Summary of Contents for ACE Solution Einthoven CR1000
- Page 1 Einthoven CR1000 Health Sensation System 愛多芬 生理感知器 衛部醫器製字 第 號 User Manual V1.0 筑波科技股份有限公司 ACE Solution Co., Ltd.
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Page 2: Product Description
Please read carefully and follow the instructions before use Please read through this user manual carefully before using the Product, and follow the instructions. Please keep this manual for future reference. ❑ Indications Einthoven Health Sensation System (Model: CR1000) is designed to continuously measuring, recording... -
Page 3: Product Contents
❑ Product Contents 1. One (1) Host Module; 2. Two (2) Sensing Patches. 3. Einthoven iOS App (Requires manual download from Apple App Store) Host Module must be combined with Patch in order to perform its functions. ❑ Components Identification ✓... - Page 4 ✓ Sensing Patch (Patch) Top Side Attaching direction arrow Releasing strip Water-retaining trench Attaching direction line Releasing strip Releasing Switch strip Attaching direction arrow Releasing strip Patch connector Indication Arrow (Patch) Caution: 1. Patches are intended for single use only. 2.
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Page 5: How To Clean The Product
✓ Einthoven iOS App Einthoven iOS App receives analyzed physiological information from the Product and display/store the information in your portable device. Please download and install the App through Apple App Store and follow the instructions to use. (*System requirement: iOS 10 or higher) ❑... - Page 6 ❑ Legends For single use only Manufacturer Do not reuse Please carefully read through Manufacturing date the user manual before use Avoid high temperature or Manufacturing batch number exposure to sunlight Product serial number Keep it dry Expiry date Storage humidity range Non-ionizing radiation Storage temperature range IP Code (protection level)
- Page 7 Side Effects ◎ Patch attached to skin for an extended period might cause an itch or allergic reaction. Contraindication ◎ Do not use this Product on patients who has acute or severe syndrome. ◎ Do not use this Product when user’s skin is allergic to adhesives or gel. ◎...
- Page 8 ◎ This Product is not designed for self-diagnosis purpose. Please seek for physicians’ advice or diagnosis. Self-diagnosis may cause life-threatening consequences. ◎ Remove this Product before being conducted an MRI scanning. ◎ This product shall not be used along with cardiac pacemaker or internal/external defibrillator.
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Page 9: Europe - Eu Declaration Of Conformity
❑ This Product Complies with the following Requirements in Administrative Regulations on Low Power Radio Waves Radiated Devices in Taiwan ◎ Art.12: Without permission granted by the NCC, any company, enterprise, or user is not allowed to change frequency, enhance transmitting power or alter original characteristic as well as performance to a approved low power radio- frequency devices. -
Page 10: Federal Communication Commission Interference Statement
❑ Federal Communication Commission Interference Statement This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to Part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. - Page 11 IMPORTANT NOTE: Radiation Exposure Statement： The product comply with the US portable RF exposure limit set forth for an uncontrolled environment and are safe for intended operation as described in this manual. The further RF exposure reduction can be achieved if the product can be kept as far as possible from the user body or set the device to lower output power if such function is available.
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Page 12: How To Use
❑ How to use Before use: 1. Please remove body hair covering the intended attaching area (left chest). 2. Please clean the attaching area (left chest) before use, in order to prevent discomfort. 3. Keep the attaching area clean and dry, please do not apply lotion, perfume or other oils. - Page 13 ◆ Step 2: Combine the Host Module with Patch and Turn on the Power 1) Put the Patch horizontally on the desk top to continuing the combining process. desk top 2) Make sure the two indication arrows on the Host Module and on the Patch are pointing to each other, and insert Host Module into the patch opening as the figure below shows.
- Page 14 3) Press down the Host Module to combine the connectors of the Host module and the Patch; make sure to press the Host Module hard until it is tightly combined with the Patch. 4) Long press the power switch on the Patch for 2 seconds until the LED light on the Host Module start to blink in green (indicating it is ready for pairing);...
- Page 15 ◆ Step 3: Turn on Einthoven iOS App and pairing it with the Host Module 1) Download Einthoven iOS App from Apple App Store to your mobile device (which is supported by the App), and turn on the App and Bluetooth connection.
- Page 16 4) After entering the main menu, press “Start recording” to enter the pairing screen; press “Historical record lookup” to enter the historical record list. 5) After entering the pairing screen, please refer to the last two digits of the serial number on the back of the Host Module or on its package, and select the corresponding name of Host Module (e.g.
- Page 17 ◆ Step 4: Attach the Product to User’s left chest 1) By pulling Releasing strip, Partially remove the release paper on the bottom side of the Patch to the extend shown in the 2 figure below. Releasing strip Partially remove the release paper The bottom side of the Patch - 16 -...
- Page 18 2) The Product should be attached onto the left chest, and the distance from the lower limit of the neck to the Product is about 3 cm (roughly the width of two fingers); the expected attaching area is shown as the dotted circle in the figure below.
- Page 19 4) Remove the remaining part of release paper of the Patch bottom, and attach the whole Patch firmly to the chest. 5) Remove the release paper covering the top surface by pulling the releasing strip toward the direction shown in the figure below. 6) Press the adhesive surrounding the Patch toward user’s skin, make sure the Patch is attached firmly to the skin.
- Page 20 ◆ Step 5: The Monitoring Screen ➢ Arrhythmia detection: shows the real-time analysis of user’s heart rhythm; the detectable abnormal heart rhythms are: ✓ “Normal”: Normal heart rhythm ✓ “VEB” (with yellow frame) : Ventricular ectopic beats ✓ “SVEB” (with yellow frame) : Supraventricular ectopic beats ✓...
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Page 21: Step 6: Start Monitoring
◆ Step 6: Start monitoring ➢ The Product will transmit real-time analysis data to user’s mobile device through Bluetooth connection to show and store the data on user’s device. Pleas keep the Einthoven App running and keep the mobile device in front of the user within 3 m, and avoid any obstacles in between, to prevent disconnection. - Page 22 ❑ How to Remove the Product 1) When the Product has been used for over 72 hours, or the “battery running out” notification is shown, please slowly tear off the Product along the direction shown in the figure below. 2) After tearing the Product off user’s skin, please first bend the Patch toward the direction of , then remove the Host Module by pulling up the Host Module toward .
- Page 23 ❑ How to Look up Stored Physiological Information and Historical Records: 1) User’s physiological information will be stored in the mobile device. In the main menu of Einthoven iOS App, please press “Historical record lookup” and enter the historical record menu. 2) In the historical record list, user can look up for specific data by “date”, “initializing time”, “record time length”...
- Page 24 3) After entering the record screen, user can select which interval to view by horizontally swiping the ECG display, or by directly selecting from recorded intervals. The functions shown in the record screen are as the following: ➢ ECG display: displays historical ECG records. ➢...
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Page 25: Product Specifications
❑ Product Specifications Einthoven CR1000 Health Sensation System Product Name Component Host Module Patch Firmware version V1.0.0 Useful life 500 times 70hours, non-rechargeable Operating 5 ~ 40 ̊ C 5 ~ 40 ̊ C temperature -25 ~ 70 ̊ C -25 ~ 70 ̊... -
Page 26: Led Light Indications
Sampling rate 250 Hz ECG resolution 12 bits Input dynamic range +/- 5 mV Initial input dynamic +/- 300 mV range Input resistance > 10 MΩ 0.05 – 40 Hz Frequency range Common-Mode > 60 dB Rejection Ratio Heart rate 25 ~ 250 bpm monitoring range ❑... -
Page 27: Arrhythmia Detection
❑ Arrhythmia Detection ➢ This Product detects arrhythmia based on user’s heart rate, heart rhythm and ECG characteristics, and will label the type of arrhythmia on each R- wave when it have detected arrhythmia event. For the types of arrhythmia this product detects, please refer to page 18. ❑... -
Page 28: Troubleshooting
❑ Troubleshooting Q1: I long pressed the switch on the Patch, but nothing happened. A: Please refer to “How to Use- Step 2” on page 13, and make sure the Host Module have been combined firmly with the Patch. Q2: After entering the main menu in the App, I pressed “Start recording”, but the App still stays at the connection screen instead of switches to the monitoring screen. - Page 29 If any adverse event happens during the use of Product, please immediately notify our customer service, and/or report to the authorities following the instruction: https://www.fda.gov/Safety/MedWatch/HowToReport/default.htm Manufacturer: ACE Solution co. ltd. Manufacturer address: 2F.-1, No.28, Taiyuan St., Zhubei City, Hsinchu County 302, Taiwan (R.O.C.) Customer service hotline: +886-3-5525633 Customer service: service@acebiotek.com...