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Related Manuals for SENZIME TETRAGRAPH TETRAHUB
Summary of Contents for SENZIME TETRAGRAPH TETRAHUB
- Page 1 English TETRAHUB ® Connectivity Solution Operating instructions...
- Page 2 Copyright © Senzime AB all rights reserved – updated 2025 The information in this document is the property and copyright of Senzime AB. This document is only intended for users of the device and shall not be copied, circulated, or transmitted electronically to other parties.
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Page 3: Table Of Contents
Contents 1. Introduction ..................4 2. Scope of Use and Contraindications ........4 Intended Users ..............................4 Intended Use ................................. 4 Indication for Use .............................. 4 Contraindications............................. 4 Clinical Benefits..............................5 3. Summary of Operation ..............5 4. Getting to Know the TetraHub ............ 5 Device Layout ............................... -
Page 4: Introduction
1. Introduction These instructions are intended to assist with the operation of the TetraHub and its connection from the TetraGraph monitor (SEN 2015) to a compatible Electronic Health Record connection hub or an external monitor. It is important that these instructions be read thoroughly and understood before using the equipment. -
Page 5: Clinical Benefits
Clinical Benefits TetraHub is part of the TetraGraph system. The clinical benefits of the TetraGraph system see TetraGraph User Manual. 3. Summary of Operation For more information about the TetraGraph and its functionality refer to the Instruction for use for the TetraGraph monitor. By using the TetraHub, the TetraGraph can be connected to any TetraGraph supported compatible Electronic Health Record connection hub or a TetraGraph supported external hub or monitor to transmit both numeric presentations and wave form display of TOF Ratio,... -
Page 6: The Tetrahub System
Further instructions are detailed in section 9. Cleaning and Disinfecting on page 9. The TetraGraph monitor and TetraHub is supplied by Senzime AB, the supported external hubs or monitors are supplied by the designated manufacturer. The external hub or monitor needs to be updated to the software version that can support the TetraGraph monitor. -
Page 7: Setting Up
5. Setting Up Assembly of TetraHub with TetraGraph and external hub or monitor 1. Disconnect the power supply cable (1) from the USB-C port (2) on the back of the TetraGraph monitor. 2. Connect the TetraHub´s integrated USB-C cable (3) to the USB-C port (2) on the back of the TetraGraph monitor. -
Page 8: Operation
Connect the TetraGraph monitor to the External Hub or Monitor via the TetraHub before the patient is connected to the system. When the TetraGraph monitor is connected to the external hub or monitor using the TetraHub, the following data is transmitted to the external device: •... -
Page 9: Troubleshooting
Any serious incident that has occurred to the user and/or the patient in rela- tion to the device should be reported to Senzime and the competent authority of the Member State (for Europe) or relevant health authority (for other coun- tries) in which the user and/or patient is located. -
Page 10: Manual Disinfection
Supported hosts Senzime’s implementation of the external communication protocol was carried out using the UART interface operating at 115200 Baud. Contact Senzime AB for more information regarding the communication protocol and the list of the supported hosts. 11. Data output... -
Page 11: Safety
NOTE Any serious incident that has occurred to the user and/or the patient in relation to the device should be reported to Senzime and the competent authority of the Member State (for Europe) or relevant health authority (for other countries) in which the user and/or patient is located. -
Page 12: Symbols And Icons
• Before cleaning, disconnect TetraHub from the power supply, TetraGraph monitor, and external hub or monitor. CAUTION! • Before use visually inspect the device and the integrated cable for any loose or damaged parts. Symbols and Icons The following symbols are seen on the labels of the TetraHub. Icon Meaning Description... -
Page 13: Environment
Icon Meaning Description Manufacturer Name and address of the manufacturer. MR unsafe The instrument is not MRI safe. Medical Device The instrument is a medical device. Unique Device The Unique Device Identification (UDI) is a system used to mark and Identification identify medical devices within the healthcare supply chain. -
Page 14: Electromagnetic Compatibility Information
14. Electromagnetic Compatibility Electromagentic environment Information on page 14 14. Electromagnetic Compatibility Information The TetraHub has been tested for electromagnetic compatibility as an accessory in conjunction with the TetraGraph (SEN 2015). See the TetraGraph (SEN 2015) IFU for complete Electromagnetic Compatibility Information. 15. - Page 15 INSTRUCTIONS FOR USE TetraHub SEN 2017, INFO0135 (2.0) 2025-03-06...
- Page 16 Manufacturer: Senzime AB Verkstadsgatan 8 753 23 Uppsala Sweden www.senzime.com info@senzime.com...
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