NC-stat® DPNCheck™ User Manual - NC
Contents
1. device fails to operate as described in this manual contact NeuroMetrix immediately Within the USA customers should contact NeuroMetrix Customer Service Phone 888 786 7287 Fax 781 663 3820 E mail customerservice neurometrix com International customers should contact the nearest authorized NeuroMetrix representative If the shipping container is damaged customers should also notify the shipping carrier 2 3 Battery Installation The NC stat DPNCheck device uses a standard 3V Lithium lon Battery Type CR123A 1 Remove the battery cover on the backside of the device 2 Insert the battery Check the battery symbol inside the device to ensure proper orientation of positive and negative contacts 3 Replace the cover 2 4 Registration In order to activate your warranty receive software updates and use various optional reporting and data management services you must register your device with NeuroMetrix Call NeuroMetrix Customer Service 888 786 7287 to register the device s serial number The serial number is an 8 digit number e g 11110001 found inside the battery compartment 2013 NeuroMetrix Inc All Rights Reserved PN2203282 Rev G NC stat DPNCheck Device User Manual CHAPTER THREE OPERATING INSTRUCTIONS This chapter explains the basic operation of the NC stat DPNCheck device 3 1 Power On To power on the device press the grey button under the LCD Display Screen The green light will blink once to ind2. opened immediately prior to use The biosensors should not be used after the expiration date shown on the package 4 5 NeuroMetrix Inc Limited One Year Warranty NeuroMetrix Inc manufactures its hardware products from new components in accordance with industry standard practices NeuroMetrix warrants the NC stat DPNCheck device to be free from defects in materials and workmanship The warranty term is one year beginning on the date of invoice as described in the following text Damage due to shipping the products is covered under this warranty Otherwise this warranty does not cover damage due to external causes including accident abuse misuse problems with electrical power servicing not authorized by NeuroMetrix Inc usage not in accordance with product instructions failure to perform required preventive maintenance and problems caused by use of parts and components not supplied by NeuroMetrix Inc This warranty does not cover any items that are in one or more of the following categories software external devices except as specifically noted or accessories or parts added to a NeuroMetrix device through authorized NeuroMetrix service centers NeuroMetrix Inc will repair or replace products covered under this limited warranty that are returned to NeuroMetrix s facility or an authorized NeuroMetrix representative To request warranty service you must call the NeuroMetrix Customer Service at 888 786 7287 or call an authorize
3. will disable the device as indicated by the Ub error code Disabled devices must be returned to NeuroMetrix for a factory reset Users will be required to pay a service fee and all shipping and handling charges 2013 NeuroMetrix Inc All Rights Reserved PN2203282 Rev G 10 NC stat DPNCheck Device User Manual CHAPTER FOUR SAFETY WARRANTY SERVICE CARE AND SERVICE 4 1 Safety Notes Do not immerse any portion of the NC stat DPNCheck device in water or other fluids Avoid spilling fluids on the Device or accessories Spilling fluids may damage the device and or present a fire or shock hazard Possible hazard of fire or explosion Use care when operating this device close to oxygen sources flammable gases and chemicals Failure to follow the Cautions listed below may change the performance of the equipment or cause damage to the equipment Radio frequency RF interference from devices such as cellular phones and two way radios may cause improper operation of the NC stat DPNCheck device if used in close proximity Accessory equipment connected to the USB port must be certified according to the respective IEC standards e g IEC60950 for data processing equipment and IEC60601 1 for medical equipment Most computers manufactured by major suppliers meet the IEC60950 standard If in doubt consult your local Information Technology support 4 2 Maintenance and Cleaning Other than changing the battery there are no user service
4. C Note If the red light on the device appears during this step the data could not be transferred See Appendix F for Troubleshooting 2013 NeuroMetrix Inc All Rights Reserved PN2203282 Rev G 17 NC stat DPNCheck Device User Manual Appendix E TEMPERATURE COMPENSATION Nerve conduction measurements may be sensitive to the temperature around the nerve which in superficially located nerves e g sural may be different than body temperature Nerve temperature is usually approximated by the skin surface temperature overlying the nerve The NC stat DPNCheck device compensates for the effect of temperature on sural nerve conduction velocity using a linear temperature compensation factor of 1 m s per C with a reference temperature of 28 C The effect of temperature on sural nerve conduction amplitude is small and therefore compensation is not applied for this parameter The temperature is measured by an infrared thermometer located at the base of the handle behind the stimulating probes If the temperature is below 23 C then the patient is too cold to reliably measure nerve conduction and Ir the test will stop with SL displayed on the LCD screen 2013 NeuroMetrix Inc All Rights Reserved PN2203282 Rev G Appendix F TROUBLESHOOTING Display Light Description Data quality issue Data quality issue stimulation issue disconnected during test Data quality issue Patient ankle cold Lo iwy H cl CO Devic
5. ETRIX INC DOES NOT ACCEPT LIABILITY BEYOND THE REMEDIES SET FORTH IN THIS WARRANTY STATEMENT OR LIABILITY FOR INCIDENTAL OR CONSEQUENTIAL DAMAGES INCLUDING WITHOUT LIMITATION ANY LIABILITY FOR PRODUCTS NOT BEING AVAILABLE FOR USE OR FOR LOST DATA OR SOFTWARE These provisions apply to NeuroMetrix s limited one year warranty only 4 6 Service Should the NC stat DPNCheck device require service contact NeuroMetrix Customer Service at 888 786 7287 When you call NeuroMetrix to request service please be prepared to provide the following information e Serial number e Description of the problem Do not return any component of the NC stat DPNCheck device without first obtaining a Return Material Authorization RMA Number from Customer Service Be sure that this number is clearly visible on the exterior of the return package If a NC stat DPNCheck device component must be shipped to a service center pack it in the original shipping container or in packaging which provides enough protection to prevent damage during shipment 4 7 FDA Notification The NC stat DPNCheck device is manufactured in compliance with the U S Federal Quality System Regulation 21 CFR Part 820 As a health care provider you may have responsibilities under the Safe Medical Devices Act SMDA for reporting to NeuroMetrix and possibly the FDA the occurrence of certain events FDA reportable events are detailed in 21 CFR Part 803 In accordance with our Quality Sys
6. NIGES tea D adi iatsvee User Manual Mies NEUROMetrix NC stat DPNCheck Device User Manual CHAPTER ONE INIRODUCIION iaia 2 LeLINAICATO NS For USE eeraa opa 2 LZ CONUAINDICAlO ice 2 1 3 Warnings Precautions amp Safety ConsideratiONS 2 POM n 2 CHAPTER TWO SETUR coirean E E E 4 LLP TeC ONEENS oire a A E a 4 22 REDOUN Daniela 4 Pd Bnr n aO T E EE EET EATA 4 PARCE O a E E A E E E E E EEEE E AA AA 4 CHAPTER THREE OPERATING INSTRUCTIONS aisi 5 HEM 5 RPM 5 3 SBollerrbliea din 5 IATE PrO OUE lira 5 LOTEC RO ON aa A E E E aiar 8 5 0 ReECOMMM ENG CO Teee PrO OCO kepre e A E OEE E A a 9 CHAPTER FOUR SAFETY MAINTENANCE AND SERVICE ccccssssssscsssccsccssccsscnsccesscescsscsesscesccessoesees 10 Dy SalWNOP0S ri na 10 A2 Maintenance and CIeaniiNg ARR O 10 4 3 Use of and Disposal of Batter OSsicccicscntsascvieadesserccedasnccesadcoussanedeoasdoadeenatessedeessasudetasvaedavasudedaeidesssavoeserdes 10 4A Sorice OF BOSEN O ica 11 4 5 NeuroMetrix Inc Limited One Year Warranty i 11 LIE iii iena 12 47 PRANDI oi lan 12 APPENDIX Appendix A SCC IT oiran 13 Appendix B Senna 14 Appendix C Sensory Nerve Conduction Principles amp Nerve Conduction Terminology nt 15 Appendix D USB C onmectiOrsiriiiinirrioir ia E iei 16 Appendix E Temperature Compensation re 17 Appendix F TroubIESNOotng eran 18 Appendix G Manufacturer s Declaration
7. able parts inside the NC stat DPNCheck device Refer to the warranty and service information included in this manual The NC stat DPNCheck device has been manufactured to the highest quality standards To ensure continued trouble free operation avoid exposing the components to excessive shock vibration or moisture Cleaning the device and any components e Remove the battery and close the battery compartment and any other external connections before cleaning the Device or any of the components e Use a soft damp cloth or sponge to clean the exterior of the unit e Do not use abrasive cleaners or strong solvents to clean the device Disinfecting the NC stat DPNCheck device e If the NC stat DPNCheck device becomes contaminated by body fluids it should be cleaned using a hospital grade disinfectant and a disposable soft cloth or paper towel per standard hospital or office protocol 4 3 Use of and Disposal of Batteries The battery is a 3 0V Lithium Battery type CR123A Dispose of used Lithium battery in accordance with national regional and local regulations 2013 NeuroMetrix Inc All Rights Reserved PN2203282 Rev G 11 NC stat DPNCheck Device User Manual 4 4 Storage of Biosensors NC stat DPNCheck biosensors are single use non sterile devices They should be stored lying flat at room temperature in a dry location Storage temperature should not fall below 22 F 30 C or exceed 140 F 60 C The package should only be
8. ablishments including domestic establishments and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes Floors should be wood concrete or ceramic tile 3 V m compliance level 3 A m compliance level 2013 NeuroMetrix Inc All Rights Reserved PN2203282 Rev G
9. action _ Confirm that the patient is relaxing leg muscles Reposition patient if necessary 3 Retest Biosensor backing not removed 1 Remove biosensor backing and retest 1 Ensure that tester s hand does not obstruct temperature detector _ Warm patient s lower leg by putting a sock on and elevating the leg If unsuccessful o instruct the patient to put on their shoes and socks then walk around for 1 2 minutes if able OR o Wrap the patient s lower leg and ankle with a blanket or heating pad OR o briskly rub the patient s lower ankle Note Although it is not an ideal approach this technique can be used if the tester is in a hurry 3 Retest 1 Replace battery 1 Contact Customer Service e Temperature detector field of view obstructed Patient s ankle temperature lt 23 C Battery is low Device hardware issue Excessive biosensor reuse detected Excessive repeat testing 1 Gontact Customer Service 2013 NeuroMetrix Inc All Rights Reserved PN2203282 Rev G 19 NC stat DPNCheck Device User Manual Appendix G MANUFACTURER S DECLARATIONS OF CONFORMITY in accordance with ISO IEC 17050 1 and ZLG 3 9 A 4 MANUFACTURER NeuroMetrix Inc 62 Fourth Avenue Waltham MA 02451 USA Object of the declaration NC stat DPNCheck Catalog Number NC 030 NC DP1 NC DP2 Under the sole responsibility of NeuroMetrix Inc the object s of the declaration described above is in co
10. d sensory nerve action potential SNAP amplitude The device includes the following elements Power Test Button allows users to turn the device on and initiate a test LCD Display area where test results and error messages are displayed LED Light status indicator Battery Compartment holds 3V Lithium battery that powers device Biosensor Port where the biosensor is connected to the device Infrared Thermometer reads the patient s skin surface temperature Stimulating Probes non invasively deliver electrical stimulation to the sural nerve Biosensor a single patient use biosensor is needed to conduct each test USB Port for communication with a PC 2013 NeuroMetrix Inc All Rights Reserved PN2203282 Rev G NC stat DPNCheck Device User Manual LCD Display Screen LED Light A Power Test Button Device Handle Battery compartment USB port Biosensor port Biosensor stimulating probes Infrared thermometer 2013 NeuroMetrix Inc All Rights Reserved PN2203282 Rev G NC stat DPNCheck Device User Manual CHAPTER TWO SETUP 2 1 Package Contents Prior to use the package should be inspected to ensure that all of the following components are included and undamaged STANDARD COMPONENTS e NC stat DPNCheck device e 3V Lithium Battery e USB Cable 2 2 Reporting Damage If any of the components appear to be damaged or if the NC stat DPNCheck
11. d technical support representative within the warranty period NeuroMetrix will issue a Return Material Authorization RMA Number The product must be shipped to NeuroMetrix in the original or equivalent packaging with prepaid shipping charges and insured against loss or damage during shipment NeuroMetrix will ship the repaired or replacement units to the originator freight prepaid to addresses within the US or Canada Shipments to other locations will be made freight collect All parts removed from repaired products will become the property of NeuroMetrix Inc If NeuroMetrix repairs or replaces a product the original warranty is not extended NEUROMETRIX INC MAKES NO EXPRESS WARRANTIES OR CONDITIONS BEYOND THOSE STATED IN THIS WARRANTY STATEMENT NEUROMETRIX DISCLAIMS ALL OTHER WARRANTIES AND CONDITIONS EXPRESS OR IMPLIED INCLUDING WITHOUT LIMITATION IMPLIED WARRANTIES AND CONDITIONS OR MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE SOME STATES OR JURISDICTIONS DO NOT ALLOW LIMITATIONS ON IMPLIED WARRANTIES OR CONDITIONS SO THIS LIMITATION MAY NOT APPLY TO YOU NEUROMETRIX S RESPONSIBILITY FOR MALFUNCTIONS AND DEFECTS IN HARDWARE IS LIMITED TO REPAIR AND REPLACEMENT AS SET FORTH IN THIS WARRANTY STATEMENT THESE WARRANTIES GIVE YOU SPECIFIC LEGAL RIGHTS IN ADDITION TO OTHER RIGHTS WHICH VARY FROM STATE TO STATE 2013 NeuroMetrix Inc All Rights Reserved PN2203282 Rev G 12 NC stat DPNCheck Device User Manual NEUROM
12. e hardware issue Excessive biosensor reuse detected Device is disabled 18 NC stat DPNCheck Device User Manual Possible Causes Solution Incorrect limb setting on device 1 Ensure that the limb setting on the device is correct 2 If incorrect re select the limb on the device by pressing the button down for 1 2 seconds until correct limb is selected left r right 3 Retest Adequate signal could not be recorded Confirm placement and retest Insufficient gel on probes Poor contact of probes with skin Inadequate skin preparation in probe contact area e Probe movement during test e Gel smeared between the probes Re do skin preparation and device placement e Clean probes and re apply gel e Vigorously scrub the ankle area Reposition the device on the patient with firm pressure to both probes and on biosensor Retest with constant force to limit device movement during test Biosensor disconnected during Re insert biosensor with tall traces test facing outward Entire biosensor tail must be inserted If problem persists replace biosensor e Check for good contact on both sides of the foam If problem persists re prepare skin and replace with new biosensor Retest e Biosensor backing not removed e Incomplete biosensor contact e Skin in biosensor contact area inadequately prepared Signal contamination due to patient movement or excessive muscle contr
13. icate power on and indicates that the device is ready for use 3 2 Power Off The device will power off automatically after 10 minutes of inactivity Note Your last test is saved on the device until a new test is performed 3 3 Battery Lifetime The NC stat DPNCheck is powered by a 3V Lithium lon Battery A solid amber light will indicate that the battery is low and should be replaced as soon as you complete the test in progress A solid red light I accompanied by indicates that the battery must be replaced before any further testing See section 2 3 for battery installation 3 4 Test Procedure Proper patient positioning skin preparation and device placement are essential to accurately administer the test The section below will demonstrate proper techniques Step 1 Lay the patient on an exam Step 2 Power on the device Step 3 Fully insert the biosensor into table and prepare the testing area The display will show and the the port The light will tum green once with a Preparation Pad light wil tum amber or red the biosensor has been properly inserted when the battery needs to be replaced Align to foam The display will show to set the leg to be tested Tip Both the outer ankle bone lateral malleolus and i l l Achilles tendon should be easily accessible as shown Tip Align the biosensor with the foam on at left Please reference the User Manual for altemative all sides REMOVE BACKING label side patient po
14. istance Latency Latency Time Nerve Conduction Terminology Amplitude size of nerve response microavolts uv Conduction Velocity CV speed of nerve response propagation meters per second ms Latency time between nerve stimulation and detection of response Distance propagation distance between site of nerve stimulation and response detection 9 22 cm Response bioelectrical nerve response typically lt 50 pV Stimulation dectrical stimulation of nerve typically 20 60 millamps for 100 microseconds Undetectable nerve response amplitude is below the threshold of electronic detection displayed as amplitude pv 2013 NeuroMetrix Inc All Rights Reserved PN2203282 Rev G 16 NC stat DPNCheck Device User Manual Appendix D USB CONNECTION Uploading Data The most recent test results may be uploaded to your PC using a USB cable A mini USB port is located on the side of the device The device can only retain data from a single test Users must upload the data after each test for report generation Note If the device powers off before performing an upload the data is still saved on the device and may be uploaded 1 2 Power on the device Open the USB port located on the side of the device Ensure that the Communicator application is open on the PC Connect the USB cable to the device and PC After connecting the device to the PC with the USB cable the device LCD screen will display P
15. n the image above 2013 NeuroMetrix Inc All Rights Reserved PN2203282 Rev G NC stat DPNCheck Device User Manual Step 9 Press the button to start the Step 10 Maintain constant force test The light will blink with each throughout the test The test time stimulation Limb selected will be may vary per patient but normally displayed lasts for 10 15 seconds The results will display once completed Tip Check for good contact on both sides of the foam Tip During test maintain a Firm pressure on probes b Firm pressure on biosensor c Steady positioning Patient Positioning The preferred position is for the patient to lie on their side on an exam table with the leg to be tested on top Figure 1 If you cannot see both the outer ankle bone and the calf midline Achilles tendon adjust patient position to their appropriate side The patient should be in a comfortable position that allows for relaxation of the leg and foot It is important that the patient remains relaxed during the test Alternative positions may include side with left leg extended Figure 2 prone with feet hanging off the exam table Figure 3 and chair with one leg resting on a chair Figure 4 The patient should bend their knee and place half of their calf on to the seat in order for the leg to be properly rested and grasp the back of the chair for stability It is recommended that a sturdy chair with no wheels and a padded seat be used for pa
16. nformity with the requirements of the following documents Medical Device Directive 93 42 EEC Annex Il NC 030 Annex VII NC DP1 NC DP2 European Authorized Representative EMERGO Europe Molenstraat 15 2513 BH The Hague The Netherlands Notified Body Annex Il Products Only TUV SUD Product Service GmbH Notified Body Number 0123 Zertifizierstelle Ridlerstasse 65 80339 Munchen Germany Date of First CE Marking September 1 2011 NC 030 NC DP1 September 11 2012 NC DP2 Signed for and on behalf of NeuroMetrix Inc C Wow Rainer Maas Director of QA RA Compliance Waltham MA 02451 USA 2013 NeuroMetrix Inc All Rights Reserved PN2203282 Rev G 20 NC stat DPNCheck Device User Manual Appendix H ELECTROMAGNETIC COMPATIBILITY DECLARATION NC stat DPNCheck is intended for use in the electromagnetic environment specified below The user should ensure that it is used in such an environment re Compliance Electromagnetic environment guidance RF emissions CISPR 11 RF emissions CISPR 11 Electrostatic Discharge Immunity ESD IEC 61000 4 2 Radiated RF IEC 61000 4 3 Magnetic Fields IEC61000 4 8 Class B 6kV contact 8kV air 3 V m 80 MHz to 2 5 GHz NC stat DPNCheck uses RF energy only for its internal function Its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment NC stat DPNCheck is suitable for use in all est
17. red on the device and need to recall the last result wait 3 minutes for the device to power down and then follow the instructions above for recalling results 2013 NeuroMetrix Inc All Rights Reserved PN2203282 Rev G NC stat DPNCheck Device User Manual 3 6 Recommended Testing Protocol This protocol is intended only as a guide It is the responsibility of the provider to determine the clinical necessity of nerve conduction testing Testing a single leg is usually clinically sufficient e Whenever possible the same leg should be tested first in all patients If the first test does not provide a result or to confirm the result the test should be repeated e Pressing the test button again is usually all that is required see Appendix F The test will provide a nerve conduction result the first time in most patients Tip In certain circumstances it may be beneficial to confirm the results Examples include Confirm CV if amplitude is lt 4 uV Confirm undetectable response Confirm result inconsistent with clinical findings If the leg setting on the device was incorrect then the test should be repeated If the repeat test does not provide a result or for further confirmation of the results the opposite leg should be tested e The same biosensor may be used on both legs Note The NC stat DPNCheck device should only be used with NeuroMetrix single patient use biosensors Repeat use of the same biosensor on multiple patients
18. s of CONformity 19 Appendix H Electromagnetic Compatibility Declaration 20 2013 NeuroMetrix Inc All Rights Reserved PN2203282 Rev G NC stat DPNCheck Device User Manual CHAPTER ONE INTRODUCTION 1 1 Indications For Use The NeuroMetrix NC stat DPNCheck is intended to measure neuromuscular signals that are useful in diagnosing and evaluating systemic and entrapment neuropathies 1 2 Contraindications None 1 3 Warnings Precautions amp Safety Considerations Federal law restricts this device to sale or use by or on the order of a health care provider appropriately licensed by the law in the state in which they practice For safe and effective operation of the device please read and understand the User Manual thoroughly Use the device only as described in this manual Failure to follow the Warnings listed below may cause injury to the patient or operator Possible hazard of fire or explosion Use care when operating this device close to oxygen sources flammable gases and chemicals Patients with implanted electronic devices should not be subjected to electrical stimulation unless specialist medical opinion has first been obtained Avoid accidental contact with connected but unapplied conductive components including electrodes Do not place any part of the device over broken skin lesions or wounds 1 4 Overview The NC stat DPNCheck device measures the sural nerve conduction velocity an
19. sitions faces up The test area should be vigorously scrubbed with the Preparation Pad provided 2013 NeuroMetrix Inc All Rights Reserved PN2203282 Rev G NC stat DPNCheck Device User Manual Step 4 Set the leg to be tasted The Step 5 Apply a small amount of device display screen will blink with conductive gel to each probe the leg selected 1 left r righi To The head of the probe should be switch the leg hold the button down covered with gel for 1 2 seconds and the selection will Tip Remove excess gel that may Cingi opposi lay lead to gal smearing between the Tip Whenever possible test the two probes same leg in all patients Step 6 Remove the backing from Step 7 Locate the patient s outer the biosensor ankle bone to align the long probe just behind it Tip The anode short probs A and cathode long probe C should be aligned to the outer ankle bone B The cathode should be adjacant to the middle central prominence of the ankle bone The nerve is stimulated only under the cathode Step 8 Align the device on the lower calf by pushing down firmly on the foam Tip The probes should be placed behind The device should point towards the back side of the knee with the inner edge but not over the outer ankle bone of the biosensor placed next to the midline Achilles tencon Ensure that the device is aligned to but does not cross over the midline as shown by the dashed line i
20. software limited to 70 mA 100 us 1 Hz maximum Non contact infrared 3 0 V Lithium Primary CR123A 2 digit 7 segment IEC 529 IPXO not protected from ingress of liquids BF Applied Part IEC 60601 1 Sural sensory orthodromic Preconfigured electrode array Behind lateral malleoulus Bipolar 2 cm separation 9 22 cm proximal to stimulation Bipolar 2 cm separation Onset of negative deflection m s Peak to peak uV Linear 1 0 m s per degree maximum correction 5 m s 28 C 2013 NeuroMetrix Inc All Rights Reserved PN2203282 Rev G 14 NC stat DPNCheck Device User Manual Appendix B SYMBOLS Attention User Manual device labeling Type BF Applied Part Mark identifying compliance with council directive 93 42 EEC Identification mark of the Notified Body TUV SUD 0123 responsible for evaluation of the CE Technical File WEEE Waste Electronic and Electrical Equipment symbol in accordance with council directive 2002 96 EC MN Abbreviation for model number 2013 NeuroMetrix Inc All Rights Reserved PN2203282 Rev G 15 NC stat DPNCheck Device User Manual Appendix C SENSORY NERVE CONDUCTION PRINCIPLES amp NERVE CONDUCTION TERMINOLOGY sensory Nerve Conduction Principles Sensory nerve conduction measures function of large myelinated axons light touch proprioception vibration and pressure sensation stimulation Response TEC 4 i Demyelination DE Po apnyjdungy CV D
21. tem NeuroMetrix should be notified of any device failures or malfunctions Issues encountered should be reported to NeuroMetrix Customer Service Outside of the United States problems should be reported to the nearest NC stat DPNCheck device distributor This information will help ensure that NeuroMetrix continues to provide products and services of the highest possible quality 2013 NeuroMetrix Inc All Rights Reserved PN2203282 Rev G Appendix A SPECIFICATIONS Dimensions Device Size Weight Environmental Shipping and Storage Temperature Humidity Altitude Operating Hardware Channels CMRR typical Gain Noise typical Frequency Response Sampling Frequency ADC Resolution Stimulator Type Constant Current Stimulator Max Voltage typical Stimulator Max Current Stimulator Pulse Width Stimulation Frequency Skin Temperature Measurement Battery LCD Display Water Resistance Classification Type Neurophysiology Nerve Methodology Stimulation Site Stimulation Configuration Recording Site Recording Configuration Conduction Velocity CV Response Amplitude Temperature Compensation Method Reference Temperature 13 NC stat DPNCheck Device User Manual 5 5 cm x 19 0 cm x 11 6 cm 160 g 20 C to 50 C 10 to 90 non condensing 55 kPa to 100 kPa 10 C to 30 C 2 gt 100 dB x977 lt 2 uV rms 3 dB 2 Hz 2 kHz 10 kHz 16 bits effective Monophasic 420 V 100 mA hardware
22. tient comfort Note Users should only use a chair when an exam table is not available Figure 1 Allernalive posilion side Figure 2 Allernalive posilion side 2013 NeuroMetrix Inc All Rights Reserved PN2203282 Rev G NC stat DPNCheck Device User Manual Figure 3 Allemalive pesilion prone Figure 4 Chair leg up 3 5 Test Results When the test is complete the device display will toggle between the sural nerve conduction amplitude in microvolts uV and the conduction velocity in meters per second m s In cases where the patient has low amplitude between 2 4 uV and the CV cannot reliably be reported only the amplitude will display on the device Amplitude result is indicated by a decimal point at the upper right corner of the screen Display Example Result Actions Conduction Velocity meters second Record and interpret result Amplitude microvolts Record and interpret result Undetectable Response no Record and interpret result Conduction Velocity displayed Test Unsuccessful Note displayed code and refer to Troubleshooting on back Recalling Results on Device If the device powers down after a test the results of that test can be recalled To recall the results press and hold the button for 3 seconds and you will see the results appear on the display Results will display for 10 seconds and then the device will power off This mode can only be accessed when the device is powered off If you have powe
Download Pdf Manuals
Related Search