Product Manual

1-6 CARESCAPE V100 Vital Signs Monitor 2036991-001C
Introduction: Product Compliance
Product Compliance
The CARESCAPE V100 Monitor is classified in the following categories for
compliance with IEC 60601-1:
 Internally powered or Class II when powered from external supply
 Transportable
 For continuous operation
 Not suitable for use in the presence of flammable anesthetics
 Not for use in the presence of an oxygen-enriched atmosphere (oxygen tent)
 Type BF applied parts
 IPX1, degree of protection against ingress of water
 Sterilization/Disinfection, see Appendix C “Maintenance”
 Software is developed in accordance with IEC 60601-1-4.
 This equipment is suitable for connection to public mains via power
adaptors as defined in CISPR 11.
 The SpO
2
parameter complies to ISO 9919:2005.
 Defibrillation protected. When used with the recommended accessories, the
monitor is protected against the effects of defibrillator discharge. If
monitoring is disrupted by the defibrillation, the monitor will recover.
CARESCAPE V100 Monitor Classified with respect to electric
shock, fire, and mechanical and other specified hazards only
in accordance with CAN/CSA C22.2 No. 60601.1. Also
evaluated to IEC-60601-2-30.
This product conforms with the essential requirements of the
Medical Device Directive 93/42. Accessories without the CE
mark are not guaranteed to meet the Essential Requirements
of the Medical Device Directive.
The CARESCAPE V100 Monitor is protected against vertically
falling drops of water and conforms with the IEC 529
standard at level of IPX1. No harmful effects will come of
vertically falling drops of water making contact with the
monitor.
0086
IPX1