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6043570_Stimuplex_HNS12_64s_GB 06.07.2007 11:19 Uhr Seite 1 Stimuplex ® HNS 12 Nerve Stimulator for Peripheral Regional Anesthesia User manual...
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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 Meliseptol®, Stimuplex® and Contiplex® are registered trademarks of B. Braun Melsungen AG...
6043570_Stimuplex_HNS12_64s_GB 06.07.2007 11:19 Uhr Seite 3 Contents Contents Page Preface ................................5 Principles of peripheral electrical nerve stimulation (PNS)...........6 Area of application ...........................6 Indications ..............................7 Contraindications ............................7 Warnings ..............................7 Constant voltage or constant current....................11 Description of the device ........................13 Checks before start-up..........................15 Technical description ..........................17 2.2.1 Plug Connections ............................17...
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6043570_Stimuplex_HNS12_64s_GB 06.07.2007 11:19 Uhr Seite 4 Contents Page 14.2.4 Automatic switch off ..........................32 14.2.5 Date and time ............................32 14.2.6 Language ..............................33 14.2.7 Options ...............................33 14.2.7.1 Factory standard............................33 14.2.7.2 Displaying the electrical charge of the stimulation pulse (electrical charge nC) ....34 14.2.7.3 Current adjustment ..........................34 14.2.7.4 Additional stimulus duration.......................34 Initial setup, maintenance and notes...................35...
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.
6043570_Stimuplex_HNS12_64s_GB 06.07.2007 11:19 Uhr Seite 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.
6043570_Stimuplex_HNS12_64s_GB 06.07.2007 11:19 Uhr Seite 7 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. 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.
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6043570_Stimuplex_HNS12_64s_GB 06.07.2007 11:19 Uhr Seite 8 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®...
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6043570_Stimuplex_HNS12_64s_GB 06.07.2007 11:19 Uhr Seite 9 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.
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6043570_Stimuplex_HNS12_64s_GB 06.07.2007 11:19 Uhr Seite 10 quency range up to 100 MHz can be picked up by the stimulation current detector and thereby trig- ger an error display and, possibly, a safety shutoff. Operation of other devices or systems with Stimuplex® HNS 12 accessories can increase emissions or reduce immunity to interference on devices or systems.
6043570_Stimuplex_HNS12_64s_GB 06.07.2007 11:19 Uhr Seite 11 Keep accessories and device away from voltage-conducting objects. The electrostatic and electro- magnetic fields they radiate can impact the stimulation outcome and, under certain circumstances, may 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.
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6043570_Stimuplex_HNS12_64s_GB 06.07.2007 11:19 Uhr Seite 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 –...
The functions of Stimuplex® 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 can a optimum of precision and reliability be achieved.
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6043570_Stimuplex_HNS12_64s_GB 06.07.2007 11:19 Uhr Seite 14 Overview of the Stimuplex® HNS 12 Nerve Stimulator LCD display LEDs Stimuplex HNS 12 Current adjustment range Dial for regulating the target Stimulus duration stimulation current Stimulation frequency MENU - On/off MENU - Home...
6043570_Stimuplex_HNS12_64s_GB 06.07.2007 11:19 Uhr Seite 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 - 2 Hz Impedance - kΩ (is calculated automatically) Range (not displayed) - 1 turn (can only be changed in the menu) 2.1 Checks before start-up The Stimuplex®...
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6043570_Stimuplex_HNS12_64s_GB 06.07.2007 11:19 Uhr Seite 16 The LCD display shows the current operating conditions: Electrical charge (when option is activated) Maximum current adjustment range Stimulus duration Stimulation frequency Impedance When Remote Control is activated Symbol for battery voltage Desired target stimulation current After switching on Stimuplex®...
6043570_Stimuplex_HNS12_64s_GB 06.07.2007 11:19 Uhr Seite 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”...
Seite 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).
6043570_Stimuplex_HNS12_64s_GB 06.07.2007 11:19 Uhr Seite 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 Stimuplex DIG RC under standard sterile conditions without an additional person.
6043570_Stimuplex_HNS12_64s_GB 06.07.2007 11:19 Uhr Seite 20 target stimulation current < current threshold, automatic switch off, EEPROM) and errors are sig- naled, 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 set- tings ranging from 0 (a very quiet ticking sound in the stimulus frequency;...
6043570_Stimuplex_HNS12_64s_GB 06.07.2007 11:19 Uhr Seite 21 2.2.6 Display modes The Stimuplex® HNS 12 has 4 basic display modes: 1. Stimulation mode - With or without electrical charge (nC) display - With or without single-handed remote control 2. Stimulation mode with warning (Actual stimulation current less than target stimulation current) 3.
6043570_Stimuplex_HNS12_64s_GB 06.07.2007 11:19 Uhr Seite 22 2.2.7 Menu structure Main Menu (arrow keys MENU) Current range: 0.00 - 5.00 mA 0.00 - 1.00 mA Stimulus duration: 1.00 ms 0.50 ms (optional) 0.30 ms 0.10 ms 0.05 ms (optional) Frequency: 2 Hz 1 Hz Current threshold: On (√) or Off (no √) Info:...
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6043570_Stimuplex_HNS12_64s_GB 06.07.2007 11:19 Uhr Seite 23 Setup: Language – Dutch – Danish – Norwegian – Finnish – Greek – Russian – Hungarian – Romanian – Czech – Slovak – Slowenian – Polish – Turkish – Estonian – Latvian – Lithuanian –...
6043570_Stimuplex_HNS12_64s_GB 06.07.2007 11:19 Uhr Seite 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: Impedance: kΩ...
6043570_Stimuplex_HNS12_64s_GB 06.07.2007 11:19 Uhr Seite 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: 1.
6043570_Stimuplex_HNS12_64s_GB 06.07.2007 11:19 Uhr Seite 26 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.
6043570_Stimuplex_HNS12_64s_GB 06.07.2007 11:19 Uhr Seite 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.
6043570_Stimuplex_HNS12_64s_GB 06.07.2007 11:19 Uhr Seite 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”...
6043570_Stimuplex_HNS12_64s_GB 06.07.2007 11:19 Uhr Seite 29 4. Setting parameters and options for future switch-on procedures 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.
6043570_Stimuplex_HNS12_64s_GB 06.07.2007 11:19 Uhr Seite 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”.
6043570_Stimuplex_HNS12_64s_GB 06.07.2007 11:19 Uhr Seite 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 –...
6043570_Stimuplex_HNS12_64s_GB 06.07.2007 11:19 Uhr Seite 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 arrow key. The contrast can be set from 0 to 8.
6043570_Stimuplex_HNS12_64s_GB 06.07.2007 11:19 Uhr Seite 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.
6043570_Stimuplex_HNS12_64s_GB 06.07.2007 11:19 Uhr Seite 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[µA] x stimulus dura- tion[ms], 1 nC = 10 As).
6043570_Stimuplex_HNS12_64s_GB 06.07.2007 11:19 Uhr Seite 35 5. Initial setup, maintenance and notes 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.
6043570_Stimuplex_HNS12_64s_GB 06.07.2007 11:19 Uhr Seite 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®...
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).
6043570_Stimuplex_HNS12_64s_GB 06.07.2007 11:19 Uhr Seite 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.
6043570_Stimuplex_HNS12_64s_GB 06.07.2007 11:19 Uhr Seite 40 Loading a language If an error occurs when changing the language, the device will automatically switch back to English. During this procedure, the LCD may briefly go blank. 5.11 Instruments and accessories The Stimuplex® HNS 12 should only be operated with the accessories and instruments referred to in this user manual.
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6043570_Stimuplex_HNS12_64s_GB 06.07.2007 11:19 Uhr Seite 41 Product description Needle Code no. Sales unit/ Ø x length pcs. Stimuplex® D needles, 30° bevel D 17/040; 22 G x 1 1 /2 “ 0.7 x 40 mm 4894189N D 17/050; 22 G x 2“ 0.7 x 50 mm 4894197N D 17/080;...
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6043570_Stimuplex_HNS12_64s_GB 06.07.2007 11:19 Uhr Seite 42 Product description Needle Code no. Sales unit/ Ø x length pcs. Contiplex® A catheter set - with polyamide catheter 0.45 x 0.85 x 400 mm Needle A 45/C; 18 G x 1 3 /4 “...
6043570_Stimuplex_HNS12_64s_GB 06.07.2007 11:19 Uhr Seite 43 6. References 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.
6043570_Stimuplex_HNS12_64s_GB 06.07.2007 11:19 Uhr Seite 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 current Output voltage Output current 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 Û...
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6043570_Stimuplex_HNS12_64s_GB 06.07.2007 11:19 Uhr Seite 46 Appendix B: Load impedance as a function of battery voltage Setting: stimulation current = 5.00 mA Battery voltage [V] Load impedance as a function of battery voltage Setting: stimulation current = 1.00 mA line1 10.5 Battery voltage [V]...
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6043570_Stimuplex_HNS12_64s_GB 06.07.2007 11:19 Uhr Seite 47 Actual stimulation current as a function of load impedance Setting: target stimulation current = 5.00 mA, battery voltage = 9.0 V 6.00 5.00 4.00 3.00 2.00 1.00 0.00 Load impedance [kΩ] Output voltage as a function of load impedance 10.0 90.0 80.0...
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6043570_Stimuplex_HNS12_64s_GB 06.07.2007 11:19 Uhr Seite 48 Target stimulation current as a function of adjustment control setting (relative to 0°) Setting: 1 turn 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 [°] 5 mA 1 mA...
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6043570_Stimuplex_HNS12_64s_GB 06.07.2007 11:19 Uhr Seite 49 Appendix C (per Section 6.8.2.aa) b) IEC 60601-2-10 : 2000 + A1:2001): Stainless Current density Bare and insulated needles steel needle Bare uncoated Stimulation needle current [mA] Plastic insulation Insulated needle Bevel uncoated Stimuplex® A Contiplex®...
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6043570_Stimuplex_HNS12_64s_GB 06.07.2007 11:19 Uhr Seite 50 Appendix D:...
6043570_Stimuplex_HNS12_64s_GB 06.07.2007 11:19 Uhr Seite 51 8. Symbols on Stimuplex® HNS 12 Display symbols Symbols on device rear panel Battery Application part, type BF Target stimulation current Refer to accompanying documents Actual stimulation current Remote Control (Single-handed remote Stimulus duration control) Stimulation current instrument 1 Hz...
6043570_Stimuplex_HNS12_64s_GB 06.07.2007 11:19 Uhr Seite 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...
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6043570_Stimuplex_HNS12_64s_GB 06.07.2007 11:19 Uhr Seite 53 Table 2 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...
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6043570_Stimuplex_HNS12_64s_GB 06.07.2007 11:19 Uhr Seite 54 Immunity IEC 60601 Compliance Electromagnetic tests test level level environment guidelines Power frequency 3 A/m 3 A/m Power frequency magnetic fields magnetic fields should (50/60 Hz) according to correspond to the IEC 610004-8 values typical to those found in commercial and hospital environments.
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6043570_Stimuplex_HNS12_64s_GB 06.07.2007 11:19 Uhr Seite 55 Table 3 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...
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6043570_Stimuplex_HNS12_64s_GB 06.07.2007 11:19 Uhr Seite 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®...
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.
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 repair or replace the defective Stimuplex® HNS 12 at no charge.
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11:19 Uhr Seite 59 B. Braun’s warranty hereunder shall not apply if: (i) the Stimuplex® 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;...
6043570_Stimuplex_HNS12_64s_GB 06.07.2007 11:19 Uhr Seite 60 10.4 Change from pages 40 and 41 of the User manual - 10.4 "Stimuplex® HNS12 and Accessories, Spare Parts, Stimuplex® and Contiplex® needles" Cross Reference Guide for USA Re-Order Numbers Product description Needle Code no. Sales unit/ USA Reorder USA Units Ø...
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6043570_Stimuplex_HNS12_64s_GB 06.07.2007 11:19 Uhr Seite 61 10.4 Change from pages 40 and 41 of the User manual - 10.4 "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 Ø...
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6043570_Stimuplex_HNS12_64s_GB 06.07.2007 11:19 Uhr Seite 62 10.4 Change from pages 40 and 41 of the User manual - 10.4 "Stimuplex® HNS12 and Accessories, Stimuplex® and Contiplex® needles" Cross Reference Guide for USA Re-Order Numbers...
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6043570_Stimuplex_HNS12_64s_GB 06.07.2007 11:19 Uhr Seite 63 10.4 Change from pages 40 and 41 of the User manual - 10.4 "Stimuplex® HNS12 and Accessories, Stimuplex® and Contiplex® needles" Cross Reference Guide for USA Re-Order Numbers...
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6043570_Stimuplex_HNS12_64s_GB 06.07.2007 11:19 Uhr Seite 64 B. Braun Melsungen AG Carl-Braun-Straße 1 34212 Melsungen Germany Tel +49 (0) 56 61-71-0 www.bbraun.com 06.07.07/1 Nr. 604 3570/0707...