Attachment 0001 - Statement of Work (SOW).docx

Statement of Work

(SOW)

GSI Audera Pro, AEP/VEMP/ASSR/OAE System at Royal Air Force (RAF) Lakenheath Rev. 2, 13 September 2022

1.0 Introduction

1.1 Mission: To provide pediatric Audiology diagnostic testing for our beneficiaries. The equipment will allow us to perform objective diagnostic testing that is critical for identification of hearing loss in infants.

1.2 Background: Historically we have provided objective diagnostic testing to identify hearing loss in infants using electrophysiological equipment. Our current system is outdated and is no longer reliable.

1.3 Scope: RAF Lakenheath is looking for a portable EP/OAE system that can be integrated into the EDIS Audiology Clinic hearing booth. Upon delivery of the equipment, training must be provided to the clinic staff to ensure proper use of the system. Maintenance shall be offered according to the manufacturer’s guidelines, with a minimum of once every 12 months.

2.0 General Requirements

2.1 Business Relations: The Contractor shall successfully integrate and coordinate all activity needed to execute this requirement. The Contractor shall manage the timeliness, completeness, and quality of problem identification. The Contractor shall promptly identify issues to the Government and take timely corrective action. The Contractor shall seek to ensure mission partner satisfaction and professional and ethical behavior of all contractor personnel.

2.2 Contract Management & Administration

2.2.1 Contract Management: The Contractor shall establish clear organizational lines of authority and responsibility to ensure effective management of resources assigned to the requirement. The Contractor must maintain continuity between the mission partner and the contractor’s corporate offices.

2.2.2 Contract Administration: The Contractor shall establish processes and assign appropriate resources to effectively administer the contract. The Contractor shall respond to the Governments requests for contractual actions in a timely fashion. The Contractor shall have a single point of contact between the Government and contractor personnel assigned to support the contract. The Contractor shall assign resources in order to maintain proper and accurate records related to this contract.

2.3 Subcontract Management: If applicable, the Contractor shall be responsible for any subcontractor and any subcontractor management necessary to integrated work executed under this contract.

2.4 Hours of Work: Workdays are from Monday through Friday excluding US federal holidays and UK bank holidays. Work hours are from 0800 to 1700 local UK time.

3.0 Product Specifications & Installation Requirements

3.1 The contractor must provide all personnel, equipment, tools, materials, supervision, transportation, safety equipment, training, maintenance, and any other items and services necessary to safely utilize the equipment.

The equipment requested is a portable EP/OAE system that is Brand Name or Equal to the Grason-Stadler (GSI) Audera Pro EP/OAE system. ‘Or equal’ products must meet the minimum specifications outlined below:

GENERAL SPECIFICATIONS

· Evoked Potentials: ECochG, ABR, MLR, LLR, SN10, P300, MMN, VEMP, ASSR

· Otoacoustic Emissions: DPOAE, TEOAE, SPOAE

TRANSDUCERS

· Insert Earphones

· Frequency Range: 125 Hz-8000 Hz

· Output Level: -10 to 132 dB SPL

· Oral Headphones

· Frequency Range: 125 Hz-8000 Hz

· Output Level: -10 to 120 dB SPL

· Bone Conductor

· Frequency Range: 250 Hz-8000 Hz

· Output Level: -10 to 109 dB SPL

· OAE Probe

· Frequency Range: 300 Hz-12,000 Hz

· Output Level: 40 to 83 dB SPL

· Speaker

· Frequency Range: 100 Hz-8000 Hz

· Output Level: -10 to 90 dB SPL

EP STIMULUS SPECIFICATIONS

· Stimulus Types: Click, CE-Chirp, Tones, CE-Chirp Octave Bands, Speech stimuli, User File

· Click Duration: 100 uSec default (adjustable)

· Tone Duration: Up to 500 ms (adjustable)

· Tone Window Types: Rectangular, Hann, Blackman, Gaussian, Trapezoidal, Extended Cosine

· Rate: 0.1 to 100 per second

· Polarity: Rarefaction, Condensation, Alternating

MASKING

· Type: White noise

· Frequency Response: Flat to 20 kHz

· Maximum Output: 125 dB SPL

· D/A: 16-bit

· Level Accuracy: ±1 dB

· Attenuation Range: 150 dB

· Frequency Accuracy: ±1%

· Total Harmonic Distortion:

· < 1% (DD45)

· < 3% (IP30)

· < 2% (B81)

· < .1% (SP90A)

EP AMPLIFIER SPECIFICATIONS

· Number of Channels: 2 minimum

· Gain: 5000-200,000 (adjustable)

· High Pass Filters: 0.1 Hz-300 Hz (adjustable) (-6 dB/Oct., -24dB/Oct. for 70 Hz)

· Low Pass Filters: 30 Hz-5000 Hz (adjustable) (-6 dB/Oct., -24dB/Oct. for 500 Hz)

· Sampling Rate: 200-40,000 Hz (adjustable)

· A/D: 16-bit

· Common Mode Rejection: ≥ 110 dB @ 1 kHz, 50/60 Hz

· Input Impedance: > 10 M Ohm

· Noise Level: ≤ 0.27 uV RMS

· Artifact Rejections: Adjustable level (0-100%) and any region within the analysis time window

· Line Frequency Filter: 50 or 60 Hz, -12 dB/Octave

· Recording Window: -2.5 sec to 2.5 sec (minimum range)

· Data Points per Waveform: 1024

· Digital Filters: Finite Impulse Response (FIR), band pass and notch

· Electrode Impedance

· Measuring frequency: 1000 Hz

· Range: 1-25k Ohm

OAE SPECIFICATIONS

· Sample Rate: 40k Hz

· A/D: 16-bit

· Frequency Accuracy: ±1% from selected

· Frequency Analysis (FFT) Points

· DPOAE: 4096

· TEOAE: 1024

· Frequency Resolution

· DPOAE: 9.8 Hz

· TEOAE: 39.1 Hz

· Acquisition Time

· DPOAE: 102.24 ms

· TEOAE: 25.56 ms

STIMULI

· TEOAE

· Stimulus: 75 uS click

· Presentation: Linear or non-linear train

· Level: 80 dB SPL (user defined 40-83 dB SPL)

· Stimulus Rate: 1-50/s (user defined)

· Stimulus Frequency Range: 250-5000 Hz

· Analysis Frequencies: 1000-4000 Hz

· DPOAE

· Stimulus: 2 Pure Tones (500-12000 Hz user defined start, end and F2/F1 ratio)

· Levels: 65/55 (user defined L1, L2, 0-80 dB SPL)

· Steps per Octave: 1-10 (user defined)

POWER

· Must include an Internal Power Supply to support being portable in nature.

QUALITY SYSTEM

· Must be an ISO 13485 certified quality system.

COMPLIANCE

· Safety and Electromagnetic compatibility (EMC)

· IEC 60601-1, Type B and BF applied parts

· IEC 60601-1-2

· IEC 60601-2-40

· Calibration and Test Signal

· ISO 389-2

· ISO 389-6

· IEC 60645-3

· OAE: IEC 60645-6: 2009, Type 1

· EP (ABR): IEC 60645-7: 2009, Type 1

· Protection from Fluids: IPX0 – Ordinary equipment

TRAINING

· Must provide on site training for equipment provided, within 30 days after delivery.

MAINTENANCE

· Must provide preventative maintenance in accordance with the manufacturer’s guidelines. At minimum, maintenance shall be provided once every 12 months.

4.0 Special Requirements

4.1 Security & Safety

4.1.1 Operational Security (OPSEC): If any installation is required to take place in a Government facility, the Contractor shall be familiar with the organizational critical information and indicators list (CIIL) and OPSEC policy of any installation they require access to. The required CIIL can be provided by the Contracting Officer.

4.1.2 Safety: The Contractor and any of its subcontractors (if applicable) shall promptly report pertinent facts regarding mishaps involving Government property damage or injury to Government/Contractor personnel that takes place on an installation. The Contractor shall notify the cognizant Contracting Officer within 24 hours of all mishaps or incidents. The Contracting Officer will in-turn notify the Safety Office. The Contractor shall cooperate in any resulting safety investigation.

4.2 Contractor Access to Installations: Access to DoD installations is limited to personnel with a valid installation access pass. Failure to submit required information to obtain required documentation will result in the exclusion of such employees from the installation until such documentation is obtained. Contractor employees may be subject to personal, and vehicle searched when entering or leaving a DoD installation. If installation access is required, the Government will provide the Contractor with the required information and documents for installation access passes upon award. Subsequently, the Contractor shall provide a list of all employees along working under this contract, along with the required documentation upon receipt of contract award, and no later than 30 days prior to the projected need for any new installation access pass requirements. The Contractor is responsible for maintaining an adequate number of personnel with active installation access passes and adhering to the timeframes stated in this section. The cognizant mission partner is responsible for the coordination of installation access passes. Upon termination of employment, termination or cancellation of the contract, or expiration of the contract the Contractor is responsible for collecting employee installation access passes and turning them in to the CO, or the cognizant mission partner in a timely fashion.

4.3 Shipping Instructions

4.3.1 For vendors located inside the United Kingdom.

4.3.1.1 Shipment shall be FOB Destination.

4.3.1.2 All shipping and transit costs must be included as part of the total purchase price submitted to the Government (vendor may either include the shipping in the costs of the items or outline it in a separate line item).

4.3.1.3 The Government will provide the shipping address as part of the solicitation document. Additionally, the Government will provide the vendor with the point of contact at the physical destination delivery address.

4.3.2 For vendors located outside of the United Kingdom.

4.3.2.1 Option One: United States Postal Service.

4.3.2.1.1 Shipping shall be FOB Destination.

4.3.2.1.2 All shipping and transit costs must be included as part of the total purchase price submitted to the Government (vendor may either included the shipping in the costs of the items or outline it in a separate line item).

4.3.2.1.3 Weight of individual shipments must not exceed 70lbs.

4.3.2.1.4 Dimensions of individual shipments must not exceed 119 inches in length, and/or 72 inches in width or height.

4.3.2.1.5 Hazardous material is not submitted.

4.3.2.1.6 The Government will provide the APO shipping address as part of the solicitation.

4.3.2.2 Option Two: Commercial small parcel carrier.

4.3.2.2.1 Shipping shall be FOB Destination.

4.3.2.2.2 All shipping and transit costs must be included as part of the total purchase price submitted to the Government (vendor may either included the shipping in the costs of the items or outline it in a separate line item).

4.3.2.2.3 Weight of individual shipments must not exceed 300lbs.

4.3.2.2.4 Dimensions of individual shipments must not exceed 119 inches in length, and/or 72 inches in width or height.

4.3.2.2.5 The Contractor is responsible for arranging and performing all shipping actions from origin to final destination.

4.3.2.2.6 The Government will provide the shipping address as part of the solicitation document. Additionally, the Government will provide the vendor with the point of contact at the physical destination delivery address.

4.3.2.3 Option Three: Consolidated Shipping Point.

4.3.2.3.1 Shipping shall be FOB Destination.

4.3.2.3.2 All shipping and transit costs must be included as part of the total purchase price submitted to the Government (vendor may either included the shipping in the costs of the items or outline it in a separate line item).

4.3.2.3.3 Weight of individual shipments must exceed 300lbs.

4.3.2.3.4 Dimensions of individual shipments must exceed 72 inches of any one dimensions (length, width, height).

4.3.2.3.5 Hazardous material may be shipped via this method.

4.3.2.3.6 The Contractor must complete a DD Form 1139 “XXX” to determine if the cargo can be shipped via MILAIR.

4.3.2.3.7 The Contractor shall ensure all cargo is marked “UNITED STATES AIR FORCE” in order to ensure shipments clear customs.

4.3.2.3.8 48 FW logistics points of contact are provided for in 4.3.3.

4.3.3 Contact Information; 48th Logistical Readiness Squadron (48 LRS)

4.3.3.1 48 LRS/Inbound Customs; 48lrs.lgrddc.inboundcustoms@us.af.mil.

4.3.3.2 48 LRS/Inbound Cargo; 48lrs.inboundcargo@us.af.mil.

4.3.3.3 Commercial phone number; +44 01638 52620.

5.0 Appendix: Related Documents