Gima OXY 110 User manual

M-34341-M-Rev.1.03.18
PULSOXIMETRO OXY 110
OXY 110 PULSE OXIMETER
PULSIOXÍMETRO OXY 110
OXYMÈTRE DE POULS OXY 110
PROFESSIONAL MEDICAL PRODUCTS
Gima S.p.A.
Via Marconi, 1 - 20060 Gessate (MI) Italy
[e-mail] - [e-mail]
www.gimaitaly.com
Manuale d’uso - User manual
Manuel de l’utilisateur - Guía de uso
ATTENZIONE: Gli operatori devono leggere
e capire completamente questo manuale
prima di utilizzare il prodotto.
ATTENTION: The operators must carefully read
and completely understand the present manual
before using the product.
AVIS: Les opérateurs doivent lire et bien
comprendre ce manuel avant d’utiliser le produit.
ATENCIÓN: Los operadores tienen que leer y entender
completamente este manual antes de utilizar el producto.
Shenzhen Creative Industry Co., Ltd.
2/F, Block 3, Nanyou Tian’an Industry Town,
Shenzhen 518054 P. R. China
Made in China
0123
Shanghai International
Holding Corp. GmbH (Europe)
Eiffestrasse 80, 20537, Hamburg, Germany
34341 / SP-20

37
Dear Customer,
Thank you for purchasing this quality product. Please read the manual very care-
fully before using this device. Failure to follow these instructions can cause mea-
suring 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 1.3
Issued Date: November 27 , 2017
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. Howe-
ver, 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 devi-
ce should be inspected minimally before each use. If there is obvious damage,
stop using the device.
Necessary service must be performed only by qualied technicians. Users are
not permitted to service this device.
The oximeter must not be used with the devices and accessories not specied
in User Manual.
Cautions
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.
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 micro-
circulation. 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 SpO2probe with excessive pressure for prolonged periods
can induce pressure injury.
Place the SpO2probe on the nger tightly will cause venous pulse and effect
blood circulation, and lead to interstitial edema, hypoxia and inaccurate mea-
surement.
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Biocompatibility tests have been performed on all the applied parts, some
exceptional 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 tis-
sue.
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 interferen-
ce exists, such as radiogram, television, radiophone, etc.
Please pay attention to the SpO2probe 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 immedia-
tely. 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 oxi-
meter 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 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.
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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 SpO2Measurement....................................................................................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
Figure 1.1 Front view
Figure 1.3 Bottom side view
Figure 1.2 Upper-side view
Record/Back
Right/Mute
Setting/Down
Display screen
Menu/Conrm
Rotate-lock /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
parameter values.
3. (Right/Mute): On data recall screen, longtime press this key, then the
delete dialog pops up; On measuring screen, short time press it to disable or
enable the sound. On menu or sub-menu screen, short time press it to move
the cursor right or adjust the parameter values.
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.
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 conrm the selection.
7. (Record/Back): Short time press it to enter into SpO2record list scre-
en, or to back to the previous level of menu.
8. (Alert indicator): If the probe is not well placed or discon-
nected, 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 ” ( ): SpO2Probe Connector.
11. Icon: “TEMP” ( ): Temperature Probe Connector.
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 rechar-
geable battery via the base

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1.2 Product Name and Model
Name: Handheld Pulse Oximeter
Model: SP-20
1.3 Structure
It consists of the main unit and SpO2probe.
(Note: with optional temperature prob, this Oximeter can make temperature me-
asurement.)
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 SpO2and 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 appli-
cable for detecting SpO2, pulse rate and temperature of adult and neonate patien-
ts 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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
Polarity markings
Micro USB connector
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.
3. The Base:
Input: Micro USB connector, 5VDC/1A
Output: Contact pins. 5VDC/1A
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 da-
maged.
2) Put the device into the base properly, and pay attention to the polarity markin-
gs, as shown in gure 2.2.
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Figura 2.2 Connection between oximeter and base
Base
Oximeter
Insert the oximeter
into the base by
this direction
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3 Make Measurement
3.1 SpO2Measurement
Operation procedures:
1. Connect the SpO2probe to the connector on the upper-side of the device mar-
ked 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 SpO2probe indicates a successful
connection.
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 SpO2 measurement
Long term use of the SpO2probe 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 SpO2sensor, as using in high temperatures can cause burns.
Do NOT place the SpO2probe on a nger with edema or fragile tissue.
Do NOT put the SpO2probe and pressure cuff on the same limb, otherwise the
blood pressure measurement may affect the SpO2measurement.
The device is calibrated to display functional oxygen saturation.
Do NOT allow the sensor cable to twist or bend.
Check the SpO2sensor and cable before use. Do NOT use a damaged SpO2
sensor.
When the temperature of the SpO2sensor is abnormal, do not use it further.
Remove nail polish or other cosmetic products from the ngernail.
The ngernail should be of normal length.
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Measuring tip of
temperature probe
Temperature
Probe Cover
Small screen
Power on/off key
Battery cover
Measuring key
Big display screen
The SpO2sensor 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 SpO2probe, 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.
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 gure 3.2 and the tempe-
rature 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 ni-
shed 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.
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• 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 measure-
ment is taken from. The following table shows the varying temperature ranges
of the different body positions.
Temperature varying range at different body positions:
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
warning message “Professional attendance is required for continuous monito-
ring!” will be shown on the screen, as shown in gure 4.1 (refer to your oximeter
for actual version).
Figure 4.1
Arm 34.7~37.3°C
Oral 35.5~37.5°C
Rectal 36.6~38.0°C
Ear 35.8~38.0°C
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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.
Figure 4.2A Default Display Screen---in vertical
Description:
• During measurement, if the nger is not inserted properly, or the probe is not
connected or the probe is off from the nger, then “Check Probe” message
prompts 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
function is enabled).
• During measurement, longtime pressing Rotate-lock/Up key , then the
Rotate-lock white icon appears on the upper right corner of the screen, it
means the auto rotation function is enabled, if you place this oximeter horizon-
tally, then the display shows in horizontal, as shown in gure 4.2B.
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
Rotate-lock icon
Auto power off
disable icon
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Figure 4.2B Default Display
Screen---in horizontal
• Sound indicator means the device is on mute status, the user can resume
the indication sound by short pressing key again. 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 blinks. During the
measurement, over-limit event or probe off event can activate the alert indica-
tion 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 SpO2spot-check record
memory is full, means SpO2trend 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/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 neonate patient type, then the User icon
turns to grey , and the patient type on upper left corner turns to
pink .
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• Recording mode: Select the data recording mode, “Spot-check Record” 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.
Figure 4.3 Main menu
• 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 brightness, sound volume, display
language, power saving mode etc., see Section 4.3.7 for details.
• Alert: Set the low alert limit for SpO2and the high/low alert limit for PR, see
Section 4.3.8 for details.
• Help: To view the tips information of SpO2measurement and temperature mea-
surement, see Section 4.3.9 for details.
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.
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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
Recording 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 Re-
cord”, 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
“SpO2Record” and press Conrm key ,
then the oximeter enters into SpO2record
review method selecting screen, as shown
in gure 4.7.
Figure 4.7 SpO2record review method
selecting screen
Refer to Section 4.4 for details.
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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.
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.
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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 Conrm key
, then the oximeter enters into system setting screen, as shown in gure
4.10.
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 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.
• Language: This oximeter provides the display with two languages: English and
Simplied Chinese, the factory default is “English”, as shown in gure 4.10C.
• Auto power off: To turn on/off the Auto Power Off mode, the factory default is
“On”, as shown in gure 4.10D.
• Wireless: To turn on/off the wireless connection function, the factory default is
“On”, as shown in gure 4.10E.
• Power saving mode: To turn on/off the Power Saving mode, the factory default
is “On”, as shown in gure 4.10F
• TEMP unit: To set the temperature unit, “°C (Celsius)” and “°F (Fahrenheit)” for
option, the factory default is “°F”, as shown in gure 4.10G.
• Factory Default: Enter into the factory default setting, as shown in gure 4.10H.
• Version: For viewing version number of the software, as shown in gure 4.10I
• Demo: Enter into the Demonstration mode, as shown in gure 4.10J.
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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
Figure 4.10G TEMP unit setup
Figure 4.10H Default setting
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