IEM Mobil-O-Graph Instructions For Use Manual
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IEM Mobil-O-Graph Instructions For Use Manual

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Marit Drønen
June 18, 2025

How to start it

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1 comments:
Marit Drønen
June 18, 2025

@Marit Drønen maritdronen@gmail.com How ro start the mobil O graph

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Marit Drønen
June 18, 2025

How ro start for 24 h testing

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Summary of Contents for IEM Mobil-O-Graph

  • Page 1 Instructions for Use...
  • Page 2 Hypertension Management Software CS (HMS CS) IEM GmbH Gewerbepark Brand 42 52078 Aachen Germany Email: info@iem.de Internet: www.iem.de The content of these instructions for use may not be reproduced or published without the written approval of IEM GmbH. © IEM GmbH 2021. All rights reserved.

  • Page 3: Table Of Contents

    Unpacking ............21 Checklist ............... 44 Description of device ......... 21 Mobil-O-Graph error description ....45 ® Blood pressure monitor ........21 Communication error Mobil-O-Graph ® Buttons ..............22 Bluetooth interface ........... 50 ® The display ............24 Rechargeable batteries/batteries ....52 Audible signals ............
  • Page 4 Appendix ..............57 Appendix 2 EMC Guidelines and Manufacturer’s Appendix 1 Important patient information ....57 Declaration ............67...

  • Page 5: Introduction

    ® patient in a few minutes. This gives you the advantage of being able to use the blood pressure monitor optimally and to conduct a 24-hour profile for each day. The Mobil-O-Graph will thus be quickly integrated into your everyday ®...

  • Page 6: About These Instructions For Use

    Introduction 1.2 About these instructions for use These instructions for use will ensure that you become familiar with the long-term blood pressure measuring device and the accessories. With a little practice you will find out how easy the blood pressure monitor is to use. The readings are evaluated using Hypertension Management Software Client Server data management, which is included on the CD together with the software handbook.

  • Page 7: Clinical Trials

     2011/65/EU (RoHS) Directives  and bears the CE Mark. IEM GmbH hereby declares that the Mobil-O-Graph corresponds to the 2014/53/EU Directive. ® The complete text of the EU declaration of conformity is available at the following website address: https://www.iem.de/doc/.

  • Page 8: Instruction Notes

    ®  described herein. Due to the risk of strangulation by the tube and cuff, the Mobil-O-Graph must not be used on patients of ® ...

  • Page 9: Essential Performance Features

    Instruction notes 2.3 Essential performance features The essential performance features are defined as blood pressure measurement with: Error tolerances of the pressure gauge and measurement results within the required limits according to  IEC 80601-2-30 Maximum change value in blood pressure determination according to IEC 80601-2-30 ...

  • Page 10: Indication

    Instruction notes 2.4 Indication The Mobil-O-Graph is intended to clarify the blood pressure situation and for diagnosis support. The field of ® application is domestic healthcare and professional facilities such as doctor’s practices and medical centres. The doctor may, at his own discretion, carry out an appropriate examination on his patients with this medical...

  • Page 11: Safety

    Instruction notes 2.6 Safety Read the safety instructions carefully before using the products! It is important that you understand the information in these instructions for use. If you have any questions, please do not hesitate to contact technical support. Defining the signal words used In order to point out dangers and important information, the following symbols and signal words are used in these instructions for use: WARNING...

  • Page 12: Defining General Notes

    Instruction notes Defining general notes Note The signal word Note indicates further information about the Mobil-O-Graph or its accessories. ® External reference Indicates reference to external documents in which further information may optionally be found. 2.7 Important safety instructions for the doctor...
  • Page 13 The Mobil-O-Graph must not be used on patients of unsound mind. ®  If the Mobil-O-Graph is used on children, this should be done with particular caution and under the ®  constant supervision of the doctor in accordance with regulations.
  • Page 14 ®  WARNING Risk of injury from putting on and pumping up a cuff over a wound Do not place the Mobil-O-Graph over a wound or bandage. ®  WARNING...
  • Page 15 Danger of injury and danger of blood flow disruptions as a result of putting on and pumping up a cuff on limbs with an intravascular drip or intravascular treatment or with an arteriovenous (AV) shunt. Do not put the Mobil-O-Graph on anyone who has an intravascular drip or arteriovenous (AV) shunt in ®...
  • Page 16 Danger of injury as a result of putting on or pumping up a cuff on an arm on the same side of the body on which a mastectomy has been carried out Do not put the Mobil-O-Graph on a person’s arm that is on the side where a mastectomy has been carried out.
  • Page 17 You should therefore only use IEM accessories. The device must not be connected to a PC or other device when it is still electrically connected to a ...
  • Page 18 Extreme temperatures, humidity or air pressure can influence measurement accuracy. Please follow the  instructions for use. The Mobil-O-Graph fulfils all requirements of the EMC standards, but the Mobil-O-Graph should not be ® ® ...
  • Page 19 Here, the device starts in the last used operating state. The appendix contains important information for the patient. This patient information can also be found in DIN A4 format at https://www.iem.de/en/patient-information/. If necessary, you can print it out and give it to the patient.

  • Page 20: Product Description

    Product description Product description 3.1 Description The ambulatory blood pressure monitoring consists of two main components: the Mobil-O-Graph monitor with various cuffs and additional accessories. ®  the Hypertension Management Software Client Server (HMS CS) evaluation software for the evaluation of ...

  • Page 21: Unpacking

    Product description Unpacking All parts included in the scope of delivery have been properly packed and checked for completeness and functionality. Should the product be incomplete or damaged, please inform the supplier immediately. 3.3 Description of device Blood pressure monitor Components: Battery compartment Data socket for PC interface cable...

  • Page 22: Buttons

    Product description Buttons All buttons are located in the housing top of the blood pressure monitor (see Fig. 1)). ON/OFF The ON/OFF button turns the blood pressure monitor on and off. To avoid accidental switching on or off, the button only reacts after 2 seconds. You can also prematurely terminate the measuring process with this button, as well as with any other button: the pressure in the cuff is then quickly released (also see the section on warnings).
  • Page 23 Product description EVENT The EVENT button can be used to trigger an additional measurement to record an event that affects blood pressure. The patient should record the circumstances of the event, such as taking medication, for example, in a personal measurement log so that he/she can discuss the events with you.

  • Page 24: The Display

    Product description The display The LCD display is located on the housing top of the blood pressure monitor (see Fig. 1). It displays useful information for the doctor and the patient regarding measurement data, blood pressure monitor settings and measurement errors. Audible signals The audible signals used consist of individual or multiple burst sequences.

  • Page 25: Cuff Connection

    Product description Cuff connection The cuff connection is located on the housing top of the Mobil-O-Graph (see Fig. 1). This metal plug is needed to ® connect the blood pressure monitor to the cuff via the cuff tube and the metal sleeve of the cuff.

  • Page 26: Preparation For Measurement

    Note Only use the IEM NiMH rechargeable batteries or alkaline batteries provided. Although zinc-carbon batteries and NiCd rechargeable batteries show sufficient voltage during the battery test, the power is often insufficient to take measurements for 24 hours.

  • Page 27: Clearing The Memory

    If an error occurs during the internal test, the blood pressure monitor will show E004 on the display and an audible signal will sound. For safety reasons, the blood pressure monitor will be out of operation. Send the blood pressure monitor immediately to your specialist supplier or directly to IEM GmbH for repair. Clearing the memory The memory must be empty before every measurement, i.e.

  • Page 28: Setting The Time/Date

    Product description Setting the time/date The Mobil-O-Graph has an internal backup battery which allows the time to continue even after removing the ® power pack or batteries from the battery compartment. Nevertheless, the time and the date should be checked before every measurement series.

  • Page 29: Specifying The Desired Measurement Log

    ® supplier or directly from IEM GmbH. Setting the logs via software To set the protocols using the software please refer to the HMS CS instructions for use for the...

  • Page 30: Putting On The Blood Pressure Monitor And Starting The Measurement

    Product description Putting on the blood pressure monitor and starting the measurement Place the monitor pouch on the patient. By varying the length of the strap, you can use it either as a waist strap or as a shoulder strap. Alternatively, a normal belt can be used that matches the clothes.
  • Page 31 Product description The cuff should only be placed on the upper arm. Correct positioning can be checked using a simple test: You should be able to insert one or two fingers under the cuff. It is important for the cuff to be the correct size to ensure accurate blood pressure measurement. To make it possible to measure reproducible values, there should be standardised measurement conditions, i.e.
  • Page 32 5 times. This termination will also be stored in the table of readings under “terminated”. If the measurement is aborted, a new measurement will start after 3 minutes. Note Before a 24-hour measurement, you should go through the patient information sheet with the patient. The information sheet is available at https://www.iem.de/en/patient-information/ .

  • Page 33: Position And Conduct Of The Patient

    Product description 3.5 Position and conduct of the patient Show the patient how to put on the cuff so that it is at the level of the right atrium during the measurement. Inform the patient that they should adopt one of the positions shown in Table 1 at the start of a blood pressure measurement if possible.
  • Page 34 Product description It is important here that the patient: is sitting/standing/lying comfortably  does not cross their legs  places their feet flat on the floor (when sitting or standing)  supports their back and arms (when sitting or lying) ...

  • Page 35: Technical Data And Environmental Conditions

    240 g including batteries Power supply: 2 x Ni-MH rechargeable batteries, each 1.2 V and min. 1500mAh (AA, Mignon) 2 x 1.5 V alkaline batteries (AA, Mignon) Interfaces: IR-MED serial or USB (IEM specific) PC combination cable USB or serial Bluetooth ®...
  • Page 36 Product description Expected operational life of 5 years the device Expected operational life of 6 months the cuff Environmental conditions: ATTENTION Extremes of temperature, humidity or air pressure can affect measurement accuracy. Please observe  the operating conditions. Extreme temperatures, humidity or altitude can affect the performance of the blood pressure monitor. ...

  • Page 37: Symbols

    Product description 3.7 Symbols Note The symbols on the buttons are described in chapter 3.3.2 “Buttons”. Explanation of the label symbols: Symbol Explanation Comply with the instructions for use! The battery symbol indicates the type of power supply. FCC marking for communication devices Manufacturer Defibrillation-proof type BF applied part The product is not to be treated as normal domestic waste, but should be taken to a recycling...
  • Page 38 Product description Symbol Explanation Date of manufacture YYYY-MM-DD MR unsafe: The product poses hazards in MRT environments Serial number Protection class...

  • Page 39: Care And Maintenance

    If liquid gets into the device, switch it off immediately and send it to your specialist supplier or directly to  IEM GmbH for inspection! Do not open the casing of the Mobil-O-Graph , otherwise any warranty will no longer be valid! ®...
  • Page 40  When using other disinfectants that have not been tested by IEM, the burden of proof that these can be used without causing damage lies with the user. Never use disinfectants which leave residue on the product or which are not suitable for contact with the skin.
  • Page 41  Balloon: Wipe the balloon with lukewarm water only, adding a mild detergent if necessary. Ensure that no water enters the tube opening. Blood pressure monitor: Only clean the Mobil-O-Graph with a damp cotton cloth. No harsh or solvent-based ®...

  • Page 42: Maintenance Plan

    We recommend that you only use the rechargeable batteries supplied by IEM, the capacity and quality of which has been tested. It is important to make sure that the capacity of the rechargeable batteries is above 1500 mAh.

  • Page 43: Troubleshooting

    Troubleshooting Troubleshooting Note In case of an error message, the device starts a new measurement after 3 minutes, except for the activation measurement. 5.1 Main sources of error The following can cause error measurements or unwanted results: The patient’s arm moving during measurement Incorrect log set ...

  • Page 44: Transmission Error

    To avoid an error during data transmission, the blood pressure monitor includes a check of the data sent. If an error has occurred, E004 will appear on the display. 5.3 Checklist Please go through the following checklist if you have encountered errors when handling the Mobil-O-Graph . Many ®...

  • Page 45: Mobil-O-Graph ® Error Description

    2. Considerable arm movement 2. Keep the arm still during measurement. 3. Problems with the pneumatics 3. If this error occurs continuously, send the device to your specialist supplier or directly to IEM GmbH for checking.
  • Page 46 2. Check the plug to see whether transmission cable are the pins on the inside are damaged. mechanically damaged. If they are, call your specialist supplier or IEM GmbH. 3. Reading not transmitted 3. Start the transmission again. correctly Err 5 1.
  • Page 47 Troubleshooting Error message Possible cause Measures Err 6 1. Build-up of air 1. Check the cuff for a build-up of air or a kink in the tube. If there is a kink in the cuff tube, lay the tube possible continuous alarm out.
  • Page 48 1. Serious error due to pressure Send the device immediately to build-up outside the measuring your specialist supplier or directly to process (pump has been switched IEM GmbH for checking and Continuous alarm until a on against orders) repairs. button is pressed 2.
  • Page 49 3. The display is faulty 3. Send the device to your specialist supplier or directly to IEM GmbH for repair. The cuff size does not fit the Check the circumference of the arm An error occurs during the patient's arm circumference.

  • Page 50: Communication Error Mobil-O-Graph ® Bluetooth ® Interface

    Remedy Bluetooth interface of the Mobil-O-Graph Send the device to your specialist ® ® did not start up correctly. supplier or directly to IEM GmbH for checking. Possible hardware fault. The Bluetooth interface of the Mobil-O- Try it again. ®...
  • Page 51 Try it again. ® mobile phone or GSM modem which is If the error persists, please contact your technically incapable of sending readings, specialist supplier or IEM GmbH. is outside the network range or is not configured correctly.

  • Page 52: Rechargeable Batteries/Batteries

    Rechargeable batteries/batteries Rechargeable batteries/batteries 6.1 Operation with rechargeable batteries IEM supplies high-quality "ready to use" NiMH rechargeable batteries with at least 1500 mAh which have very low self-discharge. We recommend that you only use these rechargeable batteries! WARNING Do not use rechargeable batteries that have been stored above 45°C or below 0°C.
  • Page 53 Rechargeable batteries/batteries Tips: Fully charge the rechargeable batteries before using them for the first time.  Please note that NiMH rechargeable batteries only reach their full charge capacity after the 4th charging  cycle. Recharge rechargeable batteries again if they have been lying around unused for a long time. ...

  • Page 54: Operating With Alkaline Batteries

    Rechargeable batteries/batteries 6.2 Operating with ALKALINE batteries The Mobil-O-Graph can also be operated with alkaline manganese batteries. These batteries are non-rechargeable ® and therefore must not be placed into the charger. Two alkaline batteries have a higher charging voltage when full (at least 3.1 V) than 2 NiMH rechargeable batteries (at least 2.6 V).

  • Page 55: Warranty And Repair Conditions

    The normal wear and tear of rechargeable batteries, transmission cables or cuffs including tube cannot be claimed under the warranty. In the scope of the warranty, IEM is only responsible for defects that already existed when the product was handed over to the customer (and possibly only showed up later).
  • Page 56 Liability clause: In all cases where IEM is obliged to pay damages or reimburse expenses on the basis of contractual or statutory claims, IEM is liable only to the extent that its executives and vicarious agents are guilty of intent or gross negligence. Strict liability according to the Product Liability Act remains unaffected.
  • Page 57 If necessary, you can print it out and give it to the patient. Patient information sheet This patient information sheet gives you important safety information about using the Mobil-O-Graph for 24-hour ® long-term blood pressure measurement. For ease of reading, only the name Mobil-O-Graph is used in this ®...
  • Page 58  Bleeding in the skin or muscles may occur in patients with sensitive body tissue (petechiae, haemorrhages  or subcutaneous haematomas). Do not place the Mobil-O-Graph over a wound or bandage. ®  If the patient has limited cognitive abilities, the device may only be used under supervision.
  • Page 59 MRI scanner. The device must not be used on aeroplanes.  The Mobil-O-Graph fulfils all requirements of the EMC standards, but it should not be exposed to strong ®...
  • Page 60 Appendix Taking off the cuff and blood pressure measuring device If you need to remove the cuff and the device (e.g. to have a shower), proceed as follows: Switch the device off using the ON/OFF button.  Remove the cuff from the arm. ...
  • Page 61 Appendix Insert the Mobil-O-Graph into the holster so that the cuff ®  connection and the buttons are freely accessible for operation. Switch the Mobil-O-Graph on using the ON/OFF button. ®  Start a new blood pressure measurement by pressing the START ...
  • Page 62 Appendix Conduct during a measurement Make sure that the middle of the cuff is located at the level of your right atrium. When a blood pressure measurement starts, adopt one of the following positions if possible: 1st Position 2nd Position 3rd Position Sitting/standing/lying comfortably Feet flat on the floor (when sitting or standing)
  • Page 63 4 buttons which can be used to perform various functions: ® ON/OFF button You can turn the Mobil-O-Graph on and off using the ON/OFF button. To avoid accidental ® switching on or off, the button must be held down for at least 2 seconds.
  • Page 64 Appendix with your doctor afterwards. Special events are, for example, taking medication, chest pains, shortness of breath or similar. WARNING After an automatic measurement, allow at least 3 minutes to elapse to avoid prolonged impairment of blood circulation before actively starting a measurement.
  • Page 65 Appendix Audible signals The audible signals generated by the device consist of individual or multiple tone burst sequences. The following tone burst sequences are emitted: Tone burst Heard when 1 tone burst Switching on and off  Starting and ending measurement (except during the night-time ...
  • Page 66 Appendix Troubleshooting In the event of measurement or system errors, an error code will appear on the display of the Mobil-O-Graph for a ® few seconds. The following support instructions will help you understand how to deal with each error code:...
  • Page 67 Guidelines and Manufacturer’s Declaration – electromagnetic emissions The blood pressure measuring device Mobil-O-Graph is intended for use in the environment specified below. ® The customer or user of the blood pressure measuring device Mobil-O-Graph should ensure that it is used in ® such an environment.
  • Page 68 Guidelines and manufacturer’s declaration – electromagnetic immunity The blood pressure measuring device Mobil-O-Graph is intended for use in the environment specified below. ® The customer or user of the blood pressure measuring device Mobil-O-Graph should ensure that it is used in ® such an environment.
  • Page 69 (50/60 Hz) according typical values found in to IEC 61000-4-8 business or hospital environments. Voltage dips, short Not applicable The Mobil-O-Graph does not ® interruptions and have an AC power supply fluctuations in supply voltage according to IEC 61000-4-11...
  • Page 70 Guidelines and manufacturer’s declaration – electromagnetic immunity The blood pressure measuring device Mobil-O-Graph is intended for use in the environment specified below. ® The customer or user of the blood pressure measuring device Mobil-O-Graph should ensure that it is used in ® such an environment.
  • Page 71 Appendix Guidelines and manufacturer’s declaration – electromagnetic immunity The Mobil-O-Graph is intended for use in the electromagnetic environment specified below. The customer ® or Mobil-O-Graph user should ensure that is used only in such an environment. ® Measurement of Test level...

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