Gima_ManualeUso
Gima_ManualeUso
Gima_ManualeUso
User manual
I
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.
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.
Please refer to the correlative literature about the clinical restrictions and caution.
II
Contents
1.Safety ........................................................................................................................................................ 1
1.3.Attention ............................................................................................................................................. 1
2.Overview .................................................................................................................................................. 2
2.1.Features .............................................................................................................................................. 2
5.Installation ............................................................................................................................................... 4
5.3.Accessories ......................................................................................................................................... 6
6.Operating Guide ..................................................................................................................................... 6
7.2.Maintain ........................................................................................................................................... 11
8.Troubleshooting ..................................................................................................................................... 12
9.Key of Symbols .................................................................................................................................... 12
Appendix 1 ............................................................................................................................................... 15
11.Disposal..........................................................................................................................................16
12.GIMA Waranty Conditions..........................................................................................................16
III
1. Safety
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' SpO2 and 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 HbO2 in 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 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 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
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
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4.2. Main Parameters
A. Measurement of SpO2
Measuring range: 0%~100%
Accuracy:
When the SpO2 measuring 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:
SpO2 and pulse rate 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).
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
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5.2. Underside View and Left View
1、Probe jack : It is used to connect a SpO2 sensor 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.
A. Refer to Figure 4. and insert the two AA size batteries properly in the right direction.
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
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).
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.
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 1 directly, 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 SpO2 trend 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 SpO2 value 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.
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E. Menu operations:
On the measuring interface, press the "menu button" can enter the menu of figure 8. Users can adjust
the settings through the main menu, such as alarm, pulse sound indication, backlight, data storage,
data transmission (with the use of data line), the specific method is as follows:
a) Alarm setting
On the main menu interface, press the "up button" or "down button" to select "Alarm", then press the
"left button" or ―right button‖ to enter the alarm setting menu of figure 9:
Press the "up button" or " down button "to choose the parameter to be adjusted, then press the "left
button‖ or ―right button" to change data. Each press of the "left button" or "right button", the data
will raise or descend for one time accordingly.
If the alarm function is on, the device will provide medium-priority alarm signal when
the data of SpO2 or pulse rate is beyond the limit. Intermittent alarm will occur and the
measurement shows in yellow.
Medium priority indicating that prompt operator response is required.
Press the" up button" or " down button" to select "Alarm", then choose the alarm state (on/off) by
pressing the "left button" o r" right button", choose ―on‖ to turn on the alarms, and choose ―off‖ to
turn off the alarms for good.
c. Exit the Alarm settings
Press the "menu button" to exit the Alarm Settings Menu.
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On the main menu interface ,press the "up button" or "down button" to select ―Pulse Sound‖, then
Press the "left button" Or "right button" to choose to have the Pulse Sound (heart beat) "on" or "off ".
c) Backlight adjustment
On the main menu interface, press the "up button" or "down button" to select" Brightness", then
press the "left button" or "right button" to change the number in order to adjust the brightness of
screen.
This device has the ability to store 24 hours worth of data. It can store the measured pulse rate and
SpO2 value accurately, transfer the data to the computer, display the data and print reports (with the
included SpO2 Software - Green Heart)
a. On the main menu interface, press the "up button" or "down button" to select "Record", then
press the "left button" or "right button" again to enter the dialog box of figure 10 or finger 11: if it is
not in recording state, will come into figure 10; if it is in recording state, will come into figure 11.
Figure 10.
b. In the status shown in Figure 10, press "left button" or "right button" can change the setting of the
item, then press "menu button" to exit the status in Figure 10, and perform setting. YES for starting
recording, NO for do not recording.
c. In the status shown in Figure 11, press "left button" or "right button" can change the setting,
press "menu button" will exit the Figure 11, and perform setting. YES for stopping recording, NO for
continue recording.
Figure 11.
d. If the data storage function is being turned on, when return to the measuring interface, a red
"REC" sign and a flashing red dot would appear on screen, which means the device is in a state of
storing.
e. In the state of storing, whatever interface the device is on (measuring interface, menu interface),
the sign "Recording" would appear on the screen in 30 seconds, and then the screen will be
automatically shut down. If pressing any button (power on/off excluded) at this moment, the sign
"Recording" would appear on the screen, and then the screen will be automatically shut down again;
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if pressing the "power on/off button", the device would return to the former interface.
f. If turning on the data storage function, the former data storage will be automatically removed.
g. In the state of data storing, after the screen is automatically shut down, the pulse sound
indication would be off for saving power.
h. When the storage space is full, it displays ―Memory is full‖ on the screen, and then shut down in
a few seconds. But it will still display ―Memory is full‖ by the next time you turn on the device on
the purpose of warning the user, if press any button (power on/off excluded) again, it will enter the
measuring interface.
e) Device ID
The user could modify device ID by software “SpO2 Assistant”.
f) Clock setting
On the main menu interface, press the "up button" or "down button" to select ―Clock‖, then
enter the clock setting interface by Press the "left button" or "right button".
On the main menu interface, press the "menu button" to exit the main menu.
E. PC software operation
Please connect the device with computer by the USB data line, then double click ―SpO2 Assistant‖
icon to run the PC software. The functions such as uploading data and change device ID could be
carried out by the software. Please refer to <SpO2 Assistant user manual> for details.
If the users choose to turn on the synchronizing display function on computer, it would
probably take several seconds for the data to appear on the computer screen. (If there is no
data on the computer screen, unplug USB data line, then repeat step “E” again).
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6.2. Attention for operation
A. Please check the device before using, and confirm that it can work normally.
B. The finger should be in a proper position (see the attached illustration of figure 4 for reference), or
else it may result in inaccurate measure.
C. The SpO2 sensor and photoelectric receiving tube should be arranged in a way with the subject’s
arteriole in a position there between.
D. The SpO2 sensor should not be used at a location or limb tied with arterial canal or blood pressure
cuff or receiving intravenous injection.
E. Do not fix the SpO2 sensor with adhesive or else it may result in venous pulsation and inaccurate
measure of SpO2 and pulse rate.
F. Excessive ambient light may affect the measuring result. It includes fluorescent lamp, dual ruby
light, infrared heater, direct sunlight and etc.
G. Strenuous action of the subject or extreme electrosurgical interference may also affect the
accuracy.
H. Testee can not use enamel or other makeup.
I. Please clean and disinfect the device after operating according to the User Manual (7.1).
A. As the measure is taken on the basis of arteriole pulse, substantial pulsating blood flow of subject
is required. For a subject with weak pulse due to shock, low ambient/body temperature, major
bleeding, or use of vascular contracting drug, the SpO2 waveform (PLETH) will decrease. In this
case, the measurement will be more sensitive to interference.
B. For those with a substantial amount of staining dilution drug (such as methylene blue, indigo
green and acid indigo blue), or carbon monoxide hemoglobin (COHb), or methionine (Me+Hb) or
thiosalicylic hemoglobin, and some with icterus problem, the SpO2 determination by this monitor
may be inaccurate.
C. The drugs like dopamine, procaine, prilocaine, lidocaine and butacaine may also be a major factor
blamed for serious error of SpO2 measure.
D. As the SpO2 value serves as a reference value for judgement of anemic anoxia and toxic anoxia,
some patients with serious anemia may also report good SpO2 measurement.
Using medical alcohol to disinfect the device, nature dry or clean it with clean soft cloth.
7.2. Maintain
A. Please clean and disinfect the device before using according to the User Manual(7.1).
B. Please change the battery when the screen shows .
C. Take out the battery if leave the equipment unused for long time.
D. The device needs to be calibrated once a year (or according to the calibrating program of hospital).
It also can be performed at the state-appointed agent or just contact us for calibration.
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7.3. Transportation and storage
A. The packed device can be transported by ordinary conveyance or according to transport contract.
The device can not be transported mixed with toxic, harmful, corrosive material.
B. The packed device should be stored in room with no corrosive gases and good ventilation.
Temperature: -40°C~60°C; Humidity: ≤95%
8. Troubleshooting
9. Key of Symbols
Signal Description
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Open the alarm sound indication
Low battery
Menu button
Right button
Down button
Up button
USB
Type BF
SN Serial number
WEEE (2002/96/EC)
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10. Function Specification
Pulse Intensity
Battery Requirement
Dry battery(2AA)
Oximeter Probe
Wavelength:660nm 880nm
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Weight About 180g (with Dry battery(2AA))
Appendix 1
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11. DISPOSAL
The product must not be disposed of along with other domestic waste. The users must dispose of this
equipment by bringing it to a specific recycling point for electric and electronic equipment. For
further information on recycling points contact the local authorities, the local recycling center or the
shop where the product was purchased. If the equipment is not disposed of correctly, fines or
penalties may be applied in accordance with the national legislation and regulations.
0123
Contec Medical Systems Co., Ltd. - 066004 Qinhuangdao, Hebei Province - P.R.C.
Rev. 1.10.10
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