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The BD Alaris Infusion System with Guardrails Suite MX is a modular infusion pump and monitoring system for the continuous or intermittent administration of fluids to adult, pediatric, and neonatal patients through clinically accepted routes of administration: intravenous (IV), intra-arterial (IA), subcutaneous, epidural, or irrigation of fluid spaces. See Pediatric*, Neonate**, and Adult Patient Population Tables 2 and 3 for the module-specific variations. Administered fluids include pharmaceutical drugs, red blood cells, and other blood components (platelets and fresh frozen plasma) as required for patient therapy. The BD Alaris Infusion System with Guardrails Suite MX is an interoperable system capable of communicating and exchanging data with compatible information technology systems. The BD Alaris Infusion System with Guardrails Suite MX includes the PC Unit (PCU) and one or more of the following: Pump Module, Syringe Module, end-tidal CO2 (EtCO2) Module, Auto-ID Module, Patient-Controlled Analgesia (PCA) Module, and associated software applications. EtCO2 Module is a capnograph that continuously monitors end-tidal carbon dioxide (EtCO2), fractional inspired carbon dioxide (FiCO2), and respiratory rate (RR). BD Alaris Pump Module and Syringe Module and the Alaris PCA Module are indicated for varying patient populations, routes of administration, and infusates.

The BD Alaris Infusion System with Guardrails Suite MX is a modular infusion and monitoring system designed to provide controlled delivery of drugs and fluids, and to provide monitoring of respiratory parameters. The BD Alaris Infusion System with Guardrails Suite MX has three (3) major components: 1. **System Hardware:** A core hardware unit with user interface (BD Alaris PC Unit or PCU) and attachable modules each with a distinct function. * BD Alaris Pump Module (LVP) * BD Alaris Syringe Module (SYR) * Alaris PCA Module (PCA) * BD Alaris EtCO2 Module (EtCO2) * Alaris Auto-ID Module (Auto-ID) 2. **Guardrails Suite MX Software:** Software applications for support and interaction with the system hardware * BD Guardrails Editor (GRE) * BD Alaris Systems Manager (SM) * BD Alaris Systems Maintenance (ASM) 3. **Interoperability Software:** Software applications for facilitating bi-directional communication between the PCU and attached LVP and SYR modules, and an electronic medical records (EMR) system via BD Alaris Infusion Systems Manager (SM) and Care Coordination Engine (CCE), a non-medical device Medical Device Data System (MDDS). * Calculation Services * Infusion Adapter (IA) The PCU is the core of the BD Alaris Infusion System with Guardrails Suite MX and necessary for its operation. It provides a common user interface for programming, and powering and monitoring attached modules. Modules must be physically connected to the PCU to operate. The connection is made by direct attachment to a PCU or through attachment to a module that is attached to a PCU. The attachment is made using inter-unit interface (IUI) connectors built into both sides of the PCU and modules, which also serve to provide power to the modules and communication between the PCU and attached modules. The PCU is powered by AC power and has a rechargeable battery to allow for continued therapy during power interruptions. The attachable modules are dedicated to controlled delivery of fluids, pharmaceutical drugs, parenteral nutrition, and blood and blood products into patients, patient-controlled administration of analgesics, monitoring of end-tidal carbon dioxide, and scanning identifications of patient, physician, and infusates into the system. - **The BD Alaris Pump Module (LVP)** delivers fluids accurately over programmed times and can detect and notify the user of situations that could impact patient safety, such as improper set loading, occlusion, and air-in-line. It can deliver fluids continuously or intermittently from any compatible container using a dedicated BD Alaris infusion set. Flow rates range from 0.1 to 999 mL/h and bolus doses can be programmed at the start or during continuous infusion. - **BD Alaris Syringe Module (SYR)** is designed for injecting fluids from compatible syringes and can detect and notify the user of situations that could impact patient safety, such as an improperly loaded syringe and occlusion. It can deliver continuous or intermittent volumes from 1 to 50 mL syringes at flow rates of 0.01 to 999 mL/hr. - **The Alaris PCA Module (PCA)** is designed for patient-controlled analgesia. It shares core components and functionality with the BD Alaris Syringe Module but includes additional features such as: a dose request cord for self-administering pain medication, software with a dose lockout interval, and a locking syringe enclosure door with a key. When configured for use with the BD Alaris EtCO2 Module, it can also trigger a pause of the PCA infusion if the respiratory rate of a patient falls outside the limits. - **The BD Alaris EtCO2 Module (EtCO2)** a capnograph used for continuous, non-invasive monitoring of end-tidal CO2, fractional inspired CO2, and respiratory rate. It can be used to monitor respiratory depression in patients when using the Alaris PCA Module. - **The Alaris Auto-ID Module (Auto-ID)** features an internal barcode image scanner and an optional handheld scanner. Scanning a clinician ID unlocks the PCU panel in authorized user mode and links clinical event logs with the clinician. Scanning a patient ID band associates logs with the patient, while scanning IV fluid or medication barcodes selects the specific item from the drug library for infusion modules. The PCU and attachable modules have multiple processors running embedded software. The embedded software provides various functions, such as: bootloader, user interface, networking, sensor monitoring, motor control, data processing, power control, keypad processing, and communication. The PCU with its attached modules is designed to be configured to communicate and interact with the Guardrails Suite MX software applications including software for interoperability with Electronic Medical Record (EMR) systems. Communication between the PCU and the software applications is accomplished through either a direct serial connection or through a wireless connection utilize the respective Guardrails Suite MX Software applications. - **The BD Guardrails Editor (GRE)** allows for the creation of drug and fluid libraries and guidelines, called 'profiles,' for specific patient populations. GRE also provides a transfer tool to transfer a profile to PCU via serial cable. - **The BD Alaris Systems Manager (SM)** manages connectivity and includes a web application, communications server, and database software for managing data, creating reports, connecting with a healthcare facility's network, and storing system configuration, user permissions, and historical data. Use of SM also supports transferring wireless software updates to the PCU during system servicing. - **BD Alaris Systems Maintenance (ASM)** is used for standard maintenance tasks, including module calibration and network configurations - **The BD Alaris Interoperable software** includes the Infusion Adapter (IA) and Calculation Services to support bi-directional communication between the BD Alaris Infusion System with Guardrails Suite MX and the healthcare facility's EMR. The Infusion Adapter facilitates data exchange ensuring correct message formats and content. Calculation Services performs pre-defined rule-based calculations to obtain infusion duration, body surface area (BSA), and weight-based dose. It is important to note that interoperability does not include remote control of the BD Alaris Infusion System with Guardrails Suite MX. The PCU and attached modules cannot be programmed remotely. Only infusion parameters can be prepopulated on the pump using interoperability and these parameters must be manually confirmed by the clinician at the bedside before they are activated.

The Multi-Link™ X2 ECG Adapter and Direct Connect Lead Wire System are used in telemetry to transmit ECG signals from the electrodes to the transmitters on ambulatory patients within a defined coverage area for monitoring purposes. The Multi-Link Direct Connect Lead Wires are single-patient-use, non-sterile and cannot be reprocessed. The Multi-Link Adapters are reusable, non-sterile and can be reprocessed. The Multi-Link X2 ECG Adapter and Direct Connect Lead Wire System are used with any patient population requiring ambulatory ECG, and are compatible with Philips, Mindray and Nihon Kohden electrocardiograph monitors.

The Multi-Link X2 ECG Adapter and Direct Connect Lead Wire System is a combination of reusable adapters, already cleared lead wires (reusable K980582 and disposable single patient use K101660) and direct connect disposable single patient use lead wires, used to transmit signals from patient electrodes to the transmitters on ambulatory patients within a defined coverage area for monitoring purposes. This type of device is common to both the industry and to most medical establishments. The Multi-Link X2 ECG Adapter and Direct Connect Lead Wire System are not stand alone devices, but are accessories to the host monitoring devices. The adapters and lead wires are conductors carrying the signal from the patient to the monitor.

The Alaris System with Guardrails Suite MX is intended for use in professional healthcare facilities that utilize infusion devices for the delivery of fluids, medications, blood and blood products. The Alaris System with Guardrails Suite MX is intended to provide trained healthcare caregivers a way to automate the programming of infusion parameters, thereby decreasing the amount of manual steps necessary to enter infusion data. All data entry and validation of infusion parameters is performed by the trained healthcare professional according to a physician's order. The Alaris System with Guardrails Suite MX is an interoperable of communicating and exchanging data accurately, effectively, securely, and consistently with different information technology systems, software applications, and networks, in various settings; and exchanging data such that the clinical or operational purpose and meaning of the data are preserved and unaltered.

The Alaris System with Guardrails Suite MX is a modular infusion pump and vital signs monitoring system intended for adult, pediatric and neonatal care that includes safety management software to help reduce medication errors. The Alaris System consists of the PC Unit and up to four detachable infusion and/or monitoring modules (channels). The Auto-ID Module can be included as a fifth module. The Alaris System with Guardrails Suite MX is intended for use by Healthcare Professionals in facilities that utilize infusion pumps for the delivery of fluids, medications, blood and blood products using continuous or intermittent delivery through clinically acceptable routes of administration such as intravenous (IV), intra-arterial (IA), subcutaneous, epidural, enteral or irrigation of fluid spaces.

The Wireless Monitoring System is intended for use by health care professionals for routine surveillance of patient physiological parameters to include, pulse rate, respiratory rate and axillary temperature, in a hospital setting. Data is transmitted wirelessly to a central location. Notifications can be prospectively set to notify healthcare professionals to excursions outside of selected parameters. The device is not intended to be used on critical care patients and is intended to supplement vital signs monitoring by healthcare professionals, not to replace current standards of care. The device is intended for use on general care patients and on patients who are 18 years of age or older.

The proposed device consists of a patient patch with integrated temperature sensor, an electronic bridge and server software. The patch is attached to the patient and connected to existing monitoring leads to capture heart rate, respiration and body temperature. This data is wirelessly transmitted to a bridge. Multiple bridges can be installed in a hospital setting to capture signals in case the patient is moved or becomes ambulatory. Data from the patch is transmitted through a hard-wire connection to the nurses' station for surveillance. The healthcare practitioner can set limits on the patient data which in turn may trigger an alert.