Product user manual Smart Peak Flow Meter Model: B1 Please read this user manual carefully before use.
Guangzhou Homesun Medical Technology Co., Ltd Version: B190315 Release date: 2019/03/15 Content 1. Product overview................................................................................................................................... 4 1.1 Basic information ........................................................................................................................ 4 1.2 Intended use...................................................................................................
11. Symbols ............................................................................................................................................. 20 12. Quality warranty ................................................................................................................................ 21 12.1 Warranty .................................................................................................................................. 21 12.2 After-sales maintenance..........................
1. Product overview 1.1 Basic information Product name: Smart Peak Flow Meter Model: B1 1.2 Intended use This device is intended for monitoring PEF (Peak Expired Flow Rate) and FEV1 (Forced Expiratory Volume in one second) for patient. The device is designed for pediatric to adult patients. The device is intended for monitoring respiratory conditions such as asthma. 1.3 Product performance and structure 1.3.
1.3.4 Measuring parameters PEF Peak Expiratory Flow (Unit: L/min) PEF% PEF real-time measured value / PEF predicted value * 100% FEV1 Forced Expiratory Volume in 1 Second (Unit: L) FEV1% FEV1 real-time measured value / FEV1 predicted value * 100% 1.3.
The following patients are prohibited from using this device: 1) Patients suffering from severe asthma; 2) Patients suffering from severe chronic obstructive pulmonary disease; 3) Patients suffering from uncontrolled high blood pressure; 4) Patients who have received chest, abdomen or ophthalmic surgery in the recent 3 months; 5) Patients who have had heart attack (such as angina, myocardial infarction, malignant arrhythmia) in the recent 3 months; 6) Patients who have been hospitalized due to he
5) Do not use this device in an environment that has anesthetics and other inflammables which may cause explosion. 6) Do not use this device in strong electromagnetic interference or direct wind source, cold source and heat source environment. 7) Do not immerse this device into liquid. 8) Do not spatter liquid onto this device which may cause damage. 9) Do not place this device in an mechanical vibration environment. 10) Do not drop this device from a high place.
marked. 4. Installation and operation When you use B1 for the first time, you should bond APP and input personal health information. 4.1 Download APP (1) Scan the QR code ,or search name “breathhome” from “App Store” or “Google Play Store” to download and install the APP. Note: This APP is supported by smart phone (all versions of iOS or Android 4.4-8.1 platform). (2) Open the APP, register by email to create a new account, enter the APP HOME after registration.
(3) Click “Health Profile” to complete personal information input and change.
(4) Connect the device. Power on the device and place it near the smart phone, activate the bluetooth mode of the smart phone, click “Manage Device”, complete device bonding according to operation instruction. 4.2 Device installation and preparation Install the mouthpiece: Hold the device, make the side of the mouthpiece with this triangular symbol “≧” face upward, insert the mouthpiece into air inlet with an angle of 30°upward, then press slightly, the mouthpiece would be firmly locked. 4.
(2) Stand up. (3) Short press function button, you will hear “Please blow ”. (4) Take a deep breath, hold your breath while put the mouthpiece into your mouth (the upper and lower teeth should nibble the front of the mouthpiece, and your lips should tightly cover the mouthpiece). Exhale quickly and forcefully, taking as much time as possible (the standard time is 6 seconds). Note: ① Adjust your breath before the test (inhale and exhale for 3 rounds), keep your breath steady.
Note: The data in the display screen will switch every 3 seconds. (6) When test is completed, long press function button to power off; when there’s no operation conducted to the device, it will automatically power off after 6 minutes. 4.
No Item 1 Manage Device 2 Health Profile Function Check device information, bind or unbind the device to APP. Fill in, modify or check personal information. Fill in questionnaire, APP will conduct an assessment to 3 Health Assessment your asthma control results based on the answers in the questionnaire. Record and check the daily Peak flow rate, Medication 4 Health Log records (Manually choose) and Records of symptoms (Manually choose).
（3）REPORT Record the best measurement results of “Today”,“1 Week”,“2 Weeks”,“4 Weeks”and generate a line chart. It also has functions of “Index Analysis” and “Create Report”.
（4）USER No Item 1 Health Profile 2 Manage Device 3 4 Check for new version (v1.0.5) Log Out Function Fill in, modify or check personal information. Check device information, bind or unbind the device to APP. Check the current version of APP. Log out 5. Maintenance and storage 5.1 Cleaning and disinfection 1) Use medicinal alcohol to wipe the shell of the device, then use clean, soft cloth to dry it or dry by natural air.
wipe it dry or dry by natural air. 3) Use cotton ball dipped in alcohol to gently wipe the spring strip to keep it clean. Caution: Only use wet cloth to wipe. It’s prohibited to immerse the device shell into liquid. Do not flush the main unit with high pressure water. Do not wash or disinfect the device with strong alkali or strong acid. 5.2 Charging When the device indicates low power, please charge as soon as possible. There are two charging methods: A.
Unable to turn on Unable to get the test data Low battery Please recharge Possible device damage Please contact the local distributor Not in test status Press again to measure or restart. Wrong blowing posture Please refer to the user manual for the correct blowing posture. Sudden disappearance of Automatically shut down display without any operation for 6 Normal phenomenon. minutes. The device usage time is too short after recharging.
Display 1.44'' TFT LCD display Sensor type Pressure sensor Transmission mode Bluetooth Safety category BF type Service life 3 years Measurement parameters Measurement parameters PEF/FEV1 Memory size 100 Measuring range of PEF 50-840L/min Measuring range of FEV1 0.01-9.99L Accuracy PEF: ±10% or ±0.3L/s (Take the larger one) FEV1: ±3% or ±0.05L (Take the larger one) Meet ATS 2005 Revision accuracy requirement. Measuring resolution PEF: 1L/min FEV1: 0.
Radio Power -23 dBm< PAV < 0 dBm Type of Modulation GFSK Channel Bandwidth 2 MHz 9. EMC statement 1） Model B1 needs special precautions regarding EMC and need to be installed and put into service according to the EMC information provided in the accompanying document; 2） Portable and mobile RF communications equipment can affect model B1.
instructions ,may cause harmful interference to radio communications.However there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures: – Reorient or relocate the receiving antenna.
Type BF applied part Low-frequency electromagnetic radiation “WEEE (Waste Electrical and Electronic Equipment)”. The waste products should be handled legally. Follow instructions for use IP22 Dustproof waterproof level. It can prevent solid object larger than12mm from intruding, and when tilt for 15 degrees, it can still prevent water from intruding, so no harmful effect will be created. CE mark and notified body code 12. Quality warranty 12.
Product number Batch code Detailed description of the problem Caution: The service center has the right to reject contaminated product for safety reasons. Please pack the product in a way that does not contaminate the package. Please use appropriate and strong package (preferably the original package). Our company has the right to return contaminated product to the sender. 13. Contact information Manufacturer: Guangzhou Homesun Medical Technology Co.
Attachment: Table 1 Guidance and manufacturer’s declaration - electromagnetic emissions Emissions test Compliance RF emissions Group 1 CISPR 11 RF emissions Class [B] CISPR 11 Harmonic emissions Class A IEC 61000-3-2 Voltage fluctuations/ flicker Comply emissions IEC 61000-3-3 Table 2 Guidance and manufacturer’s declaration - electromagnetic Immunity Immunity Test IEC 60601-1-2 Compliance level Test level Electrostatic discharge ±8 kV contact ±8 kV contact (ESD) ±2 kV, ±4 kV, ±8 kV, ±15 k
power supply input cycles; Single phase: at 0°. lines 25/30 cycles; Single phase: at 0°.
745 13, modulation 780 17 217 Hz GSM Pulse 870 800/900, modulation 930 TETRA 18 Hz 810 800 – 960 2 0.3 28 2 0.3 28 2 0.3 28 0,2 0.3 9 800, iDEN 820, CDMA 850, LTE Band 5 1720 1 700 – GSM Pulse 1845 1 990 1800; modulation CDMA 217 Hz 1970 1900; GSM 1900; DECT; LTE Band 1, 3, 4, 25; UMTS 2450 2 400 – Bluetooth, Pulse 2 570 WLAN, modulation 802.11 217 Hz b/g/n, RFID 2450, LTE Band 7 5240 5 100 – WLAN Pulse 5500 5 800 802.
