SENZIME TetraGraph Philips Interface, Operating Instructions Manual

Page 1: ...SEN 257 Issue 2 1 06 October 2020 TetraGraph Philips Interface Operating Instructions TetraGraph Philips Interface SEN 2007 ...

Page 2: ...ted Devices 3 8 Summary of Warnings and cautions 4 9 Symbols and Icons 4 10 Getting Started 5 11 Instructions for connecting 6 12 Operation 7 13 Finishing Measurement Sessions 11 14 Troubleshooting 12 15 Maintenance 12 16 Cleaning and Disinfecting 13 17 Performance and Technical Specifications 14 18 Environment 16 19 Product Warranty 17 20 Disposal of Waste Electrical and Electronic Equipment 17 ...

Page 3: ...sing the equipment Always inspect the TetraGraph Philips interface device for any physical damage or missing parts before use Make sure that the universal CAT5e cable is connected to the TetraGraph Philips Interface module before use 2 Abbreviations CAT5e Category 5e network cable EMG Electromyography IVOI IntelliBridge and VueLink Open Interface NMT Neuromuscular Transmission PTC Post Tetanic Cou...

Page 4: ...regarding this information could cause damage to the device 4 Scope of Use and Contraindications The intended use of the TetraGraph Philips interface device is to connect a TetraGraph Monitor SEN 2001 to a Philips IVOI compatible monitor so that the Neuromuscular Transmission data TOF Ratio and TOF Count PTC and ST measurements monitored by the TetraGraph can be displayed on the IVOI enabled monit...

Page 5: ...lips Interface makes use of nine standard labels as specified by Philips and two additional custom labels The custom labels are NMT measurement numeric and TOF wave NMT represents TOF responses and the label presents either TOFrat TOFcnt or PTC depending on the level of neuromuscular block This numeric is further described with the standardized Philips IntelliVue label parameters TOFrat or TOFcnt ...

Page 6: ...it is intended to be used Please use the CAT5e cable that is supplied together with the TetraGraph Philips Interface Any other cable may be incompatible with the TetraGraph Philips Interface product 9 Symbols and Icons The following symbols are used on the TetraGraph Philips Interface CE mark Indicates compliance with the European Medical Device Directive 93 42 and amendments thereto Symbol is ass...

Page 7: ...hcare supply chain 10 Getting Started List for connecting to IntelliBridge The following table identifies the equipment involved in the procedure Equipment Part number TetraGraph Monitor SEN 2001 TetraGraph Philips Interface SEN 2007 Operating Instructions SEN 257 TetraGraph Monitor IFU SEN 008 The TetraGraph monitor and TetraGraph Philips Interface are supplied by Senzime AB the Philips IntelliBr...

Page 8: ...ilips IntelliVue Monitor via an interface module such as EC10 or EC40 provided by Philips Consult the user s manual for the Philips IntelliVue monitor for Philips monitor specific handling Consult the IFU of the TetraGraph Monitor for TetraGraph specific handling The connection of TetraGraph Monitor to the Philips IntelliVue Monitor via the TetraGraph Philips Interface is recommended to take place...

Page 9: ...ault SPI labels can be removed Please see the list of labels in chapter 17 for an elaborate description 12 Operation When the TetraGraph is turned on and connected to a Philips IntelliVue monitor via the TetraGraph Philips Interface the default SPI labels will appear on the screen as in the following example from a Philips MX550 monitor Figure 4 Figure 4 Screen shot from when TetraGraph is connect...

Page 10: ...e shows four TOF responses in which the TOF ratio is 89 The custom label NMT displayes a numeric value of 89 which is further emphasized by the TOFrat 89 The purpose of the NMT numeric is to hold TOF Ratio TOF Count as well as PTC values This means that if the level of neuromuscular block would be as deep as TOFc 2 then the NMT would display a numeric value of 2 and further emphasized with a TOFcn...

Page 11: ...gs to display the wave or parameter of your preference If you would like to add or remove any wave representation then you would have to use the specific menu system of your monitor In the below example in Figures 7 the Setup Device driver is used to change from the TOF wave to the EMG wave on the MX550 monitor Different IntelliVue models might utilize a different set of menu functions to obtain t...

Page 12: ... the TOF and EMG waves The TOF label from Choices is a custom label that can be added when the TetraGraph system is used Figure 8 shows the resulting screen after removing the TOF wave and adding the EMG wave Figure 8 Screen shot from Philips IntelliVue monitor displaying TOF results with an EMG wave when the TOFrat numeric is 89 ...

Page 13: ...corner of the screen In the above case we use a screen called Dynamic Waves 13 Finishing Measurement Sessions Consult the user s manual for the Philips IntelliVue monitor to shut down the device Consult the IFU for the TetraGraph Monitor to shut down the device Disconnect the TetraGraph Philips Interface from the Philips IntelliVue Monitor and the TetraGraph Monitor Proceed with chapter 17 for cle...

Page 14: ...eshooting chart to resolve some of the most common issues identified when using a TetraGraph monitor Symptom Resolution Nothing is visible on Philips Monitor when the Tetragraph is connected Please make sure that you have the latest software in your TetraGraph The required software version is 34b 22b 12a or higher Make sure that all the cables are properly connected The data presentation on Philip...

Page 15: ...lity with use on plastics and metal surfaces Suitable disinfectants include quaternary ammonium compounds isopropyl alcohol chlorine or chlorine dioxide 0 5 and phenolics The TetraGraph Philips Interface may be cleaned with common medical device cleaning and disinfecting agents excluding solvents and abrasive material Typically cleaning will include use of diluted cleanser or disinfectants on damp...

Page 16: ...ed with integrated or modular IntelliBridge EC10 Interface IntelliVue MP series SW version H 15 or higher IntelliVue MX series all SW versions Compatible Philips Information Centers via IntelliBridge EC40 80 Tetragraph is compatible with the following Philips Information Centers when connected via EC40 80 hubs PIIC iX IntelliVue Information Center iX SW version B 0 PIC iX Patient Information Cente...

Page 17: ...graphy Low EMG TOFcnt Measurement numeric single periodic TOFcnt Unitless 0 4 0002 f8ab TOFcnt TOFcnt Train of Four TOF count Number of TOF responses TOFrat Measurement numeric single periodic TOFrat 0 120 0002 f897 TOFrat TOFrat Train of Four TOF ratio Is the ratio between the fourth and the first TOF response PTC Measurement numeric single periodic PTC Unitless 0 20 0002 f88b PTC PTC Post Tetani...

Page 18: ...ndicator which has the property Invalid useless General INOP Soft INOP Tetra Battery Low Text N A N A N A TetraGraph battery is low A general INOP inoperable indicator which has the property Invalid questionable 18 Environment Environment during initial transportation Temperature 30 C to 70 C for periods not exceeding 5 days Relative humidity 20 to 100 non condensing Atmospheric pressure 50 kPa to...

Page 19: ...ge or failure due to tampering misuse neglect accidents modifications or shipping The warranty is also void if the product is not used in accordance with the manufacturer s instructions or is repaired during the warranty period by any persons other than the manufacturer or its appointed agent No other expressed or implied warranty is given 20 Disposal of Waste Electrical and Electronic Equipment T...

Page 20: ...or Senzime AB Ulls Väg 41 756 51 Uppsala Sweden Phone 46 18 51 56 40 www senzime com Email info senzime com 2019 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 electronically to other parties ...