Manual SP20 Creative Medical

User Manual for Handheld Pulse Oximeter
Instructions to User
Dear Customer,
Thank you for purchasing this quality product. Please read the
manual very carefully before using this device. Failure to follow
these instructions can cause measuring abnormality or damage to
the Oximeter.
No part of this manual may be photocopied, reproduced or
translated into another language without the prior written consent.
We reserve the right to revise and amend it at any time without
prior notice.
Version of the Manual: Ver 1.0
Issued Date: December 20th, 2016
All rights reserved.
Notes:
 The contents contained in this manual are subject to change
without prior notice.
 Information furnished by Creative is believed to be accurate
and reliable. However, no responsibility is assumed by Creative
for its use, or any infringements of patents or other rights of
third parties that may result from its use.
3502-2290079
I
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Instructions for Safe Operation
 Check the device to make sure that there is no visible
damage that may affect user’s safety and measurement
performance. It is recommended that the device should be
inspected minimally before each use. If there is obvious
damage, stop using the device.
 Necessary service must be performed only by qualified
technicians. Users are not permitted to service this device.
 The oximeter must not be used with the 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 occur if using the sensor of this
device continuously on the same location for a long time,
especially for the patients with poor microcirculation. It is
recommended that the Oximeter should not be applied to the
same location for longer than 2 hours or less if any
abnormal condition is found. Frequently check and
re-position the Oximeter sensor.
 Misapplication of a SpO2 probe with excessive pressure for
prolonged periods can induce pressure injury.
 Place the SpO2 probe on the finger tightly will cause venous
pulse and effect blood circulation, and lead to interstitial
edema, hypoxia and inaccurate measurement.
 Biocompatibility tests have been performed on all the
applied parts, some exceptional allergic patients may still
II
have anaphylaxis. Do not apply to those who have
anaphylaxis.
 For the individual patients, there should be a more prudent
inspecting in the placing process. The sensor can not be
placed on the edema and tender tissue.
 The local law should be followed when disposing of the
expired device or its accessories.
 DO NOT operate in the environment where strong
electro-magnetic interference exists, such as radiogram,
television, radiophone, etc.
 Please pay attention to the SpO2 probe cable while using to
avoid strangulating patient.
Attentions
 Keep the oximeter away from dust, vibration, corrosive
substances, explosive materials, high temperature and
moisture.
 If the Oximeter gets wet, please stop operating 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 and humid environment, please do not use it
immediately. Allow at least 15 minutes for the 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 and probes. Refer to related
chapter for instructions regarding cleaning and disinfection.
 The intended use of this device is not for therapy purpose.
 The equipment is IP22 with protection against harmful solid

foreign objects and ingress of liquid. So that means the
III
equipment is protected against solid foreign objects of
12.5mm and greater, and protected against vertically falling
water drops when enclosure tilted up to 15°.
 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 60601-1:2005+A1: 2012, IEC60601-1-2:2014,
IEC60601-1-11:2010, ISO 80601-2-61:2011 and follows the
provisions of the council directive MDD93/42/EEC.
Caution: U.S. federal law restricts this device to sale or

use by or on the order of a physician.
IV
Table of Contents
1 Overview ..................................................................................... 1
1.1 Appearance .......................................................................... 1
1.2 Product Name and Model..................................................... 3
1.3 Structure ............................................................................... 3
1.4 Features ................................................................................ 4
1.5 Intended Use ........................................................................ 4
1.6 Working Environment .......................................................... 4
2 Preparation ................................................................................ 5
2.1 Charger Base Connection ..................................................... 5
2.2 Power Supply ....................................................................... 5
3 Make Measurement ................................................................... 7
3.1 SpO2 Measurement ............................................................... 7
3.2 Temperature Measurement (optional) .................................. 9
4 Operation.................................................................................. 11
4.1 Power on/off the Oximeter ................................................. 11
4.2 Default Display Screen ...................................................... 11
4.3 Menu .................................................................................. 14
4.4 Record ................................................................................ 27
5 Technical Specifications .......................................................... 32
6 Over-limit Indication............................................................. 34
6.1 Limit settings ..................................................................... 34
6.2 Over-limit indication sound mute setting ........................... 34
7 Packing List .............................................................................. 35
8 Repair and Maintenance ......................................................... 36
8.1 Maintenance ....................................................................... 36
8.2 Cleaning and Disinfecting Instruction ................................ 36
9 Troubleshooting ....................................................................... 37
Appendix ..................................................................................... 38
Quality Inspection Certificate .................................................... 53
V
1 Overview
1.1 Appearance
Alert
indicator
Display screen
Record/Back
Menu/Confirm
Rotate-lock /Up
Power indicator
Mute /Right
Power/Left
Setting/Down
Figure 1.1 Front View
1
SpO2: TEMP:
SpO2 probe Temperature
connector probe
connector
Figure 1.2 Upper-side view
DC power
input socket
Figure 1.3 Bottom side view
1. Display screen: Display measurement result, trends and menus.
2. (Power/Left): Power on/off the device by longtime

pressing; On menu or sub-menu screen, short time press it to move
the cursor left or adjust the parameter values.
3. (Mute/Right): On data recall screen, longtime press this

key, then the delete dialog pops up; On measuring screen, short
time press it to resume or mute the alert sound. On non-alert status,
short time press it to turn on/off beep sound. On menu or sub-menu
screen, short time press it to move the cursor right or adjust the
parameter values.
Note: when the device alert indication is on, short time pressing
will mute the alert sound, the mute state will persist for about 90s.
After this mute period (90s), then the alert sound will resume.
4. (Rotate-lock/Up): On measuring screen, longtime pressing

to enable or disable the automatic screen orientation (on horizontal
or vertical direction); On menu or sub-menu screen, short time
press it to move the cursor upwards or adjust the parameter value.
2
5. (Setting/Down): On measuring screen, longtime pressing

to enter into setting screen; On menu or sub-menu screen, short
time press it to move the cursor downwards or adjust the parameter
value.
6. (Menu/Confirm): Short time press it to enter into menu
screen, or to confirm the selection.
7. (Record/Back): Short time press it to enter into SpO2
record list screen, or to back to the previous level of menu.
8. (Alert indicator): If the probe is not well placed
or disconnected, or the measured value exceeds the preset alert
limit value, then the alert indicator will keep orange flashing.
9. (Power saving mode indicator): If the device is set as power
saving mode, then the indicator keeps on. And on measuring screen,
the indicator flashes with the pulse beep.
10. Icon: "SpO2"( ): SpO2 Probe Connector.
11. Icon: "TEMP"( ): Temperature Probe Connector.
12. (DC power input): used for connecting

external DC power input for charging the built-in rechargeable
battery.
1.2 Product Name and Model

Name: Handheld Pulse Oximeter
Model: SP-20
1.3 Structure
It consists of the main unit and SpO2 probe.
(Note: with optional temperature probe, this Oximeter can make
temperature measurement.)
3
1.4 Features
 It is lightweight, small in size and easy to carry
 Color LCD to display plethysmogram and parameters
 Measure SpO2, Pulse Rate and Temperature simultaneously
 PI (Perfusion Index) display is available
 Up to 500 hours data storage for SpO2 and PR and can be
recalled.
 16 user IDs for making data and can be added.
 A built-on holder for convenient standing on desktop and
display viewing.
 Real-time battery status display and low battery voltage
indication.
 Auto power off is available
 Audible and visual alert function is available
 Data uploading to PC for management (Optional)
 Power saving mode is available
1.5 Intended Use
This Handheld Pulse Oximeter is intended for measuring and
recording the pulse rate, functional oxygen saturation (SpO 2) and
temperature (optional). It is applicable for detecting SpO2, pulse
rate and temperature of adult and pediatric patients in clinical
institutions and homes.
1.6 Working Environment

Operating temperature: 5~40℃
Operating humidity: 15%~93% (non-condensing)
Atmospheric pressure: 70kPa~106kPa
4
2 Preparation
2.1 Charger Base Connection

Put the device into the charger
base properly, and note the
polarity markings, as shown in
figure 2.1.
Oximeter
Figure 2.1 Charger base connection

充电底座连接
Charger base
5
2.2 Power Supply

1. Internal power supply with built-in battery:
Built-in battery specification: 2000mAh lithium battery.
2. External power from the AC power adapter:
Use the AC power adapter provided by the manufacturer. Make

sure the mains power supply is 100-240VAC with 50/60Hz.
3. External power supply from the USB cable:

Use the USB cable with micro-USB connector, connect one end of
the USB cable to the connector on the device marked with
" " or to the USB connector on the charger base marked
with " ", and the other end to the USB power source with
output capacity of 5V DC/1A.
Note: When using the supplied charger base for power supply,
please do not tilt the charger base backwards too much, or the
USB cable and the connector may be damaged.
6
3 Make Measurement
3.1 SpO2 Measurement
Operation procedures:
1. Connect the SpO2 probe to the connector on the upper-side of
the device marked with "SpO2". (Note: When disconnecting the
connector, be sure to hold the head of the connector firmly and
pull).
2. The red blinking light inside the clip of the SpO2 probe
indicates a successful connection.
3. Insert one finger (index finger is preferred, the nail should be
not too long) into the clip of the probe according to the finger
mark,as shown in figure 3.1.
4. The device will begin to take the measurement, and the
measured result will be displayed on the screen, as shown in figure
4.2.
Figure 3.1 demonstration for SpO2 probe

Safety instructions for SpO2 measurement
 Continuous use of the SpO2 probe may result in discomfort or
pain, especially for those with microcirculatory problems. It is
7
recommended that the probe should NOT be applied to the

same place for over two hours, change the measurement site
periodically and when necessary.
 When the ambient temperature is over 35℃, please change
the measuring site every two hours; when the ambient
temperature is over 37℃, please do NOT use the SpO2 sensor,
as using in high temperatures can cause burns.
 Do NOT place the SpO2 probe on a finger with edema or
fragile tissue.
 Do NOT put the SpO2 probe and pressure cuff on the same
limb, otherwise the blood pressure measurement may affect the
SpO2 measurement.
 The device is calibrated to display functional oxygen
saturation.
 Do NOT allow the sensor cable to twist or bend.
 Check the SpO2 sensor and cable before use. Do NOT use a
damaged SpO2 sensor.
 When the temperature of the SpO2 sensor is abnormal, do
not use it further.
 Remove nail polish or other cosmetic products from the
fingernail.
 The fingernail should be of normal length.
 The SpO2 sensor cannot be immersed into water, liquid or
cleanser.
 The SpO2 sensor can be repeatedly used. Please clean and
disinfect before reuse.
8
☞ Connector with the label "SpO2" can only be connected with

SpO2 probe, and connector with the label "TEMP" can only be
connected with the temperature probe.
3.2 Temperature Measurement (optional)

The infrared temperature probe is a delicate transducer. To operate
please follow these steps and procedures. Failure to accurately
operate may cause damage to the probe.
The infrared temperature probe is as shown in figure 3.2.
Please place the infrared temperature probe in a stable ambient
temperature for 30 minutes before taking a measurement.
Measuring tip of
temperature probe
Temperature Measuring key
Probe Cover
Big display screen

Small screen
Power on/off key
Battery cover
Figure 3.2 the infrared temperature probe
Operation procedure:
1. Connect the infrared temperature probe to the connector on the
upper side of device marked with "TEMP".
2. When the screen shows as the big display screen in figure 3.2
9
and the temperature unit "℃" is blinking, the user can begin to
take the measurement.
3. Insert the tip of the temperature probe into the earhole and press
the measuring key to start the measurement. A short beep
means the measurement has finished and the result will be
displayed on the big display screen on temperature probe and
the display screen of the Oximeter.
Note:
 If the temperature probe detects a hardware failure, the display
screen on the infrared temperature probe will show "Err" and
will not enter into measurement mode.
 The infrared temperature probe will switch to standby state
automatically if there is no operation for 1 minute. If a further
measurement is needed, press the measuring key and repeat
step 2 and step 3.
 Normal body temperature varies depending on the position/area
the measurement is taken from. The following table shows the
varying temperature ranges of the different body positions.
Temperature varying range at different body positions:
Arm 34.7 ~ 37.3 ℃
Oral 35.5 ~ 37.5 ℃
Rectal 36.6 ~ 38.0 ℃
Ear 35.8 ~ 38.0 ℃
Safety Instruction for Temperature Measurement
 Do NOT take a measurement when the patient is moving.
 Patients with tympanitis or otitis problems should NOT use
this device.
 When the infrared temperature probe is connected to the
device, the probe will consequently be at power-on status,
10
therefore pressing the power on/off key on the temperature
probe will not cause any effect.
4 Operation
4.1 Power on/off the Oximeter
 Long pressing" " Power/Left key for 1~2 seconds, then
the oximeter will be powered on. The oximeter will do

self-test and then show the software version, as shown in
figure 4.1 (refer to your oximeter for actual version).
Figure 4.1
4.2 Default Display Screen
Press “ ”power key for 2 seconds to start up the Oximeter, then
the screen will display the default screen, as shown in Figure 4.2.
11
Rotate-lock icon Wireless icon
Auto power off disable icon Measurement mode

User ID Sound indicator
Patient type Battery indicator
SpO2 mark
SpO2 value
Pulse Strength
SpO2 high/low
bar-graph
limit setting range
Pulse rate
mark and unit Pulse symbol
HR high/low limit
setting range Pulse rate value
TEMP value
Perfusion index
Pulse
Plethysmogram
Current time
Figure 4.2A Default Display Screen---in vertical
Description:
 During measurement, if the finger is not inserted properly, or
the probe is not connected or the probe is off from the finger,
then "Check Probe" message prompts on the screen, and
"bibibi..." alert sound appears simultaneously. Alert sound is
12
sustaining for about 3 minutes, and if there is no any key

operation in this period, then the device will power off
automatically (if the auto power off function is turned on).
 During measurement, longtime pressing Rotate-lock/Up key
" ", then the Rotate-lock icon " " turns to blue " ",
it means the auto rotation function is turned on, if you place
this oximeter horizontally, then the display shows in
horizontal, as shown in figure 4.2B.
Figure 4.2B Default Display Screen---in horizontal

 Sound indicator " " means the device is on mute status,
the user can turn on the indication sound by short pressing
" " key. Short time press " " key can turn off (or
resume) the device sound (including pulse beep sound,
audible alert and key click), while the pulse symbol " " still
13
blinks. During the measurement, over-limit event or probe

off event can activate the alert indication sound. Refer to
Section 6.2 for detailed alert indication sound.
 If the memory is full, the corresponding memory full icon
appears on the screen, " " means temperature memory is
full, " " means SpO2 spot-check record memory is full,
" " means SpO2 continuous record memory is full. No
display of the icon means the current corresponding storing

space is not full. If the memory is full, the data storing will
continue in such way the new record will overwrite the
oldest record, so that it's recommended to upload the stored
data into the computer in time.
4.3 Menu
On the default measuring screen, short time press " "
Menu/Confirm key for entering into main menu screen (as shown
in Figure 4.3).
There are 9 functional icons in main menu screen, press

Up/Down/Left/Right key can move the cursor to make selection
and press " " Menu/Confirm key again to confirm the
selection.
 User ID: Add new or edit the current User ID.
 User: Select patient type, "Adult" and "Pediatric" for option.
14
Note: when the device is connecting the neonate SpO2 probe, then
the User icon " " turns to grey " ", and the patient type on
upper left corner turns to pink " ".
 Measurement mode: Select the measurement mode,
"Spot-check mode" and "Continuous mode" for option.
 SpO2 record: Recall and review the records stored on the

oximeter, two method for option: "Spot-check Record" and
"Continuous Record", see Section 4.4 for details.
Figure 4.3 Main menu
15
 TEMP Record: Review the temperature record list.
 Date: Set the time and date, see Section 4.3.6 for details.
 Setting: Set the system parameter, including lightness, sound

volume, display language, power saving mode etc., see
Section 4.3.7 for details.
 Alert: Set the low alert limit for SpO2 and the high/low alert
limit for HR, see Section 4.3.8 for details.
 Help: To view the tips information of SpO2 measurement and

temperature measurement, see Section 4.3.9 for details.
4.3.1 User ID
On main menu screen, move the cursor on "User ID" and press
Confirm key " ", then the oximeter enters into User ID
Setup screen, as shown in figure 4.4.
Figure 4.4A User ID setup screen
16
Move the cursor on "Edit" and press Confirm key " ", when
the cursor turns to blue, then the user can edit the User ID, and
move the cursor on "OK" to confirm the edit, the edit screen is as
shown in figure 4.4B.
Figure 4.4B User ID edit screen

4.3.2 User
On main menu screen, move the cursor on "User" and press
Confirm key " ", then the oximeter enters into Patient type
Setup screen, as shown in figure 4.5.
Figure 4.5 Patient type setup screen
17
4.3.3 Measurement Mode
On main menu screen, move the cursor on "Measurement Mode"
and press Confirm key " ", then the oximeter enters into
Measurement Mode Setup screen, as shown in figure 4.6.
Figure 4.6 Measurement mode setup screen
4.3.4 SpO2 Record

On main menu screen, move the cursor on "SpO2 Record" and
press Confirm key " ", then the oximeter enters into SpO2
record review method selecting screen, as shown in figure 4.7.
Figure 4.7 SpO2 record review method selecting screen

Refer to Section 4.3 for details.
4.3.5 TEMP Record
18
On main menu screen, move the cursor on "TEMP Record" and
press Confirm key " ", then the oximeter enters into
temperature record list screen, as shown in figure 4.8.
Figure 4.8 TEMP record list screen

4.3.6 Date
On main menu screen, move the cursor on "Date" and press
Confirm key " ", then the oximeter enters into date setup
screen, as shown in figure 4.9.
19
Figure 4.9 Date setup screen

Date setting procedure:
1) Move the cursor stays on the Year of the date, press Confirm key
" " to active Year option, the cursor flashes on the Year of
the date;
2) Press Up/Down key to adjust Year;
3) Press " " (Confirm) key to confirm and exit from date
setting;
4) The procedures of adjusting Month, Day, Hour, Minute and
Second value are the same with Year adjustment.
Date Format: DD-YY-MM; Time Format: HH:MM:SS
Note: The setting operations of other parameters (such as User ID,
User, Auto Power Off, Power Saving etc.) are the same with date
setting.
4.3.7 Setting
On main menu screen, move the cursor on "Setting" and press
Confirm key " ", then the oximeter enters into system
setting screen, as shown in figure 4.10.
20
Figure 4.10 System setting screen

Description:
 Brightness: To set the brightness of backlight, 6 levels for
optional, the factory default is level 3, as shown in figure
4.10A.
 Volume: To set the sound volume (including alert sound,
pulse beep sound and key click sound), 6 levels sound
volume for optional, the factory default is level 3, as shown
in figure 4.10B.
 Language: This oximeter provides the display with two
languages: English and Simplified Chinese, the factory
default is "English", as shown in figure 4.10C.
 Auto power off: To turn on/off the Auto Power Off mode, the
factory default is "On", as shown in figure 4.10D.
 Wireless: To turn on/off the wireless connection function, the
factory default is "On", as shown in figure 4.10E.
 Power saving mode: To turn on/off the Power Saving mode,
the factory default is "On", as shown in figure 4.10F
 TEMP unit: To set the temperature unit, "℃(Celsius)" and "
℉(Fahrenheit)" for option, the factory default is "℉", as
21
shown in figure 4.10G.
 Default setting: Enter into the factory default setting, as
shown in figure 4.10H.
 Version: For viewing version number of the software, as
shown in figure 4.10I
 Demo: Enter into the Demonstration mode, as shown in
figure 4.10J.
Figure 4.10A Brightness setup Figure 4.10B Volume setup
Figure 4.10C Language setup Figure 4.10D Auto Power OFF setup
Figure 4.10E Wireless setup Figure 4.10F Power Saving setup
22
Figure 4.10G TEMP unit setup Figure 4.10I Version info.
Figure 4.10H Default setting Figure 4.10J Demo mode

Notes：
 When the Auto Power Off is set to "On" option, if there is no
23
key operation for 3 minutes, then the oximeter will power off
automatically.
 When the Power Saving Mode is set to "On" option, during
the measurement, if there is no key operation for 1 minute,
the screen display will be dim for power saving. The display
brightness will resume to normal condition by pressing any
key.
4.3.8 Alert
On main menu screen, move the cursor on "Alert" and press
Confirm key " ", then the oximeter enters into alert setting
screen, as shown in figure 4.11.
Figure 4.11 Alert setting screen

 SpO2 Lo-Limit: SpO2 low limit setting; range: 50%~99%,
the step is 1%. The factory default value for adult is 90% and
95% for pediatric.
 PR Hi-Limit: High limit setting of pulse rate; range:
100~240bpm. From 100 to 150, the step is 1bpm, and from
150 to 240, the step is 5bpm. The factory default value for
adult is 120bpm and 160bpm for pediatric.
 PR Lo-Limit: Low limit setting of pulse rate; range:
30~99bpm, and the step is 1bpm. The factory default value
24
for adult is 50bpm and 60bpm for pediatric.
Note: When the SpO2 reading is lower than or equal to the preset
alert setting or the PR reading is higher than or equal to the preset
high limit or the PR reading is lower than or equal to the preset
low limit, then the over-limit alert event will be activated, that's,
the alert sound "bibibibi..." occurs, and the corresponding
reading(s) blinks. When measured on pediatric, if the SpO2
reading is lower than or equal to the preset alert setting for 10
seconds, then the alert sound and blinking display will be
activated.
4.3.9 Help
On main menu screen, move the cursor on "Help" and press
Confirm key " ", then the oximeter help information screen,
which shows SpO2 and temperature measurement tips, as shown in
figure 4.12.
25
Figure 4.12 Help information---SpO2 measurement
26
Figure 4.12 Help information---TEMP measurement
4.4 Record
4.4.1 Data Recall
On main default screen, short time press Record/Back key
" " to enter into data recall screen, as shown in figure 4.13.
27
Figure 4.13 SpO2 record

SpO2 record includes Spot-check Record and Continuous Record,
Spot-check Record list shows the recording time, SpO2 value and
pulse rate value, as shown in figure 4.14.
The
corresponding
User and User
ID for the
selected record
Figure 4.14 Spot-check Record list

If Continuos Record is selected, then the screen shows the
Continuos Record list, as shown in figure 4.15, press Up/Down
28
key( " / ") to select one record you need to review.

Select one record you need to review, and press Confirm key
" ", then the screen shows the corresponding User, User ID,
and trend graph, as shown in figure 4.16.
The
corresponding
User and User
ID for the
selected record
Figure 4.15 Continuos record---List
29
The
corresponding
User and User
Recording
ID for the
time
selected record
SpO2
trend graph
PR trend graph
Figure 4.16 Continuos record---Trend graph
4.4.2 Data Deletion

On the record list screen shown in figure 4.14 or 4.15, move the
cursor on the record you want to delete, and longtime pressing
Mute/Right key(" "), then an message ―Are you sure to delete

all?‖ prompts on the screen, as shown in figure 4.16.
30
Figure 4.16 Delete records

At this time, short time press Menu/Confirm (" ") key to
confirm and delete the records. Or short time press Record/Back
(" ") key to return to record list screen.
4.4.3 Data Upload

If you want to upload the stored data (SpO2, PR and TEMP values)
to the computer, then Make sure the provided USB data cable is
well connected between the device and PC before uploading data,
as shown in figure 4.17. Refer to the instruction in ―Oximeter Data
Manager User Manual‖for detailed operation.
Figure 417 Data uploading screen

 During data uploading, the user can not do any operation
on the oximeter.
31
5 Technical Specifications
A. Display Panel: 3.5 inch color TFT LCD;
B. Power Supply:
Internal power supply: 2000mAh lithium battery
AC power adapter: 5VDC/1A,
Working current: ≤
180mA
Input power for AC power adapter: <15VA
The typical continuous operation time of the battery: 18 hours
(when screen display is automatically off and bluetooth
function is disabled).
The typical service life of the battery: 5 years.
C. SpO2 Measurement
Transducer: dual-wavelength LED sensor with wavelength:
Red light: 663 nm, Infrared light: 890 nm.
Maximal average optical output power: ≤ 2mW
Display range: 35~100%
Measuring accuracy:
Arms is not greater than 3% for SpO2 range from 70% to 100%
*NOTE: Arms is defined as root-mean-square value of deviation
according to ISO 80601-2-61.
SpO2 low alert limit setting range: 50%~99%
The device is calibrated to display functional oxygen saturation.
The functional tester cannot be used to assess the accuracy of the
SpO2 probe or the device.
D. Pulse Rate Measurement
Display and measuring range: 30bpm~240bpm
Accuracy: ±2bpm or ±2% (whichever is greater)
Over-limit setting range: 25bpm~250bpm
E. Data update period
32
The SpO2 value update time is less than 30 seconds. The pulse
rate value update time is less than 10 seconds.
F. Perfusion Index Display
Range: 0.2%~20%
G. Temperature Measurement
Measuring range: 32.0℃~43.0℃
Measuring accuracy: ±0.2℃ for temperature range from
35.0℃ to 42.0℃, and ±0.3℃ for the rest.
Response time: ≤5s
H. Operating Environment
Operating Temperature: 5°C ~40°C
Operating Humidity: 15%~93%
Atmospheric pressure: 70kPa~106kPa
Note: portable and mobile RF communications equipment may
affect the performance of the Oximeter.
I. Low Perfusion Performance
The accuracy of SpO2 and PR measurement still meet the
precision described above when the modulation amplitude is as
low as 0.5%.
J. Resistance to interference of surrounding light:
The difference between the SpO2 value measured in the
condition of indoor natural light and that of darkroom is less
than ±1%.
K. Dimensions: 158 mm (L) × 73 mm (W) × 25 mm (H)
Net Weight: about 230g (including battery)
L. Classification
Type of protection against electric shock:
Internally powered equipment and Class II.
Degree of protection:
Type BF applied parts.
33
Degree of protection against harmful ingress of liquids:
The equipment is IP22 with protection against harmful solid
foreign objects and ingress of liquid.
Mode of operation: Continuous operation.
Electro-Magnetic Compatibility: Group I, Class B
6 Over-limit Indication
6.1 Limit settings
 SpO2 low limit setting range: 50% ~ 99%.
 Pulse Rate limits setting range:
High: 100bpm--240bpm Low: 30bpm--99bpm
During the measurement, if the measured value exceeds the preset
value, the alert beeping sound will be activated, the value that is
over-limit will blink at the same time.
6.2 Over-limit indication sound mute setting
 During the measurement, if the over-limit indication sound is
set to on, short time press Mute/Right key(" "), then the
over-limit indication sound will mute for 90 seconds, but the
over-limited value still keeps blinking. At this moment, the
speaker volume icon becomes " ". If this alert event
persists over 90 seconds, then the over-limit indication sound
will be activated again.
 During the measurement, if the probe is off or disconnected,
the message "Check Probe" shows on the display screen.
The alert sound starts (interval is 5 seconds) and lasts for
about 3 minutes. If the probe is still off, the Oximeter will
power off automatically.
34
7 Packing List
1. An Oximeter
2. A SpO2 probe
3. User Manual
4. A oximeter rubber cover
5. A charging base
6. A temperature probe (optional)
7. Charging cable (optional)
8. A USB data cable (optional)
Notes:
1. The accessories are subject to change. See the package in your
hand for detailed items and quantity.
2. All the parts of the device should NOT be replaced at will. If
necessary, please use the components provided by the manufacture
or those that are of the same model and standards as the accessories
along with the device which are provided by the same factory.
Otherwise, negative effects concerning safety and biocompatibility
etc. may be caused.
3. This device can only connect with the manufacture nominated
device.
35
8 Repair and Maintenance

8.1 Maintenance
The expected service life(not a warranty) of this device is 5 years.
In order to ensure its long service life, please pay attention to the
maintenance;
 If the battery is damaged, please contact your local sales
representative or the manufacture.
 Please store the device carefully to avoid being damaged by
pets, pests or children.
 The recommended storage environment of the device:
Ambient temperature: -20ºC ~60ºC
Relative humidity: 10%~95%
Atmospheric pressure: 50kPa~107.4kPa
Storage and Transportation between uses:
– 25℃ without relative humidity control;
and + 70 ℃ at a relative humidity up to 93%
(non-condensing).
 The oximeter is calibrated in the factory before sale, there is
no need to calibrate it during its life cycle.
However, if it is necessary to verify its accuracy routinely, the
user can do the verification by means of SpO2 simulator, or it
can be done by the local third party test house.
8.2 Cleaning and Disinfecting Instruction

 Surface-clean sensor with a soft cloth by wetting with a
solution such as 75% isopropyl alcohol, if low-level
disinfection is required, use a 1:10 bleach solution.
 Then surface-clean by a dampened cloth and let it air dry or
wipe it with a cloth.
 Please clean and disinfect the device after using to avoid
cross infection.
High-pressure disinfection cannot be used on the device.
Do not immerse the device in liquid.
36
9 Troubleshooting
Trouble Possible Reason Solution
1. The finger is not
1. Place the finger
Unstable placed far enough
correctly inside and try
SpO2 and inside.
again.
Pulse Rate 2. The finger is
2. Reduce patient
display shaking or the patient
movement.
is moving.
Unable to 1. Temperature probe
2. Reinsert the probe into
measure is not connected
the device
Temperature properly
1. The batteries are
drained or almost 1. Recharge or change
Device will drained. batteries.
not switch 2. The batteries are not 2. Reinstall batteries.
on inserted properly. 3. Please contact the local
3. The device is service center.
malfunctioning.
1. The device will
power off
automatically when
1. Normal.
there is no signal and
No Display 2. Recharge or change
no operation for 1
batteries.
minute.
2. The batteries are
almost drained.
1. Probe off or
1. Reconnect the probe
incorrect connection
2. Reinsert the finger
No Signal 2. Incorrect finger
3. Replace a new probe
insert
3. Probe is damaged
37
10 Frequently Asked Questions

1. Q: What's SpO2?
A: SpO2 means the saturation percentage of oxygen in the
blood.
2. Q: What's the normal range of SpO2 value for healthy people?
A: The normal range varies by individual, but usually over 95%,
otherwise, please consult your physician.
3. Q: What's the normal range of PR value for healthy people?
A: Usually, the normal range is 60bpm~100bpm.
4. Q: Why do the display value of SpO2 and PR vary with time?
A: The measured SpO2 and PR value changes in correspondence
with the change of patient's physiological conditions.
5. Q: What to do if there is no SpO 2 and PR reading?
A: Do not shake the finger, and keep calm during the
measurement. Please also avoid the oximeter and the cuff on the
same limb for blood pressure and oxygen saturation
measurement simultaneously.
6. Q: How to confirm that the SpO2 reading is true or accurate?
A: Hold breath for a while (50 seconds or more), if the SpO2
value significantly decreases, it means that the SpO2 reading truly
reflects the physiological condition change.
7. Q: When to replace the batteries?
A: The icon of low battery will appear on the screen when the
battery voltages are low. By then, batteries need to be replaced.
8. Q: What to do if the oximeter is moistened or sprayed by water?
A: Remove the batteries immediately and dry the oximeter
completely with a hair dryer.
9. Q: What factors will affect the SpO2 accuracy?
A:a) Intravascular dyes such as indocyanine green or
methylene blue;
38
b) Exposure to excessive illumination, such as surgical lamps,
bilirubin lamps, fluorescent lights, infrared heating lamps, or direct
sunlight;
c) Vascular dyes or external used color-up product such as nail
enamel or color skin care;
d) Excessive patient movement;
e) Placement of a sensor on an extremity with a blood pressure
cuff, arterial catheter, or intravascular line;
f) Exposure to the chamber with High pressure oxygen;
g) There is an arterial occlusion proximal to the sensor;
h) Blood vessel contraction caused by peripheral vessel
hyperkinesias or body temperature decreasing;
i) Low perfusion condition (Perfusion Index is small).
Please contact the local distributor or manufacturer if
necessary.
39
Appendix
I Key of Symbols
Symbol Description
%SpO2 The oxygen saturation
PI% Perfusion Index
bpm Pulse rate (Unit: beats per minute)
Pulse bar graph
Low battery voltage

Symbols
Battery is full
on the
Speaker mute icon
screen
Speaker volume icon
SpO2 spot-check record memory full
SpO2 continuous record memory full
Temperature memory full
Wireless transmission icon
(Pediatric/Adult) Patient type

/
40
Symbol Description
SpO2 SpO2 probe connector
TEMP Temperature probe connector
Power/Left Key
Mode/Right Key
Rotate-lock/Up Key
Symbols Setting/Down Key

on the
panels Menu/Confirm key or Record/Back key
CE mark
SN Serial number
Date of manufacture
Manufacturer (including address)
With Type BF applied part
See User Manual
Disposal of this device according to

WEEE regulations
No alarm
Do not litter at will
41
II Common Knowledge
1 Meaning of SpO2
SpO2 is the saturation percentage of oxygen in the blood, so

called O2 concentration in the blood; it is defined by the
percentage of oxyhemoglobin (HbO2) in the total hemoglobin
of the arterial blood. SpO2 is an important physiological
parameter to reflect the respiration function; it is calculated by
the following method:
SpO2 = HbO2/ (HbO2 +Hb)×100%
HbO2 are the oxyhemoglobins (oxygenized hemoglobin), Hb
are those hemoglobins which release oxygen.
2 Principle of Measurement
Based on Lamber-Beer law, the light absorbance of a given

substance is directly proportional with its density or
concentration. When the light with certain wavelength emits
on human tissue, the measured intensity of light after
absorption, reflecting and attenuation in tissue can reflect the
structure character of the tissue by which the light passes.
Due to that oxygenated hemoglobin (HbO2) and
deoxygenated hemoglobin (Hb) have different absorption
character in the spectrum range from red to infrared light
(600nm~1000nm wavelength), by using these characteristics,
SpO2 can be determined. SpO2 measured by this oximeter is
the functional oxygen saturation -- a percentage of the
hemoglobin that can transport oxygen. In contrast,
hemoximeters report fractional oxygen saturation – a
percentage of all measured hemoglobin, including
dysfunctional hemoglobin, such as carboxyhemoglobin or
metahemoglobin.
42
Clinical application of pulse oximeters: SpO2 is an important
physiological parameter to reflect the respiration and
ventilation function, so SpO2 monitoring used in clinical
becomes more popularly, such as monitoring the patient with
serious respiratory disease, the patient under anesthesia
during operation, premature and neonate. The status of SpO2
can be determined in time by measurement and find the
hypoxemia patient earlier, thereby preventing or reducing
accidental death caused by hypoxia effectively.
3 Normal SpO2 Range and Default Low Limit
In campagna area, healthy people’s SpO2 value is greater
than 94%, so the values below 94% are determined as
hypoxia. SpO2<90% is considered as the default threshold for
determining anoxia by most researchers, so SpO2 low limit of
the oximeter is set as 90% generally.
4 Factors affecting SpO2 accuracy (interference reason)
 Intravascular dyes such as indocyanine green or
methylene blue
 Exposure to excessive illumination, such as surgical
lamps, bilirubin lamps, fluorescent lights, infrared
heating lamps, or direct sunlight.
 Vascular dyes or external used color-up product such
as nail enamel or color skin care
 Excessive patient movement
 Placement of a sensor on an extremity with a blood
pressure cuff, arterial catheter, or intravascular line
 Exposure to the chamber with High pressure oxygen
 There is an arterial occlusion proximal to the sensor
 Blood vessel contraction caused by peripheral vessel
43
hyperkinesias or body temperature decreasing
5 Factors causing low SpO2 value (pathology reason)
 Hypoxemia disease, functional lack of HbO2
 Pigmentation or abnormal oxyhemoglobin level
 Abnormal oxyhemoglobin variation
 Methemoglobin disease
 Sulfhemoglobinemia or arterial occlusion exists near
sensor
 Obvious venous pulsations
 Peripheral arterial pulsation becomes weak
 Peripheral blood supply is not enough
44
III EMC
The equipment meets the requirements of IEC 60601-1-2:2014.
Table 1
Guidance and manufacturer’s declaration-electromagnetic
emission
The Oximeter is intended for use in the electromagnetic environment
specified below. The customer or the user of the Oximeter should
assure that it is used in such an environment.
Electromagnetic
Emissions test Compliance
environment-guidance
The Oximeter uses RF

energy only for its internal
function. Therefore, its RF
RF emissions
Group 1 emissions are very low and
CISPR 11
are not likely to cause any
interference in nearby
electronic equipment.
RF emissions
Class B The Oximeter suitable for
CISPR 11
Harmonic emissions use in all establishments,
IEC61000-3-2 N/A including domestic
establishments and those
Voltage directly network that
fluctuations/flicker supplies buildings used for
N/A
emissions domestic purposes.
IEC61000-3-3
45
Table 2
Guidance and manufacturer’s declaration-electromagnetic
emission
specified below. the customer or the user of the Oximeter should assure
that it is used in such an environment.
Electromagnetic
IEC60601 test Complianc
Immunity test environment
level e level
-guidance
Floors should be
wood, concrete or
ceramic tile. if
Electrostatic ±6 kV floors are covered
±6 kV contact
discharge(ESD) contact with synthetic
±8kV air
IEC61000-4-2 ±8kV air material, the
relative humidity
should be at least
30%
Electrical fast ±2kV for power

transient/ Supply lines
N/A N/A
burst ±1 kV for
IEC61000-4-4 input/output lines
±1kV line (s) to

Surge line(s)
N/A N/A
IEC 61000-4-5 ±2kV line(s) to
earth
46
<5% UT
(>95% dip in UT)
for 0.5 cycle
Voltage dips,
<40% UT
short
(60% dip in UT) for
interruptions and
5 cycles N/A
voltage variations N/A
<70% UT
on power supply
(30% dip in UT) for
input lines
25 cycles
IEC61000-4-11
<5% UT
(>95% dip in UT)
for 5 s
Power frequency
magnetic fields
should be at levels
Power frequency(
characteristic of a
50Hz/60Hz)
3A/m 3A/m typical location in
magnetic field
a typical
IEC61000-4-8
commercial or
hospital
environment.
NOTE : UT is the a.c. mains voltage prior to application of the test
level.
Table 3
Guidance and manufacturer’s declaration – electromagnetic
immunity

specified below. The customer or the user of The Oximeter should
assure that it is used in such an electromagnetic environment.
47
IEC60601 Compliance Electromagnetic

Immunity test
test level level environment -guidance
Portable and mobile RF

communications
equipment should be
used no closer to any
part of The Oximeter,
including cables, than
the recommended
Conducted RF 3 Vrms separation distance
IEC61000-4-6 150 kHz to N/A calculated from the
80 MHz equation applicable to
the frequency of the
transmitter.
Recommended
Radiated RF separation distance
IEC61000-4-3 d=1.2 P
3 V/m d=1.2 P 80MHz to
80 MHz to 3 V/m 800MHz
2.5 GHz d=2.3 P 800MHz to
2.5GHz
Where P is the
maximum output power
rating of the transmitter
in watts (W) according
to the transmitter
manufacturer and d is
the recommended
separation distance in
metres (m). b
Field strengths from
fixed RF transmitters, as
48
determined by an
electromagnetic site
survey ,a should be less
than the compliance
level in each frequency
range .b
Interference may occur
in the vicinity of
equipment marked with
the following symbol.
NOTE 1: At 80 MHz and 800 MHz, the higher frequency range

applies.
NOTE 2: These guidelines may not apply in all situations.
Electromagnetic propagation is affected by absorption and reflection
from structures, objects and people.
49
a: Field strengths from fixed transmitters, such as base stations for

radio (cellular / cordless) telephones and land mobile radios, amateur
radio, AM and FM radio broadcast and TV broadcast cannot be
predicted theoretically with accuracy. To assess the electromagnetic
environment due to fixed RF transmitters, and electromagnetic site
survey should be considered. If the measured field strength in the
location in which The Oximeter is used exceeds the applicable RF
compliance level above, The Oximeter should be observed to verify
normal operation. If abnormal performance is observed, additional
measures may be necessary, such as re-orienting or relocating The
Oximeter.
b: Over the frequency range 150 kHz to 80 MHz, field strengths should
be less than 3V/m.
Table 4
Recommended separation distances between portable and mobile

RF communication the equipment
The Oximeter is intended for use in an electromagnetic environment in
which radiated RF disturbances are controlled. The customer or the
user of The Oximeter can help prevent electromagnetic interference by
maintaining a minimum distance between portable and mobile RF
communications equipment (transmitters) and the Oximeter as
recommended below, according to the maximum output power of the
communications equipment.
Separation distance according to frequency of
Rated maximum
transmitter M(Meters)
output power of
150kHz to 80MHz to 80MHz to
transmitter
80MHz 800MHz 2,5GHz
W(Watts)
0,01 N/A 0.12 0.23

0,1 N/A 0.38 0.73
50
1 N/A 1.2 2.3

10 N/A 3.8 7.3
100 N/A 12 23
For transmitters rated at a maximum output power not listed above, the
recommended separation distance d in metres (m) can be determined
using the equation applicable to the frequency of the transmitter, where
P is the maximum output power rating of the transmitter in watts (W)
according to the transmitter manufacturer.
NOTE 1 : At 80 MHz and 800 MHz, the separation distance for the
higher frequency range applies.
NOTE 2 : These guidelines may not apply in all situations.
Electromagnetic propagation is affected by absorption and reflection
from structures, objects and people.
Caution:
This equipment has been tested and found to comply with the
limits for a Class B digital device, pursuant to part 15 of the FCC
rules. These limits are designed to provide reasonable protection
against harmful interference in a residential installation. This
equipment generates uses and can radiate radio frequency energy
and, if not installed and used in accordance with the instructions,
may cause harmful interference to radio communications.
However, there is no guarantee that interference will not occur in a
particular installation. If this equipment does cause harmful
interference to radio or television reception, which can be
determined by turning the equipment off and on, the user is
encouraged to try to correct the interference by one or more of the
following measures:
-Reorient or relocate the receiving antenna.
-Increase the separation between the equipment and receiver.
-Connect the equipment into an outlet on a circuit different from
that to which the receiver is connected.
-Consult the dealer or an experienced radio/TV technician for
help.
51
This device complies with part 15 of the FCC rules. Operation is

subject to the following two conditions: (1) This device may not
cause harmful interference, and (2) this device must accept any
interference received, including interference that may cause
undesired operation.
Any Changes or modifications not expressly approved by the party

responsible for compliance could void the user's authority to
operate the equipment.
RF Exposure
The equipment complies with FCC radiation exposure limits
set forth for an uncontrolled environment.
52
Quality Inspection Certificate
53

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User Manual for Handheld Pulse Oximeter

 The equipment is IP22 with protection against harmful solid

 Please pay attention to the effects of lint, dust, light

Caution: U.S. federal law restricts this device to sale or

Figure 1.1 Front View

Figure 1.2 Upper-side view

Figure 1.3 Bottom side view

1. Display screen: Display measurement result, trends and menus.

2. (Power/Left): Power on/off the device by longtime

3. (Mute/Right): On data recall screen, longtime press this

4. (Rotate-lock/Up): On measuring screen, longtime pressing

5. (Setting/Down): On measuring screen, longtime pressing

10. Icon: "SpO2"( ): SpO2 Probe Connector.

11. Icon: "TEMP"( ): Temperature Probe Connector.

12. (DC power input): used for connecting

1.2 Product Name and Model

1.6 Working Environment

2.1 Charger Base Connection

Figure 2.1 Charger base connection

2.2 Power Supply

Built-in battery specification: 2000mAh lithium battery.

2. External power from the AC power adapter:

Use the AC power adapter provided by the manufacturer. Make

3. External power supply from the USB cable:

" " or to the USB connector on the charger base marked

Figure 3.1 demonstration for SpO2 probe

recommended that the probe should NOT be applied to the

☞ Connector with the label "SpO2" can only be connected with

3.2 Temperature Measurement (optional)

Big display screen

Power on/off key

Figure 3.2 the infrared temperature probe

 Long pressing" " Power/Left key for 1~2 seconds, then

the oximeter will be powered on. The oximeter will do

Rotate-lock icon Wireless icon

Auto power off disable icon Measurement mode

Figure 4.2A Default Display Screen---in vertical

sustaining for about 3 minutes, and if there is no any key

Figure 4.2B Default Display Screen---in horizontal

blinks. During the measurement, over-limit event or probe

appears on the screen, " " means temperature memory is

full, " " means SpO2 spot-check record memory is full,

" " means SpO2 continuous record memory is full. No

display of the icon means the current corresponding storing

There are 9 functional icons in main menu screen, press

 User ID: Add new or edit the current User ID.

 User: Select patient type, "Adult" and "Pediatric" for option.

 SpO2 record: Recall and review the records stored on the

Figure 4.3 Main menu

 Setting: Set the system parameter, including lightness, sound

 Help: To view the tips information of SpO2 measurement and

Figure 4.4A User ID setup screen

Figure 4.4B User ID edit screen

Figure 4.5 Patient type setup screen

Figure 4.6 Measurement mode setup screen

4.3.4 SpO2 Record

Figure 4.7 SpO2 record review method selecting screen

Figure 4.8 TEMP record list screen

Figure 4.9 Date setup screen