Zimmer Biomet Sesamoid Plasty V2 User manual

User Guide
Sesamoid®Plasty V2

Table of Contents
Symbols and Icons.................................................................................................... 2
Introduction.............................................................................................................. 3
System Overview ...................................................................................................... 4
Sesamoid Plasty Computer ...................................................................................... 5
Sesamoid Plasty Camera .......................................................................................... 7
Laser Positioning System ......................................................................................... 8
Cleaning and Disinfection ........................................................................................ 9
Transportation and Storage ................................................................................... 10
Packaging the Sesamoid Plasty ............................................................................. 12
Care of Cables and Connectors .............................................................................. 12
Preventive Inspection and Maintenance................................................................ 13
Technical Specifications ......................................................................................... 14
Disposal of Equipment............................................................................................ 20
Troubleshooting of the Sesamoid Plasty................................................................ 21

2 | Sesamoid®Plasty User Guide
Symbols and Icons
The following symbols and icons can be found on the Sesamoid Plasty or on the labeling of components.
Symbol Meaning Location
General warning sign Computer
Power Indicator Camera front panel
Camera status indicator (tracking mode) Camera front panel
Camera error indicator Camera front panel
Manufacturer Computer, camera, stand, laser pointer
Laser radiation warning Laser pointer
Warning to avoid eye exposure to laser beam Laser pointer
Symbol for “Authorized EC Representative” Computer, camera, stand
Steps to put the system in its transport position Stand
No pushing label Stand
Mandatory action: When dissassembling the system,
the computer and camera must be taken out before
using the tree knobs to fold the stand.
Stand
Refer to instruction manual Computer
Symbol for “Disposal of WEEE (Waste Electrical
and Electronic Equipment).” In the EU, refer
to www.weee.zimmer.eu for information.
Laser pointer

3 | Sesamoid®Plasty User Guide
Introduction
The Sesamoid Plasty is Zimmer Biomet’s hardware
platform for the unicondylar*, total knee and total
hip replacement* applications. The platform and
its applications are designed to allow surgeons the
ability to precisely and intraoperatively visualize the
positioning of the instrumentation relative to bony
structures in real time and in three dimensions.
The Sesamoid Plasty includes both the Sesamoid
Plasty Computer and the Sesamoid Plasty Camera,
which are housed on the same stand.
Under normal conditions, the Sesamoid Plasty’s
expected useful life is 5 years.
CAUTION:
Do not put any component of the
system in contact with the patient or with users
that will be in contact with the sterile field. The
system is developed for use outside of the sterile
field and its components are not sterile.
CAUTION:
Ensure that no one touches an
accessible connector contact and the patient
simultaneously.
CAUTION:
Only connect items that have been
specified as part of the Sesamoid System
For any problem or question on the Sesamoid Plasty,
contact Zimmer CAS Customer Support:
Phone number: 1 [phone]
US toll free phone number: 1 [phone]
7:00 AM to 5:00 PM EST
Operating Principle of the Sesamoid Plasty
The laser pointer is used to orient the camera toward
the sterile field where optical trackers are fixed on
the patient’s bones and surgical instruments. The
Sesamoid Plasty Camera emits an infrared light and
detects its reflection by retro-reflective markers on the
trackers. From this, the tracker position and orientation
are acquired and the navigation information is able
to be computed via the pre-installed ORTHOsoft
Universal Applications. The navigation information is
then displayed on the Sesamoid Plasty Computer. This
will enable the surgeon to determine axial alignment
in relation to anatomical landmarks for precise
placement of instruments. The Sesamoid Plasty Stand
supports the camera and computer, and is mobile for
ease of use.
This user guide is the main primary training material
for use of the Sesamoid Plasty. It contains all the
information needed to operate the system and
provides system-specific warnings, assembly/
disassembly, transport, storage and cleaning.
*Not available in the US

4 | Sesamoid®Plasty User Guide
Platform Overview
1
2
4
5
3
Figure 1
Main components
of the Sesamoid Plasty
(Figure 1):
1. Camera
2. Laser pointer
3. Camera arm
4. Computer
5. Stand
Sesamoid Plasty Assemblies
and Accessories:
Computer kit
Camera kit
Stand
LEMO®Cable
Computer power cable
HDMI cable (optional)
Ethernet cable
CAUTION: It is recommended that
if the Sesamoid Plasty is used with
any configuration other than that
shipped by Zimmer Biomet, users
should verify compliance with General
Requirements for Basic Safety and
Essential Performance for Medical
Devices IEC 60601-1.

5 | Sesamoid®Plasty User Guide
Sesamoid Plasty Computer
The Sesamoid Plasty Computer has an internal battery that allows for approximately 15 minutes of autonomy. This
power backup is provided to prevent data loss if there is a main power outage. The battery cannot supply sucient
power to operate the Sesamoid Plasty Camera. Therefore, it is not possible to use the system to navigate while it is
in power backup mode. A warning is provided to the user if the main power is disconnected and the computer runs
on the battery.
Figure 2 summarizes all connections that can be found on the back
of the Sesamoid Plasty Computer.
1
3 4 5 6 7 8
2
Connector Panel on the Sesamoid Plasty Computer
1. Equipotential ground connector
2. AC power inlet
3. Computer power inlet (do not unplug permanent
connection)
4. USB ports (do not unplug permanent connection)
5. VGA port (do not use)
6. HDMI port
7. Ethernet connectors (do not unplug permanent
connection)
8. Serial ports (do not use)
CAUTION:
Do not remove the caps on the serial
ports (callout 8 in Figure 2) for safety reasons, these
ports are not to be used.
CAUTION:
Never disconnect the three permanent
connections at the bottom panel of the Sesamoid
Plasty Computer.
Connections
• Only use the HDMI cable provided by Zimmer Biomet
to connect the Sesamoid Plasty to an external display.
• Only use the Ethernet cable provided by Zimmer
Biomet to connect the Sesamoid Plasty to a local
network. No restrictions are in place for this type of
connection.
• The built in ground connector serves to equalize
potentials or reduce dierences of potential between
the Sesamoid Plasty’s metal components that
can be touched simultaneously or between it and
conductive objects.
CAUTION:
To avoid the risk of electric shock, this
equipment must be connected to a supply main
with protective ground.
CAUTION:
For safe use, connect the Sesamoid
Plasty to the surgical room’s equipotential
grounding system.
CAUTION:
Only connect items that have been
specified as part of the Sesamoid Plasty.
CAUTION:
Do not position the Sesamoid Plasty
in a way that makes unplugging the power cord
dicult.
Figure 2

6 | Sesamoid®Plasty User Guide
Sesamoid Plasty Computer (cont.)
View of the Sesamoid Plasty Computer’s Button
Commands:
1. Power switch and power indicator
2. Volume adjustment (+/-)
3. Light
4. Touchscreen activation/deactivation (Do not use)
5. Lights activation/deactivation
6. Light
7. Luminosity adjustment (+/-)
1
2
3456 7
Rear View of the Sesamoid Plasty Computer
(Figure 3):
1. Camera connector
(for use with next generation camera)
2. Polaris Spectra®Camera Connector
3. Additional USB ports
1
2
3
CAUTION:
Do not remove the cap on the camera
connector, this port is reserved for future use and
not to connect to a local network.
CAUTION:
The openings on the enclosure are
for air convection to protect the equipment from
overheating. Do not block the openings.
CAUTION:
If one of the following situations arise,
get the equipment checked by service personnel:
• The power cord or plug is damaged.
• Liquid has entered the equipment.
• The equipment has been exposed to moisture.
• The equipment does not work well, or you
cannot get it to work according to the user’s
manual.
• The equipment has been dropped and
damaged.
• The equipment has obvious signs of breakage.
• The date and time function stops functioning
properly.
CAUTION:
No modification of this equipment is
allowed. For safety reasons, only qualified service
personnel should open or bring modifications to
the Sesamoid Plasty Computer or Sesamoid Plasty
Camera, as they contain no replaceable parts.
CAUTION:
Never insert a foreign object in the
Sesamoid Plasty Computer’s openings. This may
cause electric shock or fire, or it may damage
hardware components.
Figure 3
Figure 4

7 | Sesamoid®Plasty User Guide
Sesamoid Plasty Camera
Overview of the Polaris
Spectra Camera
CAUTION:
Depending on ambient temperature, it
could take several minutes for the Sesamoid Plasty
Camera to reach operating temperature from
a cold-start at normal temperature (the power
LED will flash when warming up and stay lit when
ready).
CAUTION:
The tracking operation, if aected, will
be automatically inhibited by the application until
the normal operating temperature is reached,
resulting in tracked items not being displayed
temporarily.
CAUTION:
It is recommended to recalibrate the
Polaris Spectra Camera once a year, or if the user
feels that the performance of this component
has degraded. This component is sensitive and
impacts beyond normal use could aect its
performance. For more information, contact
Zimmer CAS Customer Support.
CAUTION:
The Sesamoid Plasty Camera
utilizes infrared signals to determine positional
information which results in the following:
• The system may potentially interfere with other
devices that utilize or are sensitive to infrared
signals if they are in the same frequency range
(i.e. pulse oximeters). The standard precaution
is to shield these devices from the infrared
light of the camera. The user manuals of
these devices should be consulted for specific
instructions on how to reduce the chances of
interference.
• The presence of strong infrared sources,
including some lighting systems or infrared
reflectors in the vicinity of the reflective
markers, can cause interference and aect
its performance.
Front View of the Polaris Spectra Camera
(Figure 5):
1. Sensor: Tracks IRED markers (active trackers) and/
or retro-reflective targets (passive trackers).
2. Illuminator ring: An array of IREDs provides
infrared light for reflective markers, and initiates
marker activation for active wireless tools.
3. Power LED: Flashes green when warming up
and stays lit when ready.
4. Status LED: Displays steady green light when
the camera is communicating with the Sesamoid
Plasty Computer.
5. Error LED: Flashes amber if a bump is detected.
It stays lit if a critical error is detected (if such
an error occurs, contact Zimmer CAS Customer
Support ).
Back View of the Polaris Spectra Camera
(Figure 6):
1. LEMO Connector that provides power and
communication to the camera.
1
3 5
4
2
1
Figure 5
Figure 6

8 | Sesamoid®Plasty User Guide
Laser Positioning System
The laser pointer helps approximate the correct camera aim by projecting a low-power laser beam along the center
of the camera’s field of view. Press the "On/O" trigger button to activate the laser, and release the button to
deactivate the laser.
CAUTION:
The laser pointer transmits laser radiation. Use caution when operating the device, and never aim
the laser at someone’s eye. Laser radiation, even at low levels, can damage the eyes.
Laser Batteries
There are three 1.5V LR1 (or type N) alkaline batteries
in the laser pointer. The batteries provided with the
laser pointer do not contain lead.
To change the batteries:
1. Unscrew the laser pointer shell assembly.
2. Take out the batteries.
3. Insert new 1.5V ‘N’ alkaline batteries, taking into
account the polarity of the batteries and the shell.
4. Screw down the laser pointer. The batteries should
be disposed of per appropriate methods (not to
be disposed of in normal household waste and
must be disposed of separately). See the Symbols
section, page 2, for further information.
Laser Position (Figure 6)
1. Camera field of view
2. Laser beam
Laser Identification/ Explanation Label
1
2
Laser (Figure 7)
1. Laser activation button
2. Laser aperture
3, Laser explanatory label
12
Figure 6
Figure 7
3

9 | Sesamoid®Plasty User Guide
CAUTION: Always isolate the equipment from
the main electrical supply prior to cleaning and
disinfection in order to prevent electrical shocks.
CAUTION: Immersing or soaking the Sesamoid
Plasty Computer or the Sesamoid Plasty Camera
into liquid could result in malfunction of the unit.
Do not spray a cleaning agent on the enclosure.
CAUTION: Never allow water or other liquids
to enter the equipment since they may cause
subsequent short-circuits or corrosion.
Cleaning
Enameled parts and aluminum surfaces should
only be wiped clean with a damp cloth and mild
detergent, and then rubbed down with a dry woolen
cloth. Never use corrosive cleaning agents, solvents
or abrasive detergents or polishes. If you are
uncertain of the nature of a cleaning agent, do not
use it. Do not use abrasive polishes.
Disinfection
All parts of the equipment, including accessories
and connecting cables, can be disinfected by wiping
them with a cloth dampened with a mild, alcohol-
based cleaning agent. Never use corrosive or
solvent disinfectants. If you are in any doubt of the
nature of a disinfecting agent, do not use it.
CAUTION: Disinfecting medical equipment with
sprays is not recommended since the vapor can
enter the equipment causing electrical short-
circuits or corrosion.
Cleaning and Disinfection

10 | Sesamoid®Plasty User Guide
Transportation and Storage
Moving the Sesamoid Plasty while
Assembled
The Sesamoid Plasty must be handled with care.
You must avoid any type of impact to the Sesamoid
Plasty System, and in particular to the camera. The
Sesamoid Plasty must be stored in a dry and cool
area. Prior to moving the Sesamoid Plasty System
(while it is assembled), the user must always put the
camera in its lower forward position to minimize
tilting hazards.
CAUTION:
To move the Sesamoid Plasty, put the
camera arm in its lowest position. Do not move the
system while out of this position.
Transportation Configuration Label
Assembly of the Sesamoid Plasty
1. Unfold the first pole section located close to
the base of the Sesamoid Plasty Stand. Tighten
the locking mechanism of that pole section
and complete the same operation for each pole
section.
2. Insert the camera arm into the hole situated on the
upper pole section.
3. Install the Sesamoid Plasty Camera
on the camera arm.
• To attach the Sesamoid Plasty Camera, slide its
connector in the Manfrotto™Connector located
at the end of the camera arm.
• A “click” is heard once the camera is firmly
attached to the camera arm.
4. Install the computer on the holding post by sliding
its back bracket on the post.
Assembly (Figure 8)
Attach the camera from the camera arm
Figure 8

11 | Sesamoid®Plasty User Guide
Disassembly of the Sesamoid Plasty
The steps to fold down the Sesamoid Plasty (shown in
Figure 9) are:
a. Remove the Sesamoid Plasty Computer from the
stand.
b. Remove the Sesamoid Plasty Camera and the camera
arm from the stand.
• To remove the camera from the arm, press and hold
the button on the Manfrotto Connector located
on the camera arm (Figure 9) and slide the camera
connecting device out from the bottom to the top
of the camera arm connector.
c. Undo successively the top, middle and bottom stand
locking mechanisms.
d. Fold the stand towards the floor holding the
previously folded segments to prevent them from
swinging unexpectedly.
CAUTION:
Remove the Sesamoid Plasty Camera and
the Sesamoid Plasty Computer prior to undoing any
of the locking mechanisms to fold the stand. Failure to
follow these instructions will result in an unexpected
tilt of the Sesamoid Plasty Stand.
CAUTION: The Sesamoid Plasty must never be
submerged in water or exposed to high levels of
humidity.
CAUTION:
Do not leave the equipment in an
uncontrolled environment where the storage
temperature is below –20˚ C or above 50˚ C. This may
damage the equipment.
CAUTION:
The Sesamoid Plasty must be kept away
from conditions of extreme heat or cold.
Transportation and Storage (cont.)
Disassembly of the Sesamoid Plasty Stand
a
b
c
d
Figure 9

12 | Sesamoid®Plasty User Guide
Packaging the Sesamoid Plasty
Transport Cases
If the Sesamoid Plasty is to be frequently shipped,
a series of reusable packaging material is available
(Figure 10).
A. The large box contains the Sesamoid Plasty Stand
and the camera arm.
B. The Sesamoid Plasty Computer goes in the
medium box.
C. The small box contains the Sesamoid Plasty
Camera.
D. The boxes can be assembled together for easy
transport.
CAUTION: The transport cases were designed and
tested for transport by plane and car/truck, but
not by ship or train.
To avoid damage to cables, make sure the cables
are not bent at sharp angles. Handle the connectors
with care, paying particular attention to the following
points:
• Pull connections apart by gripping the connector.
Do not pull them apart by tugging on the cable
as this can damage the connecting cable and
connector pins. The system has a lanyard on the
LEMO®Sleeve, which can be pulled directly to
unmount the connector.
• Do not leave cable connectors where they will get
damaged, particularly on the floor, where they
can easily be stepped on or rolled over by heavy
equipment.
Packaging of the Sesamoid Plasty
Care of Cables and Connectors
• Do not put heavy objects on cables or cable
connectors.
• Never force a connection.
• Make sure that the red dots on the LEMO
Connectors are lined up with each other before
connecting (the double keys of the connector
should be aligned).
CAUTION:
For safety reasons and to ensure
proper functioning of the system, do not use
cables other than those distributed by Zimmer
CAS.
A
B C
D
Figure 10

13 | Sesamoid®Plasty User Guide
Preventive Inspection and Maintenance
CAUTION:
All user maintenance must be done
by appropriately trained personnel. Individual
components of the Sesamoid Plasty Camera and
Computer contain no user-serviceable parts.
Maintenance by untrained personnel may present
an electric shock hazard.
The only user replaceable accessories are:
• The laser pointer system’s batteries
• The power, HDMI and Ethernet cables
CAUTION:
It is recommended to recalibrate the
Sesamoid Plasty Camera once a year. Contact
Zimmer CAS Customer Support for more
information.
CAUTION:
Contact Zimmer CAS Customer
Support with any doubt regarding the camera’s
accuracy.

14 | Sesamoid®Plasty User Guide
Technical Specifications
The specifications listed apply to system operation
under typical conditions.
Sesamoid Plasty Approvals
ANSI/AAMI ES 60601-1
CAN/CSA-C22.2 No. 60601-1
IEC/EN 60601-1 ed 3.1
IEC/EN 60601-1-2 ed 4
FCC Class B
Sesamoid Plasty Specifications
SESAMOID PLASTY FOOTPRINT
58.5 cm x 50.9 cm.
SESAMOID PLASTY HEIGHT
The maximum possible height of the system is 224.8 cm.
SESAMOID PLASTY WEIGHT
27.9 kg (including Sesamoid Plasty Computer, Camera
and Stand).
CLASSIFICATIONS
Electric shock protection Class 1 – protectively
earthed with power from
supply mains, without
applied parts.
Flammable atmosphere Not suitable for use in
presence of a flammable
anesthetic mixture with
air, oxygen or nitrous
oxide.
POWER
AC input requirements 100 - 240 V
1A max
50-60 Hz
OPERATING CONDITIONS
Humidity 10 ~ 90% (Non-condensing)
Temperature 10˚ C to 40˚ C
Atmospheric pressure 70 kPa - 101.3 kPa
TRANSPORT/STORAGE CONDITIONS
Humidity 80% relative humidity at high
temperature
Temperature -18˚ C to 49˚ C
USER DEVICES
Touch screen
224.8 224.8
50.958.5
Figures 11a and 11b

15 | Sesamoid®Plasty User Guide
Sesamoid Plasty Specifications (cont.)
MONITOR DIMENSIONS
55 cm x 36 cm x 11.4 cm (irregular)
MONITOR WEIGHT
11. 3 kg
CAMERA DIMENSIONS
6.13 cm x 10.4 cm x 0.86 cm
CAMERA WEIGHT
1.9 kg
CAUTION: The Sesamoid Plasty has been tested
and is in compliance with the electromagnetic
compatibility (EMC) requirements for emissions.
In some situations, it is still possible that radiated
electromagnetic fields such as those from portable
and mobile devices may cause performance
degradation.
CAUTION: Portable radio frequency (RF)
communications equipment (including peripherals
such as antenna cables and external antennas)
should be used no closer than 30 cm to the
Sesamoid Plasty, including cables. Otherwise,
degradation of the performance of the equipment
could result.
CAUTION: Use of this equipment adjacent to
other equipment should be avoided because
it could result in improper operation. If such
use is necessary, this equipment and the other
equipment should be observed to verify that they
are operating normally.
Technical Specifications (cont.)

16 | Sesamoid®Plasty User Guide
Technical Specifications (cont.)
The Sesamoid Plasty is designed for use in the
operating room, with the following exceptions:
• Near portable and mobile RF communication
equipment that radiate electromagnetic fields as
those may cause performance degradation.
• In the presence of a flammable anesthetic mixture
with air, oxygen or nitrous oxide.
To ensure adequate communication between the
Sesamoid Plasty Camera and Computer, display of
the correct navigation values and to avoid latency in
the system, it is important to use the Sesamoid Plasty
in the recommended use environment.
Use of the Sesamoid Plasty outside of a suitable
environment can result in:
• Misleading/erroneous navigation information.
• Asynchronous information relative to current state
of instruments.
• Unintentional manipulations of the system.
CAUTION:
The emission characteristics of the
Sesamoid Plasty make it suitable for use in
industrial areas and hospitals (CISPR 11 class
A). The Sesamoid Plasty is not adequate for
use in a residential environment as it might not
oer adequate protection to RF communication
services.
Product Regulatory Notices
Wireless Communications
The Sesamoid Plasty Computer contains an RF
transmitter with the following characteristics:
• Transmission frequency: 2.4/5 GHz
• Network Standard: Compliant with IEEE 802.11n,
8 02 .11g, 8 02 .11b ,8 0 2.11d, 8 02 .11e, 8 02 .11j a nd
8 02 .11i
• Modulation: OFDM with BPSK, QPSK, 16 QAM, 64
QAM;DQPSK, CCK, G-FSK, π/4-DQPSK, 8-DPSK
• Supported Data Rates: IEEE 802.11a 6 - 54 Mbps,
IEEE 802.11b 1 - 11 Mbps, IEEE 802.11g 6 - 54
Mbps, IEEE 802.11n 6.5 - 300 Mbps
• Eective isotropic radiated power: 21 dBm

17 | Sesamoid®Plasty User Guide
Technical Specifications (cont.)
Product Regulatory Notices (cont.)
FCC Notice
This equipment has been tested and found to comply
with the limits for a Class B digital device, pursuant to
part 15 of the FCC Rules.
These limits are designed to provide reasonable
protection against harmful interference in a
residential installation. This equipment generates,
uses and can radiate radio frequency energy and,
if not installed and used in accordance with the
instructions, may cause harmful interference to radio
communications. However, there is no guarantee that
interference will not occur in a particular installation.
If this equipment does cause harmful interference
to radio or television reception, which can be
determined by turning the equipment o and on, the
user is encouraged to try to correct the interference
by one or more of the following measures:
• Reorient or relocate the receiving antenna.
• Increase the separation between the equipment
and receiver.
• Connect the equipment into an outlet on a
circuit dierent from that to which the receiver is
connected.
• Consult the dealer or an experienced radio/TV
technician for help.

18 | Sesamoid®Plasty User Guide
Technical Specifications (cont.)
Guidance and Manufacturer’s Declaration
Electromagnetic Emissions
The Sesamoid Plasty Computer is intended for use in the electromagnetic environment specified below. The
customer or the user of the Sesamoid Plasty Computer should assure that it is used in such an environment.
Emissions test Compliance Electromagnetic environment – guidance
RF emissions CISPR 11 Group 1 The Sesamoid Plasty uses 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 emissionsCISPR 11 Class B The Sesamoid Plasty Computer is suitable for use in
all establishments, including domestic establishments
and those directly connected to the public low-voltage
power supply network that supplies building used for
domestic purposes.
Harmonic emissions IEC 61000-3-2 Class D
Voltage fluctuations/ flicker emissions IEC
61000-3-3
Complies
Electromagnetic Immunity
The Sesamoid Plasty Computer is intended for use in the electromagnetic environment specified below. The
customer or the user of the system controller computer should assure that it is used in such an environment.
Immunity test IEC 60601 Test level Compliance level
Electromagnetic
environment – guidance
Electrostatic discharge
(ESD) IEC 61000-4-2
± 8 kV contact
± 2, ± 4, ± 8, ± 15 kV air
± 8 kV contact
± 2, ± 4, ± 8, ± 15 kV air
Floors should be wood, concrete
or ceramic tile. If floors are covered
with synthetic material, the relative
humidity should be at least 30 %.
Electrical fast transient/
burst IEC 61000-4-4
± 2 kV for power supply lines
± 1 kV for input/output lines
± 2 kV line(s) to line(s)
± 1 kV line(s) to earth
Mains power quality should be that
of a typical commercial or hospital
environment.
Surge IEC 61000-4-5 ± 0.5, ± 1 kV line(s) to line(s)
± 0.5, ± 1, ± 2 kV line(s) to ground
for power supply lines
± 2 kV line(s) to ground for input/
output lines
± 0.5, ± 1 kV line(s) to line(s)
± 0.5, ± 1, ± 2 kV line(s) to ground
for power supply lines
± 2 kV line(s) to ground for input/
output lines
Mains power quality should be that
of a typical commercial or hospital
environment.
Voltage dips, short
interruptions and voltage
variations on power
supply input lines IEC
61000-4-11
0 % UT; 0.5 cycle
At 0°, 45°, 90°, 135°, 180°, 225°,
270° and 315°
0 % UT; 1 cycle and 70 % UT; 25/30
cycles
Single phase: at 0°
0 % UT; 250/300 cycle
0 % UT; 0.5 cycle
At 0°, 45°, 90°, 135°, 180°, 225°,
270° and 315°
0 % UT; 1 cycle and 70 % UT; 25/30
cycles
Single phase: at 0°
0 % UT; 250/300 cycle
Mains power quality should be that
of a typical commercial or hospital
environment.
Power frequency (50/60
Hz) magnetic field IEC
61000-4-8
30 A/m 30 A/m Power frequency magnetic fields
should be at levels characteristic
of a typical location in a typical
commercial or hospital environment.
NOTE: UTis the AC mains voltage prior to application of the test level.