B. Braun Stimuplex HNS 12 User Manual
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B. Braun Stimuplex HNS 12 User Manual

Nerve stimulator for peripheral regional anesthesia
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Nerve Stimulator
for Peripheral Regional Anesthesia
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User Manual

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Summary of Contents for B. Braun Stimuplex HNS 12

  • Page 1 Stimuplex HNS 12 ® Nerve Stimulator for Peripheral Regional Anesthesia User Manual...
  • Page 2 In the US: Stockert GmbH B. Braun Melsungen AG B. Braun Medical Inc. Bötzinger Strasse 72 Hospital Care Division 824 Twelfth Avenue 79111 Freiburg 34209 Melsungen Bethlehem, PA 18018-3524, USA Germany Germany Phone: 1-800-854-6851 Phone: +49-(0)761-20716-0 Phone: +49-(0)5661-71-0 Fax: 1-610-758-9020 Fax: +49-(0)761-20716-20 Fax: +49-(0)5661-71-4845 Email: inquiry@bbraunusa.com...

  • Page 3: Table Of Contents

    Contents Principles of Peripheral Electrical Nerve Stimulation 1.1. Area of Application 1.2. Intended Use 1.3. Indications 1.4. Contraindications 1.5. Warnings 1.6. Constant voltage or constant current Description of the Device 2.1. Checks before Start-up 2.2. Technical Description 2.2.1. Plug Connections 2.2.2.
  • Page 4 4.1.1. Current adjustment range 4.1.2. Stimulus duration 4.1.3. Frequency 4.1.4. Current threshold display 4.2. Setup 4.2.1. Tone 4.2.2. Dial turns 4.2.3. Contrast on the LCD display 4.2.4. Automatic switch off 4.2.5. Date and time 4.2.6. Language 4.2.7. Options Initial setup, maintenance and notes HNS 12 5.1.
  • Page 5 Specific requirements for the US market 10.1. Addition to Section “5.6. Maintenance and safety checks” of the Manual - 5 -...
  • Page 6 Preface 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 perform peripheral nerve blocks. The following chapters describe the operation of Stimuplex HNS 12.

  • Page 7: Principles Of Peripheral Electrical Nerve Stimulation

    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 elec- trical pulses generate muscle contractions at motor efferent fibers and electrically elicited paresthesias at sensory afferent fibers.
  • Page 8 Permissible and possible options: • Sedation and analgesia prior to blockade depending upon the patient’s needs • General anesthesia prior to blockade • Blockades distal to the previous site of a regional anesthesia procedure in anesthe- tized or partially anesthetized regions •...

  • Page 9: Intended Use

    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 connected to the positive pole, higher currents are required.

  • Page 10: Warnings

    1.5. Warnings Warnings and Precautionary Measures General Precautionary Measures 1. 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.
  • Page 11 Warnings and Precautionary Measures for Stimuplex HNS 12 ® Under no circumstance should the device be operated with accessories other than those released and supplied by the manufacturer or listed in Section 5.10, “Instruments and accessories”. These accessories are EMC tested and approved.

  • Page 12: Hns

    8. Only use high-grade, commercially available, CE-marked ECG single-use skin electrodes with silver/silver chloride sensors precoated with gel. For non EU countries, CE marking is not required on ECG skin electrodes. To achieve optimum nerve stimulation always make sure the electrodes are undamaged and not dried out. 9.
  • Page 13 16. Do not connect Stimuplex HNS 12 to other devices (except for instruments and acces- ® sories, see section 5.10). 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.
  • Page 14 25. 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.
  • Page 15 Conformity with the following standards: DIN EN 50581 Technical documentation for the assessment of electrical and electronic products with respect to the restriction of hazardous substances DIN EN 1041 Information supplied by the manufacturer with medical devices 93/42/EEC and MPG Council Directive 93/42/EEC of 14 June 1993 concerning medical devices - Annex I (Essential Requirements);...
  • Page 16 IEC 60601-1-6 Medical electrical equipment – Part 1-6: General requirements for safety – Collateral standard: Usability IEC 60601-1-9 Medical electrical equipment – Part 1-9: General requirement for basic safety and essential performance - Collateral standard: Requirements for the reduction of environmental impacts. IEC 60601-2-10 Medical electrical equipment –...

  • Page 17: Constant Voltage Or Constant Current

    1.6. Constant voltage or constant current According to Ohm’s Law I ~ 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.

  • Page 18: Description Of The Device

    Description of the Device 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.
  • Page 19 Overview of the Stimuplex HNS 12 Nerve Stimulator - 19 -...

  • Page 20: Checks Before Start-Up

    Manufacturer’s factory settings configured on delivery (preset in the menu). Max. desired current - 5.00 mA Stimulus duration/Frequency - SENSe (see Section 2.2.) Impedance - kΩ (is calculated automatically) Range (not displayed) - 1 turn (can only be changed in the menu) 2.1.
  • Page 21 5. Connect the red clip for the skin electrode and the insulated 2-mm male plug for the stimulation needle with the 10 kΩ test resistance (included in the equipment supplied). The LCD display shows the current operating conditions: After switching on Stimuplex HNS 12, the target stimulation current is zero;...
  • Page 22 6. Use the dial to set the maximum current of 5.00 mA. No error message should appear at a load resistance of 10 kΩ (see accessories). The LED flashes green at the selected stimulation frequency. The sound is dependent on the preselected stimulation current, when “sound variable”...

  • Page 23: Technical Description

    2.2. Technical Description Stimuplex HNS 12 generates square pulses with selectable stimulus duration and continu- ® ously 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.

  • Page 24: Plug Connections

    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 Remote Control ® is no longer available). For continuing use of a remaining remote control, please see instructions for use of remote control –...
  • Page 25 1 Dial turn 5.00 mA range - Resolution = 0.02 mA from 0.00 mA to 0.50 mA - Resolution = 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 = 0.01 mA from 0.00 mA to 0.06 mA - Resolution = 0.02 mA from 0.06 mA to 1.00 mA 2 Dial turns...

  • Page 26: Sound

    Right arrow: Is used to activate the Main Menu or submenus 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 to change values. Fast selection or change by holding down the up/down key. Left arrow: Is used to jump back one menu level 2.2.3.

  • Page 27: Display Modes

    2.2.5. Display modes The Stimuplex HNS 12 has 4 basic display modes: ® 1. Stimulation mode – With or without electrical charge (nC) display – when in SENSe mode, the stimulus duration of the three stimulus impulses generated per second is shown instead of the electrical charge (nC) 2.
  • Page 28 3. Menu mode In the menu mode, various submenus and options can be selected by using the up and down arrows. The checkmark () symbolizes the selected value and/or the selected option. Each selection (displayed by a ”>”) can be changed by using the up and down arrow keys and must be confirmed by pressing the right arrow key, if applicable.

  • Page 29: Menu Structure

    2.2.6. 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 SENSe (3 Hz) On (√) or Off (no √) Current threshold: Info:...
  • Page 30 Setup: Tone: Volume: from 0 to 8 Mode: (click or beep) On (√) or Off (no √) Variable tone: Dial turns: 1 or 2 Contrast: 0 to 8 Automatic switch off: 0 to 10 min. (in min. increments) 15 to 30 min. (in 5 min. increments) Date HH:MM - YYYY.MM.DD Language...
  • Page 31 Setup: Language DK – Danish N – Norwegian FIN – Finnish GR – Greek RUS – Russian H – Hungarian RO – Romanian CZ – Czech SK – Slovak SLO – Slowenian PL – Polish TR – Turkish EST – Estonian LV –...

  • Page 32: Operation Of The Stimuplex ® Hns 12

    Operation of the Stimuplex HNS 12 ® The device is configured with the following factory settings on delivery: Maximum current: 5.00 Stimulus duration: SENSe (two impulses at 0.1 ms, third impulse varies with current strength from 0.15 ms to 1.0 ms) Stimulation frequency: Impedance: kΩ...

  • Page 33: Selecting The Current Adjustment Range

    Please do not replace the battery if the patient is connected to the device. Please do not replace the battery while the device is turned on as this can damage the LCD display. If the key is released within the 1-second switch-off phase, the device remains turned on and switches into the stimulation mode (home function).

  • Page 34: Selecting The Stimulation Current

    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.). 3.4.
  • Page 35 Stimulation current: Stimulus duration: 0.00 - 0.19 mA 0.10 - 0.10 - 0.15 ms 0.20 - 0.29 mA 0.10 - 0.10 - 0.17 ms 0.30 - 0.39 mA 0.10 - 0.10 - 0.20 ms 0.40 - 0.49 mA 0.10 - 0.10 - 0.23 ms 0.50 - 0.59 mA 0.10 - 0.10 - 0.26 ms 0.60 - 0.69 mA...
  • Page 36 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;...

  • Page 37: Selecting The Stimulation Frequency

    3.5. Selecting the stimulation frequency Factory setting on delivery: SENSe (3 Hz) The selectable options are 2 Hz, 1 Hz or SENSe. 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.

  • Page 38: Checking The Battery Voltage

    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 remaining capacity. The battery’s remaining capacity is additionally indicated in the menu under the item ”Info” (see below) in volt and percent.

  • Page 39: Setting Parameters And Options For Future Switch-On Procedures

    Setting parameters and options for future switch-on pro- cedures 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: Left arrow key: Go back one menu level...

  • Page 40: Stimulus Duration

    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.

  • Page 41: Setup

    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.

  • Page 42: Contrast On The Lcd Display

    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. The factory setting is 5. When you change the value with the up or down keys, you can see the changes in the display contrast by checking the B|BRAUN logo.

  • Page 43: Language

    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.
  • Page 44 4.2.7.1. Factory standard Activation of this menu item resets all of the parameters back to the manufacturer’s declared factory settings on delivery (see Section 3.). However, this does not change the language setting or the current threshold display. In the ”Setup” menu, open the ”Options” submenu. The ”Factory standard” option is auto- matically highlighted and can be activated with the right arrow key.
  • Page 45 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 stimu- lation current from suddenly being given off for too long when the stimulus duration is increased without the stimulation current having been turned back to 0.00 mA.

  • Page 46: Initial Setup, Maintenance And Notes

    Initial setup, maintenance and notes 5.1. Testing the Stimuplex HNS 12 ® A device check may be conducted as follows: 1. Switch on the Stimuplex HNS 12. After the ”Stand-by” key has been released and the ® self-test successfully completed, the device is ready for operation. 2.

  • Page 47: Special Technical Features

    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).

  • Page 48: Technical Data

    5.3. Technical data Type: ® Stimuplex HNS 12 Instrument type: Battery: 9V (alkaline, max. 1000mAh) Power consumption: 6 mA (8 mA max.) Stimulation current: Î = 5 mA (max.) (0 – 12 kΩ) Stimulation voltage: Û = 95 V (max.) Stimulation frequency: 1 Hz / 2 Hz ±1% / SENSe (ca.

  • Page 49: Battery

    5.4. Battery The battery charge status must be checked regularly. The battery must be replaced immedi- ately whenever the battery symbol is flashing. Do not replace the battery if the patient is connected to the device. Please do not replace the battery while the device is turned on as otherwise the LCD display can become damaged.

  • Page 50: Cleaning And Disinfecting The Stimuplex Hns

    5.5. Cleaning and disinfecting the Stimuplex HNS 12 ® The Stimuplex HNS 12 must be regularly cleaned and disinfected before and/or after each ® use. Use only soft, damp cloths to clean, wipe and disinfect the Stimuplex HNS 12 and the ac- ®...

  • Page 51: Equipment Logbook (Specific Requirement For Use On German Market)

    5.7. Equipment logbook (Specific requirement for use on German market) 1. The operator is required to keep an equipment logbook on medical-technical devices according to the German Medical Devices Operator Ordinance (MPBetreibV). 2. Mandatory entries in the logbook include: 2.1. Designation and other information for identification of the device 2.2.

  • Page 52: Error Messages

    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. In order to ensure an appropriate disposal of the device you have the possibility to give your device back to your B.
  • Page 53 1. Actual stimulation current > target stimulation current + tolerance tolerance = 0.10 mA in the target current range = 0.00 – 0.49 mA tolerance = 0.20 mA in the target current range = 0.50 – 1.99 mA tolerance = 0.50 mA in the target current range = 2.00 – 5.00 mA 2.
  • Page 54 Warnings Information Signals Reset Action Tone Pattern Frequency Color Repetition Repetition Current threshold tiTii 0.05 s 1 Hz Stimulation 2 kHz / 1.2 kHz yellow Current threshold tiTii 0.05 s 2 kHz / 1.2 kHz yellow 2 Hz Stimulation 0.5 s 0.5 s Current threshold tiTii...
  • Page 55 Errors Information Signals Reset Action Tone Pattern Frequency Color Repetition Repetition Patient current 0.05 s Device defective Service required 2.7 kHz 8s Switch off time 0.25 s - 0.25 s - 0.5 s 0.25 s - 0.25 s - 0.5 s Impulse voltage 0.05 s 2.7 kHz...

  • Page 56: Instruments And Accessories

    If any such error occurs, the device must not be used any longer and must be sent in for repair. In the event of malfunctions that have no impact on the functional safety of the device, e.g. a deviation between internal parameters, Stimuplex HNS 12 will first try to reconstruct ®...
  • Page 57 Stimuplex HNS 12 and Accessories, Spare parts, Stimuplex and Contiplex needles ® ® ® Product Designation Product Description Ø x length Battery cover for Stimuplex® HNS 12 Carrying case for Stimuplex® HNS 12 Test resistor for Stimuplex® HNS 12 Replacement electrode cable for Stimuplex® HNS 12 1.25 m (including cable) Stimuplex D needles, 15°...
  • Page 58 Contiplex Tuohy Ultra ® Needles with Tuohy bevel with Contiplex catheter 0.45 x 0.85 x 400 mm ® 18 G x 1 1/2" 1.3 x 40 mm 18 G x 2" 1.3 x 50 mm 18 G x 4" 1.3 x 100 mm with Contiplex catheter 0.45 x 0.85 x 1000 mm...
  • Page 59 22G x 3 1/8" 0.7 x 80 mm 22G x 4 3/4" 0.7 x 120 mm Needles with 30° bevel 22G x 2" 0.7 x 50 mm Stimuplex Ultra ® Needles with 30° bevel 22G x 1 3/8” 0.7 x 35 mm 22G x 2”...

  • Page 60: References

    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. Reg Anesth 9:73 3.

  • Page 61: Appendix

    Appendix Appendix A (according to IEC 60601-2-10): 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, 2 Hz or SENSe Output voltage Û = 95 V (without load, open) Output impulse current Î...
  • Page 62 Conversion table: stimulation current [mA] and pulse width [ms] in charge (nanocou- lomb, nC) Amplitude Pulse Charge Pulse Charge Pulse Charge Width Width Width 1000 1200 1600 1800 2000 2500 3000 1050 3500 1200 4000 1350 4500 1500 5000 - 62 -...
  • Page 63 Appendix B (according to IEC 60601-2-10): Load impedance as a function of battery voltage Setting: stimulation current = 5.00 mA Load impedance as a function of battery voltage Setting: stimulation current = 1.00 mA - 63 -...
  • Page 64 Actual stimulation current as a function of load impedance Setting: target stimulation current = 5.00 mA, battery voltage = 9.0 V Output voltage as a function of load impedance - 64 -...
  • Page 65 Target stimulation current as a function of adjustment control setting (relative to 0°) Setting: 2 turns - 65 -...
  • Page 66 Appendix C (according to IEC 60601-2-10): - 66 -...

  • Page 67: Symbols On Stimuplex ® Hns 12

    Symbols on Stimuplex HNS 12 ® Symbol Description Status of the battery voltage Target stimulation current Actual stimulation current Stimulus duration 1 Hz 2 Hz SENSe (description see Section 2.2. “Technical Description”) Infrared transmission (for service only) Volume Shut-off procedure Remote control active (Single-handed remote control active;...
  • Page 68 Stimulation current instrument (needle) Battery Date of manufacture Manufacturer Consult instructions for use MEDICAL — APPLIED CURRENT/ENERGY EQUIPMENT AS TO ELECTRICAL SHOCK, FIRE AND MECHANICAL HAZARDS ONLY IN ACCORDANCE WITH ANSI/AAMI ES 60601-1: 2005 + A1:2012; CAN/CSA-C22.2 No.60601-1:2014; IEC 60601-1-6:2010 + A1:2013;...
  • Page 69 Temperature limits (storage and shipping conditions) Follow operating instructions Federal (USA) law restricts this device to sale by or on the order of a physician. Russian GOST certification UA.TR.039 Ukraine conformity assessment body sign and number Keep dry The electrical and electronic product contains some hazardous substances which can be safely used during their environment-friendly use period;...

  • Page 70: Electromagnetic Compatibility (Emc)

    Electromagnetic compatibility (EMC) 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. ®...
  • Page 71 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. ®...
  • Page 72 Voltage dips and 0 % UT; 0.5 cycle Not applicable Not applicable interruptions according at 0°, 45°, 90°, to IEC 61000-4-11 135°, 180°, 225°, 270° and 315° 0 % UT; 1 cycle and 70 % UT; 25/30 cycles Power frequency 30 A/m 30 A/m Power frequency magnetic fields should correspond to...
  • Page 73 Remark: U is the mains alternating currents prior to application of the test level. 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 ®...
  • Page 74 Recommended separation distances between portable and mobile RF telecommunication devices and Stimuplex HNS 12 ® Stimuplex HNS12 is intended for operation in an electromagnetic environment in which RF disturbances are controlled. The ® user of the Stimuplex HNS 12 can help prevent electromagnetic malfunctions by maintaining a minimum distance between ®...
  • Page 75 Specific requirements for the US market To U.S.A Customers: The User Manual packaged with the nerve stimulator includes all the procedures and re- quirements for operation the Stimuplex HNS 12 Nerve Stimulator. Please heed all warnings ® and recommendations presented in the manual. For our US customers only, the following revisions and/or additions should be used in place or in conjunction with the information provided within the manual.
  • Page 76 Should it be necessary to return the unit for repair, Customer Service will provide a 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.
  • Page 78 Stockert GmbH B. Braun Melsungen AG Bötzinger Strasse 72 Carl-Braun-Strasse 1 79111 Freiburg 34212 Melsungen Germany Germany Phone: +49-(0)761-20716-0 Phone: +49-(0)5661-71-0 http://www.stockert.de http://www.bbraun.com 6043570 - valid for software version 1.003.x 0819...

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