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FAQs


Please find below a list of frequently asked questions.

 

What is the geko™ device?

Powered by OnPulse™ technology, the geko™ device, is a non-invasive neuromuscular electro-stimulation device used to increase blood circulation by triggering the body's built in mechanisms. The disposable self-contained device is quick and easy to apply; it takes just 60 seconds to fit and is operated from one button.

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What does the geko™ device do?

The geko™ device increases arterial, venous and microcirculatory blood flow in the lower limbs. The intended use is for:

  • Increasing local blood circulation
  • Immediate post-surgical stimulation of the calf muscles to prevent venous thrombosis

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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 a single button, the self-adhesive geko™ device shapes itself easily and comfortably to the leg.

A green flashing LED light indicates 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 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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Who is using the geko™ device?

The geko™ device is already being used by doctors, surgeons and nurses for VTE prophylaxis in the United Kingdom, Europe, Canada, Australia and USA.

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

The geko™ device is only to be used on the lower limbs. Aligning the raised indicator line on the device (line of blue arrows) with the fibula head will ensure that the negative electrode is correctly positioned above the common peroneal nerve, which on stimulation, gently activates the muscle pumps of the lower leg, increasing the amount of blood pumped through the muscles and the overall venous return. 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. To view the alternative fitting locations, download from www.gekodevices.com

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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.

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What is considered the correct level of stimulation?

When the geko™ device is fitted, 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. Thereafter it is common to forget you are wearing the device.

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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 muscle 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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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 posted on the Studies section on the geko™ website.

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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.

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How do I fit the geko™ device?

Follow the fitting instructions enclosed in the foil pouch.

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How long does the battery life last?

The 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?

No specialist measures are required for the disposal of the electronics and battery in the geko™ device. You would dispose of the devices exactly the same way you dispose of your everyday house hold waste and batteries, complying with any local legislation. Do not incinerate the devices as this may be hazardous.

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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 implant/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 to check for neurological damage.

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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?

The adhesive used for the gekoTM is different to that used for sticking plasters. 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™ contain anything that will damage the environment?

No. The geko™ device does not contain anything that is known to damage the environment.

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Do we have any safety evidence for geko™?

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 the managing safety 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 ISO 60601-2-10, the latter being the International standard for electrical safety for powered muscle stimulators.

The gekoTM complies with FDA guidance for powered muscle stimulators.

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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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Does a spinal cord or epidural anaesthesia effect how the geko™ functions?

Anaesthetic agents: general anaesthesia and muscle relaxants may affect the response from the geko™. A higher stimulation setting may be required for patients under anaesthesia, and in some cases the neurostimulation can be blocked. The extent of the interaction will depend upon a wide range of factors, including the amount of agent itself, the time since administration, and patient related factors.

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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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Does a spinal cord or epidural anaesthesia effect how the geko™ functions?

The IFU contains the following warning: 'The geko™ device is not intended for use in an oxygen rich environment' because Firstkind has not verified whether the device meets the requirements for that intended purpose. An 'Oxygen rich environment' implies environments where the oxygen concentration is:

  • a. greater than 25% for ambient pressures up to 110kPa;
  • b. the partial pressure of oxygen is greater than 27,5kPa at ambient pressures exceeding 110kPa.

These conditions may typically occur in hospital oxygen tents, but not necessarily where supplemental oxygen is dispensed topically (e.g. in operating theatres). For reference, the 'normal' concentration of oxygen at sea level is 21%, the pressure at sea level is around 100kPa, and metrological 'high pressure' is about 105kPa.

In areas of lower oxygen levels, e.g. oxygen tents mimicking high altitude, the geko™ device is suitable for use. Please check with the manufacturer if you have any concerns about its use in this type of environment.

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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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