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spirodoc

 

 

 

SPIRODOC

 

 

 

cod. 980156 

 Rev 2.4   

 

EN 9/46 

 

User manual 

(1) this device must not cause harmful interference 
(2) this device must accept any interference received, including interference that may cause undesired operation. 
 
Any modifications not expressly approved by this company could void the user's authority to operate the equipment. 

NOTE

: This device has been tested and found to comply with the limits for a Class B digital device, pursuant to 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  in  accordance  with  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  simply  turning  the  equipment  off  and  on,  the  user  is  encouraged  to  try  to  correct  the 
interference with one or more of the following ways: 
 

 

Reposition the receiving antenna. 

 

Increase separation between the equipment and receiver. 

 

Connect the equipment into an outlet on a circuit different from that to which the receiver is connected. 

 

Consult the dealer or an experienced radio/TV technician for assistance. 

 
Labels and symbols are displayed on the device as shown in the following images: 
 

 

 

1.5.8 

(ESD) Electrostatic discharge sensitivity symbol 

 

 
The  (ESD)  symbol  required  by  the  international  standard  EN  60601-1-2  is  used  in  the  vicinity  of  any  connector  which  has  not  undergone 
electrostatic discharge testing. 
 

 

WARNING 

Pins  of  connectors  identified  with  the  ESD  warning  symbol  should  not  be  touched  and  the  connections  should  not  be  made  to  these 
connectors unless ESD precautionary procedures are used. 

 
Precautionary procedures are the following: 

 

Environmental procedures as: air conditioning, humidification, conductive floor coverings, non-synthetic clothing 

 

User procedures as: discharging one’s body to a large metal object, using wrist strap connected to earth. 

 
It is recommended that all staff involved receive an explanation of the ESD warning symbol and training in ESD precautionary procedures. 
 
the  electrostatic  discharge  is  defined  as  an  electric  charge  at  rest.  It  is the sudden  flow  of  electricity  between  two  objects  caused  by contact,  an 
electrical short, or dielectric breakdown. ESD can be caused by a buildup of static electricity by tribocharging, or by electrostatic induction. At lower 
relative humidity, as the environment is drier, charge generation will increase significantly. Common plastics generally will create the greatest static 
charges.  
Typical electrostatic voltage values: 
 
Walking across a carpet 

1.500 

– 35.000 volts

 

Walking over untreated vinyl floor 

250 

– 12.000 volts 

Vinyl envelope used for work instructions 

600 

– 7.000 volts 

Worker at a bench 

700 

– 6.000 volts 

 
If  two  items  are  at  different  electrostatic charge  levels,  as  they  approach  one  another,  a  spark  or  Electrostatic  Discharge  (ESD)  can occur.  This 
rapid, spontaneous transfer of electrostatic charge can generate heat and melt circuitry in electronic components. 
A latent defect can occur when an ESD sensitive item is exposed to an ESD event and is partially degraded. It may continue to perform its intended 
function, so may not be detected by normal inspection. Intermittent or permanent failures may occur at a later time. 
Static dissipative material will allow the transfer of charge to ground or to other conductive objects. The transfer of charge from a static dissipative 
material will generally take longer than from a conductive material of equivalent size. Some well known insulators are common plastics, and glass. 
An insulator will hold the charge and cannot be grounded and conduct. the charge away. 
Both conductors and insulators may become charged with static electricity and discharge. Grounding is a very effective ESD control tool, however, 
only conductors (conductive or dissipative) can be grounded. 
The fundamental ESD control principles are: 
 

 

Ground all conductors including people 

 

Remove insulators, substitute with ESD protective versions 

 

neutralize with ionizers 

 

ESDS outside the EPA (ESD protected area) to be in packaging having ESD shielding property 

 

1.6 

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.  

Содержание spirodoc

Страница 1: ...spirodoc SPIRODOC cod 980156 Rev 2 4 EN 1 46 User manual User manual rev 2 4 Issue date 10 04 2014 Approval date 10 04 2014...

Страница 2: ...23 2 7 Patient Data 24 2 7 1 Inserting data of a new patient 24 2 7 2 Patient data modification 24 2 8 Visualization of memory data 24 2 8 1 Database research modality 24 2 8 2 Visualization of databa...

Страница 3: ...mir spirometry com MIR accepts no responsibility for any loss or damage caused by the user of the device due to instructions contained in this Manual and or due to incorrect use of the product Please...

Страница 4: ...e a spirometry test is made The user is responsible to assess both the mental and the physical condition of the patient in order to perform a proper test furthermore in the evaluation of test results...

Страница 5: ...r the correct functioning and possibly cause damage The presence of any impurities such as hair sputum threads etc within the body of the turbine sensor may seriously compromise measurement accuracy 1...

Страница 6: ...with the correct operation of the device For this reason certain minimum clearances a few meters should be observed when high frequency appliances such as a TV radio portable phone etc and other elec...

Страница 7: ...rly aligned If the leads are inverted an inverse polarity connection may provoke acid leakage overheating smoke breakage and or fire Do not connect the battery pack leads to a wall socket or to the ca...

Страница 8: ...tandard this product and its component parts are of type BF and therefore protected against the dangers of direct and indirect contact with electricity 1 5 4 Warning symbol for the USB To connect to o...

Страница 9: ...ved receive an explanation of the ESD warning symbol and training in ESD precautionary procedures the electrostatic discharge is defined as an electric charge at rest It is the sudden flow of electric...

Страница 10: ...or alternatively to the personal best values from the clinical history of the subject The personal best values can vary considerably from the predicted values which are taken from healthy subjects SPI...

Страница 11: ...nt system Bi directional digital turbine Temperature sensor semiconductor 0 45 C Measurement principle Infrared interruption Volume range 10 L Flow range 16 L s Volume accuracy 3 or 50 mL Flow accurac...

Страница 12: ...to administer to the patient O2 percentage of oxygen administered to the patient before test L min SPO2 Base SPO2 base value for the SPO2 and ODI tests BPM Base BPM base value for the SPO2 and ODI te...

Страница 13: ...es SPO2 start 6MWT no SPO2 end 6MWT no BPM end 6MWT no SPO2 Base 6MWT no BPM start 6MWT no T Baseline 6MWT no T Walking 6MWT no T Recovery 6MWT no Distance 6MWT no T2 SPO2 T2 SPO2 6MWT yes T4 SPO2 T4...

Страница 14: ...ecial alarm frequency in the case of either SpO2 or cardiac pulse going outside of the programmed levels of alarm Beep with special alarm frequency during oximetry measurement in the case of a low bat...

Страница 15: ...llows access to all functions by simply touching the display The controls on the touch screen change dynamically based on the functions performed To access a specific function touch the corresponding...

Страница 16: ...ith the symbol 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 2 4 Main screen On the main sc...

Страница 17: ...via Bluetooth connection To view the pletismographic curve in real time while performing an oximetry test To check the alarms and alarm thresholds during oximetry testing To check the alarms and alarm...

Страница 18: ...egin There are four phases as follows Touch three times the top left hand point of the display Touch three times the top right hand point Touch three times the bottom right hand point Touch three time...

Страница 19: ...a menu appears to set the day and time that the device will turn on and off If turn ON mode was previously enabled and the user turns on the device at a different time from that of the programmed tim...

Страница 20: ...beep during oximetry testing WARNING The heart rate tone beep is always disabled during sleep oximetry testing please view paragraph 3 13 2 Default alarms This function allows to restore all default...

Страница 21: ...alibration allows to insert new calculated values to perform a new calibration A password is required to access this option insert the following password by touching the numbers starting from left to...

Страница 22: ...he item Configuration and insert the following password 1 2 2 3 3 3 The service menu will display the following items Doctor Patient Turn ON mode Patient data Oximetry setup Set questions Set symptoms...

Страница 23: ...ot be accepted This means that the device is not capable of correcting such a large calibration error In this case Check the correct functioning of the SPIRODOC with a new turbine and or Clean the tur...

Страница 24: ...ian Caucasian 100 Mexican American Oriental 100 Afro American Hong Kong Chinese 100 Other Giapanese 89 polinesian 90 North Indian 90 South Indian 87 Pakistani 90 African descendant 87 Aboriginal 85 Wh...

Страница 25: ...t specific date Test session in Patient Mode refers to spirometry PRE tests and oximetry tests performed within a 20 minute time span A new session is activated upon turning on the device if the time...

Страница 26: ...s can be seen on the screen to the right If a patient has instead performed a test in the current session and previous tests are archived the following screenshot is displayed 2 10 PC On line mode con...

Страница 27: ...tory parameters FIVC FIV1 FIV1 PIF are not of interest The optional initial inspiration phase can also be performed before inserting the mouthpiece in the mouth After inspiring slowly and deeply the f...

Страница 28: ...results from the PRE test as well as the relevant predicted values The following tests made by the patient show the following parameters Those values related to the test performed Those values related...

Страница 29: ...s shown Blow out all air in lungs Between tests the SPIRODOC checks the repeatability of the following parameters PEF repeatable when the difference between the two largest PEF is 0 67 L s VC repeatab...

Страница 30: ...message will appear Low battery level Touch the ESC icon to exit the test otherwise after a seconds will start the test In the event that a test is interrupted due to a complete battery discharge the...

Страница 31: ...case the icon will be shown as to then return to the previous icon when the two minutes are over For information concerning the proper setup of this function please refer to paragraph 3 6 WARNING A t...

Страница 32: ...6 minutes are up the device will automatically move on to the recovery stage and the timer will be reset to zero again Recovery stage The duration of this stage is entirely up to the doctor and it is...

Страница 33: ...agraph 3 13 1 To perform this test touch the from the main screen and subsequently select the test with the icon After approximately 5 minutes from the beginning of the test the SPIRODOC will automati...

Страница 34: ...The materials used for manufacturing the sensor are NATURAL LATEX PROTEIN FREE and are subject to biocompatibility tests WARNING The adult single patient sensor is ideal for patients weighing more th...

Страница 35: ...ximetry test walk test sleep oximetry send data via Bluetooth WARNING Spirometry test results do not include any automatic interpretation compared with the predicted values as no patient anthropometri...

Страница 36: ...Vista and Seven To avoid making any errors at this stage please read the Advanced section of the winspiroPRO User Manual carefully 3 4 Internal software upgrade SPIRODOC internal software can be upgr...

Страница 37: ...ne is still malfunctioning please replace it with a new one WARNING Do not carry out any cleaning procedures when using disposable turbines a new disposable turbine must be used for every new patient...

Страница 38: ...spiroPRO software For further information consult the winspiroPRO manual available on line within the software itself Spirometry test results are unreliable The turbine may contain dirt or foreign mat...

Страница 39: ...irometer Oximeter Brandname MIR Medical International Research Device name spirodoc Class IIa Complies with the Essential Requirements of directive 93 42 EC concerning Medical Devices and its amendmen...

Страница 40: ...ation If the product is utilised differently from the use described in the User s Manual If any alteration adjustment modification or repair has been carried out by personnel not authorised by the man...

Страница 41: ...spirodoc SPIRODOC cod 980156 Rev 2 4 EN 41 46 User manual ANNEX 1OXIMETRY TEST REPORTS EXAMPLES...

Страница 42: ...spirodoc SPIRODOC cod 980156 Rev 2 4 EN 42 46 User manual...

Страница 43: ...spirodoc SPIRODOC cod 980156 Rev 2 4 EN 43 46 User manual...

Страница 44: ...spirodoc SPIRODOC cod 980156 Rev 2 4 EN 44 46 User manual ANNEX 2SPIROMETRY TEST REPORT EXAMPLE...

Страница 45: ...for input output lines Mains power quality should be that of a typical commercial or hospital environment Surge IEC 61000 4 5 1 kV differential mode 2 kV common mode Not Applicable Mains power quality...

Страница 46: ...OC The SPIRODOC is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the SPIRODOC can help prevent electromagnetic interfe...

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