natus UltraPro S100 Скачать руководство пользователя

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Symbol

Standard Reference

Standard Title

of Symbol

Symbol Title

as per

Referenced

Standard

Explanation

21 CFR 801.109(b)(1)

Labeling-

Prescription

devices

Device is

cleared for the

US market as

requiring a

prescription

Indicates that the

product is authorized

for sale by or on the

order of a licensed

healthcare

practitioner.

IEC 60601-1, Table D.2,

Symbol 20 (IEC 60417-

5333)

Part 1: General

requirements for

basic safety and

essential

performance.

Type BF

applied part

To identify a type BF

applied part

complying with IEC

60601-1.

ISO 15223-1

Symbol 5.1.7

Medical devices

— Symbols to be

used with medical

device labels,

labelling and

information to be

supplied.

Serial number

Indicates the

manufacturer's serial

number so that a

specific medical

device can be

identified.

ISO 15223-1

Symbol 5.1.5

Medical devices

— Symbols to be

used with

information to be

supplied by the

manufacturer —

Part 1: General

requirements

Batch code or

Lot code

Indicates the

manufacturer's batch

code so that the

batch or lot can be

identified.

ISO 15223-1

Symbol 5.1.6

Medical devices

— Symbols to be

used with

information to be

supplied by the

manufacturer —

Part 1: General

requirements

Catalogue

number

Indicates the

manufacturer’s

catalogue number so

that the medical

device can be

identified.

Содержание UltraPro S100

Страница 1: ...r 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 l...

Страница 2: ...use Oxfordshire Bicester OX27 7SG England United Kingdom Rx Only Copyright 2021 2023 Natus Medical Incorporated All Rights Reserved This manual contains proprietary information which is protected by c...

Страница 3: ...42 EEC Regulation EU 2017 745 CE Marking of Conformity Signifies European technical conformity Notified body number appears under symbol if applicable ISO 15223 1 Symbol 5 1 2 Medical devices Symbols...

Страница 4: ...O 15223 1 Symbol 5 1 7 Medical devices Symbols to be used with medical device labels labelling and information to be supplied Serial number Indicates the manufacturer s serial number so that a specifi...

Страница 5: ...1 General requirements Legal Manufacturer Indicates the medical device manufacturer ISO 15223 1 Symbol 5 1 3 Medical devices Symbols to be used with information to be supplied by the manufacturer Par...

Страница 6: ...information to be supplied by the manufacturer Part 1 General requirements Temperature limit Indicates the temperature limits to which the medical device can be safely exposed ISO 15223 1 Symbol 5 3...

Страница 7: ...equipment waste should not be discarded together with unseparated waste but must be collected separately ISO 15223 1 Symbol 5 4 3 Annex A A 15 Consult Instruction for Use Indicates an instruction to c...

Страница 8: ...ial performance Follow Instructions for Use Refer to instruction manual Booklet NOTE on ME EQUIPMENT Follow Instructions for use IEC 60601 1 Table D 2 2 Medical electrical equipment Part 1 General req...

Страница 9: ...Classifications 16 Ancillary Accessories 16 2 SAFETY WARNINGS AND PRECAUTIONS 18 Contraindications 18 Operating Environment Inflammable Vapors or Gases 18 Potential Electrical Shock Line Voltage 18 Pa...

Страница 10: ...n 1 35 Right side panel Generation 1 36 Rear panel Generation 1 37 Cable Connections Generation 2 38 Right side panel Generation 2 39 Rear panel Generation 2 40 Control Panel Functions Generation 1 an...

Страница 11: ...ew 58 Deleting exams from a patient file 59 Deleting a patient 59 6 PERFORMING AN EXAM 60 Setting up the System 60 Getting started 60 UsingUltraPro S100 Study Menu vs Test Menu 60 Testing using Study...

Страница 12: ...ks 71 Device Continuity Maintenance andInstallation Test 71 Troubleshooting 72 Noisy Data 72 External Artifacts 72 Cleaning Instructions 73 Disposal at End of Operating Life Instructions 73 Natus Tech...

Страница 13: ...ols 83 UltraPro Software Symbols 84 11 TECHNICAL SPECIFICATIONS 87 Amplifiers 87 Signal Display 87 Filters 87 Electrical Stimuli 87 Auditory Stimuli 87 Visual Stimuli Visual Stimulator 88 Visual Stimu...

Страница 14: ...Interval variability The UltraPro S100 is used to detect the physiologic function of the nervous system and to support the diagnosis of neuromuscular disease or condition The listed modalities do inc...

Страница 15: ...isks or side effects for procedures performed with the UltraPro Please note the Warnings and Cautions before applying power to and using the system UltraPro S100 System Essential Performance UltraPro...

Страница 16: ...system drives which contain local databases and temporarily store data files reports Disable unnecessary windows services designed for not work related features Protective and Equipment Classification...

Страница 17: ...e a length and gauge appropriate for the test being conducted The connector is a circular 5 pin DIN connector This nonproprietary pin connector is an industry standard for EMG systems The pin configur...

Страница 18: ...pment is not designed to be used in locations with inflammable vapors or gases that may cause explosions The equipment must not be used in atmospheres with a high concentration of oxygen or in buildin...

Страница 19: ...Refer servicing to qualified personnel Patient Supplies Electrodes Interaction Do not measure the impedance of needle electrodes with the needle positioned in the patient This practice may result in p...

Страница 20: ...0 6 383 4000 100 1000 100 16 45 135 Legend Resistance is the impedance of the stimulus electrodes in ohms Maximum current used is the maximum stimulus intensity that you plan to use Stimulus duration...

Страница 21: ...considered during use of strong emission sources such as High Frequency surgical equipment and similar so that for example the HF cables are not routed on or near the device Always use appropriate Bo...

Страница 22: ...this equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation Use of this equipment adjacent to or stacke...

Страница 23: ...ust from the exterior surface of the system with a soft brush or cloth Use a brush to dislodge any dirt on or around the connectors and panel edges Remove any dirt with a soft cloth slightly dampened...

Страница 24: ...tient discomfort The output waveform of the Natus Electrical stimulator is AC coupled through a transformer Therefore there is no DC component The pulse durations can range from 10uS to 1000uS the rep...

Страница 25: ...oad impedances less than the 4k ohm rated load Accuracy of Controls Stimulator values are determined by the operator based on the electrophysiological responses and the subjective reaction of the pati...

Страница 26: ...ation 2 refers to the control panel with the amplifier connection on the back Generation 3 refers to the current base housing and control panel UltraPro S100 System Connections Before operating the de...

Страница 27: ...Unit 2 High Speed Link Cable Proprietary C Power Adapter 3 Power Adapter IEC Cable 1ft D Electrical Stimulator Probe Advanced Stimulus Probe shown Comfort Probe RS10 optional not shown 4 Hospital Grad...

Страница 28: ...onnectors are electronically isolated Stimulator Output Socket isolated For connection of stimulus electrodes with DIN plugs Support for the active stimulus probe 2 Auditory Transducer Connection 3 LE...

Страница 29: ...igger Input Output Connector Option 1 6 Trigger Input Output Connector Option 2 7 HS Link Output Connector Amplifier Connection Cat5 with built in EMI Suppression Proprietary Cable 8 Visual Transducer...

Страница 30: ...ator 7 Standby Indicator 8 Stimulus Intensity Control Knob 9 Average Key 10 Single Stimulus Key 11 Recurrent Stimulus Key 12 Cursor Knob Trigger Line Scroll 13 Delete 14 Lower Selected Trace Key 15 Ra...

Страница 31: ...to control the different software functions on the application The colors and functions of the 12 Software Function keys correspond to the Software Function buttons in the application at the bottom of...

Страница 32: ...epetitive Stimulus key or the Single Stimulus key Single Stimulus key Press to present a single stimulus The indicator blinks once The Single Stimulus key can also be used to stop Repetitive Stimulus...

Страница 33: ...t run Audio Volume Audio keys Press the top of the button to increase the volume and the bottom of the button to decrease the volume Audio Mute key Press to switch between the On and Off function The...

Страница 34: ...er or the selected entry Selection knob Rotate the knob to move the traces markers or trigger cursor Test Selection Select Test key Press to access the Home page Test menu Side Selection key Press to...

Страница 35: ...Unit 2 High Speed Link Cable Proprietary C Power Adapter 3 Power Adapter IEC Cable 1ft D Electrical Stimulator Probe Advanced Stimulus Probe shown Comfort Probe RS10 optional not shown 4 Hospital Grad...

Страница 36: ...olated Stimulator Output Socket isolated For connection of stimulus electrodes with DIN plugs Support for the active stimulus probe 2 HS Link Output Connector Amplifier Connection Cat5 with built in E...

Страница 37: ...tick 4 USB Connector Type B For computer interface 5 Patient Response Tendon Hammer Connector 6 Trigger Input Output Connector 7 Visual Transducer Connector 8 Power Inlet Input 100 240Vac 50 60Hz Max...

Страница 38: ...Unit 2 High Speed Link Cable Proprietary C Power Adapter 3 Power Adapter IEC Cable 1ft D Electrical Stimulator Probe Advanced Stimulus Probe shown Comfort Probe RS10 optional not shown 4 Hospital Grad...

Страница 39: ...stimulator output connectors are electronically isolated Stimulator Output Socket isolated For connection of stimulus electrodes with DIN plugs Support for the active stimulus probe 2 Auditory Transd...

Страница 40: ...5 Patient Response Tendon Hammer Connector 6 Trigger Input Output Connector 7 HS Link Output Connector Amplifier Connection Cat5 with built in EMI Suppression Proprietary Cable 8 Visual Transducer Con...

Страница 41: ...Keys Marker Navigation Control Keys 5 Not used 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 Enter Key 14 Sta...

Страница 42: ...ons on the application The 12 Software Function keys colors and functions correspond to the Software Function buttons on the application Display keys The Right and Left control keys allow you to modif...

Страница 43: ...nsity Control Knob Use the Stimulus Intensity control knob to adjust the intensity of the stimulus released Rotate the control knob to the right to increase the stimulus intensity Rotate the control k...

Страница 44: ...trol wheel function below Selection Knob Rotate the wheel to move the traces markers or the trigger cursor Press the wheel to cycle through the markers on the active trace Not used Trace Marker Trigge...

Страница 45: ...Channel Amplifier Amplifier Input Connectors 1 3 1 4 The amplifier input connectors feature both a DIN type socket and a pair of 1 5 mm touch proof connectors 3 Channel Amplifier 4 Channel Amplifier...

Страница 46: ...Natus UltraPro S100 3 Channel Amplifier Natus UltraPro S100 4 Channel Amplifier 3 Channel Side Panel 4 Channel Rear Panel 3 and 4 ChannelAmplifier HS Link Input Connector Main Unit Side Panel Rear Pan...

Страница 47: ...ity 4 Button C Next Study Exam Active in all tests Momentarily press the button on the handle 5 Button A Next Site Button Active in Motor and Sensory Nerve testing Momentarily press the button on the...

Страница 48: ...al symbol Footswitch with 3 Pedals Option A footswitch is available as a triple pedal model with a USB interface Pedals may be programmed by selecting Test Options Hardware Controls and inserting the...

Страница 49: ...arnings and cautions Models 9031D040x 9031D041x Function Description 1 Mains Input Plug the shielded mains power cord supplied with the system into this socket NOTE Only use a shielded power cord from...

Страница 50: ...y on basic insulation 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 th...

Страница 51: ...mulus Probe 842 695000 UltraPro S100 RS10 Stimulus Comfort Probe and adapter 9031E0258 Natus Unshielded Head Phones DDR45 9031E0277 Natus Tubal Insert Phones 9031E0223 Natus LED Goggles with 5m cable...

Страница 52: ...us Elite Viking Synergy EMG thumb drive into the USB port or the installation disk into the disk drive The Setup program should start up automatically If it does not start automatically click the Setu...

Страница 53: ...tom of screen Results Table Right click to enter functions Click the wrench symbol to enter Results Table Setup Left click to enter Site Segment Setup text values and comments Reports To display the R...

Страница 54: ...lite software release features by release version select Contents EMG Onscreen Help and Appendix 6 Shutting Down the UltraPro System Follow these procedures for a proper shutdown of your system to pre...

Страница 55: ...tor cabling 519 Could not select Impedance Check mode because Acquire is on 1 Turn Acquire off before starting an impedance check 520 Cannot do impedance check when calibration signal is on 1 Turn OFF...

Страница 56: ...3 Check ODBC driver configuration 1206 1208 1209 1210 1236 An exception was detected when accessing the database 1 If networked may be caused by network problems Check network and retry 2 May indicate...

Страница 57: ...ds place the cursor in the desired field and type the information Press the Tab key to advance the cursor to the next field 8 Click Save to save the patient data to the hard disc 9 Click Begin Testing...

Страница 58: ...ion in the main UltraPro S100 screen Patients are listed on the right b Find the patient and highlight the name c Click Catalog to display all the visits for this patient d Search by date to find the...

Страница 59: ...or this patient Find and highlight either the waveform file or visit to delete 4 From the menu bar click File Delete Test to delete a specific waveform file or click File Delete Visit to delete all da...

Страница 60: ...roaches to selecting exams for testing Test Menu or Study Menu Each is discussed in greater detail below Test menu With Test Menu exams are grouped by type motor sensory F Waves etc To start an exam o...

Страница 61: ...k the New Nerve navigation key if performing a nerve of the same type or Exit Test if the nerve is from another folder 5 Perform the exam 6 Continue with testing until completed Patient to report in s...

Страница 62: ...the selection 3 If you do not find the desired protocol select Generic Nerve 4 When testing is completed the nerveandsite labelscanbechanged Left click the site to highlight it then right click and s...

Страница 63: ...ator at the appropriate site 3 Press the Single Stimulus key on the control panel or footswitch or the Acquire button above the wheel on the stimulator probe to stimulate and acquire responses 4 Use t...

Страница 64: ...e erase right click the waveform and select Unerase IMPORTANT If unerasing data it needs to be done immediately Deleting data 1 Click the waveform to highlight it 2 Click the Delete function key 3 The...

Страница 65: ...n of the display begins displaying EMG There is no sound initially To enable sound just unmute the speakers 4 When you are finished with the first muscle press or click New Muscle from the function ke...

Страница 66: ...quadrant of Monitor EMG a quadrant of Long Trace EMG and a half screen of Cascades In both cases to acquire either Cascades or Long Trace EMG press or select Acquire from the function keys If Acquire...

Страница 67: ...Study Menu select the examyou want to use Select a protocol only if using Test Menu 1 Usetheselectthenerveandtestedside 2 PressEnter toaccept the selection 1 The filter and or stimulator settings are...

Страница 68: ...mplitude potentials i e noise 7 After the first average is complete the system begins a new trial or replicates to assess the reproducibility of the potential The data is saved After completing the se...

Страница 69: ...n the traces to their original positions Reports There are two locations to configure a report 1 From the Patient Screen Select Edit User Profile Setup Report Setup select the options for the desired...

Страница 70: ...the file and click Save A progress window appears while the data is copied to the media When completed confirmation of a successful backup is displayed 5 The patient will then need to be deleted manua...

Страница 71: ...e and wear monthly Replace frayed or worn cables immediately Clean the system and accessories monthly or sooner if the items are visibly soiled Refer to the Cleaning instructions below When using a ca...

Страница 72: ...t use dimmer switches Check the electrodes Make sure that the patient electrodes are connected to the correct channel in the amplifier and fit securely Do not use electrode cables that are broken fray...

Страница 73: ...te must be separately collectedfor the proper treatment and recovery to ensure that WEEE is reused or recycledsafely In line with that commitment Natus may pass along the obligation for takeback and r...

Страница 74: ...information ready for your communication with Technical Support Product name system serial number and or system component serial numbers Software version Detailed description of the problem The steps...

Страница 75: ...h cable Main Unit Amplifier Cable length 2 0 m Generic USB cable PC Front End Cable length 1 m Generic Video signal cable digital RGB Maximum cable length 1 7 m Generic Printer signal cable Maximum ca...

Страница 76: ...ctice and the damage that can be done to electronic components if they are touched by an OPERATOR who is electrostatically charged Further an explanation should be given of methods to prevent build up...

Страница 77: ...plies buildings used for domestic purposes provided the following warning is heeded WARNING This equipment system is intended for use by healthcare professionals only This equipment system may cause r...

Страница 78: ...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 cycle and 30 dip 25 cycles 50Hz Single phase at 0 Voltage Interruptions IEC 61000 4 11 100 dip...

Страница 79: ...ment 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...

Страница 80: ...tion 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 3 28 870 930 1 7...

Страница 81: ...arily discontinue operation If this should occur a message will display notifying the operator that such an event has occurred Once the operator has cleared this message the system will typically rein...

Страница 82: ...iated with this device A caution indicates that there is a risk of injury to the user or patient or risk of damage to the device Standby Power On or Run Protective Earth ground Earth ground Input Outp...

Страница 83: ...cer Connection Dual USB Connectors Type A LINK HS Link Output Connector Trace up for Synergy icon is for Next Trace only Trace down for Synergy icon is for Next Trace only Set Markers Decrease Duratio...

Страница 84: ...orresponds tothe red input connector 4 Channel Amplifier Run Standby indicator UltraPro Software Symbols NOTE Hover the mouse over the software symbol to display the symbol s function Click the symbol...

Страница 85: ...ummary Add Report Order By Delete Reverse Side Study Menu Test Menu Level Panel Single Sweep Repetitive Sweep Test Options Setup Right Trace Area On Off Marker Bar On Off Average Repeat Test Refilter...

Страница 86: ...oth Reference Setup EMG Volume Capture Screen Capture Video Review Previous and Next Print Screen Complex 1 and 2 Cursors Vertical and Horizontal Trigger Edge and Type EMG Display Options Monitor Casc...

Страница 87: ...0 2 Hz 5 kHz Electrical Stimuli Stimulus Output Constant current mode delivering 0 100 mA stimulus into a 4 k load Stimulus Intensity 0 02 to 0 4 mA Stimulus Duration 0 05 1 ms Stimulus Mode Monophas...

Страница 88: ...Trigger In Pin 5 Ground Notes The signal level on the pins is 5 Volt A pulse going from 5 Volt to Zero Volt is a trigger Trigger In must be at least 20 Sec long Trigger Out is a 20 Sec pulse Environm...

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