36C24218U0112-001.pdf

Equipment Statement of Work (SOW)

BRAINLAB NAVIGATION SYSTEM

1. Background

The NY Harbor Healthcare System, Manhattan campus, is the VISN 2 referral center for Neurosurgery providing comprehensive neurosurgical cranial and spine surgery service for veterans. This is an urgent request to purchase the Brain Lab Cranial/Spine

Navigation system to replace the 9-10 year-old outdated system, which has irregularly worked for the past 2 years. This has resulted in the need to outsource some brain surgery cases and all neurological cases requiring deep brain stimulation (DBA.)

This new system will be integrated with the new operating microscope and will have the capability to also perform deep brain stimulation (stereotaxy). With the addition of the BrainLab Cranial/Spine Navigation system, we will be able to continue to service our brain/spine patients; as well as those requiring DBA, resulting in significant savings and added convenience for patients. BrainLab navigation is now exclusively used by Neurosurgery affiliate at NYU and Bellevue. They attest that the requested system is superior and they are very satisfied with BrainLab’s performance. This equipment does store patient information but will not be interfaced with the VA computer system. It will be a standalone system. System updates will be done on site by the vendor. The total cost of this equipment includes a one year licensing support agreement. Licensing support agreement payments for subsequent years will need to be paid annually along with service contract payments once the one year warranty expires.

1) Complete generic identification — Cranial/Spine Navigation system

2) Applicable model/make/catalog number

Pos. Art.No. Description Qty. Period In months

P L A T F O R M

1 19901 CURVE NAVIGATION STATION 1

2 10952 PLANNING WORKSTATION SURGERY 1

P L A T F O R M S O F T W A R E

3 30038 ORIGIN DATA MANAGEMENT 2

E L E M E N T S P E R P E T U A L

4 26240 ELEMENTS IMAGE FUSION 2

C R A N I A L N A V I G A T I O N

5 22216 NAVIGATION SOFTWARE CRANIAL 1

6 21804 REGISTRATION SOFTWARE SURFACE MATCHING 1

7 21210 IPLAN STEREOTAXY SOFTWARE 1

8 21242 IPLAN FUNCTIONAL SOFTWARE (AC/PC PLANNING & BRAINATLAS) 1

S P I N E N A V I G A T I O N

9 22268 NAVIGATION SOFTWARE SPINE & TRAUMA 3D 1

10 22263 REGISTRATION SOFTWARE CT-SURFACE MATCHING 1

E L E M E N T S L I C E N S E S U P P O R T

11 87010-06 LICENSE SUPPORT ELEMENTS IMAGE FUSION 2 12

I G S L I C E N S E S U P P O R T

12 87010-27 LICENSE SUPPORT NAVIGATION SOFTWARE SPINE & TRAUMA 3D 1 12

13 87010-80 LICENSE SUPPORT NAVIGATION SOFTWARE CRANIAL 1 12

14 87030-01 LICENSE SUPPORT MICROSCOPE NAVIGATION SOFTWARE 1 12

15 87000-01 LICENSE SUPPORT ORIGIN DATA MANAGEMENT 2 12

16 87030-02 LICENSE SUPPORT MICROSCOPE NAVIGATION SOFTWARE HEAD-UP

DISPLAY 1 12

17 87010-29 LICENSE SUPPORT REGISTRATION SOFTWARE CT-SURFACE MATCHING 1 12

C R A N I A L A C C E S S O R I E S

18 B11011 BASIC ACCESSORY PACKAGE CRANIAL 2

19 B11004 VARIOGUIDE HARDWARE PACKAGE 2

20 41874 INSTRUMENT CALIBRATION MATRIX 2

21 B11005 INSTRUMENT ADAPTER PACKAGE (SET OF 2) 2

22 41779 DISPOSABLE BIOPSY NEEDLE 1.8MM / 235MM (5 PCS) 2

23 52305 STERILIZATION TRAY CRANIAL 2

S P I N E A C C E S S O R I E S

24 B23506 ACCESSORY PACKAGE SPINE BASIC 2

25 B23509 ACCESSORY PACKAGE SPINE FOR OPEN SURGERY (AWLS & PROBES) 2

26 B23510 ACCESSORY PACKAGE SPINE FOR DRILLING 2

27 B23518 ACCESSORY PACKAGE SPINE FOR MINIMALLY INVASIVE SURGERY 2

M I C R O S C O P E I N T E G R A T I O N

28 22682 MICROSCOPE NAVIGATION SOFTWARE 1

29 41769-07 MICROSCOPE ADAPTER WITH ARRAY FOR LEICA M530 OH6 2

30 22683 MICROSCOPE NAVIGATION SOFTWARE HEADS-UP DISPLAY 1

31 15239 MICROSCOPE INTERFACE CABLE 1

I G S D I S P O S A B L E S

32 55797 DISPOSABLE STYLET (10 PCS, PRE-CALIBRATED) 1

33 53153 DISPOSABLE CLIP-ON REMOTE CONTROL (20 PCS) 1

34 41773 DISPOSABLE REFLECTIVE MARKER SPHERE (90 PCS) 1

35 55846 DISPOSABLE TROCAR INSERT FOR PEDICLE ACCESS NEEDLE (5 PCS) 1

36 54908 DISPOSABLE SCHANZ SCREW (AO) 4MM X 125MM (10 PCS) 1

37 52160 MULTI-MODALITY DONUT REGISTRATION MARKER (100 PCS) 1

O N S I T E A P P L I C A T I O N T R A I N I N G - I G S

38 81012-01 CRANIAL TRAINING (1 DAY) 1

39 81042-01 SPINE TRAINING (1 DAY) 1

I G S S E R V I C E S

40 81013-01 CLINICAL CASE COVERAGE CRANIAL (1 CASE) 5

41 81043-01 CLINICAL CASE COVERAGE SPINE (1 CASE) 5

42 81001-01 INSTALLATION NAVIGATION SYSTEM (1 MOBILE UNIT) 1

F R E I G H T , I N S U R A N C E A N D F E E S

43 50780 FREIGHT, INSURANCE AND FEES 1

****TECHNICAL SPECIFICATIONS****

EASY-TO-USE NAVIGATION

With digital patient data uploaded to the BrainLab Cranial Navigation application in the O.R., surgeons can identify their approach before making an incision. Cranial Navigation tracks tools¹ in real time and displays their position in relation to the patient data.

Surgeons are guided through procedures, helping to keep skull openings small and minimize damage to healthy structures.

• Simultaneous navigation in different datasets

• Combines relevant details in overlaid views

• User interface designed for touch control

• Automated functions minimize interaction

• Universal instrument calibration on-the-fly

• Seamless import of all iPlan® data

• Variety of hardware and software options

TIME-SAVING REGISTRATION

Regardless of the patient’s position, BrainLab Cranial Navigation offers multiple techniques for referencing them to the system. Z-touch® and Softouch® are based on surface matching, making patient registration quick and easy by simply touching the patients’ skin with either a pointer or a laser. As both devices register CT and MR images without headsets or markers, registration scans can be avoided, helping to reduce neuronavigation costs and radiation exposure to the patient and O.R. team.

• Pointer registration with or without markers

• Touch-sensitive surface matching with Softouch

• Contact-free surface matching with Z-touch

• Combined surface matching registration

• Pre- and intraoperative landmark registration

AUTOMATIC IMAGE REGISTRATION

Automatic Image Registration (AIR) is the fundamental technology for seamless integration of intraoperative MRI or CT² images with image guided surgery. AIR adds intraoperatively acquired data to surgical navigation, optimizing the workflow while maintaining the preoperative surgical plan.

• Eliminates need to access anatomical landmarks

• Accurate image registration

• Available for various MR scanners

• Universal integration of CT, rotational angiograph, and cone-beam CT³

HIGH PRECISION ALIGNMENT

Surgeons can target pre-planned trajectories in less than a minute with BrainLab VarioGuide®. Universal instrument holder VarioGuide offers continuous position feedback and precise step-by-step workflow guidance for a variety of procedures. Surgeons are able to take biopsies, place shunts, or guide an endoscope with increased confidence through proven passive-marker technology.

• Bridges gap between head frame and freehand

• Flexible instrument adaptation (Ø 1.8 – 8 mm)

• Increases efficiency and patient comfort

• Pre-calibrated Biopsy Needle (Ø 1.8 mm) further increases confidence in biopsy procedures

NAVIGATED DISPOSABLE BIOPSY NEEDLE

The Disposable Biopsy Needle is designed for navigated removal of tissue samples in frameless neurosurgery procedures. The elaborate design increases safety and confidence while the pre-calibrated geometry allows for instant use of navigation. Together with

BrainLab VarioGuide and the Cranial Navigation application, pre-planned trajectories can be quickly targeted.

• Pre-calibrated and navigation-ready

• Up to 150 mm usable biopsy length

• 1.8 mm outer diameter

• 10 mm cutting window

• Stopper for securing calculated length

NAVIGATED DISPOSABLE STYLET

The Disposable Stylet is designed for the navigated placement of shunts or ventricular catheters in neurosurgery, enabling their quick and easy freehand placement. The incorporated passive marker geometry is automatically recognized by the navigation camera, allowing for instant calibration.

• Navigation-ready pre-calibrated tool

• Shunt/catheter vendor independent

• 1.1 mm diameter, 165 mm length

INCREASED ACCURACY

BrainLab Spinal Navigation provides an image-guided open navigation platform for spinal surgery which delivers more accurate pedicle screw placement compared to conventional surgical techniques¹. Navigation of implants and instruments is possible in 2D images, 3D scans, MR or CT datasets in all stages of surgery—from incision planning to implant placement.

• Accurate planning of incisions and trajectories with any instrument

• Safe placement of implants, especially in anatomical critical areas

• Guidance for posterior incision and approach for minimally invasive implant placement

DECREASED X-RAY EXPOSURE

BrainLab Spinal Navigation enables reduction of X-Ray exposure to the surgical team and the patient². Through real time visualization of instruments, skin incisions and trajectories can be planned with any instrument at skin level, for example, in routine minimally invasive lower lumbar spine surgery.

• Reduction of X-Ray exposure to surgical team and patients

• Planning of skin incision and trajectory on skin level

• Real time visualization of instruments in 2D images, 3D scans, MR or CT scans

MULTIPLE TREATABLE INDICATIONS

The indication range of BrainLab Spinal Navigation spans cervical and high thoracic dorsal instrumentations to routine lower lumbar surgery, complex deformity surgery, tumor treatment and surgery planning. Both, pre- and intraoperative images can be registered for navigation.

• Placement of C1-C2 screws and pedicle screws in any area of the spine

• Assistance in complex deformity correction and tumor surgery

• Surgical planning within the navigation software

SMART INSTRUMENT INTEGRATION

In addition to a range of BrainLab instruments, cooperations with selected 3rd party manufacturers—DePuy Synthes, ulrich medical and Aesculap—also provide navigation-ready integrated instruments for smooth and seamless workflows. Moreover, the open platform principle of BrainLab Spinal Navigation enables other suitable 3rd party instruments to be manually calibrated for navigation by attaching universal adapter clamps.

• Preservation of standard clinical workflow

• Visualization of pre-calibrated instruments in 3D geometry

• Integration of other suitable instruments with universal adapter clamps

LARGER SCREENS FOR ENHANCED INFORMATION

Curve™ Image Guided Surgery optimizes navigation with pre-op planning and surgical visualization. Surgeons are guided by images from multiple views helping increase decision-making confidence.

• Two 27” touch monitors with 16:9 screen ratio provide more space to display and efficiently organize information

• Capacitive touch technology decreases display deterioration, enhances 3D software images and produces higher contrast for crystal clear tissue differentiation

• 1920 x 1080 pixels per display for 2D and 3D images offer more anatomical detail in full HD

• Latest image guidance software powers advanced 3D displays and hallmark BrainLab image enrichment

• Shifts easily between applications with a touch of the virtual ‘Home’ button

LOADED FUNCTIONALITY WITH ERGONOMIC DESIGN

Curve Image Guided Surgery is packed with small features that add up to big performance. The centralized ‘Start’ screen – accessible at any time via the virtual ‘Home’ button – makes launching software applications and displaying contents a breeze with drag-and-drop functionality.

• Separate monitor and camera carts effortlessly dock together for easy moving and parking while fitting user needs perfectly with optimized usability and quick setup and tear down

• Mobile, wireless¹ networking lets surgeons stream and record to linked workstations

• Built-in high fidelity music dock allows surgeons to navigate to their own soundtrack

• Eight separately moving and braking wheels maneuver easily around cables and over door jams

ROBOTIC CAMERA ADJUSTMENT

Curve Image Guided Surgery adapts to virtually any operating room setup for almost any navigated surgical intervention with its independent camera stand. The motorized telescopic camera height adjustment spans from as low as 67 cm (26.37″) to as high as 254 cm (100″).

• High setup flexibility for supine patient positioning and spine surgeries

• Extra low camera position to support cranial cases with prone patient positioning

• 300 cm (118”) extended camera tracking volume broadens setup options without compromising patient registration

• Convenient laser pointer located in the camera head offers optimal orientation and positioning

FLEXIBLE SURGICAL SETUP

Surgeons and O.R. staff are free to control the operating room setup with multiple variations, including sterile and non-sterile configurations.

Smart ergonomics and docking mechanism, combined with an appealing design makes Curve transportation easy and storage the last thing on anyone’s mind.

• Surgeon and non-sterile staff operate Curve at the same time, increasing efficiency and streamlining workflows

• Surgeon controls both Curve monitors for navigating, streaming and recording while benefitting from space-saving footprint

• Surgeon uses one Curve monitor as ‘cockpit’ for changing settings while the second monitor, placed over the patient, serves as a view-only image guidance monitor

• Surgeon and sterile nurse each operate a Curve monitor for dual control and flexibility inside the sterile field

POWERFUL PLUG & PLAY CONNECTIVITY

The all-in-one smart hub connects to the outside world and rapidly integrates third party surgical devices. Curve functions as a flexible information gateway, allowing physicians to view, share and connect both inside and outside the operating room.

• Direct DICOM patient data transfer to and from 5x USB, CD/DVD±R and hospital network

• Network port for connection to Airo® Mobile Intraoperative CT and C-arm

• Digital and analog video-in and digital video-out to connect an independent display (DisplayPort 1.2 (up to full HD 3D, 4K, DVI-

I out)

• Universal microscope-in for multiple vendors

• iCT scanner-in

• WLAN¹ module to transfer patient data or to connect to ‘BrainLab O.R. web portal’

3) Manufacturer name — BrainLab

2. Objectives

This core equipment is essential for the Neurosurgery Service at the New York Campus. This equipment is needed for immediate patient care. Due to high volume of Neurosurgical procedures here at the Manhattan VA Medical Center the need for this product is high. This is a sole source outright purchase of commercially available medical equipment under a firm-fixed price contract.

3. Period of Performance

Time of delivery: Due to patient safety issues, delivery is needed ASAP after receipt of order. This is a onetime purchase.

4. Place of Performance / Place of Delivery

This equipment is to be delivered to the NY Campus of the New York Harbor Healthcare System, please notify Biomedical Engineering as soon as equipment is received.

5. Scope or Tasks

Delivery and installation should be ASAP and all parts are to be operational.

6. Security

This equipment does store patient information but will not be interfaced with the VA computer system. It will be a standalone system. System updates will be done on site by the vendor.

9. Warranty/Maintenance

Equipment will be free from defects in material and workmanship under normal use and operation for a period of one year after installation. Price shall include one year warranty, delivery, installation, training, sterilization instructions, 2 operator manuals and 2 service manuals

10. Special Material Requirements N/A

11. Personnel Working under this Purchase Order: N/A

12. Any Other Requirements unique to the solicitation. N/A