Becton Dickinson
neXus PK Directions for Use Issue 2
Directions for Use
72 Pages
Preview
Page 1
BD Alaris neXus PK Syringe Pump PKneXus1 ™
en Directions For Use
BD Alaris™ neXus PK Syringe Pump
Contents
Page
About This Manual. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 Conventions Used in this Manual. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 Intended Purpose . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 Intended Users. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 Patient Target Group. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 Clinical Benefits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 Conditions of Use... 7 Indications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 Contraindications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 Undesirable Side-Effects . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 Compatibility. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 TCI Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 TCI Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 Pharmacokinetic models in BD Alaris™ neXus PK Syringe Pump and their parameters . . . . . . . . . . . . . . . . 9 Controls. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15 Indicators. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15 Main Display Features... 16 TCI On Hold Screen. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16 TCI Induction Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16 TCI Mode – MORE Information Screen. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16 Screen Icons . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17 Labelling Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
Getting Started. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20 Initial Set-up . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20 Language Selection. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20 Power Input. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20 Wi-Fi Configuration. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20 Pole Clamp Installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21 Workstation or Equipment Rail Installation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22 Operating Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26 Syringe Loading . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26 Prepare Syringe and Administration Set . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26 Loading and Confirming a Syringe. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27 BDDF00329 Issue 2
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Operating the Pump . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29 TIVA Mode (with or without prediction). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29 TCI Mode. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
Advanced Features. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32 Bolus Infusion. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32 BOLUS Disabled. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32 BOLUS Enabled – Hands-On. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32 BOLUS Enabled – Hands-Free. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33 Purge. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33 Pressure Level . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33 Rate Titration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34 Clear Volume. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34 Concentration Target Titration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34 Operations During Use. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35 End of Operation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35 TCI Mode. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35 TIVA Mode. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35 Plasma Controlled TCI . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35 Trend Size. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35 Text/Graph Display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35 Decrement Concentration. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36 Dosing Summary... 36 24 Hour Log. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36 Event Log . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36 Data Set Details. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36 Adjust Alarm Volume . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36 Pump Details. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37 Profile Filter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37 Network Status. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37 Wireless Connection. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37 Set By Doserate/Set By ml/h (TIVA mode only). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38 Effect Site TCI. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38 Date and Time . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38 Standby. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
Alarms and Warnings. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39 Original Alarms. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39 Audio Sound Pressure Level . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40 Alarm Priority Level Indicators. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40 Third Edition Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41 BDDF00329 Issue 2
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Audio Sound Pressure Level . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42 Alarm Priority Level Indicators. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42 Prompts. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
Configuration. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44 Configured Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44 Alarm Presets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44 Additional Configured Options Available . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44 BD Alaris™ neXus Editor Software Profile Configuration. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45 BD Alaris™ neXus Editor Software Profile Drugs. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
Associated Products. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48 Recognised Syringes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48 Alaris™ Gateway Workstation v1.3.x or v1.6.x. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50 BD Alaris™ MRI Capsule v1.3.x. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50 Compatible Extension Sets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51
Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53 Routine Maintenance Procedures. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53 Battery Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53 Cleaning and Storage. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54
Technical Data. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56 Specifications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56 Infusion Specifications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56 Bolus Specifications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56 Bolus Volume Accuracy*. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56 Critical Volume. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56 Purge Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57 End Of Syringe Rate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57 Near End Of Infusion Alarm. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57 End Of Infusion (EOI) Alarm. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57 Maximum Pumping Pressure Limit*. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57 Occlusion Accuracy (% of full scale)* . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57 System Accuracy (continuous ml/h and TIVA) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57 Electrical Classification. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58 Battery Specifications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58 Wi-Fi Specifications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58 Radio Equipment Directive Declaration of Conformity Statement. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58 Memory Retention. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58 Fuse Type . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58 AC Power Supply. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58 BDDF00329 Issue 2
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Dimensions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58 Weight. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58 Protection against fluid ingress. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58 Alarm Conditions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59 Environmental Specifications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59 Electrical/Mechanical Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59 Potential Equalisation Conductor. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59 EMC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60 Guidance and Manufacturer’s Declaration – Electromagnetic Emissions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60 Guidance and Manufacturer’s Declaration – Electromagnetic Immunity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61 Guidance and Manufacturer’s Declaration Electromagnetic Immunity. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62 Occlusion Pressure Limits. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63 IrDA, RS232 and Nurse call Specification. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64 IrDA / RS232 / Nurse call Feature. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64 IrDA. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64 RS232 / Nurse call Connection Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65 Trumpet Curves and Start-up Curves . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 66
Products and Spare Parts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68 Spare Parts. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68 Compatible Software . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68
Contact Us . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69 Customer Service Information. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69
Document History. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 70
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BD Alaris™ neXus PK Syringe Pump About This Manual
About This Manual The user must be thoroughly familiar with the BD Alaris™ neXus PK Syringe Pump (hereinafter referred to as Pump) described in this manual prior to use. All illustrations used in this manual show typical settings and values which may be used in setting up the functions of the Pump. These settings and values are for illustrative use only. Where stated, a minimum infusion rate refers to a nominal rate of 1.0ml/h, and an intermediate infusion rate refers to a nominal rate of 5.0ml/h. The complete range of infusion rates, settings and values are shown in the ‘Specifications’ section. • Keep this manual for future reference during the Pump’s operational life. • It is important to ensure that you only refer to the most recent version of the Directions For Use and Technical Service Manual for your BD products. These documents are referenced on bd.com. Paper copies of the Directions For Use can be obtained free of charge by contacting your local BD representative. An estimated delivery time will be provided when the order is placed.
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Conventions Used in this Manual Bold ‘Single quotes’ Italics
Used for Display names, software commands, controls and indicators referenced in this manual, for example, Battery Indicator, PURGE, ON/OFF button. Used to indicate cross-references made to another section of this manual. For example, see ‘Flow Sensor Operation’. Used to refer to other documents or manuals and also used for emphasis. Warning symbol. A warning is a statement that alerts the user to the possibility of injury, death, or other serious adverse reactions associated with the use or misuse of the Pump.
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Caution symbol. A caution is a statement that alerts the user to the possibility of a problem with the Pump associated with its use or misuse. Such problems may include Pump malfunction, Pump failure, damage to the Pump or damage to other property. The caution statement includes the precaution(s) that should be taken to avoid the hazard.
Note:
Notes contain supplementary information or emphasize a point or procedure.
user
Trained and qualified users who interact with the device. See ‘Intended Users’.
Qualified Service Personnel
Personnel that are qualified through Global Customer Services (GCS) Technical training to perform service and repair activities, and upload and download data to the product. The service personnel are BD GCS representatives and/or hospital’s biomedical/Service Partners.
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BD Alaris™ neXus PK Syringe Pump Overview
Overview Introduction This Directions For Use can be used with the BD Alaris™ neXus PK Syringe Pump (REF: PKneXus1). Note: Any serious incident that occurs in relation to this Pump should be reported to the manufacturer, and to the relevant local regulatory authority. The BD Alaris™ neXus PK Syringe Pump provides the user with an infusion tool for the administration of drugs for anaesthesia. The embedded software within the Pump is loaded with three compartment pharmacokinetic predictive models and has four modes of operation: 1. Continuous infusion (ml/h) 2. Total Intravenous Anaesthesia (TIVA) mode. -
In this mode the user is able to select the infusion rate and administer bolus doses as required.
3. Total Intravenous Anaesthesia (TIVA) with TCI predictions mode. -
In this mode the user is able to select the infusion rate and administer bolus doses as required. The pharmacokinetic model is used to estimate the plasma and effect site concentration.
4. TCI Mode • Plasma target-controlled infusion (TCI). -
In this mode the user selects the desired (target) plasma drug concentration, and the pharmacokinetic model is used to calculate the infusion rates required to achieve that concentration. A graphic display shows the trajectory of the estimated plasma and effect site drug concentration over time.
• Effect Site target-controlled infusion (TCI). -
In this mode the user sets the desired effect site target concentration and the pharmacodynamic model is used to calculate the infusion rates required to achieve that concentration. A graphic display shows the trajectory of the estimated effect site and plasma concentration over time.
The Pump has a user-friendly interface that displays the infusion rate, the total drug dose delivered, and the estimated plasma and effect-site concentrations to enable the user to follow the drug prescription information from the relevant country. The BD Alaris™ neXus Editor is a medical device software which allows the hospital to develop a best-practice data set of IV medication dosing guidelines for patient-specific care areas referred to as profiles. Each profile contains a specific library of drugs, as well as an appropriate Pump configuration. The hospital-defined data set is developed and approved through pharmacy and clinical input, and then transferred into the Pump by Qualified Service Personnel, either manually using BD Alaris™ neXus Transfer Tool, or automatically via BD Alaris™ Communication Engine. If the BD Alaris™ Communication Engine (ACE) is deployed at the facility, the BD Alaris™ neXus PK Syringe Pump can connect to it, either by docking to a connected Alaris™ Gateway Workstation or via hospital Wi-Fi. Once connected, Pump infusion data, logs and configuration information are automatically detected and transferred to ACE.
Intended Purpose The BD Alaris™ neXus PK Syringe Pump is intended for use by medical staff for purposes of controlling infusion rate and volume.
Intended Users The primary users of the BD Alaris™ neXus PK Syringe Pump are: • Anaesthetist • Biomedical Engineer / Technician Secondary users of the BD Alaris™ neXus PK Syringe Pump include: • Nurses
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BD Alaris™ neXus PK Syringe Pump Overview
Patient Target Group The BD Alaris™ neXus PK Syringe Pump can be used on neonatal, paediatric and adult patients. When using the BD Alaris™ neXus PK Syringe Pump in TCI mode, the TCI models available with the BD Alaris™ neXus Syringe Pumps support patients between 6 months and 100 years old. When using the BD Alaris™ neXus PK Syringe Pump in TIVA or ml/h mode, the Pump can be used on all age and weight ranges from neonatal to adult.
Clinical Benefits The BD Alaris™ neXus PK Syringe Pump provides continuous or intermittent infusion of parenteral fluids and or drugs to treat a variety of medical conditions. Electronic infusion devices are used when the patient’s critical medical condition dictates a more immediate, accurate and sustained impact from the fluids and medications than can be achieved with oral therapies or other forms of intravenous administration (e.g. gravity administration or IV pushes). The additional benefits of the BD Alaris™ neXus PK Syringe Pump is the administration of anaesthesia with technology proven to improve control and predictability of the medication being delivered. This is done using the latest pharmacokinetic models which allow for both plasma and effect site targeting in adult and paediatric populations. The fluids and drugs being administered either sustain normal physiologic bodily functions or provide therapeutic effects to combat disease or an unhealthy patient condition due to injury or other compromised status.
Conditions of Use The BD Alaris™ neXus PK Syringe Pump should only be operated by a clinician competent in use of automated syringe pumps and post-placement management of intravenous catheters. Use of the BD Alaris™ neXus PK Syringe Pump does not limit the responsibility of the anaesthetist for drugs administration. It is important that users operating the BD Alaris™ neXus PK Syringe Pump are fully aware of the available literature for any model used in association with a drug and that they refer to the prescribed information for rate and dosing limits. Pharmacokinetic and Pharmacodynamic Interactions among anaesthetic drugs are known, but are not taken into account in the calculation of the plasma and effect site concentrations. The user should be appropriately trained in the use of the Pump and should follow the recommendations of this Directions For Use (DFU). In particular, the user must be aware that starting the Pump in a TCI mode will result in the automatic infusion of a pre-calculated bolus dose followed by an infusion to achieve the selected target concentration. The initial parameter calculations are displayed on screen prior to starting the infusion. It is thus essential that the user verifies that the patient characteristics and the selected infusion rate or target concentration conform with the drug prescribing information of the relevant country. Different drugs are associated with dedicated models – each model consists of a set of standard pharmacokinetic parameters which can be selected and used by the embedded 3 compartment model used in the BD Alaris™ neXus PK Syringe Pump (where use of that drug in TCI mode is authorised);
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BD cannot guarantee the continued system accuracy with other manufacturers’ syringes as identified in the ‘Recognised Syringes’ table. Manufacturers may change syringe specification significant to system accuracy without prior notification.
Indications The BD Alaris™ neXus PK is a restricted medical device intended for use by qualified, trained personnel to deliver either continuous or intermittent infusion therapy of: • Anaesthetic agents • Fluids • Medications • Nutritional supplements • Blood and blood products
Contraindications The BD Alaris™ neXus PK Syringe Pumps are contraindicated for: • Enteral therapies • Epidural infusion therapies BDDF00329 Issue 2
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BD Alaris™ neXus PK Syringe Pump Overview
Undesirable Side-Effects The BD Alaris™ neXus PK Syringe Pump has no undesirable side-effects associated with its use when used in accordance with the Directions For Use.
Compatibility The BD Alaris™ neXus PK Syringe Pump is compatible with the following: • The Alaris™ Gateway Workstation v1.3.x and v1.6.x and the BD Alaris™ MRI Capsule – see ‘Associated Products’ • Standard, single-use, disposable extension sets and syringes with Luer lock connectors – see ‘Compatible Extension Sets’ and ‘Recognised Syringes’ • The Active RFID asset tag supplied by BD with this Pump • The following software products are also compatible – see ‘Products and Spare Parts’ -
BD Alaris™ neXus Editor v5.0
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BD Alaris™ Technical Utility v2.0
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BD Alaris™ Communication Engine v2.0
TCI Information TCI Precautions When first starting the infusion the pharmacokinetic / pharmacodynamic models within the BD Alaris™ neXus PK Syringe Pump are reset to zero. Therefore, for any reason, if the Pump is switched off during the surgical procedure all current pharmacokinetic / pharmacodynamic model information will be lost. Under such circumstances switching the Pump off and 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.
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BD Alaris™ neXus PK Syringe Pump Overview
Pharmacokinetic models in BD Alaris™ neXus PK Syringe Pump and their parameters TCI Drug/Model List Drug Name / TCI model
Alfentanil / Maitre
TCI model
Maitre
TCI Targeting Mode
Plasma and Effect Site
Target Concentration Maximum
500ng/ml
Drug Concentration Range
100µg/ml - 500µg/ml
Maximum Infusion Rate
1200ml/h
Age Range
18 years - 95 years
Weight Range
15kg - 200kg
Height Range
N/A
Reference Data
Population Pharmacokinetics of Alfentanil: The Average Dose-Plasma Concentration Relationship and Interindividual Variability in Patients Maitre et al. Anesthesiology, 66:3-12, 1987
Drug Name / TCI model
Dexmedetomidine / Hannivoort-Colin
TCI model
Hannivoort-Colin
TCI Targeting Mode
Plasma Site Only
Target Concentration Maximum
5ng/ml
Drug Concentration Range
2µg/ml - 8µg/ml
Maximum Dose Rate:
0.10µg/kg/min
Age Range
16 years - 99 years
Weight Range
45kg - 120kg
Height Range
114cm - 250cm
Reference Data
Hannivoort et al., Anesthesiology 2015, 123:357 - 367; Colin et al., BJA 2017, 119 (2) : 200–10. ke0 for MOAAS : 0.0485/min
Drug Name / TCI model
Propofol 1% / Eleveld
TCI model
Eleveld
TCI Targeting Mode
Plasma and Effect Site
Target Concentration Maximum
15µg/ml
Drug Concentration Range
10mg/ml - 10mg/ml
Maximum Infusion Rate:
1200ml/h
Age Range
6 months - 99 years
Weight Range
1kg - 160kg
Height Range
25cm - 250cm
BMI Range
10 - 52
Reference Data
Eleveld et al., BJA 2018, 120(5) : 942-959
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BD Alaris™ neXus PK Syringe Pump Overview
Drug Name / TCI model
Propofol 1% / Kataria
TCI model
Kataria
TCI Targeting Mode
Plasma Site Only
Target Concentration Maximum
15µg/ml
Drug Concentration Range
10mg/ml - 10mg/ml
Maximum Infusion Rate:
1200ml/h
Age Range
3 years - 16 years
Weight Range
15kg - 61kg
Height Range
N/A
Reference Data
Kataria et al., Anesthesiology 80:104-122, 1994
Drug Name / TCI model
Propofol 1% / Marsh
TCI model
Marsh
TCI Targeting Mode
Plasma Site Only
Target Concentration Maximum
15µg/ml
Drug Concentration Range
10mg/ml - 10mg/ml
Maximum Infusion Rate:
1200ml/h
Age Range
16 years - 150 years
Weight Range
30kg - 150kg
Height Range
N/A
Reference Data
Marsh et al., BJA 67:41-48, 1991
Drug Name / TCI model
Propofol 1% / Paedfusor
TCI model
Paedfusor
TCI Targeting Mode
Plasma Site Only
Target Concentration Maximum
15µg/ml
Drug Concentration Range
10mg/ml - 10mg/ml
Maximum Infusion Rate:
1200ml/h
Age Range
1 year - 18 years
Weight Range
5kg - 61kg
Height Range
N/A
Reference Data
Absalom et al, BJA, 91:507-513, 2003 (BJA, 95:110-13,2005)
Drug Name / TCI model
Propofol 1% / Schnider
TCI model
Schnider
TCI Targeting Mode
Plasma and Effect Site
Target Concentration Maximum
15µg/ml
Drug Concentration Range
10mg/ml - 10mg/ml
Maximum Infusion Rate:
1200ml/h
Age Range
16 years - 94 years
Weight Range
30kg - 240kg
Height Range
100cm - 220cm
Reference Data
Schnider et Al. Anesthesiology 90:1502-16,1999.
Drug Name / TCI model
Propofol 2% / Eleveld
TCI model
Eleveld
TCI Targeting Mode
Plasma And Effect Site
Target Concentration Maximum
15µg/ml BDDF00329 Issue 2
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BD Alaris™ neXus PK Syringe Pump Overview
Drug Name / TCI model
Propofol 2% / Eleveld
Drug Concentration Range
20mg/ml - 20mg/ml
Maximum Infusion Rate:
600ml/h
Age Range
6 months - 99 years
Weight Range
1kg - 160kg
Height Range
25cm - 250cm
Reference Data
Eleveld et al., BJA 2018, 120(5) : 942-959
Drug Name / TCI model
Propofol 2% / Kataria
TCI model
Kataria
TCI Targeting Mode
Plasma Site Only
Target Concentration Maximum
15µg/ml
Drug Concentration Range
20mg/ml - 20mg/ml
Maximum Infusion Rate:
600ml/h
Age Range
3 years - 16 years
Weight Range
15kg - 61kg
Height Range
N/A
Reference Data
Kataria et al., Anesthesiology 80:104-122, 1994
Drug Name / TCI model
Propofol 2% / Marsh
TCI model
Marsh
TCI Targeting Mode
Plasma Site Only
Target Concentration Maximum
15µg/ml
Drug Concentration Range
20mg/ml - 20mg/ml
Maximum Infusion Rate:
600ml/h
Age Range
16 years - 150 years
Weight Range
30kg - 150kg
Height Range
N/A
Reference Data
Marsh et al., BJA 67:41-48, 1991
Drug Name / TCI model
Propofol 2% / Paedfusor
TCI model
Paedfusor
TCI Targeting Mode
Plasma Site Only
Target Concentration Maximum
15µg/ml
Drug Concentration Range
20mg/ml - 20mg/ml
Maximum Infusion Rate:
600ml/h
Age Range
1 year - 18 years
Weight Range
5kg - 61kg
Height Range
N/A
Reference Data
Absalom et al, BJA, 91:507-513, 2003 (BJA, 95:110-13,2005)
Drug Name / TCI model
Propofol 2% / Schnider
TCI model
Schnider
TCI Targeting Mode
Plasma And Effect Site
Target Concentration Maximum
15µg/ml
Drug Concentration Range
20mg/ml - 20mg/ml
Maximum Infusion Rate:
600ml/h
Age Range
16 years - 94 years BDDF00329 Issue 2
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BD Alaris™ neXus PK Syringe Pump Overview
Drug Name / TCI model
Propofol 2% / Schnider
Weight Range
30kg - 240kg
Height Range
100cm - 220cm
Reference Data
Schnider et Al. Anesthesiology 90:1502-16,1999.
Drug Name / TCI model
Remifentanil / Eleveld
TCI model
Eleveld
TCI Targeting Mode
Plasma And Effect Site
Target Concentration Maximum
20ng/ml
Drug Concentration Range
10µg/ml - 100µg/ml
Maximum Infusion Rate:
1200ml/h
Age Range
6 months - 99 years
Weight Range
2.5kg - 120kg
Height Range
45cm - 200cm
BMI Range
10 - 35
Reference Data
Eleveld et al., Anesthesiology 126:1005-18, 2017. An Allometric Model of Remifentanil Pharmacokinetics and Pharacodynamics
Drug Name / TCI model
Remifentanil / Kim-Obara-Egan
TCI model
Kim-Obara-Egan
TCI Targeting Mode
Plasma Site Only
Target Concentration Maximum
20ng/ml
Drug Concentration Range
10µg/ml - 100µg/ml
Maximum Infusion Rate:
1200ml/h
Age Range
20 years - 85 years
Weight Range
45kg - 215kg
Height Range
150cm - 200cm
Reference Data
Kim et al., Anesthesiology 126:1019-32, 2017
Drug Name / TCI model
Remifentanil / Minto
TCI model
Minto
TCI Targeting Mode
Plasma And Effect Site
Target Concentration Maximum
20ng/ml
Drug Concentration Range
10µg/ml - 100µg/ml
Maximum Infusion Rate:
1200ml/h
Age Range
12 years - 100 years
Weight Range
30kg - 250kg
Height Range
100cm - 220cm
Reference Data
Minto, Anesthesiology 86:10-33, 1997.
Drug Name / TCI model
Sufentanil / Gepts
TCI model
Gepts
TCI Targeting Mode
Plasma And Effect Site
Target Concentration Maximum
2ng/ml
Drug Concentration Range
0.20µg/ml - 5µg/ml
Maximum Infusion Rate:
1200ml/h
Age Range
12 years - 150 years BDDF00329 Issue 2
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BD Alaris™ neXus PK Syringe Pump Overview
Drug Name / TCI model
Sufentanil / Gepts
Weight Range
N/A
Height Range
N/A
Reference Data
Gepts et al.: Anesthesiology 83:1194-1204, 1995
The Propofol – Eleveld and Remifentanil – Eleveld TCI models also incorporate soft limits related to the patient’s height. The limits are detailed in the table below. These are soft limits and the user can override them. Age
Height Soft Min
Height Soft Max
0 to 1 year
45cm
80cm
1 to 2 years
65cm
95cm
2 to 5 years
75cm
120cm
5 to 8 years
95cm
140cm
8 to 10 years
115cm
155cm
10 to 12 years
120cm
165cm
12 to 15 years
130cm
185cm
15+ years
140cm
220cm
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BD Alaris™ neXus PK Syringe Pump Overview
Features of the Pump ON / OFF RUN
Release lever for rotating cam
Display
High visibility alarm indicator PURGE / BOLUS MUTE PRESSURE OPTIONS
Finger Grips Extension set hook Release lever for Rotating cam
HOLD
Shelf for chevron keys and softkeys
Syringe Clamp
Positive Plunger Grippers
Rating plate (see ‘Labelling Symbols’ for key to symbols)
M e dic al Dev
Rotating cam to lock on to horizontal rectangular bars Carrying handle
ice In
terfac e (M D
I)
IR communications port
Potential Equalisation (PE) connector BDDF00329 Issue 2
Folded pole clamp
RS232 Connector
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Extension set hook
BD Alaris™ neXus PK Syringe Pump Overview
Controls Symbol
Description ON/OFF button – Press once to switch the Pump on. Press and hold down for three seconds to switch the Pump off. Note: Pump can only be switched off at specific stages of operation, see 'Power Down Sequence' section in Configured Options for further details. Note: Logs are maintained for power down events including when the Pump is powered down or unexpected power loss.
a b h
RUN button – Press to start the infusion. The green LED will flash during infusion. HOLD button – Press to put the infusion on hold. The yellow LED will be lit while on hold. MUTE button – Press to silence alarm for two minutes. To re-enable the alarm audio press the MUTE button a second time. Note: Attention alarm only: - The two minutes silence can be configured using the BD Alaris™ neXus Editor.
R
-
When not in alarm press and hold until four audible beeps are heard for 60 minutes silence
PURGE/BOLUS button – Press to access PURGE or BOLUS softkeys. Press and hold down softkey to operate. PURGE the extension set during set up. • Pump is on hold • Extension set must not be connected to the patient
i
• Volume Infused (VI) is not added BOLUS – fluid or drug delivered at an accelerated rate. • Pump is infusing • Extension set is connected to the patient • VI is added
d
OPTIONS button – Press to access optional features, see 'Advanced Features' section. PRESSURE button – Use this button to display the pumping pressure and alarm level.
f g
CHEVRON keys – Double or single for faster/slower increase or decrease of values shown on display. BLANK SOFTKEYS – Use in conjunction with the prompts shown on the display.
Indicators Symbol
j S
Description BATTERY indicator – When illuminated the Pump is running on the internal battery. When flashing the battery power is low with less than 30 minutes of use remaining. AC POWER indicator – When illuminated the Pump is connected to an AC Power Supply and the battery is being charged.
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BD Alaris™ neXus PK Syringe Pump Overview
Main Display Features TCI On Hold Screen Pump Status
Current Concentration Cp – plasma; Ce – Effect Site
Drug Name and Concentration
Induction Duration
Pause before maintenance
Propofol 10.0mg/ml
e CONFIRM
Target Concentration (Cpt – plasma; Cet – Effect Site)
Initial Maintenance Rate
Initial Induction Rate
Initial Induction Dose
Initial Induction Volume
TCI Induction Screen Current Concentration (Cp – plasma; Ce – Effect Site
Drug Name and Concentration
Pump Status
Current Dose Rate
Total Volume Delivered
Propofol 10.0mg/ml Cp
7.0ml
8.8
e
148mg/kg/h 1200ml/h Cp 03m 41s
70.9mg 00:00:23
MORE
Target Concentration (Cpt – plasma; Cet – Effect Site) Current Concentration (Cp – plasma; Ce – Effect Site
Elapsed Time
Total Dose Delivered
Current Infusion Rate
Current Decrement Time
TCI Mode – MORE Information Screen Selecting the MORE softkey will display the following additional information: Drug Name Elapsed Time and Model
1.Propofol 10.0mg/ml Eleveld Model
WEIGHT 81.0kg OPIODS IN USE YES BMI 21.6
Patient Parameters
0h 01m 59sm
Time to End of Infusion at Current Rate
Volume and Dose Infused
0h 00m 11s 3.12ml 31.2ml 148mg/kg/h CP
Decrement Time
1.0 g/ml
00m 00s
Decrement Concentration
Press the BACK softkey to return to the TCI screen. The display will automatically revert to the TCI screen after approximately 20 seconds.
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BD Alaris™ neXus PK Syringe Pump Overview
Screen Icons Symbol
Description
l
TIME REMAINING DISPLAY icon – Indicates time before syringe will require replacing.
N
BATTERY icon – Indicates battery charge level to highlight when the battery will require recharging or re-connection to AC power supply. Note: This can be enabled/disabled with the BD Alaris™ neXus Editor software.
C D E F
Induction Phase Dose (Displayed on protocol confirmation screen) Duration of Induction Phase (Displayed on protocol confirmation screen) Duration of Hands Free Bolus (Displayed in bolus set-up screen) Maintenance Phase Dose Rate (Displayed on protocol confirmation screen) SOFT ALERT – Indicates the Pump is running at a rate above (pointing up) or below (pointing down) a Soft Alert. (Number of arrows vary depending on drug name length) LIMIT WARNING – Indicates the setting entered is under or exceeds a Soft Alert or setting entered is not permitted as it exceeds a Hard Limit. DOWN MODE – Infusion status indicating that the target concentration is below current concentration.
WiFi WiFi
Indicates when the Pump is connected, via Wi-Fi, to the BD Alaris™ Communication Engine (ACE). Indicates when the Pump is not connected via Wi-Fi to ACE.
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BD Alaris™ neXus PK Syringe Pump Overview
Labelling Symbols Symbol
Description Consult accompanying documents
Potential Equalisation (PE) Connector
y
RS232/Nurse call Connector
Defibrillation-proof type CF applied part (Degree of protection against electrical shock)
IP32
Protected against solid foreign objects of 2.5mm diameter and greater, and protected against vertically falling water drops when enclosure is tilted up to 15° Note: IP33 applies if AC power cable retainer kit, part number 1000SP01294, is fitted.
r
Alternating Current Device complies with the requirements of Council Directive 93/42/EEC as amended by 2007/47/EC
Date of Manufacture Manufacturer
U
Dispose according to local environmental regulations about disposal of electronic waste Fuse Rating
+40°C
Operation Temperature Limit
0°C
+50 C
Transport and Storage Temperature Limit
-30 C
Pump is able to communicate with BD Alaris™ Communication Engine via Wi-Fi
Medical Device
This way up
Keep dry.
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BD Alaris™ neXus PK Syringe Pump Overview
Symbol
Description Fragile, handle with care
90%
Transport and Storage Humidity limitation
106 kPa
Transport and Storage Atmospheric Pressure limitation
10%
50 kPa
Protective earth; protective ground
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