User's Manual

24
Transport & Storage Conditions
Storage
Relative Humidity Range
-0.4 – 140°F (-18 – 60°C)
10 – 85%
Classication and Approvals
Class I Equipment
Medical equipment with respect to electric shock, re, and mechanical hazards only in
accordance with UL 60601-1 and CAN/CSA C22.2 No.601.1.
IPX1 Water Ingress Protection
Continuous Operation
Compliance
Medical Safety Standards IEC 60601-1:1988 + A1:1991 + A2:1995
CAN/CSA C22.2 No 601.1-M90
UL 60601-1:2003
AS/NZS 3200.1.0:1998
CSA 22.2.601.1.1:2002
Medical EMC Standard IEC 60601-1-2:2007
FCC Regulations FCC Part 15 Class B
FCC Identier: QVXAMM190WTDSW
IC Regulations IC: 7680A-AMN12100 (WiSe 19" and 26" HDTV Surgical
Display)
Note: Please contact your local Stryker Endoscopy sales representative for information on changes
and new products.
Electromagnetic Compatibility
Like other electrical medical equipment, the WiSe™ 19" HDTV Surgical Display requires special
precautions to ensure electromagnetic compatibility with other electrical medical devices. To
ensure electromagnetic compatibility (EMC), the display must be installed and operated according
to the EMC information provided in this manual. e display has been designed and tested to
comply with IEC 60601-1-2:2001 requirements for EMC with other devices.
Warning
When this device is connected with other electrical equipment, leakage
currents may be additive. To minimize total leakage current per patient,
ensure that all systems are installed according to the requirements of IEC
60601-1-1.
Caution Portable and mobile RF communications equipment may aect the normal
function of the display.
Do not use cables or accessories other than those provided with the display,
as this may result in increased electromagnetic emissions or decreased
immunity to such emissions.
If the display is used adjacent to or stacked with other equipment, observe
and verify normal operation of the display in the conguration in which
it will be used prior to using it in a surgical procedure. Consult the tables
below for guidance in placing the display.