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Table of Contents

Table of Contents........................................................................................................i
Instruction

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1

1.1 Indented to Use

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1

1.2 Ability and Experience Required

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2

1.3 Operation and Store Environment

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2

1.4 Subject Effect on the Use of the Device

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3

1.5 Limitation and Contradiction

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3

1.6 Safety Warnings

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3

1.7 Cross-Contamination

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4

1.8 Measured Parameters

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5

Getting Started

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6

2.1 Components Description

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7

2.2 UBREATH® PRO Spirometer System

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8

2.3 LCD Touch Screen

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13

2.4 UBREATH® PRO Disposable Flow Transducer

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22

2.5 Power Supply (Rechargeable Li-ion Battery)

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23

2.6 Information for Correct Use in an Electromagnetic Environment

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24

Perform a Spirometry Test

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29

3.1 Prepare a Patient

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29

3.2 Test Posture

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31

3.3 Take a Spirometry Test

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31

3.4 Finish a Test

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38

3.5 Review Historical Data

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39

3.6 Test Validation

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41

3.7 Test Acceptability

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42

3.8 Test Repeatability

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43

3.9 Interpreting Test Result

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43

3.10 Print Test Report

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43

Calibration

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45

Linearity Verification

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47

Maintenance

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49

Содержание UBREATH PRO PF680

Страница 1: ...BREATH PRO Spirometer System 8 2 3 LCD Touch Screen 13 2 4 UBREATH PRO Disposable Flow Transducer 22 2 5 Power Supply Rechargeable Li ion Battery 23 2 6 Information for Correct Use in an Electromagnetic Environment 24 Perform a Spirometry Test 29 3 1 Prepare a Patient 29 3 2 Test Posture 31 3 3 Take a Spirometry Test 31 3 4 Finish a Test 38 3 5 Review Historical Data 39 3 6 Test Validation 41 3 7 ...

Страница 2: ...ii 5 1 Care and Cleaning 49 5 2 Replacement Items 49 5 3 Charging the Battery 50 Troubleshooting Guide 51 Specifications 52 Index of Symbols 54 Warranty Condition 55 ...

Страница 3: ...ch of children Use and store the device indoor only Do not expose this device or its accessories to direct sunrays Keep the temperature between 10 40 Celsius degrees when in use Do not attempt to open or service the device on your own return the device to distributor for all services Opening the device case will void the warranty 1 1 Indented to Use This UBREATH PRO Spirometer System Model PF680 i...

Страница 4: ... assistants In most of cases the healthcare provider may also require skills to explain demonstrate and coach the subject to achieve an acceptable result WARNING e LinkCare hold no responsibility for any damaged caused by the user of the device failing to follow the instruction and warning altered in this manual 1 3 Operation and Store Environment The device has been envisaged for use in hospital ...

Страница 5: ... and suggested courses of treatment must be given by a doctor Any subject with the following symptom or condition is not recommended to perform the test Pneumothorax Hemoptysis of unknown origin forced expiratory maneuver may aggravate the underlying condition Unstable cardiovascular status such as angina forced expiratory maneuver may worsen angina or cause changes in blood pressure or recent myo...

Страница 6: ...e system complies with the requirements of system standard IEC 60601 1 1 Whoever is responsible for securing the unit to a system needs to ensure that the mounting equipment used with this product complies to IEC standard 60601 1 If in doubt consult the technical services department or your local dealers 1 7 Cross Contamination To avoid exposing the subject to the critical danger of cross contamin...

Страница 7: ...k Expiratory Flow L s FEF25 Forced Expiratory Flow at 25 of FVC L s FEF50 Forced Expiratory Flow at 50 of FVC L s FEF75 Forced Expiratory Flow at 75 of FVC L s VC VC Vital Capacity expiratory L VT Tidal Volume during VC measurement L IRV Inspiratory Reserve Volume L ERV Expiratory Reserve Volume L IC Inspiratory Capacity L MVV MVV Maximum Voluntary Ventilation L min VT Tidal Volume during MVV meas...

Страница 8: ...mode with a built in thermal printer which also helps to be able to streamline subject information flow and its accessibility for doctors as well as improve subject care quality and safety over time Your UBREATH PRO Spirometer System is carefully inspected and packed for shipping However it is a good practice to thoroughly inspect the outside of the package for damage If any damage is noted please...

Страница 9: ... Cable Thermal Printer Paper Roll Check the list below to ensure you have all accessories received in good condition 1 Spirometer x 1 2 Remote Sensor Controller x 1 3 Disposable Flow Transducer x 1 4 Controller Cable x 1 5 Power Adaptor optional x 1 6 Type C USB Cable x 1 7 Thermal Printer Paper Roller pre install in meter x 1 8 User s Manual include Warranty Card x 1 ...

Страница 10: ...uthpiece D Controller Cable Used to connect the Spirometer and remote controller E Type C USB Cable Used to connect with power source for power recharge or data transfer F Thermal Printer Paper Roller Used for report printing G User Manual included warranty card inside Provides detailed instructions on using the Spirometer System Note Contact your local distributor for purchasing alternative power...

Страница 11: ... Sensor Remote Controller SN Label Speaker Battery Compartment a Printer Compartment Holds the thermal printer inside b Liquid Crystal Display LCD Shows your test results and the instruction helps you through the testing process c Indicator Light Tells the working condition d Controller Holder Holds the sensor remote controller at standby mode e Barcode Reader Button Hold this button could scan su...

Страница 12: ...ing Pin Port Release Button Handle Bar Holder a Stream Port Air flow tunnel b Release Button Hold this button when disassembling the remote sensor controller from the device c Handle Bar Holder To hang the remote sensor controller on the spirometer at standby mode d Connection Port Connect the remote sensor controller with the Spirometer e Locating Pin Port Lock the flow transducer with the spirom...

Страница 13: ...en insert the flow transducer into the ports which are located on the head top part of the device The sound of a click will tell that insertion is complete and correct 5 For hygienereasons do nottouch themouthpiecethroughoutthe process WARNING 1 Use only parts and accessories supplied with the device and available through e LinkCare The use of accessories other than those specified may result in d...

Страница 14: ...paper roll holder and close the paper compartment 3 Pull the paper to the right position and prepare for printing WARNING The thermal paper must be inserted as shown in this picture pay attention to the direction of the roll hence the printing occurs on the correct side of the thermal paper To avoid damage to the printer and or defects in printing it is recommended to use thermal paper with 57 mm ...

Страница 15: ... 2 2 5 Sleeping Mode UBREATH PRO Spirometer has a sleeping mode features to reducing battery consumption The device will automatically enter sleeping mode if the device is left unattended for 10 minutes Any gesture applied on the touch screen will awake the device from sleeping mode UBREATH PRO Spirometer will be automatically switched off if the device is left unattended for another 10 minutes wh...

Страница 16: ...ves used in hospitals work fine with the touchscreen Note A pair of disposable gloves are encouraged to wear when Flow transducer is being removed from the UBREATH PRO Spirometer System 2 3 1 Overview of the User Interface The icons used in the various function screens and their meanings are shown in the following table Icons Display The main menu displays the following icons ID Date Name Time Age...

Страница 17: ...er System for status information and for navigation in the menus and displays the following icons Current Date Current Time Current Battery Level 2 3 2 Interface Welcome Screen Once the device is switched on a welcome screen will pop up and a system self check will be implemented ...

Страница 18: ...ct s name tap on it and enter the name if needed Age Indicate the length of time that the subject has lived Tap on it and enter subject s date of birth the system will automatically calculate the age of the subject Sex Identify the gender of the subject Tap on it and determine if the patient is male or female Height The subject s height without wearing shoes Tap on it and enter the measurement of ...

Страница 19: ...ted Disconnected The remote sensor controller is connected Connected Once it s connected it will enter warming up process Warm up Warm up finished ready for test Ready Attention Warm up process may take up to 5 minutes for the first time when turn on the device You can only start taking test after warm up session is completed Enter a New ID A subject s ID can be entered by following below procedur...

Страница 20: ...18 WARNING Ethnicity of subjects must be entered before entering a new ID ...

Страница 21: ...19 ...

Страница 22: ...t Setting This function allows the Ambient Settings the temperature humidity and air pressure before calibrating the flow sensor Calibration This option guides the user to run a calibration check see details on Section Calibration on the section Calibration Linearity Verification This option guides the user to run a linearity verification check see details on Section Linearity Verification on the ...

Страница 23: ...you can see Ambient Setting Tap on Ambient Setting to adjust the Ambient Settings the temperature humidity and air pressure to support calibration when perform a test Or you can tap on Refresh to adjust the temperature humidity and air pressure automatically Ambient setting dialog box look like below use the keypad to enter ...

Страница 24: ...alue for the ambient barometric pressure 2 4 UBREATH PRO Disposable Flow Transducer To ensure the maximum level of hygiene and safety as well as accuracy we suggest to always substitute the disposable flow transducer between each patient A disposable Flow Transducer included three parts throttle pipe mesh and mouthpiece Mouthpiece Throttle Pipe Mesh Locating Pin Stream Port ...

Страница 25: ...away from heat and direct sunlight Do not freeze or refrigerate Do not store or use UBREATH PRO Spirometer System in a humid place such as a bathroom Do not store the UBREATH PRO Spirometer System and the flow transducer near bleach or cleaners that contain bleach 2 5 Power Supply Rechargeable Li ion Battery 2 5 1 Recharging the Battery WARNING UBREATH PRO Spirometer System is powered by the exclu...

Страница 26: ... will NOT lost when battery power is low or batteries are removed 2 6 Information for Correct Use in an Electromagnetic Environment As the UBREATH PRO Spirometer System is a medical equipment special precautions are needed regarding EMC electromagnetic compatibility It is important that the UBREATH PRO Spirometer System is properly configured in accordance with the User Manual provided herein and ...

Страница 27: ...ncluding domestic establishments and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes Harmonic emissions IEC61000 3 2 Not applicable Power input 75W Voltage fluctuations flickr emissionsIEC6100 0 3 3 Applicable Guidance and Manufacturer s Declaration Electromagnetic Immunity The UBREATH PRO Spirometer System is intended for ...

Страница 28: ...s to earth 1 kV line s to line s Not Applicable Mains power quality should be that of atypical commercial or hospital environment Voltage dips short interruptions and voltage variations on power supply input lines IEC61000 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 if or 25 cycles 5 UT 95 dip in UT for 5 s 5 UT 95 dip in UT For 0 5 cycle 40 UT 60 dip in...

Страница 29: ...rengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radios AM and FM radiobroadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which ...

Страница 30: ... 1 8 0 38 0 73 1 1 2 1 2 2 3 10 3 8 3 8 7 3 100 12 12 23 3 For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters m can be estimated using the equipment applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer NOTE 1 At 80 MHz and 800 M...

Страница 31: ...sician s responsibility to assure that pulmonary tests are properly administered evaluated and interpreted WARNING People may become lightheaded dizzy or even faint during a spirometry test Watch subjects closely If they choose to stand during testing keep a chair immediately behind them If there is any reason for concern stop the test and take appropriate action WARNING During a spirometry test a...

Страница 32: ...ding part of the flow transducer till it fits in perfectly 4 Hold UBREATH PRO Spirometer System remote sensor controller with one hand Use the other hand to hold on your nose and apply like a nose clip 5 Place lips and teeth around a mouthpiece of new flow transducer sealing their lips tightly around the transducer Grip slightly with teeth in the groove The tongue and teeth must be positioned to n...

Страница 33: ...ind the subject Watch the subject during testing for signs of light headedness Place a hand on subject s arm or back if needed to steady them WARNING If the subject experiences light headedness fainting or any other signs of distress during the test the subject should be conducted in the seated position or test should be terminated If the subject uses seated position to perform a test The subject ...

Страница 34: ...How to use mouthpiece 2 How to hold remote sensor controller with one hand and use the other hand to help with manually occlude of the nares 3 How to fill the lungs slowly then blast out immediately 4 How to keep exhaling as long as possible 5 Exaggerating each step if helpful Coach the subject to perform the maneuver Once the subject is ready instruct the patient to do the following 1 Tap on FVC ...

Страница 35: ... it reaches 6 seconds or it is fully recorded Then instruct the patient to inspire fully as rapidly as possible Press the Stop button to complete the test During testing the Flow Volume curve is synchronized displayed 7 Press restart button for two more trials without remove the mouthpiece 8 The device will show the best effort with a crown on top of it At the end of the test a comprehensive repor...

Страница 36: ...ach the subject to perform the test to obtain a meaningful result Explain the purpose of the test to see the volume change between a full inspiration and a maximal expiration Demonstrate 1 How to use mouthpiece 2 How to hold the spirometer with one hand and use the other hand to help with manually occlude of the nares 3 How to fill the lungs slowly with a full inspiration 4 How to keep expiring sl...

Страница 37: ...the patient to exhale maximally and inhale maximally Use the other hand to hold on your nose and apply like a nose clip then subsequently expire as much air as possible 6 The test stops automatically after 60 seconds or tap on STOP button to terminate the test During testing the volume time curve is displayed 7 After the whole VC test procedure finished the device will automatically show the curve...

Страница 38: ...vely coach the subject to perform the test to obtain a meaningful result Explain the purpose of the test to see the maximum volume of air a subject can breathe over a specified period Demonstrate 1 How to use mouth piece 2 How to hold the spirometer with one hand and use the other hand to help with manually occlude of the nares 3 How to fill the lungs with a full inspiration and blast all air out ...

Страница 39: ...he system will beep and instruct to begin the test 6 Start the test by making a series of forced inspirations and expirations breathing as deeply as possible The test automatically stops gathering data after 12 seconds During testing the volume time curve is displayed 7 At the end of the test the display shows the curve made and related parameters such as RR VT 8 Repeat step 5 and 6 for two more t...

Страница 40: ...on patient s profile indicate the percentage of actual value compare to predicated value 3 4 Finish a Test Follow the below procedure to finish a test 1 Press the release button to unlock the locating pins while pulling the flow transducer vertically up simultaneously 2 Discard the flow transducer directly into a waste container ...

Страница 41: ...sting results Once the test is completed The spirometry tests results are recorded in the memory of the device To display and view the historical testing results follow the steps below Return to Home screen tap on Datalist to review the subjects list the screen will show like below ...

Страница 42: ...lay like follow To delete subject s current test result from memory press Delete To go back to data list press Cancel To review the details of selected subject s for example patient 01 00629 historical test result press Read it will lead you to the previous page with selected subject information listed The screen will look like below ...

Страница 43: ...nce three acceptable curves are recorded consistency or repeatability of results is evaluated When the subject records three acceptable curves with repeatable results the test is valid and can be concluded If all three tests cannot meet the requirement of test result validation the subject will need to attempt a few extra trials No more than 8 trials in total until the correct data is collected Fo...

Страница 44: ... five attempts check that the if the subject is able to proceed since some individuals with obstructive airways disease may experience too much discomfort to continue 3 7 Test Acceptability The spirometry test interpretation is required based on the Forced Vital Capacity FVC test according to the ERS standard A curve is considered acceptable when the subject performs all aspects of the forced expi...

Страница 45: ...s can be recorded by most healthy subject when they consistently exert a maximal effort for each maneuver attempted and every effort should be made to record a valid test However subject with airway obstruction sometimes have difficulty achieving repeatability and as a result non repeatable test results should not be excluded from interpretation Failure to achieve repeatability should be documente...

Страница 46: ...with the date time subject profile detailed test results etc The thermal print paper roll can often be bought from your local medical suppliers they are usually 57mm in width size make sure the diameter of each roll should not be exceeded than 30mm ...

Страница 47: ...meter System calibration simulates inspirations and expirations for same flow levels each to ensure the product performance Follow the below procedure to complete the calibration 1 Tap on 3L button you will have three options to choose from different volume of syringes select the right syringe that you are using Press Back button to go back to previous menu 2 Connect the syringe and the adaptor to...

Страница 48: ...ibration factor 8 Once the pull and push 3 times must not calibrate You will need to run the Calibration again 9 When Diff item display 10 or 10 must not calibrate You will need to run the Calibration again 10 When the test value is discrete indicate the consistency is bad and ensure not leak between the disposable flow transducer and syringe 11 If there is no calibration value or the calibration ...

Страница 49: ...the top of screen and tap the volume of the calibrated syringe 1L 2L 3L you are using Using a 3L calibrated syringe as default setting 2 Pump air through the flowhead to bring it to ambient temperature If the flowhead has very recently been used for testing or has come from a cold environment its temperature should be equilibrated with ambient by pimping air 3 Press Start at the bottom of screen t...

Страница 50: ...ium flow rate 1 5 5 0 L s high flow rate 5 0 12 0 L s This manoeuvre should show on the graph between the area if it is a correct manoeuvre the test number and the FVC values will be updated in the table Repeat for the medium rate and high flow rate each three times 6 When the numbers of In L In L Ex M In M Ex H In H are all displayed as 3 or 3 the instrument exits after automatic verification is ...

Страница 51: ...temperature Do not direct the transducer holder towards a strong light source whilst operating the spirometer Check the AC charger for compatibility with local power rating The UBREATH PRO Spirometer System is a precision electronic instrument Please handle it with care 5 2 Replacement Items The UBREATH PRO Spirometer System is a device that requires very limited maintenance however the follow acc...

Страница 52: ...incorrect settings do not constitute a hazard for the subject 5 3 Charging the Battery The rechargeable battery of UBREATH PRO Spirometer System usually can last for an entire working day To fully charge the battery after a day of work it s recommends recharging overnight In addition you can also charge multiple times during the day between spirometry tests To charge UBREATH PRO Spirometer System ...

Страница 53: ...IBLE SOLUTIONS UBREATH PRO SPIROMETER SYSTEM DOES NOT SWITCH ON Check that battery is correctly inserted in the compartment on the back of the instrument If it is correctly positioned then replace it with new one THE DEVICE SENSOR IS NOT RESPONDING Disconnect and reconnect the transducer make sure all accessories are connected correctly REPORT DOES NOT PRINT PARAMETERS OR GRAPHS Check print and pa...

Страница 54: ...ption Built in printer Battery Life Approximately 500 complete charge cycles Power Supply 3 7 V lithium battery Input Power 10 W FVC Range of measurement 0 5 8 L Accuracy 3 or 0 050 L take the largest value Repeatability 3 or 0 050 L take the largest value VC Range of measurement 0 5 8 L Accuracy 3 or 0 050 L take the largest value Repeatability 3 or 0 050 L take the largest value PEF Range of mea...

Страница 55: ... BF Applied Parts Classification according to the type of protection against harmful ingress of water IPX0 Operating Environment 10 35 30 80 RH Storage Environment 10 45 80 RH storage in clean and ventilated room Operating altitude 0 1400 meters 1060 hPa 850 hPa ...

Страница 56: ...ial Number Do not dispose along with household waste Fragile handle with care This Side Up Keep away from sunlight and heat Keep Dry Humidity Limitation between 10 80 Thermal printer report Do not reuse single patient use Release button Barcode reader Medical electric equipment that includes a radio frequency transmitter and emits non ionizing radiation Instrument classification Type BF applied pa...

Страница 57: ...conform to the current safety norms in the country of installation If the product is utilized differently from the use described in the User s Manual If any alteration adjustment modification or repair has been carried out by personnel not authorized by the manufacturer If the fault is caused by lack of or incorrect routine maintenance of the machine If the machine has been dropped damaged or subj...

Страница 58: ...mber _________________________________________________ Meter Serial Number ____________________________________________ The problem description You expect Replace a new device Return after maintaining Note This warranty applies only to the meter in the original purchase and does not apply to the battery supplied with the meter Local Dealer Information ...

Страница 59: ...57 Contact Address Contact Name Contact Cellphone Number Address City State Province Region Postal Code Thanks so much for your kind support Effective Date 2021 05 23 ...

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