36C25619Q0756-003.doc

Statement of Work

1. Contract Title: Defibrillator Replacement

2. Background: Purpose of this project is to replace hospital critical care defibrillators that have exceeded their useful life, do not provide real time compression quality CPR feedback and essential to attaining improved resuscitation outcomes and that no longer meet current AHA recommendations. It will also improve the standard of care with the utilization of critical care transport defibrillators while transporting critical care patients.

3. Scope. A facility wide replacement of classified high risk medical equipment that has reached end of life expectancy. Many defibrillators on station over the past 1-2 years have been under extensive repair or replaced due to devices being beyond economical repair. Replacing the facility’s defibrillators will allow for another 8-10 years of usable life for clinical staff.

4. Specifications/Characteristics:

Qty. 27 ACLS Defibrillators

· with noninvasive pacing, mainstream end tidal CO2 monitoring, and Nellcor pulse oximetry

· to include defibrillator electrode pads capable of providing real time CPR feedback to the rescuer

· radiolucent electrode pads that can utilized to pace, defibrillate, cardiovert and monitor

· Main stream end tidal CO2 monitoring hardware

· Invasive Pressure Waveform Capability

· Lithium ion batteries Qty. 4 Non Clinical Training Defibrillators

· To include CPR Training Kit

· Main stream end tidal CO2 monitoring hardware Qty. 27 R Wifi Card with Clock Sync and FIPS Qty. 27 Device Communication Enablement R series Deployment and Training for Defibillator Dashboard software features Applicable Standards and Acceptance Criteria: Defibrillator

A. General Requirements

1. Unit weight, including defibrillator, patient cable, AC power supply and battery shall not exceed 13.6 pounds.

2. Unit size shall not exceed 1,075 cubic inches.

3. The defibrillator shall be designed in a manner such that the battery can be replaced by a typical caregiver in a matter of seconds without the need for tools.

4. AC power shall be a standard, internal feature of the defibrillator; detachable AC modules are not an acceptable alternative.

5. When attached to an AC power source, the defibrillator shall fully operate without a battery installed.

6. The defibrillator shall fully operate with a completely discharged battery when attached to an AC power source.

7. The defibrillator shall charge its battery when connected to an AC power source.

8. The defibrillator shall have a recorder capable of printing multiple channels when in manual mode.

9. The recorder shall be capable of printing Code Summary Reports; continuous ECG rhythm, Code, Event, and Alarm-related ECGs; code readiness test logs; code readiness test detail reports; and the troubleshooting log when in manual mode.

10. The defibrillator shall have a discharge button that illuminates when the unit is charged and ready to deliver a shock.

11. The defibrillator shall perform a self-test daily.

B. ECG Monitoring Requirements

1. Defibrillator shall be able to acquire an ECG by way of standard ECG electrodes (in a 3 or 5 lead configuration) when in manual mode, paddles when in manual mode, multifunction defibrillation pads, and resuscitation electrodes.

2. ECG cables shall utilize standard AAMI connectors.

3. Defibrillator shall have the ability to record and display multiple ECG leads when in manual mode.

4. The defibrillator shall have the ability monitor and display the ECG in multiple vectors while performing transthoracic pacing without requiring the attachment of separate ECG electrodes and leads.

5. The defibrillator shall have a clearly label, dedicated button (switch or key) for changing ECG lead displayed and recorded when in manual mode

6. The defibrillator shall continuously indicate the lead selected on the display and printed ECG recordings when in manual mode.

7. The defibrillator shall provide a filter to that removes chest compression artifact from the ECG signal.

8. The defibrillator shall have pacemaker detection capability.

9. The defibrillator shall display a pacer spike on the printed ECG recordings.

10. The defibrillator shall detect heart rates up to 300 beats per minute (±5%).

11. The defibrillator shall have the ability to print ECG recordings upon the activation of a heart rate alarm when in manual mode.

12. The defibrillator shall have a configuration that triggers an alarm and displays a “check patient” message upon the detection of ventricular fibrillation.

C. Display Requirements

1. The defibrillator shall have a color display.

2. The display shall be no less than 6.5 inches diagonally.

3. The defibrillator shall have the ability to simultaneously display 3 channels of physiologic information when in manual mode.

4. The displayed channels shall be able to show ECG leads, physiologic parameters (i.e. pulse oximetry), and chest compression performance.

5. At least two of the displayed channels shall be user selectable during a code event.

6. Each channel shall minimally present a 5 second view with an option for a 10 second view.

7. The AED mode shall have the ability to display heart rate, waveform, SpO2 and messaging.

8. The user shall have the ability to configure the AED display.

D. Defibrillator Requirements

1. The unit shall utilize a rectilinear biphasic™ defibrillation waveform in both AED and Manual Mode.

2. The defibrillator shall provide AED, manual and shock advisory operating modes.

3. The AED and advisory protocols shall comply with the recommendations in the American Heart Association’s Guidelines 2015 for chest compressions (CPR) first.

4. The AED and advisory protocols shall comply with the recommendations in the American Heart Association’s Guidelines 2015 for single shocks.

5. The defibrillator shall provide for synchronized cardioversion in manual mode.

6. At the maximal energy setting, the defibrillator shall have an average current delivered in the first phase not less than the following:

7. The defibrillator shall provide for user-configurable fixed and escalating energy capabilities in both manual and advisory modes.

8. When configured for escalating energy protocols in a manual mode, the defibrillator shall set the second and third shock levels without user intervention.

9. The defibrillator shall recognize compatible pediatric electrodes and alter energy setting for the initial and subsequent shocks to a pediatric-specific energy delivery protocol.

10. The defibrillator’s pediatric capabilities shall include discreet energy settings of 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 20, 30, and 50 joules.

11. The time for the defibrillator to charge to maximal energy shall not exceed 7 seconds.

12. The following information shall be displayed on, and stored with, defibrillation-related ECG recordings: selected energy, delivered energy and patient impedance.

E. Transthoracic Pacing Requirements (Manual Mode)

1. The defibrillator shall have an option for transthoracic (external) pacing.

2. The defibrillator shall employ a 40 msec (± 2ms), rectilinear waveform for transthoracic pacing.

3. The defibrillator shall permit the configuration of an initial pacing rate.

4. Transthoracic pacing controls shall provide for continuously variable current delivery levels and pacing rates.

5. Transthoracic pacing shall provide a 4:1 function that permits operators, to examine an underlying rhythm of a paced patient without losing capture.

6. Transthoracic pacing settings for current delivery and rates shall be maintained when switching between pacing and defibrillation, or pacing and monitoring modes.

7. The defibrillator shall have the ability monitor and display the ECG in multiple vectors while performing transthoracic pacing without requiring the attachment of separate ECG electrodes and leads.

8. Transthoracic pacing shall not be interrupted by the loss of an ECG lead and will au-tomatically switch to asynchronous mode until leads are reconnected.

F. Chest Compression Support Requirements

1. The defibrillator shall have the ability to support the delivery of quality chest compressions during CPR efforts.

2. The defibrillator shall have an integrated CPR quality indicator that displays how well chest compression delivery meets American Heart Association recommendations.

3. The defibrillator shall provide a filter to that removes chest compression artifact from the ECG signal with an adaptive filtering technique.

4. The defibrillator shall verbally and visual prompt the start and stop of chest compression cycles and display idle time after 10 seconds.

5. The defibrillator shall verbally and visually prompt the user to push harder when compression fail to meet American Heart Association 2015 recommendations for depth (adults only). The depth for each compression will be displayed for both pediatric and adults.

6. The defibrillator shall verbally and visually indicate when chest compression depth is adequate as defined by American Heart Association 2015 recommendations (adults only). The rate for each compression will be displayed for adults.

7. The defibrillator shall visually indicate when release off the chest (chest recoil) is adequate for per-fusion (adults only) as defined by American Heart Association 2015 recommendations.

8. The defibrillator shall provide an audible prompt (i.e. metronome) that meets the American Heart Association’s recommendations for rate of compression.

9. In a manual operating mode for ALS-trained responders, the rate prompting shall operate in a manner such that it is activated when the compression rate falls below the American Heart Association recommendations.

10. In the Advisory mode for BLS-trained responders, the rate prompting shall be activated at the start of a CPR cycle.

G. Code Readiness Testing Requirements

1. The defibrillator shall perform a self test at power up.

2. The defibrillator shall have a code readiness testing function.

3. The defibrillator code readiness test shall not require a separate test fixture.

4. The defibrillator code readiness test shall operate in either a manual or automatic mode.

5. The defibrillator shall employ a prominent, two-state [Pass-Fail] indicator to signify its state of code readiness; simple indicators (i.e. LEDs) are not an acceptable alternative.

6. The defibrillator code readiness test shall evaluate the functional status of the defibrillator, pacer, and ECG capabilities of the unit along with the status of the therapy cables, compatible resuscitation electrodes, and paddles.

7. The electrode component of the defibrillator readiness test shall confirm its presence and proper connection, and monitor its expiration date and condition.

8. The defibrillator code readiness test shall operate when attached to paddles or compatible resuscitation electrodes.

9. Should a defibrillator fail a code readiness test it shall display all causative items.

10. The defibrillator shall have the ability to automatically print the results of a code readiness test.

11. The results of each code readiness test, automatic or manual, shall be stored on the defibrillator in nonvolatile memory.

12. The defibrillator shall have the ability to print a log of all code readiness tests results stored in the defibrillator.

13. The defibrillator shall have the ability to display and print the detailed results of any code readiness test stored in the defibrillator.

14. The defibrillator shall have the ability to transmit the results of a code readiness test via wireless networking (IEEE 802.11) into a central log.

15. The defibrillator shall have a capability to transmit a wireless alert (IEEE 802.11 wireless networking) when its state of code readiness is found to be compromised.

H. Battery Requirements

1. The defibrillator shall use a rechargeable lithium ion battery with a minimal capacity of 5.8 amp/hrs.

2. The weight of the defibrillator battery shall not exceed 1.3 pounds.

3. The battery shall have a run time of 6 hours while operating all parameters of the defibrillator.

4. The defibrillator battery shall have an indicator of runtime; capacity indicators (i.e. 100%, 75%, 50%, etc.) are not an acceptable substitute.

5. The defibrillator battery shall have separate calibration and fault indicators.

6. The defibrillator shall use a 1-battery system with capabilities of recharging within the defibrillator when connected to an AC power source.

I. Pulse Oximetry Requirements

1. The defibrillator shall have an option for pulse oximetry utilizing both Nellcor and Masimo technology

2. The pulse oximetry shall employ Rainbow technology.

3. The pulse oximetry shall have documented minimal sensitivity and specificity levels of 99% and 97%, respectively under motion conditions.

4. The pulse oximetry shall have a saturation accuracy of +2% in adult and pediatric patients under non-motion conditions.

5. The pulse oximetry shall have a saturation accuracy of +2% in adult and pediatric patients under motion conditions.

J. End Tidal Carbon Dioxide

1. The defibrillator shall have an option for end-tidal carbon dioxide Microsteam monitoring for continuous monitoring of both intubated and non-intubated patients.

2. The defibrillator shall have the ability to display both a graphical representation of the concentration or partial pressure of expired carbon dioxide during a respiratory cycle in a capnogram waveform format as well as a numerical display.

3. The defibrillator shall have the ability to measure carbon dioxide levels from 0 to 150 mmHG.

4. The defibrillator shall have to ability to operate on Adult and Pediatric patients.

5. The defibrillator shall have to ability to obtain carbon dioxide measurements using Non-Dispersive Infrared single beam optics in dual wave.

6. The defibrillator shall have a warm up time not to exceed 2 minutes in an ambient temperature of 25 degrees C.

7. The defibrillator shall display exhaled Carbon Dioxide values and respirator rate simultaneously.

8. The defibrillator shall allow the user to zero the value and enable or disable end-tidal carbon dioxide measurements.

K. I/O Requirements

1. The defibrillator shall provide a 1.0 C/cm ECG output with a < 25 msec delay.

2. The defibrillator shall provide an ECG output a 0 to 5 volts (TTL Level) trigger pulse of 10 msec that occurs within 35 msec of the R wave peak.

3. The defibrillator shall have an ECG synch input of 0 to 5 volts (TTL Level) of 5 to 15 msec in duration.

4. Defibrillator shall have an integrated slot that accepts a commercially available Type II, compact flash card.

5. The defibrillator shall offer USB 2.0 device and host ports.

L. Storage Requirements

1. The defibrillator shall have the ability to store clinical data that includes: a summary of the code, chest compression data, code-related ECG recordings, and a full disclosure file.

2. The defibrillator shall store defibrillator maintenance data that includes: a troubleshooting log that annotates keystrokes, prompts and warning messages on a first-in first-out basis; a readiness test log that records the results of code readiness tests whether performed manually or automatically; and readiness test log detail that records the pass-fail details of individual readiness tests.

M. Communication and Transfer Requirements

1. The defibrillator shall have the ability to transmit clinical (code summary, chest compression, code-related ECGs, and full disclosure) and maintenance-related files via the IEEE 802.11 wireless networking standard.

2. The defibrillator shall have a capability to transmit a wireless alert (via 802.11 wireless networking) when its state of code readiness is found to be compromised.

3. The defibrillator shall be capable of transferring the clinical data files via Bluetooth/USB/compact flash card.

4. The defibrillator shall be capable of transferring maintenance-related files via Bluetooth/USB/compact flash card.

N. Battery Charging and Test Station Requirements

1. There shall be a battery charging and test station (battery station) available for the defibrillator battery.

2. The battery station shall produce no less than 200 watts of power.

3. The battery station shall simultaneously charge and test no less than 4 batteries.

4. The battery station shall automatically calibrate compatible lithium ion batteries after 500 amp/hrs of use or every 12 months.

5. The battery station shall minimally provide the following maintenance protocols: QuickCharge, FloatCharge, AutoTest and Manual Test.

6. The battery station shall provide a test button for each battery well.

7. The well for each battery shall have separate indicators for charging, charging completed, test in progress, and fault.

8. The battery station shall be able to download the use and maintenance history of compatible lithium ion batteries.

9. The battery station shall be able to communicate the use and maintenance history of a battery to a PC running compatible battery management software package.

O. Battery Management Software Package

1. There shall be a battery charging and test station (battery station) available for the defibrillator battery.

2. The battery station shall produce no less than 200 watts of power.

3. The battery station shall simultaneously charge and test no less than 4 batteries.

4. The battery station shall automatically calibrate compatible lithium ion batteries after 500 amp/hrs. of use or every 12 months.

5. The battery station shall minimally provide the following maintenance protocols: QuickCharge, FloatCharge, AutoTest and Manual Test.

6. The battery station shall provide a test button for each battery well.

7. The well for each battery shall have separate indicators for charging, charging completed, test in progress and fault.

8. The battery station shall be able to download the use and maintenance history of compatible lithium ion batteries.

Special Requirements: Hospital standards will apply to BLS and ACLS training of staff who will be utilizing the defibrillators and oversee their training and documentation requirements. Applications training on the defibrillators for all staff members (Technical, Physician, etc.) shall be provided with all expenses for course fees, travel, lodging, and meals covered by the vendor, if applicable. The vendor shall provide a full schedule of initial applications training for appropriate staff to include follow-up applications scheduled three to six months after initial training, if required.

6. Delivery.

Gulf Coast Veterans Health Care System

400 Veterans Avenue Building 26

Biloxi, MS 39541 Delivery to be made ASAP no later than 30 days post award Biomedical Engineering 228-523-5720 Delivery hours Monday-Friday 7:30 am-3:30 pm