Alaris PC Unit Model 8015 User Manual Ver 12.1 Jan 2020

© 2005 - 2020 CareFusion Corporation or one of its affiliates. All rights reserved. BD and the BD logo are the trademarks of Becton, Dickinson and Company. CareFusion, Alaris, and Guardrails are registered trademarks of CareFusion Corporation or one of its affiliates.

CareFusion 303, Inc. 10020 Pacific Mesa Blvd. San Diego, CA 92121 United States

BD Alaris™ System with Guardrails™ Suite MX User Manual The information in this document is subject to change and does not represent a commitment on the part of CareFusion to provide additional services or enhancements. The screens illustrated in the document are for reference purposes only and might be different than the screens displayed on your computer. Documentation provided with this product might reference product not present in your facility or not yet available for sale in your area. If difficulties are encountered while using this software, refer to the user manual, service manual, or related service bulletin(s) before contacting CareFusion. Provide a description of the difficulty experienced, any messages that were displayed at the time of the difficulty, and the software version. Before you return the software to CareFusion, contact CareFusion to get a return authorization number. Put the software in its original packaging (if available), write the return authorization number on the package, and return to the nearest facility. For countries not listed below, contact your local Alaris System distributor for technical support.

North America 888-876-4287 bd.com

Customer Advocacy - North America (Clinical and technical feedback.) Phone: 888.812.3266 E-mail: [email protected] Customer Order Management - North America (Product return, service assistance, and order placement.) Phone, United States: 800.482.4822 Phone, Canada: 800.387.8309 Technical Support - North America (Maintenance and service information support; troubleshooting.) Phone, United States: 888.812.3229 Phone, Canada: 800.387.8309

Southeast Asia Technical Support - Singapore (Maintenance and service information support; troubleshooting.) Phone: 65 6432 2099 E-mail: [email protected]

United Arab Emirates Technical Support - United Arab Emirates (Maintenance and service information support; troubleshooting.) Phone: 971.4.5592555 E-mail: [email protected]

United Kingdom Technical Support - United Kingdom (Maintenance and service information support; troubleshooting.) Phone: 0800 389 6972 E-mail: [email protected] Customer Care - United Kingdom (Product return, service assistance, and order placement.) Phone: 0800 917 8776 E-mail: [email protected] www.bd.com/en-uk/customer-support

Australia/New Zealand Technical Service - Australia (Maintenance and service information support; troubleshooting, service assistance.) Phone: 1300 729 258 http://www.bd.com/anz/contactus.asp Technical Service - New Zealand (Maintenance and service information support; troubleshooting, service assistance.) Phone: 0508 422 734 http://www.bd.com/anz/contactus.asp Customer Service - Australia (Product return and order placement.) Phone: 1800 656 100 E-mail: [email protected] Customer Service - New Zealand (Product return and order placement.) Phone: 0800 572 468 E-mail: [email protected]

Authorized Representatives Authorized Australian Representative Becton Dickinson Pty Ltd 66 Waterloo Road Macquarie Park NSW 2113 Australia Authorized New Zealand Representative Becton Dickinson Ltd 14b George Bourke Drive Mt Wellington Auckland 1060 New Zealand Authorized European Representative BD Switzerland Sàrl Route de Crassier 17 Business Park Terre-Bonne Batiment A4 1262 Eysins Switzerland

EC REP

Contents Chapter 1-Introduction Introduction... 2 Intended Use ... 3 Essential Performance ... 3 Warnings, Cautions, and Notes ... 3 Defined Terms ... 4 Approved Parts Recommendation ... 5 Installation ... 5 Symbols Glossary ... 6

Chapter 2-BD Alaris™ PCU Model 8015 and Alaris™ PCU Model 8015 Getting Started ... 16 General Setup and Operation... 18 Attaching the System to an IV Pole... 18 Attaching and Detaching a Module ... 18 Attaching a Module ... 18 Detaching a Module ... 20 Adding a Module While the System is Powered On... 20 Start-Up... 21 Powering On the System ... 21 Responding to Maintenance Reminder ... 21 Adjusting Display Contrast ... 22 Selecting New Patient and Profile Options ... 23

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Updating the Data Set ... 24 Patient ID Entry Feature... 25 Adjusting Audio Volume... 26 Locking and Unlocking Tamper Resist ... 27 Powering Off the System... 28 System Options ... 28 Adjusting Display Contrast ... 28 Patient ID... 29 Entering Clinician ID ... 31 Powering Down All Channels... 32 Anesthesia Mode ... 34 Displaying Battery Runtime... 37 System Configuration... 37 Displaying Serial Numbers ... 39 Viewing Software Versions ... 40 Setting Time of Day ... 41 Viewing Network Status ... 43 Wireless Connection ... 46 Activating a New Data Set: ... 47 Viewing Data Set Status... 47 Viewing Maintenance Due... 48 General Information... 49 Warnings and Cautions... 49 General ... 49 Electromagnetic Compatibility ... 51 Features and Displays ... 52 Features and Definitions... 52 Operating Features, Controls, Indicators... 53 Displays ... 56 System Configuration Settings ... 58 Specifications and Symbols ... 59 Specifications ... 59

Chapter 3-BD Alaris™ Pump Module Model 8100, Alaris™ Pump Module Model 8100, and Alaris™ Syringe Module Model 8110 Getting started... 62 Introduction... 62 Essential Performance ... 62 Preparing an Administration Set (Pump Module) ... 64 Priming ... 64 Loading... 65 Removing ... 70 Preparing Syringe and Administration Set (Syringe Module)... 71 Loading... 73 Prime-Using Options Menu... 79 Priming Administration Set With Pressure Sensing Disc ... 80

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Contents

Priming Administration Set With No Pressure Sensing Disc ... 84 Prime-Manual ... 84 Programming ... 87 Introduction... 87 Manual Programming with Guardrails™ Suite MX ... 88 Manually Programming - Primary Infusion... 88 Programming a Continuous Infusion ... 91 Bolus Dose ... 98 Restoring a Bolus Dose ... 103 Intermittent Infusion... 104 Fluid Infusion ... 108 Rate/Volume Infusion ... 109 Volume/Duration Infusion ... 111 Manual Programming - Secondary Infusion (Pump Module)... 114 Setup... 114 Infusion... 116 Stopping Secondary and Returning to Primary... 120 Programming with Interoperability and Guardrails™ Suite MX ... 121 Programming with Interoperability - Initial Primary Infusion... 123 Continuous Infusion ... 127 Fluid Infusion ... 128 Intermittent Infusion... 129 Programming with Interoperability - Subsequent Primary Infusion (Pump Module) ... 130 Continuous Infusion ... 132 Fluid Infusion ... 133 Intermittent Infusion... 135 Programming with Interoperability - Subsequent Primary Infusion (Syringe Module) ... 137 Programming with Interoperability - Secondary Infusion (Pump Module)... 137 Infusion... 137 Programming - No Guardrails™ Selections ... 142 Manual Programming - No Guardrails™ Selections ... 142 No Guardrails - Basic Infusion without Drug Calculation... 143 Promoting No Guardrails - Basic Infusion to Guardrails Software Protection Infusion... 144 No Guardrails - Basic Infusion with Drug Calculation... 144 Bolus Dose ... 146 Secondary Infusion ... 148 Infusion... 148 Stopping Secondary and Returning to Primary... 148 General Programming... 149 Pause, Change, Restart Infusion ... 149 Pausing and Restarting Infusion ... 149 Changing Rate or VTBI During Infusion... 150 Restoring Infusion ... 151 Viewing and Clearing Volume Infused ... 151 Channel Labels ... 153 Selecting ... 153

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Removing ... 154 Anesthesia Mode... 155 Delay Options... 155 Delaying Infusion ... 155 Scheduling a Callback ... 157 Pausing Infusion ... 158 Select Pressure Limit ... 159 Pump Module ... 159 Syringe Module ... 160 Pressure Sensing Disc NOT Installed ... 163 General Setup and Operation... 165 System Start Up/Setup ... 165 Setting Up for Gravity Infusion (Pump Module) ... 165 Changing Solution Container (Pump Module)... 165 Changing Syringe During Infusion (Syringe Module)... 165 General Information... 168 Warnings and Cautions... 168 General ... 168 Administration Sets ... 170 Occlusions ... 171 Epidural Administration ... 172 GuardrailsTM Suite MX ... 172 Administration Set/Syringe Information ... 173 SmartSite Infusion Set (Pump Module) ... 173 Compatible Syringes (Syringe Module)... 175 Features and Displays ... 176 Features and Definitions... 176 Operating Features, Controls, Indicators... 181 Displays ... 184 Drug Calculation Definitions and Formulas... 185 Configurable Settings ... 186 Shared Infusion ... 186 Pump Module ... 186 Syringe Module ... 187 Specifications... 188 Pump Module ... 188 Syringe Module ... 191 Trumpet and Start-Up Curves... 195 Pump Module ... 196 Syringe Module ... 196 Graphs ... 197

Chapter 4-Alaris™ PCA Module Model 8120 Getting Started ... 202 Introduction... 202 Attaching and Detaching Dose Request Cord ... 202

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Attaching Dose Request Cord ... 203 Detaching Dose Request Cord ... 203 Prepare and Load Syringe and Administration Set... 204 Preparing Syringe and Administration Set... 204 Loading Syringe and Administration Set ... 204 Security Lock Key Positions... 207 Programming ... 208 Preparing Infusion... 208 Selecting Syringe Type and Size... 208 Priming ... 209 Programming an Infusion... 210 Infusion Modes ... 212 Programming Parameters ... 212 Setting Up PCA Dose Only... 213 Setting Up Continuous Infusion Only ... 215 Setting Up PCA Dose and Continuous Infusion ... 218 Setting Loading Dose Only ... 220 Setting Bolus Dose... 221 Stopping a Loading, PCA, or Bolus Dose... 224 Changing Programming Parameters During an Infusion ... 224 Viewing Patient History ... 225 Clearing Patient History ... 226 Viewing Drug Event History... 227 Configuring Dose Request Cord ... 228 Security Access Levels... 229 Disabling Security Access Code ... 230 Pausing Infusion ... 231 Changing Syringe and Restore Infusion... 232 Stopping Infusion ... 233 Selecting Pressure Limit... 233 Viewing and Clearing Volume Infused... 235 PCA Pause Protocol Feature... 236 Programming an Infusion... 236 Reviewing or Changing the PCA Pause Alarm Limits ... 238 Disabling PCA Pause Alarm ... 238 General Setup and Operation... 240 System Start-Up/Setup... 240 General Information... 241 Warnings and Cautions... 241 General ... 241 Administration Sets ... 242 Epidural Administration ... 243 Dose Request Cord... 243 Guardrails Software... 243 Administration Set/Syringe Information ... 244 Compatible Syringes... 244

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Features and Displays ... 245 Features and Definitions... 245 Operating Features, Control, Indicators ... 248 Displays ... 249 Configurable Settings ... 249 Specifications and Symbols ... 251 Specifications ... 251 Trumpet and Start-Up Curves... 254

Chapter 5-Alaris™ SpO2 Module Models 8210 and 8220 Getting Started ... 258 Introduction... 258 Attaching Cable and Sensor... 259 Programming ... 260 Monitoring Mode... 260 Setting Alarm Limits ... 262 Navigating Trend Data ... 263 Navigating AlarisTM PCA Module and AlarisTM SpO2 Module Trend Data... 264 Presilencing Alarms ... 265 Channel Options ... 266 Changing Limit Mode... 266 Changing Pulse Beep Volume... 267 Changing SatSeconds Limit ... 268 Changing Saturation Averaging Time... 269 Changing Sensitivity Mode ... 270 General Setup and Operation... 271 System Start-up/Setup... 271 General Information... 272 Warnings and Cautions... 272 General ... 272 Sensors and Cables... 273 Cables and Sensors ... 273 Nellcor Patient Cables and Sensors... 273 Masimo Patient Cables and Sensors... 274 Features and Displays ... 274 Features and Definitions... 274 Model 8210 ... 275 Model 8220 ... 275 Operating Features, Controls, Indicators... 276 Displays ... 277 Configurable Settings ... 277 Specifications and Symbols ... 279 Specifications ... 279 Measurement Accuracy ... 281

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Chapter 6-Alaris™ EtCO2 Module Model 8300 Getting Started ... 284 Introduction... 284 Connecting Microstream Disposable... 285 Attaching Gas Scavenging System ... 286 Programming ... 287 Monitoring Mode... 287 Setting Alarm Limits ... 288 Navigating Trend Data ... 289 Navigating PCA Module/EtCO2 Module Trend Data... 291 Presilencing Alarm ... 292 Channel Options ... 293 Changing Limit Mode ... 293 Changing Waveform Height ... 294 Changing Waveform Time Scale ... 295 General Setup and Operation... 295 System Start-Up/Setup... 295 General Information... 296 Warnings and Cautions... 296 General ... 296 MicrostreamTM Disposable... 296 Microstream Disposable ... 297 Features and Displays ... 297 Features and Definitions... 297 Operating Features, Controls, Indicators... 298 Displays ... 298 Main Display ... 299 Configurable Settings ... 299 Specifications and Symbols ... 300 Specifications ... 300 Measurement Accuracy ... 302 Respiration Rate Test ... 303 Waveform Analysis ... 305 Principle of Operation... 306

Chapter 7-Alaris™ Auto-ID Module Model 8600 Getting Started ... 310 Introduction... 310 Programming ... 311 Patient Identification... 311 Associating PCU with New Patient ID ... 311 Associating PCU with Patient ID While Infusion is in Progress ... 313 Authorized User Mode... 313 Primary Infusion ... 314 Subsequent Primary Infusion... 314 Starting Secondary Infusion... 315

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General Setup and Operation... 316 System Start-Up/Setup... 316 Warnings and Cautions... 316 Auto-ID Handheld Scanners... 316 Features... 317 Features and Definitions... 317 Operating Features, Controls and Indicators... 318 Configurable Settings ... 318 Specifications and Symbols ... 319 Specifications ... 319 Symbology ... 320 Troubleshooting and Maintenance ... 321 Errors and Messages ... 321 Errors ... 321 Messages ... 321

Appendix A-Troubleshooting and Maintenance Troubleshooting and Maintenance ... 324 BD AlarisTM Systems Manager Connections... 324 Alarms and Alerts ... 325 Clinician’s Position for Alarm Monitoring ... 325 Display Color ... 325 Definitions ... 325 Alert Prioritization... 328 Audio Characteristics ... 329 Alarms ... 331 Storage ... 340 Battery Care and Maintenance... 340 Battery Type and Charging ... 340 Battery Charging ... 340 Battery Storage and Use Conditions ... 340 Battery Disposal ... 340 Proper Battery Maintenance... 341 Wireless Connection... 342 Wireless Connection Soft Key... 342 Wireless Connection Scenarios ... 342 Clearing Historical Log Data... 343 Inspection Requirements ... 344 Cleaning... 346 BD Alaris™ and Alaris™ System ... 346 Cleaning Products ... 346 Procedure... 346 Service Information ... 351 Auto-ID Handheld Scanner ... 351 Technical Support ... 352 Regulations and Standards... 354

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Compliance ... 354 Electromagnetic Environment... 354 Standards ... 360 Hardware Dependencies ... 361

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Chapter 1 Introduction This chapter contains the following topics: Introduction ... 2 Intended Use... 3 Essential Performance ... 3 Warnings, Cautions, and Notes ... 3 Defined Terms... 4 Approved Parts Recommendation ... 5 Installation...5 Symbols Glossary ... 6

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Chapter 1-Introduction

Introduction WARNING Read all instructions before using the BD AlarisTM system.

CAUTION

Only The BD Alaris™ PC unit (PCU) section of this user manual provides procedures and information applicable to the BD Alaris system and the PCU. Each of the other major sections provides product-specific procedures and information. The system is a portable modular system intended for adult, pediatric, and neonatal care. The system consists of the PCU, the Guardrails™ suite MX, and up to four detachable infusion and/or monitoring modules (channels). The AlarisTM auto-ID module can be included as a fifth module. The use of the system is restricted to one patient at a time. Guardrails suite MX for the system brings a new level of medication error prevention to the point of patient care. The Guardrails suite MX features medication dosing, concentration delivery rate, and optional initial programming guidelines for up to 30 patient-specific care areas, referred to as profiles. A total of up to 10,000 unique drug/concentration or fluid entries (setups) can be created and distributed between profiles with a maximum of 1,500 setups per profile. Each profile contains a specific drug library, an IV fluid library, and channel labels, as well as instrument configurations appropriate for the care area. Optional drug- or IV fluid-specific clinical advisories provide visual messages. Dosing limits for each Guardrails suite MX drug entry or rate limits for each IV fluid entry can be a hard limit that cannot be overridden during infusion programming and/or a soft limit that can be overridden, based on clinical requirements. A data set is developed and approved by the facility’s own multi-disciplinary team using the BD AlarisTM GuardrailsTM editor software, the PC-based authoring tool. A data set is then transferred to the system by qualified personnel and then activated by the clinical staff. The approved data sets are maintained by the Guardrails editor software for future updates and reference. Information about an Alert that occurs during use is stored within the PCU, and can be accessed using the GuardrailsTM CQI reporter software. Documentation provided with the system products might reference product not present in your facility or not yet available for sale in your area. A superscript number (for example,) identifies additional information provided as a NOTE at the end of the procedure.

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BD AlarisTM System with GuardrailsTM Suite MX User Manual

Intended Use

Intended Use The Alaris™ system with Guardrails suite MX is intended for use in professional healthcare facilities that utilize infusion devices for the delivery of fluids, medications, blood, and blood products. The Alaris system with Guardrails suite MX is intended to provide trained healthcare caregivers a way to automate the programming of infusion parameters, thereby decreasing the amount of manual steps necessary to enter infusion data. All data entry and validation of infusion parameters is performed by the trained healthcare professional according to a physician's order. The Alaris system with Guardrails suite MX is an interoperable system capable of communicating and exchanging data accurately, effectively, securely, and consistently with different information technology systems, software applications, and networks, in various settings; and exchanging data such that the clinical or operational purpose and meaning of the data are preserved and unaltered.

Essential Performance The BD AlarisTM pump module, AlarisTM pump module, AlarisTM syringe module, and AlarisTM PCA module are designed to accurately deliver the programmed amount of the medication or fluid over the programmed time period. The pump module, syringe module, and PCA module ensure that an infusion is not being inadvertently delivered when the user expects the system to be in a paused, stopped, or off condition. The pump module, syringe module, and PCA module employ measurement systems to detect and alarm for conditions adverse to safe administration of fluid. These include measurements of proper infusion set loading (free flow detection), pressure (occlusion detection), and air-in-line detection. The AlarisTM EtCO2 and AlarisTM SpO2 modules will monitor and alarm when a patient’s physiological condition is out of range. The Alaris system will alarm when the monitoring modules (SpO2 and/or EtCO2 modules) are unable to detect patient vitals.

Warnings, Cautions, and Notes Product-specific warnings and cautions, covered in the applicable sections of this user manual, provide information needed to safely and effectively use the system.

WARNING A statement that alerts the user to the possibility of injury, death, or other serious adverse reactions associated with the use or misuse of the device.

CAUTION A statement that alerts the user to the possibility of a problem with the device associated with the use or misuse of the device. NOTE: Notes contain supplementary information or emphasize a point or procedure.

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Chapter 1-Introduction

Defined Terms The following table identifies the defined terms used throughout this document for certain trademarked products and product features. Product/Feature

Defined Term

Alaris auto-ID module

auto-ID module

Alaris EtCO2 module

EtCO2 module

Alaris PCA module

PCA module

Alaris PC unit

PCU

Alaris pump module

pump module

Alaris SpO2 module

SpO2 module

Alaris syringe module

syringe module

BD Alaris PC unit

PCU

BD Alaris pump module

pump module

BD Alaris system or Alaris system (includes PCU system and one or more modules, such as pump module, syringe module, PCA module, EtCO2 module, SpO2 module, or auto-ID module) BD Alaris™ system maintenance

system maintenance

BD Alaris™ systems manager

systems manager

Guardrails alert

alert

Guardrails clinical advisory

clinical advisory

Guardrails™ CQI reporter

CQI reporter

Guardrails data set

data set

Guardrails drug library

drug library

Guardrails hard limit

hard limit

Guardrails IV fluid

IV fluid

Guardrails limit

limit

Guardrails PCA pause protocol

PCA pause protocol

Guardrails soft limit

soft limit

SmartSite™ needle-free valve

needle-free valve

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Approved Parts Recommendation

Approved Parts Recommendation CareFusion recommends the use of CareFusion manufactured parts in the operation and maintenance of your CareFusion equipment. Customer's use of repair or service parts, add-ons, or disposables that are not approved by CareFusion is at Customer's own risk and may void the product warranty provided by CareFusion. Any 510(k) clearance from the Food and Drug Administration (FDA) or regulatory approval secured by CareFusion to market Alaris pumps was based on use of only CareFusion manufactured parts and equipment. If non-CareFusion parts, add-ons or disposables are used for the maintenance, repair or operation of your CareFusion equipment, those parts were not validated by CareFusion for safety and efficacy with our BD Alaris and Alaris products, nor were they included in the review and approval/ clearance of the products. If it becomes necessary to replace the following cables or accessories, use only approved parts that are listed in the Technical Service Manual. Use of other parts may affect electromagnetic compliance of the Alaris System. •

PCU Power Cord

•

PCU Serial Cable

•

PCA Dose Request Cord

•

Handheld Barcode Scanner

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 system in use:

1. Perform the check-in procedure using system maintenance software (see BD AlarisTM System Maintenance User Manual, Chapter 3 Preventive Maintenance). 2. Load the hospital-defined best-practice data set using one of the following methods: •

If using systems manager, transfer the data set wirelessly to the PCU (see BD Alaris™ Systems Manager User Manual).

•

If not using systems manager, use the system maintenance or the Guardrails editor transfer tool to transfer the data set to the PCU (see BD AlarisTM System Maintenance User Manual or BD AlarisTM GuardrailsTM Editor User Manual).

3. Power cycle the PCU. 4. Press Yes on the New Patient message to activate the data set and select the desired profile (see Selecting New Patient and Profile Options on page 23).  NOTE:  To enable the profiles feature, a hospital-defined best-practice data set must be uploaded to the PCU.

5. Clean PCUs and all modules before placing the instruments in clinical use. Follow the procedure in Cleaning on page 346.

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Chapter 1-Introduction

Symbols Glossary The following table shows the symbols and the applicable standards used in this user manual.

Symbol (Graphical Image)

C

6

US

Definition

Symbol Title

Symbol Location

Ref. No. Standard

The Infusion Alarm Silence symbol indicates that infusion alarms have been acknowledged and silenced. Press the CANCEL SILENCE soft key to reactivate a previously silenced alarm audio. If the alarm condition has not been resolved, the alarm audio will resume.

Bell Canceled Acknowledge (Alarm Cancel)

PCU Interface

Ref 5576-1 IEC 60417-1 Graphical Symbols for use on equipment. Part 1: Overview and Application

The infusion alarm silence symbol indicates the module that has been acknowledged and silenced.

Bell Cancel (Alarm Cancel)

PCU Interface

Ref 5576-1 IEC 60417-1 Graphical Symbols for use on equipment. Part 1: Overview and Application

Type CF defibrillation-proof patient applied part.

Defibrillationproof Type CF Applied Part.

PCU, pump module, syringe module, PCA module device labels

Ref 5336 IEC 60417-1 Graphical Symbols for use on equipment. Part 1: Overview and Application

Products bearing this mark have been tested and certified in accordance with applicable U.S. and Canadian electrical safety and performance standards.

Canadian and U.S. Certification Mark

PCU and all modules, (except SpO2 module), and device labels

NA

Do not dispose of electronic products in the general waste stream.

Waste stream disposal status

PCU and all modules, device labels (except SpO2 module)

Directive 2002/96EC (WEEE)

Indicates the need for the user to consult the instructions for use for important cautionary information such as warnings and precautions that cannot, for a variety of reasons, be presented on the medical device itself.

Follow instructions for use

PCU, EtCO2 module device labels

Ref. 10: IEC 60601-1, Table D.2, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance.

Alternating Current: Indicates device should be attached to alternating current source, 50/60 Hz only.

Alternating Current

PCU device label

Ref 5032 IEC 60417-1 Graphical Symbols for use on equipment. Part 1: Overview and Application

BD AlarisTM System with GuardrailsTM Suite MX User Manual

Symbols Glossary

Symbol (Graphical Image)

Definition

Symbol Title

Symbol Location

Ref. No. Standard

Caution: Refer to accompanying documentation.

Caution

PCU and all modules, PCA handset, device labels, and external packaging

Ref 0434A IEC-TR-60878 Graphic symbols for electrical equipment used in a medical practice

IPX1

Degree of particle and water ingress protection.

Degrees of ingress protection provided by enclosure

SpO2 module device label

Ref. 2: IEC 60601-1, Table D.3, General requirements for basic safety and essential performance

IPX2

Degree of particle and water ingress protection.

Degrees of ingress protection provided by enclosure

PCU, pump module, syringe module, PCA module, PCA handset, EtCO2 module, and Auto-ID module device labels

Ref. 2: IEC 60601-1, Table D.3, General requirements for basic safety and essential performance

IUI Connector: Inter-Unit Interface connector used to establish power and communications between PCU and attached modules.

Input-output

PCU, all modules side panel

Ref. 5448 IEC-TR-6078 Graphic symbols for electrical equipment in a medical practice

Indicates the date on which a product was manufactured.

Date of manufacturer

Unique device identification (UDI) label for PCU, and all modules

Ref. 2497 IEC-TR-6078 Graphic symbols for electrical equipment in a medical practice

Indicates generally elevated, potentially hazardous, levels of nonionizing radiation, or to indicate equipment or systems e.g. in the medical electrical area that include RF transmitters or that intentionally apply RF electromagnetic energy for diagnosis or treatment.

Non-ionizing electromagnetic radiation

PCU front panel and user manual

Ref. 5140 IEC-TR-6078 Graphic symbols for electrical equipment in medical practice

Federal Law restricts device to sale by or on the order of a licensed health provider.

Prescription use only

User manual and external packaging

21 CFR 801.109

XXXX-XX-XX

Only

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