Stimuplex® HNS 11 Nerve Stimulator for Regional Anaesthesia, Regional Analgesia, Neurology User manual
Manufacturer: Distributor: Stockert GmbH Bötzinger Straße 72 D-79111 Freiburg Germany B. Braun Melsungen AG P.O. Box 11 20 D-34209 Melsungen Tel.
Contents Page Checks before start-up ................................................................................................................................................ 4 Technical description ..................................................................................................................................................... 6 Operating the nerve stimulator .........................................................................................................................
Checks before start-up The Stimuplex® HNS 11 is a class lla medical device according to Council Directive 93/42/EEC. An item of medical equipment may only be put into operation after the supplier has subjected the equipment to a function test on site and has instructed the person responsible for operating the equipment in the use of the equipment with the aid of the user manual. Before putting the Stimuplex® HNS 11 into operation, carry out the following tests. 1.
In the operating mode, the LCD display shows the preselected stimulation current set on the controller between 0.00 and approx. 1.00 mA (in the 1 mA range) or from 0.00 to approx. 5.00 (in the 5 mA range). In the operating mode, the Stimuplex® HNS 11 shows the stimulation current actually flowing via the stimulation electrodes through the tissue. A ”+” sign on the LCD display signals this setting. The operating mode is switched by pressing the ”mA” button. 3. Select operating mode .
Technical description 6. Refer to the Safety information section before using the Stimuplex® HNS 11 on a patient. Any instrument behaving abnormally must not be put into operation. Contact customer service. Electromedical equipment may only be repaired by the manufacturer or by an organization expressly authorized by the manufacturer. The Stimuplex® HNS 11 nerve stimulator is designed for reliable identification and location of nerves for local anaesthesia.
Operating the nerve stimulator Switching on / switching off Turn the control knob clockwise out of the O position to switch on the Stimuplex® HNS 11. A brief click signals that this has taken place. At this instant, the device automatically starts a self-test. This includes switching on all segments of the LCD display as a visual check. When the self-test is completed, the nerve stimulator immediately switches to its normal operating mode.
Selecting the current range The maximum current available can be selected by pressing the ”mA (max)” button. The Stimuplex® HNS 11 nerve stimulator offers a choice between a range up to 5 mA max. or up to 1 mA max. Values between 0.00 mA and 1.00 mA can be selected in the 1 mA range with the on/off control knob. This also allows precise adjustments to be made for extremely thin and technically sophisticated needles.
The LED displays All LEDs directly assigned to the buttons are used to monitor the selected operating mode. Since LEDs require relatively high power, the Stimuplex® HNS 11 switches them off after 8 seconds (see p. 6 Section 7). The individual displays have the following significance: Current display mode The LCD display shows the stimulation current set ( ). The LCD display shows the stimulation current actually flowing ( ). In addition, a ”+” appears in front of the current displayed.
Pulse LED display The small orange LED above the LCD display flashes according to the pulse frequency set (1 Hz: once per second; 2 Hz: twice per second) when current is flowing through the electrodes. At the same time, a louder tick can be heard. The LCD display According to the display mode selected, the LCD display shows the setting for, or the actually flowing stimulation current. The display is in mA. The ▲ symbol indicates the stimulation frequence.
The tone Each generated pulse produces a tick. When a stimulation current flows to the electrodes (greater than 2% of the maximum stimulation adjustable), the tick becomes louder. If the stimulation current flowing exceeds the current set, then taking into account the measuring tolerance (see page 12 - Technical data - Measuring tolerance), the Stimuplex® HNS 11 institutes an error message consisting of several tone groups of rapid frequency (approx. 6 Hz). The device is no longer operational.
Special technical features The configuration of the electrode connection provides protection against a wrong polarity connection of the electrode cable. This new type of plug connection system ensures correct polarity of the electrodes at all times. A high stimulation voltage is associated with an unusually wide range of adjustment with extremely small stimulation electrodes. The Stimuplex® HNS 11 generates a negative, current-stabilized square pulse.
Battery The battery must be regularly checked for correct charge by pressing the ”BAT” button. While the button is pressed, the existing battery voltage appears on the LCD display. The battery should be replaced under 7 volts – as soon as the BAT symbol appears. When the battery voltage drops below 6 V, the nerve stimulator stops operating. Four horizontal lines and the BAT symbol appear in the LCD display. Change the battery.
Cleaning and disinfecting the Stimuplex® HNS 11 Use only soft, damp cloths to clean and disinfect the Stimuplex® HNS 11 and the electrode cable. Water, soap or white spirits are especially suitable for this. Ensure that no moisture penetrates the Stimuplex® HNS 11. Use only wet disinfection, no spray disinfection! Avoid condensation! White spirit or commercially available methanol-free disinfectant in an ethyl alcohol base can be used for disinfection.
For usage of HNS 11 please refer to the individual local law restricts (eg. maintaining a logbook, etc.). In case of conducting safety checks on the device, please refer to the enclosed inspection sheet.
Caution Electromagnetic fields may interfere with the function of the nerve stimulator. Do not use the stimulator in the proximity of equipment which produces strong electromagnetic fields such as HF high frequency surgical equipment, micro wave equipment or cordless phones. Notice The cables of the nerve stimulator Stimuplex® HNS 11 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.
Safety information 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. Possible interference with the implanted devices by the stimulation current could represent a danger to the patient. The adhesive electrodes must not be applied in the area of injuries. The Stimuplex® HNS 11 nerve stimulator must not be used in areas where there is an explosion hazard.
Instruments and accessories The Stimuplex® HNS 11 nerve stimulator should only be operated with the accessories and instruments mentioned on page 13, 14, 18 and 19 of this user manual. Check the accessories and instruments for serviceable condition before every occasion of use and comply with the care and disinfection instructions supplied (p. 14).
Product discription Canula Ø x length Code number Sales unit 0.55 x 25 mm 0.70 x 25 mm 0.70 x 50 mm 0.80 x 50 mm 0.80 x 100 mm 0.90 x 150 mm 4894251 4894539 4894502 4894375 4894260 4894278 25 25 25 25 25 25 1.3 x 55 mm 1.3 x 110 mm 4894219 4894294 25 25 D 18/055/C; 18 G x 21/8" 1.3 x 55 mm 4894227 25 Contiplex® D Catheter Set – with polyamide catheter 0.45 x 0.85 x 400 mm needle D 28/055/C; 18 G; 15° bevel needle D 18/055/C; 18 G; 30° bevel – with polyamide catheter 0.45 x 0.
Peripheral electrical nerve stimulation Principles By simplifying the accurate location of peripheral nerves, peripheral electrical nerve stimulation (PNS) facilitates the performance of nerve and plexus blocks increasing their safety and reliability. The old rule ”no paraesthesia - no anaesthesia” (1) loses its validity, because information from the patient concerning paraesthesia is eliminated, and the danger of a mechanical nerve lesion (8) is largely excluded.
early detection of technical faults which could endanger the patient and place the success of the anaesthesia in jeopardy. Performing PNS with the Stimuplex® HNS 11 and the Stimuplex® or Contiplex® needles 1. Check the Stimuplex® HNS 11. 2. Check the skin electrode (ECG adhesive electrode) (the conductive gel must not have dried) and apply it to a degreased area of skin which is not in the distribution area of the nerve to be blocked. 3.
If the two values coincide, the total resistance is acceptable (impedance test) and the electric circuit is satisfactory. If the actual value is less than the set value, this indicates that the electrical resistance in the external circuit is too high. The cause must be found e.g. adhesive electrode too dry, skin resistance too high, broken cable.
Literature Literature 1. Moore DC (1965), Regional block. A handbook for use in the clinical practice of medicine and surgery. Thomas, Springfield II. (4th ed.) 2. Ford DJ, Pither CE, Raj PP (1984), Electrical characteristics of peripheral nerve stimulators. Implications for nerve Iocalization. Reg Anesth 9:73. 3. Ford DJ, Pither CE, Raj PP (1984), Comparsion of insulated and uninsulated needles for locating peripheral nerves with a peripheral nerve stimulator. Anesth. analg. 63:925 4.
Appendix A Stimulation current display in the mA range Patient current Measurement display Controller display Patient current Measurement display Controller display 0.00 mA 0.05 mA 0.10 mA 0.20 mA 0.30 mA 0.40 mA 0.60 mA 0.80 mA 1.00 mA 0.00 mA 0.05 mA ± 0.02 0.10 mA ± 0.02 0.20 mA ± 0.02 0.30 mA ± 0.02 0.40 mA ± 0.02 0.60 mA ± 0.02 0.80 mA ± 0.02 1.00 mA ± 0.02 0.00 mA 0.05 mA ± 0.03 0.10 mA ± 0.03 0.20 mA ± 0.03 0.30 mA ± 0.03 0.40 mA ± 0.03 0.60 mA ± 0.03 0.80 mA ± 0.03 1.00 mA ± 0.03 0.
Appendix C Appendix C Stimuplex® HNS 11 Nerve Stimulator Operating range Max. stimulation voltage [V] Operating range Battery voltage [V] Stimuplex® HNS 11 Nerve Stimulator Max. stimulation current as a function of tissue resistance Max.
Appendix D Current density Bare and insulated needles Stimulation current [mA] Stainless steel needle Bare, uncoated needles Plastic insulation Coated needles bevel uncoated Stimuplex® A Contiplex® A Distance from the nerve [mm] Stimuplex® D and Contiplex® D needles (DP: DE 3919666) Only 0.2 or 0.05 mA stimulation current required blunt 30° Stimulation current [mA] Fully insulated needle with bare tip Stimuplex® D Contiplex® D Distance from the nerve [mm] Threshold currents down to minimum 0.
Caution: Federal (U. S. A.) law restricts this device to sale by or on the order of physicians. W. 01.08.01/7 Nr. 604 3895 hospital care B. Braun Melsungen AG P.O. Box 11 20 D-34209 Melsungen Tel (0 56 61) 71- 0 Fax (0 56 61) 71-38 11 www.bbraun.
