Gima SP-10 User manual

PROFESSIONAL MEDICAL PRODUCTS
M33536-GB-Rev.2-09.23
SP10 (GIMA 33536)
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
Shanghai International Holding Corp. GmbH (Europe)
Eiffestrasse 80, 20537 Hamburg, Germany
ATTENTION: The operators must carefully read and completely
understand the present manual before using the product.
Imported by:
Gima S.p.A.
Via Marconi, 1 - 20060 Gessate (MI) Italy
[e-mail] - [e-mail]
www.gimaitaly.com
SP-10 POCKET SPIROMETER
User manual
0123
%
95%
0%
55°C
-40°C
106kPa
50kPa

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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 perfor-
mance 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 .....................................................................................................................................................5
1.1 Instructions for Safe Operations.......................................................................................................5
1.2 Warning.............................................................................................................................................5
1.3 Attention............................................................................................................................................6
1.4 Contraindication................................................................................................................................6
1.5 EMC declaration ...............................................................................................................................7
Chapter 2 Overview ................................................................................................................................................8
2.1 Features ............................................................................................................................................8
2.2 Major Applications and Scope..........................................................................................................8
2.3 Environment Requirements...............................................................................................................9
Chapter 3 Principle.................................................................................................................................................9
Chapter 4 Technical Specications ......................................................................................................................9
4.1 Main Performance.............................................................................................................................9
4.2 Main Parameters.............................................................................................................................10
Chapter 5 Installation ........................................................................................................................................... 11
5.1 View of the Front Panel...................................................................................................................11
5.2 Assembly and disassembly ............................................................................................................11
5.3 Accessories.....................................................................................................................................12
Chapter 6 Operating Guide..................................................................................................................................12
6.1 How to use......................................................................................................................................12
6.1.1 Power on/off ..........................................................................................................................12
6.1.2 Measurement.........................................................................................................................12
6.1.3 Main Interface........................................................................................................................13
6.1.4 Menu......................................................................................................................................15
6.1.5 Repeated measure.................................................................................................................25
6.1.6 Charge ...................................................................................................................................26
6.1.7 Upload Data...........................................................................................................................26

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6.2 Attention..........................................................................................................................................27
Chapter 7 Maintenance,Transportation and Storage.........................................................................................27
7.1 Cleaning and Disinfection...............................................................................................................27
7.2 Maintenance ...................................................................................................................................27
7.3 Transportation and Storage ............................................................................................................28
Chapter 8 Troubleshooting ..................................................................................................................................28
Chapter 9 Key of Symbols ...................................................................................................................................30
Chapter 10 Parameter Introduction.....................................................................................................................31
Appendix I .............................................................................................................................................................32

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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.
• All 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.
1.2 Warning
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.
Portable or mobile RF equipment with strong electromagnetic interference may inuence the accuracy of this
device.
Improper disposal of device and its accessories and packing (include mouthpiece, plastic bags, foams and
paper boxes) may cause environment pollution, please follow the local laws and regulations.
Please choose the accessories which are appointed or recommended by the manufacturer for avoiding device
damage.
Don’t use the device with the turbine of the same kind product.
DO NOT use the device when it is under charging state.

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The red and green indicators are all highlight in charging state, the red indicator goes out when the charge has
nished.
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.
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.
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;

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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.
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.
1.5 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.

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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.
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.
2.2 Major Applications and Scope
The SPIROMETER is a hand-held equipment for examining lung function. The product is t for hospital, clinique,
family for ordinary test. It’s only required that the user operates it according to user manual, no need for special-
ized training,so the operation of the device would be as simple and easy as possible.

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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
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%),

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Peak expiratory ow (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.
• Calibration.
• Information prompts when volume or ow goes beyond the limits.
• 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: 10L
Flow range: 0 L/s~16 L/s
Volume accuracy: ±3% or 0.05L (whichever is greater)
Flow accuracy: ±5% or 0.2L/s (whichever is greater)
Working current: 60mA
Power supply: DC3.7V 820mAh rechargeable lithium battery
Classication:
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 .
International Protection: IP22.

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Chapter 5
INSTALLATION
5.1 View of the Front Panel
Figure 1 Front panel view
5.2 Assembly and disassembly
1) Turbine assembly: Hold the turbine, align the arrowhead of the turbine with the triangular shape on the shell,
gently insert it to the bottom, counterclockwise rotate to lock it
2) Turbine disassembly: clockwise rotate the turbine, gently pull it out
3) Mouthpiece assembly: insert the mouthpiece into the turbine port directly
Turbine
Charging indicator
Power on/off;
conrm key
Up key
Down key
Repeated measure

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5.3 Accessories
1) A User Manual
2) A USB data line
3) A mouthpiece
4) A power adapter
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 How to use
6.1.1 Power on/off
1. After assembly, long press “power on” key to turn on the device.
2. When device is powered on, long press “power off” key to turn it off.
6.1.2 Measurement
1. The device is in [Selective interface] after turn on as shown in Fig.2, press “up” or “down” key to select “No”,
then press “conrm” key to enter [Testing] interface as shown in Fig.3. (Note: If select “Yes”, it will enter [Per-
sonal information] interface to edit personal information, after exit, it will return to [Testing] interface.)
2. In [Testing] interface, breath in fully, seal the lips around the mouthpiece and blast all air out as forcefully as
possible in a minimal amount of time, wait for a few seconds, the device will enter [Main parameter] interface
as shown in Fig.4.

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Figure 2 Selective interface Figure 3 Testing
6.1.3 Main Interface
Figure 4 Main parameter interface
Case No.
Health status
indicator
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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a. Main parameter interface: display the ratio of predicted value and measured value of three main parameters.
Ratio reects health status, correct settings of personal information is the key to obtain accuracy ratio. Besides,
this interface can also display battery status, time, case number and health status indicator, as shown in Fig.4.
b. Health status indicator: indicate the ratio of measured value and the predicted value, display the testee health
condition in image. I.e. Compare the measured value with the reference value in same situation. When the value
is lower than 50%, only red indicator is displayed, which means testee should pay attention and go to hospital
in time. When the value is in range from 50%-80%, red and yellow indicator are displayed, which means it
should be noticed. When the value is higher than 80%, all red, yellow and green indicator are displayed, which
means healthy. The determinate item of health status indicator is optional, it can be set in “Denote value” under
“Date management”.
c. Other parameter interface: display four parameters except the main parameter, as shown in Fig.5.
d. Under [Main parameter] interface, press “Up” or “Down” key will enter [Other parameter] [Flow rate-volume
chart] [Volume-time chart] in turn, as shown in Fig.5, 6, 7. The four interfaces above are [Main interface].
Figure 5 Other parameter interface Figure 6 Flow rate-volume chart Figure 7 Volume-time chart

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6.1.4 Menu
Under [Testing] or [Main interface], press conrm key to enter [Menu] interface as shown in Fig.8. Under the inter-
face, functions such as modify personal information, data management, device setting, power off can be realized.
Press “Up” or “Down” key to move the selection toolbar to the item that need to modied, then press “Conrm”
key to enter the sub-menu. See the following steps for details:
Figure 8 Menu interface Figure 9 Personal information interface
a. PERSONAL INFORMATION
Under [Menu] interface, select “Personal information” to enter its interface as shown in Fig.9, in which user can
edit patient information (Note: Under [Selective interface] as shown in Fig.2, if selected”Yes”, you can enter [Per-
sonal information]interface also.).
1. Case number
“Number” is the case number displayed at present. For example, if you are the 36th testee, the “Number” will
be 36. Case number can increase automatically, no need to set manually.

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2. Gender setting
Under [Personal information] interface, press “Up” or “Down” key to move the selection toolbar to “Gender”,
then press “Conrm” key to select “female” or “male”.
3. Setting of age, height, weight
Under [Personal information], select “Age” to enter [Age edit] interface, as show in Fig.10. Press “Up” or “Down”
key to change the value. At each pressing of “Up” or “Down” key, the value will plus or minus 1. When long
press the“Up” or “Down” key, the value will increase or decrease continuously. Press “Conrm” key to back to
[Personal information] interface.
The modication of “Height” and “Weight” is similar to the “Age”. In which, range of “Age” is 6~100 years old,
range of “Height” is 80~240 cm, range of “Weight” is 15~250 kg.
Figure 10 Age edit interface
4. Nation setting
The modication of “Nation” is similar to the “Gender”. The standard of predicted value can be set under “Na-
tion” interface, which including ERS, KNUDSON and USA. ERS is the European standard, KNUDSON is the
Asian standard, USA is the American standard.

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5. Setting of smoker and drug
The modication of “Smoker” and “Drug” is similar to the “Gender”, in which patient information of smoker and
drug can be modied.
For the display of screen is limited, the device won’t display all items at the same time. When selection toolbar
moved to “Smoker”, press “Down” key, the item of “Drug” and “Exit” will appear, as shown in Fig. 11, 12.
6. Exit
Under [Personal information] interface, select “Exit” to return to [Menu] interface.
Figure 11 Figure 12
b. DATA MANAGEMENT
Under [Menu] interface, select “Data management” to enter [Data management] interface, as shown in Fig.13.
Under the interface, functions such as review, view trend curve, delete data, denote value setting can be realized.

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Figure 13 Data management interface Figure 14 Case selection interface
1. Review function
Under [Data management] interface, select “Review function” to enter [Case selection] interface as shown in
Fig.14, press “Up” or “Down” key (long press is available) to change case number, then press “Conrm” key,
the device will enter [Main interface] and display history data on it. Under [Main interface], press “Up” or “Down”
key continuously can review data in adjacent case number, press “Conrm” key to return to [Menu] interface.
2. Trend curve
Under [Data management] interface, select “Trend Curve” to enter [Trend curve selection] interface as shown in
Fig.15. Select the determinant parameter, then press “Conrm” key to enter [Trend curve display] as shown in
Fig.15. The curve is a summary of stored data for selected parameter. It displays the change trend in form of visual
image, which is convenient for comparison. If the data is too much, press “Up” or “Down” key to browse all data
trend curves orderly. Press “Conrm” key to return to [Data management] interface.

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Figure 15 Trend curve selection interface Figure 16 Trend curve display interface
3. Delete data
Under [Data management] interface, select “Delete data” to en-
ter [Delete data] interface as shown in Fig.17. If choose “Yes”, the
screen displays “waiting...”, all data will be deleted, then return to
[Data management] interface. If choose “No”, it will return to [Data
management] interface directly.
Figure 17 Delete data interface

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4. Denote value
Under [Data management] interface, select “Denote value” to enter [Denote value setting] interface as shown
in Fig.18. Select one parameter to decide the denote value, after that, it will automatically return to [Data man-
agement] interface.
Figure 18 Denote value setting interface
5. Exit
Under [Data management], select “Exit” to return to [Menu] interface.
c. SETTINGS
Under [Menu] interface, select “Settings” to enter [Settings] interface as shown in Fig.19. Under this interface,
settings of language, Bluetooth on/off, time and calibration, and view device information can be realized.