Table of Contents
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IGEA
CONTENTS
1.
INTRODUCTION .............................................................................................................................................................. 2
1.1
1.2
1.3
..................................................................................................................................................................... 2
1.4
1.5
1.6
2.
I-ONE DEVICE COMPONENTS .......................................................................................................................................... 3
2.1
......................................................................................................................................................................... 3
3.
DEVICE PREPARATION .................................................................................................................................................... 4
3.1
3.2
4.
CLIP ATTACHMENT AND REMOVAL ................................................................................................................................ 5
5.
ADMINISTERING THE TREATMENT .................................................................................................................................. 6
5.1
................................................................................................................................................................. 6
5.2
5.3
5.4
5.5
5.6
.............................................................................................................................................................. 10
5.7
...................................................................................................................................................................... 10
5.8
6.
PROBLEM SOLVING ...................................................................................................................................................... 11
6.1
............................................................................................................................................................... 11
6.2
6.2.1
The device will not switch on and will not charge. .................................................................................................. 12
6.2.2
Blocked device during normal operation. ................................................................................................................ 12
6.2.3
Technical Support .................................................................................................................................................... 12
7.
SAFETY INSTRUCTIONS ................................................................................................................................................. 12
7.1
7.2
................................................................................................................................................................... 13
7.3
7.4
7.5
8.
MANUFACTURER'S LIABILITY ........................................................................................................................................ 14
9.
DEVICE RETURNS .......................................................................................................................................................... 15
10.
TECHNICAL DATA .......................................................................................................................................................... 15
10.1
T
1 - E
ABLE
LECTROMAGNETIC
10.2
T
2 - E
ABLE
LECTROMAGNETIC
10.3
10.4
10.5
11.
SYMBOLS ...................................................................................................................................................................... 20
MI-IONE-EN Revision 1.5 - April 2024
SW Rev. from 1.7
Page 1
Only use the device after reading this manual.
? .......................................................................................................................... 2
I-ONE? .................................................................................................................................................... 2
................................................................................................................................... 2
................................................................................................................................................... 3
........................................................................................................................................................ 4
................................................................................................................................ 5
................................................................................................................................................. 6
..................................................................................................................................... 8
........................................................................................................................................... 8
............................................................................................................................................................ 10
.......................................................................................................................................................... 11
............................................................................................................................................ 12
.................................................................................................................................... 12
.................................................................................................................................. 13
........................................................................................................................................ 14
............................................................................................................................................................. 14
E
................................................................................................................................ 16
MISSIONS
I
................................................................................................................................ 16
MMUNITY
............................................................................................................................. 17
........................................................................................................................................................... 19
.................................................................................................... 2
............................................................................. 17
I-ONE - User Manual
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Table of Contents
Related Manuals for IGEA I-ONE
Summary of Contents for IGEA I-ONE
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Page 1: Table Of Contents
EVICE PERFORMANCE CHARACTERISTICS I-ONE T ....................2 REATMENTS THAT CAN BE CARRIED OUT WITH HERAPY ..............................3 XPECTED CLINICAL BENEFITS I-ONE DEVICE COMPONENTS ............................3 ..................................3 ENERATOR DEVICE PREPARATION ..............................4 ................................ 4 NITIAL BATTERY CHARGE ..........................5 ONNECTING THE COIL TO THE GENERATOR CLIP ATTACHMENT AND REMOVAL .......................... -
Page 2: Introduction
The I-ONE must be used by people who are capable of independently understanding and implementing the instructions provided in this manual; otherwise, and if it is being used on children, the I-ONE may only be used under the supervision of people who are capable of understanding and implementing the instructions provided in this manual. -
Page 3: Expected Clinical Benefits
The device operates on a rechargeable battery with an external power supply. Expected clinical benefits The expected clinical benefits of using the I-ONE CBA04 pulsed electromagnetic field generator are: • Chondroprotection, •... -
Page 4: Device Preparation
NOTE on the room temperature: if the I-ONE is charged in an environment with a temperature above 30 °C, the battery may take longer than 3 hours to fully charge. To avoid this, the I-ONE should be charged in an environment with a temperature that does not exceed 30 °C, where possible. -
Page 5: Connecting The Coil To The Generator
IGEA I-ONE - User Manual Connecting the coil to the generator The coil that is compatible with the I-ONE is shown in the figure below, identified by its code: REF. 70010 REF. 70110 Insert the coil connector into the coil socket on the left side of the generator (P), pressing down until you hear a 'click'. -
Page 6: Administering The Treatment
I-ONE suggests a treatment time of 4 hours every time it is switched on, which is the recommended time in order for the treatment to be effective. The LED at the top of the display flashes green and the timer on the display starts to count down the treatment time. - Page 7 - the battery provides up to 4 hours of continuous treatment. For more than 4 hours, if the battery runs out, the external power supply must be connected while the I-ONE is in operation. This way, the I-ONE provides the treatment and, at the same time, charges the battery (see section 5.3).
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Page 8: Battery Monitoring And Charging
Under these conditions, the device behaves as described in section 5.2. At the end of treatment, leave the I-ONE switched off and connected to the power supply until the battery charge is complete. - Page 9 IGEA I-ONE - User Manual The I-ONE is switched on but is on The green LED stays on to indicate that PAUSE. To resume treatment, press the PLAY symbol on the display. the I-ONE is on PAUSE The I-ONE can also be left on PAUSE...
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Page 10: Battery Efficiency
The user must undergo the treatment for the number of days indicated by the prescribing doctor. Clinical studies have shown that the I-ONE treatment is effective if performed for 4 hours a day; in any case, there are no problems or side effects due to overdosing. -
Page 11: Cleaning The Device
30 seconds The LED at the top flashes with an alternating green and red light The I-ONE device has a verification system to ensure it works properly. The device beeps 3 times every 5 seconds When this message is displayed, the system... -
Page 12: Anomalies Or Blocked Device
Do not connect any part of the device to other equipment or devices. • Do not connect any parts to the I-ONE which are not intended for use and not supplied by the manufacturer. • Do not handle any parts of the device with wet hands, and more specifically, do not connect the external power supply to the mains. -
Page 13: Maintenance
IGEA can provide the recommended electrical safety inspection service. Contraindications and side effects There are no known contraindications to the use of I-ONE and no side effects attributable to the treatment have been observed. However, the following precautions must be taken:... -
Page 14: Electromagnetic Compatibility
• The I-ONE must not be used adjacent to or on top of other devices. If the I-ONE must be used in this way, the medical device must be observed to ensure it works correctly in the configuration in which it is used;... -
Page 15: Device Returns
9. DEVICE RETURNS If the device is to be returned to IGEA, the user is requested to use the original packaging complete with all its parts. The adjacent image shows the correct positioning of the various components to ensure that they are adequately protected. - Page 16 10 minutes for it to adjust to the room temperature before using it. End-of-life disposal The I-ONE device and each of its parts cannot be disposed of as municipal waste but are subject to a separate collection according to the procedures established by the local authorities.
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Page 17: Immunity To Proximity Magnetic Fields
Portable or mobile RF communication devices that may be present in the home such as wireless telephones, mobile phones, devices for wireless connection to the internet and similar, must be kept away from the I-ONE device to avoid the risk of interference. The recommended minimum separation distance depends on the output power of the RF device and the transmission frequency. - Page 18 The immunity levels given in the table are met as long as the device is kept at a distance of at least 30 cm from any possible source of RF interference. The I-ONE - CBA04 complies with all test levels with a distance >= 30 cm. Page 18...
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Page 19: Information Plate
Below is an example of a generator data plate located on the rear of the body containing all the information necessary for the correct identification and use of the device. NOTE: There can be two data plate attached to the I-ONE CBA04 generator, differing only in the type of power supply battery attached to the device. -
Page 20: Symbols
Separate collection and recycling of batteries: battery elements are subject to a separate collection for recycling. Separate collection: IGEA devices and their applied parts cannot be disposed of as municipal waste but are subject to a separate collection in accordance with the procedures established by the local authorities.
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