“LARGAN”ECG Holter ※Please read the Instructions for Use and follow the instructions before use Product model number: AT-202C
1. 2. 3. 4 TABLE OF CONTENTS Introduction.......................................................... 2 1.1. Federal communications commission interference statement ................................................. 2 1.3. Contraindications .......................................................................................................................... 2 1.3 Side effects ...............................................................................................................................
1. Introduction This is the manual of “LARGAN”ECG Holter. The ECG Holter is designed for continuously recording ECG data for up to 50 hours. The device does not supply with accessory of third-party ECG electrodes which attach directly on patient chest. The manual contains all information for safely using. Class B: (Section 15.105) 1.1.
Users should carefully read bellow information before using the ECG Holter. 2.1 Warranty information 2.1.1 Largan Medical recognizes the serial number on the back of the ECG Holter recorder as warranty certificate. Therefore, please be careful not to damage the logo containing the serial number, otherwise you will not be able to enjoy the free warranty repair service. 2.1.2 The warranty period is 12 months from the date of purchase.
2.2.15 Do not put ECG holter in mouth. 2.2.16 RF exposure warning: The device has been evaluated to meet general RF exposure requirement. The device can be used in portable exposure condition without restriction 2.3 Precautions 2.3.1 2.3.2 2.3.3 2.3.4 If the ECG electrode patches are insufficient adhesion, use a medical tape to strengthen the adhesion. Do not perform strenuous exercise when recording ECG signals. Do not use corrosive or abrasive substances to clean the device.
Size Weight Material Use environment 52 (diameter) × 9 (height) mm 18 g PC Ambient temperature: 20℃～35℃ Relative humidity: 45% to 75% (excluding condensation) Atmospheric pressure：86kPa～106kPa Transportation and preservation environment Ambient temperature: -10℃～45℃ Relative humidity: 45%～75% (excluding condensation) Atmospheric pressure：86kPa～106kPa Warranty 1 year 3.2 Applicable ECG electrode patch This device does not contain the electrode patches, applicable electrode patches are listed below. 3.
3.3 Device light notifications Light Meaning Actual picture Green Ready for recording/ Recording less than 1 minute Blue Ready for recording/ Recording more than 1 minute Yellow Low battery Level(< 35 %) Yellow Flash Blue tooth connected/ Connected less than 1 minute Blue tooth connected/ Connected more than 1 minute While charging White Uninitialized Green Flash Blue Flash - 3.
Wireless communication complies with NCC specifications Serial number Manufacturer Authorized representative in the European community CE approved device with notifying body identification number Keep dry Compliance with FCC rules 3.5 Operation steps 3.5.1 Remove grease and excess hair from the ECG electrode patch. 3.5.2 Attach the three grommetes to the ECG electrode patch. 3.5.3 Attach the product to the left chest or right chest for dextrocardia patients. The button should be on the up side.
While recording, the product shuts The device is in low battery level, please charge. down by itself. While recording, beep sound appears. The patch is detached from the ECG holter, please check and adjust the patch. 4 Patent information 4.1 Manual in this product is copyright Largan Medical Co. Ltd (hereinafter referred to as Largan Medical). No company or individual or other entity may copy or extract any content in this manual in any way or form without the written permission of Largan Medical.
