Cardiac Designs ECG Check Universal Скачать руководство пользователя страница 3

 
ECGC-70-002, Rev. 8, February 05, 2019 

 

Symbols Glossary 

 

Caution (0434A) Indicates the need for the user to consult the instructions for use for 
important cautionary information such as warnings and precautions that cannot, for a 
variety of reasons, be presented on the medical device itself. 

 

Follow Instructions for Use. 

 

RoHS Compliant 

 

Date of Manufacture (2497) Indicates the date when the medical device was 
manufactured.  

 

Type CF Applied Part 

 

Non-Ionizing Radiation 

 

Authorized representative in the European Community Indicates the Authorized 
representative in the European Community. 

 

European Conformity 

 

Serial Number (2498) Indicates the manufacturer

s serial number so that a specific 

device can be identified. 

 

Dispose of rechargeable batteries only in accordance with all applicable local laws 
and regulations. 

 

Keep Dry (0626) Indicates that ECG Check needs to be protected from moisture 

 

Temperature limit (0632) Indicates the temperature limits to which the medical 
device can be safely exposed. 

 

Humidity limitation (2620) Indicates the range of humidity to which the medical 
device can be safely exposed. 

Содержание ECG Check Universal

Страница 1: ...or your safety please take a moment to read it carefully and in its entirety before you begin testing For the most up to date list of compatible devices please refer to the supported list at http www...

Страница 2: ...the ECG Check 10 Setup the ECG Check Device 10 Download the ECG Check Application and Create your Account 10 General Information 11 Before Recording 11 Recording 11 Medical Records 14 Maintenance Clea...

Страница 3: ...ng Radiation Authorized representative in the European Community Indicates the Authorized representative in the European Community European Conformity Serial Number 2498 Indicates the manufacturer s s...

Страница 4: ...vided in this manual are subject to change without notice Cardiac Designs Inc SHALL NOT BE LIABLE FOR TECHNICAL OR EDITORIAL ERRORS OR OMISSIONS CONTAINED HEREIN NOR FOR INCIDENTAL OR CONSEQUENTIAL DA...

Страница 5: ...nal defibrillation procedures WARNING The ECG Check device must not be exposed to strong electromagnetic fields WARNING Do not allow conductive parts of electrodes to come into contact with other cond...

Страница 6: ...ould consult their physician before using this device Coronary heart disease Valvular heart disease Heart transplant Heart failure This device is available in the USA in both over the counter mode OTC...

Страница 7: ...ing at home These 1 lead cardiac monitors allow remote patients to display and transmit their EGG data to medical professionals via a communication device to a remote server Specifically the EGG Check...

Страница 8: ...ECGC 70 002 Rev 8 February 05 2019 8 Your ECG Check comes with the following ECG Check Device ECG Check USB Charging Cord...

Страница 9: ...til the ECG Check application has been started and the blue Make a New Recording icon has been pressed 2 Standby Power Off The device will turn off automatically after the device has detected no skin...

Страница 10: ...computer and store in an easy to find location so you will have it easily accessible for recharging when necessary Download the ECG Check Application and Create your Account 1 Download the ECG Check...

Страница 11: ...ord and transmit your ECG to an application via Bluetooth for display and analysis as shown below Before Recording For your safety read thisinstruction manual in its entirety before attempting a recor...

Страница 12: ...o be prompted on how to start recording 5 The following screen will appear once you have established a connection and the ECG Check device begins recording ECG Check Application Recording in Progress...

Страница 13: ...w If you are in Over the Counter Mode you will only see a progress bar as the recording progresses 8 The system will automatically send the ECG for analysis by the backend arrhythmia analysis algorith...

Страница 14: ...s 2 Tap on the Tap for archive recordings to view older recordings than those shown on the screen Maintenance Cleaning Rechargeable Battery Warning Do not dispose of the internal rechargeable battery...

Страница 15: ...onthly at minimum to ensure continued performance of your ECG Checkdevice at maximum capacity and to reduce the possibility of a failure Refer to the cellular device instructions for proper maintenanc...

Страница 16: ...id pouring water or other liquids on the device while cleaning Never use abrasives such as wire wool or metal polish Disinfection Using a new Sani Cloth HB cloth after cleaning wipe all exterior surfa...

Страница 17: ...rodes Ensure both electrode pads are in contact with the user s skin ECG Data is not being analyzed There is no connection to the internet Turn on your cellular data or connect to a WiFi access point...

Страница 18: ...Email info cardiacdesigns com Website www ecgcheck com Wireless Technology The ECG Check device system uses wireless technology to transmit data from the ECG Check Device to the ECG Check application...

Страница 19: ...beats per minute measured as bpm Bluetooth BT Wireless communication protocol ECG Check ECG Check wireless ECG monitor PC Personal computer ECG Check Application Cardiac Designs Inc proprietary softw...

Страница 20: ...ic and Medical Average QRS Sensitivity 99 87 Average QRS Predictability 99 77 Average VEB Sensitivity 93 91 Average VEB Predictability 94 12 Battery Type 3 7V x1 Lithium ion rechargeable battery Batte...

Страница 21: ...that it is used in such an environment Emission test Compliance Electromagnetic environment guidance RF emissions CISPR 11 Group 1 The ECG Check uses RF energy only for its internal function Therefore...

Страница 22: ...hospital environment Surge IEC 61000 4 5 1 kV line s to line s 2 kV line s to earth Not applicable Mains power quality should be that of a typical commercial or hospital environment Voltage dips short...

Страница 23: ...ut power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distance in metres m Field strengths from fixed RF transmitters as determine...

Страница 24: ...rs and the ECG Check as recommended below according to the maximum output power of the communications equipment Rated maximum output power of transmitter W Separation distance according to frequency o...

Отзывы: