Syringe Module 8110 Series Directions for Use Ver 7

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 SYRINGE MODULE... FEATURES AND DEFINITIONS... SYMBOLS...

1 3 7

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... Preparing Syringe and Administration Set... Loading Syringe and Administration Set... Selecting Syringe Type and Size... Priming...

9 9 10 10 11 13 14 14 14 14 14 15 15 15 15 15 15 15 15 16 16 20 22

PROGRAMMING BASIC INFUSION... Starting Rate / Volume Infusion... Starting Volume / Duration Infusion... Possible End of Infusion Messages and Alerts... Pausing Infusion... Restarting Infusion Following Infusion Complete... Changing Rate or VTBI During Infusion... Stopping Infusion... Selecting Pressure Limit... Viewing and Clearing Volume Infused... Changing Syringe During Infusion... CHANNEL LABELS... Selecting Channel Label... Removing Channel Label... POWERING OFF... Powering Off System... Powering Off Module...

Syringe Module, 8110 Series Direction for Use

27 28 28 30 30 31 32 32 32 34 35 36 36 37 37 37 37

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...

38 38 39 43 48 48 53 54 55 58 58 59 61 61 65 67 68 68 72 75 75

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

77 77 77 78 79 79

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

81 84 84 84 85 85 86 86 86 87

APPENDIX TRUMPET AND START-UP CURVES...

ii TABLE OF CONTENTS

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Syringe Module, 8110 Series Direction for Use

INTRODUCTION INTRODUCTION

About the Syringe Module The Medley™ Syringe Module (Model 8110) 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™ Syringe Module uses standard, single-use, disposable syringes (with luer-lock connectors) and administration sets, designed for use on syringe pumps. For specific administration set instructions, reference the directions for use provided with the set. For set priming and loading instructions, reference the “Preparing Infusion” section in the “Getting Started” chapter of this document. 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. Parallel Infusions: There are no contraindications regarding the use of the Medley™ Syringe Module with any other positive displacement infusion device when ported together into a common IV site location. 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.

Syringe Module, 8110 Series Direction for Use

INTRODUCTION 1

About the Syringe Module (Continued) Electromagnetic Compliance: When using the Syringe Module in combination with a Point-of-Care Unit which is interconnected to hospital/facility 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 950 (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. EMC: Compliance with the electromagnetic compatibility (EMC) 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.

Compliance with Federal Aviation Regulations: The Medley™ Syringe 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™ Syringe Module. NOTE: The Medley™ Point-of-Care Unit was formerly known as the Medley™ Programming Module.

2 INTRODUCTION

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

Syringe Module, 8110 Series Direction for Use

Features and Definitions

All Mode

When ALL is selected as the volume to be infused (VTBI), the entire contents of the syringe will be delivered.

Auto Pressure

When enabled and a pressure sensing disc is in use, the Auto Pressure option is displayed in the Pressure Limit screen. Auto Pressure automatically sets the alarm limit for a shorter time to alarm, as follows: • If current pressure is 100 mmHg or less, system adds 30 mmHg to current pressure, to create a new alarm limit. • If current pressure is greater than 100 mmHg, system adds 30% to current pressure, to create a new alarm limit.

Auto Pressure Limit Adjustment

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

Auto Syringe Size Identification

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

Back Off

This feature is only available when the administration set in use has a pressure sensing disc. When enabled, the motor reverses plunger movement during an occlusion until the pressure returns to preocclusion levels, automatically reducing bolus flow.

Bolus Dose

The Bolus Dose mode allows a bolus infusion to be programmed using either the Guardrails® Drug Library or the drug calculation feature. The bolus infusion can be programmed with or without a continuous infusion following the bolus.

Channel Labels

The Channel Labels feature is available when the Profiles feature is enabled. It provides a hospital-defined list of labels, displayed in the Message Display, and identifying the module with the solution being infused, the 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

The Delay Options feature allows the system to be programmed to delay the 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).

Syringe Module, 8110 Series Direction for Use

INTRODUCTION 3

INTRODUCTION

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.

Features and Definitions (Continued) Drug Calculation

The Drug Calculation mode 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

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

Event Logging

Event Logging records instrument operations.

Fast Start

When Fast Start is enabled and an administration set having a pressure sensing disc is used, the instrument runs at an increased rate when an infusion is first started, taking-up any slack in the drive mechanism.

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 bestpractice Guardrails® Limits.

Guardrails® Limit

A Guardrails® Limit is a programming limit or best-practice guideline determined by the hospital/facility and entered into the system’s data set. Supports concentration limits for all infusions that utilize concentration. Profile-specific 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 the hospital/facility 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.

Multidose Mode

The Multidose Mode option allows 2 - 24 doses to be programmed at equally spaced intervals on the same Syringe Module over a 24-hour period. This mode is designed to allow delivery of multiple, equal doses from the same syringe at regularly scheduled intervals.

4 INTRODUCTION

Syringe Module, 8110 Series Direction for Use

Features and Definitions (Continued) The NEOI option allows an alert to be configured to sound anywhere from 1 to 60 minutes before the infusion is complete. The alert will occur at the configured time or when 25% of the VTBI remains, whichever comes later.

Occlusion Pressure

A complete range of downstream occlusion detection options is provided. • With pressure sensing disc: Downstream occlusion alarm threshold is selectable between 25 and 1000 mmHg, in 1 mmHg increments. • Without pressure sensing disc: Downstream occlusion alarm threshold can be set to low, medium, or high.

Pressure Sensing Disc

When installed, the pressure sensing disc significantly improves the instrument’s pressure sensing capabilities for a faster occlusion detection time, and makes the following features available: Auto Pressure Back-Off Customizable Pressure Alarm Settings (see “Occlusion Pressure”) Fast Start Pressure Tracking

Pressure Tracking

The dynamic current pressure display is only available when the pressure sensing disc is inserted.

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.

Rapid Bolus

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

Restore

To simplify programming, the Restore feature 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.

Selectable KVO

The Selectable KVO option allows some infusions to automatically switch into KVO mode upon completion. The KVO option setting cannot be changed after the instrument is powered on and a profile selected.

Syringe Empty

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

Syringe Module, 8110 Series Direction for Use

INTRODUCTION 5

INTRODUCTION

Near End of Infusion (NEOI)

Features and Definitions (Continued) Syringe Volume Detection

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

Volume/Duration

The Volume/Duration infusion option allows a volume-to-beinfused (VTBI) and duration (infusion time) to be programmed. The flow rate is automatically calculated.

6 INTRODUCTION

Syringe Module, 8110 Series Direction for Use

Symbols

75

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 Point-of-Care Unit and attached modules.

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 XX µm

Single-Use. Do not re-use.

Product contains micron filter, where XX represents filter size.

Product contains a particular element; such as,

DEHP

= DEHP in fluid pathway.

Product DOES NOT contain a particular element; such as, LATEX = administration set is latex-free.
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.

Syringe Module, 8110 Series Direction for Use

INTRODUCTION 7

INTRODUCTION

+

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).

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

8 INTRODUCTION

Syringe Module, 8110 Series Direction for Use

GETTING STARTED Warnings and Cautions

Only

GETTING STARTED

Warnings and Cautions are provided throughout this Directions for Use (DFU) to provide information needed to safely and effectively use the Medley™ Medication Safety System and its accessories. Medley™ System Warnings and Cautions, and definitions, are covered in the Point-of-Care DFU. General WARNINGS • The Medley™ Syringe 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. • Each time the Medley™ System is turned on, verify and/or set the monitoring mode, resistance alert, and/or pressure alarm limit. If the monitoring mode, resistance alert, and/or pressure alarm limit are not verified, the instrument may not operate within the desired occlusion detection parameter(s).

Syringe Module, 8110 Series Direction for Use

GETTING STARTED 9

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 syringe, administration set, and Syringe 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.

10 GETTING STARTED

Syringe Module, 8110 Series Direction for Use

Warnings and Cautions (Continued) Administration Sets WARNINGS

GETTING STARTED

• Use only standard, single-use, disposable syringes (with luer-lock connectors) and administration sets, designed for use on syringe pumps. The use of any other syringe or administration set may cause improper instrument operation, resulting in an inaccurate fluid delivery or pressure sensing, or other potential hazards. For a list of compatible syringes, reference the “Compatible Syringes” section in the “Maintenance” chapter. For a list of compatible sets, reference the Set Compatibility Card (provided separately). • 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. • When the pressure sensing disc is not being used and 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. • 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. • Ensure the syringe manufacturer and syringe size displayed matches syringe manufacturer and syringe size installed in the Medley™ Syringe Module. Mismatches may cause an under-infusion or over-infusion to the patient that could result in serious injury and/or death. For a list of compatible syringes, reference the “Compatible Syringes” section in the “Maintenance” chapter. • Installing a pressure sensing disc after an infusion has started can result in a bolus to the patient. • Discard if packaging is not intact or protector caps are unattached.

Syringe Module, 8110 Series Direction for Use

GETTING STARTED 11

Warnings and Cautions (Continued) Administration Sets (Continued) CAUTIONS Before operating instrument, verify that administration set is free from kinks and installed correctly in instrument.

12 GETTING STARTED

Syringe Module, 8110 Series Direction for Use

Operating Features, Controls and Indicators Gripper Control / Drive Head Release (shown in closed position) Status Indicators Infusing (green)

Standby (yellow)

IUI Connector, Left Barrel Flange Grippers Rate Display Message Display

M ALAR

INFUSE

STANDB Y

Channel (Module) Identification

Syringe Barrel Sensor

IUI Connector, Right RATE (mL/h)

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

CHANNEL SELECT

Syringe Barrel Clamp / Sizer

PAUSE

Pause Key: When pressed during an infusion, temporarily stops infusion on that module. After approximately 2 minutes, a visual and audio prompt begins.

CHANNEL OFF

RESTART

Syringe Module

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.

Pressure Transducer / Pressure Sensing Disc Housing Restart Key: When pressed, resumes operation of a previously paused or alarmed infusion on that module.

Syringe Module, 8110 Series Direction for Use

Channel (Module) Release Latch: When pressed, allows module to be removed.

GETTING STARTED 13

GETTING STARTED

Alarm (red)

Plunger Grippers (shown in closed position)

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 into 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 VTBI = 250.0 mL

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

14 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 Syringe Module’s range is 0 to 1000 mmHg.

AUDIO ADJUST

Syringe Module, 8110 Series Direction 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 GETTING STARTED

Preparing Infusion Administration Set The Medley™ Syringe Module uses standard, single-use, disposable syringes (with luer-lock connectors) and administration sets, designed for use on syringe pumps. • For specific administration set instructions, reference the directions for use provided with the set. • For a list of compatible syringes, reference “Compatible Syringes” section in “Maintenance” chapter. • For a list of compatible administration sets, refer to Set Compatibility Card (provided separately). • Syringe Module 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 the United States). • Discard administration set per facility protocol. • For IV push medication (put instrument on hold), clamp tubing above the port. • Flush port(s) per facility protocol. • Use aseptic techniques when handling sets and syringes.

Syringe Module, 8110 Series Direction for Use

GETTING STARTED 15

Preparing Infusion (Continued) Preparing Syringe and Administration Set 1.

Prepare syringe (reference “Compatible Syringes” section in “Maintenance” chapter) in accordance with manufacturer’s directions for use.

2.

Prepare administration set (refer to Set Compatibility Card, provided separately) in accordance with manufacturer’s directions for use.

3.

Attach upper fitting of administration set to syringe tip.

Loading Syringe and Administration Set

WARNING Use only standard, single-use, disposable syringes (with luer-lock connectors) and administration sets, designed for use on syringe pumps. The use of any other syringe or administration set may cause improper instrument operation, resulting in inaccurate fluid delivery or pressure sensing, or other potential hazards. For a list of compatible syringes, reference the “Compatible Syringes” section in the “Maintenance” chapter. For a list of compatible administration sets, reference the Set Compatibility Card (provided separately). WARNINGS • Before loading the syringe, check it for damage or defects. • Ensure syringe barrel, flange, and plunger are installed and secured correctly. Failure to install syringe correctly can result in uncontrolled fluid flow to the patient, and may cause serious injury or death. • 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. CAUTION When initially loading the syringe, allow for the volume of fluid contained in the administration set and retained in the syringe at the end of an infusion, as this “dead space” will not be infused.

16 GETTING STARTED

Syringe Module, 8110 Series Direction for Use