User's Manual

ENGLISH –

Modem Standard ITU-T V.92/V.90/56K SocketModem module

for PSTN subscriber line.

Telecom approved in more than 50 countries.

The SMARTVIEW monitor may be interfered with by other equipment, even

if that other equipment complies with CISPR emission requirements.

12. DATA PROTECTION

Any clinical data is fully secured with restricted access. You have the

right to access this information at any time and ask for any change by

request only. Please contact your doctor or our toll-free technical

assistance.

13. DECLARATION OF CONFORMITY

Sorin CRM declares that this device:

− is in conformity with the essential requirements of Directive 1999/5/EC on Radio and

Telecommunications Terminal Equipment, with the mutual recognition of their conformity

(R&TTE) and with the Directive 90/385/EEC on Active Implantable Medical Devices and,

− carries the CE marking accordingly.

Sorin CRM declares that this device conforms to the following Product Specifications:

Safety - IEC 60601-1:2005 (Ed. 3) - Medical electrical equipment - Part 1: General

requirements for basic safety and essential performance.

EMC -IEC 60601-1-2:2007 (Ed. 3) - Medical electrical equipment - Part 1-2: General requirements

for basic safety and essential performance - Collateral standard: Electromagnetic compatibility -

Requirements and Tests.

EN 50371:2002 - Generic standard to demonstrate the compliance of low power electronic and

electrical apparatus with the basic restrictions related to human exposure to electromagnetic fields

(10 MHz - 300 GHz).

EN 50385:2002 - Product standard to demonstrate the compliance of radio base stations

and fixed terminal stations for wireless telecommunication systems with the basic restrictions

or the reference levels related.

EN 301 489 v1.8.1 - Electromagnetic compatibility and Radio spectrum Matters (ERM);

Electromagnetic Compatibility (EMC) standard for radio equipment and services.