ZOLL CMCT Monitoring System, Instructions For Use Manual

Page 1: ...CMCT Monitoring System Rx Only Instructions for Use...

Page 2: ...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...

Page 3: ...way 12 4 8 Server 12 4 9 Device sensor Patch Placement Location 12 5 Directions for Use 13 5 1 Getting started 13 5 1 1 Locate the components of the CMCT System 13 5 1 2 Connect the Charger Error Book...

Page 4: ...uctions for Use Page 4 of 31 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 Electrom...

Page 5: ...CMCT Monitoring System Instructions for Use Page 5 of 31 Part I General Information...

Page 6: ...e clinical reports to the prescribing physician The CMCT System is designed for use in outpatient clinic and home settings for up to 30 days 2 INDICATIONS FOR USE The CMCT System is intended to contin...

Page 7: ...to an MRI scan or any emergency medical procedure The CMCT System is not compatible for use with MRI machines If you have an implanted pacemaker or defibrillator do not place the Sensor directly on t...

Page 8: ...System will only be performed by ZOLL Connect the Charger to the AC adapter that is provided with the system in the original packaging Using any other AC adapter may damage the Charger and may have e...

Page 9: ...e prescribing physician Data provided in the report will aid the prescribing physicians in the diagnosis and identification of various clinical conditions events and or trends The CMCT System is desig...

Page 10: ...SENSOR The Sensor as shown in Figure 3 is a battery powered unit that acquires your measurements The Sensor connects to the Patch via the snap in clip and positioning tabs Through the adhesive backing...

Page 11: ...of 31 Figure 3 Sensor 4 6 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 Ch...

Page 12: ...ke sure you charge the gateway daily 4 8 SERVER The Server refers to the hardware and the processing software and resides in a remote cyber secure location The software analyzes the data recevied from...

Page 13: ...T 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 A Blue light on the Charger mean...

Page 14: ...Gateway screen will display battery status in percent 3 The Gateway typically takes about three hours to charge See Figure 9 5 2 PREPARING THE SKIN IMPORTANT This step ensures good adhesion to skin 1...

Page 15: ...her of the two locations detailed below Once you wear the device in one location you will continue to wear the device at the same location for the entire duration of your prescription 5 4 1 LEFT SIDE...

Page 16: ...6 Trouble Shooting if a blinking amber light appears instead Note that the green light will last for several seconds after which the light indicator will remain off Figure 13 illustrates examples of...

Page 17: ...Ensure the Patch is completely adhered to the skin 5 Stay still and wait for a green light to appear on the Sensor which signals it is ready to monitor refer to Section 6 Troubleshooting if a blinkin...

Page 18: ...the Gateway ON at all times to allow proper communication with the Sensor 4 Charge the Gateway daily for example every night while you sleep The Gateway takes about 3 hours to fully charge With an ade...

Page 19: ...Sensor will be amber when being charged It will turn green when the Sensor is fully charged and ready to go 5 8 SENSOR AND LIGHT INDICATOR STATUSES The following is a summary of the light indicator s...

Page 20: ...and is green Sensor light turns blinking amber after being applied on the patient s body Sensor Error Contact ZOLL customer service at 1 888 592 3798 Charger light indicator is not on The Charger is n...

Page 21: ...Catalogue number 5 1 6 Product catalogue number Date of manufacturer 5 1 3 Date when the device was made Batch code 5 1 5 Batch or lot number for device traceabiltiy European representative 5 1 2 Euro...

Page 22: ...fects of temporary immersion in water Ingress protection 2 Table D 3 Indicates that the Gateway is protected against solid foreign objects of 12 5mm or greater and against vertically falling water dro...

Page 23: ...CMCT Monitoring System Instructions for Use Page 23 of 31 Part II Technical Specifications...

Page 24: ...boratory Based on algorithm testing preformed using the AHA Database for Evaluation of Ventricular Arrhythmia Detectors Based on algorithm testing preformed using the MIT BIH Arrhythmia Database NOTE...

Page 25: ...01A Battery Type Li Pol 3 7V 1050mAh Charger Consumption during charging 14W Input plug 5VDC 2 8A Adapter Part Number UE24WCP1 050300SPA Input 100 to 240 VAC at 50 60Hz 0 8A Output 5VDC 3A 10 3 WIREL...

Page 26: ...dulation GFSK PSK PEAK OUTPUT POWER 9 dBm RF Sensor Frequency range 0 5 2 5 GHz Modulation CW PEAK OUTPUT POWER 10dBm max and below CISPR 11 levels 10 4 SENSOR DIMENSIONS Sensor Height 69 mm 2 72 Widt...

Page 27: ...g Pressure 700hPa to 1060hPa Storage Conditions for the CMCT System Temperature 10 C to 32 C or 50 F to 89 6 F Relative Humidity 5 93 non condensing Shipping and Transport Conditions for the CMCT Syst...

Page 28: ...dance and manufacturer s declaration electromagnetic emissions The CMCT is intended for use in the electromagnetic environment specified below The customer or the user of the CMCT should assure that i...

Page 29: ...t transient burst IEC 61000 4 4 2 kV 100 kHz Repetition frequency 2 kV Mains power quality should be that of a typical commercial or hospital environment Conductive Surges IEC 61000 4 5 1 kV line to l...

Page 30: ...MHz to 800 MHz d 2 3 P 800 MHz to 2 5 GHz where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distan...

Page 31: ...tion against harmful interference in a residential installation This equipment generates uses and can radiate radio frequency energy and if not installed and used in accordance with the instructions m...