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Summary of Contents for ZOLL CMCT Monitoring System
- Page 1 Instructions for Use CMCT Monitoring System Rx Only...
- Page 2 1.888.592.3798 Copyright Notice © 2016, ZOLL Medical Corporation. All rights reserved Trademarks ZOLL is a trademark or registered trademark of ZOLL Medical Corporation in the United States. Disclaimer Information, operation, specifications, and product appearance may change without notice. Symbols Glossary...
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Page 3: Table Of Contents
CMCT Monitoring System Instructions for Use TABLE OF CONTENTS Part I: General Information ....................5 Introduction ......................6 Conditions for Use ............Error! Bookmark not defined. Intended Use and Indications for Use ..............6 Contraindications ............Error! Bookmark not defined. General Warnings and Precautions ........Error! Bookmark not defined. - Page 4 CMCT Monitoring System Instructions for Use 10.3 Wireless Transmission Specifications ..............25 10.4 Sensor Dimensions ....................26 10.5 Environmental & Other Specifications ..............27 11 Compliances ......................28 11.1 Electrical Safety ..................... 28 11.2 Electromagnetic compatibility (EMC) ..............28 Page 4 of 31...
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Page 5: Part I: General Information
CMCT Monitoring System Instructions for Use Part I: General Information Page 5 of 31... -
Page 6: Introduction
CMCT wearable Sensor and Patch, a portable data transmission device (Gateway), and a Charger. The Sensor unit continuously records and transmits ECG data to the data transmission device, and from there to the ZOLL monitoring center. Other physiological parameters such as thoracic impedance, heart rate, respiration rate, activity and posture are recorded periodically and are also transmitted, via the data transmission device to the monitoring center. - Page 7 • Sensor and Data Transmission Device must be turned OFF prior to boarding an airplane. Remove Sensor from Patch and call ZOLL for further instructions. • Do not wear the Patch for more than 5 days. Replace the Patch every 3 days, or more frequently when needed.
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Page 8: Detailed Descripton Of The Cmct System
Using non-approved cables and accessories may affect the EMC performance • Do not stack the µCor 3.0 system with other devices or equipment. • Discontinue use and contact ZOLL if the CMCT System shows signs of damage or is not working correctly. -
Page 9: How Cmct System Works
CMCT Monitoring System Instructions for Use HOW CMCT SYSTEM WORKS Once activated, the wearable Sensor automatically acquires ECG, thoracic impedance, Heart Rate, Respiration Rate, Activity, and Posture measurements. Patients can also activate a patient trigger when they experience symptoms by double tapping the Sensor when it is on the body. -
Page 10: Patch
The Sensor connects to the Patch via the snap-in clip and positioning tabs. Through the adhesive backing on the Patch, the device becomes wearable. The Sensor is not disposable and needs to be returned to ZOLL upon the completion of the prescription. -
Page 11: Charger
CMCT Monitoring System Instructions for Use Figure 3: Sensor CHARGER A dedicated Charger (as shown in Figure 4) is supplied with the CMCT System for recharging the Sensor and the Data Transmission Device. A blue light appears when the Charger is connected to an AC outlet. -
Page 12: Data Transmission Device (Gateway)
CMCT Monitoring System Instructions for Use DATA TRANSMISSION DEVICE (GATEWAY) A Data Transmission Device or Gateway is responsible for sending data from the Sensor to the Server for data analysis. When the screen display is on, the gateway battery status is visible on the screen. Once the battery... -
Page 13: Directions For Use
5.1.2 CHARGING THE SENSOR – FIRST USE AND EVERY 3 DAYS IMPORTANT: Set up Charger in bedroom or room where you sleep. This allows device to send data to ZOLL at least once a day. 1. Connect the Charger to a power outlet in your bedroom. -
Page 14: Connecting The Sensor To The Patch
CMCT Monitoring System Instructions for Use 5.1.3 CHARGING THE GATEWAY – FIRST USE AND EVERY DAY 1. Place the Gateway on the Charger in its designated area. 2. The Gateway screen should light up and display it is being charged. Once removed from the Charger, the Gateway screen will display battery status in percent. -
Page 15: Applying The Device
1. Stand in front of a mirror. 2. Remove both parts of the Patch liner. 3. Turn the Patch so that the word “ZOLL” on the Patch is at the top. 4. Raise the left arm to shoulder height. 5. If needed, slightly move the breast aside when applying the Patch. - Page 16 CMCT Monitoring System Instructions for Use Figure 52: Device (Sensor + Patch) applied to left-side location 8. Stay still and wait for a green light to appear on the Sensor, which signals it is ready to monitor (refer to Section 6 Trouble Shooting if a blinking amber light appears instead).
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Page 17: Front Location
CMCT Monitoring System Instructions for Use 5.4.2 CHEST LOCATION 1. Stand in front of a mirror. 2. Remove both parts of the Patch liner. 3. Position the Patch on the upper left chest, just below the collarbone, and angle the device towards the nipple. -
Page 18: How To Use The Gateway
CMCT Monitoring System Instructions for Use HOW TO USE THE GATEWAY 1. Make sure to keep the Gateway not more that 10 meters away from the body at all times to allow proper communication with the Sensor. During the day, carry the Gateway with you •... -
Page 19: Recharging The Sensor
Sensor is ready for use. Sensor on the body Solid green Sensor is ready for monitoring. This solid green light will last for several seconds, after which it will disappear. Blinking Sensor error. Call ZOLL customer service at amber 1.888.592.3798. Page 19 of 31... -
Page 20: Troubleshooting
CMCT Monitoring System Instructions for Use TROUBLESHOOTING The following table lists the recommended actions for potential issues with the CMCT System. Please call ZOLL at +972-9-9603900 if you need assistance with any of these instructions Signs Possible Causes Actions Sensor light indicator... -
Page 21: Maintenance
CMCT Monitoring System Instructions for Use 8 MAINTENANCE Users are not required to perform any maintenance for the CMCT System. 9 SYMBOLS GLOSSARY Title and Title of Symbol Symbol Ref # Explanatory Text Symbol designation # of the Standard ANSI/AAMI/ISO Manufacturer 5.1.1... - Page 22 CMCT Monitoring System Instructions for Use 1:2005/(R)2012 Type BF applied part #19 (Table D.1) Device intended to deliver and A1:2012, electrophysiological signal to or C1:2009/(R)201 from the patient. 2 and A2:2010/(R)201 2, Medical Ingress protection #2 (Table D.3) Indicates that Sensor is protected...
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Page 23: Part Ii: Technical Specifications
CMCT Monitoring System Instructions for Use Part II: Technical Specifications Page 23 of 31... -
Page 24: Technical Specifications
CMCT Monitoring System Instructions for Use 10 TECHNICAL SPECIFICATIONS 10.1 ACCURACIES Parameter Measurement Accuracy Error of less than 50cc fluid at a confidence level of 90% TFC* Accuracy higher than ±2 bpm or ±2%, the higher of the two Maximum error of ±2 bpm or 10% , the higher of the two Activity Active vs resting accuracy >... -
Page 25: Electrical (Power) Requirements
CMCT Monitoring System Instructions for Use 10.2 ELECTRICAL (POWER) REQUIREMENTS Sensor 0.85W Max Power Consumption 0.02W Nominal Power Consumption 4.2V, 0.2A Max Rating 3.7V, 0.01A Nominal Rating Li-Pol, 3.7V, 1050mAh Battery Type Charger Consumption during charging - Input (plug) 5VDC, 2.8A... -
Page 26: Sensor Dimensions
CMCT Monitoring System Instructions for Use Modulation GFSK; PSK 9 dBm PEAK OUTPUT POWER RF Sensor 0.5-2.5 GHz Frequency range Modulation -10dBm max. and below CISPR 11 PEAK OUTPUT POWER levels 10.4 SENSOR DIMENSIONS Sensor 69 mm (2.72”) Height Width 53.44 mm (2.10”) -
Page 27: Environmental & Other Specifications
CMCT Monitoring System Instructions for Use 10.5 ENVIRONMENTAL & OTHER SPECIFICATIONS Operating Conditions for the CMCT System 0°C and 40°C (or 32°F and 104°F) Temperature 5%-93% non-condensing Relative humidity 700hPa to 1060hPa Pressure Storage Conditions for the CMCT System 10°C to 32°C (or 50°F to 89.6°F) -
Page 28: Compliances
CMCT Monitoring System Instructions for Use 11 COMPLIANCES 11.1 ELECTRICAL SAFETY The device complies with IEC/EN 60601-1, Edition 3.1 for general requirements of • medical electrical equipment safety: - Mode of operation: spot measurement - Degree of mobility: portable The device complies with IEC 60601-1-11. - Page 29 CMCT Monitoring System Instructions for Use Guidance and manufacturer’s declaration- electromagnetic immunity The CMCT is intended for use in the electromagnetic environment specified below. The customer or the user of the CMCT should assure that it is used in such an environment.
- Page 30 Portable and mobile RF communications IEC 61000-4-3 frequency equipment should be used no closer to 80MHz-2500 any part of the ZOLL CMCT including cables, than the recommended separation distance calculated from the equation 9-28 V/m appropriate to the frequency of the 358-5800MHz transmitter.
- Page 31 CMCT Monitoring System Instructions for Use transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the CMCT is used exceeds the applicable RF compliance level above, the CMCT System should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the CMCT.
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