AptiusIQ · Device & Product Reference

C

Solta Medical (Bausch Health) · Class 1C laser product (IEC/EN 60825-1) · confirm TGA ARTG entry

An entry-level non-ablative fractional diode laser — a gentler, lower-dose counterpart to Fraxel for early-aging skin, tone, texture and pigment with minimal downtime. The original 1440 nm handpiece treats the dermis; the Perméa 1927 nm handpiece targets superficial pigment and dullness and transiently enhances topical permeability. The Touch platform combines both handpieces.

Device specifications

Device class	Non-ablative fractional diode laser; interchangeable handpieces (Touch = both)
Wavelengths	1440 nm (Original handpiece) · 1927 nm (Perméa handpiece)
1440 nm handpiece	Max power 2.5 W · max pulse energy 9 mJ · max pulse width 3 ms · pulse repetition rate <400 Hz
1927 nm Perméa handpiece	Max power 0.9 W · max pulse energy 5 mJ · max pulse width 5 ms · pulse repetition rate <150 Hz
Spot size	≈140 µm; selectable treatment levels — low / medium / high
Delivery	Handpiece with integrated cooling and disposable treatment tips; continuous-motion application
Laser classification	Class 1C per IEC/EN 60825-1
Regulatory	Verify current TGA ARTG listing and the supplied IFU before clinical use

Mode of delivery

Fractional non-ablative — creates microscopic treatment zones at a deliberately lighter dose than Fraxel, giving a 'lunchtime' resurfacing treatment with minimal downtime, typically over a series of sessions.
1440 nm (Original) is absorbed in the dermis to address texture, fine lines and overall tone.
1927 nm (Perméa) is absorbed superficially to clear pigment and dullness, and transiently increases the permeability of the stratum corneum — used to enhance uptake of post-treatment topicals / skincare.
Treatment level (energy) and number of passes set the depth and coverage; a disposable tip tracks the handpiece across the skin.
Although a Class 1C laser (a lower-risk class than Fraxel's Class 4), laser-safety protocol and eye protection still apply.

Indications

Dermatological procedures requiring coagulation of soft tissue and general skin resurfacing.
Early signs of ageing — tone and texture, superficial pigment, dullness and fine lines.
Perméa 1927 nm — superficial pigment / photodamage and enhanced topical permeation.
Confirm wavelength-specific, jurisdiction-specific indications against the ARTG entry and current IFU.

Contraindications (including medication)

Isotretinoin (Accutane) acne treatment, or drugs of a similar class — current use or within the past 6 months.
Retinoids — to be avoided for at least 2 weeks prior to and during treatment.
Systemic / oral steroids (e.g. prednisone, dexamethasone) — rigorously avoided before and throughout the course of treatment.
Known sensitivity to light, or use of photosensitising agents / medications (anything increasing UV or artificial-light sensitivity).
Pregnancy or breastfeeding (per AU safety information).
Immune-compromising conditions — e.g. HIV, lupus erythematosus, scleroderma, or bloodstream infection.
Predisposition to keloid formation or excessive scarring.
Skin still recovering from a recent cosmetic procedure (chemical / mechanical peel or laser resurfacing); botulinum toxin or dermal fillers within the past 2 weeks.
Pre-screen for and exclude / treat first: actinic keratosis, melasma, rosacea, skin cancer, active infection, cold sores (herpes simplex), open or non-healing wounds, rashes, burns, inflammation, eczema or psoriasis in the treatment area.

Practitioner cautions & safety

Apply laser-safety protocol and eye protection despite the lower (Class 1C) classification.
Expected responses include erythema, oedema, itching / dryness, increased skin sensitivity, pain / discomfort and occasional petechiae (pinpoint bleeding) — set expectations and document.
Consider antiviral prophylaxis for patients with a history of perioral herpes before facial treatment.
PIH risk in darker Fitzpatrick types — titrate the treatment level, use a test area, and reinforce strict daily photoprotection.
Set realistic expectations — best results come from a course of treatments (commonly 4–6), not a single session.
Be cautious applying actives immediately after a Perméa treatment, given the transient rise in skin permeability.
Improper use may cause personal injury or damage the system — work from the current Operator Manual and complete device-specific training; this reference is not a substitute.

Manufacturer guides & troubleshooting

Clear + Brilliant — Important Safety Information & HCP resources (Solta) — Official indication, contraindications and Operator Manual reference for providers.
Clear + Brilliant — Important Safety Information (AU) — Australian contraindications and pre-screening guidance.
Solta Medical — manufacturer site — Operator manuals and provider resources via Solta / Bausch (Customer Care 1-877-782-2286).
Clear + Brilliant Touch — clinical study protocol (ClinicalTrials.gov, PDF) — Supplementary 1440/1927 combination safety & effectiveness data.

References

D

DermapenWorld · Automated micro-needling pen with single-use cartridges · confirm TGA ARTG entry and current IFU

A motorised microneedling pen using single-use sterile needle cartridges to create controlled micro-channels in the skin for collagen induction therapy. The device is Bluetooth-paired to the DermapenWorld mobile app, which manages registration and mandatory firmware updates. Only the troubleshooting manual has been supplied — the clinical specification, indication and contraindication set below must be completed from the operator manual / IFU before sign-off.

Device specifications

Device class	Automated micro-needling pen (motorised, single-use cartridge)
Power	Operates via battery or mains cord
Connectivity	Paired to a mobile device via Bluetooth, managed through the DermapenWorld app
Firmware	Device must be updated every 60–90 days; a countdown code appears as the update falls due
Serial numbering	Device serial numbers begin with 4MD; each device is registered to a clinic once, at setup
Warranty	7-year warranty, commencing at the date of setup/registration
Needle depth / speed / cartridge specification	Not in the supplied documentation — obtain from the Dermapen 4 operator manual / IFU.
Indications, contraindications and clinical parameters	Not in the supplied documentation — see the gap note in cautions.

Mode of delivery

Collagen induction therapy — an oscillating needle cartridge creates controlled vertical micro-channels in the epidermis and dermis, triggering a wound-healing and collagen-remodelling response.
Needle depth and oscillation speed are set on the device (Depth Up/Down and Speed Up/Down controls) and adjusted for the treatment area.
Single-use sterile cartridges are fitted per patient; the device will not start without a cartridge fitted.
⚠ Detailed treatment technique, depth selection and clinical protocol are not in the supplied troubleshooting manual and must be sourced from the operator manual before this section is signed off.

Indications

Micro-needling / collagen induction therapy for skin texture, scarring and rejuvenation.
⚠ The specific cleared indications are not in the supplied documentation — confirm against the Dermapen 4 IFU and the Australian ARTG entry before publication.

Contraindications (including medication)

⚠ Not available in the supplied documentation. The Dermapen 4 file provided is a troubleshooting manual only and contains no clinical contraindications.
Action required: obtain the Dermapen 4 operator manual / IFU so the contraindication set (typically including active acne or infection in the treatment area, active herpes simplex, isotretinoin use, keloid tendency, anticoagulation, pregnancy, immunosuppression and active skin disease) can be stated from the manufacturer's own wording rather than inferred.
This entry must not be published to practitioners until that list is sourced and signed off.

Practitioner cautions & safety

Single-use cartridges only — never reuse a needle cartridge between patients.
Keep firmware current. The device requires an update every 60–90 days; an out-of-date device will prompt with a countdown and eventually require updating before use.
⚠ Clinical cautions are not present in the supplied troubleshooting manual and must be completed from the operator manual / IFU before sign-off.

Troubleshooting (from manufacturer guide)

Issue / error	Probable cause	Resolution
SYN on screen	Device requires a firmware update	Update the device immediately via the DermapenWorld app.
D29 (or another number)	Countdown of days until the device must be updated	Update the device. To bypass temporarily, press the on button once (do not hold).
Blue light	Device is ready	No action required.
Yellow light	Attention — the device needs a cartridge fitted to start, or a software update	Fit a cartridge or run the update.
Red light	Error — battery or power source low	Charge the device or connect the power cord.
Flashing battery icon	Battery / power source low	Charge the device as soon as possible.
Device won't register	Bluetooth off, poor connection, already registered, flat batteries, or location services off	Confirm Bluetooth is on; try with Wi-Fi off; check for an existing serial under MY PEN (starts with 4MD) — if present it may already be registered; charge or use the power cord; on Android enable Location Services; on iOS enable Bluetooth for the DermapenWorld app. If stuck at 45% or 80%, cut power (remove batteries or cord) and restart.
Device already registered to another clinic	Registration occurs only once, at initial setup	The device needs updating rather than re-registering. Check for a 4MD serial under MY PEN; if it cannot be resolved, email the device serial number to Customer Care.
Device won't update	Paired to a different phone, poor Wi-Fi, or stuck mid-update	Force sync: open the app and log in, turn the device on, hold both PLUS buttons (Speed Up and Depth Up) for 5–10 seconds until the Bluetooth symbol appears, then press 'Update Pen'. Turn off Bluetooth on the originally paired phone. If stuck at 45% or 80%, cut power and restart.

Manufacturer guides & troubleshooting

DermapenWorld — manufacturer site — Product information, training and customer care.
DermapenWorld — Dermapen 4 setup and update video guides — Setup instructions, Bluetooth pairing and firmware update walkthroughs (linked from the supplied troubleshooting manual).

Source documents (held internally)

Dermapen 4 - Trouble Shooting Manual.pdf — Troubleshooting and setup manual — error codes, indicator lights, registration and firmware update issues (source of the troubleshooting table above). **Does not contain clinical specifications, indications or contraindications.**

Manufacturer documentation held internally by AptiusIQ as the source for this entry. Not published with this module — request access through your clinic lead or the manufacturer links above.

References

Dermapen 4 Troubleshooting Manual (held on file)

E

Cutera · FDA Class II medical device · CDRH Class IV laser product · Class 4 laser to IEC 60825:2014 · Type BF

A dual-wavelength solid-state laser for the coagulation and haemostasis of benign vascular, pigmented and cutaneous lesions. The 532 nm KTP wavelength targets superficial vascular and pigmented targets; the 1064 nm Nd:YAG penetrates deeper for larger, darker and deeper vessels. Delivered through the CoolView handpiece (motorised zoom + adjustable contact sapphire cooling) or the Genesis V handpiece for micro-pulse dermal heating.

Device specifications

Laser type	532 nm: high-power, frequency-doubled KTP · 1064 nm: high-power, long-pulse Nd:YAG
Wavelengths	532 nm and 1064 nm
Maximum output	532 nm: 12 J · 1064 nm: 100 J
Fluence	532 nm: 1.8–42 J/cm² · 1064 nm CoolView: 2–300 J/cm² · Genesis V: 4–7 J/cm²
Pulse duration	532 nm: 1.5–40 ms · 1064 nm CoolView: 5–60 ms · Genesis V: 0.3 ms
Repetition rate	532 nm: 0 Hz (single shot) to 4 Hz · 1064 nm CoolView: 0–2 Hz · Genesis V: 0–10 Hz
Treatment spot	532 nm: 2–12 mm circular · 1064 nm CoolView: 2–12 mm · Genesis V: 8 mm
Handpieces	CoolView (motorised zoom, adjustable sapphire contact cooling) and Genesis V (integrated temperature sensor + LED indicators; 3–4 cm working distance)
Epidermal cooling	CoolView: user-adjustable contact sapphire cooling
Aiming beam	650 nm
System cooling	Self-contained water-to-air heat exchanger
Console	0.41 m W × 0.61 m D × 0.88 m H · 84.1 kg (185 lb) · 2.7 m umbilical
Electrical	100–120 VAC 20 A or 200–240 VAC 16 A · 50/60 Hz · max heat dissipation 4,000 W
Operating environment	5–30 °C · 0–90% RH non-condensing
Eye safety	Minimum optical density for protective eyewear: 5.89 at 532 nm, 5.81 at 1064 nm · NOHD 1.45 × 10⁵ m (532 nm), 1.33 × 10⁵ m (1064 nm)

Mode of delivery

Selective photothermolysis — laser light is absorbed by haemoglobin (vascular) and melanin (pigment); absorbed energy converts to heat, coagulating the target while surrounding tissue is spared.
532 nm is visible green light, strongly absorbed by haemoglobin and melanin — the preferred wavelength for superficial facial vessels, pigment, diffuse redness and matting.
1064 nm is invisible near-infrared with deeper penetration (a coaxial aiming beam targets the tissue) — preferred for periorbital veins, venous lakes, reticular leg veins and purple/nodular port wine stains.
CoolView handpiece — contact sapphire window cools the epidermis before and during the pulse; spot size is adjusted by motorised zoom.
Genesis V handpiece — non-contact, rapid micro-pulses at 8 mm and 3–4 cm working distance, gently heating the dermis for diffuse redness and skin quality ("Laser Genesis" technique).

Indications

Intended use — surgical and aesthetic applications requiring selective photothermolysis of target chromophores in soft tissue, in general and plastic surgery and dermatology.
532 nm KTP — coagulation and haemostasis of benign vascular lesions (angiomas, haemangiomas, port wine stains, venous anomalies, telangiectasia of face or extremities, leg veins, poikiloderma of Civatte); benign pigmented lesions (naevi, lentigines); benign cutaneous lesions (warts, scars); chloasma.
1064 nm Nd:YAG — benign vascular lesions (port wine stains, haemangiomas, warts, telangiectasia, rosacea, venous lake, leg veins, spider veins, poikiloderma of Civatte); benign cutaneous lesions (warts, scars, striae); benign pigmented lesions (seborrhoeic keratoses, naevi); chloasma; mild to moderate inflammatory acne vulgaris; and wrinkles including periocular and perioral.

Contraindications (including medication)

Pregnant patients.
Patients undergoing treatment for skin cancer.
Do not treat over dysplastic naevi or questionable pigmented lesions (manufacturer warning).
Do not treat over or close to tattoos or permanent make-up (manufacturer warning).
*Manufacturer precautions — assess and adjust before treating:* photosensitising drugs (tetracyclines and similar); anticoagulants (increased risk of purpura or bruising); history of coagulopathies; history of keloids or hypertrophic scarring; diabetes (may impede wound healing); history of herpes (pre-treatment with an antiviral may be indicated); isotretinoin (Accutane) use within the previous 6 months; history of vitiligo.

Practitioner cautions & safety

Class 4 laser. Patient and all staff in the treatment room must wear eyewear rated for both 532 nm and 1064 nm (minimum OD 5.89 / 5.81). If the patient cannot wear eyewear, fit opaque eye protection that completely blocks light.
Extreme caution near the eyes — direct the beam away from the eye and treat only skin outside the orbital rim; ocular damage can result.
Begin with a low fluence and observe tissue response before increasing. Skin type and tanning limit the maximum usable fluence without epidermal damage.
Develop eye–hand–foot coordination with handpiece and footswitch to avoid inadvertent firing when the handpiece is off the tissue.
Expected transient events and possible adverse effects: erythema, oedema and purpura; hyperpigmentation, hypopigmentation, burns, erosion, epidermal crusting or blistering (some may scar); deep tissue injury and prolonged healing when treating warts; temporary or permanent leukotrichia; stimulation of terminal hair growth in or adjacent to the treated area; undesired hair loss when treating vascular lesions; red rash/bumps; haemosiderin staining; textural changes and cutaneous indentations.
Sun exposure, tanning beds and artificial tanning increase the risk of adverse events — defer treatment and reinforce photoprotection.
Operate only with appropriate training; this reference does not replace the operator manual.

Manufacturer treatment settings (starting guide — titrate to endpoint)

Indication / vessel type	Cooling temp	Spot size	Fluence	Pulse duration
Facial telangiectasia <2 mm	5 °C	5 mm	8–10 J/cm²	8–12 ms
Facial telangiectasia >2 mm	5 °C	7 mm	7.4–9 J/cm²	10–20 ms
Fine leg telangiectasia (skin types I–III only)	5 °C	5 mm	8.4–11 J/cm²	8–15 ms
Fine leg telangiectasia (skin types I–III only)	5 °C	7 mm	8–10 J/cm²	8–15 ms
Matting (face or nose) / rosacea — global treatment	5 °C	10 mm	6–9 J/cm²	8–15 ms
Matting (face or nose) / rosacea — global treatment	5 °C	12 mm	5–8 J/cm²	8–15 ms
Matting (neck or chest)	5 °C	10 mm	6–8 J/cm²	10–20 ms
Matting (neck or chest)	5 °C	12 mm	5–7.4 J/cm²	10–20 ms
Diffuse redness (face)	5 °C	10 mm	6–9 J/cm²	7–11 ms
Diffuse redness (face)	5 °C	12 mm	5–8 J/cm²	8–12 ms
Cherry or spider angiomas	10 °C	3 mm	10–14 J/cm²	6–12 ms
Cherry or spider angiomas	10 °C	5 mm	8–12 J/cm²	8–15 ms
Skin tags / sebaceous hyperplasia	15–20 °C	2 mm	16–20 J/cm²	4–10 ms
Skin tags / sebaceous hyperplasia	15–20 °C	3 mm	14–18 J/cm²	4–10 ms

532 nm vascular parameters with the CoolView handpiece, from the Cutera *excel V Clinical Training Guide* (D1091 Rev M) held on file. Guide only, for skin types I–IV unless stated. 532 nm is not recommended for periorbital veins, venous lakes, reticular leg veins or purple/nodular port wine stains — use 1064 nm. Darker III–IV skin (Asian, Latino, Mediterranean) carries higher PIH risk and should be treated more conservatively. Observe laser–tissue interaction and clinical endpoints.

Manufacturer guides & troubleshooting

Cutera excel V — product page — Manufacturer device page (indications, handpieces).
Cutera — support & service — Technical service, manuals and training requests.

Source documents (held internally)

Operator Manual excel V.pdf — Full operator manual (D1025 Rev H) — specifications, indications, contraindications, warnings, precautions. Primary source.
excel v clinical training guide.pdf — Clinical training guide (D1091 Rev M) — treatment parameters and technique by indication.

Manufacturer documentation held internally by AptiusIQ as the source for this entry. Not published with this module — request access through your clinic lead or the manufacturer links above.

References

Cutera · FDA Class II medical device · CDRH Class IV laser product · Class 4 laser to IEC 60825:2014 · Type BF

The successor platform to excel V — a dual-wavelength 532 nm / 1064 nm solid-state laser with a higher-power frequency-doubled Nd:YAG green deck, a 2–16 mm motorised-zoom CoolView handpiece, and the addition of the small-spot Dermastat handpiece for discrete lesions. Broadened indications add unwanted hair, long-term hair reduction, pseudofolliculitis barbae and wrinkles alongside benign vascular, pigmented and cutaneous lesions.

Device specifications

Laser type	532 nm: high-power, frequency-doubled Nd:YAG · 1064 nm: high-power, long-pulse Nd:YAG
Wavelengths	532 nm and 1064 nm
Maximum output	532 nm: 13.5 J · 1064 nm: 100 J
Fluence	532 nm — CoolView: 1.8–42 J/cm², Genesis V: 0.5–2 J/cm², Dermastat: 6–40 J/cm² · 1064 nm — CoolView: 2–300 J/cm², Genesis V: 4–7 J/cm²
Pulse duration	532 nm — CoolView: 0.5–40 ms, Genesis V: 0.5 and 1 ms, Dermastat: 0.5–20 ms · 1064 nm — CoolView: 5–60 ms, Genesis V: 0.3 ms
Repetition rate	532 nm — CoolView: 0–4 Hz, Genesis V: 0–4 Hz and 10 Hz, Dermastat: 0–4 Hz · 1064 nm — CoolView: 0–2 Hz, Genesis V: 0–10 Hz
Treatment spot	CoolView: 2–16 mm circular (motorised zoom) · Genesis V: 8 mm · Dermastat: 2 mm
Handpieces	CoolView (motorised zoom + user-adjustable sapphire contact cooling), Genesis V (temperature sensor + LED indicators, 3–4 cm working distance), Dermastat (shielded fibre, 1–1.5 cm working distance)
Aiming beam	635 nm
System cooling	Self-contained water-to-air heat exchanger
Console	0.41 m W × 0.61 m D × 0.88 m H · 84.1 kg (185 lb) · 2.7 m umbilical
Electrical	100–120 VAC 20 A or 200–240 VAC 16 A · 50/60 Hz · max heat dissipation 4,000 W
Operating environment	15–30 °C · 0–90% RH non-condensing
Eye safety	Minimum optical density for protective eyewear: 5.89 at 532 nm, 5.81 at 1064 nm · NOHD 1.45 × 10⁵ m (532 nm), 1.33 × 10⁵ m (1064 nm)

Mode of delivery

Selective photothermolysis — 532 nm (visible green) is absorbed by haemoglobin and melanin for superficial vascular and pigmented targets; 1064 nm (near-infrared, invisible, with coaxial aiming beam) penetrates deeper for larger and deeper vessels and for hair.
CoolView delivers the treatment beam through a cooled sapphire window with motorised zoom across 2–16 mm — larger spots cover field indications (diffuse redness, rosacea) faster, smaller spots concentrate fluence on discrete vessels.
Genesis V is applied non-contact at 3–4 cm with rapid low-fluence micro-pulses to bulk-heat the dermis — used for skin quality, texture, pore size and diffuse redness.
Dermastat is a 2 mm shielded-fibre handpiece used close to the skin (1–1.5 cm) for discrete lesions such as small angiomas, skin tags and sebaceous hyperplasia.
Epidermal cooling temperature, fluence and pulse duration are set independently on the console, allowing the operator to titrate for Fitzpatrick type and target depth.

Indications

Intended use — aesthetic and cosmetic procedures in dermatology and plastic surgery for the treatment of unwanted hair; benign vascular, pigmented and cutaneous lesions; and wrinkles.
532 nm — treatment of benign vascular lesions, benign pigmented lesions and benign cutaneous lesions.
1064 nm — treatment of unwanted hair; long-term or permanent hair reduction; pseudofolliculitis barbae (PFB); benign vascular lesions; benign cutaneous lesions; and wrinkles.
Manufacturer treatment-indication list also covers facial and nasal telangiectasia, spider and reticular veins, cherry and spider angiomas, port wine stain, haemangioma, venous lakes, rosacea, diffuse redness, matting, poikiloderma, dyschromia, age and sun spots, café-au-lait macules, naevi, DPN, melasma, freckles, wrinkles, pore size, acne scars, surgical scars, surgical and injectable bruising, seborrhoeic keratosis, chloasma, verrucae, active acne, skin tags, small-area hair removal, PFB and onychomycosis.

Contraindications (including medication)

Pregnant patients.
Patients undergoing treatment for skin cancer.
Do not treat over dysplastic naevi or questionable pigmented lesions (manufacturer warning).
Do not treat over or close to tattoos or permanent make-up (manufacturer warning).
Paradoxical hypertrichosis — laser hair removal can cause increased hair growth in some individuals; highest risk in females of Mediterranean, Middle Eastern and South Asian heritage treated on the face and neck (manufacturer warning).
*Manufacturer precautions — assess and adjust before treating:* photosensitising drugs (tetracyclines and similar); anticoagulants (increased purpura/bruising risk); history of coagulopathies; history of keloids or hypertrophic scarring; diabetes (may impede wound healing); history of herpes (antiviral pre-treatment may be indicated); isotretinoin (Accutane) within the previous 6 months; history of vitiligo.

Practitioner cautions & safety

Class 4 laser. Patient and all staff must wear eyewear rated for both 532 nm and 1064 nm (minimum OD 5.89 / 5.81); never allow anyone near the system in use without protective eyewear.
Extreme caution near the eyes — direct the beam away from the eye and treat only skin outside the orbital rim.
Begin with a low fluence and observe tissue response before increasing — skin type and tanning limit the maximum usable fluence without epidermal damage.
Expected transient events and possible adverse effects: erythema, oedema and purpura; hyperpigmentation, hypopigmentation, burns, erosion, crusting or blistering (some may scar); deep tissue injury and prolonged healing when treating warts; leukotrichia; stimulation of terminal hair growth; undesired hair loss when treating vascular lesions; red rash/bumps; haemosiderin staining; textural changes and cutaneous indentations.
Sun exposure, tanning beds and artificial tanning increase the risk of adverse events.
Operate only with appropriate training; this reference does not replace the operator manual.

Manufacturer guides & troubleshooting

Cutera excel V+ — product site — Manufacturer platform site.
Cutera excel V — product page — Device family page and indications.
Cutera — support & service — Technical service, manuals and training requests.

Source documents (held internally)

Excel V Plus Operator Manual.pdf — Full operator manual (D2371 Rev A) — specifications, indications, contraindications, warnings, precautions. Primary source.
Excel V Plus Treatment Indications.pdf — One-page indication list across vascular, pigment, skin revitalisation and other applications.
Excel Vplus Product Brochure.pdf — Manufacturer product brochure.
Cutera Excel V+ PLK 2023.pdf — Patient-facing / practice knowledge pack (treatment overview, benefits, FAQs).
Cutera Excel V Plus Cleaning Manual.pdf — Cleaning and reprocessing guidance. **Note:** supplied file is an image-only scan with no text layer.
excel v clinical training guide.pdf — excel V clinical training guide — parameter starting points and technique (see the excel V entry; confirm against the V+ console).

Manufacturer documentation held internally by AptiusIQ as the source for this entry. Not published with this module — request access through your clinic lead or the manufacturer links above.

References

F

Solta Medical (Bausch Health) · Class 4 laser product (IEC 60825-1) · 21 CFR 1040.10/.11 · confirm TGA ARTG entry

A dual-wavelength non-ablative fractional laser. A single handpiece selects either the 1550 nm Erbium fibre laser for deep dermal remodelling (wrinkles, scars, dyschromia) or the 1927 nm Thulium fibre laser for superficial epidermal correction (pigment, actinic keratosis, tone and texture). Treatment creates arrays of microthermal treatment zones (MTZs) of coagulated tissue surrounded by spared skin, driving rapid re-epithelialisation with less downtime than ablative resurfacing.

Device specifications

Device class	Non-ablative fractional laser, dual fibre, single handpiece
Wavelengths	1550 nm Erbium (Er:fibre) — deep dermal · 1927 nm Thulium (Tm:fibre) — superficial epidermal
Pulse energy	1550 nm: 4–70 mJ per MTZ · 1927 nm: 5–20 mJ per MTZ
Max output	1520–1560 nm: 30 W · 1905–1945 nm: 12 W · maximum pulse duration 10 ms
Scanner / coverage	Continuous-motion delivery up to 2,900 MTZs per second
Handpiece	Continuous-motion handpiece; movement rate 0.3–8.0 cm/sec; integrated skin-contact safety sensor
Treatment tips	Large tip 15 mm / small tip 7 mm; cool roller tips for focal cooling
Trigger	Footswitch, synchronised with hand motion
User interface	15-inch touchscreen; precise dosimetry; integrated self-test
Console	48.9 × 45.1 × 44.5 cm; 25 kg
Electrical	100–240 VAC, 50–60 Hz, universal input; <6 A @120 V / <3 A @240 V
Regulatory	Class 4 laser; complies with 21 CFR 1040.10/.11; verify current TGA ARTG listing

Mode of delivery

Non-ablative fractional resurfacing — microscopic columns of coagulated tissue (MTZs) are created within a field of untreated skin, so healing is rapid and the stratum corneum stays largely intact relative to ablative lasers.
1550 nm Er:fibre penetrates deep into the dermis to stimulate collagen and repair structural damage — wrinkles, acne and surgical scars.
1927 nm Tm:fibre is absorbed superficially in the epidermis to clear pigment, sun damage and actinic keratoses while keeping the stratum corneum intact — a safer profile than superficial ablative CO₂ for comparable epidermal effect.
Continuous-motion handpiece + dosimetry set treatment level (energy and coverage); cool roller tips provide focal cooling for comfort.
Treatment depth and density are titrated to indication and Fitzpatrick type; the footswitch fires only in synchrony with hand movement to keep MTZ density uniform.

Indications

1550 nm — dermatological procedures requiring coagulation of soft tissue and skin resurfacing; dyschromia and cutaneous lesions including lentigos (age spots), solar lentigos, actinic keratosis and melasma; periorbital wrinkles; acne and surgical scars.
1927 nm — dermatological procedures requiring coagulation of soft tissue and the treatment of actinic keratosis; superficial pigment, photodamage and tone / texture.
Indications are wavelength-specific and jurisdiction-specific — confirm against the ARTG entry and current IFU.

Contraindications (including medication)

Isotretinoin (Accutane) or drugs of a similar class — current use; standard practice is to discontinue and allow a washout (commonly 6–12 months) before treatment.
Systemic steroids (e.g. prednisone, dexamethasone) — to be rigorously avoided before and throughout the course of treatment.
Pregnancy or breastfeeding — Solta holds no clinical data in pregnant women or nursing mothers; treat as contraindicated.
Predisposition to keloid formation or excessive scarring.
Recent surgery / post-surgical change to the treatment area — skin indentations and textural changes following surgery.
Active bacterial, viral or fungal infection in the treatment area (including active herpes simplex).
Any patient who would be ineligible for general surgery; apply clinical judgement to each case.

Practitioner cautions & safety

Class 4 laser — wavelength-appropriate eye protection for the patient and every person in the room; a controlled treatment area with signage, and laser-safety governance.
Possible complications include blistering and burns, temporary or permanent dyschromia, infection, keloid formation, prolonged redness, scarring, delayed wound healing / textural change, and temporary bruising.
Post-inflammatory hyperpigmentation (PIH) risk rises in darker Fitzpatrick types — use conservative settings, a test spot, and strict photoprotection.
Consider antiviral prophylaxis for patients with a history of perioral herpes before facial treatment.
Test-spot and titrate to clinical endpoint using on-device dosimetry; eye, lip and neck areas require particular care.
Work from the current operator's manual and complete device-specific training — this reference is not a substitute.

Manufacturer treatment settings (starting guide — titrate to endpoint)

Wavelength	Indication	Fitzpatrick	Pulse energy	Treatment level (coverage)
1550 nm	General resurfacing — face	I–III	10–25 mJ	4–8 (11–23%)
1550 nm	General resurfacing — eyelids (within orbital rim)	I–III	10–20 mJ	4–7 (11–20%)
1550 nm	General resurfacing — off-face	I–III	10–25 mJ	4–7 (11–20%)
1550 nm	Deep wrinkles / acne scars — face	I–III	25–70 mJ	5–9 (14–26%)
1550 nm	Deep wrinkles / acne scars — off-face	I–III	25–40 mJ	4–8 (11–23%)
1550 nm	Melasma — face (2–3 treatments)	I–III	6–15 mJ	5–8 (14–23%)
1550 nm	Surgical scars	I–III	40–70 mJ	5–8 (14–23%)
1550 nm	General resurfacing — face	IV–VI	10–25 mJ	3–7 (9–20%)
1550 nm	General resurfacing — eyelids (within orbital rim)	IV–VI	10–20 mJ	3–6 (9–17%)
1550 nm	General resurfacing — off-face	IV–VI	10–25 mJ	3–6 (9–17%)
1550 nm	Deep wrinkles / acne scars — face	IV–VI	25–70 mJ	4–7 (11–20%)
1550 nm	Deep wrinkles / acne scars — off-face	IV–VI	25–40 mJ	4–6 (11–17%)
1550 nm	Melasma — face (2–3 treatments)	IV–VI	6–15 mJ	3–7 (9–20%)
1550 nm	Surgical scars	IV–VI	40–70 mJ	4–7 (11–20%)
1927 nm	General resurfacing — face	I–III	5–20 mJ	3–7 (30–50%)
1927 nm	General resurfacing — eyelids (within orbital rim)	I–III	5–20 mJ	1–4 (20–35%)
1927 nm	General resurfacing — off-face	I–III	5–15 mJ	1–4 (20–35%)
1927 nm	General resurfacing — face	IV–VI	5–20 mJ	1–5 (20–40%)
1927 nm	General resurfacing — eyelids (within orbital rim)	IV–VI	5–20 mJ	1–4 (20–35%)
1927 nm	General resurfacing — off-face	IV–VI	5–20 mJ	1–3 (20–30%)
1927 nm	Actinic keratosis — face (3–4 treatments)	I–III	10–20 mJ	3–5 (30–40%)
1927 nm	Actinic keratosis — off-face (3–4 treatments)	I–III	10–20 mJ	2–4 (25–35%)

8 passes recommended. Source: Solta *Fraxel DUAL 1550/1927 Laser Treatment Settings* card (held on file). Combination 1550 + 1927 treatment is also documented on the card (4 passes each). Evaluate the patient after each treatment for melasma and actinic keratosis. Higher Fitzpatrick types take lower coverage — titrate and test-spot.

Manufacturer guides & troubleshooting

Fraxel (Solta) — Important Safety Information (AU) — Official indications, contraindications and possible complications.
Fraxel — Important Safety Information & provider site (Solta, US) — Manufacturer indications and ISI; Operator Manual via Solta.
Fraxel DUAL 1550/1927 — Product Brochure (PDF) — Full specifications table and features (text saved to manufacturer-guides/).
Solta Medical — manufacturer site — Operator manuals and provider resources via Solta / Bausch (Customer Care 1-877-782-2286).
Fraxel DUAL treatment consent (American Board of Laser Surgery, PDF) — Supplementary consent / risk template.

Source documents (held internally)

Fraxel DUAL 1550 1927 Treatment Settings Card v0.pdf — Manufacturer Fitzpatrick-stratified starting parameters (source of the settings table above).

Manufacturer documentation held internally by AptiusIQ as the source for this entry. Not published with this module — request access through your clinic lead or the manufacturer links above.

References

H

Lutronic (Cynosure Lutronic) · Non-thermal, non-ablative LED system · FDA-cleared LLLT · confirm TGA ARTG entry

A high-output LED / Low-Level Light Therapy (LLLT) phototherapy panel built around deep-penetrating 830 nm near-infrared light, with optional 633 nm red and 415 nm blue, and 590 nm yellow photo-sequencing. It photomodulates cellular function without thermal injury — used standalone for healing, pain, acne and rejuvenation, and adjunctively to reduce post-procedure erythema and oedema.

Device specifications

Device class	LED phototherapy / LLLT panel (non-contact)
Wavelengths	830 nm near-infrared (primary); 633 nm red and 415 nm blue (combo model); 590 nm yellow for photo-sequencing
LED array	1,800 LEDs
Optics	Optical Lens Array Technology (OLAT) — collimated, concentrated output with reduced scatter
Core technology	Photo-Sequencing Technology (PST) — yellow light pre-conditions cells to be more receptive to NIR
Power density	Up to 180 mW/cm²
Delivery modes	Continuous and pulsed
Application	Hands-free articulated panel positioned over the treatment area (non-contact)
Typical session	10–20 minutes; no downtime as a standalone treatment
Mechanism	Photobiomodulation (non-thermal) — no risk of physical trauma or thermal damage
Regulatory	FDA-cleared LLLT device; verify current TGA ARTG listing and the supplied IFU before clinical use

Mode of delivery

Non-contact panel. The LED head is positioned a set distance above the skin; photons are absorbed by cellular chromophores (mitochondrial cytochrome c oxidase) to photomodulate cell function — there is no heating or ablation of tissue.
830 nm (near-infrared) penetrates to dermal cells, raises the cells' action potential and photostimulates dermal microcirculation — the basis for healing, pain relief and rejuvenation claims.
415 nm (blue) drives endogenous photodynamic activity against *C. acnes* porphyrins for active acne; 633 nm (red) is used for post-care, collagen stimulation and, with topical 5-ALA, exogenous photodynamic therapy (PDT).
Photo-Sequencing Technology (PST) delivers 590 nm yellow light to pre-sensitise cells before the near-infrared dose, increasing receptivity.
Standalone or adjunctive — frequently run immediately after injectables, energy-device or resurfacing procedures to reduce erythema and oedema (reported up to ~50%) and support recovery.

Indications

830 nm with 590 nm — wound healing, temporary relief of minor muscle and joint pain, arthritis and muscle spasm, temporary increase in local blood circulation, hair regrowth, acne and skin rejuvenation.
633 nm (combo) — post-procedure care, skin rejuvenation, collagen stimulation, hair rejuvenation; non-melanoma skin cancer and active acne via exogenous 5-ALA PDT (medically directed).
415 nm (combo) — active acne via endogenous PDT.
Indications vary by configuration and jurisdiction — confirm against the ARTG entry and current IFU.

Contraindications (including medication)

Photosensitising medication — e.g. isotretinoin (Accutane), tetracyclines (doxycycline), St John's Wort and other known photosensitisers — risk of a severe phototoxic skin reaction.
Systemic steroids or recent cortisone / corticosteroid injection.
Pregnancy, planning pregnancy or breastfeeding — risk to the fetus / neonate is not established.
Lupus erythematosus, photosensitive eczema, or albinism.
Any photosensitive disorder (sensitisation to light).
Light-induced headaches or photosensitive (light-induced) epilepsy.
Genetic conditions of the eye.
For 5-ALA PDT specifically: porphyria or known ALA / photosensitiser allergy — follow the PDT protocol and prescriber direction.

Practitioner cautions & safety

Eye protection for both patient and operator during every treatment.
Screen for photosensitisers at consult; advise patients to avoid photosensitising agents before treatment.
Per manufacturer guidance, advise patients to avoid exercise for at least 24 hours after treatment.
Reinforce daily broad-spectrum photoprotection, particularly where photosensitising medication or PDT is involved.
5-ALA PDT is a medically directed procedure — incubation time and light dose per protocol; deliver within scope of practice.
LED output is non-thermal but high-intensity — work from the current device manual and complete device-specific training; this reference is not a substitute.

Manufacturer guides & troubleshooting

Cynosure Lutronic Australia — Healite II product page — Official ANZ distributor product page (specs, indications).
Cynosure Lutronic Australia — Request Clinical Training — Operator manual & on-site training are provided by the distributor — request here.
Cynosure Lutronic Australia — Book a Service / technical support — Service, troubleshooting and technical support channel.
Lutronic / Cynosure — global product line — Manufacturer provider portal (manuals / MSDS via 'I need clinical training, a manual or MSDS request').
Healite II with Photo-Sequencing Technology (clinical overview PDF) — Practitioner-facing technology overview.

References

L

InMode · IPL handpiece on the InMode Optimas / Triton platform · Type B applied part · confirm TGA ARTG entry

A high peak-power intense pulsed light handpiece for photorejuvenation — the treatment of superficial vascular and pigmented lesions. Two handpieces are available: Lumecca 515 for lighter skin and Lumecca 580 for darker skin and deeper vascular targets. A pre-cooled 30 × 10 mm light guide protects the epidermis while delivering high fluence to the target chromophore.

Device specifications

Device class	IPL handpiece for the InMode Optimas / Triton platform
Handpieces	Lumecca 515 (REF AS601863A) and Lumecca 580 (REF AS601864A)
Spectral output	515–1200 nm (Lumecca 515) · 580–1200 nm (Lumecca 580)
Fluence	5–30 J/cm², system starts at the minimum setting
Light guide / spot	Pre-cooled light guide, 30 × 10 mm
Pulse width	Selectable Short or Long
Cooling	Selectable Normal or Strong contact cooling
Pulse mode	Single pulse, or Auto-Repeat in Normal or Fast repetition rate
Applicator	Flash lamp and reflector emitting optical energy through the pre-cooled light guide; 170 cm cable
Eye protection	Protective eyewear required at the Lumecca IPL wavelength range of 515–1200 nm
Compliance	IEC 60601-1-2 Ed. 4.0 (2014), professional healthcare facility environment

Mode of delivery

Selective photothermolysis — broadband light penetrates the skin and is preferentially absorbed by the lesion chromophore (melanin or haemoglobin) where it is darker than surrounding tissue; the absorbed energy converts to heat and coagulates the lesion, which fades over the following weeks.
Cut-off filter selects depth and safety margin — the 515 nm handpiece passes more of the high-absorption 500–600 nm band for superficial pigment and vessels in light skin; the 580 nm handpiece removes the shorter wavelengths to reduce epidermal melanin absorption in darker skin and reach deeper vascular targets.
Pre-cooled light guide provides contact cooling of the epidermis (Normal or Strong) throughout the pulse.
Fine textural change — macro-pores and fine lines — may improve alongside the pigmented and vascular clearance as part of photorejuvenation.
Multiple treatment sessions are typically required. Applied with slight pressure, moving to adjacent areas without overlap; a second pass in a different direction may be performed if endpoints are not obvious after a few minutes.

Indications

Treatment of superficial vascular and pigmented lesions on skin types I to IV.
Photorejuvenation — with secondary improvement in fine textural lesions such as macro-pores and fine lines.
Confirm the indications applicable to the Australian ARTG entry and the platform configuration in clinic.

Contraindications (including medication)

Current or history of skin cancer, current condition of any other type of cancer, or pre-malignant moles.
Pregnancy and nursing.
Use of isotretinoin (Accutane) within 6 months prior to treatment.
Known skin photosensitivity, or use of drugs that increase skin photosensitivity.
Diseases that may be stimulated by light — such as epilepsy, lupus and urticaria.
Impaired immune system due to immunosuppressive disease (e.g. AIDS, HIV) or use of immunosuppressive medications.
Severe concurrent conditions, such as cardiac disorders or sensory disturbances.
Poorly controlled endocrine disorders, such as diabetes or thyroid dysfunction, and hormonal virilisation.
History of diseases stimulated by heat, such as recurrent herpes simplex in the treatment area — may be treated only under a prophylactic regimen.
Any active condition in the treatment area — sores, psoriasis, eczema, rash.
History of skin disorders, keloids or abnormal wound healing, and very dry or fragile skin.
Vitiligo.
Skin types V and VI, and excessively tanned skin from sun, tanning beds, or tanning creams and sprays within the last two weeks.
A delay is recommended if other light, laser or RF treatments were recently performed on the area.

Practitioner cautions & safety

Do not treat the upper eyelids or the lips.
Do not treat over tattoos or permanent make-up.
Permanent hair reduction may occur in the treated area — counsel patients before treating hair-bearing sites.
Do not treat over areas with a high density of hair — absorption of light by hair follicles may cause an adverse skin reaction.
"Lumecca is a very powerful handpiece — take care with treatment parameters." Always start low, perform a test spot in a non-conspicuous area and wait 10–15 minutes to check the response before proceeding.
Protective eyewear must be worn by patient and operator for the 515–1200 nm range.
Possible adverse effects: discomfort or pain, excessive erythema and/or oedema, damage to skin texture (crust, blister, burn), hyper- and hypo-pigmentation, and scarring. Erythema lasting no longer than 24 hours is a typical reaction.
Post-treatment: sun block for 3 weeks following treatment; moisturiser and make-up may be applied immediately.

Manufacturer treatment settings (starting guide — titrate to endpoint)

Skin type	Lesion type	Handpiece	Fluence	Pulse width
I–II	Pigmented lesions	515 nm	8–12 J/cm²	Short / Long
I–II	Vascular lesions	515 nm	12–16 J/cm²	Short / Long
III–IV	Pigmented lesions	580 nm	6–12 J/cm²	Short / Long
III–IV	Vascular lesions	580 nm	10–16 J/cm²	Long

Typical treatment parameters from the InMode operator manual (Section 8) held on file. Cooling: Strong for all rows above. Always start at a low setting to check patient tolerance, test, then increase fluence gradually without compromising safety. Test spot and wait 10–15 minutes before proceeding.

Manufacturer guides & troubleshooting

InMode — manufacturer site — Provider resources, training and technical support.
InMode Lumecca — peak power evaluation (PDF) — Manufacturer technical paper on peak power and skin rejuvenation.

Source documents (held internally)

InMode Lumecca Advanced IPL Operator Manual.pdf — InMode Triton/Optimas operator manual — Section 8 covers Lumecca indications, contraindications, parameters and technique. Primary source. **Note:** this is the multi-handpiece platform manual; other sections cover Diolaze XL, Vasculaze, Fractora/Morpheus8, Forma/Plus and BodyFX.
Lumecca Advanced IPL Maintenance Manual V2.pdf — Maintenance guidance including water fill/drain for the Lumecca handpiece.

Manufacturer documentation held internally by AptiusIQ as the source for this entry. Not published with this module — request access through your clinic lead or the manufacturer links above.

References

T

Solta Medical (Bausch Health) · Monopolar RF at 6.78 MHz · maximum average power 400 W · confirm TGA ARTG entry

A monopolar radiofrequency system that heats the deep dermis and subdermal tissue volumetrically while cryogen cools and protects the epidermis, producing collagen contraction and remodelling for non-invasive tightening. The FLX generation adds AccuREP impedance feedback, which measures tissue impedance and adjusts energy delivery pulse by pulse, and simultaneous vibration for comfort.

Device specifications

Device class	Monopolar radiofrequency generator with treatment tips and return (grounding) pad
RF frequency	6.78 MHz ± 0.1%
Maximum average power	400 W
Maximum current	2.0 A RMS + 10%
Duty cycle	50%, intermittent use
Treatment tips	Total Tips 3.0 cm² and 4.0 cm² for face and off-face body areas (single-use, with integrated thermistors)
Energy control	AccuREP — automatic impedance measurement and energy adjustment for uniform heating
Comfort features	Simultaneous vibration (adjustable level) and cryogen epidermal cooling
AC input	100–240 V, 50/60 Hz, 10 A (must be connected to a protective-earth outlet; no extension cords or adapter plugs)
Console	49.5 cm W × 43 cm L × 125.7 cm H · approximately 45 kg (100 lb) · IPX0
Cable lengths	Power cord 3 m · footswitch 3 m · handpiece 2 m · return pad 2 m
Operating environment	10–30 °C · up to 90% RH non-condensing

Mode of delivery

Monopolar RF circuit — current flows from the treatment tip (active electrode) into the tissue, through the body, and returns via the grounding/return pad, producing volumetric heating well below the skin surface.
Capacitive coupling with simultaneous cooling — cryogen is delivered to the tip's contact surface before, during and after each pulse so the epidermis stays cool while the dermis and fibrous septae reach collagen-contraction temperatures.
AccuREP impedance feedback measures the patient's tissue impedance and adjusts output for each pulse, giving more uniform heating and better tolerability than earlier ThermaCool / NXT / CPT generations.
Vibration is applied simultaneously with RF to modulate the sensation of heat (gate-control effect), improving comfort.
The treatment tip must be held with all four corners in full contact with the skin and with adequate coupling fluid; the system enforces force and temperature limits and will fault out if technique is incorrect.

Indications

RF energy delivery components — dermatologic and general surgical procedures for electrocoagulation and haemostasis; non-invasive treatment of periorbital wrinkles and rhytids including upper and lower eyelids; non-invasive treatment of wrinkles and rhytids.
Simultaneous RF and skin vibration — as above, plus temporary improvement in the appearance of cellulite; relief of minor muscle aches and pains; relief of muscle spasms; and temporary improvement of local blood circulation.
CE-marked indications are narrower than the US set — confirm the indications applicable to the ARTG entry for the Australian market.
Use for indications other than those in the manual is off-label; the side-effect profile of off-label treatment has not been evaluated in clinical studies.

Contraindications (including medication)

Implantable pacemaker, automatic implantable cardioverter/defibrillator (AICD), or any other implantable electrical device — these may be adversely affected by the RF field or current. This is the manufacturer's contraindication for all regions.
Do not use metal eye shields. For treatment over the eye (upper and lower eyelid, or within the periorbital rim) plastic ocular shields must be used.
Do not use any form of numbing / topical anaesthetic during Thermage treatment — patient heat feedback is the primary safety signal for titrating treatment level.

Practitioner cautions & safety

Must be used by health care professionals with adequate training in the device.
Metal dental work — use caution treating skin directly over dental metal. For large surface areas (crowns, braces, implants) place dry absorbent cotton rolls between the dental work and the inner cheek to prevent RF heating, which can cause skin burns, dental pain and damage to the dental work.
Major nerve bundles — professional discretion is required when treating body areas in proximity to major nerve bundles; nerve damage may otherwise result. Be aware of potential risks from neuromuscular stimulation.
Most frequent side effect is mild to moderate pain during treatment; rarely, patients report transient aching in the treatment area lasting up to several months.
Burns — the procedure heats the upper layers of the skin and may cause burns with subsequent blister and scab formation; there is a small chance of scar formation. Topical steroid or antibiotic preparations may help.
Surface irregularities — localised dents, rippling, ridging, "waffle" patterns, or fat loss over a larger area; frequently not evident immediately post-treatment and may appear up to a month or more later.
Guide treatment level by client feedback about heat sensation at every pass; ensure adequate coupling fluid and full tip contact throughout.

Troubleshooting (from manufacturer guide)

Issue / error	Probable cause	Resolution
EC78C — tip too warm (ERR_TREATMENT_TIP_TEMP_HIGH)	One or more thermistors above the temperature limit	Verify proper treatment technique, position and orientation; ensure all four corners of the tip contact the skin; ensure plenty of coupling fluid.
EC486 — tip too hot (ERR_TREATMENT_TIP_TOO_HOT)	Average thermistor temperature above average	Press and release the blue activation button (or foot pedal) briefly, 2–3 times maximum, away from the treatment area; ensure treatment level is guided by client heat feedback; repeat with adequate tip-to-skin contact.
EC78D — ERR_ACTIVATION_BUTTON_TIMED_OUT_ARM	Not releasing the activation button and not removing skin contact after the tone ends	Release the blue activation button (or foot pedal) and remove contact with the skin; repeat the operation.
EC78E — ERR_FORCE_BEFORE_ACTIVATION	Pushing down on the skin before pressing the activation button	Ensure the blue activation button (or foot pedal) is fully depressed before making contact with the skin; repeat the operation.
EC78A — ERR_TREATMENT_TIP_FORCE_HIGH	Pressing too hard on the skin (using excessive force)	Ensure consistent contact with the skin; do not drag the tip over the skin; lift the tip off the skin completely when the tone ends; repeat the operation.
EC78B — ERR_TREATMENT_TIP_FORCE_LOW	Not pressing hard enough on the skin (using insufficient force)	Ensure consistent contact with the skin; do not drag the tip over the skin; lift the tip off the skin completely when the tone ends; repeat the operation.
INVALID TREATMENT TIP	Tip not recognised by the system (often contamination on the handpiece pins)	Turn off the Thermage FLX; detach the treatment tip; clean the handpiece including the pins with an alcohol wipe; re-attach the tip and turn the system on.
Handpiece care between treatments	Residual coupling fluid and dust	Remove coupling fluid from the handpiece including the pins; wipe a used tip clean and leave it on the handpiece to keep dust out (fit a new tip for the next treatment); detach the handpiece if the machine will be unused for 2 weeks or more.

Manufacturer guides & troubleshooting

Thermage FLX — HCP site (Solta) — Manufacturer provider site and Important Safety Information.
Thermage — Important Safety Information — Indications and safety information.
Solta Medical — manufacturer site — Operator manuals and provider resources.
Solta ANZ Technical Service — Australia/NZ technical service: **1800 251 150** · anztechservice@solta.com (per the supplied AU troubleshooting guide).

Source documents (held internally)

FLX Operator Manual Solta Medicak 0308.pdf — Full user manual (P009418-04 Rev A) — indications, contraindications, safety information, electrical and mechanical specifications. Primary source.
Thermage FLX Troubleshooting Guide THR.0034.AU.23.pdf — Australian troubleshooting guide — error codes, causes, resolutions and handpiece care (source of the troubleshooting table above).
SoltaThermage FLX.pdf — Solta Thermage FLX overview. **Note:** supplied file is an image-only scan with no text layer.
Comparative histometric analysis HIFU and RF_SUH 2015.CAL (4).pdf — Supporting evidence — comparative histometric analysis of HIFU and RF-induced tissue effects.

Manufacturer documentation held internally by AptiusIQ as the source for this entry. Not published with this module — request access through your clinic lead or the manufacturer links above.

References

Cutera · Electrical muscle stimulation (EMS) system · 4 kHz operating frequency · confirm TGA ARTG entry

An electrical muscle stimulation body-sculpting platform indicated for muscle strengthening, toning and firming. Multiple handpieces are applied to the target muscle groups and deliver a controlled 4 kHz stimulation waveform to drive involuntary muscle contraction. Because it delivers electrical current into muscle, the contraindication set is largely cardiac, neurological and implant-related rather than dermatological.

Device specifications

Device class	Electrical muscle stimulation (EMS) body-sculpting system
Frequency of operation	4 kHz
Maximum current density	1.14 mA/cm²
Maximum power density	0.0289 W/cm² at 500 Ω
Electrical input	100–240 VAC · 50/60 Hz · 75 VA
Console	0.36 m W × 0.44 m L × 1.02 m H (with cradle) · 32.66 kg (72 lb) · 3.66 m power cable
Operating environment	10–30 °C · 0–90% RH non-condensing · up to 3,658 m altitude
Transport and storage	−10 to 50 °C · 0–90% RH non-condensing

Mode of delivery

Electrical muscle stimulation — current delivered through skin-contact handpieces depolarises motor nerves and produces involuntary contraction of the underlying muscle group, independent of voluntary effort.
The 4 kHz operating frequency with a low maximum current density (1.14 mA/cm²) is selected to recruit muscle at a tolerable sensation level.
Multiple handpieces are placed over the target muscle groups (typically abdomen, flanks, glutes, thighs) and run through a programmed sequence.
Not a thermal or dermatological treatment — it does not heat or resurface tissue, and does not act on adipose tissue in the way that truSculpt iD does.

Indications

truSculpt flex is indicated for muscle strengthening, toning, and firming.

Contraindications (including medication)

Cardiac pacemakers, defibrillators, or other implanted electronic devices.
Metallic implants under the treatment area.
Epilepsy.
Cancerous lesions.
Acute trauma or fracture.
Recent surgical procedures.
Abdominal or inguinal hernia.
Critical ischaemia of the lower limbs.
Blood flow deficiencies / venous thrombosis.

Practitioner cautions & safety

Do not treat pregnant patients without physician evaluation — the safety of stimulation during pregnancy or delivery has not been established.
Do not treat patients with known myocardial arrhythmia without physician evaluation.
Do not treat patients with chronic abdominal, gut or intestinal conditions (e.g. Crohn's disease, colitis, Graves' disease) without physician evaluation.
Do not treat transthoracically — introducing electrical current into the heart may cause cardiac arrhythmia. Do not treat transcerebrally.
Do not treat over the neck and mouth — severe spasm of the laryngeal and pharyngeal muscles may occur, closing the airway and causing difficulty breathing.
Do not treat over the carotid sinus nerves, particularly in patients with known sensitivity to the carotid sinus reflex.
Do not treat the eye area.
Do not treat over swollen, infected or inflamed areas or skin eruptions — e.g. phlebitis, thrombophlebitis, varicose veins. Do not treat over metal implants.

Manufacturer guides & troubleshooting

Cutera truSculpt flex — product page — Manufacturer device page.
Cutera — support & service — Technical service, manuals and training requests.

Source documents (held internally)

TruSculpt Flex Operator guide.pdf — Full operator manual (D002606 Rev C, 06/20) — specifications, indications, contraindications, warnings and precautions. Primary source.

Manufacturer documentation held internally by AptiusIQ as the source for this entry. Not published with this module — request access through your clinic lead or the manufacturer links above.

References

Cutera truSculpt flex Operator Manual, D002606 Rev C (held on file)

Cutera · Monopolar RF body-contouring system · confirm TGA ARTG entry and current IFU

A monopolar radiofrequency body-contouring platform that heats subcutaneous adipose tissue to a therapeutic target temperature to reduce localised fat pockets. Delivered through hands-free or hand-held 40 cm² handpieces for larger areas, or a hand-held 16 cm² handpiece for smaller and anatomically difficult areas. There are no skin-type restrictions for RF treatment.

Device specifications

Device class	Monopolar radiofrequency body-contouring system
Handpieces	40 cm² hands-free (multiple placed over localised fat pockets, covering up to ~144 cm²), 40 cm² hand-held, and 16 cm² hand-held for soft tissue or anatomically difficult areas
Treatment control	Target temperature is raised gradually to a therapeutic endpoint and can be reduced quickly at patient request; treatment is not intended to be painful
Skin types	No skin-type restrictions for radiofrequency treatment with truSculpt iD
Treatment regimen — 40 cm²	Typically 1 treatment; if repeating the same area, wait the full 12 weeks for optimal results
Treatment regimen — 16 cm²	2–4 treatments, typically spaced 4–6 weeks apart
Onset of results	Typically visible 6–8 weeks after treatment; results can take up to 12 weeks
Full technical specifications	Not in the supplied documentation — the truSculpt iD Operator Manual (shipped with the system) holds the full specification, indication and contraindication list. See the gap note in cautions.

Mode of delivery

Monopolar RF heating — radiofrequency current passes through the tissue and preferentially heats subcutaneous fat, raising it to a therapeutic temperature that is held for the treatment cycle.
Target temperature is increased slowly so the patient acclimatises comfortably, and can be decreased quickly if desired — patient feedback is the control signal for the treatment level.
Hands-free 40 cm² handpieces are placed over multiple localised fat pockets within templates and run simultaneously, covering a larger area without the operator holding the applicator.
Hand-held handpieces (40 cm² and 16 cm²) are used within templates or over anatomically difficult areas where a fixed applicator will not sit flush.
The RF handpiece must maintain full contact with the skin throughout treatment for safe and even energy delivery.

Indications

Non-invasive body contouring — reduction of localised subcutaneous fat pockets.
Patients should be in general good health with focal areas of concern.
Refer to the truSculpt iD Operator Manual for the full, current list of indications for use — the supplied clinical guide is a US treatment guide and explicitly defers to the operator manual.

Contraindications (including medication)

Patients who are or may be pregnant.
Do not treat near or over reproductive organs.
Do not treat over implanted devices — including metallic implants, electronic implants, time-released medical implants, and superficially placed body-contouring implants.
Do not treat patients who have cardiac pacemakers or internal defibrillators.
Do not use any anaesthetic, including inhalation anaesthetics. Patient feedback is necessary to determine optimal treatment levels and to help prevent adverse reactions; topical anaesthetics may also damage the RF handpiece electrode.
⚠ This list is not complete. The supplied document is a treatment guide, not the operator manual — obtain the full contraindication, warning and precaution list from the truSculpt iD Operator Manual before clinical sign-off.

Practitioner cautions & safety

Operate only with appropriate training and after thoroughly reading the truSculpt iD Operator Manual; check with the local medical governing body regarding who may legally administer treatment.
Obtain a complete medical history and signed informed consent — truSculpt iD is a medical device.
Self-tanner used within the past week may leach onto the RF handpiece electrode during treatment and leave a permanent mark.
Expected post-treatment (40 cm²): hyperaemia expected, typically resolving within 24 hours; oedema may develop and typically resolves within 4 days; palpable tender nodules or lumps were reported in approximately 20% of subjects in clinical trials and resolved without medical intervention within 6 weeks — advise twice-daily massage until they dissipate.
Expected post-treatment (16 cm²): hyperaemia typically resolving within a few hours; mild oedema and tenderness typically resolving within 24 hours.
Advise patients to make contact if they develop blisters, crusting or skin burns; redness or swelling persisting beyond 4 days (40 cm²) or 24 hours (16 cm²); or tenderness, nodules or lumps persisting beyond 6 weeks.
Possible adverse effects also include infection where the skin surface is disrupted, rare scarring, and skin colour change.

Manufacturer guides & troubleshooting

Cutera truSculpt — product page — Manufacturer device page.
Cutera — support & service — Request the truSculpt iD Operator Manual, technical service and training.

Source documents (held internally)

TruSculpt Guide.pdf — Cutera truSculpt iD clinical treatment guide (D2235 rG, January 2021, US) — patient selection, handpiece use, treatment regimens and post-treatment expectations. **Defers to the Operator Manual for the full contraindication list, which is not in the supplied set.**

Manufacturer documentation held internally by AptiusIQ as the source for this entry. Not published with this module — request access through your clinic lead or the manufacturer links above.

References

Cutera truSculpt iD Clinical Treatment Guide, D2235 rG (held on file)

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