CareFusion Alaris PK Plus MK4 8005PK201 Directions For Use Manual
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CareFusion Alaris PK Plus MK4 8005PK201 Directions For Use Manual

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Alaris™ PK Plus Syringe
Pump MK4
Model: 8005PK201
s
Directions For Use
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Summary of Contents for CareFusion Alaris PK Plus MK4 8005PK201

  • Page 1 Alaris™ PK Plus Syringe Directions For Use Pump MK4 Model: 8005PK201...

  • Page 2: Table Of Contents

    Alaris™ PK Plus Syringe Pump Contents Page Introduction ....................2 About This Manual .

  • Page 3: Introduction

    CareFusion has verified the accuracy of the mathematical model implementation as well as pump delivery accuracy - (specification and accuracy of pump - delivery are available in 'Profiles from TCI Mode' section).

  • Page 4: About This Manual

    Alaris™ PK Plus Syringe Pump About This Manual CareFusion cannot guarantee the continued system accuracy with other manufacturer’s syringes as identified in the ‘Recognised Syringes’ table. Manufacturers may change syringe specification significant to system accuracy without prior notification. Indications The Alaris PK Plus Syringe Pump is indicated for the administration of drugs for anaesthesia...

  • Page 5: Tci Overview

    Alaris™ PK Plus Syringe Pump TCI Overview TCI Overview The dose-response relationship can be divided into three parts: the relationship between administered dose and plasma concentration (the pharmacokinetic phase), the relationship between effect organ concentration and clinical effect (the pharmacodynamic phase) and the coupling between pharmacokinetics and dynamics.
  • Page 6 Alaris™ PK Plus Syringe Pump TCI Overview Knowledge of the k for various agents has made targeting of the effect-site possible. With effect-site targeting the TCI system first calculates the necessary plasma concentration profile required to achieve the effect-site target as rapidly as possible, and then calculates the infusion rates required to achieve that plasma concentration profile (Fig 3).
  • Page 7 Alaris™ PK Plus Syringe Pump TCI Overview Pharmacokinetic models in Alaris PK Plus Syringe Pump and their parameters Drug: Diprivan Model: Marsh (weight adjusted) Age Limit: 16 years upwards Unit of Plasma Concentration: µg/ml Max. Plasma Concentration: 15 µg/ml Vc = 0.228 x mass (litres x kg = 0.119 minutes = 0.112 minutes = 0.0419 minutes...

  • Page 8: Creating A Data Set

    Alaris™ PK Plus Syringe Pump Creating a Data Set Creating a Data Set To fully utilise the Alaris PK Plus Syringe Pump a Data Set will need to be developed, reviewed, approved, released, uploaded and verified according to the following process. Refer to the Alaris PK Editor Software Directions for Use (1000CH00016) for further details and operating precautions.

  • Page 9: Features Of The Pump

    Alaris™ PK Plus Syringe Pump Features of the Pump Features of the Pump ON/OFF High visibility Release lever Display Alarm Indicator for MDI PURGE/BOLUS MUTE PRESSURE OPTION Finger Grips Extension set hook HOLD Shelf for chevron Syringe Clamp Positive Plunger keys and softkeys Grippers Rating Plate (see Symbol Definitions for an...

  • Page 10: Controls And Indicators

    Alaris™ PK Plus Syringe Pump Controls and Indicators Controls and Indicators Controls: Symbol Description ON/OFF button - Press once to switch the Pump on. Press and hold down for 3 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.

  • Page 11: Symbol Definitions

    Alaris™ PK Plus Syringe Pump Symbol Definitions Symbol Definitions Labelling Symbols: Symbol Description Consult accompanying documents. Potential Equalisation (PE) Connector RS232/Nurse call Connector Defibrillation-proof type CF applied part (Degree of protection against electrical shock) Protected against direct sprays of water up to 15° from vertical and protected against solid objects greater than IP32 2.5mm.

  • Page 12: Main Display Features

    Alaris™ PK Plus Syringe Pump Main Display Features Main Display Features TIVA Mode Drug Name and Pump Status Pressure Information Concentration Flow Rate and Dose and Operations Dose Rate Volume Infused During Use TCI Mode Induction Pause Before Drug Name and Pump Status Concentration Duration...
  • Page 13 Alaris™ PK Plus Syringe Pump Main Display Features Screen Icons Symbol Description TIME REMAINING DISPLAY icon - Indicates time before syringe will require replacing. BATTERY icon - Indicates battery charge level to highlight when the battery will require recharging. This can be enabled/disabled with the Alaris PK Editor Software Induction Phase Dose (Displayed on protocol confirmation screen) Duration of Induction Phase (Displayed on protocol confirmation screen)

  • Page 14: Operating Precautions

    The Pump is suitable for use in hospital and clinical environments other than domestic establishments and those directly connected to the public single phase AC Power Supply network that supplies buildings used for domestic purposes. (Consult Technical Service Manual, Qualified Service Personnel or CareFusion for further information).
  • Page 15 CareFusion. Any use of Alaris Syringe Pumps which have been altered or modified otherwise than in strict application of directions provided by CareFusion, is at your sole risk, and CareFusion does not provide any warranty for or endorsement on any Alaris Syringe Pump that has been so modified or altered.
  • Page 16 MRI compatible pump as such. If use of the Pump within an MRI environment is unavoidable, then CareFusion highly recommends securing the Pump at a safe distance from the magnetic field outside the identified ‘Controlled Access Area’ in order to evade any magnetic interference to the Pump; or MRI image distortion.

  • Page 17: Getting Started

    Alaris™ PK Plus Syringe Pump Getting Started Getting Started Initial Set-up Before operating the Pump read this Directions For Use manual carefully. 1. Check that the Pump is complete, undamaged and that the voltage rating specified on the label is compatible with your AC Power Supply.
  • Page 18 Alaris™ PK Plus Syringe Pump Getting Started Do not mount the Pump with the AC power inlet or the syringe pointing upwards. This could affect the electrical safety in the event of a fluid spill or lead to the infusion of air which may be in the syringe. Pole Clamp Installation The pole clamp is fitted to the rear of the Pump and will provide secure Recessed area...

  • Page 19: Syringe Loading

    Alaris™ PK Plus Syringe Pump Syringe Loading Syringe Loading Prepare Syringe and Administration Set To decrease potential start-up delays, delivery inaccuracies and delayed generation of occlusion alarms each time a new syringe is loaded: • Use smallest syringe size possible, for example, if infusing 9 ml of fluid, use a 10 ml syringe. •...
  • Page 20 Alaris™ PK Plus Syringe Pump Syringe Loading Loading and Confirming a Syringe Warning: To securely load and confirm a syringe carefully follow the steps below. An incorrect loading of a syringe may result in misidentification of the syringe type and size. If then confirmed, this may lead to significant inaccuracy of the infusion rate and may also affect Pump performance.
  • Page 21 Note: If the PURGE SYRINGE option has been enabled then the prompt to purge screen is displayed and the extension set can be purged as required, however ensure that the extension set is not connected to the patient during this process. CareFusion recommends limiting the number of configured syringe types and sizes available for selection on the Pump.

  • Page 22: Starting The Pump

    Alaris™ PK Plus Syringe Pump Starting the Pump Starting the Pump 1. Connect the Pump to an AC Power Supply using the AC power cable. 2. Press the button. • The Pump will run a short self-test. Warning: two beeps are activated during this self-test and the red alarm beacon illuminates and then clears. No action is required during this self-test.
  • Page 23 Alaris™ PK Plus Syringe Pump Starting the Pump TCI Mode 1. A list of available drugs and models will be displayed. Use the keys to select the required drug and associated model and press the OK softkey. Pressing the INFO key will show more information on the selection. 2.

  • Page 24: Basic Features

    Alaris™ PK Plus Syringe Pump Basic Features Basic Features Bolus Infusion BOLUS is disabled in TCI mode. Bolus Administering a controlled volume of fluid or drug at an increased rate for diagnostic or therapeutic purposes. The Pump should always be infusing and always attached to the patient. (Drugs given by an IV bolus could achieve immediate and high drug concentration levels.) Bolus can be used at the start of an infusion or during an infusion.
  • Page 25 Alaris™ PK Plus Syringe Pump Basic Features Purge button allows the delivery of a limited volume of fluid in order to purge the extension set prior to being connected to a patient or after changing a syringe. 1. Press the button when the Pump is not infusing.

  • Page 26: Operations During Use

    Alaris™ PK Plus Syringe Pump Operations During Use Operations During Use End of Operation This option will only appear in the options menu when the infusion has been stopped. 1. Press the button to access the options menu. 2. Select the END OF OPERATION option using the keys.
  • Page 27 Alaris™ PK Plus Syringe Pump Operations During Use 24 Hour Log This option allows the 24 hour log of volume infused to be reviewed. 1. Press the button to access the options menu. 2. Select the 24H LOG option using the keys and press the OK softkey.

  • Page 28: Alarms And Warnings

    Alaris™ PK Plus Syringe Pump Alarms and Warnings Alarms and Warnings Alarms are indicated by a combination of an audible alarm, flashing alarm indicator and a descriptive message in the display. 1. First press the button to silence the alarm for a maximum of 2 minutes, then check the display for an alarm message. Press CANCEL to cancel the alarm message.

  • Page 29: Prompts

    Alaris™ PK Plus Syringe Pump Prompts Prompts Display Icon Description and Troubleshooting Guide DOSE WOULD EXCEED The infusion rate has been set to a value which exceeds a Soft Alert. Check infusion setting, to continue with infusion at set rate press the button and then confirm OVERRIDE LIMIT by pressing the YES softkey.

  • Page 30: Configured Options

    Alaris™ PK Plus Syringe Pump Configured Options Configured Options This section comprises of a list of options which are configurable. Some can be entered via the Pump configuration menu (available in Technician Mode) and others through the Alaris PK Editor Software. Enter the access code on Alaris PK Plus Syringe Pump for Configured Options, see the Technical Service Manual for details.
  • Page 31 Alaris™ PK Plus Syringe Pump Configured Options Alaris PK Editor Software - Pump Configuration The following options are configurable via the Alaris PK Editor Software (PC based), see the Alaris PK Editor Software Directions for Use (1000CH00016) for details on how to alter the profile configurations. General Pump Configurations AC Fail Warning The AC Power Failure Alarm can be set to sound or be silent if the AC power is disconnected.
  • Page 32 Alaris™ PK Plus Syringe Pump Configured Options Alaris PK Editor Software - Profile Drugs The following drug parameters are only configurable via the Alaris PK Editor Software (PC based), and are referenced when the Alaris PK Plus Syringe Pump is being used with a drug name selected. Refer to the Alaris PK Editor Software Directions for Use (1000CH00016) for details on how to configure the Profile Drug Library.
  • Page 33 Alaris™ PK Plus Syringe Pump Configured Options Default Drug Profile Library The following drug parameters are programmed in the Pump. Diprivan 1% Diprivan 2% Remifentanil Remifentanil TIVA* Sufentanil Model Marsh Marsh Minto Gepts Min Concentration 10mg/ml 20mg/ml 20µg/ml 20µg/ml 0.2µg/ml Max Concentration 10mg/ml 20mg/ml...

  • Page 34: Specifications

    Alaris™ PK Plus Syringe Pump Specifications Specifications Infusion Specifications Maximum infusion rate can be set as part of the configuration. 0.1ml/h - 150ml/h 5ml syringes 0.1ml/h - 300ml/h 10ml syringes 0.1ml/h - 600ml/h 20ml syringes 0.1ml/h - 900ml/h 30ml syringes 0.1ml/h - 1200ml/h 50ml syringes Infusion Rate Increments:...
  • Page 35 Alaris™ PK Plus Syringe Pump Specifications End Of Infusion (EOI) Alarm 0.1% - 5% of syringe volume. Maximum Pumping Pressure Limit Highest alarm level 1000mmHg (nominal at L-10) Occlusion Accuracy without pressure set (% of full scale)* Pressure mmHg L-10 approx.
  • Page 36 Alaris™ PK Plus Syringe Pump Specifications Alarm Conditions Drive Disengaged Occlusion Attention (Nurse Callback) Check Syringe Near End Of Infusion End of Infusion Battery Low Battery Empty AC Power Fail Titration not confirmed Internal Malfunction Concentration not Permitted Dose Would Exceed Target Would Exceed Dose Under Dose not Permitted...

  • Page 37: Recognised Syringes

    In no event shall CareFusion be liable for any damages of any kind or nature, including without limitation, direct or indirect, special, consequential, or incidental damages arising from, or in connection with the use of syringes not listed in the ‘Recognised Syringes’...

  • Page 38: Associated Products

    Alaris™ PK Plus Syringe Pump Associated Products Associated Products The Alaris Gateway Workstation Product SKU 80203UNS0y-xx Supply Voltage 115-230VAC, ~50-60Hz Electrical Rating 460VA (Maximum) Protection Against Electrical Shock Class 1 Classification Continuous Operation Supply to Pump 115-230V, ~50-60Hz, 60VA The Alaris DS Docking Station Product SKU 80283UNS00-xx Supply Voltage...

  • Page 39: Compatible Extension Sets

    Compatible Extension Sets Compatible Extension Sets The Pump uses standard, single-use, disposable extension sets and syringes with Luer lock connectors. The user is responsible for verifying the suitability of a product used, if it is not recommended by CareFusion. 20062E7D 20038E7D 3 way extension set with 3 SmartSite Needle-Free Valves and one backcheck valve, ™...
  • Page 40 Alaris™ PK Plus Syringe Pump Compatible Extension Sets 2309E-0006 2205E-0006 Bag spike with SmartSite Needle-Free Valve and backcheck valve Vial adaptor with SmartSite Needle-Free Valve, for 20mm vials MFX2293 500-012V Extension set with backcheck valve, 14cm. Priming Volume: 0.9ml Y Connector set 2-way with anti-syphon valve and backcheck valve, 210cm 500-013V 500-002V Y Connector set 3-way with 2 anti-syphon valves and backcheck valve, 190cm...
  • Page 41 Polyethylene Syringe Extension Set, 200cm. Priming Volume: 1.8ml • New sets are continuously being developed for our customers. Please contact your local CareFusion representative for availability. • It is recommended that extension sets are changed in accordance with the Directions for Use. Carefully read the Directions For Use supplied with the extension set prior to use.

  • Page 42: Maintenance

    Alaris Syringe Pump, and in conjunction with Alaris Syringe Pump software, controls battery use, charge and temperature. Any use of battery packs that are not manufactured by CareFusion in the Alaris Syringe Pump is at your sole risk, and CareFusion does not provide any warranty for or endorsement on any battery packs that are not manufactured by CareFusion.
  • Page 43 If you wish to discard electrical and electronic equipment, please contact your CareFusion affiliate office or distributor for further information.

  • Page 44: Occlusion Pressure Limits

    Alaris™ PK Plus Syringe Pump Occlusion Pressure Limits Occlusion Pressure Limits Time to alarm following occlusion is achieved in less than 30 minutes at rates of 1 ml/h and higher by the appropriate selection of occlusion levels. The following graphs show the typical values for time to alarm and bolus volume that can be expected in the event of an occlusion when the BD Plastipak 50 ml syringe is selected with a G40020B standard extension set.

  • Page 45: Irda, Rs232 And Nurse Call Specification

    Alaris™ PK Plus Syringe Pump IrDA, RS232 and Nurse call Specification IrDA, RS232 and Nurse call Specification IrDA / RS232 / Nurse call Feature The IrDA or RS232 / Nurse call is a feature on the Pump that allows connection to a PC or another Alaris Syringe Pump. This allows data to be transferred between the Pump and a PC or another Alaris Syringe Pump, (e.g.
  • Page 46 Alaris™ PK Plus Syringe Pump IrDA, RS232 and Nurse call Specification RS232 / Nurse call Connection Data Nurse call Specification - Connector D Type - 9 Pin TXD/RXD EIA RS232-C Standard TXD Output Voltage Range Minimum: -5V (mark), +5V (space) Typical: -7V (mark), +7V (space) with 3kΩ...

  • Page 47: Trumpet Curves And Start-Up Curves

    Alaris™ PK Plus Syringe Pump Trumpet Curves and Start-up Curves Trumpet Curves and Start-up Curves In this Pump, as with all infusion systems, the action of the pumping mechanism and variations in individual syringes cause short-term fluctuations in rate accuracy. The following curves show typical performance of the system in two ways: 1) the delay in onset of fluid flow when infusion commences (start-up curves), and 2) the accuracy of fluid delivery over various time periods is measured (trumpet curves).

  • Page 48: Profiles From Tci Mode

    Alaris™ PK Plus Syringe Pump Profiles from TCI Mode Profiles from TCI Mode When targeting in TCI Mode the Alaris PK Plus Syringe Pump will automatically calculate the flow rate profile from the specific pharmacokinetic/pharmacodynamic model for the selected drug. This section of the Directions For Use is intended to help users understand the profiled infusion and the performance accuracy attained from the TCI Pump.
  • Page 49 Alaris™ PK Plus Syringe Pump Profiles from TCI Mode Infusion Rate vs Target Concentration Diprivan 1% Marsh Model BD 50ml Syringe Diprivan 2% Marsh Model BD 50ml Syringe • Patient Age: 40 Years • Patient Age: 40 Years • Patient Weight: 60kg •...
  • Page 50 Alaris™ PK Plus Syringe Pump Profiles from TCI Mode Predicted vs Ideal Concentration Diprivan 1% Marsh Model BD 50ml Syringe Diprivan 2% Marsh Model BD 50ml Syringe • Patient Age: 40 Years • Patient Age: 40 Years • Patient Weight: 60kg •...

  • Page 51: Products And Spare Parts

    A comprehensive list of spare parts for this Pump is included within the Technical Service Manual. The Technical Service Manual (1000SM00001) is now available in electronic format on the World Wide Web at :- www.carefusion.co.uk/alaris-technical/ A username and password are required to access our manuals. Please contact a local customer services representative to obtain login details.

  • Page 52: Service Contacts

    Alaris™ PK Plus Syringe Pump Service Contacts Service Contacts For service contact your local Affiliate Office or Distributor. CareFusion, CareFusion, CareFusion, CareFusion, PO Box 5527, Tullastr. 8-12 Döbrentei tér 1, Avda. São Miguel, 296 Atelier 14 Dubai, United Arab Emirates.
  • Page 53 Alaris™ PK Plus Syringe Pump Service Contacts Page Intentionally Left Blank 1000DF00741 Issue 5 52/52...
  • Page 54 CareFusion, Alaris, IVAC, SmartSite and the CareFusion logo are trademarks or registered trademarks of CareFusion Corporation or one of its affiliates. All rights reserved. All other trademarks are property of their respective owners. © 20178 CareFusion Corporation or one of its affiliates.

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