SALIENT CHARACTERISTICS & TECHNICAL SPECIFICATIONS

Commercial Steam Tabletop Sterilizers (Brand Name or Equal)

The equipment solicited under this requirement supports critical infection prevention, instrument reprocessing, and clinical patient care across Defense Health Agency Medical and Dental Treatment Facilities (MTFs/DTFs) throughout the European theater. Standardized operation, rigorous sterility assurance levels, and native European electrical compatibility are essential to sustaining uninterrupted clinical healthcare delivery.

SECTION 1 — GENERAL CLINICAL & REGULATORY REQUIREMENTS (APPLICABLE

TO ALL ITEMS)

All offered equipment must meet or exceed the following overarching minimum requirements:

1. Regulatory Clearance: Must be FDA 510(k) cleared/approved as a medical device for steam sterilization AND where available, CE marked under applicable European Medical Device Regulations. Non-FDA cleared equipment will not be evaluated or accepted.

2. Electrical Configuration: Must natively operate on 230 VAC (±10%), single-phase, 50/60 Hz standard European electrical utility power. Equipment requiring external step-up or step-down transformers is prohibited.

3. Sterility Standards: Must comply with applicable ANSI/AAMI ST79, ISO 17665-1

(Moist Heat Sterilization), and EN 13060 / EN 285 water and steam quality standards.

4. Safety & Interlocks: Must feature automatic cycle shut-off, low-water detection/protection, over-temperature/over-pressure relief valves, and a fail-safe dual door locking mechanism preventing chamber opening while pressurized. In the event of a power outage, the door must be capable of safe manual release.

5. Drying & Air Filtration: Must feature a fully automated closed-door drying cycle equipped with a replaceable 0.2 µm HEPA air filter to prevent post-cycle recontamination of sterilized instruments.

6. Documentation & Traceability: Must include an integrated/external thermal printer or USB digital data logging port capable of generating permanent, auditable records of sterilization parameters (cycle type, date, time, temperature, pressure, dry time, and operator/serial identification).

7. Manuals: Contractor shall provide at least two (2) complete sets of operator and technical maintenance manuals in English with each delivered unit.

SECTION 2 — SPECIFIC EQUIPMENT CATEGORIES & SALIENT CHARACTERISTICS

ITEM CATEGORY 1: Large-Capacity Tabletop Steam Sterilizer (~85 Liters)

• Intended Reference Model: Tuttnauer 3870EA-D (or Equal)

• Total Quantity Required: 12 Units (Landstuhl: 3 ea; Spangdahlem: 3 ea; Ramstein: 2 ea;

Aviano: 4 ea)

Item Parameter Minimum Required Salient Characteristic

1.1 Chamber

Dimensions

Chamber diameter no less than 15 inches (approx. 384 mm) and chamber depth no less than 30 inches (approx. 760 mm).

1.2 Chamber

Volume

Total chamber volume shall be no less than 84 to 85 liters (22 gallons), constructed of corrosion-resistant stainless steel (grade 316L or equivalent).

1.3 Tray & Load

Capacity

Accommodates a minimum of two (2) perforated stainless steel instrument trays (approx. 11" x 26" and 14" x 26" minimum) and a cassette capacity of no less than 12 full-size IMS instrument cassettes.

1.4 Sterilization

Programs

Minimum of four (4) pre-programmed cycles covering unwrapped instruments, wrapped instruments/pouches, porous/textile loads, and glassware (operating at 273°F/134°C and 250°F/121°C), plus an auxiliary drying-only cycle.

1.5 Water Reservoir Built-in mineral-free water reservoir with a minimum capacity of

4.5 to 7.5 liters and a removable pump strainer/filter.

1.6 Control

Interface

Intuitive digital display/touch panel for program selection, real-time cycle parameter monitoring, and active system fault alerts.

1.7 Cycle

Documentation

Dedicated internal thermal printer (e.g., MFR Part P-PR0003 or equivalent) or USB data port for direct cycle data logging and compliance auditing.

1.8 Standby Mode Energy-efficient standby heating mode to maintain chamber warmth and reduce subsequent cycle warm-up times.

ITEM CATEGORY 2: Class B Pre-Vacuum Tabletop Steam Sterilizer (~27 Liters)

• Intended Reference Model: Tuttnauer T-Top 11 (or Equal)

• Total Quantity Required: 2 Units (Landstuhl: 2 ea)

Item Parameter Minimum Required Salient Characteristic

2.1 Chamber

Dimensions

Chamber diameter no less than 11 inches (approx. 280 mm) and chamber depth no less than 18 inches (approx. 452 mm).

2.2 Chamber

Volume

Minimum usable chamber volume of 27 liters, constructed of corrosion-resistant stainless steel.

2.3 Exterior

Footprint

Compact tabletop footprint not to exceed 19.7" W x 19.7" H x 23.0" D (50 cm x 50 cm x 58 cm) for standard countertop placement.

2.4 Air Removal &

Drying

Fractionated multi-pulse pre-vacuum air removal system for deep steam penetration of hollow, pouched, and porous loads, followed by closed-door post-vacuum drying.

2.5 Cycle Diversity Pre-programmed Class B and Class S sterilization cycles at 273°F (134°C) and 250°F (121°C), with dedicated programs for wrapped/unwrapped instruments, delicate instruments, and dental handpieces.

2.6 Capacity Must accommodate a minimum of five (5) instrument trays, a dedicated capacity of at least five (5) dental handpieces, and minimum load capacities of 19.8 lbs (solid unwrapped), 11.9 lbs (solid wrapped), and 4.4 lbs (textile/porous).

2.7 Water Filling

System

Dual automatic and manual feed water filling complying with EN 13060 water quality standards ($\le 15\text{ }\mu\text{S/cm}$).

2.8 Documentation

& Data

Dedicated thermal barcode/label printer kit (e.g., MFR Part SRV000- 0648 / SRV000-0484 or equivalent) or direct exportable digital logging retaining at least 1,000 cycle records.

SECTION 3 — COMMERCIAL WARRANTY & LOGISTICAL SUPPORT

1. Commercial Warranty: Standard commercial manufacturer warranty of no less than 12 months (parts) from government acceptance, with an optional 12-month extension (total 24 months) available under a separate agreement after initial warranty period. Warranty coverage must be valid and serviceable in Germany and Italy.

2. Technical Support: Telephonic operator and technical troubleshooting support shall be provided during the warranty period to assist military Biomedical Equipment Technicians (BMETs) with installation verification and maintenance.

3. Delivery Schedule: Delivery of all fourteen (14) units shall be complete no later than 120 calendar days after contract award (ADC) to the respective site property management / medical logistics receiving warehouses at Landstuhl (Germany), Spangdahlem AB (Germany), Ramstein AB (Germany), and Aviano AB (Italy).