Cardiac Science Burdick 8300 Product Safety Manual Download Page 1

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Product Safety and Setup

70-01047-01 B

This booklet contains important safety and care information.

Contents

◆

Contact information

◆

Intended use

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Inspection at delivery

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Warnings and cautions

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Symbols and labels

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System setup

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Maintenance

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Technical specifications

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EMC guidelines

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.

Summary of Contents for Burdick 8300

Page 1: ...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 B...

Page 2: ...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...

Page 3: ...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...

Page 4: ...ipment 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...

Page 5: ...l 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 to...

Page 6: ...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...

Page 7: ...tor 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 d...

Page 8: ...ange 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...

Page 9: ...ed 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...

Page 10: ...es 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 e...

Page 11: ...ion 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 alter...

Page 12: ...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 generate...

Page 13: ...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...

Page 14: ...7 01 B Product Safety and Setup 14 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 Desc...

Page 15: ...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...

Page 16: ...EC 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 certifi...

Page 17: ...e 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 th...

Page 18: ...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...

Page 19: ...ttery 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 b...

Page 20: ...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...

Page 21: ...external power supply here Note The ECG device does not have an AC power switch To shut off AC power unplug the ECG device from the AC outlet a The ECG device conforms to all safety and essential per...

Page 22: ...p 3 Use the arrow keys Next and Previous to scroll to Date and press Select If the date is correct press Next If the date is incorrect press Select and use the keyboard to enter the correct date and p...

Page 23: ...connector on the cable is arrow side up then firmly push the connector until the arrow point is aligned with the edge of the ECG device For proper patient preparation skin preparation and electrode pl...

Page 24: ...ion press On Standby Note The internal battery charges in Standby mode Power off To power off the ECG device completely disconnect the AC power cord and then press On Standby The automatic power down...

Page 25: ...m of each sheet when the paper is low Caution Possible data loss Loading paper can create a static charge that causes the ECG device to delete unsaved ECG data If paper runs out while acquiring an ECG...

Page 26: ...The door pivots down when fully opened DO NOT ATTEMPT TO REMOVE THE DOOR FROM THE UNIT 2 Place a stack of paper in the compartment so that the black queue mark on the lower left corner of the paper is...

Page 27: ...rallel to the device Note Pushing on the slanted surface near the paper door guides puts the door in the appropriate position 5 Before snapping the door into place pull the paper out so it covers the...

Page 28: ...the same configuration or to restore settings Caution Possible data corruption This procedure requires access to the Service functions menu The Service functions menu is intended for qualified Service...

Page 29: ...ted to the ECG device 2 Press Setup 3 Scroll to the Import Export menu 4 Select Import from USB The system prompts you to enter the name of the file 5 Enter the name of the system settings file The de...

Page 30: ...trodes in any type of fluid If the ECG device is immersed in or comes in contact with large quantities of fluid immediately discontinue use and contact a qualified service technician Caution Equipment...

Page 31: ...ECG device If the ECG device appears damaged immediately discontinue use and contact a qualified service technician WARNING Misdiagnosis Operating a damaged ECG device or using worn or damaged cables...

Page 32: ...ing nicks cuts bulging or fraying contact your local representative for replacement Visually inspect the cable for cracks stress marks and broken or bent pins Connect the patient cable to the ECG and...

Page 33: ...nnually by a qualified service technician The testing must include a 1 mV calibration pulse test to verify the gain hardware is properly calibrated As needed Perform these functions as necessary To Do...

Page 34: ...rd 8500 150 records standard optional upgrade to 300 Input Power AC Operation 100 240 VAC 10 50 60 Hz 3 Hz Battery duration In manual mode at 25 mm s 8300 200 pages or 35 minutes continuous printing 8...

Page 35: ...9 Code 39 Full ASCII Tir optic Code 39 GS1 DataBar formerly RSS variants GS1 128 formerly UCC EAN 128 Code 128 Code 128 Full ASCII Interleaved 2 of 5 Discrete 2 of 5 Code 93 2 D PDF 417 microPDF417 Da...

Page 36: ...rds Electrode offset tolerance 300 mV Sampling 8000 Samples Sec 2 5 V LSB Burst acquisition 100 S Artifact filter response 40 Hz 3db Storage 500 samples second 2 5 V LSB Pacemaker display capability M...

Page 37: ...condensing Storage atmospheric pressure 1060 hPa to 190 hPa 500 ft to 40 000 ft reference to sea level Harmful Ingress of Water Normal Standards Conforms to Regulations 21 CFR Subchapter H Title 21 F...

Page 38: ...ety Collateral Standard Electromagnetic Compatibility Requirements and Tests ANSI AAMI EC53 ECG cables and leadwires EN 60601 2 51 Particular requirements for safety includingessential performance of...

Page 39: ...l precautions regarding EMC and needs to be installed an put into service according to the EMC information provided in this document Portable and mobile RF communications equipment can affect the Burd...

Page 40: ...re are no accessories other than the cables listed in Table 1 applicable to EMC compliance for the Burdick 8300 8500 Table 1 List of cables for Burdick 8300 8500 cables EMC Compliance Cable descriptio...

Page 41: ...e its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF emissions CISPR 11 Class B The Burdick 8300 8500 is suitable for use in all establishment...

Page 42: ...should be that of a typical commercial or hospital environment Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 5 UT 95 dip in UT for 0 5 cycle 40 UT...

Page 43: ...tts W according to the transmitter manufacturer and d is the recommended separation distance in metres m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey a sh...

Page 44: ...strength in the location in which the Burdick 8300 8500 is used exceeds the applicable RF compliance level above then the Burdick 8300 8500 should be observed to verify normal operation If abnormal pe...

Page 45: ...ed maximum output power of transmitter W Separation distance according to frequency of transmitter 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 73 1 1 2 1...

Page 46: ...70 01047 01 B Product Safety and Setup 46...

Page 47: ...70 01047 01 B EMC guidelines 47...

Page 48: ...500 Fax 45 4438 0501 international cardiacscience com United Kingdom The Manse 39 Northenden Road Sale Manchester M33 2DH United Kingdom 44 161 926 0000 uk cardiacscience com France Parc de la Duranne...

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