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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