SPYROMETER GIMASPIR-50
Contents
1. In the event that the same patient makes also an oxymetry test then the same symbol gt is shown next to the SpOz and indicates that an oxymetry test is held in memory Select fuction SUB gt FVC gt SpO Press and on the display the following are shown in order e the spirometry parameters of the best test FVC 4 82 89 FEV1 4 12 91 FEVi 85 8 99 PEF 9 42 91 2575 4 02 82 FET 5 72 e the minimum maximum and average values of SpO2 and of the pulse rate from the last test made Gimaspir 50 user s manual page 49 of 66 Min Max Ave SpO2 96 99 983 Min Max Med BPM 62 105 88 No test data in memory Is shown this means that no tests have been made since the new subject data were entered If the message Gimaspir 50 user s manual page 50 of 66 3 3 Print out of the results To print the results held in memory connect the Gimaspir 50 to a parallel printer and press the El key from the main menu The results are then sent automatically to the printer To make a print out of the results then the optional hardware Optoisolated RS232 interface plus serial to parallel converter To connect to the printer see the following illustration as spirodoc RS232 connector RS 232 X 4 RS232 serial interface cable serial parallel printer converter er parallel printer con RE Gimaspir 50 user s manual page 51 of 66 3 3 1 P2. The instrument is not intended for use in an operating theatre or in the presence of inflammable liquids or detergents nor in the presence of inflammable anaesthetic gases or oxygen or nitrogen gases The instrument is not designed to be used in direct air currents eg wind sources of heat or cold direct sun light or other sources or light or energy dust sand or any other chemical substances The user is responsible to check the suitability of the ambiental conditions both for the storage and for the use of the instrument If Gimaspir 50 is exposed to unsuitable ambiental conditions this could cause the device to malfunction and to give incorrect results Gimaspir 50 user s manual page 6 of 66 1 1 4 Who must can make the installation The Gimaspir 50 requires installation by qualified personnel It is the responsibility of the user of the instrument to make the required operations 1 1 5 Patient effect on the use of the instrument A spirometry test should only be carried out when the patient is at rest and is in good health and thus in a suitable condition for the test A spirometry test requires the collaboration of the patient the patient must make a complete forced expiration in order to have a meaningful test result 1 1 6 Limitations of use Contraindications An analysis of the results of a spirometry test is not in itself sufficient to make a correct diagnosis of the patient s clinical condition A detailed cl
3. as instructed in article 9 of the European Directive CE n 93 42 law D Lgs n 46 1997 1 2 1 Danger of cross contamination The instrument uses a turbine sensor A mouthpiece is required to connect a patient to the spirometer In order to avoid exposing the patient to the critical danger of cross contamination the turbine sensor must always be sterilised before each spirometry test and a new monouse mouthpiece must be used for each new patient 1 2 2 The turbine An incorrect or insufficient sterilisation or cleaning of the turbine could be a cause of infection for the patient A regular sterilising or at least cleaning is strongly recommended See the relevant paragraph within this manual for details of the correct sterilising operation Do not expose the turbine sensor to a direct jet of water or air nor allow it to come into contact with liquid at high temperature Do not allow dust or foreign bodies to enter the turbine sensor to avoid incorrect functioning and possible damage The presence of any impurities such as hairs sputum threads etc within the body of the turbine sensor may brake the propellor and thus seriously compromise the accuracy of the measurements Gimaspir 50 user s manual page 10 of 66 1 2 3 The mouthpiece Any mono use mouthpieces included with the instrument are supplied only as a guide to the correct type and dimensions of the mouthpiece required for this instrument they are clean but not s
4. RED plus a symbol J In the event of a mixed interpretation obstruction plus restriction then the colour code always refers to the more severe of the two pathologies Gimaspir 50 may show one of the following messages showing the test quality of the test made Next test start faster If the start of the forced vital capacity is not made with sufficient force and velocity Gimaspir 50 user s manual page 37 of 66 Next test avoid coughing If the test contains a fall 50 and then a successive increase in the expired velocity Blow out air for a longer time If the expiratory time is insufficient FET lt 6sec or the volume variation gt 100mL in the last 0 5sec Blow out ALL air in the lungs If the last expiratory flow measured is too high gt 0 2 L s After these test quality control messages have been shown if generated then the Gimaspir 50 shows the values of FVC FEV1 FEV1 PEF 2575 and FET of the current test FVC 482 89 FEV1 4 12 91 On each line the parameter name is shown on the left the result ie the value in the centre and the percentage of the predicted value on the right The other parameters are then shown after 8 seconds or by pressing the key A FEVi 85 8 99 PEF 9 42 91 Gimaspir 50 user s manual page 38 of 66 2575 4 02 82 FET 5 72 The measurement units of these parameters are the following FVC litres FEV1 litres FEV PEF A litres sec
5. side and the detector on the underside of the finger e From the main menu select SpOz If the following message is shown Oximetry disabled this means that your device has the oximetry option fitted but this function has not been activated Contact the manufacturer or an authorised service agent Otherwise the following message is shown Wait please STOP Gimaspir 50 user s manual page 41 of 66 Then after a few seconds SpO2 98 72 Quality of the SpO2 signal The range is STOP Soff mit po ois C At this stage the first set of values of the SpOz2 and pulse have been stored and the test continues Press 1 to enable Gon or to disable Goff the acoustic signal which indicates that the oximetry limits have been exceeded The number of square blocks the symbol m is directly proportional to the strength of the oximetry signal maximum 8 squares Position the finger carefully inside the sensor to maximise the signal strength If the value of the SpOz2 or of the pulse rate go outside of the threshold values then Gimaspir 50 emits an audible warning which continues as long as the conditions remain The oximetry measurement can be stopped by pressing STOP If SpO2 is selected Gimaspir 50 checks if the sensor is connected and if a finger is inserted into the sensor and one of the following messages may be displayed Insert finger Connect sensor STOP Son STOP Son If the symbol Gon is shown
6. for instance Any such deposit could slow or block the free movement of the turbine blade and thus compromise the measurement accuracy To clean the turbine first remove it from the machine by rotating it and then pulling it gently holding it by the mouthpiece It can help to push it gently with a finger from underneath Immerse the turbine in a sterilising liquid not hot and move it in the liquid in order to remove any impurities deposited Then rinse the turbine immersing it in clean water not hot Gimaspir 50 user s manual page 53 of 66 To avoid permanent damage do not put the turbine under a direct jet of water or other liquid If no sterilising liquid is available it is necessary to clean the turbine in clean water Leave it to soak for at least one hour Shake off the excess water from the turbine and leave it to dry standing it vertically on a drying surface To check the perfect functioning of the turbine before reinserting it inside the machine it is good practise to make a visual check that the mobile part moves freely Place the turbine horizontally and move it slowly from side to side the mobile part blade must move without any obstruction If this is not the case the accuracy of measurement is no longer guaranteed and the turbine must be replaced When the turbine is clean replace it in the Gimaspir 50 note the correct direction as indicated by the arrow gt printed on the Gimaspir 50 case T
7. then Gimaspir 50 will emit a beep in each of these two cases Gimaspir 50 user s manual page 42 of 66 In order to avoid damage to the sensor and or incorrect results do not place excessive strain nor use excessive force on the sensor cable when using connecting or disconnecting the sensor to the device or to the hand Gimaspir 50 user s manual page 43 of 66 2 7 Making long term oximetry testing The reusable wrap sensor is suitable for making continuous non invasive oximetry monitoring of the arterial oxygen saturation in patients weighing more than 30 kg Use of this sensor is NOT advised for patients with allergic reactions to adhesive tape The raw materials used in the manufacture of the sensor are FREE FROM NATURAL LACTIC protein The materials used in the sensor have been subjected to rigerous tests of biocompatibility 2 7 1 Instructions for use of the wrap sensor e Select a suitable site to apply the sensor the index finger is ideal Alternatively the thumb the big toe or another finger can be used Detector Emitter e Use a new adhesive tape for each sensor and for each patient or as required See the relevant instructions for changing the tape Gimaspir 50 user s manual page 44 of 66 e Grasp the release liner on the corner and gently pull away from sensor e Place the patient s finger nail side up on the bottom longer contoured pad as shown Fold the adhesive wings
8. OEA SPYROMETER GIMASPIR 50 USE AND MAINTENANCE BOOK GIMA Spa Via Monza 102 20060 Gessate MI Italia ITALIA Tel 199 400 401 8 linee r a Fax 199 400 403 E mail gima gimaitaly com www gimaitaly com INTERNATIONAL Tel 39 02 953854209 Fax 39 02 95380056 E mail export gimaitaly com www gimaitaly com Gimaspir 50 user s manual page 1 of 66 Thank you for choosing a GIMA product The original packaging contains e instrument Gimaspir 50 e 3V DC lithium battery model CR 123A e Gimaspir 50 user s manual Optional accessories e oxymeter finger clip sensor e wrap finger sensor for oximetry over a long period Before using your Gimaspir 50 e Read the User s Manual carefully and read all of the labels supplied with the unit e Install the operating battery if not already installed taking care to connect correctly as shown inside the battery housing e Select the required display language Please keep the original packaging In the event that your unit has a problem use the original packaging to return the unit to your distributor or to the manufacturer GIMA has a policy of constant product improvement and the technology within our products is also in constant evolution thus we reserve the right to update these instructions as necessary We appreciate all suggestions from our users GIMA cannot be held responsible for any damage caused by users failing to follow the instructions and warnings w
9. aking a test TEST RESULTS 3 1 Interpretation of the spirometry test 3 2 Viewing the results 3 3 Print out of the results 3 3 1 Print out MAINTENANCE 4 1 Cleaning and general control of the turbine 4 2 Replacement tape instructions 4 3 Changing the battery POSSIBLE PROBLEMS 5 1 Causes and solutions CONFIGURATION MANUAL FOR THE GIMASPIR 50 6 1 Configuration menu Select Language Delete Test Data Oximetry threshold values Oximetry sampling rate Date Format Change Date Time Predicted Values Unit Format DHAAMDAGS AD ee re er ee ee e CONOORWDND Gimaspir 50 user s manual page 4 of 66 9 Select Printer 63 1 6 1 6 1 10 Store All Test for future developments 64 Declaration of EC Conformity Warranty Gimaspir 50 user s manual page 5 of 66 1 INTRODUCTION 1 1 Intended use 1 1 1 User category The Gimaspir 50 spirometer oxymeter measures a series of parameters relating to human respiratory function The product is therefore intended for use by a doctor or by a paramedic under the supervision of a doctor 1 1 2 Qualification and experience required The correct use of the instrument the interpretation of the test results plus the maintenance of the instrument in particular the sterilisation to avoid the risk of cross infection all require qualified personnel 1 1 3 Operating environment The operation of the instrument is foreseen within a doctor s office or within a hospital ward
10. ced on the finger of the patient The sensor contains two light emitting diodes LEDs one in the visible red spectrum and the other in the infrared spectrum The beams of light pass through the tissues to a photodetector During passage through the tissues some light is absorbed by the blood and by soft tissues depending on the concentration of haemoglobin The amount of light absorbed at each light frequency depends on the degree of oxygenation of haemoglobin within the tissues This measurement principle guarantees accuracy and reproducibility of the measurement without the requirement of constant calibration The sensor can be disinfected with isopropyl alcohol The power supply is a 3V battery and the battery life is in the region of two years depending on the use Gimaspir 50 user s manual page 20 of 66 1 6 Method of test interpretation Following every FVC test forced expiration the instrument makes a quality control check to verify the validity of the test made and to compare the principal measured parameters FEV1 FEV1 and FVC with the respective normal predicted value It also calculates a series of indices as per the following criteria index measured value normal or best value x 100 The colours code of the functional interpretation is as follows FEV1 or PEF gt 80 Green No problem FEV1 or PEF gt 50 lt 80 Yellow Caution FEV1 of PEF lt 50 Red Alert contact doctor These default values can b
11. d out before connecting to the mouthpiece To perform a good spirometry test the following instructions must be closely followed e Fit the nose clip to the nose in order to ensure that no air can escape from the nostrils e Insert the mouthpiece well into the mouth so that at least 2 cm of the mouthpiece is inside the mouth and close the sides of the mouth tightly around the mouthpiece in order that air cannot escape It is absolutely necessary to keep the mouthpiece between the teeth in order to avoid that the opening of the mouthpiece is obstructed by the lips If the mouthpiece is obstructed this can have a negative effect on the test results After a slow and deep inspiration the forced expiration must be made by making a complete forced expiration lasting as long as possible Gimaspir 50 user s manual page 36 of 66 After six seconds of forced expiration the device emits a long beep thus helping the user to understand when the minimum expiratory time has been reached To made a correct spirometric test all air must be expired from the lungs The measurement finishes automatically several seconds after the last volume variation at zero flow or by pressing STOP The display then shows the automatic test interpretation which follow the ATS recommendations with one normal level plus 5 levels of restriction and 5 levels of obstruction Severe Restrict y In addition a colour code is also shown GREEN YELLOW
12. e modified by the doctor during the configuration process Gimaspir 50 user s manual page 21 of 66 1 7 Technical specifications The following is a complete description of the technical characteristics of the instrument and of the flow volume and Pulse Oxymeter sensors 1 7 1 Spirometer specifications Measured parameters FVC Forced Vital Capacity FEV1 Volume expired in the 1st second of test FEV1 FEV1 FVC x100 Peak Expiratory Flow FEF2575 Average flow between 25 and 75 of the FVC FET Forced expiratory time Flow Volume sensor Bi directional turbine Measuring method Infrared interruption Max volume 10L Flow range 16 L s Volume accuracy 3 or 50 mL Flow accuracy 5 or 200 mL s Dynamic resistance at 12 L s lt 1 cmH O L s Gimaspir 50 user s manual page 22 of 66 1 7 2 Pulse oximeter specifications Measured parameters SpO2 Oxygen Saturation lv _ Pulse Rate Beats Per Minutes BPM Pulse oximeter sensor e Reusable finger clip e Reusable wrap type Measuring method Red and Infrared absorption SpO2 range 0 99 Functional SpO2 1 increments SpO2 accuracy Adult 2 70 100 SpO2 less than 70 is undefined SpO2 averaging 8 beats Pulse Rate range 30 254 BPM 1 BPM increments Pulse Rate accuracy 2 BPM or 2 whichever is greater Pulse rate averaging 8 seconds Signal strength Audible warnings e Pulse Beep at the frequency of the card
13. e there are no obstructions and the sensor is clean Autoclaving ethylene oxide sterilizing or immersing the sensors in liquid may cause sensor damage which may result in inaccurate readings Unplug the sensor from the monitor before cleaning or disinfecting to prevent damaging sensor or monitor and to prevent user safety hazards 1 2 5 The instrument The maintenance operations detailed in this manual must be carried out precisely If these instructions are not followed this can cause measurement errors and or an incorrect test interpretation Any modifications adjustments repairs or reconfiguration must be made by the manufacturer or by personnel authorised by the manufacturer Never attempt to make a repair oneself Gimaspir 50 user s manual page 13 of 66 The set up of configurable parameters should only be made by qualified personnel However an incorrect set up of the parameters does not put the patient at risk High frequency emissions may interfere with the correct operation of the instrument For this reason certain minimum clearances a few metres should be observed when high frequency appliances such as a TV radio portable phone etc and other electronic units are operated at the same time in the same room The instrument may give inaccurate readings in the presence of strong electromagnetic sources such as electrosurgery equipment The instrument may give inaccurate readings in the presence of computed to
14. e time in the same way 6 1 7 Predicted Values PREDICTED VALUES 7 Esc wh Ok e press J to select PREDICTED VALUES and to choose one of the 3 available authors for the predicted values calculated for adult subjects PREDICTED VALUES oERS eKNU oUSA The symbol e indicates the values currently selected from the 3 available KNU Knudson ERS European Respiratory Society USA Crapo Bass Morris It is possible to select another author by pressing In the case of children or young adults the Knudson mode is always utilised regardless of whether this is the actual mode selected Gimaspir 50 user s manual page 62 of 66 6 1 8 Unit Forme UNIT FORMAT WF Esc dm Ok e press Okto select the measurement units required Select either Kg cm or Lb in using the o key Press Ok to confirm 6 1 9 Select Printer SELECT PRINTER W Esc wh Ok e press Okto select printer for direct printout Select with A and Vv HP 1 for the printer protocol for the HEWLETT PACKARD HP300 series through to the 500 series HP 2 corresponds to the protocol for HEWLETT PACKARD HP600 series up to the 800 series printers CANON corresponds to the protocol for CANON printers EPSON IBM corresponds to the protocol for EPSON IBM EPSON STYLUS corresponds to the protocol for EPSON STYLUS COLOR printers Press Ok to confirm Gimaspir 50 user s manual page 63 of 66 6 1 10 Store All Test for future developmen
15. ecise measurement instrument which measures the main spirometric parmeters during a test of forced expiration At the end of each test the machine gives also a suggested automatic interpretation for the respiratory function of that subject In order to make a correct evaluation of a spirometry test the measured values must be compared with the normal or predicted values These values are taken from a healthy population and are calculated from tables or formulas in function of the age height and sex of the subject in question Gimaspir 50 automatically calculates the relevant normal values and compares them as a percentage with the measured values An example of such a calculation is shown below parameter FVC FVC measured FVC normal x 100 Gimaspir 50 user s manual page 26 of 66 2 OPERATION OF THE GIMASPIR 50 2 1 Keyboard All Gimaspir 50 have a keyboard consisting of 5 keys 4999 The J key has several functions SWITCH ON to switch on the Gimaspir 50 press and release SWITCH OFF to switch off the Gimaspir 50 press the key for at least 2 seconds ENTER to confirm and to proceed to the next phase The V is generally used e to answer the questions shown on the display e to reduce modify a value highlighted with an arrow The o key is generally used e to answer the questions shown on the display Gimaspir 50 user s manual page 27 of 66 e used to change the an
16. epair centre for help Use only GIMA SpO2 sensors supplied with or specifically intended for use with the Gimaspir 50 Use of sensors not intended for use with the Gimaspir 50 may cause inaccurate readings Oximetry measurements may be inaccurate in the presence of high ambient light Shield the sensor area with a surgical towel for example if necessary Dyes introduced into the bloodstream such as methylene blue indocyanine green indigo carmine patent blue V PBV and fluorescein may adversely affect the accuracy of the oximetry reading Any condition that restricts blood flow such as the use of a blood pressure cuff or a device for systemic vascular resistance may cause an inability to determine accurate pulse rate and SpO2 readings Remove fingernail polish or false fingernails before applying oximetry sensors Fingernail polish or false fingernails may cause inaccurate SpO2 readings Gimaspir 50 user s manual page 12 of 66 Significant levels of dysfunctional hemoglobins such as carboxyhemoglobin or methemoglobin will affect the accuracy of the oximetry measurements Optical cross talk can occur when two or more sensors are placed in close proximity This can be eliminated by covering each site with opaque material Optical cross talk may adversely affect the accuracy of the SpO2 readings Obstructions or dirt on the sensor s red light or detector may cause a sensor failure or inaccurate readings Make sur
17. ess the o key 2 4 1 New subject data The cursor is shown lt 4 against the first parameter age Use the keys A and V to select the correct age Age cm kg S 354172 74 001 Press J to confirm and to move onto the next value and the cursor lt 4 moves to the next parameter Select the correct value with the A and V keys e Age On the left of the display beneath the value Age the arrow appears 4 to show that the age can be increased or reduced by pressing the keys V A Gimaspir 50 user s manual page 34 of 66 Press I to confirm the selected value e cm The arrow then appears after the height again the value can be increased or reduced using the V A keys Press J to confirm the value e Kg The arrow then appears on the weight the value can be increased or reduced using the V A keys Press J to confirm the value e S Sex The arrow then appears on the sex the sex can then be indicated using the V A keys indicates male and female Press to confirm the selection e Shows the progressive ID number of the patient If an error is made press the o key to go back to the previous value Gimaspir 50 user s manual page 35 of 66 2 5 Making a spirometry test When spirometry test is selected the display then shows EXPIRE fast STOP Press the STOP key to return to the main menu The optional inspiratory phase can be carrie
18. he SpOz2 and of the pulse rate in bpm The max and min threshold values both for the SpOz2 and for the pulse in bpm are then shown amp SpO2 80 100 amp BPM 40 180 e the current setting on or off of the acoustic signal BEEP ON OFF oOn e Off Gimaspir 50 user s manual page 32 of 66 During the oximetry measurement if the value of the SpO2 or of the pulse rate go outside of the threshold values then Gimaspir 50 emits an audible warning which continues as long as the conditions remain The default threshold values are shown If the optional oximetry module has not been purchased with the Gimaspir 50 then only spirometry testing can be carried out If the following message is shown Oximetry disabled this means that your device has the oximetry option fitted but this function has not been activated In this case contact the manufacturer or an authorised service agent The device can be switched off at any time by pressing and holding down the 1 for a few seconds After 3 minutes the device will automatically switch off Gimaspir 50 user s manual page 33 of 66 2 4 Entering subject data From the main menu select SUB Subject data New Esc To insert details of a new subject press the New key To keep these subject details ie to retest that subject press Esc Age cm kg S 35 172 74 3 001 To keep these subject details ie to retest that subject press I To insert details of a new subject pr
19. iac pulse e Continuous beep if the SpOz limit values or the pulse rate go outside of the set limits e Continuous beep during the oximetry test if the battery is low Gimaspir 50 user s manual page 23 of 66 Displayed warnings e Insert the finger e Connect sensor 1 7 3 Other specifications Display LCD 2 lines 16 characters Keyboard 5 keys Interface RS 232 bi directional Power supply Lithium battery 3 V type CR123A Dimensions 70x80x30 mm Weight 100 g including operating battery Type of electrical protection Class II device Safety level for shock hazard Apparatus type BF Protection level against water penetration IPXO plastic device not waterproof Safety levels during use in presence of inflammable anaesthetic gases or oxygen or nitrogen Apparatus not suitable Conditions of use Apparatus for continuous use Conditions of storage Temperature MIN 0 C MAX 40 C Humidity MIN 10 RH MAX 95 RH Operating Conditions Gimaspir 50 user s manual page 24 of 66 Temperature MIN 10 C MAX 40 C Humidity MIN 10 RH MAX 95 RH Applied norms Electrical Safety Standard IEC 60601 1 Electro Magnetic Compatibility IEC 60601 1 2 Expected working life A life expectancy of 10 years is declared This device is a Class lla medical device according to the European Directive 93 42 CEE Gimaspir 50 user s manual page 25 of 66 1 8 Spirometric normal values Gimaspir 50 is a pr
20. inical history of the patient is also required together with any other tests suggested by a doctor Test comments a test interpretation and suggested courses of treatment must be given by a doctor Any symptoms that the patient has at the time of the test must be carefully considered before a spirometry test is made The user is responsible to assess both the mental and the physical capacity of the patient to make a correct test and the user must also assess the degree of collaboration for each test carried out A correct spirometry test always requires full collaboration from the patient The results obtained always depend upon the patient making a complete inspiration and then a complete expiration of air at the maximum possible velocity If these conditions are not respected then the results obtained will not be reliable and therefore the results are not medically acceptable The acceptability of a test is the responsibility of the user Special attention should be given to testing elderly patients children plus handicapped people Gimaspir 50 user s manual page 7 of 66 The instrument should never be used when it is possible or probable that the validity of the results may be compromised due to any such external factors Gimaspir 50 user s manual page 8 of 66 1 2 Important safety warnings Gimaspir 50 has been examined by an independent laboratory which has certified the conformity of the device to the European Safety Standard
21. ithin this manual Note that due to printing limitations the screenshots shown in this manual may differ from the display of the machine and or from the keyboard graphics Copying this manual in whole or in part is forbidden Gimaspir 50 user s manual page 2 of 66 1 INTRODUCTION 1 1 Intended use 1 1 1 User category 1 1 2 Qualification and experience required 1 1 3 Operating environment 1 1 4 Who must can make the installation 1 1 5 Patient effect on the use of the instrument 1 1 6 Limitations of use Contraindications 1 2 Important safety warnings 1 2 1 Danger of cross contamination 1 2 2 The turbine 1 2 3 The mouthpiece 1 2 4 The Pulse oxymetry sensor 1 2 5 The instrument 1 3 Unforeseen errors 1 4 Labels and symbols 1 4 1 Identification Label 1 4 2 CE mark for medical devices 1 4 3 Electrical safety symbol 1 4 4 Warning symbol for the RS232 serial port 1 5 Product description 1 6 Method of test interpretation 1 7 Technical specifications 1 7 1 Spirometer specifications 1 7 2 Pulse oximeter specifications 1 7 3 Other specifications 1 8 Spirometric normal values OPERATION OF THE GIMASPIR 50 2 1 Keyboard 2 2 Battery level Gimaspir 50 user s manual page 3 of 66 Oo TX NNWMRAA GAG 2 3 To make a test 2 4 Entering subject data 2 4 1 New subject data 2 5 Making a spirometry test 2 6 Making a spot oxymetry test 2 7 Making long term oximetry testing 2 7 1 Instructions for use of the wrap sensor 2 7 2 M
22. ly 100g It is able to measure the most important functional respiratory parameters and to monitor the oxygen saturation and pulse rate It makes a quality control check on the test carried out Gimaspir 50 is intended for any doctor from a family doctor to a specialist requiring a small and compact instrument able to make full spirometry and oximetry tests To make a meaningful interpretation of the measured spirometry parameters the measured parameters must be compared to the so called normal or predicted values which are calculated from the anthropometric data of the subject The predicted values represent an average taken from a healthy population Gimaspir 50 gives a simple traffic light summary of the spirometric test interpretation This test interpretation is based on the ATS American Thoracic Society standards of 5 levels of obstruction 5 levels of restriction and one of normal spirometry The instrument thus gives a valid support to the doctor to make a functional diagnosis The sensor for flow and volume measurement is a turbine sensor based on the infrared interruption principle This measurement principle guarantees accuracy and reproducibility of the measurement without the requirement of constant calibration Sterilisation is simple as the only requirement is to withdraw the turbine tube and to immerse it in a cold sterilising solution Gimaspir 50 user s manual page 19 of 66 The sensor for pulse oxymetry is pla
23. mography CT eqipment Do not use the instrument in the presence of magnetic resonance imaging MRI equipment MRI equipment may cause induced current to the SpO2 sensor resulting in patient injury If the instrument is connected to any other instrument then in order to maintain the essential safety characteristics laid down by IEC 60601 1 1 only equipment which complies to the current safety regulations may be used For the recycling of the Gimaspir 50 accessories plastic consumable materials mouthpieces plus the battery use only the appropriate containers or return all such parts to the seller of the instrument or to a recycling centre All appropriate local regulations must be followed Gimaspir 50 user s manual page 14 of 66 Use only a battery of the type indicated in the Technical specifications Remove the battery from the device if the machine is not used for a long period several months Keep the device out of reach of children and of any person with mental handicap Gimaspir 50 user s manual page 15 of 66 1 3 Unforeseen errors In the case of a problem one of a series of messages to indicate the nature of the problem will appear on the screen together with a warning beep Operation of this device beyond its declared life see the relevant paragraph in the Technical Characteristics could provoke a loss of data in the memory of the device SRAM memory Errors in measurement or in interpretati
24. on can also be caused by e use by non qualified or non trained personnel lacking ability or experience e user error e use of the instrument outside the guidelines described in this User s Manual e use of the instrument even when some operational anomalies are encountered e non authorised servicing of the instrument Gimaspir 50 user s manual page 16 of 66 1 4 Labels and symbols 1 4 1 Identification Label SN A23 14300000 C Battery 3V CR123A Made in Italy by 0476 This label contains e Product name Serial number of the device Battery type and power Name and address of the manufacturer Mark of conformity with the directive 93 42 CEE 1 4 2 CE mark for medical devices CG This product is certified to conform to the requirements of the 93 42 CEE medical devices directive Gimaspir 50 user s manual page 17 of 66 1 4 3 Electrical safety symbol In accordance with the IEC 60601 1 the product and its component parts are of type BF and therefore protected against the dangers of direct and indirect contact with electricity 1 4 4 Warning symbol for the RS232 serial port F For connection to other devices such as PC or printer Use only the serial cable supplied by the manufacturer and observe the safety regulations of IEC 60601 1 1 Gimaspir 50 user s manual page 18 of 66 1 5 Product description Gimaspir 50 is a simple to operate precise pocket spirometer and pulse oxymeter weight on
25. ond 2575 litres second FET seconds If the symbol x is shown next to a result this means that the result is below the lower limits of the normal values This can be considered significant when the doctor makes the interpretation of the spirometry tests Press the A and V keys to view the messages and the results of the current test another time Press J to return to the main menu To make another spirometry test repeat the procedure already described Gimaspir 50 user s manual page 39 of 66 2 6 Making a spot oxymetry test The reusable finger sensor can be used to measure both the oxygen saturation SpO2 plus the frequency of the arterial pulse using a non invasive method This sensor is suitable for patients with body weight over 20kg measuring at rest In the default setting Gimaspir 50 stores the two oximetry parameters every 12 seconds To make a test e Connect the sensor to the device insert the connecter with the arrow head printed on the connecter towards you e Select a finger which fits correctly into the sensor e Insert the finger into the sensor until the finger touches the stop Ensure that the bottom of the finger completely covers the detector If the sensor cannot be positioned correctly then use another finger Gimaspir 50 user s manual page 40 of 66 e Position the sensor so that the cable rests along the palm of the hand This ensures that the light source is on the fingernail
26. pling W Esc de Ok e press Ok to modify the sampling rate in seconds of the oximetry parameters The default rate is every 12 seconds Select the required value 4 8 12 16 or 20 sec with A or y Press Ok to confirm 6 1 5 Date Format DATE FORMAT F Esc amp Ok Gimaspir 50 user s manual page 60 of 66 e press Ok to modify the date format Select the required format mm dd yy or dd mm yy with the o key Press Ok to confirm 6 1 6 Change Date Time CHANGE DATE TIME W Esc wm Ok e press Ok to modify the DATE and TIME Use A and V to modify the number with the cursor lt Ok to confirm Use the o key to return to the value previously inserted The actual date is shown DATE 244 01 04 dd mm yy The arrow 4 positioned to the right of the field indicates the numerical value to be modified On the second line under the date format is indicated mm dd yy or dd mm yy If you wish to change the date format please refer refer to the section DATE FORMAT With the two keys A and V you increase or decrease the value in the field selected In the case that you make an error press o to move the cursor back to the previous field and modify the data inserted Press the to confirm date to be entered Gimaspir 50 user s manual page 61 of 66 Once the date has been set it will appear as this example DATE 24 01 04 TIME 164 33 15 After the date set th
27. rint out EXAMPLE OF RESULT PRINTOUT The printout header can also be programmed Name Predicted values ERS ECCS FLOW L s e i 2 3 4 5 6 FLOW L s INTERPRETATION Not Valid MIR spirodoc Ver 1 4 Gimaspir 50 user s manual VOLUME L Signature Age 32 Height cm 184 Date 05 07 04 Spirometry PRE FVC L s 5 29 FEV1 L 4 18 FEV1 79 0 PEF L s 10 09 FEF2575 L s 3 72 FET s 3 86 Date 05 07 04 Oximetry MIN SPO2 97 Duration hh mm ss Sex M Weight Kg 88 Time 14 26 Predicted 5 43 97 4 49 93 81 5 97 10 07 100 4 89 76 Time 15 57 MAX AVG 98 97 2 00 01 00 o Predicted page 52 of 66 4 MAINTENANCE Gimaspir 50 requires very little maintenance The only periodic requirements are Cleaning and general control of the turbine flow and volume measuring system Periodic changing of the operating battery 4 1 Cleaning and general control of the turbine The turbine flow and volume measurement system used by the Gimaspir 50 guarantees accurate measurement and also has the major advantage of not requiring any periodic calibration In order to ensure the correct operation of the turbine it is necessary to carry out a simple cleaning This operation also assures a level of hygiene for the subjects who will breath through the machine It is a good rule to make a visual check from time to time that dirt or foreign bodies are not deposited inside the turbine like hair
28. roblem 5 1 Causes and solutions Gimaspir 50 does not switch on Check that the battery is inserted correctly inside the battery cover on the back of the machine If it is then change the battery When switched on the display shows 16 dark blocks Change the battery If this does not resolve the problem contact a qualified technical service company During operation the machine switches itself off and then on again Change the battery If this does not resolve the problem contact a qualified technical service company At the end of a test the measured data is not correct Clean the turbine and then control the free movement of the turbine blade Memory lost caused by unexpected event The data in the archive has been cancelled Contact a qualified technical service company Gimaspir 50 user s manual page 57 of 66 6 CONFIGURATION MANUAL FOR THE GIMASPIR 50 To change the configuration of the Gimaspir 50 ensure that the instrument is switched off e Press and hold down the on key W for at least two seconds you will hear a continuous beep until you see the following screen INSERT PASSWORD e Insert the password GreenYellowYellowRedRedRed In case of an error the following message is shown PASSWORD ERROR t Esci Retry e press J to reinput the code or A and V to exit After two attempts with the wrong code the Gimaspir 50 switches off automatically to avoid errors When the code is in
29. s IEC 60601 1 and guarantees the EMC Requirements within the limits laid down in the European Standard IEC 60601 1 2 The Gimaspir 50 is continually controlled during its production and therefore the product confirms to the established security levels and quality standards laid down by the Council Directive 93 42 CEE for MEDICAL DEVICES After removing the device from its package control that there is no visibile damage present pay particular attention to any flaws or cracks in the plastic casing that may lead to exposure of electrical components The safety and the correct performance of the unit can only be assured if the user of the instrument respects all of the current safety rules and _ regulations The manufacturer accepts no responsibility for problems or damage caused by the failure of the user to follow these instructions correctly The instrument must be used as described in the User s Manual with particular attention to Intended Use and only original spares and accessories as specified by the manufacturer may be used The use of a non original turbine sensor of other parts could cause measurement errors and or compromise the correct functioning of the instrument and is therefore not permitted Gimaspir 50 user s manual page 9 of 66 In the event of any kind of accident arising from the use of the device the patient must inform his doctor and the doctor must communicate the full details adverse event reporting
30. serted correctly the device enters into configuration mode Press e A and V to move between the various menu selections e Esc to exit from the configuration menu e Ok to enter into the selection on the screen Gimaspir 50 user s manual page 58 of 66 6 1 Configuration menu 6 1 1 Select Language SELECT LANGUAGE W Esc Ok e press Ok to modify the display language Select the required language with A and V Press Ok to confirm 6 1 2 Delete Test Data DELETE TEST DATA 7 Esc Ok e press Ok to delete the tests from memory A password is then required the same password input to enter into the config menu When inserted the test memory is cancelled Press Ok to confirm 6 1 3 Oximetry threshold values OXIMETRY THRESH W Esc Ok e press Ok to modify the threshold values either of the SpO2 and or of the pulse rate bpm a SpO2 80 lt 100 amp BPM 40 180 The values shown are the standard default values Gimaspir 50 user s manual page 59 of 66 The arrow 4 positioned to the right of the field indicates the numerical value to be modified With the two keys A and V increase or decrease the value of the field selected In the case of an error press o to move the cursor back to the previous field and to modify the data inserted Press Ok to confirm BEEP ON OFF oOn eOff Press o to switch on or off the warning beep 6 1 4 Oximetry sampling rate SpO2 sam
31. surement Gimaspir 50 user s manual page 47 of 66 3 TEST RESULTS Gimaspir 50 will memorise the details of the best spirometry test selecting the test with the highest sum of FVC FEV1 plus the most recent oximetry test made on the current subject The best spirometry test is the one made by that subject which contains the highest sum of FVC FEV1 3 1 Interpretation of the spirometry test Gimaspir 50 gives an automatic functional interpretation of the spirometry test following the latest guidelines of the ATS American Thoracic Society which has one level of normal spirometry 5 levels of obstruction and 5 levels of restriction This test interpretation is shown directly on the display of the instrument In addition a colour code is shown indicated by the symbol lJ This table illustrates the possible test interpretations 0 Green Normal spirometry Mod Severe Obst Mod Severe Rest Light Red Severe Obstruction Severe Restriction Dark Red Very Severe Obst _ Very Severe Rest In the case of a mixed interpretation obstruction plus restriction then the colour code will always refer to the more severe of the two pathologies Gimaspir 50 user s manual page 48 of 66 3 2 Viewing the results When the subject details have been inserted and at least one spirometry test made then the symbol gt is shown next to the FVC to indicate that the results are held in memory Select fuction SUB gt FVC SpO
32. t name Ver x y Gimaspir 50 user s manual page 30 of 66 The product name is indicated on the first line and the current software version on the second line After circa one second the charge of the battery and the percentage of memory remaining are displayed BATTERY MRRE Free memory 95 After circa two seconds the current date and time are shown DATE 20 01 04 TIME 16 48 55 When the date and time are shown press the o key to modify the date and time DATE 204 01 04 dd mm yy The arrow q shown to the right of the field indicates the value to be modified The current date format dd mm yy or mm dd yy is shown on the second line To modify the date format see the section describing the configuration menu e Use A and V to increase or to decrease the value of the selected field Press o to return to the previous field to correct an error e Press J to confirm each value Gimaspir 50 user s manual page 31 of 66 When the date is set the screen shows for example DATE 22 01 04 TIME 164 33 15 Use the same procedure to set the time If Gimaspir 50 was purchased without the oximetry option then only spirometry testing can be made If the oximetry module is purchased at a later date contact either the manufacturer or an authorised service centre to activate the oximetry function Otherwise the following screens are shown e the upper and lower limit values of t
33. tee period free repair and or replacement of any defective parts due to faulty manufacture will be given labour postal transport and packaging charges etc are not included The guarantee therefore excludes components subject to wear and tear such as parts in rubber or PVC etc No compensation will be given for loss of use of the product Furthermore replacement or repairs effected during the guarantee period do not lengthen the duration of the guarantee A This guarantee is void in the event of repairs effected by unauthorised persons or with spare parts not approved by GIMA damage or defects caused by negligence blows abnormal use of the appliance or faulty installation The guarantee will be invalidated if the registration number has been removed cancelled or altered Faulty appliances must be returned only to the retailer where the item was bought Any item dispatched directly to us will be refused Gimaspir 50 user s manual page 66 of 66
34. terile To purchase appropriate mouthpieces generally either paper or plastic in any case mono use disposable we suggest that you contact your local distributor who supplied the spirometer The use of a mouthpiece made from an inappropriate material could modify the bio compatibility and could cause a malfunction of the instrument and thus incorrect test results The user is responsible to obtain the correct type of mouthpieces for the instrument Those required are a standard type with an outside diameter of 30mm they are commonly used and in general easily procured 1 2 4 The Pulse oxymetry sensor Prolonged use and or the patient s condition may require changing the sensor site periodically Change sensor site and check skin integrity circulatory status and correct alignment at least every 4 hours Prolonged use may cause blisters skin deterioration and discomfort Incorrectly applied sensors may cause inaccurate readings Using a damaged sensor may cause inaccurate readings possibly resulting in patient injury or death Inspect each sensor before use If a sensor appears damaged do not use it Use another sensor or contact your authorized repair centre for help Gimaspir 50 user s manual page 11 of 66 Using a damaged patient cable may cause inaccurate readings possibly resulting in patient injury or death Inspect the patient cable If the patient cable appears damaged do not use it Contact your authorized r
35. thropometric data of the patient or to correct recently input data The A key is generally used e to answer the questions shown on the display e to increase modify the value highlighted with an arrow The i key is used to return to view some info messages Gimaspir 50 user s manual page 28 of 66 2 2 Battery level The symbol a indicates the level of the battery is charge The maximum charge of the batteries is indicated when four symbols appear As the battery charge level reduces the symbol is shown If the battery is completely discharged the following message is shown on the display LOW BATTERY If the battery discharged condition occurs during an oximetry test then Gimaspir 50 emits a constant beep providing this function is switched on Gimaspir 50 user s manual page 29 of 66 2 3 To make a test Switch on the Gimaspir 50 by pressing the WI key The following message is shown the charge of the battery and the percentage of memory remaining are displayed BATTERY BREE Free memory 95 If no tests or information have been stored the following message is shown BATTERY BREE Memory empty After circa one second the main menu is shown Select function SUB FVC SpO2 m SUB to insert the new subject s data FVC to make a spirometry test SpOz2 to make an oximetry test to view or to print the test results If i key is pressed the following info messages are shown produc
36. ts STORE ALL TEST W Esc Ok e press Okto modify the setting Press the YELLOW key to select or deselect the function The default setting of Gimaspir 50 will memorise only the best test from any session Gimaspir 50 user s manual page 64 of 66 QW ir srl MEDICAL INTERNATIONAL RESEARCH Via del Maggiolino 125 00155 Roma ITALY Declaration of EC Conformity Quality Management System according to the requirements of Annex II of the Medical Device Directive 93 42 EEC Notified body CERMET N 0476 Certificate of Conformity N MED 9826 MIR srl Medical International Research declares that the Device subject of this declaration together with its standard accessories conforms to the requirements of the Council Directive 93 42 EEC Annex ll point 3 Device Description Spirometer Oxymeter Device name spirodoc Gimaspir 50 Classification lla This device is marked with 0476 Any modifications to the Device which are not authorised by us will invalidate this declaration Roma 11 09 2000 Simon Fowler Marco Pennacchietti Sales Manager Quality Manager Rev 2 Mod PO 10DDC_spirodoc Gimaspir 50 user s manual page 65 of 66 GUARANTEE Thank you for having acquired our product This product meets the most stringent requirements regarding the selection of quality manufacturing materials and also the final control The product has a 12 month warranty valid from the date it is delivered by GIMA During the guaran
37. up onto the sides of the patient s finger Do not pull or stretch tape Do not cover the nail e Fold the emitter pad over the top of the patient s finger Align the emitter window directly opposite the detector window e Fold the adhesive wings down and around the patient s finger Do not pull or stretch the tape Ensure cont asm the positioning marks for the Aout emitter and detector are aligned Positioning marks Gimaspir 50 user s manual page 45 of 66 e Connect the sensor cable to the Gimaspir 50 and check if all is functioning correctly as previously described 2 7 2 Making atest If the spot oximetry test lasts for more than 5 minutes then the device goes into long term measurement mode and the display shows SpO 98 Esc 729 Elapsing time E E Soff The acoustic signal is switched off and the automatic switch off time becomes 30 minutes The sequence of the symbols gy ff a indicates the time intervals If the value of the SpO gt 2 or pulse rate go outside of the threshold values then Gimaspir 50 e returns from the long term measurement mode to the spot measurement mode and e emits a continuous beep Gimaspir 50 user s manual page 46 of 66 The oximetry measurement can be stopped by select ESC press i key is shown the message SpO2 98 729 STOP Press STOP within 2 seconds to return to the main menu otherwise Gimaspir 50 will continue the long term mea
38. wist to lock the turbine into the case To insert the turbine correctly into the machine push it inside and turn it anticlockwise until you hear a click which confirms that the turbine is locked inside the plastic case Gimaspir 50 user s manual page 54 of 66 4 2 Replacement tape instructions The adhesive tape is made from latex free materials It is recommended to use a new sensor tape for each new patient or as needed Genly remove used sensor tape and discard appropriately It is recommended to use a new sensor tape for each new patient or as needed e Sensor back is equipped with alignment pegs Place sensor with alignment pegs down against adhesive side of tape aligning the pegs with the tape holes properly e Press firmly on sensor to push pegs through tape holes Pick up both sensor and tape and verify sensor pegs are aligned properly Gimaspir 50 user s manual page 55 of 66 4 3 Changing the battery When BATTERY LOW appears on the display of the Gimaspir 50 at switch on or if the machine does not switch on at all then change the operating battery Only use 3V Lithium battery CR123A or equivalent When you insert the battery pay close attention to the polarity shown inside the battery cover see design below Gimaspir 50 user s manual page 56 of 66 5 POSSIBLE PROBLEMS A list of possible problem follows plus a list of messages which may appear on the display to indicate the type of p
Download Pdf Manuals
Related Search