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70-01047-01 B

Product Safety and Setup

◆

Wall outlet—Check the wall outlet for cracks or other
damage.

◆

Other cables and electrodes—Check all other cables and
electrodes for loose, bent or cracked connectors and cuts,
nicks or fraying of the cords.

Testing

The ECG device performs a self-test at power up. No additional
testing or calibration is necessary.

Check the patient cable

If the patient cable appears damaged in any way (including
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 attach each
electrode lead to an electronic heart signal simulator. (If a
simulator is not available, a test subject may be used.)

◆

Check the signal transmission through the cable by flexing
the cable and electrode lead wires and observing the ECG
rhythm for irregular tracings.

Note:

If using a test subject, be sure not to disturb the

electrode site since common baseline artifact will occur. This
should not be confused as a broken wire.

Содержание Burdick 8300

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

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

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

Страница 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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