ABM BiWaze Cough User Manual Download

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BiWaze Cough - User Reference Manual

BiWaze Cough

User Reference Manual

UI Software version 1.x

PRTN-2037351818-1888 1.0

Summary of Contents for BiWaze Cough

Page 1: ...BiWaze Cough User Reference Manual 1 BiWaze Cough User Reference Manual UI Software version 1 x PRTN 2037351818 1888 1 0...

Page 2: ...BiWaze Cough User Reference Manual 2...

Page 3: ...majority of the therapy settings are restricted locked Users cannot change the therapy air parameters beyond a preset range However users can choose different therapy settings using pre saved profile...

Page 4: ...faces 13 2 1 4 Side Panel Overview 13 2 1 5 Bottom Panel Features 14 2 2 Symbols 15 2 3 Traveling with the System 16 2 4 How to Contact ABM Respiratory Care 17 3 Therapy Modes and Features 17 3 1 Ther...

Page 5: ...e Main Therapy Screen 30 6 3 Accessing the Advanced Settings Screen 31 6 4 Accessing the Device Settings Screen 32 6 5 Accessing the Device Administration Settings Screen 33 6 6 Modifying Patient Ther...

Page 6: ...ent Circuits 47 10 2 USB Disk 47 10 3 Foot Pedal 48 10 4 BiWaze Mobile App 48 10 4 1 Pairing the mobile app to the device 49 10 4 2 Connecting the mobile app to the device 49 10 5 Carrying Bag 51 11 I...

Page 7: ...aration Electromagnetic Immunity 63 13 4 Recommended Separation Distances between Portable and Mobile RF Communications Equipment and This Device 64 13 5 Guidance and Manufacturer s Declaration Electr...

Page 8: ...Cough device only for the intended use as described in this manual Advice contained in this manual does not supersede instructions given by the prescribing physician Read the entire manual before usi...

Page 9: ...qualified trained personnel under the direction of a physician The BiWaze Cough device is not intended to be operated by persons including children with reduced physical sensory or mental capabilitie...

Page 10: ...the safe and effective use of the device Do not expose the device to excessive force dropping or shaking Keep the power cord and device away from any potential heat sources like room heater hot iron...

Page 11: ...sories Foot Pedal Various Patient Interface Accessories Mask sizes trach adapters mouthpiece interface BiWaze Coaxial Patient Circuit Tubing 2 1 System Overview The BiWaze Cough helps patients in clea...

Page 12: ...s Main Device 5 Years Breathing Tube Adaptors and power cords 5 Years Patient Breathing tubes 30 days after unpacking Carry Bag 2 years Batteries 1 year 2 1 2 Main Control Interfaces The items numbere...

Page 13: ...erfaces The items numbered in the illustration below are described in the table that follows Item Description 1 Handle Handle to carry the device 2 Power source cut off switch Cuts off AC mains and Ba...

Page 14: ...ower supply cooling Fan location Cooling fan is located here 6 MCB Fan Fan with main control board 7 Air Inlet Filter This is the inlet port for inspiratory air CAUTION Don t not attach any unapproved...

Page 15: ...ar on this device Consult accompanying instructions for use AC Power Remote Control USB Connector Type BF Applied Part Class II Double Insulated Power On Power Off Protected against solid objects over...

Page 16: ...Authorized representative in European community Product serial number FCC marking Prescription device Manufacturer CE Marking Caution Warning 2 3 Traveling with the System It may be helpful to bring t...

Page 17: ...Mode Description Manual Manual mode delivers therapy based on the Pause Pressure Inhale Pressure and Exhale Pressure prescription settings The device delivers the set Inhale Pressure for the amount o...

Page 18: ...Pressure setting for the duration of the Exhale Time setting 3 Pause pressure until the device detects the next inspiratory Effort or Pause phase timeout of 30 secs Note The device goes in standby mod...

Page 19: ...hich are super imposed on standard oscillations The Frequency and Amplitude settings of oscillations can be changed as needed 4 Therapy Setup Follow the following steps to prepare the device for the t...

Page 20: ...nterface connector d Standard 6 feet long 22 mm diameter single tube Setting Standard Patient circuit for Therapy Step 1 Identify the Patient circuit Kit If the patient circuit tube is a single tube w...

Page 21: ...Step 4 Attach the patient circuit tube to the bacterial filter Step 5 Attach the patient interface mask or mouth piece to other end of the tube Use appropriate adaptors between tube and patient interf...

Page 22: ...circuit tube is a dual coaxial with tube inside the outer tube its BiWaze special patient circuit tube Step 2 Ensure that No adaptor is attached to the device and coaxial port is visible Step 3 Take...

Page 23: ...d with appropriate connector 4 3 Supply Power to the Device The device can operate on external AC power and built in Batteries when charged 4 3 1 Using AC Power An AC power cord is included with the d...

Page 24: ...the device on AC mains The internal batteries can charge simultaneously while the device is operating on the AC mains power and switches to Battery power source when AC mains is disconnected Disposal...

Page 25: ...and enter Standby Note The device may take up to 30 seconds before the main therapy screen is presented and device is ready for use 3 Check your settings before starting therapy 4 Attach the appropri...

Page 26: ...ppropriate patient interface to the patient 5 Press the Therapy start button on the touch screen to start therapy 6 The device will automatically cycle from Inhale positive to Exhale negative to Pause...

Page 27: ...therapy Caution Ensure that the Patient circuit and the patient port are dry before using the device on the patient User can start the therapy by touching the Start Therapy Button on the main screen U...

Page 28: ...does not resume or terminate the therapy from Paused state the system automatically terminates the therapy after timeout 6 Viewing and Changing Settings 6 1 Navigating the Menu Screens Navigation for...

Page 29: ...vents may occur on the device Therapy Pause Has a timeout period of 5 minutes If the user pauses the therapy and doesn t resume it after 5 minutes the device goes into standby mode and displays therap...

Page 30: ...auto timeout 6 2 Accessing the Main Therapy Screen When you press the Power Switch at the back of the device the Startup screen appears momentarily with Device logo The Main Therapy screen then appea...

Page 31: ...op of battery symbol 5 Check the battery charge status 6 Enable Disable the Bluetooth 7 Enable Disable Wi Fi and select network 8 Change Main therapy pressure and time settings 9 Enable Disable the Os...

Page 32: ...reset profile or remove a preset profile Access Device settings Power off the device safely 6 4 Accessing the Device Settings Screen You can access the Device Settings screen from the main therapy scr...

Page 33: ...Advanced settings icon Device Settings tab Administration Note this screen is password protected please get in touch with your clinician for any changes needed on the device administration settings Yo...

Page 34: ...settings Inspiratory Pressure Allows you to set the Inspiratory Pressure setting from 0 to 70 cmH2O in increments of 1 The Inhale Pressure is the pressure the patient receives while in the Inhale pha...

Page 35: ...you to set the Pause Time from 0 0 to 30 0 seconds in increments of 1 This setting is not available when the mode is set to Manual or when Inspiratory Trigger is enabled in Auto Mode see Advanced Set...

Page 36: ...you to Enable Disable the inspiratory trigger If the inspiratory trigger is on the pause time setting is over ridden as the device trigger inspiratory phase from pause phase of breath only when it det...

Page 37: ...ation of Cough Cycles for advanced users Example to program last n cycles with only positive pressure to increase patient comfort This setting is available only in Unlocked Operation Mode Once user ha...

Page 38: ...nged the settings of that cycle User can choose to copy the same settings to other cycles by entering copy mode Copy mode is enabled by long press of a selected cycle in the selection band The selecte...

Page 39: ...gs User can enable disable the Wi Fi User can look for available networks and select them for connection Warning Connecting the device to public or unknown networks could result in previously unidenti...

Page 40: ...ay on screen You can choose either cmH2O or hPa All pressure units that appear on screen display in the unit of measure selected here LCD Brightness Select the brightness of the screen backlight from...

Page 41: ...ble for viewing and updating Setting Description Lock adjustment Admin user can change settings limits allowed in locked mode Remote server address Update remote web server address here the therapy lo...

Page 42: ...n Mode for home users The information related to access and passwords are available to home care providers The lock menu is available on top left corner of the screen The icon shows when the device is...

Page 43: ...o home user Select if user is allowed to adjust pressure and time with in set limits default 5cm for pressures 2 secs for breath phase 8 Safe Shutdown and Power off Initiate safe shutdown Bring up Adv...

Page 44: ...Caution Remove the main power chord from the device and wall outlet before cleaning the device The device s exterior surface should be cleaned before and after each patient use and more often if neede...

Page 45: ...filter from the enclosure Examine the filter for cleanliness and integrity Wash the filter in warm water with a mild detergent Rinse thoroughly to remove all detergent residue Allow the filter to air...

Page 46: ...e Note Replace the circuit after 30 days or 90 therapy cycles whichever comes first Bacteria Filter The filter which protects the device from entraining foreign material from the patient can be left i...

Page 47: ...cessories available for BiWaze Cough device Contact your home care provider for additional information When using the accessories always follow the instructions included with them 10 1 Patient Circuit...

Page 48: ...before the foot pedal can be used Caution Remove the Foot pedal from the device after use and store it safely to avoid entanglement or tripping Once therapy is started in Manual mode from the main dev...

Page 49: ...by enabling the Pairable ON toggle on the device After this step you can follow the steps in next section for connecting the app to the device Note For security purpose the Pairable ON toggle is tuned...

Page 50: ...that the ABM devices will appear with name ABM Device last 4 digits of serial number 2 Once connected the main screen will show status as connected and the current mode from BiWaze Auto Mode User can...

Page 51: ...ay appear on screen and troubleshoots some of the problems you may experience with your device and possible solutions to those problems 11 1 Informational Messages The following type of informational...

Page 52: ...capacity It also communicates with UI board and Sensor board UI Control Board UIB This board controls the user interface including the main touch screen LCD as well as USB HDMI and Foot Pedal ports T...

Page 53: ...phase is extended till the device detects patient inhale effort and applies the Inspiratory pressures when patient effort is detected The inspiratory trigger sensitivity can be set in the range 1 10 w...

Page 54: ...he flow between low medium and high The High Flow setting applies maximum flow to target the Inspiratory pressure as fast as possible providing maximum peak volumetric flow based on set pause and insp...

Page 55: ...amplitude can be set at 1 5 levels with 1 as the lowest amplitude Note The mean pressure may vary by up to 25 when the oscillations are on depending on the frequency and set pressure Vibrations Contro...

Page 56: ...thout battery 4 1 kg 9 4 lbs with battery installed 12 4 Standards Compliance This device is designed to conform to the following standards IEC 60601 1 Medical electrical equipment Part 1 General requ...

Page 57: ...1 1 2 certified Lithium Ion Battery Power 88 Whr Capacity 3200 mAh IEC 62133 2 certified Type of Protection Against Electric Shock Class II Classification According to Directive 93 42 EEC Class IIa De...

Page 58: ...11 3 dBm Typ Receive Sensitivity 1Mbps DSSS 96 3 dBm Typ 54 Mbps OFDM 74 9 dBm Typ MCS7 20MHz 72 4 dBm Typ MCS7 40MHz 67 0 dBm Typ Security Authentication Encryption Wi Fi protected access WPA and WP...

Page 59: ...ified at Temperature 20 30 C Humidity 50 relative Altitude nominally 380 meters for typical patients 12 9 Sound The sound pressure of the device set at 40 cmH2O 40 cmH2O in the Pause phase is less tha...

Page 60: ...1 minute Exhale Pressure not to exceed 75 cmH2O for 5 secs Duration of inhale phase in Auto Mode within 10 of the setting 0 5 seconds Duration of exhale phase in Auto Mode within 10 of the setting 0...

Page 61: ...verify normal operation If operation is not normal the BiWaze Cough System or the other equipment should be moved Use of accessories transducers and cables other than those specified or provided by t...

Page 62: ...romagnetic environment specified below The user of this device should make sure it is used in such an environment Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic Environment Guidan...

Page 63: ...y or a battery Power frequency 50 60 Hz magnetic field IEC 61000 4 8 30 A m 30 A m Power frequency magnetic fields should be at levels characteristic of a typical home or hospital environment NOTE UT...

Page 64: ...e guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people a Field strengths from fixed transmitters such as b...

Page 65: ...ansmitters 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 transmitter where P...

Page 66: ...e with FCC RF exposure guidelines NOTE The module must be used in strict accordance with the manufacturer s instructions as described in the user documentation that comes with the product Modification...

Page 67: ...equire servicing the device from ABM authorized service center Please get in touch with your health care provider for such service needs Example Error Message and details when information icon is pres...

Page 68: ...chnical errors with an error code number on a Red strip on the LCD Screen and device shuts down after few seconds Technical error related to temperatures or other high priority fault Try rebooting the...

Page 69: ...ll perform in accordance with the product specifications for a period of one 1 year from the date of sale by ABM to the dealer If the product fails to perform in accordance with the product specificat...

Page 70: ...also have other rights which vary from state to state To exercise your rights under this warranty contact your local authorized ABM dealer or your health care provider or contact ABM at info abmrespir...

Page 71: ...requirement for planned maintenance of this device 16 3 Service Cleaning and Maintenance There is no field service applicable for the device Any returns to the manufacturing shall be cleaned and maint...

Page 72: ...BiWaze Cough User Reference Manual 72...

Page 73: ...iWaze Cough User Reference Manual 73 ABMRC LLC 239 Fairchild St Charleston SC 29492 USA Porta Medical UG Holstenstrasse 64a 23701 Eutin Germany PRTN 2037351818 1395 Model BiWaze Cough FCC ID 2ATX9 139...

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