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Respironics BiPAP AVAPS, User Manual

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Respironics BiPAP AVAPS User Manual Download Page 42

User Manual

C

hapTer

 11: s

peCifiCaTions

11.1    e

nvironmental

Operating

Storage

Temperature

41° F to 95° F               

(5° C to 35° C)

-4° F to 140° F                        

(-20° C to 60° C)

Relative Humidity

15 to 95% 

(non-condensing)

15 to 95% 

(non-condensing)

Atmospheric Pressure (00 feet to sea level)

83 to 102kPa

11.2    P

hysiCal

Dimensions:

9.75” L  x  6.625” W  x  4.4” H 

(24.8 cm L  x  16.8 cm W  x  11.2 cm H)

Weight:

4 lbs. (1.8 kg)

11.3    e

leCtriCal

AC Voltage Source:

100 to 240 V, 50/60 Hz

DC Voltage Source:

12 VDC (when 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 AVAPS device

: 

Ordinary Equipment, IPX0

AC Power Supply:

 

Drip Proof, IPX1

DC Power Adapter:

Drip Proof, IPX1

Modes of Operation:

Continuous

Electromagnetic Compatibility: 

The BiPAP AVAPS device meets the requirements of EN 60601-1-2, 

second edition (2001).

Fuses:

There are no user-replaceable fuses.

11.4    P

ressure

Output:

4 to 30 cm H

2

O

Summary of Contents for BiPAP AVAPS

Page 1: ...BiPAP AVAPS TM User Manual ...

Page 2: ...65 6 029 664 6 305 374 and 6 539 940 Australian Patent Nos 638054 661575 698519 723681 734319 and 733655 Canadian Patent Nos 2 162 981 and 2 259 795 European Patent Pub No 0425092B1 and Japanese Patent Nos 2832812 2137336 and 2926392 Other U S and Foreign Patents Pending 2007 Respironics Inc and its affiliates All rights reserved ...

Page 3: ... 3 Display Screen 11 4 2 4 Breathing Circuit Connection 13 4 2 5 Rear Panel 14 Chapter 5 Setting up the Device 15 5 1 Installing the Air Filters 15 5 2 Where to Place the Device 16 5 3 Connecting the Breathing Circuit 16 5 4 Complete Setup 18 5 5 Plugging the Device In 18 5 5 1 Using AC Power 18 5 5 2 Using DC Power 19 Chapter 6 Operating the Device 20 6 1 Starting the Device 20 6 2 Changing the D...

Page 4: ...oting 32 Chapter 9 Cleaning and Maintenance 35 9 1 Cleaning the Device 35 9 2 Cleaning or Replacing the Inlet Filters 35 Chapter 10 Accessories 37 10 1 Adding a Humidifier 37 10 2 Adding Oxygen to the Device 37 Chapter 11 Specifications 38 11 1 Environmental 38 11 2 Physical 38 11 3 Electrical 38 11 4 Pressure 38 11 5 Control Accuracy 39 11 6 Measured Parameter Accuracy 39 11 7 Disposal 39 Appendi...

Page 5: ...ude the following items If any of these items are missing contact your home care provider Device with Encore Pro SmartCard Power Cord Filter Cap Reusable Gray Foam Filters Flexible Tubing 6 ft 1 83 m x 22 mm i d Disposable Ultrafine Filter External AC Power Supply User Manual ...

Page 6: ...ironics Pressure Valve Failure to use the Pressure Valve could 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 95 F 35 C If t...

Page 7: ...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 Cautions The device may only be operated at temperatures between 41 F 5 C and 95 F 35 C A properly installed undamaged reusable foam inlet filter is required for proper operation Do not immerse the device or allow any liquid to ...

Page 8: ...ergy or hypersensitivity to the mask materials where the risk from allergic reaction outweighs the benefit of ventilatory assistance Epistaxis causing pulmonary aspiration of blood Hypotension 2 5 Precautions Immediately report any unusual chest discomfort shortness of breath or severe headache If skin irritation or breakdown develops from the use of the mask refer to the mask instructions for appr...

Page 9: ... High Priority Alarm An alarm signal indicating a condition that requires immediate attention IPAP Inspiratory Positive Airway Pressure LED Light Emitting Diode LEAK The amount of airflow leak detected by the device Low Minute Ventilation A condition in which you are not receiving a specified volume of air on a per minute basis Low Priority Alarm An alarm signal indicating an informational message...

Page 10: ...omatically starts inhalation When the device starts inhalation it controls the time of inhalation and automatically decreases the pressure for exhalation within a set time Standby State The state of the device when the device is on but the airflow is off Tidal Volume VT The volume of each breath Timed T This is an optional bi level mode in which the device controls both inhalation and exhalation i...

Page 11: ...e Typical Circuit with Separate Exhalation Device Circuit Tubing Exhalation 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 ...

Page 12: ...p Proof Equipment UL Recognized for Canada and the United States TUV Safety Standard Compliance No User Serviceable Parts Symbol Meaning IPX1 3 5 How to Contact Respironics To have your device serviced contact your home care provider If you need to contact Respironics directly call the Respironics Customer Service department at 1 800 345 6443 USA or Canada only or 1 724 387 4000 You can also use t...

Page 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 Airflow On Airflow Off Figure 4 2 Pressure Button On Off Positions When the device is in Standby any ram...

Page 14: ...tions 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 t...

Page 15: ...riority Alarm Indicator The red High Priority Alarm LED lights up when a high priority alarm occurs Low Medium Priority Alarm Indicator 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 back...

Page 16: ... clear the Therapy Hour Meter FLEX Indicates that the C Flex Bi Flex comfort setting is being displayed or is active HEAT Indicates that the humidifier is turned on and or its setting is displayed HOURS Indicates that the Therapy Hour Meter is being displayed IPAP Indicates that an IPAP pressure setting is being displayed IPAP Max Indicates that an IPAP maximum pressure setting is being displayed ...

Page 17: ...re displaying a time value in seconds S Indicates that the device is in Spontaneous therapy mode S T Indicates that the device is in S T therapy mode SETUP Indicates that the device is in Provider mode and not in User mode Ti Indicates that an inspiratory time setting is being displayed VT Indicates that the Tidal Volume is being displayed VTE Indicates that the Estimated Exhaled Tidal Volume is b...

Page 18: ...950 devices must only be connected to the 7 pin connector with the Respironics Isolation cable The rear panel contains the following Communications Connector This connector accepts the Respironics Communications cable for computer and external communications or a remote alarm Use only with an IEC 60950 approved computer Power Inlets There are two power inlets on the rear panel one for connecting t...

Page 19: ...ur home care provider did not install the inlet air filters you must install at least the gray foam filter before using the device 1 Place the gray foam filter on top of the ultra fine filter if using the ultra fine filter 2 Slide the filters into the air inlet at the rear of the device and push them down into the recess as shown in Figure 5 1 Reusable Gray Foam Filter required Disposable Ultra fi...

Page 20: ...tructions for complete setup information 5 3 Connecting the Breathing Circuit To connect your breathing circuit to the device complete the following steps 1 Connect one end of the circuit tubing to the outlet of the bacteria filter if using one and connect the inlet of the bacteria filter to the large connector on the device as shown in Figure 5 3 If you are not using a bacteria filter connect the...

Page 21: ... blowing away from your face Exhalation Port Circuit Tubing Figure 5 5 Connecting a Exhalation Device Connect the mask s connector to the exhalation device as shown in Figure 5 6 See the mask instructions for complete setup information Exhalation Port Mask Connector Mask or Other Interface Figure 5 6 Connecting the Mask WARNING The exhalation device is designed to exhaust CO2 from the patient circ...

Page 22: ...oper use the power supply must be placed feet down in the upright position as shown in Figure 5 8 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...

Page 23: ...iner 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 U...

Page 24: ...nitially 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 LEAK Max Min ERASE HOURS RISE TIME FLEX ALARM PATIENT HEAT RAMP SETUP APNEA LIGHT START CARD 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 numb...

Page 25: ...ese features are enabled Additionally CARD displays if a SmartCard is inserted The Monitoring screen also displays the actual measured pressure and FLEX if Flex is enabled and AVAPS if AVAPS is enabled 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 instru...

Page 26: ...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 your device you can adjust the humidifier heat setting by completing the following steps 1 From either the Standby or Monitoring screen press and hold th...

Page 27: ...Figure 6 7 shows how to navigate the user display screens using the right and left user buttons Right User Button Right User Button Right User Button Left User Button Left User Button Left User Button Only displayed if the Flex feature is prescribed for you Only displayed if you can adjust the rise time setting Only displayed if the ramp feature is prescribed for you Flex Setting Screen Rise Time ...

Page 28: ...ing appears You can choose from 1 to 3 NOTE It is recommended that you start with the minimum setting of 1 which provides the least relief Levels 2 and 3 progressively increase the pressure relief 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 You can adjust the rise time to find the setting that provides you with the most comfort N...

Page 29: ...tton until the Ramp Start Setting screen appears as shown in Figure 6 10 RAMP START Figure 6 10 Ramp Start 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 0 cm H2 O to your EPAP or CPAP setting 6 2 2 4 Changing the LED Backlight Setting When airflow is turned on and the device is in the Operate state you ...

Page 30: ... Scroll Button Scroll Button Scroll Button Leak Screen Respiratory Rate Screen Minute Ventilation Screen Exhaled Tidal Volume Screen LEAK Figure 6 12 Measured Parameter Screen Navigation To return to the Monitoring or Standby Screen from these Measured Parameter screens press the SILENCE button NOTE If you view these screens from the Standby screen each of these screens will display a value of zer...

Page 31: ...ed Minute Ventilation the volume of air received on a per minute basis based on the average of the previous six breaths Figure 6 15 Minute Ventilation Screen NOTE The value shown for Exhaled Minute Ventilation is an estimate 4 Exhaled Tidal Volume Screen This screen shown in Figure 6 16 shows the estimated Exhaled Tidal Volume which is the volume of each breath Figure 6 16 Exhaled Tidal Volume Scr...

Page 32: ...consists of a yellow LED and a sound that repeats a pattern of three beeps The display has ALARM 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 ALARM at the top of the screen The tables in Sec...

Page 33: ...m LED Lights Up Note the color of the LED and whether the LED is solid or flashing 2 Look at the display for text ALARM APNEA PATIENT Figure 7 4 Sample Alarm Display ALARM 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 button to temporarily silence the alarm for one minute The display returns to ...

Page 34: ...he RESET button to reset the alarm Continue using the device Report the alarm to your home care provider Red Flash ALARM flashes and an error code Exx displays Shuts down Blower cannot be restarted Device failure Press the RESET button to reset the alarm Remove power from the unit Restore power If the alarm continues contact your home care provider Red Flash ALARM and cm H2O flash Operates Excessi...

Page 35: ...SmartCard from the device and contact your home care provider Operates The device lost AC power and is now operating on DC power Press the RESET 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 S...

Page 36: ...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 home care provider for a refitting or a different size mask There is significant air leakage round the mask This could be due to improper headgear adjustment or improper mask fitting Check the headgear adjustment as d...

Page 37: ...become disconnected from the system Press the RESET button to reset the alarm Reconnect the tubing If the alarm continues the device may not be operating correctly Contact your home care provider or Respironics for directions on having the device serviced Please have your serial number ready when you call The mask feels uncomfortable to wear This could be due to improper headgear adjustment or imp...

Page 38: ...e down or backwards Remove the SmartCard and reinsert it so that the printed side of the card is facing up and the end with the arrow goes into the device first If the error message appears again contact your home care provider or Respironics for directions on having your device serviced Please have your serial number ready when you call ...

Page 39: ...ergent Rinse thoroughly and allow to air 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...

Page 40: ...m water and a mild detergent Rinse the filter thoroughly to remove all detergent residue Allow the filter to completely dry before reinstalling it If the foam filter is torn replace it 6 If the ultra fine filter is dirty or torn replace it 7 Reinstall the filters with the ultra fine filter on the bottom Slide the filters into the air inlet at the rear of the device and push them down into the rece...

Page 41: ...2 Adding Oxygen to the Device Oxygen 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 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 fla...

Page 42: ...DC Voltage Source 12 VDC when 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 AVAPS device Ordinary Equipment IPX0 AC Power Supply Drip Proof IPX1 DC Power Adapter Drip Proof ...

Page 43: ... with a Whisper Swivel II and varying flow conditions Static pressure accuracy is 2 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 11 6 Measu...

Page 44: ...r 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 differen...

Page 45: ...ransmitters as determined by an electromagnetic site survey a should be less than the compliance level in each frequency range b Interference may occur in the vicinity of equipment marked with the following symbol NOTE 1 At 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 reflecti...

Page 46: ...paration Distance According to Frequency of Transmitter m 150 kHz to 80 MHz d 1 2 80 MHz to 800 MHz d 1 2 800 MHz to 2 5 GHz d 2 3 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 73 1 1 2 1 2 2 3 10 3 8 3 8 7 3 100 12 12 23 For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters m can be estimated using the equation applicable to the frequency of the t...

Page 47: ...economic loss loss of profits overhead or consequential damages which may be claimed to arise from any sale or use of this product Some states do not allow the exclusion or 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 warrant...

Page 48: ...1048888 JR 9 20 07 ...

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