OxySmart PC-60FW User manual

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OxySmart
Fingertip Oximeter
User Manual
Model: PC-60FW

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Notes
Please read the manual very carefully before
using this device. Failure to follow these
instructions can cause measuring abnormality
or damage to the Oximeter.
The contents contained in this manual are
subject to change without notice.
Information furnished by our company is
believed to be accurate and reliable. However,
no responsibility is assumed by us for its use, or
any infringements of patients or other rights of
third parties that may result from its use.
Instructions for Safe Operation
Check the device to make sure that there is no
visible damage that may affect user’s safety or
measurement performance with regard to
sensors and clips. It is recommended that the
device should be inspected minimally before
each use. If there is obvious damage, stop
using the device.

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Special attention should be paid while the
Oximeter is used constantly under the
ambient temperature over 37°C, burning hurt
may occur because of over-heating of the
sensor at this situation.
Necessary maintenance must be performed
only by qualified service technicians. Users
are not permitted to service this device.
The Oximeter must not be used with devices
and accessories not specified in User Manual.
Cautions
Explosive hazard—DO NOT use the Oximeter
in environment with inflammable gas such as
some ignitable anesthetic agents.
DO NOT use the Oximeter while the patient is
under MRI or CT scanning. This device is NOT
MRI Compatible.
Warnings
Discomfort or pain may appear if using the
Oximeter continuously on the same location
for a long time, especially for patient with
poor microcirculation. It is recommended that

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the Oximeter should not be applied to the
same location for longer than 2 hours. If any
abnormal condition is found, please change
the position of Oximeter.
DO NOT clip this device on edema or tender
tissue.
The light (the infrared light is invisible)
emitted from the device is harmful to the eyes.
Do not stare at the light.
The Oximeter is not a treatment device.
Local laws and Regulations must be followed
when disposing of the device.
Attentions
Keep the Oximeter away from dust, vibration,
corrosive substances, explosive materials, high
temperature and moisture.
The device should be kept out of the reach of
children.
If the Oximeter gets wet, please stop using it
and do not resume operation until it is dry and
checked for correct operation. When it is
carried from a cold environment to a warm

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and humid environment, please do not use it
immediately. Allow at least 15 minutes for
Oximeter to reach ambient temperature.
DO NOT operate the button on the front panel
with sharp materials or sharp point.
DO NOT use high temperature or high pressure
steam disinfection on the Oximeter. Refer to
the instructions regarding cleaning and
disinfection.
The equipment is IP32 with protection against
harmful solid foreign objects and ingress of
liquid.
Please pay attention to the effects of lint, dust,
light (including sunlight), etc.
Declaration of Conformity
The manufacturer hereby declares that this device
complies with the following standards:
IEC 60601-1: 2012 Medical electrical
equipment-Part 1: General requirements for basic

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safety and essential performance;
ISO 80601-2-61: 2017 Medical electrical
equipment-Part 2-61: Particular requirements for
basic safety and essential performance of pulse
oximeter equipment.
And it also follows the provisions of the council
directive MDD 93/42/EEC.
Caution: U.S. federal law restricts this device
to sale or use by or on the order of a physician.

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Table of Contents
1 Overview.............................................. 1
2 Battery Installation..............................3
3 Operation............................................. 4
4 Wireless................................................9
5 Technical Specifications....................12
6 Packing List........................................ 15
7 Repair and Maintenance.................. 16
8 Troubleshooting................................ 19
9 Key of Symbols.................................. 20
10 Frequently Asked Questions.......... 21
Appendix EMC.......................................25

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1 Overview
1.1 Appearance
Figure 1 Front View
Display Key
Nameplate
Lanyard Hole
Battery Cover
Display Screen
Figure 2 Rear View

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Note: the appearance is for demonstration only,
please refer to the oximeter you purchased.
1.2 Intended Use
This Fingertip Oximeter is intended for measuring
the pulse rate and functional oxygen saturation
(SpO2) through a patient’s finger. It is applicable
for checking SpO2and pulse rate of adult and
pediatric patients in homes and medical clinics.
1.3 Configuration
SpO2, PR, PI
Plethysmogram
Auto on/off
PR and PI shifts
Pulse bar
Over-limits setting
Pulse beep
Measuring Mode: Continuous
Record list
Wireless function

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2 Battery Installation
Figure 3 Battery Installation
1. Refer to Figure 3, insert two AAA size batteries
into the battery compartment properly, and
note the polarity markings.
2. Replace the cover.
Please make sure that the batteries are
correctly installed. Incorrect installation may
cause the device not to work.
Please remove batteries if the device is not
being used for more than 7 days to prevent and
avoid potential damage from the battery leaking.
Any such damage is not covered under the

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product warranty.
3 Operation
1. Start. Open the clip and put finger inside the
rubber cushions of the clip (make sure the finger is
in the correct position), and then clip the finger, as
shown in figure 4.
Figure 4 Put finger into the Oximeter
Wait 2 seconds, the Oximeter will power on
automatically and start to measure;
If you connect device to App, you can also check
readings in App.
2. END. When finger is out, the Oximeter shuts
down automatically.

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3. Readings display screen
The screen displays as below
：
Figure 5
4. Recording & recall
Recording & recall functions are available. At power
off status, pressing Display key can bring up record
list display screen, as shown in figure 7. In record
list screen, press Display key to shift the records
page.
Figure 6
If the time from displaying valid readings to the end
of measurement is less than 5 seconds, then no

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recording will be done.
Up to 12 groups of records can be stored in the
record list, the newest record is marked as M1,
and the oldest record is marked as M12. The new
record will override the previous record.
If the batteries are removed from the device, then
the records will be not kept or volatile.
5. Menu
When finger is in oximeter, long time pressing
display key can enter the setup menu screen.
Figure 7
Menu setup: Short time press Display Key to
choose the setting item; Longtime press Display
Key to active the setting item, then short time

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press it to modify the setting parameter; Next,
longtime press Display Key to confirm the
modification and exit from this setting item. At
last, move the setting item to “Save, exit menu”,
and long time pressing Display Key to store the
modification and exit from the setup menu.
“Beep”：Pulse beep option. If it is set to on, every
pulse beat makes a beep.
when beep is on and over-limits indication sound
is activated, then Display key will work as the
Mute key, and short time pressing it can mute the
over-limits indication sound and pulse beep for 90
seconds.
Data transmission
The user could effectively transmit the data to
App via Bluetooth.
Attention to the operation
The finger should be put into the sensor
correctly.
Do not shake the finger and relax during
measurement.

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Do not put wet finger directly into sensor.
Avoid placing the device on the same limb
which is wrapped with a cuff for blood
pressure measurement or during venous
infusion.
Do not let anything block the emitting light
from device, i.e. do not use finger nail
polish/paints.
Vigorous exercise and electrosurgical device
interference may affect the measuring
accuracy.
Nail polish may affect the measuring
accuracy, and too long fingernail may cause
failure of measurement or inaccurate result.
Existence of high intensive light sources,
such as fluorescence light, ruby lamb,
infrared heater or strong sunshine, etc. may
cause inaccuracy of measurement result.
Please put an opaque cover on the sensor or
change the measuring site if necessary.
If the first reading appears with poor
waveform (irregular or not smooth), then
the reading is unlikely true, the more stable

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value is expected by waiting for a while, or a
restart is needed when necessary.
4 Wireless
The wireless icon Definition
The icon of
Definition
flashes
The device is being to establish a
wireless connection with the
surrounding host.
Successful wireless connection
between the device and a host is
established.
No display
icon
1. "Wireless" function is disabled;
2. The device fails to setup a
wireless connection with the
surrounding host within 3 minutes;
3.Hardware failure of wireless
transmission function while the
“Wireless” function is enabled.

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4.1 Download the App
App name: ViHealth
iOS: App Store
Android: Google Play
4.2 Install the App
Install the app on an Apple product or
Android-powered device, including smart phones
and tablets.
4.3 Compatibility
The ViHealth app is compatible with iOS versions
9.0+ and Android versions 5.0+.
The compatible smart device models are listed
below:
Brand
Model
Apple
iPhone5/S, iPhone SE,
iPhone6/S/Plus, iPhone7/Plus,
iPhone8/Plus, iPhone X, iPhone XS,
iPhone XS Max, iPhone XR, iPhone11,
iPhone11 Pro, iPhone11 Pro Max
iPad 5/6/7, iPad Mini 1/2/3/4/5, iPad

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Air 1/2/3, iPad Pro 1/2/3/4
Samsung
Galaxy S5/6/7/8/9/10, Note 3/5,J7
Huawei
P9/10/20/30/40, Mate 10/Pro, Mate
20/Pro, Mate 30/Pro
OnePlus
OnePlus 5/6/7
LG
G7
Google
Pixel 1/2/3/4
4.4 Connecting to the device
1. Keep the device on
measuring.
2. Run ViHealth App on your
smart device.
3. Click the device icon when
ViHealth finds your Pulse
Oximeter.
4. Follow the screen guide to
start pairing.
5. Once paired, you can log into
ViHealth.

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Tips:Please open the APP and Bluetooth, and
then pair the app with the device.
Only when you wear the device and open the
APP at the same time, the data will be
synchronized to the APP.
For more details about ViHealth App, please refer
to the ViHealth App user manual.
5 Technical Specifications
A. SpO2Measurement
Transducer: dual-wavelength LED sensor with
wavelength:
Red light: 663 nm, Infrared light: 890 nm.
Maximal average optical output power:
≤2mW
SpO2display range: 35%~100%
SpO2measuring accuracy:
≤ 2% for SpO2range from 70% to 100%
B. Pulse Rate measurement
PR display range: 30bpm~240bpm

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PR measuring accuracy: ±2bpm or ±2%
(whichever is greater)
C. Perfusion Index(PI) Display range
0%~20%
D. Preset over-limits
SpO2low limit: 90%
Pulse Rate: high limit: 120bpm
low limit: 50bpm
E. Over-limit settings
SpO2:
low limit setting range: 85%~99%, step: 1%
Default setting: 90%
Pulse Rate:
Low limit setting range: 30~60bpm,
step: 1bpm;
High limit setting range: 100~240bpm,
step: 5bpm;
Default setting: high: 120bpm; low: 50bpm
F. Audible & visual alert function
When measuring, if SpO2value or pulse rate
value exceeds the preset limit, the device will