Medtronic AF02R Instructions for Use
Instructions for Use
175036EN C
The Midas Rex™ Legend EHS™ System
Legend EHS, Legend EHS StylusTM, and Stylus Touch
TM
Customer service
For further information regarding the use of this product or to report any problems, please contact Medtronic Customer Service, or contact your local distributor:
Medtronic Powered Surgical Solutions
4620 North Beach Street
Fort Worth, Texas 76137 USA
US Help Line (800 468 9710)
www.medtronic.com
International Service: International Customers should contact their local Medtronic representative.
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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.
The following are trademarks or registered trademarks of Medtronic, Inc. in the United States and other countries: Clearview™ , Intelliow™,
IPC™, Legend™, Legend EHS™, Legend EHS Stylus™, Midas Rex™, Mednext™, and Stylus Touch™. All other trademarks, service marks,
registered trademarks or registered service marks are the property of their respective owners in the United States and other countries.
Contents
Glossary .......................................................................................................................................................................................... 1
Indications for use ...................................................................................................................................................................... 1
Device description .....................................................................................................................................................................1
Contraindications .......................................................................................................................................................................1
No latex policy ............................................................................................................................................................................. 1
Warnings ....................................................................................................................................................................................... 1
Precautions ...................................................................................................................................................................................3
System motors ............................................................................................................................................................................. 3
Attachment assembly ............................................................................................................................................................... 4
IPC set up ....................................................................................................................................................................................... 4
IPC touchscreen controls .........................................................................................................................................................5
Multifunction foot pedal controls .........................................................................................................................................6
Technical specications ............................................................................................................................................................ 6
EMC Guidance ..............................................................................................................................................................................6
Legend EHS, Legend EHS Stylus, and Stylus Touch attachments .............................................................................. 7
General guidelines for attachments and tool applications ......................................................................................... 8
Legend EHS, Legend EHS Stylus, and Stylus Touch attachment assembly and disassembly........................11
System warnings ...................................................................................................................................................................1
Component warnings .......................................................................................................................................................... 2
Tools and disposable components warnings ..............................................................................................................2
Motor cable .............................................................................................................................................................................4
Motor nger lever ................................................................................................................................................................4
Connect to the IPC ................................................................................................................................................................ 4
IPC pump detection ............................................................................................................................................................. 4
Speed ......................................................................................................................................................................................... 5
Irrigation ................................................................................................................................................................................... 5
Acceleration and deceleration ..........................................................................................................................................5
Rotation (FWD and REV) ..................................................................................................................................................... 5
Safe mode (SAFE) ..................................................................................................................................................................5
Dissecting tool nomenclature ..........................................................................................................................................7
Aligning the motor collet ................................................................................................................................................... 7
Straight attachment ..........................................................................................................................................................11
Angled attachment ............................................................................................................................................................11
Fixed footed attachment ..................................................................................................................................................12
Rotating footed attachment............................................................................................................................................12
Contra-angle attachment AC-16 ....................................................................................................................................13
Metal cutting attachment ................................................................................................................................................13
Variable exposure straight and angled attachment ...............................................................................................13
Telescoping tube and telescoping tube base attachment straight (AT10) and angled (AT10A) ............ 14
Telescoping curved bur and telescoping base attachment straight (AT10) and angled (AT10A) .........14
Perforator (AD01 & AD03) attachment ........................................................................................................................15
Jacobs Chuck attachment ...............................................................................................................................................15
Angled double lock (DK) attachment ..........................................................................................................................15
J-latch attachment .............................................................................................................................................................16
Irrigation tubing set............................................................................................................................................................16
Trans-nasal and Clearview skull base bur attachment ..........................................................................................16
Guidance and Manufacturer’s Declaration – Electromagnetic Immunity ............................................................17
Troubleshooting ........................................................................................................................................................................17
Post-operative instructions ...................................................................................................................................................19
Disconnect accessory cable from console .................................................................................................................19
Cleaning and sterilization ......................................................................................................................................................19
Legend EHS, Legend EHS Stylus, and Stylus Touch reprocessing instructions .............................................19
Legend attachments/tubes reprocessing instructions ........................................................................................21
Return policy for devices exposed to Transmissible Spongiform Encephalopathies (TSE) ..........................22
Refurbishing or repairs ...........................................................................................................................................................22
Midas Rex Legend EHS system Limited Warranty* (U.S. customers only) ............................................................23
Preventive maintenance ........................................................................................................................................................24
Dening maintenance level ............................................................................................................................................24
Section 1: Preventive maintenance/service schedule:12 maintenance intervals .............................................24
Section 2: Instructions for completing preventive maintenance steps ................................................................25
Scheduled maintenance intervals 1, 2, 3, 5, 6, 7, 9, 10, 11 ....................................................................................25
Symbols ........................................................................................................................................................................................26
The Midas Rex Legend EHS system
Glossary
The following words and acronyms may be used in this manual:
EHS Electric High-Speed
FCU Foot Control Unit
FWD Forward - Rotation is clockwise
IPC Integrated Power Console
IV Intravenous
OSC Oscillate
REV Reverse - Rotation is counter-clockwise
Indications for use
The Electric Drill System is an electrically operated surgical instrument system. The electric motor provides power to operate removable rotating surgical cutting
tools and their accessories intended for use in neurosurgery, including craniotomy and spinal surgery; as well as Ear Nose and Throat (ENT), orthopedic, and general
surgical applications including maxillofacial, craniofacial and sternotomy surgeries.
Additionally, the Electric Drill System is indicated for the incision/cutting, removal, drilling, and sawing of soft and hard tissue, bone, and biomaterials during open
and minimally invasive spine procedures, which may incorporate application of various surgical techniques during the following lumbar spinal procedures:
• Lumbar Microdiscectomy
• Lumbar Stenosis Decompression
• Posterior Lumbar lnterbody Fusion (PLIF)
• Transforaminal Lumbar Interbody Fusion (TLIF)
• Anterior Lumbar lnterbody Fusion (ALIF)
• Direct Lateral lnterbody Fusion (DLIF)
Device description
The Legend EHS, Legend EHS Stylus, and Stylus Touch systems are powered drills that are used to remove soft tissue, hard tissue, and bone during surgical
procedures. Each system consists of a motor that powers/rotates the cutting media, attachments that are used to provide support and stability to the dissecting tools,
and dissecting tools that perform the task of removing soft and hard tissue and bone. Note that the attachments and dissecting tools are common to all systems.
Unless specically referenced, the Legend EHS Stylus when referenced, will also encompass the Stylus Touch.
These devices are intended for use by physicians trained in the procedures described.
Contraindications
None.
No latex policy
Medtronic Powered Surgical Solutions guarantees that all Legend equipment and products identied in this manual, manufactured by and/or for Medtronic Powered
Surgical Solutions, do not contain latex.
Medtronic Powered Surgical Solutions’ packaging materials, labels, pouches, package inserts, or similar items do not contain latex.
Warnings
System warnings
W1 The Legend EHS and/or Legend EHS Stylus system operator must be familiar with this Instructions for Use, the IPC User’s Guide, their precautions, procedures
and safety issues.
W2 The Legend EHS and/or Legend EHS Stylus system and its associated equipment should be used only by qualied medical professionals who are thoroughly
trained and experienced in performing surgery with Medtronic computer-assisted surgery systems.
W3 Do not place Legend EHS and/or Legend EHS Stylus handpiece in the proximity of a magnetic eld, such as magnetic drape or Magnetic Resonance Imaging
(MRI) equipment to avoid inadvertent handpiece activation.
W4 Always inspect the components before and after use for any damage. If damage is observed, do not use damaged component until it is repaired by Medtronic or replaced.
W5 Heavy side loads and/or long operating periods may cause the device to overheat.
W6 The Legend EHS and/or Legend EHS Stylus motors should only be operated when the attachment is in the locked position.
W7 The Legend EHS and/or Legend EHS Stylus motors are precision surgical instruments. With precision instruments, excessive force, beyond the design strength
of the instruments, can be caused by even simple manual overloading.
W8 Do not use excessive force to pry or push bone with the attachment or dissecting tool during surgery.
W9 Use only dissecting tools specically designed for use with this drill system. Match the nomenclature and color code on the tool packaging to the same
nomenclature and color code on the attachment.
W10 Do not use the Legend EHS and/or Legend EHS Stylus system without proper cleaning and sterilization.
W11 Refer to the IPC Instructions for Use and Clearview Insert for additional instructions, warnings, and cautions.
W12 Refer IPC User’s Guide for warnings related to IPC.
W13 The Legend EHS and/or Legend EHS Stylus system complies with EN60601-1-2 safety standard for electromagnetic compatibility (EMC), 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.
W14 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 Instructions for Use.
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The Midas Rex Legend EHS system
W15 Portable and mobile radio frequency (RF) communications equipment can aect medical electrical equipment.
W16 Do not operate the Legend EHS and/or Legend EHS Stylus motors in the presence of (MRI) devices.
W17 Use of accessories and cables other than those specied and sold by Medtronic may result in increased emissions and decreased immunity of this unit.
W18 For metal transection, observe the following safety precautions:
W18a Wear eye protection.
W18b Irrigate well to cool cutting surfaces.
W18c Protect wound site from metal debris.
W18d Use a clamp or grasping device to control loose fragments during transection of any metal component.
W19 All service must be performed by Medtronic qualied personnel only.
Component warnings
W20 Do not use any parts other than Medtronic system components as damage or substandard performance could result.
W21 Always inspect the components before and after use for any damage. If damage is observed, do not use damaged component until it is repaired by Medtronic
qualied personnel or replaced. Damaged parts may deposit metal shavings on surgical site or may cause injury.
W22 Employ visualization, including use of imaging techniques (for example, uoroscopy, image guided surgery) when using rotating powered accessories.
Discontinue powered application in the event of lack of visualization of surgical site.
W23 When using Midas Rex variable exposure attachments, surgeons should become familiar with the performance of dissecting tools before use and should
explore the eect of various levels of tool exposure on tool stability. If the tool exhibits excessive chatter, vibration, or movement, decrease the tool exposure.
W24 Motors and attachments may fail due to extended use resulting in component(s) detaching and falling from the motor or attachment, causing patient injury.
To avoid this, motors and attachments should be serviced periodically at intervals recommended by Medtronic.
W25 Electrical contacts must be dry prior to use.
W26 Do not use an overheated device, as it may cause thermal injury to the patient or operator.
W27 Use adequate irrigation. The use of a tool without irrigation may cause an inordinate amount of heat buildup resulting in a thermal injury to tissue. Depending
on the amount of irrigation used, the drill bits can achieve temperatures in excess of 50°C.
W28 Do not attempt to change a dissecting tool or attachment while the motor is running, or when the motor or attachment is in an overheated state.
W29 Do not immerse the system components, except as noted.
W30 Do not place motor, attachment, or tool on the patient or in an unsecured location during surgery.
W31 A device that is not functioning properly should not be used until the unit is repaired and tested by Medtronic to ensure that it is functioning in accordance
with Medtronic specications.
W32 Match the nomenclature and color code on the tool packaging to the nomenclature and color code on the attachment.
W33 When using Midas Rex variable exposure attachments, ensure that the attachment is still in the locked position after each adjustment of the tool exposure.
Attempting to increase the tool exposure too far may result in the attachment accidentally being unlocked.
W34 The Legend EHS motors will not run properly unless the attachment is in the locked position.
W35 Midas Rex Legend EHS motor and Midas Rex Legend EHS Stylus motor should only be operated when the attachment is in the fully locked position. Smoke
and/or excessive heat may be generated if attachment is not in the fully locked position. This may result in thermal injury to the user or sta.
W36 Do not change an accessory with the handpiece running to prevent laceration of user and/or cross-contamination through compromised glove.
W37 Remove Legend footed attachments cautiously and slowly as per instructions to avoid injury to the operator.
W38 Do not modify accessories used with the handpiece. Performance could be diminished with modied accessories.
W39 Verify reusable device was cleaned and/or sterilized prior to use. If not, do not use.
W40 Sterilize and dry reusable device before storing. Decrease likelihood of cross-contamination with timely sterilization. After each procedure, properly clean and
sterilize all reusable system components.
W41 Place Stylus Touch in Safe mode while not in use.
W42 Do not place Stylus Touch handpiece in the proximity of magnetic eld, such as a magnetic drape and MRI equipment, to avoid inadvertent handpiece activation.
W43 Excessive side loading could cause angled attachments to unlock accidentally from motor.
W44 Ensure proper installation of tool in footed attachment. Failure to follow instructions may result in the tool tip contacting the foot of the attachment causing
damage to the attachment and/or harm to patient.
W45 Any tubing or other tip protectors used during shipping must be removed prior to cleaning and sterilization.
W46 Any device that has not been used in a four year period should be serviced by Medtronic to ensure its performance.
Tools and disposable components warnings
W47 Tools are available for resection of soft tissue and bone for surgical procedures. Use of tools depends on the intended application and patient needs. Sharp-
cutting powered tools induce bleeding and removal of signicant tissue and bone.
W48 Tool utes are sharp and may perforate surgical gloves. Tool stems may be grasped with a hemostat to aid in installation and removal. Use methods at the
operative site to control bleeding that do not compromise patient safety during surgery.
W49 Keep the cutting area of the tool away from ngers and loose clothing to prevent laceration of user and cross-contamination through compromised glove.
W50 Operate the tool only after appropriate anatomical landmarks at the intended surgical site have been conrmed.
W51 Use care in application of the rotating cutting end to only appropriate anatomical landmarks and the intended surgical site when using powered accessories.
W52 Insertion of metal objects in accessory tip may cause the accessory to break leaving fragments in the wound. The fragments may be dicult to remove,
causing irritation, inammation, and foreign-body response at surgical site.
W53 Bending or prying may break the accessory, causing harm to patient or user.
W54 Do not use excessive force to pry or push bone with the attachment or tool during dissection.
W55 A tool’s size and geometry may create excessive vibration at certain speeds. Increase or decrease speed of the motor to prevent vibration. Change to a new tool
to prevent unintended tissue removal from patient.
W56 Test for wobble at desired speed prior to use. Discontinue use of accessory if tip begins to wobble and replace accessory to prevent unintended tissue removal
from patient.
W57 Carefully inspect dissecting tool both prior to and following each use for signs of excessive wear, fragmentation, eccentricities, or other defects. Replace any
suspicious dissecting tools with a new one prior to use.
W58 Eccentricity of the tool can cause tool vibration and may result in excess tissue destruction, bone destruction, and hearing damage.
W59 Excessive noise from the tool when drilling close to the cochlea or ossicular chain may cause hearing damage.
W60 Consult the cranial perforator device labeling for recommended speed specications.
W61 Tools with “L” identication are longer tools intended for light bone dissection. The increased tool head/stem conguration may aect dissection stability.
2
The Midas Rex Legend EHS system
65
W62 Do not re-sharpen used tools. Worn tools should be frequently replaced with new ones to ensure eective cutting and control.
W63 Excessive pressure applied to bur may cause bur fracture. Should a tool fracture in use, extreme care must be exercised to ensure that all fragments of the tool
are removed from the patient. Unremoved tool fragments may cause tissue damage to the patient.
W64 Do not use metal-cutting tools to cut/resect bone.
W65 Use only rotary tools specically designed for use with this drill system.
W66 Do not sterilize disposable devices. They are terminally sterilized at the factory and are not intended for repeat use. To prevent contamination, use only once.
W67 Do not use an accessory if its packaging is opened or damaged. Sterility may be compromised if packaging is opened or damaged.
W68 Properly dispose of single-use devices removed from sterile packages. Devices lose sterility upon removal from packaging.
W69 Do not use dull tools. Use of dull tools can reduce cutting eectiveness and can cause the handpiece temperature to increase.
W70 Always ensure that the tool is secured in the handpiece prior to operating the system. Always examine operation of each tool in a handpiece prior to use.
W71 Powered burs and drills should be operated in the forward mode only.
W72 Exposure of tool packaging to light for extended periods of time may cause damage to packaging.
Precautions
P1 To prevent damage to curved tools, disconnect suction tube prior to changing tool during procedure.
P2 When using an angled attachment, hold the handpiece assembly by the attachment so that the attachment does not inadvertently loosen from the handpiece.
P3 Do not run the AC-16 attachment above 62,000 rpm. This may cause overheating and damage to internal gears of attachment.
P4 Do not use twist drill or contra-angle tool at an operating speed over 62,000 rpm.
P5 Do not attempt to disconnect the cable from the Midas Rex Legend EHS Stylus or EHS Stylus Touch motor.
P6 Do not kink cables. Inspect cables and pins for cracks, tears or corrosion.
P7 Disconnect cable from Midas Rex Legend EHS motor prior to sterilization.
P8 The use of a washer-disinfector for cleaning may cause a pre-mature degradation in performance.
P9 Remove devices from instrument case before placing into washer disinfector and allow devices to drain. Orient devices in the washer-disinfector by following
manufacturer recommendations.
P10 Do not use low-temperature hydrogen peroxide gas plasma sterilization due to the lumen internal diameter and length restrictions.
P11 Do not use low-temperature liquid peracetic acid sterilization due to immersion procedure.
P12 Remove and discard accessories following local regulations for disposal of contaminated materials.
P13 Clean the EHS motor and cable while still connected together. This will help to reduce debris ingress. Use only recommended cleaning agents.
System motors
The Midas Rex Legend EHS system motors are high-speed, high-torque, reversible electric motors used to dissect bone and biomaterials at selectable speeds from
200 to 75,000 rpm.
The Legend EHS Stylus motor (Figure 1) is a smaller and more compact version of the Legend EHS motor (Figure 2). The Stylus Touch motor (Figure 3) is a small,
compact motor that includes a rotating nger lever.
1
1
2
Legend EHS Stylus motor Legend EHS motor
3
4
2
3
2
1
1. Rotating collet 2. Stationary collet 3. 4-pin cable connection
3
Stylus Touch motor
1
2
3
4
5
1. Stationary collet
2. Rotating collet
3. Ground connector
4. 4-pin cable connection
5. Locking sleeve
1. Telescoping
nger rest
2. Finger lever
3. Finger lever
safe mode switch
4. Control lever ring
5. Stationary collet
6. Rotating collet
3
The Midas Rex Legend EHS system
2
15323 4
Motor cable
The Legend EHS motor cable is separate from the handpiece, allowing it to connect and disconnect from the motor.
• To connect the Legend EHS cable to the Legend EHS motor, align the mark on the cable to the red mark on the motor (Figure 4-1) and connect the two pieces.
• To remove the Legend EHS cable from the Legend EHS motor, (1) push the cable towards the motor, then (2) pull out the cable by the locking ring only (Figure 4-2).
The Legend EHS Stylus and Stylus Touch motor cable is integrated in the handpiece and cannot be removed from the motor.
4-1
Connect Legend EHS cable to motor Disconnect Legend EHS cable from motor
Motor nger lever
The Stylus Touch motor
includes a rotating
nger lever. To rotate
the nger lever, (1) press
the control lever ring
forward, then (2) Rotate
the lever clockwise or
counter clockwise until
the lever locks in a new
position (Figure 5)
5
4-2
12
Stylus Touch nger level rotation
1
Attachment assembly
Refer to the Legend EHS, Legend EHS Stylus, and Stylus Touch attachments for attachment Assembly instructions.
IPC set up
The following instructions for the Legend EHS, Legend EHS Stylus, and Stylus Touch are in addition to the general assembly instructions found in the Integrated
Power Console User’s Guide. To obtain a copy of the IPC User’s Guide, please contact Medtronic or your local distributor.
Connect to the IPC
Locate the Legend EHS, Legend EHS Stylus, Stylus Touch, and Foot Control Unit (FCU) ports on the IPC connector panel (Figure 6) and insert the connector.
Note: To insert multi-pin connectors (indicated by a silver or red mark on the connector), align the mark on the connector to the mark on the console, then insert the
connector.
6
IPC connector panel connection ports
1. Legend EHS motor
2. Legend EHS Stylus motor
3. Stylus Touch motor
4. Intelliow irrigation remote
control
5. Foot control unit
IPC pump detection
The IPC incorporates the Legend EHS, Legend EHS Stylus, and Stylus Touch irrigation at Pump 1. If you do not use irrigation for the Stylus Touch, manually change the
Pump 1 to None. Refer to the IPC User’s Guide, Set up and Prime Pumps for more information.
When the system detects the Legend EHS or Legend EHS Stylus, Pump 2 defaults to None.
When the IPC detects both the Legend EHS and Legend EHS Stylus handpieces, the system defaults Pump 2 to the Shared conguration. Use the pumps screen to
override the Shared default by selecting the Legend EHS Stylus for Pump 1. Refer to the IPC User’s Guide, Set up and Prime Pumps for more information.
Control operation of the Legend EHS, Legend EHS Stylus, and the Stylus Touch with the IPC touchscreen and the multifunction foot pedal.
4
The Midas Rex Legend EHS system
+
IPC touchscreen controls
To set or adjust the Legend EHS and Legend EHS Stylus
(Figure 7-1) or Stylus Touch (Figure 7-2) controls, on the
IPC touchscreen, in the control box, do the following:
7-1
IPC Stylus touchscreen IPC Stylus Touch touchscreen
7-2
Speed
• To adjust speed in Forward (FWD) or Reverse
(REV) mode, in the Speed control box, press
the plus button to increase speed or the minus
button to decrease speed.
• The Legend EHS Stylus and Stylus Touch: Default
speed, 60,000 rpm; variable speed adjustment
from 200 to 75,000 rpm.
Note: When the handpiece is in safe mode, the
Speed control box displays SAFE (Figure 9). Refer
to the Safe mode (SAFE) topic for additional
information.
• The Legend EHS: Default speed, 70,000 rpm;
variable speed adjustment from 200 to 75,000 rpm.
+
Irrigation
• To adjust the irrigation ow rate, in the Pump control box, press the plus button to increase ow rate or the minus button to decrease ow rate. If intermittent
ow is available, pressing the plus or minus button progresses the system through intermittent and continuous ow. The system displays Intermittent when in
intermittent ow mode.
Note: To adjust ow rate, you can use the touchscreen or the IntelliFlow irrigation remote control.
• Default, 0cc per minute in Forward or Reverse mode.
Acceleration and deceleration
• To adjust acceleration and deceleration, on the Defaults menu (Figure 7-1 and 7-2), press the corresponding plus or minus button. Acceleration is the rate at
which the motor speeds up to reach the target speed. Deceleration is the rate at which the motor slows down to reach the target speed or stop.
Note: While in the default menu, the motor will not be active to demonstrate the selected acceleration and deceleration. In order to determine the desired
values, adjust the acceleration and deceleration during motor operation and note the preferred values.
• To enable adjustment of acceleration or deceleration during handpiece operation and to display the acceleration and deceleration adjustment options on
the motor operational screen; On the Defaults menu, select Show On Screen and then press [OK]. To hide the acceleration and deceleration during handpiece
operation, on the Defaults menu, deselect Show On Screen.
Rotation (FWD and REV)
• To change rotation mode, in the Mode control box, select FWD (forward) or REV (reverse).
Important: System conguration may be dierent from the default. If the REV (reverse) button
appears raised (Figure 8-1) and does not have a selectable radio button, you cannot select the Reverse
mode. If the REV button appears concave (Figure 8-2) and has a selectable radio button, you can select
the Reverse mode via the touchscreen or the multifunction foot pedal.
Safe mode (SAFE)
• The Stylus Touch handpiece comes with a safe mode option. When the handpiece is in safe mode, it is
inoperable until the safety is turned o. The Speed control box on the Stylus Touch touchscreen displays
SAFE when the handpiece is the active handpiece and in safe mode (Figure 9).
• Switch the device to safe mode any time it is attached to the console, but not currently being used. To
set the Stylus Touch to safe mode, on the Stylus Touch handpiece, switch the safe mode nger lever
(Figure 3) to on.
• When more than one handpiece is attached to the console, use the safety switch of an inactive
handpiece to activate that handpiece and make it ready for use.
8-1
IPC touchscreen
REV button raised
Mode
FWD
REV
9
IPC Stylus Touch safe mode
touchscreen
Speed
8-2
IPC touchscreen
REV button concave
Mode
FWD
REV
+
SAFE
+
RPM
5
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