Questions and Answers rev..docx

QUESTION: Please provide the clinical and technical specifications for the monitor and defibrillator.

a. Please specify if the defibrillator must have AED and Manual mode, or manual mode only- ANSWER: Must have manual and AED mode

b. Please specify if all submitted devices must have FDA clearance for sale and use in the US.

ANSWER: YES

c. Please specify if any devices can be submitted if they have Open FDA Class 2 Device Recalls

ANSWER:NO

QUESTION: Please provide clarification on the below salient characteristics:

a. Please explain requirement for “Two pieces - One for monitoring, one for electrical therapy” rather than one device with both functions integrated into one unit.

ANSWER: It needs to be to separate pieces.

b. Please clarify if the requirement for a “Maintenance free battery with 10.75-hour capacity” is for one single battery, or 2 batteries ANSWER: Single Battery

c. Please clarify if the “integrated video laryngoscope” must be integrated into the monitor, the defibrillator, or can be an integrated part of a kit.

ANSWER: Must be integrated into the device.

QUESTION: Will the criteria used to determine Cost/price be the total proposed price? Or will it be for each individual Line Item under DESCRIPTIONS OF ITEMS?

ANSWER: Total price

QUESTION: Please clarify how Past Performance will be evaluated.

ANSWER: Past performance will be evaluated using PIEE.

QUESTION: Will the # of years on warranty included with the submission be evaluated as part of the Lowest Price in the LPTA evaluation? How should each year of warranty be quantified?

ANSWER: The requirement is for 3 years should be included in the price. This is not a “best value” requirement.

QUESTION:

ITEM 0003 Tempus LS Manual Electrodes-Adult 2 Each ITEM 0004 Tempus LS Electrodes-Pediatric 2 Each Do you want 2 boxes of 10 (20 total) for each item? Or Do you want just two of each item?

ANSWER: We would need 2 boxes of 10 each.

QUESTION:

ITEM 0019 Service Agreement 1 Job Bio-med Service - meaning you already have the people to do the work on the machine and would only need phone-in technical support?

Bench Repair - meaning you would send the machine in for repair and Philips will send you a loaner while they fix it?

Onsite Repair - meaning Philips sends someone to repair onsite.

ANSWER: I am not sure what is being asked here. As far as the Service Agreement, this should offer the same or mostly same service to Philips Connected Care Service Agreement (item number 890416) and the warranty should cover the machines for 3 years.