FCC ID: 2ABRVSENSIFIRM OTC Home Use Device

EL Global Trade Ltd Tzoran 8th St, P.O.Box 8242, Natanya 4250608, Israel Tel: +972-9-7889069 Fax: +972-9-7734831 Sensifirm Instructions for Use - US RD 12004 E1 Page 1 of 28 Sensifirm Instructions for Use - US Authorization Name Title Signature Date issued Updated by:

Veronika Kravtsov Approved by:

Yael Liebes-Peer, PhD RA/ QA Associate RA/ QA Manager Dec 28th, 2017 Dec 28th, 2017 This document and the information contained in it are proprietary and confidential to EL Global Ltd. and associates. Nothing herein may be copied, reproduced or distributed in any form or any medium, or disclosed to any third party in any manner without prior written authorization of EL Global Ltd. EL Global Trade Ltd Tzoran 8th St, P.O.Box 8242, Natanya 4250608, Israel Tel: +972-9-7889069 Fax: +972-9-7734831 sensiFirm Instructions for Use - US RD 12004 E0 Page 2 of 28 List of Revisions Revision Paragraph Change Description Date Issued by A0 B0 B1 C0 D0 D1 E0 E1 All All Contraindications, warnings and cautions Electromagnetic compatibility

(EMC) and Specifications Electromagnetic compatibility

(EMC) and Specifications All All All All Initial release according to discussions with Prof. Avner Shemer Sections re-organization, Wording and re-phrasing Re-organized Section was added Updating information according to external lab certification Correction of typos (removal of touch from touch button and replacing treatment fingers with electrodes According to FDA comments

(K170637): Addition of indication for use statement, clearer language, removal of unique sensor description According to FDA comments

(K170637/S001) Typos correction and editing by copy Labeling Updating symbols FCC FCC Section was added According to FCC COMMENTS regarding the Bluetooth Module, added in the FCC section: Device contain FCC ID:

2ACCRMC10 February 21st, 2016 Veronika Kravtsov December 13th, 2016 Veronika Kravtsov Jan 26th, 2017 Veronika Kravtsov May 7th, 2016 Veronika Kravtsov July 13th, 2017 Nov 20th, 2017 Dec 28th, 2017 July 19th 2018 Veronika Kravtsov Veronika Kravtsov Veronika Kravtsov Eitan Blaich EL Global Trade Ltd Tzoran 8th St, P.O.Box 8242, Natanya 4250608, Israel Tel: +972-9-7889069 Fax: +972-9-7734831 sensiFirm Instructions for Use - US RD 12004 E0 Page 3 of 28 All rights reserved to EL Global Trade Ltd. Table of Contents Indications for Use ........................................................................................................................... 4 What is Sensifirm? ........................................................................................................................... 4 How does it work? ........................................................................................................................... 4 Intended use of Sensifirm ............................................................................................................... 5 Safety ............................................................................................................................................... 5 Sensifirm device description ........................................................................................................... 6 Hand-held description ................................................................................................................ 7 User interface description .......................................................................................................... 7 When Sensifirm should not be used ............................................................................................... 8 CONTRAINDICATIONS ................................................................................................................... 8 WARNINGS .................................................................................................................................. 9 CAUTIONS .................................................................................................................................. 10 Possible side effects ...................................................................................................................... 11 What to expect when using Sensifirm ........................................................................................... 11 User instructions ........................................................................................................................... 12 Device set-up .............................................................................................................................. 12 Preliminary test ........................................................................................................................ 13 How to use the Sensifirm device .............................................................................................. 14 Recommended treatment protocol ......................................................................................... 15 Treatment areas ........................................................................................................................ 15 Post-treatment care .................................................................................................................. 16 Cleaning ......................................................................................................................................... 16 Troubleshooting ............................................................................................................................ 17 Customer service ........................................................................................................................... 18 Device specifications ..................................................................................................................... 19 Electromagnetic compatibility (EMC) and Specifications.............................................................. 21 EL Global Trade Ltd Tzoran 8th St, P.O.Box 8242, Natanya 4250608, Israel Tel: +972-9-7889069 Fax: +972-9-7734831 sensiFirm Instructions for Use - US RD 12004 E0 Page 4 of 28 Indications for Use The Sensifirm device is intended to achieve the following result, using non-thermal radiofrequency combined with massage: temporary reduction in the appearance of cellulite. What is Sensifirm?

Sensifirm is a home-use device used for the temporary reduction in the appearance of cellulite. The treatment is applicable to areas of the body where cellulite occurs: the buttocks and thighs. Sensifirm brings a completely new approach to non-invasive and non-ablative treatment, featuring Sensica LIPO RF (Radio Frequency) technology, commonly used by professional medical practitioners worldwide. How does it work?

Introducing LIPO RF technology The Sensifirm device combines the advantages of localized heating produced by radiofrequency energy, together with a massage achieved by a vibration motor and manual manipulation. The massage. Massage therapy is known to be useful for various applications, including improving cellulite appearance. The Sensifirm houses a vibration motor, which causes a gentle massage sensation as you move the device over your skin. RF technology. Radio Frequency (RF) is a form of electromagnetic energy that has been used for a long time in aesthetic medicine. The spacing between Sensifirms four RF electrodes enables great treatment volume and allows multiple RF waves to reach deep into the skin layers, heating the dermis, hypodermis (inner skin layers) and subcutaneous fat layers, without damaging the epidermis (outer skin layer). The deep thermal effect of the combined RF currents and massage activates several biological mechanisms, among which are collagen and elastin remodeling and later production, improvement in microcirculation and in lymphatic drainage. Together, these effects lead to improvement in cellulite appearance, with the best possible visible results, that last for 3 months. EL Global Trade Ltd Tzoran 8th St, P.O.Box 8242, Natanya 4250608, Israel Tel: +972-9-7889069 Fax: +972-9-7734831 sensiFirm Instructions for Use - US RD 12004 E0 Page 5 of 28 Please carefully read these Instructions for Use before you start your Sensifirm treatment. This guide, as well as an instructional video, can also be found at www.sensica.com Intended use of Sensifirm Sensifirm is intended for use by women who want to improve cellulite appearance in the treatment area. Sensifirm is especially designed for use on the buttocks and thighs, where cellulite tends to appear. Note: Sensifirm is especially designed for your own personal treatment, and is intended for a single user. Safety Sensifirm is designed to protect your skin. The device has two built-in sensors, which constantly measure your skin temperature. When the temperature rises to the maximal level (41oC/ 106.7oF), the RF energy (heat) will automatically stop. When the temperature has decreased again, the RF energy (heat) will be automatically re-activated. The temperature sensors prevent local over-heating. Follow these Instructions for Use for a comfortable and pleasant treatment experience. EL Global Trade Ltd Tzoran 8th St, P.O.Box 8242, Natanya 4250608, Israel Tel: +972-9-7889069 Fax: +972-9-7734831 sensiFirm Instructions for Use - US RD 12004 E0 Page 6 of 28 Sensifirm device description The Sensifirm kit includes the following components:

External power supply. Sensifirm hand-held device:

o Four treatment electrodes for applying RF. o Two safety temperature sensors, one positioned between each pair of electrodes. o RF energy selection button and LED indicators for RF intensity selection. o LED to indicate the device status (ON/OFF). Base Gel:

Designed specifically to improve contact between the device and the skin, and to improve skin conductivity, to ensure proper delivery of RF energy and best possible results. DO NOT use Sensifirm without first applying the Base Gel, as this will compromise your safety and treatment efficacy. Base Gel ingredients: Glycerin, Aqua, Phenoxyethanol, Ethylhexylglycerin, Triethanolamine and Carbomer. This Sensifirm Instructions for Use booklet. EL Global Trade Ltd Tzoran 8th St, P.O.Box 8242, Natanya 4250608, Israel Tel: +972-9-7889069 Fax: +972-9-7734831 sensiFirm Instructions for Use - US RD 12004 E0 Page 7 of 28 Hand-held description User interface description Transient (for ~5 sec) orange light followed by transient (for

~1 sec) green light Sensifirm is in standby mode and ready to work. Status indicator Steady green light Alternating red and orange lights RF energy level selection button 1-3 energy levels lights Sensifirm is in treatment mode. RF is activated, skin contact is detected and the treatment is underway*. Sensifirm is in error mode. The device has detected a malfunction and has blocked the activation of the RF function. The green light indicates which RF energy level has been activated. Press the RF energy level selection button repeatedly until you reach the desired level: 1, 2, 3, or off. Note: RF energy is delivered only when proper contact with your skin is detected. When proper treatment is underway, the status indicator will have a steady green light and you will feel vibration.

* Upon contacting the treatment area, the massage function is automatically turned on. EL Global Trade Ltd Tzoran 8th St, P.O.Box 8242, Natanya 4250608, Israel Tel: +972-9-7889069 Fax: +972-9-7734831 sensiFirm Instructions for Use - US RD 12004 E0 Page 8 of 28 When Sensifirm should not be used Sensifirm is designed especially for you, to allow safe and effective treatment. However, Sensifirm may not be appropriate for everyone. Please read the information below before use. If you still have any doubts, and you are unsure whether Sensifirm is safe for your use, please consult your physician. CONTRAINDICATIONS Do NOT use the Sensifirm device if any of the following conditions apply:

If you have an active implant, such as a pacemaker or insulin pump, or if you have any known severe heart disorder, such as arrhythmias. If you are pregnant or breastfeeding. If you suffer from severe or uncontrolled endocrine or metabolic conditions, such as diabetes or uncontrolled thyroid disease. If you have a damaged immune system or autoimmune disorder, such as AIDS or Lupus, or if you use drugs that influence the immune system. If you suffer from blood clotting disorders, excessive bleeding or bruising, damaged wound healing or if you routinely take blood-thinning medications. If you suffer from a history of deep vein thrombosis. If you have a history of collagen disorders, or suffer from keloid scarring (growth of extra scar tissue where the skin has healed after an injury). If you have a general extreme illness, such as hepatitis, liver disease or epilepsy. If you suffer from sensitive or damaged skin such as in cases of frequent redness or rash, inflammations, breakouts (such as psoriasis), blisters, sores, infections, acne or extra dry skin. If you have diminished or exaggerated perception of temperature change. If you have taken Accutane in the past 6 months. If you have a heat-induced disease or an active skin disease, such as herpes, eczema, rashes etc., in the treatment area. EL Global Trade Ltd Tzoran 8th St, P.O.Box 8242, Natanya 4250608, Israel Tel: +972-9-7889069 Fax: +972-9-7734831 sensiFirm Instructions for Use - US RD 12004 E0 Page 9 of 28 If you have skin cancer, areas at risk of malignancy, or if you have received radiation therapy or chemotherapy within the past 3 months. WARNINGS There are some scenarios in which Sensifirms safety and effectiveness has not yet been tested or established. Therefore, if any of the following conditions apply, it is NOT advised that you use the device:

If you have any permanent implants in the designated treatment area, including but not limited to: silicon or injected chemical materials, metal plates or other metal materials. If in the past 3 months you have had surgery, including plastic surgery, or you have undergone any esthetic procedure, such as skin resurfacing, liposuction, deep peeling, cryolipolysis (fat freezing), or have had esthetic injections of fillers, such as hyaluronic acid, collagen, fat or Botox, in the treatment area. If you have any metal items, such as jewelry or piercings, or tattoos or permanent make up on the designated treatment areas. If you have sunburn, or dark brown or black spots such as freckles, birth marks, moles or blisters in the treatment area. If you are allergic or sensitive to chrome or nickel or any component of the Base Gel. If you are male. If you are under the age of 18. If you have reduced physical, sensory or mental capabilities. Do not use Sensifirm over breasts, genitals or areas not recommended in Instructions for Use guide. Do not use Sensifirm over hairy areas of the body, as this may result in the hairs being burnt. Note: If you have undergone any other aesthetic procedure in the designated treatment area, or if you have treated the skin with a prescribed drug within the past 3 months, or if you have any concerns regarding potential side effects, please consult your physician before using Sensifirm. EL Global Trade Ltd Tzoran 8th St, P.O.Box 8242, Natanya 4250608, Israel Tel: +972-9-7889069 Fax: +972-9-7734831 sensiFirm Instructions for Use - US RD 12004 E0 Page 10 of 28 CAUTIONS In order to avoid serious harm from using the Sensifirm device:

Never use flammable liquids, such as alcohol (including perfumes, sanitizers, or other applications containing alcohol) or acetone to clean the skin in the hour before using Sensifirm as it may cause burning of the skin. Do not open or repair the device, as it may expose you to dangerous electrical components. Do not place, store or use Sensifirm near bathtubs, showers, basins or other vessels containing water, as this may cause severe electrocution. Do not leave Sensifirm unattended while plugged into the electricity supply, as it may lead to electrocution. Keep out of reach of children and pets. Use the Sensifirm only in accordance with these Instructions for Use and for the intended use. Do not use the device if any part of the device is missing, damaged or loose, if the device is not working properly, if you see or smell smoke, or if the device becomes damp or wet. Make sure the device is clean, dry and intact before each use. Cleaning instructions are detailed in the Cleaning section below Do not use the Sensifirm device without first applying the Base Gel. Do not use the Base Gel after its expiration date. Note: the Base Gel is for external use only - avoid direct contact with eyes. In the event that such contact does occur, wash the eyes immediately with water. Note: Sensifirm is designed to be used by a single user. Use Sensifirm only with the original power supply. For your safety, never use DC adapters which are not approved by the manufacturer. EL Global Trade Ltd Tzoran 8th St, P.O.Box 8242, Natanya 4250608, Israel Tel: +972-9-7889069 Fax: +972-9-7734831 sensiFirm Instructions for Use - US RD 12004 E0 Page 11 of 28 Possible side effects When using the Sensifirm device according to these Instructions for Use, side effects are rare. However, every esthetic procedure, including the use of home-use devices, may cause side effects. Therefore, it is important that you understand and accept the risks and complications that can occur when using an RF cellulite appearance reduction device:

Degree of side effects Minor Rare Extremely rare Side effects Local pain Skin irritation Skin redness Minor swelling Skin sensitivity Allergies or sensitivity to Base Gel Mild skin burns Pigment changes Excessive redness, rash, swelling Subcutaneous bleeding Severe burns Infection Bruising Blistering If necessary, please consult with your physician if any of these side effects occur. What to expect when using Sensifirm The use of the Sensifirm device is simple and quick, as detailed in the User Instructions section below. The Sensifirm treatment session, may cause:

Sensations of warmth, created by the RF energy and the massage. Some mild red or pink color on the skin, during and just after the treatment session. EL Global Trade Ltd Tzoran 8th St, P.O.Box 8242, Natanya 4250608, Israel Tel: +972-9-7889069 Fax: +972-9-7734831 sensiFirm Instructions for Use - US RD 12004 E0 Page 12 of 28 User instructions Sensifirm is intended for use on buttocks and thighs. Device set-up 1. Remove all components from the box (the Sensifirm device, power supply and Base Gel). 2. Check the expiration date of the Base Gel. 3. Before beginning the treatment, make sure that the electrodes are clean, dry and intact. 4. Insert the plug end into an electrical outlet, and insert the cord end into the device socket. Your Sensifirm device is now ready for use. 1. Prepare the treatment area. Make sure your skin is dry, clean and free of topical products, such as moisturizers and lotions. Caution: Never use flammable liquids, such as alcohol (including perfumes, sanitizers, or other applications containing alcohol or acetone) to clean the skin in the hour before using Sensifirm, as it may cause burning of the skin. 2. Remove all jewelry from the treatment area. 3. Remove excessive or long hair from the treatment area. 4. Perform a preliminary test on a small patch of skin in the intended treatment area, 48 hours before the first use of Sensifirm. In the preliminary test, you can determine the energy level settings that best suit you (see Preliminary test section below). EL Global Trade Ltd Tzoran 8th St, P.O.Box 8242, Natanya 4250608, Israel Tel: +972-9-7889069 Fax: +972-9-7734831 sensiFirm Instructions for Use - US RD 12004 E0 Page 13 of 28 Preliminary test The preliminary test is intended to determine how your skin will react to the Sensifirm treatment, and to help you to find the most comfortable setting for you, for each treatment area. Perform a preliminary test on each area you intend to treat 48 hours before the first full treatment. 1. Apply a thin, even layer of Base Gel, included in your kit, on the treatment area. 2. Plug in the Sensifirm device and select RF energy level 3. 3. Place the Sensifirm device on the desired treatment area and move it in a circular motion, for 3 minutes. 4. The treatment will create a warm sensation on your skin. However, if you feel your skin is heating up too fast, reduce the RF energy level, adjusting it to suit your own comfort. 5. Stop the test immediately if you do not feel comfortable, or if you see adverse effects such as severe redness or blistering. 6. Wait 48 hours and examine the tested area. 7. If the skin in the test area seems normal (no adverse effects) you can proceed with a full treatment at the highest comfortable energy level.

*Note: The RF energy level indicates the rate at which the temperature rises when in heating mode. A high RF energy level will enable you faster and more even heating. We recommend performing all treatments at energy level 3 (highest). However, you can achieve maximum results at all RF energy levels: at lower levels, it will just take longer to reach the effective temperature. EL Global Trade Ltd Tzoran 8th St, P.O.Box 8242, Natanya 4250608, Israel Tel: +972-9-7889069 Fax: +972-9-7734831 sensiFirm Instructions for Use - US RD 12004 E0 Page 14 of 28 How to use the Sensifirm device

*Note: A preliminary test should be conducted before proceeding to a full treatment. (See Preliminary test section above.) See treatment areas, treatment time and treatments schedule in the Recommended treatment protocol section below. 1. Apply a thin, even layer of the Base Gel included in your kit, on the area that is intended for treatment. 2. Set the RF energy level to the level you found most comfortable when you carried out the preliminary test. Press the RF energy level selection button repeatedly until you reach the desired level: 1, 2, or 3. 3. Place the devices on the intended treatment area, ensuring full contact of all 4 electrodes with your skin throughout the entire treatment. If the device is not properly placed, the RF energy and massage will not be delivered. When the device is working, you will feel and hear a gentle vibration, and the indicator will be lit up in green. 4. Move the device over the treatment area in slow circular motions, while maintaining constant, firm contact with the skin. 5. If you do not feel a sensation of warmth after approximately 30 seconds, try moving the Sensifirm over a smaller treatment area, and/or increasing the RF energy. 6. At the end of each treatment session, turn off the device by pressing on the energy selection button. An orange indicator light will light up while the device is shutting down. After the light has turned off, unplug the device from the electrical outlet. 7. After completing the treatment, wipe off any remaining Base Gel from the treated area. 8. Clean the device with a soft damp cloth or paper towel, according to the cleaning instructions in the Cleaning section below. EL Global Trade Ltd Tzoran 8th St, P.O.Box 8242, Natanya 4250608, Israel Tel: +972-9-7889069 Fax: +972-9-7734831 sensiFirm Instructions for Use - US RD 12004 E0 Page 15 of 28 Recommended treatment protocol For long-lasting results, use Sensifirm once a week on each treatment area, for a period of 8 weeks. To sustain optimal results, you can repeat the Sensifirm treatment protocol as needed. You can use the Sensifirm device on buttocks and thighs. A typical treatment session takes about 20 minutes for a body area that is 15cmX30cm (6inX12in) in size - about the size of your two palms. We recommend performing all treatments at energy level 3 (the highest). However, you can achieve maximum results at all RF energy levels: at lower levels, it will just take longer to reach the effective temperature. Therefore, select your RF energy level according to your own level of comfort, as determined by you during the preliminary test. Note: The way the body responds to the Sensifirm treatment differs between individuals, depending on environmental and biological factors, heredity and age. Treatment areas Do not treat full areas with energy levels you have not tested before (as detailed in the Preliminary test section above). Buttocks and thighs (cellulite treatment) o Place the treatment electrodes on the treatment area, as indicated in the diagram. o Move the Sensifirm in continuous circular motions around the area, as indicated by the arrows in the diagram. o The recommended treatment time for this area is 20 minutes for each side. Note: For your own comfort, it is recommended to perform the treatments of all areas while lying down. EL Global Trade Ltd Tzoran 8th St, P.O.Box 8242, Natanya 4250608, Israel Tel: +972-9-7889069 Fax: +972-9-7734831 sensiFirm Instructions for Use - US RD 12004 E0 Page 16 of 28 Post-treatment care After completing the treatment, wipe off the remaining Base Gel from the treated area. Do not expose the treatment area to direct sun light without applying a high-factor sunscreen (at least 30 SPF). Uncontrolled sun exposure might cause your skin to be sensitive For 2 days after treatment, avoid the use of extremely hot water and do not use abrasive or harsh products. In cases where superficial crusting or scabbing occurs, do not rub, scratch or remove the scab. Cleanse the area gently and pat dry. Since skin cellulite formation is an ongoing process, you may repeat the Sensifirm treatment according to your needs. Cleaning 1. Make sure to turn off and unplug the device before cleaning. 2. It is recommended to use a soft damp cloth, paper towel or pre-moistened wipe to clean any residual Base Gel from the Sensifirm. Make sure the entire underside of the device, including the electrodes area, temperature sensors and plastic cover, is cleaned thoroughly. Do not rinse the Sensifirm device under running water, as this may cause device malfunction. 3. Keep the Sensifirm device dry. Never place, store or use your Sensifirm near bathtubs, showers, basins or other vessels containing water, as this may cause electrocution. 4. If you do not plan on using your Sensifirm device for a long period of time, it is recommended to keep it clean and stored in its original box. EL Global Trade Ltd Tzoran 8th St, P.O.Box 8242, Natanya 4250608, Israel Tel: +972-9-7889069 Fax: +972-9-7734831 sensiFirm Instructions for Use - US RD 12004 E0 Page 17 of 28 5. If you plan to travel and take your Sensifirm with you, you should store it in the original box and follow the maintenance instructions. Troubleshooting If you experience any problems with your Sensifirm, please refer to the information below:

If Sensifirm does not turn on:

a. Make sure that the power cord is plugged in properly to the electrical outlet and into the device socket. b. Make sure that the power outlet has power. If Sensifirm does not deliver RF signal energy and massage (i.e. you cannot feel the warm sensation or hear/ feel the gentle vibration):

a. Make sure there is full contact of the electrodes with the skin b. Make sure that the Base Gel has been applied properly over the treatment area. c. The RF signal will be activated only when all 4 electrodes are in full contact with the skin. (See indicator details set out in the User interface description section above. General error:

a. If dirt or debris get stuck on the electrodes, you should clean them in accordance with the Cleaning section above. If you cannot get the area clean, contact our customer service. b. In case of a general error, reset the device unplug the power cord from the electrical outlet on the wall, wait 10 seconds and then reconnect it. c. If you still have problems with your device, please contact our customer service. EL Global Trade Ltd Tzoran 8th St, P.O.Box 8242, Natanya 4250608, Israel Tel: +972-9-7889069 Fax: +972-9-7734831 sensiFirm Instructions for Use - US RD 12004 E0 Page 18 of 28 Customer service For more information about Sensifirm, if your Sensifirm is broken or stops working, if you need assistance or if you would like to order more Base Gel (for additional treatments or if your Base Gel has expired), please contact us:

Tel: XXXXXXX Email: support@sensica.com EL Global Trade Ltd Tzoran 8th St, P.O.Box 8242, Natanya 4250608, Israel Tel: +972-9-7889069 Fax: +972-9-7734831 sensiFirm Instructions for Use - US RD 12004 E0 Page 19 of 28 Device specifications The RF handheld device is powered by multipolar RF at 101 Watt Frequency: 10.05 MHz Selectable output power level: 3 levels Temperature sensors: RF heating is automatically deactivated when skin temperature reaches 41 oC (106.7F). The heating is reactivated when temperature decreases. Treatment area: 20cm2 ( 3.25 in) External power supply:

Input 100-240VAC, 50-60Hz, 0.5A Output 12VDC, 1.8A Device size:

146mm X 74mm X 63mm (LxHxW) 5.75in X 2.91in X 2.48in (LxHxW) Weight:

192g (6.77oz) Storage Instructions:

Storage and transport conditions Temperature Humidity Pressure Temperature Humidity

-10 C to 70 C

(14F to 158F) 10% to 90% RH at 55C (131F) Non-condensing Operational conditions 10C to 40C

(50F to 104F) 30% to 70% RH Max operating altitude 3,000 m. EL Global Trade Ltd Tzoran 8th St, P.O.Box 8242, Natanya 4250608, Israel Tel: +972-9-7889069 Fax: +972-9-7734831 sensiFirm Instructions for Use - US RD 12004 E0 Page 20 of 28 Labeling Model: CEL100US, add GUDID number Power: 9V, 1.5A, 100-240VAC, 50-60Hz Double insulation Type BF equipment Consult Instructions for Use Do not dispose Please read all warnings and safety precautions prior to use Do not use the Sensifirm device on sensitive tanned skin or after sun exposure Keep dry Use Sensifirm only with original power supply. For your safety, never use DC adapters which are not approved by the manufacturer. EL Global Trade Ltd Tzoran 8th St, P.O.Box 8242, Natanya 4250608, Israel Tel: +972-9-7889069 Fax: +972-9-7734831 sensiFirm Instructions for Use - US RD 12004 E0 Page 21 of 28 EL Global Trade Ltd Tzoran 8th St, P.O.Box 8242, Natanya 4250608, Israel Tel: +972-9-7889069 Fax: +972-9-7734831 sensiFirm Instructions for Use - US RD 12004 E0 Page 22 of 28 Electromagnetic compatibility (EMC) and Specifications The Sensifirm requires that special precautions are taken regarding EMC, and must be installed and put into service according to the EMC information provided. Portable and mobile RF communications equipment can affect Sensifirm. Portable RF communications equipment, including antennas (including peripherals such as antenna cables and external antennas) should be used no closer than 30cm

(12 inches) to any part of the Sensifirm, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result The use of accessories or replacement parts, other than those sold/specified by Sensica International, may result in increased emissions or decreased immunity of the Sensifirm. The Sensifirm should not be used adjacent to or stacked with other equipment. If this is unavoidable, the Sensifirm should be observed to verify normal operation in the configuration in which it will be used. Device Contains FCC ID: 2ACCRMC10 EMC Information IEC 60601-1-2: 2014 4th Edition The Sensifirm is intended for use in the electromagnetic environment specified below. The customer or the user of the Sensifirm should assure that it is used in such an environment. Emissions test Compliance Electromagnetic environment guidance RF emissions CISPR 11 Group 1 RF emissions CISPR 11 Class B Harmonic emissions IEC 61000-3-2 Voltage fluctuations/

flicker emissions IEC 61000-3-3 Class A Complies The Sensifirm emits electromagnetic energy in order to perform its intended function. Nearby electronic equipment may be affected. The Sensifirm is suitable for use in all establishments, including domestic establishments and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes. EL Global Trade Ltd Tzoran 8th St, P.O.Box 8242, Natanya 4250608, Israel Tel: +972-9-7889069 Fax: +972-9-7734831 sensiFirm Instructions for Use - US RD 12004 E0 Page 23 of 28 IEC 60601-1-2: 2014 4th Edition The Sensifirm is intended for use in the electromagnetic environment specified below. The customer or the user of the Sensifirm should assure that it is used in such an environment. Immunity Test IEC 60601 Test Level Compliance level Electromagnetic environment guidance Electrostatic discharge

(ESD) IEC 61000-4-2 8 kV contact 8 kV contact 2, 4. 8, 15 kV air 2, 4. 8, 15 kV air Electrical fast transient/burst IEC 61000-4-4 2 kV for power supply lines 2 kV for power supply lines Surge IEC 61000-4-5 1 kV line(s) to line(s) 1 kV line(s) to line(s) Voltage dips 0 % UT ,0,5 cycle 0 % UT ,0,5 cycle 0 % UT , 5 cycles 0 % UT , 5 cycles Voltage Interruptions 70 % UT ,30 cycles 70 % UT ,30 cycles IEC 61000-4-11 0 % UT 300 cyles 0 % UT 300 cyles Power frequency

(50/60 Hz) magnetic field 30 A/m 30 A/m IEC 61000-4-8 NOTE UT is the AC mains voltage prior to application of the test level. Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%. Mains power quality should be that of a typical commercial or hospital environment. Mains power quality should be that of a typical commercial or hospital environment. Mains power quality should be that of a typical commercial or hospital environment. If the user of the Sensifirm requires continued operation during power mains interruptions, it is recommended that the Sensifirm be powered from an uninterruptible power supply or a battery. Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment. EL Global Trade Ltd Tzoran 8th St, P.O.Box 8242, Natanya 4250608, Israel Tel: +972-9-7889069 Fax: +972-9-7734831 sensiFirm Instructions for Use - US RD 12004 E0 Page 24 of 28 IEC 60601-1-2: 2014 4th Edition The Sensifirm is intended for use in the electromagnetic environment specified below. The customer or the user of the Sensifirm should assure that it is used in such an environment. Immunity Test IEC 60601 Test Level Compliance level Electromagnetic environment guidance Conducted 3Vrms 3Vrms RF 0.15 MHz to 80 MHz 0.15 MHz to 80 IEC61000-

4-6 6Vrms in ISM and amateur radio bands between MHz 6Vrms in ISM and amateur radio bands 0.15 MHz to 80 MHz between 0.15 MHz to 80 80% AM at 1kHz 10 V/m 80 MHz to 2.7 GHz 80% AM at 1kHz MHz 80% AM at 1kHz 10 V/m 80 MHz to 2.7 GHz 80% AM at 1kHz Radiated RF IEC 61000-4-3 Portable and mobile RF communications equipment should be used no closer to any part of the Sensifirm, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance

=

3.5 3

=

3.5 6

= 1.17

= 0.58

=

3.5 10

= 0.35 80 MHz to 800 MHz

=

7 10

= 0.7 800 MHz to 2.7 GHz where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters

(m). EL Global Trade Ltd Tzoran 8th St, P.O.Box 8242, Natanya 4250608, Israel Tel: +972-9-7889069 Fax: +972-9-7734831 sensiFirm Instructions for Use - US RD 12004 E0 Page 25 of 28 Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey, a should be less than the compliance level in each frequency range. b Interference may occur in the vicinity of equipment marked with the following symbol:

NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the Sensifirm is used exceeds the applicable RF compliance level above, the Sensifirm should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the Sensifirm. b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m. IEC 60601-1-2: 2014 4th Edition Recommended separation distances between portable and mobile RF communications equipment and the Sensifirm The Sensifirm is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Sensifirm can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Sensifirm as recommended below, according to the maximum output power of the communications equipment. EL Global Trade Ltd Tzoran 8th St, P.O.Box 8242, Natanya 4250608, Israel Tel: +972-9-7889069 Fax: +972-9-7734831 sensiFirm Instructions for Use - US RD 12004 E0 Page 26 of 28 Rated Maximum Output Power of Transmitter W 0.01 0.1 1 10 100 Separation distance according to frequency of transmitter (m) 0.15 MHz to 80 MHz

=

3.5 3

= 1.17 80 MHz to 800 MHz 80 MHz to 800 MHz

=

3.5 6

= 0.58

=

3.5 10

= 0.35 800 MHz to 2,7 GHz

=

7 10

= 0.7 0.12 0.37 1.17 3.70 11.67 0.058 0.035 0.18 0.58 1.83 5.8 0.11 0.35 1.11 3.5 0.07 0.22 0.7 2.21 7 For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. EL Global Trade Ltd Tzoran 8th St, P.O.Box 8242, Natanya 4250608, Israel Tel: +972-9-7889069 Fax: +972-9-7734831 sensiFirm Instructions for Use - US RD 12004 E0 Page 27 of 28 IEC 60601-1-2: 2014 4th Edition Test specifications for ENCLOSURE PORT IMMUNITY to RF wireless communications equipment Compliance Immunity Test Maximum Band a) Service a) Modulation a) Distance Power

(W)

(m) Level

(V/m) Level

(V/m) Test Frequency

(MHz)

(MHz) Pulse 385 380-390 TETRA 400 modulation b) 1.8 0.3 27 430-470 GMRS 460 FRS 460 18Hz FM c) 5 kHz deviation 2 0.3 28 1 kHz sine 704-787 LTE Band 13, Pulse modulation b) 17 217 Hz 0.2 0.3 9 27 28 9 Pulse modulation b) 18 Hz GSM 800/900, TETRA 800, iDEN 820, CDMA 850, LTE Band 5 GSM 1800;

CDMA 1900;

GSM 1900;

2 0.3 28 28 2 0.3 28 28 Pulse modulation b) DECT;

217 Hz LTE Band 1, 3, 4, 25; UMTS Bluetooth, WLAN 802.11 b/g/n, RFID 2450, LTE Band 7 Pulse modulation b 217 Hz 2 0.3 28 28 WLAN 802.11 Pulse modulation b a/n 217 Hz 0.2 0.3 9 9 800-960 1700-

1990 2400-

2570 5100-

5800 450 710 745 780 810 870 930 1720 1845 1970 2450 5240 5500 5785 NOTE If necessary to achieve the IMMUNITY TEST LEVEL, the distance between the transmitting antenna and the ME EQUIPMENT or ME SYSTEM may be reduced to 1m. The 1m test distance is permitted by IEC 61000-4-3. a) For some services, only the uplink frequencies are included. b) The carrier shall be modulated using a 50% duty cycle square wave signal. c) As an alternative to FM modulation, 50% pulse modulation at 18Hz may be used because, while it does not represent actual modulation, it would be worst case. EL Global Trade Ltd Tzoran 8th St, P.O.Box 8242, Natanya 4250608, Israel Tel: +972-9-7889069 Fax: +972-9-7734831 sensiFirm Instructions for Use - US RD 12004 E0 Page 28 of 28 Treatment log Treatment date Treated area Comments