FOR-A TN'G SpO2 Reference guide

Fingertip Pulse Oximeter
Operations & Procedures Manual
Long-Term Care and Home Health Care

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Thank you for purchasing the FORA TN'G SpO2Fingertip Pulse Oximeter. This manual
provides important information to help you to use the device properly. Before using this
product, please read the following contents thoroughly and carefully.
If you have other questions regarding this product, please contact the place of purchase
or call Customer Service at 1-888-307-8188.
The FORA TN'G SpO2is intended for multi-patient use in a long-term or home health
care setting. Please note that the following procedures are provided only as a model
to help your facility establish its own policy and procedures. Your own policy may differ
depending upon the existing procedures. Please consult with the Director of Nursing for
further guidance.
CAUTION: Please carefully read the User’s Manual and all product instructions before
using this Long-Term Care and Home Health Care Manual.

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TABLE OF CONTENTS
WARNINGS 05
CAUTIONS 05
INTENDED USE 06
METER OVERVIEW 06
Principle of Measurement 06
Meter Appearance and Key Function 06
Battery Replacement 07
OXYGEN SATURATION AND PULSE RATE TESTING 07
CLINICAL PERFORMANCE 08
CLEANING THE OXIMETER 09
MAINTENANCE AND STORAGE 09
TROUBLESHOOTING 10
SPECIFICATIONS 10
TRAINING TOOLS 11
Attachment 1: FORA TN’G SpO2Fingertip Pulse Oximeter Training Checklist 11
Attachment 2: FORA TN’G SpO2Fingertip Pulse Oximeter Training Quiz 12
Attachment 3: FORA TN’G SpO2Fingertip Pulse Oximeter Quality Control Results Record 13
Notes 14

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WARNINGS
● 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denitivediagnosisonthe
results of a single test. A physician or
healthcare provider should make a diagnosis
afterallotherclinicalandlaboratoryndings
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 an accurate SpO2
measurement.Bloodowrestrictors(e.g.,
blood pressure cuffs) may hinder pulse
measurements.Removeanyobjectsthat
may hinder the performance of the oximeter.
● Rxonly.
● Keepthebatteriesoutofthereachofchildren.
The batteries from the device may result in
a choking hazard for children if swallowed or
inhaled.
● Thedeviceisonlyintendedtobeusedinan
indoor environment.
● Wirelesscommunicationequipmentcanaffect
the functionality of the device and should be
kept away from the equipment.
CAUTIONS
● Theoximeterdeterminesthepercentage
of arterial oxygen saturation of functional
hemoglobin.Signicantlevelsofdysfunctional
hemoglobin such as carboxyhemoglobin or
methemoglobin may affect the accuracy of the
measurement.
● Cardiogreenandintravasculardyes,depending
on the concentration, may affect the accuracy
of SpO2measurements.
● Theperformanceoftheoximetermightbe
affectedbythepresenceofadebrillator.
● 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.
Dispose 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 when disposing or recycling the
device and its components.
● 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.

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INTENDED USE
The Fingertip Pulse Oximeter is indicated for
use in measuring oxygen saturation of arterial
hemoglobin(SpO2) 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 or monitoring.
Bluetooth Indicator
Blue light appears when bluetooth is turned on.
SpO2%
The measurement result of oxygen saturation
in percentage.
Battery Indicator
Pulse Amplitude
The strength of the signal is detected by the
oximeter.
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)
Pulse Rate
The measurement result of pulse rate in beats
per minute.
On/Off Button
It is used to turn on or turn off the oximeter by
pressing On/Off button
Battery Compartment
METER OVERVIEW
Principle of Measurement
The Fingertip Pulse Oximeter determines
functional oxygen saturation of arterial
hemoglobin(SpO2) 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.
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Meter Appearance and Key
Function

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Battery Replacement
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tscorrectly.Itis
important that the cover is closed correctly to
ensure the oximeter remains waterproof.
NOTE:
• Use only 1.5V AAA new batteries
with this device. Replace the
batteries as soon as possible after a
low battery symbol appears.
NOTE:
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.
3. Check the sensor application site frequently to determine
circulation, positioning and skin sensitivity.
OXYGEN SATURATION
AND PULSE RATE
TESTING
1. Turn on the oximeter
by pressing . Do not move
yourngerwhenstartingtest.
Do not move your body while
testing.
2. Opentheclampandputoneofyourngers
intorubberholeoftheoximeter(itisbettertolet
yourngertouchthebottom)beforereleasingthe
clamp.

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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:
Below is the description of the effect on displayed and
transmitted SpO2and 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.
3. After detecting the pulse
signal, the oximeter shows
the readings of SpO2and
pulse rate on the display.
The readings will be updated
based on the signal received
with each pulse.
4. Whiletesting,ifyoupress
, the screen will rotate 180
degrees.
5. Hold and the oximeter will turn off.
NOTE:
The backlight will turn to blinking red if
the oxygen saturation value is below
85%.
CLINICAL PERFORMANCE
Tables below show Arms values measured using
Fingertip Pulse Oximeter in a clinical study. The
individual and pooled measured Arms values in
the SpO2rangesofall14subjectsarereported.
Subject
70% - 80%
SaO2
80% - 90%
SaO2
90% - 100%
SaO2
Mean
Bias Arms Mean Bias Arms Mean Bias Arms
1 -1.00 1.89 1.25 1.80 0.00 1.03
2 1.27 1.71 -1.07 1.58 -0.81 1.20
3 -2.00 2.00 -1.90 1.97 -1.15 1.33
4 2.17 2.27 1.14 1.51 0.81 1.64
5 -1.11 2.11 1.25 1.94 -0.74 1.26
6 -0.57 2.07 -1.25 1.94 -1.00 1.22
7 1.00 1.78 2.00 2.00 0.20 1.06
8 1.30 1.97 0.50 0.71 -0.64 1.16
9 2.29 2.33 0.40 1.79 0.78 1.63
10 1.30 2.07 1.20 2.00 0.50 0.89
11 -2.18 2.73 1.33 1.73 1.90 1.97
12 -1.71 2.26 -1.00 1.96 0.07 1.07
13 0.25 2.54 -1.50 1.87 -0.25 1.53
14 -1.56 1.94 1.20 1.67 0.83 1.35
Figure1Plotofdifference(SpO2- SaO2) versus
arterybloodgas(SaO2) with linear regression
tandupper95%andlower95%limitsof
agreementofallsubjects.Eachcolororsymbol
represents a different patient in the clinical study.
Subject 70% - 80%
SaO2
80% - 90%
SaO2
90% - 100%
SaO2
Mean
Bias 0.16 0.21 0.21
Arms 2.00 1.87 1.29

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NOTE:
Do not spray, pour, or spill any liquid on the oximeter,
accessories, switches or openings.
CLEANING THE OXIMETER
Cleaningthe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.
MAINTENANCE AND
STORAGE
● Replace the batteries immediately 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.
Difference plot of Fingertip Pulse Oximeter and artery blood gas

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SPECIFICATIONS
Model No.: TN'G SpO2
Dimension & Weight:
63(H)x37(W)x32(D)mm,40g(WithoutBattery)
Power Source:
two 1.5V size AAA alkaline batteries
Pulse Rate
Measurement Range: 30 to 250bpm
Resolution: 1bpm
Accuracy: ±1bpm or ±1%, whichever is greater
Operating Conditions: 50°Fto104°F(10°Cto
40°C);Below95%R.H.(non-condensing)
Meter Storage/ Transportation Conditions:
-13°Fto158°F(-25°Cto70°C);Below95%R.H.
(non-condensing)
Product Life Time: 12 months
Classication
Type BF Applied part: Type BF Applied part
Safety: IEC60601-1
EMC: IEC60601-1-2
Harmonized Standard: ISO 80601-2-61:2011
Water-resistance: IP22
Mode of Operation: Spot Check / Monitoring
TROUBLESHOOTING
Symptom Possible Causes Solutions
The oximeter
cannot be
turned on.
The batteries are
dead.
Replace all
batteries.
The batteries are
installed incorrectly.
Verify correct
battery
orientations.
SpO2or pulse
rate displays
are missing.
Defective LCD
displays.
Displayed values
may not be reliable;
discontinue use of
the oximeter.
SpO2or pulse
rate displays
unstable.
Finger might be
trembling or placed
incorrectly on the
probe.
Try not to move or
retry by placing the
ngeratthecorrect
position on the
probe.
Disruption in
the oximeter
performance.
Electromagnetic
interference(EMI).
Remove the
oximeter from the
EMIenvironment.
Battery is low
and
" "
is shown on
LCD.
The batteries are
low.
Replace the
batteries
immediately.
Backlight
turns to
blinking red
(visualalarm
is activated)
Oxygen saturation
value is below 85%.
Consult healthcare
professional
immediately.
Display: LCD
Battery Life:
Batteries can be used continuously for 8 hours
(forreferenceonly,itdependsondifferentbrands
of AAA alkaline batteries)
External Output: Bluetooth
Measurement Range: 0% to 100%
Resolution: 1%
Accuracy: 100% ~ 80% ±2%; 79% ~ 70% ±3%;
others are undefined.
Method: DualwavelengthLED

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TRAINING TOOLS
Attachment 1: FORA TN'G SpO Fingertip Pulse Oximeter
Training Checklist
Use the following checklist to assess the trainee’s understanding and knowledge of the following areas:
TASK ( )
AREA CLINICAL USE OF DEVICE
Knows key features of TN'G SpO2Fingertip Pulse Oximeter meter.
Principles of quality testing and QC materials.
Understandstheimportantfeatures,benetsandlimitationsoftheFORA TN'G SpO2Fingertip Pulse Oximeter.
Understands the displayed error messages and corresponding actions to take.
Understands the appropriate steps to take for troubleshooting.
Knows the actions to be taken when the results are abnormally high or low.
Understands the information required to be documented by law and by institution.
Locates the serial number on the device.
Knows the proper storage conditions of the pulse oximeter.
Knows how to maintain the device.
Demonstrates proper safety procedures.
Demonstrates the correct SpO2testing procedures using the TN'G SpO2Fingertip Pulse Oximeter.
Demonstrates the proper cleaning and disinfecting techniques for the FORA TN'G SpO2Fingertip Pulse Oximeter.
Demonstrates the proper actions to take for inaccurate results.
KnowledgeEquipmentPractical
The trainee must complete the training of the FORA TN'G SpO2before performing pulse measurement testing on
residents.
Training Completed by:
Name of Trainee Date Name of Instructor Signature of Instructor
2

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Training Completed by:
Answers:
1.(b)2.(b)3.(a)4.(c)5.(a)6.(a)7.(b)
Name of Trainee Date SCORE
Attachment 2: FORA TN'G SpO Fingertip Pulse Oximeter
Training Quiz
Complete the following questions to assess your understanding about using the FORA TN'G SpO2Fingertip Pulse
Oximeter to perform oxygen saturation measurement tests on patients:
NO. QUESTIONS ANSWER
1The FORA TN'G SpO2Fingertip Pulse Oximeter measures:
a) weight b) oxygen saturation c) both weight and oxygen saturation
2Only use the FORA TN'G SpO2pulse oximeter to measure oxygen saturation on patients weighing at least:
a) 100 lbs. b) 88 lbs. c) 50 lbs.
3The FORA TN'G SpO2easily pairs to your tablet device using what type of communication?
a) Bluetooth b) cellular c) cable
4The backlight will turn to blinking red if the oxygen saturation level is below:
a) 65% b) 75% c) 85%
5Whendoyoucleananddisinfectthedevice?
a) After each use b) Daily c)Weeklyd) Monthly
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If you saw the following message on the meter's display, what action should you take?
a) Replace the battery
b) Turn the meter off and on
c) Both of the above
d) None of the above
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The SpO2device should be stored:
a)At39.2°Fto104°F(4°Cto40°C),below85%humidity
b)At-13°Fto158°F(-25°Cto70°C),below95%humidity
c) In the freezer
d) None of the above
2

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Attachment 3: FORA TN'G SpO2Fingertip Pulse Oximeter Quality Control Results
Record Meter #:
Month/Year:
Results reviewed by:
Date Time Station / Shift Operator
Meter
Cleaned
(Y/N)
Corrective
Action

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Notes

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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,Mon.-Fri.)
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