36C26319Q0845-002.pdf

SOW Reference Requirements Vendor Response

Crash Cart Defibrillators

2.a.i The defibrillator shall have capability to deliver energy utilizing biphasic waveforms.

2.a.ii The defibrillator shall provide multiple energy levels, such as 50‐200J.

2.a.iii The defibrillator shall provide multiple accessories for energy delivery including disposable electrodes, internal paddles, and external paddles.

2.a.iv Changing the energy delivery accessory shall be quick and easy. The defibrillator shall minimize the need to change cable connections based on the delivery accessory selected, e.g. disposable electrodes, internal paddles, external paddles.

2.a.v The defibrillator shall provide a clear indication when the energy delivery accessory is not connected.

2.a.vi The defibrillator shall use one set of disposable electrodes for EKG monitoring and energy delivery.

2.a.vii The defibrillator shall inform user if disposable defibrillator pads are expired.

2.a.viii. The defibrillator shall have a built‐in mechanism for storing paddles when not in use, e.g. using disposable electrodes. Paddles shall fit snugly in the paddle receptacles. If the defibrillator is equipped with an internal test load, discharging the unit with the paddles in the receptacles shall be safe and easy.

2.a.ix Internal paddles and their cables shall be easy to clean, sterilizable, well‐constructed and shall have adequate strain reliefs. The internal paddle cables shall be straight, not coiled, so that the paddles can rest on a surgical field without being secured. Each set of internal paddles shall be permanently identified to uniquely identify it for tracking. The vendor shall provide Instructions for

Use (cleaning instructions) for internal paddles.

2.a.x When internal paddles are connected, the defibrillator energy level shall be limited to 50J.

2.a.xi The discharge buttons on paddles shall be well protected against inadvertent activation.

2.a.xii Paddles shall be easy to hold for a variety of hand sizes and shall minimize the risk of operator contact with the electrode area, patient skin, or areas of the handle likely to be coated with conductive gel.

2.a.xiii Patient cables shall be flexible enough to easily reach a patient at least 2 m (6.6 ft) away.

2.a.x.iv Patient cables shall connect to the defibrillator in such a way that regardless of how they are positioned, they do not interfere with the controls, the visibility of the display, or the stability of the defibrillator.

2.a.xv Operating instructions shall be placarded on the unit. These instructions shall be easy to read from a normal viewing angle and shall be easy to understand.

2.a.xvi The controls for the defibrillation sequence shall be clearly labeled in numeric order and shall be easy to activate.

2.a.xvii The defibrillator shall clearly indicate when the defibrillator is charging and when it is in the charge‐ ready state.

2.a.xviii The defibrillator shall provide time to charge that is <15 seconds for all starting battery levels except a depleted battery, and for AC powered device regardless of the battery state.

2.a.xix The defibrillator shall be able to deliver a set of three shocks within 90 seconds.

2.a.xx The defibrillator shall not lose more than 15% of the initial deliverable energy before it automatically disarms.

2.a.xxi A fully charged defibrillator shall automatically disarm (i.e. dump its charge internally) if it is not intentionally discharged within 2 minutes of being charged.

2.a.xxii The defibrillator shall disarm the energy, e.g. remove the charge from the capacitor in the event that the end point delivery devices e.g. paddles,pads, are held together (short circuit or apart to open air (open circuit) when a command to discharge at maximum energy is received.

2.a.xxiii The defibrillator shall provide synchronous delivery capability. A clearly visible marker shall be displayed on the monitor and recorded strip to indicate the synchronization point on the ECG waveform. The synchronous discharge shall occur within 60 milliseconds following the peak of the

R wave. Defibrillators shall provide both an ECG lead selector and a gain adjustment (automatic or manual) to facilitate adjustments for the most reliable synchronization on the R wave.

2.a.xxiv The defibrillator shall automatically revert to the defibrillate mode after a synchronous discharge.

2.a.xxv The defibrillator shall have external pacing capability.

2.a.xxvi The defibrillator shall have quick AC cord disconnect capability and shall be adequately protected against inadvertent disconnection.

2.a.xxvii Line cords, AC adapters (if applicable), electrodes, and a spare battery shall be easy to carry and store with the unit.

2.a.xxviii The defibrillator shall offer a mechanism that provides direct feedback to the user on the depth and rate of chest compression. The unit shall indicate when improper CPR is being performed, and the CPR feedback mechanism shall include visual or audible indicators to help users gauge how closely they are following recommended CPR procedures.

2.a.xxix The defibrillator shall remove CPR artifact from the ECG thus eliminating the need to pause CPR to visualize the patient's underlying heart rhythm.

2.a.xxx The defibrillator shall offer different modes for BLS rescuer vs. ACLS rescuers. The default mode will by for the BLS rescuer with the capability to maually change to ACLS rescuer mode.

2.a.xxxi Switching between modes shall be easy and the mode that is engaged shall be clearly indicated.

The defibrillator shall protect against inadvertent activation of a mode.

2.a.xxxii To prevent delays in initiating analysis, the unit shall start analysis automatically or shall prompt the operator to initiate analysis.

2.a.xxxiii The defibrillator shall have capability to monitor ECG, non‐invasive blood pressure, pulse oximetry

(compatible with Nellcor or Maximo probes), and end tidal CO2.

2.a.xxxix The defibrillator display shall be easy to see with good trace quality. The display shall be viewable from a wide range of angles, and the ECG waveform shall be easy to see from 2 m (6.6 ft).

Onscreen messages shall be clear and easy to understand.

2.a.xxxv Initial or default alarm limits shall be set to values that are likely to provide reasonable protection for most patients.

2.a.xxxvi The process of setting alarms shall be quick and easy. Monitoring shall continue and alarms shall remain enabled while alarm limits are being selected. It shall not be possible to set individual alarm limits to non‐physiologic values.

2.a.xxxvii To ensure that alarms are set properly, the alarm limits shall be displayed along with the value of the monitored variable or operators shall be able to easily access a single screen or menu on which the alarm limits can be both viewed and changed.

2.a.xxxviii Both audible alarm and visual indicators shall be present for any alarm condition that poses a significant risk to the patient. Visual indicators that accompany an alarm condition shall readily indicate which alarm has been violated and this feature shall not be capable of being disabled.

2.a.xxxix The status (e.g., on, off, suspended) of the alarms shall be clearly displayed at all times, regardless of which function screen is displayed.

2.a.xl Audible alarms shall be clearly audible at any setting and shall continue to sound as long as the alarm condition is present or until the alarm is acknowledged/silenced by a clinician.

2.a.xli The defibrillator shall have an alarm silence feature. However, if a sounding alarm is silenced, either the audible alarm shall automatically reactivate within a short time or a momentary tone shall sound periodically to remind the operator of a continuing alarm condition. Additionally, if a sounding alarm is silenced, a clear and obvious visual indication of this status shall be present.

2.a.xlii The defibrillator heart rate meters shall have a minimum range of 30 to 200 beats‐per‐minute.

2.a.xliii The defibrillator heart rate alarms shall activate within 10 seconds of the onset of an alarm condition.

2.a.xliv Instances in which non‐invasive blood pressure measurements cannot be made shall be indicated by an alarm.

2.a.xlv After an initial measurement, successive non‐invasive blood pressure cuff inflations shall automatically adjust to a reasonable level above the previous systolic reading to avoid over‐ compressing a patient’s arm.

2.a.xlvi Manual blood pressure measurements taken between automatic measurements shall not affect the timing of the automatic cycle for non‐invasive blood pressure monitoring.

2.a.xlvii A conspicuously marked and easy‐to‐operate control shall be available to manually deflate the non‐ invasive blood pressure cuff.

2.a.xlviii The pulse oximetry capability shall display either a pulse waveform or a signal‐strength indicator.

2.a.xlvix Both an audible alarm and a visual indicator shall be present for any alarm condition that poses a significant risk to the patient. The status (e.g., on, off, suspended) of the alarms shall be clearly displayed at all times, regardless of which function screen is displayed.

2.a.l Visual indicators that accompany an alarm condition shall readily indicate which alarm has been violated and this feature shall not be capable of being disabled.

2.a.li The unit shall have alarm limits for high and low ETCO2 as well as for high inspired CO2.

2.a.lii If the displayed CO2 concentration units are changed between mmHg and %CO2, actual alarm‐limit settings shall not be altered and shall be converted to the new units.

2.a.liii There shall be alarms for low SpO2 levels. The low alarm limit shall have a default value no lower than 80%; in addition, it shall be adjustable up to 95% and no lower than 50%.

2.a.liv A recorder with good trace quality shall be provided with the defibrillator.

2.a.lv The recorded strip shall include periodic annotation of at least the time, date, lead, gain, heart rate, and operating mode.

2.a.lvi The recorded strip shall indicate the occurrence of discharges and shall annotate the set energy. It is desirable for the recorded strip to include indications of charge and disarm status and transthoracic impedance.

2.a.lvii Units shall provide a mechanism for automatically documenting at least the ECG during a defibrillation attempt. The documentation shall include pre‐shock and post‐shock ECG waveforms with a duration of at least 14 seconds.

2.a.lviii Batteries for the defibrillators shall provide at least four hours of monitoring time or 10 maximum energy shocks.

2.a.lix Determining battery charge status shall be easy based on the availability of a battery status indicator. The defibrillator shall display run time available using battery power.

2.a.lx Users shall be able to change batteries quickly and easily.

2.a.lxi Indicate the charge time for a fully depleted battery after which the defibrillator is able to perform at least one full, application appropriate resuscitation sequence solely from battery power.

2.a.lxii A battery charging station with multiple bays shall be available for charging spare batteries.

2.a.lxiii The defibrillator shall have the capability to communicate wirelessly for data review of a rescusitation event and for synchronization of the clock. That wireless communication must be

FIPS 140‐2 compliant and the vendor shall provide their FIPS certificate number.

2.a.lxiv Stored information shall be retained until intentionally erased. Exhaustion or removal of the primary battery shall not erase the information stored in memory.

2.a.lxv A fault condition related to the documentation feature (e.g., capacity full, tape door open, module removed) shall not prevent defibrillator operation.

Automated Emergency Defibrillators (AEDs)

2.b.i To prevent delays in initiating analysis, the AED shall start analysis automatically or shall prompt the operator to initiate analysis.

2.b.ii It is desirable that AEDs that automatically analyze and charge between individual shocks in a set of three. The AED shall be able to deliver a set of three shocks within 90 seconds.

2.b.iii When not in the analyze mode,the AED shall provide an audible and visual indication of the presence of, or a change to, a potentially shockable rhythm — ventricular fibrillation or ventricular tachycardia. The indication shall appear within 30 seconds of initiation of the shockable rhythm.

This time may be extended by up to 1 additional minute between sets of three shocks when the patient would be checked and would receive CPR.

2.b.iv The unit shall indicate when improper CPR is being performed, and the CPR feedback mechanism should include visual or audible indicators to help users gauge how closely they are following recommended CPR procedures.

2.b.v The AED shall provide a built in CPR metronome.

2.b.vi A rise in ECG electrode impedance shall cause a visual and/or audible lead‐fault indication before the quality of the ECG trace or the validity of the heart‐rate meter is adversely affected. However, the indicator shall not appear for minor degradation of electrode performance to avoid unnecessary reapplication of electrodes.

2.b.vii Disposable AED electrodes shall have a shelf life of at least 5 years.

2.b.viii Displays shall be easy to see. They shall be viewable from a wide range of angles. Onscreen messages shall be clear and easy to understand.

2.b.ix The AED shall have an audible low battery indicator accompanied by a clear, easy‐to‐see visual indicator that gives sufficient, but not premature, warning.

2.b.x The operator’s manual shall provide specific instructions for battery maintenance and replacement as well as precautions and guidelines for charging. Users shall be able to change batteries quickly and easily.

2.b.xi Operating instructions shall be placarded on the AED. These instructions shall be easy to read from a normal viewing angle and shall be easy to understand.

2.b.xii All controls shall be easy to operate. The controls for the defibrillation sequence shall be clearly labeled in numeric order and shall be easy to activate.

2.b.xiii Voice commands shall be easy to understand and of adequate volume to hear in a busy hospital.

2.b.xiv Line cords, AC adapters (if applicable), electrodes, and a spare battery shall be easy to carry and store with the unit.

2.b.xv The vendor shall offer a variety of mounting options for the AED.

2.b.xvi AED training devices shall be available that prevent inadvertent energy delivery to trainees.

Informatics

3.a According to VHA Directive 2001‐059, the Code Team must review and assess each c ardiac arrest treatment as an important aspect of quality assurance. The AEDs and the defibrillators shall store data from each use and communicate wirelessy with vendor provided software to analyze that data and trend code information. Please describe the analysis capabilities of that software.

Training

3.b.i On‐site training of clinicians shall be provided for all shifts at all facilities as arranged with the facility coordinator.

3.b.ii Technical training shall be provided for biomedical engineering staff to enable performance of preventive maintenance, troubleshooting, and repair in‐house.

3.b.iii Operator and technical manuals will be provided to each healthcare system. Electronic copies are preferred.

Security Requirements

3.c.i The vendor shall comply with all security requirements of the VA'S Office of Information

Technology.

3.c.ii The vendor shall complete and return separate 6550 forms (attached) for the analytics software, defibrillators, and AEDs. Additionally, the vendor shall provide each product's MSD2 and diagram of data flow for each product.

3.c.iii The analytics software shall be approved in the Office of Information Technology's Technical

Resource Manual (TRM) or the vendor shall be willing to gain approval in TRM.

3.c.ix The vendor shall minimize the number of staff members needing access to the VHA's network.

Please indicate the number needed. These individuals shall return completed forms within 10 days of receipt from the VA.

3.c.v The crash cart defibrillator and AED shall be FIPS 140‐2 compliant. The vendor will identify the certificate number for FIPS compliance.

Project Management

3.d.i The vendor shall assign one project manager for planning and completing the implementation work. The project manager shall schedule the replacement with the facility coordinator to minimize interruption of service.

3.d.ii The vendor shall develop a project plan that includes timeline for deployment. The project plan must be provided to the COR within 1 month of contract award. This project management plan shall be vetted and coordinated through, as well as approved by Caroline Campbell, VISN 23 Chief

Biomedical Engineer.

3.d.iii The vendor shall execute the project plan.

3.d.iv The vendor shall schedule periodic status update meetings. These meetings will be conducted throughout the period of performance on an as needed basis.

3.d.v Implementation shall be completed within one year of contract award.

Maintenance

3.e.i The defibrillators and AEDs shall facilitate remote monitoring and troubleshooting, including battery status.

3.e.ii The defibrillators and AEDs shall perform daily self‐checks without manual initiation and without the use of a separate test load. The results shall be stored for later viewing and download and shall also be made available through wireless communication.

3.e.iii The crash cart defibrillator shall automatically synchronize its clock to that of the hospital network.

3.d.iv The defibrillator shall have a warranty period of at least 1 year during which all service and software upgrades are provided at no additional cost to the VA. Longer warranty periods are preferred.