B01 Attachment J02-a SOW Attachment A - cobas pure Site Requirements - Owner Facility Engineer Questions.pdf

r cobas® pure integrated solutions Site Requirements

Disclaimer

This Pre-Installation Site Checklist does not replace any user or service manual.

The site requirement document can be used as a basis for the pre-installation discussion with the customer.

Dimensions:

☐ W x D x H

SSU

Including monitor c 303

E402

18 x 48 x 69

in. 40 x 32 x 54 in 40 x 32 x 54 in

☐ Weight 441 lbs.

882 lbs. .

882 lbs

☐ The floor should have a grade (rise or fall) less than 1/200 within the footprint of the system.

Electrical Power Requirements

☐ Source

Two 115 VAC +/- 10% / 60Hz -standard wall receptacle [5-15R connection]

Two 15 Amp circuits will supply power to:

1. Roche Service use.

2. HP LaserJet Printer

30 AMP (Load tested) - Two (2) options: United States

1. Wall mounted Hubbell # 2620, 3-Wire 30 A, 250VDC -

2. Cord mounted Hubbell# 2623, 3-Wire 30 A, 250VDC -

Note: All of the above are Locking Single Receptacles

☐ Power Consumption - Entire System 4 kVA ( c303 - 1.5kVA, e402 -2.0 kVA, sample supply unit - 0.5 kVA) ☐ Power outlet (208V 30 amp) must be within 30 ft of the analyzer.

Sample Supply unit Sample Buffer ISE Unit cobas c 303 unit cobas e 402 unit Up to 50 samples input Up to 50 samples output STAT port Control unit with 21.5 inch touchscreen monitor and onscreen keyboard

20 rack positions 100 Sample Capacity

Up to 150 samples per hour Up to 450 tests per hour

Up to 450 tests per hour

Up to 42 reagent positions RFID label

Up to 120 tests per hour Up to 28 reagent positions Reaction time: 9/18/27

☐ Power outlet (115V 15 amp) must be within 8 ft of the printer/firewall/cobas link cart.

☐ It is recommended for the power to be fed from Emergency power (Generator backed up).

☐ A ground lead measuring less than 10 ohm with respect to earth ground is required. Safety ground must not be able to assume any potential above any grounded fixture located in the immediate vicinity of the analyzer (0.1 VAC maximum).

NOTE: Roche through an agreement with a power supply vendor provides an Uninterruptible Power Supply (UPS) as part of the cobas pure Integrated solutions shipment. This UPS(s) provide power conditioning and short term AC power (5-10 minutes). If the site already has an Uninterruptible Supply built-into the facility, then it is not recommended that the Roche provided supplies be utilized (Uninterruptible supply should not be powered by another uninterruptible supply).

Liquid Waste Volume c 303

Concentrated liquid waste volume: <1. 2 L/h

E 402

Concentrated liquid waste volume: ≤ 3 L/h

Diluted liquid waste volume:<14.8 L/h

Diluted liquid waste volume: <10 L/h

☐ Floor drain required ≥ 2 inches ID and within 4 inches of the floor

☐ Floor drain must be located within 16 ft of the analyzer

☐ Waste is by gravity discharge

Deionized Water Consumption

☐ Average in Operation: 16 L/h 12 L/h

☐ Clinical Laboratory Reagent Water (CLRW)

● Bacteria <10 CFU/mL Resistivity >10 MΩ.cm Total Organic Carbon(TOC) 500 PPB Particles 0.2um filtration or better

☐ Pressure 7.3 to 49.3 psi. Customer supplies a gauge and regulator valve to monitor and adjust water pressure.

☐ Temperature 54 to 86 °F (10 – 30°C) ☐ Customer supplies an approved shutoff valve near the analyzer. 5/8 hose barb with an internal diameter of 1/2 inch supplied by customer. DI water components must be either PVC or Stainless steel.

☐ Any dead leg tubing must be < 10 feet.

Note: It has been found that systems utilizing a re-circulation/polishing loop, with a minimal velocity of 5 ft/sec. and a 0.2 micron output filter, have been extremely effective in minimizing bacterial growth and maintaining overall water quality.

Note: If an acceptable floor or wall drain cannot be provided, the facility may provide, at their own discretion, an automated waste pumping solution

(ie. separate waste container and “sump pump”) capable of safely and effectively eliminating analyzer waste at the specified discharge rate.

SSU c 303 e 402

Environmental ☐ Ambient Temperature 64 - 89° F in operation ≤ 3.6° F Δ/h

☐ Relative Humidity

☐ Noise emissions to Environment

30 – 85% non-condensing

<65.4 dbA in Operation/<58.4 dbA in STBY

☐ Heat Dissipation

(BTU/h)w/SB 1707 5120 6826

☐ Normal altitude above sea level 6562 ft 6562 ft ☐ Max. altitude above sea level with specific SW settings 9843 ft 9843 ft

☐ The environment should be relatively dust and vibration free.

☐ The cobas pure integrated solutions should be located ample distance away from any equipment generating electromagnetic noise or electromagnetic wave interference (such as centrifuge, electric discharge machine, mobile telephone, transceiver, cordless telephone, etc

Routing Considerations (Uncrated)

☐ Is there a loading dock or other suitable facility to allow the analyzer to be safely unloaded?

☐ Truck with lift gate or Forklift needed? Is a forklift available onsite?

☐ Is there any restriction to the length of truck that will be used to deliver the analyzer?

☐ Is there any restriction on delivery times/days?

☐ Is there an unpacking location available?

Additional Considerations

☐ Installation Clearance: Minimum door width (opening) – 36 in. Minimum door height – 69 in. Minimum turning radius – 60 in.

☐ Elevator Clearance (if necessary): Width - 36 in. Depth - 48 in.

☐ Clearance for proper circulation and accessibility: Right: 24 in. Front: 40 in. Back: 28 in.

☐ Adequate ventilation in the immediate area of operation should be provided without airflow directly onto or across the top of the analyzer.

☐ The cobas pure analyzer should be located ample distance away from any equipment generating electromagnetic noise or electromagnetic wave interference such as centrifuge, electric discharge machine.

☐ System should be protected from direct sunlight.

☐ Adequate refrigerated storage at 2 to 8 °C must be available.

☐ Access for Maintenance is as follows:

It is recommended to have at least 20" on the right side, 40" at the front and a necessary space of 28" at the back to ensure proper air circulation and accessibility for maintenance and operation.

Network Connections

☐ A wired 10/100/1000 RJ45 female connection (1 drop per system) to the customer’s network

☐ Roche provides a Firewall. The use of the Firewall is mandatory and requires a static IP address. See separate Firewall pre-site document.

☐ The communication is outbound through port 443 (HTTPS) and port 80 (HTTP with secure payload). Secure payload means that the data is encrypted, signed, and zipped. Protocols used are HTTP, HTTPS, SSH, SOAP, and BITS.

☐ For outbound LIS communication the Firewall will require access to the customers LIS over specific ports.

☐ For inbound LIS communication, the LIS will require access to the Firewall’s static IP address.

☐ If installing at a VA account please follow IPB for Axeda setup – Veterans Affairs VPN Procedure

☐ For Roche remote diagnostics, Axeda, the Firewall’s static IP address will need access to:

IP Address Outbound Port

Host name

196.3.50.39 80 teleservice.roche.com**

62.209.44.11 443 remoteservice.roche.com

209.202.167.21 443 remoteservice-dr.roche.com

62.209.44.21 443 remoteservice-gas1.roche.com

62.209.44.22 443 remoteservice-gas2.roche.com

209.202.167.19 443 remoteservice-gas3.roche.com

209.202.167.20 443 remoteservice-gas4.roche.com

120.136.45.231 443 remoteservice-gas5.roche.com

120.136.45.230 443 remoteservice-gas6.roche.com

Cart

☐ A cart will be optional. There are two options: 24 in wide standing cart and a 36 in wide sitting cart.

☐ Cart is best used on the left side of the instrument

Configurations Total length in

<c303> 63 (57)

<c303 | e402> 102 (97)

<e402> 63 (57)

Notes

Important: The strict adherence to the site requirements contained in this document is an essential component in achieving a successful and compliant installation. Any delays in site requirement implementation over the jointly agreed dates can have a negative impact on and delay instrument shipment and/or installation. Deviations from these site specifications should be reported to the Roche Technical Support Center (1-800-428-2336).