Evaluation of the Adhesive Strength of the Geko™ X-T3 Neuromuscular Stimulator Incorporating a New Skin Adhesive Hydrogel Formulation Designated KM40C
Phase: NA
Conditions: Stroke, Acute
Sponsor: Firstkind Ltd

Protocol FSK-R&D-001 Version 2.0 
IRAS ID 289498 
Date: 29SEPT2020 
Page 1 of 40 
 
 
Evaluation of the adhesive strength of the geko™ X-T3 
neuromuscular stimulator incorporating a new skin adhesive 
hydrogel formulation 
designated KM40C 
 
Protocol No.: 
FSK-R&D-001 
Date: 
29SEPT2020 
Version: 
2.0 
IRAS ID: 
289498 
Short Title: 
Efficacy of Adhesive Strength of New Hydrogel Formulation 
Investigational Product: Hydrogel Formulation KM40C 
Indication: 
Venous Thromboembolism Prevention 
Author: 
 
 
Marie-Thérèse Targett PhD 
Clinical Project Manager 
Firstkind Ltd. 
 
FUNDER 
 
 
Firstkind Ltd. 
Hawk House, Peregrine Business Park, Gomm Road 
High Wycombe, Buckinghamshire, HP13 7DL, UK 
 
Confidentiality Statement 
The information contained in this document is privileged and confidential may not be 
disclosed, except to the extent necessary to obtain informed consent and institutional 
approval to conduct the study, or as required by governmental authorities. Persons to 
whom the information is disclosed must be informed that the information is confidential 
and may not be further disclosed by them. 
 
Firstkind Ltd 
Firstkind Ltd., is a wholly own subsidiary of Sky Medical Technology Ltd., Daresbury 
Science and Innovations Campus, Keckwick Lane, Daresbury, Cheshire, WA4 4FS, UK 

Protocol FSK-R&D-001 Version 2.0 
IRAS ID 289498 
Date: 29SEPT2020 
Page 2 of 40 
 
 
Sponsor Contacts 
 
Clinical Project Manager 
Marie-Thérèse Targett PhD 
E-mail: marie-therese.targett@firstkindmedical.com 
Tel: +44 (0) 7340 903 377 
 
Clinical Trial Administrator 
Anne-Marie Piftor 
E-mail: anne-marie.piftor@firstkindmedical.com 
Tel: +44 (0) 1494 572 056 

Protocol FSK-R&D-001 Version 2.0 
IRAS ID 289498 
Date: 29SEPT2020 
Page 3 of 40 
 
 
 
 
PROTOCOL APPROVAL SIGNATURES 
We, the undersigned, have reviewed this protocol and agree that it contains 
all relevant information required to meet Good Clinical Practice (GCP) and all 
applicable regulatory guidelines and statutes. 
 
Rachel Fallon    
Rachel Fallon (Sep 30, 2020 15:57 GMT+1) 
 
Mrs Rachel Fallon 
Date 
Chief Technical Officer 
Firstkind Ltd 
Hawk House, Peregrine Business Park 
Gomm Road, High Wycombe, 
Buckinghamshire, HP13 7DL, UK 
 
 
 Oct 27, 2020 
 
Dr Kieron Day, DPhil 
Date 
Head of Clinical Affairs 
Firstkind Ltd 
Hawk House, Peregrine Business Park 
Gomm Road, High Wycombe, 
Buckinghamshire, HP13 7DL, UK 
Sep 30, 

Protocol FSK-R&D-001 Version 2.0 
IRAS ID 289498 
Date: 29SEPT2020 
Page 4 of 40 
 
 
 
 
INVESTIGATOR SIGNATURE PAGE 
I have read the protocol specified above and agree to participate in and comply with 
the procedures, as outlined herein for the conduct of this clinical study. I also agree to 
comply with the Independent Ethics Committee (IEC) requirements for testing on 
human patients. I agree to ensure that the requirements for obtaining informed 
consent are met. 
 
 
 
 
 
Investigator’s Signature 
Date 
Print Name 
Site Number 

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IRAS ID 289498 
 
 
 
Table of Contents 
1.0 Introduction ........................................................................................................................... 7 
1.1 Electrically Conductive Adhesive Solid Hydrogels ............................................................... 7 
1.2 The geko™ T3 Neuromuscular Stimulation Device .............................................................. 7 
1.3 Rationale ............................................................................................................................. 9 
2.0 Objective ............................................................................................................................. 10 
2.1 Study Endpoints ................................................................................................................ 10 
2.1.1 Primary Efficacy Endpoints ............................................................................................. 10 
2.1.2 Secondary Efficacy Endpoints ........................................................................................ 10 
3.0 Study Design ...................................................................................................................... 10 
3.1 Study Population ............................................................................................................... 12 
3.1 Number of Participants ...................................................................................................... 12 
3.2 Eligibility Criteria ................................................................................................................ 12 
3.2.1 Inclusion Criteria............................................................................................................. 12 
3.2.2 Exclusion Criteria ........................................................................................................... 12 
4.0 Schedule of Events ............................................................................................................. 12 
4.1 Recruitment and Baseline ................................................................................................. 12 
4.2 Follow-up Days 1-9 ......................................................................................................................... 13 
4.3 Follow-up and End of Participation ...............................................................................................14 
5.0 Participant Completion and Withdrawal / Discontinuation ............................................... 15 
5.1 Participant Completion ...................................................................................................... 15 
5.2 Premature Withdrawal / Discontinuation ............................................................................ 15 
6.0 Study Treatments ............................................................................................................... 15 
6.1 Method for Assigning Eligible Patients ............................................................................... 15 
6.2 Description of Device Evaluation ....................................................................................... 16 
6.3 Device Use ........................................................................................................................ 16 
6.4 Device Labelling ................................................................................................................ 16 
6.5 Device Storage, Handling, Application and Disposal .......................................................... 16 
6.6 Device Accountability ........................................................................................................ 16 
7.0 Description of Procedures and Assessments .................................................................. 17 
7.1 Assessment of Eligibility .................................................................................................... 17 
7.2 Informed Consent .............................................................................................................. 17 
7.3 Patient Profile / Demographics .......................................................................................... 17 
7.4 Application of Device and Collection of Device Performance Data ..................................... 18 
8.0 Statistical Analysis and Sample Size Determination ........................................................ 18 
8.1 Statistical Analysis ............................................................................................................ 18 
8.2 Sample Size Determination ............................................................................................... 18 
8.3 Treatment Groups ............................................................................................................. 19 
8.4 Analysis of Study Endpoints .............................................................................................. 19 

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8.4.1 Primary Endpoints .......................................................................................................... 19 
8.4.2 Secondary Endpoints ..................................................................................................... 19 
9.0 Reporting of Adverse Events and Device Deficiencies .................................................... 19 
9.1 Serious Adverse Events .................................................................................................... 19 
9.2 Device Deficiencies ........................................................................................................... 20 
10.0 Direct Access to Source Data / Documentation .............................................................. 20 
11.0 Quality Control and Quality Assurance ........................................................................... 21 
11.1 Monitoring Requirements................................................................................................. 21 
11.2 Acceptability of Case Report Forms ................................................................................. 21 
11.3 Protocol Amendments ..................................................................................................... 22 
11.4 Reporting Protocol Deviations ......................................................................................... 22 
12.0 Ethics and Regulatory Requirements .............................................................................. 22 
12.1 Institutional Review Board / Independent Ethics Committee ............................................ 23 
12.2 Investigator Responsibilities ............................................................................................ 22 
12.3 Participant Informed Consent Requirements .................................................................... 23 
13.0 Data Handling and Record Keeping ................................................................................ 24 
13.1 Recording and Collection of Data .................................................................................... 24 
13.2 Clinical Data Management .............................................................................................. 24 
13.3 Archiving ......................................................................................................................... 24 
14.0 References ........................................................................................................................ 26 
Appendices ............................................................................................................................... 27 
Appendix 1 Details of Protocol Amendments ......................................................................... 27 
Appendix 2 Regulatory Approvals ........................................................................................... 28 
Appendix 3 Case Report Forms ............................................................................................... 31 
Appendix 4 geko™ XT-3 Instructions for Use and Fitting ...................................................... 39 

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1.0 Introduction 
1.1 Electrically Conductive Adhesive Solid Hydrogels 
Electrically conductive adhesive solid hydrogels are used in the medical device field 
to provide an electrical interface to the skin of a subject to couple electrical signals 
into and/or out of the subject (e.g., for diagnostic and/or monitoring uses) and/or to 
couple electrical stimulus into the subject (e.g., for treatment and/or preventative 
uses). 
Current hydrogels have been developed to be sufficiently adhesive to provide good 
skin adherence and good electrical contact thus ensuring an even spread of current 
density to prevent burns. At the same time, the hydrogels must be insufficiently 
cohesive to allow for easy removal from the skin1. 
A number of different hydrogel precursor formulations are commercially available. 
These generally include a monomer, a first initiator to promote polymerisation of the 
monomers in the precursor, a solubiliser, and a cross-linking agent. Some prior 
formulations have in the past exhibited undesirable properties including issues with 
adhesiveness, electrical conductivity, odour and skin irritation. It has been 
discovered that some of those problems are the result of poor polymerization of the 
monomers in the hydrogel precursors thereby leaving residual monomer and/or by- 
products, which can cause or result in the some of the above undesirable properties. 
The present hydrogels have unique and improved properties. More particularly, the 
present polymerising formulations or hydrogel precursors exhibit enhanced 
polymerisation, thereby reducing the amount of residual functional monomer and/or 
other monomeric residues in the hydrogel which are un-polymerised. The present 
hydrogels also desirably include a buffer system to help prevent discoloration and/or 
hydrolysis of the hydrogels as well as to improve shelf-life. Other additives can 
include conductivity enhancers, pharmaceuticals, humectants and skin health agents 
to provide for reduced skin irritation. 
 
1.2 The geko™ T3 Neuromuscular Stimulation Device 
The innovative geko™ T3 device manufactured by Firstkind Ltd (High Wycombe, United 
Kingdom), is a small, self-adhesive disposable, battery powered, neuromuscular 
stimulation device designed to enhance blood flow in the lower limbs. 
 
The device is made from mylar (polyethylene terephthalate (PET)) and the electronic 
circuit is enclosed in a fully insulated polypropylene protective casing, so there is no risk 
of shock to the patient. The device also has charge-balanced waveforms that yield no 
build-up of charge in the patient, therefore, provided the device is used in accordance 
with the instructions for use, galvanic effects such as electrical burns cannot occur. The 
device is powered by battery and is thus totally isolated from the mains electricity supply. 
The primary lithium coin cell battery powering the device is removable for disposal. 
Please see Figure 1 for an illustration of the device (front view) 

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Flexible strap for conformity 
to the patient leg 
 
 
 
 
 
 
 
T-3 variant branding 
Two switches (+/-) for adjusting the 
eleven stimulation levels 
 
Maximized contact area 
for patient adhesion 
 
Indicator line to assist location 
fitting 
Two LED indicator lights positioned for 
optimum visibility of setting levels, with 
repeat flashing to indicate when button 
is pressed 
Figure 1: The T-3 geko™ device (front view). 
 
The geko™ T3 device utilises an electronically conductive skin adhesive solid hydrogel 
(KM10T) that adheres to the skin and when applied externally to the leg on the 
lateral/posterior aspect of the knee, electrodes within the hydrogel layer stimulate the 
common peroneal nerve simultaneously activating the calf and foot muscle pumps that 
assist in returning blood to the heart. This simultaneous activation has the effect of 
increasing venous velocity and volume flow in the deep veins of the calf which in turn 
increases arterial and microcirculatory flow with no change to heart rate or blood 
pressure2. Figure 2 shows an illustration of the device (rear view) with hydrogel layers 
and electrodes. 
 
 
 
Figure 2: The T-3 geko™ device (rear view) with hydrogel layers and electrodes. 

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The geko™ T3 device has a range of stimulation levels to ensure activation of the 
muscle pumps irrespective of individual skin impedance balanced with patient comfort. 
The optimal stimulation level which maximises blood circulation varies between patients 
and is achieved when a stimulus results in a dorsi-flexion i.e. an involuntary upward 
outward movement of the foot. Please see Figure 3 for an illustration of the device fitted 
to the lower leg. 
 
 
Figure 3: Administering non-invasive neuromuscular electrical stimulation via the 
geko™ T3 device applied at the peroneal nerve proximal to the posterior / anterior 
bifurcation. 
The geko™ T3 device meets recognised International and European safety 
standards and is CE marked for its’ indicated use in humans for increasing blood 
circulation and preventing venous thrombosis in patients known to be at high risk of 
venous thromboembolism (VTE). The device is currently in use within the NHS 
network as a mechanical VTE prophylaxis strategy for acute stroke patients. 
 
1.3 Rationale 
As outlined above, some hydrogel precursor formulations have previously exhibited 
undesirable properties including issues with adhesiveness, electrical conductivity 
and skin irritation. Some of these negative properties are the result of poor 
polymerisation of the monomer in the hydrogel precursors thereby leaving residual 
monomer and/or by-products, which can cause or result in the some of these 
undesirable effects. By adjusting the monomer component of the hydrogel precursor, 
polymerisation can be enhanced thus reducing the amount of residual monomer 
and/or by-products remaining and negating negative properties. 
The KM10T hydrogel used in the geko™ T3 device is derived from an acrylic acid 
monomer and has good skin adhesion properties with low skin irritation. A new 
hydrogel designated KM40C has been developed that promises even lower skin 
irritation due to zero residual acrylic acid, following replacement of the acrylic acid 
monomer component of the hydrogel precursor with an acrylamide monomer. KM40C 
also promises good skin adhesion properties, like those of KM10T used in the geko™ 

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T3 device. 
As with KM10T, the new KM40C hydrogel formulation has been tested for safety in 
humans to current international biocompatibility standards (ISO10993) and 
subsequently, this new formulation has been used in the development of the geko™ 
device designated geko™ XT-3. 
Both the T3 and XT-3 devices are identical in terms of the therapy they deliver to 
patients, they differ only in the hydrogel used for adhesion to the skin and although 
the new formulation promises good adhesion properties, this has not yet been 
tested in a clinical environment on patients receiving geko™ therapy. 
As with the T3 device, the XT-3 device meets recognized, International and 
European safety standards and is also CE marked for its’ indicated use in humans 
for increasing blood circulation and preventing venous thrombosis in patients known 
to be at high risk of VTE e.g. stroke patients 
2.0 Objective 
The aim of this study is to test the skin adhesion property of the new hydrogel 
KM40C during routine clinical use of the geko™ XT-3 device for VTE prophylaxis to 
ensure that skin adhesion is at least equivalent if not superior to the hydrogel KM10T 
incorporated into the geko™T3 device which is currently in use in hospitals. 
2.1 Study Endpoints 
2.1.1 Primary Efficacy Endpoints 
• Skin adhesion performance of new hydrogel formulation KM40C 
during routine clinical use of the geko™ XT-3 device will be 
compared to that of the current formulation used in the geko™ T3 
device. Skin adhesion will be observed and scored numerically for 
statistical comparison to test for equivalency of the two 
formulations (new vs current). 
2.1.2 Secondary Efficacy Endpoints 
• The secondary endpoints are the incidence of adverse events 
(AEs), incidence of serious AEs (SAEs), incidence of study 
treatment related AEs, and the incidence of investigational device 
related AEs 
3.0 Study Design 
The study will be carried out at one clinical site and will be a non-blinded, 
non-randomised cohort observation study. 
The study objective is to compare how well the geko™ device with a new skin adhesive 
(geko™XT-3) sticks to the skin compared to that of the adhesive currently used to stick 
the current device (geko™ T3) to the skin. The performance of the new adhesive is 
expected to be at least the same if not better than the current one. This is an 
observational study or cohort study where the performance of the adhesives is observed 
and rated. There is no intervention to control the performance of the adhesives. As such, 
a randomized controlled trial is not required as the protocol does not aim to prove a 
causal relationship between an intervention and adhesive performance. 

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Group 1 
Patient presents for geko™ therapy for 
VTE prevention 
Recruitment & informed consent 
process 
PHASE 1 
Natural allocation to geko™ T3 
(KMT10 hydrogel) 
Baseline 
Application of geko™ device 
Days 1-9 
Follow-up & daily application of geko™ 
device 
Day 10 
Follow-up & participation complete 
Group 2 
Patient presents for geko™ therapy for 
VTE prevention 
Recruitment & informed consent 
process 
PHASE 2 
Natural allocation to geko™ XT-3 
(KM40C hydrogel) 
Baseline 
Application of geko™ device 
Days 1-9 
Follow-up & daily application of geko™ 
device 
Day 10 
Follow-up & participation complete 
 
To enable a direct comparison of performance, patients will be divided naturally into two 
sequential groups or cohorts. This will also ensure that the XT-3 and T3 devices are not 
mixed during routine clinical use. 
Group 1 patients will be consented and enter Phase 1 of the study. They will continue 
their treatment pathway with the geko™ T3 device as per hospital clinical protocol for 
VTE prevention. Group 1 patients will complete the 10-day, study period, before Group 2 
patients are consented and enter Phase 2 of the study. Group 2 patients will continue 
their treatment pathway as per hospital clinical protocol but with the geko™ XT-3 device. 
As both the T3 and XT-3 devices are identical in terms of the therapy they deliver to 
patients, the treatment pathway for both group 1 & 2 patients will be unaffected. The 
devices differ only in the hydrogel used for adhesion to the skin. Please see Figure. 4 for 
a schematic of the patient journey. 
 
 
 
 
 
Figure 4: Schematic diagram of the patient journey for Groups 1 & 2. 

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3.1 Study Population 
It is important that the skin adhesion strength of the new hydrogel formulation is 
evaluated together with that of the current formulation during clinical use of the 
geko™ devices. The use of healthy volunteers would not allow for this as the 
devices would not be being used in a population for the purpose for which they are 
intended. The study population will be patients who are immobile and bedbound 
following acute stroke, this population cannot be replicated within a healthy 
population. 
Both hydrogel formulations have been tested for biocompatibility in humans and 
both geko™ devices are CE marked and indicated for use in humans for increasing 
blood circulation and preventing venous thrombosis in patients known to be at high 
risk of VTE. Please refer to Appendix 1 for a list of regulatory approvals. 
As such, patients who have been admitted to the Acute Stroke Unit who will receive 
daily treatment with geko™ as an alternative VTE prophylaxis strategy as part of 
their standard care will be asked to participate. 
 
3.2 Number of Participants 
A total of 40 patients will be recruited, 20 into each phase of the study. 
3.3 Eligibility Criteria 
Eligible patients are those who meet all the following inclusion criteria and who do 
not have any listed exclusion criteria. 
3.3.1 Inclusion Criteria 
• Male or female aged ≥ 18 years 
• Currently an in-patient hospitalised for acute stroke 
• Use of geko™ as a mechanical prophylaxis strategy for venous 
thromboembolism 
• Patient understands and is willing to participate in the study and 
can comply with study procedures 
3.3.2 Exclusion Criteria 
• Pregnancy or breast feeding 
• Use of any neuro-modulation device other than geko™ 
• Participation in any other clinical study that may interfere with the 
outcome of either study 
4.0 Schedule of Events 
Procedures should take place in the following order: 
4.1 Recruitment and Baseline (Day 0) 
• Patient presents for geko™ therapy for VTE prevention following acute 

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stroke 
• Confirm patient eligibility 
• Obtain written informed consent 
• Collect demographic data 
• Fit geko™ device bilaterally for VTE prevention as per hospital standard 
care. The devices fitted will be as per allotted patient group and study 
phase. 
• Record 
• 
Ease with which device fitted (rate from very easy to impossible) 
• 
Adhesion to patient’s leg (rate from very well to not at all) 
• 
Use of additional fixation to keep the device in position 
• 
Ease of re-application if removed 
• 
Patient comfort (rate from very comfortable to extremely 
uncomfortable) 
• 
Device setting (1-11) 
• Assess for any AEs 
4.2 Follow-up and Daily Application of geko™ therapy (Days 1-9) 
During daily review of the patient by a member of the healthcare team, a new geko™ 
device will be fitted bilaterally as per standard care. In addition, the following information 
will be collected each day or until the patient is able to mobilize independently: 
• Length of time device worn for since fitting (hours) 
• Adhesion to patient’s leg (rate from very well to not at all) 
• Use of additional fixation to keep the device in position 
• Ease of re-application if removed 
• Patient comfort (rate from very comfortable to extremely uncomfortable) 
• Patient sleep post-fitting 
• Patient’s current mobility 
Fit new geko™ device bilaterally for VTE prevention as per hospital standard care. 
Devices fitted will be as per allotted patient group and study phase and the following 
post-application information recorded: 
• 
Ease with which device fitted (rate from very easy to impossible) 

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• 
Adhesion to patient’s leg (rate from very well to not at all) 
• 
Use of any additional fixation to keep the device in position. 
• 
Patient comfort (rate from very comfortable to extremely 
uncomfortable) 
• 
Device setting (1-11) 
• Assess for any AEs 
4.3 Final Follow-up and End of Participation (Day 10) 
At the final follow-up, the following information will be collected 
• Length of time device worn for since fitting (hours) 
• Adhesion to patient’s leg (rate from very well to not at all) 
• Use of additional fixation to keep the device in position 
• Ease of re-application if removed 
• Patient comfort (rate from very comfortable to extremely uncomfortable) 
• Patient sleep post-fitting 
• Patient’s current mobility 
Once the final follow-up has been completed the patient’s participation will end and the 
patient will be exited from the study. 
See Table 1 for full schedule of events. 

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Procedure / Assessment 
Baseline 
(Day 0) 
Follow-up 
(Days 1-10) 
Confirmation of eligibility 
X 
Informed Consent 
X 
Demographics (age in years, date of birth, gender, 
date of stroke diagnosis, mobility, adjunctive 
treatments to the geko™ device e.g. drugs, 
stockings 
X 
Bilateral fitting of geko™ devices as per standard care 
X 
X 
Ease of fitting 
X 
X 
Adhesion to patient’s leg 
X 
X 
Additional fixation 
X 
X 
Ease of re-application if device removed 
X 
X 
Patient comfort post fitting 
X 
X 
Device setting 
X 
X 
Patient sleep post-fitting 
X 
X 
Hours of wear since fitting 
X 
X 
Patient mobility 
X 
X 
Assess for AEs 
X 
X 
 
Table 1: Schedule of Events. 
5.0 Participant Completion and Withdrawal / Discontinuation 
5.1 Participant Completion 
Participants will have completed the study once all protocol related activities have been 
completed. 
 
5.2 Premature Withdrawal / Discontinuation 
All patients have the right to withdraw at any point without prejudice to their treatment. 
If necessary, the Investigator may discontinue a patient at any time if it is considered 
medically necessary e.g. loss of mental capacity. The Investigator may also withdraw a 
patient if it is considered that the scientific, and therefore, ethical standards of the study 
are compromised. In addition, patients will be withdrawn from the study, at the 
Investigator’s discretion, if they fail to wear the geko™ device as part of their standard 
care as directed by the treating physician. The reasons for withdrawal will be fully 
recorded in the patient’s source documents and on the appropriate case report form. 
 
If a participant is prematurely discontinued from the study at any time due to an adverse 
event (AE) or serious adverse event (SAE), the procedures stated in Section 9.0 must be 
followed. 
 
6.0 Study Treatments 
6.1 Method for Assigning Eligible Patients 
The study aims to compare the skin adhesive strength of two hydrogel formulations 
(new vs current) to ensure that adhesion strength is at least equivalent if not superior 

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with the new formulation. As such, there is no objective to prove a causal relationship 
between a treatment and an outcome, therefore patients will be divided naturally into 
two sequential groups for comparison purposes only. This will also ensure that the 
T3 and XT-3 devices are not mixed during routine clinical use. 
Group 1 patients will enter Phase 1 of the study. They will continue their treatment 
pathway with the geko™ T3 device as per hospital clinical protocol for VTE prevention. 
Group 1 patients will complete the 10-day study period, before Group 2 patients are 
consented and enter Phase 2 of the study. Group 2 patients will continue their treatment 
pathway as per hospital clinical protocol but with the geko™ XT-3 device. 
As both the T3 and XT-3 devices are identical in terms of the treatment they deliver to 
patients, the treatment pathway for both group1 & 2 patients will be unaffected. The 
devices differ only in the hydrogel used for adhesion to the skin. 
 
6.2 Description of Device for Evaluation 
 
The geko XT-3™ device is CE marked for use in humans (GB12/87339; SGS, United 
Kingdom Ltd). It is made from mylar (polyethylene terephthalate (PET)) and is enclosed 
in a polypropylene casing and has a hydrogel layer which will stick it to the skin. This 
hydrogel layer is composed of a new formulation hydrogel designated KM40C and has 
already been tested to current international biocompatibility standards in humans (ISO 
10993). Please refer to Appendix 4 for fitting instructions. 
 
6.3 Device Use 
The geko™ T3 and XT-3 devices will be used. 
 
6.4 Device Labelling 
 
Devices will be labelled in accordance with all applicable regulatory requirements. 
 
6.5 Device Storage, Handling, Application and Disposal 
 
Patients will receive treatment with the device as part of their standard care for VTE 
prevention following acute stroke. Moreover, there is no requirement or need to provide 
specific labelling, storage, handling, application, and disposal instructions. 
 
6.6 Device Accountability 
 
Patients will be receiving treatment with the device as part of their standard care for 
VTE prevention following acute stroke, therefore there is no requirement to provide 
product accountability instructions. 

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7.0 Description of Protocol Procedures and Assessments 
7.1 Assessment of Eligibility 
 
The Investigator must assess a patient’s suitability and eligibility for the study, especially 
with regards to the Inclusion and Exclusion criteria of this Protocol described in Sections 
3.3.1 and 3.3.2. 
 
Although potential participants will be in-patients hospitalised following acute stroke, in 
order to be eligible to participate all patients must be capable of giving consent for 
themselves. They must understand and be willing to participate in the study and be able 
to comply with all procedures and provide written informed consent. Patients who do not 
fulfil these requirements will not be recruited. 
7.2 Informed Consent 
 
In obtaining and documenting informed consent the Investigator must comply with 
applicable regulatory requirements, local SOPs and must adhere to Good Clinical 
Practice (GCP). 
 
The investigator will explain to each participant the nature of the study, its purpose, the 
procedures involved, the expected duration, the potential risks and benefits and any 
discomfort it may entail. Each participant will be informed that the participation in the 
study is voluntary and that he/she may withdraw from the study at any time and that 
withdrawal of consent will not affect his/her subsequent medical assistance and 
treatment. The participant must be informed that his/her medical records may be 
examined by authorised individuals other than their treating physician. All participants for 
the study will be provided a participant information sheet and a consent form describing 
the study and providing enough information for participant to make an informed decision 
about their participation in the study. The participant must be given ample time to decide 
whether to participate in the study or not. The formal consent of a participant, using the 
approved consent form, must be obtained before the participant is submitted to any 
study procedure. The participant should read and consider the statement before signing 
and dating the informed consent form and should be given a copy of the signed 
document. The consent form must also be signed and dated by the investigator (or his 
designee) and it will be retained as part of the study records. The patient's medical 
record should clearly indicate that the patient is participating in this study. 
7.3 Patient Profile / Demographics 
For the purposes of this observational study, demographic information will be collected at 
baseline (Day 0) and include: 
• Patient age in years 
• Patient gender 
• Date of stroke diagnosis 
• Current mobility – is patient able to walk independently 
• Adjunctive treatments to the geko™ device e.g. drugs, stockings 

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7.4 Application of geko™ Device and Collection of Device Performance Data 
Patients will receive treatment with either the geko™ T3 or XT-3 device as part of their 
standard care for VTE prevention as per hospital clinical protocol. During daily review of 
the patient by a member of the healthcare team, the following information will be 
collected for a maximum of 10 days or until the patient is able to mobilize independently: 
• Length of time device worn for since fitting (hours) 
• Adhesion to patient’s leg (score from very well to not at all) 
• Use of additional fixation to keep the device in position. 
• Patient comfort 
• Patient sleep post-fitting 
• Patient’s current mobility 
• Ease with which device fitted (score from very easy to impossible) 
• Device setting 
• Assess for any AEs 
 
 
8.0 Statistical Analysis and Sample Size Determination 
8.1 Statistical Analysis 
 
The ability of the geko™ XT-3 device to adhere to skin will be numerically scored and 
compared to the geko™ T3 using a non-paired t-test for equivalence. 
 
8.2 Sample Size Determination 
 
The sample size of 20 patients per phase has been determined using MIL-STD-105, a 
standard commonly used in the medical device industry to specify sample size and 
provide the basis for acceptance and rejection. We set an acceptable quality level (AQL) 
of 0.15 for the function of the new formulation hydrogel and using the C=0 sampling plan 
(Table 2), 100% testing of 80 devices with no failures would confirm that we meet our 
specified AQL. 
 
If completed on 20 patients and assuming 4 days of use (on both legs), this equates to a 
minimum of 80 XT-3 devices to test the new formulation the same numbers would be 
required for the T3 device with current hydrogel formulation for statistical comparison. 

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IRAS ID 289498 
 
 
 
Table 2: MIL-STD-105 Statistical Sampling Plan (C=0 Sampling Plan) 
 
 
MIL-STD-1916 
Verification Level 
VII 
VI 
V 
IV 
III 
II 
I 
INDEX VALUE 
AQL 
.010 
.015 
.025 
.040 
.065 
.10 
.15 
.25 
.40 
.65 
1.0 
1.5 
2.5 
4.0 
6.5 
10 
LOT SIZE 
SAMPLE SIZE 
2 TO 5 
* 
* 
* 
* 
* 
* 
* 
* 
* 
* 
* 
* 
5 
3 
2 
2 
9 TO 15 
* 
* 
* 
* 
* 
* 
* 
* 
* 
* 
13 
8 
5 
3 
2 
2 
16 TO 25 
* 
* 
* 
* 
* 
* 
* 
* 
* 
20 
13 
8 
5 
3 
3 
2 
26 TO 50 
* 
* 
* 
* 
* 
* 
* 
* 
32 
20 
13 
8 
5 
5 
5 
3 
51 TO 90 
* 
* 
* 
* 
* 
* 
80 
50 
32 
20 
13 
8 
7 
6 
5 
4 
91 TO 150 
* 
* 
* 
* 
* 
125 
80 
50 
32 
20 
13 
12 
11 
7 
6 
5 
151 TO 280 
* 
* 
* 
* 
200 
125 
80 
50 
32 
20 
20 
15 
13 
10 
7 
6 
281 TO 500 
* 
* 
* 
315 
200 
125 
80 
50 
48 
47 
29 
21 
16 
11 
9 
7 
501 TO 1,200 
* 
800 
500 
315 
200 
125 
80 
75 
73 
47 
34 
27 
19 
15 
11 
8 
1,201 TO 3,200 
1250 
800 
500 
315 
200 
125 
120 
116 
73 
53 
42 
35 
23 
18 
13 
9 
3,201 TO 10,000 
1250 
800 
500 
315 
200 
192 
189 
116 
86 
68 
50 
38 
29 
22 
15 
9 
10,001 TO 35,000 
1250 
800 
500 
315 
300 
294 
189 
135 
108 
77 
60 
46 
35 
29 
15 
9 
35,001 TO 150,000 
1250 
800 
500 
400 
4776 
294 
218 
170 
123 
96 
74 
56 
40 
29 
15 
9 
150,001 TO 
500,000 
1250 
800 
750 
715 
476 
345 
270 
200 
156 
119 
90 
64 
40 
29 
15 
9 
500,001 AND 
OVER 
1250 
1200 
1112 
715 
536 
435 
303 
244 
189 
143 
102 
64 
40 
29 
15 
9 
 
* Indicates entire Lot must be inspected 100%. Note: Acceptance number in all cases is 
zero. 
 
8.3 Treatment Groups 
 
The following treatment groups will be assessed 
 
 
Group 
Description 
Group 1 (Phase 1, n=20) 
Standard care with hydrogel KM40C 
(geko™ XT-3) 
Group 2 (Phase 2, n=20) 
Standard care with hydrogel KMT10 
(geko™ T3) 
 
 
8.4 Analysis of Study Endpoints 
8.4.1 Primary Efficacy Endpoints 
The primary efficacy endpoint for the study is: 
• the skin adhesion performance of new hydrogel formulation 

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KM40C used in the geko™ XT-3 device compared to that of the 
current formulation KMT10 used in the geko™ T3 device. As this 
is a cohort observation study, this will be a direct comparison 
between two different patient groups / cohorts (Groups1 and 2) to 
evaluate efficacy. 
Primary endpoint data from this observational study will be 
summarised descriptively. Continuous parameters may include 
mean, standard deviation, median, minimum, and maximum. 
8.4.2 Secondary Efficacy Endpoints 
The secondary endpoints are: 
• The incidence of adverse events (AEs), incidence of serious AEs 
(SAEs), incidence of study treatment related AEs, and the 
incidence of investigational device related AEs 
Secondary endpoint data from this observational study will be 
summarised descriptively. Continuous parameters may include 
mean, standard deviation, median, minimum, and maximum. 
 
9.0 Reporting of Adverse Events and Device Deficiencies 
9.1 Serious Adverse Events 
Once the treating physician becomes aware of a device related adverse event, he/she 
must report this to the Sponsor, within 24 hours. 
 
Sponsor SAE Contact: 
Kieron Day 
Tel: +44 (0) 7921 106 253 
e-mail: safety@firstkindmedical.com 
 
The report must include a full description of the event. Additional supporting 
documentation may be requested and should be provided to Sponsor as and when it 
becomes available. Such documentation includes but is not limited to lab reports, 
discharge summary, hospital notes, etc. 
 
The treating physician is responsible for reporting all SAEs in accordance with local laws 
and regulations. 
9.2 Device Deficiencies 
Any device deficiencies should be reported via Firstkind’s proprietary complaints system. 
 
10.0 Direct Access to Source Data / Documentation 
Data will be collected on paper case report forms (CRFs) by appropriately trained 
delegated members of the patient’s healthcare team at the clinical site. Only designated 
members of the team will be allowed to record and / or correct data in the CRFs. CRFs 

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will be provided by the Sponsor to the site for completion together with CRF completion 
guidelines. All CRFs for the study, can be found in Appendix 3 of this protocol. Patients 
will be assigned a unique study identification number (participant number and initials) 
and will be identified only by this unique identifier on CRFs and on source documents by 
name and date of birth. No personal identifier will be used in any publication or 
communication used to support this research study. The participant identification number 
will be used if it becomes necessary to identify data specific to a single participant. The 
monitors, auditors, personnel authorised by the Sponsor, the local IRB, and regulatory 
agencies are eligible to review medical and research records related to this study as a 
part of their responsibility to protect human participants in clinical research and will be 
given direct access to source data and documentation (e.g., medical charts/records, 
printouts etc.) for source data verification, provided that participant confidentiality is 
maintained in accordance with local requirements. Access to electronic medical records 
may be governed by institution policy and each site will be required to ensure access 
while remaining compliant with institutional requirements. 
 
 
11.0 Quality Control and Quality Assurance 
11.1 Monitoring Requirements 
 
In order to maintain knowledge of the progress of a study, the Sponsor's designated 
Clinical Research Associate (CRA) / monitor will visit the centres during the study as well 
as maintain frequent telephone and written communication. The Investigator will permit 
the Sponsor to monitor the study as frequently as is deemed necessary and provide 
access to medical records to ensure that data are being recorded adequately, that data 
are verifiable, and that protocol adherence is satisfactory. 
 
The Investigator will permit representatives of the Sponsor and/or designated CRO to 
inspect all pCRFs and corresponding study participant original medical records (source 
documents) at regular intervals throughout the study. Participant original medical records 
and other relevant data must be available to support all data recorded in the CRF. In 
addition to the original medical records, these data may include but is not limited to, 
study, laboratory and diagnostic reports, wound images and tracings, quality of life 
questionnaire, etc. 
 
Site inspections serve to verify strict adherence to the protocol and the accuracy of the 
data being entered on the CRFs, in accordance with applicable regulations. A Monitoring 
Log will be maintained at each study site which the monitor will sign, date and state the 
type of visit. 
 
The Investigator should be aware that the study site and participant records might be 
inspected and audited by the Sponsor or representatives of Sponsor or relevant 
regulatory authorities. 
 
11.2 Acceptability and Storage of Case Report Forms 
A CRF must be completed for each participant who has signed an informed consent 
form. All source documents and CRFs will be completed during or as soon as possible 
after the patient’s assessments have been completed. The Investigator will review the 

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CRFs to indicate that, to his / her knowledge, they are complete and accurate. CRFs will 
be reviewed by the Sponsor’s CRA / Monitor, at the time of a monitoring visit, for 
adherence to completion guidelines and verified against source documents. 
 
Verified / corrected CRFs will then be photocopied and submitted to the Sponsor, leaving 
the original copies of the CRFs 
at the site e.g. CRA / Monitor may hand carry completed CRFs to the Sponsor. If data is 
not retrieved at the time of the monitoring visit, the Sponsor may want copies of the 
CRFs submitted via Email or mail. As patients will be identified only by a unique study 
identification number (participant number and initials), the CRFs are already fully 
anonymized prior to being sent to the Sponsor. It is the responsibility of both the 
Investigator and the Sponsor to ensure that all CRFs are stored in a secure location 
during the course of the study and archived when the study has finished. 
 
11.3 Protocol Amendments 
A modification or alteration to this protocol may not be undertaken without first obtaining 
the concurrence of Sponsor. Both the Lead Investigator and the Sponsor representative 
must sign and date the amendment prior to implementation. In addition, the Lead 
Investigator must report all protocol amendments to, and receive all required approvals 
from, the Institutional Review Board / Independent Ethics Committee (IRB / IEC) PRIOR 
to implementation of any protocol amendment at the study Centre, with two exceptions: 
1. When necessary to eliminate apparent immediate hazard to the participant; or 
2. When the modification involves only logistics or administration. 
If a protocol change is proposed for all participants, the following procedure for ra 
protocol amendment will be followed. An amendment must be in writing and it must be 
dated by both the Sponsor and the Investigator. If necessary, the Sponsor will submit 
protocol amendments to the appropriate regulatory authorities and notify other 
Investigators using this protocol. 
An amendment may also require modification of the informed consent form. The 
Investigator will provide an approval letter for the amendment and revised informed 
consent form, if applicable, to the Sponsor. 
Any protocol amendments will be listed in the "Appendices" portion of the Table of 
Contents. 
11.4 Reporting Protocol Deviations 
The Investigator is obligated to follow the protocol without departure from the 
requirements written in the protocol. If the Investigator deviates from the protocol 
requirements, the Sponsor will make the determination as to whether the participant will 
continue in the study. The Sponsor also has the right to discontinue the participant for 
protocol deviations / violations. All protocol deviations must be documented in the CRFs. 
 
12.0 Ethics and Regulatory Requirements 
 
The study will be carried out in accordance to the protocol and with principles specified in 
the current version of the Declaration of Helsinki, the guidelines of Good Clinical 
Practice, the European Directive on medical devices 93/42/EEC and the ISO Norm 
14155 and ISO 14971. 

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12.1 Institutional Review Board / Independent Ethics Committee 
The Principal Investigator will provide the IRB / IEC with all appropriate materials as 
required by their IRB / IEC, including but not limited to the clinical study protocol, 
informed consent form, and any advertising materials. The study will not be initiated until 
the IRB / IEC provides written approval of the aforementioned documents and until 
approval documents have been obtained by the Principal Investigator and Sponsor or 
Sponsor designee. The Investigator will not participate in the decision. If the Investigator 
is an IRB or IEC member, documentation must be provided indicating recusal from the 
approval process. Appropriate reports on the progress of this study by the Principal 
Investigator will be made to the IRB / IEC as required by local and applicable 
government regulations and in agreement with policy established by the Sponsor. The 
Investigator is required to maintain an accurate and complete record of all written 
correspondence to and received from the IRB / IEC and must agree to share all such 
documents and reports with the Sponsor. No changes from the final approved protocol 
will be initiated without the 
IRB / IEC’ s prior written approval or favorable opinion of a written amendment, except 
when necessary to eliminate immediate hazards to the participants or when the change 
involves only logistics or administration. 
 
12.2 Investigator’s Responsibilities 
The Investigators are responsible for performing the study in full accordance with the 
specifications of this protocol and in accordance with principles consistent with 
Declaration of Helsinki, Good Clinical Practice and currently applicable regulations. 
Information regarding any study centres participating in this study that cannot comply 
with these standards will be documented. 
 
12.3 Participant Informed Consent Requirements 
Written and oral information about the study in a language understandable by the patient 
will be given to all patients by the Investigator and/or designee. Written informed consent 
will be obtained from each patient before any procedures or assessments that would not 
otherwise be required for the care of the patient are done and after the aims, methods, 
anticipated benefits, potential hazards, and insurance arrangements in force are 
explained and the patient has been given sufficient time to ask questions and consider 
participation in the study. It will also be explained to the patients that they are free to 
refuse entry into the study and free to withdraw from the study at any time without 
prejudice to future treatment. It is permissible for a third person (e.g., a family member) 
to be present during the explanation of the study. 
 
The written Informed Consent Form (ICF) is to be in compliance with Good Clinical 
Practice guidelines. The Sponsor and / or designated Contract Research Organisation 
(CRO) will approve the ICF and all amendments to the ICF prior to submission to the 
IRB/IEC. A copy of the ICF to be used will be submitted by the Investigator to the 
IRB/IEC for review and approval prior to the start of the study. Each study site must 
provide the Sponsor with an unsigned copy of IRB / IEC-approved ICF along with 
applicable documentation to support this approval. The original signed ICF is retained in 

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the participant's study records, and a copy is provided to the participant. A second copy 
may be filed in the participant’s medical record, if allowed by institutional policy. 
 
13.0 Data Handling and Record Keeping 
 
13.1 Recording, Collection and Transfer of Data 
The primary source document for this study will be the participant's medical record. If 
separate research records are maintained by the Investigator(s), the medical record and 
the research records will be considered the source documents for the purposes of 
auditing the study. 
 
Applicable source data will be manually transcribed to approved CRFs. The Investigator 
is ultimately responsible for the accuracy of the data transcribed on the forms. All source 
documents and CRFs will be completed as soon as possible after the patient’s 
assessments have been completed. 
 
The Principal Investigator (PI) will review CRFs to indicate that, to his / her knowledge, 
they are complete and accurate. If further changes are made after this, the PI will need 
to again sign the Investigator signature page. Designated source documents will be 
signed and dated by the appropriate study personnel. Investigators must agree to 
complete and maintain source documents and CRFs for each participant in the study. 
 
 
All research data will be entered, either electronically or manually, into a computerised 
database. The PI will maintain a confidential list of study participants which will include 
each participant’s study number, name, date of birth and unique hospital identification 
number if applicable. This list will be kept by the PI and will not be collected by Sponsor. 
A notation will be made in the participant’s case history / medical chart that he / she is 
participating in a clinical study and has provided a signed and dated ICF. The PI must 
also maintain a separate screening log of all the patients screened for participation in the 
study; it should include gender; age; eligibility status; reason for ineligibility, if applicable; 
and study allocated participant number, if applicable. 
 
13.2 Clinical Data Management 
The Sponsor and/or designated CRO will be responsible for the processing and quality 
control of the data. Data management will be carried out as described in the Sponsor’s 
or CRO’s standard operating procedures (SOPs) for clinical studies. The handling of 
data, including data quality control, will comply with applicable regulatory guidelines and 
the Sponsor’s SOPs as well as provisions of a study-specific Data Management Plan. 
 
13.3 Archiving 
All study documentation at the Study site and Sponsor site will be archived in 
accordance with Sponsor’s quality standards and SOPs. 

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The Study site will maintain all research records, reports, and case history reports for a 
period of 15 years after study closure. 
 
At the completion of the study, details of the archival process must be provided to the 
Sponsor. Study records are subject to inspection by applicable health and regulatory 
agencies at any time. 
Records to be retained at the Study site include, but are not restricted to: 
• Source data and the primary records upon which they are based (e.g., 
participant’s progress notes, adverse event data, test results, and any other 
diagnostic procedures required to evaluate the progress of the study). 
• Signed protocols and protocol amendments 
• Product accountability records 
• Study personnel signature log 
• Monitoring logs 
• Correspondence to and from the Sponsor, designee and IRB/IEC 
• Principal Investigator and co-Investigator(s) Curriculum Vitaes (CVs) 
• Signed ICFs 
• Patient screening and randomisation log 
• SAE reports 
• IRB / ICE approval letters and correspondence if applicable 
• Other documents pertaining to the conduct of the study 
 
These documents must be maintained and kept on file by the Study site so that the 
conduct of the study can be fully documented and monitored. 

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14.0 References 
 
1. McAdams E., "Surface Biomedical Electrode Technology," Int'1 Med. 
Device & Diagnostic Indus. pp. 44-48 (Sept./Oct. 1990) 
 
2. Tucker, A., Maass, A., Bain, D., Chen, L-H., Azzam, M., Dawson, H., Johnston, A 
Augmentation of venous, arterial and microvascular blood supply in the leg by 
isometric neuromuscular stimulation via the peroneal nerve. 2010 Int J Angiol: Vol 
19 No 1 Spring. 

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Appendices 
Appendix 1: Details of Protocol Amendments. 
 
Change 
Protocol Version 
No. and date 
Details of changes made 
1 
Version 1.0 
14FEB2020 
New document 
2 
Version 2.0 
25AUG2020 
Section 1.2 added to expand background information on device 
mechanism and function Figs 1 & 2 added illustrating device and 
hydrogel layers 
Section 1.3 Rationale for testing the new formulation hydrogel 
expanded. More detail regarding hydrogel formulations and testing in 
humans added. Clarified that devices are the same they differ only by 
their hydrogel layer. 
Section 2.0 Endpoints amended for clarity 
Section 3.0 Expanded for clarification of study design, more detail 
added regarding patient groups and new schematic of patient journey 
added. Rationale for not randomising patients clarified 
Section 3.1 More detail added to clarify why stroke acute stroke 
patients are to be recruited instead of using healthy volunteers 
Section 4.0 Schedule of Events added 
Section 5.0 Participant Completion and Withdrawal / Discontinuation 
added 
Section 6.0 Study Treatments added, method for device allocation also 
expanded to include rationale for a non-randomised cohort observation 
study and not a randomised controlled study 
Section 7.0 Description of Protocol Procedures and Assessments 
added. Process for obtaining informed consent expanded and 
assessment of eligibility added to ensure that stroke patients will only 
be recruited if they can give consent for themselves. Patients with 
impaired mental capacity will not be recruited on to the study 
Section 8.0 Statistical Analysis and Sample Size Determination added 
Section 9.0 Reporting of Adverse Events & Device Deficiencies added 
Section 10.0 Source Data and Documentation added 
Section 11.0 Quality Control and Quality Assurance added to clarify 
management of data 
Section 12.0 Ethics and Regulatory Requirements added 
Section 13.0 Data Handling and Record keeping added 
Appendix 2 Regulatory Approval for the devices added 
Appendix 3 Sample Case Report Forms added 

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Appendix 2: Regulatory Approvals. 
 
 
EMEA Regulatory Clearances 
by Country 
Clinical Indications 
Reference 
Date 
EU/EFTA 
− 
To increase blood 
circulation, 
− 
For the prevention of 
venous thrombosis 
− 
For the prevention 
and treatment of 
oedema 
− 
For promoting wound 
healing 
− 
For promoting 
healing of tendon and 
ligament injuries 
− 
For the treatment of 
venous insufficiency 
and ischemia 
CE Marking 
Oct 2010 
GB12/87339 
(T3, XT-3) 
Saudi Arabia 
− 
DVT prevention 
− 
Increasing blood 
circulation 
MDMA 
18020263 
Feb 2018 
AMERICAS Regulatory 
Clearances by Country 
Clinical Indications 
Reference 
Date 
USA 
− 
stimulation of healthy 
muscles in order to 
improve or facilitate 
muscle performance. 
K134001 
May 2014 
− Increasing local 
blood circulation, and 
− Immediate post- 
surgical stimulation of 
the calf muscles to 
prevent venous 
thrombosis. 
− 
Oedema reduction 
− 
Stimulation of the calf 
muscles to prevent 
venous thrombosis in 
non-surgical patients 
at risk for venous 
thromboembolism 
K133638 
Aug 2014) 
K152667 
Oct 2015 
K160299 
K163125 
(T-2, R-2) 
K180082 
(T-2, R-2) 
Apr 2016 
Apr 2017 
Feb 2018 
May 2018 
Sep2019 
K181059 
(T-3) 
K191113 
(T-2, T-3) 
− Increasing local 
blood circulation, and 
− 
oedema reduction 
K193045 
Jan 2020 
(W-2) 

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Canada 
− 
To increase blood 
circulation, 
− 
For the prevention of 
venous thrombosis 
− 
For the prevention 
and treatment of 
oedema 
− 
For promoting wound 
healing 
− 
For promoting 
healing of tendon and 
ligament injuries 
− 
For the treatment of 
venous insufficiency 
and ischemia 
License 86311 
Jun 2011 
Costa Rica 
− 
For use in patients 
with high risk of 
venous thrombus- 
embolism and in 
patients in which 
other 
pharmacological and 
mechanical 
prophylaxis methods 
are impractical or 
contraindicated 
184102 
Sep 2016 
Ecuador 
− 
To increase blood 
circulation, 
− 
For the prevention of 
venous thrombosis 
− 
For the prevention 
and treatment of 
oedema 
67680993 
Jun 2017 
Panama 
− 
To increase blood 
circulation, 
− 
For the prevention of 
venous thrombosis 
− 
For the prevention 
and treatment of 
oedema 
8-211-2528 
Aug 2016 
Mexico 
− 
To increase blood 
circulation, 
− 
For the prevention of 
venous thrombosis 
− 
For the prevention 
and treatment of 
oedema 
− 
For the treatment of 
venous insufficiency 
and ischemia 
2301C2017 
Sep 2017 

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Brazil 
− 
To increase blood 
circulation, 
− 
For the prevention of 
venous thrombosis 
− 
For the prevention 
and treatment of 
oedema 
− 
For the treatment of 
venous insufficiency 
and ischemia 
80686360256 
Dec 2019 
− 

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Appendix 3: Sample Case Report Forms 
Baseline (Day 0) 
 

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Follow-up Day 1 (please note days1-9 CRFs will be the same) 
 
 

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Final Follow-up Day 10 
 
 

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Exit Day 10 
 
 

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Appendix 4: Instructions for Use and Fitting Instructions geko™ X-T3 

 
 
3 Fi tting 
 
5 Settings 
 
 
 
 
 
2 Cleaning 
 
 
 
 
4  Turning On 
 
 
 
 
6  Switching Off 
 
 
 
 
The geko™ device is a neuromuscular 
electro-stimulation medical device and its 
intended use is: 
● to increase blood circulation 
● for the prevention of venousthrombosis 
● for the prevention and treatment of 
oedema 
● for the treatment of venous insufficiency 
and ischemia 
The device works by increasing blood 
circulation by stimulating the common 
peroneal nerve. 
It is to be used on a single patient, in 
hospital, clinic and home environments. 
Apply to the affected leg or legs as 
advised by your Healthcare Professional 
(e.g. Nurse or Doctor). Patients should be 
trained in the positioning and operation 
of the device. 
The geko device is intended for up to 24 
hours continuous use, until it is no longer 
needed. 
It may be removed for short periods of 
time when washing or having various 
tests (see warnings and precautions). 
Each device is single use and should be 
replaced every 24 hours, the device has 
an additional 6 hours run time. 
Read this document fully before use and 
use only as instructed. Improper use of 
this device can be dangerous. Do not 
switch on unless correctly attached to the 
patient. 
If assistance is required or to report 
difficulties, unexpected operation or 
events, contact the manufacturer. Visit 
the website for further advice and usage 
tips. 
► Fi tting Instruct ions 
 
The marker line 
on the geko 
device should line up with the fibula 
head, a round lump below the knee 
on the lower leg. Ask your healthcare 
provider if you need help (e.g. nurse or 
doctor). 
It should be applied to clean, dry skin. 
If there is too much hair in the area it 
should be removed using trimmers or 
clippers. Do not shave as this may cause 
irritation. Wash the skin in the area where 
the device will be fitted with mild soapy 
water, rinse, and dry thoroughly; do not 
apply any moisturizer. 
Remove the film from the geko device 
and place the marker line 
over 
the fibula head (round lump). Attach the 
short end round the front of the leg and 
the longer end towards the back of the 
leg. The geko device should not be loose, 
peel off one end and tighten if needed. 
When correctly fitted, the 
 button will 
always be at the front of the leg. 
To turn on, use a short press of 
the 
 button. 
There are 11 settings, shown by the 
number of times the light flashes before a 
pause. Use the 
 button to increase the 
setting and 
button to decrease. 
When working properly geko will cause 
a visible movement of the muscles in the 
lower leg, moving the foot out and up, 
which should continue throughout the 
whole treatment. 
To turn it off, hold button down for 3 
seconds. When the button is held the light 
will flash quickly and when turned off the 
flashing will stop. 
Remove carefully in one piece, to 
avoid damaging the skin. 
If stimulation is not achieved geko can 
also be fitted in alternative positions, see 
the website for further details. 
► Side Ef fects 
 
Skin Inflammation or Irritation 
In some cases, skin inflammation or 
irritation can develop in the contact 
area: either remove the device or re- 
attach in the alternative fitting positions. 
If the condition persists or recurs, obtain 
specialist medical advice before 
resuming use. 
► Warnings 
 
Seek specialist medical opinion if the 
patient is/has: 
● Implanted electronic devices (e.g. a 
cardiac pacemaker). 
● Recently diagnosed or suspected DVT. 
● Pregnant or breastfeeding. 
● Diagnosed heartcondition. 
● Epilepsy. 
● Had recent surgery where muscle 
contractions may disrupt thehealing 
process. 
● Used the device for 28 consecutive 
days. 
Do not use: 
● During any activity in which involuntary 
muscle contractions may put the user 
or others at risk of injury (e.g. Driving or 
operating machinery). 
● When bathing or showering – switch off 
the device and remove temporarily. 
● If the device has been worn by another 
individual – this will carry risk of infection. 
● If packaging is open or damaged. 
● If device is damaged. 
Device should not be used on the 
following areas of the body: 
● Head. 
● Eyes. 
● Mouth. 
● Neck (especially the carotidsinus). 
● On the chest, upper back or crossing 
over the heart. This may increase the risk 
of cardiac fibrillation. 
Do not apply over or near the following: 
● Sore, infected or inflamed areas, broken 
skin or skin eruptions, e.g. phlebitis, 
thrombophlebitis, 
varicose veinsetc. 
● Cancerouslesions. 
 
gekodevices.com 
3s 
INSTSKY10X/R1 - December 2019 

 
fig. 
Do not use in proximity of the following 
equipment/environments (which could 
result in the possible degradation of the 
performance of geko): 
● Short wave/ microwave equipment 
(i.e. within 1m). 
● Portable RF communications equipment 
(including peripherals such as antenna 
cables and external antennas) (i.e. 
within 30cm). 
● Heat sources, such as fires or radiant 
heaters. 
Do not use in oxygen rich environments. 
Use on children - the safety of the device 
has not been tested in children; we do 
not recommend using the device on 
children. 
► Precaut ions 
 
● Keep out of the reach of children and 
pets. 
● Do not place the geko device in the 
mouth; it is a choke and potential 
allergic hazard. 
If geko or any component is swallowed 
seek IMMEDIATE medical assistance. 
Serious harm could be caused if the 
battery is swallowed. 
● No modification of this equipment is 
allowed. 
● Excessive force may damage the 
device. 
● MRI -The device should be removed 
before the patient undergoes MRI as it 
contains ferromagnetic components. 
● ECG -The device should be switched 
off during ECG monitoring using leg 
electrodes as it may interfere with ECG 
leg electrode signals. 
► Storage and Operat ion 
 
When storing geko keep it in the 
protective foil pouch. It can be stored in 
a temperature range of -25°C to 40°C, 
but we recommend storing the device up 
to 30°C. 
► Classification 
 
The device is internally powered by a 
non-replaceable CR2032 lithium ion coin 
cell battery. The battery is intended for 
continuous operation. 
Type BF applied part – for direct electrical 
contact to patient but not direct cardiac 
application. The whole device is the 
applied part. 
► Output Speci ficat ions 
 
The device provides square wave, 
Medical Electrical Equipment needs 
special precautions regarding EMC and 
needs to be put into service according 
to the EMC information provided on 
the website. The geko device may 
switch ff if exposed to high levels of 
electromagnetic disturbance. 
► Disposal 
 
The geko device does not contain any 
toxic or environmentally hazardous 
materials. After use it may be potentially 
contaminated or infected because it 
has been in contact with skin for several 
hours, and so needs to be disposed of 
with care. Batteries must be disposed of 
in accordance with any local legislation. 
Some hospital and clinics will have 
specific requirements for disposal of used 
medical devices. If used at homegeko 
may be disposed of in your general waste 
if regulations permit. For ease of disposal 
the electrodes may be removed with 
scissors if necessary. The battery can be 
removed by breaking open the housing 
and forcing out. See the website for 
guidance. Do not incinerate the device. 
 
 
Symbols 
 
 
Type BF applied part 
 
 
Product not manufactured 
with Latex 
 
Single use only – use only on 
one patient for a single course 
of treatment 
 
 
Lot number 
 
 
Catalogue number 
 
 
Device identifier 
 
 
Expiry date – do not use after 
this date 
 
 
  Ingress protection rating 22 
 
 
Manufactured by 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Output waveform 
asymmetric, charge balanced stimulation 
pulses at a rate of 1Hz. The pulses are 
of a constant current between 27mA 
and 54mA, and with pulse widths 
between 35μs and 560μs, according to 
the stimulation level set. The stimulation 
 
 
Do not use if package is 
damaged 
Pulse width 
 
 
 
 
 
 
Voltage 
Pulse width 
 
 
 
Current 
intensity increases progressively by 
increasing the electrical charge in each 
pulse. There are 11 settings in total. For 
further information including operating 
specifications visit the website. 
The software revision level is identifiable 
through the Lot number. 
► EMC Declarat ion 
 
Use of the geko device adjacent to other 
 
 
1639 
 
- 
+40° 
See Instructions for Use 
 
 
CE Mark of Conformity 
 
Storage and transportation 
temperature range whilst 
Repetition rate: 1Hz 
 
 
 
 
 
 
XT-3 
electrical equipment should be avoided 
because it could result in improper 
operation. If such use is necessary, geko 
and the other electrical equipment 
should be observed to verify that they are 
operating normally. The geko device is 
certified to EN 60601-1-2:2015 regarding 
25°C 
 
 
70kPa 
within packaging 
 
106kPa Storage and transportation 
atmospheric pressure range 
whilst within packaging 
 
93 
Storage and transportation 
% 
humidity range whilstwithin 
Firstkind Limited 
Hawk House 
Peregrine Business Park 
Gomm Road 
High Wycombe 
HP13 7DL, United Kingdom 
1639 
T: +44 (0)1494 572040 
*Firstkind Ltd is a wholly owned 
Electromagnetic Compatibility. 
0% 
packaging 
subsidiary of Sky Medical Technology 
Limited. 
fig. A 
Peroneal nerve 
fig. B 
fLiga.teral 
muscle 
Peroneus longus 
Peroneus brevis 
Muscles extend 
into foot 
Peroneus 
longus 
Peroneus 
brevis 
Extensor hallucis 
longus 
Peroneus 

 
Created: 
2020-09-30 
By: 
Status: 
Transaction ID: 
Marie-Therese Targett (Marie-Therese.Targett@firstkindmedical.com) 
Signed 
CBJCHBCAABAAe2wVQCAqznl7Egc75Ou_DD5Di6j0eLIM 
Protocol v2.0 20200929 
Final Audit Report 
2020-10-27 
 
 
 
 
 
"Protocol v2.0 20200929" History 
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