Roche cobas p 671 User manual

Brand: Roche

Model: cobas p 671

Type: User manual

Addendum 2

For cobas p 671 centrifuge unit (47x) operator’s manual 1.4

RPM and RCF update and 5-position rack (MPA) inspection

Addendum 2

RPM and RCF update and 5-position rack (MPA) inspection

Publication information

Publication version Revision date Change description

1.0 May 2020 New document

Revisions

This addendum contains additional information for the cobas p 671 centrifuge unit (47x)

operator’s manual v1.4.

It has been created following:

• Updates to the RPM and RCF values of the Rotanta 460 Robotic centrifuges

• The need for visual inspections of the 5-position rack (MPA)

Addendum 2

RPM and RCF update and 5-position rack (MPA) inspection

Table of contents

AFFECTED INSTRUMENTS ....................................................................................................................................... 4

ABBREVIATIONS ..................................................................................................................................................... 4

RPM AND RCF VALUES ........................................................................................................................................... 5

INSPECTING THE 5-POSITION RACKS (MPA)............................................................................................................ 6

INSPECTION INTERVALS .................................................................................................................................................... 6

SUSCEPTIBLE AREAS ......................................................................................................................................................... 7

Addendum 2

RPM and RCF update and 5-position rack (MPA) inspection

Affected instruments

System Operator’s manual

publication version*

Addendum date Change

description

cobas p 671

(47x) centrifuge

unit

1.4 May 2020 Updated RPM/RCF

information and 5-

position rack (MPA)

inspections

* For US customers, this addendum is applicable to the currently approved version of the aforementioned

operator’s manual found on the US Roche Diagnostics website.

Table 1: Affected instruments

Roche recommends you familiarize yourself with the new and/or revised content provided

in this addendum.

If you print these pages, Roche recommends printing them single sided. In this way,

you can easily insert the new and/or revised content in its appropriate locations in

the existing document.

Abbreviations

The following abbreviations are used throughout this document:

Abbreviation Definition

cobas p 671 cobas p 671 centrifuge unit (47x)

MPA Modular Pre-Analytics

RCF Relative centrifugal force

RPM Revolutions per minute

Table 2: Abbreviations

Addendum 2

RPM and RCF update and 5-position rack (MPA) inspection

RPM and RCF values

This section is in addition to sections Centrifuges (page 2-17) and Hettich Rotanta 460

Robotic centrifuge (page 6-4) of the cobas p 671 centrifuge unit (47x) v1.4 operator’s

manual.

Two Rotanta 460 Robotic centrifuges, manufactured by Andreas Hettich GmbH & Co. KG,

are integrated into the cobas p 671 centrifuge unit (47x). They are preconfigured for

automatic operation by the Roche Service representative during installation.

Both centrifuges are located inside the lower part of the system, behind the doors.

The centrifuges are tempered (-20 °C to +40 °C), and, empty, with no buckets or carriers,

are capable of reaching 6200 rpm. However, the cobas p 671 centrifuge unit (47x)

software is configured to prevent the centrifuges from reaching their maximum RPM and

RCF, as follows:

• RPM: Maximum 6200 rpm, but limited to 4500 rpm by the cobas software due to

rotor specifications

• RCF: Maximum 5845 g, but limited to 4620 g

Addendum 2

RPM and RCF update and 5-position rack (MPA) inspection

Inspecting the 5-position racks (MPA)

The system operates with two types of 5-position rack (MPA):

• Rack type 1: Holds sample tubes of up to 13.4 mm in diameter.

• Rack type 2: Holds sample tubes of up to 16.3 mm in diameter.

Each rack type holds up to 5 primary sample tubes, and has a working lifetime of 7 years.

Inspection intervals

This section is in addition to section Accessories > 5-position Racks (MPA) and rack trays

(page 2-27) of the cobas p 671 centrifuge unit (47x) v1.4 operator’s manual.

CAUTION

The 5-position rack (MPA) may crack, deform or break through overuse, resulting in

possible test tube breakages.

•

Carefully inspect all racks for cracks, structural deformity, damage and breakage,

according to the frequencies described in Table 3

, below, and discard all defective 5-

position (MPA) racks immediately following identification.

Centrifuge

specifications

Inspection interval

RPM

RCF [g]

Max. 2 cycles per rack

and day

[Lifetime: 4200 cycles / 7

years]

3-8 cycles per rack and

day

[Lifetime: 6300-16800

cycles / 7 years]

9-14 cycles per rack and

day

[Lifetime: 18900 – 29400

cycles / 7 years]

0-2900

0-1885

Ø13mm: no inspection

within lifetime

Ø16mm: no inspection

within lifetime

Ø13mm: Every 9 months

Ø16mm: Every 6 months

Ø13mm: Every 6 months

Ø16mm: Every 3 months

2901-

3700

1886-

3120

Ø13mm: Every 1 year

Ø16mm: Every 6 months

Ø13mm: Every 9 months

Ø16mm: Every 2 months

Ø13mm: Every 6 months

Ø16mm: Every 1.5

months

3701-

4500

3121-

4620

Ø13mm: Every 3 months

Ø16mm: Every 1 month

Ø13mm: Every 1.5 month

Ø16mm: Every 2 weeks

Ø13mm: Every 1 month

Ø16mm: Every 7 days

Table 3: Inspection intervals

Radius of rotation axis: 204 mm

Addendum 2

RPM and RCF update and 5-position rack (MPA) inspection

Susceptible areas

Pay special attention when inspecting the areas circled in Figure 1, Figure 2 and Figure 3,

below, as they are the most vulnerable and susceptible to cracks, breakages, etc.

Figure 1: Circled tube holder

Figure 2: Circled crack

Addendum 2

RPM and RCF update and 5-position rack (MPA) inspection

Figure 3: Circled break

Roche cobas p 671 User manual

Roche cobas p 671 User manual

Roche cobas p 671 User manual

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