Burdick 8300 and 8500 ECG Product Safe Setup Rev B

Product Safety and Setup

Contact information Cardiac Science provides customer service and technical support. ◆

To order additional product or accessories, contact Customer Care.

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For assistance with the product or installation, contact Technical Support.

Customer Care 800.426. 0337 (U.S.A.) 425.402.2000 (U.S.A.) [email protected]

Technical Support 800.426.0337 (U.S.A.) 425.402.2000 (U.S.A.) [email protected] http://websupport.cardiacscience.com/webchat/

Outside the United States, contact International Operations or your local representative. International Operations Kirke Vaerloesevej 14 Vaerloese, Denmark DK3500 45.4438.0500

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Intended use

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, preexcitation 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.

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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

Inspection at delivery Please inspect the electrocardiograph (ECG device) for any shipping damage.

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If the ECG device was damaged during shipment, contact your shipping agent.

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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

Warnings and cautions Safety alert descriptions These safety statements may be used in this manual:

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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.

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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

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.

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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 explosionendangered, 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

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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.

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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

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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

Using multiple electrical apparatus

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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.

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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

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

Symbol

Description 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)

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Symbols and labels

Symbol

Description 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

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Product Safety and Setup

Symbol

Description 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 3

1 5

4 2 GND

Disposal Instructions (Waste Electronic Electrical Equipment (WEEE). Separate collection for waste electrical and electronic equipment)

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System setup

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

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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.

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WARNING! Misdiagnosis Using unshielded or excessively long cables may cause or increase susceptibility to electromagnetic interference. Always use the shortest possible shielded cables.

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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

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.

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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

Display Description

Action

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.

Connect to power The input power cable includes a 3-conductor, medical-grade power cable. To connect the ECG device to power:

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Connect the external power supply (brick cable 010-168400) to the external power connector (see 7, in Figure 1) on the back of the ECG device.

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Connect the AC power cable (007082 or 047262) to the external power supply (brick cable).

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Connect the AC power cable to a properly grounded, medical grade wall outlet.

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