HNS 12 User Manual sw ver 1.003x Aug 2019

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: [email protected]

Email: [email protected]

Email: [email protected]

http://www.bbraunusa.com

http://www.stockert.de

http://www.bbraun.com

The Stimuplex® HNS 12 may only be 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. Meliseptol®, Stimuplex® and Contiplex® are registered trademarks of B. Braun Melsungen AG

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Contents 1. 1.1. 1.2. 1.3. 1.4. 1.5. 1.6.

Principles of Peripheral Electrical Nerve Stimulation Area of Application Intended Use Indications Contraindications Warnings Constant voltage or constant current

2. Description of the Device 2.1. Checks before Start-up 2.2. Technical Description 2.2.1. Plug Connections 2.2.2. Current regulator (dial) and keys 2.2.3. Sound 2.2.4. LED 2.2.5. Display modes 2.2.6. Menu structure

7 7 9 9 9 10 17 18 20 23 24 24 26 26 27 29

3. 3.1. 3.2. 3.3. 3.4. 3.5. 3.6. 3.7. 3.8.

Operation of the Stimuplex® HNS 12 Stand-by Selecting the current adjustment range Selecting the stimulation current Selecting the stimulus duration Selecting the stimulation frequency Current threshold display Checking the battery voltage Additional information – Menu info

32 32 33 34 34 37 37 38 38

4. 4.1.

Setting parameters and options for future switch-on procedures Setting switch-on values for stimulation parameters

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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

39 40 40 40 41 41 41 42 42 42 43 43

5. Initial setup, maintenance and notes 5.1. Testing the Stimuplex® HNS 12 5.2. Special technical features 5.3. Technical data 5.4. Battery 5.5. Cleaning and disinfecting the Stimuplex® HNS 12 5.6. Maintenance and safety checks 5.7. Equipment logbook (Specific requirement for use on German market) 5.8. Notices 5.9. Error messages 5.10. Instruments and accessories

46 46 47 48 49 50 50 51 51 52 56

6.

References

60

7.

Appendix

61

8.

Symbols on Stimuplex® HNS 12

67

9.

Electromagnetic compatibility (EMC)

70

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10. 10.1.

Specific requirements for the US market Addition to Section “5.6. Maintenance and safety checks” of the Manual

75 75

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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. 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 a Stimuplex® HNS 12 with all of its accessories at hand and functional so that you can learn about the functions in practical exercises. It is helpful to simulate the patient with a wet paper tissue or a small sponge soaked in saltwater. The saline solution is required to produce electrical conductivity. The device may only be operated in compliance with the user manual. The device may only be used in professional environments (e.g. hospital). If you have further questions, the people at B. Braun Melsungen AG and STOCKERT GmbH are happy to be at your service. Yours, B. Braun Melsungen AG STOCKERT GmbH

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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. The Stimuplex® HNS 12 nerve stimulator shall be used only by medical personnel trained and experienced in the techniques of peripheral nerve stimulation and only in the clinical environment (not in home care environment). Since peripheral electrical nerve stimulation (PNS) is no substitute for the anatomical knowledge required to perform regional anesthesia, accurate knowledge of the topography and nerve distribution area is a prerequisite. Advantages of nerve stimulation: •• Objective muscle response is obtained without the user having to rely on information or cooperation from the patient •• No direct needle-nerve contact, no painful paresthesias, no mechanical nerve lesions, and no intraneural injections.

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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 anesthetized or partially anesthetized regions •• Extension of the indication spectrum •• 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 potential 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 µs). The afferent fibers that transmit pain sensation (Aδ and C-fibers) require a longer pulse (150 and/or 400 µs) 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 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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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. 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. Special attention must be paid as the current density at needle tip can exceed 2 mA/cm2 depending on stimulation settings. The Stimuplex® HNS 12 is meant for long-term usage.

1.2.

Intended Use

The nerve stimulator is intended for localisation of nerves in peripheral regional anesthesia. Under no circumstances may it be used on a patient undergoing surgery.

1.3.

Indications

•• Surgical interventions on the upper and lower extremity •• Patients with high aspiration risk •• Hemodynamically unstable patients •• Postoperative analgesia to allow early mobilization and physical therapy •• Replantation surgery •• Diagnostic and therapeutic blockades

1.4.

Contraindications

•• Refusal of regional anesthesia by the patient •• Infection at the puncture site •• Preoperatively known neurological dysfunctions •• Anatomical abnormalities •• Severe coagulation disorders •• Insufficient liver function

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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. Under no circumstances should you allow these plugs/connections to come in contact with voltage channeling components (e.g. electrical outlets) or metallic objects. 2. 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 vicinity of the patient must comply with the applicable rules and regulations. All equipment and accessories 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-threatening injury to the patient. 3. The patients themselves should not 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. 4. Unauthorized persons opening or attempting to repair Stimuplex® HNS 12 can create a dangerous situation and will cause all warranty claims to be null and void. No modification of the Stimuplex® HNS 12 is permitted.

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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. Any other accessories can lead to serious impairment of the device and system properties and cause permanent injury to the patient, user or device. 5. Whenever high frequency surgical equipment is used simultaneously, there is an acute danger of severe burns occurring at the Stimuplex® 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 stimulation 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 irreversible 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 direct currents and voltage potentials at the electrodes. The direct current stimulation generated as a result can be very painful and strong, and trigger irreversible electrophysiological reactions. 6. To prevent poor contact of the skin electrode (red clip) from leading to a malpositioning of the stimulation needle, the user must make sure that the skin electrode, which functions like a neutral electrode here, shows sufficiently safe contact with low tissue impedance. Fatty tissue, hair, dirt, repeatedly used skin electrodes and electrodes of poorer quality can negatively impact tissue impedance, thereby incurring the risk of neural damage. It is therefore recommended to select the contact surface carefully in well-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 application of the skin electrode is to be avoided. 7. The skin electrodes must not be applied to areas of injury.

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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. 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 current may cause interference with the implanted devices and thereby put the patient at risk. 10. The perithoracic application of electrodes (around the ribcage, heart) can increase the risk of cardiac fibrillation. 11. Stimulation should not be applied across or through the head, directly on the eyes, covering the mouth, on the front of the neck, (especially the carotid sinus), or from electrodes placed on the chest and the upper back or crossing over the heart. 12. The stimulation current should not drop below a specific value. By activating the option “Current threshold” (see Section 3.6.), the Stimuplex® HNS 12 alerts you with an optical and acoustic warning whenever the target stimulation current is set below this value. 13. If the stimulator shows a direct current or an offset direct current at the outlet, the stimulator should not be used and must be returned to the manufacturer for repair. These failures can be detected by performing a simple functional test with the testing resistor (see Section 5.1. Testing the Stimuplex® HNS 12). 14. The special precautionary measures specified by the EMC standard apply to electrical medical devices. Portable and mobile RF communication devices can affect Stimuplex® HNS 12 which can lead to functional failure of the device and/or system. 15. Dynamic electrical and dynamic magnetic interference fields can cause interactions between device and system to occur which can impact the actual stimulation current measurement and, in extreme cases, lead to error messages and possibly to the activation of a safety shut-off on the device. Do not use Stimuplex® HNS 12 in the proximity of equipment that produces strong electromagnetic fields such as cordless phones, high frequency surgical equipment, shortwave or microwave medical equipment. The stimulation needle may pick-up high frequency currents, which could cause damage to nerves. (See Table 4 Recommended separation distances between portable and mobile RF telecommunication devices and Stimuplex® HNS 12.)

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16. Do not connect Stimuplex® HNS 12 to other devices (except for instruments and accessories, 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. 17. Other devices can interfere with Stimuplex® HNS 12 or the system, even if they show compliance with the applicable CISPR emission requirements. Interference impulses can be picked up by the stimulation current detector and thereby trigger an error display and, possibly, a safety shutoff. 18. 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 concerning installation, initial setup and operation of the device or system (see Section 9. Electromagnetic compatibility (EMC)). 19. Do not use the device after ingress of liquids. Ingress of liquids or humidity can cause an electronic failure. 20. To avoid damage to the connecting cable and the device, do not hold or carry the device by its connecting cables and/or its accessories. Do not wrap the cable around the device or around other equipment. 21. Wrapping the connecting cable during normal operation of the stimulator generates inductive components 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. 22. For safety reasons, never operate Stimuplex® HNS 12 if the battery is leaking, but return it to the manufacturer for proper cleaning. The same applies if any liquid soaks through! 23. Do not continue to operate the device if repeated error messages appear. The device must be returned to the manufacturer for proper repair. 24. Known undesirable side effects: Hematoma at puncture site

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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. In this event, the device can no longer properly indicate the actual current flowing to the patient. 26. To prevent damage to the device and its accessories, never use aggressive cleaning agents. For further 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. 27. The user must follow the instructions for use when operating Stimuplex® HNS 12 and its corresponding accessories. Avoid any inadvertent contact of the stimulation needle with bone, since this could irreversibly damage the needle and consequently traumatize the tissue. 28. Keep accessories and device away from voltage-conducting objects. The electrostatic and electromagnetic fields they radiate can impact the stimulation outcome and, under certain circumstances, may lead to adverse stimulation effects in the tissue. 29. 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 stimulation outcome. 30. 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 malfunctions of the implants or even destroy them. 31. 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! 32. To protect the patient from electrophysiological shocks through electrostatic discharges (ESD), it is necessary for them to wear the appropriate clothing and to move around in an appropriately secured environment. An electrostatic discharge (ESD) at the tip of the needle can cause extremely high current densities to occur which can damage the surrounding tissue.

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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); Annex II (without section (4))

Directive 2006/66/ EC and ElectroG (German Battery Law)

Directive 2006/66/EC of the European Parliament and of the Council of 6 September 2006 on batteries and accumulators and waste batteries and accumulators

Directive 2011/65/ EU

Directive 2011/65/EU of the European Parliament and of the Council of 8 June 2011 on the restriction of the use of certain hazardous substances in electrical and electronic equipment (RoHS II)

Directive 2012/19/ EU

Directive 2012/19/EU of the European Parliament and of the Council of 4 July 2012 on waste electrical and electronic equipment (WEEE)

FDA 21 CFR 21

FDA - Code of Federal Regulations Title 21 Part 801 - Subpart A - Labeling

Part 801 FDA 21 CFR 21 Part 820

FDA - Code of Federal Regulations Title 21 Part 820 - QS regulation - Subpart K - Labeling and Packaging Control

FDA 21 CFR 21

FDA - Code of Federal Regulations Title 21 Part 830 - Unique device identification

Part 830 IEC 60601-1

Medical electrical equipment –Part 1: General requirements for basic safety and essential performance

IEC 60601-1-2

Medical electrical equipment - Part 1-2: General requirements for safety – Collateral standard: Electromagnetic compatibility - Requirements and tests (applicable to Ed. 3 and 4)

IEC 60601-1-4

Medical electrical equipment - Part 1-4: General requirements for safety - Collateral standard: Programmable Electrical Medical Systems

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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 – Part 2-10: Particular requirements for the safety of nerve and muscle stimulators

IEC 60812

Analysis Techniques for System Reliability – Procedure for Failure Mode and Effects Analysis (FMEA)

IEC 62304

Medical device software - Software life-cycle processes

IEC 62353

Medical electrical equipment - Recurrent test and test after repair of medical electrical equipment

IEC 62366

Medical devices - Application of usability engineering to medical devices

ISO 13485

Medical devices – Quality Management Systems – ­Requirements for regulatory purposes

ISO 14971

Medical devices – Application of risk management to medical devices

ISO 15223-1

Medical devices - Symbols to be used with medical device label, labelling and information to be supplied - Part 1: General requirements

Regulation (EC) 1907/2006

Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH)

UL 60601-1

Medical electrical equipment - Part 1: General requirements for safety

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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. It can move between < 1 kΩ and infinity. Factors such as skin moisture, conductivity of the skin and tissue and the potential resistance of the skin electrode can hardly be influenced. If voltage (V) is selected as a measure of the intensity of the stimulation pulse, currents can flow during 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 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 Stimuplex® HNS 12, the external load resistance can be up to 12 kΩ. 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 stimulation current are displayed separately, and optical and acoustic warning messages are set off. Moreover, the applied impedance is calculated constantly and indicated in the LCD display.

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2.

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. 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 only be used 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 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 an optimum of precision and reliability be achieved. For more in-depth knowledge about the use of this device, its risks and side effects we recommend 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 kΩ test resistance –– User manual (this document) –– CD-ROM with user manuals in different languages (PDF files) –– Brief instructions for use –– Technical Service Manual –– Storage case for keeping Stimuplex® HNS 12 and accessories The special knob and the Stimuplex® Pen can be purchased separately as accessories and kept safely in the storage case in the intended compartments.

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Overview of the Stimuplex HNS 12 Nerve Stimulator

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Manufacturer’s factory settings configured on delivery (preset in the menu). Max. desired current Stimulus duration/Frequency Impedance Range (not displayed)

2.1.

- 5.00 mA - SENSe (see Section 2.2.) - kΩ (is calculated automatically) - 1 turn (can only be changed in the menu)

Checks before Start-up

The Stimuplex® HNS 12 is a class lla medical device according to Council Directive 93/42/ EEC. The device should not be used until it has been subjected to an on-site function test and the persons responsible for operating the device are instructed how to use the device with the aid of the user manual. Before putting the Stimuplex® HNS 12 into operation, carry out the following tests. 1. 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. 2. Check if the battery is installed. 3. Press the ”Stand-by” key to switch on the Stimuplex® HNS 12. While you are holding down the ”Stand-by” 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 8 seconds. 4. A battery symbol appears in the right lower corner of the LCD display that allows a check of the battery 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 Section 5.4. „Battery“). Whenever the battery symbol is flashing, a new 9 V alkaline block battery must be installed immediately to avoid having to abort a stimulator treatment.

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