User Manual
Contents
1. For Peripheral Regional Anesthesia I model KNL2 NERVE LOCATOR User Manual 26 03 2014 C compliant Almanar for Electronic Components Meets IEC 60601 1 2005 MDD93 42 EEC A I O 13485 a SEC CERTIFIED Manufacturet ALMANAR for Electronic Components 3rd Advisors Building Algaber St Madkor Haram 12111 Giza Egypt Website www almanar com eg Tel Fax 20 2 3583 5215 E mail info dalmanar com eg Product Website www NerveLocator com European Authorized Representative OBELIS S A Registered Address Bd G n ral Wahis 53 1030 Brussels Belgium Office Address Avenue de Tervuren 34 bte 44 1040 Brussels Belgium www obelis net Tel 3227325954 Fax 43227326003 E mail mail obelis net All rights reserved for A manar Revision RNL2 manual 2R10 A Warning KINDI Nerve Locator KNL2 may only be used in applications for which this product is intended Law restricts this device to sale by or on the order of a physician EC REP certificates Follovving European Authorized Representative Center certificates European Authorized Representative Agreement MDD 93 42 EEC 2007 47 EC included Classes IIA IIB and Ill I Address Contact Between and ALMANAR EMBEDDED SYSTEMS SOLUTIONS ocre Ome 3 Algaber St Advisors Buildings Bd G n ral Wathis 53 Madkour Haram 1030 Brussels Giza 12111 Belgium Egypt As to be mentioned on all certificates amp official HE Tel 12. If KINDI Nerve Locator KNL2 is operated near another device the user must monitor the equipment or system and check that the configuration used in this way is operated properly and as intended KINDI Nerve Locator V2 x User manual 12 Other devices can interfere with KINDI Nerve Locator KNL2 or the system even if they show compliance with the applicable CISPR emission requirements Interference impulses greater than 3 V m within the frequency range up to 100 M Hz can be picked up by the locating current detector and thereby trigger an error display and possibly a safety shutoff Operation of other systems beside KINDI KNL2 accessories can increase emissions or reduce immunity to interference on devices or systems Observe the supplied EMC instructions concerning installation initial setup and operation of the device or system see Section 5 Electromagnetic compatibility EMC To avoid damage to the connecting cable and the device do not hold or carry the device by its connecting cables and or its accessories Do not wrap the cable around the device or around other equipment Wrapping the connecting cable during normal operation of the nerve locator generates inductive components and at every short locating pulse can lead to a reduction in locating efficacy and or false measurements of the actual locating current False interpretations of the indicated values can be the result For safety reasons never operate KINDI Nerve Loc
3. Service Manual Only original accessories labeled with the CE sign should be used 4 1 1 Language The current available language for menus and different messages is English 4 1 2 KNL2 description amp data summery KINDI KNL2 is a Nerve Locator and Mapper with Wide Screen Wide Range a Smart Hand Held shape and Meets IEC Standards ISO13485 ISO14971 MDD93 42 and IEC60601 1 2005 KINDI is used for peripheral regional anesthesia refer to section 1 2 with a unique option Auto Loc Map for automatic current pulses adjustment by needle or mapping pen approach to the intended peripheral nerve for further use KINDI competes in performance the bestseller Nerve locators stimulators 4 1 3 Device parameters Pulse durations 0 1 ms 0 3 ms 0 5 ms and 1 0 ms Custom Frequencies 1 Hz and 2 Hz Custom Auto Locator Mapper Option Disabled Option 4 1 4 International Standards met STANDARD SHORT DESCRIPTION IEC EN 60601 1 2005 Medical electrical equipment IEC EN 60601 2 10 Safety IEC EN 60601 1 6 Usability IEC EN 60601 1 2 2007 EMC compatibility IEC EN 60601 1 4 Programmable medical systems EN 1S013485 2012 Quality System MDD 93 42 EEC 2007 Medical Devices Directive 4 1 5 Special technical features Electrode connection is configured to prevent the electrode cable of the locating needles from being plugged in incorrectly and thereby creating the wrong polarity This reliable connection
4. ensures the correct polarity of the locating needle negative and skin electrode positive The latest microcontroller technology has been utilized to integrate performance and features into the KINDI Nerve Locator KNL2 Some examples of the integrated features include the actual current and battery voltage the patented Auto mode nerve locating mapping and user friendly graphic display The internal time base ensures precise locating pulse durations and signal frequencies KINDI Nerve Locator V2 x User manual 26 4 2 Maintenance and safety checks Check the serviceable condition of the KINDI Nerve Locator KNL2 and accessories on each occasion before use A defective instrument must not be used Electro medical equipment may only be repaired by the manufacturer or by an organization expressly authorized by the manufacturer An order for repairs must be accompanied by a detailed description of the fault Maintenance on medical equipment may only be performed by the manufacturer or persons explicitly authorized by the manufacturer 4 2 1 Cleaning and Disinfecting the KNL2 Use only soft damp cloths to clean wipe and disinfect the KINDI KNL2 and the accessories e g electrode cable Water or soap is particularly suitable for this purpose Ensure that no moisture penetrates the device Use only wipes disinfection no spray disinfection Avoid condensation White spirit or commercially available methanol free disinfectant in a
5. painful and strong and trigger irreversible electrophysiological reactions To prevent poor contact of the skin electrode red clip from leading to a mal positioning of the locating needle the user must make sure that the skin electrode which functions like a neutral electrode here shows sufficiently safe contact with low tissue impedance Fatty tissue hair dirt repeatedly used skin electrodes and electrodes of poorer quality can negatively impact tissue impedance thereby incurring the risk of neural damage It is therefore recommended to select the contact surface carefully in well vasiculated muscular areas only Clean shave and degrease the skin Do not position the skin electrode too far away from the puncture site However thoracic application of the skin electrode is to be avoided 11 The skin electrodes must not be applied to areas of injury Only use high grade commercially available CE marked ECG single use skin electrodes with silver silver chloride sensors pre coated with gel For non EU countries CE marking is not required on ECG skin electrodes To achieve optimum nerve locating always make sure the electrodes are undamaged and not dried out The nerve locator should not be used on patients with implanted electrical devices e g cardiac pacemakers without prior consultation with an appropriate medical specialist The locating current may cause interference with the implanted devices and thereby put the pat
6. skin electrode on the skin of the patient Under no circumstances you shouldn t allow these plugs or connections to come in contact with voltage channeling components e g electrical outlets or metallic objects To prevent anesthesia gases from exploding or flammable liquids from igniting KINDI Nerve Locator KNL2 may not be used in hazardous areas To avoid injury to the patient all ported equipment in the vicinity of the patient must comply with the applicable rules and regulations All equipment and accessories must show compliance with EN 60601 1 2005 EN 60601 1 1 as well as the applicable collateral standards The user should be aware that even when all rules are complied with for each piece of equipment under worst circumstances all leakage currents or auxiliary patient coupled currents can add up and produce unacceptably high levels that can endanger the patient The user must therefore check in advance whether the interconnected equipment might exceed allowable limits under certain circumstances Devices and equipment system building assembled improperly can cause life threatening injury to the patient KINDI Nerve Locator V2 x User manual 10 The patients themselves should not come into contact vvith metallic objects that are grounded or produce an electrical conductive connection vvith other equipment and or enable capacitive coupling On these grounds we recommend that an adequately insulated antistatic pad be pl
7. 32 2 732 59 54 Fax 32 2 732 60 03 E mail mail obelis net Tel 20 235 835 215 www obelis net Fax 20 235 835 215 E mail amr almonar com eq Registered Office www almanar com eg Address Avenue de Tervuren 34 bte 44 1040 Brussels Belgium Hereinafter Manufacturer Hereinafter Obelis This Agreement hereinafter the Agreement between the Manufacturer and Obelis entered on January 15 201 4 will be in force until any party revokes it with a notice period of 90 days Table of Contents Our European Authorized Representative Center certificates 3 Table of COTM 1G 5 ot a at 2 Prela CEcioarmsmstsnmsmminnnshnms st 4 CE CSN LIT ICA E ionoiameiosiomem simmmz tems s cmelxsm siamei 5 1 Principles of peripheral electrical nerve stimulation sccssccsseeees 6 ELPEN ODIE ac gee ceca ne catieennessoouctauiss seca tuecataanssaGesacsescseensesteneiaccuceacs eee ter 6 ds LEC EU Sc traaeeasipccttoatveeeetsasseuina sie ameaediea nasip sa antenes 7 dS A Tare Kare Lae g eee eee nr pee one oem nn ret De PDE Doe eset nnmn sett Weyer Dee ner eD 8 1 4 ORC GONG cece cts casera es sis ar 9 TY DE 5 seient AN N EA E AA T A EEE EN 9 1 6 Constant voltage or constant current ssssessssesrrsrsresrerrererserrese 14 2 Description of the device ssssssessssesssseososeoeossseososeosossossseseossssossess 15 2 1 Default parameters and Mod s ea imensmmmmntsismiedmen 15 2 2 Overview of the KINDI Nerve Locator KN
8. L2 sssesessesresrrsererrserens 16 2 2 1 Drawings for KINDI V2 X enteses tommmestnmsymstesmesituaesm 16 2 2 2 Drawings for KINDI V2 x connecting SCNEME c eeceeeeeeees 17 DO a EE E E E E PEE AT A E E E T 18 2 3 1 Checks before start up cuer matins smssssasmitsammas 18 ZSA RONNE Sre ora 18 2 4 General technical description essssssessessesrrsresrrsererresersrrsrrserserses 19 24 1 REVO AO ILE JC Ets R S an 19 De PE COM TOE A 20 PACA RE E S T ao EEEE E E V PEA E E ee E A 20 DE LED Ea E E E ere ere Tar TerenrTore 20 2 4 6 Backlight on the LCD display eesdeidedeemtssmssmmntsiisiaeiei 20 3 Operation of the KINDI Nerve Locator V2 X ccscssccsccsscesccsscsscesceees 21 LSC ON OFF a E R 21 DE LS CIC ON eE ANR 21 SLE WOOTE ee E aaa 21 3 1 3 Automatic switch OFF 2t items es iE 21 3 2 Selecting the Pulse Duration sssessssssessessesrrsresrrerserrerersererrserserses 22 3 3 Selecting the Pulse Frequency cccccecccsecseccesceeecseceneeeeceeeeeseeeees 22 34 C frent Resoluti ON erreseina mei estesos 22 DS AE MODE eessen 22 3 6 Modes of current adjustment cccceecceccescceseeeecsecenceeceeeceeeeeees 23 A Manual mode deraulll Emma 23 B Auto mode Option caretes enna er 23 3 BCE cet trate thetic gaat A ed ee 23 3 8 Additional information Menu INfO cccceeccseceeeceeeeceeeeeseeeees 23 4 Maintenance Notes and Options cccccccsccsccsccsccscescccceccecceccecceces 24 Pye SVT el NOLE
9. L2 is guaranteed for 1 years against defects in material and workmanship provided that the device is used in accordance with the operating instructions Accessories and wear parts such as electrode cables batteries etc are not covered by this warranty Do not attempt to open the device unit for any purpose this will void your warranty and result in a chargeable repair event or replacement with a refurbished unit without warranty if available at Almanar s sole discretion Opening the unit for inspection by Biomedical Engineering will void your warranty Malfunctions arising from opening the unit will result in a chargeable repair event or replacement with a refurbished unit without warranty if available at Almanar s sole discretion KINDI Nerve Locator V2 x User manual 28 4 5 Accessories Basic KINDI Nerve Locator KNL2 will be supplied with the following parts Storage case for KINDI Nerve Locator KNL2 Electrode cable for KINDI Alkaline 9V battery Brief instructions of use Manual this document CD 4 6 Specifications amp Product Information Feature Feature details Smart Shape comfort Handheld Other device colors Flammability Rating Material UL94 V 0 pe A Storage Case amp Dim Black 280X230X80 mm Auto Power OFF Li ue Visit ALMANAR Web site for more details www almanar com eg Please Visit Kindi Nerve Locator web site www Nerve Locato r com Universal Medical Device Nomenclature System UMD
10. NS Device Group 16253 29 ALMANAR for Electronic Components vvas established in 2006 vvith focus on custom design services and aim to be one of the top companies in the field of electronics amp embedded systems design A partner of choice for outsourcing embedded design services by offering most innovative solutions utilized by smart technologies Please visit ALMANAR websites www almanar com eg www nervelocator com KINDI Nerve Locator V2 x User manual Almanar For Electronic Components 3rd Advisors Building Algaber St Madkor Haram 12111 Giza Egypt Tel 20 235835215 www almanar com eg
11. S ae EE I EET nears 24 Beds MQ ae Oest E E ic E E T T estat 24 4 1 2 KNL2 description amp data summery meues tec adstes 24 4 1 3 Device parameters sssssesesesesrsrsesesersesesrsrsrsrsesesrsrsrsesesrses 25 4 1 4 International Standards Met cccccseccseccsecesececeeceeeceeeeeees 25 4 1 5 Special technical features cccccccceecescceseeeecsecesceeceeeceeeeees 25 4 2 Maintenance and safety CHECKS cccsecceeccseceseceeeeceeeceseeeeceeeees 26 4 2 1 Cleaning and Disinfecting the KNL2 seessesessseseesrrsresrrersesees 26 4 2 2 Storage and shipping conditionS essssssssessesserereseresrrserserses 26 4 2 3 Change the DO Paoimmmt ymsmmsstesstmsttammstm 27 4 3 MOUCES Warranty esesstmeste tenen ese NENEN ENEE 27 ADAE OOS ear 28 4 6 Specifications 8 Product Information essesssssserssesrssrsrrsrserrerreesens 28 KINDI Nerve Locator V2 x User manual 4 Preface Thank you for purchasing KINDI Nerve Locator KNL2 the easy device to operate so we provided you with a straightforward array of all the functions you need in any peripheral nerves blocking or mapping The following chapters describe the operation of KINDI Nerve Locator KNL2 The use of the locating needles required for performing locating is described in the instructions for use accompanying the needles which are not part of this user manual Chapter 1 describes the unique optional function of Auto Loc Map for automatic current puls
12. aced on the operating table Under no circumstance should the device be operated with accessories other than those released and supplied by the manufacturer or listed in Section 4 5 Instruments and accessories These accessories are EMC tested and approved Any other accessories can lead to serious impairment of the device and system properties and cause permanent injury to the patient user or device Don t use KNL2 outside medical environment hospital that may increase the possibilities of contamination and therefore there will be a risk of the patient s nerve damage Whenever high frequency surgical equipment is used simultaneously there is an acute danger of severe burns occurring at the KINDI Nerve Locator KNL2 connection ports the connecting cable the tip of the needle and at the skin electrode It is therefore imperative to disconnect all connections to KINDI Nerve Locator KNL2 before using high frequency surgical equipment and to also remove the locating needle from the tissue The locating needle with its connecting cable acts like an antenna for high frequency energy this can generate very high current densities at the needle tip and cause irreversible destruction to the nerve fibers in this proximity At the same time the ported nerve locator can rectify the high frequency energy which leads to extremely high direct currents and voltage potentials at the electrodes The direct current locating generated as a result can be very
13. arge ion movement reduces the membrane potential to 55 mV making the membrane freely permeable and generating an action potential Various types of nerve fiber differ regarding their sensitivity to electrical locating minimum interval of time necessary to electrically stimulate a muscle or nerve fiber KINDI Nerve Locator V2 x User manual 8 e A alpha motor fibers have the shortest chronaxia 50 100 us e The afferent fibers that transmit pain sensation A and C fibers require a longer pulse 150 and or 400 us at a minimum current e Mixed peripheral nerves can be localized using short pulses O 1ms without triggering pain sensations e For pure sensory nerves use longer pulses 0 3ms 0 5ms or 1 00 ms When unipolar needles insulated and with conductive tip are used the current necessary to trigger muscular contractions pulse amplitude correlates with the distance from the tip of the needle to the nerve The lower the current the more accurately the target nerve can be localized This allows quicker onset and ensures a more reliable success of the blockade NOTE observing and staying within predefined threshold currents is important so as to avoid a too close proximity to the nerve and prevent nerve damage The shorter the electrical pulse pulse duration the faster is the rise in current to the nerve This allows better discrimination by the physician as to whether the needle tip is sufficiently close to the ne
14. ass lla medical device according to Medical Device Directive MDD 93 42 EEC The device should not be used until it has been subjected to an on site function test and the persons responsible for operating the device are instructed how to use the device with the aid of brief instruction or the user manual Carry out a visual inspection of the electrode cable Damaged cables must not be used Connect the electrode cable for connection with the locating needle to the front of the nerve Locator to the middle 4 polar plug The plug connector configuration prevents wrong polarity connection The device automatically runs a battery test upon the start up see section 3 7 2 3 2 Running Screen The LCD display shows the pulse operating conditions SE Target current F Chosen pulse frequency P Chosen pulse duration AC Shows Actual Current measured Bat Shows the battery level After switching on KINDI Nerve Locator KNL2 the target locating current is zero in other words no locating pulse is generated and the pulse LED is not flashing If the target locating current is gt 0 00mA the pulse green LED flashes and sound becomes audible with each pulse The actual current is indicated automatically 2 4 General technical description KINDI Nerve Locator KNL2 generates square pulses with selectable duration and continuously adjustable locating current The range of adjustment of the current from 0 00
15. ator KNL2 if the battery is leaking but return it to the manufacturer for proper cleaning The same applies if any liquid soaks through Do not continue to operate the device if repeated error messages appear The device must be returned to the manufacturer for proper repair Avoid contamination at the connections Water and dirt impair the contact properties of the plug connections and lead to untargeted short circuits or leakage currents This can lead in part or even fully to channeling of the locating currents which impairs or even cancels out the locating effect completely In this event the device can no longer properly indicate the actual current flowing to the patient To prevent damage to the device and its accessories never use aggressive cleaning agents For further details see Section 4 2 1 Cleaning and disinfecting the KNL2 All accessories have to be visually inspected at regular intervals The insulation for cable and plug connections must not exhibit any damage The user must follow the instructions for use when operating KINDI Nerve Locator and its corresponding accessories When using sterile accessories always comply with standard sterile precautionary measures 13 Avoid any inadvertent contact of the locating needle vvith bone since this could irreversibly damage the needle and consequently traumatize the tissue a Keep accessories and device away from voltage conducting objects The electrostatic and electro
16. equipped with a very high output impedance ideally infinity to reduce the resistances possible in the external circuit to negligible levels and to display the actually flowing current accurately In recent years constant current devices which allow selection of the target current mA for the locating pulse have become established On the KINDI Nerve Locator KNL2 the external load resistance can be up to 20kQ If this load resistance is exceeded the nominal current flowing to the patient actual locating current may be less than the set target locating current In this case the target locating current and the actual locating current are displayed separately 2 Description of the device 15 Chapter KINDI Nerve Locator KNL2 is smart medical equipment for locating neuronal pathways in the human body It was specifically designed to stimulate nerve fibers in living organisms with special nerve locating needles that conventionally show very high contact impedance with the aim of determining their spatial position relative to the tip of the needle The locating needles are constructed in such a way that a local anesthetic can be injected near the nerve fiber which reversibly interrupts signal conductance The KINDI Nerve Locator KNL2 should only be used by a physician with knowledge in peripheral nerve blocks The physician is responsible for the correct usage of the nerve Locator The KINDI Auto Nerve locating mapping tip exists whe
17. es 0 10ms 0 30ms 0 5ms and 1 0ms Use the Right soft key to change the pulse duration The new value is written immediately on the screen 3 3 Selecting the Pulse Frequency Power on settings for pulse frequency 2Hz see section 2 2 The selectable values 1Hz and 2Hz Use the Left soft key to change the pulse frequency The new value is written immediately on the screen 3 4 Current Resolution Resolution 0 05mA from 0 00mA to 1 00mA Resolution O 1mA from 1 00mA to 5 00mA 3 5 Locating Mapping Connect the red clip to the skin electrode and the 2 mm male plug to the locating needle Set the pulse and the frequency values as target then apply a KNL2 Needle or a Locating pen and set the suitable targeted current Move Advance with Pen Needle until the muscle contractions are observed when the target contraction is reached reduce the current until the contractions are still visible then inject test dose Warning Be careful while using low current profiles Note that no more motion responses appear Set current back to maximum to ensure Nerve Blocking no muscle motion responses should be observed inject remaining dose 3 6 Modes of current adjustment A Manual mode default The target locating current level is controlled using the Up Dovvn as section 2 4 1 vvith the resolution mentioned in section 3 4 Please keep in mind that the target and set values are immediately applied to the needle
18. es adjustment by needle or mapping pen approach to the intended peripheral nerve For your study of its operational fundamentals we recommend that you have a KINDI Nerve Locator KNL2 with all of its accessories at hand and functional so that you can learn about the functions in practical exercises It is helpful to simulate the patient with a wet paper tissue or a small sponge soaked in saltwater The saline solution is required to produce electrical conductivity The device may only be operated in compliance with the user manual If you have further questions please don t hesitate to contact us Regards ALMANAR Giza Egypt manar for dedtrenie components CE certificate KINDI is CE compliant and conforms with medical devices directive MDD 93 42 EEC under Class Ila still under auditing to be certified by 3EC JEC Almanar is certified for EN 18013485 2012 Im ESE RET ON 84 CERTIFICATE This certifies that the Quality management system of Almanar for Electronic Components 3rd Advisor s Buildings Algaber St Madkour Haram Giza Egypt OS Cs has been assessed by 3EC International and found to be in conformance with the following standard 47 Cs Vs Vy 2009 for the following f DESIGN DEVELOPMENT AND Uy HA Pe ls SS 7 OF ACTIVE MEDICAL DEVICES KINDI NERVE LOCATOR oN SSS lt NNSA Certificate No M 0340 14 Date of issuance ginal date of approval Ma
19. ient at risk The per thoracic application of electrodes around the ribcage heart can increase the risk of cardiac fibrillation The locating current should not drop below a specific value By changing optionally Current threshold see Section 3 4 the KINDI Nerve Locator KNL2 alerts you with an optical and acoustic warning whenever the locating current is out of tolerance If the nerve locator shows a direct current or an offset direct current at the outlet the nerve locator should not be used and must be returned to the manufacturer for repair The special precautionary measures specified by the EMC standard apply to electrical medical devices Portable and mobile HF communication devices can affect KINDI NERVE LOCATOR KNL2 which can lead to functional failure of the device and or system Dynamic electrical and dynamic magnetic interference fields can cause interactions between device and system to occur which can impact the actual locating current measurement and in extreme cases lead to error messages and possibly to the activation of a safety shut off on the device Do not use KINDI Nerve Locator KNL2 in the proximity of equipment that produces strong electromagnetic fields such as cordless phones HF high frequency surgical equipment short wave or microwave medical equipment The locating needle may pick up high frequency currents which could cause damage to nerves Do not connect KINDI Nerve Locator KNL2 to other devices
20. l damage injury Don t use the product if it is damaged It is indicated in the manual which supplied inside the device that had followed the following standards Medical MDD Directive 93 42 EEC 2007 EN 18013485 2012 IEC 60601 1 2005 IEC 60601 1 2 2007 IEC 60601 1 4 IEC 60601 1 6 IEC 60601 1 8 IEC 60601 2 10 IEC 60812 FMEA KINDI Nerve Locator V2 x User manual 14 1 6 Constant voltage or constant current According to Ohm s Law I V it is possible to use both voltage as well as current to measure the intensity amplitude of the electrical Locating One speaks of Auto Nerve locating mapping devices The electrical resistance impedance in the circuit of a Locating which comprises the sum of skin tissue needle electrode cable resistance etc fluctuates within a large range It can move between lt 1 kQ and infinity Factors such as skin moisture conductivity of the skin and tissue and the potential resistance of the skin electrode can hardly be influenced If voltage V is selected as a measure of the intensity of the locating pulse currents can flow during treatment that differs greatly depending on the impedance and in accordance with Ohm s Law Therefore it is better to use a nerve locator that allows the user to select the target current mA exactly between the two electrodes skin electrode anode and locating needle cathode Nevertheless a nerve locator with constant current settings must be
21. magnetic fields they radiate can impact the locating outcome and under certain circumstances may lead to adverse locating effects in the tissue Before and during use the device the connecting cable and their plugs must be kept completely clean and dry Moisture and contamination will impair the function of the nerve locator and or the locating outcome Be aware of the position of metallic implants in the tissue e g plates or electrode cables which may potentially channel locating signals to other sites where it can cause damaging effects Implanted electronic equipment can be impaired by the locating current which in turn will lead to malfunctions of the implants or even destroy them To avoid malfunctions of KINDI Nerve Locator check all functions prior to the intervention and make sure that the accessories are in functional order The accessories must meet safety class type BF Inspect all parts for any visible damage or manipulations Never use any damaged or manipulated parts To protect the patient from electrophysiological shocks through electrostatic discharges ESD it is necessary for them to wear the appropriate clothing and to move around in an appropriately secured environment An electrostatic discharge ESD at the tip of the needle can cause extremely high current densities to occur which can damage the surrounding tissue KNL2 must be handled carefully by trained person only to avoid any hurt or accidental mechanica
22. n ethyl alcohol base can be used for disinfection Caution The following substances must not be used trichloroethylene acetone butanone benzene methyl ethyl ketone benzene methanol cellulose thinner and 2 propanol or any other organic sol vents acids and sodium hydroxide solution Disinfectants containing iodine or dyes can discolor the housing and should not be used 4 2 2 Storage and shipping conditions Condition for storage as follows Temperature 0 55 C Humidity relative up to 90 4 2 3 Change the battery If the KINDI Nerve Locator KNL2 is not intended to be used for a long period of time the battery must be removed to prevent leakage The battery compartment is located in the base of the nerve Locator Open the compartment change the alkaline battery 9V ensuring correct polarity is warranted Then close the compartment Recommended to use 9 V alkaline manganese batteries e g ENERGIZER 522 VARTA 4922 DURACELL MN 1604 These will provide you with an optimum operating time amp Don t use rechargeable batteries as they may cause the device to malfunction i WARNING If the battery is leaking the device should no longer be operated on the grounds of safety Acid penetrating the inside of the instrument can damage or impair essential circuitry It must be returned to the manufacturer for correct cleaning and a safety check 4 3 Notices warranty Warranty KINDI Nerve Locator KN
23. n this option bought the KINDI Pen and the KINDI needles can be purchased separately as accessories and kept safely in the storage case in the intended compartments 2 1 Default parameters and Modes The KINDI Nerve Locator KNL2 has 3 basic display parameters Pulse duration 0 1ms 0 3ms 0 5ms and 1 0msPulse Frequency 1 Hz and 2 Hz Current Full range between 0 and 5mA Auto mode optional for automatic current adjustments Manufacturer s default settings configured when equipment switched on Current 0 00mMA Pulse duration 0 1ms Pulse Frequency 2 Hz Auto mode Disabled KINDI Nerve Locator V2 x User manual 16 2 2 Overview of the KINDI Nerve Locator KNL2 2 2 1 Drawings for KINDI V2 X Battery 2 Holder 31 32 mm 1 23 in ms 67 99 mm tal a Almanar Il Nerve Locator V2 1 LCD display 6 Frequency 2 Up Down for regulating 7 Pulse duration 3 Power LED 8 Target Current 4 Signal LED 9 Actual Current 5 On off 10 Battery indicator 11 Audio hole 2 2 2 Drawings for KINDI V2 x connecting scheme KNL2 Clip to skin electrode Auto sensor connector r In k B 3 AR r NO O O OD O et O 3 to Needle Semen all Llmanar Nerve Locator V2 KINDI Nerve Locator V2 x User manual 18 2 3 Start up 2 3 1 Checks before start up The KINDI Nerve Locator KNL2 is a cl
24. ng hurts which is not a concern during anesthesia but during recovery the patient may be awake enough to experience the discomfort of nerve Locating Therefore some researchers advocate locating with submaximal current during recovery Although several investigations indicate that testing of neuromuscular function can be reliably performed postoperatively using submaximal Locating the accuracy of the monitoring is unacceptable at low current As a result supramaximal locating should be used when possible The character of the waveform produced by the electrical impulse and the length of the signal are also important The impulse should be monophasic and rectangular i e it should be a square wave because a biphasic pulse may cause a burst of action potentials in the nerve repetitive firing increasing the response to the Locating The optimal pulse duration is 0 2 to 0 3 ms A pulse exceeding 0 5 ms may stimulate the muscle directly or cause repetitive firing The blocking performance of peripheral nerve and plexus is facilitated by principles of peripheral electrical nerve locating or PNS The user has no longer 7 need to rely on patient feedback about paresthetic sensations The danger of mechanical nerve lesions is mostly eliminated When the locating needle is placed sufficiently close to the target nerve predefined electrical pulses generate muscle contractions at motor efferent fibers and electrically elicited paresthesias at se
25. nsory afferent fibers During this procedure direct contact of the injection needle with the nerve is intentionally avoided 1 2 Intended Use The nerve locator is intended only for the pre operative localization of nerves under no circumstances may it be used on a patient undergoing surgery Prerequisite Accurate knowledge of the topography and nerve distribution area since peripheral electrical nerve locating PNS a mentioned in section 1 1 has no replacement for the anatomical knowledge required to perform 55 3 regional anesthesia pet i 4 A Timi 1 5mA ama i Tore PE cm Advantages of nerve Locating p fj e Targeted muscle response obtained without ff any information or cooperation from the patient _ f eNo direct needle nerve contact A eNo mechanical nerve lesions eNo intraneural injections eNo painful paresthesias Arca Heal dear harren padik n Approximate distances between needle Permissible and possible options e General prior to blockade e Sedation and analgesia prior to blockade depending upon the patient s needs e Blockades distal to the previous site of a regional anesthesia procedure in anesthetized or partially anesthetized regions e Extension of the indication spectrum Enhancement of safety standards Resting potential at nerve membrane is around 80 mV The cell s interior is negatively charged compared to the surrounding medium Sufficiently l
26. or mapping pen only if the current is gt O OmA B Auto mode option Not currently active in this version 3 7 Battery The battery level is displayed as a symbol on the screen see section 2 3 2 If the battery voltage drops below 6 5V The nerve locator stops operating and issues an error message Battery Low displayed as the following figure All the functions will be deactivated and the device will switch off in 8 seconds while an alarm beeps 5 times per second A new alkaline 9V battery should be installed MW ERROR Battery Low Wait 8 Seconds amp Please do not replace the battery while the device is turned on as this can damage the LCD display 3 8 Additional information Menu info The version number format has the following meaning Version 2 YX 2 Model version Y software revision X null for basic KINDI and x A for auto nerve locating mapping option The KINDI Auto nerve locator probe future option not available at the moment KINDI Nerve Locator V2 x User manual 24 4 Maintenance Notes and Options Chapter 4 1 General notes The cables of the KINDI Nerve Locator V2 x should be positioned in such a way that they do not contact either the patient or other cables All accessories have to be visually inspected at regular time intervals The insulation of the cables and plug connections must not exhibit any damage you may follow the test instructions in the Technical
27. rch 28th 2014 This certificate is valid from March 28th 2014 to March condit organization will maintain effective qual management system To verify the validity of this certificate please Ge mi 0421 0 2 5891 8343 JP Un STlatiareti canin XASICO a s Sratistava 110 411 13 KINDI Nerve Locator V2 x User manual 6 1 Principles of peripheral electrical nerve stimulation Chapter 1 1 Principles Neuromuscular function is monitored by evaluating the muscular response of muscle to supramaximal electrical locating of a peripheral motor nerve The reaction of a single muscle fiber to a signal follovvs an all or none pattern By contrast the response of the whole muscle depends on the number of muscle fibers activated If a nerve is stimulated with sufficient intensity all muscle fibers supplied by the nerve will react and the maximum response will be triggered After administration of a neuromuscular blocking drug the response of the muscle decreases in parallel with the number of fibers blocked The reduction in response during constant Locating reflects the degree of neuromuscular blockade For the preceding principles to be in effect the signal must be truly maximal throughout the period of monitoring therefore the electrical signal applied is usually at least 20 to 25 percent above that necessary for a maximal response For this reason the signal is said to be supramaximal however supramaximal locati
28. rve The locating needle should always be connected to the negative pole as in Kindi KNL2 connector since if the positive pole is connected to the needle higher currents will be required The conductive tip of the locating needle affects the geometry of the electrical field The smaller the emission site of the electrons at the tip of the needle the higher is the current density at this point and the lower the threshold level once the nerve has been localized exactly 1 3 Indications e Replanting surgery e Patients with high aspiration risk e Hemodynamically unstable patients e Diagnostic and therapeutic blockades e Surgical procedures on the upper and lower extremity e Postoperative analgesia to allow early mobilization and physical therapy 1 4 Contraindications e Refusal of regional anesthesia procedure by the patient e Infection hematoma in the vicinity of puncture site e Neurological dysfunctions known preoperatively e Target nerves lesion distal to the puncture site e Neurological peripheral neuropathic pains e Severe coagulation disorders e Anatomical abnormalities e Insufficient liver function 1 5 Warnings 5 Please read the following warnings and precautionary carefully The connecting socket of the locating needle may only be connected to the counter plug of the connecting cable The connecting cable plug may only be connected to the nerve locator and the clip may only be connected to the
29. to 5 00mA peak to peak The frequency and Pulse duration can be varied for different applications The KINDI Nerve Locator KNL2 can be used accurately with tissue impedance of maximum 20 kQ Refer specifically to the Section 1 5 Warning before using the KINDI Nerve Locator KNL2 on a patient If the device does not behave as described previously it must not be put into operation Please contact the manufacturer or distributor listed KINDI Nerve Locator KNL2 is designed for regional anesthesia to optimally localize peripheral nerves 2 4 1 Keypad interface Layout refer to the following figure 1 ON OFF Power On Off the device 2 vo vown Incrementing decrementing the target Current value Press and Hold Speed change until the limits are hit ee OR 3 Or OK Navigation through menus wv 4 A BACK Navigation through menus Bo Note OK and BACK have no functions in V2 0 tailed Layout 5 ES eft Soft Key Change Pulse Frequency 6 Right Soft Key Change Pulse Duration KINDI Nerve Locator V2 x User manual 20 2 4 2 Plug Connections Tvvo polarized plug connections are located on the front of the nerve Locator 4 polar plug for connecting the electrode TO cable to the locating needle and skin electrode or the KINDI electrode cable 7 polar plug for connecting Auto nerve locating mapping probe in Auto mode option Note Auto mode is not available currently 2 4 3 Sound e Current flo
30. wing beep Always heard with each pulse signal regardless of the respective locating current preset locating e 5 beeps announced every second eight times during Battery Low Error 2 4 5 LED e Green LED Pulse indicator flashes along with pulses gt 0 00mA e Red LED Povver ON indicator 2 4 6 Backlight on the LCD display The LCD is featured with white Backlight display which will turn OFF automatically if keypad was idle for after 10 seconds 3 Operation of the KINDI Nerve Locator V2 x 21 Chapter 3 1 Svvitch ON OFF 3 1 1 Svvitch ON Press the ON OFF key After the key is released the main screen is displayed If the key is held down for a while longer an eae aa info screen about the device will show up Nerve Locator and will disappear only after releasing the KINDI v2 8 key 3 1 2 Switch OFF To turn off press and hold the ON OFF key until the Power OFF Bar filled is completely then release the Key Notes e Pressing the Power OFF key will disable all the functions and peripherals e lf the key is released at any time before the completion of the Power OFF bar the device will be reset to the defaults 3 1 3 Automatic switch OFF The KINDI Nerve Locator KNL2 automatically turns off if the device is left in Idle State for 10 minutes KINDI Nerve Locator V2 x User manual 22 3 2 Selecting the Pulse Duration Power on settings for pulse duration 0 1ms see section 2 2 The selectable valu
Download Pdf Manuals
Related Search