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September 13, 2018

6-7

Electromagnetic Compatibility (EMC)

Table 8 – Immunity Test Levels - Signal Input / Output Parts Port 

Phenomenon

Basic EMC Standard 

Immunity Test Levels - Professional Healthcare 

Facility Environment

Electrostatic Discharge

IEC 61000-4-2

± 8 kV contact

± 2 kV, ± 4 kV, ± 8 kV, ± 15 kV air

Electrical Fast Transients/Bursts

IEC 61000-4-4

± 1 kV

100 kHz repetition frequency

Surges Line-to-Ground 

(Common Mode)

IEC 61000-4-5

± 2 kV

Conducted Disturbances Induced 
by RF Fields

IEC 61000-4-6

3 V

0,15 MHz – 80 MHz

6 V in ISM bands between 0,15 MHz and 80 MHz

80% AM at 1 kHz

Содержание UltraPro S100

Страница 1: ...porated 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 trademark...

Страница 2: ......

Страница 3: ...nic Skin Response and Sympathetic Skin Response Autonomic testing also includes assessment of RR Interval variability The UltraPro S100 is used to detect the physiologic function of the nervous system...

Страница 4: ...WI USA 53562 608 829 8500 1 800 356 0007 Fax 608 829 8589 www Natus com Technical Support Domestic Natus Neurology Incorporated 3150 Pleasant View Road Middleton WI USA 53562 1 800 356 0007 madison he...

Страница 5: ...at risk ISO 7010 M002 Image on blue background Consult Operating Instructions ISO 7000 1641 European Authorized Representative Manufacturer Disposal at end of operating life instructions When the equi...

Страница 6: ...and Safety Notes for Assorted Nicolet Brand Products Reference Guide included on a CD included with your system paying special attention to the Safety information before applying power to and using yo...

Страница 7: ...the published specification ranges Use of device outside of the specified ranges may result in inaccurate results Aliasing of the displayed data can occur if the time base and the data displayed are n...

Страница 8: ...e miniumum surface area of the stimulus electrodes that should be used Required diameter of disc is the minimum diameter of a round disc electrode that should be used The diameter of disk 20 square ro...

Страница 9: ...iene authority s guidelines and the following points below Disconnect the mains power before cleaning the equipment Clean the equipment surfaces with a clean slightly damp cloth with a mild detergent...

Страница 10: ...in the event of repair 1 Inspection for visible damage to device 2 Inspection of mains cord and connecting cables 3 Check of electrode cables and patient connections 4 Measurement of insulation resist...

Страница 11: ...ce must be disconnected from all voltage sources before being opened for any adjustment replacement maintenance or repair Service must be referred to Natus Neurology Incorporated authorized service pe...

Страница 12: ...of your respective local laws and regulations for the proper disposal of batteries and any other parts of your system such as monitors UltraPro S100 amplifiers keyboards electrodes 9 Refer to your Nat...

Страница 13: ...media in which this information is preserved This copy of the User Manual shall be used only in accordance with the conditions of sale of Natus Neurology Incorporated or its distributors Natus Neurolo...

Страница 14: ...re on only one computer and by one user at a time b Make one copy of this software provided that i the copy is created as an essential step in the utilization of this software in conjunction with your...

Страница 15: ...sinfection procedure g Preventative maintenance h Safety checks h Safety i Recycling disposal j Copyright k Software copyright protection l Introduction 1 1 Technical description 1 3 Installation and...

Страница 16: ...igation software functions 2 16 Display Keys 2 17 Stimulus 2 17 Stimulus Intensity Duration Repetition Rate 2 18 Audio Volume Cursor Mode Trace Marker Trigger 2 19 Footswitch with 3 pedals option 2 20...

Страница 17: ...Select a protocol only if using Test Menu 4 7 Motor NCS electrode placement 4 7 Sensory NCS electrode placement 4 8 Acquire the data 4 8 Marking data 4 9 Resetting the markers 4 9 Erasing data 4 10 De...

Страница 18: ...nt Coupling Port 6 6 Table 8 Immunity Test Levels Signal Input Output Parts Port 6 7 Table 9 Test specifications for ENCLOSURE PORT IMMUNITY to RF wireless communications equipment 6 8 Notes 6 9 Gener...

Страница 19: ...13 September 2018 v Table of Contents Blank page...

Страница 20: ...UltraPro S100 vi 13 September 2018...

Страница 21: ...September 13 2018 1 1 1 Introduction...

Страница 22: ...UltraPro S100 1 2 September 13 2018 Blank page...

Страница 23: ...llation assembly and operation some protective ground connection points are susceptible to becoming electrically detached or not properly connected This can pose a safety hazard to both the user and p...

Страница 24: ...fying the operator that an adverse event has occurred Once the operator has cleared this message the system will indicate that acquisition can resume with the settings restored to the previous state I...

Страница 25: ...out the system UltraPro S100 systems feature a dedicated control panel color coded multifunction softkeys and easy to use Windows based interfaces to simplify operation The UltraPro S100 cart accommod...

Страница 26: ...or the test being conducted Reusable surface electrodes are made of metal and are typically fabricated from platinum gold or silver Metallic reusable electrodes must be cleaned and or conditioned for...

Страница 27: ...oap solution such as Basis Cetaphil Dove in water solution Ethyl alcohol 70 90 concentration A solution of 1 part household bleach 5 6 concentrate sodium hypocholorite and 50 parts water Connecting th...

Страница 28: ...UltraPro S100 1 8 September 13 2018 Blank page...

Страница 29: ...September 13 2018 2 1 2 System Overview This chapter introduces you to the basic hardware and software controls used to operate your UltraPro S100 system...

Страница 30: ...UltraPro S100 2 2 September 13 2018 Blank Page...

Страница 31: ...September 13 2018 2 3 System Basics UltraPro S100 base unit 1 Base Unit 4 Side Panel 2 Computer 5 Control Panel 3 Rear Panel...

Страница 32: ...only optional devices specified by Natus Neurology Incorporated in order to comply with IEC 60601 1 IEC 60601 1 1 Always use shielded power line cables from Natus Neurology Incorporated to avoid hum l...

Страница 33: ...ctions Item Description 1 USB 2 0 Cable 2M 2 High Speed Link Cable Proprietary 3 Power Adaptor IEC Cable 1ft 4a Advanced Stimulus Probe 4b Comfort Probe RS10 Optional not diagrammed 5 Hospital Grade P...

Страница 34: ...re electronically isolated 3 and 4 Channel Amplifier Electrostatic Sensitive Amplifier Input Connectors Do not touch the Amplifier input connectors because it may damage the amplifier or affect its pe...

Страница 35: ...rs Do not connect the patient ground to the protective earth connection on the Isolating Transformer Unit or to any other ground connects as the electrode inputs are galvanically isolated 4 Channel Am...

Страница 36: ...se proximity e g 1m to short wave or microwave therapy equipment may produce instability in the electrical stimulator output Dangerous physiological effects The current stimulator may give off dangero...

Страница 37: ...press the button on the handle Repetitive Stimulus Button Press and hold down the button on the handle for at least 1 second 4 Stimulus Intensity Control Wheel To increase or decrease the current inte...

Страница 38: ...September 13 2018 Changing polarity on the Comfort Probe RS10 1 Pull the Probe Head straight out from the Comfort Probe RS10 2 Rotate the Probe Head 180 degrees 3 Insert the Probe Head back into the...

Страница 39: ...are electronically isolated Stimulator Output Socket isolated For connection of stimulus electrodes with DIN plugs Support for the active stimulus probe 2 HS Link Output Connector Amplifier Connectio...

Страница 40: ...or Output isolated The stimulator output connectors are electronically isolated Stimulator Output Socket isolated For connection of stimulus electrodes with DIN plugs Support for the active stimulus p...

Страница 41: ...Limited power available Only used for footswitch and memory stick 4 USB Connector Type B For computer interface 5 Footswitch Connector 6 Trigger Input Output Connector 7 Visual Transducer Connector 8...

Страница 42: ...d memory stick 4 USB Connector Type B For computer interface 5 Footswitch Connector 6 Trigger Input Output Connector 7 HS Link Output Connector Amplifier Connection Cat5 with built in EMI Suppression...

Страница 43: ...eys Marker Navigation Control Keys 5 Cursor Mode Indicator 6 Selection Knob 7 Volume Indicator 8 Audio Mute Indicator 9 Audio Mute Key 10 Screen Navigation Keys 11 Audio Keys 12 Numeric Keypad 13 Ente...

Страница 44: ...ow you to navigate through the application tabs The 6 Software Navigation keys colors and functions correspond to the Software Screen Navigation buttons on the application Function Keys Color Coded Th...

Страница 45: ...Stimulus Indicator The stimulus indicator yellow light LED blinks once for Single Stimulus and intermittently for Repetitive Stimulus Single Stimulus Key When the Single Stimulus key is pressed a sin...

Страница 46: ...ase level When operating the current stimulators be careful not to expose the patient to high currents Before connecting or disconnecting the stimulus electrode always reset the stimulator Stimulus Du...

Страница 47: ...the wheel to cycle through the markers on the active trace Cursor Mode Indicator The green light LED indicator is on when the cursor mode is enabled When enabled it allows you to move the Trace Marker...

Страница 48: ...ith 3 pedals option Footswitch is available as a triple pedal model 1 2 and 3 features with USB interface IPX1 Degree of protection against harmful ingress of water 1 User Programmable 2 Next Site Use...

Страница 49: ...and password may vary Shutting down the system Follow these procedures for a proper shutdown of your system to prevent damages to the unit 1 Click on Start Shutdown on the lower left hand of your com...

Страница 50: ...System and click Next 5 Enter the system serial number from the supplied licensing form and click Next 6 Click Next to accept default application program destination 7 Click Next to begin installation...

Страница 51: ...September 13 2018 3 1 3 Patient Information This chapter explains how to use the Patient Information feature used for working with your patient exam files...

Страница 52: ...UltraPro S100 3 2 September 13 2018 Blank page...

Страница 53: ...atient demographics will be available The highlighted field indicates the location on the screen where the text will be entered Press Enter or Tab to advance to the next line in the form Press Shift T...

Страница 54: ...er Visit Information is unique to each visit 5 To change visit details select Restart Visit 6 Select Visit Details 7 When finished with Visit Information click Done You will be prompted to save change...

Страница 55: ...d highlight the date e Click Restart Additional testing will be assigned to this visit Recalling an exam for review 1 To review waveform data a Click the Patient List button to display all patients on...

Страница 56: ...atient Find and highlight either the waveform file or visit depending on what you d like to eliminate 4 From the menu bar click File Delete Test to delete a specific waveform file or click File Delete...

Страница 57: ...an Exam This chapter provides general instructions for performing a study or exam using a motor nerve conduction study for the example You can apply these basic steps to perform most of the exams avai...

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Страница 59: ...nd verified For information about system components please see Chapter 2 in this guide You will also need the appropriate application software installed on your system Getting started When you switch...

Страница 60: ...ange to a different exam by double clicking the Test Folder and then from a Select Protocol dialog choose the specific exam and side Study menu In Study Menu exams are typically grouped based on diagn...

Страница 61: ...he protocol and side that you want to use for this exam and click OK 3 Proceed with testing 4 When this test is completed while still in the waveform screen press or click the New Nerve navigation key...

Страница 62: ...e type of test you are performing About the waveform screen 1 The filter and or stimulator settings are indicated on the tool bar 2 The trace labels and settings are indicated to the right of the wave...

Страница 63: ...ced over the endplate zone of a muscle innervated by the tested nerve The reference electrode is placed nearby in an electrically quiet area The ground electrode is usually placed between the stimulat...

Страница 64: ...e buttonabove thewheelon the stimulator probe to stimulate and acquire responses 4 Use the Stimulus Intensity control knob or the Intensity wheel on the stimulator probe to gradually increase the inte...

Страница 65: ...arkers 5 If using the UltraPro S100 Control Panel press the Marker Control Wheel to activate advance through the markers Turning the wheel allows you to position the active marker Red appropriately No...

Страница 66: ...t needs to be done immediately Deleting data 1 Click the waveform to highlight it 2 Click the Erase function key 3 The data trace and site are deleted from the trace area and Results Table IMPORTANT T...

Страница 67: ...l table Conduction Velocities will then be calculated automatically Trace analysis and display You can use the full screen to examine your traces 1 Select Display Full Trace Area ON or double click th...

Страница 68: ...uscle press or click New Muscle from the function keys The EMG Summary Selection dialog appears again Select your muscle and side and click Acquire 5 EMG is displayed in the Monitor portion of the wav...

Страница 69: ...Monitor EMG and Cascades Complex 1 displays a quadrant of Monitor EMG a quadrant of Long Trace EMG and a half screen of Cascades In both cases if you wish to acquire either Cascades or Long Trace EMG...

Страница 70: ...Pro S100 4 14 September 13 2018 Storing data Data is stored automatically as you advance to the next trace Adding a screen shot to a report 1 Press Transfer to move the current screen display to the r...

Страница 71: ...September 13 2018 5 1 5 Backup and Restore Data This chapter provides some instructions on backing up and restoring patients and settings...

Страница 72: ...UltraPro S100 5 2 September 13 2018 Blank page...

Страница 73: ...st to display all patients on the right side of the screen 2 Find the patient to be backed up and highlight the name All visits for this patient are included in the backup 3 From the menu bar at the t...

Страница 74: ...ar the top click File Import Patient s from File A dialog appears where you can locate your back up device 4 Once the back up device has been located search for the patients by looking for mps files I...

Страница 75: ...September 13 2018 6 1 6 ElectromagneticCompatibility EMC This chapter provides EMC information for the UltraPro S100...

Страница 76: ...UltraPro S100 6 2 September 13 2018 Blank page...

Страница 77: ...ideo signal cable digital RGB Maximum cable length 1 7 m Generic Printer signal cable Maximum cable length 1 7 m Generic Electrode and stimulation cables Shielded Maximum cable length 2 m Generic Stim...

Страница 78: ...STEM or to earth Staff that could touch connectors identified with the ESD warning symbol should receive this explanation and training This includes clinical biomedical engineering and health care sta...

Страница 79: ...ning is heeded This equipment system is intended for use by healthcare professionals only This equipment system may cause radio interference or may disrupt the operation of nearby equipment It may be...

Страница 80: ...d by RF Fields IEC 61000 4 6 3 V 0 15 MHz 80 MHz 6 V in ISM bands between 0 15 MHz and 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 and 315 100 dip 1...

Страница 81: ...Healthcare Facility Environment Electrostatic Discharge IEC 61000 4 2 8 kV contact 2 kV 4 kV 8 kV 15 kV air Electrical Fast Transients Bursts IEC 61000 4 4 1 kV 100 kHz repetition frequency Surges Lin...

Страница 82: ...0 FM 5 kHz deviation 1 kHz sine 2 0 3 28 710 704 787 LTE Band 13 17 Pulse modulation 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 modulation 18 Hz 2 0...

Страница 83: ...y notifying the operator that such an event has occurred Once the operator has cleared this message the system will typically reinitialize and indicate that acquisition can resume with the settings re...

Страница 84: ...safe mode 0mA and stop pulsing Before and after immunity test pulse max deviation remains within 10 Visual Stimulation mode will be active and LED goggles will be active and visually monitored Auditor...

Страница 85: ...am start up before and after immunity test are completed to confirm test loads properly ensuring safe storing of data Compliance to not burning No fire or smoke are allowed during all immunity tests o...

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Страница 87: ...ons equipment 6 8 Decontamination 1 g Deleting data 4 10 Deleting exams from a patient file 3 6 Device continuity maintenance and installation test 1 3 Disinfection procedure 1 g Display Keys 2 17 Dis...

Страница 88: ...l Start Stop Stimulus 2 20 Starting a new visit 3 4 Stimulus 2 17 Stimulus Duration Control Keys 2 18 Stimulus Indicator 2 17 Stimulus Intensity Duration Repetition Rate 2 18 Stimulus Intensity Contr...

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