FCC ID: 2AVE5-0006 Microcurrent stimulation device

Healy Electrostimulation device Instructions for Use Frequencies for Life Frequencies for Your Life Healy Electrostimulation deviceInstructions for Use EN |

Table of contents 1. General 2. Healy 2.1 Intended Use 2.2 Indications 2.3 Contraindications 2.4 Description 2.4.1 Hardware Description 2.4.2 Software Description 2.5 General 2.6 Safety Notes 3.1 Installation 3. Preparations for Using the Healy 3.1.1 Smartphone requirements:

3.1.2 Android Operating System 3.1.3 iOS Operating System 2 | EN 4 4 4 4 4 4 5 5 5 5 6 7 7 7 7 7 3.1.4 Hardware 3.1.5 Pairing via Bluetooth 3.1.6 Connection of the Electrodes 4. Operating the Healy Device 4.1 Starting the Treatment Using the Smartphone 10 4.2 Handling of the Healy Hardware 4.3 Starting the Treatment without the Smartphone 12 4.4 Stopping the Treatment 5. Cleaning, Disinfection and Maintenance 5.1 General 5.2 Cleaning 5.3 Disinfection 5.4 Storage between Applications 5.5 Maintenance 5.6 Troubleshooting 8 8 8 10 10 12 12 12 13 13 13 13 13 6. System Components 7. Technical Data 7.1 General 7.2 Electrical Parameters 7.2.1 Power Source Requirements 7.2.2 Healy 7.2.3 Electromagnetic Compatibility 7.2.4 Radio Frequency Wireless Technology 7.2.5 FCC Statement 7.3 Mechanical Parameters 7.4 Environmental Conditions 7.4.1 Operation and Storage 7.5 Stimulation Settings (Standard Programs) 8. Disposal 9. Used Symbols and Icons 10. Revision status 14 14 14 15 15 15 16 16 17 18 18 18 18 19 19 22 EN | 3 1. General Thank you for choosing Healy. Please read this manual carefully and pay special attention to the warnings and cautions. This manual is intended for the user. Intended users include adults at home, and medical professionals in the healthcare or professional environment. It aims to ensure safe handling and enables users to become familiar with the medical device. 2.3 Contraindications Microcurrent treatment must not be performed when metallic foreign bodies are in the area of treatment, pacemakers or im-

planted defibrillators are present, bleeding, risk of bleeding or embolism are present. Treatments must not be performed on areas of the skin which have been treated radiotherapeutically or have a sensory disorder or if the user has a fever. 2. Healy 2.1 Intended Use Healy is a microcurrent stimulation device used for pain man-

agement, using currents in the microampere range with differ-

ent frequencies. It can be applied to different areas of the body. 2.2 Indications The device is designed to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, arms and legs due to strain from exercise or normal house-

hold work activities and for the symptomatic relief and manage-

ment of chronic, intractable pain and relief of pain associated with arthritis. Not for use by pregnant women Not for use by those with epilepsy Do not place the electrodes on the head or neck. Consult a medical professional before using if you have any of these contraindications. 2.4 Description The Healy is a portable device, internally powered and con-

trolled via Bluetooth by a software application that is installed on a Smartphone. It has one stimulation output. The stimula-

tion output can be varied between -10 V and +10 V, 0 to 1 MHz, 0 4 mA. The charging of the internal battery is done through the Micro-

USB-Port and the supplied power supply cable. The software application Healy APP is necessary for configuration and control of the Healy. The Healy App is available in the Play Store or the App Store. Before installation verify the smartphone requirements in section 4.1.1. 4 | EN 2.4.1 Hardware Description Figure 2.4.1.1: Healy top view: Pos. 1 Icon and LED for Bluetooth Connec-

tion; Pos. 2 On-Off But-

ton; Pos. 3 Battery icon, Pos. 4 LED for generator action (if stimulator out-

put is active, then the LED is blinking) and battery indicator; Pos. 5 Genera-

tor icon; Pos. 6 Icons for the positive and negative electrode plugs; Pos. 7 USB-Connector icon; Pos. 8 Socket for power supply through micro-USBconnector (not visible in this figure); Pos. 9 Sockets for the electrodes (not visible in this figure) 2.4.2 Software Description The Healy APP is required for configuring and controlling the hardware. It allows sending treatment programs to the device. With the App you can start and stop the treatment. The Healy APP connects to your Healy hardware using Bluetooth. The Healy APP can connect only to one device at a time. Figure 2.4.2.1: Overview in-

terface of the Healy APP. Pos. 1-Icon for the signal quality of the Bluetooth connection to the Healy; Pos. 2-Icon for the bat-

tery status of the Healy 2.5 General The Healy is for use only to treat conditions described in these instructions. Intentional misuse can be harmful or reduce the ef-

fectiveness of the device. Carefully read the instructions for use before use. This product is intended only for the purpose described in the instructions for use. EN | 5 In this manual, the word DANGER warns of possible personal In this manual, the word CAUTION warns of possible damage injury!

caused to property!

2.6 Safety Notes Danger/Warning:

Keep this device out of the reach of children. Do not immerse the device in liquids. Do not use while driving motor vehicles or operating heavy machinery. The ability to drive or to operate heavy machinery may be impaired immediately after treatment. Only charge with the supplied cable from an USB-Socket with 5V dc and max 2500 mA. In the case of a defect please contact the manufacturer. Any attempt to repair the device will void the warranty. Use with care as the cables may cause a tripping or strangu-

Dont use in presence of flammable gases or in an oxygen en-

lation hazard. riched environment. Stop treatment and remove the electrodes if any irritation, sensation, allergic reaction or burning occurs at the electrode contact points and contact us. Take care that the units output connectors are always point-

ed towards the floor. This way the device is protected against damage by water or liquids. Do not place electrodes on the chest; this can cause ventric-

ular fibrillation. The device is designed for indoor use only. The device should only be stored and transported under the conditions defined in these instructions. Do not use the device in shielded locations, such as intensive care units in hospitals, airplanes or wherever the use of mobile phones is prohibited. The device has no life-sustaining functions. The device must be operated only with supplied accessories and together with compatible smartphones. Not for use by those with a pacemaker or heart disease. Fixed, portable, mobile HF-communication devices and RF-emitters, e.g. mobile phones, RFID, diathermy and securi-

ty systems (e.g. electromagnetic anti-theft systems, metal de-

tectors), may influence medical electrical devices. You should keep a safety distance of 30 cm (12 inchs) from HF-communica-

tion devices and RF-emitters of parts and cables of the Healy, when the device is in use. Dont stack it with such devices or put it next to other electrical equipment when used. Avoid damages to the electrode cables and the charging cables caused by sharp objects. If the cables are damaged do not use them and contact the manufacturer for a replacement. Dont use cables that are damaged. To protect the device and its accessories against contamina-

tion and damage keep it closed and away from children, dust, sunlight, moisture, pets and vermin. 6 | EN Only use cables and electrodes supplied with the equipment. Other accessories, cables or electrodes could result in high-

er electromagnetic field emissions or less electromagnetic im-

munity and may lead to loss of function. Use of this equipment adjacent to or stacked with other equip-

ment should be avoided because it could result in improper operation. Do not use the adhesive electrode if the gel is dry or visible damage is present or the connecting cable is damaged. The equipment and the connecting leads used with this device must all be in good condition. Do not use if recurrent episodes of skin irritation occur. Do not apply electrodes on skin affected by abrasions, rash or wounds. Do not carry out maintenance while the equipment is in use. Operation in close proximity (i.e., less 3 feet) to a diathermy, shortwave or microwave therapy ME equipment may produce instability in the stimulator output. Simultaneous use together with RF-surgical equipment, elec-

trocautery or a defibrillator is prohibited. 3. Preparations for Using the Healy 3.1 Installation Before putting the Healy into operation you need to prepare the hardware and install the Healy APP. 3.1.1 Smartphone requirements:

Bluetooth Operating system Bluetooth 4.0 or higher iOS1 version 9.0 or higher Android2 version 4.4 or higher 1 iOS is a registered trademark of the operating system for smartphones and devices manufactured by Apple Inc. 2 Android is a registered trademark of Google Inc. for the oper-

ating system for smartphones and other devices 3.1.2 Android Operating System Open the Play Store1 Search for the Healy APP Choose Healy APP Download and install on your smartphone 3.1.3 iOS Operating System Open the Apple Store2 Search for the Healy APP Choose Healy APP Download and install on your smartphone 1 Play Store is a registered trademark of Google Inc. 2 App-Store is a registered trademark of Apple Inc. EN | 7 3.1.4 Hardware Unpack the Healy and check for damage Charge the batteries for 1.5 hours before first use Switch on the Healy device by briefly pressing the on-switch and verify that the right LED is blinking Note: The battery cannot be removed by the user. 3.1.5 Pairing via Bluetooth After installation of the App, switch on the Healy by briefly push-

ing the on-switch (see figure 2.4.1.1) of the device. After starting the App there is a short starting screen (see fig-

ure 3.1.5.1). After the App is loaded it is scanning for Bluetooth devices (see figure 3.1.5.2). Within 20 seconds the App scans the environment and connects to the Healy automa tically. If your smartphone detects a Healy figure 3.1.5.3 appears. After you scan the QR-Code on the back of the Healy or enter the serial number of the device you can connect to the Healy by pressing the Connect button (see figure 3.1.5.4). 3.1.6 Connection of the Electrodes The electrodes have been tested and evaluated together with the Healy and are safe and effective for use, if the recommenda-

tions and advice in this manual are followed. Check the package containing the electrodes and make sure the gel is intact; if the 8 | EN Figure 3.1.5.1:

Starting screen Figure 3.1.5.2:

Scanning screen package is visibly dented or damaged, do not use the product. Put the plugs of the electrode cables into the sockets of the Healy. Be sure to have the correct polarity. Place the electrodes onto the desired treatment area. Before use clean the treatment area and if necessary shave Choose an area free from hair, skin lesions or scars, folds in the skin, or bony protuberances and which is not in the vicini-

ty of metallic implants. Clean and dry the application area before placing the elec-

the area trode on it. Avoid the use of solvents as these could cause skin irritation and reduce the adherence of electrodes. If using alcohol to clean the area, make sure that it has com-

pletely dried before applying the electrodes. Connect the electrode to the cable of the electrostimulator. Check the functioning of the system before beginning the pro-

cedure. If the procedure is interrupted, check the functioning of the system again before recommencing the session. Remove the liner and apply the electrode to the skin surface. Before switching on the electrostimulator, check the adher-

ence of the electrode to the skin surface. WARNINGS:

A reduced contact between the skin and the electrode may cause the electric current to concentrate in one point and cause burning. Interrupt the treatment if there is discomfort or a burning sen-

sation. EN | 9 Figure 3.1.5.3:

Scan serial number screen Figure 3.1.5.4:

Connect screen Important note on using the adhesive electrodes:

Never place electrodes in the region of the carotid artery Do not place the electrodes on open wounds After the session, turn off the electrostimulator, disconnect the cable from the electrode and gently remove the electrode from the skin by lifting it up by one corner. Rapid removal of the electrode could cause skin traumas. Do not remove by pulling the connection part of the cable. After use, reposition the electrodes in the plastic liner and put them back in the pouch. Electrodes may be reused: Reuse only for the same person. Verify the adhesion of the electrode before use. When elec-

trodes lose adhesion, gently rub one or two drops of water on-

to the gel surface. This may extend the usability. If there is no improvement, replace with new electrode. Keep the packet closed in order to prevent the unused elec-

trodes from becoming dehydrated. Do not reposition the electrode during use. 4. Operating the Healy Device You should become familiar with these frequently used opera-

tions:

switch On-Off (please refer to chapter 4.1.5 and 5.4) select treatment (please refer to chapter 5.1) start stimulation (please refer to chapter 5.1) connect the electrodes (please refer to chapter 4.1.6) 4.1 Starting the Treatment Using the Smartphone After the installation of the App, pairing and connection of the electrodes, the Healy is ready for operation. In the overview screen you can select which program category you want to use

(see figure 4.1.1). After selecting a program category the program page with the icons of the different programs is loaded (see figure 4.1.2). After you select a program from the program page screen the information for placing the electrodes is displayed (see figure 4.1.3). After selecting Start on the information page the treatment is started and the treatment page is displayed (see figure 4.1.4). In the treatment page you can set the intensity of the treatment by using the plus and minus buttons. When the electrical circuit is closed the circle, which is an indica-

tor for the time, will switch from black to white (see figure 4.1.5). 4.2 Handling of the Healy Hardware During the treatment you should use the clip on the back of the device to attach the Healy to your clothing. The electrodes should be affixed as shown in the App (please refer to chapter 10). Route the electrode cables to the Healy so that you feel com-

fortable. 10 | EN Figure 4.1.1:

Overview interface Figure 4.1.2:

Program page Figure 4.1.3: Information page for the placing the electrodes Figure. 4.1.4:

Treatment page EN | 11 4.3 Starting the Treatment without the Smartphone The device always stores the last treatment program. By press-

ing the on-switch of the Healy hardware, the last program that was sent from the smartphone to the device will start with an in-

tensity of 15%. 4.4 Stopping the Treatment You can see the current progress of the program running on the device by using the App. To stop the treatment select one of the following:

briefly press the on/off-switch (pause mode) tap the icon in the treatment mode in the app (see figure 4.4.1) hold the on/off-switch for about 10 seconds until device hard-

ware resets in emergency situations it is possible to remove the electrodes or disconnect the electrode cables 5. Cleaning, Disinfection and Maintenance 5.1 General Maintenance activities increase the lifespan and safety of the Healy. Cleaning and disinfection reduces the risks of cross con-

tamination and infections. Please read this section carefully. Cleaning and disinfection should be performed once a week, or if used by different patients prior to use. Figure 4.1.5: Treatment page with white time indicator electrical circuit is closed Figure 4.1.6: Treatment page with black time indicator electrical circuit is open 12 | EN 5.2 Cleaning Switch off the Healy before cleaning. For cleaning, com-

mercial cleaning products may be used. The surfaces can be wiped with a damp sponge or cloth. Do not use too much liq-

uid and make sure that no liq-

uid penetrates beneath the covers or enclosures. Caution:

Do not use cleaning agents with solvents (e.g. acetone, nail polish, cleaners) or abra-

sive cleaners as they will dam-

age the surface. 5.3 Disinfection Disinfection should be per-

formed in the same manner as cleaning. Use only chem-

ical disinfectants liquid state cleared by the FDA. Use a sponge or a cloth to wipe the disinfectant over the device. in Caution:

Spray disinfection can cause a security risk. Only use disinfec-

tant wipes. 5.4 Storage between Applications After the treatment unplug all cables and electrodes and put them into the storage case and store in a cool and dry location. Refer to the safety notes for environmental storage conditions. 5.5 Maintenance There are no serviceable parts by the users. In a case of dam-

age, please contact the manufacturer. The following mainte-

nance activities are recommended and should be considered for safe working. Frequency By whom Maintenance activity Prior to each use User Check housing, cables and elec-

trodes for damages. In case of damage, contact the manufactur-

er or an authorized dealer 5.6 Troubleshooting In the following you find typical warnings or messages that are related to the app or hardware of the device. If you face an event that is not listed here or a problem still exists, please contact the manufacturer. EN | 13 Figure 4.4.1: Pause screen By pressing the X in the pause screen you cancel the program and get back to the overview interface. Event or message No connection from the smart-

phone to the device Cause Actions required Device is switched off Switch on the device and restart the App No connection from the smart-

phone to the device Bluetooth in your smart-

phone is deac-

tivated. Open connectivity settings and activate Bluetooth Repeated short blinking of right LED Batteries are low Device is not responding or Undefined error/EM disturbance Charge the device Hold the on-switch for 10 seconds. This triggers a hardware reset. No Stimulation output Undefined error/EM disturbance Contact your autho-

rized dealer or the ma-

nufacturer Healy GmbH 6. System Components The Healy is delivered with a set of electrodes and a charging cable. Reference number Description 0006 Healy hardware device 108-4063 Press button adhesive electrodes round 32 mm 108-4062 Connection cable for electrodes 96 cm - press button on 2 mm 108-4068 Charging cable USB 0.15 m Quantity 1 4 2 1 7. Technical Data 7.1 General Protection against ingress of water and parti-

culate matters IP 42 Protected against particulate matter, larger than 1mm. Protection against dripping water at an angle of 15. 14 | EN 7.2 Electrical Parameters 7.2.1 Power Source Requirements The Healy can be connected to any power source with the sup-

plied USB-charging cable and the following specifications:

Supply voltage range 4.4 V 5.5 V DC Output current Max. 2500 mA Frequency DC Socket type USB- Type A Power type High powered 500 mA or higher Insulation type Double or reinforced insulation Compliance To IEC60950 or IEC60601-1 7.2.2 Healy Input voltage See 7.2.1 Input Current 20 mA Protection class Internally powered Applied type BF, the electrodes are in contact to the patients body Compliance IEC60601-1:2012; IEC60601-1-2 Battery capacity 145 mAh Battery charging time 60 min - 90 min Charging cycles Life expectancy 500 times, more than 80% of initial capacity at 20C Output voltage -

Stimulation Output current

-10 V to +10 V Max. 4 mA (voltage control) / 2,6 mA (current control) Accuracy voltage 0.1 V with 10 %

Accuracy current 20 A with 10 %

Output frequency -

Stimulation DC up to 1 MHz Signal form Rectangular biphasic, rectangular monophasic or DC EN | 15 7.2.3 Electromagnetic Compatibility CISPR 11 -

emissions EN55022 Group 2, 30 MHz 1 GHz and 1 GHz 6 GHz, classe B The Healy is suitable for use in all establish-

Power frequency magnetic fields Complies IEC61000-4-8 Test level 30 A/m for 50 Hz and 60 Hz ments, including the domestic area and those 7.2.4 Radio Frequency Wireless Technology directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes. Class A acc. to IEC61000-3-2 Harmonic emissions Immunity Flicker Complies IEC61000-3-3 Complies IEC6061-1-2:2014 and EN61000-4-3 80 MHz 2,7 GHz, 10 V/m Immunity against wireless communication equipment 28 V/m for MHz: 450, 810, 870, 930, 1720, 1845, 1970, 2450 27 V/m for MHz: 385 9 V/m for MHz: 710, 745, 780, 5240, 5500, 5785 ESD protection Complies IEC61000-4-2 8kV contact - 15 kV air 16 | EN Description Bluetooth Low Energy RF Bluetooth V4 Compliance SIG TCRL Core - 2015-12-22; Core and Host Ver-

sion 2.0-4.2

(SIG = Bluetooth Special Interest Group) ETSI EN301 489-1; ETSI EN301 489-17 Compati-

bility Smartphones with Bluetooth Wireless techno-

logy and Bluetooth 4.0 or higher 2.4GHz Operating frequency Configura-

tion The Healy device starts the Bluetooth wireless technology automatically when it is switched on. Switch on the Bluetooth wireless techno-

logy on your smartphone and start the Hea-

ly App. During the first scan, the app scans and connects to the Healy device, see Section 3.1.5. The first connection is called pairing. Notes on usage After pairing, the Healy device is permanently connected to the Healy App. The Healy App can only control one Healy device at a time. The wireless Bluetooth technology has a limited range, therefore the smartphone should be close to the Healy during use

(distances not more than 10 m [32 feet]). If the connection is interrupted, the last configured or started application will be resumed. The pairing is not lost, only the connection can be lost. It is not necessary to perform the pairing again after each shutdown or loss of connection with the Healy device. If you want to pair with another Healy device, turn off the paired one or go to the settings and select Connect to another Healy. Then it is possible to pair again with another Healy device, see section 3.1.5. 7.2.5 FCC Statement Changes or modifications not expressly approved by the party responsible for compliance could void the users authority to op-

erate the equipment. help. This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions:

(1) This device may not cause harmful interference, and

(2) this device must accept any interference received, including interference that may cause undesired operation. Note: This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reason-

able protection against harmful interference in a residential in-

stallation. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interfer-

ence will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures:

Reorient or relocate the receiving antenna. Increase the separation between the equipment and receiver. Connect the equipment into an outlet on a circuit different from that to which the receiver is connected. Consult the dealer or an experienced radio/TV technician for EN | 17 7.3 Mechanical Parameters Dimensions Weight 55 x 55 x 7 mm 34 g 7.4 Environmental Conditions 7.4.1 Operation and Storage Temperature Range 5C to 40C / 41F to 104F Cable length charging cables 0.15 m Relative humidity 30 % to 80 %

Cable length electrode cables 96 cm (REF: 108-4062) Atmospheric pressure 700 hPa to 1060 hPa Output socket 2 x 2 mm pin Input socket USB-Type B micro 7.5 Stimulation Settings (Standard Programs) The waveform is always a biphasic rectangle. One phase is de-

fined through one positive peak and one negative peak. By the nature of the rectangle signal each current peak is considered as a DC level. There is no offset (DC or AC) to the signal. The param-

eters are valid for a load resistance of 1 kOhm. Name of the program Frequency 1 Phase Impulse width high Impulse delay/rest Impulse width low Impulse delay/rest Intensity cur-

rent or voltage

(amplitude for 100% setting) Pain

+/- 600 A Pain locally

+/- 600 A 0.5 Hz 100 Hz 1 s 2.5 ms 0 s 2.5 ms 1 s 2.5 ms 0 s 2.5 ms 18 | EN 8. Disposal The expected service life is 5 years. Ask your local authority for recycling advice. 9. Used Symbols and Icons The following icons are used on the device, the packaging and the labelling:

Electronic waste do not dispose. Recycle acc. to local regulations or contact your authorized dealer or the manufacturer. In conformity with European legislation Symbol for manufacturer Recycling symbol Use only inside Keep away from heat Applied part type BF Caution: Read instructions for use before use. Follow safety advices in this manual. Read instructions for use before use Symbol for Bluetooth Wireless connection SGS US CAN certification Mark Symbol for Battery Temperature limitations Bluetooth Symbol for on- and off-switch EN | 19 Follow the instructions for use Best before Symbol for USB-Connection Keep dry Plus icon for positive electrode socket REF 0006 Hardware reference number One patient use Icon for the bluetooth signal strength between the Healy App and Healy hardware Battery status of the Healy hardware Icon for overview interface Icon for the trademark Healy Symbol for generator opera-

tion stimulation output Minus icon for negative electrode socket The following symbols are used in the Healy App Pictograph for the placement of adhesive electrodes. Appears after selection of the stimulation program Note: the background colour may vary, depending on the selected and configured program parameter 20 | EN Button for increasing the intensity in percentage

(current or voltage) Symbol with information about actual intensity of the stimulation Button for decreasing the intensity in percentage

(current or voltage) Symbol for scanning and connecting with the Hea-

ly hardware, appears after starting the app and during establishing the Bluetooth connection Icon for Pain, Pain locally therapy program. Button for jumping two pages backwards Button for scrolling to the first page with programs Button for moving one page back Button for jumping two pages forward Button for scrolling to the last page with programs Button for moving one page forwards Note: The background colour may vary, depending on the selected and configured program parameter EN | 21 10. Revision status Revision Date Remark 0 1 2 3 21th October 2016 First edition 22th October 2017 Minor corrections 14th November 2018 Changes for FDA 27th October 2019 Changes for FDA 22 | EN Healy GmbH Darritzer Str. 6 16818 Krnzlin, Germany EN | 23 Frequencies for Your Life Frequencies for Life Healy GmbH | Schloss Krnzlin | Darritzer Str. 6 | 16818 Krnzlin Germany T. +49 3391 40022-11 | F. +49 3391 40022-99 | www.healyworld.net | info@healy.de 0482

Label TimeWaver GmbH: fr das Gert Healy Das Etikett wird in zwei Labels geteilt und auf einem Gert Healy auf 2 Stellen platziert (Rckseite oben/ unten), siehe Foto:

Melanie Anastassiou 7layers GmbH Borsigstr. 11 40880 Ratingen Germany TimeWaver Production GmbH Schloss Kraenzlin Darritzer Str.6 16818 Kraenzlin Germany AGENCY AUTHORIZATION LETTER We Name:

Address:

City:

Country:

Declare that:

Name Representative of agent:

Agent Company name:

Address:

City:

Country is authorized to apply for Certification of the following product:

Product description: Healy Type designation: Microcurrent stimulation device Trademark:

on our behalf. Date:

City:

Name:

Function:

Signature:

Babak Jafarian 23.12.2019 Kraenzlin Healy CEO

FCC, Request for non-disclosure RF_501, Issue 8 Date: 21-Nov-2018 Page 1 of 1 Company Name: TimeWaver Production GmbH Address:

City:

Country:

Schloss Krnzlin Darritzer Strae 6 16818 Krnzlin Germany To:

Telefication B.V., Dept. FCC TCB Edisonstraat 12A 6902 PK ZEVENAAR The Netherlands Subject: Request for confidentiality FCC ID: 2AVE5-0006 Reference number: ######

Dear FCC TCB, 1. Long-Term Confidentiality Pursuant to 47 CFR Section 0.459(a) & (b), we hereby requests non-disclosure and confidential treatment of the following materials submitted in support of FCC certification application:

Bill(s) of Material Block Diagrams Operational Description Schematic Diagrams Tune-up Procedure Above materials contain secrets, proprietary and technical information, which would customarily be guarded from competitors under 47 CFR, section 0.457(d)(2). Disclosure or publication or any portion of this company confidential material to other parties could cause substantial competitive harm and provide unjustified benefits for competitors. 2. Short-Term Confidentiality (STC) Pursuant to Public Notice DA 04-1705 of the Commissions policy, in order to comply with the marketing regulations in 47 CFR 2.803 and the importation rules in 47 CFR 2.1204, applicant hereby requests Short-Term Confidential treatment of the following materials (See notes below):

Internal Photos Users Manual Test Set-up Photos External Photos Justification: Above materials contain secrets, proprietary and technical information. Disclosure or publication or any portion of this company confidential material to other parties could cause substantial competitive harm and provide unjustified benefits for competitors. Date: 11/02/2020 Name and signature of applicant: Melanie Anastassiou Notes:

1) A document or type of document can only have ONE type of confidentiality!

2) Short-Term confidentiality is in principle for 45 days from date of grant; it can be extended max 3 times (total time 180 days max.)!

The planned date should stated in the RF731 application form. 3) FCC must be informed when marketing begins earlier. 4) Release takes place automatically thus extension must be requested in time. Telefication does not remind you of this!

5) Request for extension or for release must be received by Telefication at least 7 days before date of actual marketing or before expiration of the STC period