ZOLL Cardiac Monitor User manual

Cardiac Monitor
User Manual
23C0001 REV D

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Content
INTRODUCTION
About the ZOLL Cardiac Monitor ..................................................................1
Where Do My Recordings Go? .....................................................................1
This Manual .................................................................................................. 1
What’s In This Manual? ................................................................................ 1
Safety Precauons ........................................................................................2
Indicaons For Use ....................................................................................... 2-3
Contraindicaons ......................................................................................... 3
DEVICE OVERVIEW
System Components ..................................................................................... 4
Monitor — Front View .................................................................................. 5
Monitor — Side and Back View .................................................................... 5
Monitor Touchscreen ................................................................................... 6
OPERATION
Charging the Monitor Baery....................................................................... 7
Starng a Study ............................................................................................ 8-9
Marking an Event .......................................................................................... 10-11
Symptom Diary .............................................................................. 10
Acvity Diary .................................................................................11
Conrm Event ............................................................................... 11
Electrode Applicaon ...................................................................................12
Electrode Replacement ................................................................................12
Monitoring a Study ....................................................................................... 13
Ending a Study ..............................................................................................13
Returning Your Device .................................................................................. 13
MAINTENANCE
Cleaning ........................................................................................................ 14
TROUBLESHOOTING
Error Messages ............................................................................................. 14
SYSTEM INFORMATION
Equipment Symbols ......................................................................................15
Wireless Compliance .................................................................................... 16-17
Contact Informaon ..................................................................................... 18

1
About the ZOLL Cardiac Monitor
The ZOLL Cardiac Monitor uses advanced heart monitoring technology along with
mobile communicaon to detect, record, and transmit cardiac rhythms based on
parameters predetermined by your prescriber, without interfering with normal daily
acvies.
Your interacon is not required for events to be detected by the system. However,
you can record any symptoms you experience by pressing the Plus Sign on
the Monitor Display Screen.
Where Do My Recordings Go?
All your cardiac monitor recordings are sent to ZOLL for evaluaon. Depending on
your prescripon, the recordings are transmied and monitored 24 hours a day, 7
days a week, or they are downloaded when you return your device to ZOLL at the
end of your prescripon period. ZOLL provides reports to your prescriber based on
your recordings.
This Manual:
• Supports paents who are using the ZOLL Cardiac Monitor.
• Provides instrucons on the use and care of the device.
• Supplements training you may have received from your prescriber.
What’s In This Manual?
•Device Overview describes the basics of how the system works.
•Operaon goes into specic details about how to use the device.
•Maintenance covers the daily care involved in using this device.
•Troubleshoong explains situaons that might occur and what to do if
they happen.
•System Informaon covers equipment symbols, wireless compliance, and
contact informaon.
NOTE: The ZOLL Cardiac Monitor does not provide interpreve or diagnosc
statements. Interpretaon and diagnosis are the responsibilies of a physician or
other trained healthcare professional.
Introducon

2
Introducon
Safety Precauons
• Use only cables provided by ZOLL with the ZOLL Cardiac Monitor.
• Disconnect paent leads before debrillaon.
• To reduce the risks of strangulaon or asphyxiaon do not leave electrode
cables accessible to infants or children. Carefully route the electrode cables
to reduce the possibility of entanglement or strangulaon during use.
• To achieve the best recordings results, stay away from heavy electrical
equipment or other sources of electromagnec interference. This includes
equipment such as electric blankets and heang pads.
• Avoid exposing device to water or excessive moisture.
• Do not expose device to extreme temperatures.
• Use only the electrodes provided by ZOLL with the ZOLL Cardiac Monitor.
• Do not allow conducve parts of the ZOLL Cardiac Monitor paent
electrodes to contact other conducve parts including earth.
Indicaons For Use
The ZOLL Cardiac Monitor is intended for acquiring ambulatory ECG signals from
paents who either are at risk of having cardiac disease or have intermient
symptoms indicave of cardiac disease and who have demonstrated a need to be
monitored on a connuing basis.
Indicaons for conducng ambulatory recording include:
• Paents requiring monitoring for non-life-threatening arrhythmias such as
supraventricular tachycardias and ventricular ectopy.
• Paents requiring monitoring for evaluaon of bradyarrhythmias and
intermient bundle branch block including aer cardiovascular surgery and
myocardial infarcon.
• Paents requiring monitoring for arrhythmias associated with co-morbid
condions such as hyperthyroidism or chronic lung disease.
• Paents experiencing symptoms such as a) syncope of unknown eology or
b) shortness of breath which may be due to cardiac arrhythmias.
• Paents with palpitaons with or without known arrhythmias to obtain
correlaon of arrhythmias with symptoms.
• Paents who require monitoring of the eects of drugs to control
ventricular rate in atrial arrhythmias.
• Paents recovering from cardiac surgery who are indicated for outpaent
arrhythmia monitoring.
• Paents with diagnosed sleep disordered breathing including sleep apnea
(obstrucve central) to evaluate possible nocturnal arrhythmias.
• Paents requiring arrhythmia evaluaon of eology of stroke or transient
cerebral ischemia, possibly secondary to atrial brillaon or uer.

3
Introducon
Data from this device may be used by another device to discover, measure, or report
QT interval. The device is not intended to sound any alarms for QT interval changes.
Contraindicaons
The ZOLL Cardiac Monitor is not intended for use under the following condions:
• Paents with potenally life-threatening arrhythmias who require inpaent
monitoring.
• Paents who the aending physician thinks should be hospitalized.

4
Device Overview - Components
System Components
Figure 1
Major components of the system.
ITEM DESCRIPTION
1. Monitor Main unit of the ZOLL Cardiac Monitor.
2. Paent Cable Connects the Monitor to the Electrodes to monitor your
heart rhythm.
3. Power Charging
Cable
Recharges the Monitor baery. Plugs into a standard power
outlet to provide power to the Monitor (details on page 7).
4. Holster Allows you to aach the Monitor to your clothes or belt. The
Monitor is placed into the Holster with the Display Screen
facing toward your body. Once in the Holster, the Monitor
Display Screen is no longer visible.

5
Monitor — Front View (Fig. 2)
For details about operang and caring for the Monitor, see pages 7-14.
Figure 2
Front view of the ZOLL Cardiac Monitor
ITEM DESCRIPTION
1. Display Screen Color touchscreen used to show all device messages and use
opons.
2. Power Buon Pressing this buon powers the Monitor on and o. To power
o the device, you may press and hold the Power Buon for
approximately ve seconds or unl the display powers o. If the
Display Screen is dark, press the Power Buon to turn on the
Display Screen.
Figure 3
Side and back view of the ZOLL Cardiac Monitor
Monitor — Side and Back View (Fig. 3)
ITEM DESCRIPTION
3. Serial Number Idencaon number used if communicang with ZOLL
technical support. Also found on the boom of the Display
Screen.
4. Paent Cable and
Power Charging
Port
This port serves two purposes. When wearing the device,
the Paent Cable is aached to this port. When charging the
device, the Power Charging Cable is connected.
Device Overview - Components

6
Monitor Touchscreen
Shown below is an example of the Monitor Touchscreen when the device is turned
on. The menu on the device can be navigated by gently touching and releasing the
graphic buons on the touchscreen.
Figure 4
Monitor inial screen.
ITEM DESCRIPTION
1. Network Status
Indicator
Indicates the status of the network connecon. The device
periodically turns o its modem to save power.
2. Baery Level Displays the approximate charge remaining in the baery.
3. Serial Number Idencaon number used if communicang with ZOLL
technical support. Also found on the back of the Monitor.
Device Overview

7
Charging the Monitor Baery
Charge the Monitor Baery every 48 hours or as indicated by Baery Level on the
Display Screen.
1. To charge the Monitor baery during a Study, disconnect the Paent Cable from
the Monitor and then connect the Power Charging Cable to the Monitor (Fig. 5).
Figure 5
2. Connect the Power Charging Cable to
a standard power outlet to charge the
baery (Fig. 5). The ZOLL Cardiac Monitor
indicates that the baery is charging
by replacing the Baery Level on the
touchscreen with a charging indicator
(Fig. 6).
3. Once the Monitor is fully charged, the Baery Level on the Monitor is a solid
blue.
4. Disconnect the Power Charging Cable from the Monitor and standard power
outlet.
5. Connect the Paent Cable to the Monitor.
NOTE: When plugging the Paent Cable into the Monitor the cord should face
up and away from your body. The Paent Cable might need some gentle force
to be inserted completely.
6. Place the Electrodes on your body as indicated in Fig. 9. For more details on
Electrode Applicaon see page 12.
NOTE: The ZOLL Cardiac Monitor baery cannot be recharged in the device without
interrupng the data recording.
Operaon
Figure 6
The screen displays the charging
indicator in the top right corner.

88
Starng a Study
1. Press and hold down the Monitor Power Buon to begin powering the device.
2. Aer approximately three seconds, the Monitor vibrates, briey displays an
ECG (Fig. 7), and then displays the message MONITORING Please connect all
electrodes for best results. Thanks! (Fig. 8).
3. Open the Electrodes package and aach the Paent Cables to the Electrode
Snaps.
4. Remove the protecve backing from the Electrodes.
5. Place the Electrodes on your body as indicated in Fig. 9. For more details on
Electrode Applicaon see page 12.
Figure 7 Figure 8
Operaon
Figure 9
right side
of body
le side
of body

9
Starng a Study Connued...
Figure 10
6. When the Monitor displays the screen above (Fig. 10), it is recording and
analyzing ECG data. The Time Remaining on the Display Screen is the number of
days remaining for the study; however, the days remaining in your prescripon
may be less than indicated based on how oen you are wearing the device.
7. The MONITORING screen displays instrucons on how to mark an event. To
mark an event from this screen, select the Plus Sign (see next page for
instrucons).
NOTE: If you do not select the Plus Sign or Monitor Power Buon for
approximately 20 seconds, the Display Screen will go to sleep. You can wake the
display by pressing the Monitor Power Buon.
Operaon

10
Marking an Event
During a Study, the ZOLL Cardiac Monitor allows you to indicate symptoms you are
feeling for the prescriber to review.
1. To mark an event from this screen, select the Plus Sign (Fig. 11).
Figure 11
2. The NEW EVENT screen displays (Fig. 12).
3. Select the Right Arrow on this touchscreen (Fig. 12).
4. On the SYMPTOM DIARY screen (Fig. 13) select the Up or Down Arrows
to highlight the symptom that you feel.
NOTE: If at any me you would like to edit a selecon or exit without
marking an event, select the Le Arrow .
5. Select the Right Arrow .
Figure 12 Figure 13
New Event Screen Symptom Diary Screen
Operaon

11
Marking an Event Connued...
6. A second NEW EVENT screen displays with further instrucons (Fig. 14). Select
the Right Arrow .
7. On the ACTIVITY DIARY screen select the Up or Down Arrows to highlight
the acvity you are doing (Fig. 15).
8. Select the Right Arrow .
Figure 14 Figure 15
Third Screen in Marking an Event Acvity Diary Screen
9. On the CONFIRM EVENT screen (Fig. 16), select the Plus Sign to conrm
your selecons.
10. You have successfully marked an EVENT. An EVENT RECORDED message
displays on the screen (Fig. 17) and the device will vibrate for approximately
three seconds. Aer those three seconds, the device is redirected to the
MONITORING screen (Fig. 11).
Figure 16 Figure 17
Operaon

12
Electrode Applicaon
Disposable Electrodes are included in the ZOLL Cardiac Monitor box. Only use the
Electrodes supplied by ZOLL.
Contact your prescriber or ZOLL if you did not receive any Electrodes, experience
Electrode fall-o, or you need more Electrodes.
Employ the following procedure when applying Electrodes and connecng them to
the ZOLL Cardiac Monitor:
1. Wash and dry the chest areas
and abdomen where applying the
Electrodes. Do not apply powder or
loon. Shave any body hair in the
areas where Electrodes are to be
applied.
2. Open the Electrode package and
aach the Paent Cables to the
Electrode Snaps.
3. Remove the protecve backing from
the Electrodes.
4. Apply the Electrodes directly to your skin avoiding muscle areas and breast
ssue, matching the colors to Fig. 18.
• Place the Electrode with the WHITEWHITE connector just below your right
collar bone.
• Place the Electrode with the BLACK connector just below your left
collar bone.
• Place the Electrode with the RED connector on your left upper
abdomen, just below your rib cage.
5. Press adhesive border rmly to your skin for consistent adhesion.
Electrode Replacement
Replace the Electrodes every 2-3 days or when they no longer rmly adhere to your
skin. When replacing the Electrodes, vary placement slightly from their previous
locaons.
Operaon
Figure 18
Electrode Conguraon

13
Monitoring a Study
Once a Study has started, the ZOLL Cardiac Monitor silently records, detects, and
transmits ECG data with no intervenon. Briey press the Monitor Power Buon to
wake the display or Mark an Event.
If the Paent Cable is disconnected from the Electrodes or the Monitor, the device
cannot connue recording, the device automacally wakes the display, vibrates,
and displays a message. The screen shown in Fig. 19 displays if Electrode(s) are
disconnected from the Paent Cable, while the screen shown in Fig. 20 displays if
the Paent Cable is disconnected from the Monitor.
Figure 19 Figure 20
The device stopped recording ECG
data because one or more Electrodes
are disconnected from the Paent Cable.
The device stopped recording ECG
d a t a b e c a u s e t h e P a  e n t C a b l e
is disconnected from the Monitor.
Ending a Study
Connue wearing the ZOLL Cardiac Monitor
for the length of me instructed by your
prescriber. The Study will end once the
pre-congured recording duraon is reached.
The device will nofy you that the Study has
ended by vibrang and displaying the DONE
MONITORING screen shown in Fig. 21.
Returning Your Device
NOTE: Keep ALL original packaging materials from your ZOLL Cardiac Monitor box.
You will need these to return your device.
See ZOLL Cardiac Monitor packaging for instrucons on how to return your device.
Only return the unopened packages of the Electrodes.
Operaon
Figure 21

14
Cleaning
• Do not submerge the ZOLL Cardiac Monitor or the Paent Cable in water.
Do not hold either the Monitor or the Paent Cable under running water.
• Use only a damp cloth with mild detergent diluted with water to clean the
device.
Error Messages
The ZOLL Cardiac Monitor is designed to detect and recover from error condions
automacally. There may be situaons that occur in which the device may not
recover on its own.
In most cases the ZOLL Cardiac Monitor displays an informave ERROR message
(Fig. 22).
If the Monitor screen remains blank (Fig. 23) aer pressing the Monitor Power
Buon, contact ZOLL for further instrucons at 888.592.3798.
Figure 22 Figure 23
An error message displayed on the
ZOLL Cardiac Monitor screen. An error occurred that prevents the
ZOLL Cardiac Monitor
from displaying anything.
Maintenance
Troubleshoong

15
System Informaon
Equipment Symbols
Consult the Direcons For Use
Type BF device
Electrically Isolated
Manufacturer Info
RX Only Prescripon Only
Device has ingress rang of IP22 in accordance with IEC
60529
Recycling Symbol - Do not dispose of this product as
unsorted municipal waste. Prepare this product for reuse or
separate collecon as specied by Direcve 2002/96/EC of
the European Parliament and the Council of the European
Union on Waste Electronic and Electrical Equipment (WEEE).
If this product is contaminated, this direcve does not apply.

16
System Informaon
16
Wireless Compliance
Device may contain FCC ID: ZIMH40L, ZIMH40M or ZIMH41L
FCC Compliance Statement
This device complies with part 15 of the FCC Rules. Operaon is subject to the following
two condions: (1) This device may not cause harmful interference, and (2) this device must
accept any interference received, including interference that may cause undesired operaon.
This equipment has been tested and found to comply with the limits for a Class B digital
device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable
protecon against harmful interference in a residenal installaon. This equipment
generates, uses and can radiate radio frequency energy and, if not installed and used in
accordance with the instrucons, may cause harmful interference to radio communicaons.
However, there is no guarantee that interference will not occur in a parcular installaon. If
this equipment does cause harmful interference to radio or television recepon, which can be
determined by turning the equipment o and on, the user is encouraged to try to correct the
interference by one or more of the following measures:
– Reorient or relocate the receiving antenna.
– Increase the separaon between the equipment and receiver.
– Connect the equipment into an outlet on a circuit dierent from that to which the
receiver is connected.
– Consult the dealer or an experienced radio/TV technician for help.
The device contains a radio transmier and receiver. It is designed and manufactured
not to exceed the emission limits for exposure to radio frequency (RF) energy set by the
Federal Communicaons Commission of the U.S. Government. These limits are part of
comprehensive guidelines and establish permied levels of RF energy for the general
populaon. The guidelines are based on standards that were developed by independent
scienc organizaons through periodic and thorough evaluaon of scienc studies. The
standards include a substanal safety margin designed to assure the safety of all persons,
regardless of age and health.
The exposure standard for wireless mobile devices employs a unit of measurement known
as the Specic Absorpon Rate, or SAR. The SAR limit set by the FCC is 1.6W/kg. Tests for
SAR are conducted using standard operang posions accepted by the FCC with the device
transming at its highest cered power level in all tested frequency bands. Although
the SAR is determined at the highest cered power level, the actual SAR level of the
device while operang can be well below the maximum value. This is because the device is
designed to operate at mulple power levels so as to use only the power required to reach
the network. In general, the closer you are to a wireless base staon antenna, the lower the
power output.
Before a device model is available for sale to the public, it must be tested and cered to the
FCC that it does not exceed the limit established by the government-adopted requirement for

17
Wireless Compliance Connued...
safe exposure. The tests are performed in posions and locaons (for example, worn on the
body) as required by the FCC for each model. Changes or modicaons made to this
equipment not expressly approved by TZ Medical may void the FCC authorizaon to operate
this equipment.
This device has been tested and meets FCC RF exposure guidelines when worn on the body
using the Plasc Holster (PN: H3R-0027). Use of other accessories may not ensure compliance
with FCC RF exposure guidelines.
The FCC has granted an Equipment Authorizaon for this wireless electro-cardiovascular
monitor with all reported SAR levels evaluated as in compliance with the FCC RF exposure
guidelines. SAR informaon on this device is on le with the FCC and can be found under the
“Display Grant” secon of: hp://transion.fcc.gov/oet/ea/fccid/ aer searching on FCC ID:
ZIMH40L, ZIMH40M or ZIMH41L.
System Informaon