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System Specifications
Intended Use
Safety Standards
0123
NBP Standards
TeleMon is indicated for use in the monitoring, recording, and alarming of multiple
physiologic parameters in adult and pediatric patients to gain information for
treatment, to monitor adequacy of treatment, or to exclude causes of symptoms.
TeleMon is a prescription device for use in healthcare facilities by trained healthcare
professionals. TeleMon is not intended for home use.
The M2636B TeleMon Monitor complies with the Council Directive 93/42/EEC of
14 June, 1993 concerning medical devices, and carries CE marking accordingly.
The following accessories and system components are independently CE-marked:
•
Power Supply accessory
•
Battery Reconditioner accessory
•
Telemetry System
Note—
The Battery Reconditioner is not for use in the patient vicinity.
The M2636B TeleMon also complies with the following international safety
requirements for medical electrical equipment:
•
IEC 60601-1/ EN 60601-1
•
IEC 60601-1-1/ EN 60601-1-1
•
IEC 60601-1-2/ EN 60601-1-2
•
IEC 60601-2-27/ EN 60601-2-27
•
IEC 60601-2-30/ EN 60601-2-30
•
CAN/ CSA C22.2 No. 601.1-M90
•
UL 2601-1
The monitor is a Class I device and has an IPX 1 rating (excluding the power
supply). The device has BF and CF applied parts.
The system provides continuous operation when in use.
Non-invasive blood pressure measurements determined with this device are
equivalent to those obtained by a trained observer using the cuff/stethoscope
auscultation method, within the limits prescribed by the American National
Standard, Electronic or automated sphygmomanometers.
The NPB portion of the device also meets all relevant parts of the following safety
standard:
•
ANSI/AAMI SP10
NBP internal operating software ensures that:
•
Maximum cuff inflation time is limited to 60 seconds.
•
Duration of blood pressure reading is limited to 170 seconds.
System Specifications
Safety and System Specifications
9-9
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Troubleshooting
