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Il presente manuale è stato redatto per i dispositivi
(modelli BPM100, BPM200 e BPM300).
BpTRU, il logo BpTRU e la collezione di questi marchi sono si
BpTRU Medical Devices una Divisione di 0764509 B.C. Ltd.
BpTRU Medical Devices una Divisione di 0764509 B.C. Ltd.
BpTRU™ Vital Signs Monitors
proprietà della:
Tutti i diritti riservati.
© Copyright 2007
Tutti i diritti riservati.
Manuale di istruzioni
Manuale revisione: 6.1
BpTRUl

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Summary of Contents for BpTRU BPM100

  • Page 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.
  • Page 3: Table Of Contents

    Contenuto Introduzione ................1 Panoramica del prodotto ............1 BPM100 ................1 BPM200 ................2 BPM300 ................2 Informazioni di sicurezza ............2 Indicazioni d’uso ..............2 Controindicazioni d’uso ............3 Simboli di sicurezza e definizioni .......... 3 Avvertenze e precauzioni ............4 Avvertenze generali ..............
  • Page 4 Errori di temperatura (da E41 a E55) ........39 Errori di sistema non codificati ..........41 Istruzioni di preparazione..........43 Esame del BpTRU prima dell’utilizzo ........43 Installazione del BpTRU ............43 Collegamento dei bracciali ............44 Collegamento del tubo a spirale .......... 44 Installazione della sonda di temperatura (BPM300) ....
  • Page 5 Sostituzione della batteria ........... 49 Funzioni di assestamento del BpTRU ........49 Manutenzione ..............51 Frequenza cura ed ispezioni ........... 51 Ispezione ................52 Pulizia / Disinfezione............... 53 Manutenzione ................. 54 Requisiti di immagazzinamento e smaltimento ....... 54 Informazioni tecniche ............57 Specifiche: BPM100 ...............
  • Page 6 Manuale di istruzioni BpTRU Installazione accessori ............78 Specifiche alimentazione ............ 78 Informazioni utilizzatore ............80 Garanzia ................81 Garanzia limitata ..............81 ESCLUSIONI: ................. 82 Registrazione garanzia ............83 Indice ................. 85...
  • Page 7: Introduzione

    Congratulazioni per aver acquistato il vostro Monitor dei parametri vitali BpTRU. Panoramica del prodotto BpTRU è 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 diastolica e la frequenza cardiaca.
  • Page 8: Bpm200

    BpTRU. Indicazioni d’uso  Il BpTRU misura la pressione sistolica e diastolica e la frequenza cardiaca in soggetti da 3 anni di età a salire.  Il BPM300 misura la temperatura in soggetti da 3 anni di età...
  • Page 9: Controindicazioni D'uso

    Introduzione Controindicazioni d’uso  Il BpTRU non è stato progettato per l’utilizzo su neonati, infanti o bambini con meno di 3 anni di età.  Il BpTRU non è stato progettato, venduto o realizzato con scopi diversi da quelli precedentemente indicati.
  • Page 10: Avvertenze E Precauzioni

    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 del sangue nell’arto del paziente.
  • Page 11: Precauzioni Generali

    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.
  • Page 12 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 danneggerà irreparabilmente monitor e accessori. PRECAUZIONE L’utilizza di un alimentatore diverso da quello provvisto con il BpTRU può...
  • Page 13 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 stabilità. Se si utilizza uno stativo alternativo, assicurarsi che il BpTRU e i suoi accessori siano sufficentemente stabili oscillando il sistema di 10°...
  • Page 14 Manuale di istruzioni BpTRU...
  • Page 15: Indicazioni Del Display

    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).
  • Page 16: Indicatori - Tutti I Modelli

    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 modalità operative e lo stato dello strumento. Indicatori – tutti i modelli Dispositivo malfunzionante (vedere “Errori di sistema...
  • Page 17: Pulsanti

    Display Reference Pulsanti Pulsanti del pannello frontale di controllo del BpTRU. Figura 2: Pulsanti Pannello Frontale Pulsanti – tutti i modelli Start Avvia la misura della pressione arteriosa. Il bracciale si gonfierà. Stop Ferma la misura in corso e sgonfia il bracciale (una misura automatica può...
  • Page 18: Pulsanti - Solo Bpm300

    BpTRU Operator’s Manual Review Richiamo e visualizzazione misure memorizzate. In modalità Automatica, è possibile rivedere le misure memorizzate e loro valore medio quando la serie di rilevazioni è complete. E’ possibile inoltre richiamare eventuali misure sospese premendo il pulsante quando una serie di misure è...
  • Page 19: Toni Audio

    Display Reference Toni Audio 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 “Modalità Avviso/Silente pressione” a pagina 70.) Tono Audio Significato 3 suoni brevi seguiti da 1 suono...
  • Page 20 BpTRU Operator’s Manual...
  • Page 21: Misurazione Della Pressione Arteriosa

    Misura della pressione arteriosa Il BpTRU può 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 (modalità...
  • Page 22: Come Ottenere Misurazioni Accurate

    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.
  • Page 23: Posizione Corretta Del Paziente

    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.
  • Page 24: Applicazione Del Bracciale

     Avoid talking to other people in the room.  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.
  • Page 25 Take the Single BP Measurement 1. Press Clear to ensure that any previous measurements are cleared from the BpTRU’s memory. 2. Select Manual mode by pressing the Cycle button until “SP” is displayed in the Cycle display.
  • Page 26 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.
  • Page 27 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. 4. Select Automatic mode by pressing the Cycle button until the cycle time you want (i.e., the...
  • Page 28 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.
  • Page 29 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.
  • Page 30 BpTRU Operator’s Manual...
  • Page 31 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.
  • Page 32 BpTRU Operator’s Manual 1. Connect a blue temperature probe to the BpTRU if it is not already connected. 2. Take a disposable probe sheath from the packaging box. 3. Separate the tabs on the sheath and insert the probe. 4. Slide the full length of the probe into the sheath.
  • Page 33 Display Reference Taking a Temperature Measurement 1. Ensure that the patient is comfortable and relaxed. 2. Use the Mode button to cycle through the temperature measurement modes until the desired mode is selected and indicated on the front panel as: •...
  • Page 34 BpTRU Operator’s Manual 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.
  • Page 35 Display Reference 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. Remove the probe sheath by holding the arrow tab and pulling out the probe. 9.
  • Page 36 BpTRU Operator’s Manual 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.
  • Page 37 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”...
  • Page 38 Zero pressure Wait 5 seconds and calibration not 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 are all blank.
  • Page 39 Display Reference Symptoms Possible Causes Corrective Actions Power is on and E15 Battery is low. Plug BpTRU into a displays when BP wall outlet to charge Start or Temperature the battery. Start button is pressed. Monitor turns off Blown fuse.
  • Page 40 BpTRU Operator’s Manual Symptoms Possible Causes Corrective Actions Buzzer does not sound BpTRU is set to BP Exit BP Silent mode by at end of sixth Silent mode. turning off power and then holding Stop measurement in Automatic mode. button down while...
  • Page 41 Code Description Corrective Action _ _ _ User-cancelled None required. measurement. Too few pulses Check patient for pulse. Tighten cuff detected. on arm and check BpTRU for leaks in tubing or cuff. Loss of calibration Contact BpTRU Customer Support. data.
  • Page 42 BP Start, or if it does not disappear, contact BpTRU Customer Support. Low pulse amplitude. Check patient for pulse. Tighten cuff on arm and check BpTRU for leaks in tubing or cuff. Vacuum detected. Push Clear button. Disconnect cuff and wait 15 seconds before reconnecting.
  • Page 43 (ESD, power interruptions). Connect USB cable between measurements or when monitor is powered off. Data corrupted after Power the BpTRU off, wait 5 seconds reset. and power on again. Low battery Charge the battery a. In Automatic mode these errors are recorded in memory and mea- surements continue.
  • Page 44 Code Description Corrective Action 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). Indeterminate diastolic Check patient for pulse. Tighten cuff pressure (premature...
  • Page 45 Attach temperature probe and repeat connected measurement. Timeout on single Allow probe to cool to room temperature temperature for 34 minutes, press measurement Temperature Start, and then repeat measurement. Continuous Internal malfunction. Contact BpTRU measurement Customer Support. temperature circuitry not operational...
  • Page 46 Internal malfunction. Contact BpTRU temperature circuitry Customer Support. not operational 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.
  • Page 47 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.
  • Page 48 BpTRU Operator’s Manual...
  • Page 49 9. Battery irregularities such as cracks, deformation, leakage, or corrosion. 10. Cracked or deteriorating temperature probes and cables, if included. If any damage is evident, do not use the BpTRU. Call your distributor or BpTRU Customer Support. CAUTION Significant physical damage to the BpTRU could result in inaccurate results or even injury.
  • Page 50 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 one end and no fitting on the other end.
  • Page 51 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 —...
  • Page 52 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 the BpTRU. Use a Phillips screwdriver (provided) to remove both screws. 2. Join the two battery connectors. The connectors only fit one way.
  • Page 53 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.
  • Page 54  Operate the BpTRU with the power supply plugged into a wall outlet whenever possible.  Charge the battery overnight if the BpTRU was used in battery mode for more than two hours, or if the low-battery indicator is displayed ( ...
  • Page 55 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.
  • Page 56 BpTRU Operator’s Manual Similarly, 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 BP Reference Gauge Calibration Kit.
  • Page 57 Note that no manual calibration is required.  After initial setup  Monthly  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.
  • Page 58 Inspection  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.
  • Page 59 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.
  • Page 60 BpTRU. If the original packaging is not available, wrap the BpTRU in such a manner that it will not be scratched or otherwise damaged during shipping. If shipping the BpTRU or storing it for more than one month, disconnect the battery.
  • Page 61 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.
  • Page 62 BpTRU Operator’s Manual...
  • Page 63 Technical Information Specifications: BPM100 Item Specification Pressure measurement 0 to 290 mmHg range Pressure measurement Meets or exceeds ANSI/AAMI SP10:1992 accuracy Within 3 mmHg or 2%, whichever is greater Systolic blood pressure 60 to 250 mmHg measurement range Diastolic blood pressure...
  • Page 64 Height: 15 cm BPM100 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.
  • Page 65 Display Reference Specifications: BPM200 Item Specification Pressure measurement 0 to 290 mmHg range Pressure measurement Meets or exceeds ANSI/AAMI SP10:1992 accuracy Within 3 mmHg or 2%, whichever is greater Systolic blood pressure 60 to 250 mmHg measurement range Diastolic blood pressure 40 to 160 mmHg measurement range Pulse rate measurement...
  • Page 66 BpTRU Operator’s Manual Output power of universal 10 V, 1.0 - 1.25 A power supply 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...
  • Page 67 Display Reference Specifications: BPM300 Item Specification Pressure measurement 0 to 290 mmHg range Pressure measurement Meets or exceeds ANSI/AAMI SP10:1992 accuracy Within 3 mmHg or 2%, whichever is greater Systolic blood pressure 60 to 250 mmHg measurement range Diastolic blood pressure 40 to 160 mmHg measurement range Pulse rate measurement...
  • Page 68 BpTRU Operator’s Manual Item Specification Single temperature 35 °C to 39 °C (95.0 °F to 102.2 °F) measurement range Continuous temperature 28 °C to 43 °C (82.4 °F to 109.4 °F) measurement range Single temperature 15 seconds measurement time Continuous temperature 3 –...
  • Page 69 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:  CAN/CSA C22.2 No. 601.1M90, Medical Electrical Equipment – Part 1: General Requirements for Safety, 1990.
  • Page 70 BpTRU Operator’s Manual CE Mark Information 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...
  • Page 71 Guidance and manufacturer’s declaration – electromagnetic 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 –...
  • Page 72 Guidance and manufacturer’s 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...
  • Page 73 Guidance and manufacturer’s 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...
  • Page 74 Guidance and manufacturer’s 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...
  • Page 75 Recommended separation distances between portable and mobile RF communications equipment 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...
  • Page 76 BP Alert/Silent Mode 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.
  • Page 77 Review button works in the usual manner. BP Zero Calibration Check 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)”...
  • Page 78 BP Reference Gauge Calibration Check 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.)
  • Page 79 5. Connect a reference pressure gauge and pressure source in parallel with the BpTRU cuff connector to 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.
  • Page 80 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. 2. To toggle temperature display units, hold Mode while turning the BpTRU on again.
  • Page 81 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 & BPM300 models) Contact BpTRU to obtain the BpTRU connectivity manual.
  • Page 82 BpTRU Operator’s Manual...
  • Page 83 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...
  • Page 84 BpTRU MOBILE STAND UNIT includes: • Pole and Rolling Base Assembly • Basket • 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...
  • Page 85 BPM300 Model Only BPM30032 Cord Set, Continental Europe, Euro Plug For BPM200 BPM300 Model Only BPM30033 Cord Set, Australia For BPM200 BPM300 Model Only BPM30036 Lead Acid Battery for BPM200 BPM300 Please contact BpTRU Medical Devices for a complete catalogue list.
  • Page 86 BpTRU Operator’s Manual Owner Information Serial Number Date of Purchase Dealer Dealer Telephone Dealer Representative Dealer Representative Telephone...
  • Page 87 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...
  • Page 88 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...
  • Page 89 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.
  • Page 90 BpTRU Operator’s Manual...
  • Page 91 Index cuff available sizes ......77 alarms ........13 selecting size ....... 16 Alert mode Cycle button described ..... 12 BP Alert/Silent mode ....70 Cycle display described ....9 Temperature Alert/Silent mode ..73 Automatic mode (series of measurements) data transfer by USB ....
  • Page 92 BpTRU Operator’s Manual E25 ..........38 E26 ..........38 power E27 ..........39 requirements ........ 57 E3 ..........36 pressure range ......57 E4 ..........36 probe E41 ..........39 preparing ........25 E42 ..........39 pulse E43 ..........39 display described ......
  • Page 93 Index BPM-100 ........57 temperature Alert/Silent mode ......73 Calibration Check ......74 changing scale (ºC/ºF) ....74 display described ......9 rectal measurement ..... 29 single oral or axillary measurement ......25 tones .......... 13 transferring data by USB ... 75 USB, connecting .......

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