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The 740 SafeSAT is indicated for use as a bedside, portable device for use by health care professionals, clinicians and medically qualified personnel for spot checking, continuous monitoring of adult and pediatric patients, excluding neonates. The Monitor features technology to facilitate the monitoring of non-invasive blood pressure, pulse rate and functional arterial oxygen saturation (SpO2) in a variety of clinical environments.

The 740 SafeSAT physiological patient monitor is a portable and rugged non-invasive multiparameter device used for spot checking, continuous monitoring, and recording of blood pressure, pulse rate, and functional arterial oxygen saturation (SpO2) in a variety of clinical environments. The 740 SafeSAT monitor employs SafeSAT SpO2 technology which includes components from OSI Optoelectronics. The monitor is compact and lightweight, with a color touch screen for user interface. It supports point-of-care and variable acuity monitoring, including saving spot vital signs and continuous monitoring with alarms. Features include a Standby Mode, Trends Display, screen keyboard for patient data entry, serial data output for EMR connectivity, an internal isolated relay switch for nurse call systems, and support for an optional external thermal strip chart recorder. It measures non-invasive blood pressure (NIBP) using the oscillometric technique and pulse oximetry (SpO2) by measuring the absorption of red and infrared light. Alarm conditions are displayed visually and audibly.

The Zoe Medical Nightingale Monitoring System is indicated for use in adult & pediatric patient populations. The Zoe Medical Nightingale Monitoring System facilitates the monitoring of: - ECG - - Impedance respiration - - Non-Invasive blood pressure - - Invasive blood pressure - - Body temperature " - Functional arterial oxygen saturation (SpO2) - - -End-tidal & inspired CO2 The Zoe Medical Nightingale Monitoring System is a prescription device intended to be used by healthcare professionals in all areas of a healthcare facility.

The Zoe Medical Nightingale Monitoring System (NMS) facilitates the monitoring of patient physiological parameters both at the bedside on the Nightingale PPM3 monitor and remotely on the Nightingale MPC central station. The physiological parameters monitored by the NMS include: ECG. impedance respiration, non-invasive blood pressure, invasive blood pressure, body temperature, functional arterial oxygen saturation (SpO2), and end-tidal & inspired CO2 (capnography). The Nightingale Monitoring System as described in this submission is a new device, and will be marketed as the next generation product superseding the original and previously cleared Zoe Medical NMS (K001775). The part numbers for the four Nightingale PPM3 variants and their associated configurations are given below. 179-0003 NIGHTINGALE PPM3 (with NIBP, SPO2, ECG, and Temp) 179-1000 NIGHTINGALE PPM3 WITH IBP (with NIBP, SPO2, ECG, Temp, & IBP) 179-1001 NIGHTINGALE PPM3 WITH ETCO2 (with NIBP, SPO2, ECG, Temp, & Microstream ETCO2) 179-1002 NIGHTINGALE PPM3 (with NIBP, SPO2, ECG, Temp, IBP, & Microstream ETCO2) The Nightingale MPC central station (171-0001) will be sold as an option available to all customers based on their needs.

The Ultraview DM3 Monitor is indicated for use by health care professionals for monitoring patient vital signs. The Ultraview DM3 Monitor is intended for monitoring, recording, and alarming basic vital signs on adult and pediatric patients. Monitored parameters include SpO2, pulse rate, NIBP, and temperature.

The Ultraview DM3 Monitor is a portable patient monitor intended to be used by clinicians and medical qualified personnel for spot check and continuous monitoring of non-invasive blood pressure (NIBP), pulse oximetry (SpO2), and temperature.

The Well@Home System is indicated for use for patients who need home-based health care from professional clinicians. The system provides benefits for patients who need periodic remote monitoring of their vital signs (such as noninvasive blood pressure, oxygen saturation, pulse rate, temperature, respiration rate, weight, blood glucose level, heart rate, or ECG) or self-reported symptoms, who need reminders to take prescribed medications, or who need training about how to manage their illness.

The Well@Home System consists of the home-based "Well@Home Monitor" and the office-based "Well@Home Clinician Application". Using the Well@Home System, clinicians can monitor theised at home or in another remote health care facility. The use model is "daily checkups", rather them continuous monitoring. The Well@Home Monitor collects vital signs and symptom information on a periodic basis via a patientfriendly user interface. The user interface guides the patient through a schedule of activities using voice promots, instructional diagrams and large, easy-to-read buttons. The scheduled of doutinities can'nclude reminders to take medications or to take vital signs measurements. The schedule for these activities can be customized by the clinician according to the patient's medical condition. The user interface also provides opportunities for the patient to report symbons at any time, and to review training ontent related to managing the patient's illness. The Well@Home monitor measures noninvasive blood pressure, oxygen saturation, pulse rate, temperation | President rate, heart rate, and ECG. The Well@Home Monitor is designed to interface to Other Medical Devices (OMD's) for the purpose of gathering physiological data from those devices. The interface is through the monitor's three OMD serial ports. These serial ports are electrically isoated from each other and from the monitor's own physiological front-end. The list of supported OMD's is as follows: - . Fairbanks Digital Scale (private labeled and device listed as a Zoe Medical accessory) - Lifescan One Touch Ultra Blood Glucose Meter (or compatible BGM from Lifescan) . The OMD interface mechanism is designed to be expandable. Future OMD's may include a Spirometer or a PT/INR measurement device. The Well@Home Monitor transmits the gathered information to a clinician over the patient's existing telephone line. This information is received and stored by the Well(@Home Clinican Application. The Well@Home Clinician Application is essentially a patient data management and record keeping program that includes an interface to the Well@Home Monitor. The Well@Home Clinician Application stores information that is gathered from multiple Well@Home Monitors and allows a clinician to review a given patient's information. It also allows the clinician to make adjustments to a patient's schedule of activities as needed. These adjustments are sent back to the patient's Well@Home Monitor over the same telephone link. The Well@Home Clinician Application software was developed by Patient Care Technologies (PtCT) of Atlanta, Georgia, and is designed to run on standard Windows-based PC's. These PC's are typically installed at the office of a home care agency, and are referred to in this 510(k) as "Agency Servers". The Agency Servers may run other information management software developed by PtCT that is not part of the Well@Home System. The Well@Home System is product-branded to tie into PtCT's information management software product line. Because of the remote-monitoring and spot check nature of the Well@Home System, there are no realtime "alarms" as in a hospital-style monitor. Rather, the clinician defines "alerts" that are to be generated (e.g., when a vital sign parameter exceeds set limits or when a particular symptom is reported). These alerts are part of the information package that is sent from the Well@Home Monitor to the Well@Home Clinician Application. The alerts are then visually highlighted when the clinician reviews the patient's information.