CTE Instruments are stored in an Instrument Tray which has no contact with the p
CTE Instruments are stored in an Instrument Tray which has no contact with the patient. Within the tray, the Instruments are held in place by reusable Modular Brackets that contact the Instruments during sterilization and storage (while inside the Tray), but have no patient contact themselves.
The Canary Medical Drill Bit is used to create the cavity in the patient’s tibia
The Canary Medical Drill Bit is used to create the cavity in the patient’s tibial intramedullary canal to fit the CTE implant and cement mantle.
The Persona Tibial Keel length ranges from 23.4 mm to 40 mm. The Canary Medical
The Persona Tibial Keel length ranges from 23.4 mm to 40 mm. The Canary Medical Tibial Extension adds 58 mm to the length of the tibial keel nominally when assembled. This CTE Provisional is used to ensure the fit of the CTE implant within the patient’s anatomy prior to CTE implantation.
The Canary Medical Tibia Resection Cutting Guide (left or right option) is used
The Canary Medical Tibia Resection Cutting Guide (left or right option) is used for tibia preparation when implanting a Persona® Primary Knee with a Canary Medical Tibial Extension (CTE) Implant.
The OR Base Station subsystem is intended to send and receive data to and from t
The OR Base Station subsystem is intended to send and receive data to and from the CTE implant over a wireless communication interface. Data sent to the CTE implant from the OR Base Station activates the CTE implant on the day of surgery.
OUG
Medical Device Data System
1
Canary OR Base Station / OR PC App / OR Registration
Tibial Cutting guide is placed within a tray, held in place by reusable Modular
Tibial Cutting guide is placed within a tray, held in place by reusable Modular Brackets that contact the Instruments during sterilization and storage (while inside the Tray), but have no patient contact themselves.
Stem provisional is placed within a tray, held in place by reusable Modular Brac
Stem provisional is placed within a tray, held in place by reusable Modular Brackets that contact the Instruments during sterilization and storage (while inside the Tray), but have no patient contact themselves.
The Canary Medical Tibia Resection Cutting Guide (left or right option) is used
The Canary Medical Tibia Resection Cutting Guide (left or right option) is used for tibia preparation when implanting a Persona® Primary Knee with a Canary Medical Tibial Extension (CTE) Implant.
Drill Bit is placed within a tray, held in place by reusable Modular Brackets th
Drill Bit is placed within a tray, held in place by reusable Modular Brackets that contact the Instruments during sterilization and storage (while inside the Tray), but have no patient contact themselves.
The CTE with CHIRP Base Station subsystem is a unit with embedded firmware that
The CTE with CHIRP Base Station subsystem is a unit with embedded firmware that facilitate communication with the CTE implant to serve as a conduit for implant data transmission in the environments where it will be used. The Home Base Station subsystem is for use by the Patient.
The canturio te (CTE) with Canary Health Implanted Reporting Processor (CHIRP) S
The canturio te (CTE) with Canary Health Implanted Reporting Processor (CHIRP) System is intended to provide objective kinematic data from the implanted medical device during a patient's total knee arthroplasty (TKA) post-surgical care. The kinematic data are an adjunct to other physiological parameter measurement tools applied or utilized during by the physician during the course of patient monitoring and treatment post-surgery. The device is indicated for use in patients undergoing a cemented TKA procedure that are normally indicated for at least a 58mm sized tibial stem extension. The objective kinematic data generated by the CTE with CHIRP System are not intended to support clinical decision-making and have not been shown to provide any clinical benefit. The CTE with CHIRP System is compatible with Zimmer Persona Personalized Knee System.
Tibial Cutting guide is placed within a tray, held in place by reusable Modular
Tibial Cutting guide is placed within a tray, held in place by reusable Modular Brackets that contact the Instruments during sterilization and storage (while inside the Tray), but have no patient contact themselves.
The CTE 14mm x 58mm X-Ray Template is a surgical instrument used to assist the s
The CTE 14mm x 58mm X-Ray Template is a surgical instrument used to assist the surgeon during preoperative planning.
The Impaction Sleeve is a reusable (provided non-sterile), surgical instrument u
The Impaction Sleeve is a reusable (provided non-sterile), surgical instrument used to assist in attaching the CTE implant to the Zimmer Biomet Persona® Tibial Baseplate. The Impaction Sleeve protects the implant’s electronic components from impaction forces that occur during assembly.
Glucose Meter Accessory for existing glucose meters from LifeScan, providing Bl
Glucose Meter Accessory for existing glucose meters from LifeScan, providing Bluetooth 2.1 connectivity for telehealth applications. This is built on a PWR-09-02 device, which an also support other glucose meter families if appropriate cables are provided:"B" cable: Bayer Breeze2, Contour, Contour TS, Contour XT, Contour next EZ,"A" cable: Abbott FreeStyle Lite, FreeStyle Freedom Lite
This cable is used to connect the Polytel PWR-09-02 GMA2 unit to glucose meters
This cable is used to connect the Polytel PWR-09-02 GMA2 unit to glucose meters from LifeScan
Glucose meter accessory providing Bluetooth connectivity for existing glucose me
Glucose meter accessory providing Bluetooth connectivity for existing glucose meters. Depending on which cable is provisioned, this device supports different existing glucose meters."L" cable: LifeScan OneTouch Ultra, Ultra2, UltraMini, UltraEasy, Select, Basic"B" cable: Bayer Breeze2, Contour, Contour TS, Contour XT, Contour next EZ, "A" cable: Abbott FreeStyle Lite, FreeStyle Freedom Lite
MonitAir is a HIPAA compliant, FDA registered MDDS combining remote data monitor
MonitAir is a HIPAA compliant, FDA registered MDDS combining remote data monitoring and telemedicine features to support patients on PAP/NIV therapy for chronic sleep and respiratory conditions.
MonitAir is a HIPAA compliant, FDA registered MDDS combining remote data monitor
MonitAir is a HIPAA compliant, FDA registered MDDS combining remote data monitoring and telemedicine features to support patients on PAP/NIV therapy for chronic sleep and respiratory conditions.
MonitAir is a HIPAA compliant, FDA registered MDDS combining remote data monitor
MonitAir is a HIPAA compliant, FDA registered MDDS combining remote data monitoring and telemedicine features to support patients on PAP/NIV therapy for chronic sleep and respiratory conditions.
MonitAir is a HIPAA compliant, FDA registered MDDS combining remote data monitor
MonitAir is a HIPAA compliant, FDA registered MDDS combining remote data monitoring and telemedicine features to support patients on PAP/NIV therapy for chronic sleep and respiratory conditions.
TRAQinform Reports is a 100% software medical device data system that provides u
TRAQinform Reports is a 100% software medical device data system that provides users with the means to select, render and modify layouts of static and interactive reports. TRAQinform Reports does not perform any image analysis or image processing of medical images. The device provides features to render available data components to formatted PDF, web pages, or text files.
The TRAQinform Preprocessor is a 100% software medical device data system that p
The TRAQinform Preprocessor is a 100% software medical device data system that provides users with the means to filter, perform quality checks, organize, and convert images from DICOM into other file formats including but not limited to Nearly Raw Raster Data (NRRD) format.
Real time patient data monitoring, secure clinical communications, monitor & ve
Real time patient data monitoring, secure clinical communications, monitor & vent waveforms, alarms and notifications anywhere, anytime for clinicians
Brand-independent integration with Ceiba eConnect APIs of medical devices (monit
Brand-independent integration with Ceiba eConnect APIs of medical devices (monitors, respirators, pumps, blood gas) and hospital systems
eClinics is a stand-alone software product used by professional care providers i
eClinics is a stand-alone software product used by professional care providers in ICU and other critical care settings for the presentation, collection, management and storage of patient information
The CTE with CHIRP Base Station subsystem is a unit with embedded firmware that
The CTE with CHIRP Base Station subsystem is a unit with embedded firmware that facilitate communication with the CTE implant to serve as a conduit for implant data transmission in the environments where it will be used. The Home Base Station subsystem is for use by the Patient.
The OR Base Station subsystem is intended to send and receive data to and from t
The OR Base Station subsystem is intended to send and receive data to and from the CTE implant over a wireless communication interface. Data sent to the CTE implant from the OR Base Station activates the CTE implant on the day of surgery.
Canary OR Base Station / OR PC App / OR Registration
The CentrePoint Data Hub is a home-based communication gateway that securely tra
The CentrePoint Data Hub is a home-based communication gateway that securely transmits data captured by ActiGraph activity monitors.
PACSgear Enterprise Server is a program that processes DICOM and non-DICOM medic
PACSgear Enterprise Server is a program that processes DICOM and non-DICOM medical data including patient demographics, images, videos and HL7 messages. It also handles user accounts, security, client configuration, and the folow of data between modalities and destination DICOM systems. PACSgear Enterprise exclusively supports PACSgear client products such as EHR Gateway, Image Link, MDR Video Touch and Web Forms. PACSgear Enterprise Server is not labeled for diagnostic use.
PACSgear Enterprise Server is a program that processes DICOM and non-DICOM medic
PACSgear Enterprise Server is a program that processes DICOM and non-DICOM medical data includingpatient demographics, images, videos, and HL7 messages. It also handles user accounts, security, clientconfiguration, and the flow of data between modalities and destination DICOM systems. PACSgear
Image Link Plus supports imaging workflows that do not follow the radiology work
Image Link Plus supports imaging workflows that do not follow the radiology workflow by providing a pseudo order message to the modality that contains patient and visit information from the Electronic Medical Record (EMR).