Gima S.p.A.

Via Marconi, 1 - 20060 Gessate (MI) Italy

gima@gimaitaly.com - export@gimaitaly.com
www.gimaitaly.com
PROFESSIONAL MEDICAL PRODUCTS

PULSOXIMETRO OXY 110

OXY 110 PULSE OXIMETER
PULSIOXÍMETRO OXY 110
OXYMÈTRE DE POULS OXY 110

SP-20 (34341)
0123
Shenzhen Creative Industry Co., Ltd.
M34341-M-Rev.3-07.21

Floor 5, BLD 9, BaiWangxin High-Tech Industrial Park,

Songbai Road, Xili Street, Nanshan District,
518110 Shenzhen, P.R. China
Made in China
Shanghai International
Holding Corp. GmbH (Europe)
Eiffestrasse 80, 20537, Hamburg, Germany
37 ENGLISH

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 1.5

Issued Date: May 8, 2019
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.

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 de-
vice.
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.

Warnings
 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.

Cautions
 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 excep-
 ENGLISH 38

tional allergic patients may still 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 acces-
sories.
 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.

Notes
 Keep the oximeter away from dust, vibration, corrosive substances, explosive ma-
terials, 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 environ-
ment 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 disin-
fection.
 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 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 stand-
ards:
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.
39 ENGLISH

Table of Contents
1 Overview....................................................................................................... 40
1.1 Appearance............................................................................................. 40
1.2 Product Name and Model ...................................................................... 42
1.3 Structure.................................................................................................. 42
1.4 Features................................................................................................... 42
1.5 Intended Use........................................................................................... 42
1.6 Working Environment............................................................................... 42
2 Power Supply............................................................................................... 43
3 Make Measurement..................................................................................... 45
3.1 SpO2 Measurement.......................................................................................45
3.2 Temperature Measurement (optional) ..................................................... 46
4 Operation...................................................................................................... 47
4.1 Power on/off the Oximeter...................................................................... 47
4.2 Default Display Screen............................................................................ 48
4.3 Menu........................................................................................................ 49
4.4 Record .................................................................................................... 58
5 Technical Specifications............................................................................. 61
6 Over-limit Indication.................................................................................... 63
6.1 Limit settings........................................................................................... 63
6.2 Over-limit indication sound mute setting........................................................ 63
7 Packing List.................................................................................................. 63
8 Repair and Maintenance............................................................................. 64
8.1 Maintenance............................................................................................ 64
8.2 Cleaning and Disinfecting Instruction...................................................... 64
9 Troubleshooting........................................................................................... 65
10 Frequently Asked Questions....................................................................... 66
Appendix ........................................................................................................... 67
I. Key of Symbols........................................................................................... 67
II. Common Knowledge................................................................................. 69
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1 Overview
1.1 Appearance
Alert
indicator

Display screen

Menu/Confirm Record/Back
Auto-rotate /Up
Power indicator Right /Sound
Power/Left
Setting/Down

Figure 1.1 Front view

TEMP: SpO2:
Temperature SpO2 probe
probe connector
connector

Figure 1.2 Upper-side view

USB connector

DC power input
contact shoes
with polarity
Figure 1.3 Bottom side view
indication
41 ENGLISH

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 param-
eter values.

3. (Right/Sound): On data recall screen, longtime press this key, then the
delete dialog pops up; On measuring screen, longtime press it to disable or enable
the global sound.
On measuring screen, if the global sound is enabled, and alert event occurs, then
short time press it to perform audible alert reset (that’s to say, to alert sound will
be mute). When the current alert event ends or a new type of alert event occurs,
then status of audible alert reset will be ended (that’s to say, the alert sound will be
generated again when an alert event occurs). On menu or sub-menu screen, short
time press it to move the cursor right or adjust the parameter values.

4. (Auto-rotate/Up): On measuring screen, longtime pressing to enable or dis-

able 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.

5. (Setting/Down): On measuring screen, longtime pressing to enter into set-

ting 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 con-

firm 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 flash with orange color.

9. (Power saving mode indicator) If the device is set as power saving mode,
then the indicator lights up. And on measuring screen, the indicator flashes with
the pulse beep.

10. Icon: “SpO2”: ( ): SpO2 Probe Connector.

11. Icon: “TEMP”: ( ): Temperature Probe Connector.

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12. ( ) USB connector. Used for data uploading or charging.

13. ( ): DC power input contact shoes with polarity indication. Used

for connecting external DC power input for charging the built-in rechargeable bat-
tery via the base.

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 prob, this Oximeter can make temperature meas-
urement.)

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 580 hours data storage for SpO2 and PR and can be recalled.
• 16 user IDs for marking 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 (SpO2) and temperature (optional). It is applicable for
detecting SpO2, pulse rate and temperature of adult and neonate patients in clinical
institutions and homes.

1.6 Working Environment

Operating temperature: 5~40°C
Operating humidity: 15%~93% (non-condensing)
Atmospheric pressure: 70kPa~106kPa
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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.
Note: it’s recommended to use the AC power adapter provided by the manufacturer.
3. The Base:
Input: Micro USB connector, 5VDC/1A
Output: Contact pins. 5VDC/1A
Micro USB connector

Polarity markings

Figure 2.1A Base--front view Figure 2.1B Base--top view

Description:
The base is used to hold the oximeter, and also for charging the oximeter. You can
charge the oximeter by the following methods:
1) When the oximeter is held by the base, you can connect one end of the USB cable
to the USB connector on the back of the base marked with “DC 5V/1A”, and the
other end to the USB power source with output capacity of 5V DC/1A.
2) If the oximeter is not held by the base, then you can just connect one end of the USB
cable to the USB connector on the device marked with “ ”, and the other end
to the USB power source with output capacity of 5V DC/1A.
Notes:
1) During charging, if the oximeter is held by the base, please do not tilt the base
backwards too much, or the USB cable and the USB connector may be damaged.
2) Put the device into the base properly, and pay attention to the polarity markings, as
shown in figure 2.2.
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Oximeter

Insert the oximeter

into the base by this
direction

Base

Figure 2.2 Connection between oximeter and base

45 ENGLISH

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 con-
nection.
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

 Long term use of the SpO2 probe on the same place may result in discomfort or
pain, especially for those with microcirculatory problems. It is 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 sen-
sor.
 When the temperature of the SpO2 sensor is abnormal, do not use it further.
 ENGLISH 46

 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.
 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 Measuring key

Temperature
Probe Cover

Small screen Big display 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 and the temperature
unit “°C” 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.
47 ENGLISH

Nota:
• If the temperature probe detects a hardware failure, the display screen on the infra-
red 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 dif-
ferent body positions.

Temperature varying range at different body positions:

Arm 34,7 ~ 37,3°C

Oral 35,5 ~ 37,5°C
Rectal 36,6 ~ 38,0°C
Ear 35,8 ~ 38,0°C

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, 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 the software version and warn-
ing message “Professional attendance is required for continuous monitoring!” will be
shown on the screen, as shown in figure 4.1 (refer to your oximeter for actual version).

Figura 4.1
 ENGLISH 48

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.

Auto-rotate icon
Wireless icon
Auto power off
disable icon Recording mode
User ID Sound indicator

Patient type Battery indicator

SpO2 mark
SpO2 value

SpO2 high/low Pulse Strength

limit setting bar-graph
value

Pulse rate Pulse symbol

mark and unit

HR high/low limit Pulse rate value

setting value

Perfusion index TEMP value

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 con-
nected or the probe is off from the finger, then “Check Probe” message prompts and
keeps blinking on the screen, and “bibibi...” alert sound appears simultaneously.
Alert sound is 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 func-
tion is enabled).
• During measurement, longtime pressing Auto-rotate/Up key “ ”, then

the Auto-rotate white icon “ ” appears on the upper right corner of the
49 ENGLISH

screen, it means the auto rotation function is enabled, if you place this oxime-
ter horizontally, then the display shows in horizontal, as shown in figure 4.2B.

Figure 4.2B Default Display

Screen---in horizontal

• Sound indicator “ ” means that the global sound is disabled, the user can enable

the global sound by longtime pressing “ ”. key. Longtime pressing “ ”

key again can disable the global sound, that’s to say, the speaker is turned off at all,
therefore, no pulse beep sound, no audible alert and no key click sound.

• If the global sound is enabled by longtime pressing “ ”, key, then during the
measurement, over-limit alert event or probe off event can activate the audible alert.
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 trend 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).
 ENGLISH 50

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 “Neonate” for option.
Note: when the device is set to the ne-
onate patient type, then the User icon

“ ” turns to grey “ ”, and

the patient type on upper left corner
turns to pink “ ”.

• Recording mode: Select the data

recording mode, “Spot-check Re-
cord” and “Trend Record” for option.
• SpO2 record: Recall and review the
records stored on the oximeter, two
types of record for option: “Spot-
check Record” and “Trend Record”, Figure 4.3 Main menu
see Section 4.4 for details.
• TEMP Record: Review the temper-
ature record list.
• Date: Set the time and date, see Section 4.3.6 for details.
• Settings: Set the system parameter, including brightness, sound volume, display
language, power saving mode etc., see Section 4.3.7 for details.
• Alerts: Set the low alert limit for SpO2 and the high/low alert limit for PR, see Section
4.3.8 for details.
• Help: To view the tips information of SpO2 measurement and temperature measure-
ment, 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.
51 ENGLISH

Figure 4.4A User ID setup screen

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

 ENGLISH 52

4.3.3 Recording Mode

On main menu screen, move the cursor on
“Recording Mode” and press Confirm key
“ ”, then the oximeter enters into Re-
cording Mode Setup screen, as shown in figure
4.6.

Figure 4.6 Recording mode setup screen

Note: When selecting “Spot-check Record” for data recording, the measuring time
should last over 10 seconds to get one spot-check reading, or no reading value will
not be recorded in Spot-check data record; When selecting “Trend Record”, the
measuring time should exceed 30 seconds, or no one record will be recorded in Trend
data record list.

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 4.4 for details.

4.3.5 TEMP Record

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.
53 ENGLISH

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.

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

 ENGLISH 54

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 Settings
On main menu screen, move the cursor on “Settings” and press Confirm key “ ”,
then the oximeter enters into system setting screen, as shown in figure 4.10.

Figura 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.
• Pulse beep: To turn on/off pulse beep, the factory default is “On”, as shown in figure

4.10C. If the global sound is enables by longtime pressing , key, and the pulse
beep is set to “On” option, and when there is no over-limit event, then pulse beep
sound can be heard during SpO2 measurement.
• Language: This oximeter provides the display with two languages: English and Sim-
plified Chinese, the factory default is “English”, as shown in figure 4.10D.
• Auto power off: To turn on/off the Auto Power Off mode, the factory default is “On”,
as shown in figure 4.10E.
• Wireless: To turn on/off the wireless connection function, the factory default is “On”,
as shown in figure 4.10F.
• Power saving mode: To turn on/off the Power Saving mode, the factory default is
“On”, as shown in figure 4.10G.
• TEMP unit: To set the temperature unit, “°C (Celsius)” and “°F (Fahrenheit)” for
55 ENGLISH

option, the factory default is “°F”, as shown in figure 4.10H.

• Factory Default: Enter into the factory default setting, as shown in figure 4.10I.
• Version: For viewing version number of the software, as shown in figure 4.10J.
• Demo: Enter into the Demonstration mode, as shown in figure 4.10K.

Figure 4.10A Brightness setup Figure 4.10B Volume setup

Figure 4.10C Pulse beep setup Figure 4.10D Language setup

Figure 4.10E Auto Power OFF setup Figure 4.10F Wireless setup

Figure 4.10G Power Saving setup Figure 4.10I TEMP unit setup
 ENGLISH 56

Figure 4.10H Version info Figure 4.10J Default setting

Notes:
• When the Auto Power Off is set to “On” op-
tion, if there is no 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 dis-
play will be dim for power saving. The display
brightness will resume to normal condition by
pressing any key.

Figura 4.10K Modalità Demo

4.3.8 Alerts
On main menu screen, move the cursor on “Alerts”
and press Confirm key “ ”, then the oxime-
ter enters into alerts setting screen, as shown in
figure 4.11.

Figure 4.11 Alerts setting screen

57 ENGLISH

• SpO2 Lo-Limit: SpO2 low limit setting; range: 50%~99%, the step is 1%. The fac-
tory default value for adult is 90% and 95% for Neonate.
• 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 neonate.
• PR Lo-Limit: Low limit setting of pulse rate; range: 30~99bpm, and the step is
1bpm. The factory default value for adult is 50bpm and 60bpm for neonate.

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 neonate, 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 meas-
urement tips, as shown in figure 4.12.

Help Help
2/2
1/2

Baby L

Infant Pediatric

Note: Make sure the light Note: Remove temperature probe

emitting and receiving ends cover, insert the probe into earhole,
are aimed at each other. V then press key to start measurement.

Figure 4.12 Help information Figure 4.12 Help information

---SpO2 measurement ---TEMP measurement
 ENGLISH 58

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.

Figure 4.13 SpO2 record

SpO2 records include two types, Spot-check and Trend Record, Spot-check Re-
cord is a list showing the recording time, SpO2 value and pulse rate value for each
spot-checking event, as shown in figure 4.14

The corresponding
User and
User ID for the
selected record

Figure 4.14 Spot-check Record list

If Trend Record is selected, then the screen shows a list of trend data record, and
each record corresponds to a period of recording at a fixed time interval (1 second),

as shown in figure 4.15, press Up/Down 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.
59 ENGLISH

The corresponding
User and
User ID for the
selected record

Figure 4.15 Trend record---List

The corresponding
User and Recording
User ID for the time
selected record

SpO2
trend graph

PR trend graph

Figure 4.16 Trend record---Trend graph

 ENGLISH 60

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 Sound/Right key (“ ”), then an mes-
sage “Are you sure to delete all?” prompts on the screen, as shown in figure 4.16.

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.

When the wireless transmission function is on, the Handheld Pulse Oximeter can com-
municate with a host (such as computer or mobile) for viewing and management.
a. Open the host’s wireless function and procedure and start to scan the SP-20 Oxi-
meter.
b. The host will pair with the SP-20 Oximeter at a moment.
c. After connecting, the host can display and manage the measurement data of SP-20
by wireless
61 ENGLISH

The pairing and transmitting distance of wireless function is 8 meters in the normal.
If the host can’t pair with the SP-20, you will try to narrow the distance between the
host and SP-20.
The SP-20 can pair and transmit with the host under the wireless coexistence envi-
ronment, but other wireless device may still interface with pairing and transmission
between the host and the SP-20 device under uncertain environment. If the host and
the SP-20 display inconsistent, you may need to change the environment.

4.4.4 Data Management

The user can go to our website to download the corresponding PC Software “Ox-
imeter Data Manager” for this oximeter with the link: http://www.creative-sz.com/
downloads
With the computer installed this PC software, you can upload the data stored in the
oximeter to your PC via wireless or data cable . It’s convenient for user to review the
data records and statistical result, aa well as archive patients’ data.

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 wireless 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: 0~100%
Measuring accuracy: ARMS value (defined in ISO 80601-2-61) is not greater than 2%
for SpO2 range from 70% to 100%.
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~250bpm
Accuracy: ±2bpm or ±2% (whichever is greater)
E. Perfusion Index Display
Range: 0.2%~20%
 ENGLISH 62

F. Temperature Measurement
Measuring range: 32.0°C~43.0°C
Measuring accuracy: ±0.2°C for temperature range from 35.0°C to 42.0°C, and
±0.3°C for the rest.
Response time: ≤5s
Patient Group: Adult and Neonate
Measuring site: earhole
Deviation: ≤0.1°C
G. 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 perfor-
mance of the Oximeter.
H. Low Perfusion Performance
The accuracy of SpO2 and PR measurement still meet the precision described
above when the modulation amplitude is as low as 0.4%.
I. 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%.
J. Wireless (bluetooth) function
Frequency band: 2.4GHz
Working profile: BLE V4.0
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.
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
M. Data update period
The update time for determining SpO2 and PR value is 8 seconds, and the display-
ing update time is 1 second.
Remark: The oximeter calculates the SpO2 and PR value, every second by use of
recently acquired data segment, then yields the displaying value by moving aver-
age of the latest calculated parameters. The reading value of SpO2 and PR on the
oximeter is updated every second, and the displayed plethysmogram is a normal-
ized waveform. If the signal is no integral (such as with too much noise, or poor
signal to noise ratio or signal is lost), then the SpO2 and PR will be identified as an
invalid value, that’s to say, the numeric reading will disappear and be displayed as
“--” instead.
63 ENGLISH

Note: The oximeter is calibrated in the factory before sale, and there is no need for
user to calibrate again.

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 global sound is enables, then short time press “ ”
key to perform audible alert reset (that’s to say, the alert sound will be mute, and icon

“ ” appears on the upper right corner of the screen), but the over-limited value
still keeps blinking. when the current alert event ends or a new type of alert event
occurs, then the status of audible alert reset will be ended (that’s to say, the alert
sound can be generated when an alert event occurs, and icon “ ” appears on the
upper right corner of the screen).
• When the global sound is enables, then the longtime pressing “ ” key cam

disable the global sound, and the sound icon becomes “ ”. Longtime pressing
“ ” key again can enable the global sound.

Note: “ ” means the speaker volume is set as 1 or 2 grid(s); “ ” means the

speaker volume is set as 3 or 4 grids; “ ” means the speaker volume is set as 5
or 6 grids.
• During the measurement, if the probe is off or disconnected, the message “Check
Probe” shows and keeps blinking on the display screen. The alert sound starts (in-
terval is 5 seconds). If the probe is still off and lasts for about 3 minutes, then the
Oximeter will power off automatically.

7 Packing List
1. An Oximeter
2. A SpO2 probe
3. User Manual
4. A oximeter rubber cover
5. A charging base
 ENGLISH 64

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 con-
cerning safety and biocompatibility etc. may be caused.
3. This device can only connect with the manufacture nominated device.

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 man-
ufacture.
• 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°C without relative humidity control;
and + 70°C 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 verifica-
tion 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% iso-
propyl 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
65 ENGLISH

9 Troubleshooting
Trouble Possible Reason Solution
Unstable SpO2 1. The finger is not placed 1. Place the finger
and Pulse Rate far enough inside. correctly inside and try
display 2. The finger is shaking again.
or the patient is moving. 2. Reduce patient
movement.
Unable 1. Temperature probe 2. Reinsert the probe into
to measure is not connected properly the device
Temperature
Device will not 1. The batteries are drained 1. Recharge battery.
switch on or almost drained. 2. Please contact the local
2. The device is service center.
malfunctioning.
No Display 1. The device will power off 1. Normal.
automatically when there is 2. Recharge battery.
no signal and no operation
for 1 minute.
2. The battery voltage is low.
No Signal 1. Probe off or incorrect 1. Reconnect the probe.
connection. 2. Reinsert the finger.
2. Incorrect finger insert 3. Replace a new probe.
3. Probe is damaged.
 ENGLISH 66

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.
5. 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 SpO2 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 charge the batteries?
A: The icon of low battery will appear on the screen when the battery voltages are
low. By then, device need to be charged.
8. Q: What factors will affect the SpO2 accuracy?
A: a) Intravascular dyes such as indocyanine green or methylene blue;
b) Exposure to excessive illumination, such as surgical lamps, bilirubin lamps, flu-
orescent 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 cath-
eter, 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.

67 ENGLISH

Appendix
I. Key of Symbols

Symbols on the screen

Symbol Description
%SpO2 The oxygen saturation
PI% Perfusion Index

bpm Pulse rate (Unit: beats per minute)

Pulse bar graph

Low battery voltage

Battery is full

Alert reset icon

Speaker mute icon

Speaker volume icon

SpO2 spot-check record memory full

SpO2 trend record memory full

Temperature memory full

Wireless transmission icon

(Neonate/Adult) Patient type

 ENGLISH 68

Symbols on the panels

Symbol Description Symbol Description
Caution: read instructions
SpO2 SpO2 probe connector
(warnings) carefully

Temperature probe
TEMP Keep in a cool, dry place
connector

Power/Left Key Product code

Right/ Sound Key Lot number

Auto-rotate/Up Key Keep away from sunlight

Setting/Down Key Date of manufacture

Menu/Confirm key
Manufacturer
or Record/Back key

Serial number Type BF applied part

Medical Device complies

Follow instructions for use
with Directive 93/42/EEC
Authorized represent-
ative in the European Do not litter at will
community

WEEE disposal No alarm

69 ENGLISH

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 pro-
portional 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 de-
termined. 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, in-
cluding dysfunctional hemoglobin, such as carboxyhemoglobin or metahemoglobin.
Clinical application of pulse oximeters: SpO2 is an important physiological parameter
to reflect the respiration and ventilation function, so SpO2 monitoring used in clini-
cal 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 val-
ues 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 oxime-
ter 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, fluores-
cent lights, infrared heating lamps, or direct sunlight.
• Vascular dyes or external used color-up product such as nail enamel or color skin
care.
 ENGLISH 70

• 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 hyperkinesias or body tem-
perature 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.

Disposal: The product must not be disposed of along with other domestic
waste. The users must dispose of this equipment by bringing it to a specific
recycling point for electric and electronic equipment.

GIMA WARRANTY TERMS

The Gima 12-month standard B2B warranty applies.