BD Alaris PK Manual De Instrucciones página 3

en – Directions For Use Addendum
Introduction
This addendum should be used in conjunction with the Alaris™ PK or Alaris™ PK Plus Syringe Pump (hereinafter referred
to as Pump) Directions For Use . The purpose of this addendum is to provide additional material for operation when using
a drug configuration based upon the Propofol - Schnider model . To use this drug / model combination a suitable data set
must be created, see BD Alaris™ PK Editor Software Directions For Use .
Symbols Definition
Symbol
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TCI Precautions
When first starting the infusion, the pharmacokinetic / pharmacodynamic models within the Pump are reset to zero .
Therefore, if for any reason the Pump is switched off during the surgical procedure, all current pharmacokinetic /
pharmacodynamic model information will be lost . Under such circumstances switching the Pump on and restarting the
infusion whilst the patient contains a significant residual drug dose could result in an over-infusion and, therefore, the
Pump should not be restarted in TCI mode .
Pharmacokinetic and Pharmacodynamic Parameters
Drug: Propofol
Unit of Blood Concentration: µg/ml
Infusate Drug Concentration: 10mg/ml or 20mg/ml
Max . Blood Concentration: 15µg/ml
Vc = 4 .27 (litres)
V2 = 18 .9 − 0 .391 × (age − 53)
V3 = 238
cl1 = 1 .89 + 0 .0456 × (mass − 77) − 0 .0681 × (lbm − 59) + 0 .0264 × (height − 177)
cl2 = 1 .29 − 0 .024 × (age − 53)
cl3 = 0 .836
k = cl1 ÷ Vc
10
k = cl2 ÷ Vc
12
k = cl3 ÷ Vc
13
k = cl2 ÷ V2
21
k = cl3 ÷ V3
31
k is calculated using t
41 peak
Reference from the literature: Schnider et al .: Anesthesiology 1998, 88:1170–82 .
Reference for k : Schnider et al .: Anesthesiology 1999, 90:1502–16 .
41
Description
Catalogue Number
Consult electronic instructions for use
Device complies with the requirements of Council Directive 93/42/EEC as amended by
2007/47/EC
Date of Manufacture
Manufacturer
Medical Device
Model: Schnider Model (t
at 1 .6 minutes (NOT fixed ke
BDDF00869 Issue 1
1.6 minutes)
peak
) .
0
Alaris™ PK/PK Plus Syringe Pump
Propofol-Schnider Model
2/91