Cardiac Science Burdick 8500 Operating manual

1
Product Safety and Setup
70-01047-01 B
Copyright © 2011 Cardiac Science Corporation. All rights reserved.
This booklet contains important safety and care information.
Contents
◆Contact information 2
◆Intended use 3
◆Inspection at delivery 4
◆Warnings and cautions 5
◆Symbols and labels 13
◆System setup 17
◆Maintenance 30
◆Technical specifications 34
◆EMC guidelines 39
!
Caution: Read all instructions.
See the Burdick 8300, Burdick 8500 User’s Guide for all other
instructions and important safety information. Read all
instructions before using the Burdick 8300 or Burdick 8500. A
complete manual set is available on the accompanying CD.

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Product Safety and Setup
2
Contact information
Cardiac Science provides customer service and technical support.
◆To order additional product or accessories, contact
Customer Care.
◆For assistance with the product or installation, contact
Technical Support.
Outside the United States, contact International Operations or
your local representative.
Customer Care Technical Support
800.426. 0337 (U.S.A.)
425.402.2000 (U.S.A.)
[e-mail]
800.426.0337 (U.S.A.)
425.402.2000 (U.S.A.)
[e-mail]
http://websupport.cardiacscience.com/webchat/
International Operations
Kirke Vaerloesevej 14
Vaerloese, Denmark DK3500
45.4438.0500

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Intended use
3
Intended use
Under the supervision of a qualified physician trained in ECG
interpretation the Burdick 8300 electrocardiograph and Burdick
8500 electrocardiograph can be used to record the electrical
activity of the heart for the purpose of correlating the resultant
waveforms with the health of the heart muscle tissue structures.
This equipment produces a resting 12-lead electrocardiogram
which can be used as a first step for assessment of patients with
cardiac arrhythmias, intraventricular conduction block, pre-
excitation syndrome and ischemic heart disease. Records stored
and used during the life of the patient can assist physicians in the
diagnosis and natural history of heart related illnesses (such as
coronary artery disease).
This equipment is not designed to produce a definitive
interpretation nor exhaustive evaluation of the patient’s heart but
rather provide an effective beginning for evaluation of patients
with heart abnormalities.
!
WARNING! Follow all instructions
You are responsible for the safety of your device. Please follow all
safety instructions.

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Product Safety and Setup
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Inspection at delivery
Please inspect the electrocardiograph (ECG device) for any
shipping damage.
◆If the ECG device was damaged during shipment, contact
your shipping agent.
◆If an item is missing, contact your local representative or call
Customer Service. (See Contact information on page 2)
!
WARNING! Misdiagnosis, equipment damage, and warranty
void.
Only use approved accessories and cables. Using non-approved
accessories or cables may cause increased electromagnetic
emissions, damage the ECG device, or void the warranty.

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Warnings and cautions
5
Warnings and cautions
Safety alert descriptions
These safety statements may be used in this manual:
!
DANGER!
This alert identifies hazards that will cause serious personal injury
or death.
!
WARNING!
This alert identifies hazards that may cause serious personal injury
or death.
!
Caution
This alert identifies hazards that may cause minor personal injury,
product damage, or property damage.
General warnings and cautions
This section lists general warnings and cautions. Those
pertaining to specific functions and procedures are included in
the text where appropriate.
!
WARNING! Shock hazard
Do not touch the ECG device or patient during defibrillation.
Otherwise, serious injury or death could result.
!
WARNING! Burn hazard
Severe burns may result from improper placement of defibrillator
paddles. Never position defibrillator paddles close to or over ECG
electrodes. Remove all chest electrodes (V-Leads/ C-Leads) from
the patient before defibrillation.
Read and follow all defibrillator instructions before attempting
defibrillation.

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Product Safety and Setup
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!
WARNING! Contains latex
Latex adhesive is used to attach the bumpers (feet) to the device.
Exposure to products containing natural rubber latex may cause
an allergic reaction in susceptible individuals. Immediately
discontinue use if skin rashes, hives, sinus symptoms or other
allergy symptoms are present.
!
WARNING! Equipment compatibility.
Use only Cardiac Science approved and specified parts,
accessories, and any consumables. Use of other parts can degrade
performance and/or safety and may void warranty or contract
coverage.
!
WARNING! Operator or patient injury
Before performing any procedures with the ECG device, read and
follow all safety procedures.
!
WARNING! Operator or patient injury
The Burdick 8500 has a tilt display that you can reposition. Ensure
the path is clear to prevent pinching or catching items when
moving the tilt display.
!
WARNING! Misdiagnosis.
Some patient information directly affects ECG analysis. (Age,
gender, and race).Your patient’s physician uses this information
when interpreting ECG reports. Likewise, an interpretive ECG
device provides more accurate and complete analysis statements
when you enter complete patient information.
!
WARNING! Electrical safety
Mis-using the patient cable can cause shock. Use the patient cable
only as directed. Do not coil the patient cable tightly. Connect the
patient cable directly ECG device only. Never attempt to connect
the patient cable to any other type of device. Never attempt to
connect the patient cable directly to power.

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Warnings and cautions
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!
WARNING! Misdiagnosis
U.S. Federal law restricts this device to sale by or on the order of a
physician. This Burdick ECG device must be used by qualified
operators only and any results interpreted by a qualified
diagnostician.
!
WARNING! Misdiagnosis
The displayed waveform is for reference only. Always use the
printed file to make the final diagnosis.
!
WARNING: Patient injury
Ensure the device is placed on a stable surface and that it will not
fall on a patient or operator. Do not lift the device by the power
cord or patient cable.
!
WARNING! Equipment compatibility
Not for use with high frequency electrosurgery equipment.
!
WARNING! Equipment compatibility
Do not use this device. within the magnetic field during Magnetic
Resonance Imaging.
!
WARNING! Eye damage
The laser in the barcode scanner can cause a retinal burn when
directed at a person’s eyes. Do not point the barcode scanner at a
person’s eyes.
!
Caution: Misdiagnosis
This product is designed for medical personnel. A physician must
check and confirm every measurement results and diagnoses. Use
under clinical supervision only.
Perchlorate Material – special handling may apply.
See www.dtsc.ca.gov/hazardouswaste/perchlorate.

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Product Safety and Setup
8
Electrical Safety
This product is intended to be operated from a mains power
source of nominally 100 to 230V, 47 to 63 Hz and Maximum
AC Power consumption: 35 VA.
!
DANGER: Explosion hazard!
Operating electrical equipment in an environment containing
explosive gases can trigger an explosion. Use this equipment only
in a well-ventilated, ambient environment. Do not use the device
in the presence of flammable anesthetics, in an explosion-
endangered, or oxygen-enriched environment. The device is not
classified AP or APG.
!
WARNING! Electrical shock
Before plugging this device into any power source, ensure the
label on the rear panel of the ECG device displays the appropriate
voltage range for your location.
!
WARNING! Electrical hazard
Improperly grounded equipment has the potential to cause
electrical shock. Use only the power cords supplied by Cardiac
Science and plug the system into a properly grounded power
outlet only. Do not use ungrounded adapters or extension cables.
!
WARNING! Electrical hazard
Improperly grounded equipment has the potential to cause
electrical shock. Do not use the ECG device if there is any question
about the integrity of the protective ground conductor
arrangement. Immediately remove the device from AC power
until the grounding issue have been resolved.
!
WARNING: Electrical shock
Damaged power cords have the potential to cause electrical
shock. Before using the system, check for power cords that may be
broken or frayed. Do not use any system with damaged power
cords and remove power from a system with damaged power
cords. Do not tamper with the grounding pin on the plug.

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Warnings and cautions
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!
WARNING: Electrical shock
Do not connect the ECG device to an electrical outlet controlled
by a wall switch or dimmer.
!
WARNING: Electrical shock
To reduce the risk of electrical shock, do not remove the cover (or
back) of the ECG device. Refer servicing to qualified personnel.
!
WARNING: Electrical shock
To reduce the risk of shock, always disconnect the device.from
power before cleaning.
!
WARNING: Potential for electric shock
Cables in a computer network that lead outward from a system
are typically electrically conducting connections. Do not connect
any non-isolated accessories to this device.
!
WARNING! Potential for electric shock
If any matter (gaseous, liquid, or solid matter) enters the ECG
device enclosure, you must clean the device and then have it
inspected by Cardiac Science service personnel.
!
WARNING! Potential for electric shock
To prevent current from a non-medical electronic device
(computer, monitor, printer) from reaching the patient, the
operator must not touch the non-medical device and the patient
at the same time.
!
WARNING! Potential for electric shock
The ECG device was not designed to support USB devices that
connect to a standard wall socket. Do not connect externally
powered USB devices to this equipment.
!
WARNING! Fire, explosion, or contamination
Batteries must be disposed of properly. Dispose of batteries in
accordance with local regulations.

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Product Safety and Setup
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!
Caution: Electrical safety
If not all the electrodes are applied to the patient, place the
electrodes that are not in use in such a way that they cannot come
into contact with a metallic part. Do not touch the electrodes
which have not been applied.
!
Caution: Patient injury
To prevent injury, all system cables including accessories, must be
routed to prevent tripping, roll over, and snagging.
!
Caution: Electrical safety
An inappropriate or defective patient cable can damage the
amplifier circuit and prevent the display of patient reaction. Use
only Cardiac Science-supplied patient cables and check the cables
for damage before each use.
!
Caution: Equipment disposal
Dispose of batteries, cables, accessories, and the ECG device
according to the appropriate federal, state, and local regulations.
Patient cable/ECG electrodes
!
WARNING! Electrical safety.
Misusing the patient cable can cause shock. Use the patient cable
only as directed. Never attempt to connect the patient cable to
any other type of device. Never attempt to connect the patient
cable or lead wires directly to power.
!
WARNING! Patient safety
Route the patient cable to prevent injuries or cable damage. When
attaching the patient cable to the electrodes, minimize the twist
stress on the cable. Route the leads and cables to conform to body
contours. Route the leads and cables to prevent strangulation.
Ensure that no strain is placed on the electrodes. Ensure the cable
does not create a trip hazard.

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Warnings and cautions
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!
WARNING! False readings
The lead status check does not detect lead reversals.
Always ensure the correct lead placement is used for the lead
configuration selected.
!
WARNING! Misdiagnosis
Dirty, compromised, or unprepared skin may cause incorrect
readings.
Before applying electrodes, ensure the skin is clean, unbroken,
and properly prepared.
!
WARNING! Infection
Lead placement on compromised skin may cause infection.
Before applying electrodes, ensure the skin is clean, unbroken and
properly prepared.
!
Caution: Patient skin irritation
When applying electrodes, skin preparation, electrolyte solution,
or electrode material may cause skin irritation. Monitor the
electrode site and, if irritation occurs, use alternative electrolyte or
electrodes.
!
Caution: Patient safety
Disposable electrodes are single use only. Never re-use disposable
electrodes.
!
Caution: Baseline drift
Never mix patient electrode types or brands. Dissimilar metals or
other incompatibilities may cause considerable baseline drift and
may increase trace recovery time after defibrillation.
Defibrillation safety
!
WARNING! Patient cable safety
To ensure defibrillation protection, you must use the Cardiac
Science-approved patient cable. Follow all instructions for the
patient cable.

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Product Safety and Setup
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Using multiple electrical apparatus
!
WARNING! Shock hazard.
If connecting the ECG device to non-medical equipment, use only
non-medical equipment compliant with IEC 60950 or 60601-1.
In addition, the enclosure leakage current of non-medical
equipment connected to the ECG device must not exceed 150μA
in fault condition.
If necessary, use an additional isolating transformer or floating
power supply to maintain a proper enclosure leakage current and
provide additional protection.
!
WARNING! Patient safety.
Non-medical equipment connected to the ECG device must be
outside the patient’s vicinity: 6 feet (1.83 m) beyond the perimeter
of the bed, table, or chair, and 7 1/2 feet (2.29 m) above the floor.
!
WARNING! Misdiagnosis.
Electromagnetic interference may cause trace noise or input
overload conditions. This may be caused by the presence of strong
EMI fields, or generated by RF noise on the line power, or by
electronic, surgical, or diathermy instruments in close proximity to
the ECG device. Position the ECG device away from other electrical
or electronic equipment, if possible.
If used with, or around, other electrical or electronic equipment,
always carefully monitor initial readings to verify normal
operation.
The ECG device is compliant with IEC 60601-1-2 EMC immunity
requirements. Refer to EMC guidelines on page 39.
To prevent excessive patient leakage current ensure all patient
equipment meets certified IEC medical standards.
Note: The ECG device patient leads are electrically isolated from
ground and the device meets IEC medical standards for leakage
current.

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Symbols and labels
13
Symbols and labels
Cardiac Science Corporation products display one or more of
these symbols and warning labels for your protection.
Symbol Description
Attention: Consult accompanying documents
Warning symbol
Caution. Indicates potential equipment damage or minor
injury hazard.
Danger! High voltage.
Hazardous voltage
Equipotentiality (used to label the grounding lug)
Alternating Current (AC)
Direct Current (DC)
Automatic Rhythm
Manual Rhythm
On/Standby

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Product Safety and Setup
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Stop function
Home
Patient menu
Patient directory
Send/Receive menu
Setup menu
Help menu
ECG
Stat ECG
Form feed
Select
Alt key (selects special characters)
Symbol Description

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Symbols and labels
15
Back
Delete
Symbols (Special character key for adding symbols)
Ethernet port
USB port
Indoor, dry location use only
Device or component is certified for the Japanese and/or
Asian markets
Type CF equipment with defibrillation protection
Sold by prescription only
Caution: Federal law restricts this device to sale by or on the
order of a licensed healthcare practitioner
Interference may occur in the vicinity of equipment marked
with this symbol
Date of manufacture
Symbol Description

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Product Safety and Setup
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Manufactured for
This product is listed by CSA International as certified for
both the U.S. and Canadian markets, to the applicable U.S.
and Canadian safety standards
Meets or exceeds Council Directive 93/42/EEC, MDD, Class
IIa
Component is certified for both the U.S. and Canadian
markets, to the applicable U.S. and Canadian safety
standards
Battery symbol
CB Product has passed CB compliance testing.
TUV certification (EU Notified Body) device complies with
medical standard 60601-1
Ground pinout
Disposal Instructions
(Waste Electronic Electrical Equipment (WEEE). Separate
collection for waste electrical and electronic equipment)
Symbol Description
1
3
5
4
2
GND

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System setup
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System setup
External connections
Equipotential ground
The Burdick 8300 electrocardiograph and Burdick 8500
electrocardiograph are considered CLASS II (ungrounded)
equipment.
The exposed metal on the ECG device is not likely to become
energized because all the exposed metal is double insulated from
the internal live circuitry (i.e., will not become energized under
single fault conditions). As a result, it is safer not to connect the
exposed metal to the internal chassis or the functional earth of
the ECG device.
This method of protection is recognized by all national and
international consensus standards and safety agencies. Since the
exposed metal in the ECG device cannot become energized by
any fault of the internal live circuitry and cannot become
energized as a result of differences in the ground potential
(because the exposed metal is not connected to ground via any
Protective Earth conductor), then there is no reason to provide
voltage equalization.
Therefore, the equipotential ground contact is not connected to
the exposed metal.
Input power
!
WARNING! Patient shock.
The ECG device must be used with a medical grade power cord
connected to medical grade AC outlet only. Use only Cardiac
Science-approved power cables and power brick cables.

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Product Safety and Setup
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!
WARNING! Trip hazard.
Route all cables away from main work areas to minimize risk of
tripping and injury.
!
WARNING! Shock hazard
If connecting the ECG device to non-medical equipment, use only
non-medical equipment compliant with IEC 60950 or 60601-1.
In addition, the enclosure leakage current of non-medical
equipment connected to the ECG device must not exceed 150 μA
in fault condition.
If necessary, use an additional isolating transformer or floating
power supply to maintain a proper enclosure leakage current and
provide additional protection.
!
WARNING! Misdiagnosis
Using unshielded or excessively long cables may cause or increase
susceptibility to electromagnetic interference.
Always use the shortest possible shielded cables.
!
Caution: Equipment damage
You must operate the ECG device must be operated only at the
line voltage and frequency specified on the external medical
grade power supply.
Grounding
All connected equipment must be IEC 60950 approved or
equivalent. Consult a qualified technician to verify equipment
compatibility.

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System setup
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Before operating
Before using the ECG device for the first time, you must connect
the ECG device to power and charge the battery. Connecting the
device to AC power charges the battery.
Note: The battery must be charged for six hours before the ECG
device can be operated on battery power alone. To charge the
battery, connect the unit to AC power.
Charge the battery
After the battery is fully charged, you can use the ECG device on
battery power or keep it connected to AC power. Monitor the
power indications to prevent the battery from completely
discharging.
When operating on battery power, press On/Standby to power
off the device between tests.
!
Caution: Data loss.
The battery pack must be installed at all times for proper
operation.
During normal operation, the following power indications are
displayed
Display Description Action
AC Indicates the ECG device is connected
to AC power.
none
Bat Indicates the ECG device is not
connected to AC power and is running
on the battery.
none

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Product Safety and Setup
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Connect to power
The input power cable includes a 3-conductor, medical-grade
power cable.
To connect the ECG device to power:
1. Connect the external power supply (brick cable 010-1684-
00) to the external power connector (see 7, in Figure 1) on
the back of the ECG device.
2. Connect the AC power cable (007082 or 047262) to the
external power supply (brick cable).
3. Connect the AC power cable to a properly grounded,
medical grade wall outlet.
Low Indicates the ECG device is running on
battery power and less than 15 minutes
of operating time remain. The ECG
device also beeps every 30 seconds as
an audible low battery warning.
When Low displays,
immediately connect the ECG
device to AC power to
recharge the battery and
prevent operation
interruption.
Power
down
Indicates the battery no longer has
enough power to maintain normal
operation and shuts off approximately
5 seconds after the message is
displayed.
Connect the ECG device to AC
power to resume operation.
Display Description Action