Cardinal Health Alaris PK Directions For Use Manual Download Page 14

1000DF00005 Iss. 2

13/44

 Operating Precautions (continued)

Electromagnetic Compatibility & Interference

M

  This pump is protected against the effects of external interference, including high energy radio frequency 

emissions, magnetic fields and electrostatic discharge (for example, as generated by electrosurgical and 
cauterising equipment, large motors, portable radios, cellular telephones etc.) and is designed to remain 
safe when unreasonable levels of interference are encountered.

  This pump is a CISPR 11 Group 1 Class A device and uses RF energy only for its internal function in the normal 

product offering. Therefore, its RF emissions are very low and are not likely to cause any interference with 
the nearby electronic equipment. However, this pump emits a certain level of electromagnetic radiation 
which is within the levels specified by IEC/EN60601-1-2 and IEC/EN60601-2-24. If the pump interacts with 
other equipment, measures should be taken to minimise the effects, for instance by repositioning or 
relocation.

K

  In some circumstances the pump may be affected by an electrostatic discharge through air at levels close 

to or above 15kv; or by radio frequency radiation close to or above 10v/m. If the pump is affected by 
this external interference the pump will remain in a safe mode; the pump will duly stop the infusion and 
alert the user by generating a combination of visual and audible alarms. Should any encountered alarm 
condition persist even after user intervention, it is recommended to replace that particular pump and 
quarantine the pump for the attention of appropriately trained technical personnel. (Consult Technical 
Service Manual for further information).

Hazards

B

  An explosion hazard exists if the pump is used in the presence of flammable anaesthetics. Exercise care to 

locate the pump away from any such hazardous sources. 

A

  Dangerous Voltage: An electrical shock hazard exists if the pump’s casing is opened or removed. Refer all 

servicing to qualified service personnel.

  When connected to an external power source, a three-wire (Live, Neutral, Earth) supply must be used. If the 

integrity of the external protective conductor in the installation or its arrangement is in doubt, the pump 
should be operated from the battery.

V

  Do not open the  

RS232/ 

Nurse Call protective covering when not in use. Electrostatic discharge

(ESD) precautions are required when connecting  

RS232/ 

Nurse Call. Touching the pins of the

connectors may result in ESD protection failure. It is recommended that all actions must be taken by
appropriately trained personnel.

L

  If this pump is dropped, subjected to excessive moisture, fluid spillage, humidity or high temperature, or 

otherwise suspected to have been damaged, remove it from service for inspection by a qualified service 
engineer.  When transporting or storing the pump, use original packaging where possible, and adhere 
to temperature, humidity and pressure ranges stated in the Specifications section and on the outer 
packaging.

  The embedded pump software incorporates  limits and pump configuration parameters. Qualified personnel 

must ensure the appropriateness of the limits, the compatibility of the drugs, and the performance of each 
pump, as part of the overall infusion. Potential hazards include drug interactions, and inappropriate delivery 
rates and pressure alarms.

Latex Content

  The Alaris® PK Syringe Pump does not contain any Latex.

Summary of Contents for Alaris PK

Page 1: ...Directions For Use English Alaris PK Syringe Pump...

Page 2: ...tting Started 14 Basic Features 19 Operations During Use 21 Alarms and Warnings 23 Prompts 24 Configured Options 25 Specifications 29 Compatible Syringes 30 Associated Products 30 Compatible Extension...

Page 3: ...escribed 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 e...

Page 4: ...ation based on clinical judgement When a concentration in the plasma compartment is targeted this is called open loop plasma targeted TCI When a certain concentration at the effect compartment is targ...

Page 5: ...l science Edited by Breimer DD Crommelin DJA Midha KK Noordwijk Amsterdam Med Press BV 1989 pp 573 586 2 Kruger Theimer E Continuous intravenous infusion and multicompartment accumulation Eur J Pharma...

Page 6: ...Vc 5 1 0 0201 x age 40 0 072 x lbm 55 V2 9 82 0 0811 x age 40 0 108 x lbm 55 V3 5 42 CL1 2 6 0 0162 x age 40 0 0191 x lbm 55 CL2 2 05 0 0301 x age 40 CL3 0 076 0 00113 x age 40 k10 Cl1 Vc k12 Cl2 Vc k...

Page 7: ...be printed reviewed and signed as proof of approval by an authorised person according to Hospital protocol Signed printout to be kept safe for use during verification procedure Release Data Set status...

Page 8: ...ON OFF RUN HOLD PURGE BOLUS MUTE PRESSURE OPTION Extension set hook Finger Grips Extension set hook Release lever for Rotating Cam Carrying Handle IR Communications port RS232 Connector Folded Pole C...

Page 9: ...key to operate PURGE the extension set during set up Pump is on hold Extension set is not connected to the patient Volume Infused VI is not added BOLUS fluid or drug delivered at an accelerated rate P...

Page 10: ...onnector Optional Defibrillation proof type CF applied part Degree of protection against electrical shock O Protected against vertically falling drops of water r Alternating Current s Device complies...

Page 11: ...Selecting the MORE softkey will display the following additional information Patient Parameters Time to End of Infusion at Current Rate Volume and Dose Infused Elapsed Time Drug Name and Model Press...

Page 12: ...played on protocol confirmation screen E Duration of Hands Free Bolus Displayed in bolus set up screen F Maintenance Phase Dose Rate Displayed on protocol confirmation screen SOFT ALERT Indicates the...

Page 13: ...ould regularly monitor the progress of the infusion syringe extension line and patient connections and follow the priming procedure specified herein Operating Environment When using any infusion pump...

Page 14: ...trained technical personnel Consult Technical Service Manual for further information Hazards B An explosion hazard exists if the pump is used in the presence of flammable anaesthetics Exercise care t...

Page 15: ...hours to ensure that the internal battery is charged verify that the S is lit Language Selection 1 On initial start up the pump will display the Select Language screen 2 Select the required language f...

Page 16: ...cking Station Asena IDS Docking Station and Alaris Gateway Workstation Docking Station Workstation or Equipment Rail Installation Rectangular bar Rotating cam Release lever push to release Getting Sta...

Page 17: ...the syringe clamp and the syringe flange clamp This is correct if the syringe remains in position before the syringe clamp is closed 2 Insert the syringe ensuring that the barrel flange is located in...

Page 18: ...luid flows and the purging of the extension set is complete Release the softkey The volume used during purging will be displayed 12 Connect To Patient Connect the extension set to the patient access d...

Page 19: ...e cap rate will be cleared when first titration occurs 11 Target Concentration Cpt or Cet Adjust the Target Concentration if necessary using the f keys Confirm the Target Concentration and Initial Inf...

Page 20: ...ted The bolus volume is limited in the con guration 1 During infusion press the i button once to display the bolus screen 2 Use the f keys to adjust the bolus rate if required 3 To deliver the bolus p...

Page 21: ...nfusing at the new rate If Rate Titration is disabled the rate can only be adjusted whilst on hold 1 Press the h button to put the pump on hold 2 Select the new rate using the f keys 3 Press the b but...

Page 22: ...e initial doserate will be set to zero TREND SIZE The user is able to select the Trend Size of the Concentration Prediction graph 1 Press the d button to access the options menu 2 Using the f keys sel...

Page 23: ...softkey indicated on the screen A confirmation screen will be displayed DATA SET DETAILS To review the currently selected Data Set information 1 Press the d button to access the options menu 2 Select...

Page 24: ...F INFUSION The pump has reached the end of the infusion A pre set volume will remain in the syringe to minimise the risk of the infusion of air bubbles into the set This value can be configured TITRAT...

Page 25: ...OVERRIDE LIMIT is not required press the NO softkey and adjust rate below Soft Alert BOLUS DOSE OVER The bolus dose has been set to a value which exceeds a Soft Alert Check the bolus setting to conti...

Page 26: ...u Language This option is used to set the language of messages shown on the pump display 1 Select LANGUAGE from the Configured Options menu using the f keys and press the OK softkey 2 Use the f keys t...

Page 27: ...splay Purge Rate The rate used during purge operation Purge Volume Max The maximum permissible purge volume Purge Syringe Prompt Feature which prompts the user to purge the extension set prior to the...

Page 28: ...meters Induction ON OFF Enables Disables induction stage of TIVA protocol Dosing Units The induction dose units This can be based on patient weight Default Dose The default induction dose offered Defa...

Page 29: ...Maintenance Hard Max 20mg kg h 20mg kg h 2 g kg min 2 g kg min 2 g kg h Default Bolus Rate 1200ml h 600ml h 600ml h 600ml h 1200ml h Default Bolus 1 0mg kg 1 0mg kg 1 0 g kg 1 0 g kg 0 15 g kg Bolus S...

Page 30: ...ump is connected to AC power Battery life is typically 4h from fully charged 5 0ml h 20 C under normal conditions Charging takes 2 hours from discharge to 90 charge In TCI mode a fully charged battery...

Page 31: ...sed syringe with a large diameter barrel To provide protection against accidental dislodging always ensure the infusion line is secured using the infusion set hook see Loading a Syringe section TYCO H...

Page 32: ...lve low priming volume 209cm MFX 2291 2 way set with anti syphon valve and backcheck valve low priming volume 209cm MFX 2284 3 way tap blue with extension 100cm MFX 2280E 3 way tap with extension and...

Page 33: ...in accordance with the information supplied Cardinal Health will not be responsible should any of these actions be performed outside the instructions or information supplied by Cardinal Health Refer...

Page 34: ...ensure that the internal battery is fully charged A Before cleaning always switch OFF and disconnect from the AC power supply Never allow liquid to enter the casing and avoid excess fluid build up on...

Page 35: ...ssure 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...

Page 36: ...nddigitalcomponents are required to meet IEC EN60950 for data processingandIEC EN60601formedicaldevices Anyone connecting additional devices to the signal input or output is a system configurator and...

Page 37: ...e As the observation window is reduced short term fluctuations have greater effects as represented by the mouth of the trumpet Knowledge of system accuracy over various observation windows may be of i...

Page 38: ...than 5 2 By measuring the volume from the flow rate profile delivered from the Alaris PK Syringe Pump and then introducing this into a reverse pharmacokinetic model the predicted plasma or effect con...

Page 39: ...umetric Accuracy 0 4 0 5 10 15 20 25 30 35 40 45 50 55 60 65 70 75 80 0 5 10 15 20 25 30 35 40 45 50 55 60 0 0 0 5 1 0 1 5 2 0 2 5 3 0 3 5 4 0 0 5 10 15 20 25 30 35 40 45 50 55 60 65 70 75 80 0 5 10 1...

Page 40: ...lasma Concentration ng ml Ideal Plasma Concentration g ml 0 0 0 5 1 0 1 5 2 0 2 5 3 0 3 5 4 0 0 5 10 15 20 25 30 35 40 45 50 55 60 0 0 0 5 1 0 1 5 2 0 2 5 3 0 3 5 4 0 Patient Age 75 Yrs Patient Weight...

Page 41: ...n the Alaris Infusion System product family are 1 are also available without an RS232 option fitted contact local customer services representative to obtain part number details 2 For Docking Stations...

Page 42: ...Ndabeni Cape Town 7405 South Africa Tel 27 0 860 597 572 Tel 27 21 510 7562 Fax 27 21 5107567 BE Cardinal Health Otto De Mentockplein 19 1853 Strombeek Bever Belgium Tel 32 2 267 38 99 Fax 32 2 267 99...

Page 43: ...d promptly properly packaged and postage prepaid by purchaser Loss or damage in return shipment to Cardinal Health shall be at purchaser s risk In no event shall Cardinal Health be liable for any inci...

Page 44: ...31 F Fuses 32 G General Options 25 H Hands Free 19 Hands On 19 I Indicators AC POWER 8 BATTERY 8 Installation 15 Introduction 2 IrDA 35 L Labelling Symbols 9 Language 14 25 Loading a Syringe 16 M Mai...

Page 45: ...1000DF00005 Iss 2 44 44 Page Intentionally Left Blank...

Page 46: ...ment contains proprietary information of Cardinal Health Inc or one of its subsidiaries and its receipt or possession does not convey any rights to reproduce its contents or to manufacture or sell any...

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