Page 1 !20 FLAWLESS PEN USER MANUAL FLAWLESS PEN
Contents
1. No side effects Easy to transport Treatment Improves Skin Texture Improves Appearance of Scars Chemical Peels YES Some Micro dermabrasion veS ne Fractional Laser YES YES Flawless Pen Application and effects Skin tightening lifting and rejuvenation Acne scars and wound healing Improves wrinkles and fine lines Minimises pore size Improves Alopecia Improves stretch marks FLAWLESS AESTHETICS AND BEAUTY FLAWLESS PEN USER GUIDE Temporary Increase in Skin Permeability i s 7 E No No YES Risk of Hyperpigmentation FLAWLESS PEN USER MANUAL FLAWLESS PEN USER MANUAL Practitioner Notes What is Medical Needling Medical needling is aimed at stimulating the body s own collagen production to reduce the appearance of fine lines and wrinkles stretch marks skin laxity and scarring and even cases of hair loss The Flawless Pen The Flawless Pen skin needling system allows for controlled induction of the skin s self repair mechanism by creating micro injuries in the skin which triggers new collagen synthesis yet does not pose the risk of permanent scarring The result is smoother firmer and younger looking skin Skin needling procedures are performed in a safe and precise manner with the use of the sterile Flawless Pen needle head The procedure is normally completed within 30 60 minutes depending on the required treatment and anatomical site The Flawless Pen d2. C assume all risks as my own hereby release them from any liability both seen and unforeseen Patient Signature Name Printed Date 1 For Cordless use Always make sure your Flawless Pen has a full charge before Practitioner Signature Name Printed Date starting treatment 2 Do not over_tighten the Pen Driver 3 Always make sure the needle depth is set to 0 before inserting a new tip 4 Always make sure the needle depth is set to 0 before starting a new treatment 5 Always power Flawless Pen on BEFORE selecting needle depth 6 Always perform test patch on patient before continuing treatment at selected depth 7 Always lift Flawless Pen before changing directions during treatment Do not turn or pivot while in contact with the skin Lifting before changing direction will prevent scratching FLAWLESS AESTHETICS AND BEAUTY FLAWLESS PEN USER GUIDE FLAWLESS AESTHETICS AND BEAUTY FLAWLESS PEN USER GUIDE FLAWLESS PEN USER MANUAL PAIN There may be a very slight burning scratchy and irritated sensation to the skin This is usually temporary and is gone within a few hours after treatment A sudden reappearance of redness or pain is a sign of infection and you should notify our office immediately PERSISTENT REDNESS ITCHING AND OR SWELLING Itching redness and swelling are normal parts of the healing process These symptoms rarely persists longer than 24 hours with dermal needling However trea
3. FLAWLESS PEN USER MANUAL FLAWLESS PEN USER GUIDE BY Flawless Aesthetics and Beauty Aesthetics amp Beauty Winterbeck Barn 1 Manor Farm Close FLAWLESS PEN Kilvington Nottinghamshire USER MANUAL NG13 9PH Tel 01400281902 Email thecosmeticnurse mail com www flawlessaestheticsandbeauty co uk Aesthetics amp Beauty 1st Edition March 2015 FLAWLESS AESTHETICS AND BEAUTY FLAWLESS PEN USER GUIDE Contents Features and Benefits Application and Effects What is Medical Needling Contraindications Side Effects Pen Preparation Charging Instructions Pre Treatment Instructions Treatment Instructions Post Treatment Cleaning and Storage Example Medical History Example Consent Document Example Treatment Record Practitioners Notes FLAWLESS AESTHETICS AND BEAUTY FLAWLESS PEN USER GUIDE FLAWLESS PEN USER MANUAL Page 3 Page 3 Page 4 Page 5 Page 5 Page 6 Page 7 Page 8 Page 9 Page 10 Page 11 Page 12 Page 13 Page 16 Page 17 FLAWLESS PEN USER MANUAL FLAWLESS AESTHETICS AND BEAUTY FLAWLESS PEN USER GUIDE FLAWLESS PEN USER MANUAL FLAWLESS AESTHETICS AND BEAUTY FLAWLESS PEN USER GUIDE FLAWLESS PEN USER MANUAL Flawless Pen Features and Benefits Cordless device No cross infection disposable needles Variable Speed Shorter treatment times Adjustable needles depth Less pain Light weight hand_piece Easy to use Lower price of consumables
4. Lastly avoid picking and or peeling the skin during healing period Hold the needle tip and tuming counter clockwise till needle comes out tissues In rare cases thickened or keloid scars may result especially if you are prone to keloid scarring anyway Scars may 2 Separate needle E SCARRING Although normal healing after the procedure is expected abnormal scars may occur in both the skin and deeper e be unattractive and of different colour than surrounding skin Additional treatments may be needed to treat scarring FLAWLESS AESTHETICS AND BEAUTY FLAWLESS PEN USER GUIDE FLAWLESS AESTHETICS AND BEAUTY FLAWLESS PEN USER GUIDE FLAWLESS PEN USER MANUAL Medical History Questions No Comments Have you any Allergies Do you take any prescribed medication Do you take any over the counter Medication including supplements Are you pregnant planning to be or breastfeeding Please provide details of any recent surgery Have you any history of Skin Cancer Have you previously received any Wrinkle relaxation treatment or dermal fillers If so when Do you have any heart or vascular conditions Do you suffer fainting or high low blood pressure Are you Diabetic Are you sensitive to the Sun a a E Have you any needling chemical peels IPL or Laser Treatment in the last month Do you suffer from an Auto Immune Disease Do you suffer from any skin conditions Acne Ec
5. RISKS OF NEEDLING r i Although the majority of patients do not experience any complications with Dermal Needling it is important you understand that risks do Insert needle turning in a clockwise direction exist The Dermal Needling procedure is minimally invasive utilising a set of micro needles to inflict multiple tiny puncture lacerations to 2 Do not squeeze too hard the outer layer of the skin Because Dermal Needling penetrates the skin it inherently carries health risks including but not limited to Sgp l those listed below You should discuss any and all health concerns with your practitioner or attending healthcare provider PRIOR to signing this consent form fap INFECTION Infection is very unusual However viral bacterial and fungal infections can occur anytime the integrity of the i skin is compromised Should infection occur you must contact or return to our office immediately as additional treatment will likely be necessary Pm i PIGMENT COLOUR CHANGE Because dermal penetration is so superficial it doesn t extend into the layer of the skin containing melanocytes hyper pigmentation is very rare with Dermal Needling j However failure to follow post treatment instructions can put you at risk for hyperpigmentation You MUST avoid sun exposure for a 1 to 2 weeks after a Dermal Needling treatment You should also wear a daily SPF over over 30 which your To separate needle practitioner can recommend
6. diminish hyper pigmentation and improve skin tone and texture resulting in smoother firmer younger looking skin Take out the disposable needle and check needles are in good condition pull back the spring to ensure ABOUT THE PROCEDURE a fluid movement At Flawless Aesthetics and Beauty Dermal Needling is performed using The Flawless Pen This procedure is performed by a trained Inserting and removing the Needle professional The Flawless Pen Dermal Needling procedure is performed in a safe and precise manner with a single use sterile needle head The treatment session usually takes about 30 60 minutes depending on the area s being treated After the procedure the skin will be To insert needle red with mild swelling and or bruising and your skin might feel tight and sensitive to the touch Although these symptoms may take 2 3 days to resolve completely they will diminish significantly within a few hours after treatment EN A JES ALTERNATIVE TREATMENTS 42 A Be of Ft A Alternative treatments to Dermal Needling may include the use of routine skin care oral and or topical prescription and or non f P prescription medications microdermabrasion laser treatments and even cosmetic plastic surgery Each of these alternatives carry their d own inherent risks and benefits However since this treatment is elective and is done for cosmetic purpose only no treatment at all should JIII also be considered a viable alternative A L
7. ht 2 DO NOT keep or store disposable tips for later use Step 4 Apply Sunscreen of at least SPF30 Day 3 Using a clean gauze or paper towel wipe down the entire surface area with Isopropyl Days 2 amp 3 As above Alcohol before and after treatment Use Alcohol soaked cotton swab to clean in tight spaces 1 Cleanse clean Skin using Flawless Aesthetics and Beauty Clarifying Cleanser p 2 Revive apply Power Peptide Restorative Serum over entire treatment area 3 Sooth apply Vitamin C and E 2 in one Serum 4 Always wipe with alcohol before returning the Flawless Pen to its storage case for safe 4 Protect apply protective BROAD SPECTRUM Sunscreen OF AT LEAST SPF aia J 9 30 Repeat as necessary throughout the day Note Avoid sweaty exercise and keeping and sun exposure during first 12 hours Store away from children and in a safe clean dry place Day 4 Resume Normal Skin Care Routine Single Treatment Protocol Multi treatment Protocol A WARNING Fine lines Series of 3 6 Tx at 6 8 week intervals Texture Moderate to Deep Wrinkle Remember The Flawless Pen is an intricate instrument and your valuable tool Large Pore Size Atrophic Acne Scars Uneven Skin Tone Striae Stretch Marks Minor Blemishes Traumatic Scars Non Keloid Hyper trophic Scars Warranty Protocols apply to all skin types 1 This product is manufactured under strict quality control and inspection processes 2 The Practitioner Busi
8. in treatment by simultaneously making contact with the skin and gliding in a 90 degree made across the area at a rate of 1 inch per second 10 pence piece Continue until a single pass has covered the whole area 8 Observe the effect on the skin and adjust needle depth accordingly see Fig 1 and 2 9 Repeat process with a pass across the treatment area if necessary MAX 5 Fig 2 Indication Needle Size o2mm o25mm o5mm o75mm tomm i5mm 20mm 25mm Hair Regeneration Regrowth Fine Lines Anti Aging Anti Wrinkle Open Pores Pigmentation Marks Acne Scars Light Scars Cellulite Stretch Marks Deep Scars v vv viv v v v v v LSS an a a a lt 144 For proper regulatory compliance non physician use of this device should be limited to an erythematous effect only and not more than 1mm The treatment endpoint should be mild to moderate erythema Flawless Pen is a Class FDA registered device MHRA Pending LASS KS FLAWLESS AESTHETICS AND BEAUTY FLAWLESS PEN USER GUIDE FLAWLESS PEN USER MANUAL FLAWLESS PEN USER MANUAL Post Treatment Instructions Cleaning and Storage Immediately 1 Always dispose of single use needle tip in sharps container IMMEDIATELY after each Step 1 Using a damp gentle gauze or disposable cloth pat down the treated area treatment Step 2 Reapply thin layer of Flawless Hyaluronic Acid or Hydrating serum Step 3 Apply Flawless Vitamin C and E Serum and or Retinol cream at nig
9. isposable micro needling tip comes in sterilised individual packages that are easily replaced and loaded into the device The tip has twelve 12 stainless steel micro needles 32 gauge which can be adjusted from 0 25 to 2 75 mm giving physicians and aestheticians an innovative skin therapy system that is designed to cater to individual patient needs The Flawless Pen s needle depth can be adjusted during the course of the procedure to accommodate different treatment areas and can easily manoeuvre around facial contours and delicate features such as the eyes nose and mouth The Flawless Pen offers many advantages over other light based and heat based devices medical needling increases the effectiveness of the treatment while causing less epidermal damage sometimes caused by excess heat and light based therapies exceptional results is cost effective easy to use and has better precision and control than more expensive treatments This ground breaking technology combined with low cost disposable tips makes the Flawless Pen a revolutionary breakthrough for beautiful skin FLAWLESS AESTHETICS AND BEAUTY FLAWLESS PEN USER GUIDE FLAWLESS AESTHETICS AND BEAUTY FLAWLESS PEN USER GUIDE FLAWLESS PEN USER MANUAL Practitioner Name and Designation Client Consent Y N Photos Taken Y N Anaesthetic Type Cleanser Used Needling Serum ye M N a Pa S H e Flawless Pen Treatment Record Always Use Lowest Depth po
10. ness owner is responsible for getting electrical devices tested as per health and safety law 3 Warranty is to cover the operating defaults after the purchase during the warranty period 12 months after the purchase 3 When this product goes out of order under the normal use of a customer we will repair or replace it during the warranty period 4 The damages defaults prescribed below are NOT to be covered by warranty e Users faults by lack of care or water damage e Unauthorised electric currency connection defaults e Faults by the users own intention or unauthorised repairs e Damages caused by natural disaster Fire Flood Earthquake lightning etc Replacement of parts excluding disposable needles FLAWLESS AESTHETICS AND BEAUTY FLAWLESS PEN USER GUIDE FLAWLESS AESTHETICS AND BEAUTY FLAWLESS PEN USER GUIDE
11. re recognised as known contraindications to Dermal Needling Furthermore it is your responsibility to fully and accurately disclose all medical history prior to initial treatment as well as provide any necessary updates at all future treatment sessions If you have any of the conditions listed below you should bring it to the attention of your practitioner PRIOR to signing this consent form e Active acne Active infection of any type bacterial viral or fungal e Blood thinning medications e Cardiac disease abnormalities e Chemotherapy or radiation e Collagen Vascular Disease e Eczema Psoriasis or Dermatitis e Haemophilia bleeding disorders e Hormone Replacement Therapy e Keloid hypertrophic scaring e Pregnancy Lactation e Raised lesions moles warts etc e Recent chemical peel procedure e Recent use of some topical creams e Scleroderma e Skin Cancer FLAWLESS AESTHETICS AND BEAUTY FLAWLESS PEN USER GUIDE FLAWLESS PEN USER MANUAL Charging Instructions 1 Connect battery to charging unit 2 Ared light on the wall charger indicates that the power button has been depressed and the battery is charging 3 Allow the battery to charge for 75 minutes or until the light turns from red to green indicating that the battery has been fully charged Note If the power button is not depressed upon initial insertion into the charging unit a green light will be displayed This does not indicate that the bat
12. ssible Needle Size 0 25 0 5 0 75 1 Maximum For Non Medical Practitioners 1 25 1 5 2 Body Areas Only 2 5 2 75 Record Depth Number of Passes Area Area Area Area Area Post Treatment Products Serum Applied Comments FLAWLESS AESTHETICS AND BEAUTY FLAWLESS PEN USER GUIDE FLAWLESS PEN USER MANUAL THE PRACTITIONER MUST COMPLETE A FULL MEDICAL HISTORY CONSULTATION AND INFORMED CONSENT BEFORE TREATMENT Contraindications Pregnancy and Breastfeeding Keloid scars History of eczema Psoriasis and other chronic conditions History of actinic solar keratosis History of Herpes Simplex infections see precautions History of diabetes presence of raised moles warts on targeted area Absolute contraindications include Vascular diseases or cardiac abnormalities Blood clotting problems active bacterial or fungal infection Immuno suppression Precautions Discontinue Retinol Vitamin A 7 days before using the pen Do not to treat active acne rosacea or other inflamed condition Do not treat open wounds Patients with a history of cold sores medication must be used before and after treatment Medical Needling treatments not to be administered for 12 months after Accutane regimen Side Effects After the procedure the skin will be red and flushed in appearance in a similar way to moderate sunburn You may also experience skin tightness and mild sensitivity to to
13. tery is fully charged green is the default colour Press the power button FRAGILE HANDLE WITH CARE on the battery once to begin charging 1 twist and into one unity I 2 conect to the Adapter with electricity light is yellow m RD Ge 3 press the on off button of Battery light turns red it s on charging now la ee EA i 4 when fully charged light turns yellow unplug the Adapter b Zi hy Gee n SS e A 2 FLAWLESS AESTHETICS AND BEAUTY FLAWLESS PEN USER GUIDE FLAWLESS PEN USER MANUAL FLAWLESS PEN USER MANUAL DERMAL NEEDLING INFORMED CONSENT Pre Treatment Instructions INTRODUCTION TO DERMAL NEEDLING amp THE FLAWLESS PEN The concept of Dermal Needling is based on the skin s natural ability to repair itself when it suffers physical damage such as cuts burns abrasions or other injuries Immediately after an injury to the skin our body begins the healing process triggering new collagen synthesis Unseal the product just before treatment and make sure that the device is used in a sterile environment The Flawless Pen is a Dermal Needling device that intentionally creates very superficial micro injuries to the outermost layer of the skin inducing the healing process including new collagen production Dermal Needling has been shown to reduce the visibility of acne scars and handled with sterile gloves fine lines and wrinkles
14. tments received less than 4 weeks apart may induce prolonged symptoms ALLERGIC REACTION Dermal Needling is performed with a head containing 9 12 sterile hypodermic needles making an allergic reaction nearly impossible However a variety of products may be used on the face in conjunction with the Dermal Needling procedure to which an allergy can occur Additionally since Dermal Needling increases the penetration of topical substances it can cause you to be hypersensitive to products used on the face If an allergic reaction were to occur you must contact your practitioner immediately as it may require further treatment LACK OF PERMANENT RESULT Dermal Needling will not completely or permanently improve skin texture tone elasticity hyper pigmentation scars or minimise fine lines and wrinkles It is important that your expectations be realistic and understand the procedure has its limitations Additional procedures may be necessary to achieve desired effect UNSATISFACTORY RESULT Although rare from Dermal Needling there is a possibility of a poor result from any cosmetic procedure Dermal Needling may induce undesirable results including but not limited to skin sloughing scarring permanent pigment and or other undesirable skin changes You may be disappointed with the final results of Dermal Needling CONTRAINDICATIONS TO DERMAL NEEDLING Although it is impossible to list every potential risk and complication the following a
15. uch on the area being treated This will diminish greatly after a few hours following treatments and within the next 24 hours the skin will be completely healed After 3 days most visible erythema will be resolved there may also be a mild peeling FLAWLESS AESTHETICS AND BEAUTY FLAWLESS PEN USER GUIDE FLAWLESS PEN USER MANUAL FLAWLESS PEN USER MANUAL e Sunburn e Tattoos Pen Preparation e Telangiectasia erythema e Uncontrolled diabetes e Vascular lesions What s in the Box ACKNOWLEDGEMENT and CONSENT eS My signature below acknowledges that have read and understand the content of this informed consent have been given ample The Flawless Pen The Needle Tips l l l opportunity to ask questions all of which have been answered in a satisfactory manner understand that results can vary and that no guarantee neither expressed nor implied has been or will be given to me regarding my results I m aware of the risks and benefits The PowerAdapterand r associated with the Flawless Pen Dermal Needling procedure as well as available alternative treatments understand that Dermal Cord The BatterPen Driver _ ss Needling is an elective procedure performed solely for cosmetic purposes and is not critical to my health On my own free will am The Cordless Ch arger The Mains Pen Driver requesting and providing my informed consent to undergo Flawless Pen Dermal Needling treatment s at Flawless Aesthetics and Beauty
16. zema Dermatitis Psoriasis Do you have any Keloid Scars Do you suffer from Herpes Simplex Do you use retinol Products on the Skin Do you have any clotting or bleeding disorders Do you have any other medical or skin conditions not listed above If the answer to any of the above is yes your practitioner may decide you are not suitable for this treatment confirm that have answered the above questions honestly and to the best of my knowledge and that my practitioner has explained the procedure to me in detail Signed Print Date FLAWLESS AESTHETICS AND BEAUTY FLAWLESS PEN USER GUIDE FLAWLESS PEN USER MANUAL Treatment Instructions 1 Apply a topical anaesthetic leave for recommended time 2 Clean skin by removing all make up moisturiser self tanner sunscreen and numbing cream etc with Flawless Cleanser or mild soap and water 3 Section off and Mark smaller areas out if covering a large area 4 Apply lubricating topical such as Flawless Hyaluronic Acid to treatment area 5 Activate the Flawless Pen by pressing the power button 6 Select needle depth according to approximate thickness of skin and indication refer to Fig 7 and Fig 2 as a guide only for best practice always start at a lower depth first Fig 1 Epidermis Keratinocytes meianocytes piqment cells 5 i mm needle depth to reach rmis papillary epide dermis pores fine lines 7 Beg
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