CONTEC SP90 Spirometer

Product Information

Specifications:

• Product: Spirometer SP90
• Manufacturer: Contec Medical Systems Co., Ltd.
• Address: No. 112 Qinhuang West Street, Economic & Technical Development Zone, Qinhuangdao, Hebei Province, PEOPLE’S REPUBLIC OF CHINA
• Contact: Tel: +86-335-8015430, Fax: +86-335-8015588, Email: cms@contecmed.com.cn
• Website: www.contecmed.com.cn
• Model: CMS2.782.563(CE)ESS/1.1
• Manufacturing Date: 1.4.01.12.176
• Warranty: 2022.03

Product Usage Instructions:

Safety

1. Instructions for safe operations
   • Check the main unit and all accessories periodically for any visible damage that may affect safety or performance. It is recommended to inspect the device weekly. Stop using the device if there is obvious damage. Only qualified service engineers designated by the manufacturer should perform necessary maintenance. Contact the manufacturer for technical support or repair materials.
   • When replacing or maintaining the battery, ensure it is done by qualified technical personnel designated by the manufacturer to avoid hazards like battery leakage, fire, or explosion. Use only devices specified in the User Manual with the spirometer. The device comes calibrated from the factory.
2. Warning
   • Avoid using the device in environments with inflammables. Check the device and accessories according to the list provided to ensure normal operation. Avoid strong electromagnetic interference, direct breeze, cold or hot sources when using the device. Properly dispose of scrap devices and accessories following local laws to prevent environmental pollution.
   • Use recommended accessories to prevent damage to the device. Do not use airflow collectors from other products; always use the specified one from the manufacturer. Remember to calibrate before use.
3. Caution
   Avoid dust, vibration, corrosive or inflammable substances, extreme temperatures, and humidity. Stop operating if the device gets wet or coagulates. Operate within the required altitude, temperature, and humidity range.

Frequently Asked Questions

Instruction

• Dear users, thank you very much for purchasing the Spirometer.
• Please read the User Manual carefully before using this device. The User Manual which describes the operating procedures should be followed strictly. Failure to follow the User Manual may cause measuring abnormality, equipment damage or human injury. The manufacturer is NOT responsible for the safety, reliability, 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.
• Date of manufacture: see the label.
• Owing to the forthcoming renovation, the specific products you received may not be totally consistent with the description of this User Manual. We would sincerely regret for that.
• This product is a medical device, which can be used repeatedly.
• This Manual contains instructions for use and technical description.
• The patient is an intended operator.

Warning:

• Please obey the physician’s instructions during test process.
• Don’t use the device when the environment temperature is low.
• Please refer to the correlative literature about the clinical restrictions and contraindications.
• This device is not intended for treatment.
• Do not refit the device.
• The company supplies the qualified product to the user by enterprise standards.
• The company is responsible for installation, debugging, and technical training of the device in accordance with the requirements in the contract.
• The company performs device repair during the warranty period (a year) and maintenance after the warranty period.
• The company responds timely to the user’s request.
• The company reserves the right to the final interpretation of this manual.

Product and registration information

Spirometer /SP90
Registrant name/Name of production enterprise/After sales service unit: Contec Medical Systems Co., Ltd. Registered address/Domicile of production enterprise/production address: No. 112 Qinhuang West Street, Economic & Technical Development Zone, Qinhuangdao, Hebei Province, PEOPLE’S REPUBLIC OF CHINA

Registrant/Manufacturing enterprise contact information：

• Tel: +86-335-8015430 Fax: +86-335-8015588
• Technical support：0335-8015451 400-652-6552
• E-mail: cms@contecmed.com.cn
• Website: http://www.contecmed.com.cn

Safety

Instructions for safe operations

• Check the main unit and all accessories periodically to make sure that there is no visible damage that may affect safety or performance. It is recommended that the device should be inspected weekly at least. When there is obvious damage, stop using it.
• Necessary maintenance can ONLY be performed by qualified service engineers designated by the manufacturer. Users are not permitted to maintain it by themselves. If necessary, our company can provide technical support, component list, drawings, calibration rules, or other materials that can help qualified technical personnel to repair the device.
• The device is powered by a lithium battery, when replacing or maintaining the battery, it must be carried out by qualified technical personnel designated by the manufacturer. When it is disposed of casually by a person without adequate training, hazards such as battery leakage, fire, or explosion may occur.
• The product can not be used together with devices not specified in the User Manual. Only the devices appointed or recommended by the manufacturer can be used with it.
• This device has been calibrated before leaving the factory.

Warning

• Explosive hazard – DO NOT use the device in an environment with inflammables such as anesthetic.
• Please check the device and accessories by the list to avoid that the device can not work normally.
• Don’t use the device in an environment with strong electromagnetic interference, direct breeze source, cold source, and hot source.
• The disposal of scrap devices, their accessories, and packing (including mouthpieces, plastic bags, foams, and paper boxes) should follow local laws and regulations, as improper disposal may pollute the environment.
• Please choose the accessories appointed or recommended by the manufacturer to avoid damage to the device.
• Don’t use the device with the airflow collector of other similar products. When replacing it, please use the one specified by our company. Please calibrate it before use.

Caution

• Keep the device away from dust, vibration, corrosive or inflammable substances, high or low temperature, and humidity.
• If the device gets wet or coagulates, please stop operating.
• Please use the device within the required altitude, temperature, and humidity range. When the device is moved from the highest or lowest storage temperature environment to a room temperature environment, it must be prevented from working for half an hour.
• High-temperature or high-pressure steam disinfection of the device is not permitted. Refer to the relative chapter (7.1) in the User Manual for cleaning and disinfection.
• Do not immerse the device in liquid. When it needs to be cleaned, please wipe its surface with medical alcohol. Do not spray any liquid on the device directly.
• When cleaning the device with water, the temperature should be lower than 60℃.
• When the data can’t be displayed continuously or other cases happen during the test, restart the device.
• The device has a ten-year service life.
• When the measurement result goes beyond the range, there will be a prompt for exceeding the limit.
• The device may not be suitable for all people, if you can’t get a satisfactory result, please stop using it.
• The device should be calibrated prior to first use each day. Please calibrate it in time when an obvious data deviation is found; if repeated calibration fails, please contact your local customer service center.
• Please use the device properly to measure each lung function following the User Manual, to get the optimal results.
• During use, to ensure measurement accuracy, please do not cough or spit on the device to avoid its blocking due to foreign matter
• Patients with respiratory communicable diseases or infectious diseases should not take lung function tests during the acute phase; a low immunity population is not appropriate to do lung function tests either. If necessary, disease control and protection should be done strictly.
• Please consult your doctor before using this device.
• When other devices need to connect with this product for use, only the ones that meet relevant standards (such as IEC 60601 1) can be connected.
• Users should pay attention to preventing tightening caused by excessively long data cables.
• Pressing buttons may cause the operator to experience silicone allergies.
• Try to avoid cotton lint and dust from affecting this inst ru ment as much as possible
• Otherwise, degradation of the performance of this equipment could result.”
• The device needs to be kept out of the reach of children or pets, to prevent animal hair or dirt entering affecting use.
• The part of the application expected to be contacted by the patient is the mouthpiece

Contraindications
No.

Overview

The Spirometer is a common device that measures lung capacity and expiratory flow rate, it is an important examination content in chest-lung disease and respiratory health, an indispensable test project in modern Pulmonary inspection. At the same time, it has great significance in respiratory disease diagnosis, differential diagnosis, therapeutic evaluation, and selection of surgical indications. Thus, with the rapid development of clinical respiratory physiology, clinical applications of lung capacity inspection are also gaining popularity.

The Spirometer is a hand-held device for testing pulmonary function, it adopts the differential pressure acquisition principle to measure parameters related to FVC, SVC, MVV, and MV, it can display respiratory waveform: flow-volume loop and volume-time curve, connect with the master device to realize the real-time display of the waveform, which is applicable for diagnosis and therapeutic evaluation of lung diseases (such as asthma, COPD, pulmonary fibrosis and cough, etc.), preoperative safety evaluation and routine physical examination, etc. It can be used in many scenarios, such as respiratory medicine, thoracic, anesthesiology, surgery, prevention and control institutions of occupational disease, physical examination institutions, etc. It can provide the test results of pulmonary function for the users and the basis for the medical staff to make a diagnosis.

Features

1. Collect the data by a differential pressure sensor, more accurate in results and more sensitive in response.
2. Small in volume, light in weight.
3. Convenient to disassemble, easy to clean, disinfect, and replace components.
4. TFT HD LCD, clear in results.
5. Information indicator: be used to indicate the working state of the device.
6. Voice prompt function (optional).
7. Transmission mode: Bluetooth, USB data cable
8. The user’s information can be edited, stored, and uploaded.
9. Use with PC software, realizes real-time test, and real-time display of waveform and data.

Applied range
The device can be used in many scenarios, such as respiratory medicine, thoracic, anesthesiology, surgery, prevention and control institutions of occupational disease, physical examination institutions, etc. It is required that the user operates the device according to the User Manual.

Environment requirements

Storage environment

• Temperature: 20 ~ 45
• Relative humidity: ≤ 95
• Atmospheric pressure: 500 hPa 1060 hPa

Operating environment.

• Temperature: + 10 ℃ 40 ℃
• Relative humidity: 8 0 %
• Atmospheric pressure: 700 hPa 1060 hPa

Principle

The Spirometer adopts a differential pressure sensing method for signal acquisition. When the test airflow passes through the flowrate collector, the collector converts the airflow signal into a differential pressure signal, which is proportional to the airflow data; the high-precision differential pressure sensor obtains the differential pressure signal and transmits it to the processor, the processor analyzes and obtains the flow rate and volume, then via processing, generates the data required by each test parameters and curve drawing.

Technical Specification

Main function

1. Measure and display the test items related to FVC, SVC, MVV, and MV.
2. Display the respiratory waveform measured, and use it with the master device to realize real-time test.
3. With management functions of user information and case data.
4. Built-in multiple predicted values display the ratio of the measured value and the predicted value.
5. BTPS correction functions, measure environment parameters automatically.
6. Support bronchial test.
7. Voice prompt function (optional).
8. With calibration and verification functions, ensure the test accuracy.
9. Data transmission: Bluetooth, USB data cable.
10. One-button test function.
11. Rechargeable lithium battery, battery power indication.

Main parameters

• Volume range. 0 ~ 10 L (FVC value) (BTPS)
• Flow range. 0 L/s ~ 16 L/s (BTPS)
• Volume accuracy. ± 3 % or 0.05 L (whichever is greater)
• Flow accuracy. ± 5 % or 0.17 L/s (whichever is greater)
• Type of protection against electric shock: internally powered equipment.
• Degree of protection against electric shock. type BF applied part
• Degree of protection against ingress of liquid: IP22.
• Electro Magnetic Compatibility: GroupⅠclass B.
• Resistance to flow: < 0.35 KPa / (L/s)
• Battery: 3.7V，2200mAh Li-On rechargeable, the placement cycle shall not be less than 300 times.
• Equipment operation time: Estimated 24 hours.

Installation

Brief introduction

Disassembly and assembly

1. Disassembly
   The outline drawing of the device is shown in Figure 5-1. The flowrate collector is the signal acquisition part, which needs to be disassembled and cleaned after test. The disassembly steps are shown in the Figure below:
2. Installation
   After cleaning and airing, install it in the reverse order of disassembly.

Note: push the inner sleeve to the position where the limit bulge and the outer sleeve contact closely, and no gap among them.

Accessories

• A User Manual
• A nose clip
• Mouthpiece (Disposable)
• A USB data cable
• PC software

Operation

Use method

ON/OFF

1. After installing the device properly, long press the “ON/OFF/OK” button to turn on the device.
2. Under the “ON” state, long press the “ON/OFF/OK” button to turn off the device.

Operation process
After power-on, it enters the main interface as shown in Figure 6-1.

Users

• Enter the main interface, if there is no user, please create a user first. In the main interface, press the “Up” or “Down” button to select “Users” as shown in Figure 6-2, and press the “ON/OFF/OK” button to enter the user management interface, as shown in Figure 6-3. Select “New user” to enter its editing interface as shown in Figure 6-4, select an item, press the “ON/OFF/OK” button, then the parameters to be set and angle brackets will appear on the right side of the selected item, as shown in Figure 6-5. Under this state, the item can be edited, press the “Up” or “Down” button to edit the user information, press the “ON/OFF/OK” button to finish editing, and after editing each information well, select “Save” and press “ON/OFF/OK” button to finish creating the user as shown in Figure 6-6.
• After creating a user, various tests of lung function can be performed. After selecting the corresponding user, return to the main interface, then select the corresponding test item to start the test.
• For an existing user, select “Users” in the main interface to enter the interface shown in Figure 6-6, press “Up” or “Down” button to select the corresponding user, and press “ON/OFF/OK” button to enter the personal information interface. After confirming that there is no error, use the “Up” or “Down” button to select “Sel”, then press the “ON/OFF/OK” button, the user will be selected, and return to the main interface, you can select the corresponding test item to test.

FVC (forced vital capacity)
Under the main interface as shown in Figure 6-1, select “FVC” to enter the FVC test interface as in Figure 6-7.

Under this interface, seal the lips around the mouthpiece closely, after trying to inhale as much as possible to total lung capacity, exhale as soon as possible to the residual volume, as shown in Figure 6-8. Press the “Down” button under this interface to check other parameters as in Figure 6-9 and Figure 6-10. Under the interface of Figure 6-8, press the “Up” button to check the assessment of the test results.

Test procedure

1. Seal the lips around the mouthpiece closely, and breathe calmly 3-5 times;
2. Take a deep breath to the maximum at the end of a calm expiration;
3. Forced exhale all air out as fast as possible in the shortest time;
4. Forced inhale to the maximum;
5. Repeat the above steps several times, and select the best value to display.

Note: the maximum effective flow rate: is ≤ 16 L/s.

Quality control

Repeatability criteria:

• At least 3 acceptable curves;
• Deviation of the two maximum values of FVC: ± 5 % or ± 0.150 L, whichever is greater, if FVC < 1 L, the deviation < 0.1 L;
• Deviation of the two maximum values of FEV1: ± 5 % or ± 0.150 L, whichever is greater;
• Deviation of the two maximum values of PEF: ± 5% or ± 0.150 L/s, whichever is greater.

Other criteria:

• Extrapolation volume (EVOL): the explosive force is strong when no hesitation at the beginning of expiration. It should be less than 5 % of the FVC or 0.150L, whichever is greater. Otherwise, if the subject hesitated at the the beginning of of expiration, the explosive force is not enough.
• Expiration time for children under 10 years old is greater than or equal to 3 seconds.
• Expiration time for subjects over 10 years old is greater than or equal to 6 seconds.

Note:
The above criteria are part of the reference standards for quality control. The test results cannot be negated solely because the graphs or values are not repeatable. They must be analyzed in combination with the actual situation of the subject. According to the partial quality control standards given in the software combined with the overall judgment of the curve shape, the acceptable curve is selected. Other unacceptable graphs can be ignored or deleted, and not involved in the calculation of the software.

VC (vital capacity)
Under the main interface as shown in Figure 6-1, select “SVC” to enter the SVC test interface as in Figure 6-11.

The lung capacity of slow breathing. Under a relaxed condition, the subject does not need to breathe quickly, but fully breathe in and breathe out to take the vital capacity test, as shown in Figure 6-12. Under this interface, press the “Down” button to check other parameters as in Figure 6-13 and Figure 6-14.

Test procedure

1. Seal the lips around the mouthpiece closely, and keep breathing calmly (at least four steady breaths), a sound prompt appears after four smooth breaths;
2. Breath in deeply (or breathe out deeply) to the maximum at the end of a calm expiration;
3. Exhale (or inhale) at a moderate speed until full exhalation (or inhalation) ;
4. Then breathe calmly.

MVV (maximal voluntary ventilation)
Under the main interface as shown in Figure 6-1, select “MVV” to enter the MVV test interface as in Figure 6-15.

The ventilation of repeated maximal autonomous respiration during a unit of time in a manner that as fast as possible and as deep as possible, as shown in Figure 6-16. Under this interface, press the “Down” button to enter the parameter interface to check other measurement parameters as Figure 6-17.

Test procedure
Seal the lips around the mouthpiece closely, and breathe quickly for 12 ~ 15 seconds with maximum inspiration and maximum expiration.

MV (minute ventilation volume)
Under the main interface as shown in Figure 6-1, select “MV” to enter the MV test interface as in Figure 6-18.

Under the quiescent state, ventilation volume obtained by spontaneous breathing, the test result is shown in Figure 6-19. Under this interface, press the “Down” button to enter the parameter interface to check other measurement parameters as Figure 6-20.

Test process
Seal the lips around the mouthpiece closely, and breathe freely for 12 ~ 15 seconds under the quiescent state, maximum: 60 s.

Bronchial test

• The bronchial test is to compare the changes in airway function before and after the test by the stimulation of various factors (such as physical, chemical, biological, etc.), to make qualitative or even quantitative judgments on airway reactivity.
• Therefore, the bronchial test needs to compare the test data before and after external stimulation.
• In the test interface of FVC, MVV, etc., there are options for whether to take medication, as indicated by the box in Figure 6-21. Press the “Up” or “Down” button to switch whether to take medication. The bronchial test needs to compare the data of the pre-medication test and the post-medication test, so it is necessary to test in two states: PRE, and POST.

According to the doctor’s advice, after finishing the pre-medication test and post-medication test, use the “Up” or “Down” button to select “BDT” in the main interface as Figure 6-1, then press “ON/OFF/OK” button to enter its comparison interface as shown in Figure 6-22. By the actual measurement results, select the data of pre-medication and post-medication to enter the data comparison interface as shown in Figure 6-23, which displays the comparison for data and waveform of pre-medication and post-medication.

Setting
Under the interface of Figure 6-1, select “Settings” to enter the setting interface as Figure 6-24.

• Storage: in Figure 6-24, the first item represents the current remaining storage space;
• Date and time: in Figure 6-24, use the “Down” button to select “Date and time”, then press the “ON/OFF/OK” button to enter the time setting interface, when the cursor is on the “Year”, press “ON/OFF/OK” button, and angle brackets appear on the right parameter, which indicates that it can be edited. Adjust the parameter value with the “Up” or “Down” button, then press the “ON/OFF/OK” button to finish the setting. Press the “Up” or “Down” button to adjust the month, day, hour, and minute in turn as shown in Figure 6-25, select “Exit” after setting to finish the time setting, and return to the setting interface as Figure 6-24.
• Calibration: in Figure 6-24, use the “Up” or “Down” button to select “Calibration”, then press “ON/OFF/OK” to enter the calibration setting interface as shown in Figure 6-26.
  • Under the calibration setting interface as shown in Figure 6-26, press the “ON/OFF/OK” button to select “Cali Volume/L”, and press the “Up” or “Down” button to adjust the volume of the Pulmonary Syringe, after selecting, press “ON/OFF/OK” button to enter the calibration interface as shown in Figure 6-27, it displays “Push & Pull”. Under this interface, connect the Pulmonary Syringe and the device properly, then operate it following the operation prompts. During the process of pushing and pulling the Pulmonary Syringe, the number of calibrations will be displayed in turn as shown in Figure 6-28. After completing the calibration following the prompts, the device will automatically exit the calibration operation and return to the interface as Figure 6-26.
  • Under the calibration setting interface as shown in Figure 6-26, select the “Adjust” option to enter the interface as in Figure 6-29. Under this interface, you can set the parameters. First press the “ON/OFF/OK” button to select a parameter, then use the “Up” or “Down” button to adjust the coefficient. After adjusting, press the “ON/OFF/OK” button to confirm. Note: please do not set this parameter randomly without technical guidance, to avoid affecting its accuracy. After adjusting, select “Exit” and press the “ON/OFF/OK” button to return to the interface as Figure 6-26.
  • Under the calibration setting interface as shown in Figure 6-26, use the “Up” or “Down” button to select the “BTPS” option, then press the “ON/OFF/OK” button to select “Open” or “Close”, after selecting, press “ON/OFF/OK” to confirm, as shown in Figure 6-30. Then select “Exit” and press the “ON/OFF/OK” button to return to the interface as Figure 6-26. Under the calibration setting interface, select “Exit” to return to the interface as Figure 6-24.
• Language: in Figure 6-24, use the “Up” or “Down” button to select “Language”, then press “ON/OFF/OK” to enter the language setting interface as shown in Figure 6-31, press “Up” or “Down” button to select the required language, then press “ON/OFF/OK” to confirm and return to the interface as Figure 6-24.
• About: in Figure 6-24, use the “Up” or “Down” button to select “About”, then press “ON/OFF/OK” to enter the device information interface as shown in Figure 6-32, press “ON/OFF/OK” to return to the interface as Figure 6-24.
• Factory reset: in Figure 6-24, use the “Up” or “Down” button to select “Factory reset”, then press “ON/OFF/OK” to enter its setting interface as shown in Figure 6-33, select “No” to return to the interface as Figure 6-24, “Yes” to restore to factory settings, please choose it carefully.
• Return: press “ON/OFF/OK” to return to the main interface as Figure 6-1.

History
Under the main interface of Figure 6-1, select “History” to enter the historical data setting interface, as shown in Figure 6-34.

• Review Function: select “Review Function” to enter the interface as shown in Figure 6-35, select the user to be reviewed, and press “ON/OFF/OK” to enter the selection interface of the test item as shown in Figure 6-36. Among four test items, the one with the “>” option on the right represents that it had the tested data, press the “ON/OFF/OK” button to check the lists tested as Figure 6-37, press the “ON/OFF/OK” button again to check the specific test data.
• Trend Curve: select “Trend Curve” to enter the interface as shown in Figure 6-35, select the user to be reviewed, press “ON/OFF/OK” to enter the trend curve interface as Figure 6-38, press “Up” or “Down” button to check the trend curve of other parameters.
• Delete Data: select “Delete Data” to enter the interface as shown in Figure 6-35, select the user to be deleted, press “ON/OFF/OK” to enter the deletion interface as Figure 6-39, select “Exit” to return to the interface as shown in Figure 6-35, press “ON/OFF/OK” to delete all storage records about this user, after deleting, return to the interface as shown in Figure 6-35.
• Exit: select “Exit”, and press the “ON/OFF/OK” button to return to the main interface as Figure 6-1.

Automatic shutdown
The device will automatically shut down when there is no operation within 2 minutes.

Charging
When charging, the device will enter the charging interface automatically, and display the charging state, under this interface, the button operation is invalid, the device can not be used.

Two charging modes:

• Connect one end of the data cable to the computer, and the other end to the device, and then the device will be charged.
• Insert one end of the power adapter into the power socket, and the other end into the device by the data cable, then the device will be charged.

Please do not use the device during charging.

• It indicates that the device is charging when the indicator on the upper left is orange, and it is blue after fully charged.
• Do not place the device in a place where it is difficult to disconnect it from the mains when charging. After fully charging, unplug the power adapter to disconnect it from the mains.
• When charging, if the power adapter selected is not provided by our company, it should meet the following requirements: output voltage: DC 5 V, current: ≥ 1 A, and meet local laws and regulations requirements.

Data transmission
The device can communicate with the master device (PC or other devices that can be connected) by the USB data cable or Bluetooth.

• Connect the device with the master device by the data cable, the device will turn on, then open the PC software to operate for data transmission.
• With Bluetooth transmission function. When the device is turned on, the Bluetooth is always “ON”, and there is a Bluetooth icon, which indicates that it can be searched and connected. After the connection is established, it can cooperate with the main device to complete the communication. It displays the data transmission icon after connecting successfully.

Software introduction
Operating system: Windows XP or other operating systems that support the software Display: 1024 * 768 or higher

Maintenance, Transport, and Storage

Cleaning and disinfection
To ensure users’ safety and test accuracy, the device must be cleaned in time; use medical alcohol to wipe the enclosure of the device, then nature dry or clean it with a clean and soft cloth. After using, disassemble the flowrate collector for cleaning, Disassemble according to the disassembly method, unscrew the inner sleeve and disinfect the two parts of the inner sleeve and the screen, immerse the two parts of the inner sleeve and the screen into the disinfectant for soaking for 30 minutes. Note, keep them completely submerged. Then take it out, rinse it with distilled water, and after drying, re-install it for use. This disinfection method will not cause pollution to the environment, it is recommended to clean after each use or clean them according to the cleaning procedure of the institution (note: the disinfectant is 75% medical alcohol or chlorine-containing disinfectant or glutaraldehyde at 2% concentration. The concentration of chlorine-containing disinfectant:500mg/L recommended, double for infectious patients after use, not recommended to exceed 2000mg/L). When cleaning, it is recommended to wear disposable gloves or disinfect hands in time to protect nursing staff.

Please do not clean and maintain it during use.

Maintenance

• Please clean and disinfect the device before using it according to the User Manual (7.1).
• The device should be calibrated prior to first use each day. Please calibrate it in time (or calibrate according to the calibration procedure of the use institution) when an obvious data deviation is found; if repeated calibration fails, please contact your local customer service center.
• The device is powered by a lithium battery, to prolong its service life, please charge it as soon as possible when the low battery symbol “ ” appears. It should be charged once per six months when it has not been used for a long time, which can prolong its service life. The battery can not be replaced by the operator and it can only be replaced with a tool. If replacement is necessary, please contact the local designated service center or our company.

Transport and storage

• The packed device can be transported by ordinary conveyance or according to the transport contract. The device can not be transported mixed with toxic, harmful, corrosive material.
• The packed device should be stored in a room with no corrosive gases and good ventilation. Temperature: -20 ℃ ~ + 45 ℃; Relative Humidity: ≤95 %.

Troubleshooting

Symbols Interpretation

Parameter introduction

FVC

Note:
The starting time of time-related parameters in this part is time zero. Time zero is found by drawing a line with a slope equal to peak flow through the point of peak flow on the volume–time curve and setting Time zero to the point where this line intersects the time axis.

VC

MVV

MV

Initial recommended class and common reasons

• Normal lung volume test
• Restrictive abnormalities
  Lung cavity becomes smaller – after being surgically removed, interstitial fibrosis, tumor, silicosis, etc. Thorax activities restricted – pleural effusion, thickening, adhesion, thoracic deformity, etc. Thoracic compression – ascites, pregnancy, obesity, etc.;
  Respiratory muscle weakness – diaphragm fatigue, muscle weakness, muscle atrophy, malnutrition.
• Obstructive abnormalities
  • Chronic obstructive pulmonary disease, such as asthma, emphysema, etc.;
  • Upper respiratory tract tumor, foreign body, inflammation, tracheal or bronchial tumor, stenosis, etc.
• Class of pulmonary dysfunction
  • Minor
  • moderate
  • medium serious
  • serious
  • critical

Instructions for use
The ME EQUIPMENT or ME SYSTEM is suitable for home healthcare environments

• Warning: Don’t near active HF surgical equipment and the RF-shielded room of an ME system for magnetic resonance imaging, where the intensity of EM disturbances is high.
• Warning: Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally.
• Warning: Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the equipment, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result.

Instructions for use
all necessary instructions for maintaining BASIC SAFETY and ESSENTIAL PERFORMANCE about electromagnetic disturbances for the excepted service life. Guidance and manufacturer’s declaration -electromagnetic emissions and Immunity.

FCC STATEMENT

FCC Caution:

Part 15.21
Any Changes or modifications not expressly approved by the party responsible for compliance could void the user’s authority to operate the equipment.

Part 15.19
This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation.

FCC RF Radiation Exposure Statement:

1. This Transmitter must not be co-located or operating in conjunction with any other antenna or transmitter.
2. This equipment complies with RF radiation exposure limits set forth for an uncontrolled environment.
3. The device has been evaluated to meet general RF exposure requirements. The device can be used in portable exposure conditions without restriction.

Note:
This equipment has been tested and found to comply with the limits for a Class B digital device, under part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses, and can radiate radio frequency energy and, if not installed and used by the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures:

• Reorient or relocate the receiving antenna.
• Increase the separation between the equipment and the receiver.
• Connect the equipment to an outlet on a circuit different from that to which the receiver is connected.
• Consult the dealer or an experienced radio/TV technician for help.

Table 1

Table 2 

Table 3 

Table 4 

Attention:
With the exception of energy exchange and cables sold by manufacturers of lung function devices as spare parts for internal components, the use of accessories and cables other than those specified will result in increased product emission or reduced anti-interference.

The following cable types must be used to ensure compliance with interference radiation and immunity standards.

Table: Cable overview

Contec Medical Systems Co., Ltd

• Address: No. 112 Qinhuang West Street, Economic & Technical Development Zone, Qinhuangdao, Hebei Province, PEOPLE’S REPUBLIC OF CHINA
• Tel: +86-335-8015430
• Fax: +86-335-8015588
• Technical support:
  • 0335-8015451
  • 400-652-6552
• E-mail: cms@contecmed.com.cn
• Website: http://www.contecmed.com.cn.

Documents / Resources

CONTEC SP90 Spirometer [pdf] User Manual 2ABOGSP90, SP90 Spirometer, SP90, Spirometer

References

• User Manual