Gima SP-10 Manuale utente
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
gima@gimaitaly.com - export@gimaitaly.com
www.gimaitaly.com
SP-10 POCKET SPIROMETER
User manual
0123
%
95%
0%
55°C
-40°C
106kPa
50kPa
2
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 specic 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 Specications ......................................................................................................................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
5
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 qualied service engineers ONLY. Users are not permitted to maintain it
by themselves.
• The SPIROMETER cannot be used together with devices not specied 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 inuence 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 electried 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;
7
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.
8
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 signicance 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-denition 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) Reect 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 airow 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
Classication:
EMC: Group I Class B.
According to the MDD 93/42, the classication 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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