ova YL-Y8 Instuctions for Use

Contents 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13.

Introduction Precautions & Contra-Indications Contents Assembly Controls Modes Placement of Pads Application of Pads Storage of Unit Battery Replacement Questions & Answers Warranty Technical Specifications

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13. TECHNICAL SPECIFICATIONS

PERIOD PAIN RELIEVER MODEL YL-Y8

...on the rear of the Ova means refer to these Instructions. … ...in these Instructions indicates the presence of a hazard that can cause personal injury if the hazard is not avoided

1. INTRODUCTION The Ova produces electrical signals that ease the distress you are suffering in two ways. First, pain signals are blocked from reaching your brain. Second, your brain is stimulated to release endorphins, the body’s natural pain suppressant. These electrical signals are based on a proven medical therapy known as TENS. TENS stands for Transcutaneous Electrical Nerve Stimulation. Using specifically chosen frequencies and pulse widths, which together are referred to as “Modes” later on in these Instructions, the Ova effectively relieves period pain. 2

Waveform Amplitude Battery Environmental Operating Conditions Environmental Storage Conditions Type of Equipment and Safety Classification

Asymmetric Rectangular 0-60mA into 500 Ohm load 3 volt Lithium CR2025 DC Temperature 0-35˚C Humidity 20-65% RH Temperature 0-55˚C Humidity 10-90% RH Equipment providing a degree of protection against electric shock with isolated part Internal Power source Type BF This symbol on the unit’s decal label means: “Attention – Refer to accompanying instructions” 19

Can I use my Ova for other types of pain? The Ova has been developed specifically for period pain relief – it is not intended to be used to treat other pain and in any event should never be used to treat undiagnosed pain. However, once diagnosed, non-period pains can be controlled using other specific units from the TensCare range - please refer to www.tenscare.co.uk or telephone +44(0)1372 723434 to discuss your requirements 14. WARRANTY The Ova is warranted for one year from the date of purchase. This warranty refers to the unit only. It does not cover the electrode pads, lead wire or battery. This Warranty applies only if the unit has been used for its intended purpose and has not been damaged through misuse, accident or neglect and has not been modified or repaired by anyone other then TensCare or its authorised agents.

Clinical trials have shown that TENS is very effective and has none of the side effects, such as nausea and drowsiness, which are commonly associated with drugs used to relieve period pain. The Ova is easy to use and very discreet. Its small size makes it convenient to wear all day and this allows you to get on with your normal life, without pain. It is important to allow the Ova time to work. Each time a new mode or position for the pads is selected allow the OVA to run for thirty minutes. If after that time the relief is not sufficient then try another mode or pad position. Even if you obtain excellent relief it is still useful to try other settings. BEFORE USE, PLEASE NOTE THE FOLLOWING: 1. The Ova should NOT be used to mask or relieve undiagnosed pain. If in doubt, consult your doctor. 2. The Ova is supplied for use only as a period pain reliever.

If defect appears return the unit to TensCare or its authorised agents, with your proof of purchase. 18

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15. PRECAUTIONS AND CONTRA-INDICATIONS Do NOT use the Ova under the following circumstances: 1. If you have a heart pacemaker or a heart rhythm problem 2. If you have, or have had epilepsy 3. On broken skin or if normal sensation is absent. 16. CONTENTS 1 x Ova Unit 1 x Battery compartment with 3 volt Lithium Battery (CR 2025) fitted 1 x Belt Clip 1 x Zipped Carry Case 4 x Large Self-Adhesive Pads 1 x Lead Wire 1 x Instructions For Use (which you are reading) 4

Can I leave my Ova on overnight? This is not recommended in case the unit or leadwire get caught up while you are asleep. In addition, the pads should be removed for a while every 24 hours to allow the skin to breathe. However, if you need relief from your period pain while you sleep, the Ova can be used if great care is taken to ensure that the unit and the lead wire are safely tucked away. Which Mode shall I use? Use all three and see which works best for you. Do not use the same mode all the time otherwise your body will accommodate and the relief will not be as effective. Is my Ova safe? Yes, but always follow the instructions.

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QUESTIONS AND ANSWERS

Where do I get new pads for my Ova? Pads, batteries and new units can be obtained either by visiting www.ova-4u.info or by calling Tenscare on 01372 723434. If you wish to pay by cheque please mail to Tenscare Ltd., PainAway House, 81 East Street, Epsom KT17 1DT. When should I use the Ova? The Ova may be used whenever you experience or anticipate period pain. If you know that your period is due, the OVA can be used the day before in Mode C. Then, when your period starts, change to either Mode A or B. How long do I need to use the Ova? The Ova should be used for as long as you feel it necessary. You cannot use it too much.

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ASSEMBLY

Step 1: Remove Belt Clip from the Ova: The Ova is supplied with the Belt Clip already attached and needs to be separated from the unit in order to fit the Battery Compartment Drawer. Holding the Ova between the thumb and first finger of one hand, gently lift back the top clip of the Belt Clip and remove the Ova, see diagram A. Step 2: Fitting the battery compartment: Insert the battery compartment, with the battery already fitted into the Ova unit, see diagram B. The drawer will only fit correctly one way. DO NOT FORCE the drawer into the unit. To check that the battery has been correctly fitted the ON/UP grey button should be pressed once and the screen will display ‘A0’. Having made this check the OFF/DOWN blue button should be pressed once to switch the unit off. 5

19. Step 3: Fitting the lead wire and pads: Unravel the lead wire and connect the two press studs to the back of the unit; see diagram C. Now attach the belt clip to the unit. Open the bag containing the pads by tearing off the perforated strip and remove one of the two pairs of the pads. The pads are attached to a clear film liner, which is to be left in place until the unit is ready for use. Each pad has a pigtail wire with a socket connector at the end: insert the plug connector at the loose end of the lead wire into this.

STORAGE OF UNIT

After use, detach the pads from your body and replace them onto the clear film liner. Then disconnect the pads from the lead wire and place the pads back into their bag closing the resealable strip. This will keep your pads from drying out. The Ova with the lead wire still attached and the pads can be stored in the zipped carry case supplied. Remove the battery compartment if the unit will not be used for a prolonged period of time. 20.

BATTERY REPLACEMENT

When the battery requires changing carefully remove the belt clip, as previously described in Section 4, and slide out the battery compartment. Take care to note which way the existing battery has been installed into the compartment. Then simply slide the old battery out of the compartment and slide in the new battery (Only use a 3 volt Lithium CR2025).

THE OVA IS NOW READY FOR USE

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If a large part of the pad area is covered with hair the stimulation may be less effective. If hair needs to be removed, wait 48 hours after shaving, waxing or using depilatory cream before applying the pads, to avoid irritating the skin. Remove the pads from the skin or from the liner by peeling them back from the edge of the pad. Do not remove by pulling on the pad’s pigtail wire. If you find that a small part of the pad overlaps the top of your thigh, and that this is uncomfortable, then it is possible to cut off this part using scissors. Before cutting make sure that you are cutting from the opposite end to the lead wire and that you are not cutting through any of the wires which run through the pad. Do not cut off more than a small triangular piece, with sides no more than 20mm long and an area no greater than 200 sq.mm. See Diagram.

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CONTROLS

The Ova has three control buttons: GREY BUTTON marked ON/UP: This switches the unit On and also increases the Intensity. The first press will switch the Ova on at zero intensity. The screen will display ‘A0’ indicating that the unit has automatically set itself into Mode A. Each time this button is subsequently pressed and released, the intensity will increase. The Ova has fifteen levels of intensity. The screen shows the intensity level in operation. Little or no sensation, which is similar to a gentle tingling, may be felt at the lowest settings. Once you start to experience this feeling, keep pressing until the sensation is strong but comfortable. Please note that as your body accommodates to the feeling you may have to increase the intensity to keep the feeling strong: this is quite normal.

Ensure that the leadwire is slack at all times when the Ova is in use. Excessive force applied to the leadwire could cause a pigtail to separate from its pad 14

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22. BLUE BUTTON marked OFF/DOWN: This decreases the intensity and also switches off the Ova. Each time this button is pressed and released the intensity level is decreased. Once level “0” is reached, a further press will switch the unit off. An alternative method to switch the unit off is to press the purple button once and then the blue button once; this can be done with the intensity at any level, not just “0”. PURPLE BUTTON marked MODE: This button is used to select one of the Ova’s three different and specially developed modes. Each mode is the result of medical research to establish the parameters that result in maximum pain relief. When the unit is switched on it automatically goes to mode ‘A’. To change to the next mode the purple button has to be pressed and held for three seconds. This is a safety feature so as to avoid the mode being accidentally changed. Each time the mode is changed the intensity level reverts back to zero. This is also a safety feature, as all three modes feel quite different from each other.

The self-adhesive pads supplied are intended for multi-use by one person only: Do not lend used pads to others, nor use someone else’s used pads yourself. To apply the pads simply peel off the clear film liner and the pads will adhere to the skin automatically. Replace the clear film liner into the bag, as the pads will need to be replaced onto the film after use. Points to note when applying the pads: 4. 5. 6.

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APPLICATION OF PADS

Make sure the Ova is switched off before applying or removing the pads. Ensure that the skin is clean and thoroughly dry before attaching the pads, as they will not adhere well if the skin is wet or greasy. Do not worry if a small part of each pad covers the pubic hair. After use the pads can be removed gently without pulling out the hair. 13

In order to obtain the best relief the pads need to be placed over the dermatomes T10, T11 and T12, which are the nerve roots that supply the sensory fibres to the uterus. These dermatomes wrap around the body, but not quite meeting up at the front. They run from around waist height at the back down to the groin area at the front. As each person’s body is different the Ova is supplied with pads which are large enough to be effective even if not located exactly over all three dermatomes. When the pads are placed correctly the Ova will work very well so if after thirty minutes considerable relief has not been achieved, either move the pads slightly or try one of the other pad positioning areas.

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MODES

The Ova’s three modes are displayed on the screen as A, B or C. Each mode relieves pain in a different way. It is important to try all three modes to find out which suits you the best. It is also sensible to change from one mode to another regularly in order to prevent your body unduly accommodating to one particular mode. Mode A: Mode A has a constant output that produces a tingling sensation. that is likely to result in the greatest pain relief.

It is the mode

Mode B: Mode B also has a constant output but, due to a different pulse width, it will feel less strong than mode A but in fact can be equally as effective. Mode C: Mode C contains a burst signal and so the feeling will be one of pulsing. This mode can have the advantage of achieving, for a time, ongoing residual pain relief after the Ova has been switched off.

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PLACEMENT OF PADS

Four pads are supplied with the unit but only two pads are used at a time. There are THREE positions where the pads can be placed for maximum benefit. It is recommended that the positions are tried in the following order until maximum relief is obtained: 1. On the lower Back 2. On the Front, in a vertical format 3. On the Front, in a diagonal format Please refer to the diagrams below: On the lower Back: See diagram - Place the pads vertically either side of the spine, approximately 10cms (4 inches) apart, with the bottom of the electrodes no higher than the top of your buttocks. The pigtails should hang down from the pads. 10

On the Front, in a vertical format: See diagram – In the vicinity of your groin, place the pads vertically, approximately 10cms (4 inches) apart. The pigtails should be uppermost.

On the Front, in a diagonal format See diagram – In the vicinity of your groin, place the pads in a V-shape, narrowing to about 10cms (4 inches) apart at the lower end of the pads. The pigtails should be uppermost.

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