e-LinkCare UBREATH PRO PF680 User manual

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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................................................................................... 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
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 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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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

1
Instruction
Welcome and thank you for choosing UBREATH® PRO brand Spirometer System
(Model PF680) from the e-LinkCare.
It is the user’s responsibility to follow the rules of safety as established for their
protection and for the protection of their patients as described in this manual. Please
take special note of the following to ensure an accurate test result is carried out:
Read this entire instruction carefully before attempting use the product.
Use only UBREATH® PRO Disposable Flow Transducer with the UBREATH®
PRO Spirometer System.
Please consult with your physician or healthcare professional first if you are
suitable for this testing.
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
Do not immerse the unit with any fluids. See the maintenance and cleaning
section for proper cleaning procedures.
Keep out of reach 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) is intended to test
spirometry function evaluation and data management and calculates a series of
parameters relating to human respiratory function. (Excluding children under 4
years old).
The UBREATH® PRO Spirometer System is intended for doctors or by a subject
under the instruction of a doctors or healthcare professionals. UBREATH® PRO
brand Spirometer System is used to by general practitioners, specialists, and
health care professionals, in hospitals and clinics, in pharmacies, and in clinical
settings in occupational medicine.
WARNING: No person should attempt to use this device without the
necessary knowledge and training to understand how this equipment is to be
properly utilized and interpreted.
The measurement offered shall only be considered as a tool of screening but
not to be treated as reference for diagnostic purposes.

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Indications for spirometry function tests include, but are not limited to, the
following:
Shortness of breath;
Chronic cough;
Occupational exposure to dust and chemicals;
Assist in the diagnosis of Bronchitis;
Assist in the diagnosis of Asthma;
Assist in the monitoring of bronchodilators;
Wheezing.
1.2 Ability and Experience Required
Medical personnel who conduct spirometry tests by using UBREATH® PRO
Spirometer System and interpret the result should be able to identify technically
flawed curves and distinguish valid from invalid tests. Training, knowledge and
understanding of spirometry tests are essential for all medical personnel
involved.
Spirometry tests are required healthcare personnel with varied backgrounds and
credentials, ranging from doctors, physicians, healthcare professions to medical
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 / clinical facilities, do not use
the device if there are electromagnetic / dirty air currents / wet / flammable gas
environments surrounding.
The device is not designed to be used in direct air currents (e.g. wind), sources of
heat or cold, direct sun rays or other sources of light or energy, dust, sand or any
other chemical substances. The user and/or the doctor are responsible for ensuring
that the device is stored and used in appropriate environmental conditions.
WARNING: If the device is exposed to unsuitable environmental conditions,
this could cause the device to malfunction and to give incorrect results.

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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.
1.5 Limitation and Contradiction
By following the instructions outlined in this User’s Manual, you will be able to
use your UBREATH® PRO Spirometer System to see how well your lungs are
working. However, a spirometry test is not recommended to perform if the
subject presents with following conditions:
An analysis of the results of a pulmonary function test is not by itself sufficient to
make a correct diagnosis of the clinical condition of a subject. A detailed clinical
history of the subject is also required, together with the results of any other
test(s) suggested or prescribed by a doctor. Test comments, a test interpretation
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 myocardial
infarction or pulmonary embolus;
Thoracic, abdominal, or cerebral aneurysms (danger of rupture due to
increased thoracic pressure);
Cataracts or recent eye surgery;
Recent thoracic or abdominal surgery;
Nausea, vomiting, or acute illness;
Recent or current viral infection;
Undiagnosed hypertension；
Presence of an acute disease process that might interfere with test
performance (e.g., nausea, vomiting).
WARNING: The user is responsible for the test acceptability. Special attention
must be paid in the case of elderly people, children and handicapped people.
1.6 Safety Warnings
The UBREATH® PRO Spirometer System (Model PF680) is a non-invasive device
and is safe in both construction and use. However, to ensure accurate

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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;
Do not damage the UBREATH® PRO Spirometer System;
Keep the Spirometer System and all associated parts out of reach of children;
Use only original disposable and accessories from manufacturer;
Device rechargeable lithium battery life is 500 complete recharge cycles.
WARNING: The thermal paper used for printing is highly inflammable. Keep
away from open flames.
Accessory to Medical Equipment (IEC 60601-1)
Accessory equipment connected to this product must be certified according to
the respective IEC standards (i.e.,60601-1) for medical equipment. Furthermore,
all configurations shall comply with the system standard IEC 60601-1-1. Anyone,
who connects additional equipment to the signal input part or signal output part
configures a medical system, and it therefore responsible that the 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-contamination, a
single disposable mouthpiece as well as a flow transducer are required to
connect a subject to the spirometer.
WARNING: It is importance to use a new flow transducer and mouthpiece for
each subject for every pulmonary function test. The characteristics, accuracy
and the hygiene of the disposable transducer or mouthpiece can only be
guaranteed if it has been conserved beforehand in its original sealed
packaging. The disposable mouthpiece / flow transducer both are made of
plastic and its disposal after use must adhere to the local regulations and
norms in force.
To avoid incorrect functioning and possible damages, do not allow dust or
any impurities such as hair, sputum, threads etc. to enter the sensor.
WARNING: It is highly recommended to use gloves when replacing disposable
flow transducers and mouthpieces and washing hands after touching them.

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1.8 Measured Parameters
Measure-
ment
Symbol
Description
Units
FVC
FVC
Forced Vital Capacity
L
FEV1
Volume expired in the 1st second of the test
L
FEV1%
Forced Expiratory Volume in one second to
Forced Vital Capacity ratio
N/A
PEF
Peak 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 measurement
L
RR
Respiratory Rate
1/min

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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.
UBREATH® PRO Spirometer System (Model: PF680) can operate in standalone
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 notify the local distributor
and return the damaged device back to them directly.
Carefully remove the package cover and inspect the kit box and check meter and
accessories.
It is important to save all the original packing material, so the device can be
properly packed if it needs to be returned for service or repair.
The original package packaging contains the device with the following
accessories:

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2.1 Components Description
2.1.1 List of Box Contents
Remote Sensor
Controller
Disposable Flow
Transducer
Spirometer
Micro Type C USB Cable
Adapter(Optional)
Controller 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

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2.1.2 Accessory List
User Manual
User
Manual
Spirometer (with
Thermal Printer
Paper Roll)
Controller Cable
Disposable Flow Transducer
Type C USB Cable
Remote Sensor
Controller
A. UBREATH® Spirometer: measure a range of respiratory parameters.
B. Remote Sensor Controller: Used to receive signal from subjects.
C. UBREATH® PRO Disposable Flow Transducer (Pouched): A disposable item
that is used to connect user with spirometer. It’s assembled by three parts:
throttle pipe, mesh and mouthpiece.
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
adaptor that is applicable in your country.
2.2 UBREATH® PRO Spirometer System
The UBREATH® PRO Spirometer calculates the result and display the pulmonary
function parameter result. Please view below diagrams to be familiar with all the
parts of UBREATH® PRO Spirometer System.

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2.2.1 Introduction of UBREATH® PRO Spirometer
A. Overview of UBREATH® PRO Spirometer
Indicator Light
Printer
Compartment
Barcode
Reader
Button
Start Button
LCD Screen
Controller Holder
Type-C Socket
Connection
Port for
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 subject ID or QR
code;

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f) Start Button: To power on or off the device;
g) Type-C Socket: Connection port for USB cable;
h) Connection Port for Remote Sensor Controller: Connect remote
sensor controller with the device;
i) SN Label: SN series number;
j) Speaker: Tells the audio information to users;
k) Battery Compartment: Holds the battery inside.
B. Overview of Remote Sensor Controller
Stream Port
Connection Port
Locating 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 spirometer.
2.2.2 Connecting the Accessories
Before carrying out a test, it is compulsory to connect all the accessory parts into
one systematic unit, follow below steps to complete the procedure:

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1. Unpack UBREATH® PRO Spirometer System, check if all components are in
good condition.
2. Connect the controller cable to UBREATH® PRO Spirometer System main
body until hearing the click which indicates that it has been correctly
inserted
3. Connect the other end to the remote sensor controller, again the click will
indicate the correction of insert.
4. The flow transducer usually comes with a transparent sterilized bag. Tear
the bag and take out the flow transducer then 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 hygiene reasons, do not touch the mouthpiece throughout the 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 degraded performance of the device.
2. Verify that there’s no foreign bodies present inside the transducer
sensor. The insert direction of the transducer must be inserted vertically
like the picture shown above.
3. Do not use if the bag is leaking, damaged or the item inside.

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2.2.3 Loading the Thermal Paper Roll
Follow the steps to load/change the thermal paper:
1. Open the lid of the thermal paper compartment and remove it from the
device;
2. Insert the new roll of paper onto the 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 width size.

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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.
If you would like to turn if off manually, simply press the start button for 3
seconds when the device on.
Warning
：
The current test data may lose if attempt to switch off the device
during a test by force.
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 while in sleeping mode. You will need to long
press the start button for 3 seconds to restart the device.
2.3 LCD Touch Screen
UBREATH® PRO Spirometer System uses an LCD touch screen which allows a
more convenient and fast way to use the device. There are a few controls and
gestures which you can apply on the screen.

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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.
To scroll through lists or move a slider on the touchscreen, drag your finger
across the touchscreen.
You can use the touchscreen wearing disposable gloves made of any material.
Standard disposable gloves 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
Unit Format
Sex
Ethnicity
Height
Ambient Settings
Weight
Calibration
Datalist
Linearity Verification
System Setting
Wlan
Sensor Status
Language
The First Test
Firmware Version
Second Test. Yellow crown
stands for the best result
Printing
The Third Test

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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.

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Home Screen
The home screen is the starting point when working with UBREATH® PRO
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. It can be input manually or through a scanner provided within the device.
Name: Indicate the subject’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 height. (Available in Centimeters or Foot & Inch depending on
System Setting).
Weight: The subject’s weight in KG or Pound. Tap on it and enter the
measurement of weight. (Available in KG or Pound depending on System
Setting).

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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”.
System Setting: General configurations of the device.
Sensor Status:
Condition
Status indication
The remote sensor controller is disconnected
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 procedure:
1. Press ID key to enter the ID for the subject, if the ID already exist, the age,
sex, height, weight cannot be entered. Otherwise add the ID by using the
keypad.
2. Enter age, sex, weight and height accordingly.
3. All information must be filled before initiate a test.

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