Lifecare PCA System Operating Manual Sw Ver 7.x Rev F Feb 2016

LifeCare PCA Infusion System

Change History Title

Description of Change

430-97354-001 (E, 2015-05)

Initial Release

430-97354-001 (F, 2016-02)

Added information for upgraded pumps (Cover, Chapter 1, Chapter 11) Updated Programming a Loading Dose instructions (Chapter 5) Updated Clearing Shift Totals instructions (Chapter 7) Added cleaning/disinfecting instructions for the patient pendant strap (Chapter 8) Updated Appendix C to clarify alarm information

System Operating Manual

LifeCare PCA Infusion System

Contents CHAPTER 1 INTRODUCTION... 1-1 INDICATIONS FOR USE... 1-1 LIFECARE PCA INFUSION SYSTEM WITHOUT HOSPIRA MEDNET SOFTWARE... 1-2 LIFECARE PCA INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE... 1-2 LIST NUMBER 20709-04 UPGRADED TO 7.X SOFTWARE... 1-3 CONVENTIONS... 1-3 PRODUCT DESCRIPTION... 1-4 PATIENT SELECTION... 1-5 CONTRAINDICATIONS FOR USE... 1-6 USER QUALIFICATIONS... 1-6 VIEWING THE DISPLAY... 1-6 HOSPIRA PRE-FILLED VIALS... 1-7 PHARMACY-FILLED (CUSTOM) VIALS... 1-8 EQUIPMENT DESCRIPTION... 1-9 FRONT VIEW... 1-9 VIAL CRADLE ASSEMBLY... 1-10 REAR VIEW... 1-11 EQUIPOTENTIAL TERMINAL... 1-12 PATIENT PENDANT... 1-12 BUTTONS AND KEYS... 1-14 BATTERY CHARGE LEVEL... 1-17 WIRELESS STRENGTH... 1-18 ALARM TREATMENT... 1-19 EPIDURAL ADMINISTRATION... 1-20 ELECTRICAL ARTIFACTS... 1-22 INTERCONNECTING OF EQUIPMENT... 1-24 GUIDANCE ON EMC COMPATIBILITY... 1-24 FCC INFORMATION... 1-25 US FCC (FEDERAL COMMUNICATIONS COMMISSION) STATEMENT... 1-25 FCC INTERFERENCE STATEMENT... 1-26

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Contents WIRELESS DEVICE CAUTION... 1-27 RADIO FREQUENCY EXPOSURE STATEMENT... 1-27 WARNINGS AND PRECAUTIONS... 1-28 MALFUNCTION ALARM... 1-30 BATTERY OPERATION... 1-31

CHAPTER 2 SETUP AND OPERATION... 2-1 INFUSER CONFIGURATIONS ON AN IV POLE... 2-1 ATTACHING AN INFUSER TO AN IV POLE... 2-3 REMOVING AN INFUSER FROM AN IV POLE... 2-5 ADMINISTRATION SETS... 2-5 PRIMING THE ADMINISTRATION SET... 2-8 MANUALLY PRIMING THE ADMINISTRATION SET... 2-8 PRIMING THE ADMINISTRATION SET ON THE INFUSER . . . 2-9 LOADING A VIAL... 2-12 VIAL CHANGES AND DISCONTINUING THERAPY... 2-15 CHANGING OR REMOVING A VIAL WITH THE SAME MEDICATION AND CONCENTRATION... 2-15 CHANGING OR REMOVING A VIAL WITH DIFFERENT MEDICATION AND/OR CONCENTRATION... 2-16 DISCONTINUING A PCA THERAPY... 2-18

CHAPTER 3 MODES OF DELIVERY... 3-1 MODES OF DELIVERY... 3-1 PCA ONLY... 3-1 CONTINUOUS... 3-2 PCA + CONTINUOUS... 3-3 DOSE LIMIT... 3-4

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CHAPTER 4 PROGRAMMING INFUSERS WITH HOSPIRA MEDNET SOFTWARE... 4-1 WARNINGS AND CAUTIONS... 4-2 LOADING DOSE/DOSE LIMITS... 4-3 PATIENT PENDANT... 4-3 SYSTEM SETTINGS... 4-3 ADJUSTING CONTRAST OF MAIN DISPLAY... 4-5 ADJUSTING TIME AND DATE... 4-6 PROGRAMMING A PCA THERAPY... 4-8 TURNING ON THE INFUSER... 4-8 PROGRAMMING A LOADING DOSE... 4-8 PROGRAMMING A PCA + CONTINUOUS THERAPY... 4-15 PROGRAMMING A LOADING DOSE... 4-15 PROGRAMMING A CONTINUOUS THERAPY... 4-22 TURNING ON THE INFUSER... 4-22 PROGRAMMING A LOADING DOSE... 4-23 DRUG LIBRARY: SOFT LIMIT, HARD LIMIT, AND RULE SET... 4-29 SOFT LIMIT OVERRIDE... 4-29 HARD LIMIT VIOLATION... 4-30 RULE SETS CAUTION... 4-31 CHANGING THE CCA... 4-31 UPDATING THE DRUG LIBRARY... 4-33 AUTO-PROGRAMMING... 4-34

CHAPTER 5 PROGRAMMING INFUSERS WITHOUT HOSPIRA MEDNET SOFTWARE... 5-1 WARNINGS AND PRECAUTIONS... 5-2 LOADING DOSE/DOSE LIMITS... 5-3 PATIENT PENDANT... 5-3 SYSTEM SETTINGS... 5-3 ADJUSTING TIME AND DATE... 5-5 PROGRAMMING A PCA THERAPY... 5-7 TURNING ON THE INFUSER... 5-7

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Contents PROGRAMMING A PCA + CONTINUOUS THERAPY... 5-13 TURNING ON THE INFUSER... 5-13 PROGRAMMING A CONTINUOUS THERAPY... 5-19 TURNING ON THE INFUSER... 5-20 PROGRAMMING A LOADING DOSE... 5-20 PROGRAMMING WITH A PHARMACY- FILLED (CUSTOM) VIAL... 5-24

CHAPTER 6 REVIEWING AND CHANGING RX SUPPLEMENTAL LOADING DOSE... 6-1 REVIEWING THE CURRENT PROGRAM... 6-1 CHANGING THE CURRENT PROGRAM... 6-2 PROGRAMMING A SUPPLEMENTAL LOADING DOSE... 6-5

CHAPTER 7 BATTERY AND WIRELESS STATUS HISTORY AND EVENT LOG... 7-1 DATA RETENTION... 7-3 INFUSERS WITHOUT HOSPIRA MEDNET SOFTWARE... 7-3 CHECKING HISTORY AND SETTINGS... 7-10 CLEARING SHIFT TOTALS... 7-11

CHAPTER 8 MAINTENANCE... 8-1 CLEANING AND DISINFECTION... 8-1 CLEANING... 8-3 DISINFECTION... 8-18 CLEANING SPILLS... 8-26 BATTERY MAINTENANCE... 8-27 SERVICE... 8-28 PRODUCT HANDLING AND DISPOSAL... 8-28 INFUSER STORAGE... 8-29

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CHAPTER 9 SPECIFICATIONS... 9-1 WIRELESS LAN MODULE... 9-6 STORED OCCLUSION VOLUME... 9-7 TIME FROM OCCLUSION TO ALARM... 9-7 DELIVERY RATE ACCURACY... 9-8 TRUMPET CURVES... 9-9 EXAMPLE... 9-10 TRUMPET CURVES... 9-11

CHAPTER 10 PROTOCOLS... 10-1 HOSPIRA MEDNET SOFTWARE INFUSERS... 10-1 PROGRAMMING PROTOCOLS... 10-2 INFUSERS WITHOUT HOSPIRA MEDNET... 10-6 PROGRAMMING PROTOCOLS... 10-7

CHAPTER 11 INFORMATION FOR LEGACY LIFECARE PCA INFUSERS UPGRADED WITH 7.X SOFTWARE... 11-1 IEC 60601-1 COMPLIANCE... 11-2 IEC 60601-1-2 COMPLIANCE... 11-2 FLUID INGRESS PROTECTION RATING... 11-2 SPECIFICATIONS... 11-3 STORED OCCLUSION VOLUME... 11-3 TIME FROM OCCLUSION TO ALARM... 11-4 CSA MARK... 11-4

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Contents

APPENDIX A GENERATING BAR CODE LABELS (HOSPIRA MEDNET SOFTWARE ENABLED) . . . A-1 EQUIPMENT NEEDED TO PRINT A PHARMACY-GENERATED BAR CODE... A-2 LABEL DIAGRAM... A-3 VALIDATION OF THE PHARMACY-GENERATED BAR CODE... A-4 FILLING THE LIFECARE PCA STERILE EMPTY VIAL . . . A-4

APPENDIX B ADMINISTRATION SETS AND ACCESSORIES... B-1 ADMINISTRATION SETS... B-1 ACCESSORIES... B-3

APPENDIX C TROUBLESHOOTING... C-1 INFUSER ALARM SYSTEM... C-1 INVALID KEYPRESS... C-3 MALFUNCTION ALARM... C-3 RESPONDING TO AN ALARM... C-3 ADJUSTING THE AUDIO ALARM VOLUME... C-4 SILENCING AN ALARM... C-4 TESTING THE ALARM SYSTEM... C-4 OCCLUSION ALARM... C-6 NETWORK CONNECTIVITY... C-6 STATUS MESSAGES... C-7 ALARMS AND MESSAGES... C-8

APPENDIX D DEFAULT DRUG LIBRARY AND PRESCRIPTION DELIVERY LIMITS... D-1

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APPENDIX E NETWORK PRINTER SETUP... E-1 DIRECTLY CONNECTED PRINTER... E-1 EQUIPMENT NEEDED... E-1 PREPARATION... E-1 SETUP PROCEDURE... E-2 PRINTING PROCEDURE... E-3 NETWORK PRINTER... E-4 EQUIPMENT NEEDED... E-4 PREPARATION... E-4 SETUP PROCEDURE... E-4 PRINTING PROCEDURE... E-6 DOWNLOADING LOGS TO A PC... E-6 EQUIPMENT NEEDED... E-7 PREPARATION... E-7 SETUP PROCEDURE... E-7 PRINTING PROCEDURE... E-12

APPENDIX F GLOSSARY... F-1 APPENDIX G WARRANTY... G-1

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NOTES

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LifeCare PCA Infusion

Chapter 1 Introduction Indications for Use The LifeCare PCATM infuser is intended for intravenous or epidural administration of analgesic medications that are delivered by a continuous rate of infusion and/or with patient demand doses. WARNING FOR EPIDURAL USE, ADMINISTER ONLY ANESTHETICS/ ANALGESICS APPROVED FOR EPIDURAL ADMINISTRATION (AS INDICATED OR ALLOWED BY THE MEDICATIONS’ FDA APPROVED LABELING OR HEALTH CANADA APPROVED LABELING). EPIDURAL ADMINISTRATION OF MEDICATIONS OTHER THAN THOSE INDICATED FOR EPIDURAL USE COULD RESULT IN SERIOUS INJURY TO THE PATIENT.

The LifeCare PCA infuser allows patients to self-administer analgesics with defined parameters using a push-button pendant attached to the device. The LifeCare PCA is intended for the hospital environment and not for home use. A primary feature of the LifeCare PCA infuser is the bar code reader, which is designed to automate medication and concentration identification. The bar code reader identifies all Hospira-approved prefilled medication vials. The Hospira MedNetTM Software allows the LifeCare PCA infuser to read pharmacy-generated bar codes on custom-filled vials. The vials are single-use and barcoded, and are either prefilled with a medication by Hospira, or are sterile empty vials which can be custom-filled by the hospital pharmacy (see Appendix A Generating Bar Code Labels (Hospira MedNet Software Enabled)). All LifeCare PCA vials must have a bar code label that is read by the LifeCare PCA infuser. There is no ability to bypass the bar

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Introduction code reader and manually enter the medication into the LifeCare PCA infuser (see Appendix A Generating Bar Code Labels (Hospira MedNet Software Enabled)). CAUTION: FEDERAL LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN OR OTHER PRACTITIONER LICENSED BY THE LAW OF THE STATE IN WHICH HE/SHE PRACTICES TO USE OR ORDER THE USE OF THE DEVICE.

LifeCare PCA Infusion System without Hospira MedNet Software As a standalone infuser, the LifeCare PCA infuser uses the Default Drug Library (DDL) to program therapies. The default drug library uses a single set of predefined rules for all medication settings (see Appendix D Default Drug Library and Prescription Delivery Limits).

LifeCare PCA Infusion System with Hospira MedNet Software The LifeCare PCA infusion system is used in conjunction with the server-based Hospira MedNet safety software. Hospira MedNet Software facilitates networked communication between the server and Hospira Mednet-compatible infusers. The Hospira MedNet software enables facilities to define a drug library based on hospital best practices. A default drug library is active until a new drug library is downloaded to the infuser with Hospira MedNet Software. The customized drug library is downloaded into the infuser by authorized hospital personnel. Hospital personnel determine and select medications, concentrations, units of measure, lock-out intervals, dose, dose limits, and rule sets (upper and lower delivery parameters) available within a selected Clinical Care Area (CCA). A hospital-defined drug library can define up to a maximum of 18 CCAs which can include up to 25 medication entries per CCA. The infuser requires a CCA to be selected prior to programming a dose. When the CCA is selected, the medication rule sets are configured for that CCA.

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List Number 20709-04 Upgraded to 7.x Software Legacy LifeCare PCA infusion systems list number 20709-04 upgraded to 7.x software are substantially equivalent with list number 20837. Any differences associated with list number 20709-04 upgraded to 7.x software are documented in Chapter 11 Information for Legacy LifeCare PCA Infusers Upgraded with 7.x Software.

Conventions The conventions listed in Table 1-1 are used throughout this manual. Table 1-1. Conventions Convention

Application

Example

ITALIC

Reference to a chapter, figure, or table

(See Appendix A)

[BRACKETED ALL CAPS]

Keys or buttons on the device are displayed in [BRACKETED ALL CAPS]

[ON/OFF]

ITALIC SMALL CAPS>

Softkey options

PREVIOUS>

SMALL CAPS WITH INITIAL UPPERCASE

Screen displays and device labels

SELECT DELIVERY MODE

BOLD

Emphasis

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

The following conventions are used to call attention to warnings, cautions, and notes: 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.

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Introduction 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. Figures and graphics are rendered as representations to approximate the actual product, and may not exactly reflect the product.

Product Description The LifeCare PCA infuser features three infusion modes:

• Patient-Controlled Analgesia (PCA) • PCA Plus Continuous • Continuous An optional dose (loading dose) can be programmed by the clinician at any time during therapy for additional pain relief. The LifeCare PCA infuser is used in a wide range of clinical settings that include but are 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

Features of the LifeCare PCA infuser include:

• Microprocessor-based infusion device with keypad controls • Patient pendant • Barcoded medication vial • Compatible administration set 1-4

System Operating Manual

LifeCare PCA Infusion Note: 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.

• Ethernet port for computer or printer connections • Nurse call interface See Appendix B Administration Sets and Accessories for a list of compatible LifeCare PCA administration sets. The LifeCare PCA infuser is intended to operate on AC power, and an internal battery is provided to maintain operation for short periods of time when AC power is not available. The LifeCare PCA infuser is able to store frequently used prescriptions called protocols (see Chapter 10 Protocols). The protocols are available for Hospira 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).

Patient Selection Patients selected to use the LifeCare PCA infuser should be able to understand the relationship between pain and pushing the LifeCare PCA infuser patient pendant button for pain relief. Patients selected for the use of the LifeCare PCA infuser should be able to physically self-administer a PCA dose using the patient pendant. WARNING THE PATIENT PENDANT BUTTON IS TO BE PRESSED ONLY BY THE INTENDED PATIENT.

WARNING EXERCISE CAUTION WHEN THE PATIENT IS AMBULATORY WHILE CONNECTED TO THE INFUSER.

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Introduction

Contraindications For Use The LifeCare PCA infuser should not be used for patientcontrolled 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. Medications that are not compatible with silicone rubber or PVC plastic, or are unstable under infusion conditions should not be used with this system. Do not use medications that are contraindicated for use with the LifeCare PCA infuser (for example, blood products, enteral feedings and lipids, cytotoxic drugs, and high-viscosity fluids).

User Qualifications All clinicians should be appropriately trained to program the LifeCare PCA infuser prior to use. The LifeCare 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 medications, 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.

Viewing the Display When operating the infuser, position yourself at a distance of no more than 39 inches (1 meter) from the display. Ensure you are directly in front of the display, or at an angle of no more than 25 degrees off this position.

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Hospira Pre-Filled Vials Hospira pre-filled vials are available for standalone infusers and Hospira MedNet-enabled infusers. The LifeCare PCA infuser’s bar code reader identifies the bar code and displays the medication name and concentration of that pre-filled vial. The following Hospira pre-filled medication vials are FDA approved for use with the LifeCare PCA infuser:

• Hospira Morphine Sulfate 1 mg/mL • Hospira Morphine 5 mg/mL • Hospira Meperidine Hydrochloride 10 mg/mL WARNING FAILURE TO USE HOSPIRA-APPROVED VIALS, INJECTORS, AND LIFECARE PCA ADMINISTRATION SETS WITH INTEGRAL PRESSURE ACTIVATED VALVES MAY CAUSE AN INACCURATE DOSE DELIVERY TO THE PATIENT.

The LifeCare PCA sterile empty vial is made of USP Type 1 glass with a silicone rubber stopper and is the same composition as the Hospira prefilled vials. CAUTION: F OR ADMINISTRATION OF A MEDICATION VIA A STERILE EMPTY VIAL, REVIEW THE MEDICATION PACKAGE INSERT TO ENSURE VIAL COMPATIBILITY AND STABILITY OF THE MEDICATION FOR THE DURATION OF ADMINISTRATION. CONSULT WITH PHARMACY.

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Introduction

Pharmacy-Filled (Custom) Vials For standalone infusers without Hospira MedNet Software Custom vials are sterile empty 30 mL vials which are filled by the hospital pharmacy. A pharmacy-filled (custom) vial offers your facility the flexibility to infuse medications per your facility’s practice. The LifeCare PCA infuser reads the bar code on the custom-filled vial, displays the medication name as OTHER DRUG, and prompts the clinician to enter the concentration. For infusers using Hospira MedNet Software Custom vials are sterile empty 30 mL vials which are filled by the hospital pharmacy and labeled with a unique bar code. A pharmacy-filled (custom) vial offers your facility the flexibility to infuse medications per your facility’s practice. Hospira MedNet Software allows the LifeCare PCA infuser to read the pharmacy-generated bar code on the custom-filled vial. The bar codes are linked to the rule sets within the Hospira MedNet Software. This ensures that when the custom-filled vial is inserted into the infuser, the displayed medication and concentration are linked to the corresponding rule set.

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LifeCare PCA Infusion

Equipment Description This section shows the front view, vial cradle assembly, rear view, and buttons and keys of the infuser.

Front View Figure 1-1 shows the front view of the LifeCare PCA infuser.

Vial Cradle Clips

Vial

Cradle Release Mechanism (Holder)

LED Display

Security Door

LCD Display

Softkeys

Door Lock Keypad Buttons

AC Power Indicator Bar Code Reader Window

Injector

Battery Power Indicator

Figure 1-1. Front View

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Introduction

Vial Cradle Assembly Figure 1-2 shows a detailed view of the LifeCare PCA vial cradle assembly. Cradle Release Mechanism

Wireless Antenna Upper Vial Retainer

9LDO%DVH

Bar Code Reader Window (vial bar code must face toward window)

Vial Cradle Clips Vial Sensor Switch (Top Vial Cradle Clip)

Vial Stopper

Vial Lip

Lower Vial Retainer (Middle Bracket)

Injector

Injector Flange Retainer

Injector Flange (Vial Plunger)

Injector Sensor Switch (Back of Retainer)

Luer-Lock Fitment

Figure 1-2. Vial Cradle Assembly

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