INS T RUM ENT AT ION
AND HA RDW ARE
USER MANUAL
Ref: 99.30H.16US rev.02 - Last update May 2010
rev.XX
Ref.33.22.1000US
MEDACTA iMNS - Instrumentation and Hardware
CAUTION: Federal law (USA) restricts this device to sale by or on the order of
physician
Copyright 2008 Medacta International SA All Rights Reserved.
All other product or service names are the property of their respective owners.
Distributed by MEDACTA USA, Inc, 4725 Calle Quetzal Unit B Camarillo, CA
93012-9101 1 (800) 901-7836.
MEDACTA iMNS - Instrumentation and Hardware ref. 99.30H.16US rev.02
TABLE OF CONTENTS
1.
GENERAL DESCRIPTION .................................................................................................................... 4
1.1
1.2
1.3
1.4
2.
HARDWARE AND INSTRUMENTS....................................................................................................... 9
2.1
2.2
2.3
2.4
3.
INTENDED USE ......................................................................................................................................... 4
COMPLICATIONS ..................................................................................................................................... 6
STRUCTURE AND OPERATION ................................................................................................................. 7
TRAINING................................................................................................................................................. 8
®
POLARIS SPECTRA ACQUISITION SYSTEM ............................................................................................... 9
®
IMAC COMPUTER ................................................................................................................................. 12
REOMED® 600 ISOLATION TRANSFORMER ........................................................................................... 15
INSTRUMENTS ....................................................................................................................................... 16
INSTALLATION AND START ............................................................................................................. 17
3.1 WIRING DIAGRAM ................................................................................................................................. 18
3.2 ASSEMBLING THE MARKERS ON THE REFERENCE ARRAYS .................................................................... 20
3.3 ASSEMBLING THE SUPPORT TRIPOD...................................................................................................... 21
3.4 INSTALLING AND TURNING ON THE SYSTEM ......................................................................................... 23
®
3.4.1
Polaris Spectra acquisition system wiring .................................................................................. 23
®
3.4.2
iMAC Computer wiring:.............................................................................................................. 26
3.4.3
REOMED® 600 isolation transformer wiring: ............................................................................... 27
®
3.4.4
Turning on the iMNS .................................................................................................................. 29
3.5 STARTING AND USING THE NAVIGATION SOFTWARE............................................................................ 31
4.
TROUBLESHOOTING ....................................................................................................................... 32
®
4.1 POLARIS SPECTRA LEDS ............................................................................................................................. 35
4.2 AUDIO CODES ........................................................................................................................................... 36
4.3 CLEANING AND MAINTENANCE............................................................................................................. 36
4.4 CLEANING .............................................................................................................................................. 36
®
4.4.1
Polaris Spectra System cleaning ................................................................................................. 37
®
4.5 IMNS SYSTEM MAINTENANCE AND REPAIR ........................................................................................ 38
5.
TECHNICAL SPECIFICATIONS, CONFORMITY, CLASSIFICATIONS, ELECTROMAGNETIC COMPATIBILITY ....... 39
5.1 TECHNICAL DATA AND CONFORMITY .................................................................................................... 39
®
5.1.1
Polaris Spectra Technical Specification ...................................................................................... 40
®
5.1.2
iMac Computer Technical Specifications ................................................................................... 42
5.1.3
Acquisition Device Support Tripod Technical Specifications ........................................................ 42
5.1.4
REOMED® 600 Isolation Transformer .......................................................................................... 43
6.
APPENDIX - EQUIPMENT SYMBOLS ................................................................................................. 44
7.
APPENDIX – ACRONYMS AND ABBREVIATIONS ............................................................................... 45
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MEDACTA iMNS - Instrumentation and Hardware ref. 99.30H.16US rev.02
BEFORE USING THE MEDACTA iMNSTM NAVIGATION
SYSTEM, CAREFULLY READ THROUGH THE MANUALS
PROVIDED WITH THE SYSTEM AND THE OPERATING
TECHNIQUES RELATED TO THE SURGERY TO BE
PERFORMED: THE USER IS RESPONSIBLE FOR ANY
DAMAGE OR MALFUNCTION CAUSED BY IMPROPER USE
OF THE iMNSTM SYSTEM OR OF ANY OF ITS COMPONENTS.
The information contained in this manual and the
product to which it refers may be modified by MEDACTA
without giving prior notice thereof.
The trademarks and product names quoted in this
manual belong to the respective owners.
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MEDACTA iMNS - Instrumentation and Hardware ref. 99.30H.16US rev.02
1. GENERAL DESCRIPTION
1.1 INTENDED USE
The iMNSTM Medacta Navigation System is intended to be used to support
surgeon during specific orthopaedic surgical procedures by providing
information on bone resections, instrument and implant positioning.
The iMNSTM Medacta Navigation System provides computer assistance to
the surgeon based on anatomical landmarks and other specific data
obtained intra-operatively that is utilized to place surgical instruments.
Examples of surgical procedures include but are not limited to:
• Total knee replacement
• Minimally invasive total knee replacement
The MEDACTA iMNSTM system
information of diagnostic nature.
does
not
provide
Use the iMNSTM system only with the equipment
specifically supplied or approved by MEDACTA.
The iMNSTM navigation system must be cleaned and
disinfected immediately after use by qualified personnel
(see §5.1 Cleaning).
Clean and disinfect the instruments supplied in trays to
be used with the iMNSTM navigation system before
sterilization following the “Recommendations for the
Decontamination
and
Sterilization
of
Medacta
International
SA
Reusable
Orthopaedic
Devices”,
available from the company’s website www.medacta.com
or by calling 1 (800) 901-7836.
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The iMNSTM system shall not be used to perform
surgeries other than the ones indicated in the surgical
techniques described in this manual.
Do not use the iMNSTM system in the presence of sources
or reflectors of intense infrared radiation as under these
conditions the acquisition system is unable to work
properly. Additionally, avoid exposing the acquisition
system to direct daylight.
In case of knee operations, adequate mobility of the
corresponding hip joint is an essential requirement for
the effective use of the iMNSTM system.
It is essential to always bear in mind all the warnings
related to the surgery to be performed.
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1.2 COMPLICATIONS
If the MEDACTA iMNSTM system is improperly used, the following
complications may arise including but not limited to:
• Infection
• Incorrect implant positioning
• Failed recovery of the articular functionality
Refer to the respective package insert of the implants for a
comprehensive list of complications and information regarding the
implants.
Like all electrical devices, the MEDACTA iMNSTM
navigation system may be subject to malfunctioning due
to improper use or to technical reasons. It is however
always possible to complete the surgery with the aid of
the standard equipment, which must necessarily be
available in the operating theater.
Do not use the iMNSTM system in the presence of
flammable materials, such as anaesthetics, solvents,
detergents, and gases.
Although the iMNS Navigation System has been tested
and declared fully satisfying the electromagnetic
compatibility requirements indicated in the standards EN
60601-1-2 2nd ed., radio communication devices,
including portable ones, may interfere with the iMNSTM
system reducing its accuracy.
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MEDACTA iMNS - Instrumentation and Hardware ref. 99.30H.16US rev.02
1.3 STRUCTURE AND OPERATION
The iMNS system is made up of the following devices:
•
Acquisition system (1)
NDI PASSIVE POLARIS SPECTRA® SYSTEM composed of 2 infrared
cameras (Position Sensor) equipped with IR LEDs to track the
reference arrays.
•
Information processing and display system (2)
The data are processed and displayed using an Apple iMac® computer
running navigation software developed internally by MEDACTA.
•
Interface devices (3 and 4)
The iMNSTM system is controlled by means of the following devices:
keyboard, 3-pedal footswitch, and mouse (optional).
•
Manual Reusable Instruments
The system works with reusable instruments supplied in trays.
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Technical specifications of the 3-pedal footswitch
can be found on the label located on the bottom of
the unit.
1.4 TRAINING
The system shall be used exclusively by suitably trained
personnel.
Studying this manual is an integral part of the training
process. Should any part of the manual not be clear,
refer to the specialized MEDACTA staff for help.
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2. HARDWARE AND INSTRUMENTS
2.1 POLARIS SPECTRA® ACQUISITION SYSTEM
The acquisition system, NDI PASSIVE POLARIS SPECTRA® SYSTEM,
consists of a pair of cameras (Position Sensor) capable of emitting and
receiving infrared rays reflected by special reflectors (passive markers)
positioned on reference arrays (Figure 1).
Passive marker
Figure 1 – Reference arrays
During
the
surgeries,
different
reference arrays are used. Their
position is identified and represented
by the system in real-time.
Thanks to the binocular vision of the Position Sensor, a triangulation
process of the acquired images can be performed (Figure 2), identifying
the position of each marker with a tolerance of 0.5 mm. When all 3
markers positioned on the reference array are visible to the Position
Sensor, the system is able to reconstruct and represent the position and
precise orientation of the body. If some of the markers are not visible,
the system blocks the confirmation of the acquisition until the reference
array is again fully visible and recognized.
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Figure 2 – Image Acquisition
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The acquisition system is made up of very sensitive
precision instruments. Protect it against bumps and
dropping in order not to jeopardize its precision and
proper operation. Always position the POLARIS
SPECTRA® system on a stable support.
Before use, inspect the system and make sure that it is
intact and clean. Should this not be the case, the
measuring accuracy would be jeopardized.
The following label is located on the top of the position
sensor:
Do not use transparent materials (glass, Plexiglas, or
any other materials) to protect or shield the POLARIS
SPECTRA® system during the acquisitions. Even
transparent materials or clear plastic in the line-of-sight
of the cameras may degrade system performance.
The machine must be properly grounded in order to
operate safely. Do not bypass the grounding using threeto-two-prong adapters.
The POLARIS SPECTRA® system is not designed to
perform absolute measurements. Use of the system to
carry
out absolute
measurements
may produce
inaccurate results. The manufacturer recommends using
a reference instrument whenever possible to assure that
there
are
no
measuring
inaccuracies
due
to
environmental or time causes.
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Do not connect or disconnect the camera system when
the power supply unit is live, as this might damage the
system.
Never disconnect the power cables or the 14-pin cable of
the Position Sensor when the amber light ( ) on the front
of the Position Sensor is on. Make sure that the system
has been turned off before disconnecting any of these
cables.
Do not look directly into the Class 2 laser-emitting
aperture. Take precautions to ensure that patients do
not look directly into it. Direct viewing of the laser diode
emission may cause eye damage.
The follwing label is located in the back of the unit.
Please read it carefully.
Use of laser controls or adjustments or performance of
laser-related procedures other than those specified
herein may result in hazardous radiation exposure.
Information about the Polaris
Spectra in use (Item ID, Serial
Number and manufacturing date)
are reported on a label located on
the back of the unit.
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2.2 IMAC® COMPUTER
Figure 3 – Frontal view of iMAC Computer
MEDACTA has chosen to use the integrated Apple iMac® computer for
data processing and display. This compact and highly reliable system
reduces wiring complexity and space required in the operating theater. It
also allows setting up the iMNSTM system with a few simple operations.
On the base of the iMAC
computer support is located a
label indicating the manufacturer
name and
the machine serial
number.
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Figure 4 – Rear view of iMAC Computer
The machine must be properly grounded in order to
operate under safety conditions. Do not bypass the
grounding using three-to-two-prong adapters.
To prevent risks of overheating, do not obstruct the
ventilation opening on the rear of the device.
Do not insert any object in the ventilation opening on
the rear of the device.
As the iMac® system cannot be sterilized, never place it
in a sterile field for any reason whatsoever.
Before proceeding with the cleaning operations, check
that the system is off and that all the cables have been
disconnected.
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Do not turn off the system by pressing the power button.
To turn off the system exit the navigation software.
Do not sterilize the iMac® system or any of its parts in an
autoclave.
Never disconnect the power cable when the system is
on.
Do not immerse the system in water. Do not let water or
other liquids penetrate the system in any way.
To clean the outside of the computer use a soft and
clean cloth. Do not spray any liquid directly onto the
computer. Refer to § 5.1 for cleaning instructions.
IMPORTANT NOTICE:
The iMAC computer provided with the iMNS can not be used for any
purpose other than navigation with the software provided by
MEDACTA.
Please carefully take in account the label located on the back of the iMAC
computer and reported here:
Mini-DVI,
Ethernet
(10/100/1000Base-T), Audio
line-in, Headphone out and
FireWire 400 ports are NOT
used
by
the
navigation
system.
In
particular,
Ethernet port is NOT FOR
PHONE CONNECTION.
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This label is positioned above
the Ethernet port on the back
of the iMAC computer.
MEDACTA iMNS - Instrumentation and Hardware
2.3 REOMED® 600 ISOLATION TRANSFORMER
The iMac® system is connected to the mains through the REOMED® 600
isolation transformer equipped with a protection against short-circuits
and overloads and a current limiter. The transformer is equipped with a
power switch and EMC line filter.
Figure 5 –REOMED 600
Electrical device operating at potentially hazardous or
lethal voltages: the maintenance operations must be
carried out by qualified personnel.
Pull the plug from the mains socket
installation or maintenance operations.
before
any
Before using the unit, check that the mains voltage is
compatible with that of the device (see §3.4.3).
Do not use the device in the presence of flammable or
hazardous substances.
To prevent the risk of electric shocks, protect the
transformers and cables used against moisture.
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The system is supposed to function under a 115 V
voltage.
This label is positioned on the back of the Reomed®
isolation transformer.
2.4 INSTRUMENTS
For information related to the navigation instruments, refer to the
software instructions for use.
Refer to the “Recommendations for the Decontamination and Sterilization
of Medacta International SA Reusable Orthopaedic Devices”, available
from the company’s website www.medacta.com or by calling 1 (800)
901-7836
Before every surgery, make sure that the instruments
have been properly sterilized and that they are in such
conditions as to adequately perform their function.
Before sterilizing the reference
markers from the supports.
arrays,
remove
the
THE MARKERS ARE FOR SINGLE USE ONLY: do not resterilize them, do not re-use them.
Re-sterilizing or re-using the markers may deteriorate
the reflecting properties and the system may not be able
to recognize the reference array.
The user is responsible to follow the directions for
properly handling the components.
Always have the instrumentation for non-navigated
surgeries sterilized and ready as a back up to any
navigated surgical procedure.
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3. INSTALLATION AND START
To facilitate transport and at the same time guarantee adequate
protection, the Medacta iMNSTM navigation system is supplied in two rigid
cases with appropriately shaped foam rubber linings.
One case contains the Polaris Spectra® Position Sensor (c), the support
tripod (a) and the REOMED® 600 isolation transformer (b).
Figure 6 – First iMNS transport case
The other case contains the iMac® system (e) complete with keyboard
(d), 3-pedal footswitch (h), USB and power cables (g), Host UBS
Converter and feeder of the Polaris Spectra® system (f).
Figure 7 – Second iMNS transport case
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Do not use cables or accessories other than those listed
in this manual. The use of other cables or accessories
may result in increased emission and/or decreased
immunity of the Polaris Spectra System and may lead to
personal injury.
3.1 WIRING DIAGRAM
A
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Electrical plugs and their sockets differ by country in
shape, size and type of connectors.
Make sure that the supplied mains power connector (A)
matches your local socket.
Do not connect any other electrical
devices than those shown to the outlets
of the REOMED isolation transformer.
Mains power connector supplied with
iMNS for the US market is displayed in the
picture on the right
In order to achieve an appropriate grounding reliability,
the equipment must be connected to an equivalent
receptacle marked ‘Hospital Only’ or ‘Hospital Grade’.
Please take into account the following warning label,
applied on the mains power supply unit:
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3.2 ASSEMBLING THE MARKERS ON THE
REFERENCE ARRAYS
Figure 8 – Reference arrays
Before each surgery, apply the sterile markers on each
reference array. The markers are pressure-fitted on the
special supports.
Only use markers supplied by MEDACTA. Using different
markers from those supplied by MEDACTA may result in
a loss of accuracy.
Make sure that the markers are firmly inserted and at
the end of their stroke on the pin.
In addition to the markers, the discs shown in the figure
8 must be assembled on the pointer and the G-shaped
reference array. They are indispensable for accurate
acquisition. Do not proceed with navigation if the discs
have not been fitted.
STERILE MARKERS ARE FOR SINGLE USE ONLY!
Do not re-sterilize them.
Do not re-use them.
Re-sterilizing or re-using the markers may deteriorate
the reflecting properties and the system may not be able
to recognize the reference array.
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3.3
ASSEMBLING THE SUPPORT TRIPOD
Open the cases by lifting the tabs of the
closing
mechanism
and
turning
them
anticlockwise (figure 9).
Figure 9 – Case locking system
Take the support tripod out of the case, slide the locking device (P in
Figure 10) to release the opening and open the tripod legs wide apart.
Releasing the locking device (P) secure the legs in open position (Fig. 10
–b-) ensuring that they are firmly in place.
-a-
-bFigure 10 – Tripod base
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Position the ball joint (G in figure
11) of the Polaris Spectra® system
on the tripod stem and, turning
the fastening knob (M), securely
tighten the locking device to
prevent the joint from slipping
from the stem.
Figure 11
Position Sensor on the Tripod
Extend the tripod by sliding out the
telescopic rods. Once the desired
height has been reached, securely
tighten the locking devices by
turning the fastening knobs (figure
12).
Figure 12 – Adjusting tripod height.
22
Make sure that the structure is
stable.
Knocking
or
dropping
the
®
Polaris Spectra
system may
cause irreparable damage.
During acquisition, even small
system vibrations may lead to
inaccurate
and
unreliable
results.
Stability of the system will be
enhanced if the locking latches
on the castors are depressed.
MEDACTA iMNS - Instrumentation and Hardware ref. 99.30H.16US rev.02
3.4 INSTALLING AND TURNING ON THE SYSTEM
System
installation
requires
wiring
of
different
components. Make sure that this operation is carried out
in such a way as to minimize the space used in the
operating theatre and the risk of accidental detachment
of the connectors during surgery.
Should one of the connectors accidentally slip out of its
seat, check the integrity of the cable and the connector.
Make sure to reinsert the connector in the correct socket
and check device functioning. In some cases, the system
will have to be restarted.
3.4.1
Polaris Spectra® acquisition system wiring
To provide power supply to the Polaris Spectra® acquisition system, follow
the steps below.
Figure 13 – Polaris Spectra Acquisition System
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Insert the 14-pin connector of the Host USB Converter in
corresponding socket on the rear of the Position Sensor (Figure 13).
the
As shown in figure 14, connect the A end of the USB cable to the sockets
( ) and the power adapter cable of the power supply unit to the special
socket ( ) of the Host USB Converter.
Figure 14 – Host USB Converter wiring
Insert the Y end of the power cable in the Polaris Spectra® power supply
unit.
Information (Item ID, Model and Serial
Number) are reported on a label located on
the back of the USB Converter.
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Figure 15 – Polaris Spectra Power Supply Unit wiring
Detailed information about the power supply are
displayed on the label located on the unit.
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3.4.2
iMAC® Computer wiring:
As shown in the figure below, connect the Host USB Converter to the
iMAC® system inserting the B end of the USB cable in one of the three
socket ( ) on the rear of the iMAC® screen.
Figure 16 – iMAC Computer wiring
Connect the keyboard to anotherone of the USB ports ( ). If a wireless
keyboard (optional) is available, switch on the keyboard with the switch
located on the lower face of the device. Check that the green LED comes
on.
Connect the footswitch to one of the USB ports ( ) on the body of the
iMac® system or to one of the USB ports locate on the keyboard, using
the special adapter if necessary.
Connect the mouse (optional) to one of the USB ports ( ) on the body of
the iMac® system or on the keyboard.
It is advisable to insert the keyboard and the footswitch in a transparent
plastic bag large enough to cover as much cable as possible. Close the
bag around the cable using some adhesive tape.
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3.4.3
REOMED® 600 isolation transformer wiring:
Connect the X end of the iMAC® power cable in one of the sockets (C in
figure 17) of the REOMED® 600 isolation transformer, likewise insert the
power cable of the Polaris Spectra in another of these sockets.
D
Figure 17 – REOMED 600 wiring
Check that the switch (A in figure 17) is set to OFF (O) and insert the
remaining power cable into the input socket of the isolation transformer
(B in figure 17) and into the mains power outlet.
Connect the REOMED® 600 isolation transformer to an
electric system in compliance with the national
regulations regarding electrical safety in the operating
theater. In case of doubt, refer to qualified technical
staff.
Check that the input voltage agrees with the local mains
voltage reading the number you can see through the slot
of the fuse-holder on the transformer’s rear (D in figure
17). (230 for 220V mains voltage – 115 for 110V mains
voltage). If the voltages disagree, refer to the qualified
technical staff.
27
When replacing input fuses only use the same type
supplied with the unit. See section 6.1.4 for the fuse
specifications.
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Detailed technical specifications of the REOMED® 600 can be found on the
label located on one side of the unit:
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3.4.4
Turning on the iMNS®
Turn on the REOMED® 600 isolation transformer by setting the switch (A
in figure 17) to ON (I).
Check that the LED on the power supply unit and the green Power LED
(I) on the Host USB Converter become on and the Power LED (I) on the
front of the camera starts flashing (figure 18).
Figure 18 – LEDS on Polaris Spectra System
When the power LED stops flashing, you can hear two beeps.
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Never disconnect the power cable or the 14-pin cable
when the amber light (error LED ) on the front of the
Position Sensor (figure 18) is on. Check that the system
is off before disconnecting any of these cables.
It is advisable to wait 20 minutes from the turning on
the system before proceeding with the acquisitions. The
device requires a warm-up and thermal stabilization
period before being able to operate with maximum
accuracy. During warm-up the Power LED of the Position
Sensor flashes, once this LED is steady, the system is
ready to use.
To prevent damaging the cables, do not to bend them
excessively.
The power supply unit must be located outside the
patient vicinity under ALL operating conditions.
Do not obstruct the normal flow of air around the
Position Sensor (e.g. draping or bagging it). Doing so
will
affect
the
Position
Sensor’s
operational
environment,
possibly
beyond
its
recommended
thresholds.
It is the responsibility of the system integrator and/or
the end-user to ensure that the system is appropriately
configured for the operating conditions.
When these steps have been
completed, the acquisition system
is connected and powered.
Finally, start the iMAC® Computer
using the power button.
Figure 19 – iMAC Computer
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3.5 STARTING AND USING THE NAVIGATION
SOFTWARE
For the instructions on the startup and use of the software, refer to the
enclosed software manuals.
THE iMAC® COMPUTER PROVIDED WITH THE iMNSTM
SYSTEM HAS UNDERGONE HARDWARE AND SOFTWARE
MODIFICATIONS TO OPTIMIZE PERFORMANCE OF THE
NAVIGATION PROGRAM. AS A RESULT, IT IS NO LONGER
POSSIBLE TO USE iMAC® AS A PERSONAL COMPUTER OR
FOR
OTHER
APPLICATIONS
DIFFERENT
FROM
NAVIGATION WITH THE SOFTWARE SUPPLIED BY
MEDACTA.
Some applications has the possibility to jump form one screen to another
by mean of dedicated shortcuts. This label summarizing the available
shortcuts is optionally available, positioned in front of the iMAC computer.
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4. TROUBLESHOOTING
PROBLEM DESCRIPTION
TROUBLESHOOTING
1. INSTALLATION
1.1 Problem in assembling the camera
Follow the assembly instructions.
support tripod
2. SETUP
2.1 Turning on
2.1.1 The system does not turn on
Check the power cable
2.1.2 The camera does not turn on
Check the power cables
3. STARTING THE SYSTEM
3.1 A fault occurs
In case of a fault, follow the on screen instructions
Contact technical service
4. LOGIN
4.1 A keyboard problem occurs
Check the cable that connects the keyboard to the
main unit
5. NAVIGATION
Check the connection to the iMac computer
5.1 The footswitch does not transmit the
Disconnect and reconnect the footswitch cable 1
signal to the system
Then check manually via the keyboard
5.2 The system turns off unexpectedly
Check the power cable
5.3 The main unit does not see the camera
5.3.1 The camera is off
Check the connection cables
Check that there is not too much natural light in the
room.
Check the integrity 2 of the cameras, and that there
are no scratches and marks on the POLARIS
5.3.2 The camera is on but the main unit SPECTRA® Position Sensor
cannot communicate with it
Check that there are no light sources shining
directly on the camera
Check the camera position
Check the USB connection between the Host USB
Converter and the iMAC
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Clean the passive markers
Check proper assembly of the passive markers
Check that the field of view of the camera is
5.3.3 One or more reference array are not unobstructed
visible to the camera
Check the camera position
Check the integrity of the reference arrays
Remove from the field of view of the camera all the
reference arrays not currently in use
1 In some rooms, for construction reasons, an
electrostatic charge may build up on the footswitch,
which interferes with the proper operation of the
device.
2 The presence of scratches or marks on the body
of the POLARIS SPECTRA® system may be an
indication that it has not been handled with the due
care. In this case, suspend use of the navigator
and contact the Technical Service to have the
functions checked and recalibrated, if necessary.
For questions or service requests contact Medacta customer support:
www.medacta.ch
info@medacta.ch
1 (800) 901-7836.
or the sales representative in your country.
Before contacting Technical Service, make sure that the following
information is available:
• System serial number (located on the identification plate –see
below)
• Installed software version
• Possibly reference to the component for which assistance is being
requested
• Any error message that has appeared and a description of the
problem
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MEDACTA iMNS - Instrumentation and Hardware ref. 99.30H.16US rev.02
The identification plate is located on the top of the Reomed® isolation transformer.
Serial Number
Manufacturing
Date
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MEDACTA iMNS - Instrumentation and Hardware ref. 99.30H.16US rev.02
4.1 POLARIS SPECTRA® LEDS
The power, status and error LEDs on the Position Sensor indicate the
status of this component as described in the following table (Figure 18).
Power Led
(green)
Status Led
(green)
Error Led
(amber)
Flashing
(Any state)
(Any state)
Solid
Solid
Solid or off
Solid
Solid
off
Off
Flashing
Solid
Solid
off
Solid
off
off
Off
Meaning and Action Required
The power LED will stop flashing and light steady
green when system is ready for use.
The Position Sensor is ready for use; no faults
Minor recoverable fault.
Major recoverable fault.
Non-recoverable fault.
Return the Position Sensor for service.
Voltage is out of range.
Check the Position Sensor, Host USB Converter,
or cables.
On the Host USB Converter there are two LEDs (Figure 18): the Power
LED (green light) and the Error LED (amber light). They show the status
of this component as described below.
35
Power Led
(green)
Error Led
(amber)
Meaning and Action Required
Solid
Off
Solid
Solid
Off
Off
The Host USB Converter works; no faults
There’s a fault.
Unplug the cable of the power supply unit
from the special socket ( ) of the Host USB
Converter. Wait approx. 10 seconds and then
plug it in again. If the Error LED is still on,
disconnect the Position Sensor. If the Error
LED goes off replace the Position Sensor,
otherwise check or replace the Power Adapter
or the Host USB Converter.
Voltage is out of range.
Check the power cables.
MEDACTA iMNS - Instrumentation and Hardware ref. 99.30H.16US rev.02
4.2 AUDIO CODES
The Position Sensor is able to emit audio tones which provide an audible
indication of the system status.
When the power is initially applied to the system or the system is reset,
the Position Sensor emits two beeps indicating proper operation.
If a fault condition occurs the system will emit two beeps every three
seconds. In this case please contact Medacta for technical service.
4.3 CLEANING AND MAINTENANCE
4.4 CLEANING
As the iMNS system cannot be sterilized, never place it in a sterile field
for any reason whatsoever.
Before proceeding with the cleaning operations, check that the iMNS
system is off and all the cables have been disconnected.
To clean the iMNS Navigation System use soft and clean cloth moistened
with 70% isopropyl alcohol solution or specific products such as KENDALL
CURITY® Alcohol Preps or Sani-Cloth® wipes.
Additional care must be taken when cleaning the Position Sensor (see
following paragraph).
Do not immerse any part of iMNS system in water and do not let water or
other liquids penetrate the system in any way.
Do not sterilize the iMNS system or any of its parts in an autoclave.
Do not use spray detergents on or near the iMNS system. Spray
detergents might penetrate the system and damage the circuits.
Do not use solutions containing chlorinated solvents, aromatic solvents
(paint thinners, naphta,…), acetone, ammonia, benzene, xylene.
Do not use hard, pointed or abrasive objects to clean the iMNS
Navigation System.
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MEDACTA iMNS - Instrumentation and Hardware ref. 99.30H.16US rev.02
4.4.1
Polaris Spectra® System cleaning
Before cleaning the lenses of the Position Sensor, remove any possible
trace of dust using compressed air (or, preferably, nitrogen) or a brush
made for cleaning photographic lenses. Gently wipe the surface in one
direction only, by pulling the brush across the surface.
To disinfect the lenses and the remainder of the Position Sensor
disinfectant wipes containing 70% isopropanol (for example, KENDALL
CURITY® Alcohol Preps) can be used.
For actual cleaning, use a commercial lens cleaning solution formulated
for multi-coated lenses (for example, AR66) and a clean knitted
microfibre optical cleaning cloth (for example, Hitecloth)
Do not use paper towels on the lenses as this might scratch them. NEVER
use water, soap, detergents or other liquids on the lenses.
When you clean the remainder of the Position Sensor, take care not to
wipe debris from the Position Sensor case onto the illuminator filters or
lenses.
Avoid prolonged contact between the wipes and the Position Sensor.
Dirt, blood or damp on the markers may hamper their recognition by the
acquisition system. In this case, clean them by gently dabbing them with
a soft and dry cloth.
If any traces of blood have dried, remove them with a wet cloth and then
dry the markers.
Should this not be sufficient, replace the dirty markers.
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MEDACTA iMNS - Instrumentation and Hardware ref. 99.30H.16US rev.02
4.5 IMNS® SYSTEM MAINTENANCE AND REPAIR
The iMNS navigation system must undergo maintenance and be checked
at least every 24 months. Regular maintenance will ensure full
functionality of the system.
THE
REPAIR,
MAINTENANCE
AND
CHECKING
OPERATIONS SHALL BE CARRIED OUT EXCLUSIVELY BY
SPECIFICALLY TRAINED PERSONNEL AUTHORIZED BY
MEDACTA
To ship the MEDACTA iMNS system use the original
containers with all the protective wrappings to prevent
damaging the system.
Do not transport or store the system outside the
recommended storage temperature range , this may
cause the system to go out of calibration.
In the following table the transportation and storage environmental
conditions are summarized.
Specification
Atmospheric Pressure
Relative Humidity
Temperature
Value
70 kPa to 106 kPa
10% to 90% non-condensing
-10°C to +50°C
This label reminding the storing condition is positioned on the top of the
Reomed® isolation transfomer.
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MEDACTA iMNS - Instrumentation and Hardware ref. 99.30H.16US rev.02
5. TECHNICAL SPECIFICATIONS,
CONFORMITY, CLASSIFICATIONS,
ELECTROMAGNETIC COMPATIBILITY
5.1 TECHNICAL DATA AND CONFORMITY
In the following table the operating environmental conditions of the
iMNSTM System are reported.
Specification
Atmospheric Pressure
Relative Humidity
Temperature
Value
70 kPa to 106 kPa
30% to 75% non-condensing
+10°C to +30°C
The iMNS Medacta Navigation System has been tested and declared
complying with the Standard CEI-EN 60601-1 and amendments A1, A11,
A12 and A2, together with the Standard EN 60601-1-1.
The iMNS Medacta Navigation System has been tested and declared
complying with the Standard EN 60601-1-2 2nd edition.
This label is located on the back
of iMAC computer base and
shows the expiring date of
electrical safety test validity.
The frequency of the test is fixed
in at least 2 years.
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MEDACTA iMNS - Instrumentation and Hardware
5.1.1
Polaris Spectra® Technical Specification
THE NDI PASSIVE POLARIS SPECTRA® SYSTEM has been tested and
declared complying with IEC 60601-1-2, Sec. Ed., 2001 (Medical
Electrical Equipment - Collateral Standard: Electromagnetic compatibility
- Requirements and tests).
The POLARIS SPECTRA® system has been tested for electrical safety and
risk of fire. No other physiological effects have been evaluated.
The ambient operating temperature range of the Polaris Spectra® System
is dependent upon the physical location of the Host USB Converter. If the
Host USB Converter is located where it may get in touch with the patient,
the operating ambient temperature ranges from +10°C to +30°C.
Otherwise, if the Host USB Converter is placed outside this patient
vicinity, the operating ambient temperature range permitted for the
system is +10°C to +40°C.
Although the POLARIS SPECTRA®
system can operate in a wide
temperature range (10°C-30°C), all the performances specified, including
accuracy, are based on characterization and calibration performed at
20°C.
All the NDI acquisition systems are designed for use of specific NDI
components only.
Do not use the POLARIS SPECTRA® system in radioactive environments.
The system has not been tested nor approved for use in radioactive
environments.
Position Sensor
− Maximum Update Rate: 60 Hz
− Input Voltage: 18-32 VDC
− Power Consumption: 13.5 W
Host
−
−
−
USB Converter
Input Voltage: 24 VDC
Output Voltage: 26 VDC
Power Consumption: <2 W
MEDACTA iMNS - Instrumentation and Hardware ref. 99.30H.16US rev.02
Power Adapter
− Input Voltage: 100 VAC to 240 VAC, 50/60 Hz
− Output Voltage: 24 VDC @ 2.1 A
− Power Consumption: 50 W (max.) (24 W typical)
14-pin Position Sensor cable
− permanently connected to the Host USB Converter
− various lengths (max 30 m)
− screened
USB
−
−
−
cable
A-B male
double shielded
5m
Positioning Laser
The positioning laser is a Class 2 laser, with a wavelength of 635 nm and
a maximum output of 1mW. The Polaris Spectra System containing a
positioning laser conforms to the following standards:
- ANSI Z136.1 (2000)
- IEC 60825-1 (2001)
- FDA/CDRH 21 CFR 1040.10 and 1040.11 except for deviations
pursuant to Laser Notice No. 50, dated July 26, 2001
Power Adapter Output Cable
− Cable AC Line Cord
− permanently connected to the power adapter
− plug-in jack connector
Power Adapter Power Cable
− medical grade AC line cord
Electromagnetic Immunity Standards
− IEC 61000-4-2: ±6 kV in contact, ±8 kV in air
− IEC 61000-4-4: ±2 kV for the power lines, ±1 kV for the I/O lines
− IEC 61000-4-5: ±1 kV differential, ±2 kV common
− IEC 61000-4-11: <5%Ut for 0.5 cycle, 40%Ut for 5 cycles, 70%Ut
for 25 cycles, <5%Ut for 5 sec
− IEC 61000-4-8: 3 A/m
− IEC 61000-4-6: 3 V
− IEC 61000-4-3: 3 V/m
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MEDACTA iMNS - Instrumentation and Hardware ref. 99.30H.16US rev.02
5.1.2
iMac® Computer Technical Specifications
Hardware summary:
− Computer model: iMAC
− CPU type: Intel Core 2 Duo
− CPU number: 1
− CPU speed: 2 GHz
− Memory: 1 GB RAM
Power supply:
− Voltage: 100-240V AC
− Rate: 50-60 Hz
Monitor data:
− Monitor type: 20'' LCD
− Resolution: 1680 x 1050 pixels
DVD burner data:
− SuperDrive 8x
− CD-burner: -RW
− DVD-burner: +R DL, +RW
Certifications and conformity:
− CE 0984
− ICES-003 Class B
− FCC ID: BCGA1115
− IC: 579C-A1115
5.1.3
Acquisition Device Support Tripod Technical
Specifications
Made up of MA299 stem + ball joint MA486
Minimum height: 117.2 cm
Maximum height: 281.2 cm
Load at maximum extension at 10° inclination: 2.7 kg
Weight 5.2 kg
Maximum clearance on ground: 75 cm
Panoramic rotation: 360°
Lateral inclination: -90°/+90°
Stem diameter: 35, 30, 25 mm
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MEDACTA iMNS - Instrumentation and Hardware ref. 99.30H.16US rev.02
5.1.4
REOMED® 600 Isolation Transformer
Input voltage: 115V / 230 V, 50 / 60 Hz
Output voltage: 230 V, 50 / 60 Hz on 6 sockets - EN60320
Current: 2.6 A
Power: 600 VA
Equipped with input fuse: F1=6.30A T F2=3,15A T(5x20)
Case protection IP 20
Protection class I
The REOMED® 600 complies with the Low Voltage Directive 73/23/EEC.
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MEDACTA iMNS - Instrumentation and Hardware ref. 99.30H.16US rev.02
6. APPENDIX - EQUIPMENT SYMBOLS
SYMBOL
MEANING
Attention/Caution
Consult acompanying
documents
Refer to accompanying
documentation
Laser warning
Consult accompanying
documents
Polaris Spectra Position Sensor
ON (power: connection to
the mains supply)
Polaris Spectra Position Sensor
Host USB converter
REOMED 600
OFF (power: disconnection
from the mains supply)
REOMED 600
Status (see user manual)
Polaris Spectra Position Sensor
Error (see user manual)
Polaris Spectra Position Sensor
Host USB converter
Laser Activation button
Polaris Spectra Position Sensor
Connection Port
Polaris Spectra Position Sensor
Recycle where possible or
return to manufacturer
Direct Current (DC)
Alternating Current (AC)
USB port / USB plug
44
LOCATION
iMac computer
Polaris Spectra Position Sensor
Host USB converter
Polaris Spectra power adapter
REOMED 600
3-pedal footswitch
iMac computer
Polaris Spectra Position Sensor
Polaris Spectra Position Sensor
Host USB converter
Polaris Spectra power adapter
REOMED 600
Host USB converter
Polaris Spectra power adapter
iMac computer
Polaris Spectra power adapter
iMNS identification plate
Host USB converter
3-pedal footswitch
ON/OFF button
iMac computer
Indoor use only
Polaris Spectra power adapter
MEDACTA iMNS - Instrumentation and Hardware ref. 99.30H.16US rev.02
7. APPENDIX – ACRONYMS AND
ABBREVIATIONS
AC
CD
DC
DVD
EMC
IR
LED
RAM
USB
45
Alternating Current
Compact Disc
Direct Current
Digital Versatile Disc
Electromagnetic Compatibility
Infra Red
Light Emitting Diode
Random Access Memory
Universal Serial Bus