36C26118B0613-023.pdf

MMGRA-6001 - Project Document Printed: 20170529 Printed copies are uncontrolled. Consult DMS for up-to-date versions.

Motek Medical bv | Keienbergweg 77 | 1101 GE Amsterdam | The Netherlands

Project Management Plan

GRAIL System

CREATION DATE: 5TH JANUARY 2015

MODIFICATION DATE: 28TH SEPTEMBER 2015

AUTHOR: WOUTER PRAST

FILENAME/VERSION: PROJECT DOCUMENT .DOCX

Revision history

Date Author Version

05-01-2015 Wouter Prast

0.1 Initial version

28-09-2015 Wouter

Prast

1.0 Release version

29-05-2017 Wouter

Prast

2.0 Non-Confidential version

Table of contents

1 Introduction

1.1 Project Document

1.2 Project Description

1.2.1 GRAIL System

1.2.2 Configuration at VA Palo Alto

1.3 Project objectives

1.4 Project organization

2 Project Planning

2.1 Introduction

2.2 Objectives

2.3 Strategies

2.4 Planning

2.4.1 General Milestones

2.4.2 Project Document

2.4.3 System Engineering and Production

3 Checklist

i. Motek share in the project

ii. Client share in the project 4 Declaration of agreement Appendix A: Specifications R-Mill Appendix B: Specifications MIC Appendix C: Specifications of the server rack Appendix D: Power consumption and heat output to ambient surroundings Appendix E: System infrastructure and Cable Routing Appendix F: Transporting the treadmill Appendix G: A-Frame Appendix H: Main package dimensions

1 Introduction

1.1 Project Document

This Project Document describes the organization, planning and project deliverables for the engineering and delivery phase of the project. Project management personnel shall be made thoroughly familiar with the contents of this plan since it provides the construction objectives and strategies, which were established to assure a successful completion of the construction phase.

This Project Document seeks to ensure that consistency, adequate communication, coordination and controls are in place. It is intended to be a guide to all parties. It will enable all parties involved in the project to know how their contribution will fit into the overall plan.

This Project Document is intended to be a living document, which will be developed and improved throughout the course of the project. Therefore constructive comments on its content, interpretation and usage are welcomed for consideration.

1.2 Project Description

1.2.1 GRAIL System

GRAIL is a dedicated solution for gait analysis and gait training from Motek Medical B.V., offering revolutionary techniques to improve any rehabilitation facility into an industry-leading facility.

Improving the quality of rehabilitation due to standardization, optimization and revolutionary techniques is what GRAIL (Gait Real-time Analysis Interactive Lab) offers medical facilities, specialists, researchers and patients.

Each GRAIL system creates a unique virtual environment capable of creating the most realistic situation where researchers can investigate new ways and methods of stimulating patients. Next to this, clinicians can use previously documented techniques to speed recovery, and improve patient capability.

Core of the system are the D-flow software, the motion platform with treadmill and the projection system.

1.2.2 Configuration at VA Palo Alto

The requested configuration for VA is a configuration consisting of the D-flow software, a flat active 3D projection system, belt projection, a dual-belt instrumented treadmill, a motion capture system, a video system, an audio system and all required control computers. Next to the GRAIL, Motek will also be providing a weight bearing system that will need to be installed inside the suspended ceiling.

1.3 Project objectives

The stated objective of the project are:

• to create a suitable space for the GRAIL system

• to install the GRAIL system, complete acceptance and to turn it over to the client

• that it shall be executed within the agreed time schedule and with the highest efficiency without compromises on the standards set for the project with respect to:

• safety

• environment

• quality

The progress in realizing above mentioned objectives will be continuously monitored and reported throughout the project. In case of deficiencies or potential deficiencies in meeting above mentioned objectives the project management will take appropriate action to correct the deficiencies or take measures to minimize the impact.

The Management of Motek is completely committed to the successful execution of all construction related activities in accordance with specifications, safety regulations and with approved time schedule and cost estimates. In their responsibility for the performance of the site staff they delegate authority to implement this plan to the Project manager.

1.4 Project organization

Company Name Role Address E-mail Phone

VA Palo Alto Pawan Galhotra Program Director

VA Palo Alto Health Care System

(90/NCA) 3801

Miranda Ave

Palo Alto CA 94304-

Pawan.Galhotra@v a.gov

Office +01 650-493-5000

VA Palo Alto Alberto Lopez Physical Therapy Supervisor

VA Palo Alto Health Care System

(90/NCA) 3801

Miranda Ave Palo Alto CA 94304-

VA Palo Alto

Deb Pitsch Physical Therapist

VA Palo Alto Health Care System

(90/NCA) 3801

Miranda Ave

Palo Alto CA 94304-

Motek Medical BV Wouter Prast Project Manager Keienbergweg 77

1101 GE

Amsterdam wouter.prast@motek medical.com

Office +31 20 301 3020 Cell: +31 6 3042 1157 mailto:Pawan.Galhotra@va.gov mailto:Pawan.Galhotra@va.gov mailto:wouter.prast@motekmedical.com mailto:wouter.prast@motekmedical.com

2 Project Planning

2.1 Introduction

This section defines the planning, progress measurement and forecasting procedures for the construction, including the interfaces with the client, design, procurement and third parties. All involved parties, including partners and construction contractors will participate in the planning process and are required to prepare and provide detailed planning information for further processing into the integrated construction planning by the client.

2.2 Objectives

The objectives of these procedures are to support the construction organization in completing the project within the agreed timetable in a most safe and efficient cost saving manner, performed with a highest possible standard of quality. In doing this to provide construction management with relevant information to monitor construction progress, identify deviations, determine level of urgency and develop corrective actions.

2.3 Strategies

Pay special attention to integrated planning, tying together the discipline phases as well as parties on organizational level. As a result all planning output should be consistent, authorized and recognizable as the common planning.

Create awareness and acceptance, within all involved parties, for the common planning. Provide the organization of clear and easily accessible overviews of all formal planning issues, inclusive date, status and validness. Planning employees have to play an active and prominent role, forcing the organization to recognize them as being the focal point for all planning related matters.

Planning employees should inform themselves on all matters, which could have an impact on planning and act pro-active when required. Therefore communication lines should be established and maintained with all involved parties. As a result occurrences with unidentified and so unplanned scope and interfaces should be prevented.

2.4 Planning

2.4.1 General Milestones

Motek will assemble the components of the GRAIL system, whilst the Client prepares its site for the installation of the system. The final installation of the system will be done by Motek Medical staff with local assistance.

The following milestones are defined:

2.4.2 Project Document

To enable a smooth continuation of the project, it is important that both parties agree on what their responsibilities are within the project. Therefore both parties sign the declaration of agreement, agreeing on the project deliverables and work to be done by each party as described in this Project Document.

2.4.3 System Engineering and Production

When the Project Document is signed, Motek Medical will start the detail engineering and production of the system.

Milestone Date [dd/mm/yy]

Responsible

Approval Project Document (Basic Engineering) October 9th 2015 VA Palo Alto

Detail Engineering Finished October 16th 2015 Motek

Production Finished December 1st 2015 Motek

Room Preparation Finished and ready for inspection December 1st 2015 VA Palo Alto

Shipping December 11th 2015 Motek/VA Palo Alto

Start Installation August 2017 Motek/VA Palo Alto

Acceptance Test TBD Motek/VA Palo Alto

Start Training TBD Motek/VA Palo Alto

3 Checklist

i. Motek share in the project

The section below is a technical list of equipment for the GRAIL of Motek Medical for the project.

ii. Client share in the project

This section is a checklist containing the material and labor deliverables of the client for the project.

Note: due to possible dependencies it must be assured that all elements are not only completed, but also completed in the right timeframe. When these requirements are not met upon arrival of the installation team, additional costs for another visit could apply.

□ Signed Project Document

□ Building requirements

□ sufficient large room

□ sufficient room entrance according to max crate size (239x77x200cm)

□ Cable trays

□ Cable tray (150x50mm trays, preferably flush) with a removable lid, running from

MIC to underneath the treadmill

□ Power supply

□ power infrastructure installation according to specifications and drawing

□ Main switch providing 208V or 480V output for isolated transformer

□ Connection of main switch and electrical cable of transformer to be done by certified electrician

□ Lighting

□ Two lighting zones: zone 1 over treadmill and screen, zone 2 over the control desk (note: in the platform room dimmable lights are preferred)

□ optional: window shutters

□ Environment requirements

□ Climate control the system produces a lot of heat, mainly by the projectors and the server rack. Specifications can be found in appendix A

□ Vibration free Dual Belt Instrumented Treadmills are purposefully designed that the right and left forceplate are mechanically isolated from each other to prevent transmission of impact forces between the two forceplates. However, structurally weak floors might cause unwanted vibrations that affect treadmill operation. Floor vibration, especially in the upper stories of the buildings, is a common occurrence.

Therefore, it is strongly recommended that the treadmill be installed in the building at the entrance level with no basement underneath, or at the basement level. Otherwise, it is the customer’s responsibility to make sure that floor vibration is not going to affect operation of the treadmill.

□ Shielded against incoming light during operation it must be possible to completely darken the room

□ Reflection free finish

□ Noise free

□ Low EMC level the system should not be under the influence of large EMC emitting sources such as elevators, air conditioners, etc.

□ Stable power no power surges or drops of more than 10% are allowed

□ Operator desk suitable for 3 monitors (typical size is 1.6x0.8m)

Shipment of components

□ Mail address for shipment (incl. contact person and contact data)

□ Clearing customs / importing components

□ Storage facility on site

□ Dry and safe room with sufficient entrance

□ Handling equipment

□ Insurance

□ Receiving personnel

□ Facilities during installation period

□ Contact person

□ Handling equipment (2 pallet jacks, dolly)

□ Loading dock or forklift available during delivery to unload the truck

□ Motek personnel access

□ Personnel restriction

□ Cleaning crew

□ Sanitary facilities

□ Wireless or wired internet connection

□ 2 10-12 ft ladders

□ Trash disposal of crates in which the equipment will be delivered

□ Treadmill installation

□ hoisting crew

□ hoisting equipment (A-Frame or electric stacker)

□ SDS-Hammer drill

□ technician who is allowed to drill holes onsite

□ No floor heating or pipes underneath the treadmill, as 4x 12cm deep holes need to be drilled for the anchors (12mm)

□ Acceptance test

4 Declaration of agreement

Hereby VA Palo Alto approves the content of this Project Document:

Date: (dd/mm/yyyy)

Place:

Signature:

Name/function:

On behalf of Motek Medical:

Date: (dd/mm/yyyy)

Place:

Signature:

Name/function:

MMGRA-6001 - Project Document / 20170529 / Printed: 20170529

Form: QMS-00f007 / 20110809

Keienbergweg 77 | 1101 GE | Amsterdam | The Netherlands T: +031(0)20 301 30 20 | F: +31(0)20 301 30 21 | www.motekmedical.com

Appendix A: Specifications R-Mill

Both belts of the treadmill can be controlled separately. The R-Mill has two degrees of freedom: a pitch

(rotation) and a sway (translation).

Dual belts with 3D ground reaction force measurement per belt walking area per belt: 2.2×0.5 m (length x width) belt speed range: 0 – 5 m/s speed accuracy: =<1% Pitch: ±10 deg

Sway: ±5 cm

Payload capacity: 130 kg Footprint: 3.6m2

Weight: 784KG Dimensions: 220cm x 182cm x 48cm (length x width x height)

Figure 2 R-Mill Figure 3 R-Mill http://www.motekmedical.com/

Appendix B: Specifications MIC

The MIC controls the instrumented treadmill and runs the safety circuits. The main characteristics of the

MIC are:

• dimensions (L×W×H): 1×0.4×1.4 m

• weight: 150 kg

• Power input of isolated transformer: 208V(48A)/400V(25A)/480V(21A)

Figure 1 MIC

Note: the isolated transformer is delivered with a CEE32A 5-pin plug, the female counterplug is to be provided by the customer. It is also an option to cut the plug off and connect the wires directly into a main switch. Please note that the client needs to hire a certified electrician for this work.

Figure 4; Male CEE plug 32A (5-pin) as delivered with the transformer

Appendix C: Specifications of the server rack

The server rack houses the following components:

• 1 D-Flow computer

• 1 Video computer

• 1 Image generator

• 1 Mocap computer

• 1 MX giganet Lab

• 1 KVM

• 1 16-port network switch

• 1 8-port network switch

• 1 audio amplifier

The main characteristics of the server rack are:

• dimensions (L×W×H): 0.6×0.8×2 m

• gross weight: 100 kg max (empty)

• power input: 4 × 120 VAC/16A each

Figure 6 Server-rack

Appendix D: Power consumption and heat output to ambient surroundings

The table below lists the maximum current that can be used by the equipment. The value given for the heat output is at maximum use.

USA

Item Units Location in Room Voltage

Max Curr/unit

Current Total

Max Power/unit

Max Power total

Max Heat disp/Unit

Max Heat total

Max Heat/unit

Max Heat total

Comments

[PCS] [VAC] [A] [A] [W] [W] [W] [W] [BTU/h] [BTU/h]

Treadmill control (MIC) 1 Grail room 400 25 25 17320 17320 1200 1200 4096 4096 3-phase

Computers 7 Server rack 110 8 56 920 6440 872 6103 2975 20825

KVM 1 Server rack 110 2 2 230 230 235 235 805 805

Switch 1 Server rack 110 2 2 230 230 235 235 805 805

Amplifier 1 Server rack 110 3 3 345 345 359 359 1225 1225

Monitors, etc. 3 Desk 110 1 3 69 230 41 123 140 420

Projectors 4 Grail room 110 4 16 460 1840 483 1932 1650 6600

Subject 1 Grail room 440 440 1500 1500

Operator 1 Grail room 205 205 700 700

Totals 107 26635 10832 36976

Notes:

1. the power supply needs to be stable and free of surges or drops of more than 10% nominal; if this cannot be guaranteed, UPS’s must be installed

2. Cooling is often underestimated, especially when the room is small

MMGRA-6001 - Project Document Printed: 20170529

Appendix E: System infrastructure and Cable Routing

Figure 7 System infrastructure and overview

Appendix F: Transporting the treadmill

In order to get the crate with the treadmill into the room, please note the minimal door measurements below.

Figure 8 Minimal door dimensions.

Appendix G: A-Frame

In order to lift the treadmill upright and into place, an A-frame/gantry is to be delivered by the client. It needs to be able to fit the crate containing the treadmill (200cm high) underneath it. The inner width also needs to be at least 200cm for when the treadmill is lowered into a flat position.

Figure 9 A-Frame/Gantry

Appendix H: Main package dimensions

The GRAIL system is shipped in packages. It must be assured that these packages can be handled and stored on site. The estimated properties of the main packages are listed below.

Main packages

Package name Dimensions (L×W×H) [cm] Bruto Weight [kg]

Treadmill 239x77x200cm 1042

Server rack, truss, stairs 398x148x182cm 1258

MIC and other equipment 208x138x172cm 516