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Dantec Clavis User Guide

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Please consult natus.com for your local sales & service offices.

Natus Manufacturing Limited
I

DA Business Park

Gort, Co. Galway, Ireland

Rx only

Содержание Dantec Clavis

Страница 1: ...Dantec Clavis User Guide 9031M6114EN Rev D Revision Date April 15 2021...

Страница 2: ...ations may have been car ried out since the production of this manual the system package may contain one or more addenda to the manual This manual including any such addenda must be thoroughly read be...

Страница 3: ...ion 8 Operating Dantec Clavis 9 Description 9 Control Panel Overview 9 Start AutoTest 10 EMG Mode 11 Electrodes 11 EMG Buttons 12 Stimulation Mode 12 Electrodes 12 Stimulation Buttons 13 Maintenance 1...

Страница 4: ...consult the instructions for use Please read the instruction manual before using this device ISO 60601 1 Table D 2 10 Follow instructions for use IEC 606011 2005 AMD1 2012 EN 60601 1 2006 A1 2013 Type...

Страница 5: ...e ISO 15223 1 Symbol 5 3 7 Indicates the upper and lower limits of temperature to which the medical device can be safely exposed The temperature is indicated adjacent to the horizontal lines ISO 15223...

Страница 6: ...ls the impact of fall ing objects and exposure to excessive smoke dust mechanical vibration or shock Any serious incident that has occurred in relation to the Dantec Clavis device should be reported t...

Страница 7: ...onventional precautions should be taken with patients with infectious diseases and broken skin Dantec Clavis cannot be sterilized After using an alcohol prep to clean the skin make sure any flammable...

Страница 8: ...ingle hand held device Clinical Benefits Dantec Clavis assists the physician during needle electrode examinations in the treatment of neuromuscu lar diseases such as Dystonia Strabismus Essential Trem...

Страница 9: ...ivity in muscles and nerves The CCS provides current pulses used to stimulate muscles and nerves Control Panel Overview Dantec Clavis Front Panel Button Symbol Legend Figure 1 Control Panel Overview P...

Страница 10: ...es can appear 1 mA LED Intensity or Gain too low first Intensity Gain combination 2 mA LED Intensity or Gain too high first Intensity Gain combination 3 mA LED Intensity or Gain too low second Intensi...

Страница 11: ...n of this user guide for further information Connecting the Electrode Leads to the Device Before starting the procedure connect the electrode leads to their corresponding color coded connectors as sho...

Страница 12: ...al flashes a green light when EMG is activated NOTE The volume can only be adjusted while in EMG mode NOTE The stimulation level can also be adjusted while in EMG mode Refer to the Stimulation section...

Страница 13: ...ack connector 4 Attaching the Electrodes to the Patient Once the electrode leads have been connected to the device you can attach the surface electrode s an ode to the patient and when ready proceed w...

Страница 14: ...mulation level For continuous decrease of the STIM Level press and hold down the decrease button Stimulation Level Bar The Stimulation Level bar ranges from 0mA to 15mA The Stimulation Level indicator...

Страница 15: ...after using the alcohol solution WARNING Do not immerse the device in any liquid or drip water into the connectors or any other openings in the cover CAUTION Do not use solvent silicon based or abras...

Страница 16: ...into the battery compartment making sure that the plus and minus contacts are facing as indicated by the symbols 5 Slide close the battery compartment lid until it locks in place CAUTION Do not use th...

Страница 17: ...013S0452 2 50mm 0 51mm 25G Grey 1 pouch 10 box 9013S0462 3 75mm 0 71mm 22G Light Green 1 pouch 10 box Disposable Non Gelled Surface Electrode Dantec reusable cables compatible with 9013L0203 See the N...

Страница 18: ...ssure ranging from 700hPa to 1060hPa Mode of Operation Continuous operation EMG Performance Noise Level 2 Vrms 10 Vpp Amplifiers EMG Mode Amplifier gain Min 100 000 EMG amplifier bandwidth 627Hz 2 2kH...

Страница 19: ...nic equipment EEE contains materials components and substances that may be haz ardous and present a risk to human health and the environment when WEEE is not handled correctly There fore end users als...

Страница 20: ...tem and its accessories have been designed to comply with the following national and international standards Table 1 Safety Standard of Compliance and Normative References CAN CSA C22 2 No 60601 1 08...

Страница 21: ...Part 4 5 Testing and Measurement Techniques Surge Immunity Test IEC 61000 4 6 Ed 2 0 with A1 2004 A2 2006 Electromagnetic Compatibility EMC Part 4 6 Testing and Measurement Techniques Immunity to Cond...

Страница 22: ...pliance Electromagnetic Environment Guidance RF emissions CISPR 11 Group 1 The Dantec Clavis uses RF energy only for its internal function Therefore its RF emissions are very low and not likely to cau...

Страница 23: ...t lines Complies Mains power quality should be that of a typical commercial or hospital environment Surge IEC 61000 4 5 1 kV differential mode 2 kV common mode Complies Mains power quality should be t...

Страница 24: ...com mended separation distance in meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site1 should be less than the compliance level in each fre quency2 Interferenc...

Страница 25: ...nd 7 Pulse modulation b 217 Hz 2 0 3 28 5 240 5 100 5 800 WLAN 802 11 a n Pulse modulationb 217 Hz 0 2 0 3 9 5 500 5 785 NOTE If necessary to achieve the IMMUNITY TEST LEVEL the distance between the t...

Страница 26: ...Dantec Clavis User Guide 26 Please consult natus com for your local sales service offices Natus Manufacturing Limited IDA Business Park Gort Co Galway Ireland Rx only...