PCA Module 8120 Series Directions for Use

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TABLE OF CONTENTS INTRODUCTION 1 3 6

GETTING STARTED

MAINTENANCE APPENDIX

TABLE OF CONTENTS i

ALARMS, ERRORS, MESSAGES

7 14 15 15 15 15 16 16 17 18 18 18 18 18 18 19 19 21 22 23 25 29 29 29 32 34 37 39 40 41 43 45 47 48 50 51 52 53 53 54 55 56 56 56

GETTING STARTED

WARNINGS AND CAUTIONS... CONTROLS AND INDICATORS... INSTALLATION... Unpacking PCA Module... ATTACHING AND DETACHING MODULES... DISPLAYS... Main Display... PREPARING SYRINGE AND ADMINISTRATION SET... ATTACHING AND DETACHING DOSE REQUEST CORD... START-UP... Powering On System... Responding to Maintenance Reminder... Choosing YES or NO to New Patient? and Profile?... Selecting Profile... Entering Patient ID... PREPARING INFUSION... Loading Syringe and Administration Set... Security Lock Key Positions... Selecting Syringe Type and Size... Priming... Programming an Infusion... PCA INFUSION MODES... PCA Module Programming Parameters... Setting Up PCA Dose Only... Setting Up Continuous Infusion Only... Setting Up PCA Dose + Continuous Infusion... Setting Loading Dose Only... Setting Bolus Dose... Stopping a Loading, PCA or Bolus Dose... Changing Programming Parameters During an Infusion... Viewing Patient History... Clearing Patient History... Viewing Drug Event History... Configuring Dose Request Cord... Security Access Levels... Pausing Infusion... Restoring Infusion Following Syringe Empty... Stopping Infusion... Selecting Pressure Limit... Viewing and Clearing Volume Infused... Changing Syringe During Infusion... POWERING OFF... Powering Off Channel... Powering Off System...

INTRODUCTION

ABOUT THE SYSTEM... FEATURES AND DEFINITIONS... SYMBOLS...

ALARMS, ERRORS, MESSAGES DEFINITIONS... AUDIO CHARACTERISTICS... ALARMS... Syringe Adjustment Alarms... ERRORS... MESSAGES...

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MAINTENANCE SPECIFICATIONS... CONFIGURABLE SETTINGS... System Settings... PCA Module Settings... COMPATIBLE SYRINGES... COMPATIBLE SETS... CLEANING... INSPECTION REQUIREMENTS... SERVICE INFORMATION...

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APPENDIX TRUMPET AND START-UP CURVES...

ii TABLE OF CONTENTS

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GENERAL CONTACT INFORMATION

Customer Advocacy - North America Clinical and technical feedback. Phone: (800) 854-7128, Ext. 7812 E-Mail: [email protected]

Technical Support - North America Maintenance and service information support; troubleshooting. United States: Phone: (858) 458-6003 (800) 854-7128, Ext. 6003

Canada: Phone: Eastern: (800) 908-9918 Western: (800) 908-9919

Customer Care - North America Instrument return, service assistance, and order placement. United States: Phone: (800) 482-4822

Canada: Phone: (800) 387-8309

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INTRODUCTION About the System INTRODUCTION

The Medley™ Medication Safety System is a modular infusion and monitoring system intended for use in today’s growing professional healthcare environment, for use in adult, pediatric and neonatal care. The Medley™ Medication Safety System consists of the Point-of-Care Unit (PCU) (8000 Series), the Guardrails® Safety Software, and up to four detachable modules which provide infusion or monitoring capabilities. The Medley™ PCU controls the Medley™ System and provides a common user interface for programming and monitoring an infusion, which helps to reduce complexity at the point of care. The Medley™ Patient Controlled Analgesia (PCA) Module (Model 8120) is intended for facilities that utilize syringe pumps for the delivery of medications or fluids using continuous or intermittent delivery through clinically acceptable routes of administration; such as, intravenous (IV), subcutaneous or epidural. The Guardrails® Safety Software for the Medley™ System brings a new level of medication error prevention to the point of patient care. The Guardrails® Safety Software features hospital-defined medication dosing guidelines for up to ten patient-specific care areas, referred to as profiles. Each profile contains a specific drug library and channel labels, as well as instrument configurations appropriate for the care area. Optional drug-specific Guardrails® Clinical Advisories provide visual messages. Dosing limits for each drug entry may be either Guardrails® Hard Limits that cannot be overridden during infusion programming, or Guardrails® Soft Limits that can be overridden, based on clinical requirements. A data set is developed and approved through the facility’s own multi-disciplinary team using the Guardrails® Editor, the PC–based authoring tool. A data set is then transferred to the Medley™ System by qualified personnel. The approved data sets are maintained by the Guardrails® Editor for future updates and reference. A data set is required prior to using the Medley™ PCA Module. Information about Guardrails® Alerts that occur during use are stored within the Medley™ PCU, and can be accessed using the Guardrails® Continuous Quality Improvement (CQI) Event Tracker and Guardrails® CQI Reporter.

INTRODUCTION 1

About the System (Continued) This document provides directions for use for the Medley™ PCA Module. Read all instructions, for both the Medley™ PCA Module and the Medley™ PCU before using the Medley™ System. The Medley™ PCA Module uses non-dedicated standard or pre-filled, single-use, disposable syringes (with luer-lock connectors) and administration sets with anti-siphon valves, designed for use on syringe-type PCA devices. For specific administration set instructions, refer to the directions for use provided with the set. For set priming and loading instructions, refer to the “Preparing Infusion” section in the “Getting Started” chapter of this document. Contraindications: None known.

2 INTRODUCTION

Features and Definitions

Auto Pressure Limit Adjustment

When a bolus is delivered, the pressure alarm limits are temporarily raised to the maximum limit.

Auto Syringe Identification

The system automatically detects the syringe size and narrows down the syringe selection list.

Bolus Dose

The Bolus Dose feature enables a clinician to program an additional amount of medication once the PCA infusion has begun. The current PCA infusion will resume following the delivery of a bolus dose.

Dose Request Cord

When attached, the dose request cord allows a patient to selfadminister a PCA dose to be delivered according to programmed PCA parameters. The dose request cord features an indicator light which can be configured to provide feedback to the patient on requested PCA doses. The dose request cord is enabled in PCA only and PCA + Continuous modes.

Drug Event History

Records and displays sequential device events for a typical 12 hours, subject to change upon usage and number of modules.

Event Logging

Event Logging records instrument operations.

Guardrails® Clinical Advisory

A Guardrails® Clinical Advisory is a visual message that appears when a designated drug is selected, to remind a clinician of specific hospital standards of practice when programming an IV medication. A specific clinical advisory can be associated with a selected drug within any of the patient care profiles.

Guardrails® Drug Library

The Guardrails® Drug Library feature is a drug calculation mode available when the Profiles feature is enabled. It provides a hospital-defined list of drugs and concentrations appropriate for use in as many as 10 profiles. Using the Drug Library automates programming steps, including the drug name, drug amount and diluent volume, and activates the hospital-established best-practice Guardrails® Limits. A Guardrails® Safety Software data set is required prior to using the Medley™ PCA Module.

INTRODUCTION 3

INTRODUCTION

Refer to the “Alarms, Errors, Messages” chapter of this Directions for Use for the definitions of various alerts. Refer to the Medley™ PCU Directions For Use for system features and definitions.

Features and Definitions (Continued) Guardrails® Limit

A Guardrails® Limit is a programming limit or best-practice guideline for programming a dose limit parameter or instrument configuration determined by the hospital/health system and entered into the system’s data set. Dose limits can be defined by the hospital/health system as either “hard” or “soft” limits. • A Guardrails® Hard Limit is a programmed limit that cannot be overridden.

Loading Dose

• A Guardrails® Soft Limit is a programmed limit that can be overridden. The Loading Dose enables a clinician to program a bolus infusion prior to initiation of the PCA infusion. The Loading Dose may be programmed from the Infusion Modes menu or applicable PCA, PCA + Continuous or Continuous Only programming screen prior to the start of a new PCA infusion program.

Lockout Interval

Allows the clinician to program a pre-determined interval of time that must elapse between delivery of PCA doses.

Occlusion Pressure

Downstream occlusion alarm threshold can be set to low, medium, or high.

Operating Modes

The PCA Module has four operating modes available: •

PCA only

•

Continuous Infusion

•

PCA + Continuous Infusion

•

Loading Dose Only

All programming of infusions in each of the four modes are completed using the Guardrails® Drug Library. Near End of Infusion (NEOI)

4 INTRODUCTION

The NEOI option allows an alert to be configured to sound anywhere between 5 - 25% volume remaining.

Features and Definitions (Continued) Patient History

•

Total demands

•

Delivered demands

•

Total drug delivered

•

Time and date patient history last cleared

•

Average drug per hour

•

Total amount of drug delivered via: ¤ PCA Dose ¤ Continuous Infusion ¤ Loading Dose ¤ Bolus Dose

PCA Dose

The PCA Dose enables a patient to self-administer a bolus infusion to be delivered at programmed lockout intervals through the dose request cord. When programmed in the PCA+Continuous mode, the continuous infusion will resume following the PCA dose.

Priming

The Priming option allows a limited volume of fluid to be delivered in order to prime the administration set prior to being connected to a patient or after changing a syringe. When priming, a single continuous press of the PRIME soft key delivers up to 2 mL of priming/fluid.

Restore

To simplify programming, the Restore feature can be used to recall previous PCA programming parameters for the same patient. This option is only available if the patient is not new and the system is powered up within 8 hours of last usage.

Syringe Empty

The instrument gives an alert and stops when an empty syringe is detected.

Syringe Volume Detection

The system automatically detects the fluid volume in a syringe when it is inserted.

INTRODUCTION 5

INTRODUCTION

The PCA Module records and displays patient history for up to 24 hours, and may be trended to the following intervals: 1hr/2hr/4hr/8hr/12hr/24hr. Patient history includes the following trending information:

Symbols

+

75

Canadian and U.S. Certification Mark: Products bearing this mark have been tested and certified in accordance with applicable U.S. and Canadian electrical safety and performance standards (CSA C22.2 No. 601.1, UL 60601-1 and IEC 60601–2–24). Electrical Shock Protection Rating: Type CF, Defibrillation-proof (PCA Module) Electrical Shock Protection Rating: Type BF, Defibrillation-proof (Dose Request Cord)

IPX1

!

Protection against fluid ingress: Drip Proof Attention: Refer to accompanying documentation. IUI Connector: Inter-Unit Interface connector used to establish power and communications between the Point-of-Care Unit and attached channels.

MM-YYYY

Manufacturing Date: Number adjacent to symbol indicates the month and year of manufacture. Consult operating instructions.

Only

CAUTION: Federal (U.S.A.) law restricts this device to sale by or on the order of a physician.

Single-Use

2

Single-Use. Do not re-use.

Product contains a particular element; such as, DEHP = DEHP in fluid pathway. Product DOES NOT contain a particular element; such as, latex-free. » XX ml

= administration set is

Approximate administration set priming volume. Expiration date for product will be identified near hour glass symbol. Do not use if package is damaged.

xx µm

Administration set with filter may be used.

6 INTRODUCTION

GETTING STARTED NOTE: Although the Medley™ Medication Safety System is built and tested to exacting specifications, it is not intended to replace the supervision of IV infusions by medical personnel. The user should become thoroughly familiar with the features and operation of the Medley™ System and exercise vigilance in its utilization.

Only

A WARNING is an alert describing the potential for serious consequences to the patient or user; such as, death, injury or adverse reactions. GETTING STARTED

A CAUTION is an alert to take special care for the safe and effective use of the device. For WARNINGS and CAUTIONS for the The Medley™ Point-ofCare Unit, refer to the The Medley™ Point-of-Care Unit Directions for Use.

Warnings and Cautions WARNING When properly secured/snapped, the bottom latch provides a very secure connection between modules. If not properly latched, a module can be dislodged during operation. WARNING Do not use the Medley™ System in close proximity of Magnetic Resonance Imaging (MRI). WARNING This instrument is designed to stop fluid flow under alarm conditions. Periodic patient monitoring must be performed to ensure the infusion is proceeding as expected. WARNING The Guardrails® Safety Software incorporates dosing limits and instrument configuration parameters based on hospital protocol. The software adds a test of reasonableness to drug programming based on the limits defined by the hospital. Qualified personnel must ensure the appropriateness of the drug dosing limits, the compatibility of the drugs, and the performance of each instrument, as part of the overall infusion. Potential hazards include drug interactions, and inappropriate delivery rates and pressure alarms.

GETTING STARTED 7

Warnings and Cautions (Continued) WARNING When loading a data set with the Guardrails® Safety Software, ensure the correct profile (for patient care area) is selected prior to starting an infusion. Failure to use the appropriate profile could cause serious consequences. WARNING The Medley™ PCA Module is a positive displacement delivery system, capable of developing positive fluid pressures to overcome widely varying resistances to flow encountered in practice, including resistances to flow imposed by small gauge catheters and filters. It is neither designed nor intended to detect infiltrations and will not alarm under infiltration conditions. WARNING Hospital personnel must ensure the compatibility of the drugs as well as the performance of each channel as part of the overall infusion. Potential hazards include drug interactions, inaccurate delivery rates, inaccurate pressure alarms and nuisance alarms. WARNING Use only standard or pre-filled, single-use, disposable syringes (with luer-lock connectors) and non-dedicated administration sets with anti-siphon valves, designed for use on syringe-type PCA devices. The use of any other syringe or administration set may cause improper instrument operation, resulting in inaccurate fluid delivery, or other potential hazards. For a list of compatible syringes, refer to the “Compatible Syringes” section in the “Maintenance” chapter. For a list of compatible administration sets, refer to the Set Compatibility Card (provided separately and in this Directions for Use). WARNING Before loading or unloading the syringe, always turn off fluid flow to the patient, using the tubing clamp or stopcock. Uncontrolled fluid flow can occur when the administration set is not clamped or turned off, and may cause serious injury or death. WARNING When an occlusion occurs, there is a risk of infusing pressurized buildup of infusates upon correction of the occlusion. To avoid an inadvertent bolus, relieve the pressure before restarting the infusion.

8 GETTING STARTED

Warnings and Cautions (Continued) WARNING When priming: • Ensure patient is not connected. • Ensure air is expelled from line prior to beginning infusion (unexpelled air in line could have serious consequences). Failure to prime correctly can delay infusion delivery and cause the total volume to be infused to read higher than the actual total delivered to the patient. GETTING STARTED

WARNING Ensure the syringe manufacturer and syringe size displayed matches the syringe manufacturer and syringe size installed in the Medley™ PCA Module. Mismatches may cause an underinfusion or over-infusion to the patient that could result in serious injury and/or death. For a list of compatible syringes, refer to the “Compatible Syringes” section in the “Maintenance” chapter. WARNING The use of positive displacement infusion devices ported together with gravity flow infusion systems into a common IV site may impede the flow of common “gravity only” systems, affecting their performance. Hospital personnel must ensure the performance of the common IV site is satisfactory under these circumstances. WARNING Each time the Medley™ System is turned on, verify and/or set the pressure alarm limit. If the pressure alarm limit is not verified, the instrument may not operate within the desired occlusion detection parameter(s). WARNING References in this document to specific drugs and drug doses are for illustration purposes only. Refer to specific drug product labeling for information concerning appropriate administration techniques and dosages.

GETTING STARTED 9

Warnings and Cautions (Continued) WARNING When the Medley™ PCA Module is used with a primary IV line, use of an appropriate Y-set with a backcheck valve is highly recommended. Failure to properly use a Y-set may result in retrograde analgesic flow into the primary line during a partial or complete downstream occlusion. This may subsequently result in an inadvertent bolus to the patient when the occlusion is cleared. Parallel Infusions There are no contraindications regarding the use of the Medley™ System with any other positive displacement infusion device when ported together into a common IV site location.

User Precautions To ensure proper performance of the Medley™ System and to reduce potential injury, observe the following precautions: • 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 maintenance line. • It is recommended that highly viscous solutions and drugs, colloidal suspensions and emulsions should not be delivered through the inline backcheck valve on the maintenance side of the PCA set. Valve functionality may be compromised by the presence of residue. • Disconnect from main (AC) power when performing maintenance. • Do not open the instrument case. The case should only be opened by qualified service personnel using proper grounding techniques.

10 GETTING STARTED

Warnings and Cautions (Continued) User Precautions (Continued) Epidural Administration

•

Epidural administration of anesthetic drugs: Use indwelling catheters specifically indicated for short-term anesthetic epidural drug delivery.

•

Epidural administration of analgesic drugs: Use indwelling catheters specifically indicated for either short-term or long-term analgesic epidural drug delivery.

WARNING Epidural administration of drugs other than those indicated for epidural use could result in serious injury to the patient.

WARNING It is strongly recommended that the syringe, administration set, and the Medley™ PCA Module used for epidural drug delivery be clearly differentiated from those used for other types of administration.

Dose Request Cord Use •

Only the patient should press the dose request cord button.

Administration Sets and Syringes • •

•

• •

• • •

• • •

For a list of compatible syringes, refer to “Compatible Syringes” section in “Maintenance” chapter. For a list of compatible administration sets, refer to Set Compatibility Card (provided separately and in this Directions for Use). For specific administration set instructions, refer to Directions For Use provided with set. For set priming and loading instructions, refer to “Preparing Infusion” section of this document. Before operating instrument, verify that administration set is free from kinks and installed correctly in instrument. The administration sets compatible with the Medley™ PCA Module are supplied with a sterile fluid path for one-time use. Do not resterilize. Fluid path is STERILE and NONPYROGENIC. Discard if packaging is not intact or protector caps are unattached. For administration set replacement interval, refer to facility protocol and/or government standards (such as, CDC guidelines in the United States). For IV push medication, put instrument on hold, clamp tubing above the port. Flush port(s) per facility protocol. Discard administration set per facility protocol.

WARNING Use only standard or pre-filled, singleuse, disposable syringes (with luerlock connectors) and non-dedicated administration sets with anti-siphon valves, designed for use on syringetype PCA devices. The use of incompatible syringe or administration set may cause improper instrument operation, resulting in inaccurate fluid delivery, or other potential hazards. For a list of compatible syringes, refer to the “Compatible Syringes” section in the “Maintenance” chapter. For a list of compatible administration sets, refer to the Set Compatibility Card (provided separately and in this Directions for Use).

GETTING STARTED 11

GETTING STARTED

The Medley™ PCA Module can be used for epidural administration of anesthetic and analgesic drugs. This application is only appropriate when using analgesics and anesthetics labeled for continuous epidural administration and catheters intended specifically for epidural use. Use only standard, single-use, disposable syringes (with luer-lock connectors) and administration sets, designed for use on syringe pumps and without a ‘Y’ connector or injection port, for epidural infusions.

Warnings and Cautions (Continued) User Precautions (Continued) Artifacts It is normal for an infusion device to produce nonhazardous currents when infusing electrolytes. These currents vary proportional to the infusion device flow rate. When the ECG monitoring system is not functioning under optimal conditions, these currents may appear as artifacts, simulating actual ECG readings. To determine if ECG abnormalities are caused by patient condition or the ECG equipment, place the infusion device on hold. If the ECG readings become normal, the ECG equipment requires attention. Proper setup of the ECG equipment should eliminate these artifacts. Reference the appropriate ECG monitoring system documentation for instructions on setup and maintenance.

Radio Frequency Interference Operating the system near equipment which radiates highenergy radio frequencies (electrosurgical/cauterizing equipment, portable radios, cellular telephones, etc.) may cause false alarm conditions. If this happens, reposition the infusion device away from the source of interference or turn off the infusion device and manually regulate the flow with the clamp and/or monitor the vital parameters using an appropriate clinical alternative.

Electromagnetic Compatibility (EMC) When using the Medley™ PCA Module in combination with a Medley™ Point-of-Care Unit which is interconnected to hospital data communications equipment and/or nurse call systems (signal input and signal output ports), the external systems must be certified to applicable standards to ensure correct operation and electromagnetic compliance integrity Interconnected data communications systems must be certified to IEC 60950 (data processing equipment) or IEC 60601–1 electromedical equipment. Nurse call systems must be certified to UL 1069 (hospital signaling and nurse call equipment) or comply with the requirements specified in IEC 60601–1. Compliance with the electromagnetic compatibility standard (IEC 60601-1-2) is a function of all interconnected equipment including cabling and, as such, it is the responsibility of the hospital/facility to ensure external equipment complies with the applicable EMC standards. Failure to verify that external equipment meets applicable EMC standards may result in degraded electromagnetic compatibility (refer to “Radio Frequency Interference” warning for additional information)

12 GETTING STARTED

WARNING Use of accessories or cables other than those specified may result in degraded electromagnetic compatibility performance of this device.

Warnings and Cautions (Continued) User Precautions (Continued) Dropping/Jarring Should an instrument be dropped or severely jarred, it should be immediately taken out of use and inspected by qualified service personnel, to ensure its proper function prior to reuse.

DANGER Explosion risk if used in the presence of flammable anesthetics.

GETTING STARTED 13

GETTING STARTED

Operating Environment Not for use in the presence of flammable anesthetics.

Controls and Indicators Gripper Control / Drive Head Release (shown in closed position)

Security Lock Status Indicators Alarm (red)

Infusing (green)

Standby (yellow)

Plunger Grippers (shown in closed position)

IUI Connector, Left

Rate Display Syringe Barrel Sensor

Channel Message Display Channel Identification Channel Select Key - When pressed, selects corresponding channel for infusion parameter entry and infusion setup.

Syringe Barrel Clamp / Sizer Pause Key - When pressed during an infusion, temporarily stops infusion on that channel. After approximately 2 minutes, a visual and audio prompt begins.

Channel Off Key - When pressed and

Security Door

held for one second and then released, stops infusion on that channel, deselects that channel, and if only that channel had been operating, system powers down. Repeat for other operating channels to power off each channel.

Restart Key - When pressed, resumes operation of a previously paused or alarmed infusion on that channel.

Channel Release Lever Dose Request Cord Attachment

Dose Request Cord

14 GETTING STARTED