Gima OXY-50 User manual

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Cod. 35100 OXY-50 Pulse Oximeter
User manual

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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 Pulse Oximeter’s features and requirements, main
structure, 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
measuring 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 manufacturer’s
warranty service does not cover such faults.
Owing to the forthcoming renovation, 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.
WARNING:
Uncomfortable or painful feeling may appear if using the device ceaselessly, especially for
the microcirculation barrier patients. It is recommended that the sensor should not be
applied to the same finger for over 2 hours.
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.
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.
Testee can not use enamel or other makeup.
Testee’s fingernail can not be too long.
Please refer to the correlative literature about the clinical restrictions and caution.
This device is not intended for treatment.

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Contents
1.Safety........................................................................................................................................................1
1.1.Instructions for safe operations ..........................................................................................................1
1.2.Warning..............................................................................................................................................1
1.3.Attention.............................................................................................................................................1
2.Overview ..................................................................................................................................................2
2.1.Features ..............................................................................................................................................2
2.2.Major applications and scope of application......................................................................................2
2.3.Environment requirements .................................................................................................................3
3.Principle ...................................................................................................................................................3
4.Technical specifications..........................................................................................................................3
4.1.Main performance ..............................................................................................................................3
4.2.Main Parameters.................................................................................................................................4
5.Installation ...............................................................................................................................................4
5.1.View of the front panel.......................................................................................................................4
5.2.Under side View and Left View......................................................................................................5
5.3.Battery and probe installation.............................................................................................................5
5.3.Accessories.........................................................................................................................................6
6.Operating Guide.....................................................................................................................................6
6.1.Application method............................................................................................................................6
6.2.Attention for operation.....................................................................................................................10
6.3.Clinical restrictions ..........................................................................................................................11
7.Maintain、transportation and storage.............................................................................................. 11
7.1.Cleaning and Disinfecting................................................................................................................ 11
7.2.Maintain ........................................................................................................................................... 11
7.3.Transportation and storage ...............................................................................................................12
8.Troubleshooting.....................................................................................................................................12
9.Key of Symbols ....................................................................................................................................12
10.Function Specification........................................................................................................................14
Appendix 1 ...............................................................................................................................................15
11.Disposal..........................................................................................................................................16
12.GIMAWaranty Conditions..........................................................................................................16

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1. Safety
1.1. Instructions for safe operations
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 about cables and transducers. It
is recommended that the device should be inspected once a week at least. When there is obvious
damage, stop using the device.
Necessary maintenance must be performed by qualified service engineers ONLY. Users are not
permitted to maintain it by themselves.
The oximeter cannot be used together with devices not specified in User’s Manual. Only the
accessory that appointed or recommendatory by manufacture can be used with this device.
This product is calibrated before leaving factory.
1.2. Warning
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 testee measured by MRI and CT.
The person who is allergic to rubber can not use this device.
The disposal of scrap instrument and its accessories and packings (including battery, plastic
bags, foams and paper boxes) should follow the local laws and regulations.
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.
Please choose the accessories and probe which are approved or manufactured by the
manufacturer, or else it may damage the device.
The device can only be matched with the compatible probe.
Please don't measure this device with functional tester for the device's related information.
1.3. Attention
Keep the oximeter away from dust, vibration, corrosive substances, explosive materials, high
temperature and moisture.
If the oximeter gets wet, please stop operating it.
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 oximeter is not permitted. Refer to
User Manual in the relative chapter (7.1) for instructions of cleaning and disinfection.
Do not have the oximeter 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 °C .
As to the fingers which are too thin or too cold, it would probably affect the normal measure
of the patients' SpO2and pulse rate, please clip the thick finger such as thumb and middle finger
deeply enough into the probe.
The pulse oximeter can be used to adult or infant. Whether the device is used to adult or infant,
it depends on the probe selected.

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The update period of data is less than 5 seconds, which is changeable according to different
individual pulse rate.
Please read the measured value when the waveform on screen is equably and steady-going,
This measured 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 normal useful life for three years since the first electrified use.
This device has the function of alarming, users can check on this function according to chapter
6.1 as a reference.
The device has the function of limits alarming, when the measured data is beyond the highest
or lowest limit, the device would start alarming automatically on the premise of the alarming
function is on.
The device has the function of alarming, this function can either be paused, or closed (default
setting) for good. This function could be turned on through menu operation if you need. Please check
the chapter 6.1 as a reference.
The device may not work for all patients. If you are unable to achieve stable readings,
discontinue use.
2. Overview
The pulse oxygen saturation is the percentage of HbO2in the total Hb in the blood, so-called the O2
concentration in the blood. It is an important bio-parameter for the respiration. A number of diseases
relating to respiratory system may cause the decrease of SpO2in 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' SpO2is of great help for the doctor to discover the potential danger, and is of
great importance in the clinical medical field.
The Pulse Oximeter features in small volume, convenient operation and being portable. It is only
necessary for patients to put one of his fingers into a probe for diagnosis, and a display screen will
directly show the measured value of pulse oxygen saturation with the high veracity and repetition.
2.1. Features
A. Operation of the product is simple and convenient.
B. The product is small in volume, light in weight and convenient in carrying.
2.2. Major applications and scope of application
The Pulse Oximeter 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.
The problem of overrating would emerge when the patient is suffering from toxicosis
which caused by carbon monoxide, the device is not recommended to be used under this
circumstance.

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2.3. Environment requirements
Storage Environment
a) Temperature: -40°C～+60°C
b) Relative humidity: 5%～95%
c) Atmospheric pressure: 500hPa～1060hPa
Operating Environment
a) Temperature: 10°C～40°C
b) Relative Humidity: 30%～75%
c) Atmospheric pressure: 700hPa～1060hPa
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
A. SpO2value display
B. Pulse rate value display, bar graph display
C. Pulse waveform display
D. Low-voltage indication: low-voltage indicator appears before working abnormally which is due
to low-voltage
E. Screen brightness can be changed
F. A pulse sound indication
G. With alarm function
H. With SpO2value and pulse rate value of storage, the stored data can be uploaded to computers
I. It can be connected with an external oximeter probe
J. Real-time data can be transmitted to computers
K. Review function
L. Clock function

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4.2. Main Parameters
A. Measurement of SpO2
Measuring range: 0%～100％
Accuracy:
When the SpO2measuring range is 70%～100％,the permission of absolute error is ±2％；
below 70% unspecified
B. Measurement of pulse rate
Measuring range: 30bpm～250bpm
Accuracy: ±2 bpm or ±2% (select larger)
C. Resolution
SpO2: 1%, Pulse rate: 1bpm.
D. Measurement Performance in Weak Filling Condition:
SpO2and pulse rate can be shown correctly when pulse-filling ratio is 0.4%. SpO2error is ±4%,
pulse rate error is ±2 bpm or ±2% (select larger).
E. 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%.
F. Power supply requirement: : 2.6 V DC ~ 3.6V DC.
G. Optical Sensor
Red light (wavelength is 660nm，6.65mW)
Infrared (wavelength is 880nm, 6.75mW)
H. Adjustable alarm range:
SpO2：0%~100%
Pulse Rate: 0bpm~254bpm
5. Installation
5.1. View of the front panel
Figure 2. Front View

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5.2. Underside View and Left View
Figure 3. Underside View and Left View
1、Probe jack : It is used to connect a SpO2sensor to measure the oxygen saturation and pulse rate.
2、USB port :It is used to connect a personal computer to export the trend data via a data line.
5.3. Battery and probe installation
A. Refer to Figure 4. and insert the twoAA size batteries properly in the right direction.
Figure 4. Batteries installation
B. Replace the cover.
C. Inserting the SpO2probe of the pulse oximeter in the upper jack. (The probe is limited to be
produced by our company; never replace it with the similar ones by other manufacturers).
Please take care when you insert the batteries for the improper insertion may damage
the device.
If the alarm function is on, the device will provide high-priority alarm signal when the

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battery is in low power status. Intermittent alarm will occur and the battery icon turns red in
the state of flashing.
High priority indicating that immediate operator response is required.
5.3. Accessories
A. Dry battery(2AA)
B.A User Manual
C.A data line
D. A disk (PC software)
E.An adult-oximeter probe
An infant-oximeter probe
6. Operating Guide
6.1. Application method
A.
a) Put the suitable probe into the jack on the right side of the oximeter. (The probe is limited to be
produced by our company; never replace it with the similar ones by other manufacturers).
b) Put the finger into the probe.
c) Press the "power on/off button" long , until the device turns on.
d) Do not shake the finger and keep the patient in a stable state during the process.
e) The data can be read directly from the screen on the measuring interface.
Fingernails and the luminescent tube should be on the same side.
If the alarm function is on, the device will provide medium-priority alarm signal when
probe or finger is out. Intermittent alarm will occur and the user interface presents "FINGER
OUT".
Medium priority indicating that prompt operator response is required.
B. Pause alarm:
a) Alarm including the alarm of measure data's going beyond the limits, the alarm of low-voltage,
the alarm of probe or finger's out of position.
b) When alarm is on, press the "alarm pause button" can pause the alarm, it can renew alarm in
about 60s, and if pressing the "alarm pause button"Again with in 60s, it can renew alarm .
c) If you want to turn off the alarm for good, you should enter the menu for operation.
C. Review Interface
a) On the measuring interface, press "up button" to enter the Review Interface 1directly, as
shown in figure 5:

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Figure 5. Review Interface 1
b) In review interface, press "menu button" to switch between Review Interface 1 and Review
Interface 2; press "Down button" to enter the review interface for next hour or last hour; In Review
Interface 1, press "left button" or "right button" can move the trend graph for storage data, When the
trend graph cannot be moved any more, the sign——"<-"or"->" shown under the LCD screen will
disappear; in Review Interface 2, press "left button" or "right button" can move the arrow; Press "up
button" to exit the review Interface.
c) In Review Interface 1, can observe the trend waveform composed by storage data, each screen
can show storage data for 114 seconds, the yellow line shows the SpO2trend waveform, the red line
shows the PR trend waveform, the time underside shows the starting time of dispalying the date in
the screen, the middle "+" and "-" underside the screen means the operation direction of the "Down
button". Press "right button", it will show "+" in the position, then press "Down button" to enter next
hour; Press "left button", it will show "-" in the position, then press "Down button" to enter last hour.
d) The Review Interface 2 shown based on Review Interface 1, the stored SpO2value and PR
value in each second can be observed here, the underside date from left to right marks time, SpO2
value, PR value. when the stored data exceeds the upper and lower limit setted by user, the relevant
value will turn green.
Figure 6. Review Interface 2
D. Clock interface
On the measuring interface, press the "right button" can enter the clock interface of figure 7.
Press the "right button" again can return to the measuring interface.
Figure 7. Clock interface