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LTV 1200 Operator's Manual - CareFusion Emergency Preparedness

LTV 1200 Operator's Manual - CareFusion Emergency Preparedness

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Notices<br />

The <strong>LTV</strong> ® <strong>1200</strong> ventilator complies with limitations as specified in IEC 601-1-2 for Medical Products. It<br />

does however, use and radiate radio frequency energy.<br />

The function of this machine may be adversely affected by the operation of other nearby equipment,<br />

such as high frequency surgical diathermy equipment, short-wave therapy equipment, defibrillators,<br />

or MRI equipment (except the MR Conditional <strong>LTV</strong> ® <strong>1200</strong>).<br />

The <strong>LTV</strong> ® <strong>1200</strong> ventilator may emit and receive electromagnetic interference. Avoidance of this<br />

exposure is recommended whenever possible.<br />

The MR Conditional <strong>LTV</strong> ® <strong>1200</strong> System is comprised of only (i.e., no unauthorized accessories): an<br />

MR Conditional <strong>LTV</strong> ® <strong>1200</strong> ventilator (P/N 18888-2XX), <strong>LTV</strong> ® <strong>1200</strong> MR Safe 15ft Patient Circuit (P/N<br />

19189-001), MR Conditional Floor Stand (P/N 14982-001), and an <strong>LTV</strong> ® AC adapter (P/N 18053-<br />

001).<br />

The MR Conditional <strong>LTV</strong> ® <strong>1200</strong> System is suitable for use in both 1.5 and 3.0 Tesla (not to exceed<br />

3.0 Tesla static magnetic field) shielded magnetic scanners (see Chapter 16 – MR Conditional<br />

System for more information).<br />

European Regulatory Requirements per 93/42/EEC Medical Device Directives<br />

Pulmonetic Systems’ European Representative for vigilance reporting within the European<br />

Community is:<br />

MediMark® Europe Sarl.<br />

11, rue Emile Zola. BP 2332<br />

F-38033 Grenoble Cedex 2. France<br />

Tel: +33 (0)4 76 86 43 22<br />

Fax: +33 (0)4 76 17 19 82<br />

E-mail: info@medimark-europe.com<br />

Any product malfunctioning issues that fall under Medical Device Directives Essential Requirements<br />

should be directed to MediMark.<br />

Operator’s <strong>Manual</strong> <strong>LTV</strong> ® <strong>1200</strong> Ventilator Page iii<br />

p/n 18247-001, Rev. G

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