stratevac airworthiness capability package

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THIS DOCUMENT IS THE PROPERTY OF NSPA AND MAY NOT BE COPIED OR

CIRCULATED WITHOUT AUTHORIZATION

STATEMENT OF WORK

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Procurement of STRATEVAC

Airworthiness Capability Package

Version 1.3

18.03.2020

NATO Support and Procurement Agency LB General & Cooperative

Services Programme

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AMENDMENT RECORD

REVISION

AMENDMENT PAGES DATE OF ISSUE REMARKS

Version 1.0 22.01.2019

Version 1.1 54 16.10.2019

Version 1.2 60 05.02.2020

Version 1.3 60 18.03.2020 RFP Version

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Table of Contents

1. SCOPE………………………………………………………………………1

2. GLOSSARY AND TERMINOLOGY………………………………………1

3. GENERAL INFORMATION……………………………………………….1

4. GENERAL & TECHNICAL REQUIREMENTS…………………………..4

5. INTEGRATED LOGISTIC SUPPORT PACKAGE….. ………………….17

6. PACKAGING & TRANSPORTABILITY ………………….…………….17

7. SPARE PARTS AND TOOL………………………………………………18

8. TRAINING………………………………………………………………....18

9. DOCUMENTATION (CDRL 006)…………………………………….. 18

10. LABELING AND CODIFICATION …………………………………… 19

11. QUALITY ASSURANCE………………………………….. ………… 20

12. TERMS OF DELIVERY ……………………………………………… 20

13. ENVIRONMENTAL PROTECTION…………………………………….20

14. PROJECT MANAGEMENT…………………………………………… 21

15. COMMISSIONING & ACCEPTANCE TESTING………………………21

16. CDRL TABLE……………………………………………………..…… 21

17. DELIVERABLES………………………………………………………………………24

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1. SCOPE

1.1. In the logistic domain, the Strategic Evacuation capability shall be supported in order

to enhance its effectiveness and to allow the safe transport of patients and casualties

using different means of transport as rotary wing aircraft and fixed wing aircraft.

Moreover, it’s essential to face and oppose promptly at others threats as well as bio-

hazards and others in the CBRN domain that could affect crew, aircraft and

equipment.

1.2. This SOW addresses a multi years requirement for the STRATEVAC Airworthiness

Capability Package.

1.3. STRATEVAC support to NATO operations has to provide a wide spectrum of

medical and surgical response capabilities. These capabilities encompass all the

necessary resources and equipment to conduct medical treatment, achieve

aeromedical evacuation skills linking high and medium care tactical and strategic

airlift, and other functions essential to person’s health preservation.

1.4. The material depicted in this SOW are to be used by the Italian Air Force.

2. GLOSSARY AND TERMINOLOGY

The following terms, when used in this SOW, indicated the specific requirements:

Ser

(a)

Term

(b)

Definition

(c)

1 Contractor The NSPA contract definition shall apply.

2 Shall/Must Indicates a mandatory requirement: it is used to indicate

requirements strictly to be followed in order to conform to the

document and from which no deviation is permitted.

3 Should Indicates a recommendation: it is used to indicate that among several

possibilities one is recommended as particularly suitable, without

mentioning or excluding others, or that a certain course of action is

preferred but not necessarily required, or that (in the negative form,

'should not') a certain possibility or course of action is deprecated but

not prohibited.

4 May Indicates a non mandatory provisions: it is used to indicate a course

of action permissible within the limits of the document.

5 Can Indicates possibility and capability: it is used for statements of

possibility and capability, whether material, physical or casual.

3. GENERAL INFORMATION

3.1. This project is related to the Initial Operational Capability (IOC) for STRATEVAC

Airworthness Capability Package.

3.2. All drawings/figures/pictures shown in this SOW are illustrative only.

3.3. Required modules, equipment and other ancillary items shall be designed in order to

be used, to perform own capabilities and to be transported on board of several aircraft

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types (fixed and rotary wing) used by Italian Armed Forces as well as C-130J, S-J30

(stretch version), KC-767A, HH-101A, CH-47 and, if necessary, within other aircrafts

used by NATO/EU1 allied Countries in order to achieve interoperability applying

NATO SMART Defence concept: that means pooling and sharing of capabilities (as

well as competences and material commonality among NATO countries) in order to

coordinate efforts and overcome budgetary restrictions. Additionally, logistic

commonality within multinational coalition (NATO and EU) outside European

territories, permits to reduce logistic footprint without lack of Combat and Combat

Support capabilities.

3.4. The equipment shall be used over a wide range of geographical environments and

climatic condition where Strategic Aeromedical Evacuation (STRATEVAC),

Casualty Evacuation (CASEVAC) and Medical Evacuation (MEDEVAC) capabilities

have been deployed. The required equipment shall be designed in order to assure that

set-up operations for each module can be carried out in no more than 15 minutes by

workers with limited training ad minimum supervision. Moreover, these materials

shall be expected to perform reliable service for a minimum 5 (five) years without

loss of function at any time during exercises and operational use.

3.5. The equipment shall be capable to cover all NATO dependency levels: D1-D4. Also,

be equipped with vital signs centralised monitoring unit for patient’s management

(even in full medical configuration). Eventually, it shall be equipped with Integrated

Data Management System for medical C2 capability.

4. GENERAL REQUIREMENTS:

4.1. General Specifications:

4.1.1. In general, the supplier must be compliant with the latest issue of the laws,

standards, and regulations concerning health and safety at work, and

environmental.

4.1.2. Moreover, modules and apparatus shall be compliant with airworthiness

regulations.

4.1.3. In particular, but not exclusively, the supplier shall be compliant with the

following:

4.1.3.1. Directive 2006/42/EC on machinery

4.1.3.2. Directive ATA100-300/EASA on Airworthness specially

addressing aero-medical issues

4.1.3.3. Directive 2014/30/EU on the harmonisation of the laws relating

to electromagnetic compatibility

4.1.3.4. Directive 2014/35/EU on the harmonisation of the laws relating

to the making available on the market of electrical designed for

use within certain voltage limits

4.1.3.5. STANAG 4370 – Environmental Testing.

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4.1.3.6. AECTP-200 Vol. 3 – Environmental Conditions.

4.1.3.7. MIL-STD-416 F – Requirement for the control of electromagnetic

interference characteristics of substances and equipment.

4.1.3.8. CE marking for all items.

4.1.3.9. Legislative Decree D.Lgs 81/2008 and subsequent amendments:

Health & Safety at work.

4.1.3.10. Any other applicable laws and rules.

4.1.4. The contractor shall be responsible for the supply of any single items as

specified in this SOW, including performances of all materials used within the

contract and any factory test that may be required.

4.2. Design and Quality of Manufacturing and Material:

4.2.1. All equipment and associated technical documentation shall be fit-for-purpose

with all components separately and in concert, capable of fulfilling the

function for which the items were specified.

4.2.2. Air pallet is considered the aircraft interface and shall be based on a standard

size NATO 463L Cargo Pallets (length 88 inch. width 108 inch.).

4.2.3. Each module (D4 Pallet Module, Medical Equipment Cargo Pallet and

Medical Command and Control Unit excepted) shall be composed by:

4.2.3.1 two air pallets;

4.2.3.2 two data management system (to be connected with Medical

Command & Control Unit);

4.2.3.3 two proper modules arranged to face specific medical emergency

procedures;

4.2.3.4 two walls arranged to connect, set up and hang medical items (only

for D1 and D2 Pallet Module).

4.2.4. The rationale is to have twice the amount of equipment to use onto the same

aircraft in order to enhance medical evacuation capability or to split the stated

equipment for two separated medical evacuation mission.

4.3. Technical Requirements – Pallets Modules (PM)

4.3.1. Generalities

4.3.1.1. As stated above, the air pallet 463L is considered the interface between

aircraft and medical equipment and other items to install.

4.3.1.2. Each air pallet shall be tailored and equipped with proper rails in order to

allow the installation of the medical equipment, modules and seats (both

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for medical purpose and for standard use) in any directions (looking

forward and aft flight directions. Also toward transported patient) and

reconfigure it quickly (no more than 15 minutes) as requested by the

mission.

4.3.1.3. Each air pallet shall be capable to absorbe vibration and potential hits

during flight activity in order to avoid any technical and other

mulfunction affecting equipment onto installed.

4.3.1.4. Technical Specification

The D1PM (D1 Pallet Module) is devised to be set up as a mobile

intensive care unit in order to achieve any medical treatment, included

DCR (Damage Control Resuscitation).

The D1PM shall be composed, in addition to the Medical Equipment

listed at para 17.1 and subsequent Annexes, by:

- two Pallet Modules (PM);

- two Mobile Intensive Care Units (MICU- see below 4.3.1.4.1);

- two Standard NATO Stretchers (Annex 1);

- two Stretchers type Striker M1 (Annex 2);

- two medical walls (see above 4.2.3.4);

- two infant transportation equipments (Annex 3);

- two ISOPM (Isolation Pallet Module);

- two Medical Racks connected to pallet rails, used to store additional

medical equipment, single-use medical devices, or diagnostics

apparatus.

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- two IV (intravenous) fluids holders

- two Oxygen supplies;

- Eight Uninterruptible Power Supply (UPS) – Batteries and power

management systems to guarantee constant electricity to devices;

- two kits of Intensive Care Unit (ICU) Surgical tools;

- two kits of Intensive Care Unit (ICU) Medical equipment;

- two independent Lighting System;

- two Data Management System (DMS) connected to the MedIC;

- six seats for medical personnel (usable in fixed and swivel mode);

- anti vibration system applied in each air pallet;

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4.3.1.4.1 The above mentioned MICU shall be a fully stand-alone platform

capable to host, connect and to power other equipment, apparatus,

and other items (interface included). The frame shall be capable to

support the maximum load allowance and all equipment shall be

fastened to this frame. The frame shall support a connected medical

wall, capable to follow patient during medical evacuation and any

transfer. The MICU shall satisfy following requirements due to

specific dimensions of the 463L air pallet and NATO stretchers:

- Height 600-650 mm

- Width 650 mm

- Length 2000 mm

- Tare between 160 kg and 170 kg

4.3.1.4.2 The MICU frame shall be equipped with removable and reclosable

wheels for ground transportation, when no additional means of

transportation are available. When not in use, the MICU shall be

stored by creating a stack.

4.3.1.4.2 The above mentioned wall (see above 4.2.3.4) shall satisfy following

requirements :

- Height 1200 mm

- Width 100 mm or fit to hang medical items

- Length 2000 mm

4.3.1.4.3 The Medical Rack shall satisfy following requirements:

- Height 900 mm

- Width 450 mm

- Length 650 mm

- Tare between 50 kg and 80 kg

The Medical Rack shall be easy to handle, as detailed for the

MICU, easy to disconnect from the air pallet, carried independently

on wheels, follow on the patient if necessary.

The ISOPM shall allow a bio-containment capability through

certified biohazard isolation unit (NSN 6515-15-015-2237 P/N

47432) already in use within ITA Air Force. The ISOPM shall

be fully equipped with the underneath list of PPEs (Personal

Protection Equipment) in order to provide maximum protection

and operational safety for both contaminated person and items

and operational team (medics and healthcare assistants):

100 Suite, yellow color, type Tychem C standard CH45;

substrate in Tyvek, size M, L, XL; PPE category III Type

3B/4,/576; high personal protection against chemical and

biological agents;

100 Suite, white color, type 08292 ISSA CHEM PLUS,

susbstrate in polypropylene+polyethylene, microporus film type

4/5/6 coverall with hood, size M, L, XL; PPE category III;

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400 Overboots, white color, type Tyvek P080, substrate Tyvek,

high 48 cm, length 42 cm, universal size;

100 Safety Goggles type NANTES, polycarbonate lens,

antiscrab, anticrash, antifog coating, PVC frae, adjustable strap

in rubber latex, unique size, PPE category III;

400 protection ears insert type Puro-fit 7700 with cord, pocket

pack, 100% PVC free;

200 FFP3 masks type 3000 with Ventex valve;;

2000 High resistance/high protection powder free latex

disposable gloves, blue color, sizes M, L, XL, PPE category III,

100% natural rubber latex, length 300 mm, thickness 13

millimteres, width 110-120 millimeters, tensile strength (Mpa)

Min 16,0, elongation % Min 500;

2000 High resistance/high protection nitrile disposable gloves,

blue color, sizes M, L, XL, PPE category III, length 300 mm,

thickness 12 millimteres, tensile strength (Mpa) Min 16,0,

elongation % Min 500;

Moreover shall be usable within the aircrafts (Fixed Wing and

Rotary Wing) mentioned in para 3 and guarantee full

interopearability and own bio-containment capability throughout

transfer with vehicles & ambulance during road movement.

4.3.1.4.4 The ISOPM shall have ability to be converted to achieve a full capacity

to transport a patient affected by radiation, highly burnt and or

chemical disease. Therefore, bio-hazard isolation unit shall satify

following requirements:

4.3.1.4.4.1 Perfectly equivalent and interchangeable with military NATO

standard stretcher. Therefore, it shall be composed by:

4.3.1.4.4.1.1 a chamber in CBRN resistant PVC with frame, air intake

and lock for filter connection, with proper bag (NSN

6515-15- 015-2237) already in use within NATO Armed

Forces;

4.3.1.4.4.1.2 Filter, air chemical (NSN 4240-15-012-7235);

4.3.1.4.4.1.3 Plenum, tent (blower) with hose for connection (NSN

8340- 15-012-7233).

4.3.1.4.4.1.4 Perfectly equivalent to Aircraft Transit Isolator (ATI)

(NSN 6530-15- 011-6032) Type and Stretcher Transit

Isolator System (STI) (NSN 6530-15-011-6400) Type,

with removable, roll in litter, already in use within ITA

Air Force

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4.3.1.4.5 The infant transportation equipment shall allow a neonatal transport.

Therefore, the equipment shall satify following requirements:

4.3.1.4.5.1 Restraint system certified for infant air transportation;

4.3.1.4.5.2 CS25 crashworthiness;

4.3.1.4.5.3 Medical cleaning compatibility;

4.3.1.4.5.4 Ergonomically compatible with pediatric environment.

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4.4 Technical Requirements – D2 Pallet Module (D2PM)

4.4.1. The D2PM is intended for patients with a lower dependency, less than code D1,

but needed continued care and treatment, included emergency interventions during the

flight. The frame shall be the same intended for D1 Module. D2PM shall be equipped

with same D1-MICU main components and features but scalable according to

patient’s dependency.

4.4.2 If necessary, two D2PM shall be installed onto the same air pallet, mounted side

by side in order to allow easy operation and management of two patients at the same

time by medical personnel.

4.4.3 . The frame shall support a connected medical wall, that be capable to follow

patient during medical evacuation and any transfer.

4.4.3.1 The D2PM shall be composed, in addition to the Medical Equipment listed

at para 17.2 and subsequent Annexes, by:

4.4.3.1.1 two Pallet Modules (PM);

4.4.3.1.2 two Mobile Intensive Care Unit (MICU) - main component;

4.4.3.1.3 two Standard NATO Stretchers;

4.4.3.1.4 two Stretchers type Striker M1;

4.4.3.1.5 two medical walls;

4.4.3.1.6 two Medical Racks;

4.4.3.1.7 two IV (intravenous) fluids holder;

4.4.3.1.8 two Oxygen supplies;

4.4.3.1.9 Eight Uninterruptible Power Supply (UPS) – Batteries and power

management systems to guarantee constant electricity to devices;

4.4.3.1.10 two kits of Intensive Care Unit (ICU) Surgical tools;

4.4.3.1.11 two kits of Intensive Care Unit (ICU) Medical equipment;

4.4.3.1.12 two independent Lighting System;

4.4.3.1.13 two Data Management System (DMS) connected to the MedIC;

4.4.3.1.14 six seats for medical personnel (usable in fixed and swivel mode);

4.4.3.1.15 anti vibration system applied in each air pallet;

4.4.3.2 The Module shall satisfy following requirements:

4.4.3.2.1 Height 600-650 mm

4.4.3.2.2 Width 650 mm

4.4.3.2.3 Length 2000 mm

4.4.3.2.4 . Tare between 160 kg and 170 kg

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4.5.1 The D3PM is intended for patients’ transportation on the stretchers. Each D3PM

module shall have six fixing point, capable to carry up to three stretchers on each side.

4.5.1.1. The D3PM shall be composed, in addition to the Medical Equipment listed

at para 17.3 and subsequent Annexes, by:

4.5.1.1.1. two Pallet Modules (PM);

4.5.1.1.2 twelve of Standard NATO Stretcher;

4.5.1.1.3 two Oxygen supply;

4.5.1.1.two storage or space compartments for trauma kit;

4.5.1.1.5 two brackets and fasteners kit for monitors, Intravenous (IV)

equipment and Oxygen supply;

4.5.1.1.6. two independent Lighting System;

4.5.1.1.7. two Data Management System (DMS) connected to the MedIC;

4.5.1.1.8. anti vibration system applied in each air pallet;

4.5.1.1.9. CS25 Crashworthiness

4.5.1.2. The module shall be capable to host two rack for streachers. Each rack shall

satisfy following requirements:

4.5.1.2.1. Height 1800 mm

4.5.1.2.2. Width 750 mm

4.5.1.2.3. Length 2200 mm

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4.5.1.2.4. Tare between 150 kg and 180 kg

4.5.1.2.5. Load capacity at least 300 kg per module


4.6.1. The D4PM is intended for patients’ transportation on the seats. Each D4PM

module shall be capable to carry up to nine seats.

4.6.1.1. The D4PM shall be composed by:

4.6.1.1.1. two Pallet Module (PM);

4.6.1.1.2. eighteen seats equipped with own oxygen (not for medical purpose)

mask and courtesy light;


4.7 Technical Requirements – Medical Equipment Cargo (MedLog) Pallet

4.7.1. The MedLog pallet is intended for medical items’ transportation and storage.

4.7.1.1. The MedLog pallet shall be composed by:

4.7.1.1.1. two Pallet Module (PM);

4.7.1.1.2. The below listed removable medical rugged containers and boxes to

use for safe transportation and storage medicines and consumables items,

medical equipment and apparatus. Each medical rugged will be thermal

insulated, reusable and fully recyclable when disposed. The thermal insulation

shall be made of internal protection made in closed cell cross-linked

polyethylene foam (Plastazote®). Made of rotational molding thermoplastic

material, to assure maximum protection from shock and vibration. Rectangular

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shape with smooth rounded corners and edges. Self-draining in the normal

upright shipping position. Dustproof and waterproof IP67 Tested and certified

in accordance with regulation for vibration, impact / drop and dry heat.

Labelled or marked with Italian Flag, Red Cross label and marked “ITAF 3rd

Wing”. Labels or markings must be durable and last for the lifetime of the

containers.

• Eight (8 ) MRC external size (950x950x890) mm. Linear dimensions

with ± 10% tolerance; internal protection made in closed cell cross-linked

polyethylene foam; at least 2 (two) handles; provisions for forklift use;


with ± 10% tolerance; internal protection made in closed cell cross-linked

polyethylene foam; at least 2 (two) handles; provisions for forklift use;


with ± 15% tolerance; at least 3 (three) drawers with anti-roll –out devices;

each drawer with mobile interior organizers, at least 2 (two) handles

4.8 Technical Requirements – Patient Monitoring Unit (PMU) Module / C2 consolle

for Medical Information (MedIC)

4.8.1. The PMU/MedIC Module is intended as a deployable Command & Control (C2)

and Information System for medical purposes to use during in-flight patients’

transportation and treatment. Each PMU / MedIC module shall be equipped with a

control panel solution, capable to be interchangeable MCCS (NSN 7021-15-000-6667)

already in use within ITA Armed Forces, in order to allow:

- remote monitoring of vital patient parameters, collected by way of the equipment

installed within above mentioned Modules;

- secure data storage in a dedicated server.

It shall permit to get the mission achievements, and patient tracking, monitoring &

analysis - allowing the flow of medical information to be viewed through highly visual

medical data representation, using user-friendly interactive exploratory interfaces, in

order to assure usability and allow data flows analysis, to automatically detect critical

situations, record significant events, create a useful log for post-intervention.

4.8.1.1. The control panel solution shall be composed by:

4.8.1.1.1. a Pallet Module (PM);

4.8.1.1.2. a graphic tablet, data entry NSN 7025-15-000-6668 (Annex 24);

4.8.1.1.3. a dedicated software (pre-loaded) NSN 7030-15-010-8870 (Annex

25);

4.8.1.1.4. a dedicated server NSN 7030-15-010-8869 (Annex 26);

4.8.1.1.5. a centralised control station;

4.8.1.1.6. three seats equipped with own courtesy light;

4.8.1.1.7. a C2 software for medical purposes, with ability to control

simultaneously several patients;

4.8.1.1.8. wireless control in according with airworthiness regulations;

4.8.1.1.9. backup and ground communication of patient data;

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4.8.1.1.10. tablet and instrument to follow patients;


4.8.1.2. The module shall satisfy following requirements:

4.8.1.2.1. Height 1300 mm

4.8.1.2.2. Width 1000 mm

4.8.1.2.3. Length 1900 mm

4.8.1.2.4. Tare between 100 kg and 120 kg (seats are not included)

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5. INTEGRATED LOGISTIC SUPPORT PACKAGE

5.1. The Contractor shall provide the Maintenance Plan indicating when planned

maintenance is required to meet operational and sustainability requirements.

Maintenance Plans shall include all preventive maintenance routines and planned

major overhauls for 10 years life cycle. Periodic inspections, time-based parts or

Petroleum Oil and Lubricant replacement, etc., are also included as preventive

maintenance routines.

5.2. The Maintenance Plan shall equally describe the Contractor’s configuration

management system, and the mechanisms the Contractor shall emply to advise the

customer of all Engineering Changes, changes in part numbers and source of

availability.

6. PACKAGING & TRANSPORTABILITY

6.1. The equipment shall be certified to be airworthy for embarkation, usage and

transportation on C-130J, C-130J-30, and KC-767A aircrafts at least. It shall be

produced proper technical documentation (eg: means of evidence of compliance) in

order to support a certification document/statement to be released by Italian Military

Airworthness Authority (namely ARMAEREO) (CDRL 001).

6.2. All the equipment must be capable of being packed and shipped in standard

containers ISO 20’ 1C with height of 8 feet 6 inches, with opening at one end, and

meet the ISO 668 specifications and on standard 463L aircraft pallets (single or

coupled).

6.3. The total weight of each container shall not exceed 7.000 kg (including container

weight, shock absorbent, and restraint equipment). The total weight of each 463L

aircraft pallet shall not exceed 4.536 kg (including air pallet weight, shock absorbent,

and restraint equipment). Thus in order to allow the transportation by aircrafts used by

ITAF and Italian Armed Forces (such as C130J, C17, C5, IL76, AN124).

6.4. Contractor shall provide a packaging plan (CDRL 002) detailing the number of

containers and 463L air pallets, their components, how the equipment shall be packed,

and overall weight.

6.5. Provision of containers and air pallets 463L for transportation means are not part

of this requirement.

6.6. The proposed equipment shall be designed in order to assure that unpacking and

re-packing operations can be carried out by workers with limited training ad minimum

supervision.

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7. SPARE PARTS AND TOOLS

7.3 The Contractor shall provide any special tools (i.e. not found in a workman’s

toolbox) required to set up, connect, maintain, and or preserve each specific

equipment. All special tools must be delivered with the related equipment.

(CDRL 003).

7.4 The Contractor shall supply one (1) package of spare parts and consumables per

each supplied system. Each package shall be composed of spare parts and

consumables recommended for first and second level field maintenance and

repair, in support to a period of 365 days continuous operation. (CDRL 004).

8. TRAINING

8.1. The Contractor shall develop a training plan for the military personnel who will

operate and maintain all the equipment. The train-the-trainer principle shall apply.

The customer shall identify the training audiance in accordance with the set of

skills defined by the contractor.

8.2. The training course shall be performed at ITAF 3rd Wing (Villafranca di Verona),

Italy.

8.3. The training course and training documentation (syllabus, lesson plan and other

documentation) shall be provided in the Italian language. The resources and

support required on site shall be identified in the training package (e.g. power

supply, space, room, handling equipment, safety equipment and so forth).

8.4 The syllabi shall be delivered to the Customer POC not later than one month prior

to the training date. (CDRL 005).

8.5 The training session shall be arranged for a maximum of 20 ITAF personnel,

divided in two or three teams. The equipment provided (air pallet included) can be

used for certain aspects of the training. However, for maintenance training

requiring the removal and or dismantling of parts, the supplier shall provide the

appropriate support. At the end of the trainign, the contractor shal restore the

equipment and site, including all consumables and spares, to the initial state.

8.6 At the end of the training session, the contactor shall deliver a proficiency

certificate to each participant who was trained in the operation of the equipment.

9. DOCUMENTATION (CDRL 006)

9.1. The Contractor shall supply all required documentation in paper (one copy) and

electronic support (three copies), in PDF or MS Office. The Documentation shall

be submitted to NSPA for review prior to the equipment’ commissioning and

acceptance.

9.2. The User manual and other documentation useful for workers shall be in Italian

language.

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9.3. The documentation set shall include the following as a minimum:

9.3.1. Use, maintenance (1st level, if applicable), assembly and disassembly

procedures;

9.3.2. Safety devices list, position, inspection / re-certification requirements;

9.3.3. Packaging plan;

9.3.4. Optimal Storage conditions;

9.3.5. Training course syllabus and schedule.

9.4. Operational and Maintenance Manuals (O&M) that detail the following at a

minimum:

9.4.1. All information about setup, use, and 1st level (if applicable)

maintenance intervention.

9.4.2. An illustrated catalogue with exploded views together with primary

references of sub units.

9.4.3. Periodic and annual maintenance.

9.5. Tools and Spare parts list shall include the following at a minimum:

9.5.1. Exact description.

9.5.2. Identification block (reference primary article and company code).

9.5.3. kit of tools and spare parts, and if applicable related NSN.

9.5.4. Minimum required quantity.

9.5.5. Page number and corresponding markings on the table composition

shown in the technical documentation.

10. LABELING AND CODIFICATION

10.1. The major equipment assembly1 and the main items shall be provided with a

NATO Stock Number (NSN).

10.2. All labels can be external or embedded into the material. Labels on all

equipment must be durable and last for the lifetime of the equipment. (CDRL

007)

10.3. The labels shall be written in Italian.

10.4. The Contractor shall provide a label or marking sample for approval by NSPA

and the customer prior to manufacturing and after Contract Award. (CDRL 008)

11. QUALITY ASSURANCE

11.1. Quality shall be compliant with the requirements of ISO 9001 series.

1 Major Equipment Assembly – Component or end item comprising of a number of parts of subassemblies put

together to perform a specific function, and capable of disassembly without destruction.

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11.2. The Contractor shall submit a Contractor’s Quality Management System Plan

to NSPA for approval in accordance with ISO 9001 or equivalent. All production

methods shall be carried out in accordance with the approved quality assurance

system. (CDRL 009)

12. TERMS OF DELIVERY

12.1 The items shall be delivered to ITAF 3rd Wing (Villafranca di Verona), Italy.

12.3 For security access to the facility, the Contractor shall provide the names and

necessary information of their personnel who will be tasked to carry out the assembly

and the training. This information shall be passed to the selected POC’s (cc NSPA) no

later than four weeks prior to the delivery and training dates. (CDRL 010)

12.4 Delivery will be considered completed only after all required documentation

have been submitted, all equipment are delivered, installed, functionally tested and

accepted, and ready to use on site, and training has been completed.

13. ENVIRONMENTAL PROTECTION

13.1 The Contractor must take all reasonable and practical measures to protect the

public and his own employees against accidents, and to safeguard the environment and

apply the best practices available in that field.

13.2 The Contractor shall maintain and make available upon request by the NSPA:

13.2.1 A copy of his environmental management system policy.

13.1.1 Licenses and permits issued by the relevant authorizing authorities.

13.2 In the provision of the services and products that are subject to this SOW, the

Contractor shall ensure compliance with, as a minimum, the following legal

requirements:

13.2.1 European Union (or equivalent from a non-EU NATO country)

environmental protection regulations and the national implementation

references (i.e. law, regulation) pursuant to the EU Directives;

13.2.2 Host Nations national, regional and local environmental laws and

regulations, where applicable;

13.2.3 NATO STANAG 7141, where applicable.

13.3 The contractor shall fulfil all the regulatory compliance obligations and the

environmental protection requirements indicated above and supply an

''Environment Protection Declaration of Conformity' showing compliance to the

requirements and applicable laws and directives.

13.4 The design shall consider the environmental impact of the equipment during its

life cycle and disposal and the documentation shall provide the appropriate

recommendations to the user.

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14 PROJECT MANAGEMENT

14.1 Upon contract award, the Contractor shall provide to NSPA the details for the

Project Manager who will be appointed to act as the primary point of contact for

all project activities for the duration of the contract. (CDRL 011)

14.2 At their own expense, the Contractor shall participate, if so required by NSPA,

in meetings that may be held at the Contractor’s facilities or at a sub-

Contractor’s facilities, at the NSPA or at the customer’s facilities. However,

telephone, email, and video conferencing, if available, will be maximized.

15 COMMISSIONING & ACCEPTANCE TESTING

15.1 Upon final delivery, a Commissioning & Acceptance Testing (C&AT) shall be

conducted by the Italian Military authorities (Customer and or End-User) and

NSPA representative. This test is to ensure that the equipment complies with the

requirements detailed in this SOW and is to be carried out as follows:

15.1.1 The Contractor shall provide a detailed Commissioning & Acceptance

Testing Plan (C&ATP), and submit it to NSPA for review and

approval. (CDRL 012)

15.1.2 The Acceptance Test will be performed by a Technical Evaluation

Team (TET) appointed by the Italian Military authorities with the

participation of NSPA technical representatives.

15.1.3 The Contractor shall provide full technical assistance, equipment and

materials necessary to perform the Acceptance Test in accordance with

the approved AT&P.

15.1.4 In case the testing result in rejection of the equipment due to objective

non-compliance with the contractual requirements and specifications,

the Contractor shall present to NSPA a remediation plan within 15 days

for approval, along a timescale for executing the remediation activities.

Upon approval from NSPA, the implementation of the approved

recovery actions shall be performed according to the timescale therin

indicated and the equipment shall be presented for a new acceptance

test upon completion.

15.1.5 The Contractor shall issue a duly signed Certificate of Conformity

(CoC), to certify that the deliverables conform to the requirements of

the Contract. The CoC shall be presented to the Italian Military

authorities. (CDRL 013)

16 CDRL TABLE

16.1 The Contractor shall produce and deliver all data and documentation and within

the required delivery period as listed in the below Contract Data Requirements

List (CDRL). Documents shall be produced in accordance with the related

SOW task as noted in the CDRL and the related SOW task description. All

technical documents shall be in Italian, while progress reports to and

communication with NSPA shall be in English, unless otherwise stated in the

CDRL or related SOW task description.

16.2 All delivered data and documentation shall include reference to the applicable

CDRL No. and Title.

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16.3 The documentation shall be in paper and electronic support (CD/DVD), in PDF

or OFFICE 2013.

CDRL

No.

Title SOW Ref. Language Required Delivery

001

: Certificate or Statement for

embarkation, usage and

transportation on C-130J, C-

130J-30, and KC-767A

aircrafts at least.

6.1

Italian

and

English

Include a copy with the technical

documentation package

002 Packaging Plan 6.4 English Final version due NLT 30 days before

C&AT

003 Tools List 7.1 Italian Include a copy with the technical


004 Spare Parts & Consumables 7.2 Italian Include a copy with the technical


005 Training course syllabus 8.4 Italian NLT 30 days prior to C&AT

006 Technical Documentation 9 Italian &

English NLT 30 days prior to C&AT

007 Labelling system 10.2 Italian &

English

Include a copy with the technical


008 Packaging Labelling Sample 10.5 Italian &

English

Before manufacturing and after CA

009 Quality Management Plan 11.1 English Final version due NLT 2 weeks after CA

010 List of Contractor Personnel

on-site 12.3

Italian &

English

Information shall be passed to the selected

customer POC’s (cc NSPA) NLT 30 days

prior to C&AT

011

Project Manager Details

14.1 English 2 weeks after CA

012 C&AT Plan & Procedures 15.1.1 English NLT 30 days prior to C&AT

013 Certificate of Conformity 15.1.5 English &

Italian At time of delivery

CA = contract award

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17. DELIVERABLES

The Contractor shall provide the deliverables listed at table shown below in accordance

with the requirements described in this SOW:

Item Designation Quantity Year 1 Quantity Year 2 Reference

1 D1 Pallet Module (D1PM) 1 1 para 4.3.1.4;

para 17.1

2 D2 Pallet Module (D2PM) 1 1 para 4.4;

para 17.2


para 17.3


para 17.4

5 Medical Equipment Cargo

(MedLog) Pallet

1 1 para 4.7

6 Patient Monitoring Unit

(PMU)/C2 Consolle

1 1 para 4.8;

para 17.5

7 Integrated Logistic Support

Package

1 1

8 SpareParts/Consumables

Package

1 1

9 Training Course 1 (x20 ITAF

personnel in 2/3

shift)

///

10 Documentation package 1 1

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17.1 D1PM MEDICAL EQUIPMENT LIST

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17.4 D4PM

D4PM module shall be capable to carry up to nine seats. The D4PM shall be composed by:

- two Pallet Module (PM);

- eighteen seats equipped with own oxygen (not for medical purpose) mask and courtesy light;

- anti vibration system applied in each air pallet;

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17.5 PMU/MEDICAL EQUIPMENT LIST

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ANNEX 1

STRETCHERS, NATO TYPE

Lightweight, sturdy, compact litters, for mass casualty response, with the following minimum

technical specifications:

Foldable aluminum stretchers

Four aluminum foots equipped with non‐slip rubbers

Made of vinyl coated nylon

Waterproof,

Tear resistant,

Washable and easy to decontaminate

Four handles with rubber grip

Two quick release belts minimum

Color: NATO green or Black-.

Fulfilling all the requirements (length, width, height, ecce cc) listed in STANAG 2040 and

3204.

Applicable Reference standards

STANAG 2040 Ed. 7 and AMedP-2.1 Ed. A Version 1;

STANAG 3204 Ed. 8 and AAMedP-1-1- Ed. A Version. 1.

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ANNEX 2

STRETCHERS, TYPE STRYKER M1

Compact litters, for one person operation ans removable litter, to be compliant with the

following minimum technical requirements where applicable:

Head-end steer lock system;

Seven height positions

Foot-end wheel locks

Shock and knee gatch positioning;

Integrated bumper system;

Light-weight, rugged, aluminium construction;

One four-point shoulder hamess restraint;

Two lap-belt restraints:

Lengt: 1970 mm (+/- 2%); Width: 560 mm (+/- 2%); Weight: 33 kg (+7- 25);

Maximum weigh capacity: 220 kg or more;

Premium sealed bolster mattres antimicrobial;

Head extension pillow;

Removable Knee gatch litter:

o Backrest: 0 – 75°;

o Shock position: +17°;

o Knee gatch: 30°.

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ANNEX 3

INFANT TRANSPORTATION EQUIPMENT

Following minimum requirements have to be fulfilled:

stable thermoregulation to protect the baby against sudden thermal changes during

transport

ventilation system working in tandem with an integrated and active humidification system

optional flexible ventilation solutions’ support, including infusion 2 or 4 of infusion pumps

stacked with mounting rack

for longer transports

certified for all types of transport – helicopters, fixed-wing aircraft, and ambulances

integrated dampener system to lessen the impact of vibration on the baby during transport

simplified logistics with instruments placed at fingertips for quick and easy adjustments,

system needed to create an environment where the infant can thrive. and the mattress

provides consistent warmth to all parts of the body

Applicable Reference standards

IEC 60601-1:2005 / EN 60601-1:2006 / AC 2010 Medical Electrical Equipment Part 1:

General Requirements for Basic Safety and Essential Perfomance

IEC 60601-1-2:2007 / EN 60601-1-2:2007 Medical Electrical Equipment Part 1-2: General

Requirements for Basic Safety and Essential Perfomance

Collateral Standard: Electromagnetic Compatibility ‒ Requirements and Tests ‒ IEC

60601-1-6:2010 / EN 60601-1-6:2010

Medical Electrical Equipment Part 1-6: General Requirements for Basic Safety and

Essential Performance Collateral Standard: Usability

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ANNEX 4

AED DEFIBRILLATOR

The item must be compliant with the minimum technical requirements, where applicable:

Biphasic, rectangular waveform, full impedance compensation

AED protocol according to the current ERC/AHA guidelines

Transport within the hospital, during medical examinations (e.g. CT) and in the ICU

12-lead ECG with measurement, interpretation support and large printer for reliable

diagnosis

Internal shock spoons in three different sizes 46.6 cm2, 18.25 cm2, 11 cm2

Operation at temperatures ranging from -20 °C to +55 °C (basic functions: ECG

monitoring, defibrillation)

Use in conjunction with night vision goggles possible (NVG mode)

Monitoring unit:

8.4’’ colour display, transflective, backlit• 6 traces/13 vital parameters

All-around impact protection

Printer: paper width 106 mm, paper length 22 m • Weight: 2.7 kg

Patient box:

CorPatch CPR feedback sensor

12 lead diagnostic ECG, HR, BR, NIBP, CO2, 4xIBP, 2xTEMP, SpO2, PP, PI, SpCO,

SpMet, SpHb

Li-Ion Battery (3 batteries, identical in construction)

Power supply 12 V DC, 100 - 250 V AC with mains adapter

Acoustic alarm; microphone for voice recording

High Dust and splash-proof (IP55)

Vibration- and shockproofed according to DIN EN 1789

Intuitive and safe operation for extensive monitoring, diagnosis and therapy

Uninterrupted monitoring of critical patients

Accessory bag for cables and sensors

Weight: 1 - 1.3 kg (without accessories)

Applicable reference standards:

MIL STD 810 G (US military standard)

RTCA DO 160 G (Airborne Equipment)

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ANNEX 5

SUCTION UNIT

A portable, powerful and highly reliable suction unit, designed for optimal preparation in

emergency situations.


High flow / High vacuum

Air Flow: >25 LPM (free flow)

Vacuum - Max.: 500+ mmHg (67 kPA)

Vacuum - Range: 80 - 500+ mmHg (11 - 67 kPa)

Battery run time: Approximately 45 minutes (free flow)

Feature

One-hand-grip design

3 canister options

Easy to convert between the canister systems

High efficiency filter kit

HEPA rated bacterial filter

Does not contain latex

Big vacuum regulator dial

LED display for use day or night

TEST - Device Diagnostics program

Children vacuum range area (marked in blue) on the control panel

No-tools-necessary field changeable battery

Rechargeable Battery, NiMH, 12 VDC 2 Ah

External Battery Charger

12V DC Power-cord for connection to vehicle connection

5 year limited warranty (excluding the canisters, tubing systems and battery. Battery = 90

days)

Noise level: 46 - 56 dBA (80 - 500 mmHg)

Dimensions / weight

31.5 cm x 33 cm x 16 cm (12.4" x 13" x 6.3")

Weight: 4 kg (8.9 lbs)

Canister capacity: 1000 ml and 1200 ml

Power supply 12VDC and 110-220 VAC 50/60 Hz

Rechargeable Battery powered with 45 minutes autonomy

Plastic transport case: shockproof.

Fire-resistant, airtight, air-pressure regulation valve, external pressure gauge

Reusable jar (minimum 1000 cc) for secretions collection.


CE marked - This product is in compliance with the essential requirements of Council

Directive 93/42/EEC Medical Device Directive, as amended by Council Directive

2007/47/EC, class IIa

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ANNEX 6

ADVANCED VENTILATION MACHINE

An emergency ventilator covering a broad range of uses, including intensive care transport

and contaminated transport too.

Following minimum technical specifications:

Dimensions (W x H x D in mm) 345 x 163 x 149

Weight about 4.4 kg/4.6 kg (with CO2 option)

Operation

Temperature: -18° C to +50° C

Humidity: 15% to 95% without condensation

Air pressure: 54 kPa to 110 kPa Monitoring

Expiratory volume and flow measurement with hot wire transit time method (BiCheck)

Airway pressure

Inspiratory O2 concentration by means of non-consuming O2 sensor

Gas supply 2.7 to 6 bar, ideal at 4.5 bar with 145 l/min Gas types Medical-grade oxygen,

medical grade compressed air (AIR), concentrator oxygen (93% O2)

Power supply

Removable battery, external or internal charging

Device power supply 12 to 15 volts DC

Voltage for external power pack 100-240 V AC, 50/60 Hz

Product class according to Directive 93/42/EEC IIb Emergency ventilation modes •

Emergency ventilation modes

Emergency ventilation, infants (IPPV or BiLevel can be pre-configured)

Emergency ventilation, child (IPPV or BiLevel can be pre-configured)

Emergency ventilation, adult (IPPV or BiLevel can be pre-configured)


Major standards used ISO 10651-3, EN 794-3, EN 1789, RTCA-DO 160 E, EN 60601-1

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ANNEX 7

INFUSION PUMP

Two- ways infusions pump with the following minimum features:

Volumetric function

Continue infusion with separate program for each ways

Programmable and adjustable infusion speed from 0.01-1800 ml/h

Accuracy << ± 0,5 % ± 2 % according to IEC/EN 60601-2-24;

Power supply: external (with internal battery to provide an) infusion speed not less than

125ml/h

Display LCD touch screen to control and view the major parameters from all angles.

Weight not more than 1.4 kg;

Capability of sequential infusions

Free software update during the warranty period.

Self test

Alarms for: obstructions, malfunctions, end of infusion, air in the infusions, low battery.

Manual instructions (Italian and English language)


Council Directive 93/42/EEC, as amended by Directive 2007/47/CE.

Medical electrical equipment ‐ Part 1: General requirements for safety IEC 60601‐1:1988,

General requirements for basic safety and essential performance IEC 60601‐1:2005

IEC 60601‐1‐1: 2000 Medical electrical equipment: General Requirements for Safety,

IEC 60601‐1‐2: 2007 General requirements for safety and electromagnetic compatibility

IEC 60601‐1‐4:2000 Requirements for Standard Programmable electrical medical equipment

side;

IEC 60601‐2‐24: 1998: 1999 Safety of infusion pumps.

UL 60601‐1: 2006 UL Standard for medical equipment safety, Part 1: general

Requirements for Safety; Medical electrical equipment ‐

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ANNEX 8

VOLUMETRIC PUMP

Volumetric infusion pump for use in anesthesia and intensive care medicine, with following

requirements:

Direct input or automatic calculation of the delivery rates (volume over time)

Large display to provide the most important parameters at one glance

Ergonomic user interface for easy adjustments

Broad performance spectrum

Dose rate mode: Offers the automatic calculation of the delivery rate in ml/h based on the

entry of drug concentration in conjunction with the desired dose rate (e.g.: ml/kg/min)

Piggyback mode

Standby function

Compatible with the B. Braun fm system

Safety features

Flow clamp prevents "free flow" when the pump door is opened

Air detector minimizes the risk of air infusion

Adjustable pressure limits result in shorter time to alarm in the event of an occlusion

Visual and acoustic alarms

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ANNEX 9

OXYGEN CONCENTRATOR

High pressure and maximum flow concentrator, to be used with venti masks, and medication

nebulization with oxygen, in acute care environments.


enables two patients to use just one concentrator simultaneously for a maximum total

combined flow of 10 LPM

pediatric/low flow block available for this dual flow version of the product.

20 psig (138 kPa)

2-9 LPM 92% 3% 10 LPM 90% 3%

Outlet pressure 20 psig (138 kPa)

Power120 VAC, 60Hz, 4.0 Amps 220-240 VAC, 50 Hz, 2.0 Amps

Consumption 590 Watts

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ANNEX 10

PATIENT WARMING SYSTEM

High warming performance to provide the patient a soft and comfortable environment.

Minimum requirements include:

Materials used for heat isolation

Can reach 37o C within 7-10 minutes

Sealed and water proofed against all liquids

Lightweight and work silently with digital LCD and LED displays to adjust/view set and

measured temperature values.

Battery life for transport models is around 3-4 hrs. Full charging period around 4 hrs

Operate on low voltage requirements (12 Volts DC – 24 Volts AC/DC) which is cost

efficient and technically safe for patients and operators.

Once the temperature reaches the set value, heating process automatically stopped.

Allow for X-RAYS

Reference standards:

EN60601-1 Class llb Type BF

EN60601-1-2 Electrical Safety Requirements for medical devices

93/42/EEC Medical Device Directive

73/23/EEC Low Voltage Directive

EN60601-2-35 Medical Electrical Equipment

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ANNEX 11

BLOOD WARMING SYSTEM

Fluid warming system to rapidly and automatically warm blood, blood products and IV

solutions up to 40 °C, helping prevent hypothermia.


Warming fluids capacity with accuracy, mobility and speed,

Help providers deliver higher-quality care to more patients.

remains in-line for continuous patient warming, across the care continuum.

Composed of: Warmer; Controller; Disposable cartridge

Performance detail

Disposable cartridge priming volume 4 mL

Disposable cartridge sterility Gamma sterilized

Fluid temperature output 40 °C±2 °C

Flow rate range KVO to 200 mL/min

Temperature set point 40 °C

Operating temperature -5 °C to 50 °C

Storage temperature -30 °C to 70 °C


EN 60601-1:2006/AC:2010 (3rd edition),

EN 60601-1-6:2008,

EN 60601-1-8:2007

EN 62304:2006

UL 60601-1:2005 R6.03

CAN/CSA-C22.2 No. 60601.1:2008

IEC 60601-1-6:2010

AAMI ES60601-1:2005

IEC 60601-1-4:2000 (Canada) Electromagnetic emissions EN 60601-1-2:2007 CISPR11

group 1 class A Electromagnetic immunity IEC61000-4-3 level 3

10 V/M Magnetic field immunity IEC61000-4-8level 2

3 A/M Electrostatic discharge IEC61000-4-2 level 4, 8 kV contact, 15 kV air

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ANNEX 12

LED SCIALYTIC LAMP

To guarantee perfect perception of the illuminated area;


Accordance with 93/42/EEC Class I - EN 60601 ed. 3 Class I

Light beam dimension Two adjustments: 18 and 30 cm (diameter)

Power 25 W

Light intensity at 100 cm

Five adjustments available: min 6,000 - max 60,000 lx

CRI (Ra) 90

LEDs 18

Colour temperature: Three adjustments available: 3.800K, 4.300K, 5.000K

Life cycle ÷50.000 hours

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ANNEX 13

PORTABLE REFRIGERATOR

Portable refrigerator/freezer, suitable for use on board of aircraft, vehicles and ambulances,

and in field structure, with the following minimum features:

a) External structure made of single-piece polyethylene, non‐toxic, fire‐proof, dust‐resistant,

resistant to impact and atmospheric agents;

b) Internal structure made of polyethylene with rounded corners for easy cleaning;

c) Hinged Insulated lid with perimetric gasket and locking device

d) Internal basket for containment in plastic coated galvanized wire;

e) polyurethane insulation foam,with thickness not less than 50 mm.

f) static type refrigeration;

g) Noise Less than 43 dB

h) R134a refrigerant gas; CFC –free

i) Temperature range +10 ° ( ‐20 ° C, +10 °)

j) Power supply: 110-230 Volts 50760 Hz and 12 / 24 VDC

k) Capacity between 60 and 80 liters

l) Internal lighting with automatic activation at every lid opening

m) Monitor control panel with LCD display for:

temperature monitoring by digital electronic thermostat

temperature adjustment

audible and visual alarm;

error warning lamp

insufficient supplied power

temperature recorder


EC directives no. 73/23/EEC, 89/336/EEC;

IEC 66-5 Safety requirements for electrical equipment for measurement, control and

laboratory use Part 1: General requirements

IEC 62‐5 electrical equipment, Part 1: General requirements for basic safety and essential

performance

Directive 2006/95/EC of the European Parliament and the Council of 12 December 2006,

"on the approximation of the laws of the Member States relating to electrical equipment

designed for use within certain voltage limits

Directive 89/336/EEC on the approximation of the laws of the Member States relating to

electromagnetic compatibility, integrated with the changes made by Directive 93/95 and

Directive 93/68.

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ANNEX 14

PORTABLE ULTRASOUND MACHINE

A highly portable ultrasound machine to allow for an ultrasound exam or procedure while

simultaneously accessing patient records, storing exams, submitting reports and consulting

with remote providers for near real-time diagnoses.

Minimum features:

One-handed, thumb-operated user interface-

Highly portable at 1.1 lbs/520 g- 64 GB of memory, storing over 1000 studies

Rechargeable swappable battery with one hour of continuous scanning

Image optimization controls-

Measurements and calculation packages 7"/17.8 cm 1920 x 1200 pixels high-resolution

display - for Cardiac and OB- 2D, M-Mode, Color Doppler and THI, with multiple

optimization settings

Access patient information from PMU

Rechargeable swappable Lithium-Polymer battery - 8 hrs standby with 1 hr scanning

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ANNEX 15

CLINICAL CHEMICAL ANALYSER

Portable compact, and automated clinical chemistry analyser designed to perform routine

multi-chemistry panels using 0.1cc of whole blood, serum or plasma.

Minimum features:

Self calibrates with every test run - no manual data entry

Full-color touch screen with intuitive user interface

Results are printed on a self-adhesive hard copy or via electronic transfer, allowing

immediate access to critical information at the point-of-care

Large memory capacity stores up to 5000 patient records

Externally accessible bi-directional USB data transfer technology facilitates EMR

connectivity

Centrifugal action mixes the reagents and sample in a disposable self-contained disc –

reducing procedural errors

Accuracy and precision comparable to larger, more expensive laboratory analyzers

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ANNEX 16

EMERGENCY BLOOD ANALYSER

A blood analysis system to provide operators with the information they need to rapidly make

treatment decisions, which may lead to enhanced quality of care and improved system

efficiency.

Minimum features:

Acid-base, blood gas, electrolyte, chemistry, and hematology testing with one platform

Small sample size - 95 μL or less

Speed: most results in 2 minutes

Accurate and reliable

Comprehensive internal quality control

Low maintenance

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ANNEX 17

OXYGEN (GASEOUS) BOTTLES 10 LITERS

Medical oxygen cylinders for steel complete with an integrated valve, pressure regulator and

metering. It allows the opening and closing pressure than the supply, by connecting a hose

connection, and control the flow of oxygen output, adjustable from 0 to 12 L/min.

Reference standards: T‐PEDCE0123 Directive 99/36/EC, Directive 93/42/EEC Class IIb 83,922 RDM

/ R DM CNDZ120309 February 20, 2007, Decree of February 20, 2007

Reference standards EN 10524‐3:2005 production techniques; EN 1089‐3 : 2004 transportable gas

cylinders ‐ Gas cylinder identification (excluding LPG) ‐ Part 3: Colour coding; EN ISO 10524‐1:2006

Pressure regulators for use with medical gases ‐ Part 1: pressure regulators and reducers pressure flow

meter (ISO 10524‐1:2006) EN ISO 10524‐3:2006 pressure regulators for use with medical gases ‐ Part

3: Pressure built‐in cylinder valves (ISO 10524‐3:2005) ; EN ISO 10524‐4:2008 pressure regulators

for use with medical gases ‐ Part 4: low‐pressure regulators (ISO 10524‐4:2008).

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ANNEX 18

DISPOSABLE MEDICAL SUPPLY – D1PM

Disposable medical supply amount (boxes) - Blades can 2

- Biologic waste can 2

- Disposable Stretcher sheet 2

- Isothermal blanket 30

- Size adult AMBU balloon w reservoire/antibacteric filter 1

- Defibrillator pad (adult/child) each 4

- Cervical spine splint different sizes ( each) 2

- Clorexidine disinfectant 2

- Betadine disinfectant 2

- Non sterile examination nitrile gloves size. M (box) 2

- Non sterile examination nitrile gloves size. L (box) 2

- Surgical sterile gloves (box)sizes. 7,0; 7,5; 8,0; 8,5 (each) 10

- Aemostatic tourniquet (hipoallergenic) 5

- Venous cathether sizes. 14G; 16G; 18G; 20G; 22G(each) 30

- Venous cathether medication (box) 1

- Sterile gauze box size 10x10; 20x20 cm (each) 3

- Intra osseous needle kit (adult/child) each 3

- Venous 3 ways tap(box) 1

- I.V.(Intra venous) administration set 10

- Photosensitive drug I.V. administration set 10

- Canvas and paper plaster (each) 4

- Ringer lattate/ Saline/ balanced/ voluven 500 ml ( each) 10

- Intra venous fluids squeeze bag 2

- Abdominal Tourniquet 5

- C.A.T. (combat applied tourniquet) 20

- Syringe size. 2,5; 5; 10; 20;60 ml ( box each) 1

- Hemogas analysis Syringe (box) 1

- Seldinger Arterial catether radial/femoral artery (box each) 1

- Central venous Catether (double lumen) size 18 G 5

- Invasive Blood pressure measure kit + transducer 5

- I.V. fluid warmer kit (enFlow)/extension cord box. (care Fusion) 1

- Needles 18 G (box) 1

- Oxygen Masks with reservoir/ non rebreathing check valve 20

- Oxygen Nose erogator 20

- Soft drainage cannula size. CH 10; 12; 16; 18 20

- Yankauer hard drainage cannula 20

- AMBU facial masks different size ( each) 10

- Guedel/Mayo tubes different size 10

- Catether mount/Anti bacterial filter for mechanical ventilation machine 5

- Mechanical ventilation kit ( tubes) 3

- Intubation bag (Mackintosh/blades laringoscope) 1

- Endo tracheal tubes (cuffed) size 5; 6; 6,5; 7,0; 7,5; 8,0 (each) 5

- Hard boogie for intubation tube (box) 1

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- Pressure gauge for tube ballon 1

- LMA (laryngeal mask) size 3;4; 5 (each) 4

- Frova elastic boogie adult/ child Cook medical (each) 2

- Tegaderm plaster different size (box each) 1

- pnx (pneumothorax)drainage set(Cook) with drainage check valve 10

- Pnx drainage tube( Cook Wayne Pnx set) Fr 6; 14 3

- Thoracic drainage tube Cook Medical (Thal-Quick) Fr 8; 14; 16 5

- Drainage bottle, whit connection valve to mechanical drainage (Pleur evac) 5

- Melker cuffed Emergency cricothyrotomy cath. set( Cook Medical) 5mm 2

- Pneumathic splint arm/leg( each) 1

- Soft Bladder catether (different size) 5

- Urin output bottle (soft) 10

- Sterile Disposable surgical towel 10

- Sterile Disposable Surgical Kit 10

- Sterile disposable scalpels (box) 1

- Sterile ecografic gel (box) 4

- Sterile ecografic probe latex cover (box) 1

- Flashlight 1

- Stetoscope (Littman classic 3) 1

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ANNEX 19

DISPOSABLE MEDICAL SUPPLY – D2PM

Disposable medical supply amount (boxes)

- Blades can 2

- Biologic waste can 2

- Disposable Stretcher sheet 2

- Isothermal blanket 30

- Size adult AMBU balloon w reservoire/antibacteric filter 1

- Defibrillator pad (adult/child) each 4

- Cervical spine splint different sizes ( each) 2

- Clorexidine disinfectant 2

- Betadine disinfectant 2

- Non sterile examination nitrile gloves size. M (box) 2

- Non sterile examination nitrile gloves size. L (box) 2

- Surgical sterile gloves (box)sizes. 7,0; 7,5; 8,0; 8,5 (each) 10

- Aemostatic tourniquet (hipoallergenic) 5

- Venous cathether sizes. 14G; 16G; 18G; 20G; 22G(each) 30

- Venous cathether medication (box) 1

- Sterile gauze box size 10x10; 20x20 cm (each) 3

- Intra osseous needle kit (adult/child) each 3

- Venous 3 ways tap(box) 1

- I.V.(Intra venous) administration set 10

- Photosensitive drug I.V. administration set 10

- Canvas and paper plaster (each) 4

- Ringer lattate/ Saline/ balanced/ voluven 500 ml ( each) 10

- Intra venous fluids squeeze bag 2

- Abdominal Tourniquet 5

- C.A.T. (combat applied tourniquet) 20

- Syringe size. 2,5; 5; 10; 20;60 ml ( box each) 1

- Hemogas analysis Syringe (box) 1

- Seldinger Arterial catether radial/femoral artery (box each) 1

- Central venous Catether (double lumen) size 18 G 5

- Invasive Blood pressure measure kit + transducer 5

- I.V. fluid warmer kit (enFlow)/extension cord box. (care Fusion) 1

- Needles 18 G (box) 1

- Oxygen Masks with reservoir/ non rebreathing check valve 20

- Oxygen Nose erogator 20

- Soft drainage cannula size. CH 10; 12; 16; 18 20

- Yankauer hard drainage cannula 20

- AMBU facial masks different size ( each) 10

- Guedel/Mayo tubes different size 10

- Catether mount/Anti bacterial filter for mechanical ventilation machine 5

- Mechanical ventilation kit ( tubes) 3

- Intubation bag (Mackintosh/blades laringoscope) 1

- Endo tracheal tubes (cuffed) size 5; 6; 6,5; 7,0; 7,5; 8,0 (each) 5

- Hard boogie for intubation tube (box) 1

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- Pressure gauge for tube ballon 1

- LMA (laryngeal mask) size 3;4; 5 (each) 4

- Frova elastic boogie adult/ child Cook medical (each) 2

- Tegaderm plaster different size (box each) 1

- pnx (pneumothorax)drainage set(Cook) with drainage check valve 10

- Pnx drainage tube( Cook Wayne Pnx set) Fr 6; 14 3

- Thoracic drainage tube Cook Medical (Thal-Quick) Fr 8; 14; 16 5

- Drainage bottle, whit connection valve to mechanical drainage (Pleur evac) 5

- Melker cuffed Emergency cricothyrotomy cath. set( Cook Medical) 5mm 2

- Pneumathic splint arm/leg( each) 1

- Soft Bladder catether (different size) 5

- Urin output bottle (soft) 10

- Sterile Disposable surgical towel 10

- Sterile Disposable Surgical Kit 10

- Sterile disposable scalpels (box) 1

- Sterile ecografic gel (box) 4

- Sterile ecografic probe latex cover (box) 1

- Flashlight 1

- Stetoscope (Littman classic 3) 1

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ANNEX 20

PATIENT’S MONITOR

To allow continuous monitoring capabilities to care areas rugged and versatile monitor to

date, with following main features:

Heart rate, 3- or 5-lead ECG, SpO2, NIBP, respiration, motion-tolerant SpO2

Highly intuitive, easy-to-use user interface: - Custom configurable to user care area-

Operates in spot-check and/or continuous monitoring modes - Three display modes to

accommodate varying user skill sets

24-hour tabular and graphical trending

Stores up to 20 full-disclosure data snapshots

Trends and snapshots to PC printer

U.S. Military flight-certified for fixed- and rotary-wing aircraft (MIL STD 461E)

A compact design weighing about 2 pounds, around the size of the average paperback book

Shock resistance of up to 75 g, enough to withstand a 6-foot drop

Operating temperature: 0 to 40 °C

Operating relative humidity: 5 to 95%, noncondensing

Monitor operating altitude: -2,000 to 15,000 ft (-610 to 4,572 m)

Cradle operating altitude: 500 to 15,000 ft (152 to 4,572 m)

Shipping/storage temperature: -20 to 60 °C

Shock resistance: 75 g

Vibration, Random and Sinusoidal: designed to meet RTCA

DO-160D, categories section 8 modified

Electromagnetic compatibility (EMC): per IEC 601-1-2

Drip-proof per IEC 529, level IPX1

Rechargeable lithium ion internal battery pack

External recharger• Input voltage: 12-28 VDC

AC power adapter: 110 and 220 VDC vehicle conversion

Certifications/Standards

Complies with all relevant AAMI, IEC, EN, CSA and UL standards. CE marked according

to the European Medical Device Directive. CSA certificate of compliance for use in the U.S.

and Canada.

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ANNEX 21

N 36-7 TYPE

The Isolation system is composed of a powerful blower LB 36, which draws clean air from

the outside environment through the HEPA-filter at the inlet opening inside the chamber. A

negative pressure is created within the chamber and the air is passed to the highly efficient

Particle Filter AF 36 on the chamber outlet, which cleanses the contaminated air. The clean

air then expels out through the exit opening of the blower back to the outside environment.

Consists of three separate items, the chamber, the filter, the blower with the flexible hose:

A. CHAMBER IN PVC WITH FRAME, AIR INTAKE AND LOCK FOR FILTER

CONNECTION, WITH PACK BAG NSN 6515- 15-015-2237

B. FILTER, AIR CHEMICAL P/N AF-36 –NSN 4240-15-012-7235

C. PLENUM, TENT (BLOWER) WITH HOSE FOR CONNECTION P/N LB36-A – NSN

8340-15-012-7233

Main features include:

Airflow of 36m3/h the high airflow is extremely important to move heat and humidity out

of the chamber. Test from independent laboratories have shown that a chamber with half or

even less air flow, heat and humidity level inside the chamber with a patient inside is extreme.

Negative Pressure of more than -50 Pascal à High airflow paired with high negative

pressure increases the safety of the product significantly as even in an event of a certain

leakage (chamber damage, glove damage, etc.) probability of preserving the negative pressure

is x-fold higher compared to other products.

Tests and Evaluation successfully sustained many tests and evaluations including rapid

decompression, filter efficiency, disinfection, dynamic loads, etc.

Quality assurance requirements AQAP2131

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ANNEX 22

ATISOL TYPE

The Aircraft Transit Isolator (ATISol) has been designed specifically to provide a

microbiologically secure environment for a patient requiring transportation by air over long

distances. This isolator can also be used in conjunction with the Stretcher Transit Isolation

unit as the design provides a means for the linking the two together, enabling a patient to be

transferred from one to the other without breaking the microbiological barrier.

These kind of transport systems are fundamental for the management of patients affected by

bio-contamination. In case of highly contagious infectious diseases, whose transmission ways

are characterized by the ability of the causative agent to contaminate through the air (in a

direct way and through droplets expelled from the patient cough strokes) and/or through

biological fluids, like secretions, skin lesions, blood. It is also important their potential use in

the field of health management of subjects affected by bio contamination with infectious

agents used as biological weapon.

These devices provide a transport means, which is completely isolated in a negative pressure

system and with HEPA (High Efficiency Particulate Air) filters, characterized by five

fundamental elements:

a steel frame that sustains the structure (NSN: 6530-15-011-6034);

a transparent envelope in PVC (NSN: 6350-15-205-5993);

a transport stretcher (NSN: 6530-15-011-6035);

Hepa filter kit (NSN: 6530-15-011-6045 and 6530-15-011-6063);

four batteries for the ventilation system and filtering HEPA (NSN: 6140-15-011-6052).

TECHNICAL DATA

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ANNEX 23

STI TYPE

The STIsol (Stretcher Transit Isolator) has been developed specifically for the isolation of

patients believed to be suffering from highly infectious or contagious diseases, and are made

to provide maximum microbiological security with as little hindrance as possible to attendant

staff when carrying out their normal duties.

The Stretcher Transit Isolator provides a means of transporting a patient over short distances,

usually by ambulance. The unit is completely self-contained and consists basically of a

stretcher onto which is attached a lightweight frame supporting a transparent plastic envelope.

A wrap and lifting poles are included in the envelope to facilitate patient transfer.

The envelope is sealed with a clear viewing panel after the patient has entered, and a battery

powered air supply system regulates the air flow and maintains the controlled environment

within the isolator.

The batteries are housed in specially designed cases. And power connection for the blower

unit being by flying lead which can be easily and quickly unplugged and reconnected.

The air supply system includes a low battery voltage alarm and reserve batteries. Air passes

into and out of the envelope through microbiological filters, the inlet filters providing a

safeguard in the event of an air supply failure.

To prevent the inlet filters becoming clogged with airborne dust particles, replaceable

roughing filters are provided.

A negative pressure is maintained within the envelope to ensure that potentially contaminated

air is not expelled should the physical barrier be accidentally punctured.

Gloved sleeves incorporated in the walls of the envelope enable attendants to examine and

care for the patient, and a supply port is included for the introduction of material into the

isolator while in transit. Any potentially contaminated waste material or equipment should be

stored within the isolator, and the whole problem of decontamination left until the patient has

been removed. Storage Bag tying equipment is provided for this.

Supply cones, for the introduction of wires and tubes for monitoring, oxygen equipment, etc.

and an infusion drip support are also provided. A small storage box is included on the

equipment for housing spares and other small items.

The base frame includes four support feet and handles for mobility. The whole unit can also

be mounted on an optional stretcher trolley if necessary.

The STISol mainly consists of four fundamental elements:

a steel frame that sustains the structure (NSN: 6530-15-011-6401);

a transparent envelope in PVC (NSN: 6530-15-011-6402);

Hepa filter kit (NSN: 6530-15-011-6405 and 6530-15-011-6406);

batteries for the ventilation system and filtering HEPA (NSN: 6140-15-011-6408).

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TECHNICAL DATA

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ANNEX 24

GRAPHIC TABLET, DATA ENTRY

Meant to support a technology based medical information system for real time collection of

data on wounded from POI (Point Of Injury) and during MEDEVAC and STRATEVAC

operations, while allowing for electronic patient recording and monitoring.

Main features shall include:

Rugged Tablet

7" 4 finger multi touch display

Up to 500cd/m2 brightness with anti glare/reflection film

NFC technology integrated

Satellite GPS and digital compass

Up to 8 hours battery life

User replaceable battery (with handset power battery kit)

150cm shock resistant* , vibration test passed

Water and dust resistant (IP65)*

MIL-STD-810 G certificate

Certified airworthiness

CE marked

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ANNEX 25

PATIENT MONITORING, PRELOADED SOFTWARE

The software shall integrate patient’s monitoring algorithms preloaded on tablets (fully

respondent to NATO doctrines), enabling assistance personnel to automatically trace and

track health data records on the injured along all the MEDEVAC and STRATEVAC chain

and release a patient electronic health record.


Each patient’s record shall be enriched with vital patient parameters, contemporarily taken

from the set of instruments used during flight (D1PM; D2PM; D3PM);

Each Tablet shall collect the data and buffers a data packet at least every 4 seconds,

displaying information both locally and remotely to a base receiver programme;

Each Pallet module (D1PM; D2PM; D3PM) shall have the independent capacity to trace

and track health data, real time, and during treatment;

All patients’ data should be either stored locally on the Tablet devices and displayed

remotely in aggregate formats on the monitoring console hosting a Dedicated Server;

The critical patient data is retained both on the patient and within the information

management system;

It shall use current best practice as the core of the user interface;

It shall be technologically system independent (3G/4G/LTE/TETRA etc) so is therefore

upgradeable;

It shall have an inbuilt capability to prioritise messages transmitted according to bandwidth

availability providing a robust solution where bandwidth or communications are challenging

ensuring critical data is not missed by monitoring console;

It shall ensure compatibility with on board communication restrictions and be capable of

using different communications backbones, along with a system that can be scaled up or

migrated onto new communications systems, when allowed.

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ANNEX 26

COMPUTER GRAPHIC, DEDICATED SERVER

A monitoring control station hosting a Dedicated Server shall display patients’ data in

aggregated format, to rapidly identify any change in health status of patients during transport,

and therefore to alert of high level risk and need of prompt interventions.

It shall thus demonstrate the ability of:

to monitor more than one patient contemporarily;

in case of vital signs out of thresholds, display either sound or light alarms;

thus supporting to prevent and minimise y risk and prevent incidents from occurring;

making all the data described above available in aggregated formats, to support assistance

personnel healthcare functions on board;

enabling the exchange of information, ensuring that the most appropriate care, informing

patients’ receiving structures (Hospitals or others) and governmental agencies for family

reunion and prompt information;

Store information on secure data storage system, encrypted, enabling mission situation

awareness, post-mission analysis and overall picture, critical situations detection, (replay of

the mission, performance analysis, improvements, intelligence);

It shall demonstrate it has been certified fit for purpose through stringent laboratory and field

tests for its ‘ easy to use’ , ‘ intuitive’ - ‘ suitable for use on board’ purposes, during

MEDEVAC and STRATEVAC operations.

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ANNEX 27

VIDEOLARYNGOSCOPE

Device assembled to ensure an optimal management af adult and paediatric intubation trough

direct visualization of the upper airways and allow a quick and safe procedure in difficult

patients too.


3,5’’ Pocket monitor (no. 2) open to intubate display with wide view anglew (160°); high

contrast image even in bright daylight; real time documentation enables images to be

recrorded to internal memory and retrieved via the USB data cable;

Videolaryngoscope imager for adults to connect to the pocket monitor trough a specific

connecting cable and arranged to form a perfect symbiosis with single.use laryongoscope

baldes;

Videolaryngoscope imager for pedeiatric patients to connect to the pocket monitor trough a

specific connecting cable and arranged to form a perfect symbiosis with single.use

laryongoscope baldes;

Connecting cable (no. 2) to interface with pocket monitor;

USB data cable for data transfer to a computer, minimum length 200 cm;

Battery rechargeable (no. 2) for pocket monitor with optimal operation time of 60 min.;

Charging unit for one rechargeable battery por pocket monitor (no. 2);

Videolarynngoscope with blade size 3 for single use, package of 10, for use with

Videolaryngoscope imager for adults;


Videolaryngoscope imager for adults;

Videolarynngoscope with blade for difficult intubation for single use, package of 10, for

use with Videolaryngoscope imager for adults;


Videolaryngoscope imager for pediatric patients;


Videolaryngoscope imager for pediatric patients.