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T

ABLE

 

OF

 C

ONTENTS

Chapter : Package Contents ................................................................................................................
Chapter : Warnings and Cautions ......................................................................................................

. Warnings 

....................................................................................................................................

. Cautions ....................................................................................................................................
. Intended Use 

.............................................................................................................................

. Contraindications....................................................................................................................
. Precautions ...............................................................................................................................

Chapter : Introduction to the Device ..............................................................................................

. Definitions 

................................................................................................................................

.  What is Bi-level Ventilation? ..................................................................................................
.  What is the Device? ..................................................................................................................
. Symbols ......................................................................................................................................
.  How to Contact Respironics ..................................................................................................

Chapter : Device Controls and Display Features .............................................................................

.  Pressure On/Off Button ..........................................................................................................
.  Control Panel .........................................................................................................................

..  Control Buttons ..........................................................................................................
..  Alarm and Power Indicators .......................................................................................
..  Display Screen ...............................................................................................................
..  Breathing Circuit Connection...................................................................................
..  Rear Panel .....................................................................................................................

Chapter : Setting up the Device .......................................................................................................

.  Installing the Air Filters ......................................................................................................
.  Where to Place the Device ...................................................................................................
.  Connecting the Breathing Circuit .....................................................................................
. Complete Setup 

.......................................................................................................................

.  Plugging the Device In ..........................................................................................................

..  Using AC Power ............................................................................................................
..  Using DC Power ............................................................................................................

Chapter :  Operating the Device .......................................................................................................

.  Starting the Device ................................................................................................................
.  Changing the Device Settings ..............................................................................................

..  Changing the Humidifier Setting ..............................................................................
..  Navigating the User Display Screens .........................................................................

... Changing the Flex Setting ................................................................................
... Changing the Rise Time Setting ........................................................................
... Changing the Ramp Starting Pressure..............................................................
... Changing the LED Backlight Setting ..............................................................

.  Monitoring Measured Parameters .......................................................................................

Содержание BiPAPautoSV Advanced

Страница 1: ...User Manual with SmartCard ...

Страница 2: ... 2009 Koninklijke Philips Electronics N V and its affiliates All rights reserved ...

Страница 3: ...rm and Power Indicators Display Screen Breathing Circuit Connection Rear Panel Chapter Setting up the Device Installing the Air Filters Where to Place the Device Connecting the Breathing Circuit Complete Setup Plugging the Device In Using AC Power Using DC Power Chapter Operating the Device Starting the Device Changing the Device Settings Changing the Humidifier Setting Navigating the User Display...

Страница 4: ...Alarms Medium Priority Alarms Low Priority Alarms Chapter Troubleshooting Chapter Cleaning and Maintenance Cleaning the Device Cleaning or Replacing the Inlet Filters Carrying Case Chapter Accessories Adding a Humidifier Adding Oxygen to the Device Chapter Specifications Appendix A EMC Information ...

Страница 5: ...items If any of these items are missing contact your health care professional BiPAP autoSV Advanced with SmartCard Power Cord Filter Cap Reusable Gray Foam Filters Flexible Tubing 1 83 m 6 ft x 22 mm i d Disposable Ultra fine Filter External AC Power Supply User Manual Carrying Case ...

Страница 6: ... result in a fire hazard Oxygen supports combustion Oxygen should not be used while smoking or in the presence of an open flame Do not use the device in the presence of a flammable anaesthetic mixture in combination with oxygen or air or in the presence of nitrous oxide Do not use the device if the room temperature is above 35 C If the device is used at room temperatures above 35 C the temperature of...

Страница 7: ...ecautionary procedures are used Precautionary procedures include methods to prevent build up of electrostatic discharge e g air conditioning humidification conductive floor coverings non synthetic clothing discharging one s body to the frame of the equipment or system or to earth or a large metal object and grounding oneself by means of a wrist strap to the equipment or system or to earth 2 2 CAUTIO...

Страница 8: ...any of the following conditions apply to you consult your physician before using the device Inability to maintain an open airway or adequately clear secretions At risk for aspiration of gastric contents Diagnosed with acute sinusitis or otitis media Allergy or hypersensitivity to the mask materials where the risk from allergic reaction outweighs the benefit of ventilatory assistance Epistaxis causi...

Страница 9: ...ng established by the health care professional Max Pressure The maximum pressure setting established by the health care professional Medium Priority Alarm An alarm signal indicating a condition that requires operator awareness Min EPAP pressure The minimum EPAP setting established by the health care professional Min PS pressure The minimum Pressure Support setting established by the health care pr...

Страница 10: ...ssure known as EPAP Expiratory Positive Airway Pressure when you exhale The higher pressure makes it easier for you to inhale and the lower pressure makes it easier for you to exhale IPAP Pressure EPAP Pressure Rise Time Time Figure 3 1 IPAP and EPAP Breathing Levels You can adjust the Rise Time to make the pressure change more comfortable 3 3 WHAT IS THE DEVICE The device shown in Figure 3 2 supp...

Страница 11: ...on Port Patient Interface Typical Circuit with Mask with Integrated Exhalation Port Flexible Tubing Connector Mask s Connector Figure 3 3 Two Typical Breathing Circuits NOTE The exhalation port may be part of the mask or may be part of a separate exhalation device but is required to minimize the potential for CO2 rebreathing The system senses your breathing effort and changes pressure levels when y...

Страница 12: ...mpliant with the Waste Electrical and Electronic Equipment Restriction of the Use of Certain Hazardous Substances in Electrical and Electronic Equipment WEEE RoHS recycling directives Symbol Meaning IPX1 3 5 HOW TO CONTACT RESPIRONICS To have your device serviced contact your health care professional If you need to contact Respironics directly call the Respironics Customer Service department at 1 ...

Страница 13: ...e s Pressure On Off button located on the side of the device starts and stops the device s airflow To turn the airflow on press the button in as shown in Figure 4 2 This puts the device in the Operate state To turn the airflow off press the button again This puts the device in the Standby state HEAT Airflow On HEAT Airflow Off Figure 4 2 Pressure Button On Off Positions When the device is in Standby any...

Страница 14: ...included with the humidifier You can also use this button to adjust the settings shown in the user menu screens RAMP When the airflow is turned on and the ramp function is enabled this button lowers the airflow pressure allowing you to fall asleep more easily You can also use this button to adjust the settings shown in the user menu screens Press the left and right user buttons to navigate the user m...

Страница 15: ... up when the device is connected to DC power The red High Priority Alarm LED lights up when a high priority alarm occurs The yellow Low Medium Alarm LED lights up when a medium or low priority alarm occurs NOTE All LED indicators temporarily turn on when the device is first plugged in 4 2 3 DISPLAY SCREEN The display shows you the measured pressure and displays alarm messages A backlight activates ...

Страница 16: ...es that the Estimated Leak Rate is being displayed Indicates that the control pad LED backlight setting is being displayed or is active LPM Indicates that the value displayed is in liters per minute MinVent Indicates that the Estimated Minute Ventilation is being displayed ml Indicates that the value displayed is in milliliters Indicates that a Patient Disconnect alarm is active Indicates that the...

Страница 17: ...ions accessories with an IEC 60601 1 approved power supply may be connected through the SleepLink interface All IEC 950 devices must only be connected to the 7 pin connector with the Respironics Isolation cable Part Number 1012865 The rear panel contains the following Communications Connector This connector accepts the Respironics Communications cable for computer and external communications or a ...

Страница 18: ...rd plastic side of the white filter will touch the inside of the device Slide the filters into the air inlet at the rear of the device with the white filter going in first if it s used Push them down into the recess as shown in Figure 5 1 Position the cap so that the small opening on the cap is facing down Snap the cap into place NOTE The filter cap should be installed with the air inlet opening at the...

Страница 19: ... connect the end of the circuit tubing directly to the outlet connector on the device NOTE Follow the recommendations of your health care professional for using the optional bacteria filter Circuit Tubing Bacteria Filter Optional Figure 5 2 Connecting the Tubing to the Outlet 2 Connect the tubing to the mask A If you are using a mask with a built in exhalation port connect the mask s connector to t...

Страница 20: ...Figure 5 4 Connecting a Exhalation Device Connect the mask s connector to the exhalation device as shown in Figure 5 5 See the mask instructions for complete setup information Exhalation Port Mask Connector Mask or Other Interface Figure 5 5 Connecting the Mask WARNING The exhalation device is designed to exhaust CO2 from the patient circuit Do not block or seal the ports on the exhalation device ...

Страница 21: ...oper use the power supply must be placed feet down in the upright position as shown in Figure 5 7 5 5 1 USING AC POWER Complete the following steps to operate the device using AC power 1 Plug the pronged end of the AC power supply s cord into an electrical outlet 2 The external AC power supply features a cord retainer to provide strain relief for the AC power cord Wrap the cord around the AC power...

Страница 22: ...r which provides strain relief for the power cord 5 Ensure that all connections are secure NOTE If you need to disconnect the power cord from the device slide the locking connector back and then remove the power cord 5 5 2 USING DC POWER You can operate the device on DC power by using the Respironics DC power adapter accessory See the DC power adapter instructions for more information CAUTION Use ...

Страница 23: ...reens appear initially during this step a The first screen that appears is the Self Test screen shown in Figure 6 1 This is the internal test performed by the device Figure 6 1 Self Test Screen b The next screen displays the software version as shown in Figure 6 2 Figure 6 2 Software Version Screen NOTE The version number 1 0 shown in Figure 6 2 is an example Your device may have a higher software ...

Страница 24: ...erted The Monitoring screen displays if ramp is enabled and the button has been pressed The actual measured pressure is displayed with 0 1 cm H2O resolution once a breath has occurred 3 Put on your mask assembly when the air starts to flow 4 Make sure that no air is leaking from your mask into your eyes If it is adjust the mask and headgear until the air leak stops See the instructions that came wi...

Страница 25: ...um setting provided For example the minimum humidifier setting is 1 and the maximum is 5 Once the humidifier setting is increased to 5 if you press the HEAT button again the setting will go back to 1 Or once the humidifier setting is decreased to 1 if you press the RAMP button again the setting will go back to 5 6 2 1 CHANGING THE HUMIDIFIER SETTING If you are using the REMstar Heated Humidifier with ...

Страница 26: ...he HEAT and RAMP buttons to increase or decrease the setting You can exit any of the user display screens by pressing the SILENCE SILENCE button Figure 6 7 shows how to navigate the user display screens using the right and left user buttons These screens time out after 60 seconds of inactivity Right User Button Right User Button Left User Button Left User Button Only displayed if the rise time fea...

Страница 27: ...rrect setting appears You can adjust the pressure from 1 to 3 in increments of 1 6 2 2 2 CHANGING THE RISE TIME SETTING Rise time is the time it takes for the device to change from EPAP to IPAP When enabled you can adjust the rise time to find the setting that provides you with the most comfort If the Rise Time Setting screen shown in Figure 6 9 does not display you cannot adjust this setting Chang...

Страница 28: ...tart Setting Screen 2 Press the HEAT or RAMP button to increase or decrease the ramp starting pressure as needed You can adjust the setting from 4 cm H2 O to the current Min EPAP pressure setting 6 2 2 4 CHANGING THE LED BACKLIGHT SETTING When airflow is turned on and the device is in the Operate state you can turn the control pad lighting behind the buttons on or off using the LED backlight setting...

Страница 29: ... Button Scroll Button Leak Screen Respiratory Rate Screen Minute Ventilation Screen Exhaled Tidal Volume Screen ml VTE LEAK LPM RR BPM MinVent LPM Figure 6 12 Measured Parameter Screen Navigation To return to the Monitoring or Standby Screen from these Measured Parameter screens press the SILENCE SILENCE button NOTE If you view these screens from the Standby screen each of these screens will displ...

Страница 30: ...rage of the previous six breaths MinVent LPM Figure 6 15 Minute Ventilation Screen NOTE The value shown for Exhaled Minute Ventilation is an estimate The display flashes during transient conditions such as low tidal volumes erratic breathing or rapidly changing leak 4 Exhaled Tidal Volume Screen This screen shown in Figure 6 16 shows the estimated Exhaled Tidal Volume which is the volume of each br...

Страница 31: ...eps The display has the symbol at the top of the screen The tables in Section 7 3 display these sounds using the following symbols Low Priority These alarms require your awareness The alarm signal consists of a yellow LED and a sound that repeats a pattern of two beeps The display has the symbol at the top of the screen The tables in Section 7 3 display these sounds using the following symbols Som...

Страница 32: ... the LED is solid or flashing 2 Look at the display for text Figure 7 4 Sample Alarm Display The symbol appears at the top of the screen to indicate an alarm Additional codes and symbols may also appear depending on the type of alarm 3 Press the SILENCE SILENCE button to temporarily silence the alarm for one minute The display returns to the screen that was showing when the alarm occurred 4 Look up...

Страница 33: ...health care professional Red Flash symbol flashes and an error code Exx displays Shuts down Blower cannot be restarted Device failure Press the button to reset the alarm Remove power from the unit Restore power If the alarm continues contact your health care professional RESET RESET RESET RESET Red Flash and cm H2O symbols flash Operates Excessive leak or blockage malfunctioning unit Press the but...

Страница 34: ...rtCard from the device and contact your health care professional Operates The device lost AC power and is now operating on DC power Press the button to reset the alarm Check the AC power Seek a reliable power source Provide AC power if you do not want to use a battery otherwise no further action is needed At start up only alarm notifies you that a battery is being used to provide power Yellow Soli...

Страница 35: ...ay from bedding or curtains that could block the flow of air around the device Make sure the device is away from direct sunlight and heating equipment If the problem persists contact your health care professional The mask feels uncomfortable to wear This could be due to improper headgear adjustment or improper mask fitting Check the headgear adjustment as described in the headgear instructions Refer...

Страница 36: ...y fitted Check the headgear adjustment as described in the headgear instructions Refer to your mask instructions to make sure the mask is properly fitted If the problem continues contact your health care professional for a refitting or a different size mask There are unexplained changes in the performance of the device The device or power supply has been dropped or mishandled or water has been spilled...

Страница 37: ...The device s display is erratic The device or power supply has been dropped or mishandled or the device or power supply is in an area with high EMI emissions Unplug the device and the power supply Relocate the device to an area with lower EMI emissions A SmartCard error occurs The SmartCard is not inserted properly It may be inserted upside down or backwards Remove the SmartCard and reinsert it so...

Страница 38: ...dry 9 2 CLEANING OR REPLACING THE INLET FILTERS The device has two removable filters at the air inlet The gray foam filter is washable and reusable The optional white ultra fine filter is disposable The gray foam filter should be cleaned at least once every two weeks under normal usage and replaced with a new one every six months The white ultra fine filter is disposable and should be replaced after 30 n...

Страница 39: ...ystem to ensure sufficient drying time for the cleaned filter 6 If the ultra fine filter is dirty or torn replace it 7 Reinstall the filters If you are using the optional white ultra fine filter place it against the gray foam filter so the soft side of the ultra fine filter touches the gray foam filter Slide the filters into the air inlet at the rear of the device and push them into the recess When the filters ...

Страница 40: ...may be added to the mask connection Please note the warnings listed below when using oxygen with the device WARNING If you are using oxygen your device must be equipped with the Respironics Pressure Valve Part number 302418 Failure to use the Pressure Valve could result in a fire hazard WARNING Oxygen accelerates fires Keep the device and the O2 containers away from heat open flames any oily substanc...

Страница 41: ... operated with the external DC power adaptor accessory AC Current 1 25 A maximum DC Current 3 0 A maximum Protection against electric shock Class II Degree of protection against electric shock Type BF Applied Part Degree of protection against harmful ingress of water BiPAP autoSV Advanced device Ordinary Equipment IPX0 AC Power Supply Reorder number 1012832 Drip Proof IPX1 DC Power Adapter Reorder...

Страница 42: ...d varying flow conditions Static pressure accuracy is 1 25 cm H2 O measured at the patient end of the circuit with a Whisper Swivel II and no patient flow The range of values correspond to tenths of seconds e g a setting of 4 indicates a Rise Time of 0 4 seconds Measured at the patient end of circuit with a Whisper Swivel II exhalation device and no patient flow MEASURED PARAMETER ACCURACY Parameter ...

Страница 43: ... Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 Electrical FastTransient Burst IEC 61000 4 4 2 kV for power supply lines 1 kV for input output lines 2 kV for supply mains 1 kV for input output lines Mains power quality should be that of a typical home or hospital environment Surge IEC 61000 4 5 1 kV different...

Страница 44: ... assess the electromagnetic environment 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 r...

Страница 45: ...User Manual 41 NOTES ...

Страница 46: ...42 User Manual NOTES ...

Страница 47: ...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 limitation 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...

Страница 48: ...REF 1058267 1056937 JB 11 25 2008 ...

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