Page 1
文件编号 20.12.09 Aegis 产品名称 CE版-说明书 要 求 骑马钉 页 码 共24页 产品名称 经皮电神经刺激器 产品型号 KTR-2492 编制 日期 尺 寸 L180 x W125mm 材 质 审核 日期 128G双铜纸/骑马钉 批准 日期 颜 色 4色印刷 Aegis F a s t , e f f e c t i v e p a i n r e l i e f...
WARNINGS AND CONTRAINDICATIONS The following should not use Aegis: 1. Patients with an implanted electronic device (for example a cardiac pacemaker), unless specialist medical authorisation has first been obtained. 2. Patients with suspected or confirmed epilepsy or heart disease, malignant tumour, serious cerebrovascular disease or other acute disease, unless specialist medical authorisation has first been obtained.
Page 3
Thank you for choosing Aegis. This guide will tell you how to Device Overview get started and how to get the most out of your device. Front View (Assembled) What is Aegis? Aegis is a medical device that has been specifically designed to Aegis Unit help you target and manage back pain.
Page 4
Electrode contacts Preparing Aegis before use 1. Attach gel pads to the Aegis unit Remove one gel pad from its packaging. Remove the coloured Gel pads protective plastic cover from side A of the gel pad. Apply the gel pad to the Aegis unit as shown in the diagram. Side A Side B Remote Control...
Page 5
2. Attach the power unit to the main unit Now press the power button on the remote control. Two beeps The power unit attaches to the main unit via two metal press studs. will sound to indicate that the remote and the Aegis device are Align the press studs, then push firmly until the control unit clicks paired.
Page 6
To return to Automatic function press and hold down the “F” button To purchase replacement gel pads contact Tower Health Ltd. once again. www.tower-health.co.uk Tel: 0800 953 1666 6. Timer E-mail: enquiries@tower-health.co.uk Each session lasts for 15 minutes. The remaining minutes of the session are displayed in the upper right corner of the screen on the Recharging the battery remote control.
Product disposal The device is damaged Allow to dry before using the device In order to avoid environmental pollution, please dispose of Aegis according to local environmental requirements. Do not discard in Contact the point of your standard waste disposal. purchase The skin is The treatment has...
Indicates potential danger, injury or serious injury due to Main unit : Model KTR-2492: Φ49.8*12.48 Warning incorrect usage j)Product software version No.: A/0 Indicates possibility of personal injury or damaged to goods k)Service life: the shelf life of subject device is 2 years; the use life attention through incorrect usage.
Page 9
⑷It is contraindicated for use by those with acute cardiovascular or cerebrovascular diseases. ⑸Please terminate use immediately and consult with a doctor if you experience irritation of the skin during use. KTR-2491A Accessories of Transcutaneous Electronic Nerve Stimulator, Models: KTR-2492...
Page 10
2、IEC 60601-1-11:2015 Medical Electrical Equipment - Part 13. The Paraphrase of Graphic Symbol 1-11: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Requirements For Medical Symbol Explanation Electrical Equipment And Medical Electrical Systems Used In The Home Healthcare Environment Caution 3、IEC 60601-2-10:2013 Medical electrical equipment - Part Level of protection against the insertion of solid bodies of size...
Page 11
-The system must not be used adjacent or supported by other Table 2- Compliance standards equipment. The recommendations of this manual must be followed. -Do not use accessories, transducers, internal parts of components Basic Phenomenon Immunity Test Level of and other cables other than those previously specified by the Standard of manufacturer.
Page 12
Table 3- Test specifications for ENCLOSURE PORT IMMUNITY to RF wireless communications equipments Test Band Service Modulation Maximum Distance Immunity Frequency (MHz) Power Test (MHz) Level (V/m) 380-390 TETRA 400 Pulse modulation 18 Hz 430-470 GMRS 460, FM ±5 KHz deviation 1KHz sine Pulse...