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User Manual Rev. 1.3
Issued on
Approved on
INDEX
1.
EQUIPMENT AND ACCESORY LIST ................................................................ 3
2.
INTRODUction ................................................................................................... 4
2.1
Intended use ................................................................................................ 4
2.1.1
User category .......................................................................................... 5
2.1.2
Ability and experience required ............................................................... 5
2.1.3
Operating Environment ........................................................................... 5
2.1.4
Who can or must make the installation.................................................... 6
2.1.5
Patient effect on the use of the device .................................................... 6
2.1.6
Limitations of use - Contraindications...................................................... 6
2.2
Important safety warnings............................................................................ 6
2.2.1
Danger of cross-contamination ............................................................... 7
2.2.2
Turbine .................................................................................................... 7
2.2.3
Mouthpiece .............................................................................................. 8
2.2.4
I Oximetry sensor .................................................................................... 8
2.2.5
Device ................................................................................................... 10
2.3
Unforeseen errors ...................................................................................... 11
2.4
Lithium-ion battery pack warning ............................................................... 11
2.5
Labels and symbols ................................................................................... 14
2.5.1
Identification label.................................................................................. 14
2.5.2
CE mark for medical devices ................................................................. 14
2.5.3
Electrical safety symbol ......................................................................... 14
2.5.4
Warning symbol for the RS232 serial port ............................................. 14
2.5.5
Warning symbol for the USB serial port ................................................ 14
2.5.6
Warning symbol for the SpO2 port for oximetry .................................... 15
2.5.7
Warning symbol for the WEEE .............................................................. 15
2.5.8
FDA and FCC Warnings ........................................................................ 15
2.5.9
Product description................................................................................ 16
2.6
Technical specifications ............................................................................. 18
2.6.1
Features of the spirometer .................................................................... 18
2.6.2
Oximeter features .................................................................................. 19
2.6.3
Other features ....................................................................................... 23
3.
Functioning of the SPIRODOC .......................................................................... 23
3.1
Display ....................................................................................................... 23
3.2
Accensione e spegnimento di SPIRODOC ................................................ 24
3.3
Symbols and Icons .................................................................................... 24
3.4
Energy saving ............................................................................................ 25
3.5
Information ................................................................................................. 25
3.6
Service menu ............................................................................................. 26
3.6.1
Patient Mode ......................................................................................... 31
3.6.2
Reusable turbine calibration .................................................................. 32
3.7
Patient Data ............................................................................................... 34
3.7.1
Inserting data of a new patient .............................................................. 34
Spirodoc
Spirodoc
27/04/2010
27/04/2010
cod. 980156
Rev 1.3
EN 1/67
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Summary of Contents for MIR Spirodoc
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Page 1: Table Of Contents
Oximeter features .................. 19 2.6.3 Other features ..................23 Functioning of the SPIRODOC ................23 Display ....................... 23 Accensione e spegnimento di SPIRODOC ..........24 Symbols and Icons ..................24 Energy saving .................... 25 Information ....................25 Service menu ..................... 26 3.6.1... - Page 2 Causes and solutions ................56 LIMITED WARRANTY CONDITIONS ................. 59 ALLEGATO 1 OXIMETRY TEST REPORTS EXAMPLES ........60 ALLEGATO 2 SPIROMETRY TEST REPORT EXAMPLE ........63 ANNEX 3 INFORMATION FOR CORRECT USE IN AN ELECTROMAGNETIC ENVIRONMENT......................64 Spirodoc cod. 980156 Rev 1.3 EN 2/67...
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Page 3: Equipment And Accesory List
2.4 WARNING Before connecting the SPIRODOC to the PC, the winspiroPRO PC software supplied with the device must be installed correctly in the PC. The device may be connected to the PC only after the winspiroPRO software has been installed. -
Page 4: Introduction
OF A PHYSICIAN INTRODUCTION Intended use The Spirodoc spirometer and pulse oximeter is intended to be used by a physician or by a patient under the supervision/instruction of a physician or paramedic. The lung function testing device is capable of performing: ... -
Page 5: User Category
2.1.3 Operating Environment SPIRODOC has been designed for use in the doctor‟s office, in a hospital or directly by the patient to continuously monitor her/his physical conditions during routine daily activities. All information necessary for the proper use of the device in an electromagnetic environment (as required by the EN 60601-1-2 Standard) is available in Annex 3 of this manual. -
Page 6: Who Can Or Must Make The Installation
The device should not be used if any conceivable or actual anomalies or malfunctions appear which may compromise the accuracy of the results. WARNING When used as a pulse oximeter the SPIRODOC has limited alarms, therefore the device requires that the user frequently observe the SpO2 and pulse rate on the display. -
Page 7: Danger Of Cross-Contamination
SPIRODOC is continuously checked during manufacturing and therefore the product complies with the established security levels and quality standards laid down by the Council Directive 93/42/EEC for MEDICAL DEVICES. After removing the device from its packaging, check to see that there is no visible damage. -
Page 8: Mouthpiece
To avoid environmental contamination caused by the disposal of used mouthpieces, the user must follow all the relevant local regulations. 2.2.4 I Oximetry sensor The oximetry sensors which can be used with SPIRODOC are the following: Manufacturer Code Description 1300... - Page 9 Use only MIR oximetry sensors supplied with, or specifically intended for use with SPIRODOC. Use of oximetry sensors not intended for use with the SPIRODOC may cause inaccurate readings. Oximetry measurements may be inaccurate in the presence of high ambient light.
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Page 10: Device
MRI equipment may cause an induced current to the oximetry sensor, resulting in patient injury. If the PC and/or the printer connected to the SPIRODOC come into contact with the area containing patient data, ref. directive EN 60601-1-1, it is necessary that they conform to the directive EN 60601-1. -
Page 11: Unforeseen Errors
Only use suitable battery chargers and follow the instructions. Do not connect the battery to an electric plug or lighter. During charging Before charging the battery pack carefully read the user manual. Spirodoc cod. 980156 Rev 1.3 EN 11/67... - Page 12 Do not puncture the battery pack with sharp objects such as a nail. Do not hammer, step-on, throw or cause a forceful impact to the battery-pack. A damaged or deformed battery pack may cause internal short-circuits thus Spirodoc cod. 980156 Rev 1.3...
- Page 13 Do not place the battery in a micro-wave oven or in a pressurized container. Rapid overheating or loss of proofing may cause acid leakage, overheating, smoke, breakage and/or fire. If the battery pack leaks acid or gives off a bad smell, move it away from flames. Spirodoc cod. 980156 Rev 1.3 EN 13/67...
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Page 14: Labels And Symbols
Use only the serial cable supplied by the manufacturer and observe the safety regulations of IEC 60601-1-1. 2.5.5 Warning symbol for the USB serial port To connect to other devices such as PC or printer. Spirodoc cod. 980156 Rev 1.3 EN 14/67... -
Page 15: Warning Symbol For The Spo2 Port For Oximetry
Failure to observe these regulations can lead to prosecution. 2.5.8 FDA and FCC Warnings SPIRODOC…. complies with Part 15 of the FCC Rules. The correct operation is subject to the following conditions: (1) this device must not cause harmful interference (2) this device must accept any interference received, including interference that may cause undesired operation. -
Page 16: Product Description
2.5.9 Product description SPIRODOC…. is a pocket spirometer, with an optional pulse oximetry module. It can operate either in stand alone mode or it can be connected to a PC or to a printer using any one of several methods: RS232, USB, Bluetooth. - Page 17 The personal best values can vary considerably from the predicted values, which are taken from “healthy” subjects. Spirodoc…. is also able to transfer the stored test data through a simple acoustic coupling to a PC, so the patient can send test data by phone to the doctor. This method allows the doctor can check the patient‟s condition remotely.
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Page 18: Technical Specifications
Inspiratory capacity (max between EVC and IVC) - ERV Expiratory reserve volume Current volume Ventilation per minute, at rest L/min Respiratory frequency Breath/min Average time of inspiration, at rest Average time of expiration, at rest Spirodoc cod. 980156 Rev 1.3 EN 18/67... -
Page 19: Oximeter Features
Time passed with pulse frequency < 40 BPM % hh:mm:ss T> 120 BPM Time passed with pulse frequency > 120 BPM % hh:mm:ss N° Events < 40 Bradycardia events during the entire period of analysis Spirodoc cod. 980156 Rev 1.3 EN 19/67... - Page 20 Time passed with pulse frequency < 40 BPM hh:mm:ss T> 120 BPM Time passed with pulse frequency > 120 BPM hh:mm:ss Bradycardia events during the entire period of N° Events < 40 BPM analysis Spirodoc cod. 980156 Rev 1.3 EN 20/67...
- Page 21 Units SpO2 Baseline SpO2 Average in first three minutes SpO2 Min SpO2 Minimum during period of analysis SpO2 Max SpO2 Maximum during period of analysis SpO2 Mean SpO2 Average during period of analysis Spirodoc cod. 980156 Rev 1.3 EN 21/67...
- Page 22 10 seconds when the device is switched on again The specifications for both the oximetry and for the cardiac pulse are the same regardless of which of the above mentioned oximetry sensors is used. Spirodoc cod. 980156 Rev 1.3...
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Page 23: Other Features
Electrical Safety Standard IEC 60601-1 Applied norms Electro Magnetic Compatibility 60601-1-2 FUNCTIONING OF THE SPIRODOC Display The device does not have a keyboard. The touchscreen type display allows access to all functions by simply touching the display. The controls touchscreen... -
Page 24: Accensione E Spegnimento Di Spirodoc
To visualize the list of information flick through the left part of the screen. Accensione e spegnimento di SPIRODOC To turn on the SPIRODOC press and release the key placed in the middle on the side of the device. To turn off the SPIRODOC press the same key for at least two seconds. -
Page 25: Energy Saving
This image indicates that the battery pack is fully charged(6 indicators). A drop of the battery pack charge is displayed with a reduction of the indicators. Information Turn on the SPIRODOC by pressing . The display will read: device name... -
Page 26: Service Menu
LCD setting BLUETOOTH setting Firmware information Oximetry alarms SpO2 sampling rate Spirodoc mode Parameter settings Menu type Scroll through the various options in the menu as per paragraph 3.1; once the option of interest is visualized, touch the display next to it. - Page 27 Lastly by touching OK the settings will take effect and the device will return to the service menu; to return to the service menu without modifying any options touch Date format Select the option by touching the display. Spirodoc cod. 980156 Rev 1.3 EN 27/67...
- Page 28 The touch screen will be calibrated according to the dimensions of the screen. Bluetooth setting Access the menu to search for available devices, touch the option “Search Device”; Spirodoc will start to search for Bluetooth devices in the area; once one or more Spirodoc cod. 980156 Rev 1.3...
- Page 29 “telephone” list and the “PC – On line” list. Any device from these lists can be set as the default device (the device that SPIRODOC will automatically connect to via Bluetooth) by entering in the lists, touching the display and selecting the device. A listed device can be eliminated from the list.
- Page 30 To exit the settings of the service menu touch in the bottom left hand side. Spirodoc cod. 980156 Rev 1.3 EN 30/67...
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Page 31: Patient Mode
To access the service menu select the item “Inser password” and enter the following password: 1 2 2 3 3 3 In this mode the service menu displays the following items: Spirodoc mode Personal best Turbine setup ... -
Page 32: Reusable Turbine Calibration
FIVC test for the inspired parameters. To access the calibration function, select the “Turbine Calibration” option from the Service Menu as explained in paragraph 3.6. Once the password has been inserted correctly the following screen will appear: Spirodoc cod. 980156 Rev 1.3 EN 32/67... - Page 33 FIVC values will not be accepted. This means that the device cannot correct such a large calibration error. In this case: - Check the correct functioning of the Spirodoc with a new turbine and/or - Clean the turbine. To erase the calibration in use and to reset the original factory calibration, insert the number 0 in the New FVC and New FIVC fields.
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Page 34: Patient Data
Write the name of the patient with the touchscreen keyboard. Touch the OK icon to move on to the next screen Second screen (sirname) As above insert the sirname of the patient and touch the OK icon. Spirodoc cod. 980156 Rev 1.3 EN 34/67... -
Page 35: Patient Data Modification
Touch the icon to return to the main screen without modifying any data Spirodoc cod. 980156 Rev 1.3 EN 35/67... -
Page 36: Visualization Of Memory Data
Visualization of database info The result of a search performed in one of the described methods in paragraph 3.8.1 can be viewed in the adjacent image. By touching desired session one may access the performed tests Spirodoc cod. 980156 Rev 1.3 EN 36/67... -
Page 37: Display Of Last Session From Current Patient
PC. PC interface is via USB cable or Bluetooth connection. The Spirodoc becomes an intelligent transducer for the measurement of volume and flow while the PC controls the device including the on and off function. -
Page 38: Spirometry Testing
Place the noseclips on the nose so as not to let any air out of the patient‟s nostrils. Hold the Spirodoc from both ends with both hands or grasp it like a mobile phone. The touchscreen must always face the patient taking the test. -
Page 39: Fvc Test
The test may be carried out several times by repeating the cycle without taking the mouthpiece out of the mouth, in which case Spirodoc recognises the best test (FVC+FEV1) and will automatically display the results of this best test. -
Page 40: Test Vc
(FET) is sufficiently long to allow for the complete expiration of all air contained in the lungs. Six seconds from the start of the forced expiratory test, the Spirodoc emits a continuous beep. This is useful for the doctor to understand if the patient has reached the minimum expiry time, as per the requirements of the major international pneumology associations. -
Page 41: Viewing The Spirometric Results
Spirometry test interpretation is based on the Forced Vital Capacity (FVC) test. The test interpretation is indicated with one the following messages: Normal obstruction Mild obstruction Moderate obstruction Moderately severe obstruction Severe obstruction Very severe obstruction Spirodoc cod. 980156 Rev 1.3 EN 41/67... - Page 42 Through the use of a mathematical analysis applied to certain indices and parameters calculated in the FVC test , the SPIRODOC is capable of producing a list of quality control comments useful to assess the quality and reproducibility of the manouvers performed.
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Page 43: Oximetry Testing
FVC is ≤ 100 mL; 3.13 Oximetry Testing SPIRODOC is able to perform 3 different types of oximetry tests, which will be described in the following paragraphs. WARNING If SPIRODOC has been purchased without the oximetry option only spirometry testing can be performed. - Page 44 This enables the light source to remain on the fingernail and the detector on the bottom part of the finger. Select one of the tests that can be performed with SPIRODOC To access the oximetry area touch the icon on the main screen and subsequently select the type of oximetry test to carry out.
- Page 45 During oximetry testing if the SpO2 and blood pulse rate fall below the bottom threshold or raise above the threshold, the SPIRODOC will emit a continuous acoustic signal „beep‟ until such situation persists. This function can be disabled for sleep oximetry testing.
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Page 46: Walk Test (6Mwt)
Walk test (6MWT) Access the oximetry area by touching the icon from the main screen, next select the test by touching the icon. The walk test is comprised of three stages: Initial rest Spirodoc cod. 980156 Rev 1.3 EN 46/67... - Page 47 Simply touch the stage. If the user does not move on to the “walking” stage, a few seconds before reaching the 6 minute mark the SPIRODOC will emit an acoustic signal “beep” as a warning, and automatically enter the “walking” stage.
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Page 48: Sleep Oximetry
This test records overnight patient parameter variations. After approximately 5 minutes, SPIRODOC will enter standby (energy saving) mode; it stops beeping and the display turns off. The led signal remains on. To check that the... -
Page 49: Oximetry Spo2/Bpm
The oximetry sensor used in the manual is only one of the different types of sensors which can be used with SPIRODOC listed in paragraph 2.2.4. MIR does not recommend any one particular sensor, the decision is left to the doctor who will choose the sensor which she/he believes to be more suitable. -
Page 50: Data Transmission
To reduce chances of entanglement it is recommended to fasten the cable to the wrist with a bandage. DATA TRANSMISSION WARNING Please read carefully and make sure to have properly understood the instructions before commencing the data trasmission. WARNING Spirodoc cod. 980156 Rev 1.3 EN 50/67... -
Page 51: Data Transmission Via Bluetooth To A Cell Phone
Upon request from the mobile phone insert the PIN code which corresponds to the Serial number, SN, of the SPIRODOC which can be found on a label on the bottom-side of the device. ... -
Page 52: Data Transmission Via Bluetooth For Printing
Bluetooth connection; another possible solution is with the use of a USB adaptor installed on the printer, thus enabling a Bluetooth connection. The Bluetooth system enables SPIRODOC to transfer test data directly to a Bluetooth enabled printer. The procedure is listed below: 4.2.1... -
Page 53: Pc Connection Via Bluetooth
If winspiroPRO is already installed on the PC then a new installation is not required. Before connecting the SPIRODOC via USB to the PC, the WinspiroPRO software must be installed on the PC first to enable the software to interface with the device. -
Page 54: Cleaning And Checking The Reusable Turbine
Cleaning and checking the reusable turbine Two types of turbines can be used with SPIRODOC. The disposable turbine or the reusable turbine. Both guarantee precise measurements and have the advantage of requiring no periodic calibration. In order to maintain the default characteristics of the reusable turbine a simple cleaning procedure is required before use. -
Page 55: Proper Turbine Operation Check
5.1.1 Proper turbine operation check Turn on SPIRODOC and setup the device to perfom a spirometry test (for example FVC). Hold the SPIRODOC with one hand and move it slowly sideways, having the air pass through the turbine. -
Page 56: Changing The Adhesive Wrap Sensor
It is highly suggested to use a new piece of adhesive tape for each patient, or as required. Battery charging Turn on SPIRODOC and the following icon will appear on the main screen showing the charge level of the battery pack: The maximum charge level is displayed with all 6 bars inside the battery. - Page 57 Furthermore the database could be of confidential nature and as such not accessible by authorized personnel and also subject to privacy laws. Spirodoc cod. 980156 Rev 1.3 EN 57/67...
- Page 58 Spirometer/Oximeter Device Name spirobank II Classification This Device is marked Any modifications to the Device which are not authorised by MIR will invalidate this Declaration Roma 01 / 01/ 2006 Paolo Sacco Bochetti President of the Board of Trustees. Rev.0 – Mod. PO-10DDC_SPIRODOC Spirodoc cod.
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Page 59: Limited Warranty Conditions
Any device or accessory returned must be accompanied by a clear and detailed explanation of the defect or problem found. If units are to be returned to the manufacturer then written or verbal permission must be received before any devices are returned to MIR. Spirodoc cod. 980156 Rev 1.3... -
Page 60: Allegato 1 Oximetry Test Reports Examples
MIR – Medical International Research reserves the right to modify the device if required, and a description of any modification made will be sent along with the returned goods. ALLEGATO 1 OXIMETRY TEST REPORTS EXAMPLES Spirodoc cod. 980156 Rev 1.3... - Page 61 Spirodoc cod. 980156 Rev 1.3 EN 61/67...
- Page 62 Spirodoc cod. 980156 Rev 1.3 EN 62/67...
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Page 63: Allegato 2 Spirometry Test Report Example
ALLEGATO 2 SPIROMETRY TEST REPORT EXAMPLE Spirodoc cod. 980156 Rev 1.3 EN 63/67... -
Page 64: Annex 3
Electromagnetic environment – guidance Emissions test Compliance RF emissions Group 1 The SPIRODOC uses RF energy only for its internal CISPR 11 function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment. -
Page 65: Environment
[3 ] V/m where P is the maximum output power rating of the transmitter in watts (W) IEC 61000-4-3 80 MHz to 2,5 GHz according to the transmitter manufacturer and d is the recommended separation Spirodoc cod. 980156 Rev 1.3 EN 65/67... -
Page 66: Spirodoc Cod
RF compliance level above, the spirobank II should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the spirobank b) Over the frequency range 150 kHz to 80 MHz, field strengths should be less than [3] V/m. Spirodoc cod. 980156 Rev 1.3... - Page 67 NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. Spirodoc cod. 980156 Rev 1.3...
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