Pump Module Model 8100 series Directions for Use Rev 00

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

TABLE OF CONTENTS INTRODUCTION ABOUT THE PUMP MODULE... FEATURES AND DEFINITIONS... SYMBOLS...

1 2 4

GETTING STARTED WARNINGS AND CAUTIONS... General... Guardrails® Safety Software... Epidural Administration... Administration Sets... OPERATING FEATURES, CONTROLS AND INDICATORS... INSTALLATION... ATTACHING AND DETACHING MODULES... DISPLAYS... Main Display... Dynamic Pressure Display... START-UP... Powering On System... Responding to Maintenance Reminder... Selecting New Patient and Profile Options... Entering Patient ID... Modifying Patient ID... PREPARING INFUSION... Administration Set... Flo-Stop® Device... Priming Primary Administration Set... Loading and Removing Primary Administration Set... Setting Up Primary Administration Set for Gravity Infusion...

7 7 8 8 9 10 12 12 12 12 12 13 13 13 13 13 13 13 13 14 15 15 18

PROGRAMMING PRIMARY MODE - BASIC INFUSION... Starting Rate/Volume Infusion... Starting Volume/Duration Infusion... Pausing Infusion... Restarting Infusion Following Infusion Complete... Changing Rate or VTBI During Infusion... Stopping Infusion... Selecting Pressure Mode - Pump / Selectable... Viewing and Clearing Volume Infused... Auto-Restart... SECONDARY MODE... Changing Primary Infusion Parameter During Secondary Infusion... Stopping Secondary Infusion and Returning to Primary Infusion... CHANGING PRIMARY SOLUTION CONTAINER... CHANNEL LABELS... Selecting Channel Label... Removing Channel Label... POWERING OFF... Powering Off System... Powering Off Module...

Pump Module, 8100 Series Directions for Use

19 20 21 22 23 24 24 25 26 27 28 30 31 32 33 33 34 35 35 35

TABLE OF CONTENTS i

PROGRAMMING (Continued) SETTING UP DRUG CALCULATION... Drug Calculation Parameters... Using Guardrails® Drug Library... Using Non-Library Drug... BOLUS DOSE... Using Guardrails® Drug Library Calculation... Using Non-Library Drug Calculation... Stopping Bolus Dose... Restoring Bolus Dose... ANESTHESIA MODE... Enabling Anesthesia Mode... Disabling Anesthesia Mode... DELAY OPTIONS... Delaying Infusion... Scheduling a Callback... Pausing Infusion... MULTIDOSE MODE... Programming with Volume/Duration Enabled... Programming with Volume/Duration Disabled... REVIEWING SERIAL NUMBER... REVIEWING SOFTWARE VERSION...

35 35 36 40 44 44 49 51 52 54 55 56 57 58 62 64 65 66 70 73 73

ALARMS, ERRORS, MESSAGES DEFINITIONS... AUDIO CHARACTERISTICS... ALARMS... ERRORS... MESSAGES...

75 75 75 76 77

MAINTENANCE SPECIFICATIONS... CONFIGURABLE SETTINGS... System Settings... Shared Infusion Settings (Pump Module and Syringe Module)... Pump Module Settings... CLEANING... INSPECTION REQUIREMENTS... SERVICE INFORMATION... WARRANTY...

79 81 81 82 82 83 83 83 84

APPENDIX TRUMPET AND START-UP CURVES...

ii TABLE OF CONTENTS

85

Pump Module, 8100 Series Directions for Use

INTRODUCTION INTRODUCTION

About the Pump Module The Medley™ Pump Module (8100 Series) is intended for facilities that utilize infusion pumps for the delivery of fluids, medications, blood, and blood products using continuous or intermittent delivery through clinically acceptable routes of administration; such as, intravenous (IV), intra-arterial (IA), subcutaneous, epidural, enteral, or irrigation of fluid spaces. The Medley™ Pump Module is indicated for use on adults, pediatrics, and neonates. 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 an 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. Compliance with Federal Aviation Regulations: The Medley™ Pump Module has received a Statement of Compliance with Federal Aviation Regulations for use as a “Portable Electronic Device Aboard Aircraft”. This is pursuant to the FAA Advisory Circular No. 91-21-1A and attested by an FAA Designated Engineering Representative with an FAA form 8110-3, “Statement of compliance with the Federal Aviation Regulations”. Contraindications: None known. This document provides directions for use for the Medley™ Pump Module. NOTE: The Medley™ Point-of-Care Unit was formerly known as the Medley™ Programming Module.

Pump Module, 8100 Series Directions for Use

WARNING Read all instructions, for both the Pump Module and Point-of-Care Unit, before using the Medley™ System.

INTRODUCTION 1

Features and Definitions Reference the “Alarms, Errors, Messages” chapter of the Medley™ Point-of-Care Unit Directions for Use (DFU) for the definitions of various alerts. Reference the Point-of-Care Unit DFU for system features and definitions. Auto-Restart

Part of Medley™ System’s advanced Downstream Occlusion Detection system. If enabled, it minimizes nuisance patient-side occlusion alarms caused by momentary kinking of tubing, IV pushes, etc.

Bolus Dose

Allows a bolus infusion to be programmed using either the Guardrails® Drug Library or drug calculation feature. It can be programmed with or without a continuous infusion following a bolus.

Channel Labels

Available when Profiles feature is enabled. It provides a hospitaldefined list of labels, displayed in Channel (Module) Message Display, and identifies module with the solution being infused, catheter location, or other helpful information.

Concentration Limits

Limits specified for the range of concentrations allowed for a particular drug in a profile.

Delay Options

Allows system to be programmed to delay start of an infusion a) for up to 120 minutes or b) for a specific time up to 23 hours 59 minutes. A callback for a programmed delay can be scheduled to give an alert Before an infusion is to be initiated, After an infusion is completed, Before and After an infusion, or no alert (None).

Drug Calculation

Allows: • entry of drug dose (Medley™ System calculates correct flow rate to achieve desired dose), OR

• entry of flow rate (Medley™ System calculates corresponding drug dose). Dynamic Pressure Display

Appears on Main Display. If enabled, it graphically displays current patient-side occlusion pressure set point and current patient-side operating pressure for that module. (Reference “Displays” section in “Getting Started” chapter for additional “Dynamic Pressure Display” information.)

Free Flow Protection

All Medley™ System/Gemini administration sets utilize a unique clamping device, the Flo-Stop® Device, to prevent inadvertent freeflow when the administration set is removed from the instrument.

2 INTRODUCTION

Pump Module, 8100 Series Directions for Use

Features and Definitions (Continued) 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. Drug Library use automates programming steps, including drug name, drug amount and diluent volume, and activates hospital-established best-practice Guardrails® Limits.

Guardrails® Limit

A programming limit or best-practice guideline determined by hospital/health system and entered into system’s data set. Supports concentration limits for all infusions that utilize concentration. Profilespecific limits are defined for flow rate, patient weight, and maximum and minimum continuous dose for each drug in a Guardrails® Drug Library. Dose limits can be defined by hospital/health system as either “hard” or “soft” limits. • A Guardrails® Hard Limit is a programmed limit that cannot be overridden, except in anesthesia mode. • A Guardrails® Soft Limit is a programmed limit that can be overridden.

KVO Rate Adjust

Used to select KVO (Keep Vein Open) rate (0.1 to 20 mL/h allowed), which is the rate of fluid flow after an “Infusion Complete” occurs. The KVO rate will never exceed the infusion rate.

Multidose Mode

Allows 2 - 24 doses to be programmed at equally spaced intervals on the same Pump Module over a 24-hour period. This mode is designed to allow delivery of multiple, equal doses from the same IV container at regularly scheduled intervals.

Occlusion Pressure

A complete range of downstream occlusion detection options is provided. • Pump mode: Downstream occlusion alarm threshold is 525 mmHg at flow rates of 30 mL/h or greater. For rates <30 mL/h, the occlusion pressure is rate-dependent, to ensure rapid response to occlusions. • Selectable pressure mode: Downstream occlusion alarm threshold can be adjusted in 25 mmHg increments, up to maximum occlusion pressure of 525 mmHg. • Auto-Restart: (See “Auto-Restart” definition.) In addition, the Medley™ System provides fluid-side occlusion detection.

Rapid Bolus

Pump Module, 8100 Series Directions for Use

Fastest rate at which bolus dose should be delivered, as defined by facility’s clinical best-practice guidelines.

INTRODUCTION 3

INTRODUCTION

Guardrails® Drug Library

Features and Definitions (Continued) Restore

To simplify programming, can be used to recall previous rate and volume settings 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.

Secondary Infusions

Dual rate sequential piggyback (secondary) infusions may be infused at delivery rates and volumes independent of primary infusion parameters. Automatic changeover occurs to the primary infusion parameters when the secondary infusion is complete if a Medley™ System/Gemini Check Valve Administration Set is used.

Volume/Duration

Allows a volume-to-be-infused (VTBI) and duration (infusion time) to be programmed. The flow rate is automatically calculated.

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 2601-1 and IEC 60601–2–24). Electrical Shock Protection Rating: Type CF, Defibrillation-proof

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 Point-of-Care Unit and attached modules.

MM-YYYY

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

Only

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

Single-Use

2 XX µm

Single-Use. Do not re-use.

Product contains micron filter, where XX represents filter size.

4 INTRODUCTION

Pump Module, 8100 Series Directions for Use

Symbols (Continued) DEHP

= DEHP in fluid pathway.

Product DOES NOT contain a particular element; such as, LATEX = administration set is latex-free. Drops per milliliter specification for product will be identified on drop symbol.

XX

Product incorporates SmartSite® Needle-Free Valve Ports and should not be accessed by a needle.
XX ml

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

Pump Module, 8100 Series Directions for Use

INTRODUCTION 5

INTRODUCTION

Product contains a particular element; such as,

T H I S PA G E I N T E N T I O N A L LY LEFT BLANK

6 INTRODUCTION

Pump Module, 8100 Series Directions for Use

GETTING STARTED Warnings and Cautions Warnings and Cautions provided throughout this Directions for Use (DFU) provide information needed to safely and effectively use the Medley™ Pump Module and accessories. Medley™ System Warnings and Cautions, and definitions, are covered in the Point-of-Care Unit DFU.

Only

GETTING STARTED

General WARNINGS • The Medley™ Pump Module is designed to stop fluid flow under alarm conditions. Periodic patient monitoring must be performed to ensure the infusion is proceeding as expected. It 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, filters and intra-arterial infusion. It is neither designed nor intended to detect infiltrations and will not alarm under infiltration conditions. • 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/facility personnel must ensure the performance of the common IV site is satisfactory under these circumstances. • To prevent a potential free-flow condition, ensure no extraneous object (for example, bedding, tubing, glove) is enclosed or caught in the Medley™ Pump Module door.

Pump Module, 8100 Series Directions for Use

GETTING STARTED 7

Warnings and Cautions (Continued) Guardrails® Safety Software WARNINGS • The Guardrails® Safety Software incorporates dosing limits and instrument configuration parameters based on hospital/facility protocol. The software adds a test of reasonableness to drug programming based on the limits defined by the hospital/facility. Qualified personnel must ensure the appropriateness of drug dosing limits, drug compatibility, and instrument performance, as part of the overall infusion. Potential hazards include drug interactions, inaccurate delivery rates and pressure alarms, and nuisance alarms. • 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. Epidural Administration WARNINGS • Epidural administration of drugs other than those indicated for epidural use could result in serious injury to the patient. • It is strongly recommended that the source container, Medley™ System/Gemini Administration Set, and Pump Module used for epidural drug delivery be clearly differentiated from those used for other types of administration. • The Medley™ System can be used for epidural administration of anesthetic and analgesic drugs. This application is only appropriate when using anesthetics and analgesics labeled for continuous epidural administration and catheters intended specifically for epidural use. Use only a Medley™ System/Gemini Series administration set, without a ‘Y’ connector or injection port, for epidural infusions. ♦

Epidural administration of anesthetic drugs: Use indwelling catheters specifically indicated for short-term (96 hours or less) 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.

8 GETTING STARTED

Pump Module, 8100 Series Directions for Use

Warnings and Cautions (Continued) Administration Sets WARNINGS

GETTING STARTED

• Use only Medley™ System/Gemini Series Administration Sets. The use of any other set may cause improper instrument operation, resulting in an inaccurate fluid delivery or other potential hazard. For a list of compatible sets, reference the Set Compatibility Card (provided separately). • Discard if packaging is not intact or protector caps are unattached. CAUTION Before operating instrument, verify that administration set is free from kinks and installed correctly in instrument.

Pump Module, 8100 Series Directions for Use

GETTING STARTED 9

Operating Features, Controls and Indicators Front/Side View - Door Closed

IUI Connector, Right

Status Indicators

IUI Connector, Left

(not visible)

Alarm

Infusing

Standby

(red)

(green)

(yellow)

Rate Display

RM ALA

STANDBY

INFUSE

Channel (Module) Message Display Channel (Module) Identification Channel (Module) Select Key: When pressed, selects corresponding module for infusion parameter entry and infusion setup.

NEL CHAN T SELEC

Pause Key: When pressed during an PAUSE

NEL CHAN OFF

infusion, temporarily stops infusion on that module. After approximately 2 minutes, a visual and audio prompt begins.

RT

RESTA

Channel (Module) Off Key: When pressed and held until a beep is heard, stops infusion on that module, deselects that module, and if only that module had been operating, system powers down. Repeat for other operating modules to power off each module.

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

Door Handle Module Release Latch: When pressed, allows module to be removed.

10 GETTING STARTED

Pump Module, 8100 Series Directions for Use

Operating Features, Controls and Indicators (Continued) Front View - Door Open IUI Connector, Left (not visible) Upper Tubing Fitment Retainer

IUI Connector, Right

Upper Pressure Sensor Upper Occluder Upper Pumping Finger Door Latch Cam/Slide

Lower Occluder Lower Pumping Finger Lower Pressure Sensor

Flo-Stop® Device Recess Tubing Keeper Air-in-Line Sensor

Pump Module, 8100 Series Directions for Use

GETTING STARTED 11

GETTING STARTED

Platen

Installation Instruments are tested and calibrated before they are packaged for shipment. To ensure proper operation after shipment, it is recommended that an incoming inspection be performed before placing the instrument in use. Prior to placing the Medley™ System in use: Perform check-in procedure per Medley™ Maintenance Software/User Manual (Model 8970C, or later).

Attaching and Detaching Modules Reference the Medley™ Point-of-Care Unit DFU.

Displays The displays illustrated throughout this document are for illustration purposes only. The display content will vary, depending on configuration settings, type of administration set in use, hospital-defined data set uploaded using the Guardrails® Safety Software, programmed drug calculation parameters, and many other variables. Refer to specific drug product labeling for information concerning appropriate administration techniques and dosages. Main Display Reference the Medley™ Point-of-Care Unit DFU. Dynamic Pressure Display Midtown Hospital Adult ICU

Dynamic Pressure Display

VTBI = 250.0 mL

Current operating pressure is indicated by solid bar. Patient-side occlusion pressure set point is indicated by tick mark.

12 GETTING STARTED

VOLUME INFUSED

CAUTION Although the dynamic pressure display bars for the Medley™ Syringe Module and Pump Module both use the full width of the screen for display, they each represent different ranges. The Pump Module’s range is 50 to 525 mmHg.

AUDIO ADJUST

Pump Module, 8100 Series Directions for Use

Start-Up Reference the Medley™ Point-of-Care Unit DFU for the following procedures: Powering On System Responding to Maintenance Reminder Selecting New Patient and Profile Options Entering Patient ID Modifying Patient ID

Administration Set The Medley™ Pump Module uses a wide variety of Medley™ System/Gemini Administration Sets. The sets are designed for use with the Pump Module as well as for gravity-flow, stand-alone use. • For specific administration set instructions, reference directions for use provided with set. • The primary set must be primed before use (reference “Priming Primary Administration Set” section). It can be loaded into Pump Module to deliver a large volume infusion (reference “Loading and Removing Primary Administration Set” section) or it can be set up to deliver a gravity infusion (reference “Setting Up Primary Administration Set for Gravity Infusion” section).

WARNING Use only Medley™ System/Gemini Series Administration Sets. The use of any other set may cause improper instrument operation, resulting in an inaccurate fluid delivery or other potential hazard. For a list of compatible sets, refer to the Set Compatibility Card (provided separately).

• Use aseptic technique when handling sets. • Administration sets are supplied with a sterile and nonpyrogenic fluid path for one-time use. Do not resterilize. • For administration set replacement interval, refer to facility protocol and/or government standards (such as, CDC guidelines in United States). • Discard administration set per facility protocol. • For IV push medication (put instrument on hold), clamp tubing above port. • Flush port(s) per facility protocol. • Flo-Stop® Device is a tubing fitment that is part of all Medley™ System/Gemini sets (reference “Flo–Stop® Device” section).

Pump Module, 8100 Series Directions for Use

GETTING STARTED 13

GETTING STARTED

Preparing Infusion

Preparing Infusion (Continued) Administration Set (Continued) SmartSite® Needle-Free System • The SmartSite® Needle-Free Valve Port is contraindicated for blunt cannula systems. • Swab the top of the SmartSite® Needle-Free Valve Port with preferred antiseptic prior to each access. NOTES: • If applicable, attach syringe to SmartSite® Needle-Free Valve Port and aspirate minute air bubbles. • In an emergency, SmartSite® Valve may be accessed by a needle and will leak if punctured. To access port with needle without causing leakage, attach a “PRN” adapter of sufficient length to SmartSite® Needle-Free Valve Port.

Flo-Stop® Device The primary administration set’s Flo-Stop® Fitment is a unique clamping device that prevents inadvertent free-flow when the administration set is removed from the instrument. Flo-Stop® Device in Open Position

Blue Fitment

When a new Medley™ System/Gemini administration set is removed from the package, the Flo-Stop® Device is in the open position (white slide clamp aligned with blue fitment). In this open position, flow is not occluded but is allowed as required for the priming process. The roller clamp is used to control flow during the priming process (reference “Priming Primary Administration Set” section).

White Slide Clamp -- OPEN --

14 GETTING STARTED

Pump Module, 8100 Series Directions for Use

Preparing Infusion (Continued) Flo-Stop® Device (Continued) Flo-Stop® Device in Closed Position

Blue Fitment

GETTING STARTED

When a Medley™ System/Gemini administration set is removed from the Pump Module, the instrument automatically engages the Flo-Stop® Device in the closed position (white slide clamp projects out from under blue fitment). In this closed position, flow is occluded.

White Slide Clamp -- CLOSED --

Priming Primary Administration Set 1.

Prepare primary solution container in accordance with manufacturer’s directions for use.

2.

Open administration set package, remove set, and close roller clamp. (Reference set’s Directions For Use.)

3.

Insert administration set spike into prepared fluid container, following accepted hospital/facility procedure, and hang container 20 inches above Pump Module.

4.

Fill drip chamber to 2/3 full.

5.

If container requires venting, open vent cap on administration set spike.

6.

To prime tubing and clear air from injection sites and tubing fitments, slowly open roller clamp.

7.

When priming is complete, close roller clamp.

8.

Verify no fluid flow.

Pump Module, 8100 Series Directions for Use

GETTING STARTED 15

Preparing Infusion (Continued) Loading and Removing Primary Administration Set Loading Administration Set 1.

If a new set is being loaded, prime set (reference “Priming Primary Administration Set” section).

2.

Open Pump Module door.

3.

Load administration set, as follows:

CAUTION Insert upper fitment BEFORE installing the Flo-Stop® Fitment.

a. Hold upper fitment above fitment recess and lower into recess. b. Ensure tubing is not twisted.

c. Press Flo-Stop® Fitment into recess below mechanism. d. Using a finger tip, firmly push tubing toward back of Air-in-Line (AIL) Detector.

CAUTION When reloading an administration set, leave the Flo-Stop® Fitment in the closed position (reference “FloStop® Device” section). Flo-Stop® Fitment

Push tubing toward back of AIL Detector.

16 GETTING STARTED

Pump Module, 8100 Series Directions for Use