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Medick MHM 100 User Manual

Personal heart reporting service
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Personal Heart Reporting Service
Standard Operating Procedure for Pharmacy
Introduction
In order that this document is easily understood we need to define who is
who:
Healthantec Limited
[input customer name]
Your [customers/clients/members]
The Medick Personal Heart Reporting Service gives the user a level of control
over heart health previously unavailable outside the doctor's consulting room or
hospital. Most changes in the health of the heart should be spotted at an early
stage so that appropriate treatment can be given if it is required.
The MHM 100 and Medick Personal Heart Reporting Service is particularly
useful for people who fall within the following categories, as health
professionals agree that frequent monitoring is important:
• have a family history of heart attacks or strokes or are being treated for
a heart condition
MHM 100
Version 1.0
th
15
October 2007
Defined as 'we' the supplier of the
MHM 100 and Medick Personal Heart
Reporting Service
Defined as 'you' the corporate user
Defined as the individual 'user'
- 1 -

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Summary of Contents for Medick MHM 100

  • Page 1 Your [customers/clients/members] Defined as the individual ‘user’ The Medick Personal Heart Reporting Service gives the user a level of control over heart health previously unavailable outside the doctor’s consulting room or hospital. Most changes in the health of the heart should be spotted at an early stage so that appropriate treatment can be given if it is required.
  • Page 2 The MHM 100 uses intelligent neural network technology to assess the heart. This means that the MHM 100 has a level of accuracy that compares with the standard ECG (electrocardiogram) monitors used by doctors. We must point out, however, that no ECG monitoring device can claim to detect all heart irregularities.
  • Page 3 - On the MHM 100 - On your computer Retrieving the expert report The expert report - Colour-coded notification - Security and confidentiality Replacing parts How to look after your MHM 100 Environmental considerations Cleaning Faulty equipment Insurance Troubleshooting Customer support...

  • Page 4: Before You Start

    Before you start Notes on safety While the MHM 100 is suitable for most people, it is not intended for use in anyone who fits into the following categories: • Anyone younger than 16 years, as heart function is not fully stabilised...
  • Page 5 Abrasive wipes • 2 new AAA batteries. Suspected faulty equipment If you suspect that the MHM 100 is in any way faulty, call our Customer Support Team on 0845 603 7282. Opening hours as follows: Monday to Friday 9am to 5pm...
  • Page 6 Electrodes The ON/OFF switch is located on the top of the MHM 100. The connector socket is used to attach the MHM 100 either to the electrodes or to the computer, depending on which cable is used. The front of the MHM 100 looks like this:...
  • Page 7 2. Do not mix battery types or new and partially used batteries 3. The MHM 100 does not allow a test to start if the batteries are running low (i.e., if the low battery indicator is shown on the screen) 4.
  • Page 8 Setting the clock Once the batteries have been inserted, switch the MHM 100 on, using the button at the top of the device. The Medick Healthcare screen will then be visible: The Main Menu screen will then appear: The three areas of the Main Menu are: •...
  • Page 9 Connecting the electrode pads The electrode pads have been carefully selected to ensure optimum ECG readings and so you should only use the pads supplied by Medick Healthcare (additional pads can be obtained via http://club.medick.com/corporate). Ensure the pads are in date and use a new set of electrode pads for each test.
  • Page 10 Electrode leads should not be used if they appear to be damaged or worn Positioning and attaching the electrode leads The MHM 100 should be switched OFF. The pads should be removed from their backing one at a time and positioned according to the diagram below.

  • Page 11: Starting The Test

    1. The connector end of the electrode lead should be pushed firmly into the MHM 100, lining up the guide on the connector with the groove at 12 o’clock on the MHM 100. Do not twist the connector. Ensure that the groove lines up with the top of the device 2.
  • Page 12 Using the Log Button If any symptoms are experienced while running the test e.g., dizziness, palpitations, excessive sweating, the Log Button at the base of the monitor should be firmly pressed. (Medical advice should be sought if there are any persistent or worsening symptoms.) The Log Button can also be used to check how certain aspects of lifestyle affect the heart, such as smoking or caffeine consumption.
  • Page 13 • The MHM 100 must be kept dry • It is OK to wear the MHM 100 in bed, particularly if the customer has symptoms at night • If the electrode pads cause discomfort or itching, then they should be removed immediately but the test stopped using the Stop button.

  • Page 14: Selecting A Port

    • The MHM 100 and the connector cable provided Selecting a port The MHM 100 can be connected via a USB or serial port. If you choose to connect via a USB port, you will first have to install USB-to- serial converter software using the CD provided.
  • Page 15 Plug in the USB-to-serial port adapter into the computer and follow the instructions that come with the cable within the instruction leaflet and installation ‘Wizard’. Once installed, attach the other end to the MHM 100. Follow the instructions in the previous section.
  • Page 16 Serial ports are the sockets on the back of your computer where devices such as the MHM 100 can be attached. As there may be more than one, your computer must be ‘told’ which one the MHM 100 is plugged into before it will receive information from it.
  • Page 17 MHM 100 screen telling you that it is connected to your computer. You can check if the correct date and time is set up on the MHM 100 as follows: 1. Go to the Start menu and click Programs then Medick 2.
  • Page 18 Once your ECG test has been successfully transferred, you can switch off the MHM 100 monitor and store the monitor in the Medick storage bag provided. Transferring the ECG results Use the following link to access your page of the Medick Corporate website: http://club.medick.com/corporate...
  • Page 19 The user will need to take the following actions: 1. Click on the ‘club.medick.com’ link in the email 2. In the ‘Access code’ field they will then need to type the access code on the screen that was printed when you uploaded their report.
  • Page 20 Test details Provides summary of test duration and signal quality Select [Back] to return to the main menu Heart Rate Summary Gives the mean (average), maximum and minimum heart rate during the test Select [Back] to return to the main menu Tachycardia and Bradycardia Summary Shows how many times the heart was beating faster or slower that usual (see glossary for...
  • Page 21 • Heart Rate Trend – shows a graph of the heart rate over the test period - dotted lines indicate a break in the signal. The times when the Log Button was pressed are shown as lines over the graph •...
  • Page 22 Heart Rate Trend This page shows a graph of the heart rate over the test duration, including minimum, maximum and mean (average) heart rate Sample Trace The sample trace page shows the signal at 3 minutes from the start of the test - 22 -...
  • Page 23 Retrieving the expert report An email will normally be sent within 24 hours of transferring the ECG results confirming that the expert report can now be viewed via Medick corporate website. The expert report Colour-coded notification Because accurately interpreting ECG reports requires significant training and experience, a notification will be received summarising the key findings and advising whether any further action is required or not, e.g.
  • Page 24 • pink – A small percentage of people will have a heartbeat that is not suitable for analysis by the MHM 100. This does not mean that they have a heart condition. If they have any concerns or are experiencing discomfort they should discuss these with their GP.
  • Page 25 Examples of Expert Report Web pages - 25 -...
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  • Page 30 Should the userer receive either an Amber or Red report, there is the facility to download and print off a letter for them to take with their GP, in order to discuss what treatment or further analysis is required. Here are examples of these letters: - 30 -...
  • Page 31 Security and confidentiality All personal details provided to Medick Healthcare and the results of the tests are completely confidential and will not be passed on to any third parties. The Corporate section of the Medick website is username and password protected for added security.

  • Page 32: Replacing Parts

    700 to 1060mb Cleaning The MHM 100 is not waterproof and so should never be immersed in water or cleaning fluid; it is not suitable for dishwashers or washing machines. If necessary, the MHM 100 should be carefully cleaned by wiping the external surfaces with a damp cloth and soap.
  • Page 33 8-hour test. Furthermore, the 2 year warranty included in the cost of the MHM 100 will not protect you against the cost of replacing parts as a result of accidental damage.

  • Page 34: Troubleshooting

    There is a low battery warning screen; will all the test data be lost? If the MHM 100 has low battery power one of the following two screens will be seen. In the case of message A, switch off the MHM 100 and replace the batteries before trying again.
  • Page 35 ECG test once it has started, it is best that the user does not choose to use the MHM 100 if they need to fly. In the unlikely event that they are wearing the monitor whilst travelling by air, all they have to do is to switch it off and restart the test when their destination is reached.
  • Page 36 Can the MHM 100 and Medick Personal Heart Reporting Service be used in conjunction with an Apple Mac? Sorry, the Medick Explorer software – which is an essential part of the service – will only function on a Windows based PC running Windows 98, ME, 2000 or XP.

  • Page 37: Customer Support

    Customer Support Healthantec is very interested in receiving your comments on the performance of the MHM 100, its associated parts and the clarity and accuracy of its user manual and website. If you have any queries or comments (good or bad), problems or suggestions, please contact as shown below.
  • Page 38 Glossary Please note that these terms are provided because they may appear in reports. abnormal morphology Electrical emissions of the heart have been recognised as abnormal and are unsuitable for analysis. This may be due to the position or "tilt" of the heart and can be quite normal in some people.
  • Page 39 atrial fibrillation (uncontrolled) Atrial fibrillation is uncontrolled when the heart rate response lies outside normal limits (i.e. 50 to 120 beats per minute);. If AF is uncontrolled, cardiac output may be compromised by periods of inappropriate tachycardia and bradycardia. Pauses and arrests may also be evident with an uncontrolled ventricular response.
  • Page 40 bundle branch block A form of heart block in which one ventricle contracts later than the other because of a delay in its electrical conduction. couplet Two ectopic beats occurring one after the other. diaphoresis Profuse perspiration. ectopic A heart beat originating from outside the sinoatrial node. Ectopic beats may be either atrial or ventricular in source.
  • Page 41 impulse A general term for a heart beat observed on the ECG. intraventricular conduction delay Slower than normal conduction through the ventricles. These beats normally have a widened QRS complex. intraventricular Conduction Delay (ICD) This stands for Intraventricular Conduction Delay and is a generic acronym for wide morphologies.
  • Page 42 A method of computation, simulated on the way that the brain processes information. no ECG The MHM 100 could not detect a heart rhythm which may be due to a technical fault such as a broken lead. normal sinus rhythm A normal heart rhythm.
  • Page 43 The ECG signal is too small to be analysed by the MHM 100. sinoatrial exit block The failure to conduct the heart beat from the sinoatrial node to the atria.
  • Page 44 stroke A stroke is a brain attack, as opposed to a heart attack. A stroke is what happens when the blood supply to part of the brain is cut off. Without a blood supply, brain cells can be damaged or destroyed and won’t be able to do their job.
  • Page 45 third degree heart block otherwise known as complete heart block. Heartbeats are not conducted from the upper chambers to the lower. Because of this block in conduction, the lower chambers are contracting at a much slower rate than normal transient ischaemic attack Neurological symptoms caused by a temporary reduction in the supply of oxygen to the brain.
  • Page 46 ventricular ectopics (multifocal) Heartbeats originating from more than one location within the ventricles ventricular tachycardia (VT) A fast, abnormal, and life-threatening rhythm, which is more common in people who have had a myocardial infarction wide complex tachycardia (WCT) A sequence of three or more consecutive, ventricular contractions, at a fast rate.

  • Page 47: Product Specification

    Validation ANSI/AAMI EC57 Quality BS EN ISO 13485:2003 Safety EN60601-1 (1997) Under the European Union Directive 93/42/EEC, the MHM 100 is an active portable monitoring device classified as Class IIa. Under the ANSI/AAMI EC38: 1998 standard, the MHM 100 is an ambulatory ECG monitoring device and meets the Type 2 classification, which provides continuous analysis but only records full-scale examples of detected events.
  • Page 48 The following symbols appear on the label on the rear of the MHM 100. This indicates that the MHM 100 is a type B applied part, i.e., the equipment in normal use can be brought into contact with, or touched by the user, and provides protection against electric shock in accordance with EN60601.