Related Manuals for SENZIME TetraGraph Xcom SEN 2010
Summary of Contents for SENZIME TetraGraph Xcom SEN 2010
- Page 1 Operating Instructions TetraGraph Xcom Cable SEN 2010 INSTRUCTION FOR USE TetraGraph Xcom SEN 2010, INFO0082, Issue 1.0, 2022-05...
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Page 2: Table Of Contents
15. Maintenance ....................... 9 16. Cleaning and Disinfecting .................. 10 17. Performance and Technical Specifications ............10 18. Environment ...................... 10 19. Product Warranty ....................11 20. Disposal of Waste Electrical and Electronic Equipment ........11 TetraGraph Xcom SEN 2010, INFO0082, Issue 1.0, 2022-05 INSTRUCTION FOR USE... -
Page 3: Introduction
3. Warnings and Cautions The European Medical Device Regulation 2017/745 and 21 CFR Part 801 requires all manufac- turers to communicate to the user and/or other person about limitations, contraindications, cautions or warnings for their equipment and many of the warnings and cautions shown here also apply to similar devices. To make sure that all users are well informed, various warnings and cautions are made throughout these instructions. A WARNING is given when the personal safety of the patient or user may be affected and when disregarding this information could result in injury. A CAUTION is given when special instructions must be followed. Disregarding this informa- tion could cause damage to the device. Figure 1 Description of a warning and a caution INSTRUCTION FOR USE TetraGraph Xcom SEN 2010, INFO0082, Issue 1.0, 2022-05... -
Page 4: Scope Of Use And Contraindications
The associated devices for TetraGraph Xcom cable are the TetraGraph monitor and the sup- ported hub or monitor. Supported software versions The required software version of the TetraGraph monitor for the purpose of being connected with any supported hub or monitor is: 34e.22f.12d or higher. 8. Summary of Warnings and Cautions In common with all medical devices of this nature, there are inherent risks and side effects. While every effort has been made to eliminate these risks, care should be taken when using the cable. It is important that the user familiarises himself/herself with all the warnings and cautions contained within this document. TetraGraph Xcom SEN 2010, INFO0082, Issue 1.0, 2022-05 INSTRUCTION FOR USE... -
Page 5: Symbols And Icons
Name and address of the manufacturer. Date of manu- Date of manufacture, shown as year, month and day. facture Medical Device The TetraGraph Xcom cable is a Medical Device MR unsafe The TetraGraph Xcom cable is not MRI safe. INSTRUCTION FOR USE TetraGraph Xcom SEN 2010, INFO0082, Issue 1.0, 2022-05... -
Page 6: Getting Started
TetraGraph monitor SEN 2001 TetraGraph Xcom cable SEN 2010 USB power supply 0242 Primary plug depending on which country: - Primary Plug EU 0178 - Primary Plug UK 0179 - Primary Plug US/JP 0180 - Primary Plug AUS 0181 TetraGraph Xcom SEN 2010, INFO0082, Issue 1.0, 2022-05 INSTRUCTION FOR USE... -
Page 7: Instructions For Connecting
Figure 2. Figure 2 Connection block diagram Note: Please contact the distributor or Senzime AB if there are any damages with the packaging/cable upon receiving the package and/or upon starting the monitoring process. 11. Instructions for Connecting Do the following: Figure 3 Power supply installation Assemble the power supply by connecting the primary plug which is used in the country of op- eration (either 0178, 0179, 0180 or 0181), power supply (0242) and USB port of the TetraGraph Xcom cable (SEN 2010). Connect the assembled power supply to a power source as shown in Figure 3. Power supply should always be connected during operation of the cable. Please use the power supply that is supplied together with the TetraGraph Xcom cable. Any other power supply may be incompatible with the TetraGraph Xcom cable Product. INSTRUCTION FOR USE TetraGraph Xcom SEN 2010, INFO0082, Issue 1.0, 2022-05... - Page 8 Lastly, connect the DB9 port of the TetraGraph Xcom cable to the external hub or monitor as shown in Figure 5. After inserting the TetraGraph Xcom cable to the TetraGraph monitor, connect the other end of the TetraGraph Xcom cable to the external hub or monitor via the DB9 port. Consult the user’s manual for the external hub or monitor for the device-specific handling. Consult the IFU of the TetraGraph monitor for TetraGraph-specific handling. The connection of the TetraGraph monitor to the External Hub or Monitor via the TetraGraph Xcom cable is recommended to take place before the patient is connected to the system. When the TetraGraph monitor is connected to the external hub or monitor using the Tetra- Graph Xcom cable, the monitor is able to display the information described below: • TetraGraph monitor Identification (Serial number & software version), • Pulse Information, • Measurement and status flags, • TOF, PTC, and ST results, • Individual peak-to-peak amplitudes. Note: Refer to your specific external hub or monitor instructions and descriptions on which information can be displayed by the monitor. Please see the list of labels in section 9 for an elaborate description. TetraGraph Xcom SEN 2010, INFO0082, Issue 1.0, 2022-05 INSTRUCTION FOR USE...
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Page 9: Operation
TetraGraph 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 established. 15. Maintenance When not in use, keep the TetraGraph Xcom cable and the power supply in its original packag- ing. The TetraGraph Xcom cable does not have any user-serviceable parts and must not be modified. INSTRUCTION FOR USE TetraGraph Xcom SEN 2010, INFO0082, Issue 1.0, 2022-05... -
Page 10: Cleaning And Disinfecting
To locate the current version of the TetraGraph, please consult the IFU for revision of the instrument the TetraGraph. The software version is shown on the display when the OFF button is pressed. Specification Cable length 280 – 300 cm Nominal input voltage 100 – 250V AC ±10% Nominal input frequency 50 – 60 Hz Nominal output voltage 5V DC ±10% TetraGraph Xcom SEN 2010, INFO0082, Issue 1.0, 2022-05 INSTRUCTION FOR USE... -
Page 11: Environment
20. Disposal of Waste Electrical and Electronic Equipment This symbol means that used electrical and electronic products should not be mixed with general waste. Disposing of this product correctly will save valuable resources and prevent any potential negative effects on human health and the environ- ment which could otherwise arise from inappropriate waste handling. If you are unsure of your national requirements with respect to disposal, contact your local authority, dealer, or supplier for further information. Penalties may be applicable for incorrect disposal of this waste, in ac- cordance with national legislation. INSTRUCTION FOR USE TetraGraph Xcom SEN 2010, INFO0082, Issue 1.0, 2022-05... - Page 12 Manufacturer: Senzime AB Ulls Väg 41 756 51 Uppsala Sweden Website: Senzime.com © 2022 Senzime AB all rights reserved: 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 electroni- cally to other parties. TetraGraph Xcom SEN 2010, INFO0082, Issue 1.0, 2022-05 INSTRUCTION FOR USE...
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