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510(k) Data Aggregation
K Number
K011339Device Name
QUEST EXERCISE STRESS SYSTEM, MODEL CONFIGURATION 14
Manufacturer
SPACELABS BURDICK, INC.
Date Cleared
2001-08-20
(110 days)
Product Code
DSI
Regulation Number
870.1025Why did this record match?
Applicant Name (Manufacturer) :
SPACELABS BURDICK, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K952417Device Name
QUEST EXERCISE STRESS SYSTEM
Manufacturer
BURDICK, INC.
Date Cleared
1996-05-22
(365 days)
Product Code
DSI
Regulation Number
870.1025Why did this record match?
Applicant Name (Manufacturer) :
BURDICK, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Quest is designed to provide ECG information and data to qualified medical personnel for the purpose of assessing the patient's cardiac response to exercise. It is to be used in hospitals, clinics, or physician offices by a qualified and licensed physician, or by trained staff under the direct supervision of that physician.
Stress-test or exercise electrocardiography is used a) when the diagnosis of coronary artery disease is suspected, b) to determine the physical performance characteristics of a patient, c) for post myocardial infarction assessment, or d) for cardiac rehabilitation. The test involves the recording of the electrocardiogram during dynamic or, occasionally, isometric exercise. The diagnostic value of exercise testing primarily concerns either ST segment depression present in myocardial ischemia, or elevation seen in infarcts (in comparison to P-Q segment as the isoelectic line). In addition it is important to consider the patient's blood pressure response and physical symptoms. Disease assessment is most prominent in, but not limited to, adult patients.
This instrument can also serve as an adult resting interpretive electrocardiograph with the addition of Burdick's resting interpretive program.
This instrument is not intended to interpret any exercise test results but is to be used as an aid for the physician to determine normal or abnormal response of the patient to exercise.
Quest is not intended for long term monitoring of patient ECG signals. Specifically it does not substitute Quest is not intended for folly will and ices recognized by AAMI EC13 especially in the area of alarms.
Device Description
This instrument (QUEST ) is a computerized exercise stress testing system which provides a method for dynamic exercise evaluation performed by the patient who walks on a treadmill in which the speed and elevation can be adjusted (automatically or manually) to suit a variety of graded exercise protocols, or when the patient pedals an electronically braked bicycle ergometer. If the test subject is unable to walk, isometric exercise can be performed using a handheld dynamometer, or by injecting the patient with heart rate stimulants to stress the myocardial system. In each case this instrument is used to present real-time ECG waveforms and calculations to qualified medical personnel while providing automatic or manual control of the exercise equipment. Paper reports are commonly produced.
It contains a viewing screen of sufficient size to accommodate easy reading of important patient and test parameters such as heart rate, test time, ECG waveforms and ST indications. To minimize distractions to the operators and patients during tests, no alarms are used and user-defined prompting encourages timely entry and recording of important test data (such as blood pressure).
Paper test records can be obtained from the thermal recording system incorporated into the design. Formats for the test summaries and data obtained during the test are selectable, enhancing its usage for a variety of test facilities. The ability to produce print records of ECG waveforms during exercise and recovery are continuously made available to the users.
Processing of the incoming ECG signal from the (10) electrode sites results in a real time display, heart rate determination, ST measurement indices and values, ectopic beat detection, pacemaker detection, and optionally, interpretation of the resting ECG signals. Further calculations support exercise such as METS, target heart rate, calories, distance, and protocol timers.
Interfaces are provided to enable connection to Burdick's T600 treadmill, an Ergomed 840 Bike ergometer, standard electronically braked bike ergometers, non-invasive blood pressure equipment, oximetry devices supporting serial communications protocols, and computer communications equipment such as printers, fax/modems and networks. The measurement devices typically return a value to be displayed on-screen and Quest is not involved in making the actual measurements. In addition, analog outputs provide a selection of ECG signals, ergometer speed and grades, and exercise data (heart rate, workload, etc.). A digital QRS pulse output is available as a trigger typically used for echocardiography, nuclear imaging equipment, or pulmonary gas exchange equipment.
The computer system is based on an industry standard computer chip and uses a standard software operating system. Custom circuits are fabricated by Burdick and integrated with standard assemblies purchased from outside suppliers
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K Number
K954267Device Name
BURDICK 200 PULSE OXIMETER
Manufacturer
BURDICK, INC.
Date Cleared
1996-05-03
(234 days)
Product Code
DQA
Regulation Number
870.2700Why did this record match?
Applicant Name (Manufacturer) :
BURDICK, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Burdick 200 Pulse Oximeter provides SpO2, Pulse Rate, and Pulse Strength measurements. It may be used in the hospital or clinical environment, during emergency land or air transport, or for in home use.
The intended patient population is neonates to adults. The oximeter permits patient monitoring with adjustable alarm limits as well as visual and audible alarm signals.
The Oximeter has three modes of operation: Clinician Mode, Home-use Mode, and Sleep Study Mode.
The Clinician Mode aids the health care professional in monitoring patient activity.
The Home Use Mode permits the home-use caregiver to monitor a patient within the home environment.
The Sleep Study Mode allows the health care professional to record sleep study data which may be later transferred to a PC and analyzed.
Device Description
The Burdick 200 is a hand held stand alone Pulse Oximeter designed to detect (SpO2) Oxygen saturation, pulse rate, and pulse strength on any patient from neonates to adults and output the measurements.
The Burdick 200 consists of two units, a hand held pulse oximeter and a table top charger base. Nine probes of various sizes and configurations are available to accommodate the spectrum of body sizes and sites.
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K Number
K946281Device Name
ECLIPSE 4 ELECTROCARDIOGRAPH
Manufacturer
BURDICK, INC.
Date Cleared
1996-04-23
(483 days)
Product Code
LOS
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
BURDICK, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Not Found
Device Description
The Burdick Eclipse 4 performs the same functions and meets the same performance standards as the Marquette MAC PC. This version of the Burdick GRI interpretative program and Marquette s interpretative program used in the MAC PC both provide adult and pediatric resting ECGs on patients ranging in age from birth to 99 years. Both programs analyze 10 seconds of data simultaneously from the 12 standard leads and identify essentially the same set of abnormalities.
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