Summary of Contents for Byond ResPlus B-30P Bi-Level PAP
- Page 1 BEYOND ResPlus B-30P Bi-Level PAP User Manual Please read this manual carefully before using this product...
- Page 2 User Manual The following document is the User Manual for the BEYOND ResPlus B-30P Bi-Level PAP (“B-30P” or “the device”) manufactured by Hunan Beyond Medical Technology Co., Ltd. (hereafter, called “BEYOND Medical”). All the information contained in this document is the legal property...
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Page 3: Table Of Contents
Contents 1. Introduction ..................1 1.1 Intended use ................1 1.2 Warnings ................... 1 1.3 Cautions ..................2 1.4 Contraindications ..............3 2. Model ....................3 3. Package Contents ................. 4 4. Device Components ................4 5. Device Symbols ................... 5 6. -
Page 4: Introduction
1. Introduction 1.1 Intended use The BEYOND ResPlus B-30P Bi-Level PAP is designed for delivery of positive airway pressure to provide non-invasive ventilation for adult patients with respiratory insufficiency or obstructive sleep apnea (OSA) in home or hospital environment. Rx only: Federal law restricts this device to sale by or on the order of a licensed healthcare practitioner. -
Page 5: Cautions
Keep away from toxic or hazardous steam. F). If the Do not use this device if the room temperature is higher than 35℃(95° 35℃(95° F), ambient temperature of the room is higher than the air flow from the which may cause damage to the user’s 40℃(105°... -
Page 6: Contraindications
The condensate water can damage this device. Make sure that the device returns to room temperature before use. Be sure that the filter is seated properly in the device to ensure normal operation. Any tar from smoking cigarettes near the device will stop the device from working properly. -
Page 7: Package Contents
Host CPAP, S, T, B-30P Bi-Level Humidifier H20 S/T, APCV SpO2 Kit S10 (optional) 3. Package Contents Item Articles Quantity Remark Host Standard Humidifier Standard Tubing Standard Mask Standard Adapter Standard User Manual Standard Air Filter Standard SpO2 Kit Optional Carrying Case Standard TF Card... -
Page 8: Device Symbols
Dial Can be rotated in either direction or pressed to select. Mute Pressing this button turns off the voice alarm On/Off Button Pressing this button switches the device On or Off. Air Outlet This is the connection point for the tubing Humidifier Pressing this button separates the humidifier from the Separation Button... -
Page 9: Device Operation
6. Device Operation 6.1 First Use 6.1.1 Place the device on a steady flat table where the settings are easy to reach and the information on the display can be clearly seen by the user. Maintain at least 2 inches between the device and the wall to ensure that the air inlet is not obstructed. -
Page 10: Humidifier
6.2.2 Adjust the Tubing Adjust the tubing to make sure the tubing can move freely when the user is in a deep sleep. Adjust the mask and the headgear to make the user feel as comfortable as possible and prevent air from blowing into the user’s eyes. 6.2.3 Start the Device Running Press the On/Off Button. -
Page 11: Humidifier Connection & Separation With The Host Unit
7.2 Humidifier Connection & Separation with the Host Unit 7.2.1 Connect with the host unit Fig.7.2.1a Before the connection Fig.7.2.1b After the connection Push the host unit and humidifier together to connect them to each other. A “click” sound will be heard when they are properly connected. Push the humidifier to connect with the host completely. -
Page 12: Using The Spo2 Kit
(2) Add water through the Air Inlet port on top of the water tank. Make sure the water level does not exceed the Max line. Fig.7.2.3c In winter months, be sure to add warm water, but no hotter than 35℃(95° Do not fill the water tank above the Max line. -
Page 13: Pfcurve Interface
Fig.9.1: B-30P Main Interface 9.2 PFCurve interface Under main interface, rotate the “Dial” button to move the cursor onto the “PFCurve” indicator and press “Dial” button; the PFCurve Interface screen will appear on the display screen, as shown in Fig. 9.2 below. Fig.9.2: B-30P PFCurve Interface Screen Users can set the desired humidifier levels and the Ramp time in the PFCurve Interface;... -
Page 14: Parameter Setting Interface
The Ramp function has been set. The humidifier level has been se. Indicates that the parameters setting interface is locked. When the device is connected to the power, its locked by default; Unlock the parameter interface by pressing the Dial button and holding for 5 seconds while the cursor is located on “Parameter”... - Page 15 Fig.9.3b : Selected Status Screen Fig.9.3c : B-30P Parameter Setting Interface Screen 2 Fig.9.3d : B-30P Parameter Setting Interface Screen 3 Parameter Range Description Mode...
- Page 16 When the Auto ON is set to “ON”, the user can CPAP; wear the mask and take 3 breaths in device’s S; T; Auto ON ON/OFF Standby State. The device will then automatically S/T; enter into the Working State. APCV When the Auto OFF is set to “OFF, the user needs to remove the mask while the device is in the Working State.
- Page 17 CPAP Mode: The initial air pressure for the Ramp Function is equal to or less than the standard air pressure selected by the user. S; T; 4.0-25.0 S; T; S/T; APCV Mode: The initial air pressure *StartPress S/T; for the Ramp Function is equal to or less than the APCV EPAP.
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Page 18: System Setting Interface
When the user starts to inhale, the device outputs S; S/T; 0.5-4.0s an airflow with the maximum respiratory time set InspTime APCV for IPAP When the user starts to inhale, the device outputs S; S/T; 0.5-4.0s an airflow with the minimum respiratory time set InspTime APCV for IPAP... - Page 19 Fig.9.4a : System Setting Interface Screen 1 Fig.9.4b : System Setting Interface Screen 2 Fig.9.4c : System Setting Interface Screen (with Reset Dialogue Box active)
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Page 20: Information Setting Interface
Parameter Setup range Description This parameter sets the device’s internal clock to track the time. This time will then be used to Time h-m-s record the application information for users. This setting needs to be checked frequently to ensure continued accuracy. This parameter sets the device’s internal calendar to track the date. -
Page 21: Epworth Interface
Fig.9.5b : B-30P Information Setting Interface 2 Parameter Setup range Description 1/7/30/90/180 The time period over which the following UseCycle /365 information items are calculated. Unit is "day". The length of time that the device has been UseTime ------ connected to the power supply. Unit is “hour”. The average output pressure value of the device AvgPress ------... -
Page 22: Prompt
： Fig.9.6 Alarm Interface Parameter Setup range Description It sets the upper limit pressure for High Press OFF/8.0-24.0 cmH2O the device. Increment: ± 0.5 cmH2O. It sets the lower limit pressure for Low Press OFF/3.0-7.0 cmH2O the device. Increment: ± 0.5 cmH2O. -
Page 23: Cleaning, Disinfection And Maintenances
When the device’s output pressure is below the LowPress setting value, the device will provide a voice prompt via the LOW PRESS!! buzzer and "LOW PRESS!!" will appear on the display. The warning sounds can be canceled by pressing the Mute button. When the device detects that the MV is below the LowMV setting value, it will provide a voice prompt via the buzzer and LOW MV!! -
Page 24: Disinfection
To avoid the possibility of electrical shocks and damage to the electrical system, unplug the power cord from the host unit before cleaning the device. Clean the front panel and the outside of the case with a soft cloth that has been moistened with warm water or mild detergent. -
Page 25: Troubleshooting
mask, headgear, tube and air filter should be replaced with new ones. Alternatively, users can also follow the procedures listed in Section 11.3 “Disinfection”. 12. Troubleshooting The below table lists some of the common problems the device might have and provides possible solutions to those problems. - Page 26 used) output air can place a towel or condense in the tube blanket over the tube and collect in the mask. to maintain the temperature of the output air flow. Stop using the device Nasal, sinus, or ear pain Inflammation in sinus immediately and or middle ear.
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Page 27: Specifications
pressure to the treatment pressure. The tube isn’t Reconnect the tubing The device is excessively connected properly. The and ensure there are no loud. mask or tubing may also leaks in the tubing. be leaking. Turn off the Ramp The pressure can’t be set. The Ramp feature is on. - Page 28 Noise level The A-weighted sound pressure level does not exceed 30dBA, the A-weighted sound power level does not exceed 38dBA, when the device is working at the pressure of 10 cmH Pressure Accuracy According to the pressure accuracy of ISO 80601-2-70:2015 standard. Pressure Range: CPAP:4 to 20 cmH2O (in 0.5 cmH2O increments), ≤...
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Page 29: Traveling With The Device
Range: 40～ 240 BPM Margin of Error: ± 3% Tubing Length: 1.8m The Form and the Dimensions of the Patient Connection Port The 22 mm conical air outlet complies with ISO 5356-1. Filter Dimension ：45mm*33mm*10mm Humidifier Tested according to EN ISO 8185-2009 standard or equivalent methods. Output air flow ＜40℃... -
Page 30: Service
a note on the bottom of the device stating that it is medical equipment. It may be helpful to bring this manual along with you to help security personnel better understand the device. Empty the water tank of the humidifier and allow it to dry completely before packing the device for your trip. - Page 31 Product with original serial numbers that have been removed, altered or cannot be readily determined; Any damage caused as a result of improper use, abuse, excessive usage, modification or alteration of the device; Repairs carried out by any service organization that has not been expressly authorized by BEYOND Medical to perform such repairs;...
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Page 32: Emc Requirements
19. EMC Requirements Guidance and Manufacturer's Declaration: Electromagnetic Emissions This device is intended for use in the electromagnetic environment specified below. The user of the device should ensure that it is used in such an environment. Emissions test Compliance Electromagnetic environment-guidance The device uses RF energy only for its internal function. - Page 33 <5% U (>95% dip in <5% U (>95% dip in Mains power quality for 0.5 cycle Voltage dips, should be that of a typical 40% U for 0.5 cycle short commercial or hospital (60% dip in 40% U interruptions environment. If the user of (60% dip in U and voltage the device requires...
- Page 34 Measured magnetic field strengths from a fixed RF transmitter 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 applied. Note 2: These guidelines may not apply in all situations.
- Page 35 output power rating of the transmitter in watts(W) according to the transmitter manufacturer. Note 1: At 80 MHz and 800 MHz, the higher frequency range applied. Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection of the structures, objects and people.