Self-Diagnostics SD-T Flex 120 Manual Del Usuario

Termómetro digital flexible instantáneo
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Instant Flexible Digital Thermometer
EN
Owners Manual
WARNING
• Read instructions thoroughly before using digital thermometer.
• Choking hazard: Thermometer cap and battery may be fatal if swallowed. Do not allow children
to use this device without parental supervision.
• Do not use thermometer in ear. Designed use is for oral, rectal, and armpit (axilla) readings only.
• Do not place thermometer battery near extreme heat as it may explode.
• Note: Use of the probe cover may result in a 0.1°C (0.2°F) discrepency from actual temperature.
• It is recommended the performance should be checked every two years.
• Remove battery from the device when not in operation for a long time.
• The use of temperature readings for self-diagnosis is dangerous. Consult your doctor for the
interpretation of results. Self-diagnosis may lead to the worsening of existing disease conditions.
• Do not attempt measurements when the thermometer is wet as inaccurate readings may result.
• Do not bite the thermometer, doing so may lead to breakage and/or injury.
• Do not attempt to disassemble or repair the thermometer, doing so may result in inaccurate readings.
• After each use, disinfect the thermometer especially if device is used by more than one person.
• Do not force the thermometer into the rectum. Stop insertion and abort the measurement when
pain is present. Failure to do so may lead to injury.
• Do not use thermometer orally after rectal use.
• For children who are two years old or younger, please do not use the devices orally.
PLEASE READ CAREFULLY BEFORE USING
This digital thermometer provides a quick and highly accurate reading of an individual's body
temperature. To better understand its functions and to provide years of dependable results, please
read all instructions first.
This thermometer is manufactured according to the system of EN12470-3:2000+A1:2009,
ASTM E1112-00 (Reapproval 2011).
The manufacturer is EN ISO 9001:2008 and EN ISO 13485:2012/AC:2012.
CONTENT
1 Thermometer, 1 Owners Manual, 1 Storage Case
PRODUCT ILLUSTRATION
Figure 1
Probe
PRECAUTION
• The performance of the device may be reduced should one or more of the following occur:
· Operation outside the manufacturer's stated temperature and humidity range.
· Storage outside the manufacturer's stated temperature and humidity range.
· Mechanical shock (for example, dropping the device).
· Patient temperature is below room temperature.
• Portable and mobile RF communications can affect the device. The device needs special precau-
tions regarding EMC according to the EMC information pro vided in the accompanying documents.
SYMBOL EXPLANATION
Direct Current
Type BF Applied Part
!
Caution, consult accompanying documents
SPECIFICATION
Type
Range
Accuracy
Display
Memory
Battery
Battery life
Dimensions
Weight
Using enviroment
Storage & transp. condition Temperature: -20°C ~ 55°C (-4°F ~ 131°F) // Relative humidity: 15 % ~ 95 % RH
Ingress Protection Rating
Classificarion
Digital Thermometer (Not Predictive)
32.0°C-42.9°C (90.0°F-109.9°F) (°C/°F chosen by manufacturer)
± 0.1°C, 35.5°C-42.0°C (± 0.2°F, 95.9°F-107.6°F)
± 0.4°C under 35.5°C or over 42.0°C // (± 0.4°F under 95.9°F or over 107.6°F)
at ambient temperature of 18°C to 28°C (64.4°F to 82.4°F)
Liquid crystal Display, 3 1/2 digits
For storing the last measured value
One 1.5 V DC. button battery (size LR41 or SR41, UCC 392)
Approx. 200 hours
13.9cm x 2.3cm x 1.3cm (L x W x H)
Approx. 13 grams including battery
Temperature: 5°C ~ 40°C (41°F ~ 104°F) // Relative humidity: 15 % ~ 95 % RH
IP 27
Type BF
LCD
On/Off
LOT
Batch code
Manufacturer
European Authorized Representative
EC REP
Battery Cap
Button
!

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  • Página 1 Instant Flexible Digital Thermometer Owners Manual WARNING • Read instructions thoroughly before using digital thermometer. • Choking hazard: Thermometer cap and battery may be fatal if swallowed. Do not allow children to use this device without parental supervision. • Do not use thermometer in ear. Designed use is for oral, rectal, and armpit (axilla) readings only. •...
  • Página 2: Battery Replacement

    °C / °F SWITCHABLE Temperature readings are available in both Fahrenheit or Celsius scales (°C / °F; located in the upper right corner of the LCD screen). With the unit off, press and hold the On/Off Button for approxi- mately 4 seconds to change the current setting. DIRECTIONS 1.
  • Página 3: Electromagnetic Compatibility Information

    ELECTROMAGNETIC COMPATIBILITY INFORMATION The device satisfies the EMC requirements of the international standard IEC 60601-1-2. The require- ments are satisfied under the conditions described in the table below. The device is an electrical medical product and is subject to special precautionary measures with regard to EMC which must be published in the instructions for use.
  • Página 4 Table 3 Guidance and declaration of manufacturer-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. IEC 60601 Compliance IMMUNITY test Electromagnetic environment guidance...
  • Página 5 Flexibles Instant-Digital-Thermometer Gebrauchsanleitung WARNUNG • Lesen Sie die Gebrauchsanleitung gründlich durch bevor Sie das Digital-Thermometer verwenden. • Erstickungsgefahr: Die Kappe des Thermometers und die Batterie könnten verschluckt werden. Lassen Sie Kinder mit diesem Gerät nicht unbeaufsichtigt. • Verwenden Sie dieses Thermometer nicht im Ohr. Es wurde nur für die orale und rektale An- wendung sowie zur Mesung unter dem Arm (Achsel) entwickelt.
  • Página 6: Auswahl Der Temperatureinheit

    AUSWAHL DER TEMPERATUREINHEIT Messergebnisse können in Grad Fahrenheit oder Grad Celsius angezeigt werden (°C / °F; Anzeige in der oberen rechten Ecke des Bildschirms. Drücken Sie am ausgeschalteten Gerät die Ein/Aus-Taste und halten Sie diese ca. 4 Sekunden, um die Einstellung zu wechseln. ANWENDUNG 1.
  • Página 7: Informationen Zur Elektromagnetischen Kompatibilität

    INFORMATIONEN ZUR ELEKTROMAGNETISCHEN KOMPATIBILITÄT Das Gerät erfüllt die EMV-Anforderungen der internationalen Norm IEC 60601-1-2. Die Anforderun- gen wurden laut den in der folgenden Tabelle beschrieben Bedingungen erfüllt. Das Gerät ist ein elektrisches Medizinprodukt und unterliegt besonderen Vorsichtsmaßnahmen bezüglich EMV, die in der Gebrauchsanweisung veröffentlicht werden müssen.
  • Página 8 Tabelle 3 Richtlinien und Erklärungen des Herstellers über elektromagnetische Emissionen Das Gerät ist für den Einsatz in der unten angegebenen elektromagnetischen Umgebung be- stimmt. Der Kunde oder der Anwender des Gerätes sollte sicherstellen, dass es in einer solchen Umgebung benutzt wird. Überein- IEC 60601 Immunitätstest...
  • Página 9: Mesures De Securite

    Thermomètre digital flexible Notice d’utilisation NOTE • Lire attentivement la notice d’utilisation avant d’utiliser le thermomètre digital. • Risque d’étouffement : L’ingestion du bouchon ou des piles du thermomètre peut être mortelle. Ne pas laisser à la portée des enfants. •...
  • Página 10: Unité De Mesure

    UNITÉ DE MESURE Les mesures peuvent être prises en degrés Fahrenheit ou en degrés Celsius (°C / °F; en bas à droite de l’écran LCD). Le thermomètre éteint, presser le bouton On/Off et maintenir appuyer environ 4 secondes afin de modifier les réglages. UTILISATION 1.
  • Página 11: Compatibilité Électromagnétique

    COMPATIBILITÉ ÉLECTROMAGNÉTIQUE L’appareil répond aux exigences CEM, de la norme internationale CEI60601-1-2. Les exigences indiquées dans les tableaux suivants ont été remplies. L’appareil est un produit médical électrique et est soumis à des mesures de précaution concernant CEM qui doivent être publiées dans la notice d’utilisation.
  • Página 12 Tableau 3 Déclaration du fabricant – Émissions électromagnétiques Le produit est adéquat pour une utilisation dans un environnement électromagnétique spécifique. Le client ou l’utilisateur du produit devraient assurer qu’il est utilisé dans un environnement élec- tromagnétoque comme décrit ci-dessous. Niveau Niveau de Test d’immunité...
  • Página 13 Termometro flessibile digitale istantaneo Manuale utente ATTENZIONE • Leggere le istruzioni prima di utilizzare il termometro digitale. • Pericolo di soffocamento: Il tappo del termometro e la batteria possono essere fatali se ingeriti. Non permettere ai bambini di utilizzare questo dispositivo senza la supervisione dei genitori. •...
  • Página 14: Sostituzione Della Batteria

    °C / °F SELEZIONABILE Le letture di temperatura sono disponibili in entrambe le scale Fahrenheit o Celsius (°C/°F; indicato nell’angolo in alto a destra dello schermo LCD). Con l’unità spenta, tenere premuto il pulsante On / Off per circa 4 secondi per cambiare l’impostazione attuale. INDICAZIONI 1.
  • Página 15 INFORMAZIONI SULLA COMPATIBILITÀ ELECTROMAGNETICA Il dispositivo soddisfa i requisiti EMC della norma internazionale IEC 60601-1-2. I requisiti sono soddisfatti nelle condizioni descritte nella tabella seguente. Il dispositivo è un prodotto medico elettrico ed è soggetto a misure speciali in materia di EMC che devono essere pubblicate nelle istruzioni d’uso.
  • Página 16 Tabella 3 Guida e dichiarazioni del produttore sulle emissioni elettromagnetiche Il dispositivo è stato progettato per l’uso nell'ambiente elettromagnetico specificato di seguito. Il cliente o l’utente del dispositivo dovrebbero garantire che venga usato in tale ambiente. IEC 60601 Livello Test immunità Guida Ambiente elettromagnetico test livello conformitá...
  • Página 17 Termómetro digital flexible instantáneo Manual del usuario ADVERTENCIA • Lea atentamente las instrucciones antes de usar el termómetro digital. • Riesgo de asfixia: el capuchón del termómetro y la pila pueden resultar mortales en caso de ingestión. No permita que los niños utilicen este aparato sin supervisión adulta. •...
  • Página 18: Instrucciones

    MEDICIÓN EN °C / °F Las lecturas de temperatura están disponibles en escala Fahrenheit o Celsius (°C / °F; en la esquina superior derecha de la pantalla LCD). Con la unidad apagada, presione y mantenga pulsado el botón On/Off durante unos 4 segundos para cambiar el ajuste actual. INSTRUCCIONES 1.
  • Página 19: Información De Compatibilidad Electromagnética

    INFORMACIÓN DE COMPATIBILIDAD ELECTROMAGNÉTICA El aparato satisface los requisitos relativos a la compatibilidad electromagnética de la norma internacional CEI 60601-1-2. Los requisitos se satisfacen según las condiciones descritas en la siguiente tabla. El aparato es un producto médico eléctrico y está sujeto a medidas de precaución especiales que deben estar publicadas en las instrucciones de uso.
  • Página 20 Tabla 3 Guía y declaración de las emisiones electromagnéticas del fabricante Se prevé el uso del aparato en el entorno electromagnético especificado a continuación. El cliente o el usuario del aparato debe asegurarse que lo utiliza en dicho entorno. Nivel Test de Nivel test Guía entorno electromagnético...

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