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B.Braun Medical

Simuplex Nerve Stimulators

HNS 11 User Manual Aug 2001

User Manual

27 Pages

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... raun Melsungen AG P...  Box 11 20 D-34209 Melsungen Tel... 0 56 61) 71-0 Fax (0 56 61) 71-38 11
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File Size: 262KB
File Name: stimuplex_hns11_nerve_stimulator.pdf
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stimuplex_hns11_nerve_stimulator.pdf

Page 1

Stimuplex® HNS 11

Nerve Stimulator for

Regional Anaesthesia,

Regional Analgesia, Neurology

User manual

Page 2

Manufacturer:

Distributor:

Stockert GmbH

Bötzinger Straße 72

D-79111 Freiburg

Germany

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

Page 3

Contents

Page

Checks before start-up ................................................................................................................................................ 4

Technical description ..................................................................................................................................................... 6

Operating the nerve stimulator .......................................................................................................................... 7

Switching on / switching off .................................................................................................................................................. 7

Selecting the pulse frequency ............................................................................................................................................... 7

Selecting the pulse width ........................................................................................................................................................ 7

Selecting the current range .................................................................................................................................................... 8

Checking the battery voltage ................................................................................................................................................. 8

Selecting the current display mode .................................................................................................................................... 8

The LED displays .................................................................................................................................................................. 9

Current display mode ................................................................................................................................................................. 9

Current adjustment range ....................................................................................................................................................... 9

Pulse width ...................................................................................................................................................................................... 9

Pulse frequency ............................................................................................................................................................................. 9

Pulse LED display .......................................................................................................................................................................... 10

The LCD display .................................................................................................................................................................... 10

The tone ........................................................................................................................................................................................ 11

Initial set up, maintenance and general advice ................................................................................. 11

Testing the Stimuplex® HNS 11 before an application ............................................................................................... 11

Special technical features ....................................................................................................................................................... 12

Technical data ................................................................................................................................................................................ 12

Battery ............................................................................................................................................................................................... 13

Cleaning and disinfecting the Stimuplex® HNS 11 ...................................................................................................... 14

Maintenance and safety checks ........................................................................................................................................... 14

Safety checks / Local law restricts .......................................................................................................................... 15

Caution, Notice ............................................................................................................................................................................. 16

Safety information ...................................................................................................................................................................... 17

Error messages ............................................................................................................................................................................... 17

Instruments and accessories .................................................................................................................................................. 18

Stimuplex® HNS 11 and Accessories, Stimuplex® and Contiplex® needles ............. 18

Peripheral electrical nerve stimulation ...................................................................................................... 20

Performing PNS with the Stimuplex® HNS 11 and the Stimuplex® needles ........ 21

Literature .................................................................................................................................................................................... 23

Appendices A to D ............................................................................................................................................................ 24

Page 4

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. 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

devices 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 stimulator immediately

switches to its normal operating mode. The LEDs on the button

panel indicate the operating conditions selected. To conserve

power, these extinguish after 8 seconds.

If no display appears when the Stimuplex® HNS 11 is switched

on, change the battery immediately. (Refer to the ”Battery”

section, p. 13).

If the self-test detects a defective function, the corresponding

error code will appear in the LCD display and the instrument

will then be inoperative! (Refer to the ”Error messages” section).

When the LEDs are switched off, they can be reactivated by pressing any button. This does not change the existing operating mode.

The operating mode can only be changed when the LEDs are lit.

2. Carry out a visual inspection of the electrode cable. Damaged

cables must not be used.

Connect the electrode cable to the front of the nerve stimulator. The plug connector configuration prevents wrong polarity

connection.

4

Page 5

5

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 . Set the controller to 5 mA max. and

try to get a connection with the insulated, black 2 mm male plug

with a part of the red clamp. Compare – by briefly switching to

operating mode – the measured value with the set value (actual value and set value). These two values must be the same –

with shorted cables. Reset to 1 mA max. and compare these two

values (see Measuring Accuracy in Appendix A, if neccessary).

A ~ symbol appears next to the ▲ symbol in the LCD display

(Display) and the pulsed LED display (orange light-emitting diode) blinks according to the stimulation frequence.

A "+" sign appears in front of each measurement displayed.

When a current is set at O, the orange LED starts to blink at 0.02

mA, when 1 mA max. is set, and at 0.10 mA when 5 mA max. is

set.

4. When the stimulation cable is disconnected (when is set),

+0.00 appears in the display and the ~ symbol disappears. The

pulsed LED display is no longer lit.

If the "BAT" symbol appears in the display, then the battery

voltage is getting too low. Current application can be completed without a problem, but exchanging the battery afterwards

should be considered. Press the "BAT" button to display the remaining battery voltage (in volts).

When the battery voltage is approx. 6 volts, three horizontal

dashes preceded by the "+" sign (or four dashes) appear in the

display in addition to the "BAT" symbol. In this case, the stimulator shuts off automatically.

To avoid having to abort a stimulator treatment, you should

replace the 9 volt block battery as soon as the battery voltage drops to 6.5 volts.

5. To switch off the nerve stimulator, turn the control knob anticlockwise to position O.

To conserve the battery always switch off the Stimuplex ® HNS 11

after use. If you do not use it for a long period of time, remove

the battery to prevent battery leakage.

Page 6

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.

It generates consistent square pulses with selectable frequency,

selectable pulse width and continuously adjustable stimulation

current.

The range of adjustment of the pulse current from 0 to 5 mA peakto-peak can be reduced to 0 to 1 mA with the ”mA(max)” button.

This 1 mA range allows precise adjustments for extremely thin and

technically sophisticated needles.

The stimulation frequency and the pulse width can be varied for

different applications. The Stimuplex® HNS 11 nerve stimulator

offers the facility for selecting a frequency of either 1 Hz or 2 Hz

can be chosen together with pulse widths of 0.1 ms, 0.3 ms or

1.0 ms.

When the Stimuplex® HNS 11 is switched off, all set parameters

remain stored.

As a visual and audible check, the ▲ symbol and a tick occur in

time with the stimulation. Stimulation current flowing through the

electrodes is signalled by the ~ symbol next to the ▲ and a + sign

in front of the value for current in the display (in operating mode ).

To conserve battery power, the LEDs on the button panel for the

operating modes are switched off after approx. 8 seconds. They

are reactivated by pressing any button. This does not change the

operating mode setting, which can only be changed when the LEDs

are lit.

6

Page 7

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. The LEDs on

the button panel indicate the operating conditions selected (see

below). To conserve power, these extinguish after 8 seconds. They

light up again immediately when a button is pressed, but this does

not change the operating mode. The operating mode can only be

changed when the displays are lit.

To switch off the nerve stimulator, turn the control knob

anticlockwise to position O.

Selecting the pulse frequency

The selected setting is displayed and stored. You can change the

setting by pressing the "Hz" button when the LED display is lit. The

Stimuplex® HNS 11 nerve stimulator offers the facility of selecting

a frequency of 1 Hz or 2 Hz (one or two pulses per second).

Selecting the pulse width

The pulse width can be set by pressing the ”ms” button. It is possible

to set a stimulation of 0.1 ms, 0.3 ms or 1.0 ms.

The selected setting is displayed and stored. Setting can be changed

by pressing the "ms" button when the LED display is lit.

7

Page 8

8

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. For safety reasons, while a patient current is flowing, it is

not possible to switch from the 1 mA range to the 5 mA range. If

this is required, turn the control to 0.00 mA and then switch over.

The selected current range is displayed and is stored until the ”mA

(max)” button is pressed again.

Checking the battery voltage

Pressing the ”BAT” button will display the existing battery voltage

on the LCD display. Pressing this button does not affect the Stimuplex® HNS 11 functions. All settings remain unchanged.

Selecting the current display mode

During operation of the nerve stimulator, the stimulation current is

shown on the LCD display. Pressing the ”mA” button selects the current display mode: the stimulation current set (mA ) (displays set

current) or the current actually flowing in the tissue (mA ) (displays actual current). In addition, a ”+” appears in front of the current on the LCD display in the case of the actual current display.

If a current display mode is set (check this by switching to operating mode ) in the operating mode mA (actual current) and +0.00

appears in the display, then the possible source of the error could be:

-

the electrode cable is not connected to the device,

the adhesive electrode is defective (possible too dry),

the tissue resistance is very high,

the connecting cables are defective.

The measuring mode selected is displayed and is stored until the

”mA” button is pressed again.

Page 9

9

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.

Current adjustment range

Setting range from 0.00 to 5.00 mA:

Use the controller to dial a stimulation current up to 5 mA. The

current is displayed in 0.02 mA digits.

Setting range from 0.00 to 1.00 mA:

Use the controller to dial a stimulation current up to 5 mA. The

current is displayed in 0.01 mA digits.

Pulse width

Pulse width 1.0 ms: duration of stimulation pulse is 1.0 ms.

Pulse width 0.3 ms: duration of stimulation pulse is 0.3 ms.

Pulse width 0.1 ms: duration of stimulation pulse is 0.1 ms.

Pulse frequency

Pulse frequency 2 Hz (two pulses per second)

Pulse frequency 1 Hz (one pulse per second)

Page 10

10

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. At the same time,

there is a ticking sound in the same stimulation frequence. A ▲

symbol appears next to the ~ symbol in the same stimulation

frequence when the stimulation current is flowing and the ticking

sound gets louder. When the actual value display is selected, the

LCD display additionally shows a "+" in front of the current displayed.

Exceptions:

1. Pressing the ”BAT” button displays the battery voltage.

2. Equipment-related error functions produce the corresponding

error code in the display (see p. 17).

3. The ”BAT” symbol in the display indicates that the battery must

be exchanged soon.

4. When the battery voltage drops to approx. 6 volts

or

appears on the display. The stimulator switches off automatically

when these signs appear.

Display:

The ”BAT” symbol indicates that the battery voltage is too low.

(Refer to the ”Battery” section, p. 13)

Page 11

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.

Each time a button is pressed a short tone is produced of a different frequency as audible confirmation.

A click confirms that the instrument has been switched on.

Initial set up, maintenance, and general advice

Testing the Stimuplex® HNS 11 before an application

Switch on the Stimuplex® HNS 11 nerve stimulator by turning the

control knob clockwise from position O. A short click confirms that

switching on has taken place. When the self-test has been completed, the unit changes over immediately to the normal operating

mode. You can now select the frequency, pulse width and current

range according to the application required (see Section ”Operating the nerve stimulator”, p. 7).

With the set current indication (mA ), do not connect both electrodes - check both current ranges (1 mA max and 5 mA max) up

to maximum.

Switch to actual current indication (mA ) - both mA ranges give

a should reading of + 0.00 mA, independet from the set current.

Connect the two electrodes (clip and plug) together: check the mA

value in each case up to the maximum. All mA values have a ”+”

sign in front of the display. As soon as current flows, the LED above

the display flashes in time with the stimulation current. The ~

symbol appears next to the ▲ and the tick becomes louder.

Set an actual current of approx. 0.30 mA and switch to set current

(mA ): the two values should be the same (see Page 12 - Technical data - Measuring tolerance).

If all adjustments have been found to be correct, your Stimuplex®

HNS 11 is ready for application.

11

Page 12

12

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. In contrast to conventional instruments of this type,

the pulse is shaped at both slopes by extremely fast active pulse

drivers. An output amplifier specially designed for this application

has an extraordinarily wide dynamic range and produces reproducible settings even below 0.1 mA.

Use of the latest microcomputer technology has made it possible

to integrate performance characteristics which until now could

only be provided in large systems. For example: selection of current display mode, set and actual value display, display of battery

charge, error messages.

An internal quartz time base ensures precise pulse widths and

frequencies.

Technical data

Type: Stimuplex® HNS 11 nerve stimulator

Instrument type ................ BF

Battery ................................. 9 V

Power consumption ......... 3.3 mA

Stimulation current ......... max. 5 mApp / 0 ⏲ - 12 k⏲

Stimulation voltage ........ max. 65 Vpp

Stimulation frequency .... 1 Hz / 2 Hz

Measuring tolerance ....... Adjustment control display =3% (set point)

Flowing current display = 2% (actual value)

based on set mA max values (5 mA or 1 mA)

Weight ................................. 250 g

Due to its high maximum output voltage the nerve stimulator covers a wide range of skin and needle impedance. This is especially

important when using stimulation needles with an extremely small

conductive area (pin point electrode tip) such as Stimuplex® D and

Contiplex® D needles.

Page 13

13

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.

When the Stimuplex® HNS 11 nerve stimulator is not used for a

long period of time, the battery must be removed to prevent leakage.

Changing the battery

The battery compartment is in the base of the nerve stimulator.

Open the compartment by lightly pressing the OPEN symbol. At

the same time, slide the cover in the direction of the arrow.

Change the battery, ensuring correct polarity. After fitting the battery, slide the cover of the battery compartment back on again

right up to the limit stop.

Use only 9 V alkaline manganese batteries (e.g. VARTA 4022,

DURACELL MN 1604). These will provide you with a greatly

extended operating time and thus considerably more reliable

function.

Warning!

If the battery is leaking, the Stimuplex® HNS 11 should no longer

be operated for safety reasons. 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.

Page 14

14

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.

Caution!

The following substances must not be used:

trichloroethylene, acetone, methyl ethyl ketone, benzene, methanol, cellulose thinner, 1-propanol and 2-propanol.

Maintenance and safety checks

Check the serviceable condition of the Stimuplex® HNS 11 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 (acc. separate Technical Service Manual).

Page 15

15

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.

Page 16

16

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. The insulation of the cables must not exhibit any damage.

Only original accessories from B. Braun labelled with the CE sign

should be used.

Regarding the disposal of the nerve stimulator and its accessories

you should refer to the corresponding regulations in your country.

Storage and shipping conditions:

0 – 50° C, up to 90 % relative humidity, non condensation.

Warranty

Stimuplex® HNS 11 is guaranteed for two years against defects

in material and workmanship if the device is used in accordance

with the operationg instructions.

Wear and tear parts such as electrode cables, batteries, etc. are not

covered by this warranty. In addition, relevant sections of our

General Sales Conditions (Allgemeine Verkaufsbedingungen) apply

particularly in chapter IV No. 8.

Page 17

17

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.

The Stimuplex® HNS 11 nerve stimulator must not be used close to

microwave therapy equipment. The possible pick-up of radio

frequency currents by the stimulation electrode could damage the

nerves.

The patient current should not drop below a specific value (please

refer to p. 21 points 8 and 9).

If the battery has leaked, the Stimuplex® HNS 11 must not continue

to be operated for safety reasons. It must be returned to the

manufacturer for correct cleaning. The same applies if any liquid

soaks through!

In the event of warning tone sequences (tone groups of approx.

6 Hz), the Stimuplex® HNS 11 must be switched off and returned to

the manufacturer or distributor for repair.

Error messages

When the Stimuplex® HNS 11 nerve stimulator is switched on, it

automatically carries out a self-test. If this detects a faulty function,

the fault is shown on the corresponding error code on the LCD

display. The Stimuplex® HNS 11 is then no longer operational. It

must be returned to the manufacturer for repair. You should state

the error code in the repair order.

The following error codes are possible:

- F1:

- F2:

- F3:

Analogue data acquisition is faulty

Error in the program

Reference error in the analogue data acquisition system

Page 18

18

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).

Stimuplex® HNS 11 and Accessories, Stimuplex® and Contiplex® needles

Product discription

Canula

Ø x length

Code number

Sales unit

Stimuplex® HNS 11 nerve stimulator

– with electrode cable for Stimuplex® D-,

Stimuplex® A- and Contiplex® D- needles

4892097

1

Knob for sterile handling

Electrode cable for Stimuplex® D,

Stimuplex® A and Contiplex® D needles

Connection cable for Contiplex® A needles

4892283

4892070

1

1

4892925

1

0.5 x 35 mm

0.5 x 55 mm

0.6 x 40 mm

0.6 x 70 mm

0.7 x 50 mm

0.7 x 80 mm

0.7 x 120 mm

0.9 x 150 mm

4894103

4894111

4894120

4894138

4894146

4894154

4894162

4894170

25

25

25

25

25

25

25

25

0.7 x 40 mm

0.7 x 50 mm

0.7 x 80 mm

4894189

4894197

4894200

25

25

25

Stimuplex® D needles, 15° bevel

D 25/035; 25 G x 11/3"

D 25/055; 25 G x 2 1/8"

D 26/040; 23 G x 11/2"

D 26/070; 23 G x 23/4"

D 27/050; 22 G x 2"

D 27/080; 22 G x 31/8"

D 27/120; 22 G x 4 3/4"

D 29/150; 20 G x 6"

Stimuplex® D needles 30° bevel

D 17/040; 22 G x 11/2"

D 17/050; 22 G x 2"

D 17/080; 22 G x 31/8"

Page 19

19

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 0.85 x 1000 mm

needle D 28/110/C; 18 G; 15° bevel

1.3 x 55 mm

1.3 x 55 mm

4894235

4894243

10

10

1.3 x 55 mm

4894391

10

A 45/C; 18 G x 13/4"

A 55/C; 18 G x 21/8"

1.3 x 45 mm

1.3 x 55 mm

4893611

4893643

25

25

Contiplex® A Catheter Set

– with polyamide catheter

0.45 x 0.85 x 400 mm

needle A 45/C; 18 G; 30° bevel

needle A 55/C; 18 G; 30° bevel

1.3 x 45 mm

1.3 x 55 mm

4893603

4893638

10

10

Alphaplex® Catheter Set

– with catheter 0.9 m x 1.25 m x 330 mm,

– guide wire and Contiplex® D

– D 28/055/C; 15° and 30° bevel

Basic Set, 15° bevel

Super Set, 15° bevel

Basic Set, 30° bevel

Super Set, 30° bevel

1.3 x 55 mm

1.3 x 55 mm

1.3 x 55 mm

1.3 x 55 mm

U 1800 210

U 1800 200

U 1800 201

U 1800 203

10

10

10

10

Stimuplex® A needles, 30° bevel

A 25; 24 G x 1"

A 25; 22 G x 1"

A 50; 22 G x 2"

A 50; 21 G x 2"

A 100; 21 G x 4"

A 150; 20 G x 6"

Contiplex® D needles, 15° bevel

D 28/055/C; 18 G x 21/8"

D 28/110/C; 18 G x 43/8"

Contiplex® D needles, 30° bevel

®

Contiplex A needles, 30° bevel

Page 20

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. The principle consists of triggering depolarizations with electrical pulses at, but not within, the nerve, causing

muscular contractions at the effector muscle or sensitive sensations in the distribution area. Paraesthesia due to direct contact of

injection needles and nerve is consciously avoided.

PNS does not replace the anatomical knowledge required for regional anaesthesia, rather it assumes accurate knowledge of the

topography and the nerve distribution area.

The various types of nerve fibre differ in regard to their sensitivity

to electrical stimulation. The A-alpha motor fibres have the shortest chronaxia (50 - 100 µs). The fibres of pain sensation (A-delta

and C-fibres) require a longer pulse (150 and 400 µs respectively)

at minimum current. Mixed peripheral nerves can be localized with

short pulses (0.1 ms) without triggering pain sensations. For pure

sensory nerves, a longer pulse (0.3 or 1.0 ms) is recommended.

When using unipolar needles (needles with an insulated needle

shaft and a conductive tip), the current necessary to trigger muscular contractions (= pulse amplitude) correlates with the distance

of the tip of the needle from the nerve: the lower the threshold

current the more accurately is the nerve localized, and the shorter

the onset and more reliable the success of the block (4). The shorter the electrical pulse (= pulse width), the faster is the rise in current to the nerve, and the clearer the discrimination as to whether

the needle tip is sufficiently close to the nerve (2,5). The stimulation needle should always be connected to the negative pole because higher currents are required if the polarity is reversed (needle positive) (6).

The geometry of the electrical current field is dependent on the

geometry of the conductive tip of the stimulation needle. 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 current when the nerve is exactly localized.

The Stimuplex® HNS 11 stimulator has been designed according to

the most modern aspects and the requirements which originate

from the theory and practice of peripheral electrical nerve stimulation (3,6). It is provided with alarm systems necessary for the

20

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21

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. Carry out patient positioning, skin disinfection, and if necessary, local infiltration of the needle puncture site.

4. Connect the electrode cables to the stimulation needle (negative) and skin electrode (positive), switch on the Stimuplex® HNS

11 and set the mA controller current (mA ) to zero.

After the automatic self-test of the stimulator, the ▲ symbol

appears in the display in time with the stimulation pulse to

indicate that it is ready to operate.

Caution! A change to the stored parameters can only be made

when the LEDs are lit. By pressing any button the LEDs will light up

and indicate the value stored. To change press the appropriate

button.

5.

6.

7.

8.

Select pulse width (0.1 ms, 0.3 ms or 1.0 ms).

Select pulse frequency (1 Hz or 2 Hz).

Select amplitude range (1 mA max or 5 mA max.).

Advance the Stimuplex® or Contiplex® needle through the skin

and the subcutaneous tissue towards the nerve to be blocked.

Set a current of approx. 0.30 mA (set value mA ) - the orange

LED above the display flashes in time with the stimulation, the

display shows a ~ next to the ▲ and a tick signals that current

is flowing in the tissue.

Then switch to actual current flowing value indicator (mA )

and check that the actual value corresponds to the set value

(see p. 12 - Technical data, measuring tolerance).

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22

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.

After the impedance test, leave in the mA position (current

flowing at the tip of the needle indicated and a + sign in front

of the current displayed) until the block is successful.

9. Set an actual current of approx. 1 to 2 mA and advance the

needle further until the first muscles supplied by contractions

occur in the nerve sought. Then, while reducing the current,

advance the needle to the nerve until the recommanded threshold current. (For values see, for example, literature references

4, 7). The threshold current to be achieved depends on the pulse

width and the geometry of the conductive tip of the needle.

Warning! When using Stimuplex® or Contiplex® needles, it must

be noted that muscular contractions with a current of 0.2 to

0.5 mA and a stimulus duration of 0.1 ms - with a current of

0.05 to 0.2 mA and a stimulus duration of 1.0 ms - indicate

satisfactory proximity to the nerve sought. Any further reduction in the ”threshold currents” may cause direct contact of

the needle with the nerve, resulting in the danger of a mechanical nerve lesion.

If needles from other manufacturers are used, the threshold

currents may be much higher. You would have to work out

these yourself.

10. After clearly visible muscular contractions are seen using the

desired threshold current, inject local anaesthetic.

The response to the electrical stimulation will reduce or disappear within a few seconds after an injection of 2 - 3 ml. If this

effect is not definite, do not continue to search for the nerve

at the same location. For safety reasons, a more peripheral site

should be used.

Page 23

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. Kaiser H, Niesel HC, Klimpel L (1988), Einfluss der Reizstromstärke der Nervestimulation auf Latenz und Erfolg der hinteren

Ischiasdiskusblockade. Regional-Anaesthesie 11:92.

5. Kaiser H, Niesel HC, Hans V (1990), Grundlagen und Anforderungen der peripheren elektrischen Nervenstimulation. Regional-Anaesthesie 13:143

6. Kaiser H, Niesel HC, Hans V, Klimpel L (1990), Untersuchungen

zur Funktion peripherer Nervenstimulation für die Durchführung von Nerven- und Plexusblockaden. Regional-Anaesthesie

13:172.

7. März P, (1990), Kann bei der elektrischen Nervenstimulation

aus der Intensität der Muskelkontraktion 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.

Further literature:

Kaiser H, Die periphere Nervenstimulation

In Niesel HC (dir.), Regionalanästhesie, Lokalanästhesie, Regionale

Schmerztherapie. Thieme-Verlag Stuttgart New York (1994), 186-207.

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)

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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

0.00 mA

0.50 mA

1.00 mA

1.50 mA

2.00 mA

3.00 mA

4.00 mA

5.00 mA

0.00 mA

0.50 mA ±

1.00 mA ±

1.50 mA ±

2.00 mA ±

3.00 mA ±

4.00 mA ±

5.00 mA ±

0.00 mA

0.50 mA ± 0.15

1.00 mA ± 0.15

1.50 mA ± 0.15

2.00 mA ± 0.15

3.00 mA ± 0.15

4.00 mA ± 0.15

5.00 mA ± 0.15

0.1

0.1

0.1

0.1

0.1

0.1

0.1

Appendix B

Conversion table: Amplitude (mA) and pulse width (ms) to charge (nano-Coulomb, nC)

Amplitude Pulse width

mA

ms

0.1

0.1

0.2

0.1

0.3

0.1

0.4

0.1

0.5

0.1

0.6

0.1

0.7

0.1

0.8

0.1

0.9

0.1

1.0

0.1

1.2

0.1

1.6

0.1

1.8

0.1

2.0

0.1

2.5

0.1

3.0

0.1

3.5

0.1

4.0

0.1

4.5

0.1

5.0

0.1

Charge

nC

10

20

30

40

50

60

70

80

90

100

120

160

180

200

250

300

350

400

450

500

Pulse width

ms

0.3

0.3

0.3

0.3

0.3

0.3

0.3

0.3

0.3

0.3

0.3

0.3

0.3

0.3

0.3

0.3

0.3

0.3

0.3

0.3

Charge

nC

30

60

90

120

150

180

210

240

270

300

360

480

540

600

750

900

1050

1200

1350

1500

Pulse width

ms

1.0

1.0

1.0

1.0

1.0

1.0

1.0

1.0

1.0

1.0

1.0

1.0

1.0

1.0

1.0

1.0

1.0

1.0

1.0

1.0

Charge

nC

100

200

300

400

500

600

700

800

900

1000

1200

1600

1800

2000

2500

3000

3500

4000

4500

5000

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25

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. stimulation

current [mA]

Battery voltage [V]

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