Attachment B Statement of Need.docx

Attachment B 36C24825Q0957

Background The North Florida / South Georgia (NF/SG) Home Based Primary Care (HBPC) requires the purchase of nine (9) lightweight, wireless, touchscreen, rechargeable resting ECG devices that interface with the MUSE Cardiology Information System currently in use within the NF/SG VA Health System. The ECG devices must be easily portable and transportable for use in Veteran’s homes. Previous ECG devices utilized by HBPC, which were no longer supported by BioMed and taken out of service more than two (2) years ago, were large, heavy, and provided inconsistent, poor quality ECG capture. It is important for the ECG devices to have a built-in portable printer capable of printing a 12-lead ECG on-demand.

Scope of Work:

Portable, lightweight, wireless ECG devices with the ability to provide on-demand printing of 12 lead ECGs enables providers (APRNs and physicians) and RNs to quickly acquire a quality ECG in the Veteran’s home. One example of need includes Veterans taking certain medications require baseline and periodic ECG monitoring to insure timely identification of potentially life-threatening changes in the electrical activity of the heart. It is overly burdensome for most HBPC Veterans to travel outside of their home to obtain periodic, nonemergent ECG evaluation.

Must provide nine (9) portable resting ECG units that are designed to be used out in the medical field, such as HBPC.

Equipment offered Shall meet the salient characteristics in features, fit, and form outlined in the Statement of Need.

The lightweight, wireless, touchscreen, portable/transportable resting ECG device must meet the following specifications and have the following operating features:

· Provide 12-lead analysis and measurements for adults and pediatrics

· Capable of printing a 12-lead ECG on-demand

· Product must be small, lightweight, touchscreen, and portable

· Easily transportable to and from Veteran’s place of residence

· Must be internally powered and rechargeable

· Able to provide ECG interpretation and analysis for adults and pediatrics

· Must provide a heart rate meter range of 30 to 300 BPM ±10% or 5 BPM for heart rates outside this range

· Equipment must have Diagnostic Cardiology accessories.

· Equipment must provide a secure interface with the MUSE (v8 or later) Cardiology Information System via approved VA internet access points

· ECG Management Systems: MUSE v8 or later, bi-directional orders, and ADT support.

· Electronic Medical Rrecord (CPRS) Connectivity: Via MUSE cardiology information system v8 or later.

· Product must be compatible with existing VA-approved programs and workflows:

· MUSE (v8 or later)

· Order Management and ADT (cardiac data management system)

· CPRS

· Product must be VA approved through Biomedical Engineering.

· Product’s touchscreen display must have the ability to provide real-time beats per minute, waveform, and text data.

· Display and Touchscreen minimum: 8.9” diagonal, LED backlit, 892 x 558 pixels, and multi-point touch that works with medical gloves.

· Product must have data export capabilities of resting ECG and digital rhythm

· Product must have the ability to display electrode placement and quality of each lead

· Product must be capable of storing a minimum of 200 records consisting of 10-second resting ECG and rhythm records. Also, be able to store a minimum of 200 minutes of digital rhythm or full disclosure records. Additionally, for the digital rhythm storage, must be capable of up to 5 minutes of continuous rhythm storage.

· Product must provide a full disclosure record feature that is capable of review up to 5 minutes of 12 Lead ECG, ability to select 10-second Resting ECG records, and generate 5-minute single lead full disclosure report.

· Product must be able to be cleaned with FDA approved cleaning agent, such as Isopropyl alcohol 70% or current agent being used Super Sani-Cloths.

· Must include starter accessories:

· Trunk cable and lead wires with ECG clips

· Wide-mouth adapter clips

· Device Physical Specifications Requirements:

· Maximum weight of 5 kg

· Maximum height of 125 mm

· Maximum width of 325 mm

· Maximum length of 370 mm

· Device Technical Specifications Requirements:

· Dynamic Range: AC differential ±10mV, DC offset ±600 mV

· Common Mode Rejection: >125 dB

· Input Impedance: >50MΩ @ 10 Hz

· Defibrillation Protection: Per IEC 60601-2-25:2011

· Analog to Digital Conversion: 24-bit, resolution 1.22 μV

· Digital Rhythm Bandwidth: 0.04 to 300 Hz

· Device Power and Environment Requirements:

· Power Supply: AC mains or battery, 100-240 VAC, 50-60 Hz

· Battery: Minimum 180 minutes operational capacity

· Operating Temperature: 10° to 40° C

· Operating Humidity: 20% to 95% RH non-condensing

· Warranty: Must provide a minimum 2-year warranty that includes parts and labor.

· Must provide product installation and configuration.

· Training: Must provide clinical education training and support.

· Remote training minimum one (1) hour per device (total 9 remote training hours)