MIDAS REX™ ELECTRIC BONE MILL
BM110 & BM120
User’s Guide
Table of Contents
Symbols .................................................................................................................................................................... 3
When The System Arrives .................................................................................................................................... 3
Warnings and Precautions .................................................................................................................................. 3
System Description ................................................................................................................................................ 5
Indications .................................................................................................................................................... 5
Contraindications ...................................................................................................................................... 5
Setup And Operation ............................................................................................................................................ 5
Operative Procedure ................................................................................................................................. 5
Post-Operative Procedure ....................................................................................................................... 6
Cleaning .................................................................................................................................................................... 6
Sterilization ............................................................................................................................................................... 6
Limited Warranty .................................................................................................................................................... 7
Service ........................................................................................................................................................................ 7
Troubleshooting ..................................................................................................................................................... 7
Technical Specications ....................................................................................................................................... 8
Midas Rex™ Electric Bone Mill Components ............................................................................................... 8
Electromagnetic Compatability ........................................................................................................................ 9
It is important that you read this entire manual before you use the Midas Rex™
Electric Bone Mill. It is unsafe to use this device before you have read and are
thoroughly familiar with this document.
NOTICE
2
Symbols
REF
SN
D
the device, which could result in patient injury, illness, or death.
STERILE EO
Sterilized using ethylene oxide.
LOT
Medtronic.Com for instructions on proper disposal of this product.
EC REP
710044
10 mins
Bone Mill
! USA
P/N
+ XX °C
- XX °C
When the System Arrives
Caution
Follow instructions for use
Catalog number
Serial number
Date of manufacture
Manufacturer
Fuse
For single patient use only. Do not re-use, re-process, or re-sterilize this
product. Re-use, re-processing or re-sterilization may compromise the
structural integrity of the device and/or create a risk of contamination of
Lot number
O position of on-o switch
Run
Moving parts can crush and cut. Keep hands clear.
RF transmitter (interference may occur)
Do not dispose of this product in the unsorted municipal waste stream.
Dispose of this product according to local regulations. See http://recycling.
Unpacking and Inspection
As the box is unpacked, check o the contents of the box against
the items listed on the packing slip. If the contents are incomplete
or if there is damage, notify Customer Service. If the shipping
container is damaged, or the cushioning material shows signs of
stress, notify the carrier as well. Keep the shipping materials for
carrier inspection.
Aer unpacking your new Midas Rex™ Electric Bone Mill, save
the cartons and packing material. If the instrument is to be
shipped from one location to another, the carefully designed
shipping package will provide proper protection.
Warnings and Precautions
It is important that the Midas Rex™ Electric Bone Mill operator be
familiar with this manual: its precautions, procedures and safety
issues. Four labels are used in this manual to identify important
concerns, conditions, or procedures:
WARNING
Describes serious adverse reactions and potential safety
hazards that can occur during the proper or improper use
of a device.
IPX1
IPX2
Max ON 45 s
/ Min OFF
Authorized representative in the European Community
is device complies with medical device directive 93/42/EEC
Conforms to ANSI/AAMI ES 60601-1, IEC/EN 60601-1
Certied to CSA C22.2 No. 60601-1
Caution: federal law in the U.S.A. Restricts the sale, distribution or use of
this device to, by or on the order of a licensed medical practitioner.
Protected against vertically dripping water
Protected against vertically dripping water when the enclosure is inclined
15°
EN60601-1 duty cycle - maximum on time 45 seconds / minimum o time
10 minutes
Bone Mill
Sterilized using irradiation
Quantity
For U.S. Audience only
Part number
PRECAUTION
Any special care to be exercised by a practitioner or
patient for the safe and eective use of the device.
IMPORTANT
Identies conditions or practices which require attention
for most desirable results.
NOTE
Identies special information or to clarify / emphasize
important instructions.
ROHS - Environmental friendly use period - China (SJ/T11364-2006.)
Temperature Limitation
MIDAS REX™ ELECTRIC BONE MILLMIDAS REX™ ELECTRIC BONE MILL MIDAS REX™ ELECTRIC BONE MILLMIDAS REX™ ELECTRIC BONE MILL
3
WARNING
1. It is important that the Electric Bone Mill operator be familiar with this manual, its precautions, procedures and safety issues.
2. is medical device complies with EN60601-1-2 safety standard for electromagnetic compatibility, requirements and test.
However, if this equipment is operated in the presence of high levels of electromagnetic interference (EMI) or highly sensitive
equipment, interference may be encountered and the user should take whatever steps are necessary to eliminate or reduce the
source of the interference. Diminished performance may lengthen operating time for anesthetized patient.
3. Medical Electrical Equipment needs special precautions regarding EMC and needs to be installed and put into service
according to the EMC information provided in this Guide.
4. Portable and mobile RF communications equipment can aect Medical Electrical Equipment.
5. Use of accessories and cables other than those specied and sold by Medtronic may result in increased emissions and decreased
immunity of this unit.
6. A system that is not functioning properly should not be used until all necessary repairs have been made and the unit is tested
to ensure that it is functioning in accordance with Medtronic specications.
7. Always inspect the components before and aer use for any damage. If damage is observed, do not use the damaged part until
it is repaired or replaced.
8. DO NOT operate the Midas Rex™ Electric Bone Mill base without the bowl and cap secured in place.
9. Verify reusable device was sterilized prior to use. If not sterilized, do not use.
10. Achieve electrical grounding reliability with proper connections. Connect the Bone Mill to hospital grade receptacles only.
11. DO NOT operate the Midas Rex™ Electric Bone Mill in the presence of ammable anesthetics. Avoid potential ignition or
explosion of gases.
12. Take care to process bone to the desired partical size. DO NOT over process bone.
13. e Midas Rex™ Electric Bone Mill bowl, cap, and spatula are provided STERILE and are intended for SINGLE PATIENT
USE ONLY. DO NOT RESTERILIZE THESE COMPONENTS. MEDTRONIC ASSUMES NO LIABILITY FOR PRODUCTS
WHICH HAVE BEEN RESTERILIZED BY HEALTH CARE FACILITIES. In discarding the disposables, follow health-care
facility guidelines on proper disposal of contaminated materials.
14. Disconnect power to the Midas Rex™ Electric Bone Mill base before cleaning the unit to avoid electrical shock.
15. Aer each procedure, properly clean all reusable system components.
16. Sterilizing and drying the Midas Rex™ Electric Bone Mill Base before storing decreases the likelihood of cross-contamination.
17. All service must be performed by Medtronic-qualied personnel only.
18. DO NOT operate the Midas Rex™ Electric Bone Mill before following proper cleaning and sterilization protocols.
19. Properly dispose of single-use devices removed from sterile packages. Devices lose sterility upon removal from packaging.
20. DO NOT come in contact with the interior of the disposable bowl or cap during the milling of bone.
21. DO NOT operate the Midas Rex™ Electric Bone Mill in the presence of Magnetic Resonance Imaging Devices.
22. DO NOT operate the Bone Mill without eye wear protection.
23. DO NOT use any other components except for Medtronic Midas Rex™ Electric Bone Mill disposables.
24. Do not use accessory if package is opened or damaged. A broken seal oers no protection against cross-contamination.
25. No modication of this equipment is allowed.
26. To avoid the risk of electric shock, this equipment must only be connected to a supply main with protective earth.
PRECAUTION
1. e addition of any liquid to the milling process should be administered in small volume to prevent leakage.
2. Improper sterilization or overloading of the Midas Rex™ Electric Bone Mill can lead to permanent motor damage.
3. e Midas Rex™ Electric Bone Mill must not be overloaded. DO NOT process more that 10 cc of bone at one time. e
maximum starting size of the pieces should not exceed 1.5 cc. Additional bone gra may be processed in separate batches or
loads.
4. DO NOT use Midas Rex™ Electric Bone Mill Disposables to process more than 6 bone pieces approximately 1.5 cm3 in size at
one time.
5. DO NOT use Midas Rex™ Electric Bone Mill Disposables to process more than a total of 40 cc of bone during any one surgical
procedure.
6. DO NOT immerse and/or soak the Bone Mill Base or Console.
7. DO NOT use chlorine based or corrosive cleaning agents such as bleach, acetone, solutions containing glutaraldehyde, etc.
8. e equipment should not be used adjacent to or stacked with other equipment and that if adjacent or stacked use is necessary,
the equipment should be observed to verify normal operation in the conguration in which it will be used.
9. Take care when placing base unit on a surgical drape, that the base is in a stable position and that the cable is safely routed.
10. DO NOT obstruct access to the power cord connection at the rear of the console.
4
1
System Description
1
2
3
5
4
5
1
3
MIDAS REX®
BONE MILL
2
e Midas Rex™ Electric Bone Mill is composed of a non sterile
console and base with sterile single use disposable components.
e sterile single use disposable components consist of one
bowl, one cap, and one spatula. A Midas Rex
Console provides the power to drive the base and disposable
components.
Indications
™
Electric Bone Mill
Disposables
Midas Rex™ Electric Bone Mill disposable components
2
3
e Midas Rex™ Electric Bone Mill is intended to mill bone,
producing bone particles 1 to 5 mm in size.
Contraindications
ere are no known contraindications.
Setup and Operation
Base with bowl and cap.
1. Cap
2. Bowl
3. Base
4. Run switch
5. Disposable bowl release buttons.
1. Bowl
2. Spatula
3. Cap
Operative Procedure
MIDAS REX®
BONE MILL
1. Connect the base cable to console.
Correct
2. Press bowl “rmly” onto Midas Rex™ Electric Bone Mill
Base until an audible click (lock) is heard. “Observe” that
both of the “Release Buttons” are fully ou
NOTE
Incorrect
t.
Console
BM200 bowl and cap are not compatible with this unit.
1. Power Switch (lighted indicator = On / O = O).
2. Bone mill base to console control cable.
3. LED (illumination indicates “mill present”).
MIDAS REX™ ELECTRIC BONE MILLMIDAS REX™ ELECTRIC BONE MILL MIDAS REX™ ELECTRIC BONE MILLMIDAS REX™ ELECTRIC BONE MILL
3. Lay harvested bone specimens into bowl.
PRECAUTION
Please see Precautions 1, 3, 4, and 5.
5
10 cc Before Milling 10 cc Aer Milling
WARNING
DO NOT operate the Midas Rex™ Electric Bone Mill base
without the bowl and cap secured in place.
4. Secure Cap onto Bowl by rotating counterclockwise. DO
NOT activate Bone Mill without securing Cap.
5. To process bone, press the Midas Rex™ Electric Bone Mill
run switch. Continue to run until desired bone particle size
is achieved.
IMPORTANT
Milling time is dependent on the density of the patient’s
bone, the ratio of cancellous and cortical bone, the size of
the individual particles and the batch amount of the bone
to be processed. Always check bone aer 10-15 seconds to
gauge quality of milling.
WARNING
Take care to process bone to the desired partical size. DO
NOT over process bone. Over processed bone may lead to
thermal osteonecrosis.
NOTE
If the blade becomes inoperable, (jams or runs very
slowly) stop operation of the Midas Rex™ Electric Bone
Mill and remove bowl cap and use the spatula to free the
bone and blade. Remove some of the bone if needed to
obtain proper operating speed.
6. To remove bone particles:
• stop operation of the Midas Rex™ Electric Bone Mill
• press release buttons and remove bowl and cap from base.
• remove cap from bowl
• use spatula to remove bone particles from bowl and cap.
NOTE
Aer removing bone particles from Bowl, the milling
process may be repeated with additional bone specimens,
as needed, (Up to a total of 40 cc of bone may be processed
by the Bone Mill Disposable during any one surgical
procedure.)
Post-Operative Procedure
1. Turn power O at console and disconnect power cable.
2. Press release buttons and remove bowl from base.
3. Discard bowl, cap and spatula.
4. Clean and sterilize Midas Rex™ Electric Bone Mill Base
according to directions in cleaning section of manual.
5. Clean console
Cleaning & Sterilization
Warnings and
Precautions
Limitations
INSTRUCTIONS
Manual cleaning of
Midas Rex™ Electric
Bone Mill Base
(BM110) and Midas
Rex™ Bone Mill
Console (BM120)
Sterilization of Midas
Rex™ Electric Bone
Mill Base (BM110)
(Temperatureand
times are minimum
requirement.)
Please see Precautions 2, 5 and 6.
Aer cleaning and sterilization, verify functionality prior to re-use. Midas
Rex™ Electric Bone Mill Bowl, Cap and Spatula are single use devices.
Opened but unused Bone Mill Disposables may not be re-sterilized under
any sterilization method.
Wipe all surfaces of the Midas Rex™ Electric Bone Mill with a cloth
dampened with a neutral enzymatic detergent (pH 6.0 - 8.0). Dry
thoroughly. Sterilizing and drying the Midas Rex™ Electric Bone Mill Base
before storing decreases the likelihood of cross-contamination.
Steam Sterilization:
Cycle:
Temperature:
Time:
Drying:
*Reference: for items contaminated with TSE agents steam sterilization
under a temperature of 273-278°F/134-137°C may be repeated for either a
total of six 3 minute cycles OR a single cycle for 18 minutes as referenced
in NHS Estates HTM 2010 parts 4 & 6: Appendix 2, items contaminated
with TSE agents.
100% EtO Sterilization Parameters: Not Validated
Gravity
132°C
10 min
> 25 min
Pre-vac
132°C
4 min
> 20 min
Pre-vac*
134-137°C
3 min
> 20 min
PRECAUTION
Please see Precautions 1, 3, 4, and 5.
6
ese sterilization guidelines are only recommended guidelines
receptacles.
788-6441
and may vary among hospitals depending upon the type of
sterilization equipment and possible pathogens in their particular
areas. ese guidelines represent exposure time and not total cycle
time. e recommended sterilization parameters may be modied
based on standard hospital sterilization protocol. e bone mill
base should be sterilized in accordance with the guidelines in the
Midas Rex™ Electric Bone Mill user’s guide. It must be allowed to
cool prior to use. e metal portion of the bone mill base must be
less than 40ºC prior to use. Cooling time required will vary based
on sterilization containers used, wrapping method, etc. Use of the
bone mill base while still hot from sterilization (ash sterilization)
may cause the motor to overheat and fail.
Limited Warranty*
(U.S. Customers Only)
A. is Limited Warranty provides the following assurance to the
purchaser of a Medtronic Midas Rex™ Electric Bone Mill. e Midas
Rex™ Electric Bone Mill includes the Console, and Base (hereaer
referred to as “Components”), and the Disposable Bowl, Cap and
Spatula (hereaer referred to as “Accessory”) and jointly referred to as
Midas Rex™ Electric Bone Mill, unless specically noted.
(1) Should a Component fail to function within normal tolerances
due to a defect in materials or workmanship within a period of
one (1) year from the date of shipment of the new Component,
or 180 days from the date of shipment of the serviced or
refurbished Component to the purchaser (but not less than
the one year period from the date of shipment of the new
Component), or
(2) Should an Accessory fail to function within normal tolerances
due to a defect in materials or workmanship within a period
of 90 days from the date of shipment of a new Accessory or
serviced or refurbished Accessory to the purchaser.
(3) Medtronic will at its option: (a) issue a credit to the purchaser of
the replacement Component or Accessory equal to the Purchase
Price, as dened in Subsection A(4), against the purchase of any
same Component or Accessory requested as its replacement, or,
(b) provide a functionally comparable replacement Component
or Accessory at no charge.
(4) As used herein, Purchase Price shall mean the lesser of the
net invoiced price of the original or current functionally
comparable, or replacement Component or Accessory.
B. To qualify for this Limited Warranty, these conditions must be met:
(1) e Midas Rex™ Electric Bone Mill must be used in accordance
with the labeling and Instruction Manual provided with the
products.
(2) Only Midas Rex™ Electric Bone Mill Accessories that are
manufactured, authorized, and quality controlled by Medtronic
may be used.
(3) No reprocessed Accessory sets may be used.
(4) e Midas Rex™ Electric Bone Mill may not be damaged by
accident, abuse, misuse or tampering.
(5) e Midas Rex™ Electric Bone Mill or Midas Rex™ Electric
Bone Mill Accessories may not be modied without the writte
permission of Medtronic.
C. is Limited Warranty is limited to its express terms. In particular:
(1) Except as expressly provided by this Limited Warranty,
MEDTRONIC IS NOT RESPONSIBLE FOR ANY DIRECT,
INCIDENTAL OR CONSEQUENTIAL DAMAGES BASED ON
ANY DEFECT, FAILURE OR MALFUNCTION OF THE Midas
Rex™ Electric Bone Mill TO FUNCTION WITHIN
NORMAL TOLERANCES WHETHER THE CLAIM IS BASED
ON WARRANTY, CONTRACT, NEGLIGENCE, STRICT
LIABILITY, OR OTHER TORT OR OTHERWISE.
MIDAS REX™ ELECTRIC BONE MILLMIDAS REX™ ELECTRIC BONE MILL
n
(2) is Limited Warranty is made only to the purchaser. AS TO
ALL OTHERS, MEDTRONIC MAKES NO WARRANTY,
EXPRESS OR IMPLIED, INCLUDING BUT NOT LIMITED
TO, ANY IMPLIED WARRANTY OF MERCHANTABILITY
OR FITNESS FOR A PARTICULAR PURPOSE, WHETHER
ARISING FROM STATUTE, COMMON LAW, CUSTOM OR
OTHERWISE.
(3) e exclusions and limitations set out above are not intended
to, and should not be construed so as to contravene mandatory
provisions of applicable law. If any part or term of this Limited
Warranty is held to be illegal, unenforceable or in conict with
applicable law by a court of competent jurisdiction, the validity
of the remaining portions of the Limited Warranty shall not
be aected, and all rights and obligations shall be construed
and enforced as if this Limited Warranty did not contain
the particular part or term held to be invalid. is Limited
Warranty gives the purchaser specic legal rights. e purchaser
may also have other rights that vary from state to state.
(4) No such express or implied warranty to the purchaser shall
extend beyond the period specied in A(1) above.
(5) is Limited Warranty shall be the exclusive remedy available to
any person.
(6) No person has any authority to bind Medtronic to any
representation, condition, or warranty, except this Limited
Warranty.
*is Limited Warranty is provided by Medtronic Powered
Surgical Solutions, 4620 North Beach Street, Fort Worth, Texas
76137-4116. It applies only in the United States. Areas outside the
United States should contact their local Medtronic representative
for terms of the warranty.
Service
e Midas Rex™ Electric Bone Mill is not user-serviceable, and
no preventive maintenance or calibration procedures are required
except for the directions listed in this manual.
PRECAUTION
Please see Precaution 8
Troubleshooting
SYMPTOM ISSUE ACTION
e blades do not
turn with the run
switch depressed:
If there is still a problem with the Midas Rex™ Electric Bone Mill
Contact Medtronic Customer Service at 1-800-335-9557 or FAX: 817-
Loose
connection
Bone stuck
under blade.
Ensure that the power cable
and the control switch cable
are fully engaged in the
Ensure that power is O and
using spatula rotate blade in a
clockwise direction.
7
Technical Specications
Size Base 4.95”W x 4.35”H x 5.92”D
(126mm x 111mm x 151mm)
Console 8.00”W x 2.76”H x 9.09”D
(204mm x 70mm x 231mm)
Weight Base 2.73lbs (1.24kg)
Console 3.60 lbs (1.63kg)
EN 60601-1 Duty Cycle Max ON 45s/Min OFF 10 Mins
Recommended Installation: Table Top
External Power Source: 100-240VAC~, 50/60 Hz, 250 VA Max
Internal Fuse T4A, 250VAC Break 10A, 250VAC
Front Panel Control: Power (On-O) Switch
Front Panel Indicators: Power, Mill Present
Authorized Service Organization: Medtronic Xomed, Inc.
Environmental Requirements:
Operating:
Temperature: +10 °C to +40 °C
Humidity: 30% to 75% RH
Barometric Pressure: 700 to 1060 hPa
Storage and Transportation:
Temperature: -40 °C to +70 °C
Humidity: 10% to 95% RH
Barometric Pressure: 500 to 1060 hPa
Disposable Components: Bowl, Cap, and Spatula
Conforms to ANSI/AAMI ES 60601-1, IEC/EN 60601-1.
Certied to CSA C22.2 No. 60601-1, and is not for continuous operation.
Protection Against Water Ingress
Essential Performance:
Console, IPX1
Base, IPX2
ere is no essential performance per IEC
60601-1 based on the risk analysis of this
product.
Midas Rex™ Electric Bone Mill Components
BM110 BM110 Midas Rex™ Electric Bone Mill Base
BM120 BM120 Midas Rex™ Electric Bone Mill Console
BM130 Bone Mill Instrument Tray
EA600 North America 110 VAC Power Supply Cord
EA603 Japanese Power Supply Cord
EA611 Italian Power Supply Cord
EA604 Chinese Power Supply Cord
EA607 India / South Africa Power Supply Cord
EA608 Argentina Power Supply Cord
EA609 Israel Power Supply Cord
EA610 Danish Power Supply Cord
EA606 UK 240 VAC Power Supply Cord
EA602 Continental Europe 230 VAC Power Supply Cord
EA601 International 115/230 VAC Power Supply
EA605 Australia 240 VAC Power Supply Cord
175025EN Midas Rex™ Electric Bone Mill User’s Guide, English
175025MLIU Midas Rex™ Electric Bone Mill User’s Guide, 15 Language
11270037 Fuse
DISPOSABLES
BM210 Bowl, Cap and Spatula
8
Electromagnetic Compatability
Environment of Intended Use: Professional healthcare facility environment
Guidance and manufacturer’s declaration – electromagnetic emissions
e Midas Rex™ Electric Bone Mill is intended for use in the electromagnetic environment specied below. e customer or the user of the Midas Rex™ Electric Bone Mill should assure that it
is used in such an environment.
Emissions test Compliance Electromagnetic environment - guidance
RF emissions
CISPR 11
RF emissions
CISPR 11
Harmonic emissions
IEC 61000-3-2
Voltage uctuations/
icker emissions
IEC 6100-3-3
e Midas Rex™ Electric Bone Mill is intended for use in the electromagnetic environment specied below. e customer or the user of the Midas Rex™ Electric Bone Mill should assure that it
is used in such an environment.
Immunity test IEC 60601-1-2 test level Compliance level Electromagnetic environment - guidance
Electrostatic
discharge (ESD) IEC
61000-4-2
Electrical 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
eld
IEC 61000-4-8
NOTE: UT is the a.c. mains voltage prior to application of the test level.
Group 1 e Midas Rex™ Electric Bone Mill uses RF energy only for its internal function. erefore, its RF emissions are very low and are not
Class A e Midas Rex™ Electric Bone Mill is suitable for use in all establishments, other than domestic establishment and those directly
Class A
Complies
likely to cause any interference in nearby electronic equipment.
connected to the public low voltage power supply network that supplies buildings for domestic purpose.
Guidance and manufacturer’s declaration – electromagnetic immunities - part I
± 8 kV contact
± 15 kV air
± 2 kV for power supply lines
± 1 kV for input/output lines
± 1 kV line to line
± 2 kV line to earth
0% UT (100% dip in UT)
for 0.5 cycle at 0°, 45°, 90°, 135°,
180°, 225°, 270°, and 315°
0% UT (100% dip in UT)
for 1 cycle at 0°
40% UT (60% dip in UT) for
5 cycles
70% UT (30% dip in UT) for 0.5 sec
0% UT (100% dip in UT) for 5 sec
30 A/m 30 A/m Power frequency magnetic elds should be at levels characteristic of a typical location in a
± 8 kV contact
± 15 kV air
± 2 kV for power supply lines
± 1 kV for input/output lines
± 1 kV line to line
± 2 kV line to earth
0% UT (100% dip in UT)
for 0.5 cycle at 0°, 45°, 90°, 135°,
180°, 225°, 270°, and 315°
0% UT (100% dip in UT)
for 1 cycle at 0°
40% UT (60% dip in UT) for
5 cycles
70% UT (30% dip in UT) for 0.5 sec
0% UT (100% dip in UT) for 5 sec
e relative humidity should be at least 5%.
Mains power quality should be that of a typical commercial or hospital environment.
Mains power quality should be that of a typical commercial or hospital environment.
Mains power quality should be that of a typical commercial or hospital environment.
If the user of the Midas Rex™ Electric Bone Mill requires continued operation during
power mains interruptions, it is recommended that the Midas Rex™ Electric Bone Mill be
powered from an uninterruptible power supply or a battery.
typical commercial or hospital environment.
MIDAS REX™ ELECTRIC BONE MILLMIDAS REX™ ELECTRIC BONE MILL
9
Guidance and manufacturer’s declaration – electromagnetic immunities - part II
e Midas Rex™ Electric Bone Mill is intended for use in the electromagnetic environment specied below. e customer or the user of the Midas Rex™ Electric Bone Mill should assure that it
is used in such an environment.
Immunity test IEC 60601-1-2 test
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
NOTE: ese guidelines may not apply in all situations. Electromagnetic propagation is aected by absorption and reection from structures, objects and people.
level
3 Vr ms
150 kHz to 80 MHz
6 Vr ms
150 kHz to 80 MHz in
ISM bands
3 V/m
80 MHz to 2.7 GHz
9–28 V/m
Spot frequencies
385 MHz–5.785 GHz
Pulse modulation
Compliance level Electromagnetic environment - guidance
3 Vr ms
150 kHz to 80 MHz
6 Vr ms
150 kHz to 80 MHz
in ISM bands
3 V/m
80 MHz to 2.7 GHz
9–28 V/m
Spot frequencies
385 MHz–5.785 GHz
Pulse modulation
Portable RF communications equipment (including peripherals such as antenna cables and external antennas)
should be used no closer than 30cm (12 inches) to any part of the Midas Rex™ Electric Bone Mill, including cables
specied by the manufacturer. Othewise, degradation of the performance of this equipment could result.
Portable and mobile RF communications equipment should be used no closer to any part of the Midas Rex™
Electric Bone Mill including cables, than the recommended separation distance calculated from the equation
applicable to the frequency of the transmitter.
Recommended separation distance
where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter
manufacturer, E is the immunity test levels in volt per meter (V/m), and d is the recommended separation distance
in meters (m).
Interference may occur in the vicinity of equipment marked with the following symbol:
d = (6/E)√P
Recommended separation distances between
portable and mobile RF communications equipment and the Midas Rex™ Electric Bone Mill
e Midas Rex™ Electric Bone Mill is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. e customer or the user of the Midas Rex™
Electric Bone Mill can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the
Midas Rex™ Electric Bone Mill as recommended below, according to the maximum output power of the communications equipment.
Rated
maximum
output
power of
transmitter
P (W)
0.01 0.03 0.03 0.07 0.03 0.03 0.03 0.07
0.1 0.07 0.07 0.21 0.07 0.07 0.07 0.21
1 0.22 0.22 0.67 0.22 0.22 0.22 0.67
10 0.7 0.7 2.12 0.7 0.7 0.7 2.12
100 2.2 2.2 6.7 2.2 2.2 2.2 6.7
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in metres (m) can be determined 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: ese guidelines may not apply in all situations. Electromagnetic propagation is aected by absorption and reection from structures, objects and people.
380 MHz–390MHz
d = 0.22√P
430 MHz–470MHz
d = 0.22√P
Separation distance according to frequency of transmitter m
704 MHz–787MHz
d = 0.67√P
800 MHz–960MHz
d = 0.22√P
1.7 GHz–1.99GHz
d = 0.22√P
2.4 GHz–2.57GHz
d = 0.22√P
5.1 GHz–5.8GHz
d = 0.67√P
10
U.S. Customers
FAX: 817-788-6489
oce or distributor.
Medtronic Powered Surgical Solutions
4620 North Beach Street
Fort Worth, TX 76137 USA
medtronic.com
manuals.medtronic.com
Orders:
Customer Service
1-800-433-7080
Repair Department
1-800-335-9557
817-788-6440
FAX: 817-788-6441
International Customers
International Customers should contact their local Medtronic
Should your console or related equipment malfunction,
(please adhere to the following guidelines)
1. A return goods authorization number is required.
2. Please package the console as safely as possible and insure
the shipment.
3. A copy of your purchase order is required. Make certain the
purchase order includes the following:
• Shipping and billing information
• Purchase order number
• Contact person
• Phone number
• Description of malfunction
• Your Medtronic account number.
4. Please indicate preferred method of return shipment.
Otherwise the unit will be shipped back via UPS ground.
5. When the malfunctioning unit is not covered by warranty,
Medtronic will contact your facility promptly with a service
cost estimate if requested. e customer will be responsible
for freight charges on non-warranted units.
The information contained in this document is accurate at time of publication. Medtronic reserves the right to make changes to
the product described in this manual. Refer to manuals.medtronic.com for the current version.
MIDAS REX™ ELECTRIC BONE MILLMIDAS REX™ ELECTRIC BONE MILL
11
M988773A001 A
EC REP
2018 - 09
© 2018 Medtronic, Inc.
Manufactured by:
Medtronic Powered Surgical Solutions
4620 North Beach Street
Fort Worth, TX 76137 USA
Telephone: 817-788-6400
Toll-Free: 1-800-643-2773
Fax: 817-788-6401
medtronic.com
Orders:
Telephone: 817-788-6400
Toll-Free: 1-800-433-7080
Fax: 817-788-6489
Repairs:
Telephone: 817-788-6440
Toll-Free: 1-800-335-9557
Fax: 817-788-6441
EC Authorized Representative:
Medtronic B.V.
Earl Bakkenstraat 10
6422 PJ Heerlen
The Netherlands
Europe/Middle East/Africa:
Medtronic International Trading Sàrl
Route du Molliau 31
Case Postale 84
CH- 1131 Tolochenaz
Switzerland
Australia:
Medtronic Australasia Pty Ltd
5 Alma Road
Macquarie Park, NSW 2113
Australia
Canada:
Medtronic of Canada Ltd
99 Hereford Street
Brampton, Ontario L6Y 0R3
Canada
+1 905 460 3800
Technical manuals:
medtronic.com/manuals
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