Attachment C Statement of Work.pdf

Northern Arizona VA Healthcare System (NAVAHCS) Statement of Work

Defibrillators

Purpose: The Northern Arizona VA Healthcare System (NAVAHCS) has a requirement to upgrade its hospital crash cart defibrillators.

Scope of Work: All 20 crash cart defibrillators are to be replaced in the Northern Arizona VA Healthcare System with state-of-the-art rectilinear biphasic wave forms technology that meets or exceeds American Heart Association 2015 Recommendations. All new 20 crash cart defibrillators will have the ability to capture VA CPR Feedback Data and transmit wirelessly with FIPS Compliance. In-service training will be provided to clinical staff who would be utilizing these defibrillators. Electronic training aids will be made available to staff. Owner’s manuals will be provided to end users. Biomedical engineering will also be trained on the replacement units with service manuals provided.

This type of technology provides biomedical staff stats on the health of the equipment, and the data provides clinical case review optimizing quality assurance/improvement. This requirement will include all software, interfaces, 20 batteries, enablements, subscriptions, deployment, training, and trade-in value for 20 Zoll R series already existing on station.

Location of Work: All work will be performed at the NAVAHCS VA Medical Center and its corresponding clinics. In-service training will be performed in both classroom and clinical settings.

Period of Performance: The replacement program will take approximately four to six weeks from start to finish. After the units are purchased but prior to the arrival in-service training will be scheduled to commence with the training of super users/educators and biomedical staff that will later assist with the training of the clinical staff. On-line electronic training can commence at any time after a purchase order has been issued. Once the replacement defibrillators arrive at the Medical Center the units will be checked into inventory and receive biomedical inspection prior to be placed into clinical areas. When the above steps are completed the outdated units will be replaced in a coordinated manner with the new units.

The following parts list includes all items required for completion of this project: BRAND NAME ONLY: Zoll R Series Plus Defibrillators

Amounts Item:

20 ACLS Defibrillators with pacing 20 Lithium ion batteries 20 Non invasive blood pressure cuffs 20 Main stream end tidal CO2 monitoring hardware 20 Masimo pulse oximetry hardware 20 Subscriptions for wireless testing and reporting through Defibrillator Dashboard

Technology 20 Subscriptions for wireless reporting of Code Data through Case Review Technology 20 Owners and service manuals Deployments (Base Case Review and Dashboard)

A. General Requirements: BRAND NAME ONLY - Zoll R Series Plus Defibrillators

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 a 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.

12. Where installed, the handles of the external hard paddles and their attachment mechanism, shall support the weight of the defibrillator in a manner suitable for lifting the unit.

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 labeled, 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.

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:

25Ω 50Ω 100Ω 125Ω 150Ω 175Ω

27.1 amps 24.9 amps 17.5 amps 16.2 amps 14.4 amps 13.2 amps

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, and 10 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.

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.

4. The defibrillator shall verbally and visual prompt the start and stop of chest compression cycles.

5. The defibrillator shall verbally and visual prompt the user to push harder when compression fail to meet American Heart Association recommendations for depth.

6. The defibrillator shall verbally and visually indicate when chest compression depth is adequate as defined by American Heart Association recommendations.

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

8. 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.

9. 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 into a central log and have FIPS COMPLIANCE

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 1.7 pounds.

3. The battery shall store a history of its use and maintenance.

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.

I. Pulse Oximetry Requirements

1. The defibrillator shall have an option for pulse oximetry.

2. The pulse oximetry shall employ signal extraction 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 ±3% in adult and pediatric patients under motion conditions.

J. Non-Invasive Blood Pressure Requirements

1. The defibrillator shall have an option for non-invasive blood pressure.

2. The defibrillator shall have the ability to be programmed to take repeat measurements over a period or abort by pressing a single button.

3. The defibrillator shall have the option to automatically adjust based upon the previously measured systolic value.

4. The defibrillator shall be able to display at least four hours’ worth of blood pressure measurements.

5. The defibrillator shall have alarms that can be configured to alert a clinician when a blood pressure is above or below pre-set values.

K. End Tidal Carbon Monoxide

1. The defibrillator shall have an option for End Tidal Carbon Monoxide measurement.

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 mainstream capnography capable of monitoring both intubated and non-intubated patients.

L. 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.

M. 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.

N. 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 wireless networking standard.

2. The defibrillator shall have the ability to transmit time synchronized clinical files in an ad hoc mode to a device running compatible code documentation software.

3. The defibrillator shall have a capability to transmit a wireless alert when its state of code readiness is found to be compromised.

O. 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.

P. Battery Management Software Package

1. A compatible battery management software package shall available from the defibrillator vendor.

2. The battery management software package shall provide the ability to examine the state of charge, state of health, and total throughput for each compatible battery.

3. The battery management software package shall provide the following details on a compatible battery’s state of health: capacity at full charge, capacity loss, and estimated runtime at full charge.

4. The battery management software shall have the capability to select the capacity test pass-fail threshold for each compatible battery.

5. The battery management software shall have the capability to print service labels for compatible batteries that contains date of service and key state of health indicators.

6. The battery management software shall store the use and maintenance history for each compatible battery in an organization’s fleet.

7. The battery management software shall provide troubleshooting capabilities.

8. The battery management software shall provide the capability to perform searches on an organization’s fleet of batteries.

9. The battery management software shall provide budgeting and planning capabilities.

Information Security: No patient information. Test and use results only.

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. 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.