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Humphrey Matrix Visual Field Instrument
51
Rev. D 08/21/06 PN 701692
STANDARDS COMPLIANCE
Regulatory Approvals
Health Insurance Portability and Accountability Act
It is essential that the user understands the features of the Matrix and defines their workflow to
achieve compliance with the HIPAA security rule. The Welch Allyn Matrix has the capability to
both store and transmit electronic protected health information (PHI) that identifies patients. The
Matrix does not contain features that by themselves enable or prevent compliance with the
technical safeguards enumerated in the HIPAA security rule for access Control, Authentication,
Data Integrity, Audit Control, and Transmission Security. We therefore recommend that the user
take appropriate precautions to control access and use of the Matrix and its data to ensure
compliance to the HIPAA requirements.
The CE mark on this device indicates it has been tested to and conforms to the
provisions noted within the 93/42/EEC Medical Device Directive
Authorized European Representative Address:
European Regulatory Manager
Welch Allyn Ireland
Navan Business Park
Dublin Road
Navan, County Meath
Republic of Ireland
Tel: +353 46 90 67700 • Fax: +353 46 90 67756
EMC Framework of Australia
Product Safety
Class
I
IXPO- ordinary equipment
Continuous operation equipment
TYPE BF
Indicates this equipment contains Type BF applied parts; the patient forehead
rest and patient response button.
TUV listed to comply with
UL 2601-1:1997
CSA C22.2 No. 601.1-M90
IEC 60601-1:1990+A1+A2+A13
IEC 60601-1-2:2001
CB certified to Medical Electrical Equipment IEC60601-1
WELCH ALLYN PTY LTD
5/38-46 SOUTH
STREET
RYDAL MERE
NSW 2116
AUSTRALIA
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