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Manuale di istruzioni BpTRUl

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1. 57 temperature Alert Silent mode 73 Calibration Check 74 changing scale C F 74 display described 9 rectal measurement 29 single oral or axillary measurement 25 TONGS i ties iii ian 13 transferring data by USB 75 U USB connecting 75 WwW warnings cautions 4 6 WAITAMy 0 iii 81 eea OPERE aii aaa paio 57 Z Zero Calibration Check BP 71 Index 87
2. If the low battery indicator appears a maximum of 20 blood pressure measurements may be taken before the BpTRU prevents further operation Plug the BpTRU into a wall outlet to charge the battery Note that it is still possible to perform measurements while the battery is charging To allow auto calibration to complete wait at least 5 seconds after turning on the monitor before pressing the BP Start button Obtaining Accurate BP Measurements Careful patient treatment and use of the BpTRU will result in more accurate blood pressure measurements Select an Appropriate Size of Cuff The BpTRU may not provide accurate readings if you use the wrong size of cuff The five available cuff sizes are listed below with the range of arm circumferences appropriate for each The child and extra large adult sizes may be ordered separately e Child 1318 cm e Small adult 1826 cm e Regular 2634 cm adult e Large adult 3243 cm e Extra large 4152 cm adult Display Reference Position the Patient Carefully 1 Ensure that the patient avoids smoking or caffeine for at least one hour before test 2 Ensure that the patient is comfortable and relaxed either sitting or lying down The position shown in the illustration below is ideal 3 Ensure that the upper arm is at heart level and supported Cuff Selection and Placement Ensure cuff index line is within cuff range markers when wrapped around the upper arm Proper Patient
3. Mounting the Bo TRU e For mounting your BPM device please refer to the instructions included with the mounting hardware 43 BpTRU Operator s Manual Connecting Cuffs The BpTRU is equipped with a coiled tube that can be left permanently attached The individual blood pressure cuffs connect to this tube via a threaded fitting Connect the Coiled Tube The coiled tube has a threaded fitting on a one end and no fitting on the other end The bare end the end without the fitting connects to the BpTRU Push the bare end of the coiled tube onto the barbed fitting on the front of the BpTRU near the BP Start button Ensure that the tube is fully and snugly attached to the barbed fitting Loose connections may result in faulty inflation and deflation of the cuff and lead to inaccurate readings Thread the other end of the coiled tube onto the fitting on one of the cuffs Refer to Obtaining Accurate BP Measurements on page 16 for instructions on selecting an appropriate size of cuff 44 Display Reference Temperature Probe Mounts BPM300 On the BPM300 clips are provided to mount the temperature probe on the right hand side of the BpTRU near the temperature control buttons on the same side of the monitor as the temperature and power jacks To install these clips follow the instructions below There are two temperature probes a blue probe for oral and axillary measurements and a red probe for
4. 12 Toni aUdio iii 13 Misurazione della pressione arteriosa 15 Come ottenere misurazioni accurate 16 Scelta delle dimensioni corrette del bracciale 16 Posizione corretta del paziente 17 Applicazione del bracciale 18 Manuale di istruzioni BoTRU Singola misurazione della pressione modo Singolo 19 Rilevazione di una singola misurazione 19 Serie di misurazioni modo Automatico 20 Resultati di una serie automatica di misurazioni 22 Richiamo delle misurazioni i 22 Richiamo misurazioni in modo Singolo 22 Richiamo misurazioni in modo Automatico 23 Annullamento modalit di stand by ceeeeeeereeeeeeeeeeee 23 Termometro solo BPM300 1 25 Misurazioni orale e ascellare 25 Preparazione della sonda n 25 Rilevazione della temperatura corporea 27 Misurazioni rettali 29 Ricerca problematiche 1rrunzicei eee 31 Guida alla ricerca delle problematiche 32 Errori di sistema da EO a E15 35 Analisi errori da E20 a E27 aiie lia iero 37 Err
5. 70 Modalit Avviso Silente pressione enesenn 70 Modalit valori nascosti 71 Calibrazione punto zero pressione eee teeee 71 Manometro di riferimento per il controllo di calibrazione 72 Modalit Avviso Silente temperatura BPM300 73 Modalit temperatura Celsius Fahrenheit BPM300 74 Controllo calibrazione temperature BPM300 74 Modalit connessione USB modelli BPM200 e BPM300 75 ACCOSSON iss iaoiae ella iaia 77 Bracciali misurazione pressione e loro dimensioni 77 Accessori e alimentazione 78 Bracciali e tubi ii 78 Sonde temperatura e coprisonda 78 Manuale di istruzioni BoTRU Installazione accessori 78 Specifiche alimentazione 78 Informazioni utilizzatore 80 Garanzia nani ranieri anita 81 Garanzia limitat ie ille 81 ESGLUSIONI di ee ee 82 Registrazione garanzia csrl 83 Lae Lee ee E E EEE 85 vi Introduzione TRU Congratulazioni per aver acquistato il vostro Monitor dei parametri vitali BpTRU Panoramica del prodotto BpTRU un misuratore automatico non invasivo della pressione arteriosa con rilevazione opzionale della temperatura progettato specificamente per la cura primaria Misura i valori di pressione sistolica e diastoli
6. Note that it is possible to perform measurements while the battery is charging If the battery charging indicator remains on for longer than 24 hours during charging the battery needs to be replaced It is recommended that the battery be replaced every 2 years Refer to Replacing the Battery on page 49 for replacement instructions CAUTION Using batteries beyond their recommended lifetime may result in damage to the BpTRU Display Reference Replacing the Battery rn 1 Open the battery door at the back of x the BpTRU Use a Phillips screwdriver provided to remove both screws 2 Disconnect the battery wiring harness and remove the battery Do not use a metal tool Do not pull on the wires 3 Insert the new battery Join the two battery connectors The connectors only fit one way 4 Close the battery door and secure it with the 2 screws 5 Dispose of the battery safely Refer to Storage and Disposal Requirements on page 54 WARNING Do not use a metal tool to install or remove a battery The terminals may short and lead to an electrical safety hazard Functional Assessment of the BpTRU When you turn on the BpTRU all displays will illuminate showing 888 and the buzzer will sound for a few seconds If the displays or buzzer do not activate the BpTRU may not be working properly Consult the Troubleshooting section If you are concerne
7. SP indicates a single measurement Ay O 5 Initiate the series of measurements by pressing the lt p BP Start button During each measurement the cuff will inflate to the minimum required preset pressure level While inflating and deflating the Systolic display indicates the cuff pressure NOTE Initiate rapid deflation of the cuff at any time by pressing the Stop button or turning off the power It is important for the patient to remain still and not talk during inflation and deflation of the cuff During the series of measurements the Reading display shows the number of the measurement currently being taken The most recent Systolic Diastolic and Pulse measurements are shown in the respective displays until the next measurement begins If you select a one or two minute cycle time and the patient s blood pressure is high any individual measurement may take longer than one or two minutes 21 BpTRU Operator s Manual The BpTRU will not begin a new measurement until the cuff is fully deflated from the previous measurement Results of an Automatic Series of Measurements The BpTRU performs the following actions at the completion of six measurements e A tone sounds unless the tone has been disabled as described in Technical Modes of Operation on page 70 e The results of the last measurement are displayed for five seconds while the Reading display shows 6 e After five second
8. form a closed system 6 Press BP Start to close the BpTRU s valve This closes the pneumatic system and allows pressure to be applied to the BpTRU pressure transducer The maximum time for the valve to remain closed is approximately 3 minutes After this time the valve is opened and the Pulse display shows ccc When the valve has cooled the pressure display will re illuminate 7 Apply a static pressure of up to 300 mmHg and compare the pressure displayed in the BpTRU Pulse and Reading displays to the reference pressure gauge to verify accuracy A properly calibrated monitor should read within 3 mmHg of the reference pressure gauge at all pressures 8 Apply static pressure greater than 330 mmHg or pressure greater than 10 mmHg for 3 minutes to check if overpressure or over inflation time safety mechanisms are operating properly and error codes are displayed Remove the fault condition and press BP Clear to remove the error code Note that the valve will remain open for 30 seconds following activation of a safety mechanism 9 Press Stop to open the valve 10 Return to normal operation by turning the BpTRU off and then on again using the power switch Temperature Alert Silent Mode BPM300 The BpTRU makes a short audible tone after completing a single temperature measurement This feature is enabled by default but can be disabled and reenabled as follows 1 Turn the BpTRU off using the power switch 2 To togg
9. BPM with accessories or other products that are not authorized by BpTRU or any cause other than the intended normal use of the BPM Non warranty work is charged at the minimum repair rate effective at the time the BPM is returned to BpTRU All repairs include a complete functional test using factory test fixtures 81 BpTRU Operator s Manual EXCLUSIONS 82 TO THE FULL EXTENT ALLOWED BY LAW THIS LIMITED WARRANTY IS THE PURCHASER S SOLE AND EXCLUSIVE REMEDY AND NO OTHER WARRANTIES CONDITIONS OR GUARANTEES OF ANY KIND SHALL APPLY WHETHER STATUTORY WRITTEN ORAL EXPRESS OR IMPLIED INCLUDING WITHOUT LIMITATION WARRANTIES CONDITIONS OR GUARANTEES OF MERCHANTABILITY FITNESS FOR A PARTICULAR PURPOSE PERFORMANCE QUALITY OR DURABILITY ALL OF WHICH ARE DISCLAIMED IN NO EVENT WILL BpTRU BE LIABLE FOR ANY SPECIAL EXTRAORDINARY INDIRECT OR CONSEQUENTIAL DAMAGES OF ANY KIND WHATSOEVER INCLUDING WITHOUT LIMITATION DAMAGES FOR LOSS OF DATA LOST PROFITS LOSS OF OPPORTUNITY BUSINESS INTERRUPTION PERSONAL INJURY OR DEATH OR ANY OTHER LOSS ARISING OUT OF RELATING TO OR IN CONNECTION WITH THE BPM EVEN IF BpTRU IS ADVISED OF THE POSSIBILITY OF SUCH DAMAGES LIABILITY LIMITATIONS IF AS A RESULT OF OR IN CONNECTION WITH ANY USE OF THE BPM BpTRU BECOMES LIABLE TO THE PURCHASER OR ANY OTHER PERSON FOR ANY DAMAGES LOSSES COSTS EXPENSES OR OTHER LIABILITIES WHATSOEVER AND REGARDLESS OF THE FORM OF ACTION IN CONTRACT TORT
10. OR PURSUANT TO STATUTE THEN BpTRU S AGGREGATE LIABILITY TO ALL SUCH PERSONS WILL BE LIMITED TO AN AMOUNT EQUAL TO THE PURCHASE PRICE PAID FOR THE BPM The exclusion of certain conditions and warranties and the limitation of certain liabilities is prohibited in some jurisdictions so these limitations and exclusions may not apply to some purchasers Warranty This limited warranty is governed solely by the laws of the Province of British Columbia Canada and applicable federal laws of Canada excluding any rules of private international law or the conflict of laws which would lead to the application of any other laws and the courts of British Columbia Canada shall have exclusive jurisdiction over any claims relating to this limited warranty The BpTRU logo BpTRU and the collection of these marks are trademarks of BpTRU Medical Devices a Division of 0764509 B C Ltd All rights reserved Warranty Registration Device registration is required for warranty validation Please visit our website at www BpTRU com to register online Once at the homepage select BpTRU Warranty Registration from the Customer Services menu On the Warranty Registration page fill in the appropriate information and press Submit 83 BpTRU Operator s Manual 84 Index A alarms nica lecito 13 Alert mode BP Alert Silent mode 70 Temperature Alert Silent mode 73 Automatic mode series of measurements op
11. PRECAUZIONE Non utilizzare il monitor se ci sono evidenze di qualsasi danno elencato nel capitolo Ispezioni a pagina 52 Sostituire le parti danneggiate o gli accessori d obbligo per un corretto funzionamento del monitor PRECAUZIONE Umidit eccessisa o l immersione del BpTRU e dei suoi accessory in un liquido possono causare rischi per la sicurezza elettrica o il blocco dei connettori e del tubo Non tentare di utilizzare il monitor senza permettere un tempo sufficiente di asciugatura PRECAUZIONE Se necessario pulire la batteria utilizzare solamente un panno secco Non utilizzare fluidi PRECAUZIONE Il BpTRU ed i suoi accessori non sono stati realizzati per essere sterilizzati in autoclave L autoclave dannegger irreparabilmente monitor e accessori PRECAUZIONE L utilizza di un alimentatore diverso da quello provvisto con il BpTRU pu danneggiare il monitor e provocare misurazioni inaccurate PRECAUZIONE L utilizzo di accessori trasduttori e cavi differenti da quelli specificati pu aumentare le emissioni EMF o diminuire l immunit del sistema alle EMF con l ambiente circostante Introduzione PRECAUZIONE Quando si utilizza lo stativo a rotelle opzionale assicurasi che il BpTRU e gli accessori siano installati in accordo alle istruzioni fornite con lo stativo per assicurare stabilit Se si utilizza uno stativo alternativo assicurarsi che il BpT
12. aeai 9 Hide mode 71 Pulse reads CCC 72 disposal of battery 54 E electromagnetic interference 65 EMG crana eir 65 emissions EMC 65 environmental ranges 57 error codes 41 EO e a PAL ni 35 A A E E agi 35 el Siesta E 36 ed O E ETE 37 Ed eed heen inl 37 E12 RI RA i ok 37 ES aan 37 E aLaaa 37 E15 iii ar 37 Elio ad ai 36 E20 ic aloe iaia 38 Elio sreita abusa dead 38 22 a ad nil 38 E23 na ea Nano 38 E24 ri rieti ASILI 38 BpTRU Operator s Manual i223 eee dieta ie lE 38 A AE E E E 38 EET EA iii A EE 39 Edili 36 E4 usores 36 e a forati 39 E42 aaa 39 FAS soso elise ee iaia 39 E440 o clive eed eos 39 ha Pe RePEc o 39 FAT ENE E teeta chet 40 te E iii Hie ete ae te 40 Eilat ii ek ee 36 526 i lei a 40 E53i rali age 40 E54 ciale ee helene ea eae 40 EDS eli aa 40 EG aria aaa 36 ET clelia parsa 36 EB alii 36 Edito rai 36 F Fahrenheit changing between C and F 74 functional assessment 49 H hazards familiarity with instructions 15 impairment of circulation 16 perforating patient s bowel 29 30 temperature probe with child 30 Hide mode 71 l indications on start up 49 INSPECTION 51 53 interference EMC 65 M MaINtenanc
13. are all blank Power is on green indicator light is on and device malfunction LED is displayed Unrecoverable system error has occurred Turn power off and ensure cuff is deflated Turn power on again Refer to Unrecoverable System Errors on page 41 Power is on green indicator light is on BpTRU is in hide mode Refer to BP but there is only a dash Hide Mode on in the left digit of the Cycle display page 71 Turn the BpTRU off if it is on Hold down the Cycle button while turning the BpTRU on again 32 Display Reference Symptoms Possible Causes Corrective Actions Power is on and E15 displays when BP Battery is low Plug BpTRU into a wall outlet to charge Start or Temperature the battery Start button is pressed Monitor turns off Blown fuse Contact BpTRU automatically and cannot restart when power applied Customer Support No power green indicator light is off All displays remain lit on power up Power supply is not plugged into wall outlet Power supply is not plugged into BpTRU Wall outlet is not powered Battery is fully discharged Power supply is plugged in properly and power indicator light does not turn on with power switch Undetermined causes Plug power supply into wall outlet Plug power supply into BpTRU Have qualified technician inspect wall outlet and power breaker Plug
14. contact Floors should be wood discharge ESD 48 KV air 48 KV air concrete or ceramic tile If floors TEC 6100042 are covered with synthetic material the relative humidity should be at least 30 The BPM200 monitor should be poweredoff or not taking a measurement when the USB cable is installed or removed Electrical fast 2 kV for 2 kV for Mains power quality should be transients burst power supply power supply that of a typical commercial or IEC 6100044 lines lines hospital environment 1 kV for Not input output applicable lines Surge 1 kV 1 kV Mains power quality should be TEC 6100045 differential differential that of a typical commercial or mode mode hospital environment 2 kV 2 kV common common mode mode Voltage dips lt 5 Ur for Mains power quality should be short 0 5 cycles that of a typical commercial or interruptions hospital environment If you and voltage 40 Ur for 5 40 Ur for 5 require continued operation of variations on Tales cycles BPM100 during power mains power supply interruptions power the input lines 70 Ur for 25 70 Urfor25 BPM100 from an TEC 61000411 cycles cycles uninterruptible power supply lt 5 Urfor5 lt 5 Urfor5 or battery sec sec NOTE Uris the a c mains voltage prior to application of the test level 66 Display Reference Guidance and manufacturers declaration electromagnetic immunity The BpTRU monitor is intended for use in the electrom
15. inflation Ensure that cuff is applied properly and tubing is not kinked E3 Inflation too slow Check cuff and tubing for leaks due to cracks and tears Check connections for tightness E4 Inflation too fast Check cuff and tubing for kinks E5 Deflation too slow Check cuff and tubing for kinks E6 Deflation too fast Check cuff and tubing for leaks due to cracks and tears and connectors for tightness E7 Pressure offset calibration not complete E7 will occur if you press BP Start while the BP Zero Calibration Check is still in progress Wait for the E7 error code to disappear typically less than 5 seconds and push the BP Start button again If the E7 error code occurs when you have not pressed BP Start or if it does not disappear contact BpTRU Customer Support E82 Low pulse amplitude Check patient for pulse Tighten cuff on arm and check BpTRU for leaks in tubing or cuff E9 Vacuum detected Push Clear button Disconnect cuff and wait 15 seconds before reconnecting Perform zero offset check 36 Display Reference E10 Cuff over 300 mmHg Ensure patient is sitting quietly to for more than 5 reduce motion artifacts during seconds inflation Check cuff and tubing for kinks E11 Cuff pressurized for Check cuff and tubing for leaks due more than 130 seconds to cracks and tears Check connectors for tightness Check cuff and tubi
16. measurement Repeat measurement and ensure that failed curve check probe is located correctly patient is still during single temperature measurement and patient s mouth is closed Use Continuous mode if error is repeated E52 Single measurement Repeat measurement Use over display limit Continuous mode if error is repeated gt 39 C E53 Single measurement Repeat measurement Use under display limit Continuous mode if error is repeated lt 35 C E54 Single measurement Allow probe to cool to room start temperature out temperature for 34 minutes press of range lt 10 C or Temperature Start and then repeat gt 32 C measurement Use Continuous mode if error is repeated E55 Single measurement Internal malfunction Contact BpTRU temperature circuitry not operational Customer Support 40 After a temperature error the corrective action should allow a return to normal operation for the next measurement If the problem persists discontinue use and contact your distributor or BpTRU Customer Support Display Reference Unrecoverable System Errors Certain system errors could result in abnormal operation of the BpTRU which could present a hazard to the operator or patient To prevent such a hazard the BpTRU monitors the following functions and parameters 1 Proper internal voltage supply 2 Proper functioning of the microcontroller 3 Over inflation of the cuff maximum 330 mmHg 4 Overtime inflatio
17. the BpTRU should be checked annually or if there are any concerns about the safety of the monitor Refer to BP Reference Gauge Calibration Check on page 72 Replace the battery every 2 years Refer to Replacing the Battery on page 49 CAUTION Using batteries beyond their recommended lifetime may result in damage to the BpTRU 51 BpTRU Operator s Manual A CAUTION Stop using the monitor if there is evidence of any of the damage listed below Replacement of damaged parts or accessories is mandatory for correct functioning of the monitor Inspection 52 All labels on the BpTRU should be examined for integrity and legibility i e they should not be peeling Damaged or missing labels may lead to misuse of the monitor The BpTRU and power supply with cord should be examined for possible electrical hazards caused by any loose connectors cracks or other broken parts including damage which might permit access to the interior of the chassis or power supply All electrical cables should be examined for possible electrical hazards caused by cracked or broken connectors or wires The BpTRU and power supply should be examined to ensure that they do not rattle indicating loose components inside which may lead to faulty operation Prior to using the monitor or after replacing the battery check for battery irregularities such as cracks deformation leakage corrosion or other problem
18. 6 Oral blue temperature probe 1 8 m 6 Rectal red temperature probe 2 4 m 8 USB cable 3 0 m 10 A CAUTION The use of accessories transducers and cables other than those specified may result in increased EMF emissions or decreased immunity of the system to EMF within the surrounding environment Technical Modes of Operation Technical modes of operation are available for the BpTRU to change configurations check functionality and accuracy and to connect the monitor to a computer BP Alert Silent Mode 70 As well as the power up tone the BpTRU makes a short audible tone after completing a series of measurements in Automatic mode This feature is enabled by default but can be disabled and re enabled as follows 1 Turn the BpTRU off using the power switch 2 To toggle BP Alert Silent Mode hold Stop while turning the BpTRU on Repeating this toggles the BpTRU to the previous state Alert Mode is indicated by three short beeps followed by one long tone during power up Silent Mode is indicated by three short beeps during power up without a final long tone Display Reference BP Hide Mode 2 Hide mode allows the operator to hide blood pressure readings that would normally appear at the end of each measurement By default the BpTRU does not start in Hide mode Turn on Hide mode as follows 1 Turn the BpTRU off using the power switch 2 To toggle the BP Hide Mode h
19. BpTRU into wall outlet to charge the battery Have qualified technician inspect output of power supply Contact BpTRU Customer Support BpTRU is not powered down properly Turn power off wait 10 seconds and turn power on again 33 BpTRU Operator s Manual Symptoms Possible Causes Corrective Actions Buzzer does not sound at end of sixth measurement in Automatic mode BpTRU is set to BP Silent mode Exit BP Silent mode by turning off power and then holding Stop button down while turning power back on Buzzer does not sound at end of single temperature measurement BpTRU is set to Temperature Silent mode Exit Temperature Silent mode by turning off power and then holding Temperature Start button down while turning on monitor Cuff does not inflate during operation Cuff or tubing is not attached properly Leakage in cuff or tubing Internal leakage Check all cuff and tubing connectors for tightness Perform a BP Zero Calibration Check page 71 or BP Reference Gauge Calibration Check page 72 Check cuff and tubing for cracks and tears which may lead to leakages Perform a BP Zero Calibration Check page 71 or BP Reference Gauge Calibration Check page 72 Contact BpTRU Customer Support 34 Display Reference Symptoms Possible Causes Corrective Actions Systolic display BpTRU is set to BP Exit BP Zero shows software Z
20. E 93 42 Allegato IL inerente i Dispositivi Medici Dispositivo elettrico di Classe II Parte applicata di Tipo BF significante che il monitor protetto dalla scarica del defibrillatore Dopo l esposizione al voltaggio del defibrillatore il BpTRU continuer regolarmente nelle sue funzioni Non necessario nessun tempo di ripristino Attenzione Consultare la documentazione allegata per ulteriori informazioni Simbolo di alimentazione indicante la corrente diretta DC con le specifiche polarit che deve essere utilizzata con il BpTRU Solamente l alimentazione specificata deve essere utilizzata con il monitor Dispositivo malfunzionante Consultare le sezioni Messaggi di Errore e Ricerca problematiche Manuale di istruzioni BoTRU Avvertenze e precauzioni gt AVVERTENZA Le avvertenze contengono istruzioni specifiche per prevenire gravi lesioni o morte del paziente o dell operatore PRECAUZIONE Le precauzioni contengono istruzioni specifiche per prevenire lesion minori al paziente all operatore o danni allo strumento Avvertenze generali BP BP bd AVVERTENZA E necessario leggere attentamente ed avere familiarit con le istruzioni operative prima di utilizzare il monitor AVVERTENZA Un uso prolungato eccessivo o non corretto del BpTRU potrebbe portare a lesion dei tessuti stasi venosa e may lead to tissue injury venous pooling and impedimenti alla circolazione
21. Manuale di istruzioni BpTRUI DO Il presente manuale stato redatto per i dispositivi BpTRU Vital Signs Monitors modelli BPM100 BPM200 e BPM300 BpTRU il logo BpTRU e la collezione di questi marchi sono si propriet della BpTRU Medical Devices una Divisione di 0764509 B C Ltd Tutti i diritti riservati Copyright 2007 BpTRU Medical Devices una Divisione di 0764509 B C Ltd Tutti i diritti riservati Manuale revisione 6 1 Contenuto DO Introduzione ssa ica 1 Panoramica del prodolt ssrraara eee 1 BPMI0O Lellis sissi iis 1 BRM 200 at ae i de oe ee a ize E 2 BP MSO Os secret crecstectemc mttaer A inci aed te ele 2 Informazioni di SICULEZZA i 2 Indicazioni d Uso ciali Eni GLIELI 2 Controindicazioni d USO ui 3 Simboli di sicurezza e definizioni i 3 Avvertenze e precauzioni 4 Avvertenze generali e 4 Precauzioni generalizia scroll aa 5 Indicazioni del Display rreciizizi ine 9 DIsplysasa aiar 9 Indicatori tutti i modelli eee eeeeeeeeetteeeeeeees 10 Indicatori BPM200 e BPM300 n 10 Indicatori solo BPM8300 i 10 Pulsanti nas sisiazl Errore Il segnalibro non definito Pulsanti tutti i modelli 11 Pulsanti solo BPM300
22. Position Cuff at heart level back and arm supported feet flat on floor Stay still during Measurements Relax At your discretion BP can be taken while lying down or standing 17 BpTRU Operator s Manual Apply the Cuff 1 Align the artery indicator on the cuff over the brachial artery of the patient s arm shown in the figure to the left 2 Wrap the cuff around the arm and check that the white index marking on the edge of the cuff falls within the white range markings on the inside surface of the cuff 3 Check that the index falls within the range markers If the index does not fall within the range markers replace the cuff with a smaller or larger cuff as indicated 4 Ensure that the cuff is tight but that it is still possible to insert two fingers between the cuff and the arm 5 Measure BP on both arms initially then use the arm with the higher reading for all subsequent measurements During the measurement e Ensure that the patient s arm and body do not move e Avoid talking to other people in the room e To improve the accuracy of the results leave the patient alone in a room for the full six measurements with the BpTRU on an automatic cycle of one or two minutes as recommended by the American Heart Association Display Reference Single BP Measurements Single Mode This section describes how to obtain a single blood pressure measurement Begin by positioning the patient an
23. RU e i suoi accessori siano sufficentemente stabili oscillando il sistema di 10 dalla verticale Se sistema ritorna nella posizione originale significa che sufficinentemente stabile PRECAUZIONE L utilizzo delle batterie oltre la durata raccomadata pu danneggiare il dispositivo BpTRU Manuale di istruzioni BoTRU Indicazioni del display m Il pannello frontale a LED del BpTRU visualizza le rilevazioni della pressione cosi come la modalit operative e lo stato dello strumento 3 1 E Srsrouc mmHg TEMPERATURE C F e enti DDD 9 oOo lt Cai PULSE BPM oe LIL piega l BG 0 2 a oe OLE mi READING CYCLE min ooo 2 88 88 J gt 4 Figura 1 Display Pannello Frontale Displays In fuzione del modello il BpTRU ha cinque o sei display a LED multi digit per visualizzare i dati 1 Systolic Pressione sistolica espresso in millimetri di mercurio mmHg 2 Diastolic Pressione diastolica espresso in millimetri di mercurio mmHg 3 Pulse Frequenza cardiaca espressa in battiti al minuto bpm BpTRU Operator s Manual 4 Reading Indica quale misurazione visualizzata nei display della sistolica diastolica e frequenza cardiac e Un numero indica che visualizzato sul display il risultato di una msirua in modalit singola o automatica Cio se tre misurazioni della pressione sono state rilevate il display Reading mostra 3 e gli altri display mostrerann
24. U Medical Devices a Division of 0764509 B C Ltd BpTRU warrants to the original purchaser that the BpTRU device BPM will be free from defects in material and workmanship for two 2 years from the date of the original purchase from BpTRU or its authorized resellers All BPM accessories are warranted for a period of one 1 year from the date of original purchase from BpTRU or its authorized resellers This limited warranty is non transferable If the BPM is defective during the warranty period the purchaser s sole and exclusive remedy and BpTRU s sole obligation will be at BpTRU s option repair the BPM to conform to its specifications replace the BPM with a comparable product or refund to the purchaser the original price paid for the BPM Repaired or replaced products or parts may be new or reconditioned and are subject to this limited warranty through the end of the original warranty period To obtain warranty service the purchaser must contact BpTRU during the warranty period provide BpTRU with dated proof of original purchase from BpTRU or an authorized reseller or have completed their BPM registration with BpTRU ship the BPM to BpTRU by prepaid delivery and have packaged the BPM appropriately for safe shipment The purchaser is responsible for shipping costs This warranty does not apply if the defect or malfunction in the BPM was caused by misuse neglect unauthorized attempts to open repair or modify the BPM use of the
25. a e suo contenitore Informazioni di sicurezza Questa sezione descrive le indicazioni d uso le controindicazioni i simboli di sicurezza avvertenze generali e precauzioni che si dovrebbero tenere utilizzando il BpTRU Indicazioni d uso e Il BpTRU misura la pressione sistolica e diastolica e la frequenza cardiaca in soggetti da 3 anni di et a salire e Il BPM300 misura la temperatura in soggetti da 3 anni di et a salire e Il BpTRU si intende per l utilizzo nello studio medico in area infermieristica cura del paziente in ospedali e Il BpTRU deve essere utilizzato esclusivamente da medici personale paramedico o professionisti opportunamente istruiti Introduzione Controindicazioni d uso e Il BpIRU non stato progettato per l utilizzo su neonati infanti o bambini con meno di 3 anni di et e Il BpIRU non stato progettato venduto o realizzato con scopi diversi da quelli precedentemente indicati Simboli di sicurezza e definizioni CE 0086 I simboli di sicurezza che si trovano nell etichetta nella parte posteriore ed inferiore del monitor BpTRU e nel suo manuale di istruzioni hanno le seguenti definizioni Conforme agli standard CSA inerenti i dispositivi elettromedicali per il mercato canadese e statunitense con specifici standard elencati nel simbolo a fianco Il marchio CE di questo prodotto indica che stato testato in conformit alle norme previste dalla Direttiva CE
26. agnetic environment specified below The customer or the user of the BpTRU monitor should assure that it is used in such an environment Immunity Test IEC 60601 test Compliance Electromagnetic environment level level guidance Power frequency 3 A m 3 A m Power frequency magnetic 50 60 Hz magnetic field TEC 6100048 fields should be at levels characteristic of a typical location in a typical commercial or hospital environment Portable and mobile RF communications equipment should be no closer to any part of the BpTRU monitor including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter as shown below 67 BpTRU Operator s Manual Guidance and manufacturers declaration electromagnetic immunity The BpTRU monitor is intended for use in the electromagnetic environment specified below The customer or the user of the BpTRU monitor should assure that it is used in such an environment Immunity Test TEC 60601 test Compliance Electromagnetic environment level level guidance Conducted RF 3 Vrms 3 V rms Recommended separation TEC 6100046 150 kHz to 80 distance MH ui d 12P Radiated RF 3 V m m TEC 6100043 80 MHz to 2 5 d 1 2 4P GHz 80 MHz to 800 MHz d 234P 800 MHz to 2 5 GHz where P is the maximum output power rating of the transmitter in Watts according to the transmitter
27. ation Pressure measurement range 0 to 290 mmHg Pressure measurement accuracy Meets or exceeds ANSI AAMI SP10 1992 Within 3 mmHg or 2 whichever is greater Systolic blood pressure measurement range 60 to 250 mmHg Diastolic blood pressure measurement range 40 to 160 mmHg Pulse rate measurement range 40 to 200 beats per minute Blood pressure measurement efficacy Meets or exceeds ANSI AAMI SP10 1992 standard for overall efficacy of blood pressure measurements versus standard auscultation using the 5 Korotkoff sound Average error within 5 mmHg Standard deviation within 8 mmHg Pulse rate measurement efficacy Meets or exceeds specification against a clinical reference Average error within 1 beats per minute Standard deviation within 3 beats per minute Maximum operating cuff 290 mmHg pressure Maximum possible cuff 330 mmHg pressure Maximum possible cuff inflation time Over 10 mmHg for 3 minutes Temperature probe sensor type Thermistor 61 BpTRU Operator s Manual Item Specification Single temperature measurement range 35 C to 39 C 95 0 F to 102 2 F Continuous temperature measurement range 28 C to 43 C 82 4 F to 109 4 F Single temperature measurement time 15 seconds Continuous temperature measurement settling time 3 4 minutes Single temperature efficacy Average
28. ca e la frequenza cardiaca Non richiede la calibrazione manuale La modalit Automatica brevettata aumenta l accuratezza delle rilevazioni della pressione arteriosa mediante il calcolo del valore medio di misure multiple che riduce l effetto Ipertensione clinica isolate Ipertensione da camice bianco BPM100 Il modello BPM100 ha le seguenti caratteristiche e Applicazione a parete per garantire stabilit o da tavolo e Tre tipi di bracciali disponibili pediatrico per adulti e obesi e Intervalli di misura selezionabili da 1 a 5 minuti per rilevazioni multiple in modalit Automatica e Calibrazione continua e automatica del punto zero garantisce che lo strumento fornisce sempre rilevazioni accurate della pressione e Pressurizzazione automatica a 180 mmHg per la prima misura e sgonfiaggio lineare Manuale di istruzioni BoTRU BPM200 Il modello BPM200 ha le seguenti caratteristiche in aggiunta a quelle del modello BPM100 e Batteria ricaricabile con protezione dal versamento di acido e Applicazione su stativo a rotelle da parete o da tavolo e Porta USB per trasferimento dei dati a dispositive elettronici BPM300 Il modello BPM300 ha le seguenti caratteristiche in aggiunta a quelle del modello BPM300 e Singola misurazione di temperatura predittiva orale ed ascellare in 15 secondi e Misurazione continua di temperatura orale rettale ed ascellare continua da 3 a 4 minuti e Dotato di sonda di temperatur
29. che a pagina 32 13 BpTRU Operator s Manual Misura della pa pressione arteriosa tu gt Bb Il BpTRU pu rilevara una misura di pressione arteriosa singola oppure una serie di misure automaticamente Per informazioni su come ottenere una misura di pressione accurata consultare Come otterere misurazioni accurate a pagine 16 Per rilevare una singola misura fare riferimento a Singola misurazione della pressione modalit Singola a pagina 19 Per misurazione multiple della pressione fare riferimento a Series of Measurements Automatic Mode a pagina 20 Per rivedere To review separate measurements in Manual mode or to review the individual readings taken in Automatic mode refer to Reviewing Measurements on page 22 Reviewing the individual readings for a patient allows the clinician to note the high and low readings for systolic and diastolic blood pressure and pulse rate as well as assess any trending in the individual readings or error codes WARNING Warnings contain instructions to prevent serious injury or death of the patient or operator NOTE Initiate rapid deflation of the cuff at any time by pressing the Stop button or turning off the power 15 BpTRU Operator s Manual A WARNING Prolonged excessive or incorrect use of the BpTRU may lead to tissue injury venous pooling and impairment of circulation in the arm of the patient
30. d about the accuracy of the pressure measurements obtained with the BpTRU use the BP Zero Calibration and BP Reference Gauge Calibration checks to verify the pressure measurement accuracy See Technical Modes of Operation on page 70 49 BpTRU Operator s Manual 50 Similarly use the Temperature Calibration Check to verify temperature measurement accuracy See Technical Modes of Operation on page 70 Please contact Bp TRU Customer Support for information on how to order a BP Reference Gauge Calibration Kit Maintenance BO TRU Frequency of Inspection and Care The BpTRU and its accessories should be inspected for any damage that may affect safety and accuracy at the following times Note that no manual calibration is required e After initial setup e Monthly e After any mishandling for example if the BpTRU is knocked off the mounting bracket Clean the BpTRU and accessories as required using a damp cloth and mild detergent The accuracy of the pressure and temperature measurement circuitry in the BpTRU should be checked annually or if you have any concerns about the accuracy of the monitor Refer to the following sections for instructions on using these modes of operation e BP Zero Calibration Check on page 71 e BP Reference Gauge Calibration Check on page 72 e Temperature Calibration Check BPM300 on page 74 The operation of the BP overpressure and overtime safety features of
31. d attaching the cuff as described in Obtaining Accurate BP Measurements on page 16 WARNING The blood pressure cuff should not be used on the same arm as an IV or any other medical equipment that relies on the circulatory system distal to the cuff CAUTION Avoid compressing or restricting the coiled tubing which may restrict inflation or deflation of the cuff and cause mechanical failure of the tubing Take the Single BP Measurement 1 Press Clear to ensure that any previous T measurements are cleared from the BpTRU s memory Select Manual mode by pressing the Cycle button until SP is displayed in the Cycle display lag 2 3 Initiate a single blood pressure measurement by pressing the BP Start button The cuff will inflate to the 180 mmHg pressure level and then may inflate by 30 mmHg increments as required to obtain an accurate BP result During inflation and deflation the Systolic display indicates the cuff pressure 19 BpTRU Operator s Manual A NOTE Initiate rapid deflation of the cuff at any time by pressing the Stop button or turning off the power It is important for the patient to remain still and not talk during inflation and deflation of the cuff Once the measurement is complete the cuff quickly deflates and the Systolic Diastolic and Pulse displays show the appropriate readings You can initiate the next measurement in Manual mode by pressi
32. d in hundredths of mmHg in the Reading display A properly calibrated monitor reads 0 in the Pulse display and less than 10 in the Reading display Return to normal operation by powering the BpTRU off and then on again BP Reference Gauge Calibration Check 72 The BP Reference Gauge Calibration Check is a feature that allows you to compare the accuracy of the BpTRU s pressure transducer against a reference pressure gauge of known accuracy An electronic pressure gauge is recommended but a mercury or aneroid gauge is acceptable 1 Turn the BpTRU off using the power switch 2 Disconnect the coiled tubing from the BpTRU mode hold BP Start while turning the BpTRU on 4 Release BP Start The monitor now performs an automatic zero offset calibration j 3 To select the BP Reference Gauge Calibration Check BP Reference Gauge Calibration Check mode is indicated by the software version being displayed on the Systolic display The applied pressure is displayed in whole mmHg in the Pulse display and in hundredths of mmHg in the Reading display as shown below Firmware semu mmHg TEMPERATURE C F Revision mmm 9 JE LI A PULSE BPM ug 4 aay aT r O 13 0 DO OAR DO READING CYCLE min ee 68 88 DIASTOLIC mmHg Unit Pressure niis 1 100 5 Display Reference 5 Connect a reference pressure gauge and pressure source in parallel with the BpTRU cuff connector to
33. del sangue nell arto del paziente AVVERTENZA Il bracciale per la misura della pressione non deve essere utilizzato sullo stesso arto dove sono presenti fistole o altri dispositivi medici che influiscono sul sistema circolatorio distale dal bracciale AVVERTENZA L incorretto inserimento della sonda rettale di temperatura pu perforare l intestino del paziente gt Introduzione AVVERTENZA Nei bambini inserire la sonda di temperatura non oltre 1 5 cm nello sfintere AVVERTENZA Non utilizzare un utensile metallic per installare o rimouvere la batteria Il terminale potrebbe portare ad un corto circuito o un rischio per la sicurezza elettrica AVVERTENZA La sostituzione di component quali bracciale sonda di temperature o del fodero della sonda con pezzi non originali potrebbero causare misure inaccurate Precauzioni generali gt b gt gt PRECAUZIONE Evitare compressioni o strozzature del tubo a spirale che potrebbero determinare restrizioni durante la pressurizzazione e lo sgonfiamento del bracciale e causare danni meccanici al tubo PRECAUZIONE Danni fisici significanti al BpTRU potrebbero portare a risultati inaccurate o anche a lesioni PRECAUZIONE Prestare attenzione quando si sposta il BpTRU per evitare il rischio di caduta che potrebbe causare lesion Manuale di istruzioni BoTRU gt gt BE DB D
34. e 54 measurement CfICaCY iis na IENA 57 FANGESiI ina 57 multiple BP measurements Automatic Mmode 20 O operating conditions 58 86 P power FEQUITEMENTS n pressure range probe Preparing i pulse display described display reads ccc measuring rate pulse rate range Q question mark error code R ranges measurement Reading display described Reference Gauge Calibration Check BP results series of BP measurements reviewing measurements Automatic mode Single mode BP S series of BP measurements Automatic mode Silent mode BP Alert Silent mode Temperature Alert Silent mode Single manual mode reviewing measurements taking BP measurements Single Predictive mode temperature measurements single BP measurement BP measurements specifications start up indications storage requirements systolic display described Hide mode measuring systolic pressure range of measurement T taking BP measurements technical specifications BPM 100
35. efficacy of blood pressure measurements versus standard auscultation using the 5 Korotkoff sound Average error within 5 mmHg Standard deviation within 8 mmHg Pulse rate measurement efficacy Meets or exceeds specification against a clinical reference Average error within 1 beats per minute Standard deviation within 3 beats per minute Maximum operating cuff 290 mmHg pressure Maximum possible cuff 330 mmHg pressure Maximum possible cuff inflation time Over 10 mmHg for 3 minutes Input power requirements to universal power supply 100 240 VAC 390 mA 50 60 Hz 59 BpTRU Operator s Manual Output power of universal power supply 10 V 1 0 1 25 A Cord set connector type IEC 320 C7 connector Cord set plug type North American Continental Europe United Kingdom Australia Cord set length 2 m 6 7 feet Battery voltage and 8 V 3 0 Ah capacity BP measurements per battery charge 200 at 2 minute cycle time Battery charge time 12 hours trickle charge Battery charge cycles 250 Environmental operating ranges Temperature 10 to 40 degrees Celsius Humidity 15 to 90 RH non condensing Elevation 170 to 1 700 m from sea level Physical dimensions table top Height 15 cm Width 23 cm Depth 15 cm Weight 4 kg including accessories 60 Display Reference Specifications BPM300 Item Specific
36. erating IN i 20 results enti 22 reviewing measurements 23 B battery charging indicator 10 disposals sienta ipia 54 good battery management 48 installing vet goa ana 46 low battery indicator 10 25 replacing iseer eye nna 49 Deeps inisi iiinn ii 13 BP Alert Silent mode 70 BP calibration Reference Gauge Calibration Check Pai hole ie a 72 Zero Calibration Check 71 BP Hide mode 71 BP measurements Automatic mode 20 series of measurements 20 C calibration BP Reference Gauge Calibration O r EEEE E ES 72 BP Zero Calibration Check 71 Temperature Calibration Check 74 cautions warnings 4 6 ccc in pulse display BP Reference Gauge Calibration Gheck aliena 72 Celsius changing between C and F 74 cleaning disinfection 53 cuff available sizes 77 selecting SIZE teeta 16 Cycle button described 12 Cycle display described 9 D data transfer by USB 75 diastolic display described 9 Hide mode 71 measuring diastolic pressure 15 palne e ERA 57 CIMENSIONS n s sessen 57 disinfection cleaning 53 displays defined iii risa
37. ero Calibration Check Calibration Check or version number e g or BP Reference Gauge BP Reference Gauge 1 53 and Pulse and Calibration Check Calibration Check by Reading displays turning power off and show varying then on again numbers Monitor enters low Insufficient charging Charge battery for 12 power state often or hours turns off automatically Eng of battery life Replace battery part BPM200 amp BPM300 BPM20036 Battery charging End of battery life Replace battery indicator remains on for longer than 24 hours during charging BP System Errors E0 to E15 If a BP system error occurs during operation an error code will be displayed in the Systolic display only All other displays remain blank Press the BP Start button to resume measurements Code Description Corrective Action User cancelled None required measurement E0 Too few pulses Check patient for pulse Tighten cuff detected on arm and check BpTRU for leaks in tubing or cuff E07 Loss of calibration Contact BpTRU Customer Support data 35 BpTRU Operator s Manual Ela Excessive motion artifacts motion induced errors Ensure that patient is sitting quietly and the cuff and upper arm are comfortably elevated to the level of their heart in order to reduce motion artifacts during measurement E2 Cuff overpressure Ensure that patient is sitting quietly to reduce motion artifacts during
38. error within 0 1 C 0 2 F Standard deviation within 0 4 C 0 7 F Continuous temperature accuracy Meets ASTM E 111200 accuracy requirements Input power requirements to universal power supply 100 240 VAC 390 mA 50 60 Hz Output power of universal power supply 10 V 1 0 1 25 A Cord set connector type IEC 320 C7 connector Cord set plug type North American Continental Europe United Kingdom Australia Cord set length 2 m 6 7 feet Battery voltage and 8 V 3 0 Ah capacity BP measurements per battery charge 200 at 2 minute cycle time Battery charge time 12 hours trickle charge Battery charge cycles 250 Environmental operating ranges Temperature 10 to 40 degrees Celsius Humidity 15 to 90 RH non condensing Elevation 170 to 1 700 m from sea level 62 Display Reference Item Specification Physical dimensions Height 15 cm table top Width 23 cm Depth 15 cm Weight 4 kg including accessories Standards The BpTRU monitor BPM100 BPM200 and BPM300 models complies with the following standards e CAN CSA C22 2 No 601 1M90 Medical Electrical Equipment Part 1 General Requirements for Safety 1990 e UL 26011 1988 Medical Electrical Equipment Part 1 General Requirements for Safety 1988 e ANSI AAMI SP10 1992 Electronic or Automated Sphygmomanometers 1992 e IEC 606011 1988 Medical Electrical Equ
39. general troubleshooting refer to Troubleshooting Guide on page 32 For error codes E0 through E15 refer to BP System Errors E0 to E15 on page 35 For error codes E20 through E27 refer to BP Analysis Errors E20 to E27 on page 37 For error codes E41 through E55 refer to Temperature Errors E41 to E55 on page 39 If your BpTRU has made a five second alarm tone and displayed the device malfunction indicator refer to Unrecoverable System Errors on page 41 If the troubleshooting information in this manual does not solve your problem contact your distributor or BpTRU Customer Support 31 BpTRU Operator s Manual Troubleshooting Guide Symptoms Possible Causes Corrective Actions Power is on green indicator light is on but BP Start button does not initiate inflation BpTRU is in Automatic mode and six readings have already been taken Cuff pressure from previous measurement not yet fully released Zero pressure calibration not Press Clear to clear the memory and then press BP Start to initiate anew BP measurement Check pressure in system if the problem persists Perform a BP Zero Calibration Check page 71 or BP Reference Gauge Calibration Check page 72 Wait 5 seconds and push the BP Start complete button again Power is on green BpTRU is in sleep Press any button to indicator light is on mode restore the display but displays
40. gnetic emissions for the BpTRU monitor The BpTRU monitor is intended for use in the electromagnetic environment specified below The customer or the user of the BpTRU monitor should assure that it is used in such an environment Emissions test Compliance Electromagnetic environment guidance RF emissions Group 1 The BpTRU monitor uses RF energy CISPR 11 EN 55011 only for its internal function Therefore their RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF emissions Class A The BpTRU monitor is suitable for CISPR 11 EN 55011 use in all establishments other than domestic and those directly Harmonic emissions Class A connected to the public low voltage BPM100 power supply network that supplies TEC 6100032 2000 A1 2001 buildings used for domestic purposes Harmonic emissions Class D BPM200 amp BPM300 TEC 6100032 1995 Voltage fluctuations flicker Complies emissions IEC 6100033 65 BpTRU Operator s Manual Guidance and manufacturers declaration electromagnetic immunity The BpTRU monitor is intended for use in the electromagnetic environment specified below The customer or the user of the BpTRU monitor should assure that it is used in such an environment Immunity Test IEC 60601 test Compliance Electromagnetic environment level level guidance Electrostatic 6 kV contact 6 kV
41. hould allow a return to normal operation for the next measurement If the problem persists discontinue use and return the monitor for servicing Temperature Errors E41 to E55 These error codes only apply to the BPM300 If a temperature error occurs during any temperature measurement an error code will be displayed in the Temperature display Code Description Corrective Action E41 Continuous Check monitor against reference temperature over thermometer in water bath at 43 C display limit gt 43 C to ensure monitor is working properly E42 Continuous Check monitor against reference temperature under thermometer in water bath at 28 C display limit lt 28 C to ensure monitor is working properly E43 No temperature probe Attach temperature probe and repeat connected measurement E44 Timeout on single Allow probe to cool to room temperature temperature for 34 minutes press measurement Temperature Start and then repeat measurement E45 Continuous Internal malfunction Contact BpTRU measurement Customer Support temperature circuitry not operational 39 BpTRU Operator s Manual Code Description Corrective Action E47 Single measurement Repeat measurement and ensure that failed motion check probe is located correctly patient remains still during single temperature measurement and patient s mouth is closed Use Continuous mode if error is repeated E48 Single
42. ipment Part 1 General Requirements for Safety 1988 equivalent to EN 606011 e International Safe Transit Association Pre shipment Test Procedures Procedure 2A 1996 e IEC 6060112 2001 Medical Electrical Equipment Part 1 General Requirements for Safety Electromagnetic Compatibility Requirements and Tests 2001 equivalent to EN 6060112 e IEC 60601230 1999 Medical Electrical Equipment Part 230 Particular Requirements for Safety including Essential Performance of Automatic Cycling Non Invasive Blood Pressure Monitoring Equipment 2000 equivalent to EN 60601230 The BPM300 model further complies with the following temperature standard e ASTM E 111200 Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature 2000 63 BpTRU Operator s Manual CE Mark Information CE 0086 64 The CE Mark on this product indicates it has been tested to and conforms with the provision noted with the 93 42 EEC Medical Device Directive Annex II European contact for regulatory compliance MDCI Ltd Arundel House 1 Liverpool Gardens Worthing West Sussex BN11 1SL UK Tel 44 0 1293 429608 Fax 44 0 1293 519121 Display Reference EMC Guidance and Declarations The BpTRU family of monitors has the electromagnetic compatibility and immunity characteristics outlined in the following tables Guidance and manufacturers declaration electroma
43. isplay as shown below Firmware Degrees Revision _ _ __ SYSTOLIC mmHg e F I I I PULSE BPM 9 m m G H LILiti amp oc a JER Yo oe DIASTOLIC mmHg 1 1005 READING CYCLE min AAG s 89 88 74 Display Reference The probe temperature will settle to the ambient temperature in three to four minutes 5 Use a heated water bath to apply temperatures in the range 28 C to 43 C 82 4 F to 109 4 F to the probe and compare the BpTRU s displayed temperature against an independent calibrated thermometer A properly calibrated monitor should indicate within 0 1 C 0 2 F of the temperature indicated by the reference thermometer If the probe temperature is not within display limits then an error code is displayed 6 Return to normal operation by turning the BpTRU off and then on again using the power switch USB Connectivity Mode BPM200 amp BPM300 models A Contact BpTRU to obtain the BpTRU connectivity manual USB Connectivity mode allows a PC based software application such as an electronic medical record to communicate directly with the BpTRU Your application can command the BpTRU to perform a BP measurement or a temperature measurement and collect data onto the PC CAUTION The USB port on the BpTRU is susceptible to electrostatic discharges ESD and in an ESD event the monitor may reset and display an error code Precautions should be take
44. it with the two screws 46 Display Reference WARNING Do not use a metal tool to install or remove a battery The terminals may short and lead to an electrical safety hazard 1 Insert the output plug of the DC universal input power supply into the power receptacle on the BpTRU 2 Plug the cord set into the universal power supply 3 Insert the cord set plug into an AC wall outlet The charging indicator should now be lit indicating that the battery is charging On initial setup of your BpTRU charge the battery for at least 12 hours 47 BpTRU Operator s Manual Battery Management 48 The following techniques and practices help ensure proper battery performance to prolong the life of your battery e It is recommended that the BPM200 BPM300 turned off and left plugged in when not in use to ensure maximum battery life e Operate the BpTRU with the power supply plugged into a wall outlet whenever possible e Charge the battery overnight if the Bp TRU was used in battery mode for more than two hours or if the low battery indicator is displayed E e Charge and then disconnect the battery if the BpTRU is to be shipped or stored for longer than one month The low battery indicator lights when the BpTRU needs charging It will also emit a short double beep every 30 seconds when the battery is low When these indications occur plug the power cord into a wall outlet to charge the battery
45. le BP Alert Silent mode hold the Temperature Start button while turning the BpTRU on again Repeating this toggles the BpTRU to the previous state 73 BpTRU Operator s Manual Temperature Celsius Fahrenheit Mode BPM300 The BpTRU can be configured to display temperature units in either Celsius or Fahrenheit The default display unit is Celsius but the unit can be toggled as follows 1 Turn the BpTRU off using the power switch x 2 To toggle temperature display units hold Mode while mom turning the BpTRU on again Repeating this toggles the BpTRU to the previous state When a temperature probe is attached the selected units C or F are illuminated on the BpTRU display Temperature Calibration Check BPM300 The Temperature Calibration Check allows a comparison of the accuracy of the BpTRU s temperature measurement circuitry to a reference thermometer of known accuracy A precision electronic thermometer is recommended but a mercury thermometer will work as well 1 Attach a temperature probe 2 Turn the BpTRU off using the power switch a 3 To select the Temperature Calibration Check mode lt gt hold BP Start while turning the BpTRU on 4 Release BP Start Temperature Calibration Check mode is indicated by the software version being displayed in the Systolic display The probe temperature is displayed in C or F as whole degrees in the Temperature display and hundredths of a degree in the Cycle d
46. llary A Press the Temperature Start button to begin the temperature measurement The progress indicators in the Temperature display will begin to flash 4 For oral measurements insert the probe tip into the patient s mouth and carefully slide the probe under the tongue into either sublingual pocket It is important to press the Temperature Start button before inserting the probe and to ensure that the probe does not contact any other Fahrenheit Celsius surface before it is placed in the patient s mouth 96 8 36 0 To obtain an accurate measurement pa oe e Ensure that the temperature 98 0 36 7 probe is correctly positioned in the sublingual pockets of 98 4 36 9 the patient s mouth The temperature within the mouth can vary by 2 F 1 C e Ensure that the patient s mouth is closed to minimize air currents across the probe 27 BpTRU Operator s Manual 28 5 For axillary measurements lift the patient s arm so that the entire axilla is visible and place the probe as high as possible in the axilla Ensure that the probe is located deep in the axilla so that the measurement most closely reflects body core temperature 6 Lower the patient s arm so that the probe is held in the axilla Hold the arm against the side of the body to ensure minimal movement of the e temperature probe and to ensure minimal air currents across the probe A single predictive temperature measuremen
47. manufacturer and d is the recommended separation distance in metres Field strengths from fixed RF transmitters as determined by an electromagnetic site survey should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol K NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies NOTE 2 The guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people 68 Display Reference a Field strengths from fixed transmitters such as base stations or radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic enviro nment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the BpTRU monitor is used exceeds the applicable RF compli ance level above the BpTRU monitor should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as reorienting or relocating the BpTRU monitor b Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m Recommended separation distances between portable and mobile RF communications e
48. may destroy these parts The blood pressure cuffs may be cleaned by wiping with a damp cloth or sponge and a mild detergent solution Allow sufficient time to air dry CAUTION Excessive wetting or immersion of the BpTRU and accessories may lead to electrical safety hazards or to blockage of connectors and tubing Do not attempt to use the monitor without allowing sufficient time to air dry 53 BpTRU Operator s Manual only Do not use fluids CAUTION The BpTRU and accessories are not designed to be sterilized by autoclaving Autoclaving will damage the monitor and accessories CAUTION If it is necessary to clean the battery use a dry cloth Maintenance e Maintenance of the BpTRU should consist of periodic inspection and cleaning of the monitor and accessories e Customer calibration of the BpTRU is not required e Accessories including the battery should be replaced as required e There are no user serviceable parts inside the BpTRU Opening the BpTRU voids the warranty Storage and Disposal Requirements The BpTRU can be transported and stored in the following environmental conditions e Temperature from 20 to 50 degrees Celsius e Humidity from 15 to 95 percent RH non condensing For transport shipping or storage use the original packaging including the inserts to protect the BpTRU If the original packaging is not available wrap the Bp TRU in such a manner that it
49. n of the cuff over 10 mmHg for maximum 3 minutes If any of the above conditions occur the BpTRU will perform the following actions 1 Deflate the cuff 2 Sound a five second alarm tone to signify that a unrecoverable system error has occurred 3 Deactivate the main display and display the device malfunction indicator To resume normal operation turn the power off and then back on again If normal operation does not resume contact your distributor or Bp TRU Customer Support 41 BpTRU Operator s Manual 42 Setup O Instructions TRU Examine the BpTRU Before Use Before using your BpTRU confirm that it does not suffer from any of the following forms of damage 1 PON So oy DI 10 Frayed electrical cords or broken electrical connectors Cracked or broken enclosure Broken LED displays Water damage possible water in the monitor or discoloration Torn or missing labels on monitor or accessories Broken or stripped cuff or tubing connectors Cracked or deteriorating blood pressure cuffs Cracked or deteriorating coiled tubing Battery irregularities such as cracks deformation leakage or corrosion Cracked or deteriorating temperature probes and cables if included If any damage is evident do not use the BpTRU Call your distributor or Bp TRU Customer Support CAUTION Significant physical damage to the BpTRU could result in inaccurate results or even injury
50. n when using the USB cable with the monitor including turning off the monitor and not taking any measurements while the USB cable is being installed or removed The USB cable used with the BpTRU monitor must be less than 3 metres in length 75 BpTRU Operator s Manual 76 Accessories DO TRU WARNING Substitution of a component such as a blood pressure cuff temperature probe or probe sheath different from that supplied may result in measurement inaccuracy CAUTION The use of a power supply other than that supplied with the BpTRU may result in damage to the monitor or measurement inaccuracy Blood Pressure Cuff Sizes BpTRU Cuff BPM Catalog Arm Number Circumference Range cm Child BPM 100 09 13 18 Small Adult BPM 100 10 18 26 Regular Adult BPM 100 11 26 34 Large Adult BPM 100 12 32 43 Extra Large Adult BPM 100 13 41 52 Note All cuffs include connector 77 BpTRU Operator s Manual Supplies and Accessories Blood Pressure Cuffs and Tubing BPM10009 Child Cuff Assembly BPM10010 Small Adult Cuff Assembly BPM10011 Regular Adult Cuff Assembly BPM10012 Large Adult Cuff Assembly BPM10013 Extra Large Adult Cuff Assembly BPM10014 Coiled Neoprene Tubing with connector BPM10019 Coiled Neoprene Tubing Extension with connectors CAL00101 BP Reference Calibration Check Card and TConnector Temperature Probes and Covers BPM30020 O
51. ng for kinks E12 Automatic cycling Check cuff and tubing for kinks timing violation E13 Device reset Readings in memory if any are available for review Check monitor environment for electromagnetic interference ESD power interruptions Connect USB cable between measurements or when monitor is powered off E14 Data corrupted after Power the BpTRU off wait 5 seconds reset and power on again E15 Low battery Charge the battery In Automatic mode these errors are recorded in memory and mea surements continue The measurement on which the error was detected is not included in the average of measurements displayed at the end of the series of measurements BP Analysis Errors E20 to E27 If an analysis error occurs in the determination of any BP reading an error code is displayed in the corresponding display All other valid readings are still displayed in the corresponding displays If an analysis error occurs during Automatic mode the error code is stored in memory and the series automatically continues until six measurements are taken 37 BpTRU Operator s Manual Pressing the Review button shows error codes in the appropriate display Systolic Diastolic or Pulse for each reading where an error was detected The averages for systolic blood pressure diastolic blood pressure and pulse rate exclude all results for any of the readings where an error was detected Code Descrip
52. ng the BP Start button again Wait five seconds after the completion of a measurement before pressing the BP Start button to allow circulation in the patient s arm and to allow the cuff to fully deflate The BpTRU will not start a new measurement until the cuff is fully deflated Series of Measurements Automatic Mode 20 Automatic mode performs a series of six blood pressure measurements discarding the first and averaging the remaining five The interval between measurements is 1 2 3 4 or 5 minutes depending on your selection Individual readings are displayed after each measurement and the individual and averaged readings can be reviewed during or after the series of measurements refer to Reviewing Measurements on page 22 1 Select a cuff that is appropriate for the patient Refer to Select an Appropriate Size of Cuff on page 16 2 Apply the cuff to the patient Refer to Position the Patient Carefully on page 17 and Apply the Cuff on page 18 Display Reference WARNING The blood pressure cuff should not be used on the same arm as an IV or any other medical equipment that relies on the circulatory system distal to the cuff 3 Press Clear to ensure that any previous measurements are cleared from the BpTRU s memory Select Automatic mode by pressing the Cycle button until the cycle time you want i e the interval between BP measurements shows in the Cycle display
53. ngle temperature measurements may be taken before the BpTRU prevents further operation Plug the BpTRU into a wall outlet to charge the battery Note that it is still possible to perform measurements while the battery is charging Oral or Axillary Measurements This section describes the use of the BPM in making Oral or Axillary measurements Prepare the Probe Use only approved BpTRU Disposable Temperature Probe Sheaths with the BpTRU Use of a sheath from another manufacturer may result in error messages or erroneous results Sheaths are single use only 25 BpTRU Operator s Manual 26 Connect a blue temperature probe to the BpTRU if it is not already connected Take a disposable probe sheath from the packaging box Separate the tabs on the sheath and insert the probe Slide the full length of the probe into the sheath Hold the sheath tab and the probe with one hand and while twisting pull the probe and sheath out of the packaging Check that the sheath fully covers the probe and is secure If not discard the sheath and repeat the steps above Display Reference Taking a Temperature Measurement Aa 1 mom w j2 Ensure that the patient is comfortable and relaxed Use the Mode button to cycle through the temperature measurement modes until the desired mode is selected and indicated on the front panel as e single oral 0 e single axillary A e continuous oral 0 e continuous axi
54. o il risultato dell ultima rilevazione e A indica il valore medio di una serie di misura ottenute in modalit automatica 5 Cycle SP Singola Pressione indica che il BpTRU sta oeprando in modalit Manuale Un numero da 1 a 5 indica l intervallo tra le misure in minuti durante la modalit Automatica 6 Temperature Visualizza il valore della misura di temperatura solo BPM300 Il BpTRU ha in aggiunta diversi piccoli indicatori a LED che visualizzano la modalit operative e lo stato dello strumento Indicatori tutti i modelli Dispositivo malfunzionante vedere Errori di sistema non codificati a pagina 41 Indicatori BPM200 e BPM300 Di Batteria in carica E Batteria scarica Indicatori solo BPM300 C Gradi Celsius F Gradi Fahrenheit 3 Modalit Singola Predittiva misura di temperatura to Modalit Continua misura temperatura O Modalit Orale di misura temperatura A Modalit Ascellare di misura temperatura R Modalit Rettale di misura temperatura 10 Pulsanti Display Reference Pulsanti del pannello frontale di controllo del BpTRU SYSTOLIC mmHg TEMPERATURE C 131 nea 36 6 DIASTOLIC mmHg READING CYCLE min 3 min Sc 5 Figura 2 Pulsanti Pannello Frontale Pulsanti tutti i modelli lt gt Start Stop Clear Avvia la misura della pressione arteriosa Il bracciale si gonfiera Ferma la misura in corso e sgonfia il bracciale una mi
55. old the Cycle button while turning the BpTRU on Repeating this toggles the BpTRU to the previous state Hide mode is indicated by a dash in the leftmost digit of the Cycle display When a blood pressure measurement is taken the applied pressure is indicated in the Systolic display in the usual manner However when the measurement is complete dashes are displayed in the Systolic Diastolic and Pulse displays In Hide mode error messages are displayed in the usual manner and the Review button works in the usual manner BP Zero Calibration Check D The BpTRU does not normally need to be recalibrated It automatically performs a zero calibration check each time it starts up and reports error code E7 if this check does not pass see BP System Errors E0 to E15 on page 35 The BP Zero Calibration Check mode allows you to check this automatic zero offset calibration function 1 Turn the BpTRU off using the power switch 2 Disconnect the coiled tubing from the BpTRU 3 To select BP Zero Calibration Check mode hold BP Start while turning the BpTRU on 4 Release BP Start The monitor now performs an automatic zero offset calibration The BpTRU indicates that it is in BP Zero Calibration Check mode by displaying the software version e g 1 90 in the Systolic display 71 BpTRU Operator s Manual After approximately five seconds the applied pressure is displayed in whole mmHg in the Pulse display an
56. ori di temperatura da E41 a E55 eee eeeeeeteeeeeeeees 39 Errori di sistema non codificati errr nrreseereene 41 Istruzioni di preparazione 0000r 43 Esame del BpTRU prima dell utiliZZO eeen 43 Installazione del Bp FR acore aaa 43 Collegamento dei bracciali n 44 Collegamento del tubo a spirale enesenn 44 Installazione della sonda di temperatura BPM8300 45 Alimentazione del BpTRU 45 Alimentazione del BPM100 45 Alimentazione del BPM200 e BPM300 46 Gestione batteria araae 48 Sostituzione della batteria 49 Funzioni di assestamento del BpTRU 49 Manutenzione ninna 51 Frequenza cura ed ispezioni 51 ISPEZIONE 6 tcc etiam esate ea een ase en eee 52 Pulizia Dismiazione si afasia 53 Marnuicizione a rien ilari 54 Requisiti di immagazzinamento e smaltimento 54 Informazioni tecniche ssseessseeeeeeeeeeeeeeeeeeees 57 Specifiche BPM100 2 hice ie ea ea Wetec dae 57 Specifiche BPM200 2 rara 59 Speceitiehe BPMS00 3 ei ai 61 Standard Sainte dedi casse gia leon 63 Informazioni Marchio CE tulle lia 64 Guida e dichiarazione CEM nenene errenneren 65 Modalit tecniche operative
57. ossible cuff inflation time Over 10 mmHg for 3 minutes Input power requirements to regulated power supply North American AC power supply range of 104 to 127 V rms nominally 60 Hz European AC power supply range of 207 to 253 V rms nominally 50 Hz Australian AC power supply range of 216 to 264 V rms nominally 50Hz Output power of regulated power supply 8V 1A Environmental operating ranges Temperature 10 to 40 degrees Celsius Humidity 15 to 90 RH non condensing Elevation 170 to 1 700 m from sea level Monitor lifetime 10 000 full scale BP cycles of 0 to 290 mmHg and back Physical dimensions of the BPM100 Height 15 cm Width 23 cm Depth 8 cm Weight of the BPM100 2 5 kg including accessories Please note that specifications of all models are subject to change as product improvements may be made at any time to improve performance 58 Display Reference Specifications BPM200 Item Specification Pressure measurement range 0 to 290 mmHg Pressure measurement accuracy Meets or exceeds ANSI AAMI SP10 1992 Within 3 mmHg or 2 whichever is greater Systolic blood pressure measurement range 60 to 250 mmHg Diastolic blood pressure measurement range 40 to 160 mmHg Pulse rate measurement range 40 to 200 beats per minute Blood pressure measurement efficacy Meets or exceeds ANSI AAMI SP10 1992 standard for overall
58. parate the buttocks with one hand and gently insert the rectal temperature probe a maximum of 1 5 cm inside the rectal sphincter using the other hand Use a lubricating jelly on the temperature probe sheath to ease insertion if necessary Tilt the temperature probe until the tip is touching tissue WARNING Incorrectly inserting the temperature probe can perforate the bowel of the patient 29 BpTRU Operator s Manual A 30 WARNING For children insert the temperature probe less than 1 5 cm inside the rectal sphincter The Temperature display begins to show temperature readings a few seconds after placing the probe If the measured temperature is not within the display limits then an error code is displayed The probe reaches body temperature three to four minutes after being placed 5 Press the Temperature Start button to freeze the display 6 Once the measurement is complete remove the probe from the patient NOTE When removing the probe hold the cover to the probe by the arrow tab to ensure that the cover is removed with the probe 7 Remove the probe sheath by holding the arrow tab and pulling out the probe 8 Place the used probe sheath into a biohazards waste receptacle Troubleshooting BO TRU This chapter describes all of the system errors that the BpTRU may report and gives troubleshooting information for other problems you could encounter For
59. quipment and the BpTRU monitor The BpTRU monitor is intended for use in an electromagnetic environment is which radiated RF disturbances are controlled The customer or user of the BpTRU monitor can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the BpTRU monitor as recommended below according to the maximum output power of the communications equipment Separation distance according to frequency of transmitter Rated maximum output power of m eee 150 KHz to 80 MHz to 800 MHz to W 80 MHz 800 MHz 2 5 GHz d 1242 d 1 24P d 234P 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 73 1 1 2 1 2 2 3 10 3 8 3 8 7 3 100 12 12 23 For transmitters rated at maximum output power not listed above the recommended separation distance d in metres m can be estimated using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in Watts W according to the transmitter manufacturer Note 1 At 80 MHz and 800 MHz separation distance for the higher frequency applies Note 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people 69 BpTRU Operator s Manual Cables and acceptable lengths Cable Length AC power cord set 1 8 m
60. ral Axillary Temperature Probe blue and Holder BPM30021 Rectal Temperature Probe red and Holder BPM30024 Box of 100 Temperature Probe Sheaths Mounting Accessories BPM30046 BpTRU MOBILE STAND UNIT includes e Pole and Rolling Base Assembly e Basket e BPM device mounting hardware BPM10040 Wall Mount Bracket Assembly for BPM100 model BPM30040 Bracket Assembly for BPM200 BPM300 model Power Supplies BPM10030 Power Supply North America 120V 60HZ For BPM100 Model Only 78 BPM10031 BPM10032 BPM10033 BPM30035 BPM30030 BPM30031 BPM30032 BPM30033 BPM30036 Display Reference Power Supply United Kingdom 230V 50Hz For BPM100 Model Only Power Supply 230V 50Hz Continental Europe Euro Plug For BPM100 Model Only Power Supply 230V 50Hz Australia For BPM100 Model Only Power Supply Universal For BPM200 BPM300 Model Only Cord Set North America For BPM200 BPM300 Model Only Cord Set United Kingdom For BPM200 BPM300 Model Only Cord Set Continental Europe Euro Plug For BPM200 BPM300 Model Only Cord Set Australia For BPM200 BPM300 Model Only Lead Acid Battery for BPM200 BPM300 Please contact BpTRU Medical Devices for a complete catalogue list 79 BpTRU Operator s Manual Owner Information Serial Number Date of Purchase Dealer Dealer Telephone Dealer Representative Dealer Representative Telephone 80 Warranty TRU Limited Warranty BpTR
61. rectal measurements Either probe can be used for this procedure 1 Insert the temperature probe plug into the jack on the side of the BpTRU Place two temperature probe clips onto the shaft of the temperature probe Remove the protective tape to expose the adhesive backing on the temperature probe clips Attach the temperature probe and clips to the side of the BpTRU using the adhesive backing Powering the BpTRU The BPM100 must be connected to a standard wall outlet The BPM200 and BPM300 can be powered either from a wall outlet or by the internal battery Powering the BPM100 The BPM100 includes a wall mounted power supply with a plug style specific to each geographical region Connect the BPM100 as follows 45 BpTRU Operator s Manual 1 Insert the output plug of the DC power supply into the power receptacle on the BpTRU 2 Insert the input plug of the DC power supply into an AC wall outlet Powering the BPM200 and BPM300 The BPM200 and BPM300 are shipped with the internal rechargeable battery disconnected to prevent discharge and to prolong battery life They include a DC universal input power supply with a cord set specific to each geographical region 1 Open the battery door at the back of Bk the BpTRU Use a Phillips screwdriver provided to remove both screws 2 Join the two battery connectors The connectors only fit one way 3 Close the battery door and secure
62. s Discontinue use and replace the battery if any such problems arise The coiled tubing blood pressure cuffs and their connections should be examined for cracks or breaks which may lead to air leakage during inflation and deflation The blood pressure cuffs should be examined for tears in the material and seams of the cuff which may lead to the cuff rupturing when inflated The cuffs should also be inspected for legibility of cuff Display Reference markings particularly the cuff model and the markings for arm size range and index The temperature probes should be examined for cracks sharp edges or other deformations that may present a hazard to the patient or user Cleaning Disinfection The BpTRU may be cleaned as required by wiping with a cloth dampened with warm water and a mild detergent solution Allow sufficient time to air dry The BpTRU and accessories including the temperature probe may be disinfected as required for example if bodily fluids come into contact the monitor by wiping with a cloth dampened with a diluted non staining disinfectant solution such as bacteriostatic detergent Allow sufficient time to air dry The coiled tubing and power supply cabling may be cleaned by wiping with a cloth or sponge dampened with warm water and a mild detergent solution If further cleaning is required coiled tubing and cuffs may be cleaned using rubbing alcohol Do not use harsh solvents such as acetone as they
63. s the average of the last five Systolic Diastolic and Pulse measurements is shown in the respective display while the Reading display shows A for average The first measurement is always discarded from the average as it is often elevated due to patient stress white coat effect If an error code is displayed for any measurement that measurement is not included in the average The average can be computed from less than five measurements Reviewing Measurements Use the Review button to review previous measurements Review Measurements in Single Mode In Manual mode you can review previous manual lt q measurements by pressing the Review button The Review button cycles through all measurements taken since Manual mode was invoked or since the last time the Clear button was pressed up to a maximum of 99 previous measurements Pressing the Review button during a measurement has no effect 22 Display Reference Review Measurements in Automatic Mode dq D Upon completing a series of measurements in Automatic mode you can review each measurement in the series by pressing the Review button You cannot review the first measurement of the series because it is always discarded As the result of each reading is shown the reading number 2 through 6 is shown in the Reading display The value A in the Reading display indicates that the average of the last five readings is being shown If
64. singola e continua Premendo il pulsante Temperature Start inoltre possibile fermare entrambe le misure di temperature in corso singola e continua 12 Toni Audio Display Reference Il BpTRU emette dei toni audio per indicare determinate condizioni operative o funzioni come descritto nella seguente tabella Per disabilitare i suoni vedere la sezione Modalit Avviso Silente pressione a pagina 70 Tono Audio Significato 3 suoni brevi seguiti da 1 suono prolungato Suoni attivati quando il BpTRU si inizializza all accensione 1 tono prolungato La serie di 6 misurazioni della pressione completa Una misura di temperatura singola predittiva completa solo BPM300 2 suoni brevi ogni 30 secondi La carica della batteria bassa 2 suoni brevi L alimentazione a rete disconnessa Il BpTRU sta ora lavorando alimentato a batterie 1 tono breve L alimentazione a rete connessa Il BpTRU non pi alimentato a batterie Il BpTRU emette inoltre toni audio che indicato determianti errori di sistema come descritto nella seguente tabella Tono Audio Codice Errore 3 suoni E3 E4 E5 E6 E7 E9 ed E13 3 suoni seguiti da pausa di 3 secondi quindi altri 3 suoni la situazione continua fino a quando non si rimuove l errore E2 E10 E11 E12 Per la descrizione dei codici di errori fare riferimento a o Guida alla ricerca delle problemati
65. sura automatica pu essere riavviata premendo il pulsante Start Pausa tra le misure nella modalit automatic riavvio premendo il pulsante Start Cancella la memoria delle misure memorizzate sia in modalit Singola che Automatica La memoria deve essere cancellata prima che una nuova serie di misurazioni abbia inizio o quando si passa dalla modalit Singola a quella Automatica 11 BpTRU Operator s Manual Review Richiamo e visualizzazione misure 44 memorizzate In modalit Automatica possibile rivedere le misure memorizzate e loro valore medio quando la serie di rilevazioni complete E possibile inoltre richiamare eventuali misure sospese premendo il pulsante quando una serie di misure in corso riavvio premendo il pulsante Start In modalit Manuale possible rivedere tutte le misure memorizzate fino ad un massimo di of 99 rilevazioni Cycle Selezionare la modalit operativa Singola o Automatica e in modalit Automatica l intervallo di tempo delle misurazioni Per ulteriori informazioni vedere la descrizione del a pagina 10 Pulsanti solo BPM300 Ax Mode Selezione della modalit operativa di misura m temperatura RS e Singola orale Y 0 e Singola ascellare 4 A e Continua orale t 0 e Continua ascellare t A Il pulsante Mode in aggiunta cancella il display della temperatura Temperature Temperature Inizia entrambe le misure di temperatura Start
66. t takes approximately 15 seconds from the point of tissue contact At the completion of the measurement a tone sounds and the measurement shows in the Temperature display When taking a continuous temperature measurement the Temperature display begins to show temperature readings a few seconds after placing the probe The probe will reach body temperature three to four minutes after being placed At this point pressing Temperature Start will freeze the display In either the Single Predictive mode or the Continuous mode if the measured temperature is not within the display limits an error code is displayed 7 Once the measurement is complete remove the probe from the patient Display Reference A NOTE When removing the probe hold the cover to the probe by the arrow tab to ensure that the cover is removed with the probe 8 9 Rectal Remove the probe sheath by holding the arrow tab and pulling out the probe Place the used probe sheath into a biohazards waste receptacle Measurements This section describes rectal measurement which can only be made in Continuous mode 1 p Prepare and sheath the probe as described in Prepare the Probe on page 25 Ensure that the patient is lying comfortably on his or her side Press the Temperature Start button to begin the continuous temperature measurement The progress indicators in the Temperature display will begin to flash Se
67. tion Corrective Action E20 Indeterminate systolic Check patient for pulse Tighten cuff blood pressure likely on arm and check BpTRU for normal due to inadequate inflation pressures inflation threshold E21 Indeterminate diastolic Check patient for pulse Tighten cuff pressure premature on arm check for leaks in tubing or deflation excessive cuff and ensure that patient is sitting motion artifacts or quietly with arm comfortably diastolic below 40 elevated to level of heart to reduce mmHg motion artifacts during measurement E22 Indeterminate pulse Check patient for pulse Tighten cuff rate on arm check for leaks in tubing or cuff and ensure that patient is sitting quietly with arm comfortably elevated to the level of heart to reduce motion artifacts during measurement E23 Systolic blood pressure Check patient manually for blood under range lt 60 pressure and pulse mmHg E24 Diastolic blood Check patient manually for blood pressure under range pressure and pulse lt 40 mmHg E25 Systolic blood pressure Check patient using auscultation for over range gt 250 blood pressure and pulse mmHg E26 Diastolic blood Check patient using auscultation for pressure over range blood pressure and pulse gt 160 mmHg 38 Display Reference Code Description Corrective Action E27 Arithmetic overflow in data calculation Repeat measurement After a BP analysis error the corrective action s
68. will not be scratched or otherwise damaged during shipping If shipping the BpTRU or storing it for more than one month disconnect the battery 54 Display Reference Contact local authorities for disposal requirements for electronic devices and for lead acid batteries same as automobile batteries Do not throw the battery in the regular garbage 55 BpTRU Operator s Manual 56 Technical Information DO TRU Specifications BPM100 Item Specification Pressure measurement range 0 to 290 mmHg Pressure measurement accuracy Meets or exceeds ANSI AAMI SP10 1992 Within 3 mmHg or 2 whichever is greater Systolic blood pressure measurement range 60 to 250 mmHg Diastolic blood pressure measurement range 40 to 160 mmHg Pulse rate measurement range 40 to 200 beats per minute Blood pressure measurement efficacy Meets or exceeds ANSI AAMI SP10 1992 standard for overall efficacy of blood pressure measurements versus standard auscultation using the 5 Korotkoff sound Average error within 5 mmHg Standard deviation within 8 mmHg Pulse rate measurement efficacy Meets or exceeds specification against a clinical reference Average error within 1 beats per minute Standard deviation within 3 beats per minute Maximum operating cuff 290 mmHg pressure Maximum possible cuff 330 mmHg pressure 57 BpTRU Operator s Manual Maximum p
69. you press the Review button between measurements during an automatic series of measurements the BpTRU suspends measurement You can then cycle through the measurements taken to that point using the Review button Press the BP Start button to resume the automatic series Pressing the Review button during a measurement has no effect Recovering from Sleep Mode The BpTRU will enter sleep mode if left idle for 10 minutes All displays will go blank If the displays are blank press any button to reenter the normal operating mode All the data stored in memory is still available and can be viewed using the Review button Recorded measurements are only lost when the Clear button is pressed or power is turned off 23 BpTRU Operator s Manual 24 Thermometry se BPM300 Only The BPM300 model can perform oral or axillary temperature measurements either in Single Predictive mode or in Continuous mode It can also perform rectal temperature measurements in Continuous mode Two different temperature probes are available a blue probe for oral and axillary measurements and a red probe for rectal measurements The BpTRU automatically recognizes which probe is attached and adjusts its functions accordingly e For oral or axillary measurements refer to Oral or Axillary Measurements on page 25 e For rectal measurements refer to Rectal Measurements on page 29 If the low battery indictor appears a maximum of 20 si

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