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The Heartstream XLT Defibrillator/Monitor is to be used for the termination of ventricular tachycardia and ventricular fibrillation. This device is for use by emergency personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac life support, defibrillation, or other physician-authorized emergency medical response. It must be used by or on the order of a physician. The SMART Biphasic waveform utilized in the Heartstream XLT Defibrillator/Monitor has undergone clinical testing in adults. These trials support the waveform's effectiveness for defibrillation of ventricular tachyarrhythmias at 150J. In the manual mode operation, the Heartstream XLT Defibrillator/Monitor incorporates some user selectable lower energy levels that were not used in the clinical trials. AED Therapy: To be used in the presence of a suspected cardiac arrest on patients that are unresponsive, not breathing and pulseless. Pacing: Noninvasive pacing is one method of treating patients with symptomatic bradycardia. It can also be helpful in patients with asystole, if performed early. SpO2 Monitoring: SpO2 monitoring is indicated for use when it is beneficial to assess a patient's oxygen saturation level.

The Heartstream XLT Defibrillator/Monitor has two modes of operation: AED and manual. Non-invasive external pacing, as well as SpO2 and 3/5-wire ECG monitoring are also available. The Heartstream XLT defibrillator uses the Heartstream SMART biphasic waveform for defibrillation, the same waveform utilized in the Heartstream ForeRunner AED. ECG data and events can be stored on a Data Card by the Heartstream XLT for Jater downloading and reporting with the Heartstream CodeRunner data management system.

The M2376A Device Link System is indicated for use in data collection and clinical information management either connected directly or through networks with independent bedside devices. The M2376A is not intended for monitoring purpose, nor is the M2376A intended to control any of the clinical devices (independent bedside devices / information systems) it is connected to.

The Hewlett Packard M2376A Device Link System receives digital data produced by external devices through device specific cables, converts that data into the HL7 format and transmits that information to any networked Clinical Information System.

Intended Use: The Model 3810A is intended to be used upon prescription of a licensed physician or authorized healthcare provider by patients as a means to automatically collect and transmit medical information, such as weight, blood pressure and non-diagnostic ECG, over normal residential telephone lines, between a patient, typically at home, and a health care professional at the authorized provider. Indications for Use: The Model 3810A is indicated for patients at home, who are capable and willing self-administrate this device, upon prescription of their healthcare provider, to collect and transmit medical information such as weight, blood pressure (including pulse rate) and non-diagnostic ECG rhythm strip to the healthcare provider at another location. The patient takes these measurements, typically once per day, and the information is transmitted automatically via normal telephone lines to the healthcare provider. The device may be used for the management of congestive heart failure, hypertension, ischemic heart disease, weight management, cardiovascular risk management, post cardiovascular surgery, post myocardial infarction and other post cardiac events. The device does not send any real-time alarms. Clinical judgement and experience are required to check and interpret the information delivered.

The Hewlett-Packard (HP) Model 3810A telemedicine device provides a system for daily collection of weight, blood pressure and ECG used in the management of home care patients. The main flow of information originates in the home where a patient uses a blood pressure unit, a scale and an ECG rhythm recorder on a daily schedule. Each of the units automatically reports their data wirelessly to a home Hub, which in turn relays the data using a standard modem over the telephone to a secure database. Health care professionals (such as physicians, nurses, and case managers) having approval for access use a secure log-on procedure to gain access to their patient's data. The provider follows up on any unexpected or undesired changes in the patient's data trends with a phone call. The home Hub incorporates a receiver, an embedded processor with memory, a standard modem and an automatic dial up module. It is designed so that its operation does not interfere with normal use of the phone including an answering machine. Its connections are identical to those of an answering machine, consisting of a standard wall power plug and a daisy chain phone connection. The installation and use of the home Hub poses no significant risk to the patient or other people within the patient's home. The data forwarded through the home Hub arrives though a standard modem contained in the HP system server. This server is separate from the Telemedicine PC in the clinic and is programmed to decode the data from the home units. The system design provides for data security.

The Hewlett Packard External Pediatic electrodes are indicated for use in external Pacing, Defibrillation and Monitoring applications as a non-sterile, disposable device pediatric patient use, only. The M3503A & M3504A electrodes provide the conductive interface between the defibrillator and/or the external transcutaneous (noninvasive) cardiac pacemaker and the pediatric patients skin. The electrode is intended for use on pediatric patients. When a patient requires defibrillation, cardioversion or external pacing, these electrodes will be applied to the pediatic pationt and connected to the instrument. This device is intended for use on defibrillators whose output is classified as low power (360 Joule maximum.) The M3503A & M3504A Pediatric electrodes are designed for, and to be used, with the the Hewlett Packard Codemaster Defibrillator.

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The device is intended to provide ambulatory and bedside monitoring of ECG and SpO2 parameters of adult and pediatric patients in a professional healthcare facility. It is intended to be used by trained health care personnel. It is not intended for home use. The indications for use of the Viridia Telemetry System are: - Condition: The licensed clinician decides that the Viridia Telemetry System should be used to monitor the patient. - Prescription vs. Over-the-Counter: The HP Viridia Telemetry System is a prescription device. - Part of body or type of tissue interacted with: The ECG signal is obtained from accessory electrodes in contact with the patient's skin. The SpO2 signal is obtained from an accessory sensor in contact with the patient's skin. - Frequency of use: As prescribed by a licensed physician. - Physiological purpose: To monitor the ECG or SpO2 of patients on the order of a licensed clinician. - Patient Population: Adult and pediatric patients.

The HP M2600A Viridia Telemetry System is a radio frequency physiological signal transmitter and receiver. The modification in this submission is the addition of a battery extender to enable the operation of the transmitter from an external power source.

Indications: For central monitoring of multiple adult, pediatric, and neonatal patients. For monitoring cardiac arrhythmia of adult patients to gain information for addition of treatment, or to exclude causes of symptoms. For monitoring ST Segment of adult patients to gain information for addition of treatment, or to exclude causes of symptoms.

The modification is primarily a software based change that expands Remote Services Access capability to allow on-line troubleshooting while in the monitoring mode, and enhances both standalone and networking capabilities. Also, improvements were made to upgrade the hardware and operating system environments.

The HP M2331A CareVue 9000 is a clinical information system intended for use in data collection, storage, and management with independent bedside devices, and ancillary systems that are connected either directly or through networks. It is indicated for use by health care providers whenever there is a need for generation of a patient record and computation of drug dosage.

The Hewlett-Packard M2331A CareVue 9000 Clinical Information Management System. The modification is primarily a software based change that expands access to more information data bases. Also, improvements were made to upgrade the hardware and operating system environments.

The Hewlett Packard External electrodes are indicated for use in external Pacing, Defibrillation and Monitoring applications as a non-sterile, disposable, single patient use, only. The M3501A & M3502A electrodes provide the conductive interface between and the defibrillator and/or the external pacing instrument. This device is intended for use on adult patients. When a patient requires defibrillation, cardioversion or external pacing, these electrodes will be applied to the patient and connected to the instrument. This device is intended for use on defibrillators whose classified as low power (360 Joule maximum.)

Multifunction Adult Defib. Electrodes Model Numbers M3501A/M3502A

The HP M2376A Device Link System is indicated for use in data collection and clinical information management, either connected directly or through networks, with the independent bedside devices that are listed below; - 1) IMED 1310 (PC-1) channel IV Pump - 2) In-line Diagnostic HR Crit-Line Monitor - 3) Newport Wave Ventilator

The Hewlett Packard M2376A DeviceLink System receives digital data frontuced by external devices through device specific cables, converts that data into the HL7 format and transmits that information to any networked Clinical Information System. When connected to a bedside device, the HP M2376A DeviceLink System is intended for electronic data collection and clinical Information management. DeviceLink is neither patient connected, nor does it remotely control the attached source device.

Diagnostic Ultrasound Imaging and Doppler Analysis of the human body as follows: Musculo-skeletal Conventional, Musculo-skeletal Superficial, Small Parts (small organ), Peripheral Vascular. Diagnostic Ultrasound System: Fetal, Abdominal, Pediatric, Small Parts I (small organ), Neonatal Cephalic, Adult Cephalic, Cardiac, Transesophageal, Transrectal, Transvaginal, Peripheral Vascular, Musculo-skeletal Conventional, Musculo-skeletal Superficial.

This premarket notification describes modifications to the ImagePoint M2410A system. It adds two new intended uses to the operating platform covering Musculo-Skeletal and Adult Cephalic (Transcranial Doppler) imaging. It adds harmonic imaging mode for the following applications: fetal, abdominal, pediatric, adult cephalic and cardiac. Hewlett-Packard considers Harmonic imaging to be a subset of 2D / B-mode imaging. This premarket notification also adds a transducer with new patient contact materials indicated for musculo-skeletal, vascular and small parts imaging. The classification names for these devices are: Diagnostic Oltrasound Transducer, Ultrasonic Pulsed Echo Imaging System and Ultrasonic Pulsed Doppler Imaging System. The modification involves expanded intended uses to the M2410A system, as well as, the addition of a new transducer with new patient contact materials, to be known as the HP 21376A Transducer. The ImagePoint system, with new platform modes, new indications for use, and new transcucer, functions in the same way as its predicate devices, the M2410A K954028), M2424A (K964309 and K980687) and the Acuson Aspen System, with L7 probe, (K973079) by allowing ultrasound imaging of the humar anatomy. The subject platform and transqucer have the same functionality and intended uses as their bredicates. The M2410A platform and HP 21376A transducer on the M2410A are similar to the predicate devices in all respects except the transducer has new patient contact materials. This 510(k) Notification includes biocompatibility test results that demonstrate biocompatibility of the new materia s.