NeuroTrac Labour TENS Operators Manual Nov 2003

NeuroTrac™ Labour TENS Operation Manual

Warnings *

This unit must be used with the guidance of a Physiotherapist or Doctor

*

Type BF equipment

*

Do not insert lead wires into a mains power supply

*

Do not immerse unit into water or any other substance

*

Do not use the NeuroTrac™ TENS unit in the presence of a flammable anaesthetic gas mixture and air or with Oxygen or Nitrous Oxide

*

If using rechargeable 9 volt PP3 Nickel Metal Hydride or Ni-Cad batteries be sure to use a CE approved battery charger

*

Never connect the NeuroTrac™ TENS unit directly to a battery charger or any other mains powered equipment

*

Patient Electrodes are for single patient use only

*

Keep out of reach of children

*

Do not use this stimulator on your facial area unless you are under strict guidance from a qualified Clinician

*

This unit is not suitable for use during water birth

Revised Issue Date: 25/11/2003 Document Number ECS310-OM002-0 2

NeuroTrac™ Labour TENS Operation Manual

Contents Contents

Page

Warnings What is Pain? What is TENS? Method of operation for Labour Pain Contra Indications & Precautions Description of Labour TENS Unit & Functions Electrode Placement Electrode Types & Tips Care & Maintenance Commonly Asked Questions Specifications Warranty Dermatome Chart Clinical References

2 4 4 5 6 7 8 9 10 11 12 13 14 15

3

NeuroTrac™ Labour TENS Operation Manual

What is Pain? When we feel pain it is the body’s process of informing us that something is wrong. To feel pain is important, without this feeling abnormal conditions may go undetected, creating damage or injury to critical parts of the body. Although pain is essential in warning our body of trauma or malfunction, nature may have gone too far in its design. Continued long-term chronic pain has no useful value apart from its importance in diagnosis. Pain begins when a coded signal travels to the brain where it is decoded, and analysed. The pain message travels from the injured area of the body along small diameter nerves leading to the spinal cord. At this point the message is switched to a different kind of nerve that travels up the spinal cord to the brain area. The brain then analyses the pain message, refers it back and the pain is felt.

What is TENS? Transcutaneous Electrical Nerve Stimulation (TENS) uses a small battery operated unit to provide a non-invasive, drug free method of controlling acute and principally long term intractable pain. It can also be used as an adjunctive treatment in the management of post surgical traumatic pain problems. In TENS mild electrical impulses are transmuted through the skin via surface electrodes to modify the body’s pain perception. TENS does not cure problematic physiological conditions; it only helps to control the pain perception. TENS will not work for every user. However Physiotherapists and Doctors throughout the world prescribe TENS extensively and it is generally seen to work for the majority of users. There are millions of small nerve fibres throughout the body and it only requires a few impulses to produce chronic pain. In addition to small fibres, which allow the sensation of pain to be felt, the body is also made up of larger diameter nerve fibres. These larger nerve fibres transmit less unpleasant sensations such as touch or warmth, assisting us to form an impression of our environment. Stimulating the larger nerve fibres using TENS may have the effect of inhibiting the transmission of pain along the smaller nerve fibres to the spinal cord [known as the ‘Pain Gate Theory’].

4

NeuroTrac™ Labour TENS Operation Manual

Method of operation for Labour Pain The Labour TENS Stimulator uses four long skin electrodes on the skin close to the spine and connected to the device via lead wires. The stimulation intensity is adjusted until a mild tingling sensation is felt. The NeuroTrac™ Labour TENS unit has a hand held push button control to change the stimulation mode from LOW frequency burst to HIGH frequency stimulation. The low frequency is used during rest periods [Between contractions]. As soon as labour contraction is felt strongly the mode is changed to high frequency stimulation, once the contractions have subsided the mode is reverted back to low frequency burst mode stimulation. Clinical evidence suggests that to achieve the best pain relief, the stimulator should be used from the first onset of labour pain and for two to three hours after birth. If it is found that insufficient pain relief is achieved with the labour TENS unit then, improved relief can be achieved by using smaller amounts of alternative analgesia to compliment the TENS unit. From existing evidence, Labour Tens units can be an effective technique for pain control in over 80% of births with no side effects.

5

NeuroTrac™ Labour TENS Operation Manual

Contra Indications & Precautions Before using this equipment you must first seek the advice of your Physiotherapist or Doctor. Read this operating manual before using the TENS unit TENS should not be used: * * * * * *

* * *

* * *

By patients fitted with a demand style cardiac pacemakers unless so advised by their Doctor By patients with undiagnosed pain conditions With patients who have diminished mental capacity or physical competence who cannot handle the device properly On anaesthetised or desensitised skin When driving a vehicle or operating potentially dangerous equipment Do not place electrodes: * Over carotid sinus nerves * Over larynx or trachea * Inside mouth * Over the area of the heart unless so advised by your Doctor * On your facial area unless under strict guidance from a qualified Clinician The patient should use the unit only as prescribed Do not immerse the unit in water or any other liquid If you experience skin irritation this may be due to over-stimulation. In this case leave the skin to heal and use TENS only for the periods prescribed. Turning the current up too high can cause skin irritation. In this case allow the skin to heal and use TENS at a lower intensity. Some people experience an allergic reaction to the adhesive coating on the surface of the electrode. If this happens use a different make of electrode or change the electrode. If it continues try reducing the pulse width. If the problem still persists try moving the electrode position each day by just the width of the electrode, making sure the electrode positioning is still over the dermatome Keep unit out of reach of children Used only in the course of Labour Pain and not during pregnancy unless medically advised by your Doctor If in doubt about the use of the NeuroTrac™ Labour TENS unit, call your Doctor, Therapist, Clinician or Verity Medical Ltd. for advice

6

NeuroTrac™ Labour TENS Operation Manual

Description of Labour TENS Unit & Functions.

Channel A

Remote Channel B

Remote Hand Switch

CH.B

Button

CH.A

LCD Display Increase Intensity Decrease Intensity

NeuroTrac™ Labour TENS

1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11.

Front Rear Insert a 9 volt PP3 Alkaline battery. Alternatively insert a rechargeable Nickel Hydride battery [Which has a much longer life than the Ni-Cad rechargeable batteries] into the battery compartment. Insert lead wire/s to channel A and B if both channels are to be used. Insert Remote hand switch to centre connector as shown on page 8. Switch on the unit by pressing the ON/OFF button Press the remote hand switch to initially select Boost mode (BT) To start press channel A + and B + button if you are using both channels. Increase the intensity using channel A+ or B+ until you feel a slight muscle contraction, then press the button on the remote hand switch to revert back to the rest mode (RT). When you feel labour pain, press the button on the remote hand switch which will select Boost mode. When switching from Boost to Rest mode the intensity will reduce by 20%. To decrease the intensity, select boost mode and press the channel Aor B- button. Familiarise yourself with the unit before using it during labour To stop the programme, press the ON/OFF button which will turn the unit off. 7

NeuroTrac™ Labour TENS Operation Manual

Electrode Placement

Recommended Types: 100 x 50 mm (rectangular) for 4 electrodes or 204 x 50 mm (rectangular) for two electrodes. Place the electrode approximately 2 inches either side of you spine in the positions indicated by the drawings. When using two pairs of 100 x 50 mm electrodes, place the upper pair of electrodes between T10 & L1 and the lower pair of electrodes between S2 & S4 as shown on the left diagram. For 1 pair of 204 x 50 mm electrodes, place them halfway between T10 and S2 as shown on the right diagram. Please refer to the Dermatome chart on page 14 or ask your mid wife, physiotherapist or Doctor for more information.

8

NeuroTrac™ Labour TENS Operation Manual

Electrode Types & Tips Types Available: *

Self-Adhesive Hypoallergenic electrodes have a typical life span (if looked after) of 4/6 weeks. We recommend cleaning the skin before use. After use place the electrodes back onto the plastic film then enclose them back into the ziptag plastic pouch and store in a cool environment. Types available for Labour TENS: VS.9050 90 x 50 mm (rectangular) VS.10050 100 x 50 mm (rectangular) - Recommended VS.13050 130 x 50 mm (rectangular) VS.20450 204 x 50 mm (rectangular) - Recommended

A Few Good Tips [Self- Adhesive Electrodes] *

If you find the electrodes will not stick due to oily skin, cleanse the skin with soap and water, then rinse and dry the area around the electrode site. If this does not work, try cleansing the skin with a swab impregnated with alcohol.

*

Clip away hairy skin using a scissors; don’t use a razor to remove the hairs!

The electrodes conductive material is water- based. If it becomes saturated (e.g. from perspiration), it will lose its adhesive qualities. After use leave the electrodes face up overnight to dry out. At some point the electrodes will become dry. Moisten the adhesive surface with a few drops of water, and apply onto the plastic film overnight. This procedure will give you a few more days of electrode life.

9

NeuroTrac™ Labour TENS Operation Manual

Care & Maintenance Control Unit: * *

Wipe the surface once a week with a damp cloth or antiseptic wipe Do not use cleaning sprays or alcohol based cleaning solutions

Battery: * * * *

Check periodically for any discharge from the battery Remove battery completely from unit if not in use for any extended period of time (typically one week) Low battery indicator of 6.9 volts shown on LCD display When flashing change battery for a new one Preferably use a PP3 alkaline battery

Lead Wires * * * *

The lead wires should be handled carefully and never stretched, as this can cause the stimulation to function below normal standards or not at all Examine lead wires before each treatment for loose connections or damage Avoid stretching and twisting the lead wires Store the lead wires carefully after each use

Self-Adhesive Electrodes * *

Check the short connectors have not become separated from the electrodes Replace electrodes onto plastic film after use. If they drop onto the floor debris will adhere to conductive gel rendering the electrodes ineffective Caution: Static electricity may damage this product Note: Only Verity Medical Ltd. or appointed distributors/importers are approved to undertake servicing.

10

NeuroTrac™ Labour TENS Operation Manual

Commonly Asked Questions QA-

Does TENS work for all pain conditions and on all patients? There is significant variation between patients with similar pain conditions. However, it is known that TENS does work in up to 70% of cases and up to 80% when used for reducing labour pain.

QA-

How can I have a better chance of success? Seeking professional advice from your Physiotherapist or Doctor on how to best apply TENS is the best answer we can give to this question.

QA-

Are there circumstances in which TENS should not be used? Yes. For undiagnosed pain; When using a cardiac pace maker; please see page 6 for further information.

QA-

Can there be any permanent side effects? There are no known permanent side effects caused by using a TENS stimulator.

QA-

If I have any medical or product queries how can I get help? Any clinical advice on the TENS stimulator should be provided by your Physiotherapist or Doctor.

11

NeuroTrac™ Labour TENS Operation Manual

Specifications TENS 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. 14. 15. 16.

Dual channel: individually isolated circuits. Amplitude: 0-80 mA; indication only; actual mA will tend to be less than indicated due to electrode impedance. Type: Constant Current. Waveform: Asymmetrical, rectangular bi-phasic with zero DC current. Pulse width: 220µS [2% accuracy]. Pulse Rate: 90Hz (Continuous mode) [2% accuracy]. Mode: Continuous (Boost mode). Burst mode: Bursts of 9 pulses [200 µS] at 150 Hz, repeating twice every second (Rest mode). Ramp up Time: 0.8 seconds from Rest to Boost Time duration: continuous until switched off. Low Battery Indicator: If the battery goes below 6.9 volts +/- 0.2 volts the battery symbol will flash on/off once every second. If the battery voltage is below 6.6 (+/- 0.2) volts the unit will not turn on. Open Electrode Detect: If an open circuit is detected at the output of channel A or B the output current will be reset at zero. Physical dimensions: 108 x 62 x 23 mm. Weight: 0.09KG without battery, 0.14KG with battery. Environmental conditions for storage & transport: -10 to +50 degrees Centigrade 0-90% Humidity.

12

NeuroTrac™ Labour TENS Operation Manual

Warranty Verity Medical Ltd. provides a warranty to the original purchaser that this product will be free from defects in the material, components and workmanship for a period of 2 years from the date of purchase [invoice date]. If Verity Medical Ltd. are satisfied that the product/s is defective the purchaser may return this unit/s to Verity Medical Ltd. or the appointed distributor for repair or replacement with a new unit. All returns must first be authorised by Verity Medical Ltd. in advance. The liability of Verity Medical Ltd. under this limited product warranty does not extend to any misuse or abuse such as dropping or immersing the unit in water or other liquid substance or tampering with the unit or normal wear and tear. Any evidence of tampering will nullify this warranty. Customer Service Any queries should be addressed to: Verity Medical Ltd. :- Uplands Place Drove Road Chilbolton Nr Stockbridge Hampshire SO20 6AD England Tele: Fax:

+44 (0)1264 860354 +44 (0)1264 860825

Email: [email protected] Web: www.VerityMedical.co.uk

The NeuroTrac is CE Approved

Design Registration Numbers: 2095095, 2095096, 2098278

13

NeuroTrac™ Labour TENS Operation Manual

Dermatone Chart

14

NeuroTrac™ Labour TENS Operation Manual

Clinical References Conventional TENS: Bates JAV, Nathan PW [1980] Transcutaneous electrical nerve stimulation for chronic pain. Anaesthesia 35: 817-22 Ellis B [1995] Transcutaneous electrical nerve stimulators: outpatient response to a temporary home loan programme Br J The Rehabil 2 [8]: 419-23 Frampton V, Bowesher D, eds. Pain Management by Physiotherapy. Butterworth Heinemann, London: 115 –39 Hosobuchi Y, Adams J E, Linchitz R [1977] Pain relief by electrical stimulation of the central gray matter in humans and its reversal by naloxone. Science 197: 183 –186 Lundberg TMD. Et, al [1984] Physiotherapy Vol. 70 No. 3 98-100 Melzack R, Wall P D [1965] Pain mechanisms: a new theory. Science 150: 971 –979 Tulgar M, McGlone F, Bowsher D, Miles J B [1991b]Comparitive effectiveness of different stimulation modes in relieving pain: part II. A double blind controlled long-term clinical trial Pain 4: 156-62 Walker J [1992] When self-help begins at home Prof Nurse 7 [10]: 662-4

15

NeuroTrac™ Labour TENS Operation Manual

16

NeuroTrac™ Labour TENS Operation Manual

17

NeuroTrac™ Labour TENS Operation Manual

18

NeuroTrac™ Labour TENS Operation Manual

Not for sale or use in the USA

Verity Medical Ltd. Uplands Place Drove Road Chilbolton Nr Stockbridge Hampshire SO20 6AD England Tele: Fax:

+44 (0)1264 860354 +44 (0)1264 860825

Email: [email protected] Web: www.VerityMedical.co.uk

Please contact us about or Internal Vaginal Electrode Revised Issue Date: 25/11/2003 Document Number ECS310-OM002-0 19

NeuroTrac™ Labour TENS Operation Manual

20