Medley Infusion Pump Module Model 8100 Directions for Use Ver 4b

GENERAL CONTACT INFORMATION Customer Advocacy For clinical and technical questions, feedback, and troubleshooting assistance. Phone, toll-free, within the United States and Canada: (800) 854-7128, Ext. 7812 E-Mail: [email protected]

Technical Support For technical information related to maintenance procedures and service manual support. Phone: (858) 458-6003 Toll-free, within the United States: (800) 854-7128, Ext. 6003 Toll-free, within Canada: Eastern: (800) 227-7215 Western: (800) 667-2335 For more detailed information, refer to the “Service Information” section of this document.

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, including healthcare facilities and home care, for use on adults, pediatrics and neonates. The MEDLEY™ Pump Module 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™ Medication Safety System consists of the Programming Module (Model 8000), the Guardrails® Safety Software, and detachable modules (or “channels”), which provide infusion or monitoring capabilities. This document provides directions for use for the Model 8100 Infusion Pump Module. Please read all instructions, for both the Pump Module and Programming Module, before using the device. The MEDLEY™ System uses a wide variety of ALARIS® MEDLEY™/ 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, refer to the directions for use provided with the set. For set priming and loading instructions, refer to the “Start-Up Sequence” section of this document. Contraindications: None known.

INTRODUCTION 1

Features Anesthesia Mode

The Anesthesia Mode allows the anesthesiologist to access additional drugs in each profile that are appropriate to anesthesiology. This mode also features permanent pause and the ability to set higher air-in-line settings.

AutoRestart

The AutoRestart feature is part of the MEDLEY™ System’s advanced Downstream Occlusion Detection system. If enabled, the AutoRestart feature minimizes nuisance patient side occlusion alarms caused by momentary kinking of tubing, IV pushes, etc.

Bolus Dose

The Bolus Dose mode enables the clinician to program a bolus infusion. It is possible to program a bolus using the Guardrails® Drug Library or using the Drug Calculation feature. The bolus infusion can be programmed with or without a continuous infusion following the bolus.

Channel Labels

The Channel Label feature is available if the Profiles feature is enabled. It provides a hospital-defined list of labels which can be displayed in the Channel Message Display, allowing the user to identify the channel with the solution being infused, the catheter location or other helpful information.

Drug Calculation

The Drug Calculation mode allows the user to: enter the desired drug dose and the MEDLEY™ System calculates the correct flow rate to achieve the desired dose, OR

enter the desired flow rate and the MEDLEY™ System calculates the corresponding drug dose. Dynamic Pressure Display

The Dynamic Pressure Display is located just below the Channel Status information in the Main Display of the Programming Module. If enabled, it graphically displays the current patient side occlusion pressure set point and the current patient side operating pressure for that channel.

Flow Rates

The flow rate range is from 0.1 to 999 mL/h. Rates between 0.1 and 99.9 may be selected in 0.1 mL/h increments. Rates from 100 to 999 mL/h are selected in 1 mL/h increments.

Free Flow Protection

All MEDLEY™/Gemini Disposable Sets utilize a unique clamping device, the Flo–Stop® Device, to prevent inadvertent free flow when the set is removed from the instrument.

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 up to 100 drugs and concentrations appropriate for use in the selected profile. Using the Drug Library automates programming steps, including the drug name, drug amount and diluent volume, and activates the hospital-established best-practice Guardrails® Limit.

2 INTRODUCTION

Features (Continued) Guardrails® Prompt

The Guardrails® Safety Software is designed to help prevent programming errors by:

Occlusion Pressure

The MEDLEY™ System provides a complete range of Downstream Occlusion Detection options, including: • Pump mode, where the 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, where the downstream occlusion alarm threshold can be adjusted by the user in 25 mmHg increments, up to the maximum occlusion pressure of 525 mmHg. • AutoRestart (see previous page) In addition, the MEDLEY™ System provides fluid side occlusion detection.

Profiles

The Profiles feature allows a unique set of system options (profile) to be configured to optimize system function for a specific hospital area or patient type. A profile is comprised of a configuration, with system settings and defaults customized by the user to best meet the needs of the profile area/patient type.

Secondary Infusions

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

System Configuration

The System Configuration mode provides the ability for qualified personnel to customize device settings. If the Profiles feature is enabled, the system settings defined for the selected profile are automatically activated.

Tamper Resist

The Tamper Resist feature provides a quick, one-touch lockout of the front keypad.

Volume/Duration

The Volume/Duration infusion option allows the user to program a volume-to-be-infused (VTBI) and duration (infusion time), and the flow rate is automatically calculated.

Volume-To-Be-Infused (VTBI)

The volume-to-be-infused (VTBI) range is from 0.1 to 9999 mL. Volumes between 0.1 and 999.9 may be selected in 0.1 mL increments. VTBIs from 1000 to 9999 mL are selected in 1 mL increments.

INTRODUCTION 3

INTRODUCTION

• Customizing device configurable settings to meet the need of the selected hospital area/unit (profile). • Comparing user programming with hospital-defined best-practice guidelines. • Providing a Guardrails® Prompt if an out-of-limits entry is made.

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 the Programming Module and add on 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 = 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 set priming volume. Expiration date for product will be identified near hour glass symbol.

4 INTRODUCTION

GETTING STARTED NOTE: Although the MEDLEY™ 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

Definitions WARNING This heading alerts the user to potential serious outcomes (death, injury or serious adverse events) to the patient or user. GETTING STARTED

CAUTION This heading alerts the user to take special care for the safe and effective use of the device.

Warnings and Cautions For WARNINGS and CAUTIONS for the Programming Module, refer to its Directions for Use. To ensure proper performance of the MEDLEY™ System and to reduce potential injury, observe the following precautions: Epidural Administration The MEDLEY™ System 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 a MEDLEY™/Gemini Series 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.

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 infusion pump, source container and MEDLEY™/Gemini Administration Set used for epidural drug delivery be clearly differentiated from those used for other types of administration.

GETTING STARTED 5

Warnings and Cautions (Continued) 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 This infusion device is a positive pressure 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. 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 Do not use the MEDLEY™ System during Magnetic Resonance Imaging (MRI). WARNING Use only MEDLEY™/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. 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 References in this document to specific drugs and drug doses are for example only. Refer to specific drug product labeling for information concerning appropriate administration techniques and dosages.

6 GETTING STARTED

Warnings and Cautions (Continued) 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

GETTING STARTED

To ensure proper performance of the MEDLEY™ System and to reduce potential injury to the operator, observe the following precautions: • Disconnect from main (AC) and battery power when performing maintenance. • Do not open the instrument case. There are no user serviceable parts inside. The case should only be opened by qualified service personnel using proper grounding techniques. When the case is opened, an electrical shock hazard exists which can result in serious injury to persons and instrument component damage.

Administration Sets • A list of approved IV sets recommended by ALARIS Medical Systems for use with the MEDLEY™ Medication Safety System Pump Module is listed on the Set Compatibility Card. • Before operating the instrument, verify that the administration set is free from kinks and installed correctly in the instrument. • MEDLEY™/Gemini Series sets are supplied with a sterile fluid path for one time use. Do not resterilize. • For 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 MEDLEY™/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.

GETTING STARTED 7

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. 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.

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

8 GETTING STARTED

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

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

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

GETTING STARTED

GETTING STARTED 9

Controls and Indicators Front/Side View - Door Closed

IUI Connector, Right (not visible)

Status Indicators Alarm (red)

IUI Connector, Left

Infusing (green)

Standby (yellow) Rate Display

STANDBY

INFUSE

Channel Message Display

RM ALA

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

NEL CHAN T SELEC

Pause Key - When pressed during an infusion, temporarily stops infusion on that channel. (After ≈2 minutes, “PRESS START” visual and audio prompt begins.)

PAUSE

NEL CHAN OFF

RT

RESTA

Channel Off Key - When pressed and 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. Door Handle Channel Release Latch

10 GETTING STARTED

Controls and Indicators (Continued) Front View - Door Open

IUI Connector, Left (not visible)

Platen

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® Recess Tubing Keeper

Air-in-Line Sensor

GETTING STARTED 11

GETTING STARTED

Upper Tubing Fitment Retainer

Installation Procedure Instruments are tested and calibrated before they are packaged for shipment. They met the specifications listed in the Directions for Use at that time. To ensure proper operation after shipment, it is recommended that an incoming inspection be performed before placing the instrument in use. Unpacking the Pump Module 1.

Remove Pump Module from its carton.

2.

Verify door operates freely.

3.

Verify membrane covering inside surface of pumping unit is not cut or torn.

4.

Check for loose parts.

5.

Perform Periodic Inspection (see “Inspection Requirements” section in “Maintenance” chapter.)

6.

Perform check-in procedure (see “Check-In and Configuration” section in “Maintenance” chapter).

If the Pump Module is damaged, contact ALARIS Medical Systems for authorization to return the equipment for repair, whether damage or malfunction is the responsibility of the carrier or ALARIS Medical Systems.

Attaching and Detaching Channels Refer to the MEDLEY™ Programming Module (Model 8000) Directions for Use for detailed instructions on attaching and detaching channels.

Start-Up Sequence Powering On the System 1.

Connect MEDLEY™ Programming Module to an external AC power source.

2.

Press SYSTEM ON key on Programming Module.

3.

System self test begins: • Diagnostics test causes all LED display segments and Status Indicator lights of attached channel(s) to illuminate briefly. • Power Indicator illuminates.

12 GETTING STARTED

Start-Up Sequence (Continued) Powering On the System (Continued) • Appropriate channel identification (A, B, C or D) is displayed on attached channel(s). • An Audio tone sounds. 4.

At completion of system-on test, “New Patient?” screen appears on Programming Module.

GETTING STARTED

NOTE: If any of the following conditions are observed, the Programming Module or the affected channel must be removed from use and inspected by qualified personnel: • LED segments are not illuminated during system-on test. • Indicator lights do not illuminate. • Appropriate channel identification (A, B, C or D) is not displayed. • Audio tone does not sound. • Main Display does not appear backlit, appears irregular, or has evidence of a row of pixels not functioning properly. If the affected channel operates normally when it is attached via the alternate IUI connector, it may be used until a replacement channel can be substituted.

Preparing Infusion Preparing Primary Solution Container Prepare the primary solution container in accordance with the manufacturer’s directions for use. Preparing Primary Administration Set Use only a MEDLEY™/Gemini Series administration set (refer to Set Compatibility Card for a list of compatible sets). Open the administration set package, remove the set and close the roller clamp. Refer to the set’s Directions For Use, on the administration set packaging. Loading Primary Administration Set 1.

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

2.

Fill drip chamber to 2/3 full.

3.

Open roller clamp slowly, to prime tubing and clear air from injection sites and tubing fitments.

GETTING STARTED 13

Preparing Infusion (Continued) Loading Primary Administration Set (Continued) 4.

Close roller clamp.

5.

Open Pump Module door. Install administration set pumping chamber by properly positioning upper fitment into fitment recess and then inserting the Flo–Stop® Fitment into recess below mechanism, with arrow pointing into Pump Module.

6.

Using a finger tip, firmly push tubing toward back of Air-inLine Detector.

7.

Close Pump Module door and open roller clamp. Verify no fluid is flowing through drip chamber.

1. Load upper tubing fitment.

2. Load Flo-Stop® Fitment. 3. Firmly push tubing toward back of Air-in-Line Detector.

Preparing Set to Deliver Primary Fluids with Gravity Infusion 1.

Prime set per steps 1 - 4 in “Loading Primary Administration Set” section.

2.

Attach set to patient’s vascular access device.

3.

Adjust flow rate with set roller clamp.

14 GETTING STARTED

Displays Main Display Refer to the MEDLEY™ Programming Module (Model 8000) Directions for Use for general information in the Main Display. Title Bar Channel Status

VTBI = 250.0 mL

SYSTEM ON

Soft Keys VOLUME INFUSED

AUDIO ADJUST

Dynamic Pressure Display Midtown Hospital Adult ICU

VTBI = 250.0 mL

Dynamic Pressure Display Current operating pressure is indicated by solid bar.

SYSTEM ON

Patient side occlusion pressure set point is indicated by tick mark. VOLUME INFUSED

AUDIO ADJUST

Primary Mode Primary - Rate/Volume Infusion NOTE: Throughout this section, the Main Display screens are aligned so that they coincide with the applicable step.

1.

Prime and load administration set as described in “Preparing Infusion” section.

2.

Press CHANNEL SELECT key on desired Pump Module.

Infusion Setup RATE

mL/h

VTBI

mL

>Select RATE

GETTING STARTED 15

GETTING STARTED

• A solid Channel Letter display indicates channel is operating. • An outlined Channel Letter display indicates channel is attached and ready for use.

Primary Mode (Continued) Primary - Rate/Volume Infusion 3.

Press RATE soft key and use numeric data entry keys to enter desired flow rate.

Infusion Setup RATE

40 mL/h

VTBI

mL

>Select VTBI

4. 5.

Press VTBI soft key and use numeric data entry keys to enter desired VTBI. Attach set to patient’s vascular access device.

Infusion Setup RATE

VTBI

40 mL/h 250 mL

>Press START SECONDARY

PAUSE

6.

Verify correct infusion parameter entry and press START soft key on Programming Module.

START

Midtown Hospital Adult ICU

VTBI = 250.0 mL

NOTE: The infusion may also be paused by pressing the PAUSE soft key on the Programming Module.

• Green Infusing Status Indicator illuminates. • Channel Rate Display displays Rate. • VTBI counts down in Main Display. • At completion of infusion, an audio prompt sounds, “INFUSION COMPLETE–KVO” scrolls in Channel Message Display and red Alarm Status Indicator flashes. Rate Display changes to KVO rate and KVO displays next to channel indicator in Main Display.

VOLUME INFUSED

AUDIO ADJUST

Primary - Volume/Duration Infusion 1.

Prime and load administration set.

2.

Press CHANNEL SELECT key on desired Pump Module.

Infusion Setup RATE VTBI

_ _ _ mL/h _ _ _ _ mL

>Select Rate or Restore Previous Infusion VOLUME RESTORE DURATION

16 GETTING STARTED

Primary Mode (Continued) Primary - Volume/Duration Infusion (Continued) 3.

Press VOLUME/DURATION soft key.

Infusion Setup RATE =

mL/h

_ _ _ _ mL

VTBI

DURATION

h

min

>Select VTBI RESTORE

Press VTBI soft key and use numeric data entry keys to enter desired VTBI.

Infusion Setup RATE =

mL/h

VTBI

1000 mL

DURATION

h

min

>Select DURATION RATE VOLUME

5.

Press DURATION soft key and use numeric data entry keys to enter desired duration of the infusion.

Infusion Setup

125 mL/h 1000 mL

RATE = VTBI DURATION

8:00 hh:mm

>Press START PAUSE

6.

Attach set to patient’s vascular access device.

7.

Verify correct infusion parameter entry and press START soft key.

SECONDRATE ARY VOLUME

START

• Green Infusing Status Indicator illuminates. • Channel Rate Display displays Rate. • VTBI counts down in Main Display. • At completion of infusion: a. An audio prompt sounds. b. “INFUSION COMPLETE–KVO” scrolls in Channel Message Display. c. Red Alarm Status Indicator flashes. d. Rate Display changes to KVO rate. e. KVO displays next to channel indicator in Main Display. f. Channel infuses at KVO rate.

GETTING STARTED 17

GETTING STARTED

4.

RATE VOLUME

Primary Mode (Continued) Pausing an Infusion 1.

Press PAUSE key on Pump Module.

Midtown Hospital Adult ICU

PAUSED

• “PAUSE” scrolls in Channel Message Display.

VTBI = 497.0 mL

• “PAUSED” appears next to appropriate channel in Main Display.

VTBI = 57.0 mL VTBI = 249.0 mL

• Yellow Standby Status Indicator illuminates. • After two minutes, “PAUSE-RESTART CHANNEL” visual and audio prompts begin. 2.

AUDIO ADJUST

VOLUME INFUSED

To reinitiate an infusion: • Press RESTART key on Pump Module. OR

• Press CHANNEL SELECT key and press START soft key. Restarting an Infusion Following Infusion Complete - KVO 1.

Press CHANNEL SELECT key on Pump Module.

Infusion Setup RATE VTBI

40 mL/h 0 mL

>Select VTBI RESTORE

2.

3.

Press VTBI soft key on Programming Module and use numeric data entry keys to enter desired VTBI, or press RESTORE soft key to bring back original volume-to-beinfused from system memory.

VOLUME DURATION

Infusion Setup RATE VTBI

40 mL/h 500 mL

Replace solution container and refill drip chamber, if necessary. >Press START

4.

Verify correct infusion parameter entry and press START soft key.

18 GETTING STARTED

VOLUME SECONDSTART PAUSE DURATION ARY