Search Results

The Acuity® Central Monitoring System, in all configurations including the hardwired and wireless Acuity LT and Mobile Acuity LT System configurations, is intended to be used by clinicians for the central monitoring of neonatal, pediatric and adult patients in healthcare facilities. In addition to the central monitoring of patient data, waveforms, and alarms and alerts, Acuity System software can include optional modules to provide extended recording and analysis of patient data. Acuity System software can include the following optional modules: - . The Full Disclosure module stores patient data for up to 96 hours (24 hours with Acuity LT and . Mobile Acuity LT). - . The Arrhythmia Analysis module provides real-time monitoring and alarms for specific changes in cardiac rhythms. The clinician is responsible for determining the clinical significance of each detected arrhythmia event or alarm. The Arrhythmia Analysis module is not intended for use with neonatal patients. - . The ST Analysis module provides real-time monitoring and alarms for ST segment deviations for patients with suspected heart disease and anomalies. The clinician is responsible for determining the clinical significance of each selected ST segment deviation or alarm. The ST Analysis option is not intended for use with neonatal patients. - . The Welch Allyn Connectivity Server (WACS) module consists of a server platform on which one or more of the following software options are installed: Link To Acuity (Acuity System patient information delivered to mobile devices running Clinician Notifier software), Web Server (Acuty System patient printout files available on Web browsers) and HL7 options.

The Acuity® Central Monitoring System, in all configurations including the hardwired and wireless Acuity LT and Mobile Acuity LT System configurations, is intended to be used by clinicians for the central monitoring of neonatal, pediatric and adult patients in healthcare facilities. In addition to the central monitoring of patient data, waveforms, and alarms and alerts, Acuity System software can include optional modules to provide extended recording and analysis of patient data. Acuity System software can include the following optional modules: - The Full Disclosure module stores patient data for up to 96 hours (24 hours with Acuity LT and . Mobile Acuity LT). - . The Arrhythmia Analysis module provides real-time monitoring and alarms for specific changes in cardiac rhythms. The clinician is responsible for determining the clinical significance of each detected arrhythmia event or alarm. The Arrhythmia Analysis module is not intended for use with neonatal patients. - . The ST Analysis module provides real-time monitoring and alarms for ST segment deviations for patients with suspected heart disease and anomalies. The clinician is responsible for determining the clinical significance of each selected ST segment deviation or alarm. The ST Analysis option is not intended for use with neonatal patients. - . The Welch Allyn Connectivity Server (WACS) module consists of a server platform on which one or more of the following software options are installed: Link To Acuity (Acuity System patient information delivered to mobile devices running Clinician Notifier software), Web Server (Acuty System patient printout files available on Web browsers) and HL7 options. The Link To Acuity option is Welch Allyn's mobile alarm management solution. It consists of Clinician Notifier software for non-proprietary mobile devices and administrative software for the Welch Allyn Connectivity Server (WACS). Mobile devices running the Clinician Notifier software deliver patient alarm information and real-time waveforms gathered from patient monitors connected to the Acuity Central Monitoring System. The devices are not intended for use as primary alarm notification devices. Devices running Clinician Notifier software are not directly connected to patients. The Link To Acuity option is designed to extend the patient monitoring functions of the Acuity Central Monitoring System. The software enables administrators to track the status of clinician-patient assignments, and it enables clinicians to track, respond to and view Acuity System patient alarms, view historical alarm details and waveforms, and view real-time patient waveforms. The mobile devices can be used for barcode scanning to enter patient ID and room number. The Link To Acuity option is to be used by authorized health care professionals using standard institutional procedures and good clinical practice guidelines for patient monitoring. Staff training in the operation of the Link To Acuity option is essential for optimal use. Users should be skilled at the level of a technician, nurse, physician, health care provider or medical specialist, with the knowledge and experience to acquire and interpret patients' vital signs data. Individuals using the Link To Acuity option should be familiar with its operation as described in the directions for use manual, and they should understand all warnings and cautions in the directions for use manual.

The VSM series of monitors is intended to be used by clinicians and medically qualified personnel for monitoring of noninvasive blood pressure, pulse rate, body temperature, noninvasive functional oxygen saturation of arteriolar hemoglobin (SpO2), and body temperature in normal and axillary modes of neonatal, pediatric and adult patients. The most likely locations for patients to be monitored are general medical and surgical floors, general hospital and alternate care environments. This device is available for sale only upon the order of a physician or licensed health care professional.

The VSM, Vital Signs Monitor, Model 53000 Series, (VSM 300) provides real time monitoring and display of noninvasive blood pressure (NIBP), pulse rate, body temperature and nominvasive oxygen saturation of arteriolar hemoglobin (SpO2). - NIBP - Noninvasive Blood Pressure is intended to noninvasively measure systolic, diastolic and mean arterial pressures (MAP). - Temperature -- Intermittent thermometer takes patient temperature in oral, axillary or rectal mode. - SpO2 - Pulse Oximetry channel is intended to noninvasively measure oxygen saturation of arteriolar hemoglobin at a peripheral measurement site. The subject device is a modified version of the Model 53000 Series vital signs monitor, which was cleared for marketing under 510(k) K031740. The Model 53000 Series vital signs monitor has been changed to incorporate a modified NIBP module. The modified and existing NIBP modules are similar in their basic functionality. The modified NIBP module contains an updated safety processor, which replaces a discontinued safety processor. Both safety processors belong to the same microcontroller family. The modified NIBP module also incorporates other minor software and hardware changes, including the addition of a Resistor-Capacitor network to reduce sensitivity to external vibration. The modified Vital Signs Monitor, Model 53000 Series (VSM 300) monitor communicates to the user the same basic information as the Model 53000 Series vital signs monitor, specifically: - Saturation, - Pulse rate, - Pleth waveform, - Trigger waveform for audible beep, and - Status information (e.g., sensor type, board integrity). In addition, the user display of the above information (e.g., saturation, pulse rate, error codes) remains unchanged.

The Propaq LT 802 series monitors are highly portable devices intended to be used by clinicians and medically qualified personnel for single or multi-parameter vital signs monitoring of ambulatory and non-ambulatory neonate, pediatric and adult patients. These monitors are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by this device are hospital general medical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services and other healthcare applications. The monitors may be used as standalone devices or as devices networked to an Acuity " central station through wireless communication over Welch Allyn's FlexNet™ network. This device is available for sale only upon the order of a physician or licensed health care professional.

The Propaq LT 802 Series of monitors are small, lightweight patient monitoring devices intended to be used by clinicians and medically qualified personnel for monitoring of noninvasive Interious bo adou by cirite, ECG, noninvasive functional oxygen saturation of arteriolar hemoglobin (SpO2) in ambulatory, non-ambulatory and transport environments

The VSM series of monitors are intended to be used by clinicians and medically qualified personnel for monitoring of noninvasive blood pressure, pulse rate, body temperature. noninvasive functional oxygen saturation of arteriolar hemoglobin (SpO2), and body temperature in normal and axillary modes of neonatal, pediatric and adult patients. The most likely locations for patients to be monitored are general med/surg, floors, general hospital and alternate care environments. This device is available for sale only upon the order of a physician or licensed health care professional.

The model 53000 Series of monitors are intended to be used by clinicians and medically qualified personnel for monitoring of noninvasive blood pressure, pulse rate, body temperature, noninvasive functional oxygen saturation of arteriolar hemoglobin (SpOz), and body temperature in normal and axillary modes of neonatal, pediatric and adult patients. The most likely locations for patients to be monitored are general med/surg. floors, general hospital and alternate care environments. This device is available for sale only upon the order of a physician or licensed health care professional.

The Acuity system is intended to be used by skilled clinicians for the central monitoring of neonatal, pediatric, and adult patients in health care facilities. The Acuity system consists of the Acuity® Central Monitoring Station. Acuity software, FlexNet™ communications network and Welch Allyn vital signs monitors. The vital signs monitors can operate standalone (according to their individual Intended Use Statement) or be networked to the Acuity central monitoring station through the Acuity FlexNet communication network. In addition to the central monitoring of patient data, waveforms, alarms and alerts, the Acuity software can include optional modules to provide extended recording of patient data (Full Disclosure), arrhythmia monitoring and ST analysis. - . Full Disclosure stores patient data for up to 96 hours. - Arrhythmia monitoring module provides real-time monitoring and alarms for specific . changes in cardiac rhythms. The clinician is responsible for determining the clinical significance of each detected arrhythmia event or alarm. The arrhythmia module is not intended for use with neonatal patients. - ST analysis module provides real-time monitoring and alarms for ST segment deviations, . from a reference beat, for patients with suspected heart disease and anomalies. The clinician is responsible for determining the clinical significance of each detected ST segment deviation or alarm. The ST analysis module is not intended for use with neonatal patients. The most likely locations for patients monitored by an Acuity system are step-down units, telemetry departments, general med/surg floors and emergency departments. The Acuity system is available for sale only upon the order of a physician or licensed health care professional.

The Acuity system comprises four components: the Acuity Central Monitoring Station, Acuity software, the FlexNet™ communications network, and Welch Allyn vital signs monitors. The Acuity Central Monitoring Station is the heart of the system, using hardware provided by Sun Microsystems, Inc. The Acaity Central Monitation Station, Shippetwork devices on the FlexNet Betweek uring hardwired Ethernet connections (IEEE 802.3-compliant) or wireless Ethernet connections (IEEE 802.11compliant). The Acuity software operating system is Solaris™, the Unix®-based operating system from Sun Microsystems. Welch Allyn Protocol's application software provides the routines and services required to accomplish the tasks associated with central patient monitoring. These tasks include the user interface, communication with patient monitors, management of alarms and settings, and recording and review of patient data. The Archythmia Analysis and ST Analysis options are being replaced with Mortara Instrument's arrhythmia algorithm software module. Mortara Instrument's arrhythmia software will now provide the data analysis for both the Arrhythmia Analysis and the ST Analysis options. The Acuity application software receives the output from the Mortara software module and records the results in the same manner as the previous version of Acuity software. There are only a few minor changes to the user interface as described in the Acuity Directions For Use. The Acuity hardware and software operating system are not changed.

The Micropaq monitor is intended to be used by clinicians for single or multiparameter vital signs montoring of ambulatory and non-ambulatory pediatric and adult patients in health care facilities. It is also intended for patient transport. Micropaq is intended to operate with an Acuity® central station through wireless communication over Welch Allyn Protocol's FlexNet™ network. FlexNet connects multiple devices through hardwired Ethernet networks and Wireless Local Area Networks (WLANs) to an Acuity® central station. If the Micropaq is moved out of range or loses communication with the FlexNet network, it continues to monitor the patient, display patient data, and generate local patient alarms or alert messages. The ECG channel is intended for five-lead ECG monitoring. The Pulse Oximetry channel is intended for continuous noninvasive monitoring of functional oxygen saturation of arteriolar hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor). The most likely locations for patients monitored by this device are step-down units, telemetry departments, general med/surg floors, emergency departments, and in-hospital transport. This device is available for sale only upon the order of a physician or licensed health care professional.

The Micropaq is a patient wearable device that provides real time monitoring and display of ECG and SpO2. The Micropaq is powered by a rechargeable battery and has a liquid crystal display (LCD) that displays both waveforms and numerics. The Micropag communicates with Welch Allyn Protocol's Acuity® central station through a wireless local area network (WLAN) operating in the ISM 2.4 GHz band. The communication link is bi-directional, providing monitoring at the Acuity central station and remote control of the Micropaq from the Acuity central station.

The Propaq 200 Series monitors are intended to be used by skilled clinicians for multiparameter vital signs monitoring of neonatal, pediatric, and adult patients in health care facility bedside applications; as well as for intrafacility and interfacility transport.

The Propaq 200 Series monitors are small, light weight, portable, multi-parameter patient monitors equipped with either a monochrome or color display. The monitors provide real time monitoring and display of ECG, respiration, invasive blood pressure, noninvasive blood pressure, temperature, CO2 and SpO22. Rechargeable batteries power the monitors. The Propaq 200 Series monitors can communicate with Welch Allyn Protocol's Acuity® central station through a local area network. The communication link is bi-directional, ventral station and one a louity central station and remote control of the Propaq from the Acuity central station.