Medick Mhm 100 User manual

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Personal Heart Reporting Service

MHM 100

Standard Operating Procedure for Pharmacy

Version 1.0

15th October 2007

Introduction

In order that this document is easily understood we need to define who is

who:

Healthantec Limited Defined as ‘we’ the supplier of the

MHM 100 and Medick Personal Heart

Reporting Service

[input customer name] Defined as ‘you’ the corporate user

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.

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

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•have any conditions that are risk factors for heart problems, such as

diabetes, high blood pressure, smoking, obesity or high cholesterol

•have already had a heart attack

•regularly experience symptoms suggestive of poor heart function e.g.,

dizziness, palpitation, shortness of breath, chest discomfort, weakness

or excessive sweating. Please note that anyone experiencing any of

these symptoms should first discuss them with their GP.

Even if the user does not fit into any of these categories, the Medick Personal

Heart Reporting Service can give peace of mind, secure in the knowledge that

any potentially serious problems may be reported enabling the user to take

appropriate action.

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. However, the MHM 100 is as good as current technology allows.

Finally, although the doctor’s approval is not necessary to use the Personal

Heart Monitoring service, it is always a good idea for the user to inform him/her

of their decision, particularly if they have a heart condition or a disease that

puts them at higher risk of heart problems. This is more a matter of courtesy, as

the report may suggest that further tests may be necessary.

Introduction to the MHM 100

Before you start

- Notes on safety

- Check items needed to run a test

- Suspected faulty equipment

- Adverse incidents

Know your MHM 100

Setting up your MHM 100

- Inserting and replacing batteries

- Setting the clock

Running the ECG test

- Attaching the electrode pads

- Skin preparation

- Connecting the electrode pads

- Positioning and attaching the electrode leads

- Starting the test

- Using the Log Button

- Things to remember

- Ending the ECG test

Installing the Medick Explorer software

- Requirements

- Selecting a port

- Connecting to a USB port

- Installing the software

- Connecting to a serial port

- Checking if Medick Explorer is working properly

- Uninstalling Medick Explorer

Sending the ECG results for expert interpretation

- Checking date and time

- Transferring the ECG results

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- Uploading a report

- Viewing a report

- Placing an order

- Viewing the ECG results

- 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

Glossary

Product Specification

- Electrical

- Mechanical

- Regulatory standards

- Graphical symbols

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Introduction to the MHM 100

The MHM 100 is a personal ECG testing device that monitors the heart on a

beat by beat basis to detect any irregularities. It does this over a period of up

to 8 hours and automatically generates a report of the heart rhythm.

The ECG results should always be sent for expert interpretation via the

Medick Personal Heart Reporting Service.

As part of the agreement you have access to the Corporate Website home

page http://club.medick.com/corporate, an area within www.medick.com that

allows you to confidentially submit and retrieve personal ECG reports.

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

in people this young and so the MHM 100 may produce misleading

reports

•People with pacemakers

•Women in late-stage pregnancy

There are also a very small percentage of people who have the type of heart

or body shape that cannot be properly analysed by the Medick Personal Heart

Reporting Service. If this applies to one your users, we will know as soon as

you send in their first test result and will advise you accordingly. This does not

necessarily mean that they have a heart condition, but only that the MHM 100

has detected a type of heart beat that is unsuitable for automated analysis

and we would suggest that you refund the user.

There are a number of precautions which should be taken while using the

MHM 100:

1. Do not use near to flammable or explosive liquids

2. Do not use while undergoing heat treatment e.g., during physiotherapy

3. Do not use whilst immersed in water, e.g., when taking a bath/shower

or swimming. The MHM 100 is not waterproof so don’t let it get wet in

the rain

4. Try to keep away from electrical appliances as much as possible whilst

wearing the MHM 100, as certain appliances could interfere with the

device

5. Do not use on users who have a pacemaker fitted, as the MHM 100

will not recognise pace ‘spikes’

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6. UNDER NO CIRCUMSTANCES should the MHM 100 be used in

conjunction with a defibrillator

7. Do not open the MHM 100 or tamper with the connections while the

test is running. This will invalidate the warranty

Check items needed to run a test

Please check that you can supply the following to enable the user to run a

test:

•MHM 100 ECG monitor

•Quick user guide

•Monitor lead with three coloured electrodes attached – red, green and yellow

•Pouch with belt clip to hold monitor

•Storage bag

•Electrode pads (one set of three)

•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

Saturday 10am to 2pm

Sunday Closed

Bank Holidays Closed

Adverse incidents

Finally, if the user experiences any adverse incidents that you suspect may be

caused by using the MHM 100, you should call our Customer Support Team

on 0845 603 7282. Opening hours are as detailed above. There is also an

out of hours messaging service where someone from our Customer Support

Team will contact you at their earliest convenience.

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Know your MHM 100

Take some time to familiarise yourself with the parts of your MHM 100:

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:

The two scrolling buttons with arrows on allow the user to move up and down

the screen to highlight the page they want, while the soft navigation buttons at

the bottom of the screen allow a range of choices, such as selecting the

highlighted page or returning to the previous one.

Battery cover

Power on/off switch

Connector with guide

Connector socket and grooveBattery compartment

Electrode lead

Electrodes

Log button

Serial number inside battery cover

Scrolling buttons

‘Soft’ navigation buttons

Black and white LCD

screen (Screen resolution

128 x 64)

20mm depth

70mm height

120mm width

Log button

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Setting up your MHM 100

Inserting and replacing batteries

To insert batteries, firstly ensure the MHM 100 is switched OFF and then

press the button at the back of the MHM 100 before sliding off the battery

cover.

Insert two AAA batteries as indicated by the ⊕and symbols.

Only use high-quality batteries with a capacity of 600mAh or more, such as

‘Varta’, ‘Panasonic’, ‘Duracell’ or ‘Energizer’.

1. New batteries should be inserted for each 8 hour test

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. If the batteries run low during a test, the MHM 100 stops the test in order

to conserve battery power, in an attempt to avoid losing the test results

5. If the batteries run out completely, then the test results in the MHM 100

will be lost

6. The test results should be transferred onto the PC as soon as possible

after the end of a test, in case the batteries run out. (normally 24 to 36

hours)

7. All batteries should be disposed of responsibly

There is a battery indicator on the MHM 100 screen so that the user can see

when the power is getting low. Also, if the batteries are running low either at

the start of the test or during the test, the messages shown below will appear

advising them what to do. Note: The battery indicator is only visible when the

batteries are low.

If the batteries ‘run low’ during a test, a report can still be received as long as

the results are transferred to the computer immediately, however, bear in

mind that the report will be shorter than usual. However, if the batteries ‘run

out’ the report will be erased (lost). This should not happen if new batteries

are used for each test.

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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:

•Start Test

•View Report

•Settings – this allows the user to select one of three options:

Pad Placement (a visual reminder of how to position the electrode

pads)

Date & Time (the correct date and time are essential to allow

appropriate interpretation of the ECG trace by our reporting service)

1. Select Next to move between day, month, year, hour and minute

2. Use arrow buttons to change value(s)

3. Select Set to update the clock and automatically return to the Main

4. The Back option is only available if the clock has not been altered.

This will then take the user back to the Main Menu.

About (gives details of the MHM 100 specifications)

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Running the ECG test

Attaching the electrode pads

1. Skin preparation

There are three areas where the electrodes will be attached

A good electrical contact between the skin and the electrodes is needed to

get a high quality ECG signal. To ensure this, we always advise the following:

1. Any significant chest hair should be removed in the three areas by

clipping or shaving

2. The abrasive wipes should be used to clear the skin of dead cells by

lightly wiping the strips over each area three times. This should not be

overdone as results will be affected if skin is rubbed red

3. Ensure the skin is dry

2. 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. This is because the pads lose their adhesive quality and cannot detect

an ECG. For this reason, the user should never use the pads that someone

else has just used.

User Instructions

Electrode pads should be removed from the packet, keeping the backing film

on at this stage, and connected to each electrode lead by pressing firmly onto

the central stud.

Upper left chest just

below the collar bone

(

Yellow

)

On the left hand side, two ribs

up from the bottom and

approximately 2 inches below

the nipple (Green)

(women may place it under the breast)

Upper right chest just

below the collar bone

(Red)

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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. Make sure the electrodes are positioned in

such a way that the leads won’t get tangled up in clothing - moving the

electrodes away from the preferred areas could decrease the accuracy of the

test.

Pressure should be applied to the pads to ensure that they stick by running a

finger round the outer edge. The centre of the pad should not be pressed as

this will cause the gel to spread.

The pads should not be attached if:

•the skin sites are red, sore or injured in any way

•there is an allergic reaction to the pads i.e., itchiness and redness

•the gel on the pads has dried out

•the skin is wet or damp

•the chest hair has not been shaved or clipped prior to application.

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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. Switch the monitor ON

3. Select Start Test from the Main menu on the MHM 100 screen

4. Once Start Test has been selected, the MHM 100 informs the user

that it is checking for a signal; this should take no longer than 3

minutes. If the test hasn’t started within 3 minutes, the MHM 100

automatically stops and displays the Test Stopped page. The

positioning of the electrodes should then be checked and the lead

connection and the test restarted. If the test still doesn’t start the MHM

100 should be brought back to Pharmacy and the report submitted via

the Medick Personal Heart Reporting Service so that we can

endeavour to identify the problem

5. After a minute or so, if the signal is OK, ECG Detected will briefly

appear on the screen

Then Test in Progress will remain on screen while the test runs.

6. The MHM 100 can be placed in the pouch and clipped onto a

waistband or placed in a pocket

7. For best results, the test should be run for 6-8 hours, however, as long

as the test runs for at least 1 hour, a relatively useful report can still be

generated

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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. Other examples include:

•Jogging or ‘power walking’

•Drinking a glass of wine or beer

•Running for a bus

•A stressful meeting at work

•Watching an exciting/scary film

•Doing housework or gardening

•Meditating

•Having sex

•Having an argument!

It is recommended that, for the first test users just take readings whilst

undertaking their normal daily routine. Specific investigations of lifestyle

changes can follow on subsequent tests.

When the Log Button is pressed, the message Log Button will appear on the

screen to indicate that the monitor has responded.

Each time the Log Button is pressed it will show up as a black line on the

page that shows the heart rate over the whole test period. The first nine times

the button is pressed and the last one will also be included in the expert

report so that any changes in the heart rate at the time the log button was

pressed the can be easily identified.

To fully understand the impact of lifestyle on the Customers ECG, it is useful

for users to keep a diary of events/activities so that they can cross check

against where the Log Button lines appear. This will also be helpful in any

discussions of the ECG report are necessary with the users doctor.

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Things to remember

•It is important not to switch off the monitor or disconnect the electrode

lead while the test is running

•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. The

MHM 100 should be left switched on because a report can still be

retrieved

Ending the ECG test

After 8 hours the following screen can be seen:

DO NOT SWITCH OFF THE MHM 100 MONITOR. If it is switched off

before transferring the results to the computer, they will be lost.

The electrode pads can now be removed

The electrode pads can be removed by gently peeling them away from the

skin. Pulling on the leads may cause damage

1. Disconnect leads from the electrode pads

2. Disconnect the electrode lead from the MHM 100. Do not twist

3. Store the electrode leads in the bag to avoid damage (they should be

wound loosely at all times)

4. Dispose of the used electrode pads safely

If the user wishes to terminate the test before 8 hours has elapsed, they can

do so by selecting Stop, and then selecting Yes in response to the Stop

Test? prompt.

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The ECG test results are now ready to be saved onto a computer and

then sent off for expert interpretation

The test results need to be brought back to pharmacy and saved onto a

computer within 24 – 36 hours of stopping the test (immediately if the ‘low

battery’ warning is shown), otherwise, there may not be enough power in the

batteries to allow transferral and the results will be lost.

Installing the Medick Explorer software

Before viewing an ECG report on the computer or sending it off for an expert

report the Medick Explorer software must be installed

Requirements

•A computer with the minimum specification shown below:

Processor: Intel Pentium or equivalent, 120 MHz

Memory: 16 MB RAM

Display: 16 colours, 800x600 pixels

Hard disk: 5 MB free space

Mouse: Mouse or other pointing device

Ports: Serial communications (COM) port with a 9-

pin connector or USB port (a USB-to-serial

adapter is supplied)

Other: CD-ROM drive

•One of the following Microsoft Windows packages installed and ready

on your computer:

Windows 98, ME, 2000, or XP

•Internet access

•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.

If you are connecting to a serial port (see later), you will first have to install the

Medick Explorer software.

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Connecting to a USB port

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.

Installing the software

To install the software, whether it is on a personal computer or one that is part

of a network, you will need to log in as an administrator before you can

proceed. This means that if you are using a company computer, you will need

to contact your IT dept.

1. Put the Medick Resource CD in the computer

2. Click Install Medick Explorer

3. Click Next from the Welcome to the Medick Explorer Setup Wizard page

4. Having read and understood the License Agreement click Accept and then

5. Click Next from the Destination page

6. On the Select Start Menu Folder page, click Next

7. On the Select Additional Tasks page, select Create a desktop icon, then

click Next

8. Click Install from the Ready to Install page

9. Click Finish from the Completing Medick Explorer Setup Wizard page.

If the CD-ROM does not respond, use the following procedure:

1. Go to the Start menu and click Run

2. If the letter of your CD-ROM drive is ‘d’, type d:\setup If it is not ‘d’,

substitute the appropriate letter instead

3. Click OK and then follow the instructions as above

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Connecting to a serial port

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.

To select the serial port:

1. Plug the MHM 100 into a serial port on the computer using the cable

provided ensuring that the guide on the cable aligns with the groove at

12 o’clock on the monitor socket. Do not twist the connector into the

socket

2. The Wizard should start automatically, if it doesn’t, you can start it

manually as follows

3. Go to the Start menu and click Programs

4. Click Medick then Medick Explorer

5. Click Tools then Options

6. Click Setup. This will start the installation ‘Wizard’

7. After a few seconds, you should see MHM 100 Detected message in

the bar at the top of your Medick Explorer page

8. If the message MHM 100 Not Detected appears, repeat the process

9. You will not need to reselect the serial port every time the software is

used.

Checking if Medick Explorer is operating properly

1. Open Medick Explorer and click File from the toolbar at the top of the

screen

2. Click Collect New Report from the drop down menu (or click the

relevant button on the toolbar)

3. As there is no report to collect, a ‘No Report Available’ message will

appear

4. Click OK as this shows that Medick Explorer is working properly

For instructions on how to use Medick Explorer to collect, see

‘Transferring the ECG results’ section

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Uninstalling Medick Explorer

If you wish to remove Medick Explorer from the computer:

1. Go to the Start menu and click Programs

2. Click Medick then Medick Explorer

3. Click Uninstall Medick Explorer

4. Click Yes in response to Are you sure you want to uninstall Medick

Explorer and all its components?

5. Click OK in response to Medick Explorer successfully removed

Sending the ECG results for expert interpretation

Checking date and time

Attach the computer cable to the appropriate serial port on the back of the

computer, or via the USB port using the adapter if necessary. Insert the other

end into the monitor socket, making sure the guide on the connector lines up

with the groove at 12 o’clock on the monitor. Do not twist. A message will

appear on the 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. Click Medick Explorer

3. Check that Medick Explorer shows the message MHM 100 Detected

4. Click Tools

5. Click Set MHM 100 Clock – the MHM 100 will automatically

synchronise the clock in your computer with that in the MHM 100

6. If you accidentally remove the computer cable during report collection

you will get a Connection Lost message on the MHM 100 screen.

The report collection will have failed and you need to start again.

Selecting OK will take you back to the Main Menu. Reconnect cable

and repeat Collect New Report procedure as described above

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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

1. Type in your user id and press return

2. Type in your password and press return

You will now be taken to your corporate website homepage; from here you will

be able to place an order for reports and/or accessories, upload a report for a

user and review/search for a report where the user does not have access to

the internet at home. If you need to order additional MHM 100 devices,

please contact us direct on 0845 603 7282. Opening hours as follows:

Monday to Friday 9am to 5pm

Saturday 10am to 2pm

Sunday Closed

Bank Holidays Closed

Alternatively, you can email us at [email protected]

Uploading a report

1. Click on the ‘Upload Report’ button on left hand side of the screen

2. Click on the ‘browse’ button – this will open a dialog box which will list

the files in your ‘My Documents’ folder where the reports will be saved

3. Find the saved report and double click on the report. Please make sure

that you click on the report which has the Medick explorer icon (suffixed

with .mhm)

4. You will then return to the website and the ‘Report’ field will now be

populated

5. Type in the user name or unique reference number as agreed with your

internal processes in the ‘User Name/No’ field

6. Type in the user email in the ‘User Email’ field if you have it otherwise

leave this field blank

7. Click the ‘Upload’ button

8. You will then be taken to the upload confirmation screen which will

have the access code required to review and/or print the report. Click

the ‘print page’ button – a dialog box will open to select the appropriate

printer.

9. Select the required printer from the list in the ‘Select Printer’ field and

click on print

10.Check that the access code has printed and click on ‘Please click here

to return to your homepage’

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View Report - user email supplied

The user will receive an email notification to inform them that their personal

report has been produced and is ready to be reviewed. 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.

3. Click on the ‘View Report’ button.

View Report – user email not supplied

You will receive an email notification to inform you that the individual user’s

personal report has been produced and is ready to be reviewed. You will need

to take the following actions to retrieve the report:

1. Log into your corporate website homepage (as above)

2. Click on the ‘view report’ button on the left hand side of the screen

3. In the ‘User Name/No’ field type in the user name or unique reference

number used when uploading the report

4. Click on the ‘send’ button

5. Select the correct report from the list of reports found

6. Click on ‘has been analysed please click here to view’

Placing an order

1. Click on the ‘Place Order’ button on left hand side of screen

2. Type in the quantity in the appropriate box for either reports or

accessories

3. To proceed with the order click on the ‘place order’ button or click on

‘cancel button’ to cancel the order

4. You will be taken to the order confirmation screen (this can be printed if

required)

5. Click ‘Home’ (top left of the screen) to return to your corporate website

homepage

Viewing the ECG results

On the MHM 100

Select Report Menu from the Main Menu options.

Selecting Summary will give access to five pages of summarised test results

that the user can then scroll through.

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Test details

Provides summary of test duration and signal

quality