Section 1: Introduction
Contents
1. To ensure maximum safety the onboard computer executes an automatic self test routine every time the system is switched on This routine checks the equipment system parameters prior to any treatment In addition the system software continues to check all equipment functions throughout the period of use Page 10 QUADRA Q4 Diamond Series 2 1 List of Controls Figure 6 Quadra Q4 Diamond Series II Controls Page 11 530 1200nm Up 20 J cm Computer controlled pulse Single Pulse 10ms 50ms Triple Pulse up to 110ms Multiple Pulse Pattern Configurations 33mm 27mm 9 0 cm 178 J Direct Delivery Handpiece Homogeneous over treatment area 0 25 Hz average Dependent on model 230V 50Hz 5A 110V 60Hz 10A Self contained fan cooled 10 C 68F to 30 C 86F Non condensing humidity below 75 RH 340mm High x 305mm Wide x 480mm Deep 13 4 Inches x 12 Inches x 18 9 Inches 14 kgs 31 Ibs QUADRA Q4 Diamond Series 2 2 Specification Wavelength Energy Pulse Duration Spot Size Maximum pulse energy delivered to tissue Delivery Device Energy Profile to Tissue Repetition Rate Electrical Cooling Environmental Dimensions Weight Page 12 QUADRA G4 Diamond Series 3 Transport and Installation 3 1 Transport Damage The Quadra Q4 Diamond Series II has been carefully packe2. ENERGY 10JCM2 ADJUST PROGRAM NUMBER Arm Standby P 4 E 10JCM2 SR 3500 STANDBY STANDBY Mode Arm Standby Arm Standby ARMED Mode P 4 E 10JCM2 SR 3500 ARMED ADJUST ENERGY Page 27 QUADRA Q4 Diamond Series 5 Typical Treatment Protocol 5 1 Indications for Use The Quadra Q4 Diamond Series II System is indicated for use in cosmetic applications and specifically for long term stable or permanent hair reduction In addition the Quadra Q4 Diamond Series II System is indicated for the treatment of superficial benign cutaneous vascular lesions including rosacea angiomas and spider angiomas cherry angiomas and poikiloderma of Civatte ectatic matting and other superficial venous malformations Varicose veins large lower extremity telangiectasia and larger vascular lesions such as cavernous angiomas venous lakes rhynophyma etc cannot be treated successfully with pulsed light systems The Quadra Q4 Diamond Series II System is also indicated for the treatment of superficial benign pigmented lesions such as age spots solar lentigenes and other dyschromia The Quadra Q4 Diamond Series II System is also FDA cleared for the treatment on mild to inflammatory acne vulgaris The Quadra Q4 Diamond Series II system achieves the cosmetic results through the process of selective photothermolysis Light energy at the appropriate wavelength pulse duration and energy density is delivered to the target e g
3. REJUVENATON Typical Treatment Procedure There are two types of skin aging intrinsic and extrinsic The rate of intrinsic aging is genetically determined and describes how as we grow older starting around 30 35 our skin naturally becomes thinner and drier Lower levels of collagen make the skin less elastic Early signs of sagging and static deep wrinkles may begin appearing Extrinsic aging results from exposure to the environment Extrinsic aging is the critical element in determining who looks older or younger than their biological age Exposure to sunlight is a key contributor to extrinsic aging Photo aging occur when elastin and collagen breakdown is not replaced causing fine lines and wrinkles to intensify Photo aging also causes pigment changes with development of age spots sun induced freckles uneven skin tone and enlarged pores Spider veins and broken or dilated capillaries are another sign of photo aged skin Lifestyle choices also have an impact on extrinsic aging Cigarette smoking contributes to the breakdown of elastin and collagen and impairs the body s healing capacity The simplest way to see the contrast between intrinsic and extrinsic aging is to compare skin commonly exposed to the sun face hands and neck and skin not exposed to the sun usually Page 32 QUADRA Q4 Diamond Series on the breasts inner arms or buttocks Clients with fine facial wrinkles slightly loose skin brown blotchy pigmentat
4. details Page 13 QUADRA Q4 Diamond Series 4 System Operation CAUTION USE OF CONTROLS OR ADJUSTMENTS OR PERFORMANCE OF PROCEDURES OTHER THAN THOSE SPECIFIED HEREIN MAY RESULT IN HAZARDOUS LIGHT EXPOSURE 4 1 Switch on Procedure To operate the equipment system the following procedure must be followed figure 7 Quadra Q4 Diamond Series II Unit Rear Panel Page 14 QUADRA Q4 Diamond Series 1 Connect Remote Interlock or Dummy Plug rear of equipment 2 Connect equipment direct to mains supply and switch ON avoid using extension cords aye 3 Switch mains power at the rear of the equipment to the position 4 Ensure the Disposable Head is in place see Installation of Disposable Head section 4 2 5 Turn the main key clockwise into the horizontal position front of equipment NOTE The equipment can be turned off by rotating the key anti clockwise to the vertical position at any time The system is only fully switched off when the mains power switch at the rear of the equipment is in the O position in Figure 8 Quadra Q4 Key switch Page 15 QUADRA Q4 Diamond Series 4 2 Installation of the Disposable Lamp Unit CAUTION ALWAYS FOLLOW THE INSTRUCTIONS PROVIDED WITH THE REPLACEMENT DISPOSABLE HEAD The Disposable Lamp unit should be installed and removed using the following procedure Failure to follow the recommendations below may result in damag
5. e g CS02 1010A This will be displayed for 2 seconds SYSTEM START CS02 1010Ax x 4 5 Disposable Head Expiry The computer will interrogate the Disposable Head prior to each shot being fired and may display the following error message DISPOSABLE EXPIRED SWITCH OFF AND REPLACE This message will occur if the disposable head pre set number of shots has been exceeded At this point the disposable head should be removed and replaced with the new disposable head sent by your supplier 4 6 Program and Energy Selection After the start up screen the system will default to the first Mode selection screen Mode selection allows the user to choose the Treatment type Skin Type Program and Energy density of the system See Section 5 6 for Quadra Q4 Diamond Series Treatment Programs The first screen enables the user to select the desired Treatment Type e g HAIR VASULAR PIGMENT ACNE TREATMENT TYPE HAIR 4 4 THEN ENTER Page 21 QUADRA Q4 Diamond Series The required treatment program can be selected by pressing either the UP or DOWN keys as shown below When the desired treatment program has been selected press the ENTER button to register the choice Once the ENTER key has been pressed the display will change to Skin Type selection and the required skin type can be adjusted e g I II III IV SKIN TYPE A THEN ENTER Again use the UP or DOWN keys to Adjust and press ENTER to register the
6. 508 lint free cloth Please refer to section 4 3 Cleaning the Handset amp Glass Transmission Block for more cleaning and maintenance instructions 6 2 Visual Inspection The mains cable together with the handpiece and system must be inspected for possible wear cracks or breaks before each use Page 36 QUADRA G4 Diamond Series 6 3 Servicing There are no user repairable parts inside the Quadra Q4 Diamond Series II Equipment Servicing should only be carried out by factory qualified personnel The potential for electrocution is ever present Do not operate the equipment without covers and panels or other mounting hardware as supplied and properly installed Do not touch any part of an open frame unit when AC line voltage is supplied The electrical output produced by the power supply is many times the level to be fatal There is no substitute for caution prudence and clear thinking when working with high voltages 6 4 Removal and Replacement of the Disposable Lamps As described in Section 4 2 6 5 Servicing and Maintenance Schedule Please contact DermaMed Solutions LLC at 610 358 4447 for information on servicing and maintenance for the Quadra Q4 Diamond Series II 6 6 Safe Disposal For safe disposal of the unit or sub assemblies please contact DermaMed Solutions LLC at 610 358 4447 Page 37 QUADRA Q4 Diamond Series 7 Fault Diagnostics This section will help diagn
7. 6 2 Visual Inspection 6 3 Servicing 6 4 Removal and Replacement of the Disposable Lamps 6 5 Servicing and Maintenance Schedule 6 6 Safe Disposal Fault Diagnostics 7 1 Unit Will Not Switch On 7 2 QUADRA 64 DIAMOND SERIES II Error Messages Page 3 QUADRA Q4 Diamond Series 1 Safety Warnings CAUTION Use of controls or adjustments or performance of procedures other than those specified herein may result in hazardous optical radiation exposure No attempt should be made to operate this equipment until the User Manual has been read and fully understood In addition a clear understanding of the biological effects of the interaction of light with tissue should be prerequisite to use of this equipment When not in use the equipment should be protected from unqualified use by removal of the key from the key switch IT IS STRONGLY RECOMMENDED THAT ALL OPERATORS OF THIS EQUIPMENT ATTEND THE SUPPLIERS APPROVED TRAINING COURSE PRIOR TO USE Page 4 QUADRA Q4 Diamond Series 1 1 Optical Safety Suitable protective eyewear is required to be used during operation of the system In addition it is the responsibility of the User to ensure that the client is supplied with suitable protective eyewear during treatment The optical hazard warning label Figure 1 is located on the side of the Quadra Q4 Diamond Series Unit Figure I Optical Hazard Warning Label Page 5 QUADRA Q4 Diam
8. American Indian Mediterranean and Latin American descent Type V Light complexion African American individuals those of Indian descent Type VI Dark skinned individuals From Naylor M F amp Farmer K C Guidelines for Minimizing UV Exposure In The Electronic Textbook of Dermatology Drugge R and Dunn HA eds The Internet Dermatology Society 2000 Page 45 4 BROWNISH BLACK BLACK DARK BROWN NONE NEVER HAD BURNS TURN DARK BROWN QUICKLY ALWAYS NEVER HAD A PROBLEM LESS THAN 2 WEEKS AGO ALWAYS QUADRA Q4 Diamond Series II SKIN TYPE WORKSHEET Patient s Name Date 0 1 2 3 What is the Color of your LIGHT BLUE BLUE GRAY eyes GRAY OR GREEN OR GREEN BEME DARK BROWN What is the natural color of CHESTNUT your hair SANDY RED BLOND DARK BLOND DARK BROWN What is the color of your skin REDDISH VERY PALE PALE WITH BEIGE LIGHT BROWN unexposed areas TINT DOVON MAVE COMES OR SUNI WANY SEVERAL FEW INCIDENTAL exposed areas BURNS PAINFUL BLISTERING What happens when you stay ReDNess FoLLoweD By SOMETIMES RARELY BURNS in the sun too long FOLLOWED BY BLISTERING PEELING PEELING To what degree do you turn HARDLY OR NOT LIGHT COLOR REASON ABLE brown AT ALL TAN TAN TAN VERI EASIY POVOA TO U WASEVEr NEVER SELDOM SOMETIMES OFTEN hours after sun exposure How does your face respond VERY SENSITIVE SENSITIVE NORMAL VERY RESISTANT to the sun Ka rns a anning MORE
9. Quadra 04 DIAMOND SERIES II User Manual Page I QUADRA Q4 Diamond Series QUADRA Q4 DIAMOND SERIES II INTENSE PULSED LIGHT SYSTEM Page 2 QUADRA Q4 Diamond Series Table of Contents 1 Safety Warnings 1 1 Optical Safety 1 2 Optical Safety Label Placement 1 4 Safety Warnings Electrical Safety 2 Product Description 2 1 List of Controls 2 2 Specification 3 Transport and Installation 3 1 Transport Damage 3 2 Environmental Transport amp Storage Conditions 3 3 Installation 3 4 Space Requirements 3 5 Accessories 4 System Operation 4 1 Switch On Procedure 4 2 Installation of the Disposable Lamp Unit 4 3 Cleaning the Handset Glass Transmission Block 4 3 1 Outside of the Applicator amp Quartz Glass Transmission Block 4 3 2 Inside Surface of Quartz Glass Transmission Block 4 4 Start Up 4 5 Disposable Head Expiry 4 6 Program and Energy Selection 4 7 Armed Standby Mode 4 8 Cooling Periods 4 9 Switch off Procedure 4 10 QUADRA 04 Diamond Series II Set up Quick Guide 5 Typical Treatment Protocol 5 1 Indications for Use 5 2 Contraindications 5 3 Treatment Related Problems 5 4 Treatment Protocol General Considerations 5 5 Post Treatment Care 5 6 QUADRA Q4 DIAMOND SERIES Treatment Programs 5 7 HAIR REMOVAL Typical Treatment Procedure 5 8 SKIN REJUVENATON Typical Treatment Procedure 5 9 INFLAMMATORY ACNE Typical Treatment General Maintenance 6 1 Cleaning the Equipment
10. Series Appendix A Typical Client Consultation Form Clinic Name Client Name Address Client Number Therapist s Name Operators Name Date Please answer the following questions Skin Type Jother Skin Colour wnite L olive oriental JAfro Caribbean Sun Tanned Jother Skin Conditions Pigmented Patches IProne to pigmentation changes Moles Freckles _ Acne Psoriasis Eczema L Vitiligo Jother What other methods of Skin therapy have you used before Cosmeceuticals Chemical peels Botox _ Er YAG CO Jother Are you undertaking a course of treatment that may make your skin photosensitive See attached sheet for information and a list of common drugs Yes If Yes what type Do you have any kind of allergies Yes No If Yes what type Do you take medicine for any allergies Yes No If Yes what type INDEMNITY confirm that the information that have supplied is true and correct and that have read understood and accept the above mentioned information hereby indemnify the equipment operator the clinic owners and their staff the franchiser and their employees and the manufacturer of the equipment from any claims whatsoever Client Name Client Signature Date Page 41 QUADRA Q4 Diamond Series Appendix 5 Information on Drug Induced Photosensitivity Information on Drug Induced Photosensi
11. THAN 3 2 3 MONTHS 1 2 MONTHS LESS THAN 1 y DN g MONTHS AGO AGO AGO MONTH AGO bed or tanning creams Do you expose the orea 0 55 a keyi HARDLYEVER SOMETIMES OFTEN treated to the sun SCORE FITZPATRICK SKIN TYPE 0 7 8 16 ll 17 25 Ill 25 30 IV OVER 30 V VI Score TOTAL SCORE Page 46 QUADRA Q4 Diamond Series Distributed by DermaMed Solutions LLC 394 Parkmount Road P O Box 187 Lenni PA 19052 United States Phone 610 358 4447 Fax 610 361 8129 www DermaMedSolutions com FDA Cleared 510K K071883 Page 47
12. able unit and retry Remove disposable and refit If problem persists replace disposable unit and retry Potential Cause Remote Interlock on rear of machine disconnected or dummy plug missing Front of handpiece open or incorrectly closed Flashlamp misfire Incorrect or unapproved disposable inserted into handpiece Failure to communicate with disposable Switch off Quadra Q4 Diamond Series II Unit Wait for 2 minutes Switch on the Quadra Q4 Diamond Series II following standard start up procedure Check Pins Replace disposable unit and retry If problem persists call Service Operator Flashlamp misfire QUADRA G4 Diamond Series 7 2 QUADRA Q4 DIAMOND SERIES Il Error Messages Error Message INTERLOCK OPEN REPLACE SYSTEM DISCHARGED HANDPIECE OPEN CLOSE SYSTEM DISCHARGED LAMP nn FAILURE PRESS ANY KEY TO CLEAR 80 5 05481 6 ON D SWITCH OFF AND REPLACE FAULTY DISPOSABLE SWITCH OFF AND REPLACE FAILED TO CHARGE SYSTEM SWITCH SYSTEM OFF DISCHARGE RELAY CLOSED SWITCH SYSTEM OFF INCORRECT CAP VOLTS SWITCH SYSTEM OFF HEAD OVER TEMPERATURE SWITCH SYSTEM OFF SYSTEM OVER TEMPERATURE SWITCH SYSTEM OFF SYSTEM 30V SUPPLY FAILED SWITCH SYSTEM OFF HEAD COOLING FANS FAILED SWITCH SYSTEM OFF DISCHARGE RELAY OPEN SWITCH SYSTEM OFF TOP LAMP MISFIRE BOTTOM LAMP MISFIRE Page 40 QUADRA Q4 Diamond
13. am Lomefloxacin Maxaquin Especially noted for severe reactions when they occur Blood Pressure and Heart Medications Page 42 QUADRA Q4 Diamond Series Hydrochlorothiazide Hydrodiuril Oretic and other names Many drugs contain HCTZ as one of the ingredients Chlorothiazide Diuril and other names Furosemide Lasix Amiodarone Cordarone High incidence of drug induced photo reactions Other Drugs Chlorpromazine Thorazine Methoxypsoralin PABA and or PABA esters Used in sunscreens can cause hives and rashes Common Drugs That Cause Photosensitive Reactions Less Often Amitriptyline Elavil Endep and other names Captopril Capoten Chloroquine Ciprofloxacin Cipro Dapsone Diphenhydramine Benadryl Benylin and other names Oestrogens Birth Control Pills Premarin and more Glyburide Diabeta Micronase Glynase and other names Haloperidol Haldol Ibuprofen Advil Motrin and more Alprazolam Xanax Benzocaine Sensorcaine and many other numbing products Chloradiazepoxide Librium Chlortetracycline Co trimoxazole Bactrim Septra Diltiazem Cardizem and other names Enoxacin Penetrex Fluoracil 5 FU Griseofulvin GrisPeg Fulvicin and other names Hydralazine Apresoline Page 43 Isotretinoin Accutane Minoxidil Loniten Rogaine Nifedipine Procardia Adalat Nortriptyline Aventyl a
14. atment procedures In developing the procedure emphasis was placed upon the treatment being fast safe and efficacious to the client In general the only factor that has to be considered prior to treatment apart from following the standard operating procedure for the safe use of intense pulsed light equipment is the removal of any cosmetics at the desired treatment location and cooling the skin before and after treatments 5 5 Post Treatment Care Clients should be instructed in post treatment care and should be given written take home instructions recommending e Don t expose skin to UV sun exposure or the use of tanning beds or self tan for at least 2 weeks e Don t depilate for 2 weeks with waxing plucking threading or creams unless advised by the operator to do so e Don t use bleaching creams or perfumed products for 24 48 hrs e Don t pick or scratch the treated area e Avoid rough handling of the area treated e Avoid very hot baths showers steam baths sauna e Avoid swimming in strong chlorinated water e Avoid exfoliating or peels for 1 week e Avoid rough sports for 24 48 hrs e Avoid wearing tight clothing e Keep the area clean and dry e Hydrate the body by drinking plenty of water and e Use of sun block SPF 30 NB Hot and humid weather conditions can aggravate skin in the period immediately following treatment Page 30 QUADRA Q4 Diamond Series 5 6 QUADRA Q4 DIAMOND SERIES II Trea
15. choice Once the ENTER key has been pressed the display will change to Select Program SELECT PROGRAM A NN Page 22 QUADRA Q4 Diamond Series The required Program A B or C can be selected by pressing the UP DOWN key and then press ENTER To determine the appropriate treatment program refer to section 5 6 Typical Treatment Protocols Once the ENTER key has been pressed the display will change to the ARMED STANDBY screen HAIR 5 0 10 0 JCM2 DISCHARGED The STANDBY screen shows both the Treatment type e g Tx HAIR the Skin Type to be treated e g SK I and the energy density e g E 10J cm2 Also the number of pulses available on the Disposable Unit is displayed e g SR 5000 is Shots Remaining before replacement is required At this stage the ENERGY LEVEL can be adjusted by pressing the UP or DOWN keys Note The beginning of the Mode selection sequence can be returned to at any time by pressing the MODE button 4 7 Armed Standby Mode WARNING It is the responsibility of the user to ensure the client s eyes are protected during treatment Refer to the relevant standards for guidance When the ARMED STANDBY screen is displayed the Quadra Q4 Diamond Series II has been set to the desired output parameters The unit is NOT ARMED and cannot produce light output at this stage Page 23 QUADRA Q4 Diamond Series When the operator is ready to commence t
16. d and should arrive at its destination in perfect condition Upon delivery please check that the external packaging is not damaged If signs of damage are present or the shock detector labels have been activated please report them to the shipping carrier and the Customer Service Department within 24 Hrs 3 2 Environmental Transport amp Storage Conditions The transport and storage conditions for the Quadra Q4 Diamond Series were determined from specifications set by the manufacturers of critical components as follows Temperature 5 C to 40 C Relative Humidity 35 to 65 Non Condensing Atmospheric Pressure 500 1060 hPa 3 3 Installation CAUTION THE QUADRA Q4 DIAMOND SERIES II HANDPIECE IS A DELICATE COMPONENT AND WILL CAUSE DAMAGE TO THE UNIT AND HANDPIECE IF DROPPED NEVER PULL THE UNIT BY THE POWER CORD OR THE HANDPIECE EXERCISING THIS MAY RESULT IN DAMAGE TO THE HANDPIECE DELIVERY SYSTEM AND OR HARM TO THE CLIENT OR USER 3 4 Space Requirements Sufficient space is required for the equipment The dimensions of the equipment are 340mm High x 305mm Wide x 480mm Deep A distance of approximately 150mm should be left clear at the rear of the equipment to allow adequate ventilation Ambient room temperatures should not exceed 30 C 86F 3 5 Accessories To order additional quantities of Quadra Q4 Diamond Series II equipment accessories please refer to the supplied Quadra Q4 Diamond Series Accessories list for part number
17. e 13 Disposable Unit Removal 5 Remove the Peel off plastic protector from the front of the new Disposable unit Figure 13A Figure 13A New Disposable Unit Page 18 QUADRA Q4 Diamond Series 6 To fit the new Disposable Unit ensure that the recesses at the bottom of the Disposable Unit are placed towards the Font piece hinge Drop the Disposable Unit into the handpiece ensuring that the recesses fit into the keyways in the handpiece plate Clip the Disposable Retainer over the edge of the Disposable unit Figure 13B Figure 13B Rear of Disposable Unit 7 Close the front of the Handset ensuring that it clicks into place 8 After replacing the disposable switch off the unit and restart This reboots the system so that the new disposable will be recognized Page 19 QUADRA Q4 Diamond Series 4 3 Cleaning the Handset amp Glass Transmission Block CAUTION ANY CONTAMINATION OF THE GLASS BLOCK CAN LEAD TO REDUCED PERFORMANCE OR DAMAGE TO THE INSIDE SURFACE OF THE GLASS BLOCK CARE SHOULD BE TAKEN NOT TO SPILL ANY CLEANING FLUIDS ONTO THE UNIT 4 3 1 Outside of the Applicator amp Glass Transmission Block The front surface of the glass transmission block area that makes contact with skin and surrounding plastic applicator front must be kept clean using a lint free cloth At the end of each treatment session clean the glass transmission block applicator head and docking cradle The glass transmiss
18. e to the handpiece or Disposable Lamp and or harm to the client or user To remove the installed Disposable 1 Ensure the Quadra Q4 Diamond Series II unit is switched on in STANDBY and in the Mode screen The green light on the rear of the Handset should be ON If the unit is armed press ARM STANDBY wait for the red light on the rear of the handset to turn off and then press the Mode button TREATMENT TYPE HAIR THEN ENTER Figure 9 Quadra Q4 Diamond Series II Mode Program selection screens Light Function Open Red continuous Handpiece charged ready to fire Red flashing Handpiece Charging or Discharging Green continuous Handset ready to Open y Figure 10 Quadra Q4 Diamond Series II Handset LED sequence Page 16 QUADRA Q4 Diamond Series 2 When the green light on the rear of the handset is on slide the button on the side of the handset forward This will open the front section of the Handset Figure 11 Handset Opening Button 3 Once the front of the handpiece has been opened unclip the disposable retainer by sliding off the top of the disposable unit Page 17 QUADRA Q4 Diamond Series II figure 12 Disposable Retention Clip 4 Hold the sides of the disposable unit and lift upwards and away from the handpiece do not touch the glass lamps or the rear of the glass block if the glass block requires cleaning follow procedure 4 3 Figur
19. er cord is essential for safe operation To avoid fire hazards always replace fuses with ceramic types complying with IEC 127 The use of flammable anaesthetics or oxidizing gases such as nitrous oxide and oxygen should be avoided Some materials for example cotton and wool when saturated with oxygen may be ignited by high temperatures produced in NORMAL USE of the equipment The solvents of adhesives and flammable solutions used for cleaning and disinfecting should be allowed to evaporate before the equipment is used Page 7 QUADRA Q4 Diamond Series The electrical requirements for the Quadra Q4 Diamond Series II system are clearly indicated on the Product Identification label located on the rear of the equipment The product is also CE marked on the rear Figure 4 CYDEN LTD TECHNIUM KINGS ROAD SWANSEA WALES UK SA1 8PH MODEL SPEC SERIAL NO uve OE 50 60 8 1 2 A Figure 4 Product Identification Labels Use of the Top Tray The Quadra Q4 Diamond Series II top tray can be used temporarily for storing equipment e g glasses However no liquids e g coffee cups should be placed in this area Page 8 QUADRA Q4 Diamond Series 2 Product Description The Quadra Q4 Diamond Series II system is an intense pulsed light device which produces non coherent optical output in the 530 1200nm region of the spectrum The optical output is produced by the electrical excitation of xenon flashlamp
20. formation Action cool area for pain relief recommend burn sprays and creams from pharmacy consult doctor e Transient hyper pigmentation Action moisturize protect from sun exposure and further skin insult i e do not rub or scratch consult operator and doctor if condition persists e Transient hypo pigmentation Action moisturize protect from sun exposure and further skin insult i e do not rub or scratch consult operator and doctor if condition persists The use of test patches will minimize the incidences of adverse effects See also post treatment care instructions 5 4 Treatment Protocol General Considerations Prior to treatment the client s general medical history should be obtained to establish if they have any conditions that would exclude them from treatment This can be undertaken using a generic consultation form APPENDIX A The client should have the following explained to them e The potential for adverse side effects from the treatment such as transient erythema blistering and or crust formation transient hyper pigmentation transient hypo pigmentation Page 29 QUADRA Q4 Diamond Series gt How the treatment works e The length of time before a result is noticed e Post treatment care Once all this has been carried out the client should then sign a consent form The nature of the Quadra Q4 Diamond Series treatment is non invasive in nature and therefore has the minimum of pre and post tre
21. ion and scattered blood vessels can be improved with facial skin therapy using intense pulsed light technology Some collagen tightening and remodeling occurs with repeat treatments Skin therapy is a purely cosmetic treatment designed to produce younger and healthier looking skin Skin therapy can treat vascular redness the appearance of Rosacea pigmented brown spots sun damage skin texture and collagen structure all at once This new technique treats skin damage non invasively there is no disruption of the skin s epidermal surface Quadra Q4 Diamond Series II treatments address the effects of photo aging and sun damage with low risk of complications and virtually no recovery time Why choose Quadra Q4 Diamond Series II over other treatment options The Quadra 4 Diamond Series II provides a range of treatment programs suitable for skin therapy and allows the operator to select parameters which favor reduction of pigmented blemishes or vascular redness while generally improving skin tone pore size and fine lines and wrinkles 5 8 1 Treatment of Benign Pigmented Blemishes To treat benign pigmented blemishes it is recommended that an ice pack cool compress be applied to the skin before and after treatments Test patches should be undertaken as described above The pulses should be applied evenly over the treatment area as described above Following treatment it is typical that erythema occurs locally to the pigmented blemishes This may
22. ion block itself is a delicate optical component and should also be wiped with a clean soft lint free cloth or gauze slightly moistened with 7096 isopropyl alcohol or single use 70 isopropyl alcohol prep wipes e g Chemtronics Optic Prep pre saturated wipes to ensure that it is optically clean and smear free 4 3 2 Inside Surface of the Glass Transmission Block The inside surface of the glass transmission block has a delicate dichroic filter optical coating to reflect unwanted wavelengths of light and must be kept Optically Clean To gain best access to the inside surface of the glass transmission block for cleaning please refer back to Section 4 2 Installation of the Disposable Lamp Unit CAUTION DO NOT TOUCH THE LAMP GLASS OR TRIGGER WIRE AROUND THE LAMPS WHEN INSPECTING OR UNDERTAKING CLEANING PROCEDURES The inside surface should be checked at least weekly for airborne dust or other debris and cleaned carefully with a clean soft lint free cloth or gauze slightly moistened with 70 isopropyl alcohol or single use 70 isopropyl alcohol prep wipes e g Chemtronics Optic Prep pre saturated wipes to ensure that it is optically clean and smear free Wipe off and dry any excess alcohol or smears with a clean soft lint free cloth QUADRA Q4 Diamond Series 4 4 Start Up After successful installation and switch on the main display screen should appear showing the model and software version
23. jacent pulses as overlapping may lead to the excessive build up of heat in the skin While the principle of selective photothermolysis attempts to ensure that the heat generated by the optical energy is confined to the target structure e g the melanin in the hair shaft the surrounding epidermal layer of the skin also contains melanin and will therefore undergo a temperature rise Should concurrent pulses be applied to the same treatment location the heat generated from the initial pulse may not have time to fully dissipate prior to the application of the subsequent pulse This accumulation of heat may lead to blistering of the skin and increase the possibility for adverse events Page 31 QUADRA Q4 Diamond Series To ensure continued suppression of hair growth additional treatments may be required It is recommended that subsequent treatments are performed at 2 6 week intervals Post treatment cosmetics can be readily applied No other factors have to be considered HAIR REMOVAL SKIN TYPE PULSE TIMESON TIME ORF ENERGY RANGE J cm PROGRAM msec msec Single Zor Denean 12 0 to 16 0 J cm 4 A Single S I nedat 13 0 to 17 0 J cm 5 8 i Single S alr 12 0 17 0 J cm 5 A Single Oo eiei 12 0 to 17 0 J cm 6 B il Single So i ereenn 12 0 to 16 0 J cm 6 A Multiple 15 20 12 0 to 18 0 J cm2 14 B M Multiple 15 20 12 0 18 0 J cm 14 A Multiple 20 25 12 0 to 18 0 J cm 16 B 5 8 SKIN
24. nd other names Oral Contraceptives Perfenazine Trilafon Phenytoin Dilantin Prochlorperazine Compazine Protriptyline Vivactil Quinine QUinamm Thioridiazine Mellaril Tolbutamide Tolinase Trifluroperazine Stellazine QUADRA 04 Diamond Series Isoniazid INH Methotrexate Naproxen Naprosen Alleve other names Norfloxacin Noroxin Ofloxacin Floxin Oxytetracycline Terramycin Phenylbutazone Butazolidin Piroxicam Feldene Promethazine Phenergan Quinidine Quinidex Quinaglute Cardioquin other names Sulfonamide antibiotics Bactrim Septra Gantrisin and others Thiothixene Navane Tretinoin Retin A Vitamin A QUADRA Q4 Diamond Series FITZPATRICK SCALE Working Classification Color Always burns easily never tans White extremely sensitive to sun Always burns easily tans minimally very White sensitive to sun Sometimes burns Tans gradually to light White Asian brown sun sensitive skin Burns minimally always tans to Moderate brown moderate brown minimally sun sensitive Very rarely burns tans well sun Dark brown insensitive skin Never burns deep pigmented sun Black insensitive skin Type Primarily red headed individuals and blonds with light complexions Type Il Ill The largest percentage of Caucasian individuals fall into these categories Type IV Individuals of Asian
25. nt can be undertaken at regular intervals to minimize acne flare ups ACNE LESIONS SKIN TYPE PULSE ENERGY RANGE J cm Multiple 20 25 8 0 to 12 0 J cm 16 A Multiple 20 25 8 0 to 12 0 J cm 16 4 Multiple 20 25 8 0 to 11 0 J cm 16 A Multiple 20 8 0 to 10 0 J cm A Page 35 QUADRA Q4 Diamond Series PRO 10C SKIN TYPE PULSE TIMESON ENERGY RANGE J cm PROGRAM msec msec Multiple 7 8 0 to 20 0 J cm Multiple 7 8 0 to 20 0 J cm Multiple 7 8 0 to 20 0 J cm Multiple 7 8 0 to 20 0 J cm DES Skin Skin Type Program Type Program Skin Type Program Skin Type Program A A A IV A B I B 8 IV B 6 6 6 IV 6 D 1 D D IV D E 1 5 E IV E F 1 F 1 IV F 6 General Maintenance 6 1 Cleaning the Equipment Before cleaning maintenance is carried out please ensure the unit is disconnected from the mains supply The equipment system can be cleaned by wiping with a soft lint free cloth slightly dampened with 7096 Isopropyl alcohol or single use 7096 isopropyl alcohol prep wipes Care should be taken not to spill any cleaning fluids onto the unit Additionally daily checks should be made of the back of the disposable and the connection spring pins All pins should spring freely and should be clean and dry The pins and disposable can be wiped with a DRY
26. ond Series 1 2 Optical Safety Label Placement Figure 2 shows the placement on the Quadra Q4 Diamond Series II of the warning labels figure 2 Warning Label Placement Page 6 QUADRA Q4 Diamond Series 1 4 Safety Warnings Electrical Safety ONLY MANUFACTURER RECOMMENDED ACCESSORIES SHOULD BE USED WITH THE SYSTEM NON STANDARD COMPONENTS AND ACCESSORIES MAY DEGRADE PERFORMANCE OR CREATE SAFETY HAZARDS The manufacturer of the Quadra Q4 Diamond Series II has made every effort to provide as many safety features as possible to assure personal safety To be effective these safety features have to be utilized and not ignored HIGH VOLTAGE WARNING NO USER SERVICABLE PARTS INSIDE THE QUADRA Q4 DIAMOND SERIES II UNIT NO ATTEMPT SHOULD BE MADE TO REMOVE THE OUTER COVER Electrical hazards within the Quadra Q4 Diamond Series II system are clearly indicated with the hazard warning label shown in Figure 3 Figure 3 Electrical Hazard Warning Labels Example A personal injury hazard is accessible as you read the marking Do not work near or touch any related electrical connections These areas marked may have line voltage or very high voltages exposed This product is grounded through the grounding conductor of the power cord To avoid electrical shock plug the power cord into a properly wired receptacle including ground before using this product A protective ground connection by way of the grounding in the pow
27. or appear purple grey in color this is indicative of selective absorption of the incident light within the vessel structure Over a period of 10 14 days post treatment the vessel will either partially or fully resolve Additional treatments may be necessary to ensure complete clearance of the blemishes Subsequent treatments should only be performed at the same treatment site at an average of 2 week intervals or when area is completely healed Page 34 QUADRA G4 Diamond Series VASCULAR LESIONS SKIN TYPE PULSE pem pe F ENERGY RANGE J cm ere Single 20 MN yaaa Rens 12 0 to 15 0 J cm 3 A Single 255 IN enen 13 0 to 17 0 J cm 4 B I Single Zor JL 13 0 to 17 0 J cm 4 A Single 305 Tee 13 0 to 18 0 J cm 5 B i Single 25 aak 12 0 to 15 0 J cm 4 A Multiple 10 20 12 0 to 18 0 J cm 15 B Multiple 10 20 11 0 to 14 0 J cm 15 A Multiple 20 25 11 0 to 15 0 J cm 16 B 5 9 INFLAMMATORY ACNE Typical Treatment To treat mild to moderate inflammatory acne it is recommended that an ice pack cool compress be applied to the skin before and after treatment Test patches should be undertaken as described above The affected area should be uniformly covered with pulses ensuring minimal overlap Following treatment the skin may appear reddened with slight swelling around the individual spots Over a period of 3 5 days the spots should appear less inflamed and may resolve completely Further treatme
28. ose faults that may be experienced on the equipment from time to time If a fault is encountered that cannot be easily rectified please inform the nearest Service Center To help the Engineer diagnose the system it would help if the following information must be available when the service center is called e The Equipment Serial Number found at the rear of the unit e The Software Version Number found at start screen gt The number of shots fired by the equipment e Description of the fault To help with diagnosis please make a note of the system equipment serial number and software version If after checking the following points listed in each section the equipment is still not functioning correctly please call the nearest Service Center Equipment Problem System Poor Will Not Equipment Power Up Performance Page 38 QUADRA Q4 Diamond Series 7 1 Unit Will Not Switch On e Ensure the mains supply is plugged into the receptacle in the wall and power is available gt Ensure the switch on the rear of the unit is in the I position e Ensure the key switch is in the Horizontal position e Ensure Remote Interlock is connected or Dummy Plug in place Page 39 Remedy Action Connect remote interlock or replace dummy plug Ensure disposable unit located correctly and close handpiece Clear fault and retry If problem persists replace disposable unit and retry Replace dispos
29. reatment press the ARMED STANDBY key to ARM the unit Arm Standby The Red light on the back of the Handset will begin to flash After approximately 10 seconds the screen will indicate that the unit is ARMED and the red indicator on the back of the handset will be continuously illuminated An audible tone will sound when the unit is ready to pulse Tx HAIR SK I SR 5000 10 0 JOM2 ARMED Page 24 QUADRA Q4 Diamond Series Figure 15 Armed Indicator The optical pulse is triggered by either pressing the finger After the pulse has been delivered the SR Shots Remaining indicator will decrement by 1 and an audible tone will sound when the unit is ready to pulse again Note The Energy Level can be adjusted without fully discharging the system While charged press the MODE button to enter the Energy adjustment screen Use the UP and DOWN buttons to alter the Energy level Press the ENTER button to confirm and return to the ARMED screen and continue treatment By pressing the ARMED STANDBY key the unit will disarm and return to ARMED STANDBY screen Arm Standby the output parameters need to be adjusted press the MODE key to go to the start of the Mode selection sequence If during usage the SR Shots Remaining indicator reaches zero the following message will be displayed Replace disposable unit as described in Section 4 2 DISPOSABLE EXPIRED PLEASE REPLACE Note If the unit
30. remains in ARMED mode for 2 minutes without firing or user intervention the system will automatically revert to STANDBY mode with the following message displayed Page 25 DISCHARGING CAPACITORS SYSTEM TIMED OUT QUADRA Q4 Diamond Series 4 8 Cooling Periods To ensure the optimum operational use of the unit is maintained cooling periods have been incorporated into the design Once 50 pulses have been delivered to the patient continuously using the same Treatment Program and energy density e g P 4 E 10J cm2 then a Short Cooling Cycle is introduced and the following message displayed for a period of approximately 1 minute SHORT COOLING CYCLE PLEASE WAIT Once 250 pulses have been delivered to the patient continuously using the same Treatment Program and energy density e g P 4 E 10J cm2 then an Extended Cooling Cycle is introduced and the following message displayed for a period of approximately 5 minutes EXTENDED COOLING CYCLE PLEASE WAIT 4 9 Switch off Procedure 1 Ensure unit is Discharged 2 Turn key Counter clockwise and remove from device to prevent unauthorised use Page 26 QUADRA Q4 Diamond Series 4 10 QUADRA Q4 Diamond Series II Set up Quick Guide The following flowchart shows the Quadra Q4 Diamond Series II set up procedure System Start CS02 1010A1 0 Adjust Treatment Program PROG 4 ENERGY 10JCM2 ADJUST PROGRAM NUMBER Adjust Energy Density PROG 4
31. s the intensity and duration of the optical pulse being governed by the flashlamp drive current The energy is delivered directly to the treatment site from the flashlamps via a suitable cut off filter which removes unwanted wavelengths from the output spectra The Quadra Q4 Diamond Series II system is a self contained unit consisting of the following functional sub systems e User interface and control system e Flashlamp driver circuit e Umbilical lead from base unit to handpiece e Handpiece Mains electricity and an optional remote interlock are the only external connections Figure 5 Quadra Q4 Diamond Series II Unit Page 9 QUADRA Q4 Diamond Series The Quadra Q4 Diamond Series II represents the state of the art in medical equipment technology This equipment offers significant advantages over other systems gt Aesthetic ergonomic design e Increased repetition rate Full self diagnostics e Quick change lamp system In addition the equipment has been designed with ease of maintenance in mind The system utilizes a modular design which coupled with the computer controlled diagnostic capability makes a robust reliable amp safe system The Quadra Q4 Diamond Series is an advanced optical system based on a unique disposable flashlamp design The light is delivered to tissue via an ergonomically designed handpiece The spot size of the optical energy to tissue has been fixed to 33mm 27mm 9 0cm
32. take 2 to 3 minutes to appear and is typically indicative of localized heating of the selected target It is common for the treated pigmented blemish to continually darken for 2 3 days following treatment with a resulting mild desquamation Following desquamation the skin will appear reddened and should return to normal within 10 14 days Page 33 QUADRA Q4 Diamond Series Additional treatments may be necessary to ensure complete clearance of the blemish Subsequent treatments should only be performed at the same treatment site at an average of 2 week intervals or when area is completely healed PIGMENTED LESIONS SKIN TYPE PULSE rese I F ENERGY RANGE J cm ogee Single 20 gt ill ansees 13 0 to 15 0 J cm 3 A Single 25 I rr 13 0 to 17 0 J cm 4 B Single 20 paste heey 13 0 to 15 0 J cm 3 A Single 23T I 13 0 17 0 J cm 4 B Single OO eenas 12 0 to 19 0 J cm 5 6 Single 00 70 11 0 to 16 0 J cm 5 4 Single 40 LR 12 0 15 0 J cm 7 8 Multiple 15 20 12 0 18 0 J cm 14 6 Multiple 15 20 12 0 18 0 J cm 14 A Multiple 20 25 12 0 18 0 J cm 16 B 5 8 2 Treatment of Vascular Blemishes To treat vascular blemishes such as Telangiectasia again it is recommended that an ice pack cool compress be applied to the skin before and after treatment Test patches should be undertaken as described above Immediately following treatment the vessel will blanch
33. the hair shaft or melanin within pigmented blemishes with minimal interaction with the surrounding healthy skin structures 5 2 Contraindications The contraindications for the Quadra Q4 Diamond Series II procedure are minimal however the following exclusion from treatment criteria is recommended e Tanned skin active tan e Pregnancy e A history of keloid scarring e Use of medication that may induce photosensitivity to the skin e Any inflammatory skin condition at the treatment site e A history of skin cancer e The client has a history of poor wound healing including Type Diabetes e Vitiligo e Treatment over certain skin areas such as tattoos moles semi permanent make up lip vermillion or mucous membranes Page 28 QUADRA Q4 Diamond Series 5 3 Treatment Related Problems Potential side effects of treatment with any intense pulsed light system are the following e Excessive pain Action Stop treatment cool and moisturize skin review after 24 hours re treat Likely causes fluence too high tanned skin stress menstruation and tiredness e Excessive persistent heat and redness Action cool and moisturize skin treat as for mild sunburn Normally resolves in 24 hours Likely cause Fluence too high e Persistent swelling Action cool area thoroughly consult doctor e Itching of treatment area Action keep area cool apply aloe vera gel consult doctor if condition persists e Blistering or crust
34. tivity There are many drugs available at the moment that can cause the skin to become very sensitive to light Whether these drugs are taken by mouth or applied to the skin a reaction can occur This reaction is called Drug Induced Photosensitivity Therefore it is very important that you read this information and notify the Doctor Operator of any drugs that you may be using Photosensitivity reactions can be divided into two groups Photo Toxic Reactions these are dose related and can be seen to a slight degree in people who are exposed to sunlight Photo Allergic Reactions these involve the immune system and may be similar to other allergic reactions swelling rashes and hives The drugs cause this reaction by absorbing the Equipment light which is in the visible part of the spectrum that is delivered by our system Types of Photosensitivity Abnormal and extreme sunburn Stinging and burning Vesicles Hives Swelling There is a large variation in the frequency and severity of reactions from client to client Some clients may blister have a slight unnoticeable reaction or will have no reaction at all For this reason it is advisable that test patches are carried out to determine if any adverse reactions occur Common Drugs That Can Cause Photosensitive Reactions Antibiotics Dioxycycline Vibramycin Vibratabs Demeclocycline Declomycin High incidence Tetracycline Achromycin and others Nalidixic Acid NegGr
35. tment Programs The Quadra Q4 Diamond Series II is configured with 16 pre programmed pulse patterns Each pattern has been developed for a specific treatment that takes into account the clinical condition and clients skin type THE PARAMETERS CONTAINED IN THE FOLLOWING TABLES ARE TO BE CONSIDERED AS GUIDELINES ONLY THE USE OF TEST PATCHES IS STRONGLY ADVISED AS CLIENT TO CLIENT VARIATION MAY AFFECT THE TREATMENT OUTCOME AND THE POSSIBLE INCIDENCE OF SIDE EFFECTS 5 7 HAIR REMOVAL Typical Treatment Procedure For hair removal it is recommended that the treatment site be shaved or trimmed prior to treatment If the hair is trimmed care must be taken to ensure that the remaining hair protrudes no more than Imm above the surface of the skin To reduce any possible discomfort during treatment an ice pack cool compress should be applied to the skin before and after treatments The use of test spots at or near the treatment site prior to the actual treatment is recommended A sequence of test shots should be used at typical treatment energies at the low end of the described scale allow 20 minutes to elapse before review Should erythema occur the energy should be reduced to a lower level and a further test shot should be undertaken However slight erythema surrounding the hair follicles after light application is acceptable The treatment site should be covered with adjacent pulses of light Care should be taken to minimize the overlap of ad
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