Profile: Fluke Biomedical manufactures biomedical test & simulation products, including electrical safety testers, patient simulators, performance analyzers, and fully-integrated & automated performance testing and documentation systems. Our product 7600 Double Check Pro is a portable, easy-to-use, daily check device for therapy beam quality assurance. Ten ion chambers are positioned to simultaneously check beam constancy, symmetry, flatness, and energy constancy. Nine ion chambers are used for the verification of flatness, symmetry, and dose constancy while a special filtered ion chamber provides energy constancy information. The Double Check Pro consists of a detector array and software for performing linear accelerator quality assurance using physician preferred air ion chamber technology for dose measurement, avoiding the radiation damage issues of diode detectors. Windows® CE based software acquires beam profile data from the detector array. The beam profile is displayed numerically or graphically. Beam profile analysis such as flatness and symmetry is performed and is saved in a database resident on the unit, facilitating daily, weekly, yearly checks, aiding in following the guidelines in TG-40. The data is also available for correlation to TG-51 data.

The company is ISO 9001, CE certified. NYSE:DHR (SEC Filings)

FDA Registration Number: 2921581

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• Adult Blood Pressure Inflation Cuffs

• Anesthetic Infusion Pump (FDA Code: FRN / 880.5725) An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.

• Arrhythmia Simulator

• Bar Code Printer

• Bar Code Readers

• Batteries & Battery Assemblies for Pulse Oximeters

• Blood Pressure Simulator

• Cardiac Monitor (Cardiotachometer and Rate Alarm) (FDA Code: DRT / 870.2300) A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.

• Cassettes & Screens

• Child Blood Pressure Inflation Cuffs

• Computer Softwares

• Defibrillator Testers (FDA Code: DRL / 870.5325) A defibrillator tester is a device that is connected to the output of a defibrillator and is used to measure the energy delivered by the defibrillator into a standard resistive load. Some testers also provide waveform information.

• Differential Gas Pressure Transducer (FDA Code: BYR / 868.2875) A differential pressure transducer is a two-chambered device intended for medical purposes that is often used during pulmonary function testing. It generates an electrical signal for subsequent display or processing that is proportional to the difference in gas pressures in the two chambers.

• Digital Pulse Oximeter

• Disposbale Pulse Oximeter Sensors

• ECG Analyzer

• ECG Simulators

• Electrical Safety Analyzer

• Electrocardiograph (FDA Code: DPS / 870.2340) An electrocardiograph is a device used to process the electrical signal transmitted through two or more electrocardiograph electrodes and to produce a visual display of the electrical signal produced by the heart.

• Electrosurgical Cutting and Coagulation Device (FDA Code: GEI / 878.4400) An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.

• Electrosurgical Unit Analyzer

• ENT Computer Software

• Fetal Pulse Oximeter (FDA Code: MMA)

• Fingertip Pulse Oximeter

• Gas Calibrated Flowmeter (FDA Code: BXY / 868.2350) A gas calibration flowmeter is a device intended for medical purposes that is used to calibrate flowmeters and accurately measure gas flow.

• Gas Flow Transducer (FDA Code: BXP / 868.2885) A gas flow transducer is a device intended for medical purposes that is used to convert gas flow rate into an electrical signal for subsequent display or processing.

• Gas Pressure Transducer (FDA Code: BXO / 868.2900) A gas pressure transducer is a device intended for medical purposes that is used to convert gas pressure into an electrical signal for subsequent display or processing.

• Ground Fault Circuit Interrupter Tester

• Handheld Capnograph with Pulse Oximeter

• Handheld Pulse Oximeter

• Inflation Cuff

• Infusion Pump Analyzer

• Infusion Pump Tester

• Inventory-Control Bar Code Reader

• Isolated Power System Tester

• Leaded Vial Shield (FDA Code: IWW / 892.6500) A personnel protective shield is a device intended for medical purposes to protect the patient, the operator, or other persons from unnecessary exposure to radiation during radiologic procedures by providing an attenuating barrier to radiation. This generic type of device may include articles of clothing, furniture, and movable or stationary structures.

• Light Beam Patient Position Monitor (FDA Code: IWE / 892.5780) A light beam patient position indicator is a device that projects a beam of light (incoherent light or laser) to determine the alignment of the patient with a radiation beam. The beam of light is intended to be used during radiologic procedures to ensure proper positioning of the patient and to monitor alignment of the radiation beam with the patient's anatomy.

• Line Isolation Monitor (FDA Code: DRI / 870.2620) A line isolation monitor is a device used to monitor the electrical leakage current from a power supply electrically isolated from the commercial power supply received from a utility company.

• Medical Charged-Particle Radiotherapy Unit (FDA Code: LHN / 892.5050) A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.

• Medical Linear Accelerator (FDA Code: IYE / 892.5050)

• Miniaturized Optical Pulse Oximeter Tester

• Movable X-Ray Control Panel Barrier (FDA Code: IWX / 892.6500)

• Non-Invasive Blood Pressure Simulator

• Non-Invasive Blood-Pressure Measurement System (FDA Code: DXN / 870.1130) A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.

• Non-Powered Flotation Therapy Mattress (FDA Code: IKY / 880.5150) A nonpowered flotation therapy mattress is a mattress intended for medical purposes which contains air, fluid, or other materials that have the functionally equivalent effect of supporting a patient and avoiding excess pressure on local body areas. The device is intended to treat or prevent decubitus ulcers (bed sores).

• Nuclear Flood Source Phantom (FDA Code: IYQ / 892.1380) A nuclear flood source phantom is a device that consists of a radiolucent container filled with a uniformly distributed solution of a desired radionuclide. It is intended to calibrate a medical gamma camera-collimator system for uniformity of response.

• Nursing Computer Software

• Operator Radiation Protector Leaded Screen (FDA Code: EAK / 892.6500)

• Oscillometric Non-invasive Blood Pressure Simulator

• Oximeters (FDA Code: DQA / 870.2700) An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.