Clinical Safety & Usage Handbook

Clinical Safety & Usage Handbook – Overview

This Clinical Safety & Usage Handbook is designed to help you use your Skinneedlepro device safely, responsibly, and effectively in a home setting.

Skinneedlepro devices use microneedling technology (also known as Collagen Induction Therapy) to create controlled micro-channels in the skin’s surface. When used correctly, this process may support smoother-looking skin and improved absorption of topical skincare products. However, microneedling involves skin penetration and must be performed with care.

This handbook provides clear, step-by-step guidance on:

  1. Safe device handling and preparation;
  2. Correct cartridge selection and single-use requirements;
  3. Appropriate needle depths for different facial areas;
  4. Hygiene, sterilisation, and infection-prevention practices; and
  5. Aftercare and skin recovery guidelines.

The information in this handbook is intended for general guidance only and is written for consumer home use, not professional or clinical treatment. It does not replace medical advice. Results and tolerance vary between individuals.

Improper use of microneedling devices may cause adverse effects including irritation, infection, scarring, or changes in pigmentation. Following the instructions in this handbook is essential to minimise risk.

If you have a pre-existing skin condition, active acne, a history of abnormal scarring, are pregnant, or are unsure whether microneedling is suitable for you, consult a qualified healthcare professional before use.

By using a Skinneedlepro device, you acknowledge that you have read and understood this handbook and agree to follow the safety instructions contained within it.

⚠️ Important Medical & Safety Notice

This handbook is provided strictly for educational and informational purposes.

This device is a cosmetic tool and not a medical device. Microneedling involves controlled skin injury and carries inherent risks including infection, scarring, pigmentation changes, irritation, and allergic reactions.

By accessing and using this information, you acknowledge that you assume all risks associated with microneedling and agree to consult a qualified medical professional if unsure of suitability.

If you do not agree, do not proceed.

Medical Contraindications (Do Not Use)

Do not use this device if you have active acne, open wounds, infections, herpes simplex, fungal or bacterial skin conditions, a history of keloid scarring, bleeding disorders, uncontrolled diabetes, autoimmune conditions, or if you are pregnant or breastfeeding.

If you are under medical treatment or unsure of suitability, consult your healthcare provider before use.

Physiological Mechanisms of Collagen Induction

To operate the “Electric Microcrystal Introducer” safely, the user must understand the biological cascade it initiates. The device does not merely puncture the skin; it modulates the body's wound-healing mechanism to restructure the extracellular matrix.

3.1 The Histology of Micro-Trauma

The skin is a complex organ comprised of the epidermis (barrier) and the dermis (structural support). The microneedling pen uses a vertical reciprocating motor to drive needles through the stratum corneum and into the viable tissue. This creates a “micro-channel,” a controlled physical wound that triggers three distinct physiological phases:

• Hemostasis and Inflammation (Hours 0-72):

Upon penetration of the papillary dermis, rupture of capillaries leads to pinpoint bleeding. Platelets aggregate at the injury site, releasing chemotactic factors such as Platelet-Derived Growth Factor (PDGF) and Transforming Growth Factor Beta (TGF-β). Neutrophils invade the wound to clear debris and bacteria. Clinically, this manifests as erythema (redness), edema (swelling), and warmth. This inflammation is not a side effect; it is the catalyst for repair.

• Proliferation (Days 3-21):

Fibroblasts migrate to the micro-channels, stimulated by the growth factors released during inflammation. They begin to synthesize a provisional extracellular matrix composed of Type III (embryonic) collagen, elastin, and glycosaminoglycans (hyaluronic acid). Simultaneously, angiogenesis (formation of new blood vessels) occurs to supply oxygen to the rebuilding tissue. This is the “induction” phase where the skin physically thickens.

• Maturation and Remodeling (Months 1-24):

Over several months, the Type III collagen is slowly replaced by stronger, more organized Type I collagen. The collagen fibers align along the stress lines of the skin, resulting in tightening and smoothing of wrinkles and scars. This phase can continue for up to two years post-treatment.

3.2 Transdermal Drug Delivery (Nano-Infusion)

Distinct from collagen induction, the Nano-cartridge functions via a different mechanism. It utilizes a silicone or steel chip with microscopic pyramids (approx. 0.15mm height) that do not penetrate the dermis. Instead, they separate the keratinocytes of the stratum corneum, creating transient aqueous channels. This bypasses the skin's lipid barrier, allowing large molecules (like Hyaluronic Acid) to penetrate the epidermis by up to 3000% more effectively than topical application alone, without triggering a full wound-healing response.

Device Overview & Intended Use

The SkinNeedlePro microneedling system is an automated cosmetic device designed to support skin texture refinement and enhanced topical product absorption.

It is intended for personal, non-commercial cosmetic use only and must be operated strictly in accordance with safety guidance.

Device Architecture & Technical Specifications

Based on the provided manual images and technical research, the “Electric Microcrystal Introducer” is a precision-engineered instrument. Proper handling of its components is essential for consistent motor performance and needle depth accuracy.

4.1 Technical Schematics

The device consists of the following key components:

Reciprocating Motor: The core engine that converts electrical energy into vertical mechanical motion. The stability of the motor determines the cleanliness of the puncture; a weak motor may cause the needles to drag or snag.

Integrated Chip: A microprocessor that regulates the RPM (Revolutions Per Minute) of the motor, ensuring consistent speed even as resistance (skin thickness) changes.

Adjustor Ring (Graduated Display): A rotary dial located on the neck of the pen. This mechanism physically extends or retracts the cartridge seating, controlling needle depth from 0.25mm to 2.5mm.

Power System:

  • Input Voltage: 5V 1A (Standard USB protocol).
  • Battery Specification: 3.7V 0.25A Lithium-ion.
  • Charging Time: Approximately 2 hours for a full cycle.
  • Operation: The device can operate wirelessly (approx. 2-3 hours) or wired.

Note: Using the device while wired ensures maximum consistent voltage to the motor, preventing RPM drops during deep needling.

4.2 Cartridge Configurations

The website offers three cartridge types, each engineered for specific hydrodynamic and mechanical interactions with the skin.

The 12-Needle Cartridge

Configuration: 12 stainless steel needles arranged in a circle.

Physics (The Fakir Effect): With fewer needles, there is greater spacing between insertion points. This results in higher pressure per needle (Force / Area).

Indication: This high-pressure configuration allows the needles to penetrate tough, fibrotic tissue such as deep acne scars (ice-pick, boxcar), surgical scars, and stretch marks. It is the “heavy artillery” of microneedling.

Risk Profile: Higher risk of pain and bleeding; requires lower speed settings to prevent tearing.

The 36-Needle Cartridge

Configuration: 36 fine needles arranged in a dense grid.

Physics: The high density of needles creates a “bed of nails” effect (Fakir effect), distributing the pressure over a larger area. This reduces the penetration force per needle, making it less painful and less likely to penetrate deep scar tissue, but highly effective for surface saturation.

Indication: General skin rejuvenation, fine lines, large pores, hyperpigmentation, and loose skin. Ideal for larger areas (cheeks, forehead, neck) where uniform coverage is priority over depth.

Risk Profile: Moderate. If moved too quickly, the dense needles can create a “slicing” effect; requires higher RPM settings.

The Nano Cartridge

Configuration: A grid of microscopic silicone or steel pyramids (nano-pins).

Physics: Non-invasive oscillation. Does not breach the dermal-epidermal junction.

Indication: Transdermal delivery of serums, treatment of delicate areas (eyelids, lips), and daily or weekly maintenance for “glow.”

Risk Profile: Very low. No downtime, no bleeding, no anesthesia required.

Needle & Cartridge Types

Nano, 12-pin, and 36-pin cartridges are designed for different cosmetic applications.

All cartridges are sterile and single-use only. Reuse or sharing of cartridges significantly increases the risk of infection and skin injury.

Pre-Operative Protocols: Establishing the Sterile Field

In a clinical setting, an aseptic field is mandatory. The home user must replicate this environment to prevent the introduction of pathogens into the open micro-channels.

5.1 Environment and Equipment Preparation

Sanitization: Select a clean, non-porous surface (e.g., countertop). Disinfect the surface with an antibacterial wipe or alcohol spray.

Mise en place: Arrange the following items:

  • The Microneedling Pen (Charged).
  • Selected Cartridge (Sealed).
  • 70% Isopropyl Alcohol (in a small cup and a spray bottle).
  • Cotton pads or sterile gauze.
  • Serum (High Molecular Weight Hyaluronic Acid ONLY).
  • Disposable gloves (Nitrile recommended).
  • Paper towel (Clean).

5.2 Cartridge Sterilization Protocol

Although cartridges are supplied in sterile blister packs, a secondary sterilization step is a critical redundancy to ensure safety.

Inspect: Open the blister pack and inspect the needles. If any needle appears bent or hooked, discard the cartridge immediately.

Soak: Pour 70% Isopropyl Alcohol into a small cup. Dip the needle tip of the cartridge into the alcohol and let it soak for 1-2 minutes.

Note: Use 70% alcohol, not 99%. The water content in 70% alcohol is required to penetrate the cell walls of bacteria and denature their proteins effectively. 99% alcohol evaporates too quickly to ensure sterilization.

Dry: Remove the cartridge and allow it to air dry completely (approx. 1 minute) on a clean paper towel. Alcohol residue can sting and irritate the skin.

5.3 Skin Decontamination

The skin surface must be surgically clean. Makeup residue, sunscreen, or surface bacteria pushed into the dermis can cause granulomas (foreign body reactions) or infection.

Double Cleanse:

  • Step 1: Use an oil-based cleanser or balm to dissolve makeup, SPF, and sebum.
  • Step 2: Follow with a gentle, pH-balanced foaming cleanser to remove residue. Rinse thoroughly with warm water.

The Alcohol Wipe (Defatting):

  • Saturate a cotton pad with 70% Isopropyl Alcohol.
  • Wipe the entire treatment area firmly. This step removes the lipid barrier and kills resident bacteria. It may sting, but it is non-negotiable for safety.

Numbing (Optional):

If using a topical anesthetic (5% Lidocaine), apply a thick layer and leave for 20-30 minutes.

CRITICAL: You must completely remove the numbing cream before needling. Wipe the skin with alcohol again to ensure no cream enters the micro-channels, which could cause systemic toxicity or severe irritation.

Standard Operating Procedure (SOP): Device Operation

This section details the step-by-step operation of the device, integrating the manufacturer’s instructions with clinical best practices.

6.1 Device Assembly and Setup

Mounting the Cartridge:

  • Identify the slot on the top of the pen.
  • Insert the sterilized cartridge into the slot.
  • Twist the cartridge clockwise into the locking bayonet until a firm click or resistance is felt. This ensures the cartridge cannot eject during high-speed oscillation.

Adjusting Needle Length:

  • Locate the Adjustor Ring (graduated depth dial).
  • Rotate the ring until the desired depth aligns with the indicator mark.
  • Always visually confirm needle extension before contacting skin, as mechanical tolerance may vary between units.

Powering On:

  • Press and hold the Power button for 2–3 seconds.
  • The device will start at the lowest speed setting.
  • Short-press the button to cycle through speed levels (typically 1–5 or 1–6 depending on model).

6.2 Glide Medium (Slip Agent Requirement)

Microneedling on dry skin is unsafe and can cause tearing or scratching.

Recommended:

  • High Molecular Weight Hyaluronic Acid (HA) only.
  • Non-immunogenic, hydrating, and compatible with open micro-channels.

Prohibited:

  • Vitamin C (L-Ascorbic Acid)
  • Retinoids
  • Exfoliating acids (AHA/BHA)
  • Thick creams or oils

Introducing reactive ingredients into the dermis may cause granulomas, chemical burns, or prolonged inflammation.

Operational Techniques & Facial Mapping

Two distinct techniques may be used depending on cartridge type, depth, and treatment area.

Technique A: Stamping (Safety Standard)

Execution:

  • Place the pen vertically onto the skin
  • Allow needles to penetrate
  • Lift straight up
  • Move to adjacent area and repeat

Physics:

  • Ensures vertical micro-channels
  • Eliminates lateral shear and tearing

Indications:

  • Beginners
  • Scar treatment

  • Deep needling (>0.75mm)
  • Nose, upper lip, and contoured areas

Compatible Cartridges:

  • 12-Pin
  • 36-Pin

Technique B: Gliding (Advanced Application)

Execution:

  • Apply generous serum
  • Hold skin taut
  • Glide slowly at approx. 1cm per second

Physics:

  • RPM must exceed lateral hand movement
  • Incorrect speed causes “tram-track” scratches

Indications:

  • Large flat areas (forehead, cheeks)
  • Nano infusion
  • Shallow depths (<0.5mm)

Compatible Cartridges:

  • 36-Pin
  • Nano

6.4 Facial Depth Guidelines (Home Use Limits)

Forehead:

  • 0.25mm – 0.5mm
  • 36-Pin or Nano
  • Gliding

Cheeks:

  • 0.5mm – 1.0mm
  • 36-Pin or 12-Pin (scars)
  • Stamping or Gliding

Nose:

  • 0.25mm maximum
  • 36-Pin
  • Stamping only

Upper Lip:

  • 0.25mm – 0.5mm
  • 36-Pin or 12-Pin
  • Stamping

Chin:

  • 0.5mm – 1.0mm
  • 12-Pin or 36-Pin

Stamping

Peri-Orbital Area (Eyelids):

  • Nano only
  • Nano depth

Gliding

Jawline:

  • 0.75mm – 1.0mm
  • 12-Pin or 36-Pin

Gliding

Speed Guidance:

  • Face: Speed 3–5
  • Body: Speed 5–6

Treatment Guidelines & Frequency

Excessive pressure, incorrect depth, or overuse may cause skin damage.

Allow adequate recovery time between sessions. Do not treat the same area repeatedly in short intervals.

Post-Treatment Care & Risks

Temporary redness, warmth, or sensitivity may occur.

Avoid sun exposure, makeup, active skincare ingredients, and excessive heat immediately after treatment. Improper aftercare may increase the risk of pigmentation changes or irritation.

Cartridge-Specific Treatment Protocols

Each cartridge configuration requires a distinct protocol to ensure safety and effectiveness.

7.1 Nano-Infusion Protocol (“The Glow”)

Objective: Hydration, radiance, enhanced serum absorption

  • Cartridge: Nano
  • Frequency: Weekly
  • Downtime: None

Steps:

  1. Cleanse and gently exfoliate skin
  2. Apply non-reactive serum (Niacinamide or Arbutin; no acids)
  3. Set pen to Nano depth or 0.25mm at high speed
  4. Glide in circular motions for 5–10 minutes
  5. Massage remaining serum into skin
  6. Apply moisturizer

7.2 Collagen Induction Protocol (“The Reconstruction”)

Objective: Texture improvement, fine lines, laxity

  • Cartridge: 36-Pin
  • Frequency: Every 4–6 weeks

Steps:

  1. Perform full sterile preparation
  2. Apply Hyaluronic Acid to one facial section
  3. Set depth to 0.5mm
  4. Perform cross-hatch pattern (vertical + horizontal)
  5. Increase depth to 0.75mm–1.0mm on cheeks if tolerated
  6. Limit to 2–3 passes per area
  7. Pinpoint bleeding is acceptable; excessive bleeding is unnecessary

7.3 Scar Revision Protocol (“The Deep Treat”)

Objective: Break down fibrotic scar tissue

  • Cartridge: 12-Pin
  • Frequency: Every 4–6 weeks
  • Downtime: 2–3 days

Steps:

  1. Identify individual scars only
  2. Apply Hyaluronic Acid
  3. Set depth to 1.0mm–1.5mm
  4. Hold skin taut
  5. Stamp directly into each scar 3–4 times
  6. Do not treat the entire face at this depth

Adverse Reactions & Troubleshooting

The following reactions may occur. Correct response is critical.

Persistent Redness (Beyond 48 Hours):

  • May indicate inflammation or infection
  • Discontinue all active products
  • Apply cold compress
  • Seek medical attention if heat, swelling, or pus develops

Itching:

  • Normal histamine response to wound healing
  • Do not scratch
  • Oral antihistamines may reduce symptoms

Dryness & Flaking:

  • Normal epidermal shedding
  • Maintain heavy hydration
  • Do not pick or exfoliate

“Tram-Track” Scratches:

  • Caused by gliding too fast or insufficient RPM
  • Treat as superficial scratches
  • Keep skin moisturized
  • Do not re-needle until fully healed

If symptoms worsen or fail to resolve, consult a qualified medical professional.

Hygiene, Disposal & Maintenance

Used cartridges are classified as sharps and must be disposed of safely.

Clean the device according to manufacturer instructions. Never share devices or cartridges between users.

Medical Disclaimer & Liability Framework

IMPORTANT SAFETY NOTICE – PLEASE READ CAREFULLY

This Clinical Safety & Usage Handbook provides general guidance to support the safe, responsible home use of Skinneedlepro devices.

Skinneedlepro devices are cosmetic tools designed for personal, non-professional use only. They are not medical devices and are not intended to diagnose, treat, cure, or prevent any medical condition.

Microneedling involves controlled penetration of the skin surface. When used incorrectly, it may cause adverse effects including irritation, infection, scarring, or changes in pigmentation. Following the instructions in this handbook is essential to reduce these risks.

The information provided is general information only and does not constitute medical advice. Individual skin response varies.

By using a Skinneedlepro device, you acknowledge that:

  • You have read and understood this handbook;
  • You accept that microneedling carries inherent risks;
  • You agree to use the device strictly in accordance with the instructions provided.

Nothing in this handbook limits or excludes any rights or remedies available to you under the Australian Consumer Law.

Who Should NOT Use This Device

Do not use this device if any of the following apply to you:

  • Active acne, open wounds, cold sores, warts, or skin infections in the treatment area
  • History of keloid or hypertrophic scarring
  • Bleeding or clotting disorders
  • Uncontrolled diabetes or conditions affecting wound healing
  • Use of prescription blood-thinning medication
  • Pregnancy or breastfeeding
  • Any medical or dermatological condition for which microneedling is not recommended

If you are unsure whether microneedling is suitable for you, consult a qualified healthcare professional before use.

Hygiene and Cartridge Safety

Skinneedlepro cartridges are single-use only.

Re-use of cartridges is strictly prohibited. Used cartridges may retain microscopic biological material and may pose a risk of infection or cross-contamination. Re-used needles may also become damaged and increase the risk of skin injury.

Always dispose of used cartridges safely and hygienically.

Device Maintenance, Disposal & Final Notice

9.1 Battery & Motor Care

Charging:

  • Battery voltage: 3.7V
  • Full charge time: approximately 2 hours
  • Do not store device with depleted battery

Voltage Stability:

  • If motor speed fluctuates, connect to mains power (5V 1A)
  • Wired operation ensures consistent RPM and reduces skin drag

9.2 Cartridge Disposal (Sharps Protocol)

Used cartridges are classified as biohazardous sharps.

Immediately place used cartridges into:

  • Approved sharps container, or
  • Heavy-duty plastic bottle with sealed lid

Disposal:

  • Do not dispose in household waste
  • Follow local biomedical disposal regulations
  • Pharmacies often provide sharps disposal services

Warning:

  • Never reuse cartridges
  • Needle degradation and blood-borne pathogen risk are absolute

Final Notice

The Electric Microcrystal Introducer microneedling system is a precision cosmetic instrument. Safe use requires strict adherence to sterility, anatomical depth limits, and cartridge-specific protocols.

Failure to follow these guidelines may result in infection, scarring, pigment alteration, or permanent skin damage.

For warranty claims relating to non-man-made defects, refer to the Warranty Card and retain proof of purchase.