Table of Contents
Advertisement
Advertisement
Table of Contents
Related Manuals for Amiea Med EXCEED
Summary of Contents for Amiea Med EXCEED
- Page 1 EXCEED INSTRUCTION FOR USE...
-
Page 2: Table Of Contents
5.3 Clinical precautions ....................12 5.4 To reduce the risk of sharps injury or electrical shock ........13 UPON RECEIPT OF YOUR EXCEED MICRONEEDLING SYSTEM .......14 6.1 Initial setup ....................... 14 6.2 Switching the device to OPERATING or STANDBY MODE ......17 6.3 Configure control unit (menu) ................ - Page 3 17.7 Results – Effectiveness – Physician reported outcomes ....... 48 DEFINITION OF SYMBOLS ....................49 Congratulations on your purchase of this medical device which, as with all our medical de- vices, was produced by ISO 13485-certified manufacturing plants located in Germany. Version 18 – dated 10. September 2018 Exceed...
-
Page 4: General Information
Provisions on workplace safety and legal requirements for microneedling Information and content is supported by a clinical trial evaluating the effectiveness of the Exceed microneedling device on facial wrinkles. A summary of this clinical trial is found in Section 17. -
Page 5: Limitation Of Liability
Limitation of liability Do NOT use the Exceed microneedling device in any way that is not exactly as specified in this Instructions for Use. Use of Exceed other than exactly as specified in this Instructions for Use has not been tested and the risk is unknown. -
Page 6: Intended Use - Requirements For Safe Use
The device is designed to be placed on a flat surface. During the treatment, the handpiece is held by the operator and is used on a patient who is ideally sitting or lying. The user operates the device from a distance of maximum 70cm. Exceed... -
Page 7: Device Description
DEVICE DESCRIPTION The Exceed microneedling device is intended to create many, very tiny, microscopic punctures in the epidermal and dermal layers of the skin using sterile stainless steel needles. The Exceed microneedling device consists of 7 component parts: ARTICLE DESCRIPTION... - Page 8 For needle protrusion setting see section 7.5 - Setting the needle protrusion depth . The safety needle cartridge is screwed into the handpiece. The safety needle cartridge is sterile and for single use ONLY. Discard each and every safety needle cartridge immediately after use. Exceed...
- Page 9 CONTROL UNIT: KEYS AND CONNECTIONS Display Standby-LED Standby / On key Left key Right key SET key Socket for power supply Socket for handpiece Socket for footswitch Exceed...
-
Page 10: Contraindications
CONTRAINDICATIONS The use of the Exceed microneedling device is contraindicated in the following cases: Hemophilia or other blood clotting disorders Unregulated diabetes Pregnancy and nursing mothers Systemic infection or acute local skin infections (as Hepatitis disorders type A, B, C, D, E, F or HIV infection) Patients taking high doses of anti-coagulants or blood-thinning substances, e.g. -
Page 11: Warnings And Precautions
Protect freshly treated skin areas against UV-radiation and sunlight 4.1.2 Benefits In a study of 48 patients with the Exceed microneedling device, 4 treatments of the face spaced four weeks apart showed a significant improvement (≥ 1 grade change) in wrinkles,... - Page 12 ALWAYS switch OFF the device before attempting to clean or inspect any part of the device. Do NOT use the Exceed handpiece, safety needle cartridges or power supply if there are any visible signs of damage. Use of a damaged handpiece, safety needle cartridge or any other component may lead to harm to the operator and patient.
-
Page 13: Operating Conditions
Ni18-8, AISI 301).). The needle cartridge housing is made of polycarbonate (PC). Note the batch number of the safety needle cartridges used in the relevant patient record so that you can inform the manufacturer in the event that problems arise. Exceed... -
Page 14: To Reduce The Risk Of Sharps Injury Or Electrical Shock
NEVER connect the Exceed microneedling device to an electrical outlet that does not contain a reliable protective earth/ground system or voltage. NEVER use the Exceed microneedling device where it can fall or be pulled into water. NEVER use the Exceed microneedling device if you think it has been immersed in water or if you have spilt liquids on it. -
Page 15: Upon Receipt Of Your Exceed Microneedling System
Needle Cartridge for Single Use Only! – Discard Needle Cartridge Immediately After Use! UPON RECEIPT OF YOUR EXCEED MICRONEEDLING SYSTEM Damage caused by condensation If the device is exposed to high differences in temperature (e.g. during shipment) condensati- on may form on the inside and cause damage to electronic components which under certain circumstances could present an electrical shock hazard to the user. - Page 16 Safe operation of the device can then no longer be guaranteed. Unpack the system from its outer shipping container. Open the inner Exceed microneedling device box and check off all of the parts listed in the device description. Contact your distributor immediately if you observe missing parts or accessories.
- Page 17 Plug the jack for the footswitch into the socket for the footswitch on the back of the con- trol unit. Please, be aware that at first delivery the default footswitch mode is CONTINUAL (see section 6.3.2 Select footswitch mode ). Exceed...
-
Page 18: Switching The Device To Operating Or Standby Mode
Note: The device will not operate until the user accepts the Warning notice by pressing the set key If a handpiece is connected, the default puncture frequency of 120 punctures per second appears. If an error message is displayed, please read section 12. Troubleshooting . Exceed... -
Page 19: Configure Control Unit (Menu)
Alternatively: Wait 1 minute. The menu closes by itself. 6.3.1 Switching key tones ON or OFF You can switch the tones played when keys are pressed ON or OFF. Navigate to the KEY TONES menu item. Exceed... -
Page 20: Switching Handpiece On And Off
Discard Needle Cartridge Immediately After Use!” Press the SET key on the control unit. While the handpiece is running, the display on the control unit shows a rotating symbol. If the connected handpiece will not start, please read the section 12. Troubleshooting. Exceed... -
Page 21: Controlling The Device With The Footswitch
Please start with 100 Hz and adjust to higher frequency when you feel familiar. The puncture frequency is the rate at which the needles are driven into the skin. The Exceed microneedling device has a puncture frequency range of 100-150 per second and can be adjusted in steps of 5. -
Page 22: Safety Needle Cartridge And Barrier Sleeve
Use ONLY new and unused barrier sleeves to cover your handpiece. The barrier sleeve helps prevent the risk of bodily fluids soiling the handpiece and reduce risk of cross contamination. Fit the barrier sleeve BEFORE fitting the safety needle cartridge. Switch OFF the handpiece before attempting to apply the barrier sleeve. Exceed... -
Page 23: Attaching The Safety Needle Cartridge To The Handpiece
NEVER depress the needle plunger so that the needles are exposed outside of the needle cartridge. Check if the safety needle cartridge and needles are correctly aligned and if all needles are fully retracted. Holding the handpiece, pierce a hole in the sleeve with the shank of the cartridge. (2) Exceed... -
Page 24: Removing The Safety Needle Cartridge And The Barrier Sleeve From The Handpiece
WARNING! Do not touch the unprotected handpiece with dirty gloves. (hatched area in the picture below). Carefully detach the safety needle cartridge together with the barrier sleeve by turning it anti-clockwise. Carefully pull both, the barrier sleeve together with the safety needle cartridge out until it is completely detached. Exceed... - Page 25 If you see signs of contamination in the inside of the handpiece or you suspect cont- amination in the inside of the handpiece please contact your local distributor. You can find the local distributor serving your region and their contact details at the website www. amieamed.com/contact-us/distributors. Exceed...
-
Page 26: Setting The Needle Protrusion Depth
Chin: 0.9 - 1.3 mm Glabella and Jawline: 0.7 - 1.3 mm Cheek: 0.9 - 1.5 mm Forehead: 0.7 - 1.0 mm Upper lip: 0.7 - 1.0 mm * Note: treatment can be performed around but not within the orbital rim. Exceed... - Page 27 Orbital Rim Guide: Microneedling should not be used within the orbital rim Orbital Rim Treatment area The needle protrusion depth shown on the scale may vary by ±0.15 mm from the actual value. Exceed...
-
Page 28: Treatment Instructions
Move onto the next area as soon as pinpoint bleeding occurs. After treatment cleanse the skin with warm water and sterile gauze. Apply a suitable sunblock and moisturizer. Instruct patient on post treatment care. Instruct patient on possible side effects and degree of severity. Exceed... -
Page 29: Cleaning Instructions
NEVER clean the handpiece, control unit, footswitch or power supply in an autoclave or ultrasonic bath. If you see signs of contamination in the inside of the handpiece or you suspect contami nation in the inside of the handpiece please contact your local distributor. Exceed... - Page 30 Clean the following parts before and after each treatment: The technique described below is a validated cleaning procedure and needs to be followed to ensure effective cleaning of the Exceed device. ARTICLE DESCRIPTION Control unit 2a/b Handpiece with Handpiece Cable...
- Page 31 Use this technique: The technique described below is a validated cleaning procedure and needs to be followed to ensure effective cleaning of the Exceed device. Use a Chlorox wipe and apply pressure with your finger and wipe the whole surface of each part.
-
Page 32: Compatibility To Chemicals
10.1 General care and storage Store the Exceed device system and its accessories in their original packaging. Store the Exceed device system and its accessories in a clean and dry environment. Avoid storing the Exceed device system in environments where the temperature is less than -10°C or greater than 40°C (<14°... -
Page 33: Routine Maintenance
The Exceed microneedling device has NO self-serviceable parts. According to Essential Performance and Basic Safety, there are NO tests or inspections by the user necessary. Follow care and storage instructions to maintain your Exceed microneedling device in good working order. -
Page 34: Troubleshooting
ITEM NUMBER SCOPE OF DELIVERY PCS/PUS Declaration of Conformity 7E-EGK-AD6.1-USMP Inspection sheet for biennial service (STK) Accessories 6-needle plate 1.5 EMNPAED06USMP Exceed US Footswitch E100201USMP Accessories of other manufacturers MANUFAC- ITEM ITEM NUMBER SCOPE OF DELIVERY TURER Pac-Dent Barrier sleeves 100L inc. - Page 35 If the actions suggested fail to fix the problems listed above, or the problem reoccurs within the same treatment session please contact your local distributor. Do NOT attempt to investigate problems further. The Exceed microneedling device has no parts that you can repair.
-
Page 36: Disposal
DISPOSAL Performance testing has supported a lifetime to a maximum of 1200 uses of the Exceed Microneedling Device prior to disposal. Depending on the frequency of use, this correlates to: a) 24 uses per week for 1 year, b) 12 uses per week for 2 years, c) 8 uses per week for 3 years, d) 6 uses per week for 4 years or e) 4 uses per week for 6 years. -
Page 37: Technical Specifications
Continuous operation Dimensions (Width x Height x Depth) 198 x 45 x 176 mm Weight of the handpiece: Approx. 80g Total weight: Approx. 1 100g Applied part Handpiece type B needle protrusion 0 mm to 1.9 mm ±0.15 mm Exceed... -
Page 38: Electromagnetic Compatibility
RF Systems can also be built into the architecture of a cabinet, room, wall, building or other products. The Exceed device must be set up and put into opera- tion taking account of the following EMC information. In case of unlikely disturbances which may be caused by RF emitters please follow the rules according the distances described in the following tables and change the place of the device set up. -
Page 39: Accessories
Puncture frequency: Maximum puncture frequency is 165 Hz; puncture frequency ≤ 165 Hz. If the Exceed device’s puncture frequency is lost or degraded due to electromagnetic distur- bances the handpiece will shut down and the display will show the message Handpiece or device overload! / System error!. -
Page 40: Guidelines And Manufacturer's Declaration - Electromagnetic Noise Immunity
100kHz repetition frequency Surges acc. to IEC ± 1kV differential-mo- In conformity The quality of the supply 61000-4-5 de voltage voltage should match that in ± 2kV common- mode a typical business or hospital voltage environment. Exceed... -
Page 41: Guidelines And Manufacturer's Declaration - Electromagnetic Noise Immunity - For The Device (Without Life-Sustaining Function)
= 1.2 √P for 80MHz to 800MHz d = 2.3 √P for 800MHz to 2.5GHz where P is the rated power of the transmitter in watts (W), per the information from the transmitter manufacturer and d is the recommended protection distance in meters (m). Exceed... -
Page 42: Recommended Safety Distances Between Portable And Mobile Hf
Rated power of the transmitter (W) Safety distance acc. to transmission frequency (m) 150kHz up to 80MHz up to 800MHz up to 80MHz d = 1.2√P 800MHz d = 1.2√P 2.5GHz d = 2.3 √ 0.01 0.12 0.12 0.23 0.38 0.38 0.73 Exceed... - Page 43 AM 80 % 1kHz 18.07 to 18.17 AM 80 % 1kHz 21.0 to 21.4 AM 80 % 1kHz 24.89 to 24.99 AM 80 % 1kHz 28.0 to 29.7 AM 80 % 1kHz 50.0 to 54.0 AM 80 % 1kHz Exceed...
- Page 44 The Exceed device must be set up and put into operation taking account of the EMC informa- tion, especially the distances. Never use the Exceed device closer than 30cm to a RF system.
-
Page 45: Clinical Summary
The objective of the study was to assess the effectiveness of the Exceed microneedling de- vice in reducing the signs of skin aging as measured by the improvement in wrinkles, after 4 standardized treatment sessions and to assess the safety of the device as measured by the number of adverse events. -
Page 46: Measurement Of Safety
Note: Thirteen (13) out of 48 subjects (27%) reported a predisposition to HSL at the be- ginning of the study. Of this predisposed population, an HSL outbreak was observed in 8 subjects (62%). Subjects were treated for their HSL using conventional antiviral therapy Exceed... -
Page 47: Results - Safety - Patient Reported Outcomes
GRADING OF ERYTHEMA GRADING IMMEDIATELY AFTER MINOR MODERATE SEVERE TREATMENT Physician 34/48 (70%) 14/48 (30%) Subject 19/48 (40%) 29/48 (60%) Subjects indicated that although the treatment appeared to be moderately painful it was not particularly uncomfortable (table iv). Exceed... - Page 48 0 = no peeling and 10= heavy skin peeling over the whole face). Skin peeling was still reported in 31/48 (65%) subjects by the evening of day 8. figure i). Figure i – Subject assessment of pain, discomfort and peeling immediately after the treatment to day 8 Exceed...
-
Page 49: Results - Effectiveness - Physician Reported Outcomes
Subjects graded as wor- 0/48 (0%) 0/48 (0%) 0/48 (0%) sened For glabella frown lines, periorbital lines and cheek folds an improvement of >1 grade was shown for 18/48 (37.5%), 20/48 (41.7%) and 17/48 (35.4%) subjects (see Table v). Exceed... -
Page 50: Definition Of Symbols
Do NOT resterilize JAPAN TUV R-PSE Energy Efficiency Level IV Device complies with Japanese VCCI standards CHINA SJ/T 1 1364-2014 accepted component for Canada and US Double insulation / protection class II device ETL Mark – Intertek Testing Certification Exceed... - Page 51 SIQ Mark License EN60601-1 Ukraine UKRSepro For further information, see Instruction for Use Device type B, meaning that the device offers protection against electric shocks and leakage currents. Refer to instruction manual/booklet Manufacturer Date of manufacture Catalogue number Serial number Batch code Exceed...
- Page 52 Do NOT use if packaging is damaged Do NOT reuse Product may not be thrown into the household waste. Dispose properly as electronic waste Sharps hazard Inspection sticker: Inspection in accordance with manufacturer's instructions (biennial service) required every 24 months, see section 10.2 Conformité Européenne Exceed...
- Page 53 Exceed...
- Page 56 Distributed by: amiea med Inc. | 111 N Orange Ave | Orlando, FL 32801 (US) Manufactured by: MT.DERM GmbH | Gustav-Krone-Str. 3 | 14167 Berlin Phone +49 30 845885-4 | Fax +49 30 8458855-5 | info@mtderm.de | mtderm.de...
Need help?
Do you have a question about the EXCEED and is the answer not in the manual?
Questions and answers