TECH-MED TMA-3 BASIC User Manual
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TECH-MED TMA-3 BASIC User Manual

Digital blood pressure and heat rate monitor
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  • Page 32 rok zał. 1949 B. WÓJCIK s-ka jawna 0 0 - 8 0 1 W a r s z a w a , u l . C h m i e l n a B I U R O H A N D L O W E : t e l . : ( 2 2 ) 6 5 4 S K L E P F I R M O W Y : t e l .
  • Page 33 Established in 1949 P O L I S H PR O D UC E R LEADER OF THE DECADE USER MANUAL DIGITAL BLOOD PRESSURE AND HEART RATE MONITOR MODEL: TMA - 3 BASIC...
  • Page 34 INTRODUCTION General Description Thank you for selecting TECH-MED arm type blood pressure mo- nitor (TMA-3 BASIC). The monitor features blood pressure me- asurement, pulse rate measurement and the result storage. The design provides you with two years of reliable service.
  • Page 35 Safety Information The signs below might be in the user manual, labeling or other component. They are the requirement of standard and using. Symbol for “THE OPERATION GUIDE MUST BE READ” Symbol for “TYPE BF APPLIED PARTS” Symbol for “COMPLIES WITH MDD 93/42/EEC REQUIRE- 0197 MENTS”...
  • Page 36 Symbol for “Authorised Representative in the European Com- munity Symbol for “MANUFACTURE DATE” Symbol for “Recycle” Caution: These notes must be observed to prevent any damage to the device. The Green Dot is the license symbol of a European network of industry-funded systems for recycling the packaging materials of consumer goods.
  • Page 37 CAUTION This device is intended for adult use in homes only. The device is not suitable for use on neonatal patients, pregnant women,patients with implanted, electronical devices, patients with pre-eclampsia, premature ventricular beats, atrial fibrillation, peripheral, arterial disease and patients undergoing intravascular therapy or arterio-venous shunt or people who received a ma- stectomy.
  • Page 38 When using this device, please pay attention to the following si- tuation which may interrupt blood flow and influence blood cir- culation of the patient, thus cause harmful injury to the patient: connection tubing kinking too frequent and consecutive multiple measurements;...
  • Page 39 This unit is not suitable for continuous monitoring during medi- cal emergencies or operations.Otherwise, the patient’s arm and fingers will become anaesthetic, swollen and even purple due to a lack of blood. When not in use, store the device in a dry room and protect it aga- inst extreme moisture, heat, lint, dust and direct sunlight.
  • Page 40 If the cuff pressure reaches 40 kPa (300 mmHg), the unit will au- tomatically deflate. Should the cuff not deflate when pressures reaches 40 kPa (300 mmHg), detach the cuff from the arm and press the START/STOP button to stop inflation. Before use, make sure the device functions safely and is in proper working condition.
  • Page 41 Keep the unit out of reach of infants, young children or pets to avoid inhalation or swallowing of small parts. It is dangerous or even fatal. Be careful to strangulation due to cables and hoses, particularly due to excessive length. At least 30 min required for ME equipment to warm from the mini- mum storage temperature between uses until it is ready for inten- ded use.
  • Page 42 LCD Display Signal SYMBOL DESCRIPTION EXPLANATION Systolic pressure High blood pressure Diastolic pressure Low blood pressure PUL/min. Pulse display Pulse in beats per minute Deflation symbol The cuff is deflating. Current Time Year/Month/Day, Hour/Minute Indicate it is in the memory mode and Memory which group of memory it is.
  • Page 43 Blood pressure Indicate the blood pressure level level indicator Blood pressure monitor is detecting Heartbeat a heartbeat during measurement. Monitor components CUFF AIR PIPE AIR CONNECTOR PLUG PAM BUTTON UST BUTTON Start/Stop BUTTON LCD DISPLAY Component list of pressure measuring system 1 Cuff 2 Air pipe 3 PCBA...

  • Page 44: Before You Start

    BEFORE YOU START The Choice of Power Supply Battery powered mode: 6VDC 4*AA batteries AC adaptor powered mode: 1A (not included) (Please only use the recommended AC adaptor model). AC a d a p t o r CAUTION In order to get the best effect and protect your monitor,please use the right battery and special power adaptor which complies with local safety standard.
  • Page 45 Replace the batteries whenever the below happens shows The display is dim The display does not light up. CAUTION • Do not use new and used batteries together. • Do not use different types of batteries together. • Do not dispose the batteries in fire. Batteries may explode or leak. •...
  • Page 46 Repeat step 2 and 3 to set the [MONTH] and [DAY]. Start Start Stop Stop Repeat step 2 and 3 to set the [HOUR] and [MINUTE]. Start Start Stop Stop Repeat step 2 and 3 to set the [UNIT]. Start Start Stop Stop...
  • Page 47 MEASUREMENT Tie the Cuff Remove all jewelry, such as watches and bracelets from your left arm.Note: If your doctor has diagnosed you with poor circulation in your left arm, use your right arm. Roll or push up your sleeve to expose the skin. Make sure your sleeve is not too tight.
  • Page 48 Helpful tips for Patients, especially for Patients with Hyper- tension: • Rest for 5 minutes before first measurement • Wait at least 3 minutes between measurements. This allows your blood circulation to recover. • Take the measurement in a silent room. •...

  • Page 49: Data Management

    Inflating and measuring. Display and save the results . Start Press the “Start/Stop” to power off, otherwise it will turn off within 1 minute. Stop DATA MANAGEMENT Recall the Records When the monitor is off, press the “PAM” to show the last record. Press the “PAM”...
  • Page 50 Th e c u r r e n t i s t h e N o 1 8 . Th e c o r r e s p o n d i n g Th e c o r r e s p o n d i n g d a t e i s 1 1 t h O c t o b e r .

  • Page 51: Information For User

    Start If there is no record, the right display will Stop be shown on the LCD. INFORMATION FOR USER Tips for Measurement Measurements may be inaccurate if taken in the following circumstan- ces. Within 1 hour after dinner or Immediate measurement drinking after tea, coffee, smoking –...
  • Page 52 Within 20 minutes after taking When talking or moving a bath your fingers In a very cold environment When you want to dischar- ge urine – 20 –...

  • Page 53: Maintenance

    MAINTENANCE Please calibrate the blood pressure monitor in specific institute once every two years to ensure the precise measurement. In order to get the best performance, please follow the instructions below for storage. Put in a dry place and avoid the Avoid touching water, sunshine clean it with a dry cloth...

  • Page 54: About Blood Pressure

    ABOUT BLOOD PRESSURE What are systolic pressure and diastolic pressure? When ventricles contract and pump blood out of the heart, the blood pressure reaches its maximum value in the cycle, which is called systolic pressure. When the ventricles relax, the blood pressure reaches its minimum value in the cycle, which is called diastolic pressure.
  • Page 55 CAUTION Only a physician can tell your normal BP range. Please contact a physician if your measuring result falls out of the range. Please note that only a physician can tell whether your blood pressure value has reached a dangerous point. Hypertension Blood Optimal...
  • Page 56 Why does my blood pressure fluctuate throughout the day? Individual blood pressure varies multiple times everyday. It is also affected by the way you tie your cuff and your measu- rement position, so please take the measurement under the same conditions. If the person takes medicine, the pressure will vary more.

  • Page 57: Troubleshooting

    TROUBLESHOOTING This section includes a list of error messages and frequently asked questions for problems you may encounter with your blood pressure monitor. If the products not operating as you think it should, check here before arranging for servicing. PROBLEM SYMPTOM CHECK THIS REMEDY...

  • Page 58: Specifications

    The measure- Loosen the clothing on ment process E20 shows the arm and then measure does not detect again the pulse signal. The treatment of Relax for a moment and E21 shows the measurement then measure again. failed. Error Retake the measurement. message If the problem persists, contact the retailer or our...
  • Page 59 A temperature range of :+5°C to +40°C A relative humidity range of 15% to 90%, non-condensing, but not requiring a water Normal working condition vapour partial pressure greater than 50 hPa An atmospheric pressure range of : 700 hPa to 1060 hPa Temperature:-20°C to +60°C A relative humidity range of ≤...

  • Page 60: Authorized Components

    AUTHORIZED COMPONENTS Please use the TECH-MED authorized adapter (not included). Adapter Type: ZASILACZ AC/DC Input:100~240V,50~60Hz,0.4Amax Output: 6V 1000mA COMPLIED STANDARDS LIST Complied Standards List EN ISO 14971:2012 / ISO 14971:2007 Medical devices Risk management - Application of risk management to medical devices EN ISO 15223-1:2016 / ISO 15223-1:2016 Medical devices.
  • Page 61 EN 60601-1:2006+A1:2013/ IEC 60601- 1:2005+A1:2012 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance General Require- EN 60601-1-11:2015/ IEC 60601-1-11:2015 Medical ments for Safety electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral standard: Requirements for medical electrical equip- ment and medical electrical systems used in the home healthcare environment...

  • Page 62: Emc Guidance

    Software life-cyc- EN 62304:2006/AC: 2008 / IEC 62304: 2006+A1:2015 le processes Medical device software - Software life-cycle processes ISO 10993-1:2009 Biological evaluation of medical devices- Part 1: Evaluation and testing within a risk management process ISO 10993-5:2009 Biological evaluation of medical Bio-compatibility devices - Part 5: Tests for in vitro cytotoxicity ISO 10993-10:2010 Biological evaluation of medical...
  • Page 63 Table 1 Guidance and manufacturer’s declaration – electromagnetic emissions The device is intended for use in the electromagnetic environment specified below. The customer or the user of the device should assure that it is used in such an environment. Emissions test Compliance Electromagnetic environment - guidance The device uses RF energy only for its...
  • Page 64 line(s) to line(s): line(s) to line(s): Mains power qu- ±1 kV ±1 kV ality should be that line(s) to earth: Surge IEC61000-4-5 of a typical com- ±2 kV 100 kHz repetition mercial or hospital 100 kHz repetition frequency environment. frequency 0%UT;...
  • Page 65 where, P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer, d is the recom- mended sepa- ration distance in meters (m). Field strengths from fixed RF 80 MHz to 800 transmitters, MHz: as determined Radiated RF...
  • Page 66 Table 4 Recommended separation distances between portable and mobile RF communications equipment and the device. The device is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the device can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmittters) and the device as recommended below, according to the maximum output power of the...
  • Page 67 Table 5 Guidance and manufacturer’s declaration - electromagnetic immunity The device is intended for use in the electromagnetic environment specified below. The customer or the user of the device, should assure that it is used in such an environment. IMMU- Test Modula- NITY...
  • Page 68 1800; 1720 CDMA 1900; Radia- Pulse ted RF 1700- 1900; modula- 1845 1990 DECT; tion b) 61000- 217Hz Band 1, (Test specifi- 1970 4,25; cations UMTS ENCLO- Blueto- SURE oth, PORT WLAN, IMMU- Pulse 802.11 NITY 2400- modula- 2450 b/g/n, to RF 2570 tion b)
  • Page 69 Disposal Batteries and electronic instruments must be disposed of in accordance with the locally applicable regulations, not with domestics waste. Established in 1949 B. WÓJCIK s-ka jawna 0 0 - 8 0 1 W a r s a w , C h m i e l n a St r .
  • Page 70 1949 gegründet P O L N I S C H E R PR O D UZ E N T DER ANFÜHRER DES JAHRZEHNTS DES JAHRZEHNTS BENUTZERHANDBUCH DIGITALES BLUTDRUCK - UND HERZFREQUENZMESSGERÄT MODEL: TMA - 3 BASIC...

  • Page 71: Aufbau Des Gerätes

    AUFBAU DES GERÄTES Symbole des LCD-Displays SYMBOL BESCHREIBUNG ERKLÄRUNG Systolischer Druck Höheres Druckergebnis Diastolischer Druck Niedrigeres Druckergebnis PUL/min. Puls Herzschläge/Min. Abpumpen Luft wird aus der Manschette freigelassen J/M/T, Uhrzeit: Aktuelles Datum und Uhrzeit Speicher Angezeigte Messwerte aus dem Speicher Messeinheit für Blutdruckmessung mmHg mmHg Messeinheit für Blutdruckmessung...
  • Page 72 Arrhythmie Unregelmäßiger Herzrhythmus Klasse Einstufung der Druckwerte nach WHO Während der Messung angezeigtes Pulssymbol Herzschlagsymbol Aufbau des Gerätes MANSCHETTE LUFTSCHLAUCH LUFTANSCHLUSSSTECKER TASTE SPEICHER TASTE EINSTELLUNGEN TASTE START/STOP LCD-DISPLAY BATTERIEFACH – 2 –...
  • Page 73 AUSWAHL DER STROMQUELLE AC a d a p t o r Akkubetrieb: 6 VDC 4*Akkus AA 1,5 VDC Netzteilbetrieb AC/DC ((nicht enthalten)): 100-240 V, 50-60 Hz, 400 mA, (Stromversorgung ist nur über das von TECH-MED empfohlene Netzteil möglich) – 3 –...
  • Page 74 Netzteil. HINWEIS Um die beste Funktion und den Schutz des Gerätes sicherzustel- len, empfehlen wir die Verwendung von alkalischen Akkus oder einem von TECH-MED empfohlenen Netzteil. Wechseln Sie die Akkus in den folgenden Fällen aus: • erscheint auf dem Display •...
  • Page 75 Drücken Sie die PAM-Taste, um das Jahr auszuwählen. Mit jedem Tastendruck wird der Wert erhöht. Nach Einstellen des richtigen Jahres drücken Sie die Taste “UST”, um die Auswahl zu bestätigen und zum weiteren Schritt zu wechseln. Wiederholen Sie die Schritte 2 und 3, um [MONAT] und [TAG] einzustellen.
  • Page 76 Wiederholen Sie die Schritte 2 und 3, um die [MAßEINHEIT] ein- zustellen: mmHg oder kPa. Nach Einstellen der Maßeinheit wird das unten gezeigte Bild an- gezeigt und danach wird das Gerät automatisch abgeschaltet. MESSUNG Anbringen der Manschette Bringen Sie die Manschette über dem freiliegenden linken Arm an, so dass der Luftschlauch leicht in innere Richtung des Arms verschoben ist, in einer Linie mit dem kleinen Finger.
  • Page 77 Die Manschette sollte zugedrückt werden, aber nicht zu fest. Zwischen der Manschette und dem Arm sollte genug Platz sein, um einen Finger einzuschieben. Die Manschette sollte 2-3 cm über der inneren Beugung im Ellenbogen befestigt werden. Setzen Sie sich bequem mit dem linken Arm auf eine ebene Tischfläche gestützt, mit der Handinnenfläche nach oben.
  • Page 78 LCD-Display. Automatische Einstellung der Null. Automatisches Aufblasen der Erzielen des Ergebnisses Manschette und und automatisches Durchführung der Messung. Speichern im Speicher. Start Drücken Sie die “START/STOP”-Taste, um das Gerät auszuschalten, andernfalls wird das Gerät nach 1 Mi- Stop nute automatisch ausgeschaltet. –...
  • Page 79 SPEICHER Aufrufen von gespeicherten Ergebnissen Drücken Sie die “PAM”-Taste, um die letzte Au- fzeichnung anzuzeigen. Drücken Sie die “PAM”- oder “UST”-Taste, um in den gesuchten Eintrag zu wechseln. D O W N Nummer der Messung im Speicher Aktuelles Datum: 11. Oktober Zeit: 10:38.
  • Page 80 Löschen von gespeicherten Messungen aus dem Speicher Ist die Messung nicht korrekt, können Sie alle Ergebnisse löschen, indem Sie die folgenden Schritte ausführen. Halten Sie die “PA- M”-Taste 3 Sekunden lang gedrückt, Display wird angeze- igt, was bedeutet “Alle löschen”. Drücken “UST”-Taste, um das Löschen zu bestäti-...

  • Page 81: Reinigung Und Wartung

    REINIGUNG UND WARTUNG Um eine optimale Funktion zu erzielen, beachten Sie die folgenden Empfehlungen. Lagern Sie das Gerät in einem Vermeiden Sie den Kontakt trockenen Ort und vor Sonnen- mit Wasser, reinigen Sie licht geschützt. das Gerät ggf. mit einem trockenen Tuch.

  • Page 82: Fehlerbehebung

    FEHLERBEHEBUNG PROBLEM ANZEICHEN PRÜFEN ABHILFE Leere Akkus Erneuern Sie die Akkus. Das Display Kein leuchtet Falsch eingelegte Legen Sie die Akkus richtig Strom nicht Akkus. ein. Schwa- Schwacher Erneuern Sie die Akkus. cher Akku Akku. Im Display Die Manschette Korrigieren Sie die Man- E1 wird ist entweder schette und führen Sie die...

  • Page 83: Technische Daten

    Akkubetrieb: 6V DC 4* Akkus AA AC-Netzteil-Stromversorgung:100-240 V~, 56- Spannungsversorgung 60 HZ, 400 mA (nicht enthalten) Es kann nur mit dem von TECH-MED empfohle- nen AC/DC-Netzteil versorgt werden) Digitales hintergrundbeleuchtetes blaues mit Typ des Displays weißen Ziffern LCD, 60 mm x 41 mm Messverfahren Oszillometrisches Prüfverfahren...
  • Page 84 Mit Blutdruckmessgerät 4* Akkus AA, Bedienungsanleitung, Etui, enthalten Messtagebuch, Garantieschein Betriebsart Dauerbetrieb Schutzart Anwendung von BF-Teilen Schutz vor eindringendem IP21 Wasser ACHTUNG: Änderungen an diesem Gerät sind nicht gestattet. Entsorgung Batterien und elektronische Geräte müssen gemäß den örtlich gelten- den Vorschriften entsorgt werden, nicht mit dem Hausmüll. 1949 gegründet B.

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