Personal Heart Reporting Service
MHM 100
Standard Operating Procedure for Pharmacy
Version 1.0
th
October 2007
15
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
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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’
• 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
allows you to confidentially submit and retrieve personal ECG reports.
, an area within www.medick.com that
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 ye ars, as heart function is no t 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 le t 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 t h r ee)
• 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:
Battery cov er
Serial number inside battery cover
Power on/off switch
Connector with guide
Connector socket and groove Battery compartment
Log button
Electrode lead
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:
Black and white LCD
screen
128 x 64)
‘Soft’ navigation buttons
(Screen resolution
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.
Log button
120mm width
20mm depth
Scrolling buttons
70mm height
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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 batter ies ‘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 Pla cement (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
Menu
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
Upper right chest just
below the collar bone
(Red)
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 s having
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
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)
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.
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).
Electrode leads should not be used if they appear to be damaged or worn
Positioning and attaching the elect rode leads
The MHM 100 should be switched OFF.
The pads should be remo ved 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 pre ssed, the message Log Button will appea r 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 softwar e
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-
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
pin connector or USB port (a USB-to-serial
adapter is supplied)
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
Next
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 sw itch 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/searc h 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 support@medick.com
Uploading a repo r t
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 p rint 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 acce ss to five pages of summar ised test results
that the user can then scroll through.
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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
definitions)
Select [Back] to return to the main menu
Rhythm Summary
Shows how many times wide complex
tachycardia, ST segment depression and atrial
fibrillation were experienced (see glossary for
definitions)
Select [Back] to return to the main menu
Ectopic Beat Summary
Shows how many times atrial, ventricular or
multifocal ectopic beats were experienced (see
glossary for definitions)
Select [Back] to return to the main menu
If the user wants to look at individual sections in more detail, all they have to
do is scroll down the Report Menu and select the relevant page. The user
should do not be unduly concerned about any of the individual terms in the
report. The most important thing is that the user is advised on any action in
the expert report when they receive it.
The user can also have access the following screens from the Report Menu
•
Warning Messages – lets them know if the test was stopped early
due to low batteries. The report will be shorter than usual
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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
•
Sample Trace – shows a sample of what the ECG trace looked like
at 3 minutes after the start of the t est
•
Log Button Records – there is a separate page for each of the
first nine times and the last time the log button was pressed
On the computer
Open the previously named results file as you would any document on the
computer. You can either read the results on screen or print off a paper copy.
The sections you will select are as follows:
Heading
This page is where you
enter the user name
and any confidential
comments
Summary
Gives a summary of
the ECG results:
• Heart rate
• Tachycardia events
• Bradycardia events
• Heart rhythm
irregularities
• Ectopic beats
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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
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Log Buttons
There can be a
maximum of 10 Log
Button pages – one
for each of the first
nine times it was
pressed and the last
one. A thick black line
appears above the
heart rate at the time
the button was
pressed
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 in terpreting ECG reports requ ires 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. making an
appointment with the GP. To make sure there is no room for confusion about
the implications of the test, we will also colour-code the notification as follows:
• green – no significant irregularities have been detected.
• amber – some irregularities in the heart rhythm have been detected
and the user should make an appointment to see their GP within the
next few days, taking the report with them, to see if they need further
investigation. A printable letter for the doctor will also be available to
take with them.
• red – some irregularities have been detected in the heart rhythm that
may require treatment. The user shou ld make an appointment to see
their GP as a matter of urgency, taking the report with them. A
printable letter for their doctor will also be available for them to take.
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• blue – the signal quality during the test was too low to be of use. The
test may be repeated after referring to the sections on ‘Skin
preparation’, ‘Positioning electrodes’ and ‘Things to remember’ to make
sure the correct procedures were followed. Users should not be
charged for their first blue report
• pink – A small per centage 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. The cost of the test
should be refunded. For further information please call our Medick
Customer Support Team on 0845 603 7282 (calls charged at local
rate).
Opening hours as follows:
Monday to Friday 9am to 5pm
Saturday 10am to 2pm
Sunday Closed
Bank Holidays Closed
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Examples of Expert Report Web pages
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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:
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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.
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Replacing parts
The MHM 100 monitor has a number of renewable parts and items that need
regular replacement in order to maintain optimum hygiene and efficiency. All
parts can be purchased via the Corporate website
• Electrode pads – these are for single use only. Additional packs of
electrode pads are available for purchase. Abrasive wipes – these are
supplied with each order of Electrode pads.
• Electrode lead – although designed to withstand normal handling, it is
non-repairable and may sustain permanent damage if not handled or
stored correctly. You should therefore inspect the lead regularly for
signs of excessive wear and tear, such as cracked plastic wire casing,
and replace it if damaged. It is important to replace damaged leads as
they can produce inadequate reports
• Computer lead and USB to serial adapter – any damage to these
two items could prevent you from transferring your results to your
computer, so it is essential that you store them carefully and replace
them if necessary
• Batteries – a set of two high-quality AAA alkaline batteries has enough
energy to perform one test and collect the results. We recommend that
new batteries are used for each test. Please refer to ‘Inserting and
replacing batteries’ for more infor m ation on suitable battery t y pe s .
How to look after the MHM 100
Do not attempt to dismantle the MHM 100 as this will invalidate its warranty.
It is recommended that you store the monitor and its leads in the bags
provided in between tests. This will help protect them fro m accidental damage
and reduce the need for purchasing replacement parts.
Environmental considerations
Operating temperature range: 0 to 50°C
Storage temperature range: 0 to 60°C
Relative humidity: 20 to 65% non-condensing
Ambient air pressure: 700 to 1060mb
Cleaning
The MHM 100 is not waterp roof an d so shou ld neve r be im mersed in wa ter 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. If further cleaning is required, you can
use a surgical wipe.
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The electrode lead should be kept clean by wiping with lukewarm soapy
water, a surgical wipe or a neutral cleaner. Do not immerse it in water. Also,
do not use any chemical or solvent cleaning solutions as these may corrode
the lead and cause permanent damage.
Faulty equipment
It is important that you check the condition of the monitor and all its parts as
soon as you receive them to check if there has been any damage in transit. If
any of the parts are damaged please contact Customer Support – see below.
If there is no obvious sign of damage and the monitor is not working, check
that you have followed all the instructions as outlined in the SOP, especially
with respect to skin preparation and electrode positioning. If the electrode lead
is worn or damaged, you will need to buy replacements (see Replacing parts
section).
If you suspect that the monitor or any of its attachments is faulty, please call
our Customer Support Team on 0845 603 7282 (calls charged at local rate).
Opening hours as follows:
Monday to Friday 9am to 5pm
Saturday 10am to 2pm
Sunday Closed
Bank Holidays Closed
It is important that you carefully read the warranty information carefully
Insurance
This device needs to be handled with care. We recommend that you arrange
replacement insurance cover, as repair may not be cost-effective. Your
warranty will be automatically invalidated if you seek to carry out repairs
through unauthorised sources, who will not have knowledge of this proprietary
device. We also recommend that replacement accessories such as leads and
pads be obtained from us as we cannot warrant performance where
unauthorised accessories are used. Where replacement batteries are
required, unless they are of equivalent power and durability, you may find that
they do not have enough capacity to run a full 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.
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Troubleshooting
The following sections should cover any difficulties you may experience in
running your ECG test and receiving your expert report.
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.
A
In the case of message A, switch off the MHM 100 and replace the batteries
before trying again.
In the case of message B, it is important that the report is uploaded
immediately, otherwise it may be lost. It will not be a full 8-hour reading.
B
There is a ‘Test Stopped’ screen, what should the user do?
If the user sees this screen, they should double check that they followed the
correct procedures, particularly with respect to skin preparation, electrode
placement and electrical equipment, and repeat the test.
If there is still a problem, contact our Customer Support Team
Always contact your doctor if you are experiencing any symptoms.
If test is repeated without having previously switched off/switched on the MHM
100, a message will be received stating that any existing reports will be
deleted.
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If this happens, make sure the existing report is saved onto a pc before
proceeding.
The MHM 100 screen is always blank, what happens next?
Make sure the batteries are correctly inserted as outlined in the battery
compartment. If this does not fix the problem try replacing the batteries, if the
problem persists call the Customer Support Team.
Can the user wear the machine if they walk through an airport
scanner?
Airport security generally asks people to pass all electronic devices through
an X-ray machine and we would recommend compliance with airport
security’s instructions.
Can the user travel by plane while wearing it?
Airline operators always ask that electronic devices be switched off during
take-off and landing as they can interfere with vital equipment. As it is not
advisable to interrupt the 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.
Will the user’s mobile phone or other electrical equipment
such as an MP3 player interfere with the machine?
Whilst no interference has been experienced during the testing process, we
would advise the user to keep away from electrical appliances as much as is
realistically possible whilst wearing the MHM 100, as certain appliances may
affect the ECG reading.
Is the machine safe and accurate to use in a thunderstorm?
The machine is perfectly safe to use in a thunderstorm and should produce
accurate readings. Users should take normal safety precautions when caught
in a thunderstorm.
Can the machine be worn in the shower or bath?
No. Please advise the user not to use the device in the shower or bath as it is
not waterproof. Also, try to keep the device out of the rain by wearing it in the
pouch provided.
How long will the batteries last?
We would recommend a new set for each 8 hour test. This will ensure that
data is not lost if the batteries fail or run down. If rechargeable batteries are
being used, always make sure that they are fully charged before starting a
test.
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If the user thinks there is a malfunction what should I do?
For all technical queries, please call our Customer Support Team on 0845
603 7282 (calls charged at local rate). Opening hours are as follows:
Monday to Friday 9am to 5pm
Saturday 10am to 2pm
Sunday Closed
Bank Holidays Closed
Will high levels of static electricity from modern carpets and
fabrics affect the working of the machine?
No.
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.
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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.
UK Office
Healthantec Limited
th
4
Floor, Exchange House, 494 Midsummer Boulevard, Central Milton
Keynes, MK9 2EA
Customer Support Team 0845 603 7282 (calls charged at local rate).
Opening hours are as follows:
Monday to Friday 9am to 5pm
Saturday 10am to 2pm
Sunday Closed
Bank Holidays Closed
Email support@medick.com
Internet www.medick.com
Before contacting Medick’s Customer Support Team for assistance, please try
to resolve any problem you encounter using the Troubleshooting section.
Please have the following information available when contacting our
Customer Support operation:
• The serial number of your MHM 100
• The version of Medick Explorer software
• The version of your computer’s operating s ystem.
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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.
arrest
A significant delay (greater than 3 seconds) in between heartbeats.
arrhythmia
Any variation from the normal rhythm of the heart.
artefact
Insufficient available ECG data to analyse. Possibly due to inadequate skin
preparation, poor contact of electrodes and/or inaccurate positioning of
electrodes o n t h e c hest.
asystole
Absence of heart beats, e.g. pause, arrest.
atria
The two upper chambers of the heart
atrial ectopic (AE)
A premature heartbeat impulse originating from within the atria, but outside
the sinoatrial node. Atrial Ectopics are common in healthy people.
atrial fibrillation (AF)
Atrial fibrillation or atrial flutter
atrial fibrillation (controlled)
Atrial fibrillation is controlled when the heart rate response lies within normal
limits (i.e. 50 to 120 beats per minute);
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atrial fibrillation (uncontrolled)
Atrial fibrillation is uncontrolled when the heart rate response lies outside
normal limits (i.e. 50 to 120 be ats per minute);. If AF is uncontrolled, card iac
output may be compromised by periods of inappropriate tachycardia and
bradycardia. Pauses and arrests may also be evident with an uncontrolled
ventricular response.
atrial flutter (AF)
An abnormally rapid, well organised contraction of the atria at a rate of 250 to
350 per minute.
atrioventricular block
The failure to conduct the heart beat impulse from the atria to the ventricles.
atrioventricular node
Electrical relay station between the atria and the ventricles - electrical signals
from the atria must pass through this node to reach the ventricles.
atrium
one of the upper chambers of the heart
autonomic nervous system
Part of the nervous system that controls the involuntary activity of many
organs and muscles, including the heart.
autonomic tone
The effect of the autonomic nervous system on the heart rate.
bigeminy
Two ectopic beats separated by a normal beat.
bpm (BPM)
Beats per minute.
bradycardia
A slow heart rate. Appropriate bradycardia is a slow heart rate of more than
30 seconds duration between 40 and 50 beats per minute. Appropriate
bradycardia is normally associated with periods of resting and sleeping.
Inappropriate bradycardia is an abnormally slow heart rate.
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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.
electrocardiogram (ECG)
A recording, from the external wall of the chest, of electrical activity generated
by the heart.
episode
A sequence of eight or more consecutive ectopic beats, or 30 or more
seconds of a rhythm.
escape rhythm
A slow, protective rhythm that is seen after an ectopic beat.
false negative
An abnormal event which has not been detected by the ECG test.
false positive
A normal event which has been incorrectly classified as abnormal by the ECG
test.
heart attack
See myocardial infarction.
heart block
Delay, or obstruction, of electrical conduction during contraction of th e heart.
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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. Among other conditions, IVCD include bundle branch
blocks and Wolff-Parkinson-White syndrome. A previous heart attack may
also show IVCD in the ECG test report.
ischaemia
Decreased flow of oxygenated blood to an organ due to obstruction of an
artery
isolated
An ectopic beat that occurs in isolation.
missed beat
A delay between heart beats of twice the normal duration.
morphology
The form or structure of a waveform.
multifocal (MF)
Ectopic heart beats that originate from more than one location within the
heart.
myocardial infarction (MI)
Deterioration of the myocardium, as a result of interruption of the blood supply
to the area. A heart attack. An MI is specifically a deterioration beyond repair.
myocardial ischaemia
Inadequate blood fl ow in the coronar y arteries, resulting in insufficient o xygen
reaching the muscles of the heart. Myocardial ischaemia differs from a heart
attack in that it is a recoverable deterioration.
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neural networks
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.
paroxysmal
Occurring with a sudden onset.
pauses
Delays (of up to 3 seconds) between heartbeats
presyncope
The sensation of lightheadedness and loss of strength that precedes syncope.
PR interval
The section of the heart beat impulse which indicates electrical conduction
from the sinoatrial node to the ventricles. The PR interval starts at the
beginning of the P wave and ends at the beginning of the QRS complex.
P wave
The section of the hear t beat which ind icates atri al contraction . The P wave is
generally small and upright, and precedes the QRS complex on the ECG. P
waves are absent in atrial fibrillation.
QRS complex
The section of the heart beat impulse which indicates ventricular contraction.
The QRS complex is generally tall, narrow, and upright, and is normally the
easiest waveform to identify on the ECG.
RR interval
The time between two consecutive heart beats, measured from one QRS
complex to the next.
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RR variability
Variation of rhy t h m , normally due to autonomic tone.
salvo
A sequence of four to seven ectopic beats one after the other.
second degree heart block
Some, but not all, heartbeats are conducted from the upper chambers to the
lower. This may result in decreasing levels of blood being pumped around the
body.
second degree heart block (type 1)
is where the pauses between each heartbeat become gradually longer until a
beat is skipped entirely. This therefore becomes regularly occurring skipped
beats
second degree heart block (type 2)
is where the electrical impulses starting in the aria (upper chambers) are
unable to reach the ventricles (lower chambers) because of interference from
somewhere below the AV node. This therefore results in decreasing levels of
blood being pumped around the body.
sick sinus syndrome
Abnormal heart beat impulse generated by the sinoatrial node, which
produces a wide variety of intermittent rapid and slow heart rates.
signal small
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.
sinoatrial node
The heart s natural pacemaker. Contraction impulses normally start in this
node, conduct through the atria and are then transmitted to the ventricles.
sinus arrhythmia
A marked change in the heart rate over only a few beats which occurs under
normal conditions, usually linked to breathing patterns. Especially prevalent in
fit young people.
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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. Damage to the brain will therefore affect body functions. For example, if a
stroke damages the part of the brain that controls how limbs move, limb
movement will be affected.
ST segment
The section of the heart beat which indicates contracted ventricles. The ST
segment immediately follows the QRS complex.
ST segment depression
Movement in the ST segment, which is lower than normal. Abnormal
deviations may be seen with intraventricular conduction delays and
myocardinal ischaemia.
ST segment depression (non-specific)
Non-specific ST segment depression is depression of the ST segment that is
not associated with any or all of the following conditions: ischaemia, injury,
myocardial infarction (heart attack), IVCD)
ST segment deviation
Movement in the ST segment, which is lower than normal. Abnormal
deviations may be seen with intraventricular conduction delays and
myocardial ischaemia.
supraventricular
Situated or occurring above the ventricles, especially in an atrium or
atrioventricular node.
syncope
A transient loss of consciousness due to an inadequate blood supply to the
brain. This is a possible symptom of arrhythmia.
tachycardia
A fast heart rate. Appropriate tachycardia is a fast heart rate of more than 30
seconds duration between 120 and 180 beats per minute. Appropriate
tachycardia is normally associated with periods of exercise. Inappropriate
tachycardia is an abnormally fast heart rate.
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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. These include numbness, paralysis, a difficulty in
speaking or swallowing, and loss of vision. All of these can be symptoms of
stroke, if sustained.
trigeminy
Two ectopic beats separated by two normal beats.
triplet
Three ecto pic beats occurring one after the other.
T wave
The final section of the heart beat, indicating ventricular relaxation. The T
wave is generally smaller and wider than the QRS complex.
unifocal
Originating from a single location in the heart.
ventricles
The two lower chambers of the heart.
ventricular ectopics (complex)
Heartbeats originating from within the ventricles in particular patterns. These
include trigeminy, bigeminy, couplets, triplets, salvos and episodes
ventricular ectopics (frequent);
A rate of more than one heartbeat originating from the ventricles every two
minutes.
ventricular ectopics (infrequent)
A rate of less than one heartbeat originating from the ventricles every two
minutes. Infrequent Ventricular Ectopics are common in healthy people and
are usually associated with intake of caffeine and alcohol etc.
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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. In the absence of artefact, this should be considered as ventricular
tachycardia.
Wolff-Parkinson-White syndrome
An extra electrical connection inside the heart that acts as a short circui t.
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Product Specification
This Appendix contains technical information relating to your MHM 100 device.
Electrical
Frequency response: 0.1 to 23Hz
Input impedance: >20Mohm
Input dynamic range: 0 to 5mV
Intentionally applied current: -1.3 to +1.3uA
Channels: 1 bipolar
Sampling rate: 100Hz
Sampling resolution: 12-bit
Battery: 2 x AAA min. capacity 500mAh
Continuous operation: 8 hours
Mechanical
Height: 70mm
Width: 120mm
Depth: 20mm
Weight: 200g
Index of protection: IP20 rated by design
Regulatory Standards
CE Mark MDD 93/42/EC
Performance ANSI/AAMI EC38
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.
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Graphical Symbols
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.
This indicates that the MHM 100 meets the ISO 60601 Class II requirement,
being double insulated and having no earth connection.
This indicates that Medick Healthcare Limited declares that the MHM 100
conforms to all the essential requirements listed in Annex I of the Medical
Device Directive 93/42/EEC. The CE mark incorporates the registration
number of the Notified Body supervising the conduct of Medick Healthcare
Limited.
The monitor is designed in accordance with the regulations for Waste
Electrical and Electronic Equipment (WEEEE) and the Restrictions on
Hazardous Waste (RoHS0 and does not contain any hazardous materials. At
the end of its life, the Monitor must be returned to the manufacturer for
recycling and safe disposal.
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