EVOTECH Installation Requirements and Product Specifications Rev B

EVOTECH ECR ®

Installation Requirements and Product Specifications System Overview The EVOTECH® Endoscope Cleaner and Reprocessor (ECR) is the first system to eliminate the labor-intensive manual cleaning of endoscopes*. With its evolved technology, the EVOTECH® ECR helps ensure compliance, consistently clean endoscopes, and safety for staff and patients. Plus, it automatically detects leaks, eliminating the inconsistencies of manual inspection. Integrated MEC monitoring also prevents staff exposure to high-level disinfectant and saves money by removing the need for test strips. All of this enhanced automation helps save time, increases productivity, and frees staff to focus on patient care.

*Does not eliminate bedside precleaning in procedure room and no manual cleaning is required when selecting a cycle that has a wash stage.

Lids

Lid Window

Basins

Spray Arm

Endoscope Connection Diagram Alcohol Fill Port

Touch Screen

Close Lid Button

Service Doors Foot Pedals

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EVOTECH ECR ®

Installation Requirements and Product Specifications System Description The EVOTECH® ECR is composed of two independently operated sides, each with a basin. Both processing basins are operated using the control panel. The EVOTECH® basins can operate asynchronously; one basin can be idle while the other is in use. The primary components of the system are as follows: Processing Basins One endoscope is loaded into each processing basin. The basin contains channel connectors for connecting the tubing sets to an endoscope. Basin Lids Each basin lid features a seal and a rotating spray arm. Each lid also has a window, allowing you to view the activity in the basin. Service Doors A door on each side of the front panel can be opened to change filters, and replenish detergent and disinfectant. The service doors can be locked so that only authorized personnel have access to the detergent, disinfectant, and bacterial retentive filters. Alcohol Fill Port The alcohol fill port is used to fill the alcohol reservoir with 70% isopropyl alcohol. Alcohol facilitates drying of the endoscope channels. The alcohol rinse is selectable on the control panel. The system notifies you when this solution needs to be replenished. Barcode Reader (Optional)

The barcode scanner allows you to quickly enter information.

Connection Diagram Information on how to connect an endoscope is shown by a generic endoscope diagram located on the front of the unit. Touch Screen

The system is operated by means of a touch screen in the center of the top front panel.

Printer Support The printer rests on either side of the system on the provided support. The printer can also be located on a nearby shelf. Network Connection Port

The network connection port is on the rear of the unit.

Basins per System

2

Scopes per Basin

1

Scope Compatibility Where Marketed

Submersible flexible fiber optic and video endoscopes suitable for high-level disinfection United States, Canada, New Zealand, Australia, Singapore

FDA Clearance

Yes

Configuration

Floor, Stand-alone

Mobility Standard of Care

Moveable, 4 casters, 4 levelers High Level Disinfection

Positive Air Pressure Air Capability

Yes, to all internal channels

Self-Disinfect Cycle

Yes

Information Input/Output Display Hard Copy Control Interface Input

6.4-inch Color VGA Printout Microprocessor Touch Screen

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EVOTECH ECR ®

Architecture and Space Architecture/Space Height (w/ Lid Closed)

46” (117 cm)

Height (w/ Lid Open)

58” (147 cm)

Width (w/out Printer)

37” (94 cm)

Width (w/ Printer)

46” (116 cm)

Depth 33” (84 cm) Leave at least approximately 3 inches of space between the wall and the back of the EVOTECH® ECR to ensure adequate space for the expansion tank. See Exhibit 2 Weight (Empty) Weight (Operating) Basin Size

500 lbs (226.8 kg) 578 lbs (262 kg) 18.25” × 19.75” × 5.75” (46.4 cm × 50.2 cm × 14.6 cm)

Service Access Area Minimum access space around the System when in position for service is 36” behind, in front and to either the left or right side. Note: The EVOTECH® ECR is on castors and can be moved for servicing. Earthquake Restraint Tilt

Unit includes attachment points. See Exhibit 2. Up to 1 degree from vertical

Space/HVAC Min. Room Temperature

59° F (15° C)

Max. Room Temperature

86˚ F (30˚ C)

Relative Humidity Elevation External Venting

10 - 80% non condensing -330 to 9,900 feet (-100 to 3,000 meters) If desired, the system can be configured to allow it to vent to an external venting system. 2” vent

Heat Load Normal Cycle

1200 Watt (4000 BTU/hr)

Self Disinfection Cycle

2000 Watt (7000 BTU/hr)

Idle

300 Watt (1000 BTU/hr)

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EVOTECH ECR ®

Electrical EVOTECH® ECR Electrical AC Power 208 V (+5%/-10%), 3 Phase~, 60Hz, 30 A USA, Canada. Dedicated circuit. Power outlet must be ground fault protected. Do not place the GFCI under the water filtration unit. See Exhibit 5. Draw

Nominal 23 amps +10% at peak

Power Consumption Nominal peak power is approximately 9000W and idle power is approximately 300W. The average power per cycle will depend upon incoming water temperature but typically should be approximately 1800W. Electrical Connection

3-phase NEMA, L 15-30 - Locking

The electrical connection must be user accessible. The EVOTECH® System must be positioned to allow user accessibility of the power plug as an electrical disconnection device. Network interface Ground Fault

RJ45 10-Base T 30 Amp, 3 Phase 208 VAC 3-Wire (L1, L2, L3)

Circuit Interrupter Auto recovery on power loss GFCI Delta circuit w/o neutral ASP recommends the use of ground fault products by North Shore Safety (model PGFS83105 -137) or Siemens (Type ED6, or equivalent) but customers may use any GFCI vendor products that meet the above specification. Expected lead time 2-3 weeks. Printer Electrical Printer

Black and white printer included.

The printer is a separate external device from the EVOTECH® ECR. Printer Power Connection

100 - 240V~, 50/60 Hz, 1.5 A

Printer Support The printer rests on either side of the system on the provided support (brackets are included). The printer can also be located on a nearby shelf. Printer brackets can fit up to a 7.7” x 7.7” (19.5 x 19.5 cm) printer. Printer brackets extend approximately 8.7” (22 cm) from the system. Printer Connection

120 inch power cable (supplied)

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EVOTECH ECR ®

Plumbing Drain Specifications Number of Drains Peak Drain Capacity Drain Height Stand Pipe Drain Location Floor Drain

The left and right basin each has a drain tube. There is a shared overflow detector 25 liters/min 38” (minimum) - 42” (maximum) as measured from the floor - vented One 3” in diameter, or Two each 2” in diameter to accomodate EVOTECH® ECR drain lines (6” minimum length) To the right of AC outlet and within 44“ of installation system Recommended

Water Quality Hardness Less than 50 PPM (CaCO3, or Equivalent). ASP requires the use of a water softening system with all EVOTECH® ECR installations. Contact Siemens Water Technologies for recommedations. Type Potable tap water. Reverse Osmosis (RI) and Deionized (DI) water are contraindicated for use in the EVOTECH® ECR and will cause cycle cancelations. ASP Supplied Pre-Filter

Carbon filtration and 0.2 micron filtration (See page 6).

Water Pressure 40 PSI (275 kPa) minimum dynamic pressure during flow rate of 1.6 gallons per minute at EVOTECH® ECR inlet (6 lpm) per basin. Note: ASP recommends ¾ inch or greater water supply lines. 70 PSI (690 kPa) maximum static pressure. Check water filtration manual for maximum water filtration static pressure. Water Temperature 59� F (15� C) to 86� F (30� C) Note: Hot water (›86� F) is contraindicated and will cause cycle cancellations. Conductivity Recommended Silt Density Index (Water Sediment)

>132 µS/cm (Between 41 and 132 μS/cm requires the addition of salt tablets to complete self-disinfection cycle; refer to CL-103685) ≤5 For optimum performance, ASP recommends the use of pre-filtration systems when SDI >5, contact Clear Solutions, Inc. for recommendations.

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EVOTECH ECR ®

Water Filtration System Description The Water Filtration System with Chlorine Removal for use with EVOTECH® Endoscope Cleaner and Reprocessor (ECR) offers a unique combination of efficiency and capacity for particulate and chemical adsorption. This system filters contaminants such as sediment, soluble organics and chlorine found in municipal water sources. This Water Filtration System is required for use with every EVOTECH® ECR (Additional filtration may be recommended). Where Marketed Configuration

United States, Canada, New Zealand, Australia, Singapore Wall-mounted

Filter Media Hybrid Carbon Filter PAC infused/Nanoalumina charged media with a Rigid Carbon Block Core 0.2 micron Filter

Polyether Sulfone Membrane or Polypropylene Polysulfone

Water Supply Pressure

Maximum static pressure not to exceed 70 PSI (4.83 bar)

Maximum Pressure Hybrid Carbon Filter

70 PSI (4.83 bar)

0.2 micron Filter

70 PSI (4.83 bar)

Temperature Range

39-135� F (4-57� C)

Chlorine Reduction Efficiency

2 ppm to less than 1 ppm for > 30,000 gallons (Part no. PACB4.5-20)

Silt Density Index Efficiency Dirt Holding Capacity (DHC) Effective pH Range

≤ 1.0 ±0.1 > 99.9% reduction of 0.2μ particulate (monodispersed latex spheres) 925g (A2 Fine Test Dust) 5-10

Overall Size

27” (W) × 19.625” (H) × 8.25” (D)

Weight (Dry)

25 lbs

Weight (Filled w/ Water)

< 65 lbs

Water Filtration Plate (Mounting Plate) Mounting plate is required to be installed by facility prior to Water Filtration System installation Inlet Water Hose Drain Hose

58” (147.32 cm) - 3/4 inch GHT 60” (Note that the drain hose cannot be stretched straight) - 3/4 inch GHT

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EVOTECH ECR ®

Exhibit 2: Side View

Wall

58.24” (147.93 cm)

C.G.

4X M8 Thread Seismic Restraint Attachments

15.2” (38.6 cm)

4.69” (11.91 cm) 2.76” (7.0 cm) 1.44” (3.65 cm)

23.90” (60.70 cm)

14.4” (36.7 cm)

30.06” (76.35 cm)

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2.76” (7.0 cm) ≥3” (7.6 cm)

EVOTECH ECR ®

Exhibit 3: Rear View (Expansion Tank Mounted Horizontally)

8.65” (21.96 cm)

Drain Outlet

Printer Water Supply Inlet Expansion Tank Ethernet Connector 29.27” (74.33 cm)

37.62” (95.57 cm)

32.97” (83.75 cm)

Ciruit Breaker Main Power Cord

Expansion Tank Mounting Brackets

26.2” (66.46 cm) 24.89” (63.22 cm)

20.19” (51.28 cm) 12.89” (32.74 cm)

16.50” (41.92 cm)

4.8” (12.21 cm)

30.67” (77.90 cm)

20.22” (51.35 cm) 32.28” (82.0 cm)

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9.53” (24.21 cm) 14.45” (36.71 cm)

EVOTECH ECR ®

Exhibit 4: Water Filtration System and Bracket Water Filter Bracket (Contractor Installed)

22.0” (55.88 cm)

Mount 55”-65” from bottom of plate to floor if placed behind ECR unit

0.25” (0.64 cm)

22.0” (55.88 cm)

15.5” (39.37 cm)

8.25” (20.96 cm)

0.75” Ball Valve

27.0” (68.58 cm) 0-100 PSI Pressure Guages

6.50” (16.51 cm) 15.5” (39.37 cm) 23.625” (60.01 cm)

18.50” (46.99 cm)

19.625” (49.85 cm)

20” Big Blue Housing

20” Standard Housing

Pre-Installation of Bracket Select the area where the filter housing assembly is to be mounted. Make sure adequate space is available below each housing to allow the filters to be removed and replaced. The choice of location dictates whether the wall mount plate is mounted directly to a wall stud or to wall material using lag bolts. ASP cannot mount the wall plate at your facility. Be sure to mount the plate in such a way that it can safely hold the weight of the filter unit; that there is sufficient clearance to change the filters; and make sure the Water Filtration System is close enough to the drain, water source and to the EVOTECH® ECR, to prevent kinking or damage to the hoses. Verify that the water static pressure does not exceed 70 psi (4.83 bar).

Note: When filled with water, the system weighs approximately 65 lbs (29.5 kg).

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EVOTECH ECR ®

Exhibit 5: System Overview

208V Soft Water GFCI 208V 60 Inch Hose

110V

Minimum 55 Inches

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EVOTECH ECR ®

Pre-Installation Specification Checklist Space Requirement: Installation Space

Service Space

See Page 3 Height (w/ Lid Open) 58” (147 cm) Width (w/ Printer) 46” (116 cm) Depth 33” (84 cm)

36” Minimum access space around the System

Room Environment

Room Temperature 64° F (18° C) to 86° F (30° C) Room Humidity 10% to 80% relative Humidity

Power Requirements: EVOTECH® System

See Page 4 3 phase 208VAC, 60Hz, 30amp GFI Protected Dedicated circuit Electrical Connection (3-phase NEMA, L 15-30)

EVOTECH® Printer

100 - 240V~, 50/60 Hz, 1.5 A

Water Requirements: Supply: Water Temperature:

See Page 5 Water Flow: 12 liters/min (3.2 gallons/minute) Water Pressure: 40-70 psi dynamic pressure

Soft Water Available:

Water softeners are required for all Evotech installations Maintain constant <50 ppm at all time

Drain Requirement:

Drain stack: 1ea of 3 inches diameter or 2ea of 2 inches in diameter. Vented Drain Height: 38 to 42 inches high from the floor Drain Capacity: 24 liters/min (6.4 gallons/minute) per drain

*All Drain(s) shall be located on the Right Side Facing the area being prepared for the Evotech system.

Conductivity: Recommened SDI:

*All power shall be located on the Left Side Facing the area being prepared for the Evotech system.

15-30�C

>132 µS/cm (Between 41 and 132 μS/cm requires the addition of salt tablets to complete self-disinfection cycle; refer to CL-103685) ≤5 -12-

© Ethicon, Inc. 2010. All rights reserved. EVOTECH® and the EVOTECH® logo are registered trademarks owned by Advanced Sterilization Products.

S-101378 Rev. B