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The Connex Spot Monitors are intended to be used by clinicians and medically qualified personnel for monitoring of noninvasive blood pressure, pulse rate, noninvasive functional oxygen saturation of arteriolar hemoglobin (SpO2), and body temperature in normal and axillary modes of neonatal, pediatric, and adult patients. Monitoring respiration rate from photoplethysmogram (Masimo RRp®) is indicated for adult and pediatric patients greater than two years old. The most likely locations for patients to be monitored are general medical or surgical floors and general hospital and alternate care environments. This product is available for sale only upon the order of a physician or licensed health care professional.

Welch Allyn Connex® Spot Monitor (CSM) is an integrated, configurable vital signs monitor. CSM is intended to be used by clinicians and medically qualified personnel for measuring or monitoring patient vital signs. The specific vital sign measurements available are determined by the sensor/processing technology integrated into the base unit including: - · Noninvasive blood pressure (NIBP) provides measurements of noninvasive blood pressure and pulse rate - · Spo2 provides pulse rate, respiration rate, and noninvasive functional oxygen saturation of arteriolar hemoglobin - · Thermometer measures temperature in neonatal, pediatric, and adult patients - · Respiration rate from photoplethysmogram (RRp) - The custom scores option provides custom calculations based on patient vital sign values and modifiers determined by the user The CSM 1.53, in the same manner as the CSM predicate device, can display and transmit patient data that is electronically or manually entered from external and accessory devices, including weight and height data, manually entered respiration rate, barcode scanned patient and clinician data, and other patient or facility information to a connected Host system. Data is transmitted electronically via USB, Wi-Fi, Bluetooth or ethernet communications to electronic record systems, and for remote display and alarming (e.g., at a central station).

The iExaminer system with PanOptic Plus, consisting of PanOptic Plus, SmartClip, iExaminer application, and one of the following: iPhone 11 Pro, iPhone 11 Pro Max, iPhone 12 Pro, is intended to be used to capture images as an aid to clinicians in the evaluation, and documentation of ocular health. The images from the iExaminer System with PanOptic Plus are not intended to be used as a sole means of diagnosis.

The iExaminer System with PanOptic Plus is a medical device that allows the user to capture images through the use of a PanOptic Plus ophthalmoscope and a smart device. The iExaminer System with PanOptic Plus consists of (also see Figure 1): 1. PanOptic Plus Ophthalmoscope: a. Ophthalmoscope Head b. Compatible energy sources (i.e. battery handles or wall units) c. Optional Patient Eyecup 2. Smart device attachment instrument (made of SmartBracket and SmartClip); 3. Compatible smart device (iPhone X, iPhone 11 Pro, iPhone 11 Pro Max, iPhone 12 Pro). 4. iExaminer Pro Software Application. The iExaminer system with PanOptic Plus is intended to take photographs of the eye and surrounding area.

The Connex Central Station is intended to be used by clinicians for the central monitoring of neonatal, pediatric and adult patients in health care facilities. In addition to the central monitoring of patient data and alarms, the Connex software can include optional modules to provide extended recording of patient data, including full disclosure.

Both the Welch Allyn primary predicate and subject Connex Central Station devices are software devices for a Windows-based operating system that provide clinicians with a means to remotely monitor the health of several patients simultaneously.

The Welch Allyn® Diagnostic Cardiology Suite™ is a prescription device intended for use by physicians, other licensed health care practitioners, and trained personnel who are acting on the orders of a physician. Welch Allyn Diagnostic Cardiology Suite is intended for use in medical clinics, physician offices and hospital settings to acquire, analyze, display, transmit and print certain physiological signals identified below and provide the data for consideration by a physician. Welch Allyn Diagnostic Cardiology Suite utilizes a software platform to support 12-lead diagnostic resting ECG and diagnostic Spirometry applications and is designed to operate within the inherent capabilities of an off-the-shelf laptop or PC Windows operating system. Welch Allyn Diagnostic Cardiology Suite also provides functions related to patient data management including communication with electronic medical records systems. Welch Allyn Diagnostic Cardiology Suite Resting ECG's are intended to be taken with the patient in the supine position and offer VERITAS™ resting ECG algorithm to generate measurements and advisory statements for review and interpretation by the physician. Welch Allyn Diagnostic Cardiology Suite is not intended to be used as a physiological vital signs monitor, not intended to be used in a mobile medical environment (e.g. ambulance, helicopter), in magnetic resonance (MR) environments, in operating theaters, nor in conjunction with high frequency surgical equipment. Indications for Welch Allyn Diagnostic Cardiology Suite ECG range from routine screening of cardiac health in the physician office environment to directed diagnostic differentiation in a hospital cardiology department. Welch Allyn Diagnostic Cardiology Suite ECG is indicated for patients of all ages. There are no known contraindications for resting ECG. Welch Allyn Diagnostic Cardiology Suite Spirometry is indicated for pulmonary function testing, providing forced expiratory flow-volume and time measurements. The device is intended to be a general assessment tool assisting the clinician in the diagnosis of pulmonary function. These devices are commonly used on patients with occupational exposure to dust or chemicals; presenting with symptoms such as chronic cough, shortness of breath and wheezing; disorders such as interstitial lung disease, bronchitis, asthma, and COPD; or other patients where the clinician determines these pulmonary function measurements are needed. Welch Allyn Diagnostic Cardiology Suite with Spirometry is indicated for adult and pediatric patients age 6 years and older and should only be used with patients able to understand the instructions for performing the test.

The Welch Allyn Diagnostic Cardiology Suite is a PC-based software device. Section 16 details the software technology including its requirements, architecture, detailed design, development environment, verification and validation and lifecycle management plan. Medical device software development and management is characterized in IEC 62304 Medical device software – Software life cycle processes. The technology of the hardware accessories are: - For diagnostic ECG, the technology involves applying surface electrodes to the patient's skin to obtain signals of the heart's electrical activity. The electrical signals are then amplified, analyzed (VERITAS algorithms) and displayed on Welch Allyn Diagnostic Cardiology Suite ECG module user interface. Clinical Users can evaluate these ECGs, store them, save them or send them via the technological characteristics provided by the Welch Allyn Diagnostic Cardiology Suite. The diagnostic ECG technology is characterized in IEC 60601-2-25 Medical electrical equipment - Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs. The Welch Allyn RScribe K120865 utilizes the same VERITAS algorithms as Welch Allyn Diagnostic Cardiology Suite ECG and therefore is being cited herein as a reference device. - For diagnostic Spirometry, a pneumotach air flow sensor obtains signals of a patient's forced expiratory breathing maneuvers, called "efforts", that are then analyzed against norms contained within Welch Allyn Diagnostic Cardiology Suite Spirometry module. Patient breathing efforts are displayed on the Welch Allyn Diagnostic Cardiology Suite Spirometry user interface. Clinical Users can evaluate these Spirometry efforts, store them, save them or send them via the technological characteristics provided by the Welch Allyn Diagnostic Cardiology Suite. The diagnostic Spirometry technology is characterized in ISO 26782 Anaesthetic and respiratory equipment - Spirometers intended for the measurement of time forced expired volumes in humans and follows ATS 2005 Standardization of Spirometry quidelines.

The Welch Allyn RetinaVue Network is a web-based software system application intended for use in storing, managing, and displaying patient data, diagnostic data, and images from computerized diagnostic instruments. Original and enhanced images can be viewed by trained healthcare professionals.

The RetinaVue Network software enables providers to transfer eye images. 1. Transfer images via the Client or Customer portal to the database for storage and/or to the Over-read (Physician) Portal for interpretation. 2. Allow for the enhancement and interpretation of images and report generation at the Over-read (Physician) Portal. 3. Transfer reports from the Over-read (Physician) Portal to the Customer Portal for download.

The VSM 6000 series of monitors is intended to be used by clinicians and medically qualified personnel for monitoring of neonatal, pediatric, and adult patients for: - noninvasive blood pressure, - pulse rate. - noninvasive functional oxygen saturation of arteriolar hemoglobin (SpO2), and - body temperature in normal and axillary modes. The most likely locations for patients to be monitored are general medical floors, general hospital, and alternate care environments. The optional Masimo Rainbow SET® Pulse CO-Oximeter and accessories are indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, total hemoglobin concentration (SpHb), and/or respiration rate (RRa). The Masimo Rainbow SET® Radical 7R Pulse CO-Oximeter and accessories are indicated for use with adult, pediatric, and neonatal patients during both motion conditions, and for patients who are well or poorly perfused in hospitals and hospital-type facilities. The optional Oridion module and accessories are intended for the continuous non invasive measurement and monitoring of carbon dioxide concentration of the expired and inspired breath and respiration rate. It is intended for use with neonatal, pediatric and adult patients in hospitals and hospital type facilities. The optional Oridion module also provides the clinician with an integrated pulmonary index (IPI). The IPI is based on four parameters provided by the monitor; end tidal carbon dioxide, respiration rate, oxygen saturation and pulse rate. The IPI is a single index of an adult or pentilatory status displayed on a scale of 1 - 10, where 10 indicates optimal pulmonary status. IPI monitoring displays a single value that represents the patient's pulmonary parameters and alerts clinicians to changes in the patient's pulmonary status. The IPI is an adjunct to, and is not intended to replace, vital sign monitoring. Optional compatible weight scales (e.g., Health o meter®) can be used for height, weight, and BMI input. The Welch Allyn Connex® Vital Signs Monitor (CVSM) 6000 Series also contains the Welch Allyn Applications Framework ("Framework"). The Framework is general purpose software that allows medical device and non-medical device software applications to be run on the CVSM independently of, and isolated from, the CVSM's vital signs monitoring functionality. All such applications are intended to be used on the CVSM by trained professionals in a health care setting. The EarlySense (Everon) module is intended for continuous measurement of respiration rate, heart rate and movement. in an automatic contact-less manner, in a hospital or clinic setting. The system is indicated for use in children, adolescents and adults. The operation of the EarlySense has been studied in children (weight > 10 Kg) and adults (weight <11 Kg) during sleep and resting condition. The Welch Allyn ECG/Impedance Respiration module and associated software acquires and analyzes ECG signals from patients. Patients are people with coronary problems, suspected coronary problems, or recent medical procedures that require cardiac monitoring. This ECG module can be used on adult and pediatric patients. The ECG module is indicated for use by healthcare professionals whenever there is aneed to monitor a patient's physiological parameters for the following: · ECG - · ECG with alarms for ventricular tachycardia, ventricular fibrillation, and asystole - · Impedance respiration Handle module assembly (Connex Integrated Wall System 8000 series only - Handle Module) - Handles supply power to Welch Allyn 3.5V instruments. This product is available for sale only upon the order of a physician or licensed health care professional.

The Welch Allyn Connex® Vital Signs Monitor 6000 Series (CVSM) is designed to provide a scalable, modular system of components which can be configured to address the needs for vital signs spot checking and continuous monitoring. The Welch Allyn Connex® Vital Signs Monitor 6000 Series monitor is intended to be used by clinicians and medically qualified personnel for measuring or monitoring patient vital signs. The particular vital sign measurements available are determined by the sensor/processing modules installed into the base unit including; - NIBP Module provides measurements of noninvasive blood pressure and pulse rate, - SpO2 Modules from Nellcor and Masimo provide pulse rate, noninvasive functional oxygen saturation of arteriolar hemoglobin, - The Masimo SpO2 Module can also provide hemoglobin measurements (SpHb, SpHbv) and acoustic ● respiration rate (RRa), - . The SureTemp Temperature Module measures body temperature in normal and axillary modes of neonatal, pediatric, and adult patients. Temperature can also be measured IR ear thermometer. - . The Oridion Capnography Module equipped systems are also capable of carbon dioxide (CO2), respiration rate (RR) and calculation of Integrated Pulmonary Index (IPI) measurements, - The EarlySense Module provide users the option of continuous and contact-less monitoring of respiration rate, heart rate and patient movement. - The Global Instruments module provides 3 -5 lead ECG/Impedance Respiration. The ECG modules is for continuous measurement of respiration rate, heart rate and detection of cardiac standstill (asystole), ventricular tachycardia and ventricular fibrillation of this Global Instruments Module is the subject of this 510(k) The CVSM can also display and transmit patient data that is electronically or manually entered from external and accessory devices, e.g., weight and height data, barcode scanner, IR temperature, and other patient or facility information. Data can be transmitted electronically via USB, wired Ethernet, or wireless communications, including, for example, to electronic record systems and for remote display and alarming (e.g., central station).

The Connex Spot monitors are intended to be used by clinicians and medically qualified personnel for monitoring of noninvasive blood pressure, pulse rate, 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.

The Welch Allyn Connex® Spot Monitor (CSM) is an integrated, configurable monitor designed to facilitate the workflows of its users. The Welch Allyn Connex® Spot Monitor is intended to be used by clinicians and medically qualified personnel for measuring or monitoring patient vital signs. The particular vital sign measurements available are determined by the sensor/processing technology integrated into the base unit including; NIBP, provides measurements of noninvasive blood pressure and pulse rate, SpO2 , provides pulse rate and noninvasive functional oxygen saturation of arteriolar hemoglobin, Thermometer measures temperature, e.g., in neonatal, pediatric, and adult patients. The Custom Scores option provides custom calculations based on patient vital sign values and modifiers determined by the user. The CSM can also display and transmit patient data that is electronically or manually entered from external and accessory devices, e.g., weight and height data, barcode scanner, and other patient or facility information. Data can be transmitted electronically via USB, wired Ethernet, or wireless communications including Bluetooth, for example, to electronic record systems and for remote display and alarming (e.g., central station).

The electrocardiograph is one of the tools that clinicians use to evaluate, diagnose, and monitor patient cardiac function. The 12-lead optional interpretation algorithm provides a computer-generated analysis of potential patient cardiac abnormalities, which must be confirmed by a physician with other relevant clinical information. The Spirometer is a device that measures lung air volume and airflow rate for pulmonary disease diagnosis and screening. These measurements provide information about a patient's pulmonary function which may be compared with normal values or the patient's previous values. The device is designed to test pulmonary function and obtain spirometric indices for: - adult and pediatric patients 12 years and older, - hospital and clinic use only.

The Welch Allyn CP150™ Electrocardiograph with Spirometry Option is an electrocardiograph 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 and it provides an optional interface to a pulmonary function device that allows the user to acquire, view, store, and print measures and waveforms of pulmonary function. Its features include a 7" color touch screen display for ECG and Spirometry preview and user-friendly interface, full-size user-programmable reports, and the ability to operate on either battery or AC power. Communication of ECG and spirometry data with a central data-management system is optional. The CP150™ Electrocardiograph with Spirometry is able to connect via USB cable or via wired ethernet (RJ45 connector) across the ethernet network, which in turn can connect with other electronic patient-information systems, such as billing and medical records. The USB port can also be used to connect other accessory devices. The CP150™ Electrocardiograph is specifically intended for acquiring and printing ECG signals from adults and pediatric patients. It will be used in clinical settings by trained healthcare providers. The optional interpretation algorithm analyzes these ECG signals to generate measurements and interpretive statements. The interpretive results are intended only as guidance for qualified physicians and must not be relied upon as diagnoses. The CP 150™ spirometry option allows the user to acquire, view, store, and print measures and waveforms of pulmonary function including, but not limited to, maximal volume and flow of air that can be moved in and out of a patient's lungs. These measures are used in the diagnosis and monitoring of lung diseases and interventions for the treatment of certain lung diseases. The spirometer should only be used with patients who are able to understand the instructions for performing the test.

The Connex Central Station (CS) is intended to be used by clinicians for the central monitoring of neonatal, pediatric, and adult patients in health care facilities. In addition to the central monitoring of patient data and alarms, the Connex software can include optional modules to provide extended recording of patient data, including full disclosure.

Connex Central Station, also known as Monitoring Station, is a Windows-based product that provides clinicians with a means to remotely monitor the health of several patients simultaneously. The Monitoring Station receives patient vital signs and alarm data from patient monitors and spot check devices over a network, then displays the data and sounds audio alarms in a centralized location.