Roche cobas b 123 User Manual

Roche Diagnostics
212 Instructions for Use · Version 13.0
7 Quality control cobas b 123 POC system
Multirules
Multirules
Overview
q
The Multirules process is applied after each individual QC measurement. The Multirules
are always applied only to the respective level.
The QC concept of the system uses combinations of multiple Multirules rules for
evaluation.
Rule combinations
q
The activation of range 2SD automatically deactivates all other rules (rules 1–6).
The following Multirules rule combinations are possible on the system:
Set 1 Rule 1 and Rule 2.
Figure 7-42 Multirules set 1
N
L
number of individual measurements per level (L=Level)
m
QC measurement value of one level and one parameter
x
mean value taken from the insert sheet or calculated based on at least 20 and no
more than 100 individual measurements

standard deviation
Rule Description
1. 1
2
QC measurement value (m) is outside x ± 2
2. 1
3
QC measurement value (m) is outside x ± 3
3.
(2 of 3)
2
(1)
(1) This rule is not used for QC evaluation on the system
2 of 3 QC measurement values are outside x ± 2
N
L
= 3
4. 2
2
2 QC measurement values (m) are outside x ± 2
N
L
 2
5. 6
1
6 QC measurement values (m) are outside x ± 1
N
T
 6
6. 9
m
9 QC measurement values (m) are on the same side as the mean value
N
T
 9
2SD range Defined target values (ranges)
Table 7-1 Multirules
A (Rule 1 = NOK) AND (Rule 2 = OK) = OK B (Rule 1 = NOK) AND (Rule 2 = NOK) = NOK
OK
OUT OF
CONTROL 2
+3σ
+2σ
X
M
–2σ
–3σ
+3σ
+2σ
X
M
–2σ
–3σ

Roche cobas b 123 Specifications

General

Brand	Roche
Model	cobas b 123
Category	Medical Equipment
Language	English