6. SPECIFICATIONS, COMPLIANCE AND SYMBOLS ................................ 59
Contents i
DRAFT
Caution:Caution:
Caution: Federal law restricts this device
Caution:Caution:
to sale by or on the order of a physician.
Copyright 2004
All rights reserved
Model Number 1001
Lit Number - 100526
ii
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Revision B
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! February 2004
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1
INTRODUCTION
We Help Find Answers
The CardioNet
Service monitors
your heart rhythms
continuously. This
helps your doctor
detect problems
that occur
infrequently, even
while you sleep.
CardioNet works
with you and your
physician.
The CardioNet Service was developed to help doctors
detect and treat heart problems that may not happen
often enough to be found during a routine ECG in the
physician’s office. CardioNet monitors heart rhythm
continuously, while people go about their normal daily
activities. We can help physicians detect problems that
may occur infrequently, whether you feel them or not,
even while you are sleeping.
Our goal at CardioNet is to work as a team with patients
and physicians to help people receive the best possible
care. We are honored that we were chosen to serve you.
Introduction 1
1. Introduction
HOW THE CARDIONET SERVICE WORKS
When you’re using the CardioNet Service, you’ll
wear a small, lightweight sensor. The sensor monitors
each heartbeat and sends data to the portable
CardioNet monitor.
The CardioNet monitor can be tucked away in a pocket
or purse. It sends wireless communications to the
CardioNet Center automatically when it detects an
event, or when you report an event using the touch
screen on the monitor.
Lightweight sensor monitors each heartbeat.
CardioNet monitor sends your
information to the CardioNet Center
2 Introduction
Sensor with lead Wires
CardioNet Patient Service Center
Monitors Heart Rhythms
The CardioNet Patient Service Center operates 24 hours
a day, seven days a week. At the Center, specially
trained cardiac technicians analyze your heart rhythms
and report results to your physician.
1. Introduction
Your physician reviews the results,
discusses results with you and prescribes
or adjusts treatment.
Physician Reviews Results
Introduction 3
THE CARDIONET MONITORING KIT
Avoid extra
charges. Return all
kit items except
used batteries and
used electrode
1. Introduction
pads to CardioNet
when service is
completed.
You might receive
the latest version of
the CardioNet
Monitor, which has
a color screen.
The CardioNet Monitoring Kit contains the supplies you
will need while you are on the CardioNet Monitoring
Service. If any items are missing or broken, or if you
have any questions about how to use them, please call
the CardioNet Patient Service Center at 1-866-426-4401.
When service is ended, please return all the items to
their labeled slots and send the kit back to the
monitoring center, following the directions on the
enclosed return address label.
It is important to return the patient supply kit no later
than the very next day. Other patients may need to use
the equipment.
YOUR SERVICE KIT CONTAINS
1.1.
The CardioNet MonitorThe CardioNet Monitor
1.
The CardioNet Monitor
1.1.
The CardioNet MonitorThe CardioNet Monitor
This portable device constantly monitors your
heartbeat and sends information to the CardioNet
Patient Service Center. The CardioNet monitor uses
wireless communication when you are away from
home. It uses the regular phone system when the
monitor is placed in the CardioNet base station. You
will not be charged by the telephone company for
calls made by your monitor.
1. CardioNet Monitor
4 Introduction
Please handle the CardioNet monitor with
care – don’t drop it, lose it, or get it wet.
2. CardioNet Base Station
2.2.
The CardioNet Base StationThe CardioNet Base Station
2.
The CardioNet Base Station
2.2.
The CardioNet Base StationThe CardioNet Base Station
The CardioNet base station is connected to your
home telephone line and plugged into an electrical
outlet in the bedroom or a central location in your
house. The base station recharges the CardioNet
monitor overnight and allows the CardioNet monitor
to communicate with the monitoring center through
the regular phone system. You will not be charged
by the telephone company for calls made by
your monitor.
1. Introduction
Please put the CardioNet monitor in the base station
whenever you are at home. In larger homes, two
base stations may be required, so you can keep your
sensor and monitor in contact as you walk around
the house.
Introduction 5
1. Introduction
3. CardioNet Sensor
3.3.
The CarThe Car
3.
The Car
3.3.
The CarThe Car
dioNet Sensor and Lead WdioNet Sensor and Lead W
dioNet Sensor and Lead W
dioNet Sensor and Lead WdioNet Sensor and Lead W
irir
ir
irir
eses
es
eses
The CardioNet sensor, which can be worn around the
neck or on a belt, senses each heartbeat and
constantly sends the information to the CardioNet
monitor. To communicate with the monitor, the sensor
must remain within 30 feet of the monitor. Walls and
other obstructions can reduce the range. If you go out
of communication range, the sensor will beep to alert
you – to either move back within range or to pick up
the monitor and take it with you.
4.4.
Electrode PadsElectrode Pads
4.
Electrode Pads
4.4.
Electrode PadsElectrode Pads
These sticky disposable pads snap onto the three
electrode leads on the CardioNet sensor. You remove
the backing and stick them onto your skin.
5.5.
BatteriesBatteries
5.
Batteries
5.5.
BatteriesBatteries
These batteries are for the CardioNet sensor. The
sensor battery must be replaced each day. Any new
commercially available AA battery can be used with
the CardioNet sensor.
6.6.
Sensor Neck StrapSensor Neck Strap
6.
Sensor Neck Strap
6.6.
Sensor Neck StrapSensor Neck Strap
Use if you prefer to wear the sensor around your neck.
6 Introduction
7.7.
Sensor Belt ClipSensor Belt Clip
7.
Sensor Belt Clip
7.7.
Sensor Belt ClipSensor Belt Clip
Use if you prefer to wear the sensor on your belt.
8.8.
TT
elephone Line In/Outelephone Line In/Out
8.
T
elephone Line In/Out
8.8.
TT
elephone Line In/Outelephone Line In/Out
Use to plug your CardioNet base station into the
telephone wall jack.
9.9.
Base Power PlugBase Power Plug
9.
Base Power Plug
9.9.
Base Power PlugBase Power Plug
Use to plug your CardioNet base station into an
electrical outlet.
Patient Education Guide & Pocket Reference CardPatient Education Guide & Pocket Reference Card
These guides contain helpful information about the
CardioNet service and important contact numbers.
11.11.
Patient InforPatient Infor
11.
Patient Infor
11.11.
Patient InforPatient Infor
mation Vmation V
mation V
mation Vmation V
ideoideo
ideo
ideoideo
This ten-minute video contains helpful information
about the CardioNet Monitoring Service.
12.12.
12.
12.12.
ReturRetur
Retur
ReturRetur
n Addrn Addr
n Addr
n Addrn Addr
ess Label and Shipping Foress Label and Shipping For
ess Label and Shipping For
ess Label and Shipping Foress Label and Shipping For
mm
m
mm
Use the label and prepaid shipping form to return the
kit after monitoring is finished.
PATIENT RIGHTS
1. You have the right to be treated with dignity,
courtesy and respect
2. You have the right to high quality service
3. You have the right to excellent training on how to use
the CardioNet technology and service
4. You have the right to receive high quality service
regardless of race, religion, political belief, sex, sexual
preference or source of payment
5. You have the right to complain or suggest
improvements in service without worrying that we
will stop providing service or provide poorer quality
of service
6. You have the right to refuse service
7. By federal law (the HIPAA act) you have the right to
privacy with regard to your medical information and
to control the use of that information
The HIPAA act also provides that you have the right to
request copies of your medical records and to have
corrections made if there are errors in your records
Remember: Avoid
additional charges.
All kit items, except
used batteries and
used electrode pads
must be immediately
returned to
CardioNet once
service is completed,
or you will be
charged for them.
1. Introduction
PATIENT RESPONSIBILITIES
1. Use the CardioNet equipment with care
2. Return equipment to CardioNet immediately, when
monitoring is completed
3. Provide CardioNet with the information we need to
provide you with quality care
4. Treat CardioNet employees with respect
Introduction 7
1. Introduction
WHO TO CALL FOR HELP
If you have any questions about your monitoring service
or billing, please call one of our toll free numbers.
Customer service is available 24 hours a day,
7 days a week.
MONITORING QUESTIONS: (866) 426-4401
BILLING QUESTIONS: (866) 426-4402
IMPORTANT INFORMATION
CardioNet home monitoring is a service used to help
doctors diagnose and treat rhythm problems, not an
emergency response service. If you require immediate
medical assistance, you should contact Emergency
Medical Services (9-1-1 in most communities).
It is possible that CardioNet could detect a problem
that needs immediate attention while a patient is being
monitored. If we do detect a problem that needs
immediate attention, we will attempt to notify you so
that you can obtain assistance from Emergency Medical
Services. Our ability to contact and assist patients is
limited by several factors such as cell phone coverage,
our ability to determine patient location and differing
Emergency Medical Services policies and systems in
local communities.
8 Introduction
2
SETTING UP
This section describes:
Connecting the CardioNet Base
"
Recharging the Battery
"
Staying in Communications Range
"
Wearing the Sensor
"
Setting Up 9
2. Set Up
CONNECTING AT HOME
To connect the CardioNet base, find an electrical outlet
and phone jack in a central location, preferably in your
bedroom. As long as you are within range of the
CardioNet monitor, your CardioNet sensor can continue
sending heartbeats to the monitor. If you go out of range,
the sensor beeps to alert you.
When you go to any area in your house where your sensor
is out of communications range with your monitor, simply
take the CardioNet monitor out of the recharging base
and bring it with you.
In larger houses, a second base station is often used so
that you can stay within range without carrying your
monitor around.
At night, keep the CardioNet monitor in the recharging
base near your bed. If you sleep on your stomach, your
body may block communications between the monitor
and the sensor and you may need to put the sensor next
to your pillow. Whenever possible keep the monitor in
the base. It takes around four hours in the base station to
completely recharge the monitor battery.
10 Setting Up
PHONE IN PHONE OUT
2. Set Up
PC
POWER
Phone In
(your
phone
line)
SETTING UP THE BASE
11
1. Find an electrical outlet located close to a phone jack,
11
Line Out
(phone
line from
Service
Kit)
Power
(Insert
power
line)
preferably in your bedroom.
22
2. Unplug the telephone line from the back of
22
your telephone.
3. Take the telephone line that you just unplugged
and plug that line into the slot on the base
labeled “Phone In”.
4. Locate the second telephone line included in your
CardioNet Service Kit. Plug one end of this line into the
slot on the base labeled “Line Out”. Plug the other end
of this line into the back of your telephone.
5. Locate the power cord in your CardioNet Service Kit.
Insert the small, round end of this line into the slot on
the base labeled “Power”. Plug the other end into
an outlet.
Setting Up 11
CHECKING BATTERY POWER
2. Set Up
See Page 20 for
more details about
checking battery
power.
At home, leave the
monitor in the base
whenever possible.
When your monitor is in the base, touch the battery
symbol on the screen and the unit will tell you if the
battery is fully charged. If the battery is not fully charged,
leave the monitor in the base for a full recharge, which
takes four hours.
STAYING IN RANGE
The monitor’s rechargeable battery provides between 12
and 16 hours of use for each four hours of recharging. If
your battery indicator is low and it is still early in the day,
we recommend you place the monitor in the base for
recharging. When you are at home, leave the monitor in
the base, unless you go to a part of the house where the
sensor and monitor would be out of communications
range. Whenever you begin to go out of communications
range, the sensor will beep to alert you – reminding you
either return within range or take your monitor with you.
LIMITATIONS OF CELL PHONE COVERAGE
12 Setting Up
When your CardioNet monitor is in the base station, it
uses the regular telephone system for communications
with the CardioNet center. When you are away from
home – or whenever your CardioNet monitor is out of the
base station – the monitor uses cell phone technology to
contact the CardioNet center and transmit ECG data.
As with consumer cell phones, calls can sometimes be
delayed or blocked by coverage problems, heavy traffic
on cell phone networks, or physical obstructions such as
buildings or mountains.
When the CardioNet monitor has data to transmit and is
unable to communicate with the CardioNet center through
cell phone communications, it will save the data and
transmit it to the Center through the phone line when it is
replaced in the base.
2. Set Up
Place Monitor in Base to Recharge
Setting Up 13
2. Set Up
WEARING THE CARDIONET SENSOR
The CardioNet sensor uses three electrode pads,
carefully placed on your body to detect heartbeats by
sensing electrical changes on the surface of your skin. The
electrode pads are attached to the sensor by three lead
wires: a white wire, a black wire and a red wire. The lead
wires can be snapped on and off the electrodes. This
allows you to take off the lead wires and attached sensor
before showering – without removing the electrodes.
See Page 36 for more details about
removing your sensor while showering.
If you notice an irritation or a
rash developing where you
place the electrode pads,
please call us. You may need
to use a different type of
electrode pad.
14 Setting Up
Sensor with Lead Wires
Placement of Lead Wires and Pads
The electrode pads are placed as shown in the
diagram below.
White lead – snaps on an electrode pad placed just below
the center of your right collarbone.
Black lead – snaps on an electrode pad placed just below
the center of your left collarbone.
Red lead –snaps on an electrode pad placed just on your
left side, on the lower part of your rib cage.
Upper Right Chest
Upper Left Chest
Lower Left Rib Cage
When you enroll in the CardioNet
System, you will be shown the best
locations for the electrode pads to
detect changes in heart rhythms.
Placement of Pads
Upper Right Chest
White Lead
2. Set Up
Upper Right Chest
White Lead
Upper Left Chest
Black Lead
Lower Left Rib Cage
Red Lead
Placement of Leads Shown with
Neck Strap
Upper Left Chest
Black Lead
Lower Left Rib Cage
Red Lead
Placement of Leads Shown with
Belt Buckle
Setting Up 15
2. Set Up
SKIN PREP
This is a protective barrier for patients with known
sensitivity or adhesion difficulties. Apply to clean, dry skin
before electrode placement and allow to dry completely.
Use one skin prep pad for all 3 electrodes.
Alternate
Placement Areas
16 Setting Up
Alternate Placement for Pads
If redness or irritation develops, you can place the
electrode pad at another location near the original site.
If redness or irritation develops at the alternate site,
please call the CardioNet center immediately.
3
USING THE MONITOR
This sectiondescribes:
Monitor On and OFF
"
Using the Touch Screen
"
Recording a Symptom
"
Cell Phone Coverage
"
Changing Monitor Options
"
Checking Monitor Status
"
Warnings and Alarms
"
The CardioNet monitor is your link with the CardioNet
Patient Service Center. The CardioNet sensor sends each
heartbeat to the monitor. When the monitor detects a
targeted change in rhythm, or when you detect a
symptom and enter your information, the monitor will
establish a communications link with the CardioNet
Patient Service Center. The monitor sends your ECG
data, as well as any symptoms and activity information
you have entered using the monitor’s touch screen.
Using Your CardioNet Monitor 17
See pages 38 - 41 for more information
about how to remove the sensor while
bathing or showering.
When the monitor
is awake you see
the main menu.
When off or asleep,
the screen is blank.
Touch the button
3. Monitor
to wake it up.
MONITOR ON AND OFF
Keep the monitor on at all times while you are on the
CardioNet Service, unless you are changing the sensor
batteries or not wearing the sensor – for example, when
you take a shower.
The green button at the bottom of the monitor turns it
on or off and wakes it up. To turn the monitor off, you
must also use the touch screen to confirm that you want to
turn the monitor off.
LED Light
The CardioNet monitor
uses cellular communications to transmit data
when you are away from
home. If you have an
implanted pacemaker
or defibrillator, please
follow the manufacturer’s
instructions regarding
the use of cell phones.
(See page 55 for
more information.)
18 Using Your CardioNet Monitor
Touch Screen
On/Off Button
MONITOR IS ON
The LED indicator light flashes green when you are
being actively monitored. When the light flashes red,
the monitor is trying to get your attention. An alert
screen will appear with help or information.
MONITOR SCREEN IS ASLEEP
To save on battery power, the monitor screen
becomes blank while you are not using the touch
screen menus. You can tell that the monitor is still on
because the LED indicator light will be flashing.
To wake the monitor up press the On/Off button. The
screen information will appear.
MONITOR IS OFF
When you turn the monitor off, the screen is blank and
the LED indicator light is not lit.
3. Monitor
The LED light still
flashes when the
monitor is asleep.
It goes off when
the monitor is
turned off.
The screen is
blank when the
monitor is asleep
or turned off.
Using Your CardioNet Monitor 19
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