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User Manual

Chapter 11: Specifications

Environmental

Operating

Storage

Temperature

41º F to 95º F

-4º F to 140º F

Relative Humidity

15 to 95%

(non-condensing)

15 to 95%

(non-condensing)

Atmospheric Pressure

(5600 feet to sea level)

83 to 102kPa

Physical

Dimensions:

9.75” L x 6.625” W x 4.4” H

Weight:

Approximately 4 lb.

Electrical

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:

S/T unit

: Ordinary Equipment, IPX0

AC Power Supply (Reorder number 1012832):

Drip Proof, IPX1

DC Power Adapter (Reorder number 1012975):

Drip Proof, IPX1

Modes of Operation:

Continuous

Electromagnetic Compatibility:

The BiPAP S/T meets the requirements

of EN 60601-1-2, second edition (2001).

Fuses:

There are no user-replaceable fuses.

Содержание BiPAP S/T

Страница 1: ...BiPAP S T User Manual ...

Страница 3: ...een 13 4 2 4 Breathing Circuit Connection 15 4 2 5 Rear Panel 15 Chapter 5 Setting up the Device 17 5 1 Installing the Air Filters 17 5 2 Where to Place the BiPAP S T 18 5 3 Connecting the Breathing Circuit 19 5 4 Complete the Setup 21 5 5 Plugging It In 21 5 5 1 Using AC Power 22 5 5 2 Using DC Power 23 Chapter 6 Operating the BiPAP S T 24 6 1 Starting the Device 24 6 2 Changing the Device Settin...

Страница 4: ...6 Chapter 8 Troubleshooting 37 Chapter 9 Cleaning and Maintenance 41 9 1 Cleaning the Device 41 9 2 Cleaning or Replacing the Inlet Filters 41 9 3 Carrying Case 43 Chapter 10 Accessories 44 10 1 Adding a Humidifier 44 10 2 Adding Oxygen to the Device 44 Chapter 11 Specifications 45 Environmental 45 Physical 45 Electrical 45 Pressure 46 Control Accuracy 46 Disposal 46 Appendix A EMC Information 47 ...

Страница 5: ...e the following items If any of these items are missing contact your home care provider BiPAP S T with Encore Pro SmartCard Power Cord Filter Cap Gray Foam Filters Flexible Tubing 1 83 m 6 ft X 22 mm i d Ultrafine Filter User Manual External AC Power Supply Carrying Case ...

Страница 6: ... device is turned on and operating properly The exhalation port s associated with the mask should never be blocked Explanation of the Warning The BiPAP S T is intended to be used with special masks or connectors that have exhalation ports to allow continuous flow of air out of the mask When the device is turned on and functioning properly new air from the device flushes the exhaled air out through...

Страница 7: ...erate the device in direct sunlight or near a heating appliance because these conditions can increase the temperature of the air coming out of the device When using this product IEC 60601 1 1 requirements safety requirements for medical electrical systems must be met For proper use the power supply must be placed feet down in the upright position When the BiPAP S T is used with a humidiﬁer positio...

Страница 8: ...res between 41º F 5 C and 95º 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 enter the enclosure or the inlet ﬁlter Condensation may damage the device Always allow the device to reach room temperature before use NOTE Additional warnings cautions and notes are located throughout this manual 2 3 Inten...

Страница 9: ...Allergy 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 a...

Страница 10: ...halation to improve patient comfort High Priority Alarm Alarm signal indicating a condition that requires immediate attention IPAP Inspiratory Positive Airway Pressure LED Light Emitting Diode Low Priority Alarm Alarm signal indicating an informational message Medium Priority Alarm Alarm signal indicating a condition that requires operator awareness Operate State The state of the device when the u...

Страница 11: ...u do not inhale Spontaneous Timed S T A bi level mode which responds to both your inhalation and exhalation by increasing pressure when you start to inhale and decreasing pressure when you start to exhale If you do not start inhaling within a set time the device automatically starts inhalation When the device starts inhalation it controls the time of inhalation and automatically decreases the pres...

Страница 12: ...it with Mask with Integrated Exhalation Port Flexible Tubing Connector Mask s Connector Exhalation Port Figure 3 2 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 you inhale and exhale depen...

Страница 13: ...trostatic Discharge Drip Proof Equipment UL Recognized for Canada and the United States TUV Safety Standard Compliance No User Serviceable Parts Symbol Meaning IPX1 3 4 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 1 724 387 4000 or 1 800 345 6443 You can also u...

Страница 14: ...op 4 1 Pressure On Off Button The Pressure On Off button located on the side of the unit starts and stops the unit s airflow Press the button in to turn the airflow on This puts the device in the Operate state Depress the button to turn the airflow off and put the device in the Standby state When the device is in Standby any ramp in progress is terminated the alarms are reset except for the System...

Страница 15: ...ate setting Follow the instructions provided 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 USER The left and rig...

Страница 16: ... 4 3 Alarm and Power Indicators AC Power Indicator This green LED lights up when the device is connected to AC Power DC Power Indicator This green LED lights up when the device is connected to DC power Red Alarm Indicator The red LED lights up when a high priority alarm occurs Yellow Alarm Indicator This yellow LED lights up when a medium or low priority alarm occurs NOTE All LED indicators tempor...

Страница 17: ...a alarm has occurred BPM Indicates that a breath rate setting is being displayed BPM flashes on the screen when the device is providing timed backup breaths in S T mode CARD Indicates that a SmartCard is inserted and detected CPAP Indicates that the device is in the Continuous Positive Airway Pressure CPAP mode cm H2 O Indicates that the alphanumeric digits are displaying a pressure value EPAP Ind...

Страница 18: ...onnect alarm is active RAMP Indicates that the Ramp function is in progress RAMP START Indicates that the Ramp Starting Pressure is being displayed RISE TIME Indicates that a rise time setting is being displayed S The s on the right side of the display above cm H2 O indicates that the alphanumeric digits are displaying a time value in seconds S or S T Indicates that the device is in the Spontaneou...

Страница 19: ... panel Communications Connector Port Power Inlets SmartCard Connector Filter Cap Cord Retainer Cord Retainer Figure 4 6 Rear Panel NOTE The SmartCard Connector is located on the side of the device WARNING In order to ensure proper protection against electric shock only communications accessories with an IEC 60601 1 approved power supply may be connected through the SleepLink interface All IEC 950 ...

Страница 20: ...larm Use only with an IEC 60950 approved computer Power Inlets There are two power inlets on the rear panel one for connecting the external AC power supply and another for connecting the external DC power adapter Filter Cap The filter cap can be removed to inspect the inlet air filters Cord Retainers Two cord retainers are located on the rear panel to provide strain relief for the power cord ...

Страница 21: ...sable and an optional white ultra fine filter that is disposable One filter of each kind is supplied with the unit If your 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...

Страница 22: ...m See Chapter 9 to clean or replace the filters 5 2 Where to Place the BiPAP S T Place the device on its base somewhere within easy reach of where you will use it Make sure that the air inlet on the rear of the unit is not blocked Place the unit on a hard flat surface If you block the air flow around the unit the device may not work properly WARNING Position the humidifier so the water level is lo...

Страница 23: ...lter connect the end of the circuit tubing directly to the outlet connector on the device NOTE Follow the recommendations of your home care provider for using the optional bacteria filter Circuit Tubing Bacteria Filter Optional Figure 5 3 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 th...

Страница 24: ...Figure 5 5 Connecting an 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 Device Mask Connector Mask or Other Interface Figure 5 6 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 devi...

Страница 25: ...erface Bacteria Filter Optional Exhalation Port Figure 5 7 Complete Breathing Circuit 5 5 Plugging It In You can use AC or DC power to operate the device WARNING The DC power option is not intended as a battery backup when using AC power WARNING For proper use the power supply must be placed feet down in the upright position as shown in Figure 5 7 ...

Страница 26: ...using the wire tie supplied with your power supply WARNING Never plug the AC power supply into an outlet that is controlled by a wall switch WARNING Route the wires to avoid tripping 3 Leaving a small amount of slack in the cord connect the cord on the other side of the power supply to one of the power inlets on the device as shown in Figure 5 8 The power cord has a locking connector To properly p...

Страница 27: ...d 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 when available See the DC power adapter instructions for more information CAUTION Only use the Respironics DC power adapter available from your home care provider Use of any other system may cause damage to the device or the vehicle CAUTION When DC power is o...

Страница 28: ... or the buttons do not light up the device requires servicing Contact your home care provider Several screens 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 Scr...

Страница 29: ... screen shown in Figure 6 4 This indicates that the device is in the Standby state Figure 6 4 Standby Screen 2 Press the Pressure On Off button to put the unit into the Operate state The Monitoring screen shown in Figure 6 5 appears Figure 6 5 Monitoring Screen Both the Monitoring and the Standby screens display the Patient Disconnect Apnea and LED backlight icons if these features are enabled Add...

Страница 30: ...some suggestions 6 2 Changing the Device Settings You can view the following settings and indicators on the device display screen Measured pressure Mode SmartCard Patient alarms Additionally you can view and modify the following settings using the display screens Humidifier heat Flex Rise Time Ramp start pressure LED backlight NOTE When changing any setting except for the Ramp Start Pressure setti...

Страница 31: ...ress the Ramp button to decrease the setting You can adjust the setting from 1 to 5 The change takes effect immediately as you adjust the setting 3 You can exit this screen by pressing the Left or Right User buttons or the Silence button For additional information on using a humidifier with the device see Chapter 10 6 2 2 Navigating the User Display Screens You can navigate the rest of the user di...

Страница 32: ...x Setting Screen Rise Time Setting Screen Ramp Start Pressure Setting Screen LED Backlight Setting Screen Figure 6 7 Navigating the User Display Screens 6 2 2 1 Changing the Flex Setting The Flex setting allows you to adjust the level of air pressure relief that you feel when you exhale during therapy WARNING The effectiveness of Bi Flex therapy has not been established for pediatric patients at t...

Страница 33: ...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 NOTE The rise time feature is not prescribed for all users If the screen shown in Figure 6 9 does not displa...

Страница 34: ...mp feature This feature will reduce the pressure and then gradually increase ramp the pressure to the prescription pressure setting so you can fall asleep more comfortably NOTE The ramp feature is not prescribed for all users If the screen shown in Figure 6 10 does not appear on your display you cannot adjust this setting To change the ramp starting pressure setting complete the following steps 1 ...

Страница 35: ...re always on when the airflow is off and the unit is in Standby To change the LED backlight setting complete the following steps 1 From either the Monitoring or Standby screens press the Right User button until the LED Backlight Setting screen appears as shown in Figure 6 11 Figure 6 11 LED Backlight Setting Screen 2 Press the Heat or Ramp button to select a new setting A setting of 1 means the li...

Страница 36: ...The tables in Section 7 3 display these sounds using the following symbols or Medium Priority These alarms require prompt response The alarm signal consists of a yellow LED and a sound that repeats a pattern of three beeps The display has the message 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 awar...

Страница 37: ...ty Alarm LED RED Low Medium Priority Alarm LED Yellow AC DC Alarms Power Figure 7 1 Alarm LED Indicators In addition to the alarm LED indicators the control pad also contains Alarm Reset and Alarm Silence buttons as shown in Figure 7 2 Alarm Silence Button RAMP HEAT SILENCE RESET Alarm Reset Button Figure 7 2 Alarm Buttons ...

Страница 38: ...he LED and whether the LED is solid or flashing 2 Look at the display for text Figure 7 4 Sample Alarm Display The word ALARM appears at the top of the screen to indicate an alarm Additional codes and icons 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 the screen that was showing when the alarm occur...

Страница 39: ...uts 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 icons flash Operates Excessive leak or blockage malfunctioning unit Press the RESET button to reset the alarm Check for the following dirty inlet filters blocked air intake excessive l...

Страница 40: ...ce and contact your home care provider Operates 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 Solid DC power LED flashes U...

Страница 41: ... around the device Make sure the unit is away from direct sunlight and heating equipment If the problem persists contact your home care provider The air out of the mask is much warmer than usual This could be due to improper headgear adjustment or improper mask fitting Check the headgear adjustment as described in the headgear instructions Refer to your mask instructions to make sure the mask is p...

Страница 42: ...or the mask is not properly 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 home care provider for a refitting or a different size mask Sore or dry eyes This could be due to improper mask fitting or improper mask cleaning This could be due to improper headge...

Страница 43: ...ow If the airflow does not restart the device may not be operating correctly Contact your home care provider or Respironics for directions on having the unit serviced Please have your serial number ready when you call A patient disconnect alarm occurs Problem Why It Happened What To Do The unit or power supply has been dropped or mishandled or water has been spilled onto or into the device or the ...

Страница 44: ...Problem Why It Happened What To Do The SmartCard is not inserted properly It may be inserted upside 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 unit serviced Please have you...

Страница 45: ... the device to dry completely before plugging in the power cord Gently wash the reusable circuit tubing in a solution of warm water and a mild detergent 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 ...

Страница 46: ...anel and pulling the cap out away from the device Figure 9 1 Removing the Filter 3 Remove the filters from the enclosure as shown in Figure 9 2 The top filter is the reusable gray foam filter The bottom filter is the optional disposable white ultra fine filter Reusable Gray Foam Filter Disposable Ultra fine Filter Figure 9 2 Removing the Air Filters 4 Check the filters to see if they are dirty or ...

Страница 47: ...8 Replace the filter cap Contact your home care provider to order additional filters NOTE To clean the breathing circuit accessories refer to each accessory s instruction sheet 9 3 Carrying Case A carrying case is now included with your BiPAP S T system reorder number 1005965 The case is designed to hold your BiPAP S T system along with your breathing circuit accessories and humidifier When you ar...

Страница 48: ...xygen 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 BiPAP S T 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 h...

Страница 49: ...en 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 S T unit Ordinary Equipment IPX0 AC Power Supply Reorder number 1012832 Drip Proof IPX1 DC Power Adapter Reorder number 1012975 Dr...

Страница 50: ...o 20 cm H2 O when using the Bi Flex feature in S mode Dynamic pressure accuracy is 5 cm H2 O measured at the patient end of the circuit 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 Ri...

Страница 51: ...onment Guidance RF emissions CISPR 11 Group 1 The device uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF emissions CISPR 11 Class B The device is suitable for use in all establishments including domestic establishments and those directly connected to the public low voltage power sup...

Страница 52: ...mode 1 kV differential mode 2 kV for common mode Mains power quality should be that of a typical home or hospital environment Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 5 UT 95 dip in UT for 0 5 cycle 40 UT 60 dip in UT for 5 cycles 70 UT 30 dip in UT for 25 cycles 5 UT 95 dip in UT for 5 sec 5 UT 95 dip in UT for 0 5 cycle 40 UT 60 dip in UT...

Страница 53: ...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...

Страница 54: ...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...

Страница 55: ...conomic 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 warranty...

Страница 56: ...R E F 1 0 1 2 8 9 0 1 0 0 6 7 7 6 R 0 1 J J B 1 0 3 1 2 0 1 1 ...

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