Lifecare PCA with MedNet System Operating Manual Rev A Oct 2010

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For Systems With Hospira MedNetTM Software

Change History Title

Description of Change

Pages Affected

430-04685-001 Original Release (Rev. 7/05)

All

430-04685-002 Second Release (Rev. 09/05)

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430-04685-003 Third Release (Rev. 10/05)

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430-04685-004 Fourth Release (Rev. 01/06)

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430-04685-005 Fifth Release (B, Rev. 07/07)

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430-04685-007 Seventh Release (A, Rev. 10/10)

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LifeCare PCA® Infusion System

Table Of Contents SECTION 1 DESCRIPTIVE INFORMATION...1-1 PRODUCT DESCRIPTION... 1-1 INDICATIONS FOR USE... 1-2 PATIENT SELECTION... 1-3 USER QUALIFICATIONS... 1-3

CONTRAINDICATIONS FOR USE... 1-4 CONVENTIONS... 1-5 WARNINGS, CAUTIONS, AND NOTES... 1-5

DEFINITIONS (GENERAL AND CLINICAL)... 1-7 PRECAUTIONS AND WARNINGS... 1-12 UNPACKING... 1-12 GENERAL... 1-12 PROGRAMMING... 1-13 LOADING DOSE/DOSE LIMITS... 1-13 OPERATION... 1-14 MAINTENANCE... 1-14 ALARMS... 1-15 EPIDURAL ADMINISTRATION... 1-15 BATTERY OPERATION... 1-16 SETS AND ACCESSORIES... 1-17 ELECTRICAL ARTIFACTS... 1-17 INTERCONNECTING OF EQUIPMENT... 1-19

GUIDANCE ON EMC COMPATIBILITY... 1-19 FCC INFORMATION... 1-20 US FCC (FEDERAL COMMUNICATIONS COMMISSION) STATEMENT 1-20 FCC INTERFERENCE STATEMENT... 1-21 WIRELESS DEVICE CAUTION... 1-21 RADIO FREQUENCY EXPOSURE STATEMENT... 1-22

SECTION 2 PRINCIPLES OF OPERATION...2-1 FEATURES... 2-3 DRUG RECOGNITION... 2-3

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For Systems With Hospira MedNetTM Software

MODES OF DELIVERY... 2-3 PROGRAMMING... 2-3 BATTERY... 2-3 BIOMEDICAL... 2-4 OPTIONS... 2-4 OTHER FEATURES... 2-4

ADMINISTRATION EQUIPMENT... 2-5

SECTION 3 EQUIPMENT DESCRIPTION... 3-1 FRONT PANEL... 3-2 VIAL CRADLE ASSEMBLE... 3-3 REAR PANEL... 3-4 OPERATING BUTTONS & KEYS... 3-5 ATTACHING INFUSERS TO AN IV POLE... 3-8

SECTION 4 BASIC OPERATION... 4-1 OPERATING THE PCA INFUSER... 4-2 INTRAVENOUS PCA INFUSER ADMINISTRATION... 4-2 EPIDURAL PCA INFUSER ADMINISTRATION... 4-2

LOADING A VIAL... 4-5 GUIDED START UP FOR PREFILLED VIALS... 4-6 GUIDED START UP FOR CUSTOM VIALS... 4-12 GETTING STARTED... 4-19 UNPACKING... 4-19 CONNECTING THE PATIENT PENDANT... 4-19 SYSTEM SELF-TESTS... 4-20 DATA RETENTION... 4-21

ADJUSTING SETTINGS... 4-21 CHANGING ALARM VOLUME... 4-22 CHANGING CONTRAST OF MAIN DISPLAY... 4-23 CHANGING OR CONFIRMING TIME AND DATE... 4-24

NEW PATIENT... 4-26 PURGING THE SYSTEM... 4-26

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LifeCare PCA® Infusion System

LOADING DOSE... 4-29

SECTION 5 SELECT MODE... 5-1 MODES OF DELIVERY... 5-2 PROTOCOLS... 5-2 PCA ONLY... 5-2 CONTINUOUS... 5-3 PCA+CONTINUOUS... 5-3

PCA ONLY MODE... 5-4 CONTINUOUS MODE... 5-9 PCA+CONTINUOUS MODE... 5-13 PROTOCOLS... 5-18 DOSE LIMIT... 5-21 PROGRAMMING THE 4 (OR 1) HOUR DOSE LIMIT... 5-22 PROGRAMMING A DOSE LIMIT... 5-22 PROGRAMMING NO DOSE LIMIT... 5-23 CLEARING OR CHANGING A DOSE LIMIT... 5-25

CLEARING THE HISTORY AND/OR RX SETTINGS... 5-27 USING REVIEW/CONFIRMATION SCREENS... 5-28 CHANGING SETTINGS DURING SETUP... 5-29 STOPPING INFUSION... 5-29 TURNING THE INFUSER OFF... 5-30

MAKING CHANGES AFTER SETUP... 5-30 REVIEWING THE CURRENT SETTINGS... 5-30 CHANGING SETTINGS... 5-30

CHANGING THE CCA... 5-32 CLEARING SHIFT TOTALS... 5-34 CHANGING A VIAL... 5-35 ADDING A SUPPLEMENTAL LOADING DOSE... 5-37 CHECKING HISTORY & SETTINGS... 5-38 HISTORY AND EVENT LOG... 5-40

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LifeCare PCA® Infusion System

WIRELESS LAN MODULE... 9-5 STORED OCCLUSION VOLUME... 9-6 TIME FROM OCCLUSION TO ALARM... 9-6 DELIVERY RATE ACCURACY... 9-6 TRUMPET CURVES... 9-7 EXAMPLE... 9-7

TRUMPET CURVES... 9-9

SECTION 10 PRESCRIPTION DELIVERY LIMITS...10-1 APPENDIX A GENERATING BAR CODE LABELS (HOSPIRA MEDNET® SOFTWARE ENABLED) A-1 EQUIPMENT:... A-2 EXAMPLE OF LABEL LAYOUT & SAMPLE... A-3 LABEL DIAGRAM... A-4

APPENDIX B NETWORK PRINTER SETUP... B-1 EQUIPMENT NEEDED... B-1 PREPARATION... B-1 PROCEDURE... B-1 PRINTING EVENT HISTORY LOG... B-2

DOWNLOADING LOGS TO A PC... B-3 EQUIPMENT NEEDED... B-3 PREPARATION... B-3 PROCEDURE... B-3

APPENDIX C WARRANTY... C-1

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For Systems With Hospira MedNetTM Software

INDEX... I-1 CONTACT INFORMATION... D-1

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LifeCare PCA® Infusion System

Section 1 Descriptive Information The latest patient controlled analgesia (PCA) offered by Hospira, LifeCare PCA® Infusion System with Hospira MedNet® Software, allows clinicians to administer, or patients to self-administer analgesia, safely and effectively within clinician programmed limits and/or hospital-defined medication limits. The LifeCare PCA® Infusion System is used in a wide range of clinical settings that includes but is not limited to the following: MEDICAL

LABOR/DELIVERY/POST PARTUM

BURN UNIT

SURGICAL

OPERATING ROOM

ONCOLOGY

CRITICAL CARE UNITS

POST ANESTHESIA CARE UNIT (PACU)

PEDIATRICS

Product Description The primary drug safety features of the LifeCare PCA® Infuser device are the Hospira MedNet® Software and the bar code reader that are designed to enhance patient safety and automate drug identification. Other enhancements include new programming features and the ability to read pharmacygenerated bar codes. The PCA Infusion System includes a microprocessor based infusion device with keypad controls, patient pendant, a bar coded drug vial, and a compatible administration set (see Administration Equipment on page 2-5 for list of compatible sets). The infuser has an Ethernet port for computer or printer connections.

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Descriptive Information The LifeCare PCA® Infuser contains a Connectivity Engine module that provides wired Ethernet and wireless 802.11 a/b/g local area networking capabilities. This allows the Hospira MedNet® networked application software to download drug libraries to the infuser and enable the auto-programming feature. The infuser is intended to operate on AC power, but an internal battery is provided to maintain operation for short periods of time when AC power is not available. The vials are single-use, bar coded, and prefilled with a prescription drug by Hospira/Abbott, or the vials are sterile and empty to be custom-filled by the hospital pharmacy. The PCA Infuser offers the following modes of delivery:

• • •

PCA ONLY CONTINUOUS ONLY PCA+CONTINUOUS

The PCA Infuser is able to store frequently used prescriptions called protocols. The protocols are available for Hospira/Abbott prefilled vials and custom syringes. The protocols must be set up by a hospital-designated authority in the Biomed Mode or through Hospira MedNet® Software (if enabled).

Indications for Use The LifeCare PCA® Infusion System with Hospira MedNet® Software is intended for accurate, volumetric, infusion of analgesic drugs by continuous or patient demanded intravenous administration. It is intended for short-term continuous (less than 96 hours) epidural administration of analgesic drugs.

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LifeCare PCA® Infusion System WARNING For epidural use, administer only anesthetics/ analgesics approved for epidural administration (as indicated or allowed by the drugs’ FDA approved labeling). Epidural administration of drugs other than those indicated for epidural use could result in serious injury to the patient.

PATIENT SELECTION Patients selected to use the PCA Infuser should be able to understand the relationship between pain and pushing the PCA Infuser patient pendant for pain relief. Patients selected for the use of the PCA Infuser should be able to physically selfadminister a PCA dose using the patient pendant.

WARNING Patient Pendant Is only to be pressed by the patient.

USER QUALIFICATIONS All clinicians should be appropriately trained to program the PCA Infuser prior to use.The PCA Infuser is intended for use at the direction or under the supervision of licensed physicians or certified health care professionals. Clinicians must be trained in infuser use, administration of parenteral and epidural fluids and drugs, and the prevention of related IV complications and precautions to prevent accidental infusion of air. Training should emphasize the assessment and monitoring of patients receiving potent analgesic medications, and the appropriate treatment for possible adverse reactions.

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Descriptive Information

Contraindications For Use The PCA Infuser should not be used for patient controlled analgesia by patients who do not have the cognitive ability to understand the use of self-administered pain medication, nor have the physical capacity to operate the patient pendant, if required. Drugs not compatible with silicone rubber or PVC plastic, or drugs not stable under infusion conditions should not be used with this system.

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LifeCare PCA® Infusion System

Conventions This section describes the conventions used throughout this manual: CONVENTION

APPLICATION

EXAMPLE

ITALIC

REFERENCE TO A SECTION, FIGURE, OR TABLE.

(See Front Panel on page 3-2.)

[BRACKETED ALLCAPS]

KEYS OR BUTTONS ON THE DEVICE ARE DISPLAYED IN

[ON/OFF]

[BRACKETED ALLCAPS] OR WITH A GRAPHIC.

OR

ITALIC SMALLCAPS>

SOFTKEY OPTIONS

PREVIOUS>

INITIAL CAPS LOWERCASE

SCREEN DISPLAYS AND DEVICE LABELS (AS APPROPRIATE)

SELECT DELIVERY MODE

BOLD

EMPHASIS

...SETS ARE SUPPLIED STERILE AND ARE FOR...

WARNINGS, CAUTIONS, AND NOTES Alert Messages used throughout this manual are described below. Pay particular attention to these messages.

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. IT CONTAINS INFORMATION THAT COULD PREVENT IRREVERSIBLE PRODUCT DAMAGE OR HARDWARE FAILURE. FAILURE TO OBSERVE A CAUTION COULD RESULT IN SERIOUS PATIENT OR USER INJURY. NOTE: A Note highlights information that helps explain a concept or procedure.

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Descriptive Information This symbol directs the user to consult accompanying documents.

NOTE: Figures are rendered as graphic representations to approximate the actual product. Therefore, figures may not exactly reflect the product.

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LifeCare PCA® Infusion System

Definitions (General and Clinical) TERMS

DEFINITIONS

Accuracy

The degree to which the instrument is capable of delivering the volume of analgesic drug that is displayed or targeted to be delivered. Accuracy shall be specified as the maximum allowable delivery error from a targeted or displayed value (see Section 9 Specifications on page 9-1).

Autoprogramming

Complete or partial program received from a bar code enabled Point-of-Care System requiring clinician confirmation prior to administration.

Battery Fault

A battery that will not accept a full charge.

Bolus

A fixed amount of drug delivered in a short amount of time. A PCA dose.

Button

A hard key on the front panel or on the patient pendant.

Clinical Care Area (CCA)

An area of the hospital that authorized hospital staff is permitted to use specific drugs. The clinician selects a CCA after turning on the infuser. The hospital may create from one to eighteen CCA’s.

Connectivity Engine (CE)

A component of the infuser that controls Ethernet and wireless communication between the network server and infuser.

Continuous

Infusion program characterized by a constant, fixed-rate dose.

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Descriptive Information TERMS

DEFINITIONS

Custom Syringe or Vial

A bar coded Hospira/Abbott sterile empty vial that is custom-filled by a pharmacy.

Default Drug Library (DDL)

A pre-programmed drug library embedded in the infuser software. The infuser uses the DDL until a User-defined Drug Library is installed and supersedes the DDL.

Dose Limit

User-programmable parameter specifying the maximum amount of drug that can be administered via PCA dose and continuous delivery in a programmable rolling time period consisting of discrete accumulation periods of 6 minutes. NOTE: Dose Limit periods are specified as 1 and 4 hours on an infuser with the DDL; on infusers with a User-defined Drug Library, the dose limit periods can be defined as 1, 4, 6, or 12 hours.

Drug Library Download

The process of moving the User-defined Drug Library from the network server to the infuser.

Drug Library Installation

The process of moving the User-defined Drug Library from the CE to the infuser.

History

Displays Rx Settings, PCA Summary and the Event Log.

Hospira MedNet® Software

Network based application software used to upload event logs and download the user-defined drug library to the infuser.

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LifeCare PCA® Infusion System TERMS

DEFINITIONS

Infusing

The infuser is ON and a DELIVERY SCREEN is displayed. The infusing mechanism may or may not be actually infusing at any given time.

LCD

Liquid Crystal Display

LED

Light Emitting Diode

Loading Dose

An optional dose programmed during Setup before entering the program. The loading dose can be administered at any time by the clinician during the programmed therapy. For more information see Loading Dose on page 4-29.

Lockout Interval

A programmed time interval specifying the minimum time that must pass after a loading dose or PCA dose (bolus) is administered; this time interval specifies when the next PCA dose can begin infusing. Bolus requests made during the lock out interval are denied.

Muting Period

The period between the silencing of an alarm by pressing the [SILENCE] key and the resumption of the alarm.

Occlusion

A blockage in the PCA Infuser set that prevents the infuser from pumping fluid into the patient. Possible causes of occlusions are kinked or plugged non-patent IV tubing.

Occlusion Pressure

The maximum pressure produced as a result of an occlusion in the PCA Infuser set.

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Descriptive Information TERMS

DEFINITIONS

On

The infuser is turned on using either A/C or battery power. The infuser is not necessarily pumping when ON.

Patient Pendant

A hand held pendant connected to the infuser that allows the patient to request a PCA dose (bolus) by pressing a button.

PCA Mode

Infusion therapy characterized by bolus doses administered on patient demand subject to a lockout interval and, optionally, a dose limit.

PCA Set

Tubing connecting the PCA Vial to the patient.

PCA Vial

Vial compatible with the infuser that is either prefilled with drug by Abbott or Hospira (standard vial) or filled by the hospital pharmacy (custom vial).

Prime

Manually removing air from the syringe and line.

Purge

The process during which the pumping mechanism is run to remove air from the PCA set.

Rule Set

A list of upper, lower, soft and/or hard limits for delivery parameters. Rule sets reside in the User-Defined Drug Library and are associated with a specific vial within a CCA.

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LifeCare PCA® Infusion System TERMS

DEFINITIONS

Rx Settings

The current programmed therapy. Includes PCA Dose, PCA Lockout Interval, Continuous Rate, Loading Dose and Dose Limit amount.

Soft Keys

The five keys to the right of the device’s LCD display. Each key’s function is dependent on the screen displayed data.

Stored Protocols

Frequently used therapy settings stored in the infuser's memory. Stored protocols can be recalled again, making it unnecessary for the operator to program the same therapy settings each time they are needed. Stored protocols are determined by the health care facility.

Standard Syringe

A prefilled bar coded drug vial in which the infuser identifies the drug and concentration. The drug and concentration are found in the Drug Library by using the bar code on the vial. Standard syringes are also known as prefilled drug vials.

User-defined Drug Library

A drug library that contains hospital defined clinical care areas (CCAs) and rule sets created with Hospira MedNet® Software.

Warning

An indication to advise the clinician of a possible dangerous condition.

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Descriptive Information

Precautions and Warnings UNPACKING Product damage may occur unless proper care is exercised during the unpacking and setup process. The battery may not be fully charged upon receipt.

GENERAL This section addresses general safety and operational procedures.

•

Possible explosion hazard exists if used in the presence of flammable anesthetics.

WARNING Possible explosion hazard exists if the infuser is used in the presence of flammable anesthetics.

•

Potent analgesic medications are used with this device. Refer to drug package insert for precautions and possible adverse reactions.

•

Refer to analgesic package enclosure for possible incompatibility with fluid or drug being delivered through the IV line.

•

Coupling together of more than one infuser into one patient line may significantly affect the infusion rate of at least one of the infusers.

•

Do not use sharp objects such as pens, scissors, or fingernails to press keys. Such objects may damage keys and cause a malfunction.

•

Arrange tubing, cords, and cables to minimize the risk of patient strangulation or entanglement.

•

Failure to use Hospira/Abbott vials and Hospira/Abbott PCA Infuser sets with the integral anti-siphon valve may cause an inaccurate dose delivery to the patient.

•

The system must be primed prior to purging. Remove all air from vial before placing it into the infuser.

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LifeCare PCA® Infusion System •

Always close the slide clamp on the PCA Infuser administration set before removing or the replacing syringe, and before discontinuing infusion.

•

Patient must be disconnected from the PCA Infuser set before the purge cycle.

•

Vial and injector must be securely locked into the infuser before beginning delivery.

PROGRAMMING This section presents known infuser programming cautions.

WARNING For custom syringes, confirm that the displayed concentration (mg/mL) or (mcg/mL) exactly matches the concentration value and drug name on the syringe. If they do not match, under/overdosage may result.

•

In the CONTINUOUS and PCA+CONTINUOUS modes, if a purge is not performed after a syringe change, the infuser automatically performs a small system compliance step to remove slack when the [START/PAUSE] key is pressed (with the door locked). Although, fluid is not normally delivered to the patient during the compliance step, under some conditions up to 0.3 mL of fluid may be delivered. If 0.3 mL of fluid represents a hazard to the patient, disconnect the set during this operation.

•

At flow rates less than 0.5 mL/hr, there may be a significant delay before flow is established if the system is not purged.

•

Selections are rounded up to the nearest tenth of a digit for mg/ mL values or to the nearest digit for mcg/mL values.

LOADING DOSE/DOSE LIMITS This section presents Loading Dose and Loading Dose information and cautions.

• • •

The loading dose is always included in the total dose delivered.

•

Patient Pendant is only to be pressed by the intended patient.

Setting a new dose limit will not erase the previous dose history. Always monitor the PCA Infuser when delivering medication with the door open.

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