Operator`s manual

Electromagnetic Compatibility Standards
ThePRMhasbeentestedandfoundtocomp
ly with the applicable portions of
the electromagnetic compatibility (EMC) standards:
• FCC Part 15.209:2004 + 15.207:2004 + 15
.249:2004
• EN 302 195 -2 V1.1.1:2004
• EN 300 220 -2 V2.1.2:2007
• EN 301 489 -1 V1.8.1:2008
• EN 301 489 -3 V1.4.1:2002
The ZWT h as been tested and fo und to comply with the ap plicable po r tions of
the electromagnetic compatibility (EMC) standards:
• EN 301 489–1 V1.9.2:2011
• EN 301 489– 27 V1.1.1:2004
• EN 301 839– 2 V1.3.1:2009
• IC RSS-243:2010
NOTE:
Use special precautions regarding EMC during the installa tion and the use
ofthePRMandZWT,accordingtotheEM
C instructions give n throughout
this manu al. Refer to the details about the PRM and ZWT electromagnetic
emissions and immunity (Table 5 on page 3 6, Table 6 on page 36).
NOTE:
Use caution when using RF porta ble an
d mobile equipment in close
proximity to the PRM and Z WT. Refer to the details about t he PRM and ZWT
electromagn etic immunity (Table 7 on page 38, Table 8 on page 39).
IEC 60601-1-2:2007 Information
This equipment has been tested and found to comply with the applicable
limits for medical devices to ANSI/AAMI/IEC 60601-1-2:2007 [or BS EN
60601-1-2:2007 + C1:2010 or Acti
ve Implantable Medical Devi ce Directive
90/385/EEC]. This testing shows the device provides reasonable protection
against harmful interfe r ence in a typical m edical installatio n. However, there is
no guarantee that interferen
ce will not occur in a particular installation.
Federal Communications Commi
ssion (FCC)
This device complies with Title 47, Part 1 5 of th e FCC rules. Operation is
subject to the following two co
nditions:
• This device may not cause harmful interference, and
• This device mus t accept any interference received, including inter ference
that may cause undesired operation.
CAUTION: Changes or modifications not expressly approved by Boston
Scientific could void the user’s authority to operate the equipm ent.
Electromagnetic Emissions and Immunity
The electromagnetic emissio
ns and immunity info rmation is provided below.
35