S02-Roche 8100 Pre-Site CHECKLIST.pdf

cobas c8100 Installation Site Requirements

RPS-FS.1.C.1-FM-c8100 Version 05

CUSTOMER NAME:

ADDRESS:

CITY/STATE/ZIP:

CONTACT:

TELEPHONE: __________________________________ DATE:

IMPORTANT Roche Service Personnel instructions:

1. Download from GRIPS – Latest Pre-Site documents

INCLUDE – Separate DI, Firewall pre-site form (if applicable).

2. Go over pre-site document with customer and complete on computer. Leave a copy with the customer.

Include "Person Responsible" name for action items where NO is answered on any part of the form.

Include the "Completion Due Date".

3. (desktop) File name "Save As":

Cust name City

ST

Equipment type Date Example: Covance_Indianapolis_IN_C8000_9-2-09

4. UPLOAD electronic per-site to SharePoint site. Place under RSM's name.

5. Email Pre-site document to RSM.

RPS-FS.1.C.1-FM-c8100 Version 05

I. DELIVERY ACCOMMODATIONS

RECEIVING/ROUTING

The system can be unpacked at the time of receiving. This is the preferred way. This will require an area of about 10’ x 20’ to temporarily store the components. This area cannot be the location for the installation itself. A location near the install site is preferred. Ultimately, please check with the installation engineer involved.

Storage Conditions

Temperature Range: -10°C to 60°C (14°F to 140°F) Relative Humidity: 10% to 95% (non-condensing) Altitude / Pressure: 0m to 2000m / 106kPa to 80kPa (6561 feet)

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

Yes No

If No, what special arrangements are required?

Is a pallet jack available? Yes No

RPS-FS.1.C.1-FM-c8100 Version 05

I. DELIVERY ACCOMMODATIONS, (CONTINUED)

Can the system be safely moved from the unloading point (Storage Area) to the proposed point of operation?

Yes No

Minimum door width: 42” uncrated Note: If the door width is not available, then the IPB + HS unit can be separated in order to deliver to the lab.

Minimum turning radius required: 60” Uncrated Confirm elevator load capacity. Should an elevator be required to move the system to lab.

Do available clearances and elevator meet the above requirements? Yes No

If No, what special arrangements are required?

NOTE: If special arrangements are required concerning receiving or routing, please contact the instrument install team prior to the shipment of the system.

RPS-FS.1.C.1-FM-c8100 Version 05

II. PHYSICAL SPACE REQUIREMENTS (see: Instrument Layouts Below) c8100 System Layout

MAINTENANCE CLEARANCE

At least 500 mm (19 ¾”) on the left and right side of the system, 1000mm (39 3/8”) on the front side and 800mm (31 ½”) is required in the rear to ensure proper air circulation and maintenance accessibility.

The width of the cobas 8100 system will differ depending on system design.

FLOOR SPECIFICATIONS

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

The floor must be capable of sustaining the load of the system. Roche will supply the weight of the system if requested.

Does available floor space and flatness meet the above requirements? Yes No If No, what arrangements are required?

Dimensions, Weights, Heat Emission

RPS-FS.1.C.1-FM-c8100 Version 05

II. PHYSICAL SPACE REQUIREMENTS

Module Name Kg Lbs. mm Inches K cal Btu

IPB + HS 330 726

1050 x 1100 x

1500 41x 43 x 59 378 1501 SCM 150 330 300 x 1100 x 1500 12 x 43 x 59 378 1501

ACB + ACU 370 814 900 x 1100 x 1500 35 x 43 x 59 1498 5940 DSP 150 330 300 x 1100 x 1500 12 x 43 x 59 378 1501 BCL 250 550 600 x 1100 x 1500 23x 43 x 59 464 1842 AQM 250 550 600 x 1100 x 1500 23 x 43 x 59 586 2322

RSF/RSS 150 330 300 x 1100 x 1500 12 x 43 x 59 378 1501 AOB 320 704 900 x 1100 x 1500 35x 43 x 59 570 2259 OBS 230 506 600 x 1100 x 1500 23 x 43 x 59 292 1159 CRW 130 286 450 x 1100 x 990 18 x 43 x 39 275 1091 CRO 120 265 450 x 1100 x 990 18 x 43 x 39 313 1241 CLW 130 286 450 x 1100 x 990 18 x 43 x 39 275 1091 CLO 120 265 450 x 1100 x 990 18 x 43 x 39 313 1241

TLJ 300 80 176 252 x 800 x 990 10x 32 x 39 95 377 TLJ 600 110 242 252 x 1100 x 990 10 x 44 x 39 129 512 TLJ 900 120 264 252 x 1400 x 990 10 x 55 x 39 129 512 TLJ 1200 135 297 252 x 1700 x 990 10x 67 x 39 146 579 TLJ 1500 150 330 252 x 2000 x 990 10 x 79 x 39 181 718 TLJ 1800 165 363 252 x 2300 x 990 10 x 90 x 39 181 718 TLJ 2100 180 396 252 x 2600 x 990 10x 103 x 39 215 853 TLJ 2400 210 462 252 x 2900x 990 10 x 114x 39 258 1023 TLJ 2700 220 484 252 x 3200 x 990 10 x 126 x 39 258 1023 TLJ 3000 235 517 252x 3500 x 990 10x 138 x 39 310 1229

BRF 300 660 800 x 1100 x 1500 32 x 43 x 59 585 2320 URF 300 660 800 x 1100 x 1500 32 x 43 x 59 490 1943 RFX 300 660 800 x 1100 x 1500 32 x 43 x 59 525 2082 PXT 100 220 450 x 450 x 600 18 x18 x 24 108 429 CU 80 175 600 x 600 x 1200 24 x 24 x 48 27 107 SLL 100 220 600 x 600 x 1000 24 x 24 x 39 275 1091 SLR 210 462 1400 x 1400x 1000 55 x 55 x 39 457 1812 UCU 130 286 450 x 1100 x 1000 18 x 43 x 39 241 956

RPS-FS.1.C.1-FM-c8100 Version 05

III. ENVIRONMENTAL AND VENTILATION REQUIREMENTS

The cobas 8100 configurations require the following environmental conditions:

(1) A dust-free environment with adequate ventilation.

(2) No direct sunlight.

(3) The floor is level (angle: less than 1/200).

(4) The floor must be able to support loads of the supplied equipment.

(5) Room temperature: 15 to 32 °C.

(6) Any temperature changes should be no greater than ± 2°C when using this system.

(7) Room humidity: 30% to 85% (non-condensing).

(8) No perceptible vibration.

(9) No significant power supply fluctuations (208VAC ± 10).

(10) No machines discharging ultra-high frequencies (for example, electric discharger).

(11) Motors without noise canceller (starter, vibrator etc.) shall not use the same power line with the system.

(12) Maximum Altitude for installation is 2000m.

Noise Level: Operation <65dB (A) Stand By < 55dB (A)

Waste: Solid waste in DSP and AQM

Interface: USB - Printer, standard Ethernet

The above requirements will ensure proper computer operation and environmental comfort in your laboratory.

Will the air conditioning/heating equipment be able to maintain the above requirements during system operation?

Yes No

RPS-FS.1.C.1-FM-c8100 Version 05

IV. ELECTRICAL REQUIREMENTS

POWER SUPPLY SPECIFICATIONS

The electrical specifications for the cobas 8100 System are as follows:

3 Phase Power Requirement

Power Requirement: 1 - Dedicated 208 VAC 60 Hz (+ 0.5 Hz) circuits

Protection Current Rating: 1 -150 Amp primary service.

UPS Power

1 - 40 KVA UPS

KVA load = 40 KVA The instrument does not monitor feedback signals from the UPS (e.g. for automatic shutdown) in the event of a power failure.

Line Fluctuations: Not to exceed 10%

Sags & Surges:

Not to fall below 188 VAC @ 208 Not to exceed 229 VAC @ 208

Safety Ground:

Ground lead of less than 10 ohms. Not to be able to assume any potential above any fixture located in the immediate vicinity of the system > 0.1 VAC Max.

Maximum Impulse Magnitude: Not to exceed 4.5 kV with rise time of 1.2 m sec and a pulse width of 50 µsec. (Cat. A, IEEE C62-41-1980).

Harmonic Waveform Distribution: Not to exceed 5.0%

Wiring: cables supplied by manufacturer

10 m (32 ft) NEMA L6-30 Plug Qty. of 5

Customer Supplied 150 Amp Circuit

NOTE: Power is the responsibility of the customer

RPS-FS.1.C.1-FM-c8100 Version 05

IV. ELECTRICAL REQUIREMENTS – Continued

POWER SUPPLY SPECIFICATIONS (CONTINUED)

Does the power in the laboratory meet the needed requirements? Yes No

Power connection will happen on day 2 of the install. Ensure the customer is prepared to connect the power at that time.

RPS-FS.1.C.1-FM-c8100 Version 05

V. Middleware DI Instrument Installation Requirements

Please refer to and complete the Middleware DI Installation Site Requirements document.

The c8100 requires a customer network connection in order to operate.

This network will be the CU connection

Are the requirements set forth in the “Middleware DI Installation Site Requirements” document met?

Yes No

RPS-FS.1.C.1-FM-c8100 Version 05

VI. cobas® IT Firewall Installation Requirements Please refer to and complete the cobas IT Firewall Installation Site Requirements document.

Are the requirements set forth in the cobas “IT Firewall Installation Site Requirements” document met?

Yes No

If No, what arrangements are required?

Complete the site requirements prior to system installation. Report deviations from the site specifications to the Roche Technical Support Center (1-800-428-2336).

Adherence to the specifications listed herein greatly enhances proper operation of the cobas 8100 system. The Customer, by signature, acknowledges that any attempt to operate the System outside of these specifications without the prior approval of Roche Technical Support Center may void the System warranty.

FIELD SERVICE REPRESENTATIVE DATE

CUSTOMER DATE

REGIONAL SERVICE MANAGER (if required) DATE