Summary of Contents for Zero-Plus 02392
- Page 1 02392 Operating Instructions from page 3 02392_EN_180x140_GM_V1.indd 1 02392_EN_180x140_GM_V1.indd 1 19.11.2019 15:54:13 19.11.2019 15:54:13...
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Page 3: Table Of Contents
Contents Dear Customer, Explanation of the Symbols _______________ 4 We are delighted that you have chosen this ultrasound Explanation of the Signal Words ____________ 5 pain therapy device. Intended Use ___________________________ 5 Before using this device for the fi rst time, please read the operating instructions carefully and keep them for fu- Indications _____________________________ 5 ture reference. -
Page 4: Explanation Of The Symbols
Explanation of the Symbols The following symbols are used in the operating instructions for the “ultrasound pain therapy device” or accessories: Danger symbols: These symbols indicate dangers of injury. Read Concordance with Directive 93/42 0123 through the associated safety notic- es carefully and follow them. -
Page 5: Explanation Of The Signal Words
Explanation of the Signal Words DANGER Warning of serious and life-threatening injuries. WARNING Warning of possible serious and life-threatening injuries. NOTICE Warning of damage to property. Intended Use • The device is intended to be used only on humans. Use the device exclusively for the applications described. •... -
Page 6: Contraindications
Contraindications If you have any health concerns, suff er from health problems or belong to a risk group, consult your doctor before using the device. • The following people must not use the device or do so only after consulting a doctor: –... - Page 7 • Do not use the device near to or on the following areas: – heart; – chest area for people who wear a pacemaker or similar medical implants; – brain tissue; – carotid sinus nerves; – carotid artery; – laryngeal or throat muscles; –...
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Page 8: Read Carefully Before First Use
Read Carefully Before First Use Caution! • Read, understand and follow the safety precautions and these operating instructions. You should be aware of the restrictions and risks which occur when using all ultrasound devices. • Regularly fi nd out information about all contraindications. •... - Page 9 The device must always be disconnected from the mains power when left unattended ■ and before cleaning it. The mains adapter contains a transformer. Do not replace the mains adapter with ■ another adapter as this can be dangerous. In the interest of your own safety, check the device and the connecting cable for ■...
- Page 10 WARNING – Danger of Injury ■ Danger of injury and suff ocation! Keep children and animals away from the device and packaging material. ■ Danger of strangulation! Make sure that the connecting cable is always kept out of the reach of small children and animals.
- Page 11 WARNING – Danger of Fire ■ Do not use the device in rooms containing easily ignitable dust or poisonous and explosive fumes. ■ Do not operate the device in the vicinity of combustible material. ■ Do not cover the device during operation in order to prevent it from catching fi re. NOTICE –...
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Page 12: Product Description
Product Description The device has a round ultrasound head which is placed directly on the patient's skin and transmits ultrasonic waves. This involves applying an ultrasonic gel which optimises the transmission of the ultrasonic waves on the whole head. A frequency of 1 MHz is used in the ultrasound treatment. The waves are generated by a piezoelectric eff... -
Page 13: Items Supplied
Items Supplied Check the items supplied for completeness and the components for transport damage. If you notice any damage, do not use the device, but contact the customer service department. • Ultrasound pain therapy device (1 x) • Mains adapter (1 x) •... -
Page 14: Operation
Operation PLEASE NOTE! ■ Use the device for no more than 15 minutes in one go and no more than 30 minutes daily on one body part. ■ Keep the ultrasonic gel clean. It must be free of dust, dirt or similar. Ultrasonic gel is required to use the device to establish a connection between the skin and the device and thus ensure its eff... - Page 15 4. Switching On Press the button once to switch on the device. The presettings are 5 minutes and light sound intensity (the indicator lights show the values “5” and “L”). 5. Setting the Operating Time Press the button to set the appropriate timer setting (5 / 10 / 15 minutes). 6.
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Page 16: Cleaning And Storage
Cleaning and Storage PLEASE NOTE! ■ Make sure that no water enters the device or is spilled over the device. ■ Do not use any caustic or abrasive cleaning agents to clean the device. They may damage the surface. • Make sure that the device has been disconnected from the mains and has cooled down. -
Page 17: Faqs
FAQs Do not use the device if is damaged or not working. Try to fi x the problem using the table of FAQs. If the problem persists, contact the customer service department or your dealer as repairs can only be carried out with a special tool. Never try to repair the device yourself! Problem Possible cause... -
Page 18: Technical Data
Lifespan of the device: 3 years ID of operating instructions: Z 02392 M GM V1 1119 * Error on rating plate possible! A indication on the rating plate corresponds to ERA indication in the operating instructions. Subject to technical changes. -
Page 19: Disposal
Disposal Please dispose of the packaging material in an environmentally friendly manner and take it to a recycling centre. Please note that this device is marked with the WEEE symbol on its left-hand side. The symbol denotes that the device may not be disposed of together with normal household waste but must be properly disposed of in accordance with the regulations for electronic waste. - Page 20 • Do not use in the vicinity of high-frequency surgical equipment which is switched on and RF-shielded rooms of an ME system for magnetic resonance imaging as the intensity of the electromagnetic interfer- ence is high there. • Mobile RF communications devices (including peripherals such as antenna cables or external antennae) should only be used with a minimum gap of 30 cm from each part of this device, including the power cable.
- Page 21 Immunity Test standard IEC 60601-1-2 Test Level Compliance Level Electrostatic discharge (ESD) ±8 kV contact ±8 kV contact IEC 61000-4-2 ±2 kV, ±4 kV,±8 kV, ±5 kV air ±2 kV, ±4 kV,±8 kV, ±5 kV air ±2 kV, for power supply lines ±2 kV, for power supply lines Electrical fast transient / burst ±1 kV...
- Page 22 Guidance and manufacturer’s declaration – electromagnetic Immunity Radiated RF IMMUNITY Test Band Modulation Distance IEC61000-4-3 Frequency Service Modulation TEST LEVEL (MHz) (Test specifi ca- (MHz) (V/m) tion for ENCLO- Pulse modulation 380 – 390 TETRA 400 SURE PORT 18 Hz IMMUNITY to RF wireless GMRS 460,...
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- Page 24 The “ultrasound pain therapy device” is manufactured by: Zero-Plus International Limited Room1004,10/F, Join-In Hang Sing Centre, 71-75 Container Port Road, Kwai Chung, N.T., HK The “ultrasound pain therapy device” is distributed by: DS Produkte GmbH Am Heisterbusch 1, 19258 Gallin, Germany Customer service for medical questions: +49 (0) 38851 314337* (Mon –...