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The Halo II Ambulatory Infusion System is intended to deliver medications and/or fluids to a patient under the direction or supervision of physician or other certified healthcare professional in clinical and nonclinical environments, such as homes. The device is intended for subcutaneous, perineural, epidural and intravenous infusion, including but not limited to patient controlled analgesia (PCA) delivery.

The Halo II Ambulatory Infusion System includes an ambulatory infusion pump and administration set. It is used to deliver medications and/or fluids to a patient under the direction or supervision of physician or other certified healthcare professional. This is a device modified from its predicate device Halo Ambulatory Infusion System (K140783). Modifications include allowing users to change battery therefore enabling pump use beyond 240 hours / 1500mL. The original motor was replaced with a longer life one to support extended pump life. Software was updated accordingly to realize the changes. The administration set remains exactly the same. The Halo II Ambulatory Infusion Pump has a microprocessor controlled motor that drives a peristaltic pumping mechanism to deliver fluid at a controlled rate, same as the Halo ambulatory infusion pump (K140783) and CADD-Solis VIP ambulatory infusion pump (K11275). The pump interfaces with user via keypad, LED and LCD. Infusion parameters can be set up by operating the keypad, and displayed on the LCD. The pump includes sensors for detection of upstream occlusion, downstream occlusion, cassette loading error, and pumping mechanism malfunction. Error conditions can be displayed on LCD, and redundantly indicated by a LED light and audio alert. The electronics is powered by a battery. The materials of construction for the Halo II pump components are widely used in the medical industry. The pump is intended for therapies that require a continuous infusion with optional Patient Controlled Analgesia (PCA). The Halo II Administration Set is exactly the same as Halo Administration Set (K140783). It is designed to administer fluids / medication from a container to a patient through a needle or a catheter. Major components include spike, cassette, slide clamp, filter, and luer lock. The air-eliminating filter prevents air from entering into a patient. The administration set can be used with Halo II Pump or for gravity infusion. It is similar to the predicate device, Zyno Medical Administration Sets (K120685), which can be used with Z-800 Infusion Pump or gravity infusion.

The Halo Ambulatory Infusion System is intended to deliver medications and/or fluids to a patient under the direction or supervision of physician or other certified healthcare professional. The device is intended for subcutaneous, perineural, epidural and intravenous infusion. The device is intended for 240 hours or 1500mL of infusion, whichever limit is reached first.

The Halo Ambulatory Infusion System includes Halo Ambulatory Infusion Pump ("Halo Pump'') and Halo Administration Set. The system provides measured drug / fluid therapy for subcutaneous, perineural, evidural and intravenous delivery to patient under the direction or supervision of physician or other certified health care professional. The design philosophy was "Simplicity = Safety". Verification and validation data have demonstrated that this is a simple, safe and reliable infusion device for patient in the clinical and non-clinical environments, including but not limited to hospital, homecare, and outpatient settings. Halo Ambulatory Infusion Pump: The Halo Ambulatory Infusion Pump ("Halo Pump") has a microprocessor controlled motor that drives a mechanical pumping mechanism to deliver fluid at a controlled rate, same as the CADD-Legacy PCA 6300 Ambulatory Infusion Pump (K982839) and ambIT Continuous Ambulatory Infusion Pump (K033325). The Halo Pump interfaces with user via keypad, LED and LCD. Infusion parameters can be set up by operating the keypad, and displayed on the LCD. The pump includes sensors for detection of upstream occlusion, downstream occlusion, cassette loading error, and pumping mechanism malfunction. Error conditions can be displayed on LCD, and redundantly indicated by a LED light and audio alert. The electronics is powered by a battery. The materials of construction for Halo Pump components are widely used in the medical industry. The Halo Pump is intended for therapies that require a continuous infusion with optional Patient Controlled Analgesia (PCA). Halo Administration Set: The Halo Administration Set is designed to administer fluids / medication from a container to a patient through a needle or a catheter. Major components include spike, cassette, slide clamp, filter, and luer lock. The air-eliminating filter prevents air from entering into a patient. The Halo Administration Set can be used with Halo Pump or for gravity infusion. It is similar to the predicate device, Zyno Medical Administration Sets(K120685), which can be used with Z-800 Infusion Pump or gravity infusion.

Zyno Medical Administration Set is a device used to administer fluids from a container to a patient's vascular system through a needle or a catheter inserted into a vein.

Zyno Medical Administration Set is a device used to administer fluids from a container to a patient's vascular system through a needle or a catheter inserted into a vein. The major modifications are: 1) extended selection of interchangeable components manufactured by additional suppliers; 2) additional contract manufacturer for the device: 3) Gamma Irradiation as additional sterilization method.

The Z-800 Infusion system is intended to provide intravenous infusion of parenteral fluids, blood and blood products to a patient under the direction or supervision of physician or other certified health care professional.

The Z-800 Infusion System consists of the infusion pumps and approved external IV administration sets. The major modifications are as following: 1. Added a counter in software for cumulative volume of fluid infused in order to monitor pump utilization. The odometer feature enables pump display a reminder for user to service the pump once a preset volume limit is reached. 2. Implemented optional set based free flow protection. Modified set based free flow protection mechanism consists of a proprietary pinch clamp on the standard IV set tubing and an optional spring loaded clamp holder module on the pump. The pinch clamp can be manually opened for priming. The clamp holder is designed such that the pinch clamp is automatically closed once it is loaded into the clamp holder. Upon pump door close, the pump door activates the pinch clamp loaded in the clamp holder to open to allow flow go through. Upon pump door open, the spring in the clamp holder forces the pinch clamp to close. When the IV set is removed from the pump, the pinch clamp remains at closed position to avoid unintended free flow. A sensor on the clamp holder detects presence of the pinch clamp. "No Clamp" status can be displayed on pump screen to inform user that the clamp is absent. 3. Implemented optional Wi-Fi communication module for serial port to enable bidirectional communication through RF signal. A self-contained serial Wi-Fi convertor module is embedded into the Z-800 infusion pump to enable wireless communication. The Z-800 infusion pump sends serial command to the Wi-Fi convertor module. The Wi- Fi convertor module translates the serial communication command from the Z-800 infusion pump to RF signals and responsible for handling communication protocol with external devices. The serial Wi-Fi convertor enables the user to initiate a query on the pump for external information by entering partial patient identifier information as search criteria. External information returned from the query may include patient information, such as name, date of birth, and IV medication order. The patient and order information are presented to the healthcare professional during infusion programming process to be confirmed for association with the infusion. The Wi-Fi convertor also enables Z-800 infusion pump to publish infusion status data, with the associated patient and order identifiers, which can be utilized by external systems such as EMR. 4. Added an ESD/EMI shielding cap for serial port to enhance pump survivability under injection of Electromagnetic noise and Electrostatic Discharge. 5. Optimized pressure sensor zero point value determination process for better accuracy. 6. Optimized peristaltic plate to maximize durability of peristaltic module. 7. Optimized peristaltic cams in peristaltic module to maximize its durability. 8. Optimized rubber feet for increased durability.

The Zyno Medical Administration Set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein.

The Zyno Medical's I.V. Administration Set is a single use, latex-free, non-DEHP device sterilized with Ethylene Oxide gas. It is utilized to administer fluids from a container to a patient's vascular system through a catheter or needle inserted into a vein. Depending on configuration, the device may include the following components: tubing, protective cap(s), drip chamber (s) with spike, tubing, back check valve(s), needleless Y-site(s), slide clamp(s), roller clamp(s), pinch clamp(s), 0.22 micron filter or 1.2 micron filter, male luer lock (with cap), and pressure activated valve(s). Seven (7) representative administration sets and one (1) representative extension set are described in the application package to illustrate the device confiqurations.

The Z-800 Infusion system is intended to provide intravenous infusion of parenteral fluids, blood and blood products to a human patient under the direction of physician or other certified health care professional.

The Z-800 Infusion system is intended to provide intravenous infusion of parenteral fluids. blood and blood products to a human patient under the direction of physician or other certified health care professional. The Z-800 Infusion System consists of the Z-800 Infusion Pump and approved external IV administration sets. The scope of this 510K is to qualify CareFusion's blood administration sets (K882302) for use with the currently marketed Z-800 infusion pump system so as to extend the intended use of the Z-800 Volumetric Infusion Pumps to include intravenous administration of blood and blood products. The infusion pump remains the same as currently marketed Z-800 infusion pump, as in the predicated device Z-800 infusion system (K0717545). The Z-800 infusion system contains the following components: - The infusion delivery mechanism: Volumetric linear peristaltic pumping mechanism assembly. - Approved IV administration sets include External IV sets for intravenous parenteral fluid delivery . and for intravenous blood and blood product delivery. - . User Interface consists of a 128 X 64 dot matrix LCD display; a 14 key membrane keypad; a LED flow rate display; two device status indicator LEDs; power status indicator LEDs (AC & Battery); an audio speaker; an external alarm light accessory; an software alarm handler. - The embedded software on the main CPU execute an infusion pump state machine, which monitors . the execution of currently programmed infusion as well as a collection of safety related alarm conditions. - A watchdog timer is set at 50ms interval. Fail to satisfy the watchdog timer will cause both main . CPU and motor control CPU reset, pump device parks at a fail safe state, and an audible alarm to sound. - Power supply consists of AC/DC power. Z-800 infusion pump is intended to be used as a pole . mounted pump. It contains a medical device grade switch power supply (input 100-240V 50-60Hz, 0-1.4A. output 15vdc) and a rechargeable 4700mA. 8X1.2 volt Nickel Metal Hydride battery pack. A fully charged new battery will power at least 8hr of continuous infusion (at 125mL/hr). A full battery charging time on a new battery is around 5hr. The battery charging circuitry has a dedicated controlling CPU, which manages the charging current as well as the battery safety monitoring. Redundant temperature sensor is embedded in the battery pack capable of shut off the charging current if battery pack temperature is above the safety threshold. - . There is 128K flash EPROM memory which stores the embedded software along with 8K NVRAM for user specified configuration as well as preserving infusion parameters between power cycles. - . Z-800 infusion pump uses linear peristaltic pumping mechanism driven by a step motor through driving belt. The ID/OD, wall thickness and the durometer of the IV set are specified by Zyno to the IV set manufacturers to ensure the accuracy specification of flow rate. - . The user interface design requirement of the Z-800 pump is focused on simplicity and intuitiveness. The keypad contains 3 groups of keys: the navigation key group; the data entry key group; and the action key group. There is no numeric data entry keypad. All data entry kevs are scroll key. This design is to focus user's attention to the data entry results on the display while entering the infusion parameters, so as to mitigate data entry error caused by key bounce or user hitting the wrong keys, - . The Z-800 infusion pump has an all metal casing to improve the durability of the pump and the integrity of the pumping/free flow protection mechanism. The pump door and the mating pump front panel are made in milled aluminum. The tubing guide cavity is designed to mitigate tubing loading error. If the tubing is not loaded correctly, the door can not be closed. Even user jam close the door, the mating pump door and the front panel will shut off the tubing to prevent free flow, and the drip sensor accessory will report no flow to alert user of misloaded tubine. - . There is no known contraindication.

The Z-800 Infusion pump is intended to provide accurate delivery of parenteral fluids to a human patient under the direction or supervision of physician or other certified health care professional.

The Z-800 Infusion pump contains the filter assemblies. The electronics subsequently contains all of the electronics in the microprocessors that run the software. The electronics assembly also contains communications electronics. The pump has two microprocessors, one master processor which controls operation of the device, another pump processor which controls operation of the motor and sensors specific to the pump.