P Spec Attch 01.pdf

SPECIAL OPERATIONS FORCES

TACTICAL COMBAT CASUALTY CARE

GROUP LEVEL SET

CASEVAC

Performance Specification

Program Manager

Special Operations Forces Warrior Systems

12 March 2010

USSOCOM

1 December 2009 (revised 12 March 2010) Attachment 1

1 SCOPE

2 APPLICABLE DOCUMENTS

2.1 GOVERNMENT DOCUMENTS

2.2 DOCUMENTS SOURCE

2.3 ORDER OF PRECEDENCE

3 TCCC CASEVAC Set Mission

4 REQUIREMENTS

4.1 CASEVAC Set CHARACTERISTICS

4.1.1 CASEVAC Set General Characteristics

4.1.1.1 Employment (KPP)

4.1.1.2 Training (KPP)

4.1.1.3 Equipment Items

4.1.1.4 Lightweight

4.1.1.5 Packaging / Modularity

4.1.1.6 Reliability/Quality

4.1.1.7 Simplicity/Accessibility

4.1.1.8 Adaptability

4.1.1.9 Air Transport

4.1.1.10 Environment

4.1.1.11 Power

4.1.1.12 Maintenance

4.1.1.13 Sustainment

4.1.1.14 Manuals and Media

4.1.2 CASEVAC Extraction Kit

4.1.2.1 Extraction Kit General Characteristics

4.1.2.2 Extraction Module 1 (E-1)

4.1.2.3 Extraction Module 2 (E-2)

4.1.2.4 Extraction Module 3 (E-3)

4.1.3 CASEVAC Mobility Kit

4.1.3.1 Mobility Kit General Characteristics

4.1.3.2 Mobility Module 1 (M-1)

4.1.3.3 Mobility Module 2 (M-2)

4.1.4 CASEVAC Transport Kit

4.1.4.1 Transport Kit General Characteristics

4.1.4.2 Transport Module 1 (T-1)

4.1.4.3 Transport Module 2 (T-2)

4.1.4.4 Transport Module 3 (T-3)

4.1.4.5 Transport Module 4 (T-4)

4.1.4.6 Transport Module 5 (T-5)

4.1.4.7 Transport Module 6 (T-6)

4.1.5 CASEVAC Sustainment Kit

4.1.5.1 Sustainment Kit General Characteristics

4.1.5.2 Sustainment Module 1 (S-1)

4.1.5.3 Sustainment Module 2 (S-2)

4.2 Management

4.2.1 Delivery

4.2.2 Surge Requirements

4.2.3 CASEVAC Set Quality Assurance Plan

4.2.4 Configuration Management

4.2.5 Supply Chain Management

4.2.6 Warranty

4.2.7 Part Numbers

4.2.8 Program Management

4.2.9 Packaging, Labels and Marking

ANNEX 1 Equipment Specifications

1 SCOPE

This document provides performance specifications for a Special Operations Forces (SOF) Tactical Combat Casualty Care (TCCC) Casualty Evacuation (CASEVAC) Set.

This Performance Specification describes the technical performance requirements for the SOF TCCC CASEVAC Set and the associated modules which make up four distinct kits each filling a different capability gap. The TCCC CASEVAC Set facilitates the rescue, recovery, and evacuation of casualties; stabilizes and sustains casualties in case of a delayed or difficult CASEVAC and is capable of adapting to military and non-military modes of transportation.

2 APPLICABLE DOCUMENTS

2.1 GOVERNMENT DOCUMENTS

Documents cited or used for this performance specification are as follows:

Tactical Combat Casualty Care Guidelines 2009 (online) Army Regulation (AR) 70-62, Airworthiness of United States (US) Army Aircraft Systems (online) Military Standard (MIL-STD) 810G, Department of Defense (DOD) Test Method Standard for Environmental Engineering Considerations and Laboratory Tests (online) Military Edition, Pre-Hospital Trauma Life Support Version 6E (Amazon) National Fire Protection Association (NFPA) Standards 1936/1983 Standards-National Fire Protection Association (NFPA) standard 1983 (online) Union International des Associations dâ Alpinism (UIAA) or European Committee for Standardization (CE) climbing certifications of complicity (online) http://safety.theuiaa.org/front/index_public.php Food and Drug Administration (FDA) approved for medical use certification (Devices@FDA.gov)

2.2 DOCUMENTS SOURCE

Copies of military specifications, standards, handbooks, drawings, and publications can be obtained from the contracting activity or as directed by the contracting activity. Potential Contractors and bidders are responsible for obtaining any and all documents referenced.

Possible sources of other documents are listed below:

Food and Drug Administration (FDA)

National Fire Protection Agency (NFPA)

United International Alpine Agency (UIAA)

United States Army Aeromedical Research Laboratory (USAARL)

2.3 ORDER OF PRECEDENCE

In the event of a conflict between this Performance Specification and cited references, this Performance Specification shall take precedence. If there is a conflict between references, the Contractor is required to contact, in writing, the contracting activity for clarification.

3 TCCC CASEVAC Set Mission The SOF CASEVAC Set mission is to facilitate the rescue, recovery, extrication and evacuation of casualties; stabilize and sustain casualties in case of a delayed or difficult CASEVAC and is capable of adapting to military and non-military modes of transportation. SOF gaps include insufficient Medical Evacuation (MEDEVAC) ambulance capability of supporting SOF under fire in denied areas. SOF utilizes specialized military air, land, and sea mobility platforms, as well as indigenous modes of transportation, to accomplish their missions.

4 REQUIREMENTS

Requirements specified in section 4.2 and 4.3 are defined as thresholds (T) unless noted as objectives (O).

4.1 CASEVAC Set CHARACTERISTICS

The overall intent for the CASEVAC Set is to have individual modules capable of being used independently based on current SOF mission requirements. A grab-and-go mentality should be used when designing the packaging for the CASEVAC Set. The specifications listed are not all encompassing but pose the minimum requirements in order to meet the SOF mission. Innovation and ingenuity are essential for equipment selection in order to meet and exceed the performance specifications outlined in this document. The design of the CASEVAC Set should focus on the desired functional effectiveness; not on an item-specific compilation of equipment.

PERFORMANCE CHARACTERISTICS

4.1.1 CASEVAC Set General Characteristics

4.1.1.1 Employment (KPP)

4.1.1.1.1 The CASEVAC Set’s medical items and protocols shall be within the ability of SOF Advanced Tactical Practitioners (ATPs) to effectively employ in harsh environments, during limited visibility, while under fire, and possibly when wounded.

4.1.1.1.2 The CASEVAC Set shall facilitate the rescue, recovery, and evacuation of trauma casualties, provide the capability to stabilize and sustain in case of a delayed or difficult casualty evacuation, and adapt to military and non-military modes of transportation.

4.1.1.1.3 The CASEVAC Set’s design, use protocols, and packaging shall consider these employment requirements.

4.1.1.2 Training (KPP)

4.1.1.2.1 The CASEVAC Set’s non-medical equipment shall not require specific training (beyond that resident in the force). This training may be new training and institutionalized during the development of the program.

4.1.1.2.2 The CASEVAC Set’s medical equipment/supplies shall not require complicated additional SOF ATP training and shall include all applicable training materials.

4.1.1.2.3 The CASEVAC Set shall include the training needed to pack, operate, and operator level service the equipment/supplies contained within (e.g. changing batteries, reset the device). The training shall include an automated interactive training compact disc (CD) for the Service and Operator Manuals (2 ea) (of any device requiring instruction) and a Packing List incorporated into each Module of the CASEVAC Set. An Interactive Training Compact Disc (CD) is desirable.

4.1.1.2.4 The CASEVAC Set shall be effectively employed by a trained SOF ATP.

The following SOF occupational series personnel are the primary users of this equipment: United States Army Special Operations Command (USASOC): 68W_W1, 18D; Marine Special Operations Command (MARSOC): 8404; Naval Special Warfare Command (NAVSPECWARCOM)- Advanced Special Operations Combat Medic (ADSOCM): 8404; and Air Force Special Operations Command (AFSOC): 1T and 4N.

4.1.1.3 Equipment Items

4.1.1.3.1 The CASEVAC Set’s medical equipment and supplies shall be approved or cleared by the FDA and or the USSOCOM Surgeon General for use.

4.1.1.3.2 The CASEVAC Set’s equipment/supplies shall meet all applicable electrical safety standards and regulations to include but not limit to UL 544, and ANSI/AAMI HF-18 Electrical Safety Standards.

4.1.1.3.3 The CASEVAC Set shall incorporate equipment/supply items that allow SOF ATPs to perform the capabilities and requirements of each individual kit outlined in sections 4.1.2-4.1.5.

4.1.1.3.4 The CASEVAC Set shall incorporate: all equipment/supply items listed in Annex 1, Notional Equipment List (T) all equipment/supply items required to perform the CASEVAC mission utilizing the latest technology, lightest weight, most compact design, and integration of multiple capabilities, highest durability, and highest reliability (O).

4.1.1.4 Lightweight

4.1.1.4.1 The CASEVAC Set shall be lightweight and each individual module outlined in sections 4.1.2-4.1.5 shall be either man-packable or man-portable as specified in their respective sections.

4.1.1.4.2 The man-packable kits shall weigh less than 55 (T) 40 (O) lbs.

4.1.1.4.3 The man-portable kits shall weigh less than 100 (T) 80 (O) lbs.

4.1.1.5 Packaging / Modularity

4.1.1.5.1 The CASEVAC Set shall include all packaging necessary to transport/store all equipment/supply items in an organized manner.

4.1.1.5.2 The CASEVAC Set’s packaging shall include additional storage compartments to accommodate extra supplies or mission unique items.

4.1.1.5.3 Each individual kit outlined in sections 4.1.2-4.1.5 shall be self-contained (T). The modules within each kit shall be modularized and able to be combined with/connected to each other to the maximum extent practicable (O).

4.1.1.5.4 The man-packable packaging shall consist of bags, snaps, zippers, hooks, straps, pouches, pockets, and other SOF common packaging to be as streamlined and compact to the maximum extent practicable.

4.1.1.5.5 The man-portable packaging shall consist of man-packable packaging and/or ruggedized, air-worthy containers suitable to organize transport and protect the equipment/supplies stored within.

4.1.1.5.6 All external packaging will be constructed of materials able to accept various camouflage patterns to include but not limited to Army Combat Uniform (ACU), AOR1/2 (Naval Special Warfare Pattern), Multi-Camouflage, and MARPAT (Marine Corps Pattern)

4.1.1.6 Reliability/Quality

4.1.1.6.1 The CASEVAC Set packaging shall be manufactured using materials and processes providing the highest quality and durability needed to meet SOF mission requirements and operate in the intended environment for a minimum of a two year life-cycle management period.

4.1.1.6.2 The CASEVAC Set man-packable packaging stress points shall be double-stitched (T) triple-stitched (O).

4.1.1.6.3 Mean Time Between Failure (MTBF) for all medical electronic items:

4.1.1.6.3.1 Threshold:

A. The mean time between Operational Mission Failure will be at least 360 hours.

B. The operational availability will be .95 when operated over a 30-day period.

C. The mean time to repair will be 3 hours.

4.1.1.6.3.2 Objective:

A. The mean time between Operational Mission Failure will be at least 540 hours.

B. The operational availability will be .98 when operated over a 30-day period.

C. The mean time to repair will be 1 hour.

4.1.1.7 Simplicity/Accessibility

4.1.1.7.1 The CASEVAC Set’s packaging shall be simple in design and permit easy access to the equipment/supplies contained within.

4.1.1.7.2 The CASEVAC Set’s packaging shall go no more than 1-zipper deep to access the main contents of any bag.

4.1.1.7.3 The CASEVAC Set’s packaging shall include basic labels for each compartment.

4.1.1.7.4 The CASEVAC Set’s packaging shall allow the equipment/supplies to be accessible by SOF Operators/ATP’s wearing gloves.

4.1.1.8 Adaptability

4.1.1.8.1 The CASEVAC Set shall have universal connectors, straps, and other attachments to safely and quickly secure the individual CASEVAC modules to SOF standard and non-standard mobility platforms.

4.1.1.8.2 The adaptation shall allow easy access to the equipment/supplies contained within the CASEVAC modules (O).

4.1.1.9 Air Transport

4.1.1.9.1 The CASEVAC Set shall meet all requirements to be transported by aircraft IAW USAARL policies.

4.1.1.9.2 The CASEVAC Set’s individual kits shall be air and crash worthy as specified in their respective sections IAW USAARL policies.

4.1.1.10 Environment

4.1.1.10.1 The CASEVAC Set shall meet SOF mission environmental requirements.

4.1.1.10.2 The CASEVAC Set’s non-medical equipment/supplies and packaging shall have an operating temperature range of -25°F/-33°C to 120°F/49°C.

4.1.1.10.3 The CASEVAC Set’s medical equipment shall have an operating temperature range of 40°F/4°C to 120°F/49°C (T) -25°F/-33°C to 120°F/49°C (O).

4.1.1.10.4 The CASEVAC Set’s equipment/supplies and packaging shall have a storage/transport temperature range of -25°F/-33°C to 160°F/71°C.

4.1.1.10.5 The CASEVAC Set’s equipment/supplies and packaging shall be able to withstand shock and vibration expected during shipment or transport.

4.1.1.10.6 The CASEVAC Set’s packaging shall protect all equipment/supplies from moisture, high winds, dust, sand, and other environmental hazards when prepared for transport.

4.1.1.11 Power

4.1.1.11.1 The CASEVAC Set’s electrical equipment shall be operated utilizing lightweight (T), maintenance-free (T), low-heat (O), extended-life (T), rechargeable (T) batteries.

4.1.1.11.2 The batteries shall be rechargeable by a 110/120VAC (T), 220/240VAC (T), 20VDC (O), 12VDC (O), non-standard voltage (O) power source.

4.1.1.11.3 The electrical equipment shall have the capability to operate off of the corresponding power source (O).

4.1.1.11.4 The electrical equipment shall utilize common batteries already in the Government system to the maximum extent practicable.

4.1.1.11.5 One common battery shall be used throughout all of the electronic equipment (O).

4.1.1.12 Maintenance

4.1.1.12.1 The CASEVAC Set’s equipment/supplies shall be maintenance free to the maximum extent practicable.

4.1.1.12.2 The CASEVAC Set’s medical equipment shall be able to be maintained, repaired and calibrated by Department of Defense medical maintenance personnel.

4.1.1.12.3 The CASEVAC Set’s medical equipment shall have maintenance cycles, procedures, and preventative maintenance part requirements taken into consideration for selection.

4.2.1.12.4 Manufacturer shall provide either 24/7 telephonic technical support or have the ability to perform remote diagnosis of the equipment.

4.1.1.13 Sustainment

4.1.1.13.1 The CASEVAC Set’s equipment/supplies shall be readily available in the DoD’s supply chain to the maximum extent practicable.

4.1.1.13.2 The CASEVAC Set’s equipment/supplies shall have sustainment attributes such as availability, shelf-life, lead-time, spare parts, supportability, warranty, etc. taken into consideration for selection.

4.1.1.14 Manuals and Media

4.1.1.14.1 The CASEVAC Set’s equipment shall include two (2) each operator and service manuals per Kit/Module as required for reference.

4.1.1.14.2 Each CASEVAC Set module shall include a packing list detailing all items contained within and the item’s location made of paper (T) durable, readable fabric (O).

4.1.1.14.3 Each CASEVAC Set will come with appropriate training media, web based, Compact Disc (CD) or Digital Versatile Disc (DVD) to ensure adequate New Equipment Training and Refresher Training requirements are met with the least impact on operational schedules. Back up hard copy files will be made available on the TCCC web page.

4.1.2 CASEVAC Extraction Kit

4.1.2.1 Extraction Kit General Characteristics

4.1.2.1.1 All items incorporated into the Extraction Kit shall meet air and crash worthy certification requirements.

4.1.2.1.2 All items incorporated into the Extraction Kit shall meet National Fire Protection Agency (NFPA) and United International Alpine Agency (UIAA) standards.

4.1.2.1.3 Where applicable, colors of all items incorporated into the Extraction Kit shall relate to subdued earth tones.

4.1.2.2 Extraction Module 1 (E-1)

4.1.2.2.1 The E-1 Module shall be man-packable to be transported by one SOF Operator.

4.1.2.2.2 The E-1 Module shall have the capability to extricate casualties from all terrain to include water obstacles during day or night in transition to a rigid litter for ground/air evacuation.

4.1.2.2.3 The E-1 Module shall have the capability to package a casualty with spinal injury.

4.1.2.2.3.1 The E-1 Module shall include straps capable of attaching to spinal immobilization board incorporating quick-disconnect single hand operation.

4.1.2.2.3.2 The E-1 Module shall incorporate cervical spine immobilization w/ tracheal access.

4.1.2.2.4. The E-1 Module shall have the capability to splint upper/lower extremity and pelvic fractures of casualties to include a stabilization device with independent inflatable air chambers and a multi-positional rigid articulating splinting device.

4.1.2.2.4.1 The E-1 Module shall include a collapsible, pole-less, hoist-able litter for both ground & water rescue.

4.1.2.2.4.2 The E-1 Module shall include an inflatable flotation system with a quick connect/release (rescue system) that maintains positive flotation when added to extrication system.

4.1.2.2.5 The E-1 Module shall have the capability to protect and package the remains of dead personnel and shall be fluid retaining.

4.1.2.3 Extraction Module 2 (E-2)

4.1.2.3.1 The E-2 Module shall be man-packable to be transported by one SOF Operator.

4.1.2.3.2 The E-2 Module shall have the capability to safely access and recover casualties from high angle terrain and urban obstacles using rope and rigging equipment.

4.1.2.3.2.1 The E-2 Module shall include a headlamp which provides for blood identification, utilizes a common battery, and is capable of multiple color lighting (Light Emitting Diode (LED), Infrared (IR), Green, White & Red) and multi-color emergency lighting; chemical or battery;

multi-use; Landing Zone (LZ) marking; patient/litter marking devices.

4.1.2.3.2.2 The E-2 Module shall include both a rescue tool which incorporates glass breakage and a seatbelt cutter, and also a folding rescue knife which incorporates a blunt tip for glass breakage capability and a seatbelt cutter.

4.1.2.3.3 The E-2 Module shall have the capability to conduct immediate water rescue and ground safety line operations for vertical hoist extractions of casualties.

Tag lines shall be a minimum of 75’ and include a breakaway link. Throw ropes shall be 60’ and be floatable with an identifiable bag.

4.1.2.3.4 The E-2 Module shall have the capability for vertical hoist operations.

Static ropes shall be 150’ e-z bend with a To Be Determined (TBD) minimum strength.

Rope bags shall be sized appropriately. Bag will include rappelling gloves (as ordered) in small – Extra Extra Large (XXL) sizes, compatible ascenders, and locking gate carabineers.

4.1.2.3.4.1 The E-2 Module shall include a full body rescue harness which is adjustable with lift capability.

4.1.2.3.4.2 The E-2 Module shall include a double open end rope bag (8" diameter x 21” long). Extrication straps shall be black and 20' with a 4000lb breaking strength. Sling anchors shall be heavy duty (2" x 8') and black with a 4000lb breaking strength. Tubular webbing shall be 20’ with a 2500lb breaking strength.

4.1.2.4 Extraction Module 3 (E-3)

4.1.2.4.1 The E-3 Module shall be man-portable to be transported by two SOF Operators.

4.1.2.4.2 The E-3 Module shall have the capability to pry and cut wreckage to facilitate rapid extrication. It should be powered by either battery or diesel / JP8 powered (TBD) and man packable.

4.1.2.4.3 The E-3 Module shall have the capability to lift and move large objects, i.e. vehicles, wreckage, building debris, etc, high enough to remove casualties trapped underneath. If a pneumatic device is used, it should be capable of using the vehicle as its primary air source.

4.1.3 CASEVAC Mobility Kit

4.1.3.1 Mobility Kit General Characteristics

4.1.3.1.1 All items incorporated in the Mobility Kit shall meet air and crash worthy certification requirements.

4.1.3.2 Mobility Module 1 (M-1)

4.1.3.2.1 The M-1 Module shall be man-packable to be transported by one SOF Operator; with the backpack available in multi-camouflage and/or earth tone patterns and capable of supporting provided litter. The pack cover should provide weather and dust proof protection of casualty’s equipment.

4.1.3.2.2 The M-1 Module shall have the capability to secure and safely transport a casualty on a rigid litter through all phases of TCCC to Level III medical treatment.

4.1.3.2.3 The M-1 Module shall include a rigid litter that meets CBRNE criteria, is hands-free capable, self-contained and compatible with US/North Atlantic Treaty Organization (NATO) medical evacuation transport equipment (to include lower stanchion of Mine Resistant Ambush Protected (MRAP)). Hands-free refers to usage of a sling, strap or other device that enables a SOF Operator to transport the litter “hands-free” and thus able to use hands to respond to enemy fire with a weapon.

Litters will have retractable handles, automatic locking hinges, be slip-resistant, chemical-resistant and utilize a light weight fabric.

4.1.3.3 The M-1 Module shall be compatible with MOLLE/PALS

configurations. Mobility Module 2 (M-2)

4.1.3.3.1 The M-2 Module shall be man-packable to be transported by one SOF Operator.

4.1.3.3.2 The M-2 Module shall transport the M-1 Module in a modular format.

4.1.3.3.3 The M-2 Module shall have the capability to attach the rigid litter from the M-1 Module to current SOF ground/air mobility or ad hoc platforms utilizing a quick ejector snap for one handed operation.

4.1.3.3.4 The M-2 Module shall have the capability to provide day/night landing zone marking, using a standard aviation self anchoring marker panel in 2 sizes or a multi-use, multi-color emergency lighting system for LZ and/or patient litter marking;

either chemical or battery.

4.1.3.3.5 The M-2 Module shall provide a casualty marking system to identify basic triage categories on casualties.

4.1.3.3.6 The M-2 Module shall have the capability to carry additional initial TCCC medical supplies to include TCCC Form One (US Army Medical Material Agency

(USAMMA) provided)1. Reflective warming blankets shall incorporate warming cells.

Nitrile gloves shall be provided at a minimum of two pair per size per kit and be of a color to best identify bleeding of the casualty. Headlamps shall provide for blood identification, utilize a common battery and be capable of multiple color lighting (LED, IR, Green, White & Red).

4.1.3.3.6.1 The M-2 Module shall have a blunt tipped seatbelt cutting tool capable of window breakage [straight blade blunt tip knife].

4.1.3.3.6.2 The M-2 Module shall include a Bandage, 6" Emergency, w/ Mobile Pad; Unit, catheter-Needle, IV 14gauge x 3.25"; Airway, Nasopharyngeal, 28 French; Pack, Surgical Lubricant; Dressing, Hemostatic Gauze, Combat; Bandage, Occlusive Chest Wound; and Gauze, Petroleum. Trauma shears shall have blunt tips to ensure that patients are not further injured.

4.1.3.3.6.3 The M-2 Module shall include a tourniquet which is small and lightweight with one-handed operation that completely occludes arterial blood flow in an extremity. It shall also use a self-adhering band and a friction adaptor buckle to fit a wide range of extremities combined with a one-handed windlass system.

4.1.3.3.7 The M-2 Module shall be compatible with Modular Lightweight Load-carrying Equipment (MOLLE)/ Pouch Attachment Ladder System (PALS) configurations.

1 TCCC Form One: (insert description) Provided by USAMMA

4.1.4 CASEVAC Transport Kit

4.1.4.1 Transport Kit General Characteristics

4.1.4.1.1 The medical equipment contained within the Transport Kit shall conform to specifications outlined in Annex 1, Equipment Specifications.

4.1.4.1.2 Each module shall incorporate all support items to include accessories and supplies necessary to operate and charge the associated pieces of medical equipment.

4.1.4.1.3 All modules contained within the Transport Kit shall be combined to be man-portable to be transported by two (T) one (O) SOF Operator(s).

4.1.4.1.4 All medical equipment contained within the Transport Kit shall meet air and crash worthy requirements.

4.1.4.2 Transport Module 1 (T-1)

4.1.4.2.1 The T-1 Module shall be man-packable to be transported by one SOF Operator.

4.1.4.2.2 The T-1 Module shall be capable of being man-portable when combined with other transport modules.

4.1.4.2.3 The T-1 Module shall have the capability to monitor casualty vital signs to include blood pressure (T), oxygen saturation (T), cardiac output (T), heart rate (T), temperature (O), and carbon dioxide levels (O). The device (s) will have a readable screen under any light or light sensitive condition and the ability to manually cancel audio-visual alarms. This module shall include a Thermometer- Digital, Clinical.

4.1.4.3 Transport Module 2 (T-2)

4.1.4.3.1 The T-2 module shall incorporate all accessories and supplies necessary to operate and charge the associated pieces of medical equipment.

4.1.4.3.2 The T-2 Module shall be man-packable to be transported by one SOF Operator.

4.1.4.3.3 The T-2 Module shall be capable of being man-portable when combined with other transport modules.

4.1.4.3.4 The T-2 Module shall have the capability to provide casualty electric cardiac therapy to include external defibrillation (T) and cardiac output monitoring (T).

The device (s) will have a readable screen under any light or light sensitive condition and the ability to manually cancel audio-visual alarms.

4.1.4.4 Transport Module 3 (T-3)

4.1.4.4.1 The T-3 module shall incorporate all accessories and supplies necessary to operate and charge the associated pieces of medical equipment.

4.1.4.4.2 The T-3 Module shall be capable of being man-portable when combined with other transport modules.

4.1.4.4.3 The T-3 Module shall be man-packable to be transported by one SOF Operator.

4.1.4.4.4 The T-3 Module shall have the capability to generate a fraction of inspired oxygen (FiO2) of 50% without use of a pressurized cylinder.

4.1.4.4.5 The T-3 Module shall have the capability to provide casualty mechanical ventilation (T) to be used with the oxygen generation capability in 4.1.4.4.1 (O). This module shall include Advanced Airway Management capability.

4.1.4.5 Transport Module 4 (T-4)

4.1.4.5.1 The T-4 module shall incorporate all accessories and supplies necessary to operate and charge the associated pieces of medical equipment.

4.1.4.5.2 The T-4 Module shall be capable of being man-portable when combined with other transport modules.

4.1.4.5.3 The T-4 Module shall be man-packable to be transported by one SOF Operator.

4.1.4.5.4 The T-4 Module shall have the capability to store and transport 2 (T) 4

(O) standard blood storage bags.

4.1.4.5.5 The T-4 Module shall have the capability to warm blood to 32° C (T) 38° C (O) for casualty transfusions similar to the "Golden Hour Container. 2

4.1.4.5.6 The T-4 Module shall have the capability to provide controlled casualty fluid resuscitation administered intravenously.

4.1.4.5.7 The T-4 Module shall have the capability to monitor casualty bodily fluid input and output.

4.1.4.6 Transport Module 5 (T-5)

4.1.4.6.1 The T-5 Module shall be capable of being man-portable when combined with other transport modules.

4.1.4.6.2 The T-5 Module shall be man-packable to be transported by one SOF Operator.

4.1.4.6.3 The T-5 Module shall have the capability to warm casualties with decreased bodily temperature using a full-body wrap with hood and heat packs.

These devices shall incorporate active heat and be light weight while utilizing battery and/or vehicle power.

2 Golden Hour Container: Prime vendor supported item coded AAC L “Local Purchase”.

Customers may purchase new Golden Hour Containers using the following NSNs: NSN 6530-01-

505-5301 NSN 6530-01-505-5306

4.1.4.6.4 The T-5 module shall be capable of warming casualties in cold temperatures.

4.1.4.7 Transport Module 6 (T-6)

4.1.4.7.1 The T-6 module shall be capable of being man-portable when combined with other Transport modules.

4.1.4.7.2 The T-6 module itself shall be capable of being man-packable.

4.1.4.7.3 The T-6 Module shall have the capability to mount the medical equipment contained in modules 1-5 within the Transport to the rigid litter specified in Mobility. The device shall mount anywhere on a standard NATO litter and be capable of holding portable medical equipment, including a ventilator, suction, monitor, infusion pump, power supply and steel and carbon-fiber oxygen cylinders. Electronic Casualty Cards or Personal Digital Assistant (PDA’s) can be ruggedized wireless handheld computers capable of recording an injured soldier’s name, vital statistics, and the initial medical treatment to be quickly transmitted to follow-on casualty care providers.

4.1.5 CASEVAC Sustainment Kit

4.1.5.1 Sustainment Kit General Characteristics

4.1.5.1.1 The medical equipment contained within the Sustainment Kit shall conform to specifications outlined in Annex 1, Equipment Specifications.

4.1.5.1.2 All medical equipment contained within the Sustainment Kit shall meet air and crash worthy requirements.

4.1.5.1.3 All modules in the Sustainment Kit shall fit in an organized manner within a standard A-series container utilized with the Container Delivery System (CDS).

Additional space in the A-series container shall be available to accommodate the largest size cargo parachute.

4.1.5.2 Sustainment Module 1 (S-1)

4.1.5.2.1 The S-1 Module shall be man-packable with multiple packs to be transported by multiple SOF Operators.

4.1.5.2.2 The S-1 Module shall have the capability to provide and sustain the control of life-threatening bleeding for 2 (T) 5 (O) casualties for up to twenty four hours. This Module shall include a pressure dressing with built in tension bar.

4.1.5.2.3 The S-1 Module shall have the capability to provide and sustain the treatment and prevention of shock for 2 (T) 5 (O) casualties for up to twenty four hours.

4.1.5.2.4 The S-1 Module shall have the capability to provide and sustain the protection of wounds to include burns from contamination, infection or further injury for 2 (T) 5 (O) casualties for up to twenty four hours.

4.1.5.2.5 The S-1 Module shall have the capability to provide and sustain pain management without adverse affects for 2 (T) 5 (O) casualties for up to twenty four hours.

4.1.5.2.6 The S-1 Module shall have the capability to provide and sustain the control of vomiting for 2 (T) 5 (O) casualties for up to twenty four hours.

4.1.5.2.7 The S-1 Module shall have the capability to provide portable suction with a capacity of 500mL for 2 (T) 5(O) casualties.

4.1.5.2.8 The S-1 Module shall have the capability to provide additional TCCC Operator and Medic Kits supplies for 4 (T) unit Operators. This module shall include Supplies, Trauma, Operator & Medic Kits; a bi-folding backboard; cervical spine immobilization w/ tracheal access; headlamp providing blood identification with a common battery and LED;IR, green, white and red lighting; a low signature Night Vision Goggle (NVG) secure flashlight; a blunt tipped seatbelt cutting tool capable of window breakage [straight blade blunt tip knife]; Structural Aluminum Malleable (SAM) Splints x 2; and provide the capabilities of an altitude sickness chamber.

4.1.5.2.8.1 Patient communications sets must be compatible with SOF Comms (Maritime Integrated Communications Helmet (MICH)) Land Communications).

4.1.5.2.8.2 Stethoscopes should be cleanable and the head

diaphragms kept clean with the use of disposable antimicrobial covers or similar protection. Sphygmomanometers must be of the regular adult and XL adult sizes with thigh cup. All Nitrile exam gloves must be green for easier detection of casualty bleeding. Bandage scissors will be of the trauma shears type. Combat and abdominal bandages will be of the “Israeli Bandage type”, the latter being large. Reflective warming blankets shall incorporate warming cells.

4.1.5.2.8.3 Laryngoscope blades will be both metal/durable and disposable and the handle will be fiber optic utilizing AA batteries. Hand resuscitators will be of the Ambu Bag type. Sharps containers will be of 1-quart size. Medication storage cases shall protect contents from breakage, come in two sizes with dimensions being external 31.5" h x 22.87" w x 19" d, internal 28.18" h x 19.75" w x 17.62" d, and also approximately 9" x 4" x 3".

4.1.5.2.8.4 The S-1 module shall include Set, IV Protection, 12s -catheter security devices.

4.1.5.2.8.5 The S-1 Module shall include a tourniquet which is small and lightweight with one-handed operation that completely occludes arterial blood flow in an extremity. They shall also use a self-adhering band and a friction adaptor buckle to fit a wide range of extremities combined with a one-handed windlass system.

4.1.5.3 Sustainment Module 2 (S-2)

4.1.5.3.1 The S-2 Module shall be man-packable to be transported by one SOF Operator.

4.1.5.3.2 The S-2 Module shall have the capability to provide advanced airway care up to and including surgical airway procedures. Suction kits shall be manual and disposable. Combi-tube, Trachial, Airway shall be of sizes 4, 5 & 6 and be non-latex.

Nitrile gloves shall be provided in XL size and be of a color (green) to best identify bleeding of the casualty. Laryngoscope blades will be both metal/durable and disposable to include both Miller #3 and Macintosh #3 types and the handles will be fiber optic utilizing AA batteries. A minimum of 48 AA batteries must be supplied.

Forceps shall be angled to guide a tracheal tube into the larynx or a nasogastric tube into the esophagus under direct vision. They shall also be capable of placing pharyngeal packs and removing foreign bodies.

4.1.5.3.3 The S-2 Module shall have the capability to provide casualty mechanical ventilation (T) to be used with an oxygen generation capability giving a fraction of inspired oxygen (FiO2) of 50% (O).

4.1.5.3.4 The S-2 Module shall have the capability to provide additional TCCC Operator and Medic Kits supplies for 4 (T) unit Operators.

4.2 Management

4.2.1 Delivery

Upon release of any delivery order the Contractor shall deliver in accordance with the terms and conditions of the contract.

4.2.2 Surge Requirements

The Contractor shall have the ability to meet the desired monthly surge requirement in accordance with the schedule set forth in FAR 52.211-8 of the solicitation. The contract will identify the required/desired surge capability or the proposed percentage above the base delivery capacity.

4.2.3 CASEVAC Set Quality Assurance Plan

Production items shall meet all requirements specified herein. The Contractor shall establish, maintain and submit with their proposal a CASEVAC Set Quality Assurance Plan relating to the inspection, test methods, and other testing activities used to verify that the specified requirements for this product are met and that there is no variation in the quality or quantity of the individual items contained within the CASEVAC Sets. The Government reserves the right to inspect records to determine the validity of the data. The Government also reserves the right to perform any of the inspections set forth in the CASEVAC Set Quality Assurance Plan and the requirements matrix as deemed necessary to ensure supplies and services conform to the prescribed requirements.

4.2.4 Configuration Management

The contractor shall submit a Configuration Management Baseline with their proposal detailing the raw materials and manufacturer part numbers used in the design/construction of the CASEVAC Set. When appropriate, the Contractor shall identify any construction details. Any changes to the initial accepted Configuration Management Baseline shall be reviewed and approved by the Government. The Government reserves the right to exclude from consideration for acceptance any material or service that is not identified in an accepted/approved Configuration Management Baseline.

4.2.5 Supply Chain Management

The Contractor shall be responsible for its supply chain management relationships to ensure successful timely delivery of quality products from key suppliers for vital and/or long lead components.

4.2.6 Warranty

The Contractor shall specify which items included in the CASEVAC Set are under warranty and specify the duration of that warranty.

4.2.7 Part Numbers

The Contractor shall submit a unique manufacturer’s part number for each Contract Line Item (CLIN) in the contract. The Contractor will also provide a unique item identifier for all items in which the Governments unit acquisition cost is greater than $5,000.00. The part number shall not change for the life of the contract without prior approval from the Government.

4.2.8 Program Management

The Contractor shall appoint a single Point of Contact (POC) for all issues relating to this contract. The POC shall be responsible for advising the Government representatives of any delays in deliveries. This person shall be identified as Key Personnel In Accordance With (IAW) the terms and conditions of the contract.

4.2.9 Packaging, Labels and Marking

The Contractor shall label, mark and properly pack all shipments for each delivery. If the Contractor can identify other cost-effective packaging solutions, which may enhance the integrity of the product at destination, the Contractor shall recommend an alternative packaging procedure.

ANNEX 1 Equipment Specifications The equipment specifications below describe the specifications for particular medical and non-medical equipment items needed in the CASEVAC Set to meet the capabilities required. If two or more items can be integrated into one item, that item shall meet the thresholds stated for all items integrated into it. When applicable the equipment should be able to utilize, if needed, the transport vehicles power or a standard BA5590 12VDC battery.

A1.1 Monitor, vital signs, lightweight, compact

A1.1.1 The vital signs monitor shall provide the following physiological monitoring capabilities:

A1.1.1.1 Blood Pressure (T)

A1.1.1.2 Oxygen Saturation (T)

A1.1.1.3 Cardiac Monitoring (T)

A1.1.1.4 Heart Rate (T)

A1.1.1.5 Carbon Dioxide Levels (O)

A1.1.1.6 Temperature (O)

A1.1.2 The vital signs monitor shall be able to store and transfer data to an outside source.

A1.1.3 The vital signs monitor shall have audible and visual alarms that can be silenced / adjusted for all critical parameters.

A1.1.4 The vital signs monitor shall have brightness adjustable displays to be Night Vision Goggle (NVG) readable.

A1.1.5 The vital signs monitor shall have a casing either internal or external that protects the monitor from damage during operation.

A1.1.6 The vital signs monitor shall be water resistant. (O)

A1.2 Pump, IV

A1.2.1 The IV Pump shall be no larger than 65 in3 with any one dimension not to exceed 6 in.

A1.3 Defibrillator

A1.3.1 The defibrillator shall be an Automated External Defibrillator (AED).

A1.3.2 The defibrillator shall perform cardiac monitoring with visual display.

A1.3.3 The defibrillator shall have an integrated external noninvasive pacemaker (O).

A1.4 Device, Fluid Warming (blood / IV)

A1.4.1 The fluid warming device shall be an inline fluid warmer.

A1.4.2 The fluid warming device shall warm the fluid to 100°F/38°C.

A1.4.3 The fluid warming device shall have an adjustable flow rate of 2-150 mL/min.

A1.4.4 The fluid warming device shall have an integrated infusion pump (O)

A1.5 Ventilator, mechanical

A1.5.1 The mechanical ventilator shall be a transport ventilator designed to take the place of manual “bagging” in emergency or transport situations.

A1.5.2 The mechanical ventilator shall run without external air sources.

A1.5.3 The mechanical ventilator shall have audible and visual alarms that can be silenced / adjusted for all critical parameters.

A1.5.4 The mechanical ventilator shall incorporate an oxygen generator in its design to provide a fraction of inspired oxygen (FiO2) of 50% to the casualty (O).

A1.6 Oxygen generator 50% FIO2

A2.6.1 The oxygen generator shall provide a minimum fraction of inspired oxygen (FiO2) of 50%.

A2.6.2 The oxygen generator shall not contain a high pressure gas cylinder.

A1.7 Litter, collapsible, lightweight, rigid

A1.7.1 The litter shall be collapsible to 20 inches in length.

A1.7.2 The litter shall weigh less than 17 (T) 12 (O) pounds.

A1.7.3 The litter shall have a capacity of 400 (T) 1200 (O) pounds.

A1.7.4 The litter shall have two casualty straps that can withstand 5,500 pounds of force.

A1.7.5 The litter shall meet Chemical, Biological, Radiological, Nuclear, Explosion (CBRNE) decontamination criteria.

A1.7.6 The littler shall be NATO compatible (T) but with collapsible handles (O).

A1.8 Supplies, trauma, Operator and Medic Kits

A1.8.1 SOF Combat Operator Trauma Kit

A1.8.1.1 Pouch Medical Aid SOF Individual with Insert Coyote Brown

A1.8.1.2 Wound Pack F/Moxiflixcin 400MG Meloxican15MG Acetaminophen

650MG

A1.8.1.3 Tourniquet Nonpneumatic Combat Application One-Handed

A1.8.1.4 Airway Nasopharyngeal Robertazzi 28FR 9.3mm Flanged 125mm L 10S

A1.8.1.5 Lubricant Surgical 5 Gram 144S

A1.8.1.6 Bandage Gauze Impregnated 3"X4YD Kaolin Hemostatic Quick Clot (Combat Gauze)

A1.8.1.7 SOF-TCCC Form 1 (Tactical Combat Casualty Care Card)

A1.8.2 SOF Combat Medic Trauma Kit

A1.8.2.1 Medical Aid M-9 CT

A1.8.2.2 Hetastarch In Lactated Electrolyte Injection 500ML Container 12S

A1.8.2.3 IV Protection Set Combat Tapeless Desert Beige Color 12S

A1.8.2.4 Promethazine Hydrochloride Injection USP Sterile Pyrogen-Free 50MG/ML 1ML Vial25S

A1.8.2.5 Intraosseous Infusion System F/Treating Hemorrhagic Shock

A1.8.2.6 Ertapenem Sodium for Injection 1GM Vial 10S

A1.8.2.7 Nonin Onyx II Pulse Oximeter

A1.8.2.8 Justice Mark II (Hard Case for Pulse Oximeter Onyx II)

A1.8.2.9 Transmucosal Fentanyl 800mcg

A1.8.2.10 Bandage Gauze Impregnated 3"X4YD Kaolin Hemostatic Quick Clot (Combat Gauze)

A1.8.2.11 Unit Level Training Package CDs

A1.8.2.12 SOF-TCCC Form 1 (Tactical Combat Casualty Care Card)