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VIDION Operator's Manual

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					                      OPERATOR’S MANUAL
                                                               ®
                    For use only with the NeoVista
                  ®                         ®
            VIDION Anti-Neovascular (ANV ) Therapy System


                                     NEOVISTA, INC.



                               47865 Fremont Boulevard
                               Fremont, CA 94538-6506
                                          USA
                               OFFICE : (+) 510-933-7600
                          CUSTOMER SERVICE: (+) 510-933-7601
                         EMERGENCY CONTACT: (+) 510-933-7650
                                FAX: (+) 510-933-7659


                      NeoVista Document Number: PRT-0956-LBL1
                                    CO# CO-1321



                            Disposable Delivery Assembly                          0086
AR-MED Ltd                     manufactured in USA and         Reusable Delivery Module
Runnymede Malthouse       distributed by Hantel Technologies    manufactured in USA by
                                   for NeoVista, Inc.                     NeoVista, Inc.
Egham TW20 9BD
United Kingdom
                                                                                                       NeoVista Doc. #PRT-0956-LBL1
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                                                   TABLE OF CONTENTS
    PREFACE
    CUSTOMER SUPPORT
    REPLACEMENT PARTS AND ACCESSORIES
1        Prescribing Information ................................................................................................ 1
    1.1 VIDION Device Description ........................................................................................... 1
    1.2 Indications for Use ........................................................................................................... 2
    1.3 Contraindications ............................................................................................................. 2
    1.4 Warnings .......................................................................................................................... 3
    1.5 Precautions ....................................................................................................................... 3
    1.6 Risks Associated with the VIDION System .................................................................... 5
    1.7 Conformance to Standards ............................................................................................... 6
    1.8 Product Configuration ...................................................................................................... 6
2        Detailed System Description ......................................................................................... 8
    2.1 Overview .......................................................................................................................... 8
    2.2 Radiation Source .............................................................................................................. 8
    2.3 Disposable Delivery Module ......................................................................................... 11
    2.4 Disposable Applicator .................................................................................................... 11
    2.5 Handheld Cable Actuator ............................................................................................... 11
    2.6 Radiation Dose Characterization ................................................................................... 12
3        System Assembly and Initiation of Treatment .......................................................... 15
    3.1 Preparing the Reusable Delivery Module ...................................................................... 16
    3.2 Opening the Thermoformed Package ............................................................................ 16
    3.3 Attaching the RDM to the Disposable Delivery Module (DDM ................................... 17
    3.4 Attaching the Disposable Applicator ............................................................................. 17
    3.5 Pre-Treatment Planning ................................................................................................. 19
    3.6 Vitrectomy Procedure .................................................................................................... 20
    3.7 Initiating Treatment ....................................................................................................... 20
    3.8 Completion of Treatment ............................................................................................... 24
    3.9 Post Treatment Source Position Verification ................................................................. 26
    3.10 Discard Single-Use Items .............................................................................................. 27
4        Cleaning and Sterilization of the Reusable Delivery Module, Calibration Device
         Holder and Position Check Tool ................................................................................. 29
    4.1 Cleaning the Reusable Delivery Module ....................................................................... 29
    4.2 Cleaning the Calibration Device Holder and Position Check Tool ............................... 30
    4.3 Sterilizing the Reusable Delivery Module ..................................................................... 33
    4.4 Sterilizing the Calibration Device Holder and Position Check Tool ............................. 34
5        Storage of the Reusable Delivery Module .................................................................. 35
    5.1 Storage Container........................................................................................................... 35
    5.2 Emergency Cap .............................................................................................................. 35
6        Package and Device Labeling ..................................................................................... 36
    6.1 Labeling of Single-Use Disposable Components .......................................................... 36
    6.2 Labeling for Unit Carton and Six Pack Shipper ............................................................ 36
    6.3 Labeling of Reusable Delivery Module ......................................................................... 37
    6.4 Labeling of Type A Shipping Container ........................................................................ 37
    6.5 Labeling of Storage Container ....................................................................................... 38

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  6.6 Labeling of Physics Package ......................................................................................... 38
7     Technical Specifications .............................................................................................. 41
  7.1 Single-Use Disposable Components .............................................................................. 41
  7.2 Reusable Delivery Module ............................................................................................ 41
8     System Malfunction and Emergency Procedures ..................................................... 43
  8.1 Device Malfunction ....................................................................................................... 43
  8.2 Emergency Procedure .................................................................................................... 43
  8.3 Actions Required In The Event Accidental Damage to a VIDION Device Occurs ...... 46
NeoVista Customer Support ................................................................................................... 48




PREFACE
This document provides a complete description of and instructions for the operation of the
NeoVista VIDION Anti-Neovascular (ANV) Therapy System, also called the “VIDION
System” or “the System.”


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The System includes a single use Handheld Cable Actuator, Disposable Delivery Module, and
Disposable Applicator, plus a set of 20-gauge scleral plugs and a 20-gauge microvitreoretinal
(MVR) blade, all of which are single-use components. Provided separately, as part of the
System, are a Reusable Delivery Module (RDM) with a specific Calibration Sheet for the serial
number of the device and Emergency Cap in the RDM Storage Container.

Additional reusable items shipped separately include this Operator’s Manual, a “Physics
Package” consisting of a Standard Imaging, Inc. Well Ion Chamber, Electrometer, Calibration
Device Holder, Position Check Tool, Calibration Device Holder and Position Check Tool User
Manual; and NeoVista supplied Physics Actuator Assembly, Position Verification Curved
Cannula, Output Verification Straight Cannula, Countdown Timer, Barometer/Thermometer,
and Emergency Cable Cutter in a rugged carrying case.

This document does not address “Commissioning” of the VIDION System. This activity,
which includes initial verification of the radiation source calibration parameters, is beyond the
scope of this manual and is covered under PRT-1615-EN, Commissioning of VIDION Guide.

This Operator’s Manual should be read thoroughly by both the physicians who will be utilizing
these devices and the physicists/operating technologists who will be assisting with the treatment.
This document does not replace required training and certification, but serves as an instructional
guide to support the training.

The Operator’s Manual is organized as follows:

       Preface: Describes the intent of the document, its intended audiences, and the
       standards and conventions used within the document.

       Customer support: Provides part numbers for replacement parts and accessories, as
       well as contact information for service and customer support.

       Section 1: Sets forth the Prescribing Information, including the System’s intended
       indications for use, warnings, precautions, and adverse effects that may be associated
       with the device.

       Section 2: Describes the VIDION System in detail, including drawings and
       illustrations, and explains device characteristics.

       Section 3: Describes the preparation, treatment and post procedure instructions of the
       VIDION System.

       Section 4: Provides a detailed explanation of the Calibration Device Holder, Position
       Check Tool and Reusable Delivery Module cleaning and sterilization procedures.

       Section 5: Provides a detailed explanation of the Reusable Delivery Module storage
       procedures.

       Section 6: Describes the package labeling for the VIDION System.

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     Section 7: Lists the technical specifications for the VIDION System.

     Section 8: Explains procedures in the event of a problem or an emergency.

     Section 9: Revision history: Details the revision level of the Operator’s Manual.

     General safety information applies to both operating and servicing personnel.

     Warnings and Cautions are used throughout the document to alert the reader to
     potential hazards other than those that are contraindications to the use of the VIDION
     System. Notes are used to draw attention to specific details. These notices will appear
     in the following formats.

         A warning alerts the user to potential serious outcomes (injury or serious
         adverse events) by indicating that a person may be endangered if
WARNING! instructions or procedures are followed incorrectly, or ignored, and/or
         that equipment may be damaged if instructions or procedures are
         followed incorrectly, or ignored.

              A caution alerts the reader that special care should be exercised in the
              effective use of the VIDION System, by indicating that equipment may be
CAUTION!
              damaged if instructions or procedures are followed incorrectly, or
              ignored.

              A note is used to provide specific information or guidance or to draw
 NOTE         attention to specific details




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      Table 1: Acronyms and abbreviations used in the manual
       Age-related Macular Degeneration           AMD
       Choroidal NeoVascularization               CNV
       Anti-NeoVascular                           ANV
       Radiation Safety Officer                   RSO
       Disposable Applicator                          DA
       Disposable Delivery Assembly               DDA
       Disposable Delivery Module                 DDM
       Radiation Source Wire                      RSW
       Reusable Delivery Module                   RDM
       Handheld Cable Actuator                    HCA
                                                      90
       Strontium-90                                    Sr
                                                 90
       Strontium-90/Yttrium-90                    Sr/90Y

                         Table 2: Symbols Used
        EC Authorized                                 Sterile: sterilized using
        Representative                                ethylene oxide
        Serial number                                 Do not reuse

QTY     Package quantity                              Do not resterilize
        Lot number                                    No Latex
        Use by date: xxxx-xx
                                                      Non-pyrogenic
        (year-month)
        Radioactive material                          Non-Sterile
        Consult instructions for
                                                      Caution
        use
        Date of manufacture
                                                      Manufacturer
        xxxx-xx (year-month)




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CUSTOMER SUPPORT
The VIDION System is not serviceable at the customer facility. If any anomaly is noted, please
remove the System from service and contact NeoVista for instructions. For questions about
calibration, customer support, or training, or to order supplies for the VIDION System, use the
contact information as follows.

International headquarters:                                           Contact: Information
NeoVista, Inc.                                            Customer Service (+) 510-933-7601
47865 Fremont Boulevard                                               Fax: (+) 510-933-7659
Fremont, CA 94538-6506                                       Email: device@neovistainc.com
Office (+) 510-933-7600                                 EMERGENCY CONTACT: (+) 510-933-7650




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REPLACEMENT PARTS AND ACCESSORIES
The following table shows part numbers for ordering replacement parts or accessories from
NeoVista, Inc.

           Table 3: Replacement parts and accessories for the VIDION System
             Part Number                               Description
             NVA-100003            Reusable Delivery Module (RDM)
              ASY-2000             Disposable VIDION System Assembly (6 Pack)
               PRT-0956            VIDION System Operator’s Manual
               NVI-0203            Radiation source leak test procedure
               PRT-1376            Emergency Cable Cutter
                 0061              RDM Storage Container
                 0062              Type A Shipping Container
             NVA-200057            Emergency Cap

           Table 4: Replacement parts and accessories for the Physics Package
             Part Number                               Description
                                  Standard Imaging, Inc. HDR-1000 Plus Well
               PRT-1403
                                  Chamber
                                  Standard Imaging, Inc. CDX 2000B
               PRT-1405
                                  Electrometer
                                  Calibration Device Holder and Position Check
               PRT-1577
                                  Tool User Manual
               PRT-1406           Calibration Device Holder
               PRT-1402           Position Check Tool
               PRT-1091           Timer, Countdown
               PRT-1400           Traceable® Digital Barometer Module
               ASY-1397           Physics Actuator
              NVA-100005          Output Verification Straight Cannula
               PRT-1580           Position Verification Curved Cannula




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1 Prescribing Information
      NeoVista, Inc. has developed the VIDION ANV Therapy System for the focal delivery of 90Sr
      beta radiation directly to the site of choroidal neovascularization (CNV) in the treatment of
      wet age-related macular degeneration (AMD). The retinal surgeon will perform a core pars
      plana vitrectomy to minimize mechanical traction on the peripheral retina. Local delivery of
      radiation will permit targeted ANV treatment of the AMD lesion while minimizing the risk of
      degeneration of neighboring ocular structures due to radiation exposure.

1.1    VIDION Device Description
       The NeoVista VIDION ANV Therapy System consists of several components. Single-use
       elements, provided in a sterilized surgical package, include the Disposable Handheld Cable
       Actuator (Figure 1.1), and the Disposable Delivery Assembly, which includes the Disposable
       Delivery Module and Disposable Applicator. The Reusable Delivery Module (RDM)
       encloses the radiation source and is stored in a Storage Container until ready for assembly
       with the Disposable Delivery Module (Figure 1.2).




                                                    Disposable Delivery Assembly with installed
                                                    Reusable Delivery Module and Disposable
                                                    Applicator
                    Figure 1.1                                         Figure 1.2



       The radiation source is advanced into the Disposable Applicator and is temporarily placed
       over the AMD lesion. (For complete instructions for use, see Section 3)

       Radiation shielding is a safety concern that was considered throughout the design of the
       RDM. When in the retracted (storage) position within the RDM, the radiation source is
       surrounded by a DENSIMET® shield that effectively reduces occupational exposure to the
       surgeon and patient during handling and initial positioning.

       During treatment, the radiation source is advanced into the Disposable Applicator through a
       stainless steel cannula that allows delivery of the beta radiation directly to the site of the
       proliferative neovascular tissue. Because the radiation source is an emitter of beta particles
       that have a very short range in bodily tissues, very little radiation reaches other tissues within
       the eye.

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       In addition to the single-use disposable components and the Reusable Delivery Module, the
       VIDION System also includes the following:
        RDM Storage Container to transport and storage of the RDM.
        Emergency Cap for immediate shielding in the event the radiation source cannot be
           retracted back into the RDM
        Timer for monitoring the treatment duration
        Physics package to perform post-treatment position check procedure and quarterly source
           verification
            Well Chamber used after each procedure to provide assurance that the radioactive
               source was properly located for treatment.
            A Calibration Device Holder and Position Check Tool for use with the Well Chamber

                All components of the VIDION System are designed and validated to be
                used together only as specified. In order for the System to work
      NOTE      properly and safely, it is very important to keep the products together
                as a complete System and not to exchange them with components not
                provided by NeoVista, Inc.

                User Manuals and data calibration certificates for using the
                Electrometer and Well Chamber are included. The Electrometer and
                Well Chamber are designed to test System positional accuracy. It is
      NOTE
                suggested that these manuals be kept in a secure location where all
                personnel may have access. Extra copies are available from your
                NeoVista, Inc. representative.

1.2    Indications for Use
       The NeoVista VIDION ANV Therapy System is indicated for the treatment of subfoveal
       CNV secondary to wet AMD.

1.3    Contraindications

1.3.1 Diabetes mellitus
      Use of the VIDION System is contraindicated in patients with type 1 or type 2 diabetes
      mellitus.

1.3.2 Retinal vasculopathies
      Use of the VIDION System is contraindicated in patients with retinal vasculopathies
      including diabetic retinopathy, retinal vein occlusion, etc.

1.3.3 Other CNV etiologies
      Use of the VIDION System is contraindicated in patients who present with CNV due to
      causes other than wet AMD.




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1.3.4 Concomitant chemotherapy
      Use of the VIDION System is contraindicated in patients receiving concurrent
      chemotherapeutic medication, or who have received chemotherapy within the past 6
      months.

1.3.5 Previous radiation to the head or neck
      Use of the VIDION System is contraindicated in patients who have received previous
      radiation to the head or neck.

1.3.6 Ocular or periocular infections
      Use of the VIDION System is contraindicated in patients with ocular or periocular
      infections.

1.3.7 Long-term therapies
      Use of the VIDION System is contraindicated in patients on long-term systemic
      corticosteroid or other immunosuppressive therapy that may affect wound healing.

1.4   Warnings

                 Failure to adhere to predefined treatment time or product positioning
 WARNING!        can result in the delivery of an elevated or lowered radiation exposure
                 to the target area.

                 Failure to fully support the weight of the device may result in damage
 WARNING!        to the retina. Contact with the retina should be limited to a very light
                 touch, with the surgeon fully supporting the weight of the device.

                 Appropriate radiation monitoring of the patient, surgeon and assistant
                 during treatment is recommended and specified by national, state, and
 WARNING!        local regulations, as well as by the Radiation Safety Officer (RSO) at
                 the participating institution.
                 See Section 8 for additional information on Radiation Safety.

                 Should a situation occur in which the radiation source cannot be
                 retracted from the Disposable Applicator to the RDM, do not attempt
                 to remove the Disposable Applicator from the Disposable Delivery
 WARNING!        Assembly. Place the Emergency Cap over the Disposable Applicator
                 cannula. Secure in a safe location and contact your institution’s RSO.
                 See Section 8 for specific information on Radiation Safety.

          During non-treatment procedures (cleaning, sterilization, and
 WARNING! pretreatment verification), it is recommended that the RDM be handled
          by the end farthest from the radiation source to minimize exposure.

1.5   Precautions
      The VIDION System is intended for use by physicians who have received appropriate
      training. Read all product handling instructions in this manual before placing the device into
      service.
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         Special care should be taken when handling the VIDION System with the
CAUTION! Disposable Applicator in place; the tip is very delicate. If the radiation
         source is engaged in the tip, be aware of exposure risks.

             DO NOT resterilize or reuse the Disposable Delivery Assembly, 20-gauge
CAUTION!
             MVR blade, or 20-gauge scleral plugs. For single use only.

             DO NOT expose any part of the VIDION System to acids, oxidants, or
CAUTION!
             ketones in liquid or vapor form.

             DO NOT use the System if the VIDION surgical package is open or
CAUTION!
             damaged.

         DO NOT allow sharp bends or twists in the drive cable between the
         Disposable Delivery Module and Handheld Cable Actuator; this could
         prevent the 90Sr source from advancing fully into the Disposable
CAUTION!
         Applicator or slow down the rate of travel of the source. The cable
         should not be pulled so tight that it interferes with the ability of the
         surgeon to maneuver within the eye.

             DO NOT touch any part of the Disposable Applicator cannula when the
CAUTION!
             radiation source is in the exposed (advanced) position.

         DO NOT advance or retract the radiation source into or out of the
CAUTION! Disposable Applicator until the tip is in a stable position in the
         midvitreous cavity.

             DO use the Electrometer and Well Chamber, to test the VIDION System
CAUTION!
             to ensure positional accuracy after the procedure.

             DO ensure proper magnification in the surgical field before engaging the
CAUTION!
             Delivery System.

             DO take care during placement of the intraocular tip to avoid damage to
CAUTION!
             the tip from other surgical tools.

             DO ensure that placement of the intraocular tip avoids tamponade of the
CAUTION!
             retinal vasculature.

         DO ensure that the intraocular tip remains steady during the entire
CAUTION! activation sequence specified on the Calibration Sheet for the particular
         device (3 to 5 minutes).




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1.6   Risks Associated with the VIDION System

1.6.1 Possible risks of radiation
      Since the VIDION System delivers radiation directly to the CNV, it is anticipated that
      damage to structures outside of the target area will be minimal. However, the following
      are potential complications of ocular irradiation:

       Damage to the optic nerve, retina, or               Very small risk of cancer from exposure
        underlying choroid (including scarring)              to radiation
       Cataract                                            Glaucoma
       Radiation retinopathy                               Visual loss

1.6.2 Possible risks of ocular surgery
      Possible risks from the surgical procedure are similar to those associated with the
      performance of a standard vitrectomy, and may include:

       Bleeding within the eye (subretinal or              Eye inflammation (endophthalmitis),
        vitreous hemorrhage)                                 possibly resulting in the loss of the eye
       Retinal tears/breaks                                Retinal detachment
       Retinal edema                                       Cataract formation or progression
       Visual loss

1.6.3 The following table is provided as a general guide for annual exposure rates using the
      VIDION® device.
      1.6.3.1   By following the procedures of this Operator Manual in detail, the annual
                exposure rates would fall in line with the number depicted below.
      1.6.3.2   Excursions from the handling procedures as described (position, longer /
                shorter handling times, source activity rate) would affect the annual amount of
                exposure.
      1.6.3.3   These values were derived from studies using defined times, distances, and a 95
                percentile activity (470MBq) for the device:
                       Occupational Dose                  Finger         Body
                          Per Procedure                 (extremity)
              Surgeon                                       260 μSv          3 μSv
              Assistant to Surgeon                           21 μSv          3 μSv
                Medical Physicist                                    38 μSv            6 μSv
                Scrub/Circulating Nurse                              18 μSv            3 μSv
                Cleaning and Sterilization Technician                23 μSv            3 μSv
                    Annual Occupational Dose
                ICRP 103 for 30% of NRC value on 150,000 μSv 15,000 μSv
                annual basis
                NRC 10CFR20 Annual Occupational 500,000 μSv 50,000 μSv
                Exposure Limit per area
                     Note: 1000 μSv (micro-Sievert) = 1 mSv (milli-Sievert)
                   ICRP = International Commission on Radiation Protection)
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1.7   Conformance to Standards
      Quality Management Systems:         Radiation Leakage Testing:
       ISO 13485:2003                     ISO 9978:1992
      Sealed Radioactive Sources:        Transportation (Type A Packaging):
       10CFR35                           USA DOT 7A Type A has been evaluated and
       BS 5288:1976                      has passed testing required for use with material
       ISO 2919:1999                     per the requirements of 49 CFR 173.465.
       ANSI N542                         49 CFR 178.2 (c)
       ANSI N43.6:1997                   ISO 11607-1:2006
       IAEA ST-1                         ISO 11607-2:2006
      DIN 25 426:1988                    ASTM D-4169-DC13
      10 CFR 20

       Sterilization:                     Biocompatibility:
       ANSI/AAMI/ISO 17665-1:2006         ISO 10993-1:2003(E)
       ISO 17664:2004
       ISO 11138-1:2006
       ISO 11135-1:2007
       AAMI TIR12:2004
       AAMI ST37:1996
       Labeling:
       BS EN 980:2008



1.8   Product Configuration

                     Table 5: Single use surgical pack components
           Part number      Quantity                        Description
           NVA-200043           1         Disposable Applicator (DA)
           NVA-300198            1        Safety Cap
           NVA-200033            1        Disposable Delivery Assembly
           NVA-400069            1        20-gauge scleral plug set
           NVA-400067            1        20-gauge (microvitreoretinal) MVR blade

                    Table 6: Reusable Delivery Module components
           Part number      Quantity                      Description
           NVA-100003           1       Reusable Delivery Module (RDM)
           NVA-200057           1       Emergency Cap
            PRT-1376            1       Emergency Cable Cutter
               0061             1       RDM Storage Container


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          Table 7: Physics Accessories Kit components
Part number      Quantity                        Description
                             Standard Imaging, Inc. HDR1000 Plus Well
 PRT-1403           1
                             Chamber
 PRT-1405           1        Standard Imaging, Inc. CDX 2000B Electrometer
 PRT-1406           1        Calibration Device Holder
 PRT-1402           1        Position Check Tool
 ASY-1397           1        Physics Actuator
 PRT-1580           1        Position Verification Curved Cannula
NVA-100005          1        Output Verification Straight Cannula



               Table 8: Other reusable components
Part number      Quantity                      Description
 PRT-1091            1        Timer, Countdown
 PRT-1400            1        Barometer/Thermometer Module




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2 Detailed System Description
2.1   Overview
      The VIDION ANV Therapy System is intended for the treatment of neovascularization
      secondary to wet age-related macular degeneration (AMD) by means of focal delivery of
      beta radiation to target tissues. The VIDION System is intended for use by physicians who
      have received appropriate training. Read this manual before placing the device into service.

      When in the retracted (storage) position within the RDM, the radiation source is surrounded
      by a DENSIMET shield that effectively reduces occupational exposure to the surgeon and
      patient from unnecessary radiation exposure during handling and initial positioning.

      During treatment, the radiation source is advanced into the Disposable Applicator, which is a
      stainless steel cannula that allows delivery of the beta radiation directly to the site of the
      neovascular tissue. Because the radiation source is an emitter of beta particles that have a
      very short range in bodily tissues, very little radiation reaches other tissues within the eye.

      In addition to the single-use disposable components and RDM, the VIDION System also
      includes the following:
          The Output Verification Straight Cannula is to be used to verify radiation source
            output with a well ion chamber.
          A Position Verification Curved Cannula to be used with a well ion chamber for
            functionality check of the radiation source.
          A storage container to hold the RDM when not in use
          An Emergency Cap for shielding in the event of the radiation source cannot be
            retracted back into the RDM
          An Electrometer, Well Chamber, Calibration Device Holder and Position Check Tool
            to check source position post-treatment verification and quarterly source verification
          VIDION Operator’s Manual
          Countdown Timer
          Barometer/Thermometer

2.2   Radiation Source
      The radiation source in the VIDION Reusable Delivery Module (RDM) is based on
      strontium 90/yttrium 90 beta-emitting isotopes. Strontium 90 (90Sr), with a 29-year half-life,
      decays into its daughter nuclide yttrium 90 (90Y) with a half-life of 64 hours. Both isotopes
      are beta emitters and have a relatively short depth of effective penetration. This provides the
      ability to deliver the therapeutic dose to the treatment area while limiting the exposure to
      other tissues. With a maximum source activity of 555 MBq (15 mCi), the treatment duration
      will be approximately 3 to 5 minutes.

      The source itself consists of a cylindrical aluminum insert that is infused with the 90Sr/90Y
      isotope and located inside a sealed stainless steel source canister. This canister is enclosed
      within a shielded module section that is fitted into the Reusable Delivery Module
      (Figure 2.1).

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             DENSIMET Shield




                                           Figure 2.1

         During non-treatment procedures (cleaning, sterilization, and post-
CAUTION! treatment verification), it is recommended that the RDM be held at the
         end farthest from the DENSIMET shield, to limit radiation exposure.

              DO NOT expose the RDM to acids, oxidants, or ketones in liquid or
CAUTION!
              vapor form.

              Store the RDM in its storage container until ready to begin the
CAUTION!
              procedure, and clean it and return it immediately after the procedure.

              Leak test the sealed RDM according to national regulatory requirements
CAUTION!
              in country of use.

         Only the outside surface of the RDM should be cleaned. Care should be
         taken to avoid getting cleaning fluids and debris in the inner cavity of
CAUTION!
         the device; hold the module with the slot facing down (and bottom of the
         RDM up) during the cleaning process.

         The RDM shall be handled, used, and stored in accordance with
         International and Local regulations governing radioactive medical
CAUTION! devices. Under no circumstances shall this device be disposed of
         improperly. Contact NeoVista to address any handling or end of useful
         life inquiries.


    When not in use, the beta radiation source is positioned inside the shielded RDM. The RDM
    shield is composed of the tungsten alloy, DENSIMET, which is further surrounded by the
    stainless steel housing. This shielding ensures that external exposure rates stay within the
    limits of applicable standards.

    The stainless steel storage canister that contains the radiation source is laser welded to a
    stainless steel braided cable that is used to move the source forward to the treatment position
    and to retract the source back to the storage position.


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         The VIDION RDM Storage Container (Figure 2.2) is used to store the RDM and the
         Emergency Cap when it is not in use. The Storage Container contains a 1/8” thick lead liner.
         In preparation for treatment, the RDM is removed from the Container, sterilized, and
         assembled with the Disposable Delivery Module (Figure 2.3). The Disposable Applicator
         (Figure 2.4) is then locked in place and its Safety Cap removed just before the treatment.




                                                     Figure 2.2


                                                                            Disposable Delivery Module




        Reusable Delivery Module


                                                     Figure 2.3




                                                                                            Disposable Applicator
                                                                                            covered by Safety Cap




                                                     Figure 2.4


    The Storage Container is made by Biodex Medical Systems and is also called a Shielded Syringe Carrier
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2.3   Disposable Delivery Module
      The VIDION System allows the retinal surgeon to deliver radiation to the treatment site
      safely and effectively.

      The Disposable Delivery Module is a single-use component designed to hold the RDM and
      to allow the radiation source to advance into the Disposable Applicator. The Disposable
      Delivery Module is connected to the Handheld Cable Actuator by a drive cable that allows
      an assistant to advance and retract the radiation source while the surgeon maintains the
      Disposable Delivery Module (with RDM) in a steady position.

2.4   Disposable Applicator
      The Disposable Applicator is attached to the RDM at the time of treatment. It consists of a
      bayonet-style mounting base and a stainless steel cannula that guides the radiation source as
      it is advanced forward from the RDM and seated at the curved end portion of the Disposable
      Applicator during the allotted treatment time, and then retracted back into the RDM for
      storage.

      The Disposable Applicator cannula is an integral part of the VIDION System. It is
      constructed of 20 gauge (outside diameter) stainless steel. The cannula is sealed to prevent
      contact between the radiation source and the patient, and to prohibit the introduction of body
      fluids into the Disposable Applicator. The cannula is curved to allow for proper alignment
      of the radiation source with the treatment area.

2.5   Handheld Cable Actuator
      The Handheld Cable Actuator is a single patientuse disposable component that allows the
      surgeon to hold the Disposable Delivery Module (with RDM) steady while an assistant
      advances and retracts the radiation source during the surgical procedure.

      In preparation for treatment, the retinal surgeon indicates when the Disposable Applicator is
      in a stable position in the midvitreous cavity of the eye; an assistant operates the
      advancement lever on the Handheld Cable Actuator (Figure 2.5) to advance the radiation
      source from the RDM into the Disposable Applicator. The drive cable indicator window on
      the Disposable Delivery Assembly is checked to confirm that the source has moved into
      position. The tip of the Disposable Applicator is then lowered to the appropriate treatment
      position on the retina, the timer is initiated and treatment begins.




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             Drive Cable

                                                                                     Advancement
                   Release Trigger                                                      Lever

                                             Figure 2.5

                  Appropriate radiation dosimeter monitoring devices for the surgeon,
                  assistant and other staff involved during treatment is recommended and
 WARNING!         specified by national, state, and local regulations, as well as the Radiation
                  Safety Officer (RSO) at the participating institution.

                  Should a situation occur in which the radiation source cannot be retracted
                  from the Disposable Applicator to the RDM, do not attempt to remove the
 WARNING!         Disposable Applicator from the Disposable Delivery Assembly. Place the
                  Emergency Cap over the Disposable Applicator cannula. Secure in a safe
                  location and contact your institution’s RSO.

2.6    Radiation Dose Characterization
       Each VIDION System RDM is provided with a unique manufacturer’s calibration certificate,
       that is specific to the RDM that it accompanies. The specified dose rate is used to calculate
       the treatment time, based on a predefined dose of 24 Gy, the dose at the peak of the dose rate
       profile, as shown in Tables 9 and 10 which designate the peak dose delivered to the
       irradiated area.

                 Note that each VIDION RDM is unique; therefore, each System will have
      NOTE       its own specific treatment time as indicated by the Calibration Certificate
                 which lists the serial number of the RDM.

                 When used as indicated in Section 3 of this manual, with the distal tip in
                 soft contact with the retina, the distance from the mid-volume of the
      NOTE
                 radiation source below the Disposable Applicator cannula’s cross hair, to
                 the target tissue layer is 2.5 mm

       The manufacturer’s calibration certificate will provide the peak dose rate and the calculated
       treatment time.




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 Table 9 indicates the estimated peak dose received by the lens and optic disc, and Table 10
 describes the estimated peak dose received by areas having a diameter less than 0.5 mm
 (foveola), 0.5 mm to 1.5 mm (fovea), 1.5 mm to 6.0 mm (macula), and greater than 6.0 mm
 (periphery).

             Table 9: Estimated radiation dose received by ocular structures

                                              Estimated distance
                                                                                  Shortest distance
 Structure              Peak Dose           from target (i.e., center
                                                                             to device surface at source
                                                 of the lesion)
                                                                                        center
                                                     >15 mm
    Lens                0.35 mGy              (choroid to posterior                     ≈11.7 mm
                                               aspect of the lens)
                                                       3 mm
  Optic disc
                          6.5 Gy            (optic disc edge to fovea                    3.6 mm
(closest edge)
                                                      center)

      Table 10: Estimated peak radiation dose received by retinal substructures
          Structure                   Diameter                    Peak Dose
       Retina – Foveola               <0.5 mm                       24 Gy
        Retina – fovea              0.5 – 1.5 mm                    24 Gy
       Retina – macula              1.5 – 6.0 mm                    23 Gy
      Retina – peripheral             >6.0 mm                       *8 Gy
     *At edge of 6.0 mm diameter circle, decreasing sharply thereafter. For the other estimates, if we
     divide the retina in circular segments (eg, a ring having a diameter that ranges from 0.5 to 1.5
     mm describes the fovea) then we would produce a detailed description of the dose delivered to
     various parts of the retina.

 Figures 2.6 and 2.7 represent the distribution of the dose spatially from the treatment site.




                                          Figure 2.6
                                Isodose curves at treatment site
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                                           Figure 2.7
                                  Dose profile at treatment site

         (Figure 2.7 represents the target site dose distribution of the applicator 52-R2. 3,
         and is an example of a dose profile for a VIDION source. Please note that each
         source will have a unique dose distribution.


2.6.1 Treatment time
      Radiation treatment time is based on calibration at time of shipment and is provided on the
      VIDION System calibration certificate. Treatment time will be based on the time to
      deliver 24Gy.

       Treatment of lesions up to a Greatest Linear Dimension of 5.4 mm has been studied in
       previous trials of the VIDION system, and treatment of larger lesions is not recommended.
       A delivery of 24 Gy to the target tissue allows for delivery of at least 6 Gy to the edges of a
       5.4 mm GLD lesion. A dose of 6 Gy has been shown to induce endothelial cell apoptosis
       in vitro.


               The predefined treatment time as well as the actual treatment time in
   NOTE        minutes and seconds must be documented in the patient’s chart.


2.6.2 Recalculation of treatment time

       Since the radioactive source 90Sr decays with a half-life of 29 years, there is a slight
       reduction in radioactivity over time. Within the United States, NRC regulations require
       that the calibration be corrected by a medical physicist at 1% physical decay
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     (approximately 6 month intervals. For use outside the United States use appropriate
     regulations specific for country of use.


             Radiation dosimetry is required. NeoVista recommends the use of whole-
             body and ring-badge dosimetry, but the final decision regarding what is
CAUTION!     used at your facility is the responsibility of your RSO. Please contact this
             individual for determination of dosimetry requirements and methods for
             your facility.

         Leak test the sealed RDM at a frequency according to national regulatory
CAUTION! requirements in country of use.



3 System Assembly and Initiation of Treatment
  The NeoVista VIDION ANV Therapy System can be assembled in the operating room
  immediately before surgery, or during the period when the surgeon is performing the pars
  plana vitrectomy which precedes the use of the System.

  The single-use components of the VIDION System are sterilized and packaged in a
  thermoformed tray with a Tyvek® lid (Figure 3.1). If the device package is punctured, torn, or
  damaged in any way, discard it and choose another device.




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                                                                  Each sterile tray contains
                                                                  the following:
                                                                  • Disposable Delivery
                                                                      Assembly
                                                                  • Safety Cap
                                                                  • Disposable Applicator

                                                                  Included (not shown) in the
                                                                  package are:
                                                                  • 20-gauge
                                                                      (microvitreoretinal)
                                                                      MVR blade
                                                                  • 20-gauge scleral plugs




                                              Figure 3.1


                 All disposable components are sterile; if any part of the single use,
      NOTE       sterile system touches a non-sterile surface it should be discarded and a
                 new package selected.



3.1    Preparing the Reusable Delivery Module
       Before the surgical procedure can begin follow the Sterilization Procedure in Section 4.3 of
       this Operator’s manual to sterilize the RDM before assembling into the VIDION System.
       Note: Also required is to follow the Sterilization Procedure in Section 4.4 of this Operator’s
       manual to sterilize the Calibration Device Holder and Position Check Tool.

3.2    Opening the Thermoformed Package




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      Examine the tray packaging; do not use any package that is torn, punctured, or otherwise
      damaged. In a sterile setting, remove the Tyvek cover of the outer tray. NOTE: The Tyvek
      lid is a sterile barrier and once removed the contents should be handled with appropriate
      sterile technique. Using the central finger holes, remove the sterile tray containing the
      Disposable Delivery Assembly, and Disposable Applicator with its Safety Cap.
      Using sterile technique, remove the Disposable Delivery Assembly. Do not allow any
      component to touch a non-sterile surface.

3.3   Attaching the RDM to the Disposable Delivery Module (DDM
      In the sterile field, attach the RDM to the Disposable Delivery Module by snapping it into
      place (Figure 3.2). The RDM will lock into place with an audible click




                                            Figure 3.2




3.4   Attaching the Disposable Applicator
      Once the RDM is in place on the Disposable Delivery Module, remove the Disposable
      Applicator from the thermoformed package. Align the notch on the Safety Cap with the
      marker on the RDM and press the pieces together gently (Figure 3.3).




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                                           Figure 3.3

               The Disposable Applicator is covered by a Safety Cap; do not remove
   NOTE
               the Safety Cap until ready to begin the treatment process.


3.4.1 Turn the Disposable Applicator section clockwise to lock it into place on the end of the
      RDM (Figure 3.4)




                                           Figure 3.4



3.4.2 The slot on the Safety Cap should line up with the notch on the top edge of the Reusable
      Delivery Module. (Figure 3. 5)




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                                             Figure 3.5

          DO NOT press the Handheld Cable Actuator advancement lever until
          ready to begin treatment. The VIDION System will be disabled
 CAUTION!
          permanently if the advancement lever is activated more than four times; one
          of these is required for the Post-treatment position check.

                DO NOT touch the exposed cannula or allow it to touch a non-sterile
 CAUTION!
                surface.

          DO NOT allow sharp bends or twists in the drive cable between the
          Disposable Delivery Module and Handheld Cable Actuator; this could
          prevent the 90Sr source from advancing fully into the Disposable
 CAUTION!
          Applicator or slow down the rate of travel of the source. The cable
          should not be pulled so tight that it interferes with the ability of the
          surgeon to maneuver within the eye.




3.5   Pre-Treatment Planning
       Prior to treatment, the surgeon will confirm the location of the lesion using retinal vascular
       landmarks. The preferred location of the sclerotomy entry point will be identified (i.e.,
       temporal, nasal, and specific clock hour) to provide limited exposure of the fovea and optic
       nerve during treatment. It is recommended that the surgeon have a representative

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        fluorescein angiogram or color fundus photograph within view at the time of surgery to aid
        in the localization of the lesion during the procedure.

3.6    Vitrectomy Procedure
       A standard 3-port pars plana vitrectomy must be performed to create access for the device
       into the vitreous cavity and minimize tractional forces on the peripheral retina.

       It is recommended to deliver the VIDION system into the temporal sclerotomy port to
       minimize dose delivery to the optic nerve.

3.7    Initiating Treatment

3.7.1 At this point, the surgeon should have completed the pars plana vitrectomy and opened the
      vitrectomy port for the VIDION system using the 20-gauge microvitreoretinal (MVR) blade
      provided (if not already using 20 gauge surgical approach). With the components of the
      Disposable Delivery Assembly in place and the required time specified for correct dosage
      of the radiation source confirmed, the VIDION System is now ready to use. DO NOT
      place the VIDION system through any trocar system as damage to the cannula will occur!
      NOTE: Ensure that there is adequate magnification and visualization of the surgical field

3.7.2 Remove The Safety Cap from the Disposable Applicator (Figure 3.6).

                Retain the Safety Cap for removal and disposal of the Disposable
      NOTE
                Applicator at the end of treatment




                                            Figure 3.6




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3.7.3 Information for the Retina Surgeon on Holding the Device

       3.7.3.1   The finger pattern shown below is how the device was designed to be held. The
                 image reflects the same position used for determining the occupational dose.




                                            Figure 3.7a



                         Position #1
                      Most distal – Index
                     finger – top of RDM

                                                                            Position #2
                                                                         Thumb – proximal
                                                                             support

                        Position #3
                     Middle finger –
                     under the RDM

                                            Figure 3.7b




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       3.7.3.2      The finger location that is nearest the unshielded cannula, notably making
                    contact with the plastic hub and distally beyond, have the largest exposure rate.
                    The dosimetry for the “intended” finger pattern positions and corresponding
                    dose rates are explained in the table:

       Finger            Source in Storage      Transit Dose      Source in Eye          Total
       Position            (Prep. Phase)         (in & out)        (Treatment)
                                                                                      
                             2 minutes        0.10 sec Avg          5 minutes
                                                                                       Exposure
             1               26.4 μSv             202 μSv             31 μSv          259.4 μSv
             2                25 μSv               16 μSv            55.5 μSv          96.5 μSv
             3               35.4 μSv               4 μSv             23 μSv           62.4 μSv


                  Do ensure that finger positioning is controlled as shown in Figure 3.7b
                  when holding the device. Finger locations placed distal to Densimet
 CAUTION!         housing will increase the occupational exposure dose and reduce the
                  annual number of procedures safely performed.


3.7.4 Insert the cannula of the Disposable Applicator into the incision.

3.7.5 Position the Disposable Applicator cannula in the midvitreous position (Figure 3.8).




                                              Figure 3.8

          DO NOT advance the radiation source into the Disposable Applicator
 CAUTION! until the tip is in the midvitreous position.




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3.7.6 Prior to activating the VIDION system, it is recommended to “train” the Disposable
      Applicator tip onto the retina surface. Confirm that the crosshair on the top of the cannula
      is visible and in the correct position over the area to be treated according to the pre-
      treatment planning. Place the Disposable Applicator Tip so that it is in soft contact with
      the surface of the retina. This will allow the surgeon to check for landmarks to aid in final
      placement, and make sure that retinal vessels are not at risk for tamponade from the
      Disposable Applicator tip. Following this exercise, bring the Disposable Applicator tip
      back to the midvitreous position.

                DO NOT allow sharp bends or twists in the drive cable between the
                Disposable Delivery Module and Handheld Cable Actuator; this could
                prevent the 90Sr source from advancing fully into the Disposable
 CAUTION!       Applicator or slow down the rate of travel of the source. The cable
                should not be pulled so tight that it interferes with the ability of the
                surgeon to maneuver within the eye


3.7.7 When the surgeon indicates that the Disposable Applicator tip is in the midvitreous
      position, an assistant compresses the Advancement Lever on the Handheld Cable Actuator
      (Figure 3.9). The Advancement Lever will lock into place.

3.7.8 Check the Drive Cable Indicator Windows on the Handheld Cable Actuator to confirm that
      the radiation source has moved into position in the Disposable Applicator. Both indicator
      windows should change from white to black (Figure 3.8).

            Drive Cable
            Indicator Windows
                                                                              Advancement Lever




                                                                    Release Trigger


                                            Figure 3.9

3.7.9 Check the Drive Cable Indicator Windows on the Disposable Delivery Module to confirm
      that the radiation source has moved into position in the Disposable Applicator. The
      proximal indicator window should change from black to white and the distal indicator
      window should change from white to black when the source is in the distal position
      (Figure 3.10).



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                                          Proximal Indicator Window
                                                              Distal Indicator Window




                                            Figure 3.10


3.7.10 The surgeon then moves the device downward until the applicator tip is in the correct
       position with the cross hair (+) over the area to be treated and the distal end of the cannula
       in soft contact with the retina. The surgeon then notifies the physicist (or authorized
       assistant) to start the time for the treatment time selected. Treatment time should start
       when the Disposable Applicator tip is placed in position on the retina. (See the System
       calibration certificate for exact treatment time) Hold the Delivery Assembly steady for the
       entire treatment time to ensure the full dose is delivered to the CNV lesion.

                Unless requested by the retinal surgeon, DO NOT operate the Release
 CAUTION!       Trigger until the procedure is completed. Doing so will retract the
                radiation source and interrupt the procedure.

                If the retinal surgeon interrupts the procedure the radiation source must
                be retracted into the shielded position prior to removal from the eye. In
                this case depress the Release Trigger while ensuring that the
                Advancement Lever is not depressed. Whenever possible advance and
                retract the device only when the tip is in the mid-vitreous cavity to avoid
 CAUTION!       damage to the retina.

                Note: Each time the device is removed the timer must be stopped. When
                the cannula is positioned properly again and the radiation source is
                advanced, the timer can be re-started for the remainder of the duration
                of the treatment time as specified in 3.7.10.


3.8   Completion of Treatment

3.8.1 Upon completion of confirmed treatment time by the individual monitoring the timer, the
      Retina Surgeon will raise the Disposable Applicator tip from the retinal surface into the
      midvitreous position. The Assistant supporting the cable will then be instructed by the
      Retina Surgeon to press the Release Trigger on the Handheld Cable Actuator to retract the
      radiation source (Figure 3.11). The Advancement Lever will return to its ready position.


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               DO NOT allow sharp bends or twists in the drive cable between the
               Disposable Delivery Module and Handheld Cable Actuator; this could
               prevent the 90Sr source from advancing fully into the Disposable
 CAUTION!      Applicator or slow down the rate of travel of the source. The cable should
               not be pulled so tight that it interferes with the ability of the surgeon to
               maneuver within the eye

               Remove hand from Advancement Lever to allow the Release Trigger to
 CAUTION!      operate. Radiation Source will not to return to its retracted/shielded
               position if the Advancement Lever is held in place.

3.8.2 Check the Drive Cable Indicator Windows on the Handheld Cable Actuator to confirm that
      the radiation source has moved into position in the Disposable Delivery Module. Both
      indicator windows should change from black to white (Figure 3.11).


          Drive Cable
          Indicator Windows                                                 Advancement Lever




                                                                Release Trigger


                                         Figure 3.11




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3.8.3 Check the Drive Cable Indicator Windows on the Disposable Delivery Module to confirm
      that the radiation source has been retracted successfully. The proximal indicator window
      should change from white to black and the distal indicator window should change from
      black to white (Figure 3.12).
                                      Proximal Indicator Window
                                                            Distal Indicator Window




                                          Figure 3.12

3.8.4 Remove the Disposable Applicator from the eye and plug the incision with one of the 20-
      gauge scleral plugs provided, if needed, until ready for suturing.

3.9   Post Treatment Source Position Verification

3.9.1 Wipe down the Disposable Applicator cannula. Handle the cannula with care to avoid
      dropping or bending.
       Follow standard biohazard material handling protocol. Wear gloves.
       Use a disposable wipe to remove any visible material on the cannula.
       Wipe the cannula with a wet (water) disposable wipe.
       Wipe the cannula dry with a new disposable wipe.


3.9.2 Replace the Safety Cap on the Disposable Applicator until ready for use in the Calibration
      Device Holder and Position Check Tool.

3.9.3 Perform a Position Check measurement using the Standard Imaging Electrometer, Well
      Chamber, Calibration Device Holder and Position Check Tool. Refer to the User Manuals
      listed below.
        Calibration Device Holder and Position Check Tool User Manual
        Standard Imaging, Inc. HDR-1000 Plus Well Chamber User Manual
        Standard Imaging, Inc. CDX 2000B Electrometer User Manual


                 DO NOT discard any disposable components until post-treatment position
CAUTION!         check verification procedure has been performed




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3.10 Discard Single-Use Items

               The VIDION System position verification check is intended to be performed
               only after treatment. Because of the risk of contamination and subsequent
               infection, Neovista, Inc. does not recommend a pre-procedure position
               verification check when the Disposable Applicator has just been removed
CAUTION!       from its sterile package. Rigorous validations have been performed
               demonstrating that the radiation source reliably advances to the treatment
               position and retracts to the shielded location when the distal and proximal
               indicator windows change color as described above. More then one position
               verification check is not required or recommended.


3.10.1 Snap the Safety Cap onto the Disposable Applicator, and remove the Disposable
       Applicator assembly from the Disposable Delivery Module (Figure 3.13), by rotating
       counter-clockwise, as shown. Dispose of the used Disposable Applicator in a sharps
       container.




                                         Figure 3.13




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3.10.2 Slide the RDM release latch back to remove the RDM from the Disposable Delivery
       Module (Figure 3.14). The Disposable Delivery Assembly and all single use items should
       be disposed of using the facility’s standard operating procedure for handling and disposal
       of medical waste. Clean and sterilize the RDM according to Section 4.1 and 4.3. The
       Emergency Cap is placed on the RDM before it is returned to its Storage Container.

                                           Figure 3.14




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4 Cleaning and Sterilization of the Reusable Delivery Module,
  Calibration Device Holder and Position Check Tool
                 The RDM is provided separately. It is to be stored in a Storage
      NOTE
                 Container and must be sterilized before each use.

4.1    Cleaning the Reusable Delivery Module
       During non-treatment procedures (i.e. cleaning, sterilization and post-treatment verification),
       it is recommended to hold the Reusable Delivery Module at the end opposite the
       DENSIMET shielding.

       Radiation trained personnel will be responsible for handling the device in accordance
       Radiation Safety policies

       Cleaning of the Reusable Delivery Module is intended for the outside surface only. Care
       should be taken to avoid getting cleaning fluid and debris into the inner cavity of the device
       (sliding mechanisms) by holding the end opposite the DENSIMET shielding with the slot
       facing down during the washing process (Figure 4.1).




                                                               Hold this end




                                                                          DENSIMET Shield




                                              Figure 4.1


4.1.1 The following materials are required to complete the cleaning procedure:
       Reusable Delivery Module (RDM)
       Clean, non-sterile gloves
       Water (deionized or distilled), 15 °C to 25 °C (59 °F to 77 °F)
       Cleaning agent: Neodisher® Mediclean Forte or equivalent
       Soft bristle brush


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               During non-treatment procedures (i.e., cleaning, sterilization), it is
 CAUTION!      recommended to hold the RDM at the end farthest from the Densimet tip,
               to limit radiation exposure.

          DO NOT expose the Reusable Delivery Module (RDM), Calibration
 CAUTION! Device Holder or the Position Check Tool to acids, oxidants, or ketones in
          liquid or vapor form.

               Only the outside surface of the RDM should be cleaned. Care should be
 CAUTION!      taken to avoid getting cleaning fluids and debris in the inner cavity of the
               device. Rinse water is allowable.

4.1.2 Procedure:
       Always wear gloves while handling and cleaning the Reusable Delivery Module.
       Prepare the cleaning agent according to manufacturer recommendation. The solution
          should be used at room temperature.
       IMPORTANT: Avoid ingress of the cleaning solution into the interior of the Reusable
          Delivery Module.
       With great care, manually clean the outside of the Reusable Delivery Module for about
          10 minutes with a soft bristle brush. (Note: Never use hard brushes or abrasive
          material) Pay particular attention to the edges where the single use components
          (Disposable Applicator and Disposable Delivery Module) mate to the Reusable
          Delivery Module.
       Thoroughly rinse the Reusable Delivery Module in clean water.
            o Rinse under a stream of water for one (1) minute
            o Immerse the Reusable Delivery Module in deionized or distilled water for at
               least 3 minutes, agitating the device periodically.
            o Rinse under a stream of water for one (1) minute

          Drain the rinse water as completely as possible.
          Discard the remaining used cleaning solution in accordance with institution’s standard
           operating procedures.
          Place the RDM in a sterilization tray

4.2   Cleaning the Calibration Device Holder and Position Check Tool

4.2.1 The following materials are required to complete the cleaning procedure:
       Calibration Device Holder and Position Check Tool
       Clean, non-sterile gloves
       Water (de-ionized or distilled), 15 °C to 25 °C (59 °F to 77 °F)
       Cleaning agent: Neodisher® Mediclean Forte or equivalent
       Clean lint-free cloth
       Soft bristle brush




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4.2.2 Procedure:
       Always wear gloves while handling and cleaning the Calibration Device Holder and
          Position Check Tool
       Dilute the Cleaning agent to 2% by volume with distilled or deionized water. The
          solution should be used at room temperature.
       Immerse the Calibration Device Holder in the cleaning solution for 15 minutes.
       Use a soft bristle brush and cleaning solution to remove any visible contamination,
          especially concentrating on the Slide Clamp of the Device Holder (Figure 4.2).




                                                   Device Holder

                                                                                  Slide Clamp




                                         Figure 4.2

          Manually clean the remainder of the Calibration Device Holder for about 5 minutes
           with a clean soft cloth soaked in the cleaning solution and then wrung out.
          Rinse the Calibration Device Holder and Slide Clamp thoroughly by immersing them
           in deionized or distilled water for 5 minutes, agitating these item periodically.




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             To clean the Position Check Tool (Figure 4.3), remove the Shield, Shield Retainer and
              Shield Retainer Nut to access the interior of the tool. USE NO TOOLS FOR
              DISASSEMBLY / ASSEMBLY.




                          Shield



                                                                      Shield Retainer &
                                                                      Shield Retainer Nut
                                                                      (Not shown)

                                               Figure 4.3


             Immerse the Position Check Tool components in the cleaning solution for 15 minutes.
             Use a soft bristle brush and cleaning solution to remove any visible contamination,
              especially concentrating on the inside slot and shelf of the Position Check Tool (Figure
              4.4 and Figure 4.5).



Inside Slot




                                                                                                  Shelf



                    Figure 4.4                                          Figure 4.5
             Rinse the Position Check Tool components thoroughly by immersing them in
              deionized or distilled water for 5 minutes, agitating it periodically.
             When cleaning and rinsing are complete, reinstall the shield and shield retainer,
              tightening the shield retainer nut finger tight only. USE NO TOOLS FOR
              DISASSEMBLY / ASSEMBLY.



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4.3   Sterilizing the Reusable Delivery Module
      The Reusable Delivery Module is initially delivered and then designed to be stored as a non-
      sterile device. Radiation trained personnel will be responsible for handling the device in
      accordance Radiation Safety policies.

4.3.1 Sterilization Procedure
      The following procedures must be carried out using generally accepted sterile process
      protocol before and after each surgical procedure to assure sterility and cleanliness of the
      RDM.

          The RDM MUST be sterilized before use. When handling the RDM, it is
 CAUTION! recommended to hold it at the end of the handle furthest away from the
          device tip (Densimet housing) to limit radiation exposure.

           . Remove the RDM from the Storage Container
           Remove The Emergency Cap from the RDM and set the cap aside.
           Holding the device from the proximal (non-Densimet) end, wrap the RDM
            individually: place a small outline of “wicking pad” around the device. Then apply a
            “primary” layer of autoclave wrapping and secure with autoclave tape, apply secondary
            wrapping and secure with autoclave tape. **

           Place the RDM(s) onto the autoclave’s sterilization tray and then into the autoclave.

           The autoclave settings are as follows:
                      Sterilizer Type         Pre-vacuum
                      Min. Temperature 134°C (273°F)
                      Min. Hold Time          3 minutes
                      Min. Dry Time           15 minutes
                      Pressure                207 kPa (30 psi)

           Alternatively, a “gravity” sterilizer may be used:
                       Sterilizer Type         Gravity
                       Min. Temperature 134°C (273°F)
                       Min. Hold Time          10 minutes
                       Min. Dry Time           15 minutes
                       Pressure                207 kPa (30 psi)

           Notify Authorized Personnel when the devices are cool and ready for storage or use.
           If the RDM is to be used in a case, Authorized Personnel transport the wrapped device
            to the operating room (go to 3.1).
           If the RDM is to be returned to storage, Radiation Trained Personnel will remove the
            RDM from the wrapping to inspect for any damage and to ensure that all components
            are dry prior to closure of the Storage Container.
           Place the RDM in the Storage Container.
           Close lid.

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               ** Note: NeoVista validated their product sterility using a wicking pad
               around each part, and then applying a primary and secondary wrapping
               with sterile polyester based material intended for autoclave processing.
               These items were then placed directly onto autoclave’s tray and
               processed successfully. NeoVista strongly recommends that any
               departure from this process (wrap configurations, autoclave cycles,
               plastic containers, etc…) be validated in accordance with local or
               regional practices.

4.4   Sterilizing the Calibration Device Holder and Position Check Tool
      The Calibration Device Holder and Position Check Tool are initially delivered and to be
      stored as non-sterile.

4.4.1 Sterilization Procedure
      The following procedures must be carried out using generally accepted sterile process
      protocol before and after each surgical procedure to assure sterility and cleanliness of the
      Calibration Device Holder and Position Check Tool.

           Separate the Calibration Device Holder, the Device Holder Slide Clip, and Position
            Check Tool (note: sterilize screws as loose parts with the Position Check Tool.)

            Wrap each item individually: place a small outline of “wicking pad” around each
            device then apply a “primary” layer of autoclave wrapping and secure with autoclave
            tape. Then apply secondary wrapping and secure with autoclave tape.

           Place the items onto the autoclave’s sterilization tray and into the autoclave.

            The autoclave settings are as follows:
                      Sterilizer Type          Pre-vacuum
                      Min. Temperature 134°C (273°F)
                      Min. Hold Time           3 minutes
                      Min. Dry Time            15 minutes
                      Pressure                 207 kPa (30 psi)

           Alternatively, a “gravity” sterilizer may be used:
                       Sterilizer Type         Gravity
                       Min. Temperature 134°C (273°F)
                       Min. Hold Time          10 minutes
                       Min. Dry Time           15 minutes
                       Pressure                207 kPa (30 psi)

           When the devices are cool and ready for storage, remove the Calibration Device
            Holder and Position Check Tool from the sterilization tray to inspect for any damage
            and to ensure that all components are dry.
           Place the Calibration Device Holder and Position Check Tool in the Physics/Accessory
            Kit Carrying Case.
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5 Storage of the Reusable Delivery Module
5.1   Storage Container
      The Storage Container (Figure 5.1) is used to store the RDM when not in use. Additionally,
      the Storage Container can be used in the event of an emergency if the user is unable to move
      the radiation source to the storage position in the RDM. The Storage Container contains a
      1/8” thick lead liner.




                                            Figure 5.1

5.2   Emergency Cap
      Included in the Storage Container is an Emergency Cap (Figure 5.2) designed for use in the
      event that the radiation source cannot be retracted from the Disposable Applicator into the
      RDM for storage, or if the applicator cannula is damaged. The Emergency Cap is placed on
      the RDM for routine storage.




                                            Figure 5.2




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6 Package and Device Labeling
6.1   Labeling of Single-Use Disposable Components
      The following label (Figure 6.1) is placed on the outside of the Disposable Delivery
      Assembly Container. See Table 2 of this Operator’s Manual for description of the symbols
      used on this label.




                                                 Figure 6.1


6.2   Labeling for Unit Carton and Six Pack Shipper
      The following label (Figure 6.2) is placed on the outside of the VIDION Disposable Delivery
      Assembly Unit Carton and a check mark is placed in the “Quantity 1” box. This same label
      is placed on the outside of the VIDION Six Pack Shipper and a check mark is placed in the
      “Quantity 6” box. See Table 2 of this Operator’s Manual for description of the symbols
      used on this label.




                                                 Figure 6.2


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6.3   Labeling of Reusable Delivery Module
       The bottom of the RDM (Figure 6.3) has the following markings:
       • A unique serial number (S/N)
       • The radionuclide and amount of activity
       • The NeoVista name, CE Mark and the radiation trefoil (Figure 6.4)




                                                                 Bottom of the RDM
                                          Figure 6.3




                                            Figure 6.4

6.4   Labeling of Type A Shipping Container
      The Type A shipping Container contains the Storage Container for the RDM as well as the
      Radioactive Yellow II 7 label, and UN2915 label (Figures 6.5and 6.6).




                                          Figure 6.5


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                                                         Figure 6.6


6.5   Labeling of Storage Container
      The following label (Figure 6.7) is placed on the outside of the Storage Container. See
      Table 2 of this Operator’s Manual for description of the symbols used on this label.




                                                         Figure 6.7

6.6   Labeling of Physics Package
      The Output Verification Straight Cannula label (Figure 6.8) and the Position Verification
      Curved Cannula label (Figure 6.9) are placed on outside of the appropriate vials in the
      Physics Package Carrying Case.




                                              Output Verification
                                              Straight Cannula
                                                 NOT FOR HUMAN USE
                                                    NON STERILE
                              NeoVista®, Inc.
                              47865 Fremont Blvd.
                              Fremont, California 94538 USA
                              T: 510-933-7601
                              F: 510-933-7659                            PRT-1525-EN.B




               Figure 6.8 Output Verification Straight Cannula label PRT 1525

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                            Positioning Verification
                              Curved Cannula
                                    NOT FOR HUMAN USE
                                       NON STERILE
                        ®
                NeoVista , Inc.
                47865 Fremont Blvd.
                Fremont, California 94538 USA
                T: 510-933-7601
                F: 510-933-7659                         PRT-1526-EN.B




Figure 6.9 Position Verification Curved Cannula label PRT 1526




            Figure 6.10 Physics Actuator PRT-1608




    Figure 6.11 Sterilization Package CE Label PRT-1558




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Figure 6.12 Physics Kit CE Label PRT-1559




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7 Technical Specifications
7.1   Single-Use Disposable Components

7.1.1 Disposable Delivery Assembly
      The Disposable Delivery Assembly includes the Disposable Delivery Module, drive cable,
      and Handheld Cable Actuator. These parts are assembled and packaged.

        Sterilization                               Sterile, for single use only
        Working length, assembled                   1.39 Meters (54.9”)
        Material                                    Thermoset polymers, Stainless Steel

7.1.2 Disposable Applicator
       Sterilization                                Sterile, for single use only
       Cannula length                               0.90 mm x 73 mm (d x 1)
       Cannula material                             304 Stainless steel
       Welded tip material                          304 Stainless steel
       Tip curve angle                              31.5°

7.1.3 Surgical accessories
       20-gauge microvitreoretinal (MVR)
                                                    Sterile, for single use only
       blade
       20-gauge scleral plugs                       Sterile, for single use only

7.2   Reusable Delivery Module
                                               Non-sterile, must be cleaned and steam
        Sterilization
                                               sterilized prior to each use
        Reusability – based upon the number of 200 procedures or three years,
        validated cleaning cycles              whichever comes first
                                               The RDM will be returned to NeoVista
                                               for the following reasons:
                                                 Used to the Reusability limit
                                                 In the event of the RDM device is
                                                  believed to have incurred damage
                                                 In the event a clinic discontinues the
                                                  service that utilizes this device.
        Radioactive Source Control
                                                 Termination of radiation license by
                                                  regulatory agency
                                               NeoVista will review the circumstance
                                               under which a device was returned and
                                               either re-commission or convert to non
                                               use reprocessing directive (possibly
                                               disposal)
        Source type                            Sealed source (beta)
                                               90
        Source isotope                           Sr/90Y

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Source half-life                          29 years
                                          370 to 555 MBq: 0.52 mm x 2.5 mm
Source sizes and activity
                                          (d x 1)
                                          C.53X11 (Certificate available upon
ISO 2919 classification
                                          request)
                                          Absorbed dose rate in water at the
                                          predefined distance is determined with
Dose rate                                 a NIST-traceable source by NeoVista
                                          using AALA-accredited methods.

                                          Retina Surgeon:
                                          Each Retinal Surgeon may perform up
                                          to a maximum of 480 procedures per
                                          year, and stay within 30% of maximum
Occupational Dose – for those on a        dose as defined by 10 CFR 20.
managed dosimeter program, based
upon validated dosimetry studies, and     Occupationally Exposed Staff may be
utilizing a 30% level of the maximum      involved up to a maximum of 960
allowable limits as stated in 10 CFR      procedures per year
20, the annual dose levels are as
follows:                                  The maximum patient effective dose
    • Extremities 150 mSv/yr.             equivalent (TEDE) shall not exceed
    • Eye          45 mSv/yr              100 μSv (not including the dose to the
    • Body         15 mSv/yr              treatment site).
(all numbers reflect ICRP 103 for 30%
of NRC value on annual basis)             All other staff not wearing dosimeter
                                          equipment will be maintained at less
                                          than 10% of maximum allowable dose
                                          as stated in 10 CFR 20.




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8 System Malfunction and Emergency Procedures
8.1   Device Malfunction
       1.     A device malfunction is defined as a failure of the device to meet its performance
              specifications or otherwise perform as intended.
       2.     Examples of malfunctions could include:
               Missing product components
               Missing or illegible product associated labeling
               Devices which appear malformed or disfigured
               Failure of the RSW to deploy
               Failure of the RSW to retract after deployment

       All device malfunctions will be recorded in the patient’s record and reported to NeoVista,
       Inc:
              Radiation and Clinical EMERGENCY Phone: (+) 510-933-7650

              Non-Emergency Customer Service Phone: (+) 510-933-7601

              Fax: (+) 510-933-7654

              E-mail: device@neovistainc.com



8.2   Emergency Procedure
      This procedure provides guidance for recovering a Radiation Source when it cannot be
      confirmed to have reached the treatment site, or will not return to the shielded storage
      position of the VIDION System. This procedure should be augmented with any institutional
      policies and procedures on radiological emergencies involving source recovery.

      Emergency procedure should be used for the following situations (procedures are not limited
      to the situations listed):
       Source wire does not advance.
       Source wire does not retract.
       Source wire sticks at any position along its path.
       Source wire breaks
       Disposable Applicator does not readily remove from the VIDION System
       Disposable Applicator or any part of the Disposable Applicator breaks off
       Any noticeable damage to the shielded storage section of the VIDION System
       Radiation personnel deem the VIDION System unsafe through verification of a survey
          meter.
       Any other scenario where the user feels that the integrity of the VIDION System has
          been compromised.


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    This section provides direction for the user to safely return a source to a controlled location.

          Retrieve the Emergency Cap.

  1. Withdraw the VIDION System from the eye and pass the device to the physicist who will
     then move away from all operating suite staff.

  2. Slide open end of Emergency Cap over Disposable Applicator end of the VIDION System
     (Figure 8.1).




             Emergency Cap




                                            Figure 8.1

WARNING! Avoid direct contact with the unshielded delivery probe, as unintended
         radiation exposure WILL occur.

  3. Gently push the Emergency Cap and VIDION System together, rotated 1/4 turn to assure
     firm attachment.

  4. Cut the drive cable at the end of the strain relief with the provided Emergency Cable
     Cutter. (Figure 8.2).




           Emergency Cap


                                                                         Cut here with Emergency
                                                                         Cable Cutter




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                                         Figure 8.2

   5. Remove the top and bottom inserts from the Storage Container.

   6. Place the VIDION Device with Emergency Cap into the Storage Container (Figure 8.3).




 Emergency
                                                                                     VIDION
 Cap
                                                                                     Device




Storage
Container                                                                            Cable cut at
                                                                                     Strain Relief




                                           Figure 8.3

   7. Close and lock the lid on the Storage Container.
   8. Remove the Storage Container to a safe location.
   9. NOTIFY RADIATION SAFETY PERSONNEL IMMEDIATELY OF THE
      SITUATION.

          Only Authorized Persons may handle the VIDION Device when in an
 WARNING! Emergency State.

               Should a situation occur when the radiation source cannot be returned to
               the retracted/shielded position, there is a risk of unintended radiation
               exposure to operating room personnel. Immediately notify personnel
               present of the situation. Individuals involved in this procedure should
 WARNING!      wear disposable gloves. NeoVista recommends that personnel wear an
               extremity dosimeter on both hands and a whole body dosimeter on the
               front of the body between the neck and the waist. The appropriate
               institution personnel should be immediately notified. NeoVista should be
               immediately notified.




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8.3   Actions Required In The Event Accidental Damage to a VIDION Device Occurs

       1. Approach any emergency action with caution and thought. Do not rush into any action
          until you have accessed the situation and the damage to the device.

       2. If the device is dropped, verify that the source can be returned to the shielded position
          and do so immediately.

       3. If the source can not been restored to the stored positions or the cannula has been bent,
          the Emergency Cap should be applied to the device (see Figures 8.1 through 8.3)


8.3.1 If the VIDION delivery assembly is dropped:

       1. Verify that the radiation source can be returned to the shielded position, and do so
          immediately. Check the white and black position indicators.

       2. Remove the Disposable Applicator and dispose of it in a sharps container, only after
          survey for radiation contamination. If the Disposable Applicator cannot be removed,
          assume that the source is advanced and proceed with emergency procedures.

       3. Remove the RDM from the Disposable Delivery Module and return it to its Storage
          Container. If the Disposable Applicator cannot be removed, assume that the source is
          advanced and proceed with emergency procedures.


8.3.2 In the event of other damage, or if the radiation source cannot be returned to the shielded
      position within the RDM, or if the cannula has been bent:

       1. DO NOT attempt to remove the Disposable Applicator from the Disposable Delivery
          Assembly; gently push the Emergency Cap and VIDION Device together, rotated 1/4
          turn to assure firm attachment.

       2. If the cannula is bent in such a way that the placement of the Emergency Cap is not
          possible, hold the device firmly and bend the cannula using the inside of the
          Emergency Cap; this should allow you to straighten the cannula enough to put the
          Emergency Cap on the device. Gently push the Emergency Cap and VIDION Device
          together, rotated 1/4 turn to assure firm attachment.

                DO NOT physically touch or hold the Disposable Applicator if the radiation
                source is in the advanced position. At a distance of 5 cm, the radiation source
                in the exposed position emits a radiation field of 540 mSv/hr. This equates to
WARNING!        9 mSv/minute at 5 cm. With the Emergency Cap in place, this is reduced to 6
                mSv/hr if the source is centered in the cap. The allowable yearly extremity
                dose per ICRP 103 for 30% of NRC value on annual basis of extremity exposure,
                for personnel is considered to be 150 mSv annually.


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             Properly wearing your radiation finger dosimeter will allow the exposure
CAUTION!     value to be measured. The maximum allowable annual radiation exposure
             to your extremities shall not exceed 500 mSv.

    3. Placement of the Emergency Cap over the Disposable Applicator should take less than
       ten (10) seconds.

    4. Minimize the time spent handling the damaged device and limit your presence in the
       vicinity of it.

    5. If the cannula is physically damaged, you may have to handle the Emergency Cap with
       a long handled pair of hemostats or forceps that will allow grasping of the cap surface.
       If these are not immediately available to you, your radiation exposure risk will not
       increase if you do not handle the damaged device.

    6. If the Disposable Applicator cannula is severed, lower the Disposable Delivery Module
       and Disposable Applicator into the Emergency Cap rather than sliding the Emergency
       Cap onto the cannula. Gently push the Emergency Cap and VIDION Device together,
       rotated 1/4 turn to assure firm attachment. Place it in the Storage Container.

    7.   Conduct a radiation survey of the area to ensure that the 90Sr/90Y source integrity has
         not been compromised.




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             NeoVista Customer Support
The NeoVista VIDION Anti-NeoVascular Therapy System is
               NOT serviceable at the site.

  If any anomaly is noted, the System must be returned to
               a qualified service provider.




         For supply orders, customer support, and training
              on the VIDION System, please contact:

                      NeoVista, Inc.
                 47865 Fremont Boulevard
                 Fremont, CA 94538-6506
                    OFFICE : (+) 510-933-7600
               CUSTOMER SERVICE: (+) 510-933-7601
              EMERGENCY CONTACT: (+) 510-933-7650
                     FAX: (+) 510-933-7659




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                      9 Revision History
 CO#      Revision                         Description                               By
CO-0948      A       Initial Release                                              MB
CO-1169      B       Updates: added reference Commissioning Document to           JJ, BW,
                     Preface, changed “Delivery” Device to “VIDION”
                     Device throughout, added footnote on page describing
                                                                                  AP, MW
                     Biodex syringe carrier, in 3.4.5 added clarification of
                     visibility and placement of cannula crosshair over AMD
                     lesion, in 3.4.9 added two Caution statements dealing
                     with procedure interruptions and limits to actuations,
                     rearranged Section 3.6 to reflect correct order of
                     procedural steps, corrected note in Section 4, other minor
                     clarifications.
                      Table 3 - removed RDM insert tray and reference to a
                       PRT-1037 Position Check Tool User Manual
                      Table 4 - Removed Physics Access insert tray, added
                       reference to PRT-1577 Calibration Device Holder and
                       Position Check Tool User Manual
                      Sect 1.4 3rd and 4th warning blocks, I added location
                       of specific Emergency information located in the
                       Operator Manual.
                      Sect 1.5 – 4th caution note: revised cable straightness
                       notes
                      Table 7 removed Physics Access insert tray
                      Table 8 removed RDM insert tray
                      Sect 2.2 Fig 2.2 footnote added for reference to           DG
                       Storage Container being a Biodex Shielded Syringe
                       Carrier.
                      Sect 2.6 revised wording for readability.
                      Sect 2.6.2 – removed reference to issuance of new
                       calibration certificate issuance policy.
                      Sect 3.1 – moved opening sterile tray to 3.2, and
                       revised wording to introduce idea that RDM (and
                       Physics items) must be sterilized prior to procedure
                       beginning.
                      Sect 3.2 – clarified opening sequence of sterile tray
                      Sect 3.4.2 - 3rd caution note - added cable straightness
                       notes
                      Sect 3.5.5 - added 1st caution note - cable straightness
                       notes
                      Sect 3.5.9 2nd caution note - revised format to separate
                       message with same caution block
                      Sect 3.5.1 - inserted 1st caution note - added cable
                       straightness block
                      Sect 3.6 – revised wording to include Retina Surgeon
                       instruction
                      Sect 3.7.1 – revised format of section to bullet point
                      Sect 4.1 - inserted note on Radiation trained personnel
                       to handle parts
                      Sect 4.1.1 - 1st Caution Box - added word Densimet to
                       further describe "tip" to avoid holding when handling.
                      Sect 4.1.2 – added soft bristle brush to cleaning
                                    - 49   -
                                                                  NeoVista Doc. #PRT-0956-LBL1
                                                                                     Revision: E
                                                                         Effective Date: 07/14/09
                                                                      OPERATOR’S MANUAL


 CO#      Revision                          Description                                By
                       instruction
                      Sect 4.2.1 and 4.2.2 – clarified brush to be bristle brush
                      Sect 4.3 & 4.3.1 - revised wording to clarify arrival
                       and ongoing status of RDM regarding sterility. Again
                       cited note on Radiation trained personnel to handle
                       parts
                      Sect 4.1.1- 1st Caution Box - added word Densimet to
                       further describe "tip" to avoid holding when handling.
                      Sect 4.3.1 - bullet areas -
                       o Removed insert tray references
                       o Revised sequence of when RDM is removed from
                            Storage Container, and cap is removed.
                       o Clarified how to prepare parts for steam
                            autoclave, referred reader to ** note.
                       o REVISED GRAVITY drying time to 15 minutes
                      Sect 4.3.1 (end) - Added ** note on how NeoVista
                       validated their sterility, and what clinic should do if
                       they desire to deviate from the validated procedure.
                      Sect 4.4.1 - revised description on how to prep Physics
                       Access parts for steam autoclave, place into
                       Phys/Access Kit box
                      REVISED GRAVITY drying time to 15 minutes
                      Sect 7.2 – 2nd box down - clarified basis of single
                       RDM usage as being cleaning/sterilization validation
                       based.
                      Sect 7.2 – 8th box down – added section on
                       occupational dose limits for involved staff, defined
                       source of reference values, and ALARA value of 30%.

CO-1179      C       Reformat “WARNING!” and “CAUTION!” text                           TM
                     throughout manual, Figure 2.7 revise Vidion to VIDION,
                     in Section 3.3 correct spelling from Delivery to Delivery
CO-1285      D        Sect 1.5 Bullet 5 & 3.4.2 Bullet 3 changed isotope to        DG, JJ, JN,
                        source.                                                      MW, TM
                      Sect 1.6.3 capitalized VIDION, added R trademark
                      Section 2.2 - added Caution on handling and disposal
                        of RDM
                      In Table 4 added PRT-1091.
                      In Table 7 added PRT-1580.
                      Sect 2.5 add: (with RDM)
                      Sect 2.6: Domestic changed to Local
                      Sect 2.6.2 revised wording to be: at 1% physical
                        decay (approximately 6 month intervals).
                      Table 9: revised Peak Dose Lens – was: 0.56 is:
                        0.35.mGy Optic Disc was 6.3 is: 6.5 Gy per TPR
                        0959
                      Sect 3.2 revised wording to be: Disposable
                        Applicator ‘with its Safety Cap.”
                      Sect 3.5 and 3.6 Added additional pre-treatment
                        planning and vitrectomy location respectively.
                      Figure 3.7b - Renumbered text boxes within image.
                        Removed colored lines and repositioned arrow lines.
                      Sect 3.7.1 Inserted note to provide adequate

                                     - 50   -
                                                            NeoVista Doc. #PRT-0956-LBL1
                                                                               Revision: E
                                                                   Effective Date: 07/14/09
                                                                OPERATOR’S MANUAL


CO#   Revision                         Description                               By
                   magnification.

                  Sect 3.7.3.2 Revised wording to be:
                     o The finger location that is nearest the unshielded
                        cannula, notably making contact with the plastic
                        hub and distally beyond, have the largest
                        exposure rate. The dosimetry for intended finger
                        pattern positions and corresponding dose rates are
                        explained in the table below:.....
                  Table under 3.7.3.2
                     o changed transit dose from 60 cm/sec to 0.10 sec
                        average
                  Sect 3.7.10 - second Caution - added
                   recommendation to retract or advance the device only
                   in mid-vitreous.
                  Sect 4.1.2
                     o bullet 4 - deleted .”..followed by a clean soft
                        cloth soaked in the cleaning solution and then
                        wrung out".
                     o bullet 5 - deleted: Using a new clean cloth,
                        gently wipe and then...
                     o add sub bullet: Rinse under a stream of water for
                        one (1) minute
                     o revise and sub bullet: was 5 minutes, now 3
                        minutes
                     o add sub bullet: Rinse under a stream of water for
                        one (1) minute
                  Sect 4.2.2
                     o bullet 5 - deleted: clean soft cloth soaked in the
                        cleaning solution and then wrung out.\
                     o added: soft brush dipped in the Neodisher
                        solution.
                     o bullet 6 added: "these items" periodically
                  Updated front cover, product labels in Figures 6.1,
                   6.2, 6.7, 6.11, 6.12 and Table 2 to include
                   manufacturer “filled factory” symbol based on BSI
                   input.
                  Sect 3.7.2Added diagram on how to hold the device
                   based on dosimetry measurements
                  Sect 1.6.3, inserted occupation dose table and related
                   procedure per year calculations.
                  Sect 3.7.3 and Figures 3.7a and 3.7b: Inserted
                   section, figures, and Caution Note to outline finger
                   position and related dosimetry.
                  Sect 6 - Revised Labeling of Physics Package –
                   updated Logo, added PRT 1558/1559, revised title
                   font, and added Figures 6.10, 6.11, and 6.12.
                  Sect 8, revised phone contact and title information.
                   Increased FONT after Sect 8.3.2. Step 7. Other minor
                   edits for clarification.
                  Sect 7.2 - added Radioactive Source Control
                   information to Technical Specifications based on BSI
                   recommendations.
                  Sect 8.3.2 – Caution Note - reduced annual extremity
                   exposure limit from 500 mSv to 150 mSv based upon
                                - 51   -
                                                              NeoVista Doc. #PRT-0956-LBL1
                                                                                 Revision: E
                                                                     Effective Date: 07/14/09
                                                                  OPERATOR’S MANUAL


 CO#      Revision                         Description                             By
                       ICRP (International Commission on Radiation
                       Protection) and cited in TPR-0959 findings; provided
                       hourly dose rate;
                      moved Caution statement verbiage into Warning box.
CO-1321      E        Sect 1.6.3.3 Change “maximum activity allowed (555         B.W
                       MBq)” to “95 percentile activity (470 MBq)”
                      Delete 4th column in table, labeled “Possible
                       Procedure per Year”




                                    - 52   -

				
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