Hospira Lifecare PCA3 Operating Manual
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Hospira Lifecare PCA3 Operating Manual

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System
Operating
Manual
Hospira, Inc., Lake Forest, IL 60045, USA
430-04684-002 (Rev. 01/06)

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Summary of Contents for Hospira Lifecare PCA3

  • Page 1 System Operating Manual Hospira, Inc., Lake Forest, IL 60045, USA 430-04684-002 (Rev. 01/06)
  • Page 2 Change History Pages Title Description of Change Affected 430-04684-001 Initial Release (Rev. 1/05) 430-04684-002 Second Release (Rev. 01/06) 430-04684-002 (Rev. 01/06)

  • Page 3: Table Of Contents

    LifeCare PCA 3 Infusion System Contents 1) DESCRIPTIVE INFORMATION ....1-1 1.1 P ....1-1 RODUCT ESCRIPTION 1.2 I...
  • Page 4 Contents 3) EQUIPMENT DESCRIPTION ....3-1 3.1 C ......3-1 OMPONENTS 3.2 O &...
  • Page 5 LifeCare PCA 3 Infusion System to clear or change dose limit ....5-22 clearing the history & Rx settings... 5-23 5.7 U .
  • Page 6 Hospira retains all the exclusive rights of dissemination, reproduction, manufacture and sale. Any party using this document accepts it in confidence, and agrees not to duplicate it in whole or in part nor disclose it to others without the written consent of Hospira. 430-04684-002...

  • Page 7: Descriptive Information

    1- 1 Descriptive Information ® The LifeCare PCA 3 Infusion System is the newest Hospira ® LifeCare PCA device. Like its predecessor, the PCA Plus II, the PCA 3 system can be used in a wide range of clinical settings,...

  • Page 8: Indications For Use

    The vials are single-use, bar coded and prefilled with a prescription drug by , or sterile and empty to be custom- Hospira filled by the hospital pharmacy. The PCA 3 system is capable of the following modes of delivery: PCA ONLY •...

  • Page 9: User Qualification

    LifeCare PCA 3 Infusion System 1- 3 WARNING F O R E P I D U R A L U S E , A D M I N I S T E R O N L Y ANESTHETICS/ANALGESICS APPROVED FOR EPIDURAL ADMINISTRATION (AS INDICATED OR ALLOWED BY THE DRUGS’...

  • Page 10: Conventions

    1- 4 1) Descriptive Information 1.4 Conventions This section describes the conventions used throughout this manual, as follows: ONVENTION PPLICATION XAMPLE Italic Reference to a (See Section 3-1, section, figure, or Components) table Primary Only: Function or mode Attach an empty specific container.
  • Page 11 LifeCare PCA 3 Infusion System 1- 5 WARNING A WARNING MESSAGE CONTAINS SPECIAL SAFETY EMPHASIS AND MUST BE OBSERVED AT ALL TIMES. FAILURE TO OBSERVE A WARNING MESSAGE IS POTENTIALLY LIFE THREATENING. CAUTION: A CAUTION USUALLY APPEARS IN FRONT OF A PROCEDURE OR STATEMENT T CONTAINS INFORMATION THAT COULD PREVENT IRREVERSIBLE PRODUCT DAMAGE OR...

  • Page 12: Definitions (General And Clinical)

    (see product specification, Section Continuous Infusion therapy characterized by a constant fixed-rate dose. Custom Syringe or Bar coded Hospira sterile empty Vial vial which is custom-filled by a licensed pharmacy. Default Generally refers to the factory setting for parameters or options.
  • Page 13 LifeCare PCA 3 Infusion System 1- 7 EFINITION Lockout Interval Programmed time interval specifying the minimum time that must pass after a PCA dose or Loading Dose is administered before the next PCA dose can be infused. The bolus requests made during this period are not delivered.

  • Page 14: Precautions

    1- 8 1) Descriptive Information EFINITION Prime Manually removing air from the syringe and line. Purge Running the mechanism to remove system slack when a new vial/ injector is installed. (The system must be primed first and disconnected from the patient.) Warning An indication to advise the clinician:...

  • Page 15: General

    LifeCare PCA 3 Infusion System 1- 9 physiological signals. To determine if the abnormality in the monitoring equipment is caused by the infusion device instead of some other source in the environment, set the infusion device so that it is temporarily not delivering fluid.

  • Page 16: Programming

    Arrange tubing, cords, and cables to minimize the risk of • patient strangulation or entanglement. Failure to use Hospira vials and Hospira PCA sets with • integral anti-siphon valve may cause an inaccurate dose delivery to the patient.

  • Page 17: Loading Dose/Dose Limits

    LifeCare PCA 3 Infusion System 1- 11 At flow rates less than 0.5 mL/hr, there may be a • significant delay before flow is established if system is not purged. Selections are rounded up to the nearest tenth of a digit •...

  • Page 18: Operation

    Some cleaning and sanitizing compounds may slowly • degrade components made from some plastic materials. Using abrasive cleaners or cleaning solutions not recommended by Hospira may result in product damage. Do not use compounds containing combinations of isopropyl alcohol and dimethyl benzyl ammonium chloride.

  • Page 19: Alarms

    LifeCare PCA 3 Infusion System 1- 13 Hospira will be responsible for the effect on safety, • reliability, and performance of this device only if: adjustments, modifications, or repairs are performed by persons authorized by Hospira; the electrical setup at the point of use complies with appropriate local requirements;...

  • Page 20: Battery Operation

    1- 14 1) Descriptive Information and patient management problems. Proper epidural placement of the catheter is essential since catheter migration could result in intravascular or intrathecal administration. Facilities practicing epidural administration must be equipped with resuscitative equipment, oxygen, naloxone, and other resuscitative drugs.

  • Page 21: Sets And Accessories

    If the low-battery alarm sounds, connect to AC power • immediately. SETS AND ACCESSORIES Use Hospira Lifecare PCA Set List 6517 whenever the pump is in CONTINUOUS or PCA+CONTINUOUS modes. When using PCA or PCA+CONTINUOUS mode, another • fluid line may be attached to the distal backcheck “Y”...
  • Page 22 1- 16 1) Descriptive Information NOTES 430-04684-002...

  • Page 23: Principles Of Operation

    LifeCare PCA 3 Infusion System 2- 1 Principles of Operation The PCA 3 Infuser is a portable infusion pump that allows a patient to self-administer analgesia within programmed limits as well as providing continuous infusion of desired drug. Generally, a nurse following a physician’s order programs the infuser with operating parameters, which may include the following: Loading Dose...

  • Page 24: Features

    2.1 Features DRUG RECOGNITION Bar code reader identifies drug name and concentra- • tion in the vial (prefilled Hospira vials only) Bar code reader identifies custom-filled vials when • pharmacy-filled vial is used MODES OF DELIVERY PCA Only •...

  • Page 25: Programming

    BIO MEDICAL Serial Communication • Upgradability (Field) • Diagnostics Setup Options • Alarm History • Ability to store protocols for Hospira prefilled vials • OPTIONS Infusion History • OTHER FEATURES Microprocessor control • Liquid crystal display (LCD) and Light-Emitting •...

  • Page 26: Administration Equipment

    2- 4 2) Principles of Operation 2.2 Administration Equipment The following sets and catheters are supplied sterile and are for single use only. ADMINISTRATION SETS List 3559: PCA Set, Mini-Bore with Integral Anti- Siphon Valve-SL 170 cm. Approximate Priming Volume 2.3 mL. For use in PCA mode via Intravenous route.

  • Page 27: Printer Kits

    LifeCare PCA 3 Infusion System 2- 5 2.3 Printer Kits List Complete thermal printer kit includes: 12406-01: printer, connector cable, battery pack, AC adaptor, & paper pack. List Connector cable only 12406-02: ** See current product sales catalog for available drugs ** 430-04684-002...
  • Page 28 2- 6 2) Principles of Operation NOTES 430-04684-002...

  • Page 29: Equipment Description

    LifeCare PCA 3 Infusion System 3- 1 Equipment Description 3.1 Components Security Vial Cradle Door Release Mechanism Display (Holder) Display Vial Cradle Softkeys Clips Door code Lock Reader Window Keypad Buttons Injector Power Indicator Battery Vial Power Plunger Indicator Basic Layout of Front Panel and Keypad 430-04684-002...
  • Page 30 3- 2 3) Equipment Description Cradle Release Upper Vial Mechanism Retainer Vial Base Bar code Vial Cradle Reader Clips Window (Vial Bar code must Vial Sensor face) Switch (Top Vial Vial Cradle Stopper Clip) Vial Lip Lower Vial Retainer (Middle Bracket) Injector Injector...
  • Page 31 LifeCare PCA 3 Infusion System 3- 3 Ground Patient Patient Printer Test Point Pendant Pendant Connector Jack Button Patient Pendant Cable fastener PCA 3 Patient Pendant (blue handle) Universal IV Pole Clamp with Dual Lock NOTE: Pole Clamp is locked when security door is closed and locked.

  • Page 32: Operating Buttons & Keys

    3- 4 3) Equipment Description 3.2 Operating Buttons & Keys The [ON/OFF] button is used to control the power of the PCA 3 instrument. The [CLEAR] button is used to clear an entry. The [ENTER] button ENTER is used to select and accept various screen options.
  • Page 33 LifeCare PCA 3 Infusion System 3- 5 The [SILENCE/ VOLUME] button is SILENCE used to temporarily VOLUME silence an alarm while correcting a condition or to adjust alarm volume when the pump is in run mode. The [START/PAUSE] button is used to START start or pause a PAUSE...
  • Page 34 3- 6 3) Equipment Description The numeric buttons are used to enter values for any field requiring numeric data. The [DECIMAL POINT] button is used for entering numbers with a decimal point. An example would be 10.5 mL. Keys (or Softkeys) are touchkeys which are located to the right of the main display.
  • Page 35 LifeCare PCA 3 Infusion System 3- 7 AC (mains) power indicator illuminates when pump is plugged into AC power. LED displays the dose delivered. When displaying dose delivery in micrograms, a vertical “walking stick” appears on the right side of the display.
  • Page 36 3- 8 3) Equipment Description PCA 3 Patient Pendant is used by the patient to deliver the drug upon the press of the button. WARNING PATIENT PENDANT IS ONLY TO BE PRESSED B Y T H E I N T E N D E D PATIENT.

  • Page 37: Basic Operation

    Use care when unpacking the PCA 3. Retain the packing slip and save all packing material in case the PCA 3 is damaged or fails the pump self-test and has to be returned to Hospira. Inspect the PCA 3 thoroughly for damage.

  • Page 38: System Self-Tests

    4- 2 4) Basic Operation SYSTEM SELF-TESTS Connect the AC power (mains) cord to an AC power receptacle, then confirm that the power plug icon is illuminated on the front of the pump. A systematic self-testing of the processing, delivery, and safety systems is performed whenever the PCA 3 is turned on, to verify readiness for operation.

  • Page 39: Data Retention

    4- 3 Power the pump ON. If the alarm recurs, remove the PCA 3 from service and contact the hospital biomedical department or your local Hospira representative. DATA RETENTION Delivery program settings and programming option selections are retained in memory.

  • Page 40: Epidural Pca Administration

    4- 4 4) Basic Operation EPIDURAL PCA ADMINISTRATION NOTE: The administration of drugs is restricted to those analgesic drugs approved for continuous epidural administration. Recommended use of the epidural route is for labor and delivery, acute pain control, or post-operative analgesia for periods up to 96 hours.
  • Page 41 LifeCare PCA 3 Infusion System 4- 5 CAUTION: E PIDURAL ADMINISTRATION OF DRUGS BY ONTINUOUS MODES SHOULD BE LIMITED TO PERSONNEL FAMILIAR WITH ASSOCIATED TECHNIQUES AND PATIENT MANAGEMENT PROBLEMS ROPER EPIDURAL PLACEMENT OF THE CATHETER IS ESSENTIAL SINCE CATHETER MIGRATION COULD RESULT IN INTRAVASCULAR AND INTRATHECAL ADMINISTRATION ACILITIES PRACTICING CONTINUOUS EPIDURAL ADMINISTRATION MUST BE EQUIPPED...

  • Page 42: Loading Vial

    4) Basic Operation 4.3 Loading Vial WARNING FAILURE TO USE COMPATIBLE HOSPIRA VIAL/ INJECTOR AND HOSPIRA PCA SETS WITH INTEGRAL ANTI-SIPHON VALVE MAY CAUSE AN INACCURATE DOSE DELIVERY TO THE PATIENT. 1. Squeeze Cradle Release Mechanism together at the top of the holder and move to the uppermost position.

  • Page 43: Adjusting Settings

    LifeCare PCA 3 Infusion System 4- 7 CAUTION: V IAL AND INJECTOR MUST BE SECURELY LOCKED INTO THE INFUSER BEFORE BEGINNING DELIVERY WARNING CRACKED VIALS MAY NOT SHOW EVIDENCE OF LEAKAGE UNTIL DELIVERY PRESSURE IS APPLIED. NOTE: If the device is OFF, improper loading of syringe will turn ON the device and activate a non-silenceable CHECK SYRINGE alarm within 30 seconds after >...

  • Page 44: Changing Alarm Volume

    4- 8 4) Basic Operation 3) Choose the setting to change by selecting the SELECT appropriate softkey. SETTING TO CHANGE VOLUME CONTRAST TIME/DATE CONTINUE CHANGING ALARM VOLUME 1) Select V >. OLUME SELECT SETTING TO CHANGE VOLUME CONTRAST TIME/DATE CONTINUE 2) Select desired volume, then S &...

  • Page 45: Changing Contrast Of Main Display

    LifeCare PCA 3 Infusion System 4- 9 CHANGING CONTRAST OF MAIN DISPLAY 1) Select C >. ONTRAST SELECT SETTING TO CHANGE VOLUME CONTRAST TIME/DATE CONTINUE 2) Select desired adjustment softkey repeatedly until ADJUST LCD contrast is optimized for CONTRAST TO DESIRED LEVEL viewing.
  • Page 46 4- 10 4) Basic Operation 1) Select T >. SELECT SELECT After selecting T >, a warning SETTING SETTING screen appears to inform you that TO CHANGE TO CHANGE changing the date or time will clear all VOLUME totals. The current program will remain CONTRAST intact when the time/date function is TIME/DATE...
  • Page 47 LifeCare PCA 3 Infusion System 4- 11 4) After changing time, select > to change Date. Set SET DATE WITH date with numbers buttons. NUMBERS BUTTONS 01/15/05 Current setting for Date will flash. NOTE: Date must be entered in MM/DD/YY sequence. NEXT 5) Select N >...

  • Page 48: Guided Start-Up For Prefilled Vials

    4- 12 4) Basic Operation 4.5 Guided Start-Up for Prefilled vials 1) Press button, or load LIFECARE PCA 3 drug vial into cradle, to power SELF TEST on the pump. Upon initial start-up, the self-test begins. (See Section 4.3) This screen will be followed by another displaying all self-test information, including time, date, software version and copyright information.

  • Page 49: Purging The System

    LifeCare PCA 3 Infusion System 4- 13 4) Select either Y > or N > MORPHINE to clear history and dose 1 mg/mL CLEAR settings if pump has been HISTORY AND OFF for 1 hour or less. RX SETTINGS? 5) Select C >...
  • Page 50 4- 14 4) Basic Operation After the pump is turned on, and the self-tests complete, you are prompted to purge the system. Confirm the PCA set is disconnected from the patient’s IV line before pressing Y > to initiate the purge cycle. Press and hold the P >...

  • Page 51: Loading Dose

    LifeCare PCA 3 Infusion System 4- 15 7) If Y > is selected, MORPHINE disconnect the set from the 1 mg/mL patient, and press and hold DISCONNECT SET FROM the P > softkey. PATIENT URGE PRESS AND HOLD PURGE KEY While purging is occurring, the word PURGING will be displayed.
  • Page 52 4- 16 4) Basic Operation NOTE: A supplemental (booster) dose can be delivered at any time during operation by opening the door and selecting the L > key. If the 4 (1) Hr Dose OADING Limit is set and has been reached, using the loading dose function may result in exceeding the dose limit.

  • Page 53: Guided Start-Up For Custom Vials

    LifeCare PCA 3 Infusion System 4- 17 Example screen displaying Loading MORPHINE Dose Value as it infuses. Bottom of 1 mg/mL screen displays text confirming PRESS PAUSE BUTTON Loading Dose is active. Upon TO STOP completion, Red LED (above LCD) displays Dose Delivered.
  • Page 54 4- 18 4) Basic Operation 3) Select C > to accept ONFIRM CUSTOM VIAL the inserted drug or remove CONFIRM the vial if not correct. CUSTOM VIAL TO RX REMOVE VIAL IF NOT CORRECT CONFIRM 4) Select either Y > or N >...
  • Page 55 LifeCare PCA 3 Infusion System 4- 19 6) Select either Y > or N > CUSTOM VIAL to purge the system. PURGE? 7) If Y > is selected, CUSTOM VIAL disconnect the set from the patient, and press and hold DISCONNECT SET FROM the P...
  • Page 56 4- 20 4) Basic Operation 10) Select desired Units of CUSTOM VIAL Measure. SELECT UNITS OF MEASURE For the purposes of this instruction, Micrograms is selected. MILLIGRAMS (mg) MICROGRAMS (mcg) 11) Enter desired Drug CUSTOM VIAL Concentration within the ENTER DRUG displayed range.
  • Page 57 LifeCare PCA 3 Infusion System 4- 21 14) Set Loading Dose (if CUSTOM VIAL desired) by selecting Y >. 10 mcg/mL SET LOADING DOSE? If N > is selected, you will go directly to the Select Mode screen. Information on modes can be found in Section 5.
  • Page 58 4- 22 4) Basic Operation Example screen displaying Loading CUSTOM VIAL Dose Value as it infuses. Bottom of 10 mcg/mL screen displays text confirming PRESS PAUSE BUTTON Loading Dose is active. Upon TO STOP completion, Red LED (above LCD) displays Dose Delivered. 25 mcg This will bring you to the Select Mode micrograms...

  • Page 59: Select Mode

    PCA+CONTINUOUS PROTOCOLS Pre-programmed settings for the 3 delivery modes, created in the Service Mode for Hospira prefilled drug vials. For information on using the Service Mode, contact Hospira Technical Support Operations at 1-800-241-4002. NOTE: Protocols not available for Custom Vials.

  • Page 60: Continuous

    5- 2 5) Select Mode CONTINUOUS A programmed continuous infusion is started by pressing the [START/PAUSE] button after the door is closed and locked. The patient pendant is disabled in CONTINUOUS mode. Upon reaching the DOSE LIMIT, if entered, the pump stops drug delivery and the 4 (or 1)-HR LIMIT REACHED message is displayed.

  • Page 61: Programming Pca Only

    LifeCare PCA 3 Infusion System 5- 3 5.2 Programming PCA Only For detailed Startup information including Vial Insertion, Clearing Settings, Purging, and setting a Loading Dose, see Section 4. Also refer to Section 4 for information on adjusting system settings such as contrast and volume. 1) Unlock door and press LIFECARE PCA 3 button, or load drug vial into...
  • Page 62 5- 4 5) Select Mode 8) Select Y > to continue, or select N > to purge again until complete. 9) Reconnect Set to patient. 10) Set Loading Dose (if desired) by selecting >. 11) Enter a Loading Dose within the displayed range.
  • Page 63 LifeCare PCA 3 Infusion System 5- 5 15) Enter the desired PCA MORPHINE dose using the numeric 1 mg/mL ENTER keypad. (Value range is PCA DOSE displayed on screen) THEN PRESS ENTER BUTTON 0.1-5 mg If value is entered incorrectly, press 2 mg to change value.
  • Page 64 5- 6 5) Select Mode NOTE: See Section 5.6 Dose Limit (1 or 4 hour) for complete information on this feature. 20) Select C > to ONFIRM MORPHINE 1 mg/mL confirm No Dose Limit CONFIRM NO selection. DOSE LIMIT Select P >...

  • Page 65: Continuous Mode

    LifeCare PCA 3 Infusion System 5- 7 When Dose Limit is reached, a message will be displayed indicating Dose Limit has been reached. 5.3 Continuous Mode For detailed Startup information including Vial Insertion, Clearing Settings, Purging, and setting a Loading Dose, see Section 4. Also refer to Section 4 for information on adjusting system settings such as contrast and volume.
  • Page 66 5- 8 5) Select Mode 7) If Y > is selected, disconnect the set from the patient, and press and hold the P > softkey. URGE 8) Select Y > to continue, or select N > to purge again until complete. 9) Reconnect Set to patient.
  • Page 67 LifeCare PCA 3 Infusion System 5- 9 15) Enter a value using the MORPHINE keypad. (Value range is 1 mg/mL ENTER displayed on screen) CONT. RATE THEN PRESS ENTER BUTTON 0.1-20 mg/hr If value is entered incorrectly, press to change value. milligrams 16) Then press ENTER...

  • Page 68: Pca + Continuous Mode

    5- 10 5) Select Mode 19) Select C > to ONFIRM MORPHINE 1 mg/mL confirm settings. CONTINUOUS PCA DOSE Or, select P > to return to the REVIOUS LOCKOUT previous screen. CONT. RATE 2 mg/hr 4 HOUR LIMIT 20) Close and lock door. NONE Place key in a secure location.
  • Page 69 LifeCare PCA 3 Infusion System 5- 11 1) Unlock door and press LIFECARE PCA 3 button, or load drug vial into SELF TEST cradle, to power on the pump. Upon initial start-up, the self- test begins. 2) Select C > to ONTINUE advance to next programming screen.
  • Page 70 5- 12 5) Select Mode range. 12) Then press ENTER 13) Press button to infuse programmed Loading Dose. 14) From the Select Mode MORPHINE screen, select PCA + .>. 1 mg/mL CONT SELECT DELIVERY MODE PCA ONLY PCA + CONT CONTINUOUS PROTOCOLS PREVIOUS...
  • Page 71 LifeCare PCA 3 Infusion System 5- 13 17) Enter a Lockout Interval MORPHINE value. (Value range is 1 mg/mL ENTER LOCKOUT displayed on screen) INTERVAL THEN PRESS ENTER BUTTON 5-120 min If value is entered incorrectly, press 10 min to change value. minutes 18) Then press ENTER...
  • Page 72 5- 14 5) Select Mode If programming changes need to be made, select P > to REVIOUS return to the previous screen. 21) Set a specific dose limit MORPHINE 1 mg/mL by selecting Y > and SET A DOSE advancing to the Dose Limit LIMIT? Enter Value screen.
  • Page 73 LifeCare PCA 3 Infusion System 5- 15 24) Select C > to ONFIRM MORPHINE confirm settings. 1 mg/mL PCA+CONT PCA DOSE 2 mg Or, select P > to return to the REVIOUS LOCKOUT previous screen. 10 min CONT. RATE 2 mg/hr 4 HOUR LIMIT 25) Close and lock door.

  • Page 74: Protocols

    NOTE: Standard Protocols must be established by hospital through the Service Mode. Protocols can only be established for Hospira prefilled vials. Only Protocols associated with the inserted drug vial will be available. For detailed Startup information including Vial Insertion, Clearing Settings, Purging, and setting a Loading Dose, see Section 4.
  • Page 75 LifeCare PCA 3 Infusion System 5- 17 7) If Y > is selected, disconnect the set from the patient, and press and hold the P > softkey. URGE 8) Select Y > to continue, or select N > to purge again until complete.

  • Page 76: Dose Limit (1 Or 4 Hour)

    5- 18 5) Select Mode 15) Press to accept ENTER MORPHINE PRESS ENTER protocol, or select N TO SELECT > and P > to PCA DOSE ROTOCOL REVIOUS 2 mg view other stored protocols if LOCKOUT 10 min available. 4HOUR LIMIT Press P >...
  • Page 77 LifeCare PCA 3 Infusion System 5- 19 NOTE: A loading or supplemental loading dose is included in the 4 hr dose limit calculation ONLY if it is administered AFTER the 4 hr dose limit has been programmed. If a loading or supplemental loading dose is administered BEFORE a 4 hr dose limit has been programmed, it will NOT be included in the 4 hr dose limit calculation.

  • Page 78: Programming The 4 (Or 1) Hr Dose Limit

    5- 20 5) Select Mode PROGRAMMING THE 4 (OR 1) HR DOSE LIMIT The opportunity to program this feature is presented in two entry screens. The first screen prompts the clinician to choose whether or not to set a Dose Limit. Selecting N >...

  • Page 79: To Program No Dose Limit

    LifeCare PCA 3 Infusion System 5- 21 TO PROGRAM NO DOSE LIMIT: 1) Select N > at the Dose MORPHINE 1 mg/mL Limit Selection screen. SET A DOSE LIMIT? The display will advance to the Confirm No Dose Limit screen. PREVIOUS 2) Select C >...

  • Page 80: To Clear Or Change Dose Limit

    5- 22 5) Select Mode TO CLEAR OR CHANGE DOSE LIMIT 1) Unlock door while pump is MORPHINE running. 1 mg/mL PAUSED PCA+CONT 2) Select C >. HANGE LOCK DOOR TO BEGIN REVIEW RX 3) Select N > to display CHANGE RX more change options.

  • Page 81: Clearing The History & Rx Settings

    LifeCare PCA 3 Infusion System 5- 23 CLEARING THE HISTORY & RX SETTINGS To clear the dose limit history, turn the pump off and on, and press C > when the "CONFIRM TO CLEAR HISTORY ONFIRM AND Rx" screen appears. 430-04684-002...

  • Page 82: Using Review Screens

    5- 24 5) Select Mode 5.7 Using Review Screens REVIEW SCREENS Prior to locking the pump and removing the key, a review screen will appear as shown below. As determined by the programmed mode of delivery, the screen will display the current settings for the applicable parameters (including PCA Dose, Lockout Interval, Continuous Rate, and 4 (1) Hr Dose Limit) MORPHINE...

  • Page 83: Changing Settings During Setup

    LifeCare PCA 3 Infusion System 5- 25 • Clinicians should review each programmed parameter and ensure that the displayed pro- gram agrees with the physician’s order. • If all of the programmed parameters AGREE with the physician’s order, the clinician can confirm the settings by selecting CONFIRM>.

  • Page 84: Stopping Infusion Or Turning Pump Off

    5- 26 5) Select Mode 5.9 Stopping Infusion or Turning Pump STOPPING INFUSION 1) Close slide clamp on PCA administration set. WARNING A L W A Y S C L O S E S L I D E C L A M P O N P C A ADMINISTRATION SET BEFORE REMOVING OR R E P L A C I N G S Y R I N G E ,...

  • Page 85: Making Changes After Setup

    LifeCare PCA 3 Infusion System 5- 27 5.10 Making Changes After Setup TO REVIEW CURRENT SETTINGS HILE NFUSION IS UNNING 1) Press button twice. 2) Press to return to main menu. EXIT HILE NFUSION IS TOPPED 1) Unlock door. MORPHINE 1 mg/mL PAUSED 2) Select R...

  • Page 86: To Change Settings

    5- 28 5) Select Mode TO CHANGE SETTINGS 1) Unlock door while pump is MORPHINE running. 1 mg/mL PAUSED PCA+CONT 2) Select C > to HANGE LOCK DOOR TO BEGIN change individual settings. REVIEW RX CHANGE RX CLEAR SHIFT LOADING DOSE 3) Select desired field to MORPHINE change.

  • Page 87: To Clear Shift Totals

    LifeCare PCA 3 Infusion System 5- 29 If programming changes need to be made, select P > to REVIOUS return to the previous screen. 6) Select S & E > at next screen to confirm desired changes. 7) Select C >...

  • Page 88: To Change A Vial

    5- 30 5) Select Mode 4) Select Y > to clear dose MORPHINE delivered and return to 1 mg/mL previous screen. CLEAR SHIFT TOTALS? NOTE: Selecting Y > will clear PCA Summary data but does not clear 4HR dose limit data 5) Or, select N >...
  • Page 89 LifeCare PCA 3 Infusion System 5- 31 • disconnect the set from the patient • release the slide clamp on the PCA adminis- tration set • select & hold the Purge> key until fluid is seen at the end of the set and no air remains inside the set NOTE: Purging is recommended to remove slack when a new vial is inserted.

  • Page 90: To Add A Supplemental Loading Dose

    5- 32 5) Select Mode TO ADD A SUPPLEMENTAL LOADING DOSE 1) Unlock door while pump is MORPHINE running. 1 mg/mL PAUSED PCA+CONT 2) Select L >. OADING LOCK DOOR TO BEGIN REVIEW RX CHANGE RX CLEAR SHIFT LOADING DOSE 3) Enter a Loading Dose MORPHINE 1 mg/mL...

  • Page 91: Checking History & Settings

    LifeCare PCA 3 Infusion System 5- 33 5.11 Checking History & Settings 1) To Check History or Settings, press button at any time. NOTE: Partial boluses can be the result of interrupting delivery by pressing [START/STOP] (PCA + Cont.), opening the door (PCA Only), loss of power, reaching the dose limit, emptying the vial, or a malfunction alarm.

  • Page 92: Printer Setup

    5- 34 5) Select Mode 4) Continue to press TIME : 8:04 PM DATE : 01/15/01 S/N:12920191 button for more ENTER DELIVERED: information such as: LOADING DOSE •Last Hour Only information 65 MG TOTAL DEL. •Last 24-Hour information 282.6 MG MORE...
  • Page 93 LifeCare PCA 3 Infusion System 5- 35 To program the Seiko printer, hold the "ONLINE" button while turning on the power. The printer will then display (on the paper tape output) the configuration it has stored in memory, and prompt the user for input. The print-out of the user settings should look like the following: [DIP SW setting mode] Dip SW-1...
  • Page 94 5- 36 5) Select Mode If the above is already configured, press the [PAPER FEED], and the printer will display : DIP SW settings complete !! If the above is not displayed, the printer may not communicate correctly with the PCA3, or may print gibberish. To make any change, all the settings for that DIP SW need to be made as a block of entries using the [ONLINE] button for ON, and [PAPER FEED] button for OFF.
  • Page 95 LifeCare PCA 3 Infusion System 5- 37 4. The remainder of the settings are then entered, pressing [ONLINE] for ON, and [PAPER FEED] for OFF. This is done sequentially for ALL 24 fields [DIP SW-1(8), 2(8), & 3(8)]. The remainder of settings should be set as follows, continuing with SW1-2: 430-04684-002...
  • Page 96 5- 38 5) Select Mode REQUIRED PRINTER SETTINGS TO OPERATE WITH PCA 3 Switch Function Setting Button to Press SW1-1 Input Method: Serial Feed SW1-2 Printing Speed: High On line SW1-3 Auto loading: On On line SW1-4 Auto LF: Off Feed SW1-5 DIP SW setting command: Enabled...

  • Page 97: Printing Event History Log

    LifeCare PCA 3 Infusion System 5- 39 5.13 Printing Event History Log The history event log can be printed by connecting the pump to a Seiko Instruments SII DPU-414 thermal printer, using the previous instructions. Two custom printer cables are available. They are not interchangeable.

  • Page 98: Downloading To Apc

    5- 40 5) Select Mode 5.14 Downloading to a PC EQUIPMENT NEEDED • Pump • Computer with Windows 3.1 or Windows 95/98/ NT/2000 • Standard Printing Cable • 25-pin to 9-pin converter • Null Modem Adapter PUMP TO WINDOWS 95, 98, NT OR 2000 NITIAL YPER ERMINAL...
  • Page 99 LifeCare PCA 3 Infusion System 5- 41 17. Click OK in the ASCII setup window. 18. Click OK in the properties window. 19. Select File from the menu bar. 20. Select Save from the file menu. YPER ERMINAL CCESS SING AN XISTING ONNECTION 1.
  • Page 100 5- 42 5) Select Mode PRINT TO WINDOWS 3.1 NITIAL ERMINAL CCESS REATING A ONNECTION 1. Open the Accessories group. 2. Select Terminal from the Accessories group. 3. Select Settings from the menu bar. 4. Select Terminal Preferences from the Settings menu. 5.

  • Page 101: History And Event Log

    LifeCare PCA 3 Infusion System 5- 43 8. Exit Terminal. 9. Pull up the file in your word processor of choice and print or view as desired. 5.15 History and Event Log The infuser stores data on therapy settings, quantity and/or number of doses delivered, and chronological record of approximately 400 most recent events occurring during infusion.
  • Page 102 5- 44 5) Select Mode Note: PCA requested doses (patient demands) as recorded in the history display and event log may not reflect the total number of demands. (Maximum of 100 patient demands per 10 minute interval.) Note: Events occurring while printing is in progress are stored in memory, but not included in the current printout.
  • Page 103 LifeCare PCA 3 Infusion System 5- 45 **************************************** LIFECARE PCA 3 PATIENT RECORD **************************************** SERIAL NUMBER: PATIENT NAME: ________________________________________ DRUG ADMINISTERED: ________________________________________ PM 03:09 JUN 25 2002 MODE: PCA + CONTINUOUS SETTINGS: CUSTOM VIAL 1.0 mg/mL PCA DOSE 0.5 mg PCA LOCKOUT 5 min CONTINUOUS RATE...
  • Page 104 5- 46 5) Select Mode LAST 24 HOURS: PCA COMPLETED PCA PARTIAL PCA DENIED LOADING DOSE 0.0 mg TOTAL 2.3 mg HOUR-BY-HOUR: 03:00P-03:09P PCA COMPLETED PCA PARTIAL PCA DENIED 02:24P-03:00P PCA COMPLETED PCA PARTIAL PCA DENIED EVENT LOG: 03:07P PCA END 0.5 mg 03:01P PCA END 0.5 mg...

  • Page 105: Troubleshooting

    LifeCare PCA 3 Infusion System 6- 1 Troubleshooting The PCA 3 is programmed to display status and alarm messages and to sound an audible tone for most alarm conditions. These messages and alarm conditions are described in the following sections. 6.1 Status Messages Displayed status messages are defined in the following table: ESSAGE...

  • Page 106: Pump Alarm System

    6- 2 6) Troubleshooting ESSAGE EFINITION PCA+CONT. Message displayed when pump is in PCA+CONTINUOUS mode. PAUSED Message displayed when pump is stopped, but door is locked. Or, if door is opened. 6.2 Pump Alarm System During an Alarm condition, the system performs the following actions: •...

  • Page 107: Silencing An Alarm

    [ON/OFF] key to turn the pump off. Turn the pump on. If the malfunction repeats, remove pump from service. Refer pump to the hospital’s technical support or contact Hospira Technical Support Operations. NOTE: In the event two or more alarms conditions simultaneously occur, the alarm with shortest muting period will take priority and be displayed first.

  • Page 108: Alarms And Messages

    6- 4 6) Troubleshooting 6.4 Alarms and Messages UTING OSSIBLE ORRECTIVE ESSAGE IMES AUSE CTION Bar Code Not 1 minute Vial not loaded • Position vial Read properly correctly • Clean bar code reader window Check 1 minute Door locked •...
  • Page 109 LifeCare PCA 3 Infusion System 6- 5 UTING OSSIBLE ORRECTIVE ESSAGE IMES AUSE CTION Empty Empty vial • Press [Silence] to Syringe minutes detected silence the alarm. Unlock and open the security door and squeeze and release handles in order to replace vial.
  • Page 110 6- 6 6) Troubleshooting UTING OSSIBLE ORRECTIVE ESSAGE IMES AUSE CTION Pendant Visible Pendant not • Secure pendant into Fault - O Flashing secured into port port Occurs Faulty Connection • Replace pendant or or pendant pump Partial Pendant • Release pendant press button Using PCA Plus II...

  • Page 111: Maintenance

    LifeCare PCA 3 Infusion System 7- 1 Maintenance 7.1 Pump Storage To prolong the life of the PCA 3, observe the following storage precautions: • Store away from excessive heat, cold, and humidity • Store the PCA 3 connected to AC (mains) power •...
  • Page 112 7- 2 7) Maintenance OUTSIDE SURFACE OF THE PUMP ONLY SING ABRASIVE CLEANERS OR CLEANING SOLUTIONS NOT RECOMMENDED BY OSPIRA MAY RESULT IN PRODUCT DAMAGE CAUTION: O A V O ID P UM P DA M AG E C L EA N I NG SOLUTIONS SHOULD ONLY BE USED AS DIRECTED DISINFECTING PROPERTIES OF CLEANING SOLUTIONS VARY CONSULT THE MANUFACTURER FOR SPECIFIC INFORMATION...

  • Page 113: Battery Maintenance

    The door may be unlatched from the door handle to facilitate cleaning. No other routine maintenance is required; the pump has no other user serviceable parts. All service must be carried out by Hospira qualified technical personnel. A technical service manual may be ordered from Hospira Technical Service.

  • Page 114: Service

    PCA 3 to AC (mains) power whenever possible. SERVICE All servicing or adjustments to the PCA 3 should be referred to qualified technical personnel. A technical service manual may be ordered from the local Hospira sales office. 430-04684-002...

  • Page 115: Specifications

    LifeCare PCA 3 Infusion System 8- 1 Specifications Dimensions: Approximately 8”W 13”H 6”D, excluding pole clamp protrusion and power cord storage. Weight: Approximately 10 lbs. with battery. Casing: High-impact plastic Drug Concentration Settings: See Section 9 Delivery Rate: See Section 9 PCA Mode: Approximately 1 mL in 35 seconds...
  • Page 116 8- 2 8) Specifications Atmospheric Pressure: 0 - 10,000 feet (0 - 3,000m) or equivalent pressure Power Requirements: 105-130 Volts, 57 - 63 Hz, <50 W. Power Cord: Hospital-grade AC cord. 10 ft long, with transparent plug and retainer plate. Fuses: 1.0 A, 250 V, Slow Blowing.
  • Page 117 Electrical Leakage: Risk current limits meet AAMI/ANSI SCL (ungrounded) 12/78 standard. Administration Sets: Use only compatible Hospira PCA sets with Integral Anti-Siphon Valve Electrical Safety: Meets IEC 60601-1 standards for: Class 1: AC (mains) supply equipment using protective...

  • Page 118: Stored Occlusion Volume

    8- 4 8) Specifications Equipotential Post: Terminal for connection of an equipotential conductor Printer Port: Maximum nondestruct voltage is 5 V Maximum Overinfusion: The maximum overinfusion under single fault conditions is 25% 8.1 Stored Occlusion Volume DELIVERY PRESSURE STORED VOLUME RATE LIMIT (Average) (Average)

  • Page 119: Trumpet Curves

    LifeCare PCA 3 Infusion System 8- 5 than 0.5 mL/hr or bolus volumes less than 0.5 mL may be substantially greater than 5%, and is due primarily to the variability of friction between the syringe plunger and barrel. This underdelivery may include periods of no delivery. If multiple, partial PCA doses are delivered, the accumulated total reflected in the history totals may be more than the sum of the PCA doses logged in the event log.
  • Page 120 8- 6 8) Specifications hour of operation was within the limits of +2.8% and -0.5% from the nominal rate. The average delivery rate error over the entire 2nd hour was +1.6% (D). For other time intervals look at other points at the horizontal axis and determine corresponding limits as above.

  • Page 121: Trumpet Curves

    LifeCare PCA 3 Infusion System 8- 7 8.4 Trumpet Curves PCA 3, 0.1 ml/hr, 0 mmHg Delivery Head, 0.9% Saline Maxima/Minima of 3 Pumps 100.0% 80.0% 60.0% 40.0% 20.0% 0.0% -20.0% -40.0% -60.0% -80.0% -100.0% Observation Interval (min) Mean PCA 3, 1 ml/hr, 0 mmHg Delivery Head, 0.9% Saline Maxima/Minima of 3 Pumps 15.0% 10.0%...
  • Page 122 8- 8 8) Specifications PCA 3, 5 ml/hr, -100 mmHg Delivery Head, 0.9% Saline Maxima/Minima of 3 Pumps 15.0% 10.0% 5.0% 0.0% -5.0% -10.0% -15.0% -20.0% -25.0% Obse rvation Inte rva l (min) Mean PCA 3, 5 ml/hr, +100 mmHg Delivery Head, 0.9% Saline Maxima/Minima of 3 Pumps 20.0% 15.0%...

  • Page 123: Prescription Delivery Limits

    LifeCare PCA 3 Infusion System 9- 1 9) Prescription Delivery Limits Prescription Delivery limits for loading dose, PCA dose, 4-hour dose limit, and continuous delivery rate parameters will vary with the drug and concentration selected. See the following table for listings of the lower and upper limits. NOTE: Drug and concentration selections are rounded up to the nearest tenth of a digit for mg/mL values or to the nearest digit for mcg/mL values.
  • Page 124 9- 2 9) Prescription Delivery Limits NOTES 430-04684-002...

  • Page 125: Warranty

    Warranty Subject to the terms and conditions herein, Hospira, Inc., herein referred to as Hospira, warrants that (a) the product shall conform to Hospira's standard specifications and be free from defects in material and workmanship under normal use and service for a...
  • Page 126 10- 2 10) Warranty In providing any parts for repair or service of the product, Hospira shall have no responsibility or liability for the actions or inactions of the person performing such repair or service, regardless of whether such person has been trained to perform such repair or service.
  • Page 127 WWW.HOSPIRAPARTS.COM After authorization, ship prepaid product returns to the following address: Hospira Technical Support Operations 755 Jarvis Drive Morgan Hill, CA 95037 NOTE: Outside the U.S., contact your local Hospira sales office. 430-04684-002...
  • Page 128 POSSIBLE EXPLOSION HAZARD EXISTS IF THE PUMP IS USED IN THE PRESENCE OF FLAMMABLE ANESTHETICS. LifeCare PCA3 Infusion Pump, LifeShield, and E.L.I. are trademarks of Hospira. Teflon, Formula C, Manu-Klenz, Dispatch, Precise, Coverage, and Sporicidin are not trademarks of Hospira.

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