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e-LinkCare UBREATH PRO PF680 Manual

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Table of Contents........................................................................................................i
Instruction......................................................................................................................1
1.1 Indented to Use.............................................................................................1
1.2 Ability and Experience Required....................................................................2
1.3 Operation and Store Environment.................................................................2
1.4 Subject Effect on the Use of the Device.........................................................3
1.5 Limitation and Contradiction.........................................................................3
1.6 Safety Warnings............................................................................................ 3
1.7 Cross-Contamination.....................................................................................4
1.8 Measured Parameters................................................................................... 5
Getting Started...............................................................................................................6
2.1 Components Description...............................................................................7
2.2 UBREATH® 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
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 Test Acceptability........................................................................................ 42
3.8 Test Repeatability........................................................................................ 43
3.9 Interpreting Test Result............................................................................... 43
3.10 Print Test Report........................................................................................43
Calibration....................................................................................................................45
Linearity Verification....................................................................................................47
Maintenance................................................................................................................ 49

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Summary of Contents for e-LinkCare UBREATH PRO PF680

  • Page 1: Table Of Contents

    Table of Contents Table of Contents......................i Instruction........................1 1.1 Indented to Use.....................1 1.2 Ability and Experience Required..............2 1.3 Operation and Store Environment..............2 1.4 Subject Effect on the Use of the Device............3 1.5 Limitation and Contradiction.................3 1.6 Safety Warnings.................... 3 1.7 Cross-Contamination..................4 1.8 Measured Parameters...................
  • Page 2 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...

  • Page 3: Instruction

    The UBREATH® PRO Disposable Flow Transducers are disposable and for single patient use only. Do not clean or reuse them.  Use rechargeable battery only which is provided by e-LinkCare.  Remove the battery from the device if it will not be used for 4 weeks or more ...

  • Page 4: Ability And Experience Required

    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.

  • Page 5: Subject Effect On The Use Of The Device

    1.4 Subject Effect on the Use of the Device A spirometry test should only be carried out when the subject is at rest and in good health, and thus in a suitable condition for the test. The subject must make a complete forced expiration, in order to have a meaningful test result.

  • Page 6: Cross-Contamination

    performance, there are certain safety issues need attention to when use the device, please follow the following guidance carefully:  Do not sprinkle water or any liquids on the device;  Keep your portable spirometer dry and avoid exposing it to extremes in temperature or humidity;...

  • Page 7: Measured Parameters

    1.8 Measured Parameters Measure- Symbol Description Units ment Forced Vital Capacity FEV1 Volume expired in the 1st second of the test Forced Expiratory Volume in one second to FEV1% Forced Vital Capacity ratio Peak Expiratory Flow FEF25 Forced Expiratory Flow at 25% of FVC FEF50 Forced Expiratory Flow at 50% of FVC FEF75...

  • Page 8: Getting Started

    Getting Started UBREATH® PRO Spirometer System (Model:PF680) is a bench-top spirometer designed for professionals that could meet most valuations of pulmonary function tests and give results both on-spot and HIS/LIS connections for the maximum subject satisfaction. It is a powerful and compact measurement device intended for use by a physician (respiratory specialist) to diagnose and monitoring subjects with COPD and asthma, it can calculate more than 15 parameters including FVC, VC, MVV and corresponding breathing profile tests.

  • Page 9: Components Description

    2.1 Components Description 2.1.1 List of Box Contents Spirometer Thermal Printer Paper Roll Micro Type C USB Cable Adapter(Optional) Disposable Flow Transducer Controller Cable Remote Sensor Controller Check the list below to ensure you have all accessories received in good condition Spirometer Remote Sensor Controller...

  • Page 10: Ubreath® Pro Spirometer System

    2.1.2 Accessory List Disposable Flow Transducer Spirometer (with Type C USB Cable Thermal Printer Paper Roll) User Manual Remote Sensor Controller User Manual Controller Cable UBREATH® Spirometer: measure a range of respiratory parameters. Remote Sensor Controller: Used to receive signal from subjects. UBREATH®...
  • Page 11 2.2.1 Introduction of UBREATH® PRO Spirometer A. Overview of UBREATH® PRO Spirometer Printer Indicator Light Controller Holder Compartment LCD Screen Connection Barcode Port Reader Sensor Button Start Button Type-C Socket Remote Controller Speaker SN Label Battery Compartment Printer Compartment: Holds the thermal printer inside; Liquid Crystal Display (LCD): Shows your test results, and the instruction helps you through the testing process;...
  • Page 12 Start Button: To power on or off the device; Type-C Socket: Connection port for USB cable; Connection Port for Remote Sensor Controller: Connect remote sensor controller with the device; SN Label: SN series number; Speaker: Tells the audio information to users; Battery Compartment: Holds the battery inside Overview of Remote Sensor Controller...
  • Page 13 WARNING: 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 degraded performance of the device. Verify that there’s no foreign bodies present inside the transducer sensor.
  • Page 14 2.2.3 Loading the Thermal Paper Roll Follow the steps to load/change the thermal paper: Open the lid of the thermal paper compartment and remove it from the device; Insert the new roll of paper onto the paper roll holder and close the paper compartment;...

  • Page 15: Lcd Touch Screen

    2.2.4 Switching on/off the Device Before switching on the device, please check that all the accessories are complete and in good condition. Long press the start button on the left-hand side of the device for approximately 3 seconds. When the device is turned on, it will beep and a welcome screen will appear.
  • Page 16 To choose a button or to select a list item, tap on the button or list item on the touchscreen. For every tap, you hear a clicking sound as audible feedback. Also, for every tap, the area or the key that you have tapped is highlighted as visible feedback.
  • Page 17 Status Bar Basic interface elements are used throughout UBREATH® PRO Spirometer 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.
  • Page 18 Home Screen The home screen is the starting point when working with UBREATH® Spirometer System. The Home screen displays the following icons: Tap on it and it will lead you to the expanded System Settings page, where you can see: ID: Indicate the subject number or identification code which is inserted by the user.
  • Page 19 Datalist: The historical subject test result list. Tap on it to view the full test result list. You can only view the datalist if there’s an actual test stored in the device memory. For more details on viewing test result, refer to Displaying and viewing spirometry testing results on the section 3.5 “Review Historical Data”.
  • Page 20 WARNING: Ethnicity of subjects must be entered before entering a new ID.
  • Page 22 System Setting Tab on System Setting and it will lead you to the expanded System Settings page as below, where you can see: Date: System date in Year Month Day format. Time: System time in 24H format. Unit format: Available in CM or Inch for height, KG or Pound for weight. Ethnicity: This function allows the correction of the predicted values for a subject with the ethnic group to which he or she belongs.
  • Page 23 Ethnicity Setting Tap on Ethnicity Settings and it will lead you to the expanded Ethnicity Settings page as below, where 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”...

  • Page 24: Ubreath® Pro Disposable Flow Transducer

     TEMP: Enter the Temperature value. (The value for the ambient temperature.)  HUMID: Enter the Humidity value. (The value for the ambient air humidity.)  ATMP: Enter the Pressure value. (The value 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.

  • Page 25: Power Supply (Rechargeable Li-Ion Battery)

    NOTE:  Use disposable parts that are not from original manufacturer can cause measurement error and false results.  You must only use UBREATH® PRO Flow Transducer by the manufacturer to assure accuracy, and full warranty coverage. Contact your local distributor for purchasing disposable items.

  • Page 26: Information For Correct Use In An Electromagnetic Environment

    Contact your local distributor to change the battery. Take the battery out from the battery compartment, replace the battery exclusively provided by e-LinkCare. NOTE: Data saved in non-volatile memory will NOT lost when battery power is low or batteries are removed.
  • Page 27 Guidance and Manufacturer’s Declaration - Electromagnetic Emissions The UBREATH® PRO Spirometer System is intended for use in the electromagnetic environment specified below. The customer or the user of the UBREATH® PRO Spirometer System should assure that it is used in such an environment.
  • Page 28 +/-2 kV for Mains power quality should power supply Electrical fast +/-2 kV for power that atypical lines transient /burst supply lines commercial hospital +/-1 kV for IEC61000-4-4 [Not Applicable] environment input /output lines Mains power quality should +/-1 kV line(s) +/-1 kV line(s) to that atypical...
  • Page 29 recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance d= 1.2√P 150kHz-80MHz Radiated 3V/m 80 3V/m d= 1.2√P 80MHz-800MHz RFIEC6100 d= 2.3√P 800MHz-2.5GHz 0-4-3 2.7 Ghz Where P is the maximum output power rating of the transmitter in watts (W) according transmitter...
  • Page 30 between portable and mobile RF communications equipment (transmitters) and the UBREATH® PRO Spirometer System as recommended below, according to the maximum output power of the communications equipment. Rated Maximum Separation Distance in Meters (m) according to Output Power of Frequency of Transmitter Transmitter 150 KHz to 80 80 MHz to 800...

  • Page 31: Perform A Spirometry Test

    Perform a Spirometry Test After subject’s profile is entered, now the device is ready to make a spirometry test. Press start button will lead you to FVC testing page by default. When a test is being performed the display will show the real time Flow/Volume curve or the Volume/Time curve.
  • Page 32 Instruct the subjects to do the following to prepare for a test: Loosen any tight articles of clothing that might constrict lung function, for example, a tight belt, tie, vest, bra, girdle, or corset, if they will restrict maximal breathing Remove any foreign objects from the mouth, including loose dentures.

  • Page 33: Test Posture

    Do not touch the buttons of during the test to avoid switching off the system or stopping a test too soon. WARNING: It’s preferable that following activities should be avoided before the test:  Smoking within at least one hour before testing ...
  • Page 34 It is recommended to explain, demonstrate and actively coach the subject to perform the test to obtain a meaningful result: Explain the purpose of the test to see the maximal volume of gas that can be expired as forcefully and rapidly as possible after a maximal inspiration to total lung capacity.
  • Page 35 Insert the mouthpiece well into the mouth beyond the teeth, being careful to ensure that air cannot escape from the sides of the mouth. Press the “Start” button, the system will beep and instruct to begin the test. Make several breaths through the disposable flow transducer. Then inspire slowly as much air as possible and then use the hand to hold on the nose and apply like a nose clip, then expire all the air as rapidly, forcefully and completely as possible.
  • Page 36 WARNING: The performance of the Spirometer can be affected by the patient spitting or coughing into the Spirometer during expiration or by extremes of temperature, humidity and altitude. Again, it is recommended to explain, demonstrate and actively coach 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.
  • Page 37 Coach the subject to perform the maneuver Once the subject is ready, instruct the patient to do the following: Tap on VC icon on the bottom part of screen to initiate VC test. Place the device on the table and hold the remote sensor controller vertically with one hand.
  • Page 38 Item: Indicate the type of parameter. Act: Indicate the actual test results of the test. Pred: Indicate the predicted value based on patient’s profile. %: indicate the percentage of actual value compare to predicated value. Again, it is recommended to explain, demonstrate and actively 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.
  • Page 39 Coach the subject to perform the maneuver Once the subject is ready, instruct the patient to do the following: Make several breaths at rest before the test. Tap on MVV icon on the bottom part of screen to initiate the MVV test. Place the device on the table and hold the remote sensor controller with one hand.

  • Page 40: Finish A Test

    Item: Indicate the type of parameter. Act: Indicate the actual test results of the test. Pred: Indicate the predicted value based 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: Press the release button to unlock the locating pins while pulling the flow transducer vertically up simultaneously.

  • Page 41: Review Historical Data

    3.5 Review Historical Data Displaying and viewing the historical spirometry testing 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: ...
  • Page 42  The detail of the subject’s test information will be shown when tap on one data, a menu with 3 options “Read” “ Delete” “Cancel” will display like follow:  To delete subject’s current test result from memory, press “Delete”. ...

  • Page 43: Test Validation

     Press FVC, VC and MVV on the screen to review this patient’s testing report respectively.  Press “PageUp” and “PageDw” button for more test results. Note: Once the data has been deleted, it cannot be recovered. 3.6 Test Validation The goal of spirometry testing is to obtain accurate measurements of lung function.

  • Page 44: Test Acceptability

     After the test is finished, the following screen will show with options  Select “First” if you would like to replace the first testing record  Select “Second” if you would like to replace the second testing record  Select “Third”...

  • Page 45: Test Repeatability

    second, weak expiratory push, early terminations could cause unacceptability of the test result. However, following condition shall be assessed when evaluate the tests:  Cough during the initial second  Glottis closure  Effort that is not maximal throughout  Mouth piece air leaking ...
  • Page 46 The printout report includes a header line 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.

  • Page 47: Calibration

    Calibration When the UBREATH® PRO Spirometer System is in use, the users should always verify its accuracy by frequently checking its performing maintenance procedures at regular intervals (not required, but optional). The following picture shows the “Calibration" screen. You may need a syringe and adaptor separately. Contact your local distributor for more information.
  • Page 48 Pull the piston all the way out at a steady speed of 1.5 - 5L/s. Push the piston all the way in again with the same speed. Repeat step 4 and 5 for more than three times until the Ex-M and In-M both show 3, the spirometer can calculate the average value of flow and calibration factor.

  • Page 49: Linearity Verification

    Linearity Verification The UBREATH® PRO Spirometer should never be outside accuracy limits unless damaged or in a fault condition. In this event, please see troubleshooting. In normal use, calibration traceability certification is recommended as a part of the routine annual service. Press "Linearity Verification"...
  • Page 50 pop-up window notice for your attention. Press “YES” to move on the verification procedure. Follow the voice instruction and perform low, medium and high flow linearity verification on the spirometer. Pump air into the flowhead at a slow rate of 0 ~ 1.5 L/s, immediately withdraw the syringe at a slow rate. This manoeuvre should show on graph between the light blue area.

  • Page 51: Maintenance

    Despite the thermal printing paper roll which can be bought from your local general medical suppliers, the UBREATH® PRO Disposable Flow Transducer and Rechargeable battery are exclusively from e-LinkCare. Contact your local distributor to enquires from them. WARNING: The maintenance operations set forth in the User’s Manual must be carried out carefully.

  • Page 52: Charging The Battery

    must be carried out by the manufacturer or authorized persons. In case problems arise do not attempt to personally repair the unit. The setting of configuration parameters must be carried out by qualified personnel. In any case the risks pertaining to incorrect settings do not constitute a hazard for the subject.

  • Page 53: Troubleshooting Guide

    Troubleshooting Guide The following table refers some of the issues that can occur with your Test & Measurement products and provides useful troubleshooting steps to help you resolve an issue yourself. CONDITION POSSIBLE SOLUTIONS Check that battery is correctly inserted in the compartment on the UBREATH®...

  • Page 54: Specifications

    Specifications Feature Specification Spirometer: about 206 × 86 x 72 mm Size Sensor Handle: about 81 x 59 x 34 mm Flow Transducer: about 138 x 34 x 47 mm Weight 575 g (including flow transducer) Measuring Sensitivity 0.025 L/s Volume: 0.01 L Measuring Resolution Flow: 1 L/s...
  • Page 55 Classification according to the type of applied Type BF Applied Parts part Classification according type protection against IPX0 harmful ingress water Operating Environment 10 - 35℃, 30% - 80% RH -10 - 45 ℃ , ≤ 80% RH, storage in clean and ventilated Storage Environment room.

  • Page 56: Index Of Symbols

    Index of Symbols Consult instructions for use Store between -10ºC - 45ºC (14°F - 113°F) Use by Lot Number Manufacturer Authorized Representative Sterilized using Ethylene oxide Model Number Catalog # Serial Number Do not dispose along with household waste Fragile, handle with care This Side Up Keep away from sunlight and heat Keep Dry...

  • Page 57: Warranty Condition

    Warranty Condition UBREATH® PRO Spirometer System (Model PF680) together with its standard accessories is guaranteed for a period of 3 years, while the battery is guaranteed for 1 year. The warranty is effective from the date of purchase shown on the relevant sales invoice or proof of purchase.
  • Page 58 Warranty Card For records, also write the purchase date of your product here. Date of purchase: _______________________________________________ Model Number: _________________________________________________ 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.
  • Page 59 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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