device will flash red The message window can display up to three alarm messages at a time listed in descending order of priority The table below shows the priority order starting with highest If an alarm occurs with higher priority than the three being displayed on the message window it is inserted on the display and the lowest priority alarm is removed until space becomes available again When more than one corrective action is listed follow them in order until the alarm is resolved If the suggested corrective actions do not resolve the problem provide alternate breathing support and contact a qualified service technician Alarm Message Description Corrective Action Audio Visual Indicator Any alarm not listed here Provide Audible Alarm alternate Message window breathing Flashing red support alarm bar at top and contact of device customer service Unexpected Restart Internal fault or 1 Verify internal Audible Alarm system connection battery Message window to AC power connection then without internal cycle power battery or internal battery disconnected then Flashing red alarm bar at top 2 If alarm persists of device provide alternate breathing support and contact service reconnected Low Battery Less than 2 minutes 1 Connect the Audible Alarm of battery power system to AC Message window remain power and Flashing red alarm bar at top of device allow battery to recharge
39. for use in the electromagnetic environment specified below The user of this device should make sure it is used in such an environment Emissions Test Compliance Electromagnetic Environment Guidance RF emissions Group 1 The device uses RF energy only for its internal function CISPR 11 Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF emissions Class A The device is suitable for use in all establishments other CISPR 11 Ee 55 than domestic and those directly connected to the public Harmonic emissions Class low voltage power supply network that supplies buildings IEC 61000 3 2 p used for domestic purposes Voltage fluctuations Flicker Complies emissions IEC 61000 3 3 m ES 5 D NeoPAP Neonatal CPAP User Manual A 1 Appendix EMC Information A 2 This device is intended for use in the electromagnetic environment specified below The user of this device should make sure it is used in such an environment Immunity Test Electrostatic Discharge ESD IEC 61000 4 2 Electrical Fast Transient Burst IEC 61000 4 4 Surge IEC 61000 4 5 Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 Power frequency 50 60 Hz magnetic field IEC 61000 4 8 IEC 60601 Test Level 6 kV contact 8 kV air 2 kV for power supply lines 1 kV for input outp
40. iance Electromagnetic Environment Guidance Level Level Portable and mobile RF communications equipment should be used no closer to any part of the device including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Conducted RF 3 Vrms Recommended separation distance IEC 61000 4 6 150 kHz to 1 2 4 150 kHz to 80 MHz 80 MHz Radiated RF IEC 61000 4 3 3V m d 80 MHz to 2 5 GHz d 1 2 JP 80 MHz to 800 MHz 2 3 800 MHz to 2 5 GHz Where P is the maximum output power rating of the transmitter in watts according to the transmitter manufacturer and d is the recommended separation distance in meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey 2 should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol is NOTE 1 80 MHz and 800 MHz the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic e
41. ice Audible Alarm Message window Flashing red alarm bar at top of device Audible Alarm Message window Flashing red alarm bar at top of device Chapter 6 Alarms Alarm Message Description Corrective Action Audio Visual Indicator Pressure Unstable Circuit conditions 1 Check patient Audible Alarm Check Tube for may cause instability settings Verify that Message window Water in the level of delivery tube or Flashing red CPAP mode only delivered CPAP nasal cannula is alarm bar at top not covered or af device obstructed Pressure bar 2 Check nasal graph turns red cannula or mask tubing for water High FiO Measured is 1 Check that air and Audible Alarm above the oxygen supplies Message window setting are functional Alarm tolerance is selected in the View Alarm Settings menu Flashing red 2 Verify that the alarm bar at top atmospheric of device pressure Patim FiO LED display setting in the configuration menu is within 50 hPa 37 5 mmHg of ambient pressure turns red Recalibrate oxygen sensor Replace oxygen sensor if necessary see Chapter 7 Maintenance NeoPAP Neonatal CPAP User Manual 6 5 sulJe v Chapter 6 Alarms 6 6 Alarm Message Description Corrective Action Audio Visual Indicator Low FIO No internal battery No AC Power Replace Battery Measured O is below the O alarm setting Disabled if operator chooses to turn on without oxyg
42. isplay will read 87 e mf o NeoPAP Neonatal CPAP User Manual 5 15 Chapter 5 Operation 2 Turn the O knob to adjust the setting up or down until the desired value is displayed NOTE The new FiO setting will flash and increase or decrease based on the direction in which the knob is moved 3 After the desired value is selected press The new FiO setting is now active and will remain active when Resuscitation mode is exited NOTE If the V key is not pressed within 10 seconds of moving the O knob the message window will timeout and return to the previous screen The new FiO setting will not be activated Changing Settings in Standby Mode To change settings during Standby mode follow the steps below 1 While in Standby mode turn the cmH O L min knob The message window will show the current CPAP or Flow and FiO settings For example if the device was in Flow mode prior to Stand by mode and the user wants to change the Flow settings they would turn the cmH O L min knob until the desired value appears as shown in the following graphic 2 After the desired value is selected press the key The new Flow setting will be active when the device exits Standby mode NOTE If the V key is not pressed within 10 seconds of moving the knob the message window will timeout and return to the Standby mode screen 5 16 NeoPAP Neonatal CPAP User Manual Chapter 5
43. it is operated under conditions of normal use as described in this manual At its discretion Children s Medical Ventures LLC will make replacements repairs or issue credits for equipment or parts that are found to be defective The warranty set forth above is the sole and exclusive warranty with respect to the product and Children s Medical Ventures LLC does not make and hereby specifically disclaims all other warranties express or implied including without limitation any implied warranty of merchantability or implied warranty of fitness for a particular purpose The repair replacement or credit remedy set forth above will be the sole remedy for breach of warranty In no event shall Children s Medical Ventures LLC be liable for lost profits loss of good will or incidental or consequential damages even if Children s Medical Ventures LLC has been advised of the possibility of the same Exclusions This warranty does not apply to any unit or individual parts which have been repaired or altered in any way that in Children Medical Ventures LLC s judgment affect its ability or reliability or which has been subjected to misuse negligence abuse or accident Unauthorized service and or failure to perform periodic maintenance may void this warranty This warranty does not cover damage that may occur in shipment To exercise your rights under this warranty contact Children s Medical Ventures LLC at the address below
44. l 1 1 Chapter 1 Introduction About NeoPAP Intended Use 1 2 The NeoPAP Neonatal CPAP System provides breathing support for infants weighing less than 5 kg The NeoPAP Baby Trak feature actively regulates pressure at all times eliminating the need for a closely fitted patient interface that can damage fragile tissues The NeoPAP System provides continuous positive airway pressure CPAP for use with a nasal cannula or mask A compact patient interface allows the infant to move with minimal restriction The NeoPAP System also offers a constant flow mode and a resuscitation mode for use with resuscitation or hyperinflation bags as well as a stand by mode to pause therapy to accommodate other patient procedures The NeoPAP System alarms when pressure levels or oxygen concentration are above or below alarm limits The system also detects occlusion disconnect or other alarm conditions The system displays a real time bar graph that indicates delivered pressure The NeoPAP System includes alarm silence and alarm pre silence features Battery backup provides up to two hours of backup power in case AC power is not available for example during transport within the hospital Intended to provide CPAP Continuous Positive Airway Pressure for use in hospitals to treat newborns and infants with RDS Respiratory Distress Syndrome or who are recovering from RDS NeoPAP Neonatal CPAP User Manual Symbols Chapter 1 Introduction De
45. l Ventures approved fan filters Because some environments cause a quicker collection of lint and dust than others inspect the filters more often when needed To prevent possible damage to the NeoPAP always ship it with the original packing material If the original material is not available contact Philips Children s Medical Ventures to order replacements Service including repair and modification on this device should only be performed by qualified service technicians See the Chapter 7 Maintenance for user replaceable parts and instructions NeoPAP Neonatal CPAP User Manual Chapter 2 Warnings Cautions and Notes This page is intentionally blank 2 6 NeoPAP Neonatal CPAP User Manual Chapter 3 Front Panel Features System Description This chapter describes the front bottom and rear device controls connections and features WARNING To avoid damage to the user interface do not use pens or other sharp objects to change settings The front panel contains the control buttons visual indicators and display screen Display Control Buttons These buttons are used to navigate the display and change settings 1 Clear Cancels a change that has not been accepted 2 Accept Proceed Selects a new configuration or proceeds to the next step 3 Up Increase and Down Decrease Moves sequentially backward forward through the items in a screen or increases decreases a numerical value Alarm Indicators an
46. lay window indicating that the battery was installed properly Replace the oxygen sensor every year or as needed 1 Turn the system off and disconnect AC power cord 2 Loosen the screw using a screwdriver to remove the right side panel when facing the front panel from the system cable NeoPAP Neonatal CPAP User Manual Chapter 7 Maintenance 3 Insert the oxygen sensor tool into the top of the oxygen sensor Use the marker notch and arrow marker etching on the tool to determine the proper orientation Remove the oxygen sensor from the socket by rotating counterclockwise lt E 5 fad 5 4 Insert new oxygen sensor into the socket secure the sensor using the oxygen sensor tool and plug the cable into its connector 5 Replace the side panel and tighten the screw to secure 6 Calibrate the oxygen sensor see Calibrating the Oxygen Sensor later in this section Calibrating the Oxygen Sensor NOTE Before calibrating the Oxygen Sensor reference the atmospheric pressure specifications in Chapter 8 Specifications Calibrate the oxygen sensor whenever a new sensor is installed or as required CAUTION Always run the unit for 30 minutes prior to performing calibration NOTE The system may alarm during warm up when a new oxygen sensor has been installed but has not yet been calibrated 1 Ensure that the air and oxygen gas supplies are connected and that start up part is con
47. low rate is 2 L min below the flow setting Oxygen sensor disconnected or depleted Oxygen supply pressure is below 30 psi 207 kPa Disabled if operator chooses to power up without oxygen supply connected Oxygen supply pressure is over 58 psi 400 kPa Air supply pressure is below 30 psi 207 kPa Disabled if operator chooses to turn on without air supply connected Air supply pressure is over 58 psi 400 kPa Check gas supply Press RESET to resume normal operation without oxygen sensor O display shows 2 Check oxygen sensor connection 3 If necessary replace and recalibrate Check oxygen supply connection and ensure that oxygen supply is within specified range of 50 70 psi 345 483 kPa Check oxygen supply connection and ensure that oxygen supply pressure is within specified range of 50 70 psi 345 483 kPa Check air supply connection and ensure that air supply pressure is within specified range of 50 70 psi 345 483 kPa Check air supply connection and ensure that air supply is with in specified range of 50 70 psi 345 483 kPa NeoPAP Neonatal CPAP User Manual Audible Alarm Message window Flashing red alarm bar at top of device Audible Alarm Message window Flashing red alarm bar at top of device Audible Alarm Message window Flashing red alarm bar at top of device Audible Alarm Message window Flashing red alarm bar at top of dev
48. mation NeoPAP Neonatal CPAP User Manual 3 3 Chapter 3 System Description 3 4 This page is intentionally blank NeoPAP Neonatal CPAP User Manual Chapter 4 Setup This chapter provides instructions on how to assemble the NeoPAP System It includes the following setup information Mounting Connecting to power Selecting menu items from the configuration menu Connecting to air and oxygen supplies Connecting a resuscitation or hyperinflation bag Connecting start up part Connecting to a humidifier To avoid the risk of personal injury or equipment damage Set up the device so that tubes wires and hoses do not pose a tripping hazard Use proper technique for lifting the device Lower the device on the pole to improve stability during transport Unpacking When unpacking the NeoPAP System ensure that all parts listed on the packing list are included in the shipment Inspect all parts for damage before use and immediately report any discrepancies to your Philips Children s Medical Ventures representative Mounting The NeoPAP device can be mounted to a pole or vertical rail mounting bracket fan filters shim IV Pole IV pole mount cover NeoPAP Neonatal CPAP User Manual 4 1 Chapter 4 Setup Connecting to Power 4 2 Remove the IV pole mount cover on the back of the NeoPAP device by removing the two screws using one of the allen keys provided Remove the mounting bracket from the back
49. n the View Alarm Settings menu Measured patient pressure is below the pressure alarm setting Alarm tolerance and delay are selected in the View Alarm Settings menu Measured flow rate is 2 L min above the flow setting reconnect tubing or nasal cannula nasal mask N Verify that size of nasal cannula nasal mask is appropriate to avoid excessive leakage Adjust leak sensitivity setting to make alarm less sensitive See Changing Leak Sensitivity CPAP mode only in Chapter 5 Operation A Verify that the atmospheric pressure Patm setting in the configuration menu is within 50 hPa 37 5 mmHg of ambient pressure 1 Check the nasal cannula or nasal mask fit for excessive leaks 2 Check that delivery tube circuit is properly connected Provide alternative breathing support and contact service NeoPAP Neonatal CPAP User Manual Chapter 6 Alarms Audible Alarm Message window Flashing red alarm bar at top of device Audible Alarm Message window Flashing red alarm bar at top of device Pressure bar graph turns red Audible Alarm Message window Flashing red alarm bar at top of device 6 3 Chapter 6 Alarms Alarm Message Description Corrective Action Audio Visual Indicator Low Flow Flow mode only No Sensor Low O Supply Pres High O Supply Pres Low Air Supply Pres High Air Supply Pres 6 4 Measured f
50. nected to the system 2 To enter service mode turn the system on while holding down the key 3 When you see this message Press V to confirm that no patient is connected NeoPAP Neonatal CPAP User Manual 7 5 Chapter 7 Maintenance 7 6 4 At the service mode menu select Calibrate O Sensor then press to start the calibration 5 During the calibration which takes three minutes do not disconnect the air or oxygen gas supplies 6 When the calibration is complete this message appears in addition to technical information on the sensor 7 Turn the system off then on to resume normal operation NOTE The NeoPAP System checks oxygen sensor calibration every time the system turns on To perform an additional check of oxygen sensor calibration set O to 100 then disconnect the air supply from the system The window should show a value from 97 to 100 O NeoPAP Neonatal CPAP User Manual Chapter 8 Technical Specifications Environmental Operating Storage Temperature 41 to 95 F 5 35 C 4 to 140 F 20 to 60 C Relative Humidity 15 95 15 95 Atmospheric Pressure 815 to 1100 cmH O 800 to 1070 hPa Physical Dimensions 13 8 x 9 0 x 7 3 in 35 0 x 23 0 x 18 5 cm Weight Approximately 11 Ibs 5 05 kg Mechanical pop off valve opens during fully occulded exhalation tube condition Patient pressure will never exceed 40 cmH O 39 2hPa Mounting Pole or
51. needed CAUTION To ensure proper system performance only use Philips Children s Medical Ventures approved fan filters 1 Turn the system off and disconnect AC power cord 2 Remove the two screws that connect the IV pole mount cover to the back of the NeoPAP 3 Remove the IV pole mount cover from the back of the device to provide access to the fan filters 4 Remove the old fan filters and replace with new filters 5 Place the IV pole mount cover on the back of the NeoPAP device Affix the two screws and tighten in place NeoPAP Neonatal CPAP User Manual Chapter 7 Maintenance Replacing the Internal Battery CAUTION Never attempt to disconnect or connect the battery during operation as it has the potential to damage the device Replace the battery pack every year or when battery voltage remains low after recharge 1 Turn the system off and disconnect AC power cord 2 Loosen the screw using a screwdriver to remove the left side panel when facing the front panel from the system K4 e D 3 Carefully unplug the battery cable and lift the old battery 4 Insert a new battery and plug the battery cable into its connector NeoPAP Neonatal CPAP User Manual 7 3 Chapter 7 Maintenance 7 4 5 Replace the side panel and tighten the screw to secure 6 Reconnect the AC power cord 7 Verify that the Battery icon appears on the message disp
52. nvironment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the device is used exceeds the applicable RF compliance level above the device should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as re orienting or relocating the device b Over the frequency range 150 kHz to 80 MHz the field strengths should be less than 3 V m m ES 5 D NeoPAP Neonatal CPAP User Manual A 3 Appendix EMC Information The device is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of this device can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and this device as recommended below according to the maximum output power of the communications equipment Rated Maximum Power Separation Distance According to Frequency of Transmitter Output of Transmitter 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz dz 1 2 1 2 4 For transmitters rated at maximum output power not listed above the recommended separation distance 4 meters be estimated using the equation applicable to the frequency of the transmitter where is the maximum output power rating
53. r around the nose Connecting the Interface Before connecting the interface inspect the mask or nasal cannula and replace if it is hardened or torn or if any parts are broken WARNING To avoid the possibility of damage to the infant s septum the infant should be checked regularly to ensure all connections including the mask and or prong position are secure Ensure that the infant s nose is not pushed upwards and that the nasal area is clean and dry Gentle massage may be useful to stimulate circulation to the infant s tissues WARNING Ensure that the bonnet fits over the infant s forehead covering the ears which should lie flat against the infant s head The infant s eyes should be clearly visible 1 Place the bonnet on the infant a Open the bonnet and place it on the mattress b hook and loop attachment c Gently close the bonnet by bringing the sides together on the infant s forehead To fit the bonnet make sure the infant s ears lie flat A hook and loop attachment holds the bonnet in place Make sure there is no exposed portion of hook material touching the infant s skin as this could cause irritation 5 4 NeoPAP Neonatal CPAP User Manual Chapter 5 NOTE Do not overtighten the bonnet d Place the bonnet clips in the desired location and orientation on the bonnet as shown below For proper orientation of the bonnet clips the bottom of the clip
54. rcuit tubing connects the humidifier to the modular air delivery adapter and connects to the delivery circuit adapter Pressure barb the pressure line on the delivery circuit adapter connects to the pressure barb located on the bottom of the NeoPAP device Delivery circuit adapter with pressure line the delivery circuit adapter connects to the NeoPAP interface In addition the delivery circuit tubing connects to the delivery circuit adapter and the pressure line coming from the delivery circuit adapter connects to the pressure barb on the bottom of the NeoPAP device Once the NeoPAP System is set up follow these steps to start operation e c NeoPAP Neonatal CPAP User Manual 5 1 Chapter 5 Operation Powering the System 1 Open front door on the NeoPAP device and press the Power On Off button On dy to power the system on During startup two distinct beeps sound to verify alarm functionality cmH 0 L min 1 f N Resuscitation Power On Off 2 The message window will show 3 Connect the start up part to the modular air delivery adapter and pressure barb on the bottom of the NeoPAP device as shown in Chapter 4 Setup and press V to proceed WARNING Ensure that the start up part is not obstructed during startup NOTE Each time the NeoPAP device is powered off and then back on the system must complete the start up self test before the device can deliver gas to the pati
55. ring CPAP and Flow modes 5 To exit Resuscitation mode and resume normal operation according to the previous settings press the Resuscitation mode button again Suspension of Operation Under certain conditions the system suspends operation during system startup or respiratory support When the system halts it sounds an audible alarm tone and requires your intervention to resume normal operation Follow the corrective actions in order until normal operation resumes NeoPAP Neonatal CPAP User Manual 5 9 U S e ct Chapter 5 Operation 5 10 Message High Air Supply Pres High O Supply Pres System Halted Battery Depleted System Halted Check Delivery Tube System Halted Room Temperature Turn unit off and on System Halted Call Service Description Air supply pressure is over 93 psi 641 kPa Oxygen supply pressure is over 93 psi 641 kPa Internal battery voltage is depleted System displays message for 10 seconds then turns off Delivery tube disconnected during operation Gas delivery and measurement suspended Ambient temperature out of range Gas delivery and measurement suspended NeoPAP Neonatal CPAP User Manual Corrective Action Check air supply connection and ensure that air supply is within specified range of 50 70 psi 345 483 kPa Check oxygen supply con nection and ensure that oxygen supply is within specified range of 50 70 psi 345 483 kPa Conne
56. ry support WARNING reduce the risk of fire explosion leakage or other hazard take these precautions with respect to the battery Do not attempt to disassemble open drop crush bend or deform insert foreign objects into puncture or shred the battery pack modify or remanufacture it immerse or expose it to water or other liquids expose it to fire excessive heat including soldering irons or put it in a microwave oven Do not attempt to connect incorrectly Replace the battery only with another battery specified by the manufacturer Follow all instructions for proper use of the battery Do not short circuit the battery or allow metallic or conductive objects to contact the battery connector housing Use the battery with the Philips Children s Medical Ventures NeoPAP only NeoPAP Neonatal CPAP User Manual Chapter 2 Warnings Cautions and Notes CAUTIONS Do not attempt to sterilize or autoclave the To prevent possible damage to the user interface take care when cleaning it After cleaning and rinsing remove all moisture with a dry soft cloth Never clean the user interface with an abrasive brush or device since this will cause irreparable damage To avoid introducing foreign matter into the NeoPAP and to ensure proper system performance change the air inlet filter at regular intervals See Chapter 7 Maintenance To ensure proper system performance only use Philips Children s Medica
57. s on the message window screen It includes the following information Powering the System On Connecting the Patient Interface Modes of Operation Settings Warnings For optimal oxygen sensor accuracy and occlusion alarm accuracy the displayed pressure should be within 50 hPa of ambient atmospheric pressure During startup the system displays the atmospheric pressure setting for example 1010 hPa If the setting needs to be adjusted use the configuration menu to enter the correct value For more information see the Selecting Menu Items from the Configuration Menu section in Chapter 4 Setup NOTE 1 hPa 1 mbar 1 022 cmH O Ensure that a patient is not connected to the NeoPAP System during start up self test Do not operate the NeoPAP without an internal battery or oxygen sensor installed NOTE The NeoPAP System cannot complete its start up self test unless the start up part is correctly installed NOTE Ensure that the internal battery and the oxygen sensor are installed If the internal battery or oxygen sensor is not installed STOP Refer to Chapter 7 Maintenance for instructions on installing either of these items before proceeding NOTE The delivery tube connection includes the following Modular air delivery adapter the delivery circuit tubing from the humidifier connects to the modular air delivery adapter located on the bottom of the NeoPAP device Delivery circuit tubing the delivery ci
58. sal CPAP therapy include pneumothorax nasal obstruction gastric distention nasal necrosis and necrosis of the nasal septum To avoid the possibility of damage to the infant s septum the infant should be checked regularly to ensure all connections including the mask and or prong position are secure Ensure that the infant s nose is not pushed upwards and that the nasal area is clean and dry Gentle massage may be useful to stimulate circulation to the infant s tissues Ensure that the bonnet fits over the infant s forehead covering the ears which should lie flat against the infant s head The infant s eyes should be clearly visible To reduce the risk that the patient will aspirate condensed water from the breathing circuit position any humidifier lower than both the NeoPAP device and the patient Only use supplied gas fitting that are connected to the regulators Do not attempt to remove the fittings Only use hoses whose gas fittings correspond to the gas connectors installed on the NeoPAP System Any additional accessories in the patient interface may substantially increase flow resistance and impair respiratory support To prevent unintentional disconnection of the power cord always use the correct manufacturer supplied power cord and lock it into place with the power cord clamp before turning on the NeoPAP The clamp is designed to hold the connector end of the supplied cord securely in place NeoPAP Neonatal CPAP
59. scription AC Power Indicator DC Battery Indicator Save Proceed Button Cancel Clear Button Up Down Navigation Arrows Humidifier Cable Connector future option Delivery Tube Connector Pressure Line Connector Power On Off also used to access Standby Mode Resuscitation Button Resuscitation Connection Alarm Reset Button Alarm Silence Button Alarm Indicator Bar a DA m A a 8 4 cmH O hPa display bars 1 Heat future option Symbol Description R Caution US federal law restricts this device to sale by or on the order ONLY of a physician Serial Interface Connector Type BF Applied Part IPX1 Drip Proof Equipment NeoPAP Neonatal CPAP User Manual 1 3 DCE C P NEN uononpo au Chapter 1 Introduction 1 4 Description Canadian US Certification US Refer to accompanying instructions for use 0 Oxygen Regulator Internal Battery Door CI Oxygen Sensor Door Symbol Description EC REP European Representative Caution US federal law restricts this device to sale by or on the order ONLY of a physician CNM Reorder Number European Declaration of Conformity DEHP Free Does not contain natural rubber latex Single Patient Use Only Consult Accompanying Instructions for Use NeoPAP Neonatal CPAP User Manual Chapter 2 Warnings Cautions and Notes Before using the Philips Children s Medical Ventures NeoPAP device
60. t Follow all applicable federal and local regulations for disposal or recycling This product has been validated under a range of simulated patient conditions for newborns and infants weighing less than 5 kg and has not been validated for patients weighing more than 5 kg Keep any sources of ignition as far as possible from the device when using oxygen enriched gas Be aware of the possibility of contamination from patient exhaled gases being exhausted into the room or incubator through the exhalation port NeoPAP Neonatal CPAP User Manual 2 1 Chapter 2 Warnings Cautions and Notes 2 2 To avoid the risk of fire use this device in a well ventilated area away from flammable anesthetics Do not use in a hyperbaric chamber or other similarly oxygen enriched environments To reduce the risk of electric shock from liquid entering the device do not put a container filled with a liquid on the NeoPAP device The remote alarm should be considered a backup to the primary alarm system To ensure that the alarm will be heard make sure the alarm volume is adequate and avoid blocking the alarm speakers on the NeoPAP device This device is not for use with intubated patients Medical electrical equipment requires special precautions regarding electromagnetic compatibility EMC and must be installed and put into service according to the EMC information provided in this user manual see Appendix A EMC Information Use only manufacturer specified
61. the device calibrates the oxygen sensor cell on start up it is important to power on the device in the ambient operating conditions of use To minimize the risk of overheating the device do not operate adjacent to heaters NeoPAP Neonatal CPAP User Manual Chapter 2 Warnings Cautions and Notes NOTES This product has been validated for patient inspiratory flows of up to 5 L min Always use a pulse oximeter to monitor patient oxygen saturation when using the NeoPAP System to deliver CPAP therapy to the patient Setup WARNINGS Connect the NeoPAP to an appropriate medical grade oxygen source only The source must be able to deliver 100 oxygen regulated from 276 to 600 kPa 40 to 87 psig To reduce the risk of hypoxia connect only oxygen to the high pressure oxygen connector at the rear of the NeoPAP To reduce the risk of fire do not use a high pressure oxygen hose that is worn or contaminated with combustible material like grease or oil Always check the status of the air and oxygen cylinders before using the NeoPAP during transport Do not block or otherwise try to seal the exhalation ports at the delivery circuit patient interface connection Rebreathing of exhaled air for longer 5 5 22 than several minutes in some circumstances may lead to suffocation Use only manufacturer supplied or specified delivery tubes with the patient interface Potential side effects of na
62. ut lines 1 kV differential mode 2 kV common mode lt 5 0 295 dip in for 0 5 cycle 40 60 dip in U for 5 cycles 70 U 30 dip U for 25 cycles lt 5 295 dip in U for 5 sec Compliance Level 6 kV contact 8 kV air 2 kV for supply mains 1 kV for input output lines 1 kV differential mode 2 kV for common mode lt 5 0 295 dip in U for 0 5 cycle 40 0 60 dip U for 5 cycles 70 30 dip for 25 cycles lt 5 gt 95 dip in U for 5 sec NOTE U is the a c mains voltage prior to application of the test level Electromagnetic Environment Guidance Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 Mains power quality should be that of a typical home or hospital environment Mains power quality should be that of a typical home or hospital environment Mains power quality should be that of a typical home or hospital environment Power frequency magnetic fields should be at levels characteristic of a typical location in a typical hospital or home environment NeoPAP Neonatal CPAP User Manual Appendix EMC Information This device is intended for use in the electromagnetic environment specified below The user of this device should make sure it is used in such an environment Immunity Test IEC 60601 Test Compl
63. vity setting is dependent on the CPAP setting For more information see Appendix C WARNING A high leak sensitivity setting can prevent an alarm from occurring when the nasal cannula is disconnected from the patient s nose NOTE When the current leak sensitivity value exceeds the maximum leak sensitivity value for the new CPAP setting the leak sensitivity value will be reduced to the new maximum value see Appendix C for the corresponding values 5 12 NeoPAP Neonatal CPAP User Manual Chapter 5 Follow these steps to change the leak sensitivity CPAP mode only 1 From the current settings screen use the and V keys to scroll through the screens until Leak Sensitivity is displayed then press to ACCEPT 2 The message window will display this message 3 Use the and V keys to change the Leak Sens value then press to Save the new setting Flow Mode Changing Flow Level Follow these steps to change the flow level Flow mode only 1 Open the front door that covers the settings knobs The message window will read 2 From the current settings screen turn the cmH O L min knob to adjust the setting up or down Turn the knob until the desired value is in the message window as shown below NOTE The new Flow setting value will flash and increase or decrease based on the direction in which the knob is moved 3 After the desired value is selected press the V key The new

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