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Exhibit 1 - REMSA Protocol 3303- Cardiac Monitor Specifications

Corona City Council
July 6, 2022

Document
Exhibit 1 - REMSA Protocol 3303- Cardiac Monitor Specifications
Meeting
July 6, 2022
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Corona City Council
Original file
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Text extracted from the city's file for reading and search. Open the original on corona.legistar1.com. That file is the official record.

3303 —Drug and Equipment List (3/29/22 - 14:13) 19 of 22 CDC Medications
CDC medications are listed per unit or vehicle. Of the authorized options, the preferred medication is in bold print.

Note that these medications are for administration to patients; and that these same medications when listed under Personal Protective Equipment are for personal use.

Cardiac Monitor Specification
Attributes/capabilities for Cardiac Monitor, Pacemaker, Defibrillator Cardiac Monitor/Defibrillator/Pacemakers shall adhere to the below specifications and meet all current applicable and relevant REMSA policies/ protocols, guidelines and standards, including: American Heart Association (A.H.A.), American National Standards Institute (A.N.S.I.), American Society for Testing and Materials (A.S.T.M.), Association for the Advancement of Medical Instrumentation (A.A.M.I.), E.C.R.I. Institute, Federal Communications Commission (F.C.C.), Food and Drug Administration (F.D.A.).Health Insurance Portability and Accountability Act (H.I.P.A.A.), and National Fire Protection Association (N.F.P.A.).

Physical Attributes
Six (6) foot lead set with removable precordial lead connection Multifunction cable with hands-free MFP capability
CPR diagnostic qualitative and quantitative feedback and reporting capability (*not optional – additional specification below) A/C power adapter/battery charger
- Full functionality should be present while device is functioning with A/C power Lithium-ion batteries, two/device, must be smart batteries lasting minimum of 3 hours each Battery charging device, minimum of 2 bay/bank charger. - Charging support systems must recalibrate and test batteries in addition to charging.

Minimum one (1) year EMS warranty
Biphasic waveform with hands-free defibrillation functionality with adult and pediatric capability. Energy setting options must be compatible with applicable REMSA protocols.

Functionality to operate in Automated External Defibrillator or Semi-Automated External defibrillator mode Functionality to provide synchronized cardioversion at multiple age-appropriate energy levels. Energy setting options must be compatible with applicable REMSA protocols.

Adjustable and controllable amperage and rate for transthoracic pacing with adult and pediatric capability Ability to operate in fixed, demand, and overdrive modes Capability to detect and indicate presence of internal pacemaker Capability to print field user machine test/internal diagnostic test results Display, select and/or cascade multiple waveforms simultaneously (e.g.: paddles/MFP, Lead I, Lead II, Lead III, capnography, SpO2 Photoplethysmograph (pleth) – all are required as options for display) Programmable audio and visual alert systems for fatal arrhythmias, VF/VT at a minimum Separate programmable alerts for biometric parameters of NiBP, heart rate, respiratory rate, etCO2, SpO2 Record, display, and import into the REMSA ePCR system: the etCO2 value – waveform and quantitative measure. In-line and Side-Stream capabilities are required, capability for use on the intubated and non-intubated patient.

Record, display, and import into the REMSA ePCR system: SpO2 value – waveform and quantitative measure. All patient age ranges must be accommodated in disposable/hard wired probes, and diagnostic feedback Record, display, and import into the REMSA ePCR system: Non-invasive blood pressure measure accounting for vibration resistance both at vehicle rest and vehicle motion. All patient age ranges must be accommodated in disposable/hard wired cuffs. Cuff sizes must meet REMSA Policy for Drug and Equipment List. (*NIBP is an optional component and, if purchased, specification must be met)
Calculate and display Mean Arterial Pressure reading
CDC Medications
Light Response First Response Ground Transport Air

EMT AEMT EMT-P PSP EMT AEMT EMT-P EMT AEMT EMT-P EMT-P
DuoDote
Nerve Agent Antidote Kit O O O X O O O O O O O
or Mark I
Nerve Agent Antidote Kit O O O X O O O O O O O
3303 —Drug and Equipment List (3/29/22 - 14:13) 20 of 22 Record, display, and import temperature* readings into the REMSA ePCR system. Device must have a minimum of one (1) temperature channel and must be able to monitor skin and/or ambient temperature, esophageal temperature, and rectal temperature.

Temperature must measure from 25°C to 45°C at minimum
o Temperature monitoring is an optional component and, if purchased, specification above must be met.

Record, display, and import into the REMSA ePCR system: Non-invasive carbon monoxide* waveform and quantitative measure (spCO).

Display, print, and mark in events and/or code summary carbon monoxide waveforms and quantitative values. Probe for measure shall cover adult and pediatric patients. Precision and accuracy must be at least within three (3) digits (+/-) when spCO is 0-10%.
o Carbon monoxide (spCO) monitoring is an optional component and, if purchased, specification above must be met Record, display, and import into the REMSA ePCR system: non-invasive methemoglobin* quantitative levels (spMet).

Display, print, and mark in events and/or code summary methemoglobin quantitative value. Probe for measurement shall cover adult and pediatric patients. Precision and accuracy must be at least within one (1) digit (+/-) when spMet is 0-10%. o Methemoglobin (spMet) level monitoring is an optional component and, if purchased, specification above must be met)
Physical Attributes continued
Record, print and have capability to import customizable Code Summary records from individual patient contacts into REMSA ePCR system.

Display that is color capable, subject to wide angle viewing, and adaptable to changes in brightness.

Customizable audio/visual alerts (configurable w/o vendor involvement) of biometric parameters (at minimum NiBP, HR, RR) Capability for users to adjust automatically performed vital sign intervals Capability to mark events in Code Summary recording
Patient biometric trending is automatically engaged with device use, and can be viewed on screen and/or printed Safe user-driven discharge of electricity, outside of therapeutic energy delivery Audio/visual alerts for detached leads
Device vendor must facilitate data integrations with REMSA ePCR vendor Device, including any add-on features must be upgradeable as technological advances and research permit. Including but not limited to, CPR qualitative and quantitative feedback, 12 lead ECG algorithms, capnography diagnostics, temperature monitoring.
12 Lead Functionalities
Acquire, interpret, transmit and print diagnostic quality 12 lead ECGs

1. The unit shall be capable of diagnostic 12-lead monitoring in leads I, II, III, aVR, aVL, aVF, V1, V2, V3, V4, V5 and V6

2. Vendor must provide data regarding the maintenance / update of specificity and sensitivity of algorithms utilized for STEMI interpretation. Data must be provided annually and at any maintenance or update periods.

3. Transmitted data shall be secured in a HIPAA compliant manner, and meet current applicable REMSA Information Security policies / standards
12 lead ECG print capability shall include configuration to print interval measurements, interpretation, axes measurements, and clinician entered patient demographic variables of name, age and gender at minimum Continually monitor and trend 12 lead ECG when leads are attached, without requirement of obtaining a specific 12 lead ECG Acquired 12 lead ECGs must be chronologically and numerically ordered as obtained during individual patient contact (serial 12 lead ECG capability)
Device must be able to transmit 12 lead ECGs, to any / all REMSA designated STEMI receiving center (at minimum).

1. ECG transmissions shall generate an electronic notification, which will provide an alert to the facility, and can include multiple facility designated personnel.

2. Reports regarding 12 lead ECG transmissions – success, failure, aggregate frequency, shall be available to the service provider, STEMI receiving center, and REMSA.

3. ECG transmission shall be field-user feasible with mobile gateways, hot spots, cellular / data services, or the like.

4. ECG transmission must not require any software / server purchase, or proprietary service to view, distribute.

Cardiopulmonary Resuscitation (CPR) diagnostics/feedback device must:

Measure / gauge depth, rate and chest recoil of each compression / cycle of compressions during active CPR, in both static patient situations and dynamic movement of the patient
Provide for synchronous and asynchronous CPR qualitative and quantitative feedback 3303 —Drug and Equipment List (3/29/22 - 14:13) 21 of 22 Provide audio and/or visual feedback to correct cadence, depth of compressions, and chest recoil/release, whether patient is static or dynamically moving
Provide an inactivity timer, indicating time duration of no chest compressions Provide real time visual and auditory feedback to clinicians CPR diagnostics/feedback must provide retrospective case by case, and aggregate feedback to EMS Providers, and REMSA.

Be able to transmit from device via cable or WIFI connection, into reportable software or database accessible by individual EMS Providers and REMSA.

Be stored by individual patient encounters and provide a minimum of two (2) unique identifiers (such as date of service, time of service, patient demographics or combinations to enable accuracy in data collection and reporting).

As able with ePCR technology, CPR diagnostics/feedback/summary must import into the REMSA ePCR system.

Data Integration and Management:

Device automatically stores patient information on internal memory per device application. Data stored must include at least two unique identifiers (incident number, date of service, time of service, patient information or combination), clinician entered events, therapies delivered.

Archived patient records must be able to be transmitted, printed and deleted by staff without vendor involvement.

Device must provide for the option of a USB cell modem for the wireless transmission of biometric parameters, CPR diagnostic feedback and 12 lead ECG.

Data Integration and Management continued:

Device must be capable of transferring data (including 12 Lead ECG, historical patient trends, event/code summary, CPR feedback and biometric parameters) into the REMSA ePCR system utilizing a directly connected cable or WIFI connection.

1. All applicable REMSA Information Security policies and procedures must be followed during data transmissions, imports or other sharing methodologies.

DEFINITIONS
California Code of Regulations, Title 22, Division 9, Prehospital Emergency Medical Services. (2019, January 1). Retrieved January 1, 2021, from https://emsa.ca.gov/wp-content/uploads/sites/71/2019/07/2019-EMS-Statute-Book.pdf California EMS authority, Prehospital EMS Aircraft Guidelines, Definitions. (2010, December 1). Retrieved January 1, 2021, from
https://govt.westlaw.com/calregs/Browse/Home/California/CaliforniaCodeofRegulations?guid=I7649C910D4C0 11DE8879F88E8B0DAAAE&originationContext=documenttoc&transitionType=Default&contextData=(sc.Default) Merriam-Webster. Retrieved March 19, 2015, from http://www.merriam-webster.com/ NEMSIS Version 3.4.0 Build 200910 Data Dictionary. (2020, September 10). Retrieved January 1, 2021, from https://nemsis.org/media/nemsis_v3/release-3.4.0/DataDictionary/PDFHTML/DEMEMS/index.html

REFERENCES
California Health and Safety Code - Division 2.5: Emergency Medical Services California Code of Regulations, Title 22. Social Security, Division 9. Prehospital Emergency Medical Services California Code of Regulations, Title 13. Motor Vehicles, Section 1103.2 California Vehicle Code Section 2418.5 Resuscitator Requirements for Ambulances California Code of Regulations, Title 8. Industrial Relations Occupational Safety and Health Administration (OSHA), Occupational Safety and Health Standards, Standard 1910 California Fire Service and Rescue Emergency Mutual Aid System, Mutual Aid Plan (2-12) American National Standards Institute (ANSI)
British Standards Institution (BSI)
Canadian Standards Association (CSA)
Commission on Accreditation of Medical Transport Services (CAMTS) National Fire Protection Association (NFPA)
National Institute for Occupational Safety and Health (NIOSH) EMSA #216: Minimum Personal Protective Equipment (PPE)

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