Human Tecar HCR 1002 User Manual

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USER MANUAL

HCR 1002

Unibell Srl

via Indipendenza, 27 - 23885 Calco (LC) - Italy

T. +39 039991131

info@humantecar.com

humantecar.com

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Summary of Contents for Human Tecar HCR 1002

Page 1 USER MANUAL HCR 1002 Unibell Srl T. +39 039991131 via Indipendenza, 27 - 23885 Calco (LC) - Italy info@humantecar.com humantecar.com...
Page 2 humantecar.com © 2016 UNIBELL srl - All rights reserved English language text. Any duplication, reproduction, storage and transmission of this publication in any form (electronic, mechanical, by photocopying, translation or any other means), is expressly prohibited, unless authorized in writing by Unibell Srl.
Page 3 INDEX INTRODUCTION GENERAL SAFETY NOTE device presentation general warnings and precautions acronyms and symbol warnings and contraindications to treatment MAINTENANCE DEVICE DESCRIPTION training and educational programs for technicians components of device required equipment for technicians control unit routine maintenance work handpieces emergency maintenance work active electrodes...
Page 4 USER MANUAL HCR 1002 Please read the present user guide before using device, with particular attention to the warnings, precautions and operating instructions marked with this symbol. DOCUMENTATION PROVIDED Operating instructions for the present device are supplied either in paper form than in electronic format PDF (Portable Document Format).
Page 5: Introduction 8
1 INTRODUCTION Dear Customer, we would like to thank you for choosing HUMAN TECAR® and trust you will derive great professional satisfaction from using the present device, HCR 1002. The device was designed and manufactured in accordance with current CE requirements and in compliance with the harmonized technical norms for medical devices as detailed in the CE Declaration of Conformity relative to the device itself and/or paragraph 13.
Page 7 DEVICE PRESENTATION The technology HCR 1002 is a scientifically and technologically advanced device, whose technical and therapeutic principles are based on the use of high-frequency variable alternating current, with direct low-impedance diathermic application mode (Resistive Electric Transfer - RES) and insulated high-impedance diathermic application (Capacitive Electric Transfer - CAP).
Page 8 USER MANUAL HCR 1002 ACRONYMS AND SYMBOLS This user guide uses graphic symbols and conventional acronyms that also appear on the device itself. Following is their list and corresponding meanings: Operating instructions Means you need to consult user guide before using the device...
Page 9: Device Description 9
COMPONENTS OF DEVICE The device is made up of a control unit and of essential accessories. List of parts: Code Description Q.ty 16576 HCR 1002 - sales kit - complete with: 16577 Control Unit: HCR 1002 16579 Power cord 16607 Power filter 16458 High-impedance CAP electrode, flat, thermodynamic Ø...
Page 10: Control Unit
USER MANUAL HCR 1002 CONTROL UNIT The case of control unit consists of a mold made of ABS (thermoplastic polymer), housing the memory cards and all electrical and electronic components. It comprises a front panel or user interface and a rear panel for connection, laid out as follows:...
Page 11 Control panel TREATMENT SETUP ON-OFF RESET START STOP Green power LED LIT UP AND STEADY: power cable connected and rear power switch ON. ON - OFF OFF: power cable not connected or rear power switch OFF. On/Off Switch Active for shutdown solely when device is on standby. Menu selection key in setup Select parameter you want to configurate / confirm Button enabled when treatment is on standby.
Page 12: Active Electrodes
USER MANUAL HCR 1002 Connection electrodes In order to make things easier for user and ensure safety of device, the connectors for high-impedance capacitive electrode handpieces, for low-impedance resistive electrode handpieces and indifferent, flat or cylindrical electrode, have been distinguished as follows:...
Page 13 INDIFFERENT (OR NEUTRAL) ELECTRODES They are applied parts to patient. Made of stainless steel, they have distinctive shapes, plate or cylinder, and are chosen by user according to type of treatment and body part treated: Flat indifferent electrode comes into contact with body parts and its outer edges are coated with silicone rubber to avoid slipping.
Page 14: Radio Remote Control
USER MANUAL HCR 1002 RADIO REMOTE CONTROL Allows remote control of the following: Switching device on and off Increasing and diminishing output power COMPLEMENTARY ACCESSORIES Electrolytic Emulsion Electrolytic emulsion is recommended for best performance of device.o. The product performs various actions: conductive - thus maximizing the affinity of electrode and biological tissue during treatment;...
Page 15: Operating Principle
3 INTENDED USE OPERATING PRINCIPLE HCR 1002 produces an alternating current at a specific and unique frequency (0.447 MHz), which is applied to the area to be treated by means of moveable active electrodes. The active electrodes are placed so they adhere to tissue to be treated and moved by operator all the time –...
Page 16: Installation Procedure
USER MANUAL HCR 1002 4 INSTALLATION PROCEDURE INSTALLATION Unpacking The present device has already been tested and subsequently packaged by manufacturer, in order to ensure in-transit integrity. It has also been assembled in all its parts, save for accessories. Unpacking and installation procedures may be carried out by user. They require no special training; it is sufficient to comply with the following instructions.
Page 17: Mains Power Connection
PLACING HCR 1002 should be placed on a flat-topped, solid and stable surface, with a capacity adequate to device’s weight (ideally, above 50kg/m2) and sufficiently large to guarantee an unobstructed working surface and a safety margin against unexpected shocks and jolts (ideally, 800 mm wide and 600 mm deep).
Page 18: Setup Menu
USER MANUAL HCR 1002 SETUP MENU Once the device is turned on, it is possible to define certain setup parameters, such as: • Brightness • Volume • Acoustic signal at end of treatment session (active/disbled) • Remote control: battery charge level •...
Page 19: Operating Methods
5 OPERATING METHODS SWITCHING ON AND OFF Switching on In order to connect device to power, position the switch on the rear panel onto “I”. The green LED above the ON/OFF switch on the front control panel will light up. WARNING The green LED above the ON/OFF switch on the front control panel will light up.
Page 20: Setting Time Of Treatment
USER MANUAL HCR 1002 SETTING TIME OF TREATMENT When the device is turned on, the display screen will show the default duration of treatment session, default to 30 minutes. Using the increase and decrease keys of treatment time to set the desired duration.
Page 21: Connecting Accessories
CONNECTING ACCESSORIES Connect the electrode handpieces to unit control, then connect electrodes in their respective seatings, CAP, RES and neutral. Insert electrodes into the corresponding handpiece. The device is provided with both hardware and software safety systems for erroneous insertions. In case of incorrect connection, the signal will appear on the display, as shown in the figures below: 0:18:29 0:16:45...
Page 22: Applying Electrodes
USER MANUAL HCR 1002 APPLYING ELECTRODES It is essential for electrodes to be used and applied in the correct manner. The neutral indifferent electrode should always be placed in contact with the body of patient. To minimize interface resistance between the electrode and skin of the patient, a suitable conductive emulsion should be placed between electrode and body tissue.
Page 23 TREATMENT 0:16:45 0:14:25 183 VA 100% 1372 Ω 250 V 0,085 A 39 V 0,01 A 4587 Ω VOLTAGE INTENSITY Z - IMPEDANCE VOLTAGE INTENSITY R-RESISTANCE R-RESISTANCE Select the operating mode When device is switched on, default setting of treatment is with low-impedance electrodes (RES).
Page 24 USER MANUAL HCR 1002 0:18:29 0:16:45 90000 Ω 20 V 30 V 90000 Ω INTENSITY Z - IMPEDANCE VOLTAGE INTENSITY VOLTAGE R-RESISTANCE 0:16:45 0:18:29 90000 Ω 20 V 30 V 90000 Ω VOLTAGE INTENSITY VOLTAGE INTENSITY Z - IMPEDANCE R-RESISTANCE In case of treatment involving considerable increase in temperature, thus employing higher power (above c.
Page 25: End Of Treatment
With every new start, the device verifies whether there is any connection problem with handpiece; should there be a problem, it will be shown on the display and the machine will go on standby. In order to ensure safety during treatment involving considerable increase in temperature, therefore an output power above 5%, any time the active electrode is no longer in contact with the biological tissue being treated, output power is reduced and, after a few seconds, the device goes on standby, at 0% power.
Page 26: Precautions For Use
USER MANUAL HCR 1002 PRECAUTIONS FOR USE User Characteristics The present equipment must be used by healthcare personnel, physician or physiotherapist, who are professionally qualified to use medical devices. It is important to ascertain that user is aware of and follows all the instructions indicated in the user manual.
Page 27 Skin should be cleansed prior to treatment. Only Human Tecar electrolytic emulsion should be used. Applying other conductive creams or products (e.g. cosmetics, essential oils, medications) is liable to cause damage to device and/or patient.
Page 28: Warnings And Precautions In Using Accessories And
USER MANUAL HCR 1002 Alert Signal YELLOW LED lit up: this indicates a device failure. In this case, you need to call technical support. BLUE LED flashing: pause or standby. BLUE LED steady: treatment in progress. GREEN LED: powered device.
Page 29 High-impedance Electrodes (CAP) Check integrity of electrode before treatment. Replace if broken. Avoid shocks and jolts with sharp or pointed objects. Clean and sanitize electrodes according to instructions in corresponding chapter. Using high temperatures (over 90° C) or unsuitable detergents (alcohol) reduces working life of electrode and deteriorates its coating.
Page 30: Technical Specifications
USER MANUAL HCR 1002 6 TECHNICAL SPECIFICATIONS CLASSIFICATION The device, according to the harmonized technical norms for safety evaluation EN 60601-1 and EN 60601-1-2, is classified as follows: For type of protection against electrical hazard Class I Device Level of protection against electrical hazards of applied parts...
Page 31: Life Expectancy
Table of indicative values of impedance and load curves for the nominal power output loads measured: 47Ω loads measured: 330 pF/235Ω V (V) I (A) R (Ω) V (V) I (A) R (Ω) 0,26 0,15 1400 0,09 1400 0,73 0,14 1300 0,99 0,19...
Page 32: Cleaning And Disinfection
MANUALE D’ISTRUZIONE HCR 1002 7 CLEANING AND DISINFECTION Correct cleaning and disinfection procedures, together with adequate operating procedures, are essential to prevent the spread of infection or cross-contamination. This paragraph lists the activities you need to carry out during normal use and maintenance, to ensure device is correctly cleaned and disinfected.
Page 33: Cleaning The Device
GENERAL PROCEDURE FOR CLEANING AND DISINFECTION Cleaning and disinfection need to be carried out after each treatment (application). If the product used only contains detergents or only disinfectants, steps to be taken are two: cleaning and disinfecting, in two stages. If the product used contains both detergents and disinfectants, the cleaning procedure will be all in one stage.
Page 34: Decontamination
USER MANUAL HCR 1002 CLEANING INDIFFERENT (OR NEUTRAL) ELECTRODES - FLAT AND CYLINDRICAL Indifferent electrodes are made of steel and therefore present no particular contraindication to products and procedures that are normally used in cleaning, sanitizing, disinfecting and decontaminating. Remove excess cream from electrode.
Page 35: General Safety Notes
8 GENERAL SAFETY NOTES GENERAL WARNINGS AND PRECAUTIONS Carefully read all warnings and precautions listed in the present user guide and bearing the symbol here shown. THE MANUFACTURER, IMPORTER AND AUTHORIZED INSTALLER ARE RESPONSIBLE FOR THE SAFETY, RELIABILITY AND CORRECT OPERATION OF DEVICE only on the following conditions: •...
Page 36 USER MANUAL HCR 1002 8.2 WARNINGS AND CONTRAINDICATIONS TO TREATMENT The present device is non-invasive. It is intended to come into contact with subject of treatment only temporarily and only on healthy skin. The device does not replace or modify the body of patient.
Page 37: Routine Maintenance Work
9 MAINTENANCE WARNING - Do not modify this device without written authorization from manufacturer. No maintenance work may be performed on device by user or third parties except as expressly specified in the present user guide. Should the device fail or malfunction, contact a qualified operator authorized by manufacturer. Installation, repair work and modifications should be exclusively carried out by qualified personnel authorized by manufacturer.
Page 38 USER MANUAL HCR 1002 EMERGENCY MAINTENANCE WORK Replacing fuses The device is provided with two outer fuses as voltage surge protection. The device is provided with two outer fuses as voltage surge protection. The outer fuses are located in the connection plug of the power cord and may be replaced by competent personnel that will refer to the values indicated in manual and identification plate data.
Page 39: Disposal At End Of Life
10 PACKAGING AND LABELING Following are instructions concerning packaging, transport and labeling. 10.1 PACKAGING The Manufacturer has packaged device in every one of its parts at the close of the production cycle. The control unit has been inserted in apposite preformed holders, then placed in a cardboard box. All accessories have been adequately bubble-wrapped and inserted in a cardboard box.
Page 40: Warranty
USER MANUAL HCR 1002 12 WARRANTY The Manufacturer guarantees that each device is free from material or manufacturing defects and that it complies with the specific technical norms detailed in the declaration of conformity and/or at point 13. This warranty is valid for a two-year period from date of purchase and covers material or manufacturing defects.
Page 41: Electromagnetic Compatibility (Emc)
13 SAFETY TESTS PERFORMED 13.1 LIST OF DIRECTIVES, TECHNICAL STANDARDS AND REGULATIONS APPLIED Here below are the main European Directives and Technical Standards applied. In particular, electrical security and electromagnetic compatibility tests were performed complying with the regulatory standards of: CEI EN 60601-1;...
Page 42 USER MANUAL HCR 1002 Following are the EMC assessment tables. (Tables follow the numbering system detailed in EN 60601-1-2 for portions used in assessment). Table 1 - For all EM equipment or system This device is intended for use in the environment specified below. The customer or user of device should ensure that it is used in such an environment.
Page 43 Table 4 - For all EM equipment or system that is not of sustenance to vital functions This device is intended for use in the electromagnetic environment specified below. The customer or user of device should ensure that it is used in such an environment. IMMUNITY EN 60601-1-2 COMPLIANCE...
Page 44 USER MANUAL HCR 1002 Table 6 - Recommended separation distances between portable and mobile RF communications equipment and EM devices that are not used for sustaining vital functions The device is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled.
Page 46 Unibell Srl Via Indipendenza, 27 - 23885 Calco (LC), Italia info@humantecar.com - humantecar.com...