Head Coil and Stabilization System Instructions for Use

Transcription

1 Head Coil and Stabilization System Instructions for Use Part Number: Rev B

2 AtamA System Instructions for Use Catalog Numbers: AT152-IM, AT152-SI, ATB002, ATB002-AS, ATB002-AC, ATB002-IG ATH100-GE, ATS102, ATF001, ASA / 3.0 T CAUTION Federal (U.S.A.) law restricts this device to sale by or on the order of a physician. Carefully read all instructions prior to use. Observe all contraindications, warnings and cautions noted in these directions. Failure to do so may result in patient complications. Page 1 of 43

3 TABLE OF CONTENTS Section Page Table of Contents System Description Head Coil Subsystem MRI Flex Coil Holder Patient Stabilization Subsystem Indications for Use Contraindications Warnings, Cautions, and General Safety Requirements Warning and Identification Labels Warnings Cautions MRI Compatibility: MRI Conditional Status Head Fixation Workflow Directions for Use Outline of AtamA System Workflow Steps Device Set-Up Head Fixation of the Anesthetized Patient Surgical Field Preparation Attach Lower Head Coil or Flex Coil Holder Attach the AtamA Upper Head Coil & Sterile Draping Connection of Monteris NeuroBlate System Interface Platform Patient Lifting and Transport Instructions Disassembly and Cleaning Disassembly AtamA Cleaning Guidelines: Suggested Materials AtamA Cleaning Guidelines Storage and Rolling Utility Stand Troubleshooting Operating Conditions Storage Conditions Contact Information Distributor/rep contact: Manufactured by: Page 2 of 43

4 1. System Description The AtamA Head Coil and Stabilization System (AtamA System) is a combination MRI head coil and patient stabilization system (Figure 1). It is comprised of two subsystems: (i) MR Head Coil (ii) Patient stabilization system. These two subsystems are designed to work in unison to meet the varied needs of surgeons performing neurosurgical procedures utilizing MRI. The patient stabilization subsystem can also be used for other neurosurgical procedures requiring the patient s head to be stabilized or fixed. It can also be used with other available head coils. The head coil can also be used as a standard diagnostic head coil for diagnostic MR imaging. Specifically, the AtamA System allows a streamlined workflow for procedures requiring the patient to undergo MRI examination before, during, or after neurosurgical procedures. The AtamA System maintains patient head fixation while providing a convenient, safe and effective method of moving the patient from an OR table to transport gurney to MRI couch without the need to unpin and re-pin the patient. Figure 1. Two Part Head Coil Head Fixation Ring Cradle Patient Pad Patient Board MRI/OR Table Illustration of AtamA System, shown over MRI table (not included). Page 3 of 43

5 The summary of the AtamA System Catalog Numbers is shown in Table 1. The subsystems of the AtamA System are listed in Table 2. Required accessories which are not included with AtamA are listed in Table 3. Table 1. Summary of AtamA System Catalog Numbers AtamA Configuration Catalog # Siemens With 1.5 T Head Coil Subsystem Patient Stabilization Subsystem Only (Without Head Coil Subsystem) Patient Stabilization Subsystem Only For Aera or Skyra (Without Head Coil Subsystem) IMRIS With 1.5 T Head Coil Subsystem Without Head Coil Subsystem GE Patient Stabilization Subsystem Only (Flex Coil Holder Ordered Separately) Philips For Philips Achieva (1.5 T or 3.0 T) For Philips Ingenia (1.5 T or 3.0 T) AT152-SI ATB002 ATB002-AS AT152-IM ATB002 ATB002 ATB002-AC ATB002-IG Page 4 of 43

6 Table 2. Subsystems of the AtamA System Subsystem Name Compatible System Cat # or Assembly # Head Coil & Coil Holder Monteris 1.5T Head Coil Siemens 1.5T (Siemens) Monteris 1.5T Head Coil with Extension IMRIS 1.5T (IMRIS) Monteris 3.0T Head Coil Siemens 3.0T (Siemens) Monteris 3.0T Head Coil with Extension IMRIS 3.0T (IMRIS) Flex Coil Holder GE (any type) ATH100-GE Head Fixation One Piece Head Fixation Ring Subsystem Any System ATF001 Split Head Fixation Ring with Standard & Extended Front Section Split Head Fixation Ring with Standard Front Section Patient Board Style 1 Patient Board Siemens (any type) IMRIS (any type) GE (any type) Philips (Ingenia ONLY) Philips (Achieva) Siemens (any type except Aera & Skyra) IMRIS (any type) GE (any type) Patient Board Style 2 Philips (Achieva) Patient Board Style 3 Philips (Ingenia) Patient Board Style 1 with Risers Siemens (Aera & Skyra) Accessories Rolling Utility Stand Any System ATS102 Starburst Adapter Any System ASA001 Table 3. Accessories Required for use with the AtamA System DORO Disposable Skull Pins, Titanium, Adult (MRI Conditional) Order from Pro Med Instruments: Standard Sterile Drapes Item-No (box of 12 sterile packs - 3 pins each) Each hospital will determine the appropriate sterile draping scheme based on standard practices. Typically a combination of commonly available clear, plastic bag drapes such as Snap Covers or Isolation Drapes are used to maintain the sterile field. Page 5 of 43

7 1.1. HEAD COIL SUBSYSTEM The Head Coil subsystem (Figure 2) is a split-array multi-channel (8 channel) receive coil. It is comprised of a common Lower Coil, two interchangeable Upper Coils and the appropriate coil configuration data ( coil files ) for the selected MRI system. Extended Upper Coil Lower Coil Standard Upper Coil Figure 2. Illustration of the Head Coil Subsystem Openings in the two-part coil can be positioned to allow surgical access to any supratentorial skull location without repositioning the patient. This allows for expedient collection of high quality MR data and maintenance of spatial registration. Page 6 of 43

8 Coil Connector Electrical Connector (6 Places) Front Raised Edge Alignment Socket (4 Places) Back Ridge Figure 3. Detail of Lower Coil The Head Coil subsystem (Figure 2) comes with two interchangeable Upper Coils: Standard - for accommodating trajectories extending from the top of the patient head; Extended - for accommodating trajectories extending at an angle away from the top of the head. The Upper Coils have four (4) alignment pins that insert into corresponding sockets in the Lower Coil, ensuring that the 6 electrical connectors will be properly aligned. The Lower Coil (Figure 3) carries the MRI connection cable. Page 7 of 43

9 1.2. MRI FLEX COIL HOLDER The MRI Flex Coil Holder (Figure 4) is designed to be used in place of the AtamA Head Coil Subsystem in conjunction with a Monteris approved and qualified third party head coil. The holder is designed to accept two flexible paddle-style MRI coils and form them around the patient head. It is comprised of a main coil holder housing and two cover plates which attach to the coil housing with thumbscrews to hold the flex coils in place (Figure 5). Figure 4. Flex Coil Holder for GE Assembled with GE 6 Channel Flex coil Figure 5. Flex Coil Placed in Holder and Retained by Cover Plate and Thumbscrews Page 8 of 43

10 1.3. PATIENT STABILIZATION SUBSYSTEM The Patient Stabilization subsystem has three major components (Figure 6): Head Fixation Ring (HFR) providing three to six point skull fixation. Two options are available: o Solid Ring one piece ring o Split Ring multiple piece ring with interchangeable Standard and Extended front sections Cradle to maintain the position of the HFR and the Head Coil relative to each other and to the MRI system bore; two Locking Knobs are used to lock the rotation of the ring (Figure 6). Patient Board for the efficient transport of the patient while maintaining stability and spatial registration of the patient. Standard Ring Front Extended Ring Front Figure 6. Detail of the Stabilization Subsystem (Patient Board and HFR) Page 9 of 43

11 Head Fixation Ring (HFR) The HFR posts (Figure 7) can be inserted into any of the cutouts in the ring. The ring can be configured to use 3 to 6 point fixation. Each post provides 4 location options for inserting the pin holder and disposable, MRI compatible skull pin. Varying lengths of pin holders provide accommodation for a range of patient head sizes. An extra long pin holder length is provided with the Split Head Fixation Ring assembly. A convenient Storage Tray (Figure 8 and Figure 9) holds all of the HFR components. Pin Holder with Pin Standard Ring Front Clamp Knob Extended Ring Front Post Lower Ring Note: The individual components shown can be replaced if lost or damaged. Contact your Monteris Medical representative for details. Figure 7. Detail of the Split Head Fixation Ring (HFR), showing the Ring, Posts, Pin Holders, Head Rest Pads, Clamp Knobs, and both Ring Front Sections (Standard & Extended) Clamp Knob Post Head Fixation Ring Page 10 of 43

12 Pin Drivers (2) Pin Removal Tools (2) Disassembly Hex Keys (2) 3/16 & 5/32 Clamp Knobs (6) Posts (6) Pin Holders, Long (6) Pin Holders, Medium (6) One Piece Ring (1) Pin Holders, Short (6) Figure 8. Storage Tray with One Piece Head Fixation Ring (HFR) Components Page 11 of 43

13 Pin Drivers (2) Extended Upper Ring (1) Pin Removal Tools (2) Disassembly Hex Keys (2) 3/16 & 5/32 Posts (6) Lower Ring (1) Clamp Knobs (8) Pin Holders, Extra Long (6) Pin Holders, Long (6) Pin Holders, Medium (6) Standard Upper Ring (1) Pin Holders, Short (6) Figure 9. Storage Tray with Split Head Fixation Ring (HFR) Components Connection between HFR and Cradle The Head Fixation Ring fits into a groove in the Cradle allowing the ring to rotate freely (see Figure 6). The ring is locked in place by two Locking Knobs located on the patient side of Cradle. These knobs apply friction to outer surface of the ring to lock it into position. Once the patient s head is fixed (pinned), the ring can be rotated within the cradle and locked into place to provide the desired head position for the procedure. No tools are required to rotate or lock the Ring. Page 12 of 43

14 The Patient Board The Patient Board (Figure 10) has a patient load capacity of 350 pounds. It has 12 lifting handles to assist patient transfer and 5 straps to secure the patient. A Patient Pad is attached with Velcro to the top of the Board. Patient Pad (1) Lifting Handles (12) Patient Immobilization Straps (5) Rubber Feet (44) Figure 10. Details of the Patient Board Style 1 Shown Page 13 of 43

15 The Head Fixation Ring attaches to the Cradle, maintaining its relative position to the patient s head when the patient is transported. The Cradle provides 2 universal attachment posts (clamping locations) for an IGS system reference array (Figure 11a). These posts are removable and are held in place with a large blue thumbscrew. See the specific IGS system Instructions for Use for proper utilization of the reference array for image-guided procedures. Universal IGS Reference Array Attachment Post (2 Places) Figure 11a. Reference Array Attachment The Starburst Adapter is an aluminum plate with a standard starburst fitting which attaches to the Patient Board via two stainless steel thumbscrews. It facilitates attachment of ancillary equipment such as imageguided navigation hardware that use a standard starburst connections. The Starburst Adapter is not intended to be used in the MRI environment. IGS Attachment Post Thumb Screw (2 Places) Figure 12b. Starburst Adapter Attached to Patient Board Page 14 of 43

16 Coil to Cradle Connection The Lower Coil has a raised ridge around each end which fits into grooves in the Cradle. The coil is rotated to align with the desired trajectory and then a set of locks (Figure 12) are engaged to prevent the coil from lifting or rotating. Board Front Groove Coil Locks Cradle Figure 13. Board with Cradle showing Lower Coil Locks Page 15 of 43

17 2. Indications for Use The intended use of the AtamA System (comprised of two major subsystems: a MR head coil apparatus and a patient stabilization apparatus), in conjunction with a magnetic resonance (MR) imaging system, is the collection of MR data and images of the human brain before, during, and at the end of brain surgery, in a standard operating room, diagnostic MRI rooms, or in a MR intra-operative room, while stabilizing the patient s head during neurosurgical procedures and imaging. The patient head-stabilizing apparatus can also be used for other neurosurgical procedures requiring the patient s head to be stabilized or fixed. The head coil can also be used as a standard diagnostic head coil for diagnostic MR imaging. When interpreted by a trained physician, these images provide information that can be useful in determining diagnosis. 3. Contraindications Follow general guidelines concerning the suitability of neurosurgery involving the insertion of electrodes, instruments, or devices into the brain or nervous system. Observe all contraindications for MRI scanning of patients. Page 16 of 43

18 4. Warnings, Cautions, and General Safety Requirements The following are warnings, cautions, and safety requirements that apply to the AtamA System; consult the device specific instructions for all devices used in conjunction with the AtamA System for warnings specific to those devices WARNING AND IDENTIFICATION LABELS Symbols displayed on Monteris products or in their documentation are: 1.5 T / 3.0 T MRI Unsafe - item is NOT MRI compatible and is known to pose a hazard in MR environments. This equipment should not be taken into the MRI room within the 5 Gauss perimeter line. MR Conditional - the item has been demonstrated to pose no known hazards in a 1.5T or 3.0T MR environments as described in Section 4.4 of the Instructions for Use. or MRI Safe - the item poses NO known hazards in ALL MR environments. Caution followed by text message. Consult instructions for use. Keep away from sunlight. Page 17 of 43

19 4.2. WARNINGS WARNING: Do not attempt to use the AtamA System before thoroughly reading Instructions for Use. For future reference, keep this document in a convenient, accessible place. The physician must decide which type of head fixation is warranted and the clamping force required. Refer to the Pro Med Instruments DORO Disposable Skull Pins Instructions for Use. Failure to properly position the Skull Pins may cause injury to the patient. Avoid using pins near the frontal sinus, temporal fossa, blood vessels or nerves. Refer to the Pro Med Instruments DORO Disposable Skull Pins Instructions for Use. Use extreme caution during transport and movement of the board when the patient is secured by skull pins. At least one person should be assigned to monitor and protect the patient. Failure to remove all magnetic materials associated with the patient or the IGS Reference Array affixed to the AtamA System may result in damage to the MRI system, damage to the AtamA System, interference with MR data, and possible injury or death to the patient or operators. Assure that all ancillary magnetic materials are removed prior to locating the AtamA System within the MRI magnetic field. To disassemble and remove the front section of the Ring while the head is fixed, any Pin Holders in the front section MUST be removed to prevent patient injury. Page 18 of 43

20 4.3. CAUTIONS CAUTION: Exercise caution when using accessories not qualified by Monteris Medical with this equipment. Failure to do so may result in improper performance, damage to the equipment, or injury to patient or user. Exercise caution when using head coils other than the Monteris head coils. Be sure to use only head coils qualified by Monteris Medical for compatibility with this equipment. Failure to do so may result in improper performance, damage to the equipment, or injury to patient or user The Aluminum Pin Driver, the Aluminum Pin Removal Tool and the Beryllium Copper Disassembly Allen Wrench components of the Head Fixation Kit must be removed from the scanner bore before MRI scanning. Skull pins are for single use only. Do not reuse, reprocess or resterilize. Reuse, reprocessing or re-sterilization may compromise the structural integrity of the device and/or lead to device failure which in turn may result in patient injury, illness or death. Reuse, reprocessing or re-sterilization of skull pins may create a risk of contamination and/or cause patient infection or crossinfection, including, but not limited to, the transmission of infectious disease(s) from one patient to another. Contamination of the device may lead to injury, illness or death of the patient. After use, dispose skull pins and packaging in accordance with hospital, administrative and/or local government policy. Page 19 of 43

21 4.4. MRI COMPATIBILITY: MRI CONDITIONAL STATUS With the exception of the Starburst Adapter, testing has demonstrated the AtamA System is MR Conditional in compatibility. It can be used under the following conditions: Static magnetic field of: o 1.5 Tesla for the Patient Stabilization Subsystem o 3.0 Tesla for the Patient Stabilization Subsystem o 1.5 Tesla for the 152-XX series of Head Coils. Scan in Normal Operating Mode only with a maximum whole-body-averaged specific absorption rate (SAR) of 2 W/kg. The AtamA System is compatible with the following 1.5T or 3.0T MRI systems: o Siemens Avanto (1.5T) o Siemens Espree (1.5T) o Siemens Aera (1.5T) o IMRIS Neuro-II SE (1.5T) o Siemens Verio (3.0T) o Siemens Trio (3.0T) o Siemens Skyra (3.0T) o IMRIS Neuro-III SV (3.0T) o GE Signa HDxT (1.5T and 3.0T) o GE Discovery MR450 / MR750 (1.5T and 3.0T) o GE Optima MR450W / MR750W (1.5T and 3.0T) o Philips Achieva (1.5T and 3.0T) o Philips Ingenia (1.5T and 3.0T) 1.5 T / 3.0 T WARNING: The Starburst Adapter should be removed prior to placing the AtamA System into the MRI environment to avoid injury or MRI damage. Page 20 of 43

22 5. Head Fixation The physician must decide on the type of fixation and the clamping force required, based on the thickness of the skull and the bone structure. Refer to the Pro Med Instruments DORO Disposable Skull Pins Instructions for Use. Head fixation is accomplished using a three to six-point arrangement of post/pin holder/pin combinations. The pins are tightened/loosened by turning the pin holders mounted in threaded holes in the posts, using the torque limiting driver. Failure to properly position the skull pins may cause serious injury to the patient. Avoid the frontal sinus, temporal fossa, blood vessels or nerves. Skull Pins are for single use only. Do not reuse, reprocess or re-sterilize. Reuse, reprocessing or re-sterilization may compromise the structural integrity of the device and/or lead to device failure which in turn may result in patient injury, illness or death. Page 21 of 43

23 6. Workflow Directions for Use 1. Device Set-Up 6.1. OUTLINE OF ATAMA SYSTEM WORKFLOW STEPS 2. Patient Head Fixation a. Anesthetized Patient b. Awake Patient 3. Surgical Prep and Initial Operating Room Procedures a. Prep of entry area b. Establish local sterile field: Draping c. Initial Operating Room Procedures, such as: 4. Prepare for Transport. i. Setting Stereotactic Trajectory ii. Stereotactic Biopsy 5. Attach Coil Halves or Flex Coil Holder (draped/covered for contamination control). 6. Perform procedure: MRI series, Stereotactic Procedure, NeuroBlate procedures, fmri. 7. Reverse (steps 4 thru 1) to finish. Page 22 of 43

24 6.2. DEVICE SET-UP 1. Place the Board with Cradle attached on the operating room table or MR procedure table. 2. Cover the Cradle inner surface with a fluid-proof drape to prevent contamination of the Cradle during the subsequent steps of Head Fixation and Patient Prep SPECIAL INSTRUCTIONS FOR IMRIS SET-UP 1. Ensure the IMRIS semi-circular head rest is inserted into the head end of the IMRIS table. 2. Place the Patient Board with Cradle on the IMRIS table. 3. Slide the Patient Board forward or back to ensure the patient head will be centered at BO within the MRI scanner. Figure 13 shows the approximate position of the board on the IMRIS table. 4. Use the additional Velcro straps supplied with the IMRIS table to secure the Board to the OR table. 7 Figure 14. Position of Patient Board on the IMRIS Surgical Table CAUTION: Do not cantilever (raise) the head end of the IMRIS table once the Patient Board has been positioned to avoid changing the desired board placement. Page 23 of 43

25 SPECIAL INSTRUCTIONS FOR SIEMENS AERA / SKYRA SET-UP 1. Remove all coils from the MRI table (including the spine coil). 2. Place both Riser parts (large body Riser and small foot Riser) into the MRI table. 3. Place a fluid barrier over the coil connections and connectors at the head end of the MRI table. Small Foot Riser Large Body Riser Place fluid barrier over coil connections and connectors Figure 15a. Risers for AtamA Board in Siemens Aera / Skyra Table WARNING: Fluids must not come in contact with the MR coil connections at the head end of the MRI table. A fluid barrier must be placed over the coil connections to prevent patient or operator injury and damage to the MRI system. 4. Place the Patient Board with Cradle on the Risers in the MRI table. Ensure that the foot end of the Board is approximately 1 away from the bottom of the MRI table. This ensures adequate clearance at the head end. Page 24 of 43

26 Align Bottom of Patient Board ~1 from Bottom of MRI table as shown Figure 16. Alignment of AtamA Patient Board on Siemens Aera / Skyra MRI Table 5. Place plastic drapes over the coil connectors after they are connected to prevent fluids from contacting them SPECIAL INSTRUCTIONS FOR PHILIPS INGENIA SET-UP 1. Insert the coil connector d-stream box into the head end of the MRI table. 2. Place Patient Board onto the MRI table. Note, the bottom part of the Board is narrow to fit into the narrow section of the MRI table. d-stream box fills in upper section of MRI Table as shown. Narrow Foot Section of Board fits into narrow section of MRI Table. Figure 17. Fit of AtamA Patient Board on Philips Ingenia MRI Table Page 25 of 43

27 OPTIONAL: INSTRUCTIONS FOR STARBURST ADAPTER 1. Remove each of the Interface Platform (IP) Arm Interfaces from the Patient Board by removing the two thumbscrews (Figure 16a) Figure 18a. Remove the IP Arm Interfaces 2. Attach the Starburst Adapter to the forked head end side of the Patient Board using the two Knurled Head Thumb Screws threaded into the top screw receptacles located on each fork of the Patient Board (Figure 16b). Figure 19b. Attach the Starburst Adapter to the Patient Board 3. Attach the desired ancillary devices to the Starburst and secure with the ancillary device s attachment screw. 4. When use of ancillary devices and Starburst Adapter is complete, remove the Starburst adapter and reattach the IP Arm Interfaces. WARNING: The Starburst Adapter must be removed prior to placing the AtamA System into the MRI environment to avoid injury or MRI damage. Page 26 of 43

28 6.3. HEAD FIXATION OF THE ANESTHETIZED PATIENT 1. The awake patient is placed onto the Board, which is positioned on the OR table; use a rolled towel or other padding to temporarily cushion the patient s head. 2. Administer anesthesia. 3. Attach two Posts to the Ring (Lower Ring if using the Split Head Fixation) section with one to three slots separation; finger-tighten the Clamp Knobs. WARNING: Post / Pin Location Considerations: 1. Be certain that pins are inserted into regions of the skull with adequate strength and integrity (avoid prior surgical defects or thin regions). 2. If applicable, account for AXiiiS mounting location / entry point. 3. Avoid placing pins adjacent to the treatment target site as the Pins may affect MRI images. Specific Instructions for Solid Ring Design (if using Split Head Fixation, skip to step 10): 4. Gently lift the head and shoulders and place the Ring with the Posts around the head (the Posts should be on the posterior skull). 5. Remove the temporary cushion material from Step Gently lower the patient s head and shoulders towards the Board. Cushioning can be used between the Posts and the patient s head. 7. Place the Ring in the Cradle and tighten the two Ring Locking Knobs to fix the Ring in the Cradle. 8. Gently adjust the patient s position within the Ring so that the Ring and patient s head are in proper alignment (Figure 17c). 9. Continue to Step 16. Page 27 of 43

29 Specific Instructions for Split Head Fixation Ring Design: 10. Gently lift the head and shoulders and place the Lower Ring Section with the Posts under the head (the Posts should be on the posterior skull). 11. Gently lower the patient s head and shoulders towards the Board. Remove the temporary cushion material from Step Place the Ring in the Cradle and tighten the two Ring Locking Knobs to fix the Ring in the Cradle. 13. Attach one Short Pin Holder in the desired position on each post and insert a sterile Doro Disposable Pin in each Pin Holder. 14. Lower the patient s head towards the ring and onto the two pins (Figure 17a). Assess if the Standard Front section of the ring will accommodate the size of the patient s head (Figure 17a). If not, use the Extended Front section. WARNING: To prevent patient injury, do not attach the front ring section with fixation pins in place. a. Pinning With Front Section b. Alternative Pinning Without Front Section Page 28 of 43

30 c. Side View d. Front (top down) View Figure 20. Split Head Fixation Ring Attachment a. Placing the head onto the lower ring section followed by front attachment b. Alternative pinning without the front ring section c/d. Proper alignment of Split Head Fixation Ring with attached front Note: Figure 17b shows alternative pinning scenario w/o the use of the front section. CAUTION: Account for AXiiiS Stereotactic Miniframe (AXiiiS) mounting location when positioning head in ring and when selecting Post / Pin locations. 15. If using Figure 17a scenario, attach the front ring section, insert the two Clamp Knobs and locate the desired pin positions on the patient s skull. WARNING: If using pinning scenario shown in Figure 17b, DO NOT tighten posterior Pin Holders after the anterior Pin Holders have been engaged to the skull to prevent patient injury. 16. Insert the desired number of Posts into the appropriate ring slots and lock in place with Clamp Knobs. Page 29 of 43

31 Pin Holder length is determined by where the outer face of the Post crosses the Driver. Figure 21. Pin Holder size selection using Torque Limiting Driver 17. Insert the Torque Limiting Driver through each desired hole in the Post (hex end first) until the Driver touches the patient s head (Figure 18). Determine the length of each Pin Holder required, based on driver gradation seen at the outer face of the Post (Figure 19). Extra Long Pin Holder Long Pin Holder Medium Pin Holder Short Pin Holder STOP Line Figure 22. Torque Limiting Driver Pin Holder size selection gradation 18. Insert Pins into the appropriately sized Pin Holders. While maintaining sterility and protecting sleeves on each pin, press pins into the Pin Holders. 19. Carefully thread each Pin Holder/Pin assembly through the appropriate hole in the Posts, using fingers. Follow with the Torque Limiting Driver, until the pins protrude slightly from the patient side of the Posts. 20. Prepare targeted areas of the patient s head for fixation using routine procedures. 21. Carefully remove the sterile-protectant sleeves from the pins. Page 30 of 43

32 CAUTION! The points of skull pins are very sharp. Injury to operator or patient can occur unless care is exercised. 22. With an assistant holding the patient s head, gently and carefully tighten each Pin Holder / Pin using the Torque Limiting Driver. The Driver prevents over tightening of the Pins. When tightening Pins, stop turning when STOP line on Driver reaches the outer face of the Post (Figure 18). If more force is required, remove Pin Holder and replace with a longer one. When the Pins are tight, ensure that they do not extend more than 2mm (~1.5 threads) beyond the outer face of the Post or they will interfere with the Head Coil (if using Monteris Head Coil). If the pins extend too far, remove the pin/pin holder and, replace Pin Holder with a shorter one. Use a new disposable skull pin. WARNING: Do not use the Pin Removal Tool when tightening the pins. This may cause excessive force and may result in damage to the Head Fixation components or patient injury. 23. Carefully inspect patient fixation in relation to intended treatment entry point (or foot attachment locations for AXiiiS. 24. Determine if the patient s head needs to be rotated for correct position for the neurosurgical procedure. If so, carefully loosen the Ring Locking Knobs. With an assistant coordinating movement of the patient s torso, slowly rotate the patient s head and body (with the Ring rotating in the Cradle) to the desired position. Support the patient s body with padding as necessary and engage the Ring Locking Knobs to lock the Ring in place. WARNING: Loosen Pin Holders in Front Section prior to separating the Front and Back Ring Sections to prevent patient injury SURGICAL FIELD PREPARATION 1. Prepare the surgical site as necessary for the procedures based on standard operating room techniques. 2. Establish the required sterile field using a draping technique compatible with subsequent placement of Head Coil (see 6.6 Attach the AtamA Upper Head Coil & Sterile Draping). Note: If using the Flex Coil Holder, the entire holder with attached paddle-style coils may be placed into a sterile, plastic bag drape. Page 31 of 43

33 6.5. ATTACH LOWER HEAD COIL OR FLEX COIL HOLDER 1. Slide the Lower Head Coil or Flex Coil Holder between the IP Arm Supports and the HFR Posts/Head Rest. Raised ridges located on either end of the lower Coil fit into grooves in the Cradle. Make certain the ridges are fully inserted into the grooves (Figure 20). 2. Rotate the Lower Coil or Flex Coil Holder to the desired orientation. 3. Rotate the locking arms to the locked position to hold the Lower Head Coil or Flex Coil Holder in place (Figure 20). 4. Plug AtamA Head Coil cable into the Siemens MRI system. Note: For IMRIS MRI systems, plug Head Coil cable into the corresponding socket attached to the Board. Plug extension into sockets located on the MRI. If using a Monteris approved third party head coil, consult the manufacturer s Use Instructions to ensure proper coil connections. WARNING: Extreme care must be exercised during transport and movement of the Patient Board while a head-pinned patient is attached. At least one person should be dedicated to monitoring and protecting the patient (especially the neck and skull base areas). IP Arm Support (2) Coil Locking Arm (2) Figure 23. Attaching the Lower Head Coil to the Cradle Page 32 of 43

34 Figure 24. Attaching the Flex Coil Holder to the Cradle Note: The Flex Coil Holder can be placed into a sterile, plastic bag drape to maintain a sterile field around the head ATTACH THE ATAMA UPPER HEAD COIL & STERILE DRAPING If using the Flex Coil Holder, proceed to section 6.7 Connection of Monteris NeuroBlate System Interface Platform. Determine whether the Standard or Extended Upper Head Coil provides the optimum opening for the selected trajectory or procedure. Attach the selected Upper Head Coil to the Lower Coil by aligning the alignment pins and electrical connectors and pressing the two halves together. Make certain that the electrical connectors are fully engaged and that the draping does not interfere with the coil connections. Page 33 of 43

35 Sterile Draping: For recommendation only - should not supersede physician s best judgment or health care provider s standard procedures for sterile draping. Place a sterile bag drape such as a large Snap Cover around the head and over the anterior portion of the head fixation ring to create a sterile field around the AXiiiS and to prevent the leakage of liquids or bodily fluids onto or into the Head Coil. Do not cover the electrical connectors with the drape (image below - left). Pull the excess drape through the slotted opening of the upper coil half (or out the opening between the two coil halves) and cut the bottom of the drape open (image below - right). Splay the cut open bag about the outer surface of the coil to create a sterile field around the opening into the coil (image below). Page 34 of 43

36 6.7. CONNECTION OF MONTERIS NEUROBLATE SYSTEM INTERFACE PLATFORM The AtamA System provides locking thumbscrews for the NeuroBlate System Interface Platform (Figure 22). To mount the Interface Platform, slide the two IP Arms into the IP Arm Interface holes at the head end of the AtamA Board (Figure 22). To disengage, loosen the locking thumbscrews above each IP Arm Interface and slide the IP Arms out of the Arm Interface holes. IP Arm Interface IP Arm Locking Thumbscrew (2) IP Arm Interface Figure 25. Detail of Monteris NeuroBlate System Interface Platform Attachment Page 35 of 43

37 Note for GE MRI Use: during NeuroBlate System Laser Delivery Probe insertion, the user may need to disengage the IP locking thumbscrews and slide the IP arms out away from the patient (red arrows Figure 23). IP Crossbar IP Locking Thumbscrew (2) Figure 26. Detail of Monteris NeuroBlate Interface Platform Attachment. Page 36 of 43

38 7. Patient Lifting and Transport Instructions Consult Figure 24 and Figure 25 for proper and Figure 26 for improper lifting positions. Depending on the patient weight, a minimum of four (4) people are required to move the patient when secured to the AtamA System. For heavier patients, it is recommended that six (6) people move the patient. Figure 27. Lifting/Transporting a Patient with Six People Figure 28. Lifting/Transporting a Patient with Four People Page 37 of 43

39 Figure 29. INCORRECT Location of People for Four Person lift. Page 38 of 43

40 8. Disassembly and Cleaning 8.1. DISASSEMBLY After the procedure is completed and the patient is removed from the AtamA System, disassemble the System into the following subassemblies: Patient Board, Pad and Risers (if applicable) o Cradle (Figure 27 - left) o IP Arm Supports (Figure 27 - right) Head Fixation (including Ring, Posts, Clamp Knobs and Pin Holders) Lower Head Coil Upper Head Coil - standard Upper Head Coil - extended Figure 30. Disassembly of Cradle and IP Arm Supports for Cleaning 8.2. ATAMA CLEANING GUIDELINES: SUGGESTED MATERIALS GOJO Scrubbing Wipes Gojo Steris Coverage Plus Germicidal Wipes Steris 1608-WC Conflikt Detergent Disinfectant Decon Labs 4101 Steris Prolystica Neutral Detergent Steris 1C07-T6WR Steris Resert HLD Disinfectant-Chemosterilant Steris Page 39 of 43

41 8.3. ATAMA CLEANING GUIDELINES Head Coil (including IMRIS Connection Box & Extension): WARNING: Do Not Sterilize! Protect Device from Fluids! Do Not Submerge! Do Not Spray to Clean! 1. Wipe each half of the head coil down with a Germicidal Wipe (use at least one for each half), and allow the halves to sit for at least three minutes (to allow for complete decontamination). Do not allow excess liquid make contact with the electrical connectors. Dry the head coil components with a soft cloth or paper towels. 2. Store the cleaned and disinfected Head Coil halves appropriately to prevent damage and contamination. Head Fixation Parts: 1. Collect AtamA Ring, Posts, Knobs, and Pin Holders WARNING the pins are sharp. Dispose pins in approved Sharps containers. Use Germicidal Wipes to remove the bulk of any soiled material. Place parts in the utility box. Let sit for at least 3 minutes. 2. Remove any residual adhesive using the Gojo Scrubbing wipes, rinse with water, and return the parts to the utility box. 3. All obvious contaminants or foreign material must be removed before proceeding. 4. Add 0.5 ounce of Prolystica Neutral Detergent to Gray Tray, followed by 2 gallons of warm-to-hot tap water. Allow the parts to soak for 1 to 5 hours. Drain detergent solution and rinse parts with tap water. Dry the AtamA parts with paper towels or a soft cloth and return to storage tray. Board Components: 1. Use Germicidal Wipes to remove excess soil and to fully cover the Patient Board, Cradle, IP Arm Supports and Risers (if applicable) with a film of the Germicidal liquid. Allow to sit for at least three minutes. Wipe with dry paper towels. 2. Clean the patient-supporting part of the board with Germicidal Wipes. 3. If excessive soiling of any surface of the board occurred, use paper towels saturated with the Conflikt Disinfecting Detergent to clean. In particular, pay attention to potential contamination of joints and crevices. Allow disinfecting liquid film to remain for 3-5 minutes. Rinse with tap water dampened paper towels, followed by dry paper towels. If required, the board may be disassembled for cleaning access of contaminated areas. Page 40 of 43

42 NOTE: The Head Fixation parts and the Board (without straps and pads) can be disinfected using Steris Resert HLD Disinfectant-Chemosterilant according to the manufacturer s instructions for manual processing. NOTE: The Head Fixation components, Cradle, IP Arm Supports and assorted thumbscrews can be disinfected using an automated wash apparatus according to the manufacturer s instructions for manual processing. CAUTION: the Coil halves ARE NOT compatible with sterilization procedures. 9. Storage and Rolling Utility Stand Carefully inspect the system prior to use for any damage or contamination. The AtamA System subassemblies listed in section 8.1 should be stored together on the Rolling Utility Stand as shown in Figure 28. Avoid locations that may introduce magnetic items. Figure 31. Left/Middle: Utility Stand with AtamA Head Coils Right: Utility Stand with Flex Coil Holder Page 41 of 43

43 10. Troubleshooting Contact Monteris Customer Support for specific trouble shooting tips: Monteris Toll Free Customer Support: Callers may choose between being connected directly to a Technical Services Representative, leaving a message requesting service, or be connected to the Monteris Medical operator. Monteris Reporting System: reporting@monteris.com Contact Monteris Medical via to request service, make product improvement suggestions, report system issues or register complaints. 11. Operating Conditions Temperature: 15 C (59 F) to 30 C (86 F) Relative Humidity: < 70% 12. Storage Conditions Temperature: 10 C (50 F) to 40 C (104 F) Relative Humidity: < 60% Not in direct sunlight 13. Contact Information DISTRIBUTOR/REP CONTACT: 13.2.MANUFACTURED BY: Monteris Medical Corporation th Avenue North, Suite 200 Plymouth MN (763) / (866) Monteris Medical Corporation th Avenue North, Suite 200 Plymouth MN (763) / (866) reporting@monteris.com Page 42 of 43

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