BpTRU BPM100 Manual Download Page 1

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Manuale di istruzioni

BpTRUl

Manuale revisione: 6.1

Il presente manuale è 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

proprietà della:

BpTRU Medical Devices una Divisione di 0764509 B.C. Ltd.

Summary of Contents for BPM100

Page 1: ...U 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...

Page 2: ......

Page 3: ...cauzioni generali 5 Indicazioni del Display 9 Displays 9 Indicatori tutti i modelli 10 Indicatori BPM200 e BPM300 10 Indicatori solo BPM300 10 Pulsanti Errore Il segnalibro non definito Pulsanti tutti...

Page 4: ...Preparazione della sonda 25 Rilevazione della temperatura corporea 27 Misurazioni rettali 29 Ricerca problematiche 31 Guida alla ricerca delle problematiche 32 Errori di sistema da E0 a E15 35 Analis...

Page 5: ...e dichiarazione CEM 65 Modalit tecniche operative 70 Modalit Avviso Silente pressione 70 Modalit valori nascosti 71 Calibrazione punto zero pressione 71 Manometro di riferimento per il controllo di ca...

Page 6: ...Manuale di istruzioni BpTRU vi Installazione accessori 78 Specifiche alimentazione 78 Informazioni utilizzatore 80 Garanzia 81 Garanzia limitata 81 ESCLUSIONI 82 Registrazione garanzia 83 Indice 85...

Page 7: ...evazioni 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 l...

Page 8: ...le rettale ed ascellare continua da 3 a 4 minuti Dotato di sonda di temperatura e suo contenitore Informazioni di sicurezza Questa sezione descrive le indicazioni d uso le controindicazioni i simboli...

Page 9: ...Il marchio CE di questo prodotto indica che stato testato in conformit alle norme previste dalla Direttiva CEE 93 42 Allegato II inerente i Dispositivi Medici Dispositivo elettrico di Classe II Parte...

Page 10: ...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 ve...

Page 11: ...temperature o del fodero della sonda con pezzi non originali potrebbero causare misure inaccurate Precauzioni generali PRECAUZIONE Evitare compressioni o strozzature del tubo a spirale che potrebbero...

Page 12: ...onitor 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 access...

Page 13: ...stativo per assicurare stabilit Se si utilizza uno stativo alternativo assicurarsi che il BpTRU e i suoi accessori siano sufficentemente stabili oscillando il sistema di 10 dalla verticale Se sistema...

Page 14: ...Manuale di istruzioni BpTRU 8...

Page 15: ...o 1 2 4 3 5 6 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 m...

Page 16: ...do 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 h...

Page 17: ...la misura in corso e sgonfia il bracciale una misura automatica pu essere riavviata premendo il pulsante Start Pausa tra le misure nella modalit automatic riavvio premendo il pulsante Start Clear Can...

Page 18: ...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 pag...

Page 19: ...a 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 ali...

Page 20: ...BpTRU Operator s Manual 14...

Page 21: ...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: ...rging 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 us...

Page 23: ...wn The position shown in the illustration below is ideal 3 Ensure that the upper arm is at heart level and supported Cuff at heart level Relax At your discretion BP can be taken while lying down or st...

Page 24: ...nge 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...

Page 25: ...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...

Page 26: ...nt 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 Automatic mode performs a series of si...

Page 27: ...t 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 ti...

Page 28: ...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 dis...

Page 29: ...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...

Page 30: ...BpTRU Operator s Manual 24...

Page 31: ...Axillary Measurements on page 25 For rectal measurements refer to Rectal Measurements on page 29 If the low battery indictor appears a maximum of 20 single temperature measurements may be taken befor...

Page 32: ...ckaging box 3 Separate the tabs on the sheath and insert the probe 4 Slide the full length of the probe into the sheath 5 Hold the sheath tab and the probe with one hand and while twisting pull the pr...

Page 33: ...heit Celsius 96 8 36 0 97 4 36 3 98 0 36 7 98 4 36 9 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...

Page 34: ...predictive temperature measurement 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 displ...

Page 35: ...epare the Probe on page 25 2 Ensure that the patient is lying comfortably on his or her side 3 Press the Temperature Start button to begin the continuous temperature measurement The progress indicator...

Page 36: ...or 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 th...

Page 37: ...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 pag...

Page 38: ...ration Check page 72 Zero pressure calibration not complete Wait 5 seconds and push the BP Start button again Power is on green indicator light is on but displays are all blank BpTRU is in sleep mode...

Page 39: ...et Plug power supply into wall outlet Power supply is not plugged into BpTRU Plug power supply into BpTRU Wall outlet is not powered Have qualified technician inspect wall outlet and power breaker Bat...

Page 40: ...it 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 C...

Page 41: ...Charge battery for 12 hours End of battery life Replace battery part BPM20036 Battery charging indicator remains on for longer than 24 hours during charging End of battery life Replace battery BP Syst...

Page 42: ...ing 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 calibr...

Page 43: ...etween measurements or when monitor is powered off E14 Data corrupted after reset Power the BpTRU off wait 5 seconds and power on again E15 Low battery Charge the battery a In Automatic mode these err...

Page 44: ...pulse Tighten cuff on arm check for leaks in tubing or cuff and ensure that patient is sitting quietly with arm comfortably elevated to level of heart to reduce motion artifacts during measurement E22...

Page 45: ...play Code Description Corrective Action E41 Continuous temperature over display limit 43 C Check monitor against reference thermometer in water bath at 43 C to ensure monitor is working properly E42 C...

Page 46: ...easurement over display limit 39 C Repeat measurement Use Continuous mode if error is repeated E53 Single measurement under display limit 35 C Repeat measurement Use Continuous mode if error is repeat...

Page 47: ...Over inflation of the cuff maximum 330 mmHg 4 Overtime inflation 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 Def...

Page 48: ...BpTRU Operator s Manual 42...

Page 49: ...or stripped cuff or tubing connectors 7 Cracked or deteriorating blood pressure cuffs 8 Cracked or deteriorating coiled tubing 9 Battery irregularities such as cracks deformation leakage or corrosion...

Page 50: ...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 a...

Page 51: ...s procedure 1 Insert the temperature probe plug into the jack on the side of the BpTRU 2 Place two temperature probe clips onto the shaft of the temperature probe 3 Remove the protective tape to expos...

Page 52: ...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 geographica...

Page 53: ...ert 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...

Page 54: ...e 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 t...

Page 55: ...al 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 tu...

Page 56: ...ly use the Temperature Calibration Check to verify temperature measurement accuracy See Technical Modes of Operation on page 70 Please contact BpTRU Customer Support for information on how to order a...

Page 57: ...ld 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 BP Zero Calibration Check on pag...

Page 58: ...bles 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...

Page 59: ...th 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 sp...

Page 60: ...ould be replaced as required 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...

Page 61: ...Display Reference 55 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...

Page 62: ...BpTRU Operator s Manual 56...

Page 63: ...ent 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...

Page 64: ...nominally 50Hz Output power of regulated power supply 8 V 1 A Environmental operating ranges Temperature 10 to 40 degrees Celsius Humidity 15 to 90 RH non condensing Elevation 170 to 1 700 m from sea...

Page 65: ...eets or exceeds ANSI AAMI SP10 1992 standard for overall efficacy of blood pressure measurements versus standard auscultation using the 5th Korotkoff sound Average error within 5 mmHg Standard deviati...

Page 66: ...6 7 feet Battery voltage and capacity 8 V 3 0 Ah BP measurements per battery charge 200 at 2 minute cycle time Battery charge time 12 hours trickle charge Battery charge cycles 250 Environmental opera...

Page 67: ...surement efficacy Meets or exceeds ANSI AAMI SP10 1992 standard for overall efficacy of blood pressure measurements versus standard auscultation using the 5th Korotkoff sound Average error within 5 mm...

Page 68: ...M 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 C...

Page 69: ...t 1 General Requirements for Safety 1988 equivalent to EN 606011 International Safe Transit Association Pre shipment Test Procedures Procedure 2A 1996 IEC 6060112 2001 Medical Electrical Equipment Par...

Page 70: ...cates 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 Gar...

Page 71: ...Electromagnetic environment guidance RF emissions CISPR 11 EN 55011 Group 1 The BpTRU monitor uses RF energy only for its internal function Therefore their RF emissions are very low and are not likel...

Page 72: ...transients burst IEC 6100044 2 kV for power supply lines 1 kV for input output lines 2 kV for power supply lines Not applicable Mains power quality should be that of a typical commercial or hospital...

Page 73: ...l Compliance level Electromagnetic environment guidance Power frequency 50 60 Hz magnetic field IEC 6100048 3 A m 3 A m Power frequency magnetic fields should be at levels characteristic of a typical...

Page 74: ...distance d 1 2 P d 1 2 P 80 MHz to 800 MHz d 2 3 P 800 MHz to 2 5 GHz where P is the maximum output power rating of the transmitter in Watts according to the transmitter manufacturer and d is the rec...

Page 75: ...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...

Page 76: ...to change configurations check functionality and accuracy and to connect the monitor to a computer BP Alert Silent Mode As well as the power up tone the BpTRU makes a short audible tone after completi...

Page 77: ...ic 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 The BpTRU does not normally need...

Page 78: ...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 t...

Page 79: ...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 opera...

Page 80: ...M300 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 thermome...

Page 81: ...the power switch USB Connectivity Mode BPM200 BPM300 models Contact BpTRU to obtain the BpTRU connectivity manual USB Connectivity mode allows a PC based software application such as an electronic me...

Page 82: ...BpTRU Operator s Manual 76...

Page 83: ...he 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 Number Arm Circumference...

Page 84: ...ors CAL00101 BP Reference Calibration Check Card and TConnector Temperature Probes and Covers BPM30020 Oral Axillary Temperature Probe blue and Holder BPM30021 Rectal Temperature Probe red and Holder...

Page 85: ...nly BPM30035 Power Supply Universal For BPM200 BPM300 Model Only BPM30030 Cord Set North America For BPM200 BPM300 Model Only BPM30031 Cord Set United Kingdom For BPM200 BPM300 Model Only BPM30032 Cor...

Page 86: ...BpTRU Operator s Manual 80 Owner Information Serial Number Date of Purchase Dealer Dealer Telephone Dealer Representative Dealer Representative Telephone...

Page 87: ...ced 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 d...

Page 88: ...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 SUC...

Page 89: ...lusive 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 r...

Page 90: ...BpTRU Operator s Manual 84...

Page 91: ...ion Check 72 BP Zero Calibration Check 71 Temperature Calibration Check 74 cautions warnings 4 6 ccc in pulse display BP Reference Gauge Calibration Check 72 Celsius changing between C and F 74 cleani...

Page 92: ...obe preparing 25 pulse display described 9 display reads ccc 72 measuring rate 15 pulse rate range 57 Q question mark error code 41 R ranges measurement 57 Reading display described 9 Reference Gauge...

Page 93: ...libration Check 74 changing scale C F 74 display described 9 rectal measurement 29 single oral or axillary measurement 25 tones 13 transferring data by USB 75 U USB connecting 75 W warnings cautions 4...

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