Standards And Regulations Compliance; Electromagnetic Effects - Verathon BladderScan BVI 9400 User Manual

Product Specifications

Standards and Regulations Compliance

Verathon
national standards and regulations, including but not limited to the following:
Specification
International Electrotechnical
Commission
Safety Standard
Medical Device Directive
Canadian Standards Association
Underwriters Laboratories, Inc.
Health Insurance Portability and Accountability Act (HIPAA)*
*For details on Verathon
the QuickPrint Help menu (select P

Electromagnetic Effects

There are no restrictions on the use of BladderScan
characteristics. Both the emissions from BladderScan
instrument to interference from other sources are within prescribed limits of all applicable
standards at the date of manufacture. The emissions test procedure that was used is
specified in EN/ IEC55011: 1991 for Group 1, Class A equipment (per EN/IEC60601-1-2,
36.201.1.7).
BladderScan
environments, and in domestic environments under the jurisdiction of a health care
professional. An indication of adverse electromagnetic effects from BladderScan
9400 on another electronic device would be a degradation of performance in the other
device when the devices are operated simultaneously. If such interference is suspected,
separate the two devices as much as possible, or discontinue simultaneous operation, if
practical, and contact Verathon
BladderScan
interference sources, and has demonstrated immunity at a field strength of 3 V/m (per
EN/IEC 60601-1-2, 36.202.2.1). You do not need to take any other precautions regarding
exposure in reasonably foreseeable environmental conditions to magnetic fields,
pressure, or variations in pressure, acceleration, or thermal ignition sources.
page 68
®
certifies that all units are in compliance with all applicable international and
®
compliance with privacy rules, please refer to the information in
®
BVI 9400 is suitable for use in industrial, scientific, and medical (ISM)
®
.
®
BVI 9400 will operate normally in the proximity of other potential
Standard
EN/IEC 60601-1 Amendments 1 and 2 and
EN/IEC 60601-1-2 (EMC)
EN/IEC 60601-2
MDD 93/42/EEC Annex 1
C22.2 No. 601.1-M90 (Master Contract No.
177198)
UL 60601-1
A ).
RIVACY GREEMENT
®
BVI 9400 due to its electromagnetic
®
and the susceptibility of this
®
BladderScan BVI 9400
®
BVI
User's Manual