23. Patient Monitoring and Telemetry System.pdf

FOR OFFICIAL USE ONLY

(October 2018)

DHA PERFORMANCE STANDARDS

FOR

SECTION 27 52 13

PATIENT MONITORING AND TELEMETRY SYSTEM

10/18

TABLE OF CONTENTS

GENERAL

1.1 REFERENCE

2.1 DESCRIPTION & MATERIALS

3.1 SUBMITTALS

3.2 PERFORMANCE VERIFICATION AND ACCEPTANCE TESTING

3.2.1 Qualifications of Installers and Inspectors

3.2.2 Inspections and Tests to be Performed

3.3 WARRANTY

3.4 OPERATIONS AND MAINTENANCE (O & M)

GENERAL

This Performance Specification (PS) specifies the requirements for patient monitoring and telemetry systems.

Note: A typical patient monitoring and telemetry system consists of a network of sensors and displays with event logging and visual display of real-time patient parameters and trends. The system provides visual and auditory alarms whenever conditions exceed the monitored parameters. Real property, including raceway, cable tray, junction boxes, etc. are addressed in their respective UFGS sections and not included in this specification.

1.1 REFERENCES

Contractor must comply with the following:

1.1.1 United Facilities Criteria (UFC)

A. UFC 1-200-01 General Building Requirements B. UFC 3-501-01 Electrical Engineering C. UFC 4-010-06 Cybersecurity D. UFC 4-510-01 Military Medical Facilities

1.1.2 Military Standard

A. MIL-STD 1691 - JSN, Nomenclature, and Description.

1.1.3 Food and Drug Administration

A. Reserved for future

1.1.4 Military Department Surgeon General Standards

A. Reserved for future

1.1.5 Defense Health Agency Standards

A. Building Control Systems Categorization Memorandum B. Cyber Security Controls for Physically Isolated Systems C. Cyber Security Controls for Medical Community of Interest (MEDCOI)

1.1.6 Department of Defense Standards

A. Department of Defense Instruction (DoDI) Number 8500.01

B. Department of Defense Instruction (DoDI) Number 8510.01

1.1.7 Other Standards

A. International Electrotechnical Commission (IEC) 60601 Medical Electrical Equipment and Systems B. FCC Approved RF Communicating Device

2.1 DESCRIPTION & MATERIALS

All requirements within the MIL-STD 1691 Joint Schedule Number (JSN) descriptions are to be met as well as the performance guidelines listed in the following descriptions.

2.1.1 General

A. All product finishes must be capable of maintaining sheen and color through warranty period when using industry standard cleaning solutions.

B. Electrified equipment is to be [120 Volt 20 amp maximum] [___] unless noted otherwise.

C. Provide cabling and other appurtenances in accordance with the manufacturer’s recommendations.

D. Coordinate with Medical Treatment Facility (MTF) IT department for currently installed servers, switches, PCs and other similar hardware components. Where no manufacturer’s requirements conflict, provide hardware components to be fully compatible with those currently installed in the MTF.

E. System and other appurtenances must not have an anticipated end of system support in the next [18] [___] months.

Systems being phased out are not acceptable.

2.1.2 Patient Monitoring and Telemetry

M4880, M7806, M7807, M7815, M7818, M7820, M7825, M7845, M7850, M7855, M7865, M7900, M7925 A. Display to be LCD high contrast with continuous display of patient parameters. Display text must be readable in any ambient light level.

1. User configurable with up to eight (8) [____] pre-configured views, including split-screen views with real-time patient information.

2. Views configured based on care areas, patient, acuity, and environment.

3. Central Station to be comprised of two (2) [____] displays providing remote viewing of patient displays and alarms.

4. [Minimum [17in] [20in] [___] secondary display adjacent to central station with 250ms maximum display delay, connected via DVI-I.] B. Patient parameters must include [ECG], [respiration and heart rates], [invasive/ non-invasive blood pressure], [body temperature and SpO2].

1. High resolution trends with 2-second viewing for beat-to-beat evaluation of bradycardia and apnea events, with

Arrhythmia monitoring of up to 12-leads.

2. Scalable and interchangeable modules for specific monitoring needs.

3. [Wireless] [Hardwired] connectivity between patient monitor display and monitoring leads.

4. Operating temperature: [32° to 104° F (0° to 40° C)] [___].

5. Provides up to 96 hours of trends, with data resolution 30-second sampling.

6. Event storage to be provided for up to 150 events, 20-second strips, and all waveforms.

C. Central Station to be located in [Med/Surg. Nurse Station], [ED Nurse Station], [and/or] [_____], to be comprised of central workstation, display(s), and printer.

1. Central Station to provide historical data viewable for up to six (6) days post-discharge.

2. Provides up to 96 hours of trends, with data resolution 30-second sampling.

3. Event storage to be provided for up to 150 events, 20-second strips, and all waveforms, per patient station.

4. Central Station Printer connected [wirelessly] [hardwired] to Central Station.

D. [User controlled] [System controlled] alarm notifications must have options using visual or auditory or both. All alarm indicators cannot be turned off at the same time.

E. Unit to be table-top, wall mounted, or mobile. Mobile to be mounted on included mobile cart or trolley supplied by the manufacturer. Unit must have optional accessory brackets available for wall mounting.

F. Construction to be free of sharp edges, resistant to corrosion, and splashproof. External parts must allow for thorough cleaning and disinfection. All components contacting patient must be protected by a disposable cover or sterilizable if being reused.

G. Hardware to include wireless, Ethernet, and USB to PC connectivity for data transmission with optional connection to

EMR/HER.

H. Power to be provided through battery during transportation. Include battery backup switch and low battery alert in case of power loss. Provide minimum [30] [60] [___] minutes of runtime at rated load.

I. Provide documentation for each display, central station, monitoring equipment and leads which can be stored and accessed.

3.1 SUBMITTALS

3.1.1 Submittals required for government review

A. Submittal requirements are outlined in [Division 01] [PWS SOW] [___].

B. [Submit the following for government review in addition to the submittal requirements in the [PWS SOW] [Division 1]

C. [Product Literature that includes manufacturers’ installation instructions, sizing, options, utility requirements and accessories being provided.] D. [Warranty information.]

E. [Contact Information for Repair Technician or Emergency Repair Company] F. [Qualifications of installers and inspectors.] G. [Specification Compliance Document]

3.2 PERFORMANCE VERIFICATION AND ACCEPTANCE TESTING

Install patient monitoring and telemetry systems in accordance with manufacturer’s instructions. Demonstrate system is in operating condition in accordance with manufacturers’ specifications, and meets performance requirements stated in referenced criteria. Perform final verification and acceptance testing after facility construction is complete. If portions of the system were tested before final construction completion, retest system communications and functionality after completion of facility construction.

3.2.1 Qualifications of Company, Lead Installers, and Inspectors A. Company specializing in installing the products specified in this section with minimum 5 years of documented experience.

B. Provide written Specification Compliance Document that the system and products submitted meet or exceed all requirements stated in this specification and referenced criteria as installed or that declares any omissions to the specification and referenced criteria compliance.

3.2.2 Inspections and Tests to be Performed

A. Simulate a power outage to demonstrate functionality of back-up power system and power loss alarms.

B. Demonstrate functionality of interfaces to other systems and networks required.

C. Demonstrate implementation of cyber-security controls in accordance with DoDI 8510.

3.3 WARRANTY

3.3.1 Minimum Requirements:

A. Warranty requirements are outlined in [Division 01] [PWS SOW] [___].

3.4 OPERATIONS AND MAINTENANCE (O & M)

3.4.1 Provide the following to the final owner:

A. Provide O & M data for all FFE-LVS as outlined in [Division 01] [PWS SOW] [___].

B. Train designated staff in the operation and maintenance of the provided system. Provide two training sessions for system users and two training sessions for maintenance personnel scheduled to accommodate shift work. [Eleven months after the system is installed, provide a refresher course for each group of trainees.] Provide video of the training with the O & M data.

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