ACE Solution Einthoven CR1000 User Manual Download | Manualshive

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筑波科技股份有限公司

ACE Solution Co., Ltd.

Einthoven

TM

CR1000

愛多芬

TM

生理感知器

Health Sensation System

衛部醫器製字第

號

User Manual V1.0

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Summary of Contents for Einthoven CR1000

Page 1: ...筑波科技股份有限公司 ACE Solution Co Ltd EinthovenTM CR1000 愛多芬 TM 生理感知器 Health Sensation System 衛部醫器製字第號 User Manual V1 0 ...

Page 2: ... and display Electrocardiography ECG heart rate and events of arrhythmia Product description An Einthoven Health Sensation System Model CR1000 consists of a Sensing Patch Patch and a Host Module This Product receives ECG signals through attaching the Product to a user s left chest and analyzes heart rate arrhythmia events with the Host Module combined with the Patch the analyzed data can be transm...

Page 3: ...der to perform its functions Components Identification Host Module Indication Arrow Host LED Light Invisible when not lit Top side Bottom side Connector Caution 1 When connecting Host Module to the Patch make sure the both indication arrows are pointing to each other 2 The connector should always be kept dry 02 Description Cautions How to Use Specifications Troubleshooting ...

Page 4: ...ical adhesive this side attaches to skin Caution 1 Patches are intended for single use only 2 Please partially remove the releasing strips only following the manual s direction Releasing strip 03 Attaching direction arrow Attaching direction arrow Releasing strip Releasing strip Releasing strip Description Cautions How to Use Specifications Troubleshooting ...

Page 5: ...ions to use System requirement iOS 10 or higher Product Usages Monitoring and collecting personal physiological information Real time analyzing common arrhythmia events Providing reference for clinical diagnosis related to heart rhythm or arrhythmia events 04 How to Clean the Product Please clean the outside surface of the Host Module with a clean cloth moistened with ethanol Description Cautions ...

Page 6: ...iry date Storage humidity range Non ionizing radiation Storage temperature range IP Code protection level Solid particle protection 3 Liquid ingress protection 3 Direct current Do not use if the package is damaged Type BF applied part Electronic waste shall be recycled properly Caution Please pay attention to the important notice in order to prevent unwanted consequences IP33 05 Description Cautio...

Page 7: ...the Patch to a user s body please do not remove the Host Module from the Patch before the end of monitoring The Patch is for single use only Reuse may make the user feel uncomfortable and derogate normal functions of the Product 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 Do not use this Product if a ...

Page 8: ...us please store it safely at a dry and clean place before use and prevent direct sunlight The Host Module and Patch individually shall be kept dry before combined The Product when the Host Module is combined with the Patch is water resistant but not water proof do not soak the Product in water It is fine to take a shower while wearing it but please do not swim or take a bath The Product contains s...

Page 9: ...io communications is operated in compliance with the Telecommunications Act The low power radio frequency devices must be susceptible with the interference from legal communications or ISM radio wave radiated devices Europe EU Declaration of Conformity This device complies with the essential requirements of the Radio Equipment directive 2014 53 EU The following test methods have been applied in or...

Page 10: ...d by turning the equipment off and on the user is encouraged to try to correct the interference by one of the following measures Reorient or relocate the receiving antenna Increase the separation between the equipment and receiver Connect the equipment into an outlet on a circuit different from that to which the receiver is connected Consult the dealer or an experienced radio TV technician for hel...

Page 11: ... 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 This transmitter must not be co located or operating in conjunction with any other antenna or transmitter FCC ID 2AO36BIOTEK EINCR1K 10 Description Cautions How to Use Specifications Troubleshooting ...

Page 12: ... use only open its seal will make it be seemed as used 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 11 Description Cautions How to Use Specifications Troubleshooting ...

Page 13: ...op to continuing the combining process 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 12 pointing to each other desk top Description Cautions How to Use Specifications Troubleshooting ...

Page 14: ...Host Module start to blink in green indicating it is ready for pairing the LED light will be off after 10 seconds and the Host Module will turn into stand by mode at the same time waiting for setting up connection with a mobile device If the green light is not on after pressing the switch please repeat step 2 and make sure the Host Module is tightly combined with the Patch 13 desk top Switch Descr...

Page 15: ...d by the App and turn on the App and Bluetooth connection 2 At the first time use or when adding a new user please press Register to enter the registration page for log in press Log in to enter the main menu 3 After entering the registration page please enter name and gender then press confirm 14 Description Cautions How to Use Specifications Troubleshooting ...

Page 16: ...ame of Host Module e g If the last two digits is 00 please select Einthoven CR1K 00 from the list a monitoring screen will shown up if the connection is successfully set up 6 First after entering the monitoring screen a message suggesting attaching the Product will be shown on the screen Please be prepared to attach the Product onto the user s left chest The App will make a beep sound every 10 sec...

Page 17: ...sing strip Partially remove the release paper on the bottom side of the Patch to the extend shown in the 2nd figure below Releasing strip The bottom side of the Patch Partially remove the release paper 16 Description Cautions How to Use Specifications Troubleshooting ...

Page 18: ...hly the width of two fingers the expected attaching area is shown as the dotted circle in the figure below 17 3 Attach the Product which the release paper is partially removed to the left chest with the attaching direction arrow and attaching direction lines pointing upwards Description Cautions How to Use Specifications Troubleshooting ...

Page 19: ...st 18 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 Description Cautions How to Use Specifications Troubleshooting ...

Page 20: ...SVEB with yellow frame Supraventricular ectopic beats Unreadable Too much noise unable to analyze ECG display Showing user s real time single lead ECG Settings User can change language and heart rate notification settings here Stop recording To stop recording and return to the main menu Amplitude adjustment To change the amplitude unit in the ECG display 19 Description Cautions How to Use Specific...

Page 21: ... device in front of the user within 3 m and avoid any obstacles in between to prevent disconnection 20 If the Bluetooth connection is lost the Einthoven App will notify the user with sound and message at the same time to try reconnecting automatically If the App does not automatically reconnect please combine the Host Module and the Patch following the figure below Description Cautions How to Use ...

Page 22: ...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 2 1 21 Description Cautions How to Use Specifications Troubleshooting ...

Page 23: ...e 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 and labels then click and enter the record screen 22 Description Cautions How to Use Specifications Troubleshooting ...

Page 24: ...ump to the previous or next interval with S or V labels Press the smart interval message itself to switch between S and V interval Product link status shows if the Product is connected or disconnected from this device Interval selection immediately jump to specific time point in the ECG record Time and date Shows the time and date of the current displayed ECG interval Amplitude adjustment To chang...

Page 25: ...emperature 5 40 C 5 40 C Storage temperature 25 70 C 25 70 C Operating humidity 15 93 15 93 Storage humidity 15 93 15 93 Operating pressure 700 1060 hPa 700 1060 hPa Wireless connection Bluetooth 4 0 N A Battery N A Lithium battery 3 V 600 mAh Weight 4 7 g 22 9 g Dimensions 24 x 31 x 7 mm W x L x H 40 x 102 x 7 23 mm W x L x H 24 Description Cautions How to Use Specifications Troubleshooting ...

Page 26: ...onitoring range 25 250 bpm LED Light Indications Product Status Switch LED Color Blinking interval Meaning Not attached Press long Green Short 0 5 sec Pairing with device Attached to user Press long Green Short 0 5 sec Pairing with device Green Long 3sec Sending data Press long Green Long 3sec Sending data LED Light Invisible when not lit 25 Description Cautions How to Use Specifications Troublesh...

Page 27: ...et a notification range in Einthoven iOS App when the detected heart rate is not within the set range a notification will show in the App This Product complies the requirement in ANSI EC57 The sensitivity and positive predictivity of the Product based on the testing results by conducting test with database data are listed in the table below Testing objective Sensitivity positive predictivity QRS w...

Page 28: ...cations section on page 25 to check if the Host Module is pairing with your mobile device Q3 Why do I keep receiving the connection lost message while monitoring A Please keep your mobile device in front of you within 3 m range If you still keep receiving this message please try hanging your mobile device against your chest Q4 What should I do if the Host Module disengages from the Patch while I m...

Page 29: ...525633 Customer service service acebiotek com Adverse Event Reporting 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 28 Description Cautions How to Use Specifications Troubleshooting ...

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