Related Manuals for Medical International Research spirodoc
Summary of Contents for Medical International Research spirodoc
- Page 1 User manual User manual rev. 2.4 Issue date 10.04.2014 Approval date 10.04.2014 SPIRODOC cod. 980156 Rev 2.4 EN 1/46...
-
Page 2: Table Of Contents
Oximeter features ................................... 11 1.7.3 Other features ....................................14 FUNCTIONING OF THE SPIRODOC ................................15 Display......................................... 15 Switching on and off the SPIRODOC ..............................15 Energy saving ...................................... 16 Main screen ......................................16 Symbols and Icons ....................................16 Service menu ....................................... 17 2.6.1... -
Page 3: Introduction
FEDERAL LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER 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 instruction of a physician. The device is intended to test lung function and can make: ... -
Page 4: Operating Environment
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 5: Danger Of Cross-Contamination
3444 adult sensor reusable (Comfort Clip) 3044 adult finger sensor, reusable These sensors require the use of an extension cable (product code 919200) for a proper connection to SPIRODOC. Two cable lengths are available: Cod. 919200 length 1.5 m Cod. 919210_INV length 0.5 m... -
Page 6: Device
If the device is connected to other instruments, to satisfy the safety requirements of the system required by the standard CEI EN 60601-1, it is necessary to use exclusively devices compliant to the safety standard. Therefore the PC or the printer which the SPIRODOC is connected must be compliant to the standard CEI EN 60601-1. - Page 7 User manual DANGER Do not disassemble or modify the battery pack. The battery pack comes with an internal safety sensor; which if tampered with may cause acid leakage, overheating, smoke, breakage an explosion and/or fire. Do not short-circuit the positive(+) and negative (-) poles with any metal objects.
-
Page 8: Unforessen Errors
Failure to observe these regulations can lead to prosecution. 1.5.7 FDA and FCC Warnings SPIRODOC complies with Part 15 of the FCC Rules. The correct operation is subject to the following conditions: SPIRODOC cod. 980156 Rev 2.4 EN 8/46... -
Page 9: Esd) Electrostatic Discharge Sensitivity Symbol
Product description The 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: USB, Bluetooth. -
Page 10: Technical Specification
The personal best values can vary considerably from the predicted values, which are taken from “healthy” subjects. SPIRODOC can also be connected to a PC (or to another computerised system) to configure the instrument. All spirometry test data including the related patient details stored inside the device can be transferred from the device to the PC and then viewed on the PC (Flow/volume curves, spirometry parameters, plus optional oximetry parameters). -
Page 11: Oximeter Features
User manual Symbol Description Units FEV1/VC FEV1 / best between EVC and IVC x 100 Peak expiratory flow FEF2575 Average flow between 25% and 75% of the FVC FEF25 Forced Expiratory Flow at 25% of FVC FEF50 Forced Expiratory Flow at 50% of FVC... - Page 12 User manual Symbol Description Units %SPO2 end Final SPO2 reading during walking phase BPM end Final BPM reading during walking phase %SPO2 Base Initial phase SPO2 base value, before walking test BPM start Initial phase BMP base value, before walking test...
- Page 13 User manual Calzetta, MC. Basili, MA. Porretta, L. Senis, P. Rogliani, M. Cazzola, C. Saltini, University of Roma "Tor Vergata” Italy, presented at: ERS (European Respiratoty Society Congress), Barcelona - Spain: 21 September 2010 The following table lists all the symbols used for the parameters in the service menu under item “Set parameters” describing to which test each is...
-
Page 14: Other Features
User manual Symbol Symbol in menu "Set parameters" Test Optional Max Drop MAX DROP BPM Variation BPM VAR. NOD4% NOD4% NOD89% NOD89% NOD90% NOD90% t.NOD4% t.NOD4% t.NOD89% t.NOD89% t.NOD90% t.NOD90% =DELTA Parameters requested for six minute walk test analysis... -
Page 15: Functioning Of The Spirodoc
To visualize the list of information scroll through the left part of the screen. Switching on and off the SPIRODOC To turn on the SPIRODOC press and release the power key placed in the middle on the side of the device. -
Page 16: Energy Saving
Free memory available To turn off SPIRODOC press the key placed on top and subsequently touch OK on the bottom right side of the screen. It is possible to turn off the device by keeping the top key pressed. -
Page 17: Service Menu
The service menu shows different items according to whether the device is set to either Patient or Doctor mode; The item “SPIRODOC mode” is the first one displayed in both modes. The configuration of the item menus for the two modes is the following:... -
Page 18: Doctor Mode
Access this menu to search for active Bluetooth devices, touch the option “Search Device”; SPIRODOC will start to search for Bluetooth devices in the area; once one or more devices are found the display will list these devices with their respective names. By touching the device of interest it will be memorized as a printer, a phone, or as a PC –... - Page 19 User manual Turn ON mode This function enables the device to turn on automatically at a predetermined time. The device will automatically turn on and commence a sleep oximetry test (this test is also capable of monitoring the patient all day long, and includes as a step counter and a triaxial accelerometer to measure the VMU) The device will turn off automatically at a predetermined time.
- Page 20 User manual The sequence of values is the following: Parameter Min value setting Max value setting SpO2 min SpO2 max BPM min BPM max WARNING If the maximum value of a SpO2/BPM parameter is set lower or equal to the minimum value the setting will not take effect. The device will emit an acoustic warning and automatically return to the setting of the minimum value.
- Page 21 User manual complete The “simplified” mode only allows for the main parameters to be viewed according to the main standards in effect. In paragraphs 2.7.1. and 2.7.2 these parameters are shown. In “personal” mode the user may select which parameters will be displayed. The parameters highlighted in white will be displayed. To remove a parameter from the list simply touch the white highlighted parameter and it will turn grey.
-
Page 22: Patient Mode
User manual Info firmware In this menu the user may view the current software version of the following components: SPIRODOC Bluetooth Oximeter After approximately 10 seconds the device will automatically return to the service menu, otherwise touch Once all of the items in the service menu have been set it is possible to exit the menu by touching on bottom left side of the screen. -
Page 23: Reusable Turbine Calibration
The correction of the inspired volumes and flows is made automatically as the machine has an internal temperature sensor; the BTPS values are thus calculated. If a 3L syringe is used to make the calibration and if the SPIRODOC is calibrated correctly then the FVC (syringe) value will be: 3.00 (FVC) x 1.026 (BTPS) = 3.08 L (FVC at BTPS). -
Page 24: Patient Data
User manual Patient Data From the main screen the user can access the patient data management by using the icon . By entering this menu it is possible to: Modify current patient data * Insert a new patient *this function is visualized only if a patient file was previously inserted in the database If the database is empty the device will automatically direct the user to insert the name of the patient. -
Page 25: Visualization Of Database Info
User manual Reseach by patient date of birth. Research by the date of testing. Visual of all tests in the database starting form the most recent. Research by patient surname. Research by patient date of birth: patient date of birth must be inserted; after all the data has been inserted touch the OK icon. All data visualized concerns tests performed by patients whose date of birth corresponds to the inserted date of birth. -
Page 26: Display Of Last Test Session From Current Patient
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 touch screen must always face the patient taking the SPIRODOC cod. -
Page 27: Fvc Test
Accurate spirometry testing requires that the patient expire all the air in the lungs. 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 (largest FVC+FEV1) and will automatically display the results of the best test. -
Page 28: Mvv Test
For a POST test the messages are the same but instead of dealing with an “obstruction” the POST test refers to a “restriction”. 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. -
Page 29: Oximetry Testing
During oximetry testing the SPIRODOC cannot be turned off. To turn off the device the oximetry test must be stopped first. This has been implemented so as to avoid any unwanted interruptions which could compromise the accuracy of the data. - Page 30 The first few seconds are used to find the best signal possible; after which the SPIRODOC timer resets itself and the device starts recording data. For any type of oximetry test if the sensor is not properly connected the following message will be displayed on screen after a few seconds:...
-
Page 31: Walk Test (6Mwt)
User manual During oximetry testing if the SpO2 and blood pulse rate fall below the bottom threshold or raise above the upper threshold, the SPIRODOC will emit an acoustic alarm ‘(if previously set in the service menu.)’ until such situation persists. For sleep oximetry testing the heart rate tone is always disabled. - Page 32 This stage will continue for a minimum of 2 minutes, after which the icon for a few seconds. If the “walking” stage continues for more than 6 minutes SPIRODOC will emit an acoustic signal “beep” and after 6 minutes are up the device will automatically move on to the “recovery” stage and the timer will be reset to zero again.
-
Page 33: Sleep Oximetry
When the patient is lying down the SPIRODOC recognizes the prone or supine position, and whether the patient is lying down either on the left or right side. If the patient is standing up the SPIRODOC will record whether the patient is still or moving including the entity of the movement that is if he/she is moving slowly, medium or at fast speed. -
Page 34: Instructions For Adult Single Patient Sensor
WARNING 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 35: Testing Without Patient Data
Printing data from the patient management function will only work with a Bluetooth embedded printer or 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: 3.2.1 How to print a test saved in the database ... -
Page 36: How To Print A Test Of The Last Session
PC connection via USB port WARNING 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. Before initiating the following procedure it is important to know the operating system version installed on the PC used for the connection (from control panel click on “System”, where the type of operating system installed on the PC can be checked). -
Page 37: Proper Turbine Operation Check
Being disposable, 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 38: Problem Solving
Always disconnect the battery charger from the device when the charge cycle has terminated. PROBLEM SOLVING Please find below a list of problems that may arise when using SPIRODOC. Diagnostic messages are also shown on the display indicating the type of malfunction:... - Page 39 (annex II excluding par.4) We hereby declare that the following device: Type Spirometer/Oximeter Brandname MIR Medical International Research Device name spirodoc Class Complies with the Essential Requirements of directive 93/42/EC concerning Medical Devices, and its amendments, and its transposition in the Member States.
-
Page 40: Limited Warranty Conditions
MIR. 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. -
Page 41: Annex 1 Oximetry Test Reports Examples
User manual ANNEX 1 OXIMETRY TEST REPORTS EXAMPLES SPIRODOC cod. 980156 Rev 2.4 EN 41/46... - Page 42 User manual SPIRODOC cod. 980156 Rev 2.4 EN 42/46...
- Page 43 User manual SPIRODOC cod. 980156 Rev 2.4 EN 43/46...
-
Page 44: Annex 2 Spirometry Test Report Example
User manual ANNEX 2 SPIROMETRY TEST REPORT EXAMPLE SPIRODOC cod. 980156 Rev 2.4 EN 44/46... -
Page 45: Annex 3 Information For Correct Use In An Electromagnetic Environment
RF emissions Class B The SPIRODOC is suitable for use in all establishments, including domestic establishments and those CISPR 11 directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes. - Page 46 User manual NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. a) Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy.
Need help?
Do you have a question about the spirodoc and is the answer not in the manual?
Questions and answers