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Stimuplex® HNS 12 - Frank`s Hospital Workshop

1. HR 31 p m EET EET IN 31 IH cm C 31 Contrast on The ED Payne 32 4 2 4 4 2 5 4 2 6 4 2 7 4 2 7 1 4 2 7 2 4 2 7 3 4 2 7 4 5 1 5 2 5 3 5 4 5 5 5 6 9 5 8 5 9 5 10 5 11 10 10 1 10 2 10 3 10 4 Contents Page AULOMALC SWI CH DIT een EET EET Re ENDE ERNE UE ERE Rn 32 Date Orid Un ee ee 32 LANG EET ee ae 33 Soll 33 FACE SERO nennen nennen 33 Displaying the electrical charge of the stimulation pulse electrical charge nC 34 RUT A SINE een san 34 Additional stimulus CF ON RI 34 Initial setup maintenance and notes scs scenerne renere ere re 35 Being Ne EVD HNS T2 een ee ee 35 x else Ense nu gt Msc VI RENTE ETE T TT AE 35 TECHN ur NM ERR t 36 sra e RTT P 36 Cleaning and disinfecting the Stimuplex HNS Tr ae 37 Maintenance and sarety BONS oec eitrrucpernE iat ins rro ctii Teenie een 37 Safety inspections according to Section 6 of the German Medical Devices Operator Ordinance MPBSIUSIDV nee 37 Solas elec Ce ee een ee 37 POG SS WANN RR RR NR NOR ROC 38 EO IE SO een ee es E MEDIE T 38 NSLFUMIENIES and accessories 40 Stimuplex HNS 12 and Accessories Stimuplex und Contiplex needles 40 References en T TTD 43 ADDEN ee AA Symbols an Stimuplex HNS 12 akin bv cree Rer nt tace E rnb E
2. 5mA 1mA Setting 2 turns Stimulation current mA 0 0 50 0 100 0 150 0 200 0 250 0 300 0 350 0 400 0 450 0 500 0 550 0 600 0 650 0 700 0 750 0 800 0 Dial position n 5m 1mA 49 Appendix C per Section 6 8 2 aa b IEC 50501 2 10 2000 A1 2001 Current density Stainless Bare and insulated needles steel needle d 10 8 Bare Stimulation 7 needle current B 6 I I mA Plastic 5 insulation i NER ME d ol ES Zio mulate i needle 2 lt Bevel uncoated 1 Stimuplex A Contiplex A 0 i 40 10 Distance from the nerve mm Stimuplex D and Contiplex D needles Patent DE 3919666 0 2 or 0 05 mA threshold current required only blunt pointed i i 30 15 4 Stimulation a Fully insulated current needle with mA i I jet bare tip gt 1 l Stimuplex D 0 Contiplex D 10 0 10 Distance from the nerve mm 50 Appendix D 27 EC Declaration of Conformity Medical product Class IIa Manufacturer s name and address STOCKERT GmbH B tzinger Stra e 72 D 79111 Freiburg Product Nerve stimulator Type designation Stimuplex HNS 12 The designated product is in conformity with the European Directive 93 42 EEC Council Directive of 14th June 1993 on the approximation of the laws of the Member States concerning medical devices The technical documentation as submitted and full com
3. 1 4 Warnings Warnings and precautionary measures General precautionary measures The connecting socket of the stimulation needle may only be connected to the counter plug of the connecting cable The connecting cable plug may only be connected to the nerve stimulator and the clip may only be connected to the skin electrode on the skin of the patient Under no circumstances should you allow these plugs 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 Stimuplex HNS 12 may not be used in hazardous areas To avoid injury to the patient all ported equipment in the vicin ity of the patient must comply with the applicable rules and regulations All equipment and acces sories must show compliance with EN 60601 1 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 threat ening injury to the patient The patients themselves should not
4. EN 60601 1 EN 60601 1 1 EN 60601 1 2 EN 60601 1 4 EN 60601 1 6 EN 60601 1 8 EN 60601 2 10 UL 60601 60812 FMEA 9001 2000 13485 2003 14971 2000 MPG Council Directive 93 42 EEC FDA 510 k approved 1 5 Constant voltage or constant current According to Ohm s Law U it is possible to use both voltage as well as current to measure the intensity amplitude of the electrical stimulation One speaks of constant voltage or constant current devices The electrical resistance impedance in the circuit of a stimulation which comprises the sum of skin tissue needle electrode cable resistance etc fluctuates within a large range It can move between 1 KQ and infinity Factors such as skin moisture conductivity of the skin and tissue and the poten tial resistance of the skin electrode can hardly be influenced 12 If voltage V is selected as a measure of the intensity of the stimulation pulse currents can flow dur ing treatment that differ greatly depending on the impedance and in accordance with Ohm s Law Therefore it is better to use a nerve stimulator that allows the user to select the desired current mA exactly between the two electrodes skin electrode anode and stimulation needle cathode Nevertheless a stimulator with constant current settings must be equipped with a very high output impedance ideally infinity to reduce the resistances possible in the external circuit to negligible levels and to
5. 15 Manufacturer s factory settings configured on delivery preset in the menu Max desired current 5 00 mA Stimulus duration 0 10 ms Stimulation frequency 2Hz Impedance kQ is calculated automatically Range not displayed 1 turn can only be changed in the menu 2 1 Checks before start up The Stimuplex HNS 12 is a class lla medical device according to Council Directive 93 42 EEC The device may not be put into operation until the supplier has subjected the device to an on site func tion test and has instructed the persons responsible for operating the device about the device s han dling with the aid of the user manual Before putting the Stimuplex9 HNS 12 into operation carry out the following tests Carry out a visual inspection of the electrode cable Damaged cables must not be used Connect the electrode cable for connection with the stimulation needle to the front of the nerve stimulator to the middle 4 polar plug The plug connector configuration prevents wrong polarity connection Check if the battery is installed Press the ON OFF key to switch on the Stimuplex HNS 12 While you are holding down the ON OFF key to switch on Stimuplex HNS 12 important equipment parameters are indicated in the unit s display After releasing the key the device automatically runs a self test If the self test detects a defective function an error code will appear in the LCD display that switches off automatically after
6. 3 Menu mode i i m ON MENU mmm In the menu mode various submenus and options can be selected by using the up and down arrows The checkmark Current range V symbolizes the selected value and or the selected option Ls duration n n requency Each selection displayed by a gt can be changed by using Current threshold Y the up and down arrow keys and must be confirmed by Info pressing the right arrow key if applicable The checkmark V 25etuP 0000 then appears at the corresponding position 4 Error display mode o For example indicating that the stimulation voltage is too Impulse voltage 30V ia Device defecti If an error message appears in the LCD display the device is PUL E ORIEC iier S i Service requlred automatically switched off within 8 seconds During this 8 s Suitch off process the target stimulation current is set to zero and the QUON ET me stimulation voltage turned off 22 2 2 7 Menu structure Main Menu arrow keys MENU Current range Stimulus duration Frequency Current threshold Info Setup 0 00 5 00 mA 0 00 1 00 mA 1 00 ms 0 50 ms optional 0 30 ms 0 10 ms 0 05 ms optional 2 Hz 1 Hz On V or Off no V Battery level date serial no version Distributor Manufacturer USER INFO 1 future option not available at the moment USER INFO 2 future option not available at the moment Activate infrared interface future option not available
7. 3 seconds 3 6 Current threshold display Highlight the option Current threshold in the Main Menu and confirm using the right arrow key V appears on the right This option can be used to visually and acoustically indicate when the stimulus duration dependent current threshold goes out of tolerance e Visual warning The full digits of the target current display are converted to 5 ma contoured digits when the current threshold drops below 010 ns the preset level 2 Hz The LED flashes yellow instead of green 1 0 kQ e Acoustic warning A warning signal is additionally sounded o m NE Stimulus duration ms 0 05 0 10 0 30 0 50 1 00 Current threshold mA 0 50 0 30 0 20 0 15 0 10 28 3 7 Checking the battery voltage The battery level is displayed as a symbol in the stimulation mode on the bottom right of the LCD display The filling level of the symbol indicates the battery s state of charge The battery s state of charge is additionally indicated in the menu under the item Info see below in volt and percent Press the right arrow key to activate the menu Navigate with the up down keys until the highligh ting arrow gt is in front of the menu item Info Press the right arrow key to open the Info menu In the upper row the battery s state of charge is indicated in 9 o and volt 3 8 Additional information Menu info The menu Info has 6 pages With the up down keys yo
8. 8 seconds A battery symbol appears in the right lower corner of the LCD display that allows a check of the bat tery voltage The symbol flashes when the battery voltage drops below 7 V The device automatically shuts off when the battery voltage reaches 6 V If no display appears when the Stimuplex HNS 12 is switched on change the battery immediately Refer to the Battery section Whenever the battery symbol is flashing a new 9 V alkaline block battery should be installed immediately to avoid having to abort a stimulator treatment Connect the red clip for the skin electrode and the insulated 2 mm male plug for the stimulation nee dle with the 10 kQ test resistance included in the equipment supplied 16 The LCD display shows the current operating conditions Electrical charge when option is activated Maximum current adjustment range 900r J MAT Stimulus duration 0 10 ns H2 Stimulation frequency 1 0 KQ Impedance h 0 when Remote Control is activated B T orna for battery voltage Desired target stimulation current After switching on Stimuplex9 HNS 12 the target stimulation current is zero in other words no stim ulation pulse is generated and the LED is not flashing If the target stimulation current is 0 00 mA and the actual stimulation current flowing does not deviate by more than 0 04 mA from the target stimulation current the green LED lights up or yellow if the option
9. 150 20 G x 6 0 9 x 150 mm 4894170N 25 41 Product description Needle Code no Sales unit x length pcs Stimuplex D needles 30 bevel D 17 040 22 G x 11 2 0 7 x 40 mm 4894189N 25 D 17 050 22 G x2 0 7 x 50 mm 4894197N 25 D 17 080 22 G x 31 8 0 7 x 80 mm 4894200N 25 Stimuplex A needles 30 bevel A 25 24Gx 1 0 55x 25 mm 4894251 25 A 25 226 x1 0 70x 25mm 4894539 25 A 50 22 G x 2 0 70 x 50 mm 4894502 25 A 50 21 G x 2 0 80 x 50mm 4894375 25 A 100 21 G x 4 0 80 x 100 mm 4894260 25 A 150 20 G x 6 0 90 x 150 mm 4894278 25 Contiplex D needles 15 bevel D 28 055 C 18 G x 21 8 1 3 x 55mm 4894219N 25 D 28 110 C 18 G x 4318 1 3 x 110 mm 4894294N 25 Contiplex D needles 30 bevel D 18 055 C 18 G x 21 8 1 3x 55 mm 4894227N 25 Contiplex D catheter set with polyamide catheter 0 41 x 0 71 x 400 mm Needle D 20 033 C 20 G 15 bevel 1 1 x 33mm 4892402N 10 Needle D 20 055 C 20 G 15 bevel 1 1 x 55 mm 4892410N 10 with polyamide catheter 0 45 x 0 85 x 400 mm Needle D 28 055 C 18 G 15 bevel 1 3x 55 mm 4894235N 10 Needle D 18 055 C 18 G 30 bevel 13x 55mm 4894243N 10 with polyamide catheter 0 45 x 0 85 x 1000 mm Needle D 28 80 C 18 G 15 bevel 1 3 x 80mm 4895819N 10 Needle D 28 110 C 18 G 15 bevel 1 3 x 110 mm 4894391N 10 Contiplex A needles 30 bevel A 45 C 18 G x 13 4 4893611 25 A 55 C 18 G x 21 8 4893643 25 Contipl
10. HNS 12 Stimuplex and Contiplex stimulation needles as well as the connecting cable by B Braun are designed to work in perfect harmony Only in this way an optimum of precision and reliability can be achieved For more in depth knowledge about the use of this device and its risks and side effects we recom mend studying in detail the relevant literature cited in the References Section Stimuplex HNS 12 is supplied with the following basic equipment Stimuplex HNS 12 nerve stimulator 9 volt block battery Cable for connecting B Braun stimulation needles cable length 1 25 m 10 kQ test resistance User manual this document Brief instructions for use Storage case for keeping Stimuplex9 HNS 12 and accessories The Remote Control Stimuplex9 DIG RC the control knob for sterile handling and the Stimuplex Pen can be purchased separately as accessories and kept safely in the storage case in the intended compartments Overview of the Stimuplex HNS 12 Nerve Stimulator LCD display LEDs Dial for regulating Current adjustment range the target Stimulus duration stimulation current Stimulation frequency MENU On off Home MIN Single handed remote control optional for sterile operation LL Connecting cable Stimuplex HNS 12 e Stimulation needle o 99
11. Order Numbers 61 Product description Needle Code no Sales unit USA Reorder USA Units x length pcs Number per Case Contiplex D needles 15 bevel D 28 055 C 18 G x 2 Je 13x 55 mm 4894219N N A N A D 28 110 C 18 G x A3 g 1 3 x 110 mm 4894294N N A N A Contiplex D needles 30 bevel D 18 055 C 18 G x 2 s 13x 55 mm 4894227N N A N A Contiplex D catheter set with polyamide catheter 0 41 x 0 71 x 400 mm Needle D 20 033 C 20 G 15 bevel 1 1x 33mm 4892402N 331681 12 Needle D 20 055 C 20 G 15 bevel 1 1x 55mm 4892410N 331686 12 with polyamide catheter 0 45 x 0 85 x 400 mm Needle D 28 055 C 18 G 15 bevel 13x 55 mm 4894235N 331680 12 Needle D 18 055 C 18 G 30 bevel 13x 55 mm 4894243N 331685 12 with polyamide catheter 0 45 x 0 85 x 1000 mm Needle D 28 80 C 18 G 15 bevel 13x 80mm 4895819N N A N A Needle D 28 110 C 18 G 15 bevel 1 3 x 110 mm 4894391N 331687 12 Contiplex A Kan len 30 bevel A 45 C 18 G x 13 4 13x 45mm 4893611 N A N A A 55 C 18 G x 2 s 13x 55mm 4893643 N A N A Contiplex A catheter set with polyamide catheter 0 45 x 0 85 x 400 mm Needle A 45 C 18 G x 1 1 3x 45 mm 4893603 10 N A N A Needle A 55 C 18 G x 2f 13x 55mm 4893638 10 331692 12 Contiplex Tuohy set with polyamide catheter 0 45 x 0 85 x 1000 mm and sideport insulated Tuohy type CNB 150 18 G 13x 38 mm 331695 331695N 12 10 331695 12 10 insulated Tuohy type CNB 200 18 G 1 3x 52 mm 331691 3316
12. at the moment Tone Volume from O to 8 Mode click or beep Variable tone On V or Off no V Dial turns 1 or 2 Contrast 0 to 8 Automatic switch off O to 10 min in min increments 15 to 30 min in 5 min increments Date HH MM YYYY MM DD Language GB English D German F French E Spanish Italian E Portuguese S Swedish Setup Options Sprache Factory standard 23 NL Dutch DK Danish N Norwegian FIN Finnish GR 7 Greek RUS Russian H Hungarian RO Romanian CZ Czech SK Slovak SLO Slowenian PL Polish TR Turkish EST Estonian LV Latvian LT Lithuanian BG Bulgarisan CN Chinese J Japanese Yes Y Confirm using the right arrow key El charge nC On V or Off no V Auto adjust current On V or Off no V Add stimulus duration On V or Off no V 24 3 Operation of the Stimuplex HNS 12 The device is configured with the following factory settings on delivery Maximum current 5 00 mA Stimulus duration 0 10 ms from the numerical series 0 10 ms 0 30 ms and 1 00 ms Stimulation frequency 2 Hz Impedance kQ is calculated Scale range not displayed 1 turn can only be changed in the menu Auto switch off 20 min can only be changed in the menu Current threshold Off changes only possible in the menu is not reset by the option Factory setting Language English can only be changed in the menu is n
13. batteries etc are not covered by this warranty In addition relevant sections of our General Sales Conditions apply specifically Chapter IV No 8 Do not attempt to remove the control knob from the Stimuplex HNS12 for any purpose Properly atta ching the knob requires a special tool This will void your warranty and result in a chargeable repair event or replacement with a refurbished unit without warranty if available at B Braun s sole dis cretion The Stimuplex HNS12 unit case should not be opened for any purpose Opening the unit even 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 warran ty if available at B Braun s sole discretion 39 5 10 Error messages Stimuplex HNS 12 checks the battery voltage periodically If the voltage is less than 6 00 V an error message will be displayed and the device will switch off automatically The used battery must be replaced immediately Caution An empty battery can leak damaging the device and making it unusable If the device is not used for a longer period of time it is imperative that the battery is removed Any damage caused by a leaking battery is not covered under the warranty Stimuplex HNS 12 conducts safety checks periodically In the event of the following malfunctions the device switches off automatically within 8 sec
14. day as described above The changes are immediately active 33 4 2 6 Language The desired language for menus and warning messages can be configured under the menu item Language With the right arrow key activate Main Menu highlight the Setup menu with the down key and open with the right arrow key With the up or down key highlight the menu Language and open with the right arrow key Now you have the option of highlighting the desired language with the up or down key and activating your selection with the right arrow key Y appears on the right 4 2 7 Options This menu page offers the following options 1 Factory standard restores factory settings 2 Electrical charge nC additional display of the amount of electricity to be given off in nano coulomb 3 Auto current adjustment the current is adjusted automatically when the stimulus duration is changed 4 Add stimulus duration additional stimulus duration parameters Use the right arrow key to activate V appears on the right or deactivate these options V not visible 4 2 7 1 Factory standard Activation of this menu item resets all of the parameters back to the manufacturer s declared facto ry settings on delivery see Section 3 However this does not change the language setting or the cur rent threshold display In the Setup menu open the Options submenu The Factory standard option is automatically highlighted and can be activated with the rig
15. interim the target stimulation current is turned up to the old value again In the Setup menu open Options highlight Auto adjust current and activate V or deactivate with the right arrow key 4 2 7 4 Additional stimulus duration With this option you can add the stimulus durations 0 05 ms and 0 50 ms to the selection series see Section 3 4 In Setup open Options highlight Add stimulus duration and activate V or deac tivate with the right arrow key 5 Initial setup maintenance and notes 35 5 1 Testing the Stimuplex HNS 12 A device check may be conducted as follows Switch on the Stimuplex HNS 12 After the ON OFF key has been released and the self test successfully completed the device is ready for operation With the stimulus duration set at 0 30 ms and the current adjustment range at 5 00 mA and the circuit open check that the actual current equals zero over the entire adjustment range from 0 10 to 5 00 mA The warning Patient current lower than your setting must appear in the display the warning signal must be audible and the LED in the stimulation frequency must light up red Now connect the electrodes clip and plugs using the 10 kQ resistance supplied as an accessory At this time recheck the entire adjustment range to make sure that no warning is displayed the LED lights up green or yellow if applicable and the sound is audible at the pitch of the selected stimulation frequency I
16. the submenu item Volume by opening it with the right arrow key With the up down keys the volume can be set between O lowest volume and 8 loudest volume The setting is immediately active Additional confirmation is not required In the submenu Mode the type of sound i e click or beep can be set with the up down keys Additional confirmation is not required here Use the option Variable tone to set whether the tone pitch should be dependent on the target stimulation current or whether you desire a consistent stimulation tone over the entire setting range Activate this option with the right arrow key V appears on the right or inactivate it N disappears The setting is active immediately 4 2 2 Dial turns The setting accuracy can be adjusted to suit to your needs by configuring the number of dial turns one or two turns for the entire current range of 1 00 mA or 5 00 mA In the Main Menu select the item Setup and open it with the right arrow key Highlight the option Dial turns and open it with the right arrow key With the up or down key select 1 or 2 turns and activate this selection at the same time Additional confirmation is not required For safety reasons the stimulation current is always reset to zero during this procedure 32 4 2 3 Contrast on the LCD display The contrast on the LCD display can be changed under the menu item Contrast Open the Setup menu select Contrast and open with the right arr
17. their results and the date of maintenance work including the name of the person or company responsible for carrying out these measures 38 5 9 Notices warranty General notes The cables of the nerve stimulator Stimuplex HNS 12 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 Only original accessories from B Braun labeled with the CE sign should be used All electrical and electronic equipment provided with systems released after 13 August 2005 are marked with a symbol indicating that this equipment must undergo separate collection for disposal Figure W Separate collection for electrical and electronic equipment currently applicable to EU community only In order to ensure an appropriate disposal of the device you have the possibility to give your device back to your B Braun contact person or to return the device to Stockert GmbH free of charge Please decontaminate the device before shipping see page 37 Storage and shipping conditions 0 50 C up to 90 relative humidity no condensation Warranty Stimuplex HNS 12 is guaranteed for two years against defects in material and workmanship provi ded that the device is used in accordance with the operating instructions Accessories and wear parts such as electrode cables
18. 3 4 Selecting the stimulus duration Factory setting on delivery 0 10 ms Stimulus duration values can be selected from two numerical series The first series includes 0 10 ms 0 30 ms and 1 00 ms these values are equivalent to those on Stimuplex HNS 11 If these 3 values are not sufficient for your application you can activate the menu item Add stimulus duration in the menu Setup Options V appears next to Add stimulus duration on the right You can then choose between the values from the second series below The second series includes 0 05 ms 0 10 ms 0 30 ms 0 50 ms and 1 00 ms The stimulus duration setting can be changed in three ways 1 Changing the stimulus duration for future switch on processes Switch on the device and activate the Main Menu using the right arrow key Use the down key to select Stimulus duration and activate the menu page using the right arrow key Use the up or down key to highlight the desired ms value select and confirm using the right arrow key V appears on the right Switch off the stimulator The value now selected will be set when device is switched on the next time 2 Changing the configured setting during an application 1st possible way Press the ms key The current value is highlighted by a border By repeatedly pressing the ms key the next higher value appears from the numerical series selected above Repeatedly press the ms key to switch on all values consecutively The
19. 91N 12 10 331691 12 130 insulated Tuohy type CNB 400 18 G 1 3 x 102 mm 331693 331693N 12 10 331693 12 10 insulated Tuohy type CNB 600 18 G 1 3 x 152 mm 331694 331694N 12 10 331694 12 10 B BRAUN B Braun Melsungen AG Carl Braun StraBe 1 34212 Melsungen Germany Tel 49 0 5661 71 0 W 01 12 05 2 Nr 6043570 www bbraun com
20. QUIPMENT CLASSIFIED BY UNDERWRITERS LABORATORIES INC 9 WITH RESPECT TO ELECTRIC SHOCK FIRE AND MECHANICAL HAZARDS ONLY IN ACCORDANCE WITH UL 60601 1 AND CAN CSA C 22 2 NO 601 1 40 GF Separate collection for electrical and electronic equipment currently applicable to EU community only 52 9 Electromagnetic compatibility EMC Table 1 Guidelines and manufacturer s declaration concerning electromagnetic emissions Stimuplex HNS12 is intended for use in an environment as stated below The customer or user of Stimuplex HNS 12 should ensure that the device is operated in this type of environment Emitted interference Compliance Electromagnetic environment guidelines HF emissions according to CISPR 11 Group 1 The Stimuplex HNS 12 utilizes HF energy for its internal function exclusively Therefore its HF emissions are very low and are unlikely to interfere with electronic equipment in the proximity HF emissions according to CISPR 11 Class B The Stimuplex9 HNS 12 is suitable for use in other facilities than the residential Harmonic current emissions Not applicable environments and such facilities that are according to IEC 61000 3 2 directly connected to a public mains Voltage fluctuations flicker Not applicable network that also supplies buildings used emissions according to IEC 61000 3 3 for domestic purposes Table 2 53 Guidelines and manufacturer s declaration concerning electromagn
21. Setting switch on values for stimulation parameters Press the right arrow key MENU to activate the Main Menu 4 1 1 Current adjustment range The desired switch on value for the current range can be set under the menu item Current range Navigate with the up down keys until the marking arrow is in front of the menu item Current range Press the right arrow key to confirm the menu item thereby the desired switch on value is activated for the current range The switch on value is indicated by a checkmark V Changing this menu item during an application has no impact on the previously set values The chan ges will not be active until Stimuplex HNS 12 has been switched off and back on 30 4 1 2 Stimulus duration The desired switch on value for the stimulus duration can be set under the menu item Stimulus duration Navigate with the arrow up down keys until the marking arrow is in front of the menu item Stimulus Duration Press the right arrow key to confirm the menu item and thereby activate the adjustable stimulus duration values Using the arrow up down keys you can now select the desired switch on value for the stimulus duration Confirm your selection with the right arrow key The switch on value is now indicated by a checkmark N Changes to the stimulus duration values in the menu item Stimulus Duration will not be active until Stimuplex HNS 12 has been switched off and back on Changing this menu item duri
22. Stimuplex HNS 12 Nerve Stimulator for Peripheral Regional Anesthesia pas Un U ie WY Va U lt n oO U es User manual BIBRAUN Manufacturer Distributor In the US and Canada distributed by STOCKERT GMBH B Braun Melsungen AG B Braun Medical Inc B tzinger Stra e 72 Hospital Care Division 824 Twelfth Avenue 79111 Freiburg 34209 Melsungen P O Box 4027 Germany Germany Bethlehem PA 18018 Telefon 49 0 761 20716 0 Telefon 49 0 5661 71 0 Phone 1 800 854 6851 Telefax 49 0 761 20716 20 Telefax 49 0 5661 71 4845 Fax 1 610 758 9020 Email Info stockert de Email Email inquiry bbraunusa com http www stockert de StimuplexHNS12 bbraun com http www bbraunusa com stimuplex http www bbraun com Caution The Stimuplex HNS 12 may only used in applications for which this product is intended Federal US law restricts this device to sale by or on the order of a physician Stimuplex HNS 12 User manual Order number 604 3570 Rev B valid for software version 1 002 x Stimuplex and Contiplex are protected trademarks of B Braun Melsungen AG Contents 1 1 1 2 1 3 1 4 15 2 1 2 2 2 2 1 2 2 2 2 2 3 2 2 4 2 2 5 2 2 6 2 2 7 3 1 3 2 3 3 3 4 3 5 3 6 3 7 3 8 4 1 4 1 1 4 1 2 4 1 3 4 1 4 4 2 4 2 1 4 2 2 4 2 3 Contents Page PT ee Eee 5 Principles of peripheral electrical nerve stimulation PNS eneneee 6 Are OT DECKE 8 gerne ae Bee ee ee 6 dn
23. ally adjustable current threshold has been undershot and a stimulation frequency sound becomes audible The actual current is indicated automatically and only indicated as a warning when it deviates from the target current In this state the LED will light up red and a higher pitch warning signal will be sounded Use the dial to set the maximum current of 5 00 mA No error message should appear at a load resist ance of 10 kQ see accessories The LED flashes green at the selected stimulation frequency The sound is dependent on the preselected stimulation current when sound variable has been config ured in the sound menu Now release the connection between clip and male plug The warning message actual current is less than target current appears both stimulation currents are displayed see Section 2 2 6 2 Stimulation mode with warning the LED flashes red because no current is flowing and the click or beep sound starts ticking louder at a higher pitch To switch off the nerve stimulator hold down the ON OFF key until the display disappears switch off time 2 seconds If the key is released during this switch off phase the device switches back to ON status Refer specifically to the Section Warning and Safety information before using the Stimuplex 9 HNS 12 on a patient If the device does not behave as previously described it may not be put into operation Please contact the manufacturer or distributor listed Maintenance on m
24. come into contact with metallic objects that are grounded or produce an electrical conductive connection with other equipment and or enable capacitive coupling On these grounds we recommend that an adequately insulated antistatic pad be placed on the operating table Warnings and precautionary measures for Stimuplex HNS 12 Under no circumstances may the device be operated with other accessories than those released and supplied by the manufacturer or listed in Section 5 11 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 Whenever high frequency surgical equipment is used simultaneously there is an acute danger of severe burns occurring at the Stimuplex9 HNS 12 connection ports the connecting cable the tip of the needle and at the skin electrode It is therefore imperative to disconnect all connections to Stimuplex HNS 12 before using high frequency surgical equipment and to also remove the stimula tion needle from the tissue The stimulation 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 irre versible destruction to the nerve fibers in this proximity At the same time the ported stimulator can rectify the high frequency energy which leads to extremely high direc
25. ded for operation in an electromagnetic environment in which HF distur bances are controlled The user of the Stimuplex9 HNS 12 can help prevent electromagnetic mal functions by maintaining a minimum distance between portable and mobile HF telecommunications equipment transmitters and the Stimuplex HNS 12 dependent on the output power of the com munications equipment as listed below Rated power of the Separation distance as a function of modulation frequency m transmitter W 80 MHz to 800 MHz 800 MHz to 2 5 GHz d 0 88 P d 1 75 P 0 01 0 09 0 18 0 1 0 28 0 55 1 0 88 1 75 10 2 71 5 53 100 8 75 17 5 For transmitters whose maximal rated power is not listed in the table above the recommended sepa ration distance d in meters m can be calculated by applying the equation that belongs to each column where P is the maximum rated power of the transmitter in watts W as stated in the trans mitter manufacturer s information Remark 1 The higher frequency range applies at 80 MHz Remark 2 These regulations may not apply in all cases The distribution of electromagnetic fields is affected by absorptions and reflections of buildings objects and persons 10 Specific requirements for the US market 57 To U S A Canada Customers The user manual packaged with the nerve stimulator includes all the procedures and requirements for operation the Stimuplex HNS 12 Nerve Stimulator Please heed all warnings and recommenda
26. display the actually flowing current accurately In recent years constant current devices which allow selection of the desired current mA for the stimulation pulse have become established On the Stimuplex9 HNS 12 the external load resistance can be up to 12 kQ If this load resistance is exceeded the nominal current flowing to the patient actual stimulation current may be less than the set target stimulation current In this case the target stimulation current and the actual stimu lation current are displayed separately and optical and acoustic warning messages are given off Moreover the applied impedance is calculated constantly and indicated in the LCD display 2 Description of the device 13 Stimuplex HNS 12 is a precision instrument for localizing neuronal pathways in the human body It was specifically designed to stimulate nerve fibers in living organisms with special nerve stimulation needles that conventionally show a very high contact impedance with the aim of determining their spatial position relative to the tip of the needle The stimulation needles are constructed in such a way that a local anesthetic can be injected near the nerve fiber which reversibly interrupts stimulus conductance The Stimuplex HNS 12 nerve stimulator should be used only by a physician with an appropriate knowledge in peripheral nerve blocks The physician is responsible for the correct usage of the nerve stimulator The functions of Stimuplex9
27. displayed value is immediately active The bor der disappears after approx 3 seconds 3 Changing the configured setting during an application 2nd possible way Press the ms key The current value is highlighted by a border The stimulus duration can be extended or shortened with the up or down arrow keys in accordance with numerical series selected above The new value is immediately active The highlighting disappears after 3 seconds or when the ms key is pressed again or the ON OFF key is pressed briefly 27 3 5 Selecting the stimulation frequency Factory setting on delivery 2 Hz The selectable options are 2 Hz or 1 Hz Two setting options are available to change the stimulation frequency 1 Changing the stimulation frequency for future switch on processes Switch on the device and activate the Main Menu using the right arrow key Use the down key to highlight Frequency and activate the menu page using the right arrow key Select 1 Hz using the down key and confirm it using the right arrow key N appears on the right The value now selected will be set when device is switched on the next time 2 Changing the configured setting during an application Press the Hz key The set value is highlighted by a border By repeatedly pressing the Hz key the other value appears Repeatedly pressing the Hz key switches on the values alternately The displayed value is now active for this application the highlighting disappears after approx
28. e Stimuplex HNS 12 nerve stimulator 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 stimulator Open the com partment Change the battery ensuring correct polarity Then close the compartment ovarkau Use only 9 V alkaline manganese batteries e g VARTA 4922 DURACELL MN 1604 These will provide you with an optimum operating time WARNING If the battery is leaking the Stimuplex HNS 12 should no longer be operated on the grounds of safe ty 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 37 5 5 Cleaning and disinfecting the Stimuplex HNS 12 Use only soft damp cloths to clean and disinfect the Stimuplex HNS 12 and the electrode cable Water or soap are particularly suitable for this purpose Ensure that no moisture penetrates the Stimuplex HNS 12 Use only wipe disinfection no spray disinfection Avoid condensation White spirit or commercially available methanol free disinfectant in an ethyl alcohol base can be used for disinfection Meliseptol or white spirit can be used or wipe 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 s
29. edical equipment may only be performed by the manufacturer himself or persons explicitly authorized by him Stimuplex HNS 12 is designed for regional anesthesia to optimally localize peripheral nerves 17 2 2 Technical description Stimuplex HNS 12 generates square pulses with selectable stimulus duration and continuously adjustable stimulation current The range of adjustment of the pulse current from 0 00 to 5 00 mA peak to peak can be reduced to 0 00 to 1 00 mA with the mA button This 1 mA range allows extremely precise adjustments of the stimulation current The stimulation frequency and stimulus duration can be varied for different applications The Stimuplex HNS 12 nerve stimulator features the option of selecting a frequency of either 1 Hz or 2 Hz and a stimulus duration of 0 05 ms 0 10 ms 0 30 ms 0 50 ms 1 00 ms The Stimuplex HNS 12 measures the tissue impedance and displays it in kQ This measurement allows for a quick check and visualization of the current state of the circuits The Stimuplex9 HNS 12 is very user friendly in its handling It features a menu structure with Main Menu and Setup with which the user can configure user settings such as switch on settings volume and tone pitch dial resolution display contrast automatic switch off time date time and language as well as further options Navigation through these menus is done with the arrow keys Right arrow Is used to activate the Main Menu or sub
30. el L 1990 Untersuchungen zur Funktion peripherer Nerven stimulatoren f r die Durchf hrung von Nerven und Plexusblockaden Regional Anaesthesie 13 172 7 M rz P 1990 Kann bei der elektrischen Nervenstimulation aus der Intensit t der Muskelkontrak tion auf den Abstand zum Nerven geschlossen werden Regional Anaesthesie 13 179 8 Selander D Edshage S Wolff T 1979 Paraesthesiae or no paraesthesiae nerve lesions after axillary block Acta anaesthesiol scand 23 27 Additional reading Kaiser H Die periphere Nervenstimulation In Niesel HC Hrsg Regionalan sthesie Lokalan sthesie Regionale Schmerztherapie Thieme Verlag Stuttgart New York 1994 186 207 Kaiser H Periphere elektrische Nervenstimulation 139 160 G Meier J B ttner Allgemeine Aspekte peripherer Nervenblockaden der Extremit ten Nerven blockaden an den oberen und unteren Extremit ten 237 401 in H C Niesel H van Aken Lokalan sthesie Regionalan sthesie Regionale Schmerztherapie Thieme Verlag Stuttgart New York 2003 Prithvi Raj P Editor Clinical practice of regional anaesthesia Churchill Livingstone New York 1991 Pinncock CA Fischer HBJ Jones RP Peripheral nerve blockade Churchill Livingstone New York 1996 Scott DB Introduction to regional anaesthesia Mediglobe Fribourg 1989 44 7 Appendix Appendix A per IEC 60601 2 10 2000 A1 2001 Section 6 8 2 aa a Output curve shape rectangle negative constant curr
31. ent Output voltage Output current lt gt Stimulus pulse duration Stimulus period where Stimulus duration 0 05 ms or 0 10 ms or 0 30 ms or 0 50 ms or 1 00 ms Stimulation frequency 1 Hz or 2 Hz Output voltage U 95 V without load open Output impulse current maximal 1 00 mA or 5 00 mA short circuit 45 Conversion table stimulation current mA and pulse width ms in charge nanocoulomb nC 46 Appendix B Load impedance as a function of battery voltage Setting stimulation current 5 00 mA ON PO OODMN gt OD Load impedance kQ 6 6 5 7 725 8 8 5 9 9 5 10 Battery voltage V Load impedance as a function of battery voltage Setting stimulation current 1 00 mA Load impedance kQ Battery voltage V 47 Actual stimulation current as a function of load impedance Setting target stimulation current 5 00 mA battery voltage 9 0 V Patient stimulus current mA 6 00 5 00 4 00 3 00 2 00 1 00 0 00 Load impedance kQ Output voltage as a function of load impedance Stimulus voltage V 00 10 0 20 0 30 0 40 0 50 0 60 0 70 0 Load impedance kQ 48 Target stimulation current as a function of adjustment control setting relative to 0 Setting 1 turn Stimulation current mA 0 0 20 0 40 0 60 0 80 0 100 0 120 0 140 0 160 0 180 0 200 0 220 0 240 0 260 0 280 0 300 0 320 0 340 0 360 0 380 0 400 0 Dial position
32. espective stimulation current The type of sound can be selected in the Setup menu Tone Mode The user can choose between a click and a beep sound When warnings actual stimulation current target stimulation current 20 target stimulation current lt current threshold automatical switch off EEPROM and errors are sig nalled the click or beep changes to a louder and higher alarm pitch Whenever any key is operated a short clear beep is audible The volume can be adjusted in the Setup menu Tone Volume at settings ranging from O a very quiet ticking sound in the stimulus frequency warning signals remain to 8 max volume 2 2 5 LED e Green LED Actual stimulation current target stimulation current e Yellow LED Actual stimulation current target stimulation current below the threshold current if current threshold activated is see Section 3 6 e Red LED deviation actual stimulation current lt target stimulation current starting from a deviation of 0 04 mA errors 2 2 6 Display modes The Stimuplex HNS 12 has 4 basic display modes 1 Stimulation mode D mA Without or with electrical charge nC display IOV xc 040 ns Without or with single handed remote control h 00 2 Hz 1 0 kQ 2 Stimulation mode with warning an 00 S 5 m Actual stimulation current less than target 0 10 ms stimulation current 2 Hz 400 Patient current ES than your setting
33. etic immunity to interference Stimuplex HNS12 is intended for use in an environment as stated below The customer or user of Stimuplex HNS 12 should ensure that the device is operated in this type of environment Immunity tests Electrostatic discharge ESD according to IEC 61000 4 2 Fast transient electrical disturbances bursts according to IEC 61000 4 4 IEC 60601 test level 6 kV Contact discharge mode 8 kV Air discharge mode 2 kV for mains power lines 1 kV for in and output lines Compliance level 6 kV Contact discharge mode 8 kV Air discharge mode Not applicable Electromagnetic environment guidelines The floors should be made of wood or cement or paved with ceramic tiles If the floor is made of synthetic material the relative humidity must be a minimum of 30 Not applicable Surges according to IEC 61000 4 5 Voltage dips and interruptions according to IEC 61000 4 11 1 kV Differential mode voltage 2 kV Common mode voltage lt 5 U gt 95 dip in U for 1 2 period 40 U 60 dip in Ur for 5 periods 70 U 30 dip in U for 25 periods lt 5 Ui 95 dip in Ui for 5s Not applicable Not applicable Not applicable Not applicable 54 Immunity IEC 60601 tests test level Power frequency 3 Alm magnetic fields 50 60 Hz according to IEC 610004 8 Compliance level 3 Alm Electromagnetic env
34. ex A catheter set with polyamide catheter 0 45 x 0 85 x 400 mm Needle A 45 C 18 G x 13 4 13x 45 mm 4893603 10 Needle A 55 C 18 G x 21 8 13x 55mm 4893638 10 42 Product description Needle Code no Sales unit x length pcs Contiplex Tuohy set with polyamide catheter 0 45 x 0 85 x 1000 mm and sideport insulated Tuohy type CNB 150 18 G 13x 38mm 331695 331695N 12 10 insulated Tuohy type CNB 200 18 G 13x 52mm 331691 331691N 12 10 insulated Tuohy type CNB 400 18 G 1 3 x 102 mm 331693 331693N 12 10 insulated Tuohy type CNB 600 18 G 1 3 x 152 mm 331694 331694N 12 10 6 References 43 1 Moore DC 1965 Regional Block A handbook for use in the clinical practice of medicine and surgery Thomas Springfield III 4th ed 2 Ford DJ Pither CE Raj PP 1984 Electrical characteristics of peripheral nerve stimulators Implications for nerve localization Reg Anesth 9 73 3 Ford DJ Pither CE Raj PP 1984 Comparison of insulated and uninsulated needles for locating peripheral nerves with a peripheral nerve stimulator Anesth Analg 63 925 4 Kaiser H Niesel HC Klimpel L 1988 EinfluB der Reizstromst rke der Nervenstimulation auf latenz und Erfolg der hinteren Ischiadikusblockade Regional Anaesthesie 11 92 5 Kaiser H Niesel HC Hans V 1990 Grundlagen und Anforderungen der peripheren elektrischen Nervenstimulation Regional Anaesthese 13 143 6 Kaiser H Niesel HC Hans V Klimp
35. f the user wants to perform a safety check it is recommended to follow the test instructions in the Technical Service Manual 5 2 Special technical features The electrode connection is configured to prevent the electrode cable for the stimulation needles from being plugged in incorrectly and thereby creating the wrong polarity This reliable plug connection system ensures the correct polarity of the stimulation needle negative and skin electrode positive As a result of the high peak stimulation voltage the working spectrum is extremely broad even when extremely small stimulation electrodes are used fully insulated needles with pinpoint electrode The Stimuplex HNS 12 generates a negative current stabilized square pulse Unlike conventional instru ments of this type the pulse of Stimuplex9 HNS 12 is shaped by extremely fast active pulse drivers at both slopes An output amplifier specially designed for this application has an extraordinarily wide dynamic range and generates reproducible settings even below 0 10 mA The latest microcomputer technology has made it possible to integrate performance features into the Stimuplex HNS 12 that until now could only be provided by large and expensive systems Some examples of the integrated features include the exact measurement of actual current and battery vol tage display of tissue impedance menu structure and error messages available in various languages configuration of user specific
36. ht arrow key First Y appears to ask the user whether they really want to activate the factory settings The factory standard are not reset until the right arrow key is pressed once more and V appears on the right Now the following parameters are immediately activated Current range 5 00 mA Dial turns 1 Stimulus duration 0 10 ms Contrast 5 Frequency 2 Hz Autom switch off 20 Min Tone Beep El charge nC Off Volume 5 Auto adjust current On Variable tone On Add stimulus duration Off 34 4 2 7 2 Displaying the electrical charge of the stimulation pulse electrical charge nC By activating this menu item the electrical charge to be given off per stimulation pulse in nC is addi tionally displayed in the upper line on the LCD display el Charge nC current uA x stimulus dura tion ms 1 nC 10 As In the Setup menu open Options highlight El charge nC and activate with the right arrow key V appears on the right 4 2 7 3 Current adjustment This option allows automatic adjustment of the set stimulation current to the new settings when the stimulus duration is increased during an application This prevents the set stimulation current from suddenly being given off for too long when the stimulus duration is increased without the stimula tion current having been turned back to 0 00 mA Caution When the stimulus duration is lowered with the ms key and then increased again without the dial being operated in the
37. intenance in accordance with applicable written recommendations of B Braun Except as expressly provided herein B Braun makes no warranty of any kind expressed or implied with respect to the Stimuplex9 HNS 12 including but not limited to the implied warranties mer chantability and fitness for a particular purpose The sole and exclusive remedy for breach of any war ranty is limited to the remedies provided in the above paragraphs B Braun shall not be liable to customer for any indirect incidental special consequential or punitive damages including any damage for lost profits arising out of or in connection with furnishing of the Stimuplex HNS 12 or service hereunder or the performance use of or inability to use the Stimuplex9 HNS 12 or otherwise whether based on contract warranty tort including without lim itation negligence or any other legal or equitable theory 60 10 4 Change from pages 40 and 41 of the User manual Stimuplex HNS12 and Accessories Stimuplex and Contiplex needles Cross Reference Guide for USA Re Order Numbers Product description Needle Code no Sales unit USA Reorder USA Units x length pcs Number per Case Stimuplex9 HNS 12 Nerve Stimulator 4892098 4892098 1 with electrode cable for Stimuplex D Stimuplex9 A and Contiplex9 D needles Special knob for sterile handling 4892283 333578 1 Stimuplex Pen for percutaneous 1 25 m 4892099 4892099 1 nerve mapping Rem
38. ired stimulation current range e ms key Sets the desired stimulus duration e Hz key Sets the desired stimulation frequency e MENU arrow keys For navigation and settings in the menu e ON OFF key On and off switch for the Stimuplex9 HNS 12 Briefly press the ON OFF key To jump from the menu mode to the normal stimulation mode or to immediately delete a potentially existing marking in the stimulation mode e g 5 00 mA 19 2 2 3 Single handed remote control Stimuplex Remote Control As an alternative to the dial the target stimulation current can also be set using the single handed remote control available as an optional accessory With this feature Stimuplex HNS 12 can be easily operated under standard sterile conditions without an additional person The device recognizes the single handed remote control automatically as soon as it is used A symbol for the single handed remote control appears in the LCD display above the battery symbol activated when dots appear inactivated when no dots and the downward arrow are displayed For safety reasons the single handed remote control is not activated by the device until the target stimulation current has been set to zero with both the dial as well as with the single handed remote control Afterwards it is possible to set the target stimulation current with the remote control If required please press the unlabelled key on the single handed remote control lowers
39. ironment guidelines Power frequency magnetic fields should correspond to the values typical to those found in commercial and hospital environments Remark U is the mains alternating currents prior to use at the test level Table 3 55 Guidelines and manufacturer s declaration concerning electromagnetic immunity to interference Stimuplex HNS12 is intended for use in an environment as stated below The customer or user of Stimuplex HNS 12 should ensure that the device is operated in this type of environment Immunity IEC 60601 Compliance Electromagnetic environment guidelines tests test level level Mobile and portable radio frequency communication equipment should not be used at a lesser distance to Stimuplex HNS 12 including its lines than the recommended separation distance which is calculated according to the equation applicable to the modulation frequency Recommended separation distances d 3 5 V1 VP for 150 kHz to 80 MHz d 3 5 E1 VP for 80 MHz to 800 MHz d 7 E1 VP for 800 MHz to 2 5 GHz HF conducted 3 Veff Not with P as rated power of the transmitters in watts disturbances 150 kHz to applicable according to the transmitter manufacturer s according to W 60 MHz information and d as recommended separation IEC 61000 4 6 distance in meters m HF radiated 3 V m 4 V m The field strength of stationary radio transmitters disturbances 80 MHz to should be less than the compliance level at all acc
40. menus and select or confirm an option Up and down arrows Up and down keys Are used to select a menu item or option and or changes values Fast selection or change by holding down the up down key o MENU Left arrow Is used to jump back one menu level 2 2 1 Plug Connections Two polarized plug connections are located on the front of the nerve stimulator 3 polar plug for connecting single handed remote control Stimuplex DIG RC can be operated under sterile conditions 4 polar plug for connecting the electrode cable to the stimulation needle and skin electrode 18 2 2 2 Current regulator dial and keys Current regulator dial Stimuplex HNS 12 The current regulator dial is used to adjust the target stimulation current The dial has no stop The maximum currents 5 or 1 mA can be achieved either with 2 turns or 1 Dial factory setting The settings 1 or 2 dial turns are configured in the Setup menu Dial turns When set at 2 dial turns a higher resolution is achieved setting accuracy ze 1 Dial turn 5 00 mA range Resolution 0 02 mA from 0 00 mA to 0 50 mA Resolution 2 0 10 mA from 0 50 mA to 2 00 mA Resolution 0 25 mA from 2 00 mA to 5 00 mA 1 00 mA range Resolution 0 02 mA 2 Dial turns 5 00 mA range Resolution 0 01 mA of 0 00 mA to 0 55 mA Resolution 0 10 mA of 0 60 mA to 5 00 mA 1 00 mA range Resolution 0 01 mA Keys e mA key Sets the des
41. muplex HNS 12 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 undesired short circuits or leakage currents This can lead in part or even fully to channeling of the stimulation currents which impairs or even cancels out the stimulation 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 fur ther details see Section 5 5 Cleaning and disinfecting the Stimuplex HNS 12 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 Stimuplex HNS 12 and its correspon ding accessories When using sterile accessories always comply with standard sterile precautionary measures Avoid any inadvertent contact of the stimulation needle with bone since this could irreversibly dam age the needle and consequently traumatize the tissue 11 Keep accessories and device away from voltage conducting objects The elec
42. ng an applica tion has no impact on the currently set values 4 1 3 Frequency The desired switch on value for the stimulation frequency can be set under the menu item Frequency Navigate with the up down keys until the marking arrow is in front of the menu item Frequency Press the right arrow key to confirm the menu item thereby activating the desired switch on value for the stimulation frequency The switch on value is indicated by a checkmark V Changing this menu item during an application has no impact on the current settings The changes will not be active until Stimuplex HNS 12 has been switched off and back on 4 1 4 Current threshold display The desired current threshold warning visual and acoustical can be activated or deactivated under Main Menu Current threshold Highlight Current threshold using the arrow up down keys and confirm and activate N appears on the right or deactivate V disappears with the right arrow key 31 4 2 Setup Press the right menu arrow key to go to the Main Menu Using the up down keys choose Setup With the right arrow key open the Setup menu and you can select from the following menu items Tone Dial turns Contrast Auto switch off Date Language Options 4 2 1 Tone The desired volume the sound mode and the dependency of the tone pitch on the target stimulation current can be set in this menu On the menu page Tone use the up down keys to highlight
43. ntact no painful paresthesias no mechanical nerve lesions and no intraneural injections Permissible and possible options e Sedation and analgesia prior to blockade depending the patient s needs e General anesthesia prior to blockade e Blockades distal to the previous site of a regional anesthesia procedure in anesthetized or partially anesthetized regions e Extension of the indication spectrum e Enhancement of safety standards The resting potential at the nerve membrane is around 80 mV The cell s interior is negatively charged compared to the surrounding medium Sufficiently large ion movement reduces the membrane poten tial to 55 mV making the membrane freely permeable and generating an action potential The various types of nerve fiber differ with regard to their sensitivity to electrical stimulation The A alpha motor fibers have the shortest chronaxia 50 100 us The afferent fibers that transmit pain sensation Ad and C fibers require a longer pulse 150 and or 400 us at a minimum current Mixed peripheral nerves can be localized using short pulses 0 10 ms without triggering pain sensations For pure sensory nerves a longer pulse is recommended 0 30 ms 0 50 ms 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
44. ol vents acids and sodium hydroxide solution Disinfectants containing iodine or dyes can discolor the housing and should therefore not be used 5 6 Maintenance and safety checks Check the serviceable condition of the Stimuplex9 HNS 12 and accessories on each occasion before use A defective instrument must not be used Electromedical 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 5 7 Safety inspections according to Section 6 of the German Medical Devices Operator Ordinance MPBetreibV According to Section 6 of the German Medical Devices Operator Ordinance MPBetreibV the manu facturer distributor does not conduct safety check 5 8 Equipment logbook 1 The operator is required to keep an equipment logbook on medical technical devices according to MPG Class Il 2 Mandatory entries in the logbook include 2 1 Designation and other information for identification of the device 2 2 Certification about the function testing performed and instructions given in accordance with Section 5 para 1 of the German Medical Devices Operator Ordinance MPBetreibV 2 3 Name of the officer authorized in accordance with Section 5 para 1 no 2 time of instruc tional training and the name of the instructed persons 2 4 Deadlines and dates for performing prescribed safety checks and mechanical inspections and
45. ollowing information with each complaint 1 Unit Serial Number 2 Verification of last battery replacement date 3 Verification of completion of unit Short Test 4 contact name address phone number and e mail address 5 Account name and or number 6 Any information which might aid in the investigation of the complaint Also please note that no Inspection Sheet has been included with this unit as it does not contain any pertinent information to our U S A customers 10 2 Change from Page 38 of the Manual 5 9 Notices warranty Stated in manual Only original accessories from B Braun labeled with the CE sign should be used Revision Braun of America does not have or require the CE mark on its product packaging However only stimulation needles and HNS 12 Accessories offered by B Braun and labeled with B Braun logos should be utilized with this nerve stimulator 10 3 Change from Page 38 of the Manual 5 9 Notices warranty The existing warranty statement should be replaced in whole with the following B Braun Medical Inc hereby warrants to the original Customer that each Stimuplex9 HNS 12 shall be free from defects in material and workmanship when used and maintained in accordance with the Operation Manual All warranties shall expire two years from the date of shipment from B Braun B Braun s sole obligation and Customer s sole remedy for a breach of the foregoing warranty shall be at B Braun Medical s option either to re
46. onds During this time the cause of the error is displayed 1 Actual stimulation current gt target stimulation current tolerance tolerance 0 10 mA in the target current range 0 00 0 50 mA tolerance 0 20 mA in the target current range 0 50 2 00 mA tolerance 0 50 mA in the target current range 2 00 5 00 mA Max stimulation voltage of the stimulation pulse less than 50 V RAM memory error ROM program memory error 2 3 4 CPU computer error 5 6 ADC analog digital converter error 7 Frequency error If such an error occurs the device may no longer be used and must be sent in for repairs In the event of malfunctions that have no impact on the functional safety of the device e g a devi ation between internal parameters Stimuplex9 HNS 12 will first try to reconstruct these parameters During this procedure the message EEPROM Corrrection appears The display automatically disap pears after the error has been corrected successfully and the device is again ready for operation If the error cannot be corrected the factory set default values are used The error message K U EEPROM INIT then appears during every switch on procedure In this case the device might run at slightly changed stimulation settings Please send in the device immediately to the manufacturer or distributor for repairs or testing 40 Loading a language If an error occurs when changing the language the device will automaticall
47. options the infrared interface and the large high contrast and user friendly graphic display The internal quartz time base ensures precise stimulus durations and stimulus frequencies 36 5 3 Technical data Type Stimuplex HNS 12 Instrument type BF Battery 9V alkaline Power consumption 6 mA 8 mA max Stimulation current 5 mA max 0 12 Q Stimulation voltage U 95 V max Stimulation frequency 1 Hz 2 Hz 1 Stimulus duration 0 05 ms 0 10 ms 0 30 ms 0 50 ms 1 00 ms 1 Allowable load impedance 0 2 12 Q Current measuring accuracy 0 02 mA Impedance measuring range 1 KQ 90 kQ for target stimulation current gt 0 5 mA Impedance measuring accuracy 10 20 for target stimulation current gt 1mA lt 1mA Sound pressure level 51 dB 54 dB 63 dB for stimulation warning error Weight 250g Operational environmental conditions 0 50 C max 90 relative humidity no condensation 5 4 Battery The battery charge status must be checked regularly The battery should be replaced immediately whenever the battery symbol is flashing Please do not replace the battery when the device is turned on as otherwise the LCD display can become damaged When the battery voltage drops below 6 V the nerve stimulator stops operating and issues an error message Change the battery While not performing a stimulation you can save battery power by set ting the stimulation current to 0 00 mA If th
48. ording to 2 6Hz frequencies based on on site testing IEC 61000 4 3 test methods Malfunctions are possible in the environment of equipment that bears te this symbol Remark 1 The higher frequency range is applicable at 80 MHz and 800 MHz Remark 2 These regulations may not apply in all cases The distribution of electromagnetic fields is affected by absorptions and reflections of buildings objects and persons a The field strength of stationary transmitters such as base stations for mobile phones and mobile land radio telephones amateur radio stations AM and FM radio broadcasting and television transmitters can in theory not be exactly determined beforehand An inspection of the location should be considered to determine whether there are any stationary transmitters creating an elec tromagnetic environment If the measured field strength at the location where Stimuplex HNS 12 is operated exceeds the above stated compliance level Stimuplex9 HNS 12 should be monitored 56 to verify that it functions properly If abnormal performance features are observed additional mea sures may be required such as changing the orientation of Stimuplex HNS 12 or moving it to another location b The field strength should be less than 3 V m over a frequency range of 150 kHz to 80 MHz Table 4 Recommended separation distances between portable and mobile HF telecommunication devi ces and Stimuplex HNS 12 Stimuplex HNS12 is inten
49. ot reset by the factory setting option 3 1 Switch on Switch off ON OFF Switch on Press the ON OFF key After the key is released a self test not displayed is run the stimulation mode is displayed and the device is ready for operation or Hold down the ON OFF key the equipment data are displayed After the key is released a self test Is run as described above and the device is ready for operation Switch off Hold down the ON OFF key for approx 2 sec After the display of a progress bar is completed the display disappears The device is switched off Please do not replace the battery while the device is turned on as this can otherwise damage the LCD display If the key is released within the 2 second switch off phase the device remains turned on and swit ches into the stimulation mode home function If neither the dial nor the keys are operated for a period of 20 minutes the stimulator switches off automatically An audible warning signal will sound 4 Hz rhythm during the last minute In the Setup menu Auto switch off the automatic switch off time can be set to between 1 and 30 minutes using the up and down keys 25 3 2 Selecting the current adjustment range Factory setting on delivery 0 00 to 5 00 mA max The two ranges are selectable 0 00 to 5 00 mA 0 00 to 1 00 mA The current range can be changed in two ways T Selecting the current range for future switch on proced
50. ote Control for sterile one hand L 16 m 4892216B 333559 1 operation Finger rings for remote control RC 4892224B 333551 1 Electrode cable for Stimuplex D 4892070 333576 1 Stimuplex A and Contiplex D needles Connection cable for Contiplex A needles 4892925 333545 1 Stimuplex D needles 15 bevel D 25 035 25 G x 11 3 0 5 x 35 mm 4894103N 333670 25 D 25 055 25 G x 2 Je 0 5x 55 mm 4894111N N A N A D 26 040 23 G x 11 2 0 6 x 40 mm 4894120N N A N A D 26 070 23 G x 2 4 0 6x 70mm 4894138N 333672 2b D 27 050 22 G x 2 0 7x 50 mm 4894146N N A N A D 27 080 22 G x 3 s 0 7x 80mm 4894154N 333674 25 D 27 120 22 G x 4 4 0 7 x 120 mm 4894162N 333676 25 D 29 150 20G x 6 0 9 x 150 mm 4894170N N A N A Stimuplex D needles 30 bevel D 17 040 22 G x 11 2 0 7 x 40 mm 4894189N 25 N A N A D 17 050 22 G x 2 0 7x 50 mm 4894197N 25 333689 20 D 17 080 22 G x 37 8 0 7 x 80 mm 4894200N 25 333684 25 Stimuplex A needles 30 bevel A 25 24Gx 1 0 55 x 25 mm 4894251 25 333694 25 A 25 22Gx 1 0 70x 25 mm 4894539 25 333691 25 A 22 22 Gx fe 0 70x 35 mm 4894367 25 333693 25 A 50 22 G x 2 0 70 x 50mm 4894502 25 333690 25 A 507521 6x 2 0 80 x 50mm 4894375 25 N A N A A 100 21 G x 4 0 80 x 100 mm 4894260 25 333686 25 A 150 20 G x 6 0 90 x 150 mm 4894278 25 333680 25 10 4 Change from pages 40 and 41 of the User manual Stimuplex HNS12 and Accessories Stimuplex and Contiplex needles Cross Reference Guide for USA Re
51. ow key The contrast can be set from O to 8 The factory setting is 5 When you change the value with the up or down keys you can see the changes in the display con trast by checking the BIBRAUN logo The displayed value is immediately activated and remains set after you have exited the menu 4 2 4 Automatic switch off The set time interval for the automatic switch off applies from the last time the stimulator has been operated It is factory set to 20 minutes on delivery Nevertheless the switch off time can be set to between 1 and 30 minutes If the value is set to O the device does not switch off automatically Open the Setup menu select the option Auto switch off and open it with the right arrow key Using the up or down key set the desired automatic switch off time The increment is 1 minute bet ween 1 and 10 minutes above this the increment is 5 minutes Each setting is immediately activa ted 4 2 5 Date and time After every battery replacement the date and time must be reset Open the Setup menu highlight Date and open with the right arrow key Order for the setting 00 00 0000 00 00 Hour Set the hour using the Up down keys With the right arrow key move the cursor underline to the next position The minutes are displayed Set the minutes with the arrow up down keys With the cursor over the right arrow key go to the next position Year and set it with the up down keys Afterwards set month and
52. pair or replace the defective Stimuplex HNS 12 at no charge Customer shall bear all risk of loss or damage to returned goods while in transit In the event no defect or breach of warranty is discovered by B Braun upon receipt of the product the product will be returned to Customer at Customer s expense and Customer will reimburse B Braun for the trans portation charges labor and associated charges incurred in testing the allegedly defective product The defective product should be returned promptly to B Braun Medical properly packaged postage prepaid with appropriate identification per the instructions of B Braun Medical Customer Service All repairs or services not covered under the warranty will be billed at B Braun s then current rates 59 B Braun s warranty hereunder shall not apply if i the Stimuplex9 HNS 12 is not used in accordance with the instruction in the Operation Manual ii any repairs alterations or other work has been per formed by Customer or others on such item other than work performed with B Braun s authoriza tion and according to its approved procedures iii the alleged defect is a result of abuse misuse improper maintenance accident or the negligence of any party other than B Braun or iv used with any needles or devices not manufactured by B Braun Medical or not intended for use with the Stimuplex HNS 12 The warranty set forth herein is conditioned upon proper storage installation use and ma
53. pliance with the standards listed below proves the conformity with the essential requirements of the above mentioned EC Directive DIN EN 60601 1 Classification VDE 0750 Part 1 03 96 EN 60601 1 1990 A1 1993 A2 1995 IEC 601 1 1988 A1 1991 A2 1995 The compliance with requirements of Annexes II IV V VI has been proved by the following certificates Certificate Reg No 16075 QM 06 96 AA from VDE Institute Germany about the implementation and maintenance ofa QM System in compliance with the requirements of DIN EN ISO 9001 2000 Certificate Reg No 288842 MO21CMDR from DQS GmbH Germany about the implementation and maintenance of a QM System in compliance with ISO 13485 2003 A A CD Ou Freiburg 21 01 2005 uy Cl Dominika Schuler Management Representative STOCKERT GmbH 8 Symbols on Stimuplex HNS 12 Display symbols kQ Battery Target stimulation current Actual stimulation current Stimulus duration 1 HZ 2 Hz Infrared transmission Volume Shut off procedure Remote control active Single handed remote control active Remote control inactive Single handed remote control inactive Patient coupled circuit open 51 Symbols on device rear panel Application part type BF Refer to accompanying documents Remote Control Single handed remote control Stimulation current instrument needle Battery Date of manufacture year month MEDICAL ELECTRICAL E
54. s helpful to simulate the patient with a wet paper tissue or a small sponge soaked in salt water 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 the people at B Braun Melsungen AG and STOCKERT GmbH are happy to be at your service Your B Braun Melsungen AG STOCKERT GmbH 6 1 Principles of peripheral electrical nerve stimulation 1 1 Area of application Peripheral nerve stimulation facilitates the performance of peripheral nerve and plexus blocks The user no longer needs to rely on feedback from the patient about paresthetic sensations The danger of mechanical nerve lesions is mostly eliminated When the stimulation needle is placed sufficiently close to the target nerve predefined electrical pulses generate muscle contractions at motor efferent fibers and electrically elicited paresthesias at sensory afferent fibers During this procedure direct contact of the injection needle with the nerve is intentionally avoided Since peripheral electrical nerve stimulation PNS is no substitute for the anatomical knowl edge required to perform regional anesthesia accurate knowledge of the topography and nerve distribution area is prerequisite Advantages of nerve stimulation e Objective muscle response is obtained without the user having to rely on information or cooperation from the patient e No direct needle nerve co
55. srea e 7 COBESIDndie3t 97 a essai dune ee ede eap ierat asm ee mE eee 7 Milano EN E m T RN 7 Constant voltage or constant CUNEN euere 11 Description of the device en 13 Cheers before SEE t R 15 UR sly ge cers Rie acca oe ee er rere 17 FE PAG OV CANS oases cre sez ceseescoe E E E NE 17 Current regulator dial and KEYS anne 18 Single handed remote control Stimuplex9 Remote Control 19 SOU t n 19 Hp aceeprsancaecs 20 Bicis MIND ee S 21 Men SEDULO en ne ee REDE EI GREMIEN UM GI PIS MISI IE UE 22 Operation of the Stimuplex HNS 12 sees tententnnns 24 Swich om Switch OF ON OFF een reinen 24 Selecung the current adjustment Fangen 25 Selecuho the stiulauoH CUEN ae es 25 Selecung the sumus UT ATION censcunscsetikien patcr rentis Er sepa tueri Pe SEESE 26 Selecting the stimulation Freguend un nee een 27 Curent Chresnold OP IV e G 27 Eheeking the Dale Vol lag een need 28 Additional information Menu info een em 28 Setting parameters and options for future switch on procedures 29 Setting switch on values for stimulation parameters sse 29 Curent adjustment TIU Goran generi NEID e AEEA EER EREEREER 29 SEE AUS Oh rr E E een 30 Be aie E AE E E E E A E O E A te E TRE 30 cornent reca PE c ee en ee een 30 cod T
56. t currents and voltage poten tials at the electrodes The direct current stimulation generated as a result can be very painful and strong and trigger irreversible electrophysiological reactions To prevent poor contact of the skin electrode red clip from leading to a malpositioning of the stim ulation needle the user must make sure that the skin electrode which functions like a neutral elec trode here shows sufficiently safe contact with low tissue impedance Fatty tissue hair dirt repeat edly 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 sur face carefully in well vasculated muscular areas only Clean shave and degrease the skin At the same time do not position the skin electrode too far away from the puncture site However thoracic appli cation of the skin electrode is to be avoided The skin electrodes must not be applied to areas of injury Only use high grade commercially available CE marked EKG single use skin electrodes with silver silver chloride sensors precoated with gel To achieve optimum nerve stimulation always make sure the electrodes are undamaged and not dried out The nerve stimulator should not be used on patients with implanted electrical devices e g cardiac pacemakers without prior consultation with an appropriate medical specialist The stimulation cur rent may ca
57. target nerve can be localized This allows quicker onset and ensures a more reliable success of the blockade Nevertheless it is important to observe and stay within the predefined threshold currents so as to avoid a too close proximity to the nerve and prevent nerve damage The shorter the electrical pulse pulse width 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 nerve The stimulation needle should always be connected to the negative pole If the needle is con nected to the positive pole higher currents are required The conductive tip of the stimulation 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 2 Indications e Surgical interventions on the upper and lower extremity e Patients with high aspiration risk e Hemodynamically unstable patients e Postoperative analgesia to allow early mobilization and physical therapy e Replantation surgery e Diagnostic and therapeutic blockades 1 3 Contraindications e Refusal of regional anesthesia by the patient e Infection at the puncture site e Preoperatively known neurological dysfunctions e Anatomical abnormalities e Severe coagulation disorders e Insufficient liver function
58. the value until the symbol without dots disappears The single handed remote control is released when the target stimulation current is set to 0 00 mA and the remote control symbol is invis ible When single handed remote control is activated symbol with 2 dots the dial has no function For safety reasons neither the current range nor the stimulus duration can be increased when the sin gle handed remote control is activated without having previously set the target current to zero The automatic current adjustment option is also turned off When the single handed remote control is in use the smallest adjustable stimulation current is approx 0 09 mA due to technical reasons Attention The target stimulation current can be modified during menu navigation if the remote control is activated For safety reasons if the single handed remote control is disconnected from the Stimuplex9 HNS 12 the device automatically resets the stimulation current back to zero and the dial is reactivated for setting the stimulation current 2 2 4 Sound Fach stimulation pulse preset stimulation current is flowing generates a clear click or beep sound The volume increases from a low pitch during maximum stimulus current to a high pitch tone to audibly signal that the current threshold is being approached However changes in sound pitch can also be turned off in the Setup menu Tone Variable tone so that the same sound is always heard regardless of the r
59. tions presented in the manual For our US and Canada customers only the following revisions and or addi tions should be used in place or in conjunction with the information provided within the manual Thank you B Braun Medical Inc 10 1 Addition to Page 37 of the Manual 5 6 Maintenance and safety checks Service and Technical Support If during the initial warranty period the Stimuplex HNS 12 fails to respond to the operating or trou bleshooting procedures listed in this manual and the cause cannot be determined discontinue using the unit and contact B Braun Medical Customer Service for further instruction regarding Warranty Service Support and Repair B Braun Medical Inc 824 Twelfth Avenue Bethlehem PA 18018 0027 Ph 1 800 345 7744 Should it be necessary to return the unit for repair Customer Service will provide at Returned Goods Authorization RGA number and instruction for the return Carefully package the unit preferably in the original case mark it with the RGA number and ship according to Customer Service instruction B Braun Medical cannot assume any responsibility for loss and damage to returned units while they are in transit Please contact B Braun Medical Clinical and Technical Support with product function complaints B Braun Medical Inc Clinical and Technical Support 824 Twelfth Avenue Bethlehem PA 18018 0027 Ph 1 800 854 6851 Fax 1 610 758 9020 58 You will be asked to provide the f
60. trostatic and electro magnetic fields they radiate can impact the stimulation outcome and under certain circumstances themselves even lead to adverse stimulation 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 stimulator and or the stimu lation outcome Be aware of the position of metallic implants in the tissue e g plates or electrode cables which may potentially channel stimulation signals to other sites where it can cause damaging effects Implanted electronic equipment can be impaired by the stimulation current which in turn will lead to mal functions of the implants or even destroy them To avoid malfunctions of Stimuplex HNS 12 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 cur rent densities to occur which can damage the surrounding tissue Conformity with the following standards
61. u can scroll through these pages The version number format has the following meaning Version 1 002 x 1 hardware revision number 002 software revision number X language module revision number In addition to the equipment data distribution and manufacturer information is displayed You can configure the two User Info pages yourself using an infrared interface available as an accessory together with the corresponding service software via a PC The infrared interface future option not available at the moment is activated by selecting the Infrared page using the up down keys in the Info menu 4 Setting parameters and options for future switch on procedures 29 The parameters and options desired by the user which should be available when the device is switched on can be configured via the menu The arrow keys up down and right left are used for navigating through the menu structure These keys have the following functions 9 0 o Left arrow key Go back one menu level Right arrow key Go down one menu level or select confirm the highlighted value Up key Jump to the upper menu items or increase the highlighted value Down key Jump to the lower menu items or reduce the highlighted value Please keep in mind that the desired and set values are immediately saved with the checkmark V If you forget this and Stimuplex HNS 12 meanwhile switches off automatically the pre vious values remain configured 4 1
62. uCE 51 Electromagnetic compatibility EMC cc cscssssssssecsssessssssssesssessssessseesssecsseecssecssneersseessses 52 Specific requirements for the US market senes 57 Addition to Page 37 of the Manual 5 6 Maintenance and safety checks 57 Change from Page 38 of the Manual 5 9 Notices warranty sse 58 Change from Page 38 of the Manual 5 9 Notices warranty essen 58 Change from pages 40 and 41 of the User manual senes 60 Stimuplex HNS12 and Accessories Stimuplex and Contiplex needles Preface 5 With your purchase of the Stimuplex HNS 12 nerve stimulator you have acquired a device that is easy to operate and provides you with a straightforward array of all the functions you need to per form peripheral nerve blocks The following chapters describe the operation of Stimuplex HNS 12 The use of the stimulation needles required for performing stimulation is described in the instructions for use accompanying the needles which are not part of this user manual Chapter 1 describes the basic functions of unipolar nerve stimulation including a discussion of the principle of constant current stimulation For your study of its operational fundamentals we recommend that you have Stimuplex HNS 12 with all its accessories ready at hand and functional so that you can learn about the functions in practical exercises Here it i
63. ures Switch on the device Activate the Main Menu using the right arrow key and activate Current range using the right arrow key Select the desired range using the up or down key indicated by gt on the left and confirm with the right arrow key V appears on the right next to the selection Switch off the device The current range now selected will be configured when the device is switched on the next time Changing the current range during the application Press the mA key the displayed value is highlighted by a border and press the mA key again immediately the second possible value is set and highlighted This value is now activated for this application the border disappears after approx 3 sec If the mA key is pressed repeatedly while the border is activated each of the other current ranges is set If the current range is changed during the application and a target current has been set the target current may be reduced slightly automatically for technical reasons 3 3 Selecting the stimulation current The amplitude of the stimulation current desired current is set using the dial The resolution of the regulator increments is dependent on whether one or two dial turns have been set in the Setup menu see Section 2 2 2 When the single handed remote control is connected and active operation using the dial is not possible The automatic current adjustment see Section 4 2 7 3 is then likewise no longer active 26
64. use interference with the implanted devices and thereby put the patient at risk The perithoracic application of electrodes around the ribcage heart can increase the risk of cardiac fib rillation The stimulation current should not drop below a specific value By activating the option Current threshold see Section 3 6 the Stimuplex9 HNS 12 alerts you with an optical and acoustic warning whenever the stimulation current is out of tolerance If the stimulator shows a direct current or an offset direct current at the outlet the stimulator may no longer be used and must be sent back for repair The special precautionary measures specified by the EMC standard apply to electrical medical devices Portable and mobile HF communication devices can affect Stimuplex9 HNS12 which can lead to func tional failure of the device and or system Dynamic electrical and dynamic magnetic interference fields can cause interactions between device and system to occur and which can impact the actual stimulation current measurement and in extreme cases lead to error messages and possibly to activation of a safety shut off on the device Do not use Stimuplex9 HNS 12 in the proximity of equipment that produces strong electromagnetic fields such as cordless phones HF high frequency surgical equipment short wave or microwave med ical equipment The stimulation needle may pick up high frequency currents which could cause dam age to nerves Do not connect Stimuple
65. x9 HNS 12 to other devices If Stimuplex HNS 12 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 Other devices can interfere with Stimuplex HNS 12 or the system even if they show compliance with the applicable CISPR emission requirements Interference impulses greater than 3 V m within the fre quency range up to 100 MHz can be picked up by the stimulation current detector and thereby trig ger an error display and if appropriate a safety shutoff 10 Operation of other devices or systems with Stimuplex HNS 12 accessories can increase emissions or reduce immunity to interference on devices or systems Observe the supplied EMC instructions con cerning installation initial setup and operation of the device or system see Section 9 Electromagnetic compatibility EMC To avoid damage to the connecting cable and the device do not hold or carry the device by its con necting cables and or its accessories Do not wrap the cable around the device or around other equip ment Wrapping the connecting cable during normal operation of the stimulator generates inductive com ponents and at very short stimulation pulses can lead to a reduction in stimulation efficacy and or false measurements of the actual stimulation current False interpretations of the indicated values can be the result For safety reasons never operate Sti
66. y switch back to English During this procedure the LCD may briefly go blank 5 11 Instruments and accessories The Stimuplex9 HNS 12 should only be operated with the accessories and instruments referred to in this user manual Before every use check the accessories and instruments to make sure they are in serviceable condi tion and follow the care and disinfection instructions supplied see 5 5 Stimuplex HNS 12 and Accessories Stimuplex and Contiplex needles Product description Needle Code no Sales unit x length pcs Stimuplex HNS 12 Nerve Stimulator 4892098 1 with electrode cable for Stimuplex D Stimuplex A and Contiplex D needles Special knob for sterile handling 4892283 1 Stimuplex Pen for percutaneous nerve mapping 4892099 1 Stimuplex Remote Control for sterile 4892216B 1 one hand operation Finger rings for Stimuplex Remote Control 4892224B 1 Test resistance for Stimuplex HNS 12 4892096 1 Electrode cable for Stimuplex D 4892070 1 Stimuplex A and Contiplex D needles Connection cable for Contiplex A needles 4892925 1 Stimuplex D needles 15 bevel D 25 035 25 G x 1173 0 5x 35 mm 4894103N 25 D 25 055 25 G x 21 8 0 5x 55mm 4894111N 25 D 26 040 23 G x 11 2 0 6x 40mm 4894120N 25 D 26 070 23 G x 23 4 0 6x 70mm 4894138N 25 D 27 050 22 G x 2 0 7x 50 mm 4894146N 25 D 27 080 22 G x 31 8 0 7x 80mm 4894154N 25 D 27 120 22 G x 43 4 0 7 x 120 mm 4894162N 2b D 29

Stimuplex® HNS 12 - Frank`s Hospital Workshop

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Stimuplex&reg; HNS 12 - Frank`s Hospital Workshop

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Stimuplex® HNS 12 - Frank`s Hospital Workshop