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Dantec

Keypoint

User and Service Guide

Part Number: 9031M1506 Rev F

23/NOV/2022

System Model Number: 9031A0701
© 2016 - 2022 Natus Medical Incorporated or one of its subsidiaries. All rights reserved. Natus is a registered trademark of Natus Medical

Incorporated. All product names appearing on this document are trademarks or registered trademarks owned, licensed to, promoted or

distributed by Natus Medical Incorporated, its subsidiaries or affiliates. All other trademarks are the property of their respective owners.

Содержание Dantec Keypoint G4

Страница 1: ...of its subsidiaries All rights reserved Natus is a registered trademark of Natus Medical Incorporated All product names appearing on this document are trademarks or registered trademarks owned licens...

Страница 2: ...England United Kingdom Copyright 2016 2022 Natus Medical Incorporated All Rights Reserved This manual contains proprietary information which is protected by copyright laws and may not be copied in wh...

Страница 3: ...ss Authorized Representative Swiss authorized representative Indicates the Authorized representative in Switzerland 21 CFR 801 109 b 1 Labeling Prescription Devices Device is cleared for the US market...

Страница 4: ...ture Indicates the date when the medical device was manufactured ISO 15223 1 Symbol 5 3 7 Medical devices Symbols to be used with information to be supplied by the manufacturer Part 1 General requirem...

Страница 5: ...onsult the instructions for use for important cautionary information such as warnings and precautions that cannot for a variety of reasons be presented on the medical device itself IEC 60601 1 Table D...

Страница 6: ...nments 10 Windows Systems Secure Access 10 Data Confidentiality 10 Data Protection 10 Protective and Equipment Classification 10 Accuracy of Controls 10 Ancillary Accessories 11 Safety Warnings and Pr...

Страница 7: ...nd Software Options 30 Additional Accessories 30 Software Options 30 System Operation 31 StartingDantec Keypoint NET 31 Home Page 31 New Study Patient Data 32 Study List 32 Test Menu 34 Test Example1...

Страница 8: ...ing Life Instructions 52 Natus Technical Support Contact Information 53 Electromagnetic Compatibility EMC 54 Maintaining 54 EMC Acceptance Criteria 54 Deviations from collateral standard 55 Electromag...

Страница 9: ...t G4 system include System startup with device check Test protocol selection customization and execution Control of amplifier signals Control of electrical visual and auditory stimuli User controlled...

Страница 10: ...ers for different functionality Windows Systems Secure Access Users should require an account with suitable privileges to use the system note no special elevated rights are required to use the EMG app...

Страница 11: ...made of metal and are typically fabricated from platinum gold or silver Metallic reusable electrodes must be cleaned and or conditioned for reuse according to instructions provided by the manufacturer...

Страница 12: ...ence of flammable anesthetics Any interruption of the protective earth conductor inside or outside of the device or disconnection of the protective earth connector is likely to make the device dangero...

Страница 13: ...ommunication equipment can affect electrical equipment for medical use Dangerous physiological effects The current stimulator may give off dangerous currents and voltage Do not use cleaning detergents...

Страница 14: ...is connected to its mains supply connectors may be live and any opening of covers or removal of parts possible only with the aid of a tool is likely to expose live parts The device must be disconnect...

Страница 15: ...ther be placed outside the patient environment the patient environment is any area in which intentional or unintentional contact can occur between patient and parts of the system e g a printer VEP Mon...

Страница 16: ...rs to the length of time from point A to point B The pulse amplitude refers to the output level reference from points C and D with the rated load See Figure 1 Figure 1 Accuracy of Controls Stimulator...

Страница 17: ...2 Power Switch 10 Connection Panel 3 Monitor 11 Accessory Box Kit optional 4 Internal Speaker 12 Mouse 5 Control Panel 13 Printer optional 6 PC Keyboard 14 LAN Socket optional 7 Electrode Arm optional...

Страница 18: ...ettings b On the Isolating Transformer unit make sure that the correct voltage type is used 4 Connect the mains cable to the wall outlet blue dotted 5 Press the Power on off button on the front panel...

Страница 19: ...ation and or reduced leakage current to comply with existing safety standards This device has been designed and tested in accordance with IEC 60601 1 Medical Electrical Equipment standard To ensure a...

Страница 20: ...ulation only but which includes an additional safety precaution in that means are provided for the connection of the equipment to the protective earth conductor in the fixed wiring of the installation...

Страница 21: ...ator 9 Stimulation Repetition Rate Arrow Keys 18 Software Function Keys Control Functions Software Navigation Software Functions Software Navigation Keys Color Coded The Software Navigation keys allow...

Страница 22: ...ndicator blinks intermittently To stop repetitive stimulation press either the same Repetitive Stimulation key or the Single Stimulation key Stimulus Intensity Duration Repetition Rate Stimulation Int...

Страница 23: ...rsor Mode is enabled rotate the knob to move the traces markers or the trigger cursor Cursor Mode Indicator The green light LED indicator is on when the cursor mode is enabled When enabled it allows m...

Страница 24: ...the black input connector The green light LED indicates the results of the impedance test as described LED Status All LEDs Off Constantly lit LEDs Result Acceptable Impedance High Impedance Reference...

Страница 25: ...D Status and Results description under the Active Electrode Indicator Rear Panel LINK HS Link Input Connector Connection Panel internal LINK HS Link Output Connector Current Stimulator Connection HS L...

Страница 26: ...een light LED indicates the results of the impedance test See the LED Status and Results description under the Amplifier Input Connectors Common Array above Rear Panel LINK HS Link Input Connector Amp...

Страница 27: ...s and hold down the button on the handle for at least 1 second Stop To stop the repetitive stimulation press the Repetitive Stimulation button again 7 Stimulus Intensity Control Wheel To increase or d...

Страница 28: ...held Stimulation Electrode 9031E017 Advanced Stimulation Handgrip When using the surface cutaneous electrodes the following applies Before applying the 9013L035 felt tips they should be soaked in sali...

Страница 29: ...during the power up test of the stimulator Exit the Keypoint NET program and verify the cable connection to the current stimulator Do not use the current stimulator when this message is shown the sti...

Страница 30: ...lator 22 TFT Display with Connection Kit 9031B0521 Amplifier Arm Single 9031B0511 Amplifier Arm Dual 9033B0761 Flex Arm with Clamp 40cm 9031F0361 Color Printer 100 V 240 V 9031F0416 Laser Printer Blac...

Страница 31: ...rosoft Windows desktop The Home Page will then be displayed Home Page The Home Page is the start view when the program opens From the Home Page the following options are available Create a New Study O...

Страница 32: ...data Comments Conclusions Memo 1 2 3 Notes read only Note that data cannot be entered when the Study Complete check box is selected Study List Clicking the Study List button in the Home page or the S...

Страница 33: ...and may be edited Visit information is cleared for a new visit Double clicking a Study Double clicking a study opens the Patient Data Menu tab for review the data entry Fields may be edited Right cli...

Страница 34: ...bs 7 Anatomy box 2 Application Setting Selection 8 Test type view 3 Left or right option buttons 9 Patient status bar 4 Filter root drop down list 10 Tree view structure 5 Muscle dropdown list 11 Show...

Страница 35: ...Boxes 7 containing the available muscle nerve sites See figure above Starting a Test 1 Select Motor from the Test tree view 2 Select the side Left or Right by clicking the appropriate option On the Co...

Страница 36: ...ion tabs These can be selected using the PC Keyboard keys F7 F12 and by clicking with the mouse On the Keypoint G4 Focus the Test Navigation tabs can also be selected using the Control Panel Right and...

Страница 37: ...nd Acquire Views Click the show all traces button to show all traces for the site Click the show selected trace button to show the selected trace only The selected trace is marked in blue A new trace...

Страница 38: ...e over the trace where the first marker shall be placed in motor NCS the takeoff marker and left click to insert it The remaining markers shall be placed automatically If the markers are not placed au...

Страница 39: ...he right click menu or Press on the Amplifier box not available for the Focus 3 channel Amplifier The impedance test starts on all the connected electrodes Adjust the electrodes until an acceptable le...

Страница 40: ...e field in the table and enter the value If the result field has a corresponding reference limit the result will be colored as follows o Abnormal red background o Normal light green background o Super...

Страница 41: ...ngs page without saving the changes The customized settings carried out through Settings and if available Design pages are only valid for that specific test and patient New tests will use the default...

Страница 42: ...ters overview curves gain sweep speed and analysis buttons The default setup for the Views can be modified through Options from the Home page Scope Top Bar 3 The scope top bar displays the name the si...

Страница 43: ...l Window Trigger The window trigger consists of the normal trigger A and the window indicator B and can be selected in the right click menu Please see the figure above Change the length of the window...

Страница 44: ...e view to allow on line scoring for the selected muscle The Findings bar can be activated by right clicking in the curve window or by selecting a view where it is predefined as active In both cases sc...

Страница 45: ...Inter discharge interval IDI Motor Unit Potential MUP Turns Amplitude Number of Small Segments NSS Envelope and Peak Ratio Note that the plot windows do not contain any values until an analysis has be...

Страница 46: ...averages individual discharges from the same motor unit The action after analysis is predefined and depends on the Test configuration Types of actions if MUPs are found o Stay in Current View auto acc...

Страница 47: ...Ps The following functions become available when the cursor is placed over a MUP Click to delete the MUP The MUP is then marked with a red cross Click to open the MUP in the MUP Edit view Click and dr...

Страница 48: ...Moved and the change is reflected in the Raster Window Averaging and Merging two Templates In the bottom of the active template there is a firing pattern To perform an average of the two templates si...

Страница 49: ...lines In the main scope a box marks the enclosed single MUP Locating a MUP When moving the mouse in the scope a box will appear around the detected MUP A small tab in the middle of the box indicates t...

Страница 50: ...activated by left clicking the print icon in the top right corner or by pressing ctrl print screen on the PC keyboard The printer to be used and other settings can be changed by right clicking the pr...

Страница 51: ...t IFU as needed When moving the Keypoint G4 system take care to not allow the system to hit objects during transport to prevent damage to the system and its components The Keypoint G4 does not require...

Страница 52: ...o meeting the requirements of the European Union WEEE Waste Electrical and Electronic Equipment Regulations 2014 These regulations state that electrical and electronic waste must be separately collect...

Страница 53: ...tus com Phone 33 5 56 08 54 76 Or contact the local Natus representative Please have the following information ready for communication with Technical Support Product name system serial number and or s...

Страница 54: ...ter changes It is not considered an unacceptable risk or affect on the ESSENTIAL PERFORMANCE if the DIAGNOSTIC EQUIPMENT covered in this RMF becomes completely non functional due to it s intended use...

Страница 55: ...shall remain safe and be restorable in case of cessation or interruption of any intended operation during immunity tests Disturbance of display reconnections of PC USB keyboard and USB mouse or loss...

Страница 56: ...ds 0 15 MHz to 80 MHz 80 AM at 1 kHz Voltage Dips IEC 61000 4 11 100 dip 0 5 cycle At 0 45 90 135 180 225 270 315 100 dip 1 cycle And 30 dip 25 cycles 50 Hz Single phase 0 Voltage Interruptions IEC 61...

Страница 57: ...z sine 2 0 3 28 710 704 787 LTE Band 13 17 Pulse 217 Hz 0 2 0 3 9 745 780 810 800 960 GSM 800 900 TETRA 800 iDEN 820 CDMA 850 LTE Band 5 Pulse 18 Hz 2 0 3 28 870 930 1 720 1 700 1 990 GSM 1800 CDMA 19...

Страница 58: ...oof DIN socket Calibration Signal With supplied test cable ADC Resolution 24 Bits See section Data Sampling Sampling Rate 48kHz per amplifier See section Data Sampling Averager Max Averager per Channe...

Страница 59: ...current 20 0 001 50mA 1mA This cause an output voltage of maximum U 320V This means that output current may be limited for R 320V 50mA 6 4kOhm Example 2 Stimulation frequency 5Hz pulse duration 0 2mS...

Страница 60: ...d with a resolution of 24 bits Digital filtering High and low pass and Notch filtering is performed with this resolution to avoid clipping Raw input curves are stored and handled as 16 bit values with...

Страница 61: ...mpling frequency Example with recording length 200 ms number of points 200 ms 24 kHz 4800 Displayed sampling frequency As the number of pixels horizontally may be lower than the number of samples stor...

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