Gima OXY-200 User Manual
PROFESSIONAL MEDICAL PRODUCTS
OXY-200 PULSE OXIMETER
35101 / CMS70A
CONTEC MEDICAL SYSTEMS CO., LTD
No.112 Qinhuang West Street,
Economic & Technical Development Zone,
066004 Qinhuangdao, Hebei Province,
PEOPLE’S REPUBLIC OF CHINA
Made in China
Shanghai International Holding Corp. GmbH (Europe)
Eiffestrasse 80, 20537 Hamburg, Germany
Imported by:
Gima S.p.A.
Via Marconi, 1 - 20060 Gessate (MI) Italy
gima@gimaitaly.com - export@gimaitaly.com
www.gimaitaly.com
M35101-GB-Rev.2-02.20
0123
IP21
I
Instructions to User
Dear users, thank you very much for purchasing the device.
This Manual is written and compiled in accordance with the council directive MDD93/42/EEC
for medical devices and harmonized standards. In case of modifications and software upgrades,
the information contained in this document is subject to change without notice.
The Manual describes, in accordance with the device’s fea tures an d r equirem ent s, mai n s truc tur e,
functions, specifications, correct methods for transportation, installation, usage, operation, repair,
maintenance and storage, etc. As well as the safety procedures to protect both the user and
equipment. Refer to the respective chapters for details.
Please read the User Manual carefully before using this product. The User Manual which
describes the operating procedures should be followed strictly. Failure to follow the User Manual
may cause measure abnormality, equipment damage and human injury. The manufacturer is NOT
responsible for the safety, reliability and performance issues and any monitoring abnormality,
human injury and equipment damage due to users' negligence of the operation instructions.The
manufactu rer’s warra nty service does not cover su ch faults.
Owing to the forthcoming ren ovation, the specific products you received may not be totally in
accordance with the description of this User Manual. We would sincerely regret for that.
This product is medical device, which can be used repeatedly.
WA R N I N G :
M Uncomfortable or painful feeling may appear if using the device ceaselessly, especially
for the microcirculation barrier patients. It is recommended that the device should not
be applied to the same finger for over 2 hours.
M For the special patients, there should be a more prudent inspecting in the placing
process. The device can not be clipped on the edema and tender tissue.
M The light (the infrared is invisible) emitted from the device is harmful to the eyes, so the
user and the maintenance man should not stare at the light.
M Te st ee ca n n ot u se en a me l o r ot he r m ak e up .
M Te stee’s fingernail can not be too long.
M Please refer to the correlative literature about the clinical restrictions a nd caution.
M This device is not intended for treatment.
The User Manual is published by our c ompany. All r ights reserved.
II
Contents
1 Safety ............................................................................................................................... 1
1.1 Instructions for Safe Operation ........................................................................... 1
1.2 Wa rn i ng ................................................................................................................ 1
1.3 Attention ............................................................................................................... 1
1.4 EMC Statement .................................................................................................... 2
2 Overview ......................................................................................................................... 3
2.1 Features................................................................................................................. 3
2.2 Major Applications and Scope of Application ................................................... 3
2.3 Contraindications ................................................................................................. 3
3 Principle .......................................................................................................................... 4
4 Te ch n ic al Specifications............................................................................................... 4
4.1 Main Performance................................................................................................ 4
4.2 Main Parameters .................................................................................................. 5
4.3 Envir onment Requirements ................................................................................. 5
5 Installation ...................................................................................................................... 6
5.1 View of the Front Panel ....................................................................................... 6
5.2 View of the Back Panel ....................................................................................... 7
5.3 Accessories ........................................................................................................... 7
6 Operating Guide ........................................................................................................... 8
6.1 Application Method ............................................................................................. 8
6.2 Attention for Operation ..................................................................................... 15
6.3 Clinical Restrictions........................................................................................... 16
7 Maintenance,Transportation and Storage ............................................................ 16
7.1 Cleaning and Disinfecting ................................................................................. 16
7.2 Maintenance ....................................................................................................... 16
7.3 Transportation and Storage ............................................................................... 16
8 Troubleshooting ........................................................................................................... 17
9 Key of Symbols .......................................................................................................... 18
10 Function Specification ............................................................................................. 20
11 Factory Defa ult ......................................................................................................... 21
Appendix I ......................................................................................................................... 22
1
1 Safety
1.1 Instructions for Safe O peration
² Check the main unit and all accessories periodically to make sure that there is no visible
damage that may affect patient’s safety and monitoring performance. It is recommended that
the device should be inspected weekly at least. When there is obvious damage,stop using the
device.
² Necessary maintenance must be performed by qualified service engineers ONLY. Users are
not permitted to maintain it by themselves.
² If the battery has to be replaced, the battery shall be provided by manufacture and replaced
only by trained service personnel.Incorrect replacement and model of battery may cause
device damage and patient injury.
² The device can't be used together with devices not specified in User Manual.Only the
accessory that is appointed or recommendatory by manufacture can be used with this device.
² This product is calibrated before leaving factory.
² Users should have basic text distinguish ability.
² The patient is also an intended operator.Patient can use the device for measurement, storage
and data upload. While device maintenance, clean or batteries replacement is not allowed.
² During normal use，please do not position this device to make it difficult to disconnect form
power supply.
² After use,please switch off and unplug the device.
1.2 War nin g
M Don't open the enclosure of the device to avoid tip-and-run danger.Necessary maintenance
and upgrade must be performed by qualified serv ice engineers who have been trained and
accredited by our company ONLY
M Explosive hazard—DO NOT use the device in the environment with tinder such as
anesthetic .
M DO NOT use the device while the patient is being scanned by MRI or CT.
M The disposal of scrap instrument and its accessories and packing (including battery, plastic
bags, foams and paper boxes) should follow the local laws and regulations,and place them in
the place where the children can't reach.
M Please check the packing before use to make sure the device and accessories are totally in
accordance with the packing list, or else the device may have the possibility of working
abnormally.
M Please choose the accessories and probe which are approved or manufactured by the
manufactu rer, or else it may damage the device.
M The device can only be matched with the c ompatible probe.
M Please don't measure this device with functional tester for the device's related information.
M Parts of this device are not allowed to be serviced or maintained while in use with the patient.
1.3 Attention
% Keep the device away from dust, vibration, corrosive substances, tinder, high temperature and
moisture.
% If the device gets wet, please stop operating it.
2
% When it is carried from cold environment to warm or humid environment, please do not use it
immediately.
% DO NOT operate keys on front panel with sharp materials.
% High temperature or high pressure steam disinfection of the device is not permitted. Refer to
User Manual in the relative chapter (7.1) for instructions of cleaning and disinfection.
% DO NOT have the device immerged in liquid. When it needs cleaning, please wipe its surface
with medical alcohol by soft material. Do not spray any liquid on the device directly.
% When cleaning the device with water, the temperature should be lower than 60℃.
% The fingers which are too thin or too cold may affect the measure accuracy, please clip the
thicker finger such as thumb and middle finger deeply enough into the probe.
% The device can be u sed to adult and child.Whether the device is used to adult or children, it
depends on the probe selected.
% The update period of data is less than 5 seconds, which is changeable according to different
individual pulse rate.
% Please read the measure value when the waveform on screen is equably and steady-going.This
measure value is optimal value,and the waveform at the moment is the standard one.
% If some abnormal conditions appear on the screen during test process, pull out the finger and
reinsert to restore normal use.
% The device has life for three years.
% The device has alarm function, users can check on this function according to chapter 6.1 as
reference.
% The device has the function of limit alarm.When the measure data is beyond limit, the device
would start to alarm automatically if the alarm function is on.
% The device has alarm function.This function can either be paused, or closed for good.Please
check the chapter 6.1 as reference.
% The device may not w ork for all patients.If you are unable to achieve stable readings,
discontinue use.
1.4 EMC Statement
Electromagnetic compatibility shall be considered during device in use, because high
electromagnetic portable or mobile RF equipment will interfere the working of the device.
Usage of other cables will affect the EMC performance of the device, please use the standard
accessories.
3
2 Overview
The pulse oxygen saturation is the percentage of HbO
O
concentration in the blood. It is an important bio-parameter for the respiration. A numb er of
2
diseases relating to respiratory system may cause the decrease of SpO2 in the blood, furthermore,
some other causes such as the malfunction of human body's self-adjustment, damages during
surgery, and the injuries caused by some medical checkup would also lead to the difficulty of
oxygen supply in human body, and the corresponding symptoms would appear as a consequence,
such as vertigo, impotence, vomit etc. Serious symptoms might bring danger to human's life.
Therefore, prompt information of patients' SpO2 is of great help for the doctor to discover the
potential danger, and is of great importance in the clinical medical field.
The device is fashion and portable.It is only necessary for patient to put one finger into probe for
diagnosis,and display screen will directly show the measure value of pulse oxygen saturation
with the high veracity and repetition.
2.1 Features
A Operation is simple and convenient.
B Product is handsome and fashion,and easy to observe
C With two kinds of power supply mode(alternating current and internal electrical power source)
2.2 Major Applications and Scope of Application
The device can be used in measuring the pulse oxygen saturation and pulse rate through finger.
The product is suitable for being used in family, hospital, oxygen bar, community healthcare,
physical care in sports (It can be used before or after doing sports and it is not recommended to
use the device during the process of having sport) and etc.
2.3 Contraindications
The problem of overrating would emerge when t he patient is suffering from toxicosis
which caused by carbon monoxide,and the device is not recommended to be used under
this circumstance.
The person who is allergic to rubber can not use this device.
in the total Hb in the blood, s o-called the
2
4
3 Principle
Principle of the Oximeter is as follows: An experience formula of data process is established
taking use of Lambert Beer Law according to Spectrum Absorption Characteristics of Reductive
Hemoglobin (Hb) and Oxyhemoglobin (HbO2) in glow & near-infrared zones. Operation
principle of the device is: Photoelectric Oxyhemoglobin Inspection Technology is adopted in
accordance with Capacity Pulse Scanning & Recording Technology, so that two beams of
different wavelength of lights can be focused onto human nail tip through perspective clamp
finger-type sensor. Then measured signal can be obtained by a photosensitive element,
information acquired through which will be shown on screen through treatment in electronic
circuits and microprocessor.
Figure 1.
4 Technical Specifications
4.1 Main Performance
l SpO2 value display
l Pulse rate value display, bar graph display
l PI value display
l Pulse waveform display
l Battery power display
l Low-power indication: low-power indication symbol appears before working abnormity
which is due to low-power.
l Review function
l Screen brightness can be adjusted
l Volume can be adjusted
l Display mode can be adjusted
l Pulse sound indication
l With alarm function,the user c ould set alarm limit.
l With real-time data uploading function.
l With clock function
l With two kin ds of power supply mode(alternating current and internal electrical power
5
source)
4.2 Main Parameters
A Measure of SpO2
Measure range: 0~100%
Accuracy:
When the SpO2 measu re range is 70%~100%,the permission of absolute error is ±2%;
Below 70% unspecified.
B Measure of pulse rate
Measure range:30bpm~250bpm
Accuracy: ±2 bpm or ±2% (select larger)
C Measure of PI
Range: 0~20%
When the PI measure range is 1%~20%,the permission of absolute error is ±1%
When the PI measure range is 0%~0.9%,the permission of absolute error is ±0.2%;
D Resolution
SpO2 : 1%
Pulse rate: 1bpm
PI: 0.1%
E Measure performance in weak filling condition:
SpO2 and pulse rate value can be shown correctly when pulse-filling ratio is 0.4%. SpO2
error is ±4%; pulse rate error is ±2 bpm or ±2% (select larger).
F Resistance to surrounding light:
The deviation between the value measured in the condition of man-made light or indoor
natural light and that of darkroom is less than ±1%.
G Power supply requirement:
Alternating current supply:100～240V AC 50/60Hz
Internal electrical power source:3.6 V DC ~4.2V DC.
H Optical sensor
Red light (wavelength is 660nm,6.65mW)
Infrared (wavelength is 880nm, 6.75mW)
I Adjustable alarm range:
SpO2 : 0~100%
Pulse Rate: 0bpm~254bpm
4.3 Environment Requirements
Storage Transportation Environment
a) Temp er atu re :-40℃~60℃
b) Relative humidity :≤95%
c) Atmospheric pressure :500hPa~1060hPa
Operating Environment
a) Temp er atu re :0℃~40℃
b) Relative Humidity :≤75%
c) Atmospheric pressure:700hPa~1060hPa
6
5 Installation
5.1 View o f the Front Panel
Figure 2. Front view
Alternating current indicator lint:the light is green when powered on.
Probe jack : it is used to connect Oximeter probe to measure the oxygen saturation,pulse rate and
PI.
Display area: display measure information
Button Area:
1 Mode switch button:click it to switch mode (Measure interface 1 / Measure interface 2)
2 Alarm pause button:when alarm happens,press it to make alarm sound pause.The pause time
could be set by menu.
3 Return button:return to the previous menu.
4 Up button/down button/left button/right button:change the choice bar position left/right button:
set part function
5 Menu button:in waveform measure interface,press the button to enter the menu setting;in menu
interface,press the button to enter the corresponding submenu.
6 Power button:in power-off state,long press the button to turn on the device;in power-on
state,long press the button to turn off the device.
7
5.2 View of the Back Panel
Figure 3. Back view
USB port :It is used to connect computer to transmit data by data line.
R pinhole Restoration key:restore the device.
The computer intended to be connected with this device,shall be approved and certificated
according to IEC 60950.
During data transmitting,please do not use this device with patient.
Power supply jack:power supply line interface
5.3 Accessories
A A User M anu al
B A p owe r su pply line
C A d ata li ne
D An Oximeter probe
Optional:
A Other Oximeter probe (refer to <Probe Application Introduction>)
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