Stimuplex Dig RC User Manual Aug 2005

Caution! This User’s manual contains important information regarding the use of the Stimuplex® Dig RC nerve stimulator. Please read this manual thoroughly before using the unit in order to become familiar with its functions. A sound knowledge of anatomy and block technique together with the correct use of the Stimuplex® Dig RC is essential for successful neural blockade.

For requests please contact: B. Braun Melsungen AG (Distributor) Hospital Care Regional Anaesthesia Password: Plexus HC-MS-DE08P P.O. Box 11 20 D-34209 Melsungen Tel. (0 56 61) 71-0 E-Mail: http:// www.bbraun.de

Contents

Page

Design and Functions... 4 Stimuplex® Dig RC Short Test... 6 Remote Control Short Test... 7 Application without Remote Control... 8 Application with Remote Control... 9 Note... 10 Purpose... 11 Important Notes... 11 Troubleshooting... 12 Care and Maintenance... 13 Warranty... 13 EC-Declaration of Conformity... 14 References... 15 Technical Data... 16 Models, Accessories... 18

Design and Functions

Current Regulator To turn on the device, move the current regulator clockwise from “0“ to “I“. To increase the current, turn the dial in the direction of the arrow.

Digital Display The digital display indicates current settings. The set value flashes when the circuit is open. If the cable contacts are shorted, the flashing will stop because the circuit is closed. It is also closed when the needle is connected to the device and inserted into the patient, allowing the current impulse to flow through the patient via the skin electrode, back to the device. The scale in the lower region of the current regulator has been expanded to allow fine adjustment of current in 0.01 mA increments using the digital display. Fine adjustment allows optimal location of the needle in relationship to the nerve and, thus, the highest success rates for nerve blocks. The stimulus pulse current is held constant via an electronically-controlled constant current generator despite variable tissue resistance. If the control range of the constant current generator is exceeded (higher resistance due to faulty contact), the digital display will flash. Signal Tone Simultaneously to every current impulse you can recognize a short signal when circuit is open. On a close circuit a longer signal is heard. The frequency of the signal is proportional to the amplitude of the set current and flowing current respectively. Red “Bat“ LED The red LED is the battery voltage check light. It should flash for a short time when the unit is switched on, but if it flashes continuously, the battery needs to be replaced.

4

5

Yellow LED With a closed circuit this LED flashes simultaneously with each impulse and thus indicates the pulsed current (0.1 mA and up) that is flowing. Frequency Switch Toggle switch for switching the impulse frequency to 1 Hz or 2 Hz. Integrated Electrode Cable The electrode cable is firmly connected with the device. For replacement please see Technical Service Manual.

Connecting socket for Remote Control Tripolar plug of the Stimuplex® Dig RC. When the Remote Control is connected to the device the initial value of 0.2 mA (± 10%) is indicated on the display.

Remote Control Single-handed Remote Control with finger rings to be placed onto the palm under the sterile glove in order to set the required current in a sterile way. – “Up“ button: 5.0 mA final value (20 sec.) – “Down“ button: 0.2 mA initial value (20 sec.) – Finger rings for ideal fixation Replacement Please see Service Manual.

Stimuplex® Dig RC Short Test

Check the external condition of the device – Housing clean and undamaged – Lables legible – Dials (current regulator, frequency switch) functional – Cable set functional Function Test Turn on the device (current regulator to “I“): – red LED “Bat“ will flash briefly for control – digital display shows initial value 0.2 mA – brief audio signal (beep) sounds in synchrony with selected frequency (e.g. 1 Hz = 1 signal/second) Slowly increase the current regulator: – digital display flashes and shows the present current value – maximum current available is 5.0 mA – the frequence of the signal changes proportionally to the preselected current value The yellow LED should not light up at any setting during an open circuit. To check the Electrode Cable Short the contacts at the ends of the electrode cables: – insert the closed alligator clip into the black socket in order to close the circuit – the yellow LED flashes and the digital display stops flashing and indicates the current – prolonged signal tone If the yellow LED does not light when the cable ends are shorted, the cable connection is defective and the cable set should be replaced. (For replacement of the integrated electrode cable see point 4 of the Technical Service Manual.) Functional safety should be verified before each use. In case of functional failure, the unit should be tested by technical staff according to the check-list as follows.

6

Remote Control Short Test

To check the Remote Control After the Stimuplex® Dig RC short test connect the Remote Control to the nerve stimulator. Turn on the device by using the current regulator: – the digital display shows the initial value 0.20 mA Press the buttons “Up“/“Down“ in succession and the pitch of the audio signal will change proportionally to the preselected current value: – the digital display shows the preselected current

7

Application

1. Application without Remote Control 1.1 Verify the Stimuplex® Dig RC’s functional safety (short test). 1.2 Connect the electrode cable to the skin electrode using the red alligator clip (anode). 1.3 Connect the socket of the Stimuplex® needle to the insulated jack at the electrode cable. (If the Contiplex® A cannula is used, the socket of the Contiplex® A connection cable is connected to the tube in the needle hub. The black plug from the electrode cable is inserted into the insulated jack of the connection cable.) 1.4 Switch the Stimuplex® Dig RC unit by turning the current regulator and select the desired current (approx. 1 mA): – digital display flashes – short signal tone to be heard 1.5 Insert the needle at the puncture site: – the digital display stops flashing and displays the value of the current flow – prolonged signal tone to be heard, the tone level is proportional to the set current – the yellow LED flashes in synchrony with each current impulse. If the LED does not flash, the circuit is interrupted (defective adhesive electrode, broken cable, etc.) 1.6 Advance the needle in the direction to the nerve until distinct muscle contractions occur in the innervated area. 1.7 Reduce the current by using the current regulator and optimize the needle position until muscle contractions occur at lower current levels. If necessary rotate the needle to optimize its position. The tip of the needle has reached an optimal position when noticeable contractions occur at a current of approximately 0.2-0.5 mA. 1.8 Inject a test dose of local anaesthetic (1-2 ml). Muscle contractions will cease almost immediately (5-10 sec.). 1.9 After the entire dose of local anaesthetic has been administered, no contractions should occur even with an increase of current.

8

9

Caution: If the digital display flashes (short signal tone to be heard) with an increased current, the skin electrode does not have sufficient skin contact and the actual current flow is lower than the displayed value. Apply a new skin electrode or reduce the current value until the digital display stops flashing (prolonged signal tone to be heard). The displayed value now corresponds to the actual current flow.

2. Application with Remote Control 2.1 Verify the Stimuplex® Dig RC’s functional safety (short test). 2.2 Connect the electrode cable to the skin electrode using the red alligator clip (anode). 2.3 Connect the socket of the Stimuplex® needle to the insulated jack at the electrode cable. (If the Contiplex® A cannula is used, the socket of the Contiplex® A connection cable is connected to the tube in the needle hub. The black socket from the electrode cable is inserted into the insulated jack of the connection cable.) 2.4 Insert the tripolar plug of the Remote Control into the output socket of the Stimuplex® Dig RC’s front panel. 2.5 Switch on the device and carry out a short test (see page 10): - digital display flashes - short signal tone to be heard 2.6 Slip the Remote Control with its finger rings on two fingers of the left hand – left-handers onto the right – in order to position the Remote Control on the palm. Put a sterile glove on the hand which is holding the Remote Control, covering it with the glove in a way that the buttons can be operated easily either with the index finger and the middle finger or with the middle finger and the ring finger. (Carry out a short test before using). Making sure that the cable of the Remote Control is orientated and fixed in direction of the wrist to avoid contact with the sterile area. 2.7 Test confirmation to be carried out whilst watching the tone level of the signal tone: - button “Up“  increasing current  increasing signal tone level - button “Down“  decreasing current  decreasing signal tone level

Application/Note

- set required initial current (approx. 1 mA) - insert the needle at the appropriate puncture site Advance the needle slowly towards the nerve which is to be blokked whilst pushing the “Down“ button (see par. 1.5 to 1.7). If required the position of the needle may be optimized by pressing the “Up“ or “Down“ buttons whilst observing the subsequent muscular contractions and then the local anaesthetic is injected as described in par. 1.8 and 1.9.

Note When the Remote Control is connected, the setting of the current is exclusively controlled by the “Up“ and “Down“ buttons of the Remote Control, whereas the current regulator knob on the nerve stimulator, in this mode functions only as an “On“/“Off“ switch. In case the current setting is required to be operated only by the current regulator knob the connection cable of the Remote Control needs to be disconnected. Moreover the nerve stimulator Stimuplex® Dig RC needs to be switched off by the current regulator knob and then switched to “On“ again.

10

Purpose of Stimuplex® Dig RC

When using the nerve stimulator Stimuplex® Dig RC in regional Anaesthesia and regional pain therapy peripheral nerves are stimulated and located via electrical current impulses flowing through an insulated needle. The stimulation current is concentrated at the uninsulated tips. Accurate localisation of nerves is only possible when during the pulsating discharge of minimal current (0.2-0.5 mA), nerve stimulation causes visible muscle contraction. Important Notes: ● To avoid nerve lesions, use needles with a short bevel (Contiplex® cannulae or Stimuplex® needles). To avoid tissue entering the needle, fill it with saline or local anaesthetic, which then act like a stylet. ● The recommended disposable ECG tape skin electrodes are commercially available, high-grade, CE-marked products. These include a silver/silver chloride sensor precoated with gel. To achieve optimum nerve stimulation with Stimuplex® Dig RC, always make sure the electrodes are undamaged and have not dried out. ● Avoid traumatised areas when attaching the skin electrodes to the patient. ● This device is not approved for insertion in or around the heart. ● Stimuplex® Dig RC may be used only by trained staff. Instruction can be provided by employees of the distributor or by the biomedical engineer of the hospital. ● Functional safety and appropriate device status must be verified before operating the unit (see short test). ● Caution! Not to be used for patients with cardiac pacemakers because malfunction of the pacemaker may occur. ● This device must not be connected to AC power: only a 9 volt battery may be used as a power supply. ● Do not use Stimuplex® Dig RC in conjunction with other devices.

11

Purpose of Stimuplex® Dig RC

● If the patient is simultaneously connected to a high-frequency surgery device, burns under the stimulation current electrodes can result. ● Shortwave or microwave therapy devices located near the unit (i.e. within 1 m) can cause fluctuations in the stimulation current output values.

Troubleshooting Yellow “closed circuit“ LED does not light: ● if it is defective (see functional check) ● if the cable connections to the needle or electrode are defective The digital display flashes (short signal tone) when the circuit is closed: ● if the skin electrode does not have sufficient contact with the patient’s skin or the cable connection is defective Red “Bat“ LED flashes (continuously): ● if battery voltage drops below 5,6 volts. A blockade which is in progress can be continued, but the battery must be replaced afterwards. (Care and Maintenance, p. 12) There is no audio signal after the unit is switched on: ● if the battery is low. Replace the battery

12

Care and Maintenance

Care and Maintenance The Stimuplex® Dig RC nerve stimulator is essentially maintenance-free. The plastic housing and cables can be disinfected with common disinfectants such as Meliseptol® or Meliseptol® Rapid. Battery replacement: The battery should be replaced if the red LED flashes continuously. Loosen the safety screw next to the battery lid on the bottom of the unit. Open the battery lid and replace the battery. Use only a 9 volt battery, type 6LR-61. Close the battery lid and tighten the safety screw. Note: For long term storage of the device, remove the battery. Repairs may be carried out only by manufacturer-authorized service personnel. Service documents please see Technical Service Manual. Only use the equipment with accessories authorized by the manufacturer (see page 18 and 19). EU contries: If other prducts are used, a declaration must be supplied in accordance with article 12 of Council Directive 93/42 EEC. Other contries: Please refer to national law. Warranty Stimuplex® Dig RC is guaranteed for two years against defects in material and workmanship if the device is used in accordance with the operating 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. For usage of Stimuplex® Dig RC 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.

13

Technical Data

Impulse amplitude Impulse frequency Impulse width Impulse form Digital display Resolution Accuracy Output voltage Battery Electrode cable Monitoring equipment: Symbol explanation Open circuit

Closed circuit

Battery check Case (Housing) Mounting bracket Dimensions Output impulse

16

0.20–5.0 mA constant current infinitely adjustable 1 Hz and 2 Hz, switchable 0.1 msec Monophasic rectangular impulse 3 digits from 0.20–4.99 mA 2 digits from 5.0 mA 0.01 mA 앐 10% 앐 1 digit 40 Vp max. 9 volt, type 6LR-61 integrated Degree of protection against electric shock, type BF ● brief audio signal (beep) indicates an open circuit ● flashing digital display indicates the preselected current value ● prolonged audio signal indicates closed circuit ● frequency of the signal changes proportionally to the flowing current ● flashing digital display indicates an exceeding of the control range (actual flowing current 쏝 value indicated). ● Yellow LED indicates the current pulse red LED Plastic Foldable 12,6 x 7,2 x 3,8 cm Current 1 mA at 1000 and 500 ohms load resistance

17

Constant current depending on load resistance

Option: Single-handed Remote Control for sterile use of the Stimuplex® Dig RC Fixing: Via finger rings on the palm Sterility: To be placed under the sterile glove Adjustment: Set required current value by pressing the buttons “Up“ or “Down“ Connection: Via steering-cable to the tripolar output socket on the front panel of the Stimuplex® Dig RC Case (Housing): Plastic

Models, Accessories

18

Stimuplex® Dig RC and Accessories, Stimuplex® needles and Contiplex® cannulae sets Product description

Cannula 얒 x length

Stimuplex® Dig RC nerve stimulator - with integrated electrode cable for Stimuplex® D, Stimuplex® A and Contiplex® D Remote Control for sterile one-hand-operation Finger rings Electrode cable for Stimuplex® D, Stimuplex® A and Contiplex® D Adaptor cable for Contiplex® A Stimuplex® D, 15° bevel D 25/035; 25 G x 1 1/3” 0.5 x 35 mm 0.5 x 55 mm D 25/055; 25 G x 2 1/8” 1 D 26/040; 23 G x 1 /2” 0.6 x 40 mm D 26/070; 23 G x 2 3/4” 0.6 x 70 mm D 27/050; 22 G x 2 ” 0.7 x 50 mm D 27/080; 22 G x 3 1/8” 0.7 x 80 mm D 27/120; 22 G x 4 3/4” 0.7 x 120 mm D 29/150; 20 G x 6 ” 0.9 x 150 mm Stimuplex® D, 30° bevel D 17/040; 22 G 1 1/2” 0.7 x 40 mm D 17/050; 22 G 2 ” 0.7 x 50 mm 0.7 x 80 mm D 17/080; 22 G 3 1/8” Stimuplex® A, 30° bevel A 25, 24 G x 1” 0.55 x 25 mm A 25, 22 G x 1” 0.70 x 25 mm A 35, 22 G x 1 1/3” 0.70 x 35 mm A 50, 22 G x 2” 0.70 x 50 mm A 50, 21 G x 2” 0.80 x 50 mm A 100, 21 G x 4” 0.80 x 100 mm A 150, 20 G x 6” 0.90 x 150 mm Contiplex® D cannula, 15° bevel 1.3 x 55 mm D 28/055/C; 18 G x 2 1/8” D 28/110/C; 18 G x 4 3/8” 1.3 x 110 mm Contiplex® D cannula, 30° bevel D 18/055/C; 18 G x 2 1/8” 1.3 x 55 mm

Code number

Sales unit

4891996B

1

4892216B

1

4892224B

1

4892917B

1

4892925B

1

4894103N 4894111N 4894120N 4894138N 4894146N 4894154N 4894162N 4894170N

25 25 25 25 25 25 25 25

4894189N 4894197N 4894200N

25 25 25

4894251N 4894539N 4894367N 4894502N 4894375N 4894260N 4894278N

25 25 25 25 25 25 25

4894219N 4894294N

25 25

4894227N

25

19

Product description Contiplex® D, Sets – with Contiplex® Catheter – 0,41 x 0,71 x 400 mm with cannula D 20/033/C, 20 G x 1 1/3”, 15° bevel with cannula D 20/055/C, 20 G x 2 1/8” – with Contiplex® Catheter – 0,45 x 0,85 x 400 mm with cannula D 28/055/C, 18 G x 2 1/8”, 15° bevel with cannula D 18/055/C, 18 G x 2 1/8”, 30° bevel – with Contiplex® Catheter – 0,45 x 0,85 x 1000 mm with cannula D 28/80/C, 18 G x 3”, 15° bevel with cannula D 28/110/C, 18 G x 4 3/8”, 15° bevel Contiplex® A cannula with 30° bevel A 55/C; 18 G x 2 1/8” A 45/C; 18 G x 1 3/4” Contiplex® A Catheter Set, 30° bevel – with polyamide catheter – 0,45 x 0,85 x 400 mm needle A 55/C; 18 G; 30° bevel needle A 45/C; 18 G; 30° bevel Contiplex® Tuohy Set – with Contiplex® Catheter – 0,45 x 0,85 x 1000 mm and sideport with cannula 18 G x 1 1/2”, insulated Tuohy type CNB 150 with cannula 18 G x 2”, insulated Tuohy type CNB 200 with cannula 18 G x 4”, insulated Tuohy type CNB 400 with cannula 18 G x 6”, insulated Tuohy type CNB 600

Cannula 얒 x length

Code number

Sales unit

1.1 x 33 mm

4892402N

10

1.1 x 55 mm

4892410N

10

1.3 x 55 mm

4894235N

10

1.3 x 55 mm

4894243N

10

1.3 x 80 mm

4895819N

10

1.3 x 110 mm

4894391N

10

1.3 x 55 mm 1.3 x 45 mm

4893643N 4893611N

25 25

1.3 x 55 mm 1.3 x 45 mm

4893638N 4893603N

10 10

1.3 x 38 mm

3316950N

12

1.3 x 52 mm

3336910N

12

1.3 x 102 mm

3316930N

12

1.3 x 152 mm

3316940N

12