The protocol we treat you to

1.1Practitioner and premises

Only a practitioner who is trained, competent and insured for the exact BTL device, applicator, treatment area and indication may perform treatment. Training certificates, insurance, device servicing, electrical safety checks, consumable traceability and cleaning records must be kept current.

For Ultra Femme 360, the practitioner must also be specifically trained and insured for intimate treatment. The clinic must confirm whether any aspect of the service falls within CQC registration or another regulated activity and obtain professional advice where necessary.

1.2Device safety before every clinic session

• Check the device is in service, has passed required maintenance and has no unresolved fault or safety notice.
• Inspect the handpiece, applicator, cable, return electrode and accessories for damage.
• Confirm correct approved consumables are available, in date and stored correctly.
• Clean and disinfect reusable parts exactly as stated in the BTL IFU. Never improvise a chemical, immersion method or sterilisation cycle.
• Complete the opening device check and record the device serial number, software/protocol version where required, operator and date.
• Do not use a device or accessory that is damaged, contaminated, out of service or producing an unexpected warning.

1.3Mandatory client record

The record must contain:

• client identity and contact details;
• consultation date, practitioner and treatment goal;
• relevant medical history, medication, allergies and previous procedures;
• contraindication screening and any medical clearance;
• capacity, informed consent and consent for intimate examination/treatment where applicable;
• agreed area, indication, plan, realistic outcome and alternatives;
• baseline assessment and standardised photographs where separately consented;
• treatment date, device and applicator used, consumable/lot details where applicable;
• all device parameters and treatment endpoints required by the BTL IFU;
• treatment duration, skin/tissue response and client feedback;
• any modification, interruption, adverse response or action taken;
• aftercare supplied and review arrangements.

Health information and photographs must be stored securely and handled in line with UK GDPR, clinic privacy policy and the clinic's record-retention policy. Marketing use requires separate, specific and withdrawable consent; treatment consent is not marketing consent.

1.4Stop rule

Stop energy delivery immediately if the client reports sharp pain, burning, unexpected intense heat, dizziness, feeling unwell, loss of sensation or any other concerning symptom, or if the practitioner observes blanching, blistering, marked swelling, broken skin, bleeding, an unexpected tissue change, poor contact, abnormal impedance or a device warning. Assess, cool or provide first aid only within training, document fully, give appropriate safety-net advice and escalate for medical assessment when indicated.

2.1First consultation

• Welcome and privacy: Confirm identity and provide a private consultation. Explain the practitioner's qualifications and limits of practice.
• Client concern: Ask what the client would like to improve, how long it has concerned them and what result they expect.
• Assessment: Assess skin condition, laxity, facial volume, symmetry, sensation, previous scarring and suitability of the requested area. Do not diagnose a medical condition.
• Medical screening: Complete the clinic's current BTL-approved contraindication form. Specifically ask about pregnancy/breastfeeding, implanted electronic devices, metal or other implants in or near the area, active cancer or treatment, significant uncontrolled illness, bleeding/clotting problems or anticoagulants, altered sensation or neuropathy, active infection, cold sores, inflammatory skin disease, wounds, recent surgery, dental work or facial procedures, and recent/current fillers, threads, toxins, energy treatments, peels or medicines affecting healing. Classify items according to the current IFU as absolute contraindications, precautions or matters requiring medical clearance.
• Examine and refer: Do not treat suspicious lesions, unexplained swelling, infection, acute dental problems, new neurological symptoms or any condition outside competence. Refer to the client's GP, dentist, dermatologist or other appropriate clinician.
• Explain treatment: Explain that Exilis Ultra 360 combines radiofrequency heating and ultrasound and is used non-invasively for aesthetic skin rejuvenation. Explain the expected warm sensation, possible temporary responses, alternatives, limitations, course and maintenance without guaranteeing results.
• Consent and planning: Agree precise areas and exclusions. Obtain written informed consent. Obtain separate photography consent. Allow time for questions and do not pressure the client to purchase a course.
• Baseline: Record standardised photographs, skin assessment and measurements where relevant. Create an individual plan using only BTL-approved facial protocols.

2.2Treatment-day procedure

• Confirm there has been no change in health, medication, pregnancy status, skin condition or recent procedure since consultation.
• Reconfirm the area, desired outcome and consent. Remove jewellery and other metal from the treatment area as directed by the IFU.
• Inspect the skin. Postpone if there is infection, broken skin, active inflammation, significant sunburn or another new concern.
• Take pre-treatment photographs when due and with consent.
• Position the client comfortably and protect hair, clothing and sensitive areas. Maintain eye safety and avoid anatomical areas excluded by the IFU.
• Prepare the skin and apply only the BTL-approved coupling medium and accessories in the amount directed by the IFU.
• Select the correct BTL applicator and the device protocol prescribed for the assessed indication and area.
• Maintain full applicator contact and continuous controlled movement as trained. Never hold an active applicator stationary.
• Monitor the device display, impedance/contact indicators, tissue temperature/endpoints required by the IFU and the client's comfort continuously. Ask for feedback throughout; do not rely only on the display.
• Adjust or stop only within the BTL protocol and training. Never exceed trained limits to obtain a quicker result.
• On completion, stop energy delivery, remove the applicator safely, cleanse the area and inspect the skin.
• Record all required parameters, endpoint, response and client feedback before the client leaves.

2.3Aftercare and follow-up

Explain that temporary warmth, redness or mild tenderness may occur, but significant or worsening pain, blistering, marked swelling, colour change, numbness, visual symptoms or feeling unwell is not expected and must be reported promptly.

Give written, BTL-approved aftercare. Include sun protection and gentle skincare advice where appropriate; avoid adding restrictions not supported by the IFU.

Provide the clinic's daytime and out-of-hours contact instructions and emergency advice.

Arrange the next treatment only at the interval permitted by the current BTL protocol and after reviewing the response.

Use consistent photographs and assessment methods at review. Do not promise a specific degree or timing of improvement.

3.1First consultation

• Goal and expectations: Identify whether the concern is localised skin laxity, contour or another BTL-approved indication. Explain clearly that this is not a treatment for obesity or a substitute for medical weight management.
• Assessment: Record the exact anatomical area, skin integrity, laxity, localised tissue, sensation, scars, hernia risk, swelling, varicose veins and symmetry. Use measurements and standardised photographs with consent.
• Medical screening: Complete the current BTL-approved contraindication form. Ask specifically about pregnancy/breastfeeding, electronic or metal implants, active cancer, significant uncontrolled disease, circulatory or lymphatic problems, thrombosis history or symptoms, anticoagulants/bleeding disorders, neuropathy or impaired heat sensation, hernia, active infection, wounds, dermatitis, recent surgery, unexplained swelling or pain, and recent procedures in the area. Apply the IFU classification and obtain medical clearance when required.
• Red flags: Do not treat unexplained unilateral swelling, suspected thrombosis, acute pain, infection, a new lump, an untreated hernia or a condition outside competence. Refer appropriately.
• Plan: Define and photograph each treatment zone. Do not treat over excluded anatomy, implants, compromised tissue or any area prohibited by the IFU. Explain expected sensations, possible temporary responses, alternatives, likely course and maintenance without guarantees.
• Consent: Obtain informed written consent and separate photography/marketing consent where applicable.

3.2Treatment-day procedure

• Update the medical history and confirm no new contraindication, medicine, procedure, pregnancy or illness.
• Confirm the marked area and consent while the client is upright if that gives the most reliable anatomical reference; then position safely and comfortably.
• Inspect the area and confirm normal sensation. Postpone and refer if there is a new concern.
• Remove metal/jewellery as required. Preserve modesty and expose only the area being treated.
• Prepare the skin and apply the BTL-approved coupling medium/accessories as instructed.
• Select the correct applicator and BTL protocol for the indication, tissue and anatomical area.
• Treat one clearly defined zone at a time. Maintain correct contact and continuous movement; do not concentrate energy over bony prominences, vulnerable anatomy or prohibited areas.
• Continuously monitor the client's comfort, skin response and every device safety indicator and endpoint required by the IFU.
• Stop immediately for pain, burning, neurological symptoms, unexpected skin change, poor contact, abnormal device behaviour or client request.
• Complete the planned zone only when trained endpoints are met safely. Do not chase a visual result during the session by exceeding the protocol.
• Cleanse and inspect the area, assist the client to sit/stand safely and check how they feel.
• Document the zone map, parameters, endpoint, response, consumables and aftercare.

3.3Aftercare and follow-up

Provide BTL-approved written aftercare and hydration/general wellbeing advice only where appropriate and evidence-based.

Advise the client to contact the clinic promptly for worsening pain, blistering, persistent marked redness/swelling, altered sensation, colour change or any unexpected symptom. Acute chest pain, breathlessness or a painful swollen limb requires urgent medical help.

Review before each session and amend or discontinue the plan if the response is not normal.

Repeat measurements and photographs under the same conditions. Avoid implying that weight, fat loss or centimetre reduction is guaranteed.

4.1Governance and scope

Ultra Femme 360 must only be offered for indications, anatomical sites and client groups authorised by the current UK device documentation, BTL training, the practitioner's insurance and the clinic's regulatory position. An aesthetic practitioner must not diagnose or claim to treat urinary, gynaecological, sexual or pelvic-floor disease unless appropriately qualified and authorised to do so.

Symptoms such as urinary leakage, vaginal dryness, discomfort or sexual concerns may have medical causes. Treatment must not delay assessment by a GP, gynaecologist, sexual-health service, menopause specialist, pelvic-health physiotherapist or other appropriate clinician.

4.2First consultation

• Private, sensitive consultation: Use respectful, inclusive language. Confirm the client's identity, age, capacity and voluntary decision. Explain the practitioner's role and scope.
• Presenting concern: Ask the client to describe the concern in her own words, its duration, severity, impact and any previous assessment or treatment. Do not make assumptions about relationships, childbirth, menopause, sexual activity or gender identity.
• Medical and gynaecological history: Record pregnancies/births, breastfeeding, menopausal status, relevant surgery, pelvic-floor treatment, cervical screening history where appropriate, contraception/devices, medication, allergies, urinary/gynaecological symptoms, infections and previous intimate procedures.
• Specific safety screen: Use the current BTL Ultra Femme IFU checklist. Screen for pregnancy or possible pregnancy; recent childbirth or surgery; active vaginal/vulval/urinary infection or suspected STI; unexplained bleeding or discharge; pelvic or vulval pain; sores, lesions or broken tissue; abnormal or overdue investigation requiring follow-up; current/recent cancer or treatment; significant prolapse; implanted electronic/metal devices; bleeding disorder/anticoagulants; altered sensation; and any condition or medicine affecting healing. Determine from the IFU whether menstruation, an intrauterine device, breastfeeding or a previous implant is a contraindication, precaution or scheduling issue; do not guess.
• Medical referral: Do not proceed where symptoms are unexplained, new, worsening or outside scope. Refer for medical assessment for bleeding, offensive/unusual discharge, suspected infection/STI, pelvic pain, a new lesion/lump, haematuria, significant prolapse, abnormal screening follow-up, recurrent unexplained urinary symptoms or possible pregnancy.
• Explain the option: Explain the treatment mechanism and whether the proposed plan is external, intravaginal or both. Discuss realistic potential benefits, uncertainty, alternatives, expected sensation, possible temporary effects, recognised risks, course, maintenance and the right to stop at any time. Do not use terms such as “cure,” “guaranteed,” “risk-free” or “permanent.”
• Consent: Obtain procedure-specific written consent. Consent must cover the exact external and/or internal component and can be withdrawn at any time. Ask whether the client would like a trained chaperone; record the offer and response. A clinic may adopt a mandatory chaperone policy for internal procedures.
• Planning: Allow adequate reflection time, especially where the treatment is elective. Do not perform intimate treatment if the client feels pressured, uncertain or unable to give free consent.

4.3Treatment-day procedure

• Confirm identity privately and repeat the health, pregnancy, infection, bleeding, discharge, pain, medication and procedure update.
• Confirm the exact external and/or intravaginal treatment and renew verbal consent. Remind the client that she may pause or stop at any time.
• Confirm chaperone arrangements and document the chaperone's name. Maintain privacy with a closed room, appropriate draping and exposure of only the treatment area.
• Provide time and facilities for the client to prepare according to the BTL protocol. Follow hand hygiene and PPE requirements.
• Before internal treatment, inspect only within training and consent. Do not proceed if tissue appears inflamed, infected, injured or otherwise abnormal. Do not diagnose; refer.
• Confirm the correct BTL applicator, approved single-use barrier/consumable and expiry/lot details. Never reuse a single-use component. Assemble, apply approved medium and position exactly as trained and stated in the IFU.
• Use only the BTL Ultra Femme protocol assigned to the applicator, indication and anatomy. Do not improvise parameters, treatment time, insertion depth or technique.
• Communicate throughout. Monitor comfort, tissue response, temperature/endpoints, contact/impedance and every device indicator required by the IFU continuously.
• Stop immediately at the client's request or for pain, burning, bleeding, tissue trauma, unexpected discharge, loss of safe contact, an abnormal device warning or any concerning response.
• At completion, deactivate energy before removing or repositioning the applicator. Inspect the client for any immediate abnormal response within consent and competence.
• Dispose of single-use items as clinical waste and decontaminate reusable parts strictly according to the IFU and infection-control policy.
• Allow the client privacy to dress. Check wellbeing, give written aftercare and document the full procedure, including consent, chaperone, applicator/consumable traceability, device parameters, endpoint and response.

4.4Aftercare and follow-up

Give only the current BTL-approved instructions regarding washing, products, bathing, exercise, tampon use and sexual activity; the restrictions may differ between external and internal treatment.

Explain what mild, short-lived effects may occur according to the IFU and what is not expected.

Ask the client to contact the clinic promptly for persistent or worsening pain, bleeding, burns/blistering, marked swelling, offensive/unusual discharge, urinary difficulty, fever or suspected infection. Severe pain, heavy bleeding, fever with illness, inability to urinate or another acute concern requires urgent medical assessment through NHS 111, urgent care or 999 as appropriate.

Make a follow-up contact after the first treatment according to clinic policy. Re-screen before every session.

If symptoms persist, worsen or fail to respond as expected, stop the course and refer for appropriate clinical assessment rather than extending or intensifying treatment.

• Stop treatment and make the area/device safe.
• Assess the client and provide only first aid within competence. Call 999 for a medical emergency; otherwise direct to NHS 111, urgent care, GP or an appropriate specialist based on severity.
• Give clear written safety-net instructions and arrange active follow-up.
• Record the event contemporaneously, including settings, applicator, device serial number, consumable lot, observed response, client account, photographs with consent and actions taken.
• Quarantine the device/accessory if malfunction or contamination is suspected. Do not alter, repair, discard or return it until advice is received.
• Notify the clinic's insurer, medical governance adviser and BTL/service provider as required.
• Report a suspected medical-device adverse incident through the MHRA Yellow Card scheme when applicable, following the clinic's incident policy.
• Complete a root-cause review and do not resume the relevant treatment/device until it is safe and authorised.

1.1Practitioner, premises and scope

Only a practitioner who is trained, competent and insured for the Zemits DermeLuxx Pro and each function being used may perform treatment. Training certificates, insurance, electrical safety checks, servicing, product traceability, cleaning records and incident procedures must be current.

The DermeLuxx Pro is a 3-in-1 professional platform providing HydroDiamond hydrodermabrasion, oxygen-serum spray and a cooling application. Treatment is cosmetic skin care; it must not be presented as diagnosing or curing a medical skin condition. Persistent, severe, unexplained or changing skin concerns must be referred to an appropriate medical professional.

1.2Opening device safety check

• Confirm that the device is in service with no unresolved fault, recall or safety notice.
• Inspect the power cable, connections, hydro handpiece, tubing, solution container, waste container, spray tool, cooling handpiece and tips for damage, blockage, leakage or contamination.
• Confirm that approved products and cleaning materials are available, in date and stored correctly.
• Ensure the waste container is empty, correctly fitted and below its permitted fill level.
• Confirm clean and dirty components have been kept separate and reusable parts have been reprocessed according to the IFU.
• Assemble and prime the system only as taught by Zemits. Test flow, suction, spray and cooling safely before client contact.
• Do not use the device if a connection is loose, suction or flow is irregular, the cooling handpiece behaves unexpectedly, liquid enters an electrical area, or any component is damaged.

1.3Mandatory client record

Record:

• identity, contact details, consultation date and practitioner;
• concerns, expectations and agreed treatment area;
• skin type/condition, barrier integrity, sensitivity, vascularity, pigmentation risk and relevant lesions;
• medical history, medication, allergies, pregnancy/breastfeeding status and previous procedures;
• contraindication/precaution screening and any medical clearance;
• products selected, ingredients checked and any patch testing required by product instructions or insurer;
• informed consent and separate photography/marketing consent where applicable;
• baseline photographs using consistent lighting and positioning;
• date, device serial number where required, functions used, tip, suction/flow/air/cooling settings, products, batch details, passes, time and endpoint;
• client comfort, skin response, modifications, interruption or adverse event;
• aftercare and follow-up plan.

Store health information and photographs securely under UK GDPR and clinic policy. Treatment consent is not consent for marketing.

1.4Universal stop rule

Stop immediately at the client's request or if there is sharp pain, strong burning/stinging, dizziness, breathing difficulty, faintness, eye symptoms, unexpected bleeding, skin lifting, marked blanching, rapidly increasing redness/swelling, bruising, broken capillaries, hives, blistering, equipment leakage, loss of flow/suction or any abnormal device behaviour. Remove product, assess within competence, provide appropriate first aid, document, give safety-net advice and escalate for urgent or medical care when indicated.

2.1Consultation sequence

• Welcome and privacy: Confirm identity and explain your qualifications, role and limits of practice.
• Client agenda: Ask what the client would like to improve, how long it has been present, current routine, previous treatments and the result expected.
• Skin assessment: Examine the face, neck, décolleté or approved body area in good light. Assess barrier health, hydration, oiliness, congestion, sensitivity, inflammation, vascular fragility, pigment response, scarring and lesions. Do not diagnose.
• Medical screening: Ask about current illness, allergies, medication and supplements, pregnancy/breastfeeding, diabetes/healing problems, bleeding tendency or anticoagulants, immune suppression, cancer treatment, skin disease, altered sensation and previous adverse reactions.
• Recent skin events: Ask about sunburn/tanning, waxing/threading, shaving irritation, peels, resurfacing, laser/IPL, microneedling, injectables, surgery and use of retinoids, isotretinoin, acids, benzoyl peroxide or other sensitising products.
• Product check: Check every planned cleanser, hydro solution, oxygen serum, mask and finishing product against allergies, sensitivities, pregnancy status and manufacturer restrictions. An aspirin/salicylate sensitivity is relevant before any salicylic-acid product.
• Explain treatment: Explain the three functions proposed, expected sensations, realistic potential benefits, limitations, temporary reactions, alternatives and aftercare. Results vary and cannot be guaranteed.
• Plan and consent: Agree functions, products, areas and exclusions. Obtain written informed consent. Allow questions and do not pressure the client to purchase a course.

2.2Do not treat / postpone and refer where appropriate

Do not treat over or proceed in the presence of:

• active bacterial, viral or fungal infection, including an active cold sore;
• open wounds, broken skin, weeping lesions, fresh scabs, sunburn, heat rash or significant irritation;
• active flare of eczema, dermatitis, psoriasis, rosacea or another inflammatory skin condition in the treatment area;
• severe inflamed or cystic acne where exfoliation/suction may worsen the condition;
• suspicious, changing or undiagnosed lesions, unexplained rash, swelling or pain;
• known allergy or sensitivity to a planned product or tip material;
• skin that is too thin, fragile or vascular for safe suction/abrasion;
• impaired sensation preventing reliable feedback;
• recent procedure, medicine or illness that compromises barrier integrity, healing or infection control;
• any contraindication stated in the current Zemits IFU, product instructions, training or insurance policy.

Pregnancy/breastfeeding, anticoagulants/bleeding disorders, uncontrolled diabetes, immune suppression, active cancer treatment, systemic steroid therapy, isotretinoin use, recent injectables or resurfacing, and significant medical or skin conditions require classification under current Zemits/product/insurer guidance. Adapt, obtain medical clearance or postpone as required; do not invent a universal waiting period.

2.3Treatment planning

Choose a protocol based on the skin observed that day, not only the treatment booked. Sensitive, vascular, thin, dry or reactive skin requires a more conservative plan and may be unsuitable for HydroDiamond abrasion or extraction. Record excluded areas such as eyelids, lips, mucosa, thyroid region where excluded, wounds, inflamed lesions and raised/suspicious lesions.

3.1Advice before the appointment

Give written preparation advice consistent with Zemits and the products used. In general, the client should avoid deliberate tanning/sunburn and should not arrive with irritated or freshly exfoliated skin. Tell the client which retinoids, acids, scrubs, acne products, waxing/threading or other treatments must be paused and for how long according to the relevant manufacturer and insurer. Ask them to report any new medicine, illness, pregnancy, cold sore, rash or procedure before attending.

3.2Treatment-room setup

• Perform hand hygiene and prepare PPE according to risk assessment.
• Disinfect the couch, trolley and touch surfaces with compatible products.
• Prepare only the approved clean handpieces, tips and accessories required for this client.
• Decant products hygienically without contaminating the original container. Record lot/batch where required.
• Fit and secure clean solution and waste containers; check tubing orientation and seals.
• Keep clean accessories away from the waste side of the system.
• Prepare sterile eye irrigation/saline and first-aid resources according to clinic policy; products must never be sprayed toward open eyes or inhaled.

3.3Client preparation on the day

• Update medical history, medication, products, procedures and skin condition.
• Reconfirm consent, areas, functions and products.
• Remove jewellery where relevant and protect hair and clothing.
• Position the client comfortably with eyes protected as required.
• Remove makeup and cleanse thoroughly with a suitable non-irritating cleanser.
• Inspect clean skin under magnification. Modify or postpone if the barrier is compromised or a new concern is present.
• Take standardised photographs when due and consented.

4.1Aim and selection

HydroDiamond combines a diamond-coated tip with fluid delivery and suction to exfoliate, lift debris and support topical hydration. It may be planned for dullness, superficial congestion, rough or uneven texture and general cosmetic skin maintenance when the client is suitable. It is not a treatment for diagnosing or curing acne, pigmentation disease or scarring.

Select the approved tip, product, suction/flow, time and number of passes from current Zemits training for the assessed skin. Begin conservatively and never increase suction simply to create stronger erythema or more waste.

4.2Step-by-step procedure

• Confirm the correct hydro solution and complete ingredient/allergy checks.
• Fit the selected clean/disinfected or single-use tip as specified by Zemits.
• Prime the handpiece and confirm steady flow into the waste system before touching the client.
• Select the lowest appropriate trained starting suction/flow for the area and skin condition.
• Stabilise the skin where appropriate. Place the tip flat to obtain controlled contact.
• Work in an organised pattern using smooth, continuous strokes. Follow Zemits-trained direction and pass limits; do not repeatedly cross fragile or already-reactive skin.
• Keep away from eyelids, lips/mucosa, nostrils, active lesions, wounds, telangiectatic/fragile areas and all IFU exclusions.
• Use extra caution around bony contours and reduce intensity or omit abrasion where required.
• Monitor comfort, erythema, capillary response, skin drag and fluid return continuously. The endpoint should be the trained cosmetic endpoint, not trauma.
• For extraction-focused work, use only the approved tip and technique on suitable, softened congestion. Do not hold suction stationary, aggressively chase closed lesions or extract inflamed acne.
• Stop, reduce or omit further passes if there is excessive redness, pinpoint bleeding, bruising, skin lifting, strong stinging or poor tolerance.
• At completion, release suction before lifting where trained, switch off safely, remove residue and inspect the skin.
• Record tip, products, settings, passes, zones, duration, endpoint and response.

4.3Areas

Treat only areas included in Zemits training and insurance. Zemits identifies face, neck, décolleté, back and buttocks as possible HydroDiamond areas; each requires area-specific assessment, hygiene, positioning and settings. Do not automatically extend a facial protocol to a body area.

5.1Aim and product safety

The spray function applies an approved topical serum as a fine mist after assessment, commonly as a post-exfoliation hydration/nourishing step. Use only products confirmed compatible with the DermeLuxx Pro spray system. Never use injectable, prescription, unapproved, oil-based, particulate or home-mixed products, and never imply that topical spraying is an injection or medical mesotherapy.

5.2Step-by-step procedure

• Confirm the serum is appropriate for the client, area and freshly exfoliated skin; check ingredients, expiry and batch.
• Assemble and test the clean spray tool away from the client according to Zemits training.
• Protect the client's eyes and ask them to keep eyes and mouth closed as required.
• Hold the applicator at the trained distance and angle. Use controlled, even passes; avoid pooling.
• Never aim into the eyes, nostrils, mouth, ear canal or directly toward inhalation. Do not spray over broken or infected skin.
• Check comfort throughout. Stop for coughing, breathing difficulty, eye exposure, burning, itching, hives or unexpected redness.
• Use only the quantity and airflow taught for the product and device. Do not over-saturate freshly exfoliated skin.
• On completion, switch off, inspect the skin and record serum, batch, quantity/settings where required, response and endpoint.

6.1Aim and precautions

The cooling handpiece is intended as a soothing finishing application. Zemits lists a device cooling temperature of approximately 0–5°C; this is a technical specification, not an instruction to hold the handpiece stationary or to force the skin to that temperature. Do not use on clients with cold hypersensitivity, cold urticaria, impaired sensation/circulation or another IFU contraindication.

6.2Step-by-step procedure

• Confirm the handpiece is intact, clean and operating normally.
• Apply only an approved compatible medium if required by the current protocol.
• Test client sensation and explain that it should feel cool, not painful, burning or numb.
• Use continuous controlled movement and trained contact/pressure. Never leave the cold handpiece stationary.
• Avoid eyes, mucosa, broken skin, areas with impaired sensation and all Zemits exclusions.
• Monitor skin colour, comfort and sensation continuously. Stop for pain, marked pallor, mottling, numbness, hives or unexpected reaction.
• Complete only the trained duration, remove the medium and inspect the skin.
• Record area, setting/time as required, product and response.

The full service should follow this order unless current Zemits training specifies otherwise:

• update consultation, suitability and consent;
• cleanse and complete final skin analysis;
• perform HydroDiamond hydrodermabrasion using the personalised tip, solution and conservative settings;
• remove residue and reassess the skin before any add-on;
• apply an approved oxygen serum only if still suitable;
• use the cooling application as the soothing final device stage when appropriate;
• apply suitable finishing hydration and broad-spectrum sunscreen when indicated;
• photograph if scheduled, provide written aftercare and document the full treatment.

Each function remains optional. Do not complete every stage simply because it was booked if the skin response makes an add-on inappropriate.

8.1Expected short-term response

Explain that temporary mild pinkness, tightness, tingling, dryness or sensitivity can occur after exfoliation. The client must contact the clinic promptly for worsening or persistent pain, marked swelling, blistering, hives, spreading redness, discharge, eye symptoms, pigment change or any reaction that concerns them. Breathing difficulty, facial/throat swelling or a severe allergic reaction requires emergency help.

8.2Written aftercare

• Keep the skin clean and use a gentle cleanser, bland moisturiser and broad-spectrum sunscreen.
• Avoid picking, scrubbing, abrasive tools and additional exfoliation while the skin is sensitive.
• Avoid retinoids, acids, benzoyl peroxide and other potentially irritating actives for the period specified by the products used and the client's skin response.
• Avoid deliberate sun exposure and tanning; reapply sunscreen as directed.
• Avoid excessive heat, sauna, steam, vigorous exercise, chlorinated water and heavy makeup for the period advised under the approved protocol when the skin is flushed or sensitive.
• Do not introduce a new active skincare product immediately after treatment.
• Follow any personalised restrictions related to injectables, peels, laser/IPL, microneedling, waxing or other procedures.
• Do not promise “no downtime.” The advice and duration must be individualised and must match Zemits/product instructions and insurer requirements.

8.3Course and maintenance

The Zemits UK page describes a HydroDiamond facial as approximately 20–30 minutes for the HydroDiamond component, but total appointment time depends on consultation, cleansing, skin condition and add-ons. Do not publish a universal course or interval without support from current training. Reassess before every visit and schedule only after the skin has recovered normally. Many clients may choose periodic maintenance, but frequency must be individualised.

• Wear appropriate PPE and switch the device to the safe/off state before disconnecting parts as instructed.
• Dispose of single-use items immediately in the correct waste stream; never reprocess an item labelled single use.
• Empty and clean the waste container without splashing or cross-contaminating clean areas.
• Flush the HydroDiamond pathway with the exact solution, volume and sequence specified by Zemits. Never substitute a chemical that may damage seals, tubing or the handpiece.
• Clean and disinfect the hydro handpiece, reusable tips, spray tool, cooling handpiece, containers and external surfaces using their device-specific contact times and compatibility instructions. Do not immerse electrical components.
• Dry, inspect and store components protected from contamination. Replace damaged, scratched, cloudy, blocked or degraded parts.
• Wipe the device and trolley, perform hand hygiene and complete the cleaning log.
• At the end of the day, complete the Zemits shutdown, waste, flushing and storage procedure. Escalate leaks, blockages, odour, irregular suction/flow or cooling faults and quarantine the device if safety is uncertain.

• Stop the treatment and remove the device/product safely.
• Assess the client and provide first aid only within training.
• For eye exposure, follow the product safety data/instructions and clinic eye-irrigation procedure; seek urgent advice when indicated.
• Call 999 for anaphylaxis, breathing difficulty, collapse or another emergency. Advise NHS 111/urgent medical assessment for significant non-emergency reactions as appropriate.
• Give written safety-net and clinic contact information; arrange follow-up.
• Record the event, photographs with consent, settings, products/batches, timeline and action taken.
• Quarantine implicated equipment/product where appropriate and notify the insurer, manufacturer/supplier and relevant regulator under clinic policy.
• Complete a review and do not resume the affected protocol until it is confirmed safe.

1.1Practitioner, premises and scope

Only a practitioner who is trained, competent and insured for the iMEDpen X, microneedling, the anatomical area and any product used may perform treatment. Keep current evidence of training, insurance, device purchase/traceability, servicing, electrical safety checks, cleaning, waste arrangements and incident procedures.

Microneedling creates controlled microchannels in the skin. It must be performed within the practitioner's qualifications and local legal/regulatory position. Do not diagnose, prescribe, inject, claim to cure disease or treat beyond competence. Refer persistent, severe, unexplained or changing concerns to an appropriate healthcare professional.

1.2Opening device safety check

• Confirm the device is the correct iMEDpen X, is in service, charged/connected as instructed and has no unresolved fault, recall or safety notice.
• Inspect the pen body, power/charging equipment, controls and cartridge connection for damage, contamination, liquid ingress or abnormal movement/noise.
• Confirm genuine approved 16-pin cartridges are sealed, in date, undamaged and stored correctly. One sterile cartridge is used for one client and one appointment only.
• Confirm approved skin-preparation products, sterile/appropriate glide or treatment solutions, PPE, clinical-waste and sharps containers are ready and in date.
• Power on and verify normal function without touching the client. Confirm the Smart CRS cartridge-recognition indication operates as stated by Ivanmed.
• Do not use a cartridge when recognition is incorrect, the package is damaged, sterility is uncertain, needles appear abnormal or the anti-backflow system is compromised.
• Do not use the device if it has been dropped, is overheating, vibrating irregularly, damaged, contaminated internally or behaving unexpectedly. Quarantine and contact Ivanmed/service support.

1.3Device facts that do not replace treatment training

• Six speed settings.
• Adjustable needle-depth range: 0.25–2.5 mm.
• 16-pin cartridges; Ivanmed states approximately 1,600–2,200 microchannels per second depending on operation.
• Smart CRS uses red/green indication to support correct cartridge insertion.
• An anti-backflow membrane is intended to reduce cross-contamination risk; it does not replace single-use cartridges, PPE, surface decontamination or correct handling.

PARAMETER RULE. The device range is not a universal treatment prescription. Select and record depth, speed, passes, pattern and endpoint only from current iMEDpen training for the client, area and indication. Never use 2.5 mm simply because the device permits it.

1.4Mandatory client record

• identity, contact details, date, practitioner and emergency/contact information;
• concerns, duration, expectations, treatment area, Fitzpatrick/skin phototype where trained, skin condition, barrier health and pigment/scar risk;
• medical history, medication/supplements, allergies, pregnancy/breastfeeding status, healing history and previous procedures;
• contraindication/precaution screen, referrals, medical clearance and rationale for suitability;
• informed treatment consent; separate photography/marketing consent where applicable—treatment consent is not marketing consent;
• standardised baseline photographs where consented;
• device identity/serial where required, cartridge type and lot/expiry, product name/lot/expiry, anaesthetic details if lawfully used, treatment map, depth, speed, passes, technique, time and endpoint by zone;
• comfort, skin response, bleeding level/endpoint, modifications, interruption, adverse event, aftercare and follow-up.

Store health data and photographs securely under UK GDPR, clinic retention policy and insurer requirements.

1.5Universal stop rule

Stop immediately at the client's request or for sharp/severe pain, strong burning, dizziness/faintness, breathing difficulty, eye symptoms, excessive or uncontrolled bleeding, marked blanching, rapidly increasing redness/swelling, hives, blistering, skin tearing, unexpected pigment change, needle/cartridge damage, fluid reaching the pen body, loss of cartridge recognition or abnormal device behaviour. Make the area and device safe, assess within competence, provide appropriate first aid, document and escalate.

2.1Consultation sequence

• Welcome and privacy: confirm identity, explain your qualifications, role, scope and the client's right to pause, decline or stop.
• Client agenda: ask what the client would like to improve, how long it has been present, previous treatment and the result expected.
• Skin assessment: examine in good light. Assess barrier integrity, hydration, sensitivity, inflammation, vascularity, active acne/infection, lesions, scarring, pigmentation tendency and healing risk. Do not diagnose.
• Medical screen: ask about current illness, allergies, pregnancy/breastfeeding, diabetes or delayed healing, bleeding disorder/anticoagulants, immune suppression, cancer/current treatment, seizures where relevant, keloid/hypertrophic scarring, altered sensation and previous adverse reactions.
• Medicine and product screen: ask about isotretinoin and other retinoids, steroids, immunosuppressants, antibiotics, anticoagulants, acne medicines, sensitising actives and any medicine affecting healing or infection/bleeding risk. Do not advise stopping prescribed medicine; obtain prescriber advice where required.
• Infection screen: ask about cold sores/herpes history, active bacterial/fungal/viral infection, fever, recent illness, dental/facial infection and household exposure concerns where relevant.
• Recent procedures/exposure: ask about sunburn/tanning, waxing, depilatory cream, peels, laser/IPL, microneedling, surgery, injectables, threads and other resurfacing or skin injury.
• Explain treatment: discuss controlled microchannels, expected sensation and temporary inflammation, potential benefits, limitations, alternatives, downtime, risks including infection, prolonged inflammation, bruising/bleeding, herpes reactivation, pigment change, scarring and unsatisfactory result. Results vary and are not guaranteed.
• Plan and consent: agree the area, exclusions, products, trained parameters, photography and follow-up. Obtain written informed consent without pressure to buy a course.

2.2Do not treat / postpone and refer where appropriate

Do not needle over, or proceed in the presence of:

• active bacterial, viral or fungal infection, including an active cold sore/herpes outbreak;
• open wound, broken skin, weeping lesion, fresh scab, sunburn, significant irritation or compromised barrier;
• active inflammatory flare such as eczema, dermatitis, psoriasis or papulopustular rosacea in the area;
• severe active inflammatory/cystic acne or stage IV acne;
• suspicious, changing or undiagnosed lesion, active skin cancer or unexplained rash, lump, swelling or pain;
• known allergy/sensitivity to any planned product or material;
• uncontrolled bleeding disorder/haemophilia, inability to stop bleeding safely or medicine-related risk not cleared under protocol;
• impaired immunity, healing or sensation that makes treatment unsafe;
• history of keloid or abnormal scarring where current training/medical advice/insurance does not permit treatment;
• recent procedure, illness, medicine or exposure that has not completed the waiting period required by current Ivanmed/product/insurer guidance;
• any contraindication or exclusion in the current iMEDpen IFU, Ivanmed training, solution instructions or insurance policy.

Pregnancy/breastfeeding, isotretinoin or systemic retinoid history, anticoagulants, uncontrolled diabetes, immune suppression, active/recent cancer treatment, systemic steroid therapy, herpes history, recent injectables/resurfacing/surgery and significant medical or skin conditions must be classified using current manufacturer, product and insurer guidance. Adapt, seek written medical clearance or postpone as required. Do not invent a universal waiting period.

2.3Pigment and scar-risk planning

Microneedling may be used across skin phototypes when the client is otherwise suitable, but "suitable for all skin types" does not mean identical settings or zero pigment risk. Record recent tanning, post-inflammatory hyperpigmentation history, melasma activity, previous response to injury and scar history. Use conservative trained parameters, strict sun advice and appropriate review; refer or decline when risk exceeds competence.

3.1Pre-appointment advice

• Avoid deliberate tanning and attend with intact, uninfected, non-irritated skin.
• Pause retinoids, acids, scrubs, benzoyl peroxide, waxing/depilatory methods and other sensitising products only for the exact period required by current Ivanmed/product/insurer instructions.
• Do not stop prescribed medicine without the prescriber's advice.
• Report any new medicine, illness, pregnancy, cold sore, rash, sunburn, procedure or change in skin before attending.
• Follow clinic instructions regarding makeup, shaving and skincare on the day.

3.2Room and aseptic setup

• Perform hand hygiene. Wear PPE according to the procedure risk assessment; change gloves whenever contaminated and before handling clean/sterile items.
• Disinfect couch, trolley, lamp, device cable/stand and high-touch surfaces with compatible products and required contact time.
• Create separate clean and contaminated zones. Position an approved sharps container and clinical-waste bag within safe reach.
• Prepare one sealed genuine cartridge. Check label, integrity, expiry and lot number before opening at point of use.
• Prepare only products authorised for use with the planned microneedling protocol. Check ingredients, sterility/appropriateness for compromised skin, expiry, lot and storage.
• Use single-use applicators/gauze and aseptic dispensing. Never return decanted product to a container and never touch a dispenser tip to the client or contaminated glove.
• Protect the pen body from contamination using the manufacturer-approved barrier method if specified, without obstructing ventilation, controls or cartridge connection.
• Prepare first-aid resources and the clinic's urgent referral/contact information.

3.3Topical anaesthetic governance

Use topical anaesthetic only when it is lawful, within training, insurance and a written medicines protocol. Verify the exact medicine, client suitability, allergy, dose/quantity, treated surface area, application time, removal and documentation from the product information and authorised prescriber/pharmacy arrangements. Never exceed directions, apply to prohibited areas, occlude unless authorised, or allow anaesthetic to mask unsafe pain feedback. Record product, strength, batch, expiry, amount, site, times and any reaction. If these requirements are not in place, do not use topical anaesthetic.

3.4Client preparation on the day

• Update medical history, medication, products, procedures and infection/skin status.
• Reconfirm consent, treatment map, products, expected endpoint and aftercare.
• Remove jewellery where relevant; protect hair and clothing; position comfortably with safe access and lighting.
• Remove makeup and cleanse thoroughly. Complete the trained skin antisepsis/preparation using a compatible product and full contact/drying time.
• Inspect clean skin. Exclude lesions, wounds, inflamed/infected areas, eyelids, lash line, lips/mucosa, nostrils and any anatomy not covered by training/IFU.
• Take standardised photographs when scheduled and separately consented.
• If lawful topical anaesthetic has been used, remove it fully and repeat skin preparation exactly as the medicines and microneedling protocol require.

4.1Cartridge installation

• With clean hands/gloves and the device in the safe state, open the cartridge package without touching the needles or client-contact surfaces.
• Fit the cartridge exactly as trained. Confirm it is secure and verify the correct Smart CRS indication before treatment.
• Do not reuse, remove and refit a contaminated cartridge, share a cartridge between areas/clients, or retain it for a later appointment.
• Set the initial trained depth and speed before skin contact. Recheck whenever changing anatomical zone.
• If priming or product application is required, follow the exact Ivanmed/solution protocol and prevent liquid tracking toward the pen body.

4.2Individual parameter record

Complete this table in the client record. Values must come from current accredited iMEDpen training—not from the device maximum or a generic online chart.

Zone · Concern/skin · Depth (mm) · Speed 1–6 · Passes/pattern · Endpoint · Exclude/modify

4.3Parameter and endpoint rules

• Use the lowest trained intensity that achieves the intended endpoint for that client and zone.
• Adjust depth for anatomy, skin thickness, condition, vascularity, bony contours and risk; never use one depth across the whole face by habit.
• Set speed and movement so the pen does not drag, scratch, stall or repeatedly overwork the same skin.
• Use only the trained pass count and pattern. Keep a visible zone map and avoid overlapping beyond the taught protocol.
• The endpoint must be defined before treatment and monitored continuously. Do not chase diffuse bleeding, severe erythema or immediate swelling as proof of efficacy.
• Reduce, omit or stop when response exceeds the planned endpoint, comfort is poor, product drag occurs or tissue behaves unexpectedly.

NO GENERIC DEPTH CHART. Forehead, periorbital skin, cheeks, nose, upper lip, chin, neck, décolleté, scars and body areas differ. Use your current Ivanmed training manual for each specific indication and anatomy, then document the chosen settings.

• Complete the time-out: correct client, area, device, cartridge, product, consent, contraindication update and emergency readiness.
• Apply only the approved sterile/appropriate glide or treatment solution in a small working zone using aseptic technique. Do not flood the cartridge or pen.
• Switch on and select the documented trained speed. Confirm depth for the first zone before contact.
• Hold the pen at the trained angle—typically perpendicular/90° for controlled vertical insertion—and maintain light, stable contact without force.
• Work systematically in small sections using the exact trained movement and pass pattern. Maintain even coverage and controlled overlap.
• Keep the skin appropriately tensioned where trained. Reduce intensity or omit vulnerable, thin, vascular and bony areas.
• Avoid eyelids/lash line, lips and mucosa, nostrils, thyroid area if excluded by training, active lesions, inflamed acne, infection, wounds, raised/suspicious lesions and all IFU exclusions.
• Continuously observe erythema, pinpoint bleeding where applicable, swelling, skin integrity, glide, cartridge function and client comfort. Ask for feedback throughout.
• Before changing zones, stop contact, adjust only within the planned trained parameters and record the change. Do not adjust depth while needles are engaged with skin.
• Use fresh aseptic product/application materials as required. Never dip a contaminated item into the original container.
• Stop immediately for any universal stop-rule sign. Do not continue merely to finish the booked area.
• At the planned endpoint, lift the pen from skin, switch to safe/off state and inspect the treated area.
• Remove the cartridge without touching the needle end and place it immediately into the approved sharps container. Never recap, clean or reuse it.
• Apply only an approved post-procedure product or dressing compatible with freshly microneedled skin. Do not apply fragrance, exfoliants, retinoids, makeup or unapproved products.
• Take post-treatment photographs when scheduled/consented, give written aftercare, check wellbeing and complete the record before discharge.

5.1Products, boosters and combination treatments

Use only products specifically authorised by their manufacturer and your iMEDpen protocol for microneedling at the selected depth. Cosmetic topical use is not injection. Do not needle injectable-only, prescription, non-sterile, oil-based, particulate, fragranced, home-mixed or repackaged products unless explicit product/device instructions and governance permit that exact use.

Exosomes, polynucleotides/PDRN, peels, growth-factor products and other advanced add-ons require separate product-specific training, contraindications, consent, traceability, advertising review and insurance. Do not assume a product marketed as a serum is suitable for transdermal delivery. Combination treatments must follow the most restrictive applicable protocol and authorised sequencing.

5.2Blood and contamination management

Treat used cartridges, blood-contaminated gauze and barriers as clinical waste/sharps under clinic policy. Manage splashes, needlestick injuries and blood exposure immediately under the clinic exposure procedure. Never use client blood, platelet products or autologous material unless separately qualified, authorised, insured and governed for that procedure.

6.1Expected short-term response

Explain that temporary redness, warmth, tightness, tenderness, mild swelling, dryness/flaking and small areas of pinpoint bleeding may occur according to treatment intensity and individual response. Reactions should follow the pattern described in the approved protocol. Do not promise "no downtime."

6.2Written aftercare

• Keep hands away from the area and do not pick, rub, scratch or peel the skin.
• Use only the gentle cleanser, moisturiser/repair product and broad-spectrum sunscreen approved for the post-treatment period.
• Do not apply makeup or non-approved skincare until the minimum period in the current Ivanmed/product aftercare has passed and the barrier is settled.
• Avoid retinoids, acids, scrubs, benzoyl peroxide, exfoliating tools, fragranced products and other irritating actives for the exact advised period.
• Avoid deliberate sun exposure and tanning; use and reapply broad-spectrum sunscreen as directed.
• Avoid excessive heat, sauna/steam, strenuous exercise, swimming/chlorinated water and activities that increase contamination or inflammation for the period stated in the approved protocol.
• Avoid waxing, depilatory creams, peels, laser/IPL, further microneedling, injectables or other procedures until the required interval and full recovery are confirmed.
• Do not self-treat a suspected infection or significant reaction with leftover medicine. Contact the clinic and seek medical advice as directed.

6.3Safety-net advice

Ask the client to contact the clinic promptly for worsening or persistent pain, marked swelling, blistering, pus/discharge, spreading redness/heat, fever, a new cold-sore outbreak, eye symptoms, pronounced bruising/bleeding, prolonged inflammation, darkening/lightening of skin or any concerning reaction. Breathing difficulty, facial/throat swelling, severe allergic reaction, rapidly spreading infection, severe eye symptoms or serious illness requires emergency assessment through 999/A&E; use NHS 111 or urgent care when clinically appropriate.

6.4Follow-up, course and maintenance

Arrange follow-up according to treatment intensity, first-treatment policy and risk. Re-screen before every session and do not retreat until the skin has recovered normally and the minimum interval in current Ivanmed training is met. Ivanmed public guidance commonly describes spacing treatments around 4–6 weeks, but the exact interval, number of sessions and maintenance plan must be individualised to indication, depth, recovery, product protocol and insurer requirements. Do not guarantee a course result.

• Keep gloves on while handling the contaminated cartridge. Deactivate the device and dispose of the cartridge immediately into an approved sharps container.
• Discard all single-use contaminated items in the correct clinical-waste stream. Never reprocess a single-use cartridge or barrier.
• Remove barriers without contaminating the pen. If blood/product has reached an area that cannot be safely cleaned, quarantine the device and contact Ivanmed before reuse.
• Clean then disinfect the external pen body, cable/stand and reusable accessories with products, method and contact time confirmed compatible by Ivanmed. Do not immerse the pen, spray liquid into openings or wipe exposed cartridge mechanisms unless the IFU directs it.
• Decontaminate couch, trolley, lamp and touch surfaces. Manage visible blood spill using the clinic's blood-spill procedure and suitable product/contact time.
• Remove PPE safely, perform hand hygiene and complete cleaning, cartridge lot and waste records.
• Inspect the device after cleaning. Store dry, protected and separated from contaminated equipment. Recharge only as directed.
• At close-down, check sharps fill line, clinical-waste security, stock expiry, device condition and any fault/incident log.

7.1Cross-contamination rule

The anti-backflow membrane is an engineering control, not permission to relax infection prevention. A new sealed cartridge, clean preparation, correct PPE, safe product dispensing, compatible device decontamination and documented waste handling are mandatory for every treatment.

• Stop treatment; make the client, area and device safe. Remove product only when appropriate and do not apply unplanned actives.
• Assess within competence and provide appropriate first aid. Call 999 for emergency symptoms; otherwise direct to NHS 111, urgent care, GP, pharmacist, eye service, dermatologist or other appropriate clinician based on the presentation.
• Give clear written safety-net instructions and arrange active follow-up. Do not minimise symptoms or promise they will settle.
• Record the event contemporaneously: consultation findings, area, settings/map, passes, endpoint, cartridge/product lots, anaesthetic details, device serial, observed response, client account, photographs with consent and all actions/advice.
• Quarantine the device, cartridge packaging and relevant product when malfunction, contamination or product reaction is suspected. Do not alter, repair, discard or return evidence until advised.
• Notify the clinic owner/governance lead, insurer, Ivanmed/device supplier and product manufacturer as required.
• Report a suspected reportable medical-device safety concern through the MHRA Yellow Card scheme and meet any local-authority/RIDDOR/insurer duties that apply.
• Complete a root-cause review. Do not resume the relevant treatment, product or device until it is confirmed safe and authorised.

These are the clinic's standard operating procedures for the devices it runs, built on each manufacturer's clinical protocol. They are published here because a client is entitled to know what their practitioner is required to do, and because a summary on a treatment page is our words rather than the protocol's.

Two sections of each are not reproduced. Each document ends with an advertising checklist governing how this website is written rather than how a treatment is performed — those are published separately, in full, and every page on this site is checked against them automatically. Each also ends with an internal approval and version-control record.

Nothing here is a claim about what a treatment will do for you. It describes how treatment is carried out, not what it achieves — and as every section of it says in one form or another, individual results vary and no specific outcome can be promised.

Status. Both are draft version 1.0, dated 23 August 2026. Each requires checking against the exact model, serial number, software, applicators, accessories and products held by the clinic; the current UK instructions for use and manufacturer training protocols, and the instructions and safety data for every product used; the practitioner's certificates, scope and insurance wording; and current infection-control, consent, photography, data-protection, emergency, referral and incident policies. Each must then be signed by the manufacturer's trainer or representative, the insurer or governance adviser, and the clinic owner. Neither sign-off has yet happened. Both are reviewed after any instructions-for-use or training update, product change, fault, safety notice, incident, change of insurer or regulatory change, and at least annually.

References cited by the BTL Exilis Ultra 360 protocol

• BTL Aesthetics — Exilis Ultra 360 patient information Mechanism, non-invasive use, treatment journey and variable results.
• BTL Aesthetics — Exilis Ultra 360 product information Combined radiofrequency and ultrasound, EFC monitoring, Ultra Femme platform.
• MHRA — Yellow Card scheme Reporting suspected medical-device adverse incidents.

References cited by the Zemits DermeLuxx Pro protocol

• Zemits UK — DermeLuxx Pro 3-in-1 HydroDiamond system Device specification, functions and stated component timings.
• Zemits — DermeLuxx PRO hydrodermabrasion system Manufacturer product information.
• MHRA — Yellow Card scheme Reporting suspected medical-device adverse incidents.
• ASA / CAP — the advertising codes The rules every claim on this website is written against.

References cited by the Ivanmed iMEDpen X protocol

• Ivanmed — iMEDpen X microneedling device Device features and public treatment information.
• Ivanmed — iMEDpen microneedling training The manufacturer training route the parameters must come from.
• Ivanmed — iMEDpen X microneedling cartridges 16-pin cartridge and performance information.
• Ivanmed — microneedling aftercare The manufacturer aftercare the clinic’s written advice follows.
• MHRA — report a problem with a medicine or medical device Yellow Card reporting.