Zimmer® UNIVERSAL Power System

Instruction Manual

Battery / Electric

REF 89-8507-400-00 UNIVERSAL Modular Electric/Battery Double Trigger Handpiece

REF 89-8507-400-10 UNIVERSAL Modular Electric/Battery Single Trigger Handpiece
REF 89-8507-400-60 UNIVERSAL Dedicated Oscillating Handpiece
REF 89-8507-401-20 UNIVERSAL Dedicated Reciprocating Handpiece
REF 89-8510-420-00 UNIVERSAL Electric Power Supply with cord
REF 89-8510-420-10 UNIVERSAL Electric Power Supply without cord
REF 89-8510-420-20 UNIVERSAL Sterilizable Cord for Electric Power Supply
REF 89-8510-421-00 UNIVERSAL Compact Battery Charger
REF 89-8510-440-00 UNIVERSAL Complete Aseptic Transfer Kit with Battery
REF 89-8510-440-10 UNIVERSAL Aseptic Transfer Kit Housing
REF 89-8510-440-20 UNIVERSAL Battery for Aseptic Transfer Kit
REF 89-8510-440-30 UNIVERSAL Funnel for Aseptic Transfer Kit
REF 89-8510-440-50 UNIVERSAL Flash Battery 
 TABLE OF CONTENTS

Contents
1. INDICATIONS FOR USE................................................................................................... 3
2. DESCRIPTION AND TECHNICAL DATA ......................................................................... 3
2.1 Battery / Electric Handpiece.........................................................................................................3
2.2 Electric Power Supply ..................................................................................................................4
2.3 Compact Battery Charger.............................................................................................................4
2.4 Battery and Aseptic Transfer Kit (ATK) Housing..........................................................................5
2.5 Flash Battery.................................................................................................................................6
3. OPERATING PROCEDURE.............................................................................................. 6
3.1 To connect and disconnect the attachments..................................................................................6
3.2 To connect and disconnect the battery..........................................................................................7
3.3 To connect and disconnect the power cord...................................................................................7
3.4 To turn on and off the handpiece...................................................................................................8
3.5 To start the motor Forward and Reverse......................................................................................8
3.6 To charge the Batteries..................................................................................................................9
3.7 To transfer Battery into sterile ATK Housing................................................................................9
3.8 To connect the UNIVERSAL Power Supply.................................................................................11
4. CLEANING, DECONTAMINATION AND STERILIZATION............................................. 11
5. ELECTRICAL SAFETY.................................................................................................... 18
5.1 Electromagnetic Emissions.........................................................................................................18
5.2 Electromagnetic Immunity..........................................................................................................19
5.3 Electromagnetic Immunity, RF Portable Equipment..................................................................20
5.4 Recommended Separation Distances..........................................................................................21
5.5 Cord (Cable) Length...................................................................................................................22
6. WARNING AND PRECAUTIONS.................................................................................... 23
7. TECHNICAL SERVICE.................................................................................................... 24
8. WARRANTY INFORMATION (U.S.A. only).................................................................... 25
9. WARRANTY (Outside U.S.A.)........................................................................................ 25
10. CONTACT INFORMATION.............................................................................................. 25
11. SYMBOLOGY.................................................................................................................. 26

2
1. INDICATIONS FOR 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). It is to be used by surgeons in
the operating room environment.

2. DESCRIPTION AND TECHNICAL DATA

The Zimmer UNIVERSAL Power System Handpiece can be connected to all Zimmer
UNIVERSAL Power System Attachments which enable high precision drilling, sawing and
reaming. The handpiece is also available as a dedicated oscillating or reciprocating saw.

The UNIVERSAL Handpiece can run on battery power or electric power when used with
the supplied power cord. It features forward and reverse functions and is offered in a single
trigger and double trigger model.

2.1 Battery / Electric Handpiece

REF
89-8507-400-00 89-8507-400-60
89-8507-400-10 89-8507-401-20

Universal locking
mechanism

Safety
lock

Variable speed single

or double trigger

High-capacity lithium
rechargeable battery

Electric connection
Electric power cord

- Modular design offering drilling, sawing, - Single or Double Trigger

and reaming - Progressive trigger mechanism
- Optional dedicated oscillating or - Forward and reverse device
reciprocating saw - Safety locking position
- Rechargeable lithium battery or electric - Autoclavable
power supply

Power 250 Watts approximately

Weight 780 Grams (without battery)
Dimensions 120 mm x 150 mm x 45 mm
Speed adjustment 0 to 12,000 rpm approximately
Cannulation channel diameter 5 mm

3
 Power source Mains or Battery
Power supply Battery: 18V DC / 20A
Mains: 100-240V~, 50/60Hz, 4.6-1.6A
Operation Intermittent: 1 min on / 5 min off
Run time with battery Up to 15 min
Type of protection against electric shock Battery: Internally powered equipment
Mains: Class I
Degree of protection against electric shock Type BF
Degree of protection against water ingress IPXO (ordinary)
Operating conditions Operating room environment
Transport and storage Normal warehouse conditions

Use only with UNIVERSAL Attachments

Do not immerse handpiece.

2.2 Electric Power Supply

REF 89-8510-420-00 89-8510-420-20
89-8510-420-10

- Electronic power supply

- Compatible with 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)
Operating Conditions Operating room environment
Transport and Storage Normal warehouse conditions

Use only with UNIVERSAL Battery / Electric Handpieces.

Use exclusively a certified main power cord integrating earth connection.
Do not use Electric Power Supply if it has been damaged or immersed.
Ensure power cord does not hinder the free passage of people.
Check that the voltage of the mains power supply is 100-240 volts.
Before unplugging power cord, switch the heandpiece and power supply off.
Do not immerse power supply or power cord.

2.3 Compact Battery Charger

REF 89-8510-421-00

- Electric battery charger

- Compatible with UNIVERSAL Battery for Aseptic
Transfer Kit and UNIVERSAL Flash Battery
- Able to charge four batteries simultaneously
- Indicator light shows charge status of battery

Input 100-240V~, 50/60Hz, 2-1A

4
 Output 4x 18V DC, 1.5A
Dimensions 321 mm x 206 mm x 93.65 mm
Weight 2.7 kg approximately (without battery)
Operating Conditions 5 - 25°C; Do not use in patient area
Transport and Storage Normal warehouse conditions

Do not operate in patient area. UNIVERSAL Compact Battery Charger (REF

89-8510-421-00) does not meet IEC 60601-1 requirements.
Use only with UNIVERSAL Flash Battery (REF 89-8510-440-50) or
UNIVERSAL Battery for Aseptic Transfer Kit (REF 89-8510-440-20).
Never block the air vents.
Do not immerse battery charger.
Remove batteries from charger when recharged (green indicator light).

2.4 Battery and Aseptic Transfer Kit (ATK) Housing Battery

REF 89-8510-440-00 89-8510-440-20

89-8510-440-10 89-8510-440-30
ATK Housing
- Rechargeable lithium battery
- Sterilizable housing with detachable funnel for
easy aseptic transfer of battery into housing

Rated Voltage 18VDC/20A

Dimensions Battery: 76 x 60 x 40 mm
Housing: 88 x 66 x 62 mm
Seal Lid
Weight Battery: 0.23 kg Housing
Housing: 0.09 kg
Operating Conditions Standard operating room
Transport and Storage -20°C - 30°C; 65% relative humidity
for no more than 90 days

Battery Do not sterilize; do not autoclave.

REF 89-8510-440-20 Use only with UNIVERSAL Compact Battery
Charger (REF 89-8510-421-00).
Remove from charger when recharged (green
indicator light).
Do not immerse or place in automated washer.
Do not open.
Do not incinerate or expose to heat.
Do not discard; return to recycling center.

ATK Housing Remove ATK Housing from handpiece after use.

REF 89-8510-440-10 Remove battery from housing before sterilizing.
Do not sterilize with lid closed.
Seal between lid and housing must be present
and pressed to guarantee seal.

5
2.5 Flash Battery
REF
89-8510-440-50

- Rechargeable lithium battery

- Sterilizable using FLASH autoclave cycle

Rated Voltage 18VDC/20A

Dimensions 88 x 66 x 62 mm
Weight 0.31 kg
Operating Conditions Standard operating room
Transport and Storage -20°C - 30°C; 65% relative humidity
for no more than 90 days

Remove Flash Battery from handpiece after use.

Use only FLASH autoclave cycle (See Sterilization section).
Do not exceed 3 min at 135°C / 270°F.
Use only with UNIVERSAL Compact Battery Charger (REF 89-8510-421-00).
Remove from charger when recharged (green indicator light).
Allow sufficient time for cooling the Flash 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.
Do not open.
Do not incinerate or expose to heat.
Do not discard; return to recycling center.

3. OPERATING PROCEDURE
3.1 To connect and disconnect the attachments

Push

Assemble Assembled Disconnect

until “click” is heard pressing both buttons
simultaneously

6
3.2 To connect and disconnect the battery

Assemble Assembled Disconnect

until “click” is heard pressing both buttons simultaneously

Remove the battery from the handpiece after use.

Recommended hand position to disconnect the battery and power cord

3.3 To connect and disconnect the power cord

Assemble Assembled Disconnect

until “click” is heard pressing both buttons simultaneously

7
3.4 To turn on and off the handpiece

UNIVERSAL Double Trigger Handpiece (REF 89-8507-400-00)

1: On 0: Safety position - off

Position switch to either side Position switch in center

UNIVERSAL Single Trigger Handpiece (REF 89-8507-400-10, 89-8507-400-60, 89-8507-401-20)

P: On (Forward) Q: On (Reverse) 0: Safety position - off

Position switch to left Position switch to right Position switch in center

3.5 To start the motor Forward and Reverse

UNIVERSAL Double Trigger Handpiece (REF 89-8507-400-00)

Forward - Lower Trigger Reverse - Both triggers

simultaneously

UNIVERSAL Single Trigger Handpiece (REF 89-8507-400-10, 89-8507-400-60, 89-8507-401-20)

P: On (Forward) Q: On (Reverse) Choose the direction of rotation

Position switch to left Position switch to right and then press the trigger

8
3.6 To charge the Batteries
Power Switch button

- Connect the UNIVERSAL Compact Battery Charger to the

mains using cord provided.

- Push power switch button to I to power on charger.

- Four indicator lights on top of charger will be green when
Mains connection
no batteries are connected.
- Connect up to four batteries as illustrated below
- Indicator Light RED: Battery is charging
GREEN: Battery is charged and ready for use
OFF: Consult trouble shooting guid

Indicator
Light
Remove batteries from charger when recharged.
Remove batteries before switching off charger.

- Push power switch button to O to power off charger.

UNIVERSAL Battery for Aseptic Transfer Kit (REF 89-8510-440-20)

Contacts

UNIVERSAL Flash Battery (REF 89-8510-440-50)

Contacts

3.7 To transfer Battery into sterile ATK Housing

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.

9
STERILE PERSON (A): Position locking system to and open lid of housing.

Unlocked
Locked

STERILE PERSON (A): Assemble the funnel on the housing.

NON-STERILE PERSON (B): Insert battery into housing through funnel opening.
Push until fully inserted, and remove funnel.

Funnel B

A B B

A A A A

STERILE PERSON (A): Close lid. Position the locking system to to lock the
housing.

A
Unlocked Locked

Once a “click” has been heard, the battery pack is ready to use.

10
3.8 To connect the UNIVERSAL Power Supply Power Switch button

- Connect the UNIVERSAL Power Supply to the mains

using cord provided.

Mains connection button Fuse

- Push power switch button to I to power on power supply

Indicator
- Indicator light will turn green when the power is on.
Lights Connector

- To ensure the Power Cord is connected to the handpiece,

check that the 2 red points are lined up.

- Push power switch button to O to power off power supply

Red points

- To disconnect Power Cord to handpiece, hold connector

while removing cord from the Power Supply.

Hold by the
connector to
take off the
cord

4. CLEANING, DECONTAMINATION AND STERILIZATION

Use of the UNIVERSAL Sterilization Case (REF89-8510-459-4x) is strongly recommended.

These instructions need to be performed by professional staff appropriately trained in

cleaning and disinfection methods.

These instructions are applicable to the reusable components of the Zimmer UNIVERSAL
Power System, excluding the electronic power supply, battery, and battery charger.

11
4.1 PROCESS FLOW CHART

4.2. Preparation before

cleaning

4.4. Pre-disinfection

4.9. AUTOMATIC disinfectant

4.5. MANUAL disinfectant
cleaning (with washer
cleaning
disinfector)

4.6. Manual cleaning 4.10. Manual cleaning of

critical site

4.10. Automatic disinfectant

4.7. Inspection cleaning

4.11. Inspection
4.8. Disinfection

4.12. Sterilization

12
4.2 PREPARATION BEFORE CLEANING

The devices must be cleaned as soon as possible after use.

The Zimmer UNIVERSAL Electric Power Supply (REF 89-8510-420-10), the Zimmer
UNIVERSAL Battery for Aseptic Transfer Kit (ATK), (REF 89-8510-440-20), and the
Zimmer UNIVERSAL Compact Battery Charger (REF 89-8510-421-00) must not be
cleaned in a washer disinfector or sterilized.

4.3 GENERAL RECOMMENDATIONS

1. Disconnect air hoses, power cords or remove the batteries.

2. Remove the attachments from the handpiece.
3. Remove and dispose of all saw blades in an appropriate container.
4. Remove all accessories (attachments, chucks…).
5. Open the box of the battery and remove the battery if using the Aseptic Transfer
Battery housing.
6. Don’t forget to disinfect, clean and sterilize the battery housing and funnel when
using the Aseptic Transfer Kit.

For additional information about the dismantling of the device, refer to the specific Zimmer
UNIVERSAL Power System Instruction for Use

4.4 PRE-DISINFECTION

Immediately after use, carefully rinse the device with sterile water in order to remove all
visible soil.

Remove any visible soil with a non-shedding soft cloth saturated with detergent (per hospital
protocol). Discard the soft cloth after use.

If the cleaning action cannot be done immediately, put the disconnected devices in a new
soft cloth strongly saturated with a detergent (per hospital protocol).

4.5 MANUAL DISINFECTANT CLEANING

The Manual Cleaning process has been validated according to AAMI TIR Number 12
and ISO 17664 guidelines

Materials:

Do not utilize detergents with phenol, aldehyde and non alkaline type (pH should be
less than 9) active principles: quaternary ammonium and guanidine derivatives (process
validated with Deconex 53 plus, 4%).

Dilution and parameter temperature must follow the detergent manufacturer’s specification

Utilize Sterile and soft water (hardness lower than 120 mg/L of CaCO3)

Utilize Non abrasive brushes and non abrasive, non shedding soft cloth.

13
Zimmer UNIVERSAL Power System should not be immersed or cleaned in an ultrasonic
machine.

4.6 DISINFECTANT CLEANING

Carefully clean each part of the device with a brush and/or a soft cloth with an appropriate
detergent for a minimum of 2 minutes.

While cleaning, pay particular attention to critical sites: exposed parts, narrow cavities, small
openings and moving parts.

Let the detergent flow into the cavities and areas that are difficult to reach.

Rinse carefully with sterile water in order to remove all detergent.

Dry the device utilizing a dry non-shedding cloth. Medical quality filtered air may be utilized if
available.

4.7 INSPECTION

Inspect all devices carefully to ensure all visible soil and detergent is removed.
If necessary, repeat the steps for disinfectant cleaning.

Note: If the devices are not disinfected immediately after rinsing, carefully dry the devices with
a soft cloth to avoid any microbial contamination due to humidity.

4.8 DISINFECTION

Place and cover the device in a soft cloth strongly saturated with the recommended
detergent/disinfectant for 30 minutes.

After the 30 minute contact time, wipe the device down with the saturated cloth paying
particular attention to joints, mated areas, crevices, and small openings.

Rinse all parts of the devices with sterile water.

Carefully dry the device with a non-shedding soft cloth or air.

14
 Validated Manual Cleaning and Disinfection Procedure
Step Step Description Step Instruction Accessories Duration

Cleaning 1 Contamination Rinse product -Cold/RoomTemperature Until all visible

Steps Removal with sterile water sterile Water soil is removed
removing any visible -Soft bristle brush Minimum
organic material. -Non-shedding cloth of two (2)
Apply detergent a -Recommended minutes is
with non-shedding Detergent/Disinfectant recommended
cloth and as
necessary, with
assistance of a soft
bristle brush, any
visible soil.
2 Rinse Rinse product with -Cold/RoomTemperature Until all visible
sterile water. sterile Water detergent is
removed
3 Drying Dry the device -Non-shedding cloth Until product is
utilizing a dry non- -Medical quality filtered visually dry
shedding cloth. compressed air
Medical quality
filtered air may be
utilized if available.
Disinfection 4 Disinfection Apply the -Recommended Minimum of
Steps Application recommended Detergent/Disinfectant thirty (30)
Detergent/ -Non-shedding cloth minutes is
Disinfectant -Spray bottle or other recommended
to a Non-shedding manual applicator
cloth. Cover the
device’s surface
area with the
saturated cloth.
4 Manual After 30 minute -Recommended Manual
Disinfection contact time, wipe Detergent/Disinfectant cleaning time
the device contact -Non-shedding cloth duration is
surfaces, joints and complete when
mated areas utilizing the device’s
the cover cloth. surface, joints,
& crevices
have been
manually
cleaned.
5 Final Rinse Rinse product under -Room Temperature Minimum of
Room Temperature -Sterile Water 30 seconds
sterile water.
6 Final Drying Dry the device -Non-shedding cloth Until product is
utilizing a dry non- -Medical quality filtered visually dry
shedding cloth. compressed air
Medical quality
filtered air may be
utilized if available.

WARNING:
Zimmer UNIVERSAL Power System should not be immersed or submerged in water
or cleaner.

15
4.9 AUTOMATIC DISINFECTANT CLEANING (Recommended)

The Automatic Cleaning and Disinfection process has been validated according to
AAMI TIR Number 30 and ISO 17664 guidelines

Materials:
Non abrasive and non shedding soft cloth.

Non abrasive soft brush.

Detergent with neutral pH or lightly alkaline: pH <10

(Validated with a liquid detergent with surfactants (at 20°C: pH: 10.5-10.9; specific gravity: 1.1g/cm3;
viscosity: <50 mPas))

Neutralizing agent.
(Validated with a neutralizing agent (at 20°C: pH: 2.6-3; specific gravity: 1.2g/cm3; viscosity:
<10mPas)).

Rinse aid
(Validated with a rinse liquid (at 20°C: pH: 5.9-6; specific gravity: 1.02g/cm3; viscosity: <50mPas)).

Washer disinfector
(Validated with a medical use washer disinfector according to the EN ISO 15883).

4.10 AUTOMATIC DISINFECTANT CLEANING

Critical sites must be manually precleaned with a non-shedding soft cloth and/or non-
abrasive brush before the washer disinfector cycle. While cleaning, pay particular attention to
critical sites such as narrow cavities, small openings and moving parts.

Use an Automated Washing/Disinfection program with:

- A prewash with cold water (20°C) for a minimum of 2 minutes

- A cleaning step lasting a minimum of 5 minutes at a temperature between 40°C and 60°C
- A neutralization step lasting a minimum of 2 minutes at a temperature of 20°C
- A rinse step lasting a minimum of 2 minutes at a temperature of 20°C
- A Second rinse step lasting a minimum of 5 minutes at a temperature of 93°C
- A Drying step lasting a minimum of 35 minutes at a temperature of 99°C

Put medical devices in the washer disinfector. Avoid all contact between the devices
(movement may damage devices and may jeopardize the cleaning operation)

Put implements so that holes are aimed downwards (to make the flow easier).

Start the washer disinfector.

16
 Automated Cleaning/Disinfection Procedure
Step Step Step Instruction Accessories Duration
Description
1 Contamination Rinse product with -Cold/ Until all visible soil
Removal of sterile water removing Roomtemperature is removed.
Critical Sites any visible organic sterile Water Minimum of two
material. Apply -Soft bristle brush (2) minutes is
detergent with a (Do not utilize metal recommended
non shedding cloth cleaning brushes)
and as necessary -Non-shedding cloth
with assistance of a -Recommended
soft bristle brush to Detergent/Disinfectant
remove any visible
soil.
2 Rinse Rinse product with -Cold/ Until all visible
sterile water. RoomTemperature detergent is
sterile Water removed

3 Drying Dry the device utilizing -Non-shedding cloth Until product is

a dry non-shedding -Medical quality filtered visually dry
wipe. Medical quality compressed air
filtered air may be
utilized if available.
4 Automated Place entire device -Automated Washer Minimum total
Washer into the automated -Disassembled Device cycle time: 51
washer, placing -Washer Cleaning minutes when
implements so that Solution including all steps
holes are aligned -Washer Neutralizing below.
downward. Solution
Validated Automatic Washer Cycle
Step Minimum Time Recommended Temperature
Pre-Wash 2:00 minutes Water Temperature 20°C
Cleaning 5:00 minutes Water Temperature 55°C
Neutralizing 2:00 minutes Water Temperature 20°C
Rinse I 2:00 minutes Water Temperature 20°C
Rinse II(Final) 5:00 minutes Water Temperature 93°C
Drying 35:00 minutes Chamber Temperature 99°C

4.11 INSPECTION

Inspect each part of the devices to make sure all soil is removed.
If necessary, repeat the cleaning process.
4.12 STERILIZATION

Sterilization parameters have been validated according to AAMI TIR Number 12, ISO
17664 and ISO 17665 guidelines (warranty of a Security Assurance Level (SAL) of 10-6)

The Steam sterilization procedure must be carried out in a qualified autoclave.

Remove all washing caps (REF 89-8510-455-50) on hoses and on pneumatic handpiece
air inlet before the sterilization process.
Do not insert any cap for the sterilization process.

17
The Zimmer handpieces and accessories have been designed to withstand the longest
sterilization process. Under this requirement the following Steam sterilization cycle has been
validated: 134°C with a holding time of 18 minutes (Prion cycle), minimum drying time of

5. ELECTRICAL SAFETY
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.

5.1 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 Groupe 1 The Zimmer UNIVERSAL Power System and Zimmer
CISPR 11 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 Class B The Zimmer UNIVERSAL Power System and Zimmer
CISPR 11 UNIVERSAL Compact Battery Charger are suitable for use
Harmonic emissions Class A in all establishments, including domestic establishments and
IEC 61000-3-2 those directly connected to the public low-voltage power supply
Voltage fluctuations/ Complies network that supplies buildings used for domestic purposes.
Flicker emissions The Zimmer UNIVERSAL Compact Battery Charger must not
IEC 61000-3-3 be used in patient care areas.

18
5.2 Electromagnetic Immunity
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.

Immunity test IEC 60601 Compliance level Electromagnetic environment -

test level guidance
Electrostatic ± 6 kV contact ± 6 kV contact Floors should be wood, concrete
discharge (ESD) or ceramic tile. If floors are covered
± 8 kV air ± 8 kV air with synthetic material, the relative
IEC 61000-4-2 humidity should be at least 30%.
Electrical fast ±2 kV for power ±2 kV for power Mains power quality should be that
transient/burst supply lines supply lines of a typical commercial or hospital
environment.
IEC 61000-4-4
Surge ±1 kV differential ±1 kV differential Mains power quality should be that
mode mode of a typical commercial or hospital
IEC 61000-4-5 environment.
± 2 kV common ± 2 kV common
mode mode
Voltage dips, short <5 % UT <5 % UT Mains power quality should be that
interruptions and (>95 % dip in UT) (>95 % dip in UT) of a typical commercial or hospital
voltage variations for 0,5 cycle for 0,5 cycle environment. If the user of the
on power supply Zimmer UNIVERSAL Power System
input lines 40 % UT 40 % UT or Zimmer UNIVERSAL Compact
(60 % dip in UT) (60 % dip in UT) Battery Charger requires continued
IEC 61000-4-11 for 5 cycles for 5 cycles operation during power mains
interruptions, it is recommended
70 % UT 70 % UT that the devices be powered from
(30 % dip in UT) (30 % dip in UT) an uninterruptible power supply or a
for 25 cycles for 25 cycles battery.

<5 % UT <5 % UT
(>95 % dip in UT) (>95 % dip in UT)
for 5 sec for 5 sec
Power frequency 3 A/m 3 A/m Power frequency magnetic fields
(50/60 Hz) should be at levels characteristic
magnetic field of a typical location in a typical
commercial or hospital environment.
IEC 61000-4-8

NOTE: UT is the a.c. mains voltage prior to application of the test level.

19
5.3 Electromagnetic Immunity, RF Portable Equipment
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.

Immunity test IEC 60601 Compliance Electromagnetic environment - guidance

test level level
Portable and mobile RF communications equipment should be used no closer to any part of the Zimmer
UNIEVRSAL Power System or Zimmer UNIVERSAL Compact Battery Charger, including cables, than the
recommended separation distance calculated from the equation applicable to the frequency of the transmitter.
Recommended separation distance

Conducted RF 3 Vrms 3 Vrms d = 1.2 √P

IEC 61000-4-6 150 kHz to

80 MHz

Radiated RF 3 V/m 3 V/m d = 1.2 √P 80 MHz to 800 MHz

IEC 61000-4-3 80 MHz to d = 2.3 √P 800 MHz to 2,5 GHz

2,5 GHz
where P is the maximum output power rating
of the transmitter in watts (W) according to
the transmitter manufacturer and d is the
recommended separation distance in metres (m).
Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey,a should be less
than the compliance level in each frequency range.b

Interference may occur in the vicinity of equipment marked with the following symbol:

NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is
affected by absorption and reflection from structures, objects and people.
a
Field strengths from fixed transmitters, such as base stations for radio telephones (cellular/
cordless) and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast
cannot be predicted theoretically with accuracy. To assess the electromagnetic environment
due to fixed RF transmitters, an electromagnetic site survey should be considered. If the
measured field strength in the location in which the Zimmer Power System is used exceeds
the applicable RF compliance level above, the Zimmer Power System should be observed
to verify normal operation. If abnormal performance is observed, additional measures may
be necessary, such as re-orienting or relocating the Zimmer Power System.
b
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

20
5.4 Recommended Separation Distances
The Zimmer UNIVERSAL Power System and Zimmer UNIVERSAL Compact Battery
Charger are intended for use in an electromagnetic environment in which radiated RF
disturbances are controlled. The customer or the user can help prevent electromagnetic
interference by maintaining a minimum distance between portable and mobile RF
communications equipment (transmitters) and the Zimmer UNIVERSAL Power System or
Zimmer UNIVERSAL Compact Battery Charger as recommended below, according to the
maximum output power of the communications equipment.

Rated maximum output Separation distance according to frequency of transmitter

power of transmitter
150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2,5 GHz
W
d = 1.2 √P d = 1.2 √P d = 2.3 √P

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 transmitters rated at a maximum output power not listed above, the recommended separation distance
d in metres (m) can be estimated using the equation applicable to the frequency of the transmitter,
where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter
manufacturer.

NOTE 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range
applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is
affected by absorption and reflection from structures, objects and people.

21
5.5 Cord (Cable) Length

Cables and accessories Maximum length Complies with

RF emissions, CISPR 11,
Power Cord 3.5 m Class B/Group 1
REF 89-8510-420-20
Harmonic emissions,
(for Zimmer UNIVERSAL IEC 61000-3-2
Power System)
Voltage fluctuations/flicker emission,
IEC 61000-3-3

Electrostatic discharge (ESD),

IEC 61000-4-2

Electric fast transient/burst,

IEC 61000-4-4

Surge,
IEC 61000-4-5

Voltage dips, short interruptions and voltage

variations on power supply input lines
IEC 61000-4-11

Power frequency (50/60 Hz) magnetic field

IEC 61000-4-8

Conducted RF
IEC 61000-4-6

Radiated RF,
IEC 61000-4-3

22
6. WARNING AND PRECAUTIONS
- Only medical professionals who are thoroughly familiar with the Zimmer UNIVERSAL
Power System function, application and instruction for use should operate any Zimmer
equipment.
-- Do not use devices if they appear to be damaged or defective.
-- Do not use in presence of flammable products.
-- Do not use accessories or cords other than those specified or provided by Zimmer.
-- The use of Flash Batteries (REF 89-8510-440-50) may not be authorised in some
countries.
-- The use of accessories and cords other than those specified or sold by Zimmer may
result in increased emissions.
-- Certain types of mobile telecommunication equipment could potentially interfere with this
product.
-- 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.
-- For intermittent (1 min on / 5 min off) operation only.
-- It is highly recommended to continuously moisten bones when drilling, cutting, or
reaming.
-- The handpieces have built-in software that protects the internal electronic components.
When this protection is activated, the handpiece may not be responsive. To reinitiate the
system, disconnect the battery and reconnect it.
-- When not in use, turn handpiece off (safety position “0”) and remove the Flash Battery or
ATK Housing.
-- Do not touch the contacts of the batteries nor put them in a “short circuit” situation.
-- Do not touch the contacts of the battery charger or Sterilizable Cord for Electric Power
when powered “on” nor put them in a “short circuit” situation.
-- Do not introduce any object into the Electric Power Supply or Compact Battery Charger.
-- Do not use alkaline cleaning agents on the devices.
-- Do not immerse.
-- Do not put the Battery (REF 89-8510-440-20) or Flash Battery (REF 89-8510-440-50) in
an automated washer.
-- Do not expose the Electronic Power Supply (REF 89-8510-420-00 / 89-8510-420-10),
Battery (REF 89-8510-440-20) and Compact Battery Charger (REF 89-8510-421-00) to
wet environment.
-- Do not sterilize the Electronic Power Supply (REF 89-8510-420-00 / 89-8510-420-10),
Battery (REF 89-8510-440-20) and Compact Battery Charger (REF 89-8510-421-00) to
wet environment.
-- The ATK Housing (REF 89-8510-440-10) must be sterilized with his lid open.
-- After sterilization, make sure the handpiece has reached temperature below 40°C before
use.
-- The use of a Zimmer UNIVERSAL Sterilization Case is strongly recommended.
-- Do not open the device as electrocution hazard may endanger health.
-- Device must be disconnected when servicing as electrocution hazard may seriously
damage health.

23
7. TECHNICAL SERVICE
Risk of electric shock. Do not remove cover.
Rough shocks/handling should be avoided.
No lubrication or maintenance needed.
Do not attempt to disassemble the handpiece. It is a factory sealed unit with no
user serviceable parts inside.
Zimmer is not liable for any device malfunction resulting from repairs or service
not performed by a Zimmer authorized service center.
Always decontaminate the system before returning to Zimmer.

The Zimmer UNIVERSAL Power System should be returned every 12 months for inspection
and preventive maintenance. Annual factory calibration checks are strongly recommended to
verify continued accuracy.

The handpieces have built-in software that protects the internal electronic components.
When this protection is activated, the handpiece may not be responsive. To reinitiate the
system, disconnect the battery and reconnect it.

When it is necessary to return the Zimmer UNIVERSAL Power System for preventive
maintenance or repair within the U.S.A. call 1-800-830-0970 to receive a Return Goods
Authorization (RGA) number. Outside the U.S.A., contact your local Zimmer representative.

The instrument must be properly packaged when sent in for repair. If the original packaging
is no longer available, proper packaging can be requested when the RGA is received. A
purchase order must accompany all equipment for repair. The customer will be responsible
for all shipping charges.

Fuse Replacement
Fuse replacement should be performed by a person familiar with electronic medical devices.

UNIVERSAL Electronic Power Supply fuse replacement:

- Disconnect Power Supply from mains.
- Open the fuse compartment j j
- Replace fuses with two T5AL250V fuses.

UNIVERSAL Compact Battery Charger fuse replacement:

- Disconnect Power Supply from mains. k
- Open the fuse compartment k
- Replace fuses with two T2.5AL250V fuses.

Use only fuse type noted above.

24
8. WARRANTY INFORMATION (U.S.A. only)
Zimmer Surgical warrants that the Zimmer UNIVERSAL Power System, along with all
parts and accessories, have been tested and inspected, and have left the factory in
proper working condition, free from visible defects.

Zimmer Surgical warrants to the first consumer purchaser of new Zimmer UNIVERSAL
Power System and accessories will, under normal and reasonable use, be free from
defects in material and workmanship for one (1) year after the date of shipment from the
factory. The warranty period for hoses is six (6) months. Zimmer UNIVERSAL Power
System consumables are warranted to be free from defects in material and workmanship
upon delivery. During the warranty period, Zimmer Surgical shall repair (or at its sole
option replace) the defective product or part without cost to the purchaser. Defective parts
replaced under this warranty shall become the property of Zimmer Surgical. This warranty
does not cover damage caused by misuse, abuse, accident, neglect, or any use not
prescribed in this manual. If the unit becomes defective because of misuse or abnormal
conditions of operation, repairs will be billed at our current rate.

ALL OTHER WARRANTIES, EXPRESS, IMPLIED, OR STATUTORY, INCLUDING, BUT

NOT LIMITED TO, IMPLIED WARRANTIES OF MERCHANTABILITY OR FITNESS
FOR A PARTICULAR PURPOSE, ARE LIMITED IN TIME TO THE PERIOD OF THE
WARRANTY GRANTED HEREBY. SOME STATES DO NOT ALLOW LIMITATIONS ON
THE DURATION OF AN IMPLIED WARRANTY, SO THE ABOVE LIMITATIONS MAY NOT
APPLY TO YOU.

Neither Zimmer Surgical nor the Zimmer distributor who sells the Zimmer UNIVERSAL
Power System is responsible for indirect, incidental, or consequential damages. Some
states do not allow the exclusion of incidental or consequential damages, so the above
limitations or exclusions may not apply to you.

9. WARRANTY (Outside U.S.A.)

Contact your local Zimmer sales representative for warranty information.

10. CONTACT INFORMATION

Inside the U.S.A., call the Zimmer Customer Service Department at 1-800-348-2759.
Outside the U.S.A., contact your local Zimmer sales representative.

25
11. SYMBOLOGY
Symbol Description

Consult instructions for use and accompanying documents

Caution

Type BF against electric shock applied part according to IEC 60601-1

Do not immerse

Do not discard with household waste

Conform to the European Medical Device Directive 93/42/CEE + 2007/47/CE

for class I medical devices
Conform to the European Medical Device Directive 93/42/CEE + 2007/47/CE
for class IIa medical devices (notified body number)

Serial number

Reference number or product number

Can be recycled

For sterile cutting tools only

Single use, Do not reuse

Use by: shelf life date

Sterilization by irradiation
Do not use if package is damaged or open

Lot number

26