Gima SP-10 User manual

PROFESSIONAL MEDICAL PRODUCTS
33535 / SP10W
M33535-GB-Rev.1.01.19
CONTEC MEDICAL SYSTEMS CO., LTD
ADD: No 112 Qinhuang West Street, Economic & Technical Development Zone,
Qinhuangdao, Hebei Province, 066004, PEOPLE’S REPUBLIC OF CHINA
Made in China
0168
Shanghai International Holding Corp. GmbH (Europe)
Eiestrasse 80, 20537 Hamburg, Germany
0123
ATTENTION: The operators must carefully read and completely
understand the present manual before using the product.
Importer: Gima S.p.A. - Via Marconi, 1
20060 Gessate (MI) Italy
Gima S.p.A.
Via Marconi, 1 - 20060 Gessate (MI) Italy
[e-mail] - [e-mail]
www.gimaitaly.com
SP-10 POCKET SPIROMETER
WITH BLUETOOTH
User manual

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Instructions to User
Dear users, thank you very much for purchasing the SPIROMETER.
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 specic 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:
For accuracy,it is recommended that the SPIROMETER should not be tested on the same testee for more
than 5 times.
The testee should breathe out all air during testing,don’t exchange air or cough.
Don’t use the device in environment with lower temperature.
Automatic power off when there is no operation in one minute.
Please refer to the correlative literature about the clinical restrictions and caution.
This device is not intended for treatment.
Our company reserves the nal elucidative right.

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Contents
Chapter 1 Safety................................................................................................................................................ 4
1.1 Instructions for safe operations................................................................................................... 4
1.2 Warning ....................................................................................................................................... 5
1.3 Attention ...................................................................................................................................... 5
EMC declaration:.................................................................................................................................................. 6
1.4 Contraindication .......................................................................................................................... 6
1.4.1 Absolute contraindication .................................................................................................. 6
1.4.2 Relative contraindication.................................................................................................... 7
Chapter 2 Overview........................................................................................................................................... 7
2.1 Features....................................................................................................................................... 8
2.2 Major applications and scope ..................................................................................................... 8
2.3 Environment requirements .......................................................................................................... 8
Chapter 3 Principle ........................................................................................................................................... 9
Chapter 4 Technical Specifications................................................................................................................. 8
4.1 Main performance ..................................................................................................................... 10
4.2 Main parameters ....................................................................................................................... 11
Chapter 5 Installation...................................................................................................................................... 11
5.1 View of the front panel .............................................................................................................. 11
5.2 Installation ................................................................................................................................. 12
5.3 Accessories ............................................................................................................................... 12
Chapter 6 Operating Guide ............................................................................................................................ 12
6.1 Application method ................................................................................................................... 12
6.1.1 Installation ........................................................................................................................ 12
6.1.2 Measurement ................................................................................................................... 13
6.1.3 Parameter interface.......................................................................................................... 13
6.1.4 Menu operations .............................................................................................................. 15
6.1.5 Repeated measure........................................................................................................... 22

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6.1.6 Charge.............................................................................................................................. 23
6.1.7 Upload data...................................................................................................................... 23
6.2 Attention .................................................................................................................................... 24
Chapter 7 Maintenance,Transportation and Storage .................................................................................. 24
7.1 Cleaning and disinfection.......................................................................................................... 24
7.2 Maintenance.............................................................................................................................. 25
7.3 Transportation and storage ....................................................................................................... 25
Chapter 8 Troubleshooting............................................................................................................................. 26
Chapter 9 Key of Symbols.............................................................................................................................. 28
Chapter 10 Parameter Introduction................................................................................................................ 30
Appendix ......................................................................................................................................................... 31
Chapter 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. It is recommended that the device should be inspected weekly at
least. When there is obvious damage, stop using the device.
• Necessary maintenance must be performed by qualied service engineers ONLY. Users are not permitted to
maintain it by themselves.
• The SPIROMETER cannot be used together with devices not specied in User Manual. Only the accessory that
is appointed or recommendatory by manufacture can be used with this device.
• This product has been calibrated before leaving factory.

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1.2 Warning
Please don’t measure this device with functional tester for the device’s related information.
Explosive hazard—DO NOT use the SPIROMETER in the environment with tinder such as anesthetic.
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.
Don’t use the device in environment with strong electromagnetic interference, direct breeze source, cold source
and hot source.
The disposal of scrap instrument and its accessories and packing (including mouthpiece, plastic bags, foams
and paper boxes) should follow the local laws and regulations.
Please choose the accessories which are appointed or recommended by the manufacturer to avoid damage to
the device.
Don’t use the device with the turbine of the same kind product.
1.3 Attention
Keep the SPIROMETER away from dust, vibration, corrosive substances, tinder, high temperature and mois-
ture.
If the SPIROMETER gets wet, please stop operation.
When it is carried from cold environment to warm or humid environment, please do not use it immediately.
DO NOT operate button on front panel with sharp things.
High temperature or high pressure steam disinfection to the device is not permitted. Refer to User Manual in
the relative chapter (7.1) for cleaning and disinfection.
Do not have the SPIROMETER 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.
The display period of data is less than 5 seconds, which is changeable according to the end rate.

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When data can’t be displayed at all times or other cases happened during testing, press “repeated measure”
key to remeasure, or power off to restart.
The device has normal life for three years since the rst electried use.
When the data goes beyond the limits, the main screen shows “Error!”.
The device doesn’t suit all users, if you can’t get good measurement data, please stop using it.
The device needs to be calibrated once per year or less.
The device is forced SPIROMETER, according to the User Manual to use right to gain best result.
EMC declaration:
When this device is installed or putted into service, EMC should be paid more attention, as the portable and
mobile RF communications equipment with higher EM interference can affect this device.
The internal components and cables should not be changed, as this may decreased IMMUNITY of the device.
The SPIROMETER should not be used adjacent to or stacked with other equipments.
1.4 Contraindication
1.4.1 Absolute contraindication
• The one with MI or shock in recent 3 months;
• The one with serious cardiac function unstable or angina pectoris in recent 4 weeks;
• The one with massive hemoptysis in recent 4 weeks;
• The one who needs medication in epileptic seizure;
• The one with uncontrolled hypertensive disease (SYS>200mmHg, DIA>100mmHg);
• The one with aortic aneurysm;
• The one with serious hyperthyroidism.

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1.4.2 Relative contraindication
• Heart rate >120 beats/min;
• The one with pneumothorax or giant pulmonary bulla and not plan for surgical treatment;
• The one with pregnancy;
• The one with tympanic membrane perforation (need to block the ear canal of affected side before taking meas-
urement);
• The one with RTI recently (less than 4 weeks);
• The one with hypoimmunity.
Patients of respiratory communicable disease or infectious disease shall not take lung function examination in the
acute stage. The one with low immunity is not appropriate to take the examination also. If it is necessary, disease
control and protection shall be strictly followed.
Chapter 2
OVERVIEW
Forced Vital Capacity is the maximum expiration after taking a full breath, it’s an important examination content in
chest-lung disease and respiratory health, and it is indispensable testing project in modern Pulmonary inspection.
At the same time, it has great signicance in respiratory diseases, differential diagnosis, treatment evaluation and
selection of surgical indications. Thus, with the rapid development of clinical respiratory physiology, clinical appli-
cations of lung capacity inspection are also gaining popularity.
The SPIROMETER is small in volume, low in power consumption, convenient in operation and portable.
With high-denition display screen, the device is concise and fashion. It is only necessary for patient to breath
in fully and seal the lips around the mouthpiece and blast the air out in best times for measure, then the display
screen will directly show the Forced Vital Capacity (FVC), Forced Expired Volume in one second (FEV1), Peak
Expiratory Flow (PEF) with the high veracity and repetition.

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2.1 Features
1) Ultra-thin design, concise and fashion.
2) Small in volume, light in weight and convenient in carrying.
3) Low power consumption.
4) TFT display.
5) Reect lung function by measuring FVC, FEV1, PEF etc.
6) Take the function of wireless transmission.
2.2 Major applications and scope
The SPIROMETER is a hand-held equipment for examining lung function. The product is t for hospital, clinique
for ordinary test. It’s only required that the user operates it according to user manual, no need for specialized
training, so the operation of the device would be as simple and easy as possible.
2.3 Environment requirements
Storage Environment:
Temperature: -40°C~+55°C
Relative humidity: ≤95%
Atmospheric pressure: 500hPa~1060hPa
Operating Environment:
Temperature: +10°C~+40°C
Relative humidity: ≤80%
Atmospheric pressure: 700hPa~1060hPa

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Chapter 3
PRINCIPLE
Firstly, testee deep inspires, then seals the lips around the mouthpiece and blasts all air out as forcefully as possi-
ble, the exhalant gas transforms to rotary airow by turbine, then makes the blade rotate. The reception part of the
infrared pair diodes (one is for infrared emission, the other is reception) towards to the blade is used for receiving
the infrared ray, when the blade rotates, the received ray strength of the reception diode will be different as the
difference of the blade angle, so form the various signal of same proportion in reception diode, which forms ac-
quisition signal by SCM after processing. At last, various parameters to be measured formed from the information
which were processed by the microprocessor, and displayed from the screen.
Chapter 4
TECHNICAL SPECIFICATIONS
4.1 Main performance
• Forced Vital Capacity (FVC), Forced Expired Volume in one second (FEV1), the ratio of FEV1 and FVC (FEV1%),
Peak Expiratory Flow (PEF), 25% ow of the FVC (FEF25), 75% ow of the FVC (FEF75) and average ow be-
tween 25% and 75% of the FVC (FEF2575) can be measured. Besides, the testee condition can be shown by
the ratio of the measured value and the predicted value.
• Flow rate-volume chart, volume-time chart display.
• Data memory,delete, upload and review.
• Trend chart display.
• Scaling (Calibration).
• Information prompts when volume or ow goes beyond the limits.

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• Automatic power off when there is no operation in one minute.
• Rechargeable lithium battery and with charging tips.
• Battery power display.
4.2 Main parameters
Volume Range: 0 L ~ 10 L
Flow range: 0 L/s~16 L/s
Volume accuracy: ±3% or 0.05L (whichever is greater)
Flow accuracy: ±5 % or 0,2 L/s (whichever is greater)
Working current: 60mA
Power supply: DC3.7V 820mAh rechargeable lithium battery
Classification:
EMC: Group I Class B.
According to the MDD 93/42, the classication of this medical device: IIa.
The type of protection against electroshock: Internally powered equipment.
The degree of protection against electroshock: Type BF applied part.
The degree of protection against ingress of water: IP22.

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Chapter 5
INSTALLATION
5.1 View of the front panel
Figure 5-1 Front panel view
5.2 Installation
1) Hold the turbine, make the arrowhead of the turbine to the triangular shape on the shell, gently insert into the
bottom, counterclockwise rotate to lock it.
Turbine
Charging indicator Up key
Power on, menu, conrm key
(notice: Power off was controlled
by main menu)
Repeated measure: press it when you want
to next Measure (only need repeat measure
to press this key for a long time, other times
please don’t press it
Down key

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2) Insert the disposable mouthpiece into the turbine port.
5.3 Accessories
1) An User Manual
2) An USB data line
3) Disposable mouthpiece
4) A power adapter (optional)
5) A CD (PC software)
6) A nose clip (optional)
Other type adapter should meet the following conditions: output voltage:DC 5V; output current
≥500mA, the power adapter must meet the requirements of EN60601 related standards and have
the CE mark
Chapter 6
OPERATING GUIDE
6.1 Application method
6.1.1 Installation
Hold the turbine, make the arrowhead of the turbine to the triangular shape on the shell,gently insert into the
bottom, counterclockwise rotate to lock it, then insert the disposable mouthpiece directly into the turbine port.

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6.1.2 Measurement
1) Long press “Power On” key to turn on the power after installed.
2) The device is in selective interface after turn on as Figure 6-1, press “Up”, “Down” key to adjust, select “No” to
“Testing” interface as Figure 6-2.
Figure 6-1 Figure 6-2
3) Then breath in fully and seal the lips around the mouthpiece and blast all air out as forcefully as possible in best
times, wait for a few seconds, then the data will be gained, measure is over (Note: “Yes” indicates that you can
edit patient information, exit after edit, or return to “Testing” interface, the detail operations are as following).
6.1.3 Parameter interface
In testing interface, breath in fully and seal the lips around the mouthpiece and blast all air out as forcefully as pos-
sible in best times, wait for a few seconds, then the measured parameter will pop up automatically as Figure 6-3.

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Figure 6-3.
(Note: Status indicator bar indicates the measured state, displays the testee condition by the ratio of measured
value and the predicted value. I.e. Compared the measured value with the reference value in same situation, when
the value is lower than 50% indicates that should be noticed and hospitalized in time; The value in range from
50%-80% indicates that should be noticed; It is green when the value is higher than 80%, which is normal. The
state value is optional, press “Control Setting” in main menu, then press “Denote Value” to select.)
Flow rate-volume chart, volume-time chart: Press “Up”, “Down” key will appear two charts: Flow rate-volume
chart, volume-time chart (as Figure 6-4 and Figure 6-5). The above three interfaces are main interface, in its inter-
face, press “Menu” to main menu as Figure 6-6.
Forced Vital Capacity
Forced Expired Volume in one second
Peak expiratory flow
Status indicator bar
The ratio of measured
value and predicted value
Predicted value is a reference under the
situation that values (gender,age,height
etc.) have been set,it is a popularize value.

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Figure 6-4 Flow rate-volume chart Figure 6-5 Volume-time chart
6.1.4 Menu operations
When testing, press “Menu” to its main-menu as Figure 6-6, then user can browse other parameters, and control
setting, patient information, real time setting, power off etc. can be operated, the detail methods are as following:
Figure 6-6.

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a. OTHER PARAMETERS
Press “Other Par” in main menu to its sub-menu as Figure 6-7 which displays other parameters except for the
three parameters in main menu (see following for details), press conrm key to return to the main menu (press
“Up”, “Down” key in this interface is no effect).
Figure 6-7.
b. CONTROL SETTING
Press “Control Setting” in main menu interface to its sub-menu as Figure 6-8, then the relative operations can
be done.
1) Trend Curve
Select “Trend Curve” to the determinant interface of trend curve as Figure 6-9. Press “Up” or “Down” key to select
the determinant value, then press the conrm key to the trend curve interface as Figure 6-10 which gathers all data
in current and displays the variational trend visually, which is convenient for user to contrast the data.. If the data
is too much, then press “Up” or “Down” key in curve interface to browse all data trend curves orderly. Press the
conrm key to exit the current interface, return to the control setting interface (as Figure 6-8).

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Figure 6-8. Figure 6-9 Figure 6-10
2) Review Information
Select “Review Fun” to its sub-menu. If the previous display state is “OFF”, then press the conrm key to open
the function (Note: the review function only can be opened when the case numbers are more than one), then the
interface will jump to Number interface as shown in Figure 6-11. In this interface, use the “Up” or “Down” key to
select the case number, then press the conrm key to review the selected case information.
If the previous display is “ON”, then press the conrm key to jump to previous
state (Namely: If the measurement has been completed before reviewing, then
close this function, display “OFF” state, or jump to the measurement interface
shown as Figure 6-1).
Figure 6-11

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Attention: Open the review function can browse all measured data, the path is:Enter the main menu as Figure 6-6,
select “Patient Info”, press the conrm key to enter its sub-menu as Figure 6-20. Select “Number”, then press the
conrm key to case number interface as Figure 6-11 (The function only can be selected in case of opening the
review function), then use “Up” or “Down” key to select case number, press the conrm key to browse the cor-
responding information. If you want to browse other cases, then repeat the above steps (If the case data is error,
then it will display “Error!” after pressing the conrm key).
3) Denote Value
Select “Denote Value” to its sub-menu, press conrm key to choose which one to decide the denote value (as
Figure 6-13, the denote value is decided by the ratio of FVC and predicted value), after selected, press conrm
key to exit the interface (Note: the state value is a percentum which was decided by the ratio of measured value
and predicted value).
Figure 6-12 Figure 6-13
4) Delete Data
Select “Delete Data” to its sub-menu as Figure 6-15, select “Yes” to delete all the data, and display “waiting...”,
then return to “Control Setting” interface as Figure 6-14, in the case of this state, exit in turn until to the interface
as Figure 6-1, then you can continue testing. Select “No” to exit directly to the interface as Figure 6-14.

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Figure 6-14 Figure 6-15
5) Wireless Transmission
When select “Wireless”, if the device has built-in wireless module, press the conrm key to achieve turning on/off
the wireless module, when it is ON, it can transmit data.
6) Scaler Operation(Calibration)
Select “Scaler (Calibration)” to its sub-menu as Figure 6-16, then the scaler (Calibration) volume can be selected,
after selected the volume, it will enter scaler (Calibration) interface as Figure 6-17. In this interface, when moving
the scaler once, the interface will display “REPEAT”, then move the scaler continuously. After twice right scaler
(Calibration), the scaler (Calibration) is successful, then the interface will display “OK!”.
Finally the interface will jump to the former interface before scaling (Calibration). If Figure 6-18 appears, it indicates
the scaler (Calibration) is error, then repeat scaling (Calibration) until succeeding. If Figure 6-19 appears, then
please conrm the volume between scaler (Calibration) and selected is accordant, then scaling (Calibrate) until
succeeding. If you need to stop scaling (Calibration), only press the conrm key to exit to the former interface
before scaling (Calibration). (The interface before scaling (Calibration) refers to: If scaling (Calibrate) after com-
pleting measuring, then it will exit to the control setting interface, otherwise jump to the measurement interface
as Figure 6-1).

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Figure 6-16 Figure 6-17 Figure 6-18 Figure 6-19
7) Exit
Select “Exit” to exit “Control Setting” interface and return to the main menu.
c. PATIENT INFORMATION
Press “Patient Info” to its sub-menu as Figure 6-20
(Note: Figure 6-1 is selective interface, and “Yes” indicates that you can edit patient information).
Figure 6-20