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HD11 XE Getting Started
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Device Standards
Table 6-2 lists and describes the classification symbols and their meanings. See
Table 2-3 for a description of the symbols used on this system.
This system is in continuous operation.
This system is Group 1: It is provided with basic insulation and protective earth
accessible metal parts.
WARNING
The equipment is not suitable for use in the presence of a flammable anesthetic
mixture with air, oxygen, or nitrous oxide.
Audible Acoustic Output
The maximum sound pressure level achieved when the system is operated in tem-
peratures up to 40°C (104°F) is 50 dBa.
Electromagnetic Compatibility
The testing for electromagnetic compatibility (EMC) of this system has been per-
formed according to the international standard for EMC with medical devices
(IEC 60601-1-2). This IEC standard was adopted in Europe as the European norm
(EN 60601-1-2).
Table 6-2 Classification Symbols
Symbol Meaning
All remaining transducers are rated for type BF isolation.
All intraoperative transducers are rated for type CF isolation. Some
additional transducers are rated for type CF isolation.
ECG physio isolation is type CF, defibrillator proof.
Suitable for all patient applications including direct cardiac application.
IPX0 The system has ordinary protection against the entry of liquids.
IPX1 The foot switch meets drip-proof construction requirements.
IPX7 Protected against the effects of temporary immersion in water.
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