Welch Allyn ABPM 7100 Directions For Use Manual
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Welch Allyn ABPM 7100 Directions For Use Manual

Ambulatory blood pressure monitor
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ABPM 7100
Ambulatory Blood Pressure Monitor
Directions for Use

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Summary of Contents for Welch Allyn ABPM 7100

  • Page 1 ABPM 7100 Ambulatory Blood Pressure Monitor Directions for Use...
  • Page 2 Caution: Federal US law restricts sale of the device identified in this manual to, or on the order of, licensed physicians. Welch Allyn does not accept liability for injuries or unlawful or improper use of the product which may result from the fact that the product is not used in accordance with the instructions, cautions and warnings, as well as the indications for use published in this manual.

  • Page 3: Table Of Contents

    Clearing the memory Transferring patient data (ID) Setting measurement logs Selecting a suitable cuff Applying the ABP Monitor and cuff Connecting the cuff tubing to the ABPM 7100 Positioning the patient for measurement Measurement process Safety instructions Initial measurement 24-hour measurement...

  • Page 4: Symbols

    Attention The attention statement marks possible Note The note statement marks further material damage. Non-adherence may information on the ABPM 7100 or its lead to damage to the device or its accessories accessories INTERNAL REFERENCE Marks EXTERNAL REFERENCE Marks...

  • Page 5: Introduction

    Pressure Monitoring System (ABPM System) at your disposal. The ABPM 7100, also specified as ABP Monitor, can be prepared for a new patient in just a few minutes. This permits the optimum use of the ABP Monitor and allows you to process one 24-hour profile per day.

  • Page 6: Content

    Direction for use Intended use The ABPM 7100 is intended for clarifying the blood pressure status and for use as a diagnostic aid for an individual adult patient (in the patient’s environment). The ABPM 7100 may only be used under medical supervision and after detailed instruction has been provided by the doctors or healthcare professionals.

  • Page 7: Essential Performance

    The ABPM 7100 can be prepared immediately for the next patient. With little practice this procedure can be completed in just a few minutes. This allows the doctor to use the ABPM 7100 around the clock on each work day.

  • Page 8: The Abpm 7100

    LCD Display The LCD display is located on the front of the ABPM 7100 casing. It displays useful information for the doctor and the patient regarding measurement data, monitor settings and measurement errors. When the START button is pressed, the number of previously registered measurements will be shown before starting a manual...
  • Page 9 ABPM 7100 and cuff will result in measurement errors. The Arm Cuff The arm cuff Air tube Air tube connection PC Interface Cable In order to read data from the ABPM 7100, the interface cable must be connected to an USB slot on a PC.

  • Page 10: Technical Data

    To disconnect, pull on the knurled ring of the connector. Connecting the ABPM 7100 to the PC To transfer the data from the ABPM 7100, ensure that the interface cable is connected correctly to an USB port on the PC and to the interface cable port on the device.

  • Page 11: Preparing The Abpm 7100

    Preparing the ABPM 7100 - 11 Preparing the ABPM 7100 Safety instructions Warning Risk of strangulation posed by the shoulder strap and cuff tubing.  If the patient has limited cognitive abilities, the device may only be used under supervision.

  • Page 12: Inserting The Batteries

    Do not open the casing. Once the device is opened, all warranties will lapse. Open the batteries compartment on the rear of the ABPM 7100 casing to insert the batteries into the ABPM 7100 according to the battery polarities ( + / - ) and close the compartment.

  • Page 13: Activating The Device

    Always check the condition of the ABPM 7100 by observing the initial display shown on the device shortly after turning it on and before handing it to a patient. The ABPM 7100 performs a self-test. In addition, a beep sounds to check the speaker. The following should be displayed in this sequence:...

  • Page 14: Transferring Patient Data (Id)

    14 - Preparing the ABPM 7100 Transferring patient data (ID) The ABPM 7100 must be prepared by transferring patient data (ID) with the help of the patient management software, so that correct data allocation is possible when it is read out after measurement.

  • Page 15: Selecting A Suitable Cuff

    Preparing the ABPM 7100 - 15 Selecting a suitable cuff Caution Risk of injury caused by incorrect application of the cuff.  The doctor must ensure that, due to the patient’s medical condition, the use of the device does not result in impaired blood circulation in the arm.
  • Page 16 16 - Preparing the ABPM 7100 Warning Placement and inflation of the cuff over a wound may lead to further injuries. Placement and inflation of the cuff on any limb with an intravascular access or under intravascular treatment or an arteriovenous (A-V) shunt may lead to temporary interruption of circulation and therefore to further patient injury.

  • Page 17: Connecting The Cuff Tubing To The Abpm 7100

    1. Push the tube firmly onto the connection, with the cuff tubing engaging with an audible “CLICK” (to detach, simply pull back the knurled ring). 2. Before measurement, check to ensure that tubing, ABPM 7100 and cuff are positioned correctly. The ABPM 7100 is ready for measurement only once this is ensured.

  • Page 18: Positioning The Patient For Measurement

    18 - Measurement process Positioning the patient for measurement The patient should take the following position during blood pressure measurement:  Comfortably seated  Legs uncrossed  Feet flat on the ground  With support to the back and the arms ...
  • Page 19 Attention Damage to device  Do not wear the ABPM 7100 while showering. If you suspect that liquid has entered the device while cleaning or using it, the device shall no longer be used on the patient.  In the device was exposed to moisture, switch off the device and remove the batteries.

  • Page 20: Initial Measurement

    Medical electrical equipment is subject to special EMC precautions. Please observe the directives attached.  The cuff tubing between the ABPM 7100 and the cuff may not be knotted, compressed or pulled apart.  The cuff connection must always engage with an audible “CLICK”. A loose connection between the tubing and the device leads to measurement errors.

  • Page 21: Cancelling A Measurement

    A measurement will be cancelled by pressing any buttons during the measurement process. The LCD display will then show -StoP- and the ABPM 7100 will beep 5 times. This cancellation will be stored in the measurement value table under Cancel.

  • Page 22: Maintenance Plan

    Ensure that no liquid enters the device.  If liquid does penetrate the device, switch if off immediately and return it to your Welch Allyn specialist for inspection. 1. Use only a moistened cotton cloth to clean the ABPM 7100.

  • Page 23: Troubleshooting

     Kinked or knotted cuff tubing Transmission error The ABPM 7100 reviews the transmitted data to prevent errors. If an error occurs, “E004” will be shown on the display. Checklist Please review the following checklist for any errors occurring during the operation of the ABPM 7100. Many errors have simple causes: ...

  • Page 24: Error Codes

    Incorrect log set. Set log 1 or 2. The programmed log does not correspond Incorrect log set. with the set log in the ABPM 7100. Check The measurement the log manually on the device. interval does not meet your expectations.
  • Page 25 Strong arm movements. Keep the arm still during measurement. If the error persists permanently, send the Problems with the pneumatics. device to your Welch Allyn specialist. Data transmission cable incorrectly Insert the cable into the ABP Monitor inserted in ABP Monitor.
  • Page 26 These will be sent once further Code 6 7100 contains unsent blood pressure values. measurements have been performed. The ABPM 7100 is paired with a cell phone or GSM modem, which is technically incapable of Try again. If the error persists, contact Code 7 transmitting measurement values, is outside the your Welch Allyn specialist.

  • Page 27: Limited Warranty

    Limited Warranty - 27 Limited Warranty Welch Allyn warrants the product to be free of defects in material and workmanship and to perform in accordance with manufacturer's specifications for the period of one year from the date of purchase from Welch Allyn or its authorized distributors or agents.

  • Page 28: Emc Guidelines And Manufacturer Declaration

    The customer or user of the ABPM 7100 can assist in preventing electromagnetic interferences by adhering to the minimum distance between portable and mobile HF telecommunication devices (transmitters) and the ABPM 7100 – depending on the output power of the device, as specified below.
  • Page 29 Electromagnetic immunity – for all ME devices and ME systems Guidelines and Manufacturer Declaration - Electromagnetic immunity The ABPM 7100 is intended for operation in an electromagnetic environment as specified below. The customer or user of the ABPM 7100 should ensure its operation in such an environment.
  • Page 30 If the measured field strength in the location in which the ABPM 7100 is used exceeds the applicable RF compliance level above, the ABPM 7100 should be monitored to verify normal function. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the ABPM 7100.

  • Page 31: Patient Information - Operation Of The Abpm 7100

    Patient Information - operation of the ABPM 7100 - 31 Pos : 21 /_Steuer ung/==========SEIT ENUM BRUCH========== @ 0\mod_1399967957149_6.doc x @ 4804 @ @ 1 Pos : 22 /Sammel/09_Bedienung für den Patienten ** KOPIERVORLAGE** @ 0\mod_1398849974787_6.doc x @ 4762 @ 122222 @ 1...
  • Page 32 Attention Damage to device  Do not wear the ABPM 7100 while showering. If you suspect that liquid has entered the device while cleaning or using it, the device shall no longer be used on the patient.  In the device was exposed to moisture, switch off the device and remove the batteries.
  • Page 33 A measurement will be cancelled by pressing any buttons during the measurement process causing the cuff to be quickly deflated automatically. The LCD display will then show “-StoP-” and the ABPM 7100 will beep 5 times. This cancellation will be stored in the measurement value table under Cancel.
  • Page 34 Reorder No. 106169 Material No. 722592 80019691 Ver. A === Ende der Liste für T extmar ke Rüc ksei te ===...

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