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Safety Summary
Regulatory
Compliance
SciMed Ltd. is an ISO 9001: 2000
and ISO 13485: 1996 and
CMDCAS approved manufacturer of medical equipment.
The Pioneer TC8080 and
Companion III systems have
been certified and tested by
Intertek Testing Services, ETL
SEMKO, to comply with the
General Requirements for Safety
UL2601-1: 1997, CAN/CSAC22.2 No. 601.1-M90 (ETL listed
and labeled), EN60601-1: 1990 +
A1: 93, A11: 93, A12: 93, A2: 95,
A13: 96, Corrigendum: 94 and
IEC 601-1: 1998 + A1: 91, A2:
95, Corrigendum 95.
The Pioneer TC8080 and
Companion III systems have
been certified and tested by TRL
Compliance Services Ltd. to
comply with the Medical Collateral Standard for Electromagnetic
Compatibility IEC 60601-1-2:
2001 and IEC 60601-1-2-AM1:
2004.
The Pioneer TC8080 and
Companion III systems have
been certified and tested by
Intertek Testing Services, ETL
SEMKO, to comply with the
Collateral Standard: Safety
requirements for medical electrical systems EN 60601-1-1: 2001
and IEC 60601-1-1: 2000.
The Pioneer TC8080 and
Companion III systems are class
IIa products that have been CE
approved to the Medical Devices
Directive 93/42/EEC by Lloyds
Register Quality Assurance
(LRQA) in the United Kingdom,
Notified Body no. 0088.
The degree of protection in the
system against electric shock
conforms to EN60601-1 : 1990.
Precautions
IMPORTANT:
Please read this manual carefully before setting up the
system or before connecting
other instruments. Read and
follow all WARNINGS, CAUTIONS and NOTES provided in
this user manual. To avoid the
possibility of personal injury,
damage to your system or lost
data, observe these safety
precautions during system
operation.
In this manual, two labels identify
potentially dangerous or destructive conditions or procedures:
!
WARNING
The WARNING label identifies
conditions or practices that may
present danger to the patient
and/or user.
!
CAUTION
The CAUTION label identifies
conditions or practices that could
result in damage to the equipment.
Notes: These help you identify
areas of possible confusion and
avoid potential problems during
system operation.
H1-3