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FAQs


Please find below a list of frequently asked questions.

 

What is the geko™ device?

The geko™ device powered by Onpulse™ neuromuscular electro-stimulation technology, is clinicaly proven to increase blood circulation which can help a range of conditions, including the prevention of venous thrombosis (VTE), prevention and treatment of oedema and for promoting wound healing. It is used in hospitals (NHS and private), clinics and at home.

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What does the geko™ device do?

The geko™ device increases arterial, venous and microcirculatory blood flow. It is CE marked and the intended use is for:

  • increased blood circulation
  • the prevention of venous thrombosis
  • the prevention and treatment of oedema
  • promoting wound healing
  • the treatment of venous insufficiency and ischemia
  • promoting the healing of tendon and ligament injuries.

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How does the geko™ device work?

Worn at the knee, the geko™ device delivers painless electrical impulses to the common peroneal nerve to activate the muscle pumps of the lower leg that return blood towards the heart.

The geko™ device emulates the process normally achieved by walking (up to 60%) without the patient having to move or exert energy and without uncomfortable muscle movements.

Powered by a wrist-watch size battery with software controlled by plus and minus buttons, the self-adhesive geko™ device shapes itself easily and comfortably to the leg.

Green flashing LED lights indicate when the device is switched on and which of seven possible stimulation levels has been set. On the underside of the strap, covered by a water-based conductive hydrogel for secure adhesion, two electrodes deliver painless neuromuscular electro-stimulation to the common peroneal nerve.

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What conditions can the geko™ device be used for?

The geko™ device can be used to:

  • prevent DVT in hospitalised patients
  • prevent DVT and lower limb swelling during travel
  • increase blood flow in an immobilised leg e.g. leg cast
  • help leg ulcers and surgical wounds heal
  • reduce swelling after lower limb surgery (e.g. ankle ligaments, bunions)
  • manage recurring lower limb swelling
  • reduce swelling and promote the healing of tendon and ligament injuries in the lower limb
  • aid recovery from strains and sprains in the lower limb
  • alleviate the symptoms of poor leg circulation, including those associated with diabetes and Raynaud's

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Who is using the geko™ device?

The geko™ device is used by surgeons and nurses in NHS and private hospitals; physiotherapists; podiatrists and other professionals in both clinical practice and clinical studies. The geko™ device is also used by elite athletes and professional sports teams as part of their recovery strategies

 


 

Which locations on the body can I wear the geko™ device?

The geko™ device is only to be used on the lower limbs. Secure the device to the leg so that the location marker (the line of arrows) is positioned directly over the centre of the fibula head. Correctly fitted, the longer tail should wrap around to the rear of the leg, below and parallel to the crease of the knee. This will place the negative electrode over the common peroneal nerve (on stimulation gently activating the muscle pumps of the lower leg) and will position the 'plus' button at the front of the leg and the 'minus' button to the rear. The device can also be placed in two alternative fitting locations, just above and just below the crease of the knee aligned to the lateral outer tendon.

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How long do I have to wear geko™ device for?

The healthcare professional from whom you get the device will advise on the protocol for wearing the device depending on your condition. For example, to prevent post-operative venous thromboembolism the device should be worn on both legs for 24 hours per day until you are able to walk. Following foot and ankle surgery a typical protocol to reduce post-operative swelling might be to wear the geko™ device only on the operated leg for 3 consecutive days for 24 hours per day, followed by 6 hours a day for the next 7 days.

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What is considered the correct level of stimulation?

When fitted you look for a discernible movement of the muscles in the lower leg and visible outwards and upwards movement of the foot. It is not sufficient to see only a slight movement in the muscles of the lower leg alone. The movement in both the lower leg and foot should be discernible.

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Is the geko™ device painful to use?

No, there is no sensation of pain. There is the feeling of the muscles in the lower leg contracting every second which can take a few moments to adjust to. Thereafter it is common to forget you are wearing the device.

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How does the geko™ device increase peripheral arterial blood flow?

The geko™ device increases venous return in the lower limbs. This reduction in venous pressure reduces peripheral capillary resistance, which enhances arterial blood flow - illustrated by direct measurement of arterial system, increased cardiac ejection and a reduction/abolition of the diastolic flow reversal, the consequences of which allow delivery of more oxygenated blood and nutrients to flow to the entire lower limb.

  • Increases lower limb and foot skin tissue oxygen
  • Also assists in the removal of carbon dioxide and metabolic waste from the lower limb

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Can I sleep with the geko™ device on?

There is no detrimental effect to sleeping with the devices on. However if you are finding the devices to be disruptive then discuss this with your healthcare professional who may advise you to either lower the settings or just turn them off completely, if that is consistent with your treatment.

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Is the geko™ device waterproof?

The geko™ device must be kept clean & dry. Do not bathe or shower whilst wearing the device. Prolonged exposure to water will soften the hydrogel and adhesion may be lost. Immersion may also affect the electronics and prevent proper operation. In the event that the device becomes wet, either by water or bodily fluid, there is no danger to the patient.  The adhesive gel is water based and therefore slight dampening of the gel will remove the device from the leg once treatment is complete. 

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How many times can I use a single geko™ device?

The geko™ is a single-use medical device. This means that it is intended to be used on a single patient as part of a single course of treatment.

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How does it differ from other electrical stimulation devices?

The geko™ device is unique in that it delivers neuromuscular electro-stimulation via the common peroneal nerve to activate the calf and foot muscle pumps of the lower leg, as opposed to other electro-stimulation devices that stimulate the muscles directly and can be less well tolerated.

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What is the difference between NMES and TENS?

NMES differs from transcutaneous or percutaneous electrical nerve stimulation (TENS), in that NMES stimulation is directed to the motor nerves and TENS is directed to the sensory nerves

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What type of electrical stimulation pulse is used by the geko™ device?

The geko™ device has a constant current, square wave, asymmetrical, charge balanced pulse. The Constant current refers to the output of the geko™ device which is constant during the duration of the pulse. The voltage of the device will vary according to the patient's electrical resistance in order to achieve the current output. The stimulation pulse is defined as a square wave. This means that the stimulation current rises rapidly to the required value, which is maintained for the duration of the pulse, followed by a rapid fall to zero. This creates a rectangular or square shape when measured on an oscilloscope, hence the name. The stimulation pulse is followed by another (return) pulse of lower intensity, but longer duration (asymmetrical) and opposite polarity, to ensure that the overall electrical charge is zero (charge balanced). This prevents electro-chemical changes in the skin.

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Can the gekoTM device be used in close proximity to microwave ovens?

A microwave oven is a closed sealed unit, tested to a high standard, as such it will not interfere with the gekoTM device.

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Can the gekoTM device be used in close proximity to open radar or transmitter sources of short wave radiation?

Do not use in proximity (i.e. within 1m) of short wave / microwave equipment as this may affect the device.

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What published evidence do you have to support the geko™ claims?

We have a range of published research available to download from the studies section of the geko™ website.

 

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Has NICE issued guidance on the use of the geko™ device for the prevention or Venous Thromboembolism (VTE)?

The savings, as outlined within the NICE guidance, would result from a reduction in the relative risk of DVT and the associated conditions of VTE such as post thrombotic syndrome as well as reduced length of stay.

NICE guidance estimates a saving of £284 per patient when the device is used for a period of 6 days when compared to no VTE prophylaxis and that under these circumstances use of the device will be cost saving until day 14.

In high risk patients when a combination of pharmacological and mechanical VTE prophylaxis is desirable but current mechanical prophylaxis is contraindicated or impractical, the geko™ device in combination with pharmacological prophylaxis will be cost neutral for up to 3 days compared to pharmacological prophylaxis alone.

The adoption of the NICE guidance and the use of the geko™ device supports the NHS objective of providing VTE prevention to all at risk hospital patients.

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Are there any contraindications for using the geko™ device?

For a full list of contraindications please refer to the Instructions for Use leaflet inside your geko™ foil pouch or available to download from the Specifications page on our website.

  

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How do I fit the T1 geko™ device?

Follow the fitting instructions enclosed in the foil pouch or download them from the Specifications page on our website.

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How do I fit the T2/R2 geko™ device?

Follow the fitting instructions enclosed in the foil pouch or download them from the Specifications page on our website.

 

 


 

How long does the battery life last?

The geko™ device is intended for 24 hour use - it has a battery life nominally up to 30 hours. After that the software switches the device off, permanently.

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How do I dispose of the geko™ device once I have used it?

The geko™ device is compliant with the requirements of Directive 2011/65/EU of the European Parliament and of the Council of 8 June 2011 on the restriction of the use of certain hazardous substances in electrical and electronic equipment.

  • No specialist measures are required for the disposal of the electronics and battery in the geko™ device
  • Batteries must be disposed of in accordance with any local legislation
  • The battery can be removed by breaking open the housing and prising out
  • Do not incinerate the battery
  • Dispose of the geko™ device as domestic waste

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What is the shelf life of the geko™ device?

The geko™ device has a shelf life of two years and the expiration date is printed on each pack.

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Are there any precautions or warnings for use of the geko™ device near to metal implants?

There are no warnings or contraindications for using the geko™ device in proximity to surgical metal work. The only problem a user might encounter is if the metal work/surgery has damaged the common peroneal nerve and there is peripheral neuropathy. The device stimulates the common peroneal nerve which causes the muscle contraction and increased blood flow so if your nerve is damaged it might not stimulate the muscle. In this event you would suffer no ill effects. However seek advice from a healthcare professional, such as a GP or a Physiotherapist, to check for neuropathy damage. To locate your nearest Physiotherapist, refer to the Find a Clinic page.

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Does the hydrogel in the geko™ device contain gelatin?

No. There are no materials of animal origin used in the geko™ at all.

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Does the geko™ hydrogel contain latex or phthalates?

No. The geko™ device is not manufactured using either latex or phthalates.

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I am allergic to sticking plasters. Is the geko™ device likely to cause skin irritation? Sticking plasters use a different adhesive to that used by the geko™.

Skin reactions, such as rashes, are a recognised minor complication associated with electro-stimulation. Some skin reactions with the geko™ device have been reported to us, but we do not yet have enough data to say whether the incidences reported are in line with other electro-stimulation devices. We do warn users of the potential for skin reactions in our Instructions for Use. In some cases skin inflammation or irritation can develop in the contact area, either remove the device or re-attach in the alternative fitting location. Details on the alternative fitting locations are explained in the Instructions for Use.

We are not aware of any instances where the skin reactions represent a serious risk to the health of the patient.

There may be some instances where a minor irritation is acceptable when weighed against the therapeutic benefits of the geko™. This must be discussed and agreed with your healthcare professional.

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Does the geko™ device contain anything that will damage the environment?

No. The geko™ device does not contain anything that is known to damage the environment. The geko™ complies with current EU environmental legislation.

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Do we have any safety evidence for the geko™ device?

We have considered the possible risks associated with using the geko™ device. To ensure its safety we have designed and manufactured the geko™ device in accordance with the International standard for managing the risks of medical devices, ISO 14971. Using this standard as a basis we have designed and manufactured the geko™ devices to be intrinsically safe.

We have conducted extensive biological safety testing, to the International biocompatibility standard, ISO 10993, and we have data that shows that the hydrogel has tested negative for cytotoxicity, sensitisation and irritation, and can therefore be considered to hypoallergenic. We have also conducted extensive electrical safety testing. The key International standards are ISO 60601-1, ISO 60601-1-2 and IEC 60601-2-10, the latter being the International standard for electrical safety for powered muscle stimulators.

All of the above data has been reviewed by our Notified Body (SGS United Kingdom Ltd) prior to giving us the CE Marking certification. SGS United Kingdom Ltd employs experts in biological and electrical safety testing to scrutinise the data that we have to demonstrate that the geko™ devices are intrinsically safe and comply with appropriate International safety standards.

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Can the geko™ device can be used during Cardiac Arrest?

The geko™ device has not specifically been tested when external defibrillators are being used. There is a theoretical risk that the geko™ could stop working because of electrical interference, but the device would not incur any damage and there is no additional risk to the patient. The geko™ device will continue to work during the use of electro-surgery equipment (diathermy), and so this risk may be small.

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Can the geko™ device be used for patients who are recovering from cardiac arrest?

The geko™ device does not affect the heart rate or blood pressure and therefore the geko™ device can be safely used with these patients.

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Is the geko™ device difficult to keep on with confused patients?

Under 'precautions' in the instructions for use we do advise to check the device is functioning correctly every 2 hours, so that there is no significant loss of prophylaxis or treatment should the device be interfered with by the patient.

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Can the geko™ device be used on a patient following general anaesthetic?

General anaesthesia effects the conduction of nerve impulses and will affect the sensitivity of the peroneal nerve to stimulation by the gekoTM device. It is very likely that the stimulation level will be affected by anaesthesia, and in some cases may not achieve stimulation. If stimulation is visible in the patient (i.e. by a twitch of the foot) then there is an increase in blood flow.

There will be a period of 'wash out' post anaesthesia where the stimulation setting may be reduced on subsequent days.

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Can the geko™ device be used on children over the age of 13?

The Instruction for Use states that the geko™ device must be kept out of reach from children and pets. The safety and effectiveness of the geko™ has not been tested on people under the age of 18. The geko™ device uses NMES to emulate the increase in blood flow normally achieved by walking (up to 60%), so it is unlikely to cause problems in normal adolescents. Therefore, it is a Clinician's decision, exercised with caution, to prescribe the use of the geko™ device to a child between the ages of 13-18 years old, however we advise that it is used under supervision to prevent mis-use.

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Who is Firstkind?

Firstkind Ltd is a wholly owned subsidiary of Sky Medical Technology Ltd, a privately held UK company based in High Wycombe and Daresbury. Firstkind manufacture medical devices utilising OnPulse™, Sky Medical's proprietary neuromuscular electro-stimulation technology designed to enhance the body's own circulation to increase lower limb blood circulation. 

The OnPulse™ technology has been developed, manufactured and brought to market by Firstkind Ltd following a three year programme of applied research with St. Bartholomew's Hospital and Queen Mary, University of London. The OnPulse™ technology leverages a deep understanding of the anatomy and physiology of the human body, biomedical engineering and isometric neuromuscular stimulation. 

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