I.E.M. Mobil-O-Graph PWA Operating Manual
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I.E.M. Mobil-O-Graph PWA Operating Manual

Long-term blood pressure measuring device, ambulatory blood pressure monitor
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Operating manual
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Mobil-O-Graph
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PWA
Mobil-O-Graph
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NG

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Summary of Contents for I.E.M. Mobil-O-Graph PWA

  • Page 1 Operating manual Mobil-O-Graph ® Mobil-O-Graph ®...
  • Page 2 ® Mobil-O-Graph ® Mobil-O-Graph Long-term blood pressure measuring device Ambulatory Blood Pressure Monitor Evaluation unit: Hypertension Management Software CS (HMS CS) I.E.M. Industrielle Entwicklung Medizintechnik und Vertriebsgesellschaft mbH (I.E.M GmbH) Cockerillstr. 69 52222 Stolberg Deutschland Telephone: +49 2402 9500-0 Fax: +49 2402 9500-11 Email: info@iem.de Internet: www.iem.de...

  • Page 3: Table Of Contents

    Table of contents Switching on ..........84 Clearing the memory ........85 Introduction ..........66 Setting the time/date ........85 Preliminary note ..........66 Transferring patient data (ID) ....... 85 About this operating manual ......66 Specifying the desired measurement log ..86 Clinical trials ..........67 Putting on the blood pressure monitor and CE Mark ............67...

  • Page 4: Introduction

    Introduction Introduction 1.1 Preliminary note ® Thank you for choosing a Mobil-O-Graph New Generation (NG) or 24-hour pulse wave analysis monitor (PWA) long-term blood pressure measuring device. Both blood pressure measuring devices have been specially developed for 24-hour measurement and work according to the oscillometric measuring principle. As an additional ®...

  • Page 5: Clinical Trials

    Introduction 1.3 Clinical trials ® The Mobil-O-Graph NG and PWA fulfil the requirements of the ESH (European Society of Hypertension), BHS (British Hypertension Society) and ISO 81060-2:2013. 1.4 CE Mark ® The Mobil-O-Graph NG and PWA fulfil the requirements of the ▪...

  • Page 6: Directions For Use

    Directions for use Directions for use 2.1 Intended use The intended use is 24-hour blood pressure measurement and pulse wave analysis (PWA). ® The Mobil-O-Graph is only to be used under medical supervision by medical personnel. 2.2 Improper use ▪ ®...

  • Page 7: Indication

    Directions for use Basic safety means that the patient cannot be endangered by automatic operation of the device. In the event of an unclear status or state of the device, the device must enter the secure standby mode by the device releasing the air in the cuff.

  • Page 8: Defining The Signal Words Used

    Directions for use Defining the signal words used In order to point out dangers and important information, the following symbols and signal words are used in this operating manual: WARNING Short description of the danger This warning symbol in connection with the signal word WARNING indicates a possible or immediately threatening danger.

  • Page 9: Defining General Notes

    Directions for use 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 WARNING Danger of blood flow interruptions as a result of constant cuff pressure or as a result of too frequent measuring...
  • Page 10 Directions for use WARNING Risk of strangulation by shoulder strap and cuff tube ▪ If the patient has limited cognitive abilities, the device may only be used under supervision. ▪ ® The Mobil-O-Graph must not be used on patients of unsound mind. ▪...
  • Page 11 Directions for use WARNING Danger of a temporary loss of function of a present electrical medical device as a result of putting on or pumping up a cuff when the patient is wearing a further electrical medical device for monitoring on the same limb.
  • Page 12 Directions for use WARNING Danger of injury as a result of using unapproved accessories ▪ Only use accessories approved and distributed by the manufacturer. ▪ Read the respective information provided by the manufacturer before using the accessories for the first time. ▪...
  • Page 13 Directions for use ATTENTION Damage to the device ▪ Liquid must not get into the device. If you think that liquid has entered the device during cleaning or use of the device, the device must not be used any more. ▪...
  • Page 14 Directions for use device itself must not touch the patient since the device can be damaged as a result of this discharging which may result in incorrect values being displayed. ▪ Extreme temperatures, humidity or air pressure can influence measurement accuracy. Please follow the operating instructions.
  • Page 15 Directions for use Note Electrostatic discharges, such as discharges of synthetic textile clothing, can trigger a reboot of the device. The same behaviour occurs when the internal memory batteries are empty and the external batteries are replaced. Here, the device starts in the last used operating state. The appendix contains important information for the patient.

  • Page 16: Product Description

    Product description Product description 3.1 Description The outpatient blood pressure measuring system consists of two main components: ▪ ® ® the Mobil-O-Graph NG or the Mobil-O-Graph PWA monitor with various cuffs and additional accessories. ▪ the Hypertension Management Software Client Server (HMS CS) evaluation software for the evaluation of the measurement results by the doctor.

  • Page 17: Description Of Device

    Product description 3.3 Description of device Blood pressure monitor Components: Cuff tube Cuff connection START button DAY/NIGHT button EVENT button ON/OFF button LCD Display Infrared interface Battery compartment lid Battery compartment PC interface cable Data socket Bluetooth interface (not visible) Fig.

  • Page 18: Buttons

    Product description Buttons All buttons are located in the front casing of the blood pressure monitor (see Fig. 1)). The ON/OFF button turns the blood pressure monitor on and off. To avoid accidental switching ON/OFF 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 19 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 20: The Display

    Product description The display The LCD display is located on the front casing 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 21: Data Socket

    Product description ATTENTION The metal plug (air coupling) must always engage with an audible “click”. Otherwise there will be a leaky ® connection between the Mobil-O-Graph and tube which will lead to measurement errors. Data socket The data socket is located on the left side of the casing (see Fig. 1). The connection cable provided is connected to this socket.

  • Page 22: Switching On

    Product description Note Only use the I.E.M. NiMH power packs or alkaline batteries provided. Although zinc-carbon batteries and NiCd power packs show sufficient voltage during the battery test, the power is often insufficient to take measurements for 24 hours. The power packs should be discharged and recharged several times before their first use.

  • Page 23: Clearing The Memory

    Product description Clearing the memory The memory must be empty before every measurement, i.e. there must be no blood pressure data from the previous patient in the memory. If there are still values in there, these can be cleared using the delete function of the evaluation software.

  • Page 24: Specifying The Desired Measurement Log

    Product description Specifying the desired measurement log You can choose between eleven (1-11) logs. As soon as you have conducted a measurement, the log can only be changed once you have completely deleted all data. You can set the log manually by pressing and holding the day/night button while simultaneously pressing the event button.
  • Page 25 Product description Log table Audible Display of Measurements Interval Time signal readings on Adjustability per hour (buzzer) the display 08:00 - 23:59 Night 00:00 - 07:59 08:00 - 22:59 Night 23:00 - 07:59 07:00 - 21:59 Night 22:00 - 06:59 08:00 - 23:59 Night 00:00 - 07:59...
  • Page 26 Product description Setting the logs via software To set the logs using software please refer to the HMS CS operating manual for the respective piece of patient data management software. Note: ▪ Logs 1, 2.10 and 11 can be changed via the HMS CS evaluation software. The changeable parameters are: Display of readings on the display Start of the 4 day intervals and the number of measurements per hour.

  • Page 27: Putting On The Blood Pressure Monitor And Starting Measurement

    Product description Putting on the blood pressure monitor and starting measurement Place the holster 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 28 Product description 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. the cuff size should be adjusted to the patient. The arm circumference can be measured with the tape measure included in the delivery package in the middle of the upper arm and the cuff is then selected: Upper arm circumference...

  • Page 29: Position And Conduct Of The Patient

    Product description Note Before a 24-hour measurement, you should go through the patient information sheet with the patient. The information sheet is available at www.iem.de. 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 30 Product description ▪ places their feet flat on the floor (when sitting or standing) ▪ supports their back and arms (when sitting or lying) ▪ keeps quiet and does not speak Note ▪ The patient should relax as much as possible during the measurement and must not speak, unless this is to express discomfort.

  • Page 31: Technical Data

    Product description Technical data Measuring method: Oscillometric measuring method Measurement Systolic 60 to 290 mmHg pressure range: Diastolic 30 to 195 mmHg Accuracy: +/- 3 mmHg in display range Static pressure 0 to 300 mmHg range: Pulse range: 30 to 240 beats per minute Procedure: Oscillometric Measurement...
  • Page 32 Product description Interfaces: IR-MED serial or USB (I.E.M. specific) PC combination cable USB or serial Bluetooth Expected operational life of 5 years the device Expected operational life of 6 months the cuff...

  • Page 33: 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 operating manual! 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 34 Product description Symbol Explanation ® The product has a Bluetooth interface. Date of manufacture YYYY-MM-DD MR unsafe: The product poses hazards in MRT environments Serial number Protection class...

  • Page 35: Care And Maintenance

    Care and maintenance Care and maintenance ® Regular maintenance and care of your Mobil-O-Graph is required in order to maintain the proper functioning of ® your Mobil-O-Graph in the long term. 4.1 Disinfection and cleaning The user (doctor) decides whether and when the cuff sleeve needs to be disinfected for hygienic reasons (e.g. after each use).
  • Page 36 Care and maintenance Disinfection: I.E.M. has tested the following means for the disinfection of the cuff sleeve: ▪ Isopropanol (70%) ▪ Terralin liquid (manufacturer: Schülke & Mayr) When using other disinfectants that have not been tested by I.E.M., the burden of proof that these can be used without causing damage lies with the user.

  • Page 37: Maintenance Plan

    Care and maintenance 4.2 Maintenance plan Please check the battery/power pack voltage on a weekly basis. For the battery/power pack voltage curve, please refer to the HMS CS operating manual. Every 2 years: As proof of continuous compliance to “Basic Requirements” pursuant to Directive 93/42/EEC, the Mobil- ®...

  • Page 38: Troubleshooting

    Troubleshooting Troubleshooting 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 ▪ ▪ Device being switched off (e.g. at night) Not fully charged, incorrectly charged or outdated power packs used ▪...

  • Page 39: Mobil-O-Graph Error Description

    Troubleshooting Note Some errors are combined with a continuous alarm for safety reasons. The continuous alarm can be ended by pressing any button. If there is residual pressure inside the cuff, open the cuff immediately. ® 5.4 Mobil-O-Graph error description Error message Possible cause Measures...
  • Page 40 Troubleshooting Error message Possible cause Measures Err 3 1. Blood pressure is beyond the 1. Permanent notifications render measurement range the blood pressure monitor unsuitable for the patient. 2. Considerable arm movement 2. Keep the arm still during measurement. 3. Problems with the pneumatics 3.
  • Page 41 Troubleshooting Error message Possible cause Measures Err 5 1. Power pack or battery voltage 1. Replace the power packs or too low batteries bAtt 2. Power packs or batteries 2. The power pack or battery defective voltage is correct but bAtt is shown on the display during cuff inflation.
  • Page 42 Troubleshooting Error message Possible cause Measures Err 7 The memory of the blood pressure Delete the data in the blood measuring device is full (a pressure monitor but make sure maximum of 300 measurements that the data has been saved (see chapter 3.4.2 “Clearing the and events can be stored or in the memory”).
  • Page 43 Troubleshooting Error message Possible cause Measures The evaluation unit is not 1. Data transmission cable has not 1. Check whether the 9-pin plug of reacting to data transfer but been inserted properly into the the data transmission cable is securely located in the device’s co is shown on the display.

  • Page 44: Communication Error Mobil-O-Graph Bluetooth Interface

    Troubleshooting Error message Possible cause Measures An error occurs during the The cuff size does not fit the arm Check the circumference of the first measurement. circumference of the patient. arm using the tape measure provided and compare it to the information printed on the cuff.
  • Page 45 Troubleshooting Error indication Possible cause Remedy Code 5 The Bluetooth interface of the Mobil-O- Try it again. ® Graph could not connect to the Bluetooth If the error persists, send the device to your dongle on the computer. specialist supplier or directly to I.E.M. GmbH for checking.

  • Page 46: Power Packs/Batteries

    Power packs/batteries Power packs/batteries 6.1 Operation with power packs I.E.M. supplies high-quality "ready to use" NiMH power packs with at least 1500 mAh which have very low self- discharge. We recommend that you only use these power packs! Tips: ▪ Fully charge the power packs before using them for the first time.
  • Page 47 Power packs/batteries Two alkaline batteries have a higher charging voltage when full (at least 3.1 V) than 2 NiMH power packs (at least 2.6 V). The battery indicator in the recorder will therefore also display a higher voltage. Insert these batteries into the battery compartment in the same way as the power packs (pay attention to polarity). After the 24-hour measurement cycle, remove the batteries and dispose of them.

  • Page 48: Warranty And Repair Conditions

    Warranty and repair conditions Warranty and repair conditions Warranty: I.E.M. GmbH provides a two-year warranty on the hardware, i.e. the blood pressure monitor itself. The warranty is no longer valid if the device has been opened, misused or negligently or intentionally damaged. Likewise, the warranty is no longer valid if the device has been repaired by an unauthorised body.
  • Page 49 Warranty and repair conditions Repairs: If the device malfunctions or if you experience continuous measurement errors, contact ® your Mobil-O-Graph specialist dealer or I.E.M. GmbH directly for repairs and shipping instructions. ATTENTION Do not open the casing. ▪ Once the device has been opened, any warranty will no longer be valid. As proof of continuous compliance to “Basic Requirements”...

  • Page 50: Appendix

    Appendix Appendix Appendix 1 Important patient information This patient information can also be found in DIN A4 format at www.iem.de. 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 NG and ®...
  • Page 51 Appendix ▪ Turn off the device, remove the cuff and inform the doctor if you experience any pain, swelling, redness or numbness in the arm around which the cuff is placed. (It is expected that some mild to moderate discomfort experienced during blood...
  • Page 52 Appendix ATTENTION ▪ Do not open the casing. Once the device has been opened, any warranty will no longer be valid. ▪ Liquid must not get into the device. If you want to have a shower or bath, switch off the device and take it off.
  • Page 53 Appendix ▪ Align the cuff so that no part of the cuff tube can be kinked. Align the cuff so that the lower edge of the cuff is about 2 cm above your elbow, see Fig. 2. ▪ Place the cuff around the upper arm in such a way that one finger can be inserted underneath the cuff. ▪...
  • Page 54 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 ▪...
  • Page 55 Appendix ® Buttons of the Mobil-O-Graph ® The Mobil-O-Graph has 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. You can also prematurely terminate the measuring process with this button, as well as with any other button.
  • Page 56 Appendix WARNING After an automatic measurement, allow at least 3 minutes to elapse to avoid prolonged impairment of blood circulation before actively starting a measurement. 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...
  • Page 57 Appendix Troubleshooting ® In the event of measurement or system errors, an error code will appear on the display of the Mobil-O-Graph a few seconds. The following support instructions will help you understand how to deal with each error code: Error code Measures ERR 1...

  • Page 58: Appendix 2 Emc Guidelines And Manufacturer's Declaration

    Appendix Appendix 2 EMC Guidelines and Manufacturer’s Declaration 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 59 Appendix 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 60 Appendix Immunity test IEC 60601-1 test level Compliance level Electromagnetic environment – guidelines Magnetic field at 30 A/m 30 A/m Magnetic fields at mains supply frequency frequency should match the (50/60 Hz) according typical values found in to IEC 61000-4-8 business or hospital environments.
  • Page 61 Appendix 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 62 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 it used only in such an environment. Measurement of IEC 60601-1 test level Compliance level interference emissions Radiated RF...

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