Lifecare PCA for use with Hospira MedNet System Operating Manual Rev C March 2016

For Systems With Hospira MedNet Software

NOTES

For Systems With Hospira MedNet Software

Change History Title

Description of Change

430-04685-009

Ninth Release

(A, 2014-05)

- Update the LifeCare PCA logo from ® to a trademark TM. - Update the certification requirement to IEC 60601-1 Medical Equipment for the accessory equipment connected to the analog and digital interfaces. - Update the power requirement to 120 VAC, 50-60 Hz, 50 VA max.

430-04685-010 (C, 2016-03)

Note: 430-04685-010 Revisions A and B were not released. Changes listed are the changes from 430-04685-009 Rev. A to 430-04685-010 Rev. C. Tenth Release - Add Cleaning and Disinfection. - Add Cleaning Spills - Update PCA + Continuous Mode. Moved the following from step 19 to step 20: “The PCA bolus is available for infusion. The patient presses the pendant to initiate PCA dose.” - Added Administration Equipment section with new list numbers for administration sets that are specified for specific delivery modes. - Updated Front Panel and Rear Panel drawings.

For Systems With Hospira MedNet Software

NOTES

LifeCare PCA Infusion System

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... 1-3 CONVENTIONS... 1-4 WARNINGS, CAUTIONS, AND NOTES... 1-5 DEFINITIONS (GENERAL AND CLINICAL)... 1-6 PRECAUTIONS AND WARNINGS... 1-10 UNPACKING... 1-10 GENERAL... 1-10 PROGRAMMING... 1-12 LOADING DOSE/DOSE LIMITS... 1-12 OPERATION... 1-13 MAINTENANCE... 1-13 ALARMS... 1-14 EPIDURAL ADMINISTRATION... 1-14 BATTERY OPERATION... 1-15 SETS AND ACCESSORIES... 1-16 ELECTRICAL ARTIFACTS... 1-17 INTERCONNECTING OF EQUIPMENT... 1-18 GUIDANCE ON EMC COMPATIBILITY... 1-19 FCC INFORMATION... 1-20 US FCC (FEDERAL COMMUNICATIONS COMMISSION) STATEMENT... 1-20 FCC INTERFERENCE STATEMENT... 1-20 WIRELESS DEVICE CAUTION... 1-21 RADIO FREQUENCY EXPOSURE STATEMENT... 1-21

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

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For Systems With Hospira MedNet Software MODES OF DELIVERY... 2-3 PROGRAMMING... 2-3 BATTERY... 2-4 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 ASSEMBLY... 3-3 REAR PANEL... 3-4 OPERATING BUTTONS & KEYS... 3-5 ATTACHING AN INFUSER TO AN IV POLE... 3-9 REMOVING AN INFUSER FROM AN IV POLE... 3-11

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... 4-4 GUIDED START UP FOR PREFILLED VIALS... 4-6 GUIDED START UP FOR CUSTOM VIALS... 4-11 GETTING STARTED... 4-17 UNPACKING... 4-17 CONNECTING THE PATIENT PENDANT... 4-18 SYSTEM SELF-TESTS... 4-19 DATA RETENTION... 4-20 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... 4-27 LOADING DOSE... 4-29

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LifeCare PCA Infusion System 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... 5-8 PCA + CONTINUOUS MODE... 5-12 PROTOCOLS... 5-16 DOSE LIMIT... 5-19 PROGRAMMING THE 4 (OR 1) HOUR DOSE LIMIT... 5-20 PROGRAMMING A DOSE LIMIT... 5-20 PROGRAMMING NO DOSE LIMIT... 5-21 CLEARING OR CHANGING A DOSE LIMIT... 5-22 CLEARING THE HISTORY AND/OR RX SETTINGS... 5-25 USING REVIEW/CONFIRMATION SCREENS... 5-26 CHANGING SETTINGS DURING SETUP... 5-27 STOPPING INFUSION... 5-27 TURNING THE INFUSER OFF... 5-27 MAKING CHANGES AFTER SETUP... 5-28 REVIEWING THE CURRENT SETTINGS... 5-28 CHANGING SETTINGS... 5-28 CHANGING THE CCA... 5-30 CLEARING SHIFT TOTALS... 5-31 CHANGING A VIAL... 5-32 ADDING A SUPPLEMENTAL LOADING DOSE... 5-34 CHECKING HISTORY & SETTINGS... 5-35 HISTORY AND EVENT LOG... 5-37

SECTION 6 ADVANCED PROGRAMMING WITH HOSPIRA MEDNET SOFTWARE... 6-1 GUIDED START-UP USING HOSPIRA MEDNET SOFTWARE... 6-1 SELECT CCA... 6-8

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For Systems With Hospira MedNet Software UPDATING THE DRUG LIBRARY... 6-9 SOFT LIMIT OVERRIDE... 6-11 HARD LIMIT VIOLATION... 6-11 IMPORTANT SYMBOLS... 6-12 NO RULE SETS... 6-12 SOFT LIMIT OVERRIDE... 6-12 WIRELESS... 6-13 AUTOPROGRAMMING... 6-13

SECTION 7 TROUBLESHOOTING... 7-1 STATUS MESSAGES... 7-2 INFUSER ALARM SYSTEM... 7-3 SILENCING AN ALARM... 7-4 ALARMS AND MESSAGES... 7-5 INFUSER STALLING... 7-8

SECTION 8 MAINTENANCE... 8-1 INFUSER STORAGE... 8-1 CLEANING AND DISINFECTION... 8-2 CLEANING... 8-3 APPROVED CLEANING SOLUTIONS... 8-3 CLEANING SUPPLIES... 8-5 PREPARING THE INFUSER FOR CLEANING... 8-5 GENERAL CLEANING INSTRUCTIONS... 8-6 CLEANING EXTERIOR SURFACES... 8-8 CLEANING THE VIAL COMPARTMENT... 8-13 CLEANING THE INJECTOR SWITCH PIN... 8-15 CLEANING THE POWER CORD STRAP... 8-17 CLEANING INFUSER ACCESSORIES... 8-17 RINSING THE INFUSER... 8-18 DRYING THE INFUSER... 8-18 DISINFECTION... 8-19 APPROVED DISINFECTION SOLUTIONS... 8-19 DISINFECTION SUPPLIES... 8-20 PREPARING THE INFUSER FOR DISINFECTION... 8-20 GENERAL DISINFECTION INSTRUCTIONS... 8-20 DISINFECTING EXTERIOR SURFACES... 8-23

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LifeCare PCA Infusion System DISINFECTING THE VIAL COMPARTMENT... 8-24 DISINFECTING THE POWER CORD STRAP... 8-25 DISINFECTING ACCESSORIES... 8-26 RINSING THE INFUSER... 8-26 DRYING THE INFUSER... 8-26 CLEANING SPILLS... 8-27 BATTERY MAINTENANCE... 8-28 SERVICE... 8-28

SECTION 9 SPECIFICATIONS... 9-1 WIRELESS LAN MODULE... 9-5 STORED OCCLUSION VOLUME... 9-5 TIME FROM OCCLUSION TO ALARM... 9-6 DELIVERY RATE ACCURACY... 9-6 TRUMPET CURVES... 9-6 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 NEEDED...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

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For Systems With Hospira MedNet Software 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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LifeCare PCA Infusion System

Section 1 Descriptive Information The LifeCare PCATM Infusion System with Hospira MedNetTM Software allows clinicians to administer, or patients to selfadminister, 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 barcode reader that are designed to enhance patient safety and automate drug identification. Other enhancements include new programming features and the ability to read pharmacy-generated barcodes. The PCA Infusion System includes a microprocessor based infusion device with keypad controls, patient pendant, a barcoded drug vial, and a compatible administration set (See Administration Equipment on page 2-5 for a 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, barcoded, and prefilled with a prescription drug by Hospira, 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 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.

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,

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Descriptive Information 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.

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

Application

Example

ITALIC

REFERENCE TO A SECTION, FIGURE, OR TABLE

(See Front Panel on page 3-2)

[BRACKETED ALL CAPS]

KEYS OR BUTTONS ON THE DEVICE ARE DISPLAYED IN [BRACKETED ALL CAPS] OR WITH A GRAPHIC

[ON/OFF]

ITALIC SMALL CAPS>

SOFTKEY OPTIONS

PREVIOUS>

INITIAL CAPS LOWERCASE

SCREEN DISPLAYS

SELECT DELIVERY MODE

OR

AND DEVICE LABELS (AS APPROPRIATE)

BOLD

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EMPHASIS

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

LifeCare PCA Infusion System 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. 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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Descriptive Information

Definitions (General and Clinical) Table 1-2: Definitions Term

Definition

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.

Custom Syringe or Vial

A barcoded Hospira sterile empty vial that is custom-filled by a pharmacy.

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LifeCare PCA Infusion System Table 1-2: Definitions (Continued) Term

Definition

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 userdefined drug library to the infuser.

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

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Descriptive Information Table 1-2: Definitions (Continued) Term

Definition

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.

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.

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LifeCare PCA Infusion System Table 1-2: Definitions (Continued) Term

Definition

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 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.

Rx Settings

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

Softkeys

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

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Descriptive Information Table 1-2: Definitions (Continued) Term

Definition

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.

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.

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