FOR-A TN'G SpO2 User manual

Quick Start Guide
EN
Pulse Oximeter

Performing a Test
Testing Conditions
• In the case of cold weather or low circulation,
warming up the hands will give best test
results. Device may not be able to complete
reading if there is low blood flow to the
fingertips.
• Thick nail polish and fake nails could interfere
with readings.
Uploading Results
• The FORA SpO2 has Bluetooth capabilities
and is compatible with various FORA Apps as
well as the Gateway.
• To upload results via the Gateway, please refer
to the Gateway guide.
• To pair the device to the iFORA Smart or
iFORA MP app, please refer to the iFORA App
Quick Guides.
1. Turn on the oximeter by pressing the power
button.
2. Open the clamp and put one finger into the
rubber hole of the oximeter (letting the finger
touch the bottom) before releasing the clamp.
3. Do not move when starting or during the test.
4. After detecting the pulse signal, the oximeter
shows the readings of SpO2 and pulse rate
on the display.
5. For Gateway users: You will see both the
WSN and NET lights blink on the Gateway
device. Keep your finger on the Oximeter until
you hear two short beeps from the Gateway
indicating a successful upload.
Note: Pressing the power button during a test will
rotate the display.
Helpful Information

Where can I review my data?
To keep track of your trends, the Bluetooth-enabled meter
will connect to the iFORA Smart App, iFORA O2 App,
or iFORA MP App, which can be downloaded from your
smartphone’s app store. The meter also automatically
uploads data to the 24/7 HealthView Telehealth System via
Bluetooth or cellular Gateway. The product user manual
can be downloaded from the website product page.
I followed the correct steps, but the pulse oximeter is not
operating correctly. What can I do?
The most common errors and their solutions are listed
on the next page. Refer to the manual for a complete
troubleshooting guide.
What are the cleaning and disinfection procedures for the
TN’G SpO2?
Turn off the oximeter before cleaning. Wipe the exterior
surfaces thoroughly with a soft cloth containing 75%
isopropyl alcohol solution. Remove the wipe and allow the
meter to air dry completely. Discard the wipes.
For additional information on the SpO2 device, please refer
to the user manual.
Why would I need an SpO2 monitoring system?
A pulse oximeter checks how well your heart is pumping
oxygen through your body. It’s used to monitor health
conditions such as COPD and heart failure. It also helps
determine how effective supplemental oxygen therapy is,
especially when treatment is new, and evaluates whether
a person momentarily stops breathing while sleeping, like
sleep apnea.
How does the TN’G SpO2 device work?
The fingertip pulse oximeter determines functional
oxygen saturation of arterial hemoglobin by measuring
the absorption of red and infrared light passing through
perfused tissue. Changes in absorption caused by
the pulsation of blood in the vascular bed are used to
determine oxygen saturation and pulse rate. Download the
iFORA Smart App, iFORA O2 App, or iFORA MP App from
your smartphone’s app store to review your data. Data
automatically uploads to the 24/7 HealthView Telehealth
System via Bluetooth or cellular Gateway.
What’s the proper way to take a measurement?
Press the power button. Simply open the clamp and place
one of your fingers into the rubber hole of the oximeter
before releasing the clamp. Make sure you don’t have long
nails or dark colored nail polish.
How often should I replace the batteries?
The lifespan of your battery will vary considerably with
how it is used, how it is maintained, temperature, and
other factors such as frequency of testing. The pulse
oximeter comes with two 1.5V AAA alkaline batteries.
Replace them when the low battery icon appears.
FAQ

For questions on how to use the FORA medical devices, please contact the
FORA Customer Service Line at 1-888-307-8188
Troubleshooting
Below is the description of the effect on
displayed and transmitted SpO and
pulse rate data values by:
- data averaging and other signal
processing for 8 seconds,
- the data update period for 1 second,
- the alarm condition delay for 1
second,
- alarm signal generation delay for 1
second including the effects of any
selectable operating mode that affects
these properties.
NOTE
• While the meter is in transmission
mode, it will be unable to perform a
test.
• The meter is compatible with the
following devices, iOS (6 or above) and
Android system (4.3 or above). Make
sure device is in proper receiving
range of the meter before transmitting
data.
• The Bluetooth functionality is
implemented in different ways by the
various mobile device manufacturers,
the compatibility issue between your
mobile device and the meter may
occur.
NOTE
Do not spray, pour, or spill any liquid on
the oximeter, accessories, switches or
openings.
Fingertip
Pulse Oximeter
Operating
Instructions
Battery Replacement
Contents of the System
Version 2.0 Apr. 2018
311-8255200-017
Make sure the oximeter is off when
replacing the batteries.
The oximeter is powered by two 1.5V
AAA size alkaline batteries. You can
replace new batteries by the following
steps.
1. Press the edge of the battery cover
and lift it up to remove.
2. Remove the old batteries and replace
with two 1.5V AAA size alkaline
batteries.
3. Close the battery cover carefully and
make sure the cover is snug and fits
correctly. It is important that the cover
is closed correctly to ensure the
oximeter remains waterproof.
The Fingertip Pulse Oximeter includes
the following items:
Operation
STEP 1. Turn on the
oximeter by pressing
. Do not move your
finger when starting test.
Do not move your body
while testing.
Confirm that the items listed are packed
with the Fingertip Pulse Oximeter. If any
item on this list is missing or damaged,
contact your distributor. All of the
system with accessories is provided
non-sterile.
A. Fingertip Pulse Oximeter
B. Operating Instructions x 1
C. AAA-Size Alkaline Batteries x 2
D. Warranty Card
• Do not use the oximeter in an MRI or CT
environment.
• The oximeter is not intended for use in
the diagnosis or screening of any
symptoms or diseases. The data
measured is for reference only, do not
base a definitive diagnosis on the
results of a single test. A physician or
healthcare provider should make a
diagnosis after all other clinical and
laboratory findings are evaluated.
• If subjects’ monitoring sites have
trauma, disability or other medical
status that make inaccurate results,
operators should consult doctors
before use.
• The oximeter has to measure the pulse
properly to obtain accurate SpO
measurement. Blood flow restrictors
(e.g., blood pressure cuffs) may hinder
pulse measurements. Remove any
objects that may hinder the
performance of the oximeter.
1. Bluetooth Indicator
Blue light appears when bluetooth is turned on.
2. SpO %
The measurement result of oxygen saturation in
percentage.
3. Battery Indicator
4. Pulse Amplitude
The strength of the signal is detected by the
oximeter.
5. Backlight (White or Red)
Backlight is white while in measuring mode.
Backlight is blinking red while the oxygen
saturation value is below 85%. (high priority
visual alarm)
6. Pulse Rate
The measurement result of pulse rate in beats per
minute.
7. On/Off Button
It is used to turn on or turn off the oximeter by
pressing On/Off button
8. Battery Compartment
A B C D
BEFORE USE
Intended Use
The Fingertip Pulse Oximeter is
indicated for use in measuring oxygen
saturation of arterial hemoglobin (SpO )
and pulse rate. It is intended for patients
during no-motion condition. The
patients are limited to adults with
weight above 88 lb.
This device is indicated for non-invasive
spot checking.
Principle of Measurement
MeterAppearance and Key Function
The Fingertip Pulse Oximeter
determines functional oxygen saturation
of arterial hemoglobin (SpO ) by
measuring the absorption of red and
infrared light passing through perfused
tissue. Changes in absorption caused by
the pulsation of blood in the vascular
bed are used to determine oxygen
saturation and pulse rate.
INTRODUCTION
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• Cardio green and intravascular dyes,
depending on the concentration, may
affect the accuracy of SpO measure-
ments.
• The performance of the oximeter
might be affected by the presence of a
defibrillator.
• The oximeter may not work on all
subjects. If you are unable to achieve
stable readings, discontinue use.
• Do not use caustic or abrasive cleaning
agents on the oximeter or probes.
• Do not mix new and old batteries at
the same time. It may cause the
batteries to leak. Disposed of batteries
properly.
• Batteries might leak chemicals if
unused for a long period of time.
Remove the batteries if the oximeter
is going to be stored for more than
one month.
• The oximeter is a precision electronic
instrument and must be repaired by
trained personnel only.
• Follow local governing ordinances and
recycling instructions regards disposal
or recycling of the device and device
components.
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MAINTENANCE AND STORAGE
CLEANING THE OXIMETER
TROUBLESHOOTING
You can transmit your SpO and pulse
rate data from the meter to your device
(e.g. smart phone, tablet, PC…) via
Bluetooth. Please contact your local
customer service or place of purchase
for assistance.
Please note that you must complete the
pairing between meter and Bluetooth
receiver before transmitting data.
1. With the meter off, press and hold
for 4 seconds. The meter enters pairing
mode.
2. Turn on the Bluetooth function of your
device so that it can begin searching for
the meter. When the name of the meter
appears on the pairing list, select and
add it to the list.
3. On your device, the meter will be
shown as a paired device, suggesting
successful pairing.
Bluetooth indicator on the oximeter:
Cleaning oximeter is just as important as
proper use. For surface-cleaning and
disinfecting the oximeter we
recommend the following procedures:
1. Turn off the oximeter before cleaning.
2. Wipe the exterior surfaces thoroughly
with a soft cloth containing 75%
isopropyl alcohol solution.
3. Remove the wipe. Allow the oximeter
surface to air dry completely.
4. Discard the used wipes and never
reuse them.
• Replace the batteries timely when low
voltage indicator is on.
• Clean surface of the Fingertip
Oximeter before use.
• Remove the batteries inside the
battery compartment if the oximeter
will not be operated for a long time.
• It is best to preserve the product in a
place where ambient temperatures
range from -25°C to 70°C (-13°F to
158°F) and humidity range below
95% R.H.
• It is recommended that the product be
kept in a dry place. A damp ambient
might affect its lifetime and even
might damage the product.
The oximeter cannot
be turned on.
The batteries are dead. Replace all batteries.
The batteries are
installed incorrectly.
Verify correct battery
orientations.
Error
BLUETOOTH
INDICATOR
Flash Fast
Lit Solid
The meter is pairing
and connecting
The connection is
established. The meter
is transmitting data
now.
STATUS
Possible Causes Solutions
1. Consult healthcare professionals
before you start to use the oximeter.
2. The oximeter sensor might not work
on cold extremities due to reduced
circulation. Warm or rub the finger to
increase circulation, or reposition the
sensor.
STEP 2. Open the clamp and put one of
your fingers into rubber hole of the
oximeter (it is better to let your finger
touch the bottom.) before releasing the
clamp.
DATA TRANSMISSION VIA BLUETOOTH
STEP 3. After detecting
the pulse signal, the
oximeter shows the
readings of SpO and
pulse rate on the display.
The readings will be
updated based on the
signal received with each
pulse.
2
Battery is low and
" " is shown
on LCD.
Backlight turns to
blinking red (visual
alarm is activated)
SpO or pulse rate
displays are missing.
Defective LCD screens. Displayed values may not
be reliable; discontinue use
of the oximeter.
SpO or pulse rate
displays unstably.
Finger might be trembling
or placed incorrectly on
the probe.
Try not to move or retry by
placing the finger at the
correct position on the probe.
Disruption in the
oximeter performance.
Electromagnetic
interference (EMI).
Remove the oximeter from
the EMI environment.
The batteries are low.
Oxygen saturation value
is below 85%.
Replace the batteries
immediately.
Consult healthcare
professional immediately.
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2
Under which situations the pairing is
required: (A) you first receive and use
the meter; (B) change a new device for
re-pairing.
• Federal law (USA) restricts this device
to sale by or on the order of a
physician.
• Keep the batteries out of reach of
small unsupervised children. The
batteries detached from the device
may result children choking from
inhaling or swallowing.
• The device is only applied to use under
indoor environment.
• The device is not recommended to
wear for a long period.
• Wireless communications equipment
can affect the device and should be
kept at least a distance away from the
equipment.
• The oximeter is not an apnea monitor.
• The oximeter determines the
percentage of arterial oxygen
saturation of functional hemoglobin.
Significant levels of dysfunctional
hemoglobin such as carbonxyhemo
globin or methemoglobin may affect
the accuracy of the measurement.
CAUTIONS
WARNINGS
Use only 1.5V AAA new
batteries with this
device. Replace the
batteries as soon as
possible after a low
battery symbol appears.
NOTE
NOTE
NOTE
NOTE
The pulse rate reading with the
maximum (250) or minimum (30) values
may not be the actual pulse rate, it may
be inaccurate.
NOTE
Distributed by ForaCare, Inc.
893 Patriot Drive Suite D
Moorpark, CA 93021 USA
Products made in Taiwan
Toll Free: 1-888-307-8188
(8:30 am-5:00 pm PST, Monday-Friday)
For assistance outside of these hours, please contact
your healthcare professional.
www.foracare.com
Read instructions before use.
Caution, consult accompanying documents
1.
Bluetooth Indicator
3.
Battery Indicator
4.
Pulse Amplitude
7.
On/Off Button
8.
Battery Compartment
6.
Pulse Rate
5.
Backlight
(White or Red)
2.
SpO %
STEP 4. While testing, if
you press , the screen
will rotate 180 degrees.
STEP 5. Keep pressing and the
oximeter will turn off.
The backlight will turn
to blinking red if the
oxygen saturation value
is below 85%.
NOTE
3. Check the sensor application site
frequently to determine circulation,
positioning and skin sensitivity. The
recommended maximum application
time at a single site is 4 hours.
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bAt Lo
Fingertip
Pulse Oximeter
Operating Instructions
• Always store the oximeter in a cool
and dry place: temperature range of
-13°F to 158°F (-25°C to 70°C) at
relative humidity less than 95%. Avoid
direct sunlight.
2