6515--Neurology Electromyography (EMG) System/Orlando Va Healtcare System/One Time Order

Sources Sought Notice only. This is neither a solicitation nor a request for quote (RFQ) and does not obligate the Government to award a contract. Request for a solicitation will not receive a response. The Government will not pay nor reimburse any costs of preparing this response. The purpose of this sources sought notice is for market research to make the appropriate acquisition decisions and to gain knowledge of potential qualified and their Small Business Administration (SBA) size classification in relation to North American Industry Classification System (NAICS) 334510, Electromedical and Electrotherapeutic Apparatus Manufacturing, size standard of 1,250 Employees. The Network Contracting Office (NCO) 08, Orlando Veterans Affairs Healthcare System is seeking a source to provide Neurology Electromyography (EMG) System to the Department of Veterans Affairs Orlando VA Healthcare System, 13800 Veterans Way, Orlando, FL, 32827. Seeking qualified businesses to provide the following: The contractor shall deliver the following item Brand Name or Equal: The salient features of the set are as follows: Desktop Base Unit The desktop base unit should provide the following components: Two electrical stimulators; one auditory stimulator and one visual LED stimulator. (External monitor for pattern display and or goggles.) Up to 12 switchable output sites. (Applicable for IOM. Not in NCS) Built-in audio speaker for output of both live signals as well as playback of recorded data (line-out, line-in, and speaker out connections), with Audio speaker Notch filter adjustable to 50 Hz, 60 Hz, or off. Able to connect via USB (2.0) connection to computer. Two trigger inputs and two trigger outputs for connection to external devices. Input/output for additional devices to connect (patient response unit, footswitch, control panel, reflex hammer, bone conductors, etc.) Disconnect/reconnect feature to stop any stimulation after a few seconds of lost communication between base unit and the computer. Built-in Digital Signal Processor. Computer Monitor Minimum display resolution of 1024 x 768 pixels Amplifier The amplifier connects to the base unit, and should have the following components: 5-channel minimum with 2 non-switched amplifier channels (option of up to 16 channels) Utilizes a 24-bit Analog to Digital Converter. 4800 data points per trace in routine motor and sensory nerve conduction study (i.e. 48 kHz sampling rate for saved data). Disconnect/reconnect feature that will allow amplifier to be disconnected or reconnected without powering off the base unit. Stimuli artifact suppression hardware to prevent stimuli artifact from saturating the amplifier. This allows for a quicker baseline recovery making it easier to detect and measure small responses. Electrode impedance measurement minimum at 20 Hz with a range from 500 to 450 k . Rectangular calibration pulse selectable between 2, 20, 200, 2,000, 20,000 µV. Sensitivity adjustment from 1 µV/division to 10 mV/division in at least 13 steps. (Update) Adjustable filter settings for fixed and switched, and high and low. Stimulator (Electrical) Supports constant voltage and constant current mode Two stimulators can be used for collision based techniques Stimulus output: monophasic or biphasic; single, double or train mode. Conditioning mode delivers two pulses of different intensity from the same stimulator) Programmable buttons. Analog output Available for all channels and in all tests A patient bedside control panel to navigate through software during patient testing. Contains numerical keypad for entering distance. Dedicated keys for single and recurrent stimulation Switch side. 2 Customizable function keys. Dedicated controls of sweep, sensitivity, stimulation, site selection, impedance check, stimulus duration, etc. Single/Triple Footswitch Allows extensive control of the application using a foot. Should be rated IP68 for dust and water immersion. Triple Footswitch allows 2 pedals for customizable functions. Operating System Software The C&A requirements do not apply, and a Security Accreditation Package is not required. Software options and functionality may vary, and should have the following specifications: Windows 10, Office 2016 Clinical tests should include: Motor Nerve Conduction: Reference values based on age, gender, height and body mass index as recommended by American Association of Neuromuscular and Electrodiagnostic Medicine. Compare findings with previous study. Supports pediatric reference values. Sensory Nerve Conduction: Same as above. Reduce artifact via signal Enhance software feature, on-line and off-line averaging. Replicate and average responses for reproducibility. Supports pediatric reference values. Combined motor and sensory NCS. Carpal tunnel sensory index (CSI). Multi-channel F-Wave: Enhance software feature responses for better assessment H Reflex: Support reflex hammer for stimulation Blink Reflex: Support reflex hammer for stimulation Repetitive Nerve Stimulation: Calculate facilitation within and across a train. Automation in long and short exercise test. Needle EMG: With dual time base. Anatomy images for muscle localization. Store and replay EMG with audio and signal manipulation (1 channel: 960 second, 2 Chan: 600 seconds) Macro EMG: Save and re-play/analyze recording using 2 channels of recordings. Includes entry of fiber density. Volitional and Stimulated Single Fiber EMG: Jitter measurements using level and peak. Multimodality Evoked Potentials: AEP, SEP, VEP, P300, ERG/EOG: Artifact reject per channel. Display of residual noise, Quantitative noise estimate (Fsp). Save individual responses. Multiple averaging algorithms. Replicate and average multiple trials to increase signal quality and reproducibility. Multi-Modality: Sympathetic skin response (single & multi-channel), R-R interval analysis (using Root mean square of successive difference and other calculations), Bareitschafts potential Conduction Velocity Distribution: Automated collision protocol to study conduction is slow fibers. Bareitschafts Potentials: Multi-channel recordings. Save EMG signals for replay and re-analysis. R-R Interval: Analysis using Root mean square of successive difference and other calculations. Valsalva ratio measurement. Sympathetic /Galvanic Skin Response: Multi-channel recordings. Low frequency setting of 0.05 Hz is possible. Spike Triggered Averaging: Motor unit potential analysis. Multi-channel recordings. Level & peak trigger (above and below baseline). Intraoperative Monitoring Motor Unit Number Index (MUNIX): Fastest way to study motor unit loss in patients with motor neuron disease. Motor Unit Number Estimation (MUNE): Incremental stimulation, multiple point stimulation, Spike triggered averaging. CMAP Scan: Study of motor unit loss in motor neuron disease. Report Generation On-line mode: Instantaneous synchronization between patient waveforms and reports. One button access to waveform from the report. Stand-alone: Generate report when needed. Includes tables, traces, references values and highlights normal and abnormal findings. Automatic summary generation of clinical findings based on AANEM reference values. One click export of report across network via docx or pdf format. Patient workflow List patients based on their status: Appointment, In Progress, Acquisition Complete, Finalized (Report completed) Build a patient list using Search parameters, e.g. gender. Examining physician, etc. Patient data protection SQL database Hide patient list Close system when not in use. Requires password to re-start Waveform Acquisition and Display: High Definition (HD) EMG recordings: 4800 data points per trace in routine motor and sensory nerve conduction study (i.e. 48 kHz sampling rate for saved data). Routine needle EMG signals can be saved at 48 kHz sampling rate for playback and analysis. Dual time base in needle EMG for better assessment of EMG waveforms Free-run monitor in all tests for baseline quality Cascades, long trace display in EMG Compare findings from left and right sides. Compare findings with previous examinations. Backward compatibility for review of old patient data and test protocols Network Compatibility and Data Integrity: Uploading of patient data and reports via bidirectional HL7 compatible with Vista Imaging and CPRS. Backward compatibility of existing patient data. Migration of archived patient data must be direct transfer preserving all original formats, data integrity, and without the use of third party conversion software. Ability to retrieve, merge, or move archived Patient Visits and Tests with new studies forming a seamless progressive care record. Vendor software must meet consolidated and coordinated guidance for VA information technology concerning approved and prohibited technologies and standards that the VA owns, operates, patches, manages and version controls on the VA production network as directed by the VA Technical Reference Model v 21.2. https://trm.oit.va.gov/TRMHomePage.aspx System must have the ability to retrieve customized end-user defined settings already built into the current system. Must meet all HL7 connectivity/compatibility standards with our VISTA/CPRS system including dynamic message formatting. Power Requirements The base unit can be powered by 100-120 V, 220-240 V, 50/60 Hz Environmental Limits Operating (in use): Temperature should be 60 to 90 F (15.6 to 32.2 C). Non-Operating (in storage): Temperature should be 0 to 132 F (17.7 to 55 C). Compliance/Regulatory Standards Unit should meet the following domestic (USA) standards: 510(k) Clearance UL 60601-1 Medical Electrical Safety Standard Interested parties may respond by submitting a qualifications letter to include the following information: Company Name Address Point of Contact Phone, Fax, and Email DUNS Number Authorized Distributor Letter Capability Statement specific to the technical requirements. This must not be a generic line card but something that the government can positivity use to determine the procurement strategy of this requisition. Socio-Economic Category (i.e., SDVOSB, VOSB, HUBZone, etc...) Provide verification that your firm can prove the requested item(s) to include past and/or current contract for the same requirements and any other convincing evidence to help the Government determine your company s capabilities. To be eligible for award, prospective offerors must be registered in the System for Award Management (SAM) Internet Site, www.sam.gov. Responses to this notice shall be sent to via email, no later than 1:00 PM Eastern Standard Time on February 24, 2021. Telephone and facsimile responses will not be considered. Responses shall be submitted via email only to contact@example.gov. When responding via email ensure the subject line is titled with RFI# 3624821Q0521 Neurology Electromyography (EMG) System for the Orlando VA Healthcare System. No other information is available at present time. Thank you for your interest and time to prepare and submit a response.