Zimmer Universal Power System User manual
Zimmer® UNIVERSAL Power System
CONTENTS
2
TABLE OF CONTENTS
INTENDED USE 3
DESCRIPTION AND TECHNICAL DATA 3
ELECTRIC POWER SUPPLY 4
STERILIZABLE BATTERY 7
8
TO CONNECT AND DISCONNECT THE BATTERY 8
TO CONNECT AND DISCONNECT THE POWER CORD 9
TO TURN ON AND OFF THE HANDPIECE 9
TECHNICAL SERVICE
DESCRIPTION AND TECHNICAL DATA
3
INTENDED USE
The Zimmer® UNIVERSAL Power System is a power tool intended to be used for large and small bone surgeries (such as knee,
hip, foot, hand, and shoulder).
The Zimmer® UNIVERSAL Power System is to be used by surgeons in the operang room environment. The populaon of paents
is determined by the nature of the surgery and it is the responsibility of the surgeon to treat the paents according to the
common pracce.
The Zimmer® UNIVERSAL Power System can run on either baery power, electric power (when ulizing the appropriate power
cord), or pneumac power. Handpieces are designed with single or double triggers, which enable the forward and reverse
funcons.
All Zimmer® UNIVERSAL Power System aachments for drilling, sawing and reaming are designed to be connected to Zimmer®
UNIVERSAL handpieces.
DESCRIPTION AND TECHNICAL DATA
The Zimmer® UNIVERSAL Power System handpiece delivers kinec energy to cung tools, under the form of rotaon, oscillaon
or translaon.
REF 89-8507-400-00
89-8507-400-10
Modular aachment
Safety lock
Variable speed single or double
trigger
High-capacity lithium
rechargeable baery
Electric connecon
Electric power cord
• Modular design offering drilling, sawing, and reaming
• Rechargeable lithium battery or electric power supply
• Single or double trigger
• Progressive trigger mechanism
• Forward and reverse function
• Safety locking position
• Autoclavable high tech compound housing
ENGLISH
DESCRIPTION AND TECHNICAL DATA
4
Power 250 Was typical
Weight 780 grams (without baery)
Dimensions 120 mm x 150 mm x 45 mm
Speed adjustment 0 to 12’000 rpm approximately
Cannulaon channel diameter 5 mm
Power source Mains or Baery
Power supply Baery: 16.5V DC, 20A
Mains: 15V DC, 300W
Operaon mode Intermient: 1 min on / 5 min o; 5 mes with a 2 hour rest
Run me with baery Up to 15 min
Type of protecon against electric shock Baery: Internally powered equipment
Mains: Class I
Degree of protecon against electric shock Type BF applied part
Degree of protecon against water ingress IPXO (ordinary)
Ambient temperature 10°C to 38°C (50°F to 100°F)
Relave humidity 30% to 60%
Altude ≤2,000 m – Not intended for high altude environments
NOTE: There are no special requirements for transport or storage. Transport or store in an environment that limits exposure
to dust, moisture and temperature extremes.
CAUTIONS:
• Use only with Zimmer® UNIVERSAL attachments
• Do not immerse handpiece.
ELECTRIC POWER SUPPLY
REF 89-8510-420-00
89-8510-420-10
89-8510-420-20
• Electric power supply
• Compatible with Zimmer® UNIVERSAL Battery / Electric
handpieces
Input 100-240V~, 50-60Hz, 4.6-1.6A
Output 15V DC, 300W
Dimensions 321 mm x 206 mm x 67 mm
Weight 2.76 kg approximately (without cord)
Type of protecon against electric shock Class I
Degree of protecon against electric shock Type BF applied part
Degree of protecon against water ingress IPXO (ordinary)
DESCRIPTION AND TECHNICAL DATA
5
Ambient temperature 10°C to 38°C (50°F to 100°F)
Relave humidity 30% to 60%
Altude ≤2,000 m – Not intended for high altude environments
NOTE: There are no special requirements for transport or storage. Transport or store in an environment that limits exposure
to dust, moisture and temperature extremes.
CAUTIONS:
• Use only with Zimmer® UNIVERSAL Battery / Electric handpieces and Zimmer® UNIVERSAL sterilizable power cord.
• Use exclusively a certified main power cord integrating earth connection.
• Do not use the electric power supply if it has been damaged or immersed.
• Ensure the sterilizable power cord does not create a trip hazard.
• Check that the voltage of the mains power supply is 100-240 volts.
• Before unplugging power cords, switch the handpiece and power supply off.
• Never block the air vents.
• Do not immerse power supply or power cords.
• The ON/OFF switch on this unit will not completely shut off all power from the AC outlet. Since the power cord serves as the
main disconnect device for the unit, you will need to unplug it from the AC outlet to shut down all power. Therefore, make
sure the unit has been installed so that the main power cord does not create a trip hazard and can be easily unplugged
from the AC outlet if needed
REF 89-8510-421-00
• Electric battery charger
• Compatible with Zimmer® UNIVERSAL battery
for Aseptic Transfer Kit and Zimmer® UNIVERSAL
sterilizable battery
• Able to charge four batteries simultaneously
• Indicator light shows charge status of battery
Input 100-240V~, 50-60Hz, 2-1A
Output 4 x 18V DC, 1.5A
Dimensions 321 mm x 206 mm x 94 mm
Weight 2.7 kg approximately (without baery)
Type of protecon against electric shock Class I
Ambient temperature 5°C to 25°C (41°F to 77°F)
Do not operate in paent area
Relave humidity 30% to 60%
NOTE: There are no special requirements for transport or storage. Transport or store in an environment that limits exposure
to dust, moisture and temperature extremes.
ENGLISH
DESCRIPTION AND TECHNICAL DATA
6
CAUTIONS:
• Do not operate in patient area.
• Zimmer® UNIVERSAL compact battery charger (REF 89-8510-421-00) does not meet IEC 60601-1 requirements.
• Use only with Zimmer® UNIVERSAL sterilizable battery (REF 89-8510-440-50) or Zimmer® UNIVERSAL battery for Aseptic
Transfer Kit (REF 89-8510-440-20).
• Check that the voltage of the mains power supply is 100-240 volts.
• Never block the air vents.
• Do not immerse compact battery charger.
• Remove batteries from compact battery charger when recharged (green indicator light).
• The ON/OFF switch on this unit will not completely shut off all power from the AC outlet. Since the power cord serves as
the main disconnect device for the unit, you will need to unplug it from the AC outlet to shut down all power. Therefore,
make sure the unit has been installed so that the power cord does not create a trip hazard and can be easily unplugged
from the AC outlet if needed.
REF 89-8510-440-00
89-8510-440-10
89-8510-440-20
89-8510-440-30
Housing Seal
Lid
ATK Housing
Baery
• Rechargeable lithium battery
• Sterilizable housing with detachable
funnel for easy aseptic transfer of
battery into housing
Rated Voltage 16.5V DC, 20A
Dimensions Baery: 76 mm x 60 mm x 40 mm
Housing: 88 mm x 66 mm x 62 mm
Weight Baery: 230 grams
Housing: 90 grams
Ambient temperature 10°C to 38°C (50°F to 100°F)
Relave humidity 30% to 60%
: Fire and burn hazard. Do not heat above 80°C (176°F) during storage and transportaon or incinerate. Exposure
to elevated temperature may reduce baery capacity and performance.
CAUTIONS:
• Do not sterilize; do not autoclave.
• Charge only with Zimmer® UNIVERSAL Compact Battery Charger (REF 89-8510-421-00).
• Use only with Zimmer® UNIVERSAL Aseptic Transfer Kit Housing (REF 89-8510-440-10).
• Remove from charger when recharged (green indicator light).
• Do not immerse or place in automated washer.
DESCRIPTION AND TECHNICAL DATA
7
CAUTIONS:
• Remove ATK housing from handpiece after use.
• Remove battery from housing before sterilizing.
• Use only with Zimmer® UNIVERSAL battery (REF 89-8510-440-20).
• Do not wash and sterilize with lid closed.
• Seal between lid and housing must be present and pressed to guarantee seal.
STERILIZABLE BATTERY
REF 89-8510-440-50
• Rechargeable lithium battery
• Sterilizable using FLASH autoclave cycle
Rated Voltage 16.5V DC, 20A
Dimensions 88 mm x 66 mm x 62 mm
Weight 310 grams
Ambient temperature 10°C to 38°C (50°F to 100°F)
Relave humidity 30% to 60%
: Fire and burn hazard. Do not heat above 80°C (176°F) during storage and transportaon or incinerate. Exposure
to elevated temperature may reduce baery capacity and performance. When using heat for sterilizaon strictly follow the
instrucons given in the Cleaning, Decontaminaon and Sterilizaon secon.
CAUTIONS:
• Remove sterilizable battery from handpiece after use.
• Use only FLASH autoclave cycle (See Sterilization section). 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.
• Charge only with Zimmer® UNIVERSAL compact battery charger (REF 89-8510-421-00).
• Remove from charger when recharged (green indicator light).
• Allow sufficient time for cooling the sterilizable battery after charging in order to introduce it at a normal operating room
temperature in the autoclave.
• Do not immerse or place in automated washer.
ENGLISH
OPERATING PROCEDURE
8
CAUTION: Prior to inial usage, the Zimmer® UNIVERSAL Power System must be cleaned and sterilized per the instrucons
(See Cleaning, Decontaminaon and Sterilizaon Instrucons).
Assemble unl “click” is heard Assembled Disconnect pressing both buons
simultaneously
TO CONNECT AND DISCONNECT THE BATTERY
Assemble unl “click” is heard Assembled Disconnect pressing both buons simultaneously
CAUTION: Remove the baery from the handpiece aer use.
Recommended hand posion to disconnect the baery and power cord
Push
OPERATING PROCEDURE
9
TO CONNECT AND DISCONNECT THE POWER CORD
Assemble unl “click” is
heard
Assembled Disconnect pressing both buons simultaneously
TO TURN ON AND OFF THE HANDPIECE
1: On
Posion switch to either side
0: Safety posion - o Posion switch
in center
P: On (Forward)
Posion switch to le
Q
: On (Reverse)
Posion switch to right 0: Safety posion - o
Posion switch in center
ENGLISH
OPERATING PROCEDURE
10
Forward – Lower Trigger Reverse – Both triggers simultaneously
NOTE : Pressing higher trigger alone will not result in any operaon of the handpiece.
P: On (Forward)
Posion switch to le
Q
: On (Reverse)
Posion switch to right
Choose the direcon of rotaon and then
press the trigger
• Connect the Zimmer® UNIVERSAL compact battery
charger to the mains using cord provided.
• Push power switch button to Ito power on charger.
• Four indicator lights on top of charger will be green
when no batteries are connected.
• Connect up to four batteries as illustrated below.
Mains connecon
Power Switch buon
OPERATING PROCEDURE
11
• Indicator
Light
RED:
GREEN:
OFF:
Baery is charging
Baery is charged and ready
for use
Contact your Zimmer local
representave Indicator Light
• Push power switch button to to power off charger.
CAUTIONS:
• Remove batteries from charger when recharged.
• Remove batteries before switching off charger.
Contacts
Contacts
CAUTIONS:
• Battery is not sterile; STERILE PERSON must not touch battery during transfer.
• Housing is sterile; NON-STERILE PERSON must not touch housing during transfer.
• Seal between the lid and housing must be present and pressed to guarantee seal.
• STERILE PERSON (A): Position locking system to and open lid of housing.
Locked
Unlocked
ENGLISH
OPERATING PROCEDURE
12
• STERILE PERSON (A): Assemble the funnel on the housing.
• NON-STERILE PERSON (B): Insert battery into housing through funnel opening.
Push unl fully inserted, and remove funnel.
A
B
A
B
A
B
A
Funnel
A
• STERILE PERSON (A): Close lid. Position the locking system to to lock the housing.
A
A
Locked
Unlocked
Once a “click” has been heard, the baery pack is ready to use.
Aer the procedure is completed, the NON-STERILE PERSON (B) disassembles the Asepc Transfer Kit (ATK) by removing the
baery from the ATK housing. The instrucons from the prior secon should be followed with the steps in reverse manner,
without using the funnel.
: The Zimmer® UNIVERSAL baery (REF 89-8510-440-20) for Asepc Transfer Kit (ATK) must not be cleaned in an
automated washer or sterilized.
OPERATING PROCEDURE
13
TO CONNECT THE UNIVERSAL POWER SUPPLY
• Connect the Zimmer® UNIVERSAL power supply to the mains using
cord provided.
• Push power switch button to Ito power on power supply.
• Indicator light will turn green when the power is on.
• To ensure the sterilizable power cord is connected to the power
supply, check that the 2 red points are lined up.
• Push power switch button to Oto power off power supply.
Mains connecon Fuses
Power switch buon
Indicator light Connector
• To disconnect sterilizable power cord to the power supply, hold
connector while removing cord from the power supply.
Hold by the connector to take o
the cord
Red points
ENGLISH
CLEANING, DECONTAMINATION AND STERILIZATION
14
These instrucons cover the enre Zimmer® UNIVERSAL Power System and its accessories.
The electric power supply (REF89-8510-420-10), the baery (REF 89-8510-440-20) for Asepc Transfer Kit (ATK) and the compact
baery charger (REF 89-8510-421-00) do not required to be sterilized. From that, they are not designed to withstand any
sterilizaon process.
These instrucons need to be performed by professional sta appropriately trained in cleaning and disinfecon methods.
PROCESS FLOW CHART
PRE-DISINFECTION
INSPECTION
DISINFECTION
INSPECTION
STERILIZATION
The devices must be cleaned as soon as possible aer use.
: The following components must not be cleaned in an automated washer or sterilized.
For these units, the exterior may be cleaned with a cloth that has been dampened (not dripping) with a mild detergent (pH-
value should be less than 9):
Zimmer® UNIVERSAL electric power supply (REF 89-8510-420-10)
Zimmer® UNIVERSAL baery (REF 89-8510-440-20) for Asepc Transfer Kit (ATK)
Zimmer® UNIVERSAL compact baery charger (REF 89-8510-421-00)
The Zimmer® UNIVERSAL sterilizable baery (REF 89-8510-440-50) must not be cleaned and disinfected in an automated washer.
When using the Zimmer® UNIVERSAL complete Asepc Transfer Kit (ATK) with baery, the ATK housing (REF 89-8510-440-10) and
the funnel for ATK (REF 89-8510-440-30) must be cleaned, disinfected and sterilized.
Cleaners with pH 7 to 9 are recommended. The use of cleaners with higher pH-value may cause dissoluon of the surface of
aluminum and its alloys, plascs or compound materials. Addionally, at pH-values higher than 11, the surfaces of stainless steel
can be aected.
For cleaning and decontaminaon, use only detergents compable with anodized aluminum surfaces.
CLEANING, DECONTAMINATION AND STERILIZATION
15
Place the handpiece in the posion.
Disconnect air hoses, power cords or remove the baeries as instructed in Operang Procedure secon of the handpiece
manual.
Remove single use cung consumables as instructed in Aachments manual and dispose in an appropriate container.
Remove all aachments as instructed in Operang Procedure secon of the handpiece manual.
If using the ATK baery housing, open lid and remove baery from housing as instructed in Operang Procedure secon of
the baery/electric handpiece manual.
PRE-DISINFECTION
Immediately aer use, carefully rinse the device with Reverse Osmosis (RO) or dislled water in order to remove all visible soil.
Remove any visible soil with a non-shedding so cloth saturated with detergent (per hospital protocol).
Discard the so cloth aer use.
If the cleaning acon cannot be done immediately, put the disconnected devices in a new so cloth heavily saturated with a
detergent (per hospital protocol).
The manual cleaning process has been validated according to AAMI TIR Number 12 and ISO 17664 guidelines.
Do not ulize detergents with phenol, aldehyde and non alkaline type (pH-value should be less than 9) acve principles:
quaternary ammonium and guanidine derivaves (process validated with STERIS Prolysca 2X).
Diluon and temperature parameters must follow the detergent manufacturer’s specicaon.
Ulize RO or dislled water (hardness lower than 120 mg/L of CaCO3).
Ulize non-abrasive brushes and non-abrasive, non-shedding so cloth.
CAUTION: Zimmer® UNIVERSAL Power System should not be immersed or cleaned in an ultrasonic machine.
Rinse the handpieces, aachements, sterilizable baery and ATK housing with RO or dislled water unl all visible body uids
and ssues have been removed.
Carefully clean each part of the device with a brush and/or a so cloth with an appropriate detergent for a minimum of 2 minutes.
While cleaning, pay parcular aenon to crical sites: exposed parts, narrow cavies, small openings and moving parts.
Let the detergent ow into the cavies and areas that are dicult to reach.
Rinse carefully with RO or dislled water in order to remove all detergent.
Dry the device ulizing a dry non-shedding cloth. Medical quality ltered air may be ulized if available.
INSPECTION
Inspect all devices carefully to ensure all visible soil and detergent is removed.
If necessary, repeat the steps for manual cleaning.
NOTE: If the devices are not disinfected immediately aer rinsing, carefully dry the devices with a so cloth to avoid any
microbial contaminaon due to humidity.
DISINFECTION
Place and cover the device in a so cloth heavily saturated with the recommended pH-value detergent/disinfectant for 30
minutes.
Aer the 30 minute contact me, wipe the device down with the saturated cloth, paying parcular aenon to joints, mated
areas, crevices, and small openings.
Rinse all parts of the device with RO or dislled water.
Carefully dry the device with a non-shedding so cloth or air.
ENGLISH
CLEANING, DECONTAMINATION AND STERILIZATION
16
STEP STEP DESCRIPTION STEP INSTRUCTION
ACCESSORIES
DURATION
1
Rinse product with RO or
dislled water removing
any visible organic
material. Apply detergent
with a non-shedding cloth
and as necessary, with
assistance of a so bristle
to brush any visible soil.
− Cold/Room temperature
RO or distilled water
−Soft bristle brush
−Non-shedding cloth
− Recommended pH-value
detergent/ disinfectant
Unl all visible soil is
removed.
2Rinse Rinse product with RO or
dislled water.
− Cold/Room temperature
RO or distilled water
Unl all visible detergent
is removed.
3 Dry the device ulizing a
dry non-shedding cloth.
Medical quality ltered
air may be ulized if
available.
−Non-shedding cloth
− Medical quality filtered
compressed air
Unl product is visually
dry.
4
Apply the recommended
pH-value detergent/
disinfectant
to a non-shedding cloth.
Cover the device’s surface
area with the saturated
cloth.
− Recommended pH-value
detergent/ disinfectant
−Non-shedding cloth.
−Spray bottle or other
manual applicator
5
Aer 30 minutes contact
me, wipe the device
contact surfaces, joints
and mated areas ulizing
the cover cloth.
− Recommended pH-
value detergent/
disinfectant
−Non-shedding cloth
Manual disinfecon
is complete when the
device’s surface, joints
and crevices have been
manually wiped.
6 Rinse product under
room temperature RO or
dislled water.
−Room temperature RO
or distilled water
7 Dry the device ulizing a
dry non-shedding cloth.
Medical quality ltered
air may be ulized if
available.
−Non-shedding cloth
− Medical quality filtered
compressed air
Unl product is visually
dry.
: Zimmer® UNIVERSAL Power System should not be immersed or submerged in water or cleaner.
The automated cleaning and disinfecon process has been validated according to AAMI TIR Number 30 and ISO 17664 guidelines.
CAUTION: The manual cleaning and disinfecon procedure must be performed prior to the automated cleaning and
disinfecon procedure.
Detergent with neutral pH or lightly alkaline: pH < 9
Neutralizing agent
Rinse aid
Automated washer
The UNIVERSAL li out tray (REF 89-8510-459-48) and the UNIVERSAL sterilizaon case (REF 89-8510-459-47) are also sold as
a kit (REF 89-8510-459-46). The use of the li out tray (REF 89-8510-459-48) has been validated and is recommended for the
automated cleaning and disinfecon procedure following the manual cleaning and disinfecon procedure.
CLEANING, DECONTAMINATION AND STERILIZATION
17
If the li out tray (REF 89-8510-459-48) is not being used, load the equipment into the automated washer in a wire basket. Make
sure to orient the equipment vercally to assist in drainage. Load the equipment carefully to prevent movement that may inhibit
proper cleaning and always avoid contact between mulple components.
The components should be posioned on the li out tray following the diagrams printed on the li out tray. Do not overload
the li out tray.
Put medical devices in the automated washer. Avoid all contact between the devices (movement may damage devices and may
jeopardize the cleaning operaon).
Put implements so that holes are aimed downwards to allow proper water drainage.
Start the automated washer.
STEP DESCRIPTION STEP INSTRUCTION ACCESSORIES DURATION
Place enre device into the
automated washer, placing
implements so that holes are
aligned downward.
−Automated washer
− Disassembled device
−Washer cleaning solution
− Washer neutralizing
solution
Minimum total cycle me: 51
minutes when including all
steps below.
Pre-Wash 2:00 minutes Water temperature 20°C (68°F)
Cleaning 5:00 minutes Water temperature 55°C (131°F)
Neutralizing 2:00 minutes Water temperature 20°C (68°F)
Rinse I 2:00 minutes Water temperature 20°C (68°F)
Rinse II (Final) 5:00 minutes Water temperature 93°C (200°F)
Drying 35:00 minutes Chamber temperature 99°C (210°F)
Only washing parameters shown above have been validated for cleaning eecveness.
However, the performance of Zimmer® UNIVERSAL Power System is not aected in case lower temperature and/or shorter dwell
me are used.
INSPECTION
Inspect each part of the devices to make sure all soil is removed.
If necessary, repeat the cleaning process.
STERILIZATION
The referenced steam sterilizaon cycle parameters listed below have been validated and provide a sterile result by steam
sterilizaon according to ANSI/AAMI/ISO 17665-1:2006, Sterilizaon of Health Care Products. Part 1: Moist Heat. The steam
sterilizaon process for these products has been validated to provide a sterility assurance level (SAL) of 10-6 or beer when
using the sterilizaon cases (REF 89-8510-459-41 or REF 89-8510-459-42 or REF 89-8510-459-43 or REF 89-8510-459-45 or REF
89-8510-459-46). Use of these UNIVERSAL sterilizaon cases is strongly recommended.
Please note that the processes described in this chapter are the only ones covered by our warranty condions. Any other
sterilizaon processes must not be used, with the risk to induce a premature wear and a deterioraon of the device.
The steam sterilizaon procedure must be carried out in a qualied autoclave.
The components should be posioned in the cases following the diagrams printed on the cases. Do not overload the cases.
CAUTIONS:
• Remove all washing caps (REF 89-8510-455-50, REF 89-8510-555-00) on hoses and on handpiece
air inlet before the sterilization process.
• Do not subject any cap to the sterilization process.
ENGLISH
18
:
• The Zimmer® UNIVERSAL sterilizable battery (REF 89-8510-440-50) must be sterilized with flash autoclave cycle. Do not
• 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 baery REF 89-8510-440-50) have been
validated to withstand the following steam sterilizaon processes:
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
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.
The Zimmer® UNIVERSAL power system and Zimmer® UNIVERSAL compact baery charger are intended for use in the
electromagnec environment specied below. The customer or the user should assure that it is used in such an environment.
RF emissions
CISPR 11
Group 1 The Zimmer® UNIVERSAL power system and Zimmer®
UNIVERSAL compact baery charger use RF energy only for its
internal funcon. 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 baery charger are suitable for use in all
establishments, including domesc establishments and those
directly connected to the public low-voltage power supply
network that supplies buildings used for domesc purposes.
The Zimmer® UNIVERSAL compact baery charger must not be
used in paent care areas.
Harmonic emissions
IEC 61000-3-2
Charger: Class A
Power supply: Class B
Voltage uctuaons/ Flicker
emissions
IEC 61000-3-3
Complies
19
The Zimmer® UNIVERSAL power system and Zimmer® UNIVERSAL compact baery charger are intended for use in the
electromagnec environment specied below. The customer or the user should assure that it is used in such an environment.
Electrostac
discharge (ESD)
IEC 61000-4-2
± 6 kV contact
± 8 kV air ± 8 kV air
Floors should be wood, concrete or ceramic le.
If oors are covered with synthec materials,
the relave humidity should be at least 30%. An
electrostac discharge on contact of enclosure
may stop the motor. The handpiece returns
to normal operaon once the disturbance is
removed.
Electrical fast
transient/burst
IEC 61000-4-4
± 2 kV for power supply
lines
± 1 kV for output/input
lines
± 2 kV for power supply
lines
± 1 kV for output/input
lines
Mains power quality should be that of a typical
commercial or hospital environment.
Surge
IEC 61000-4-5
± 1 kV dierenal mode
± 2 kV common mode
± 1 kV dierenal mode
± 2 kV common mode
Mains power quality should be that of a typical
commercial or hospital environment.
Voltage
dips, short
interrupons and
voltage variaons
on power supply
input lines
IEC 61000-4-11
<5 % UT(>95 % dip in UT)
for 0,5 cycle
40 % UT (60 % dip in UT)
for 5 cycles
70 % UT(30 % dip in UT)
for 25 cycles
<5 % UT(>95 % dip in UT)
for 5 sec
<5 % UT(>95 % dip in UT)
for 0,5 cycle
40 % UT (60 % dip in UT)
for 5 cycles
70 % UT(30 % dip in UT)
for 25 cycles
<5 % UT(>95 % dip in UT)
for 5 sec
Mains power quality should be that of a typical
commercial or hospital environment. If the user
of the Zimmer® UNIVERSAL power system or
Zimmer® UNIVERSAL compact baery charger
requires connued operaon during power
mains interrupons, it is recommended that the
devices be powered from an uninterrupble
power supply or a baery.
Power frequency
(50/60 Hz)
magnec eld
IEC 61000-4-8
3 A/m 3 A/m Power frequency magnec elds should be at
levels characterisc of a typical locaon in a
typical commercial or hospital environment.
NOTE: UT is the ~ AC Power Mains voltage prior to applicaon of the test level.
The Zimmer® UNIVERSAL power system and Zimmer® UNIVERSAL compact baery charger are intended for use in the
electromagnec environment specied below. The customer or the user should assure that it is used in such an environment.
Portable and mobile RF communicaons equipment should be used no closer to any part of the Zimmer® UNIVERSAL power
system or Zimmer® UNIVERSAL compact baery charger, including cables, than the recommended separaon distance
calculated from the equaon applicable to the frequency of the transmier.
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
3 Vrms
150 kHz to 80 MHz
3 V/m
80 MHz to 2,5 GHz
3 Vrms
3 V/m
d = 1.2 √P
d = 1.2 √P 80 MHz to 800 MHz
d = 2.3 √P 800 MHz to 2,5 GHz
where P is the maximum output power rang of the
transmier in was (W) according to the transmier
manufacturer and d is the recommended separaon
distance in metres (m).
ENGLISH
20
NOTES:
• Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey
, should be less than the
compliance levels in each frequency range
b
.
• Interference may occur in the vicinity of equipment marked with the following symbol:
• At 80 MHz and 800 MHz, the higher frequency range applies.
• These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from
structures, objects and people.
Field strengths from xed transmiers, such as base staons for radio (cellular/cordless) telephone and land mobile radios,
amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theorecally with accuracy. To assess
the electromagnec environment due to xed RF transmiers, an electromagnec site survey should be considered. If the
measured eld strength in the locaon in which the Zimmer® UNIVERSAL power system or Zimmer® UNIVERSAL compact
baery charger is used exceeds the applicaon RF compliance levels above, the Zimmer® UNIVERSAL power system or
Zimmer® UNIVERSAL compact baery charger should be observed to verify normal operaon. If abnormal performance is
observed, addional measures may be necessary, such as re-orienng or relocang the Zimmer® UNIVERSAL power system or
Zimmer® UNIVERSAL compact baery charger.
b Over the frequency range 150 kHz to 80 MHz, eld strengths should be less than 3 V/m.
The Zimmer® UNIVERSAL power system and Zimmer® UNIVERSAL compact baery charger are intended for use in an
electromagnec environment in which radiated RF disturbances are controlled. The customer or the user can help prevent
electromagnec interference by maintaining a minimum distance between portable and mobile RF communicaons equipment
(transmiers) and the Zimmer® UNIVERSAL power system or Zimmer® UNIVERSAL compact baery charger as recommended
below, according to the maximum output power of the communicaons equipment.
0.01 0.12 m 0.12 m 0.23 m
0.1 0.38 m 0.38 m 0.73 m
1 1.2 m 1.2 m 2.3 m
10 3.8 m 3.8 m 7.3 m
100 12 m 12 m 23 m
For transmiers rated at a maximum output power not listed above, the recommended separaon distance d in meters (m)
can be determined using the equaon applicable to the frequency of the transmier, where P is the maximum output power
rang of the transmier in was (W) according to the transmier manufacturer.
NOTES:
• At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
• These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from
structures, objects and people.
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