IEM Tel-O-Graph BT Operating Instructions Manual
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IEM Tel-O-Graph BT Operating Instructions Manual

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Summary of Contents for IEM Tel-O-Graph BT

  • Page 1 ® Tel-O-Graph Operating instructions...
  • Page 2 52222 Stolberg Germany Telephone: +49 2402 9500-0 Fax: +49 2402 9500-11 E-mail: info@iem.de Website: www.iem.de The content of this operating manual must not be reproduced or published without the written approval of I.E.M. GmbH. Revision: A – 06.11.2017 - EN...
  • Page 3 Table of contents Table of contents Putting the blood pressure cuff on ....21 Correct posture ..........23 Table of contents ............3 Measuring ............24 Introduction ............4 Stopping the measurement ......25 Clinical validation ..........4 Transmitting the measurement values via CE Mark ............

  • Page 4: Introduction

    If you have any questions about our services or ® declares that the Tel-O-Graph BT corresponds to the products, feel free to contact us. 2014/53/EU (RED) guideline. External reference The complete text of the EU declaration of conformity is available at the following website address: www.iem.de.

  • Page 5: Contents

    Instructions for use Contents Contents ▪ Blood pressure monitor ▪ Blood pressure cuff "M" (Arm circumference: 24-32 cm (9.5-12.6 in)) ▪ Operating manual ▪ Batteries (4x, AA, alkaline) Optional accessories ▪ Blood pressure cuff "S" (Arm circumference:20-24 cm (7.9-9,5 in)) ▪...

  • Page 6: Instructions For Use

    Instructions for use Instructions for use Improper use Intended use The blood pressure monitor must not be used for ® newborns, during operations, in the vicinity of MRI The Tel-O-Graph BT is intended for the home scanners or other strong magnetic fields, or for clinical measurement of blood pressure and pulse on the upper arm in adults.

  • Page 7: Essential Performance

    Instructions for use the cuff. The cuff is not automatically pressurised, to Essential Performance do so, the device must be initiated manually. The essential performance features are defined as See IEC 81060-1 201.4.3.101, IEC 60601-1, sect. 4.2 blood pressure measurement with: and IEC 60601-1-2, sect.

  • Page 8: Safety

    Safety Safety ATTENTION This section explains all the safety information for the Short description of the danger device. This warning symbol, in connection with the signal Read this section carefully before using the blood word ATTENTION, indicates possible material pressure monitor. damage.

  • Page 9: Important Patient Information

    Safety Important patient information WARNING WARNING Danger of tissue bleeding or haematoma. ▪ When using the blood pressure monitor, make Danger as a result of self-diagnosis sure it does not impede the blood circulation in ▪ Do not undertake any changes to your your arm.
  • Page 10 Safety WARNING WARNING Danger of a temporary loss of function of a Danger of injury as a result of using unapproved present electrical medical device as a result of accessories putting on or pumping up a cuff if you are wearing a further electrical medical device for ▪...
  • Page 11 Safety supervision or instruction by a responsible WARNING person. ▪ The blood pressure monitor may not be used Danger of blood flow interruptions as a result of by those with limited mental competencies. steady cuff pressure or too frequent measuring (Keep out of reach.) ▪...

  • Page 12: Important Device Instructions

    Safety that does not conduct electricity. They thus Important device instructions protect the device against the effects of discharging a defibrillator. In the event of ATTENTION discharging a defibrillator, the device itself must not touch the patient since the device Equipment failure can be damaged as a result of such a ▪...
  • Page 13 Safety ATTENTION ATTENTION Batteries Electric fields ▪ ▪ Remove the batteries from the battery Measurements may be faulty if the device is compartment when they no longer have any operated in the vicinity of strong electrical charge or if you do not expect to use the blood fields.
  • Page 14 Safety ATTENTION Fluid damage to the blood pressure monitor ▪ Liquid must not penetrate the device. If you believe that liquid has penetrated the device during cleaning or use of the blood pressure monitor, the device must no longer be used. ▪...

  • Page 15: Description Of Device

    Description of device Description of device Blood pressure monitor Fig. 1: Blood pressure monitor Display Battery cover Infrared interface (for service) Air hose socket button...

  • Page 16: Blood Pressure Cuff

    Description of device Blood pressure cuff Fig. 2: Blood pressure cuff Blood pressure cuff Air hose Air hose connection...

  • Page 17: Display

    Description of device Display Fig. 3: Display When this appears: Battery empty Number of pulse beats per minutes Display of systolic (upper) value Pulse detected Data transmission Number of measurement values ® Bluetooth Display of diastolic (lower) value Infra-red communication...

  • Page 18: Ambient Conditions

    Description of device Ambient conditions ATTENTION Extreme temperatures, humidity or air pressure can influence measurement accuracy. Please follow the operating instructions. ▪ Never store the blood pressure monitor outside a temperature range of -25 °C to +70 °C. ▪ Never use the blood pressure monitor outside a temperature range of +5 °C to +40 °C. ▪...

  • Page 19: Preparing The Measurement

    Preparing the measurement Preparing the measurement Keep the packaging so that it can be safely packaged at a later date. Unpacking Note Inserting the batteries All parts included in delivery package have been properly packed and checked for completeness and functionality.

  • Page 20: Switching The Blood Pressure Monitor On/Off

    Preparing the measurement Open the battery cover on the underside of the Switching the blood pressure monitor blood pressure monitor. on/off Insert four batteries (AA, alkaline), with the poles Switching on aligned correctly. Close the battery cover.  The blood pressure monitor switches on automatically, carries out a display test and displays the start screen.

  • Page 21: Measuring Blood Pressure And Pulse

    Measuring blood pressure and pulse Measuring blood pressure and pulse Putting the blood pressure cuff on Before measuring WARNING ▪ Choose the right blood pressure cuff size. The blood Risk of injury due to incorrectly connected air pressure cuff size is printed on the cuff. hose! ▪...
  • Page 22 Measuring blood pressure and pulse Fig. 8: Correct position of blood pressure cuff Fig. 7: Insert air hose Position the blood pressure cuff correctly (see Insert the air hose connection into the air hose Fig. 8): socket on the left-hand side of the blood ▪...
  • Page 23 Measuring blood pressure and pulse Once the blood pressure cuff is positioned Correct posture correctly, fasten the end with the Velcro. After positioning the blood pressure cuff, assume the correct posture to take the measurements (Fig. 9). Note Place the blood pressure cuff so that there is enough room to insert your index and middle fingers between the skin and the material of the blood pressure cuff.
  • Page 24 Measuring blood pressure and pulse Hold your arm so that the blood pressure cuff is Measuring at the same height as your heart. WARNING Relax your arm and turn the palm of your hand to face upwards. Risk of injuries during measurement! Place your feet flat on the floor and leave your ▪...

  • Page 25: Stopping The Measurement

    Measuring blood pressure and pulse ♥ monitor detects a pulse, the icon appears. The Stopping the measurement reading is taken as the air is let out. The blood If the measurement causes you pain, press the pressure monitor confirms the end of the button during the measurement.

  • Page 26: Transmitting The Measurement Values Via Bluetooth

    Transmitting the measurement values via Bluetooth® Transmitting the measurement values Active Pairing (Bluetooth modem) ® via Bluetooth Note If the blood pressure monitor is set up to transmit your ® measurement values via Bluetooth , the measurement The Pairing requires basic knowledge of Bluetooth. values will be automatically transmitted to the Otherwise, please contact your healthcare provider database.

  • Page 27: Passive Pairing (Tablet, Smartphone)

    Transmitting the measurement values via Bluetooth®  Press the button. Active pairing begins and the display of the blood pressure monitor displays [PA/ A]  The display shows the start screen und the symbols. The (see Fig. 6). transmission device is automatically added Press and hold the button for more to the device list.

  • Page 28: Memory

    Memory The number of readings is shown on the display (Fig. Memory 10). Saving readings Deleting readings from the blood pressure monitor To clear the memory on your blood pressure monitor, proceed as follows: Fig. 10: Number of readings The blood pressure monitor can save 15 blood pressure readings and 15 pulse rate readings.
  • Page 29 Memory  The acoustic signal sounds 3 times and the Note display shows [M00] (see Fig. 11/C). The display automatically shows each menu entry The measurements are deleted. The device returns to for 3 seconds. The display order is: standby mode displays start...

  • Page 30: Cleaning And Disinfection

    Cleaning and disinfection Cleaning and disinfection Note WARNING Always observe the manufacturer's instructions on the disinfection and cleaning of these products. ▪ When putting the blood pressure monitor on, there must no longer be any disinfectants on the blood pressure cuff! Cleaning ▪...

  • Page 31: Disinfection

    Cleaning and disinfection Disinfection Ask your doctor if and when the cuff needs to be disinfected for hygienic reasons. I.E.M. GmbH has tested the following means for the disinfection: ▪ Isopropanol (70%) ▪ Terralin Liquid (Manufacturer: Schülke & Mayr) When using other disinfectants not checked by I.E.M. GmbH, the user is responsible for the proof of use without damage.

  • Page 32: Maintenance

    Maintenance Maintenance The monitor and the cuff are calibrated by the manufacturer for a period of two years. Maintenance (metrological check) must be carried out in accordance with Directive 93/42/EEC every two years at the latest if the device is used professionally. In certain countries, this requirement may be regulated by national laws or regulations.

  • Page 33: Disposal

    Disposal Disposal Batteries Batteries must not be disposed of with domestic Blood pressure monitor waste. As a consumer you are legally bound to return used batteries. You can return your old batteries to official collection points within your community or everywhere batteries of that type are sold.

  • Page 34: Error Messages

    Error messages Error messages 12.1 Blood pressure measurement errors The blood pressure monitor indicates blood pressure measurement errors and communication errors by emitting 12 short acoustic signals. Error Cause Remedy description Arm moved during  Keep your arm still during the measurement ( Chapter 6.3).
  • Page 35 Error messages Error Cause Remedy description Power pack or battery  Change the batteries ( Chapter 5.2). voltage too low. Err 5 Battery contacts are Clean the battery contacts with a cotton cloth and a little alcohol. corroded. Check the blood pressure cuff for air congestion or a kink in the air hose.

  • Page 36: Communication Error

    Error messages 12.2 Communication error Error Cause Remedy description  Error during pairing Re-pair the blood pressure monitor ( Chapter7.2). Cod 1 Transmission device is Turn on the transmission device. switched off. ® No Bluetooth Check that your transmission device is switched on. If this error Cod 2 connection occurs repeatedly, contact your healthcare provider.

  • Page 37: Technical Data And Symbols

    Technical data and symbols Technical data and symbols Technical data The blood pressure monitor complies with the EMC directives. The blood pressure cuff and air hose are made of a non-conductive material. This makes the device defibrillator- safe. Specification Value Unit Measuring method Oscillometric...
  • Page 38 Technical data and symbols Specification Value Unit Material (cuff) Polyester Operating temperature +5 to +40 °C Ambient pressure 700 to 1060 Transport temperature -25 to +70 °C Storage temperature -25 to +70 °C Air humidity, not condensing (operation, 15 to 93 transport and storage) Battery capacity c.
  • Page 39 Technical data and symbols Symbols Symbol Meaning 4 x LR6 or HR6, AA with 1.5 V Manufacturer Date of manufacture YYYY-MM-DD Designation of the FCC radio authorisation CE 0044: Labelling of a medical device in accordance with directive 93/42/EEC It may not be possible to use the device everywhere in Europe. Protect from rain and moisture Comply with the operating manual...
  • Page 40 Technical data and symbols Symbol Meaning The symbol on the product or packaging means that this product should not be treated as normal domestic waste, but should be taken to a recycling point for electric and electronic devices. You can find out more about this from your local authority, the communal disposal companies or the shop in which you bought the product.

  • Page 41: Warranty And Repairs

    Warranty and repairs ▪ Liability for direct or indirect consequential damages Warranty and repairs caused by the device is excluded even in the event Warranty information that the damage to the device is acknowledged as a ▪ I.E.M. GmbH provides a two-year warranty on the warranty case.

  • Page 42: Manufacturer's Emc Guidelines

    Manufacturer’s EMC guidelines Manufacturer’s EMC guidelines Electromagnetic interference emissions ® The Tel-O-Graph BT is intended to be operated in the electromagnetic environment specified below. Only use the ® Tel-O-Graph BT in such an environment. Measurement of – Compliance Electromagnetic environment guidelines interference emissions ®...
  • Page 43 Manufacturer’s EMC guidelines Electromagnetic immunity ® The Tel-O-Graph BT is intended to be operated in the electromagnetic environment specified below. Only use the ® Tel-O-Graph BT in such an environment. – Measurement of IEC 60601-1 test Electromagnetic environment Compliance level interference emissions level guidelines...
  • Page 44 Manufacturer’s EMC guidelines – Measurement of IEC 60601-1 test Electromagnetic environment Compliance level interference emissions level guidelines IEC 61000-4-3 80 MHz to 2.5 GHz used no closer to the ® Tel-O-Graph BT (including wires) than the recommended safety distance calculated using the equation that applies to the transmission frequency.
  • Page 45 Manufacturer’s EMC guidelines NOTE 1: The higher frequency range applies for 80 MHz and 800 MHz. NOTE 2: These guidelines may not apply in all cases. The distribution of electromagnetic variables is influenced by the absorption and reflection of buildings, objects and people. The field intensity of stationary transmitters such as base stations of mobile telephones and mobile terrestrial radios, amateur radio stations, AM and FM radio and TV transmitters, cannot, theoretically, be accurately determined in advance.
  • Page 46 Manufacturer’s EMC guidelines Recommended safety distances between portable and mobile HF telecommunication devices and the Tel- ® O-Graph ® The Tel-O-Graph BT is designed for operation in an electromagnetic environment in which disturbance variables are controlled. Maintain the minimum distances between portable and mobile telecommunication devices (transmitters) and the measuring device as specified below, depending on the output of the communication device.

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