Gima SP-20 User manual

M34341-M-Rev.4-10.23
PULSOXIMETRO OXY 110
OXY 110 PULSE OXIMETER
PULSIOXÍMETRO OXY 110
OXYMÈTRE DE POULS OXY 110
PROFESSIONAL MEDICAL PRODUCTS
Importato da / Imported by / Importé par / Importado por
Gima S.p.A.
Via Marconi, 1 - 20060 Gessate (MI) Italy
[e-mail] - [email protected]
www.gimaitaly.com
Shenzhen Creative Industry Co., Ltd.
Floor 5, BLD 9, BaiWangxin High-Tech Industrial Park,
Songbai Road, Xili Street, Nanshan District,
518110 Shenzhen, P.R. China
Made in China
0123
Shanghai International
Holding Corp. GmbH (Europe)
Eiffestrasse 80, 20537, Hamburg, Germany
SP-20 (Gima 34341)

37
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 1.8
Issued Date: October 12, 2023
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 inammable 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 nger 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-
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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: 2020 Medical electrical equipment-Part 1: General requirements for ba-
sic safety and essential performance;
ISO 80601-2-61: 2017 - Medical electrical equipment -- Part 2-61: Particular require-
ments for basic safety and essential performance of pulse Oximeter equipment.
And it also follows the provisions of the council directive MDD 93/42/EEC.
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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 Specications ............................................................................ 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
III. EMC compliance.................................................................................... 147
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1 Overview
1.1 Appearance
Alert
indicator
Figure 1.1 Front view
Figure 1.3 Bottom side view
Figure 1.2 Upper-side view
Record/Back
Right /Sound
Setting/Down
Display screen
Menu/Conrm
Auto-rotate /Up
Power indicator
Power/Left
SpO2:
SpO2probe
connector
USB connector
DC power input
contact shoes
with polarity
indication
TEMP:
Temperature
probe
connector
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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 de-
lete 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/Conrm): Short time press it to enter into menu screen, or to con-
rm 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 ash 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 ashes 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
2 Power Supply
1. Internal power supply with built-in battery:
Built-in battery specication: 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.
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3.The Base:
Input: Micro USB connector, 5VDC/1A
Output: Contact pins. 5VDC/1A

Polarity markings
Micro USB connector
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 gure 2.2.
Cautions:
The external 5V DC output power supply device (computer or power adapter) con-
nected to charging base or directly connected to the Oximeter must comply with
standard IEC 60950 or IEC 60601-1. It’s strongly recommended to use the power
adapter provided by manufacturer for your safety!
Please unplug the SpO2 probe and temperature probe while charging to prevent
danger caused by children touching and playing by mistake.
Do not measure temperature or SpO2 while charging to avoid electric shock.
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Base
Oximeter
Insert the oximeter
into the base by this
direction
Figure 2.2 Connection between oximeter and base
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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 rmly and pull).
2. The red blinking light inside the clip of the SpO2 probe indicates a successful con-
nection.
3. Insert one nger (index nger is preferred, the nail should be not too long) into the
clip of the probe according to the nger mark,as shown in gure 3.1.
4. The device will begin to take the measurement, and the measured result will be
displayed on the screen, as shown in gure 4.2.
Figure 3.1 demonstration for SpO2probe
Safety instructions for SpO2measurement
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°C, please change the measuring site
every two hours; when the ambient temperature is over 37°C, please do NOT use
the SpO2 sensor, as using in high temperatures can cause burns.
Do NOT place the SpO2 probe on a nger 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.
Remove nail polish or other cosmetic products from the ngernail.
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The ngernail 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 ear thermometer 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 gure 3.2.
Please place the ear thermometer probe in a stable ambient temperature for 30 min-
utes before taking a measurement.
1. Display screen
2. Unit key (°C/°F)
3. Measuring key
4. Measuring tip of the ear
thermometer probe
5. Battery cover
6. Temperature Probe Cover
Figure 3.2 the infrared temperature probe
Mode of operation of the clinic thermometer: Adjusted mode
Note: The default mode is ear temperature measurement.
Operation procedure:
1. Connect the ear thermometer probe to the connector on the upper side of device
marked with “TEMP”. Press the measuring key. When the LCD screen of the device
displays “ “, this indicates that the probe is successfully connected.
2. When the temperature unit “°C” on the screen of the probe is blinking, the user can
begin to take the measurement.
3. Take off the probe cover and insert the tip of the ear thermometer probe into the
earhole, Press the measuring key to start the measurement. A short beep means the
measurement has nished and the result will be displayed on the screen.
4. Press the unit key to switch between °C and °F.
Note:
If the ear thermometer probe detects a hardware failure, a red screen will appear
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on the display screen and the probe will not enter into measuring mode. Press the
measuring key to restart the measurement.
The ear thermometer probe will switch to stand by automatically if there is no oper-
ation for 1 minute. If a further measurement is needed, press the measuring key and
repeat step 2 and step 3.
Normal range of ear temperature: 35.8 ~ 38.0 °C
Each person has his/her own normal temperature value, and the normal tempera-
ture value also changes at different time within a day. Therefore, it’s recommended to
report your doctor not only the temperature value, but also the measuring position,
if possible you may provide your own normal temperature range to your doctor for
reference.
Safety Instruction for Temperature Measurement
 This device meets requirements established in ASTM Standard (E1965-98).
 Do NOT use the ear thermometer probe when the subject temperature and am-
bient temperature are outside the operating ranges specied by the manufacturer.
 Performance of the device may be adversely affected when one or more of the
following occur:
A. Operation outside of the manufacturer specied subject temperature range.
B. Operation outside of the manufacturer specied operating temperature and hu-
midity ranges.
C. Storage outside of the manufacturer specied ambient temperature and humidity
ranges.
D. Mechanical shock.
Manufacturer dened soiled or damaged infrared optical components.
Do NOT take a measurement when the patient is moving.
Patients with tympanitis and otitis problems should NOT use this device
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 gure 4.1 (refer to your oximeter for actual version).
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Figura 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.
Patient type Battery indicator
SpO2mark
SpO2high/low
limit setting
value
SpO2value
Pulse rate
mark and unit
HR high/low limit
setting value
Perfusion index
Current time
Pulse Strength
bar-graph
Pulse symbol
Pulse rate value
TEMP value
Plethysmogram
Sound indicator
Recording mode
Wireless icon
User ID
Auto-rotate icon
Auto power off
disable icon
Figure 4.2A Default Display Screen---in vertical
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Description:
• During measurement, if the nger is not inserted properly, or the probe is not con-
nected or the probe is off from the nger, 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
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 gure 4.2B.
Figure 4.2B Default DisplayScreen--
-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.
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4.3 Menu
On the default measuring screen, short time press “ ”Menu/Conrm 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/Conrm key again to conrm
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.
• SpO2record: Recall and review the
records stored on the oximeter, two
types of record for option: “Spot-
check Record” and “Trend Record”,
see Section 4.4 for details.
• TEMP Record: Review the tempera-
ture 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 Sec-
tion 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.
Figure 4.3 Main menu
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4.3.1 User ID
On main menu screen, move the cursor on “User ID” and press Conrm key “ ”,
then the oximeter enters into User ID Setup screen, as shown in gure 4.4.
Figure 4.4A User ID setup screen
Move the cursor on “Edit” and press Conrm
key “ ”; when the cursor turns to blue,
then the user can edit the User ID, and move
the cursor on “OK” to conrm the edit, the edit
screen is as shown in gure 4.4B.
Figure 4.4B User ID edit screen
4.3.2 User
On main menu screen, move the cursor on “User” and press Conrm key “ ”,
then the oximeter enters into Patient type Setup screen, as shown in gure 4.5.
Figure 4.5 Patient type setup screen
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4.3.3 Recording Mode
On main menu screen, move the cursor on
“Recording Mode” and press Conrm key
“ ”, then the oximeter enters into Re-
cording Mode Setup screen, as shown in gure
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 SpO2Record
On main menu screen, move the cursor on “ SpO2 Record” and press Conrm key
“ ”, then the oximeter enters into SpO2 record review method selecting screen,
as shown in gure 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 Conrm key
“ ”, then the oximeter enters into temperature record list screen, as shown in
gure 4.8.
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Figure 4.8 TEMP record list screen
4.3.6 Date
On main menu screen, move the cursor on
“Date” and press Conrm key “ ”, then
the oximeter enters into date setup screen, as
shown in gure 4.9.
Figure 4.9 Date setup screen
Date setting procedure:
1) Move the cursor stays on the Year of the date, press Conrm key “ ”to active
Year option, the cursor ashes on the Year of the date.
2) Press Up/Down key to adjust Year.
3) Press “ ” (Conrm) key to conrm 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
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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 Conrm key “ ”,
then the oximeter enters into system setting screen, as shown in gure 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 gure 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 gure 4.10B.
• Pulse beep: To turn on/off pulse beep, the factory default is “On”, as shown in gure
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-
plied Chinese, the factory default is “English”, as shown in gure 4.10D.
• Auto power off: To turn on/off the Auto Power Off mode, the factory default is “On”,
as shown in gure 4.10E.
• Wireless: To turn on/off the wireless connection function, the factory default is “On”,
as shown in gure 4.10F.
• Power saving mode: To turn on/off the Power Saving mode, the factory default is
“On”, as shown in gure 4.10G.
• TEMP unit: To set the temperature unit, “°C (Celsius)” and “°F (Fahrenheit)” for op-
tion, the factory default is “°F”, as shown in gure 4.10H.
• Factory Default: Enter into the factory default setting, as shown in gure 4.10I.
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• Version: For viewing version number of the software, as shown in gure 4.10J.
• Demo: Enter into the Demonstration mode, as shown in gure 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
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