Page 70 - Abbott

Environmental Information
 Operation: 5º to 40ºC (41º to 104ºF), 15% to 93% humidity (non-condensing), 700-1060 hPa (Electronics), 800-1150 hPa
(implanted sensor)
 Transportation: -25º to 70ºC (-13º to 158ºF) and up to 93% humidity (non-condensing)
 Storage: -25º to 70ºC (-13º to 158ºF) and up to 93% humidity (non-condensing)
Classification
 Class II equipment
 Type BF insulation
 Ordinary Equipment IP 21
 Continuous Use

Testing
System Testing
 System Accuracy (under typical environmental conditions): +/- 2 mmHg at baseline and +/-3% of difference between measured
pressure and baseline
 System Accuracy: +/-4 mmHg over the range of environmental conditions
 The CM3000 was issued an ETL/cETL Listing Mark
Safety Testing
 IEC 60601-1
 ANSI ES 60601-1
 CENELEC EN 60601-1
 CAN/CSA-C22.2 No. 60601-1
EMI/EMC Testing
 CENELEC EN 60601-1-2
 ETSI EN 301 489-1
Wireless Testing
 FCC part 18 (Electronics System)
 FCC part 15 (Sensor)
 ETSI EN 301 489-3
 ETSI EN 302 510
 CISPR 11
 CISPR 22
Software

This device contains open source software. Source code is available upon request.
Technical Support
In North America:
For Merlin.net™ PCN patients, telephone Technical Support is available Monday through Friday (8AM to 8PM Eastern Standard
Time). For clinicians, telephone Technical Support is available 24-hours a day.
For Merlin.net Patient Care Network support:
 1 877 696 3754 (1 877 MY MERLIN) (toll-free within North America)
In Europe:
Telephone Technical Support is available Monday through Friday (8:00 to 17:00 Central European Time).
 +46 8 474 4756 (Sweden) (Support in English and Swedish)
St. Jude Medical maintains 24-hour phone lines for technical questions and support:
 1 818 362 6822
 1 800 722 3774 (toll-free within North America)
 + 46 8 474 4147 (Sweden)
For additional assistance, call your local St. Jude Medical representative.
Symbols
The following symbols are used on the system labels.
Symbol Description
Reorder number

66