Healy Electrostimulation device Instructions for Use Frequencies for Your Frequencies forLifeLife
Healy Electrostimulation device Instructions for Use EN | Table of contents 1. General 2. Healy 4 4 2.1 Intended Use 4 2.2 Indications 4 2.3 Contraindications 4 2.4 Description 4 2.4.1 Hardware 5 Description 5 2.4.2 Software Description 5 2.5 General 2.6 Safety Notes 3. Preparations for Using the Healy 3.1 Installation 3.1.1 Smartphone requirements: 3.1.2 Android Operating System 3.1.3 iOS Operating System 2 | EN 3.1.4 Hardware 3.1.5 Pairing via Bluetooth 3.1.
6. System Components 7. Technical Data 14 14 7.1 General 14 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 15 15 15 16 16 17 7.3 Mechanical Parameters 18 7.4 Environmental Conditions 7.4.1 Operation and Storage 18 18 7.5 Stimulation Settings (Standard Programs) 8. Disposal 9. Used Symbols and Icons 10. Revision status 18 19 19 22 T. +49 30 54905949-1 | www.
1. General 2.3 Contraindications 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.
2.4.1 Hardware Description Figure 2.4.1.1: Healy top view: Pos. 1 Icon and LED for Bluetooth Connec tion; Pos. 2 On-Off Button; Pos. 3 Battery icon, Pos. 4 LED for generator action (if stimulator output is active, then the LED is blinking) and battery indicator; Pos. 5 Generator icon; Pos. 6 Icons for the positive and negative electrode plugs; Pos. 7 USB-Connector icon; Pos. 8 Socket for power supply through micro-USB–connector (not visible in this figure); Pos.
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.
• Only use cables and electrodes supplied with the equipment. Other accessories, cables or electrodes could result in higher electromagnetic field emissions or less electromagnetic immunity and may lead to loss of function. • Use of this equipment adjacent to or stacked with other equipment 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.
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 pushing the on-switch (see figure 2.4.1.1) of the d evice. After starting the App there is a short starting screen (see figure 3.1.5.1).
Figure 3.1.5.3: Scan serial n umber 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 • Before use clean the treatment area and if necessary shave the area • C hoose an area free from hair, skin lesions or scars, folds in the skin, or bony protuberances and which is not in the vicinity of metallic implants.
• A fter 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.
Figure 4.1.1: Overview interface Figure 4.1.2: Program page Figure 4.1.3: Information page for the placing the electrodes T. +49 30 54905949-1 | www.healy.eu | info@healy.de Figure. 4.1.
4.3 Starting the Treatment without the Smartphone The device always stores the last treatment program. By pressing the on-switch of the Healy hardware, the last program that was sent from the smartphone to the device will start with an intensity of 15%. 4.4 Stopping the Treatment You can see the current progress of the program running on the device by using the App.
5.2 Cleaning Switch off the Healy before cleaning. For cleaning, commercial cleaning products may be used. The surfaces can be wiped with a damp sponge or cloth. Do not use too much liquid and make sure that no liquid penetrates beneath the covers or enclosures. Caution: Do not use cleaning agents with solvents (e.g. acetone, nail polish, cleaners) or abrasive cleaners as they will damage the surface. 5.3 Disinfection Figure 4.4.
Event or message Cause Actions required No connection from the smartphone to the device Device is switched off Switch on the device and restart the App No connection from the smartphone to the device Bluetooth in your smartphone is deactivated. Open connectivity settings and activate Bluetooth Repeated short blinking of right LED Batteries are low Charge the device Device is not responding or Undefined error/EM disturbance Hold the on-switch for 10 seconds. This triggers a hardware reset.
7.2 Electrical Parameters 7.2.1 Power Source Requirements The Healy can be connected to any power source with the supplied USB-charging cable and the following specifications: Applied type BF, the electrodes are in contact to the patient’s 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 20°C Supply voltage range 4.4 V – 5.5 V DC Output current Max.
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 establishments, including the domestic area and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes. Harmonic emissions Class A acc.
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.
7.3 Mechanical Parameters 7.4 Environmental Conditions 7.4.1 Operation and Storage Dimensions 55 x 55 x 7 mm Weight 34 g Temperature Range 5°C to 40°C / 41°F to 104°F 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 7.5 Stimulation Settings (Standard Programs) Input socket USB-Type B micro The waveform is always a biphasic rectangle.
8. Disposal 9. Used Symbols and Icons The expected service life is 5 years. Ask your local authority for recycling advice. The following icons are used on the device, the packaging and the labelling: Symbol for manufacturer Electronic waste – do not dispose. Recycle acc. to local regulations or contact your authorized dealer or the manufacturer.
Follow the instructions for use Best before Symbol for USB-Connection Keep dry Plus icon for positive electrode socket Icon for the bluetooth signal s trength between the Healy App and H ealy hardware One patient use Battery status of the Healy hardware Icon for overview interface Icon for the trademark Healy Hardware reference number REF 0006 Symbol for generator operation – stimulation output Minus icon for negative electrode socket The following symbols are used in the Healy – App Pictogra
Button for increasing the intensity in percentage (current or voltage) Button for decreasing the intensity in percentage (current or voltage) Icon for “Pain, Pain locally” therapy program.
10. Revision status Revision Date Remark 0 21th October 2016 First edition 1 22th October 2017 Minor corrections 2 14th November 2018 Changes for FDA 3 27th October 2019 Changes for FDA 22 | EN Healy GmbH | Schloss Kränzlin | Darritzer Str.
Healy GmbH Darritzer Str. 6 16818 Kränzlin, Germany T. +49 30 54905949-1 | www.healy.eu | info@healy.
0482 Frequencies for Your Life Frequencies for Life Healy GmbH | Schloss Kränzlin | Darritzer Str. 6 | 16818 Kränzlin – Germany T. +49 3391 40022-11 | F. +49 3391 40022-99 | www.healyworld.net | info@healy.
