Hutchinson Technology InSpectra StO2 650 Manual Del Usuario página 29

Technical Specifications
Electrical and Constructional Safety
Standards
Electromagnetic Compatibility
Enclosure
Laser Safety
Alarms
Shipping Stock
This equipment has been tested and found to comply with the limits for medical devices to IEC
60601-1-2:2001. This testing shows the device provides reasonable protection against harmful
interference in a typical medical installation. However, there is no guarantee that interference will
not occur in a particular installation. If this equipment does cause harmful interference to other
devices or is negatively impacted by other devices, the user is encouraged to try to correct the
Electromagnetic
interference by one or more of the following measures:
Emissions and
Immunity
• Reorient or relocate the devices.
• Increase the separation between the devices.
• Connect the equipment to an outlet on a different circuit.
• Contact the Service Center.
Size
Sensor Cable Length
Attachment to patient
InSpectra™
StO Sensor
2
Send to receive optical spacing
Biocompatibility Standards
(continued)
CEI IEC 60601-1
Second Edition v1988; Amendment 1:1991 and
Amendment 2:1995 and Corrigendum 1:1995
CEI IEC 60601-1-1 Second Edition v2000
UL-60601-1 First Edition v2003
CAN/CSA-C22.2 NO. 601.1
vM90 Reaffirmed 2001 Amendment 1:1991 Amendment
2:1998
IEC 60601-1-2
Second Edition v2001; Amendment 1:2004
CEI IEC 60529 Edition 2.1 v2001, IPX1
IEC 60825-1: Edition 1.2 v2001
Corrigendum 1:2002; Class 1
EN60601-1-8: v2004
ASTM D 4169 – V2004: DC13, Assurance Level 2
One size fits left or right thenar eminence
Flexible portion of sensor is 30cm (12 in)
• Adhesive placement on thenar eminence
• Intact skin only
• Single patient use only
15mm (0.6 in)
Cytotoxicity: ISO 10993-5: v1999
Irritation and Sensitization: ISO 10993-10
Second Edition v2002
27
Technical Specifications