Zimmer Universal Power System, Instruction Manual

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ELECTROMAGNETIC COMPATIBILITY (EMC)
18
WARNINGS :
• The
Zimmer
® UNIVERSAL sterilizable battery (REF 89-8510-440-50) must be sterilized with flash autoclave cycle.
Do not
exceed 4 minutes at 132°C (270°F) or 3 minutes at 134°C (273°F).
• The
Zimmer
® UNIVERSAL sterilizable battery is the only component of the
Zimmer
® UNIVERSAL Power System that can be
sterilized using STERRAD® Technology. For details refer to the STERRAD® STERILITY GUIDE.
•
The use of lift out tray (REF 89-8510-459-48) with another sterilization case than the recommended (REF 89-8510-459-47),
must be validated prior to use.
The
Zimmer
® UNIVERSAL handpieces and accessories (except the UNIVERSAL sterilizable battery REF 89-8510-440-50) have been
validated to withstand the following steam sterilization processes:
Steam sterilization cycle parameters
Steam cycle type Temperature Steam dwell time Minimum dry time
Pre-Vacuum
132° C / 270° F
4 Minutes 8 Minutes
Pre-Vacuum
132° C / 270° F
8 Minutes 8 Minutes
Pre-Vacuum
134° C / 273° F
3 Minutes 8 Minutes
Pre-Vacuum
134° C / 273° F
18 Minutes 8 Minutes
ELECTROMAGNETIC COMPATIBILITY (EMC)
CAUTIONS
:
• This
Zimmer®
UNIVERSAL power system complies with the Electromagnetic Compatibility Standard IEC 60601. The
Zimmer®
UNIVERSAL compact battery charger complies with the Electromagnetic Compatibility Standard EN 55014. Both
devices need to be installed and put into service according to the section “Electromagnetic compatibility” provided in this
document.
•
Certain types of mobile telecommunication equipment could potentially interfere with this product. The separation
distances recommended in the section “Electromagnetic compatibility” of this document must be taken into account.
•
This product should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, this
product should be observed to verify normal operation in the configuration in which it will be used
• The use of accessories and cables other than those specified or sold by the manufacturer of this product as replacement
parts, may result in increased emissions or decreased immunity of this product.
ELECTROMAGNETIC EMISSIONS
The
Zimmer®
UNIVERSAL power system and
Zimmer®
UNIVERSAL compact battery charger are intended for use in the
electromagnetic environment specified below. The customer or the user should assure that it is used in such an environment.
EMISSIONS TEST COMPLIANCE ELECTROMAGNETIC ENVIRONMENT - GUIDANCE
RF emissions
CISPR 11
Group 1
The
Zimmer®
UNIVERSAL power system and
Zimmer®
UNIVERSAL compact battery charger use RF energy only for its
internal function. Therefore, its RF emissions are very low and
are not likely to cause any interference in nearby electronic
equipment.
RF emissions
CISPR 11 Class B The
Zimmer®
UNIVERSAL power system and
Zimmer®
UNIVERSAL compact battery charger are suitable for use in all
establishments, including domestic establishments and those
directly connected to the public low-voltage power supply
network that supplies buildings used for domestic purposes.
The
Zimmer®
UNIVERSAL compact battery charger must not be
used in patient care areas.
Harmonic emissions
IEC 61000-3-2
Charger: Class A
Power supply: Class B
Voltage fluctuations/ Flicker
emissions
IEC 61000-3-3
Complies