BD IntelliportMedication Managment System Injecting Confidence

Essential Prescribing Information
and User Manual

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

TECHNICAL SUPPORT:

Dial 866-488-1408 and select option 4

This document contains confidential information. No part of this document may be transmitted, reproduced,
used, or disclosed outside of the receiving organization without the written consent of Becton, Dickinson and
Company.

Becton, Dickinson and Company

1 Becton Drive

Franklin Lakes, NJ 07417 USA

Sani-Cloth® is a registered trademark of Professional Disposables International, Inc.

Clorox® is a registered trademark of The Clorox Company.

Windows Defender is a trademark of Microsoft Corporation.

GCX is a registered trademark of GCX Corporation.

Cerner® and SurgiNet® are registered trademarks of Cerner Corporation.

Epic® is a trademark and is a registered trademark of Epic Systems Corporation.

© 2017 BD. BD, the BD Logo and all other trademarks are property of Becton, Dickinson and Company.

1000014303001 Rev. 2017-03

Table of Contents

Chapter 1. Product Description 7

Chapter 2. Indications for Use 10

Chapter 3. Contraindications 11

Chapter 4. Warnings 12

Chapter 5. Precautions 16

Chapter 6. How Supplied 20

Chapter 7. Maintaining Device Effectiveness 21

Chapter 8. Complete Device Description 23

CHAPTER 9. DIRECTIONS FOR USE 35

How it Works 35

Operation: AIMS CONFIGURATION 35

Preparing the BD Intelliport™ Injection Site. 35

Set up the Tablet at the Start of a Case 38

Giving an IV Injection Using the BD Intelliport™ Injection Site 43

Medication Delivery with Syringes Not Having Encoding 45

Specifying a Diluted or Reconstituted Medication 47

Specifying a Mixed Medication (Admixture) 47

Address Pending Medications 48

Responding to Messages 49

Transferring a Patient from One Care Area to Another 51

Power Down the Injection Site at the End of a Case 53

Deactivating a Device, Disposing of the Sensor, and Preparing the Base for Reuse 54

Special Activities 55

Giving Injections Without a Tablet Present 55

Adding Additional Sensors 55

Viewing Controlled Drugs 56

OPERATION: PAPER CHARTING CONFIGURATION 59

Preparing the BD Intelliport™ Injection Site 59

Set up the Tablet for the Start of a Case 61

Giving an IV injection Using the BD Intelliport™ Injection Site 66

Medication Delivery with Syringes Not Having Encoding 68

Specifying a Diluted or Reconstituted Medication 69

Specifying a Mixed Medication (Admixture) 70

Transferring a Patient to Another Care Area 71

Power Down the Injection Site at the End of a Case 71

Deactivating a Device, Disposing of the Sensor, and Preparing the Base for Reuse 71

Special Activities 72

Giving Injections Without a Tablet Present 72

Using the System With an Emergency Patient 73

Identifying an Unknown Patient 74

Adding Additional Sensors 76

Adding a Comment 77

Adding Manual Injection 78

Responding to Messages 79

Reviewing the Medication Record 80

Printing a Report (for Paper Anesthesia Records) 81

Viewing Controlled Drugs 82

UTILITIES 84

Shutting Down the Tablet 84

Setting User Preferences 84

chapter 10. Troubleshooting 85

Chapter 11. Appendices 88

Appendix A BD Intelliport™ Base and Sensor Technical Specifications 88

Appendix B Tablet Technical Specifications 89

Appendix C Cleaning and Disinfectant Agents 90

Appendix D Unpacking and Setting Up the Tablet 90

Section 1 Unpackaging and Powering on the Tablet 90

Section 2 Updating Configuration Settings at the Tablet 91

Section 3 Registering the Tablet with the Gateway 93

Section 4 Updating the Device Drug Library and Tablet Configuration Profile 94

Section 5. Positioning for Use 95

Section 6 Conducting Deployment Testing 95

Appendix E Standards 95

Appendix F Glossary 96

Appendix G Quick Reference Operation Guide for Paper Charting Preparing the BD Intelliport™ Injection Site 97

Preparing the BD Intelliport™ Injection Site 97

Setting up the BD Intelliport™ Tablet 98

Giving IV Injections and Viewing Medication Administrations 99

Appendix H Quick Reference Operation Guide for AIMS Integration 100

Preparing the BD Intelliport™ Injection Site 100

Setting up the BD Intelliport™ Tablet 101

Giving IV Injections and Viewing Medication Administrations 102

Appendix I Accessories 103

Appendix J Radio Frequency Wireless Technology 104

BD Intelliport™ Base to Tablet 104

Tablet to Gateway through the Hospital Network 105

Appendix K Reference Documents 105

Appendix L Description of Symbols 106

Appendix M ASTM Drug Category Color Schema 107

Table of Figures

Figure 1 - BD Intelliport™ System Components 7

Figure 2 - BD Intelliport™ Injection Site 8

Figure 3 - Encoded Syringe 8

Figure 4 - Syringe Without Encoding 8

Figure 5 - Tablet With Mounting Arm (not included) 9

Figure 6 - BD Intelliport™ Sensor with Last 4 Digits of the Serial Number 24

Figure 7 - BD Intelliport™ Injection Site Components 24

Figure 8 - Tablet Feature Layout 26

Figure 9 - Syringe Labels 26

Figure 10 - Configuration for Paper Anesthesia Records 27

Figure 11 - Anesthesia View 28

Figure 12 - Unit Total 29

Figure 13 - Allergies Button 29

Figure 14 - Nursing View 30

Figure 15 - Main Menu 31

Figure 16 - Configuration for AIMS 33

Figure 17 - Companion View 34

Figure 18 - Connect BD Intelliport™ Sensor to BD Intelliport™ Base 36

Figure 19 - BD Intelliport™ Base lights 36

Figure 20 - Login 38

Figure 21 - Login 39

Figure 22 - Serial Number on BD Intelliport™ Sensor. 39

Figure 23 - Connect Sensor 40

Figure 24 - Serial Number on BD Intelliport™ Sensor. 40

Figure 25 - Confirm Connected Injection Site and Patient 41

Figure 26 - Patient Allergies 42

Figure 27 - Proper Syringe Alignment 43

Figure 28 - Improper Syringe Alignment 43

Figure 29 - Potential Allergy Reaction Screen 44

Figure 30 - Tablet at Medication Administration 44

Figure 31 - Dose Displayed on Tablet 45

Figure 32 - Select Medication 46

Figure 33 - Select Medication More Screen 46

Figure 34 - Admixture Medication 48

Figure 35 - Select Med Pending Resolution 49

Figure 36 - Patient Setup Screen 52

Figure 37 - Confirm Connected Sensor and Patient 52

Figure 38 - Patient Allergies 53

Figure 39 - BD Intelliport™Sensor Removal 54

Figure 40 - Connecting Additional Sensors 56

Figure 41 - Controlled Drugs Screen 57

Figure 42 - Connect BD Intelliport™ Sensor to BD Intelliport™ Base 59

Figure 43 - Connect BD Intelliport™ Sensor to BD Intelliport™ Base 59

Figure 44 - BD Intelliport™ Base Lights 60

Figure 45 - Login 62

Figure 46 - Serial Number on BD Intelliport™ Sensor 62

Figure 47 -Connecting a BD Intelliport™ Injection Site 62

Figure 48 - Matching a Patient Wrist Band to the List 63

Figure 49 - Patient Setup 64

Figure 50 - ADT Patient List 64

Figure 51 - Confirm Connected Sensor and Patient 65

Figure 52 - Patient Allergies 65

Figure 53 - Proper Syringe Alignment 67

Figure 54 - Improper Syringe Alignment 67

Figure 55 - Potential Allergy Reaction screen 67

Figure 56 - Select Medication 69

Figure 57 - Select Medication More Screen 69

Figure 58 - Modify Selected Medication 70

Figure 59 - Admixture Medication 70

Figure 60 - BD Intelliport™ Sensor Removal 72

Figure 61 - Patient Setup Screen 73

Figure 62 - Unknown Patient Confirmation 73

Figure 63 - Allergies Pop-up for an Unknown Patient 74

Figure 64 - The Review Case Option on the Main Menu 74

Figure 65 - The Review Case Screen 75

Figure 66 - Select Patient for Sensor 75

Figure 67 - Confirm Connected Sensor and Patient 76

Figure 68 - Connecting Additional Sensors 77

Figure 69 - Add Comment for Medication 78

Figure 70 - Messages 79

Figure 71 - Review Case 80

Figure 72 - Print Reports 82

Figure 73 - Controlled Drugs Screen 82

Figure 74 - Preferences 84

Figure 75 - Tablet on Mounting Arm 89

Figure 76 - Location of AC Power Adapter 91

Figure 77 - Restart BD Intelliport™ Application Button 93

Figure 78 - Boot Up Screen 94

Figure 79 - Connect BD Intelliport™ Sensor to BD Intelliport™ Base 97

Figure 80 - BD Intelliport™ Base Lights 98

Figure 81 - BD Intelliport™ Sensor Removal 100

Figure 82 - Connect BD Intelliport™ Sensor to BD Intelliport™ Base 101

Figure 83 - BD Intelliport™ Base Lights 102

Figure 84 - BD Intelliport™ Sensor Removal 103

Figure 85 - BD Intelliport™ System Two Wireless Technologies 104

Table of Tables

Table 1 - Status Indicators 25

Table 2 - Add Menu Options 30

Table 3 - Main Menu Buttons 31

Table 4 - Messages 50

Table 5 - Messages 79

Table 6 - Troubleshooting 85

Table 7 - BD Intelliport™ Base and Sensor Technical Specifications 88

Table 8 - BD Intelliport™ 5-Bay Charger Specifications 89

Table 9 - Tablet Technical Specifications 90

Table 10 - Summary of IEC 60601-1-2 Testing and Specifications 105

Table 11 - Reference Documents 105

Table 12 - Description of Symbols 106

Table 13 - Drug Category Color Schema 107

Encoded Syringes

Tablet Computer

BD Intelliport
Injection Site

Gateway or Hospital server

Chapter 1. Product Description

The BD Intelliport™ Medication Management System (system) can be used when intravenous bolus injections of medication
are given to a patient by a nurse or anesthetist/physician for automated documentation of medication, concentration, dose, volume and time of each intravenous injection during a surgical case or patient procedure.

The system is connected to the intravenous line and automatically captures information about drugs injected, and wirelessly transmits that information in real-time to the BD Intelliport™ Tablet (tablet). The tablet uses that information and other manually-entered information to display a time-stamped medication record. It provides you with data to help you make
clinical care decisions. It also makes that information available for reporting and electronic recordkeeping purposes.

The system has two operating configurations.

The first configuration is a system that supports a paper anesthesia record. This configuration is designed for recording manual IV bolus medication administrations at hospitals using a paper anesthesia record. The BD Intelliport system records information about medication administrations and provides this in printable reports.

The second configuration involves integration with an anesthesia information management system (AIMS). (Requires a software interface.) This configuration is designed for recording manual IV bolus medication administrations at hospitals using an AIMS for documenting the anesthesia record. The BD Intelliport system records and shares information about medication administrations with the AIMS. Medications delivered through the injection site are automatically charted to the AIMS flowsheet.

There are four components to the BD Intelliport™ System:

Figure 1 - BD Intelliport™ System Components

BD Intelliport™ Injection Site is an intelligent injection port. It attaches to a “Y Site” or stopcock for manually administered IV injections. It is comprised of the BD Intelliport™ Sensor (sensor) and the BD Intelliport™ Base (base), which snap together prior to use (Figure 2). The BD Intelliport™ Sensor is a sterile disposable having an injection port and a BD Luer-Lok™ connection. The BD Intelliport™ Sensor is supplied in a sterile package for single patient use. The BD Intelliport™ Base is a non-sterile, reusable device that houses the electronics and wireless transmitter. It contains a non-replaceable rechargeable battery. A separate BD Intelliport™ 5-Bay Charger (charger) recharges the battery as needed. (In the tablet’s screens the term “sensor” is used to refer
to the sensor and base combination to preserve screen space).

Figure 2 - BD Intelliport™ Injection Site

Encoded syringes are syringes with a special barcode that stores information about the medication contained within the
syringe. Encoded syringes are ready-to-use, passive and disposable. The BD Intelliport™ system also accommodates syringes
not having encoding.

Encoded Syringe

Includes a barcode label on the syringe tip that provides information on the medication and concentration in the syringe. User interaction at the tablet is generally not required for recording medication administrations.

Syringe without Encoding

Non-encoded syringe does NOT
includea barcode label on the luer
tip of the syringe.

BD Intelliport Sensor

BD Intelliport Base

Figure 3 - Encoded Syringe

Figure 4 - Syringe Without Encoding

Encoded
Syringe

Syringe
without
encoding

BD Intelliport™ Tablet (tablet) runs the BD Intelliport™ system software. It continuously captures and displays the medication administration record (MAR) data from the BD Intelliport™ Injection Site (injection site) each time an injection occurs. It also enables clinicians to manually document other pertinent clinical information, and it provides clinical decision support to help improve safety and aid clinicians during treatment.

Figure 5 Tablet with Mounting Arm (not included)

Typically the tablet is mounted to the anesthesia machine in operating room and adjacent to the treatment space in the perioperative nursing care areas. Refer to Appendix B for mounting specifications.

BD Intelliport™ Gateway (gateway) is software that enables the BD Intelliport™ system to function as an enterprise device and information system. The gateway provides a central hub to which all tablets connect via the hospital network. It also includes an interface engine for the BD Intelliport™ system to exchange data with other networked hospital information systems, along with a suite of utilities for general gateway implementation, operation, and maintenance.

The gateway includes a browser-based user interface for administrators of the BD Intelliport™ system to configure the Device Drug Library and the tablet settings.

BD Intelliport™ 5-Bay Charger (charger) is used to charge the BD Intelliport™ Base. It can charge up to five (5) bases at a time.

In this manual “you” refers to a clinician using the system

Chapter 2. Indications for Use

The BD Intelliport™ system is an automated record keeping system that incorporates patient safety features that are
aligned with hospital patient records and protocols. The system is comprised of an injection port and software that enables
the identification, measurement, alerting and documentation of the administration of medications to patients.

The BD Intelliport™ system allows the clinician to record anesthesia-related, medication administration events in the pre-op,
intra-op, and PACU. The system is indicated for use by healthcare professionals in a hospital or medical center setting with patients who are receiving manually administered bolus intravenous injections as part of their care to facilitate documentation
of the medications.

Chapter 3. Contraindications

None known.

Chapter 4. Warnings

General

Any changes or modifications not expressly approved by the party responsible for compliance could void the user’s authority
to operate the equipment.

Les changements ou modifications non approuvés extouchément par la partie responsable de la conformité pourrait annuler l’autorité de l’utilisateur à faire fonctionner l’équipement.

This device complies with Industry Canada license-exempt RSS standard(s). Operation is subject to the following two conditions: (1) this device may not cause interference, and (2) this device must accept any interference, including interference that may cause undesired operation of the device.

BD Intelliport™ Tablet

BD Intelliport™ Injection Site

Chapter 5. Precautions

PRECAUTION: Indicates either potential damage to the hardware or loss of data and instructs how to avoid
the problem.

General

Do not modify or tamper with BD Intelliport™ system components for any reason. Doing so will void the manufacturer warranty. The BD Intelliport™ system does not include serviceable components. Contact your BD Intelliport™ system representative for all repairs.

Do not use damaged equipment, frayed or damaged power cords.

Do not expose the BD Intelliport™ system to gas or heat sterilization. Autoclaving will seriously damage the BD Intelliport™ Base, charger and tablet.

Avoid liquid ingress to the tablet or BD Intelliport™ Base. Fluids may interfere with their performance.

Operation of electro convulsive therapy (ECT) equipment during use of the BD Intelliport™ system may temporarily result in signal loss between the BD Intelliport™ Site and tablet.

If any part of the BD Intelliport™ system (tablet, injection site, charger) is dropped or severely damaged, immediately remove it from use and have it inspected by service personnel. Ensure its proper function prior to reuse.

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

If the BD Intelliport™ system is not working or not recording injections, use manual documentation process to capture delivered injections.

BD Intelliport™ Tablet

To completely remove power from the unit, disconnect the power cord from the power receptacle of the tablet.

Properly secure the tablet prior to use or after positioning. Do not loosely place the tablet on other equipment.

Do not block the ventilation inlet holes on the underside of the tablet.

Do not open or modify the tablet for any reason. There is a seal to prevent liquids from entering, which may be
damaged if opened.

The tablet can be used only with the BD Intelliport™ system.

Before each use, check the volume of audible alerts to ensure they are not muted. Silencing the alerts may adversely
affect patient safety.

Do not push any objects into the air vents or other opening on the tablet. Doing so can cause fire or electric shock.

Do not allow fluid to seep down to the tablet ports and the buttons.

To avoid damaging the tablet’s touch screen, do not spray cleaning solution directly onto the touch screen.

Do not use aerosol cleaners or pressurized sprays, which may contain flammable substances, when cleaning the
tablet screen.

Do not use hard or pointed objects on the tablet touch screen.

If the patient allergies are not available for the tablet, the message “Unable to Obtain” displays.

If the patient does not have allergies, the message “No Known Allergies” displays.

The tablet checks for updates to patient allergy information at the start of a case and upon a care transition.

“Normal Saline flush” will appear on the active injection bar with the amount of mL delivered. If so configured, Normal saline flush” will not display on the medication history.

Reconstituted drugs will not display a dose value on the medication flag until the clinician modifies the medication.

A medication administration time cannot be in the future nor more than one hour before the first BD Intelliport™
Injection Site has been activated.

If communication between the tablet and gateway has been disrupted, users may not be able to print clinical reports from the tablet.

A clinician is able to correct and amend (adding information to) the patient’s medication record so long as a BD Intelliport™ Injection Site for that patient is connected or if it has been less than 24 hours since powering down ports
but has not yet been “finalized ”.

It is good practice to resolve medication administrations prior to a care transition or closing a case.

Do not power down the Injections Site unless the injection site is no longer in use. Doing so will prevent additional medication administrations from being recorded for this case.

Do not remove the tablet from its protective case for storage.

BD Intelliport™ Injection Site

Verify the encoding label is clean and secured to the syringe Luer collar prior to attaching to the BD Intelliport™ Sensor.

Check the medication syringe before connecting to the BD Intelliport™ injection site for air or bubbles. If present,
make sure all air or bubbles are removed from the syringe before connecting the medication syringe and injecting
the medication.

When reconstituting medications in a syringe, make sure the granules/powder is completely dissolved prior to connecting
the medication syringe to the BD Intelliport™ injection site.

When connecting the syringe to the sensor, attach the syringe with the label facing up and rotate the syringe barrel a full
180 degrees (and not beyond) to ensure the syringe is properly seated. When properly attached, the syringe graduations
will be visible when viewed from above.

When connecting and disconnecting the syringe always use a “straight-on/straight off” approach. Once the syringe is attached, make sure the syringe and injection port are aligned in a straight line with no angles at the connection.” Incorrect seating of the syringe may result in the tablet not announcing the medication and recording dose.

Should the injection site not measure the injected volume upon syringe removal, the tablet temporarily records a placeholder dose and prompts you to specify a dose.Discontinue use of the BD Intelliport™ Sensor if the syringe is
securely attached and you observe leaking (droplets forming at the injection port) during an injection.

Dispose of the BD Intelliport™ Base according to your facility’s protocol for battery disposal of lithium ion batteries.

Clinicians must be familiar with and be trained in the use of the BD Intelliport™ system. Its use should be preceded by an established facility protocol.

Change the BD Intelliport™ Sensor according to facility policy for IV administration set change or using CDC (USA)
Guidelines; or if the integrity of the BD Intelliport™ Injection Site has been compromised.

The charger should be cleaned with a disinfectant cloth. Unplug before cleaning.

The distance between the BD Intelliport™ Injection Site and a tablet should be 10 meters or less in order for the BD Intelliport™ Injection Site to send and receive wireless communications.

Verify that the BD Intelliport™ Injection Site is securely Luer locked to the Y-site and the IV tubing is free from kinks
before operating.

A fully-charged BD Intelliport™ Base has sufficient power for 24 hours of use under typical conditions. Inspect the BD Intelliport™ Base charge level. Replace a BD Intelliport™ Base with less than 25% charge. This can be done at any time,
so long as an injection is not being given.

Avoid inadvertently discarding the BD Intelliport™ Base after use. It is intended for reuse with multiple patients.

It takes approximately 2-4 hours to fully recharge a BD Intelliport™ Base when discharged to <25% of power.

The BD Intelliport™ Base will illuminate a red light while charging if it has exceeded its Useful Life.

Four bars indicate a full charge. The BD Intelliport™ Base is not damaged when left on the charger after being
fully charged.

Avoid using a BD Intelliport™ Base that has exceeded its Useful Life.

Do not place a BD Intelliport™ Base in storage without first cleaning and disinfecting according to hospital policy.

For hospitals that keep a spare BD Intelliport™ Base in the OR, be sure to periodically swap out BD Intelliport™ Base to ensure it is fully charged.

Should you miss the visual confirmation, highlight the appropriate BD Intelliport™ Injection Site again to initiate the
blinking lights.

If the wrong patient was inadvertently confirmed to the BD Intelliport™ Tablet when configured for paper charting, use the “Remove Sensor” button on the Preferences Screen to disassociate the patient from the BD Intelliport™ Injection Site and undo any medication administration history.

If the wrong patient was inadvertently confirmed to the BD Intelliport™ Tablet when configured for an AIMS, then the injection site cannot be used. Discard the sensor and replace it with an unused sensor. If an injection has been recorded
at the AIMS, then correct the patient’s medical record at the AIMS by removing the doses that were assigned to the wrong patient as a result of the mistake.

Should the BD Intelliport™ Base become disconnected from the BD Intelliport™ Sensor during operation, reattach and verify patient association. Verify entire patient case record to confirm all information is correct.

If air is detected in the sensor fluid path, a message may display prompting you to confirm the amount measured. Refer
to Chapter 4 for more information.

If the medication is administered slowly, the green lights on the base will not illuminate and a message may display prompting you to confirm the amount measured. Refer to Chapter 9 Responding to Messages for more information.

If a small volume (<0.4 mL) is administered or the volume given is not measured accurately, a message will display “Confirm volume and dose.” prompting you to confirm the amount measured.. Refer to Chapter 9 Responding to
Messages for more information.

Chapter 6. How Supplied

Verify the green “Ready” icon displays on the tablet before confirming the set up. Not preparing the sensor before use
may introduce air into the IV line or cause inaccurate dose measurement.

The system is not recommended for use with non-BD Luer-Lok™ syringes. When using a syringe without a BD Luer-Lok™, medication should be administered through an available y-site on the primary IV line and documented manually.

For sensors sufficiently prepared, green lights on the base illuminate to provide a visual confirmation that the volume being injected is measured.

When delivering medications, observe the graduations on the syringe to determine the amount of drug delivered.

Avoid disconnecting the sensor from the base and replacing it with a different sensor before wirelessly connecting to
a tablet. This will erase the medication administration data from the base.

Avoid completely depleting the battery charge on the base before wirelessly connecting to a tablet. This will erase the medication administration data from the base.

Chapter 7. Maintaining Device Effectiveness

This guide provides instructions for the safe and proper operation of the BD Intelliport™ system, as well as care information, set-up, and configuration. Read this entire manual carefully and familiarize yourself with the features and operation of the BD Intelliport™ system prior to use. This product is to be used as specified within these Instructions for Use and in accordance with federal guidelines.

READ ALL INSTRUCTIONS BEFORE USING. SAVE THESE INSTRUCTIONS.

Care

Observe the following procedures for care of the BD Intelliport™ system. Components of the BD Intelliport™ system do not require user maintenance. There are no user serviceable parts. The BD Intelliport™ system has been designed to work in normal perioperative environment lighting, outside of a surgery site focal light point. Do not use within six inches of the surgical site
focal light.

Cleaning and Disinfecting the BD Intelliport™ Base for Reuse

1. Clean and disinfect the BD Intelliport™ Base and charger with a commercial hospital disinfectant. For a list of approved hospital cleaning products to use on the BD Intelliport™ Base, please see Cleaning and Disinfectant Agents in Appendix C.

The charger should be cleaned with a disinfectant cloth. Unplug the charger before cleaning.

2. Allow it to dry.

3. Inspect the BD Intelliport™ Base for cracks or other damage. If damage is evident, then dispose of it according to your facility’s protocols for disposing of electronic waste.

Recharging the BD Intelliport™ Base for Reuse

1. Plug the charger into an isolated AC outlet.

2. Clean the base with an approved disinfectant before charging.

3. Insert the BD Intelliport™ Base into one of the five recharging ports in the charger. The BD Intelliport™ Base will illuminate showing the amount of charge in the battery. See below should a red indicator light illuminate.

Four bars indicate a full charge. The BD Intelliport™ Base is not damaged when left on the charger after
being fully charged.

4. Clean and disinfect the charger by using the procedure used for the BD Intelliport™ Base.

Determining the Useful Life for a BD Intelliport™ Base

The BD Intelliport™ Base is designed to be reusable. A solid red light will illuminate on the BD Intelliport™ Base when the unit is charging to indicate it is no longer suitable for use with patients (exceeded its Useful Life).

Avoid using a BD Intelliport™ Base that has exceeded its Useful Life.

1. Insert the BD Intelliport™ Base into a charger.

2. If the BD Intelliport™ Base has exceeded its Useful Life, then the BD Intelliport™ Base will illuminate a red light while charging. If so, discontinue use.

If a BD Intelliport™ Base has exceeded its Useful Life, then dispose of it according to your hospital’s protocols for electrical waste. The BD Intelliport™ Base contains a lithium ion battery.

Should a BD Intelliport™ Base be used after it has exceeded its Useful Life, a message will display when the BD Intelliport™ Injection Site is wirelessly connected to the tablet during Patient Setup. Should you see this message, replace the BD Intelliport™ Base with another and repeat the wireless connection to the tablet.

Cleaning the BD Intelliport™ Tablet

1. Turn the tablet off and disconnect the power cable.

2. Wipe the surface of the tablet with one the approved disinfectant wipes:

Use only products specified for cleaning the tablet, and follow the manufacturer’s instructions that are included with the product. For a list of approved cleaning products to use on your tablet, please see Cleaning and Disinfectant Agents in Appendix C.

Maintenance

Components of the BD Intelliport™ system do not require user maintenance. There are no user serviceable parts. Contact Technical Support in the event a tablet or a BD Intelliport™ Base is not functioning properly.

BD Intelliport™ Tablet

When not in use, the tablet may remain mounted and powered on, when connected to an isolated AC power source.

Do not remove the tablet from its protective case for storage.

BD Intelliport™ Base

When not in use, a clean and disinfected BD Intelliport™ Base should remain in the charger.

Do not place a BD Intelliport™ Base in storage without first cleaning and disinfecting it according to hospital policy.

If your hospital keeps a spare BD Intelliport™ Base in the OR, be sure to periodically swap out the BD Intelliport™ Base
to ensure it is fully charged.

BD Intelliport™ Sensor

BD Intelliport™ Sensors are stored in the sterile packaging.

BD Intelliport™ Sensors have an expiration date to ensure sterility. Discard BD Intelliport™ Sensors that have not been
used by their expiration dates.

Chapter 8. Complete Device Description

The BD Intelliport™ system is designed with your needs, safety and workflow in mind. This chapter will familiarize you with
the BD Intelliport™ system components, operational modes, display views, controls, and indicators.

The BD Intelliport™ system is designed for use with the following equipment:

BD Intelliport™ Injection Site

The BD Intelliport™ Injection Site is an intelligent injection port. It attaches to an injection site (“Y Site” or stopcock) for
manually administered IV injections. It comprises a single-use BD Intelliport™ Sensor and a reusable BD Intelliport™ Base,
which snap together prior to use. Up to three BD Intelliport™ Injection Sites may be in use with a patient at one time. These
may be attached to two or three separate IV lines for the patient or attached via a manifold or different Y-sites on the same
IV line. The BD Intelliport™ Injection Site has memory that will store a time-based medication history log from the time of activation to the time when these data are sent to a tablet.

BD Intelliport™ Sensor

The BD Intelliport™ Sensor is a sterile disposable having an injection port and a BD Luer-Lok™ connection. The BD Intelliport™ Sensor is supplied in a sterile package for single patient use. The BD Intelliport™ Sensor has a male Luer-Lock connection on a one-inch IV tubing pigtail. This can be attached to an IV line at a Y-site or IV manifold. A BD Intelliport™ Sensor cannot be
reused with a different patient. Each BD Intelliport™ Sensor has a unique serial number. The last 4 digits of the serial number
are imprinted on the surface next to its bar code. This number is used to identify a BD Intelliport™ Sensor within wireless range using the tablet.

Figure 6 - BD Intelliport™ Sensor with Last 4 Digits of the Serial Number

Figure 7 - BD Intelliport™ Injection Site Components

The BD Intelliport™ Sensor includes an injection port and an IV connection to the IV line. The injection port is a common needleless, BD Luer-Lok™ type. It should be cleaned prior to giving an injection according to hospital policy. Preparing the BD Intelliport™ Sensor is required before use. The injection port on the BD Intelliport™ Sensor supports up to 100 injections.

Confirm the BD Luer-Lok™ is securely connected to a fully primed primary infusion set before use.

Discontinue use of the sensor if the syringe is securely attached and you observe leaking (droplets forming at the
injection port) during an injection.

BD Intelliport™ Base

The BD Intelliport™ Base is a non-sterile, reusable device, rechargeable and battery-operated. It can be used until it has exceeded its useful life (red light illuminates while charging). Each base has a unique serial number printed on its surface. This number is transmitted to the tablet during use.

The distance between the BD Intelliport™ Injection Site and a tablet should be 10 meters or less in order for the BD Intelliport™ Injection Site to send and receive wireless communications.

The rechargeable lithium ion battery is not removable. The entire BD Intelliport™ Base connects to a charger. A fully-charged base will accommodate an entire patient case. When the base is connected to a charger, up to four green light bars will illuminate on the top. The number of solid green light bars indicates the level of charge. A green blinking light will indicate it is recharging.

................greater than 20% charged

............greater than 40% charged

........greater than 60% charged

....greater than 80% charged, fully charged after 4 hours

When the BD Intelliport™ Base is connected to a charger, a red light indicates the base has exceeded its Useful Life. Refer to Chapter 7. Maintaining Device Effectiveness for more information.

Status Indicators

The BD Intelliport™ Base is equipped with status indicators to convey the following information:

Operating

A double-blinking, green light indicates the BD Intelliport™ Injection Site is powered on and not yet wirelessly connected to a tablet. A single blinking light indicates the BD Intelliport™ Injection Site is linked to the tablet and communicating OK.

Error

A red light indicates an error is present. Refer to Troubleshooting for more information.

Identity

Green/yellow lights flash for 3 seconds when a BD Intelliport™ Injection Site has been selected at the tablet.

Push Speed

Green lights illuminate in sequence during medication delivery when the injection rate is adequate to determine a dose.

Clinical Alert

Red/green/yellow lights flash for 3 seconds when a priority clinical alert has been triggered. This informs you of an alert message on the Tablet. (e.g., a known allergy to a drug in a connected syringe).

End of Use

A red light in the lowest battery charge position indicates the Base has exceeded its Useful Life.

Last 4 digits of
Serial Number

BD Intelliport Sensor

BD Intelliport Base

Table 1 - Status Indicators

BD Intelliport™ Tablet

The tablet is a standard, commercial computer with embedded BD Intelliport™ system software for operations, a touch screen, and a wireless communications (Radio). It is typically mounted near your work envelope. The On-Off switch is located at the top right of the tablet. It includes an AC power adapter.

Figure 8 - Tablet Feature Layout

The tablet can be associated with only one patient at a time and one clinician at a time. During an active case, no other cases can be accessed.

Encoded Syringes

The BD Intelliport™ system supports injections using any BD Luer-Lok™ syringe. In addition, the system has been designed to work with encoded syringes that have a special barcode identifier on the syringe BD Luer-Lok™ collar, called “encoding”. The encoding stores information about the medication contained within the syringe. When an encoded syringe is attached to the injection port, this information is wirelessly transmitted by the BD Intelliport™ Injection Site to the tablet.

Figure 9 - Syringe Labels

Encoded Label

Color-Coded Barrel Label

On/Off Switch

AC power adapter

BD Intelliport™ 5-Bay Charger

A separate charger charges the battery that is inside the reusable BD Intelliport™ Base as needed. To use the charger, plug it into an electrical wall outlet and insert a BD Intelliport™ Base into it. The charger can recharge of to five bases at the same time. Keep bases in the charger when not in use. The batteries will not be harmed by being left in the charger when fully charged.

Configuration for Paper Anesthesia Records

When used in a hospital having a paper anesthesia record, the tablet supports features that assist with documenting the flow sheet portion and may help you make the right decisions. In this configuration, the tablet complements the paper recordkeeping activities by tracking and displaying injections given through the BD Intelliport™ Injection Site. It also enables clinicians to manually document other pertinent IV drug injection information.

The software screens follow a three-step approach consisting of:

1. Connecting the BD Intelliport™ Injection Site

2. Setting up the patient

3. Viewing medication administration in either the Anesthesia View or Nursing View.

Refer to the detailed operating instructions for information on connecting the tablet to an injection site and setting up a patient.

Figure 10 – Configuration for Paper Anesthesia Records

This chapter describes the screens of the tablet.

Anesthesia View

The Anesthesia View is a primary screen for you to interface with the BD Intelliport™ system when configured for paper anesthesia records. It is accessed by touching the Anesthesia View button on the Main menu. This view provides information about the patient, displays drug name/concentration and dose for a current injection as well as a historical list of medications that have been delivered to the patient since the current case was opened.

Figure 11 - Anesthesia View

Injection Bars -Up to three injection bars display across the top of the screen, one corresponding to each wirelessly connected BD Intelliport™ Injection Site. Each injection bar is a real time representation of the medication being administered through an injection site. When an encoded syringe is attached to an injection site, the injection bar displays the drug name and concentration. When a non-encoded syringe is attached, the Injection Bar will read “Select Med” prompting you to identify the medication and concentration. As the medication is being delivered, the volume pushed (in mL) and the corresponding dose displays in real time in the injection bar.

Medication History -The Anesthesia View includes a historical list of medications delivered to the patient organized by the surgical care area (medications given in the transition time between care areas, will post to the tablet in the next care area) arranged in a flow sheet format. This includes all medications that were administered to the patient since the BD Intelliport™ Injection Site was activated with the more recent medication administrations at the bottom of the list. A scroll bar is enabled when the list exceeds the visible space on the screen. When a new medication is added, the medication list scrolls automatically so the new medication name is visible. Horizontal hand gesturing in the flow sheet will scroll the flow sheet to view hidden medication administrations.

A color tile corresponding to American Society for Testing and Materials International (ASTM) standards and endorsed by the American Society of Anesthesiologists displays to the left of the drug name. (See Appendix K for a list of the colors.) The flow sheet time scale is adjustable between 1-minute, 5-minute, and 10-minute increments by repeatedly touching the Change Time Scale menu option.

"Dose" is shown on a flag based on the time in which it was delivered (the Dose Flag). Touching the flag for a specific medication displays the “Modify Selected Medication” pop-up. From this pop-up, you can view and modify the medication concentration and dose. This screen is also used to specify an admixture (mixed medication), or a diluted or reconstituted medication.

The total amount of medication delivered per care area is shown on the Unit Total on the right side of the medication row for you to check. In addition, touching the “Unit Total” number for a specific medication displays a pop-up box indicating the medication and concentration, total dose given, number of doses given by care area, and time of each dose. To close, touch the OK button on the pop-up window.

NOTE: The Unit Total shows a running total of how much of the dose has been delivered of the medication and concentration. Medication administrations will not be included in the Unit Total if the dose is has not yet been ascertained. The Unit Total resets upon a care transition and when the injection site has been connected to another tablet.

Medication History

Title Bar

Injection Bar

Dose Flag

Unit Total

Message Section

Figure 12 - Unit Total

The Case Header information lists the patient name, date of birth, age in years, medical record number and patient
identification number.

The Message Section displays clinical and system messages ordered by importance and time. The Message icon shows the number of unaddressed messages for you. Clinical messages that have higher importance, such as allergy alerts, will appear
in the center of the display screen (See Figure 26).

In Figure 10 the patient has “No known allergies”. If the patient has allergies that text is replaced by a button. The number
on the button indicates the number of allergies. Touching the button opens the Potential Allergic Reaction pop-up.

Figure 13 - Allergies Button

The Title Bar displays across the top of the screen. It includes the name of the clinician logged in (if so configured) and the location assigned to the tablet. The first icon to the right of the Bar specifies whether the computer speakers are muted or unmuted. The battery icon indicates the remaining amount of charge on the computer. A third icon indicates if wireless communication between the gateway and the tablet are active. Lastly, the hospital network time is shown. Should the
gateway/hospital server lose communication, a yellow message will display in the center of the Title Bar to inform you.

Nursing View

The Nursing View is a second screen for you to interact with the BD Intelliport™ system. It is accessed by touching the Nursing View button from the Main menu. Like the Anesthesia View, this view provides information about the patient, displays drug name/concentration and dose for a current injection as well as a historical list of medications that have been delivered to
the patient.

Figure 14 - Nursing View

The Nursing View has many of the features of the Anesthesia View; however it is arranged in a tabular format. The column headings in this view include time administered, medication with concentration, dose, and unit total. The medications are displayed in reverse chronological order with most recent medication administered at the top of the list. A scroll bar is enabled when the list exceeds the visible space on the screen. Vertical touch motion on the tablet will scroll to view hidden medication administrations. The black horizontal bars identify the care area in which the medications were given to the patient, or when transitioning from one care area to another.

Button and Menu Options

The following functions are available from this screen.

The Add menu is accessed from the Add Button in the lower right corner of the screen.

Select this option to record details about an injection given prior to activating an Injection Site, given through a port other than the BD Intelliport™ Injection Site. See “Adding Manual Injection” for more information.

Select this option to record general comments. (there are additional ways to pair a comment with an allergy or drug injection). See “Adding a Comment” for more information.

Table 2 - Add Menu Options

Figure 15 - Main Menu

Pause Case

Select this option when transferring a patient to another care area. In doing so, it disconnects all connected BD Intelliport™ Injection Sites in preparation for transfer. See Transferring a Patient from One Care Area to Another on page 51.

Power Down Port(s)

Select this option when transferring a patient to another care area. In doing so, it disconnects all connected BD Intelliport™ Injection Sites in preparation for transfer. See Transferring a Patient from One Care Area to Another on page 51.

Switch User

Select this option to change the clinician logged in, if so configured.

Print Reports

Select this option to print the Controlled Substance, Handoff, and Medication Administration
reports. See Printing a Report (for Paper Anesthesia Records) on page 81 for more information.

Change Time Scale

Select this option to toggle between 1 minute, 5 minute and 10 minute time intervals on the Anesthesia View flow sheet.

Unmute (Mute)

Select this option to toggle between audible announcements and mute. This button overrides the setting made in the Preferences screen.

Preferences

Select this option to view and modify preferences for announcements, volume and screen brightness. See Setting User preferences on page 83.

Review Case

Select this option to review and finalize the Medication Administration report. It’s available in the Paper Anesthesia Records mode only. See Reviewing the Medication Record (for Paper Anesthesia Records) on page 80 for more information.

Controlled Drugs

Select this option to switch to the Controlled Drugs screen. See Viewing Controlled Drugs on page 56 for details on the screen.

Nursing View

Touch this button to switch to the Nursing View from the Anesthesia View. See Nursing View
on page 30.

Anesthesia View

Touch this button to view the Anesthesia View from the Nursing View. See Anesthesia View on
page 28 for more information.

Help

Select this option when seeking assistance in operation. It provides helpful information, including
the Directions for Use.

Table 3 - Main menu buttons

Configuration for AIMS

NOTE: The gateway has an interface engine to exchange data with networked hospital information systems. When configured as a companion to an Electronic Medical Record (EMR) system, the gateway is designed to send medication administration data to the EMR system across a common software interface. A software interface with the corresponding EMR system is required for the system to operate as described in this section.

When used in a hospital having electronic medical records in the perioperative care areas, the tablet serves as a companion to the EMR system or anesthesia information management system (called an AIMS). In this configuration, the tablet provides a real-time display while the drug is being injected, then it sends the injection data in real time to the EMR. Refer to the tablet for immediate information about a medication being administered; refer to the AIMS for a history of medications given.

The Configuration for an AIMS varies slightly based on the care area:

The tablet workflow follows a three-step approach consisting of 1) connecting the BD Intelliport™ Injection Site, 2) verifying the patient information received from the EMR, and 3) giving injections. Refer to Chapter 9, Directions for Use, which starts on page 35 for information on connecting the tablet to an injection site and setting up a patient.

The Companion View is the primary screen for clinicians to interface with the BD Intelliport™ system. This View provides information about the patient, displays drug name/concentration and dose for the current injection, relevant clinical and system messages and a history of medications delivered.

Figure 16 - Configuration for AIMS

The Companion View consists of the following screen features: 1) Active Injection Bar; 2) Title Bar with clinician name and configured tablet location; 3) Case Header information on patient name, MRN, Patient identification number; 4) Allergies; 5) Clinical or system Messages; and 6) history of medications delivered.

Figure 17 - Companion View

Injection Bars -Up to three injection bars display on the screen, one corresponding to each wirelessly connected injection site. Each injection bar is a real time representation of the medication being administered through an injection site. When an encoded syringe is attached to an injection site, the injection bar displays the drug name and concentration. When a non-encoded syringe is attached, the Injection Bar will read “Select Med” prompting you to identify the medication and concentration. As the medication is being delivered, the volume pushed (in mL) and the corresponding dose displays in real time in the injection bar. Upon completion of medication dosing, the medication and dose will pass immediately to the EMR with a confirmation message confirming such in the message area.

A color tile corresponding to American Society for Testing and Materials International (ASTM) standards displays to the left of
the drug name.

The Case Header information lists the patient name, date of birth, age in years, medical record number and patient
identification number.

Historical Medication List displays in reverse order of medications delivered. The Message Section displays clinical and
system messages prioritized by importance and time.
The Message icon shows the number of unaddressed messages for
you. Clinical messages that have higher importance, such as allergy alerts, will appear in the center of the display screen
(see figure 26 on Page 42).

The Title Bar displays across the top of the screen. It includes the name of the clinician logged in (if so configured by the Administrator) and the location assigned to the tablet. The name of the companion workstation location displays when paired with a companion AIMS workstation in the operating room.The first icon to the right of the Bar specifies whether the computer speakers are muted or unmuted. A second icon, the battery icon, indicates the remaining amount of charge on the tablet. The third icon indicates if wireless communication between the gateway and the tablet are active and lastly, the hospital network time is shown. Should the gateway/hospital server lose communication, a yellow message will open in the center of the Title Bar to inform you.

Chapter 9. Directions For Use

The BD Intelliport™ system is designed with your drug administration needs, safety and workflow in mind. This chapter
acquaints you with the BD Intelliport™ system operational modes, display views, controls and indicators. It also provides
general information on use of the device.

How it Works

The medication administration process using the BD Intelliport™ system is illustrated in Figure 4. Prior to treatment, you prepare and connect the injection site to the patient’s catheter or injection port (Y-site). During medication administration, you perform standard drug-delivery of bolus medications.

When a syringe is attached to the injection port, the injection site identifies the medication and concentration for an
encoded syringe by optically imaging and decoding a barcode on the BD Luer-Lok™ collar of the syringe. This information
is wirelessly transmitted to the tablet and the tablet displays and audibly announces the drug attached. It also may perform
allergy safety checks.

As the drug is pushed, the injection site measures the volume dosed ultrasonically. The BD Intelliport™ Injection Site wirelessly sends volume measurement information to the tablet. The tablet uses this information to provide clinicians with a medication administration record which is time stamped and displays for clinical reference during surgical procedures. Manually entered information pertaining to non-encoded drug injections may be included in the patient medication record.

The tablet wirelessly communicates with the gateway on the hospital network, and it may send medication administration to Hospital Information Systems, when configured, for reporting and electronic recordkeeping purposes.

Operation: AIMS Configuration

This Section describes how to operate the system when configured to record manual IV bolus medication administrations at hospitals using an Anesthesia Information Management System (AIMS) for the anesthesia record. The BD Intelliport system records and shares information about medication administrations with the AIMS. Medications delivered through the injection site are automatically charted in the AIMS flowsheet. Refer to Section Operation: Paper Charting Configuration for operating instructions if your hospital is configured for paper anesthesia record keeping.

Preparing the BD Intelliport™ Injection Site

The BD Intelliport™ Injection Site must be assembled, prepared and attached to an IV line before use. Follow the instructions located on the BD Intelliport™ Sensor pouch.

1. Gather a BD Intelliport™ Sensor in its sterile packaging and a fully-charged and disinfected BD Intelliport™ Base and three (3) 10mL flush syringes. Before attaching to the Y-site of the primary IV fluid line follow instructions on the BD Intelliport™ Sensor pouch.

A fully-charged BD Intelliport™ Base has sufficient power for 24 hours of use under typical conditions. Inspect the BD Intelliport™ Base charge level. Replace a BD Intelliport™ Base with less than 25% charge. This can be done at any time
so long as an injection is not being given.

NOTE: Confirm that both Sensor tabs are fully engaged to base.

The connection of BD Intelliport™ Sensor to the BD Intelliport™ Base is verified by a blinking green light on the
BD Intelliport™ Base. If you don’t see this, view the injection site on its side to determine if the two are properly connected. If you see a space between the BD Intelliport™ Sensor and the BD Intelliport™ Base, then they are not attached properly. Separate the two pieces and re-attach. Confirm that both Sensor tabs are fully engaged to base. If you don’t see a blinking green light, replace the BD Intelliport™ Sensor and the BD Intelliport™ Base as needed.

NOTE: the Injection Site should not be attached to the patient IV line at this point.

3. Attach the 10mL flush syringe (purged of air bubbles) to the Intelliport Site and push 4mL sterile IV fluid with full force. Wait 5 seconds, then push an additional 5ml of fluid with full force (avoid pushing the plunger to the bottom of the flush syringe).

4. As you push, watch for sequential green flow indicator lights (runway lights) on the base.

5. If the sequential green flow indicator lights do not illuminate, wait 5 seconds and repeat Steps 3 and 4 with additional flush syringes, until the runway lights illuminate.

If the sequential green flow indicator lights illuminate, then the Injection Site is ready for use.

Recognizing a sufficiently prepared Injection Site: A sufficiently prepared injection site displays a series of green indicator lights on the base when flushing the Sensor. If green lights are not visible when flushing the Sensor, repeat steps 3 and 4 above.

Recognizing a sufficiently prepared Sensor when in the vicinity of a tablet having a case underway: A sufficiently prepared injection site displays a green “Ready” message on the tablet. If there is a yellow “Continue Flushing” message, repeat steps 3 and 4 above.

6. Attach the injection site to the Y-site of the primary IV fluid line.

7. Where appropriate, secure the injection site to a surface in preparation for giving injections. Avoid kinks in the line between the injection site and IV line.

The BD Intelliport™ Injection Site is now ready for delivery of IV medications. Any medications given through the injection site will be recorded in the BD Intelliport™ Base memory. You should see the sequential green flow indicator lights during all injections.

READ ALL INSTRUCTIONS BEFORE USING. SAVE THESE INSTRUCTIONS.

Note: Keep the end cap on the BD Intelliport™ Sensor while the Injection Site is being assembled and being prepared.

2. Attach the BD Intelliport™ Sensor to the BD Intelliport™ Base by joining the BD Intelliport™ Sensor (tubing side) and BD Intelliport™ Base front section first, and then snap the two together.

An audible snapping sound should be heard and both white tabs on the Sensor should be fully engaged to the base. Connecting the BD Intelliport™ Sensor to the BD Intelliport™ Base automatically powers on the injection site.

Figure 18 - Connect BD Intelliport™ Sensor to BD Intelliport™ Base

Figure 19 - BD Intelliport™ Base lights

Green light will flash green when the BD IntelliportSensor is properly attahced to the BD IntelliportBase

“Runway lights” — sequential green lights will illuminate during flush, when the sensor is deemed ready

Hook tab into Hole

Press Firmly Here

Tabs

Set up the Tablet at the Start of a Case

Before each use with a patient, the tablet must be set up to wirelessly communicate with the injection site and to be associated with a patient.

1. Touch the screen to undim. If not powered on, turn on the tablet by pressing and holding its power switch.

The tablet can operate on battery power alone (not plugged in to a power supply) for a few hours. For extended use verify
the tablet is plugged in prior to use by checking the power indicator icon on the Title bar on the tablet screen.

On startup, the initial screen displays information about the software, drug library and configuration versions—as well as information on network connectivity. Take time to allow the tablet to boot-up prior to using. Contact your System Administration if so instructed.

The Login screen will display (if the BD Intelliport™ system is configured for user login).

2. If configured for login, type your User Name and Password, and then touch the Log In button.

Figure 20 - Login

The Login screen hides when the user name and password has been authenticated.

A blue pop-up displays so long as the case has not yet started at the AIMS. You are unable to proceed with the tablet
until a case has been started at the companion AIMS workstation.

Figure 21 - Login

When the Start Case or similar event has occurred at the AIMS workstation, then case information from the AIMS is made available to the tablet. The blue pop-up is replaced with patient demographics for the patient selected at the AIMS.

3. Confirm the patient’s full name, patient ID, medical record number and birth date from the patient and wrist band match the information on the screen. Do not proceed if the patient information does not match. Otherwise, proceed to wirelessly connect the injection site to the tablet.

4. Identify the 4-digit number on the BD Intelliport™ Sensor.

Figure 22 - Serial Number on BD Intelliport™ Sensor.

A list of BD Intelliport™ Injection Sites within wireless range is viewable as well. The distance between the BD Intelliport™ Injection Site and a tablet should be 10 meters or less in order for the BD Intelliport™ Injection Site to send and receive
wireless communications.

Last four digits
of serial number

Figure 23 - Connect Sensor

5. Identify the 4-digit number on the BD Intelliport™ Sensor that is connected to the patient’s IV line.

Figure 24 - Serial Number on BD Intelliport™ Sensor.

6. Match the serial number on the Sensor to a serial number on the setup screen.

7. Check the injection site has a fully charged battery and sufficiently prepared.

Sufficiently Prepared – A sensor that was sufficiently prepared has a green “Ready” icon to the right of the MRN. If a Sensor was not sufficiently prepared (sufficiently flushed), a yellow icon stating “Continue Flushing” will display on the right hand side of the screen. The Sensor is not ready. Remove the injection site from the IV line and repeat the injection site preparation steps in the Prepare the Intelliport Sensor section above. Attach the fully prepared Intelliport injection site to the Y-site of the patient’s primary IV fluid line.

Not preparing the Sensor before use may introduce air into the IV line or cause inaccurate dose measurement.

Fully Charged Battery – A fully charged battery icon shows four green bars. A fully-charged BD Intelliport™ Base has sufficient power for 24 hours of use under typical conditions. Inspect the BD Intelliport™ Base charge level. Replace a
BD Intelliport™ Base with less than 25% charge. This can be done at any time, so long as an injection is not being given

The battery icon will be yellow when less than 25% of battery charge remains (approximately 4 hours under
typical conditions).

Consider replacing with a fully-charged BD Intelliport™ Base before connecting.

8. Select the injection site for your patient by touching and highlighting the appropriate BD Intelliport™ Injection Site
serial number.

9. Verify that the green and yellow lights are flashing on the injection site itself. Should you miss the visual confirmation,
touch appropriate BD Intelliport™ Injection Site on the tablet again to initiate the blinking lights.

The screen will highlight your selection.

10. Touch the Confirm button to complete the setup.

The BD Intelliport™ Injection Site will illuminate a single, repeating green light when it is wirelessly connected to the tablet and associated with a patient.

Last four digits
of serial number

Figure 25 - Confirm Connected Injection Site and Patient

If the wrong patient was inadvertently confirmed to the tablet, then the injection site cannot be used. Discard the Sensor and replace it with an unused Sensor. If an injection has been recorded at the AIMS, then correct the patient’s medical record at the AIMS by removing the doses that were assigned to the wrong patient as a result of the mistake. Following Patient Setup, the tablet displays medication allergies for the selected patient. Food and environmental allergies are not available (figure below).

Figure 26 - Patient Allergies

11. Removing Injection Site Preparation Flushes from the Record

Because the flushes used to prepare the sensor are not administered to the patient, it is important to distinguish those at the Tablet. Each flush syringe attached to the Injection Site during preparation will display in the medication history section as a “Select Med” (if not encoded) or “Normal Saline Flush” (if encoded).

NOTE: Normal saline flush may not display on the medication history, if so configured.

Locate each flush and modify the volume to 0mL to remove it from the medication history.

• For syringes not having encoding refer to the Medication Delivery with Syringes Not Having Encoding section for instruction to modify.

• For encoded flush syringes touch the Edit button. The Modify Selected Medication box will appear. Change the volume to 0mL and tap “Save”.

Giving an IV Injection Using the BD Intelliport™ Injection Site

In the event of a BD Intelliport™ system or BD Intelliport™ Injection Site failure, (excluding the IV fluid pathway), the injection site will allow standard medication or fluid delivery through the port.

1. Clean the injection port by swabbing the hub according to your hospital procedure.

2. Double check each medication name and concentration on the syringe prior to attachment to the injection port to assure “right medication.”

3. Attach a syringe to the BD Intelliport™ Injection Site starting with the barrel label visible on top. and rotate the syringe barrel
a full 180 degrees (and not beyond) to ensure the syringe is properly seated (graduations will be visible on top).

When connecting and disconnecting the syringe always use a “straight-on/straight off” approach. Once the syringe is attached, make sure the syringe and injection port are aligned in a straight line with no angles at the connection.” Incorrect seating of the syringe may result in the tablet not announcing the medication and recording dose.

Figure 27 - Proper Syringe Alignment

4. Verify the drug and concentration displayed and announced by the tablet is the intended drug and concentration.

For syringes not having encoding, see Medication Delivery when Syringes Not encoded on page 45, then return to this step. The BD Intelliport™ Injection Site will flash red, green and yellow lights if a medication allergy is detected.

Figure 28 - Improper Syringe Alignment

Figure 29 - Potential Allergy Reaction Screen

The Potential Allergy Reaction screen appears when either of these conditions is true:

4. If the Potential Allergy Reaction box has appeared take the appropriate action and then touch the OK button to close the box.

5. While delivering the medication, observe the graduations on the syringe to determine the amount of drug delivered.

Figure 30 - Tablet at Medication Administration

For Sensors sufficiently prepared, green lights on the base illuminate to provide a visual confirmation that the volume being injected is measured.

Do not lift up on the syringe while delivering medication.

6. Disconnect the syringe, and verify dose shown in the tablet.

Figure 31 - Dose Displayed on Tablet

In the event of a BD Intelliport™ system or BD Intelliport™ Injection Site failure, (excluding the IV fluid pathway), the injection site will allow standard medication or fluid delivery through the port.

7. Follow all medication injections through the injection site with an encoded Normal Saline flush syringe to ensure the full dose of medications reaches the patient, especially when successively delivering two incompatible medications.

If encoded, “Normal Saline flush” appears on the active injection bar with the amount of mL delivered. Normal saline flush may not display on the medication history, if so configured.

8. Make adjustments to the medication administration record on the tablet for injections involving a diluted drug, reconstituted drug, or mixed drugs, if so configured.

9. If the tablet determines user interaction for this does is required, a message will display. Read the message and respond accordingly. Refer to Section Responding to Messages for information.

Otherwise, the tablet sends medication administration information directly to the AIMS when the dose has been completed.
The tablet will display the Sending message until it gets confirmation that the AIMS has received the message. It displays Sent when confirmed.

10. Verify each medication administered using the injection site displays in the AIMS flowsheet.

It is good practice to resolve medication administrations prior to a care transition or closing a case.

When the BD Intelliport system is integrated with an AIMS, all medications given through the injection site are automatically charted to the anesthesia record. To prevent duplicate charting of medications, do not manually
chart at the AIMS workstation for those medications administered using the injection site.

Medication Delivery with Syringes Not Having Encoding

The BD Intelliport™ system is designed to work with both encoded and non-encoded syringes. When a non-encoded syringe is attached to the Sensor, the blank collar triggers the base and the tablet displays the Select Medication pop-up, which contains the perioperative medication list.

1. Deliver the medication as described in Section Giving an IV injection using the BD Intelliport™ Injection.

When the syringe attaches to the injection site, the tablet announces “Select Medication” and a pop-up displays prompting
you to specify the medication.

You can identify the medication in the syringe before giving the injection (recommended) or afterwards. You should verify all medication selections on the tablet. If postponed, the tablet tracks injections not yet identified and later prompts you to resolve them.

2. Select the medication, concentration and container type from the Select Medication dialog box by touching its name.

NOTE: The tablet provides pre-configured medication concentrations that align with those in the AIMS workstation. To record a medication concentration other than one listed at the tablet, make the change at the AIMS workstation.

Figure 32 - Select Medication

3. If the desired medication is not found on the Select Medication dialog touch the More button to view a longer list of perioperative medications.

Figure 33 - Select Medication More Screen

4. You can filter the list by touching the first letters of the drug name using the keypad.

5. Highlight the desired medication and concentration, verify the information and touch the Save button.

The tablet sends the medication administration information to the AIMS upon saving.

Specifying a Diluted or Reconstituted Medication

The tablet provides a simple approach to document medications given with a non-encoded syringe that require dilution or reconstitution from a powder form prior to preparation for injection. It tracks frequently diluted and reconstituted medications. The tablet prompts you to confirm dilution or reconstitution by a message and an accompanying Edit button.

NOTE: The tablet provides pre-configured medication concentrations that align with those in the AIMS workstation. To record a medication concentration other than one listed at the tablet, make the change at the AIMS workstation.

When reconstituting medications, make sure the granules/powder is completely dissolved prior to connecting the medication syringe to the BD Intelliport injection site.

1. Pick the medication and concentration from the list in the Select Med popup.

2. Press Save.

A prompt displays if the concentration selected is typically diluted before being administered to the patient or if it is reconstituted and you want to adjust the volume to have the dose match the dose given.

3. Press the Send button adjacent to the medication in the pending medication list if the appropriate dose displays. Otherwise, press the Edit button to select a different dilution or to modify the volume given.

The tablet sends the medication administration information to the AIMS upon saving.

Specifying a Mixed Medication (Admixture)

Adding two medications into one syringe is called a mixed medication or admixture. Depending on your institution, mixed medications might include the following:

Figure 34 - Admixture Medication

The tablet provides a simple approach to document mixed medications. It tracks frequently mixed medications, if configured
on the tablet, and it prompts you to confirm whether a drug has been mixed. If not configured, no user action is required.

1. To specify a mixed medication, Press the Edit button adjacent to the medication in the pending medication list.

The Modify Selected Medication pop up displays two medication name slots, with the first one already identified.

2. Touch the bottom field. The Select Medication pop-up opens.

3. Select the desired drug from the list.

Touching the Other button allows you to identify the correct medication from the Frequent Use or perioperative
drug library list.

4. Enter the volume injected for either drug. The tablet calculates the volume for the other medication using the total
volume injected.

5. Touch the Save button.

The tablet sends the medication administration information to the AIMS upon saving.

Address Pending Medications

When configured for AIMS integration, the tablet sends medication administration information in real time unless a user response to a message is required or information is missing. The missing information could include the drug name/concentration of a non-encoded syringe, the dose of a reconstituted drug, or use of an admixture. In these situations, the tablet retains this medication administration in a pending list until you resolve it.

Figure 35 – Select Med Pending Resolution

Promptly resolve pending medications. It is good practice to resolve medication administrations prior to a care transition or closing a case.

A list of medication administrations display below the Active Injection Bar, when the Show All check box is selected (lower left corner). This includes medications that have previously been sent to the AIMS as well as those that require resolution. The tablet does not send medication administrations to the companion AIMS when information is pending.

NOTE: Unselecting the Show All checkbox will show pending medications administrations (requiring resolution) and hide medication administrations that have been sent.

1. Review the list after each injection. The list includes the time administered, medication and concentration, volume, dose
and reason for review (e.g. unencoded syringe, medication identified as frequently diluted).

2. Touch the Show All button at the bottom of the screen to display all medications. The display indicates any that
require resolutions.

3. Read each medication administration and answer those that have not been sent because a question exists.

For example, a question may prompt you to confirm whether epinephrine has been diluted.

A. Touch the Send button if no changes are required for that medication administration. Doing so will send this
information to the companion AIMS and display a message that it was sent.

B. Touch the Edit button to answer questions about the medication administration (e.g. concentration, volume or dose).

As each medication administration is resolved, the unresolved record will no longer display.

Responding to Messages

The BD Intelliport™ system provides two types of messages: “Clinical” and “System.” “Clinical” messages are alerts and reminders that relate directly to an aspect of patient care delivery (e.g. contraindication or a reminder that it may be time to re-dose antibiotics). System messages provide status on relevant system operating parameters, such as tablet battery charge.

Messages provide instructions and a button for acknowledging or resolving. Refer to Table 4 below for a description of clinical messages and Troubleshooting on page 85 for resolving system messages. Messages display in the Message chapter of the
tablet until they are acknowledged or are no longer clinically relevant. Messages can be answered any time during a case. Prior
to pausing or closing a case, you are prompted to respond/answer unresolved medication messages generated during the case.

Allergy Alert

An allergy alert illuminates the injection site and displays on the tablet when you attach an encoded syringe or selects a medication for a non-encoded syringe to which the patient has a known allergy. Touch the OK button to acknowledge.

  • Use clinical judgment before proceeding when the tablet announces and displays a known allergy
    for the drug attached to the injection site.

Consider redosing an antibiotic

The tablet tracks elapsed time since an antibiotic was last administered and displays and announces an antibiotic redosing message if the configured redosing interval has elapsed. The redosing interval is individual to each antibiotic, and it is configured in the drug library. Touch the OK button to acknowledge. The BD Intelliport™ injection site does not prevent or block the injection of a medication

  • Antibiotic redosing reminders are based on preconfigured, medication-specific time intervals which do not take into consideration renal or hepatic dysfunction, excessive blood loss, obesity, or other clinical factors which may affect serum drug levels.

The reminder repeats every 30 min if not acknowledged by the user.

Medication Questions

The tablet posts a message when a medication is configured as reconstituted, diluted or mixed (admixture) Touching the message text opens a screen to edit the concentration or dose.

Confirm volume
and dose

If a small volume (<0.4 mL) is administered or the volume given is not measured accurately, a message will display “Confirm volume and dose.” prompting you to confirm the amount measured.

Touching the message text opens a screen to edit the volume or dose.

Volume not measured

The tablet did not receive a volume measurement from the injection site following syringe removal. Reasons may include incorrect syringe attachment. The tablet temporarily records a placeholder
dose and prompts you to specify a volume.

Touching the message text opens a screen to edit the volume or dose.

Air detected

The dose may have been administered with air which made it difficult for the BD Intelliport™ Base to identify the full dose. Verify dose amount and adjust if needed.

Slow push

If the medication is administered slowly, the green lights on the base will not illuminate and a message may display “Slow push, confirm dose.” prompting you to confirm the amount measured.

The dose may have been administered too slow for the BD Intelliport™ Base to identify the full dose. Verify dose amount and adjust if needed.

Verify on record

If more than 1 hour has elapsed from the time of dose, the tablet prompts to confirm the medication administration.

Table 4 - Messages

Clinical messages originating in a prior care area will display in subsequent care areas, if not already acknowledged by the user.

Transferring a Patient from One Care Area to Another

Prepping to Leave the Operating Room

It is important to prepare the patient and tablet prior to moving the patient from one care area to another.

1. Pause (also called suspending, or closing) a case at the AIMS as you typically do.

The tablet will prompt you to confirm you want to Pause the tablet. Doing so will disconnect the injection site(s) from
the current tablet. This enables another tablet in a subsequent care area to connect to the injection site(s).

2. Respond to any messages for Pending meds.

It is good practice to resolve Pending meds before the care transition. If any medication administrations have been incompletely processed (Sending, Resolution pending, manual verification), those messages will also be available
following the care transition at the next tablet.

3. Press Confirm at the tablet.

NOTE: Injections given through the injection site while not connected with a tablet will be saved in the Injections Site’s memory and uploaded to the next tablet when wirelessly connected.

Continuing at the Recovery Area

Before viewing patient information at a tablet in the recovery area, the tablet must be set up to wirelessly communicate with the injection site.

1. If not powered on, turn on the tablet by pressing and holding its power switch.

The tablet can operate on battery power alone (not plugged in to a power supply) for a few hours. For extended use
verify the tablet is plugged in prior to use by checking the power indicator icon on the Title bar on the tablet screen.

On startup, the initial screen displays information about the software, drug library and configuration versions—as well as information on network connectivity. Take time to allow the tablet to boot-up prior to using. Contact your System Administration if so instructed.

The Login screen will display (if the BD Intelliport™ system is configured for user login).

2. If configured for login, type your User Name and Password, and then touch the Log in button.

3. At the new care area, a list of BD Intelliport™ Injection Sites within wireless range is viewable on the Patient Setup screen.

4. Identify the patient’s full name, patient ID, medical record number and birth date from the patient and wrist band. Locate the patient information on the setup screen.

Figure 36 - Patient Setup Screen

NOTE: If the case was not paused at the tablet and the patient is moved to a subsequent care location that is within about 30 feet of the earlier tablet, the injection site(s) will remain wirelessly connected to the earlier tablet. In this situation, you can disconnect the BD Intelliport™ Injection Site by touching the Show All button from the Patient Setup screen and following the screen instructions.

5. Select the injection site for your patient by touching and highlighting the appropriate BD Intelliport™ Injection Site
serial number.

6. Verify that the green and yellow lights are flashing on the injection site itself. Should you miss the visual confirmation, highlight by touching the appropriate BD Intelliport™ Injection Site again to initiate the blinking lights.

The screen will highlight your selection.

7. Touch the Confirm button to complete the setup.

The BD Intelliport™ Injection Site will illuminate a single, repeating green light when it is wirelessly connected to the
tablet and associated with a patient.

Figure 37 - Confirm Connected Sensor and Patient

Following Patient Setup, the tablet displays medication allergies for the selected patient. (figure below).

Figure 38 - Patient Allergies

The tablet displays the Active Injection bar. The system is ready to continue care.

Power Down the Injection Site at the End of a Case

It is good practice to power down the injection site when the surgical case has ended. Once powered down you will be unable to record injections using that injection site.

Do not power down the Injections Site unless the injection site is no longer in use. Doing so will prevent additional medication administrations from being recorded for this case.

1. From the tablet menu, Press Power Down Ports.

2. A message will prompt you to confirm.

3. Press yes.

NOTE: If you do not power down an Injection site - but instead deactivate it by disengaging the Sensor from the base, the gateway will administratively close the case if a specified time has elapsed without activity. The tablet checks for updates to patient allergy information at the start of a case and upon each care transition.

Deactivating a Device, Disposing of the Sensor, and Preparing the Base for Reuse

When the injection site is no longer in use:

1. Disconnect the Sensor from the base by squeezing together the two finger tabs on top of the Sensor while lifting up to disengage from the base.

When properly separated, the base will power off and stop transmitting wirelessly to the tablet.

Figure 39 - BD Intelliport™Sensor Removal

2. Dispose of the Sensor according to your hospital’s medical waste protocols.

Avoid inadvertently discarding the base after use. It is intended for reuse with multiple patients.

3. Clean and disinfect the base. The first wipe with a commercial hospital disinfectant will clean and the second wipe will disinfect. Follow the disinfectant manufacturer’s instructions.

For a list of approved hospital products to use, refer to Appendix C on page 90.

4. Allow it to dry.

5. Inspect the base for cracks or damage.

6. If damage is evident, then dispose of it according to your hospital’s protocols.

7. Insert the base into the charger.

8. If the base has reached its End of Life as indicated by a message on the tablet screen or by a persistent red light when seated on the charger, then dispose of it according to your hospital’s protocols for electrical waste.

The base contains a lithium ion battery.

The base will illuminate a red light while charging if it has exceeded its Useful Life.

Special Activities

Giving Injections Without a Tablet Present

We recommend administering medications while the injection site is wireless connected to the tablet. The tablet provides medication announcement/identification, dose measurement, alerting and documentation in the AIMS anesthesia flowsheet. The injection site also supports medication administrations when a tablet is not present. In this situation, the injection site operates like a standard y-site. It also retains the dose information until it later connects to a tablet.

1. Deliver medication according to the instructions described in the Section Giving an IV injection using the BD Intelliport™ Injection Site.

Avoid disconnecting the Sensor from the base and replacing it with a different Sensor before wirelessly connecting to a tablet. This will erase the medication administration data from the base.

Avoid completely depleting the battery charge on the base before wirelessly connecting to a tablet. This will erase the medication administration data from the base.

2. When the patient moves to another care area having a tablet present, follow the instructions to in Section Set up the Tablet.

Once connection to a tablet, prior medication administration history displays along with allergy alerts, if any.

3. Respond to messages, as appropriate.

Adding Additional Sensors

The BD Intelliport™ system can accommodate up to three BD Intelliport™ Injection Sites connected to one patient at a time. An additional BD Intelliport™ Injection Site can be added at any time during a case. The first connected BD Intelliport™ Injection Site displays at the topmost injection bar. The second in the middle and the third the lowermost injection bar. See Figure 11.

When an injection site is connected to a tablet and there is no syringe attached to the Sensor, the active injection bar reads “Sensor Connected, No syringe attached”.

A battery status icon in the upper right corner of the injection bar indicates the battery charge level of the base to which the Sensor is connected. The battery status icon in the upper right corner of the screen indicates the battery charge level of the
tablet. See Figure 11.

To add an injection site:

1. Prepare an injection site according to the instructions in Preparing the Sensor on page 35.

Verify green “Ready” on the tablet screen. If the Sensor is not sufficiently prepared it may cause inaccurate
dose measurement.

2. Touch “Add Port” button to display a pop-up window that lists available BD Intelliport™ Injection Sites within wireless range.

3. Identify the 4-digit number on the BD Intelliport™ Sensor.

4. Highlight (select) your BD Intelliport™ Injection Site based on the time of initial activation and the four-digit number on the
BD Intelliport™ Sensor.

To remove Sensor from Base, Squeeze together white Sensor tabs

Squeeze tabs and lift

Lift Sensor from Base. Dispose of Sensor. Clean and recharge Base.

Lift up

Figure 40 - Connecting Additional Sensors

A low battery icon displays when the selected base has less than 10% of battery power remaining. The selected base flashes for three seconds.

5. Verify that the green and yellow lights are flashing for the correct base.

Should you miss the visual confirmation, highlight the appropriate BD Intelliport™ injection site again to initiate the
blinking lights.

1. If the identified Sensor is correct, touch Connect.

2. Touch Confirm.

3. Verify the base is flashing a single, repeating green blinking light indicating it is wirelessly connected to the tablet.

An Active Injection Bar displays the connected Sensor.

Viewing Controlled Drugs

The Controlled Drugs screen lists all controlled drugs administered from the beginning of the case. It’s accessed by selecting the Controlled Drugs option on the Main Menu.

Figure 41 - Controlled Drugs Screen

The screen shows this information on each injected controlled drug

2. Attach the BD Intelliport™ Sensor to the BD Intelliport™ Base by joining the BD Intelliport™ Sensor (tubing side) and BD Intelliport™ Base front section first, and then snap the two together.

An audible snapping sound should be heard and both white tabs on the Sensor should be fully engaged to the base. Connecting the BD Intelliport™ Sensor to the BD Intelliport™ Base automatically powers on the injection site.

NOTE: Confirm that both Sensor tabs are fully engaged to base.

The connection of BD Intelliport™ Sensor to the BD Intelliport™ Base is verified by a blinking green light on the BD Intelliport™ Base. If you don’t see this, view the injection site on its side to determine if the two are properly connected. If you see a space between the BD Intelliport™ Sensor and the BD Intelliport™ Base, then they are not attached properly. Separate the two pieces and re-attach. Confirm that both Sensor tabs are fully engaged to base. If you don’t see a blinking green light, replace the BD Intelliport™ Sensor and the BD Intelliport™ Base as needed.

NOTE: the Injection Site should not be attached to the patient IV line at this point.

3. Attach the 10mL flush syringe (purged of air bubbles) to the Intelliport Site and push 4mL sterile IV fluid with full force. Wait 5 seconds, then push an additional 5ml of fluid with full force (avoid pushing the plunger to the bottom of the flush syringe).

4. As you push, watch for sequential green flow indicator lights (runway lights) on the base.

5. If the sequential green flow indicator lights do not illuminate, wait 5 seconds and repeat Steps 3 and 4 with additional flush syringes, until the runway lights illuminate.

If the sequential green flow indicator lights illuminate, then the Injection Site is ready for use.

OPERATION: PAPER CHARTING CONFIGURATION

This Section describes how to operate the system when configured to record manual IV bolus medication administrations at hospitals using a paper anesthesia record. Refer to Section Y for operating instructions if your hospital is configured differently.

Preparing the BD Intelliport™ Injection Site

The BD Intelliport™ Injection Site must be assembled, prepared and attached to an IV line before use. Follow the instructions located on the BD Intelliport™ Sensor pouch.

1. Gather a BD Intelliport™ Sensor in its sterile packaging and a fully-charged and disinfected BD Intelliport™ Base and three (3) 10mL flush syringes. Before attaching to the Y-site of the primary IV fluid line follow instructions on the BD Intelliport™ Sensor pouch.

A fully-charged BD Intelliport™ Base has sufficient power for 24 hours of use under typical conditions. Inspect the BD Intelliport™ Base charge level. Replace a BD Intelliport™ Base with less than 25% charge. This can be done at any time so long as an injection is not being given.

NOTE: Keep the end cap on the BD Intelliport™ Sensor while the Injection Site is being assembled and being prepared.

Hook tab into Hole

Figure 42 - Connect BD Intelliport™ Sensor to BD Intelliport™ Base

2. Attach the BD Intelliport™ Sensor to the BD Intelliport™ Base by joining the BD Intelliport™ Sensor (tubing side) and BD Intelliport™ Base front section first, and then snap the two together.

An audible snapping sound should be heard and both white tabs on the Sensor should be fully engaged to the base. Connecting the BD Intelliport™ Sensor to the BD Intelliport™ Base automatically powers on the injection site.

NOTE: Confirm that both Sensor tabs are fully engaged to base.

The connection of BD Intelliport™ Sensor to the BD Intelliport™ Base is verified by a blinking green light on the BD Intelliport™ Base. If you don’t see this, view the injection site on its side to determine if the two are properly connected. If you see a space between the BD Intelliport™ Sensor and the BD Intelliport™ Base, then they are not attached properly. Separate the two pieces and re-attach. Confirm that both Sensor tabs are fully engaged to base. If you don’t see a blinking green light, replace the BD Intelliport™ Sensor and the BD Intelliport™ Base as needed.

NOTE: the Injection Site should not be attached to the patient IV line at this point.

3. Attach the 10mL flush syringe (purged of air bubbles) to the Intelliport Site and push 4mL sterile IV fluid with full force. Wait 5 seconds, then push an additional 5ml of fluid with full force (avoid pushing the plunger to the bottom of the flush syringe).

4. As you push, watch for sequential green flow indicator lights (runway lights) on the base.

5. If the sequential green flow indicator lights do not illuminate, wait 5 seconds and repeat Steps 3 and 4 with additional flush syringes, until the runway lights illuminate.

If the sequential green flow indicator lights illuminate, then the Injection Site is ready for use.

Press Firmly Here

Tabs

Figure 43 - Connect BD Intelliport™ Sensor to BD Intelliport™ Base

Green light will flash green when the BD IntelliportSensor is properly attahced to the BD IntelliportBase

“Runway lights” — sequential green lights will illuminate during flush, when the sensor is deemed ready

Figure 44 - BD Intelliport™ Base lights

6. Attach the injection site to the Y-site of the primary IV fluid line and follow instructions on the BD Intelliport™ Sensor package.

7. Where appropriate, secure the injection site to a surface in preparation for giving injections. Avoid kinks in the line between the injection site and IV line.

The BD Intelliport™ Injection Site is now ready for delivery of IV medications. Any medications given through the
injection site will be recorded in the BD Intelliport™ Base memory. You should see the sequential green flow indicator
lights during all injections.

8. Attach the injection site to the Y-site of the primary IV fluid line and follow instructions on the BD Intelliport™ Sensor package.

9. Where appropriate, secure the injection site to a surface in preparation for giving injections. Avoid kinks in the line between the injection site and IV line.

The BD Intelliport™ Injection Site is now ready for delivery of IV medications. Any medications given through the
injection site will be recorded in the BD Intelliport™ Base memory. You should see the sequential green flow indicator
lights during all injections.

Set up the Tablet for the Start of a Case

Before each use with a patient, the tablet must be set up to wirelessly communicate with the injection site and to be associated with a patient.

1. Touch the screen to undim. If not powered on, turn on the tablet by pressing and holding its power switch.

The tablet can operate on battery power alone (not plugged in to a power supply) for a few hours. For extended use verify the tablet is plugged in prior to use by checking the power indicator icon on the Title bar on the tablet screen.

On startup, the initial screen displays information about the software, drug library and configuration versions—as well as information on network connectivity. Take time to allow the tablet to boot-up prior to using. Contact your System Administration if so instructed.

The Login screen will display (if the BD Intelliport™ system is configured for user login).

2. If configured for login, type your User Name and Password, and then touch the Log In button.

Figure 45 - Login

The Login screen hides when the user name and password has been authenticated. A list of BD Intelliport™ Injection Sites within wireless range is viewable on the Patient Setup screen. The distance between the BD Intelliport™ Injection Site and a tablet should be 10 meters or less in order for the BD Intelliport™ Injection Site to send and receive wireless communications.

3. Identify the 4-digit number on the BD Intelliport™ Sensor connected to the patient’s IV line.

Last four digits
of serial number

Figure 46- Serial Number on BD Intelliport™ Sensor

4. Match the serial number on the Sensor to a serial number on the setup screen.

Figure 47 -Connecting a BD Intelliport™ Injection Site

5. Check the injection site has a fully charged battery and sufficiently prepared.

Sufficiently Prepared – A sensor that was sufficiently prepared has a green “Ready” icon to the right of the MRN. If a Sensor was not sufficiently prepared (sufficiently flushed), a yellow icon stating “Continue Flushing” will display on the right hand side of the screen. The Sensor is not ready. Remove the injection site from the IV line and repeat the injection site preparation steps in the Prepare the Intelliport Sensor section above. Attach the fully prepared Intelliport injection site to
the Y-site of the patient’s primary IV fluid line.

Not preparing the Sensor before use may introduce air into the IV line or cause inaccurate dose measurement.

Fully Charged Battery – A fully charged battery icon shows four green bars. A fully-charged BD Intelliport™ Base has sufficient power for 24 hours of use under typical conditions. Inspect the BD Intelliport™ Base charge level. Replace a BD Intelliport™ Base with less than 25% charge. This can be done at any time, so long as an injection is not being given.

A yellow battery icon will display at the extreme right-hand side of a listed injection site when less than 25% of battery charge remains (approximately 4 hours under typical conditions).

Consider replacing with a fully-charged BD Intelliport™ Base before connecting.

6. Select the injection site for your patient by touching and highlighting the appropriate BD Intelliport™ Injection Site serial number.

7. Verify that the green and yellow lights are flashing on the injection site itself. Should you miss the visual confirmation, highlight by touching the appropriate BD Intelliport™ Injection Site again to initiate the blinking lights.

The screen will highlight your selection.

8. Identify the patient’s full name, patient ID, medical record number and birth date from the patient and wrist band.

Figure 48 - Matching a Patient Wrist Band to the List

9. On the Patient Setup screen, select the patient from the list.

Figure 49 - Patient Setup

If the patient is not listed, touch the More Patients button to find the patient on the ADT list by filtering this longer list by the patient name, patient ID or MRN. Touching the column heading will sort the list in ascending/descending order for that column. A keyboard will appear and you can type the first letters of the Last Name. For example, typing “F” will filter the list to just those patients who have a last name beginning with “F”.

Figure 50 - ADT Patient List

If the patient’s name is unknown, see Using the System with an Emergency Patient on page 73.

10. Touch the Confirm button to complete the setup.

The BD Intelliport™ Injection Site will illuminate a single, repeating green light when it is wirelessly connected to the tablet and associated with a patient.

Should any part of the association be incorrect, there is an opportunity to touch the Remove button and repeat the patient identification step process. (See Figure 37 Confirm Connected Sensor) Once confirmed, the BD Intelliport™ system has established a permanent association between the patient and BD Intelliport™ Sensor. A BD Intelliport™ Sensor can be paired with only one patient.

Figure 51 - Confirm Connected Sensor and Patient

If the wrong patient was inadvertently confirmed to the BD Intelliport™ Tablet, use the “Remove Sensor” button on the Preferences Screen to disassociate the patient from the BD Intelliport™ Injection Site and undo any medication administration history.

Should the BD Intelliport™ Base become disconnected from the BD Intelliport™ Sensor during operation, reattach and verify patient association. Verify entire patient case record to confirm all information is correct.

Following Patient Setup, the tablet displays medication allergies for the selected patient. Food and environmental allergies are not available (figure below).

Figure 52 - Patient Allergies

If the patient allergies are not available for the tablet, the message “Unable to Obtain” appears. Verify allergy
information following your current practice.

If the patient does not have allergies, the allergy screen with “No Known Allergies” message appears.

10. Removing Injection Site Preparation Flushes from the Record

Because the flushes used to prepare the sensor are not administered to the patient, it is important to distinguish those
at the Tablet. Each flush syringe attached to the Injection Site during preparation will display in the medication history section as a “Select Med” (if not encoded) or “Normal Saline Flush” (if encoded).

Note: Normal saline flush may not display on the medication history, if so configured.

Locate each flush and modify the volume to 0mL to remove it from the medication history.

• For syringes not having encoding refer to the Medication Delivery with Syringes Not Having Encoding section for instruction to modify.

• For encoded flush syringes touch the Edit button. The Modify Selected Medication box will appear. Change the volume
to 0mL and tap “Save”.

There is an opportunity to type a comment for an allergy. To add a comment:

1. Touch the Comment button. A keyboard displays to type a comment.

2. Type the comment.

3. Touch the Save button. This will return you to the Allergy list.

4. Touch the OK button to close the allergy dialog box.

Giving an IV injection using the BD Intelliport™ Injection Site

In the event of a BD Intelliport™ system or BD Intelliport™ Injection Site failure, (excluding the IV fluid pathway), the injection site will allow standard medication or fluid delivery through the port.

1. Clean the injection port by swabbing the hub according to your hospital procedure.

2. Double check each medication name and concentration on the syringe prior to attachment to the injection port to assure “right medication.”

3. Attach a syringe to the BD Intelliport™ Injection Site starting with the barrel label visible on top and rotate the syringe barrel a full 180 degrees (and not beyond) to ensure the syringe is properly seated (graduations will be visible on top).

When connecting and disconnecting the syringe always use a “straight-on/straight off” approach. Once the syringe is attached, make sure the syringe and injection port are aligned in a straight line with no angles at the connection.” Incorrect seating of the syringe may result in the tablet not announcing the medication and recording dose.

Figure 53 - Proper Syringe Alignment

4. Verify the drug and concentration displayed and announced by the tablet is the intended drug and concentration.

For syringes not having encoding, see Medication Delivery with Syringes Not Having Encoding on page 45, then return to
this step. The BD Intelliport™ Injection Site will flash red, green and yellow lights if a medication allergy is detected.

Figure 55 - Potential Allergy Reaction screen

Figure 54 - Improper Syringe Alignment

The Potential Allergy Reaction screen appears when any of these conditions is true:

5. If the Potential Allergy Reaction box has appeared take the appropriate action and then touch the OK button to close the box.

There is no check valve in the BD Intelliport™ Sensor, nor is one needed to use the BD Intelliport™ Sensor safely and effectively. Should you choose a stopcock, manifold or check valve can be used. If you leave a syringe in place for long durations it is recommended that you use a check valve to prevent backflow.

6. While delivering the medication, observe the graduations on the syringe to determine the amount of drug delivered.

For Sensors sufficiently prepared, green lights on the base illuminate to provide a visual confirmation that the volume being injected is measured.

Do not lift up on the syringe while delivering medication.

Pushing medication from a 50 mL syringe rapidly has the potential to cause collapse of the IV line. Push slower to accommodate delivery of a large amount of medication.

7. Disconnect the syringe, and verify dose shown in the tablet.

8. Follow all medication injections through the injection site with an encoded Normal Saline flush syringe to ensure the full dose of medications reaches the patient, especially when successively delivering two incompatible medications.

“Normal Saline flush” appears on the active injection bar with the amount of mL delivered. Normal saline flush may not display on the medication history, if so configured.

9. Make adjustments to the medication administration record on the tablet for injections involving a diluted drug, reconstituted drug, or mixed drugs, if so configured.

10. If the tablet determines user interaction for this dose is required, a message will display. Read the message and respond accordingly. Refer to section Responding to Messages for information.

Medication Delivery with Syringes Not Having Encoding

The BD Intelliport™ system is designed to work with both encoded and non-encoded syringes. When a non-encoded syringe is attached to the Sensor, the blank collar triggers the base and the tablet displays the Select Medication pop-up, which contains the perioperative medication list.

1. Deliver the medication as described in Section Giving an IV injection using the BD Intelliport™ Injection.

When the syringe attaches to the injection site, the tablet announces “Select Medication” and a pop-up displays prompting
you to specify the medication.

You can identify the medication in the syringe before giving the injection (recommended) or afterwards. You should verify
all medication selections on the tablet. If postponed, the tablet tracks injections not yet identified and later prompts you to resolve them.

2. Select the medication, concentration and container type from the Select Medication dialog box by touching its name.

This list includes medications previously identified during the case as given by a non-encoded syringe.

Figure 56 - Select Medication

3. If the desired medication is not found on the Select Medication dialog touch the More button to view a longer list of perioperative medications.

Figure 57 - Select Medication More Screen

4. You can filter the list by touching the first letters of the drug name using the keypad.

5. Highlight the desired medication and concentration, verify the information and touch the Save button.

Specifying a Diluted or Reconstituted Medication

The tablet provides a simple approach to document medications given with a non-encoded syringe that require dilution or reconstitution from a powder form prior to preparation for injection. It tracks frequently diluted and reconstituted medications. The tablet prompts you to confirm dilution or reconstitution by a message.

When reconstituting medications, make sure the granules/powder is completely dissolved prior to connecting the medication syringe to the BD Intelliport™ injection site.

Reconstituted drugs will not display a dose value on the medication flag until you modify the medication.

1. To specify a dilution or reconstitution, touch on the dose flag (Anesthesia View flowsheet) or dose row (Nursing view). The Modify Selected Medication dialogue box appears.

2. Change the medication concentration or dose by touching the Concentration or Dose box, and entering the value using the numerical keypad.

3. Review the numbers entered, then touch the Save button to record the new value. This change is now reflected in the medication administration history.

Figure 58 - Modify Selected Medication

Specifying a Mixed Medication (Admixture)

Adding two medications into one syringe is called a mixed medication or admixture. Depending on your institution, mixed medications might include the following:

Figure 59 - Admixture Medication

The tablet provides a simple approach to document mixed medications. It tracks frequently mixed medications if configured on the tablet, and it prompts you to confirm whether a drug has been mixed. If not configured, no user action is required.

1. To specify a mixed medication, touch the Admixture button on the Select Medication pop-up.

OR

1. Touch the dose flag (Anesthesia View, Figure 11).

OR

1. Touch the Dose row (Nursing view, Figure 14). The Modify Selected Medication pop up displays two medication name slots, with the first one already identified.

2. Touch the bottom field. The Select Medication pop-up opens.

3. Select the desired drug from the list.

Touching the Other button allows you to identify the correct medication from the Frequent Use or perioperative drug library list.

4. Enter the volume injected for either drug. The tablet calculates the volume for the other medication using the total volume injected.

5. Touch the Save button.

Transferring a Patient to Another Care Area

It is important to prepare the patient and tablet prior to moving the patient from one care area to another.

1. Touch the Pause Case button from the Menu to disconnect the injection site(s) from the current tablet.

This enables another tablet in a subsequent care area to connect to the injection site(s).

2. If the Pause Case button has not been touched and the patient is moved to a subsequent care location that is within
about 30 feet of the earlier tablet, the injection site(s) will remain wirelessly connected to the earlier tablet.

3. In this situation, you can disconnect the BD Intelliport™ Injection Site by touching the Show All button from the Patient Setup screen and following the screen instructions.

Power Down the Injection Site at the End of a Case

It is good practice to power down the injection site when the surgical case has ended. Once powered down you will be unable to record injections using that injection site.

Do not power down the Injections Site unless the injection site is no longer in use. Doing so will prevent additional medication administrations from being recorded for this case.

1. From the tablet menu, Press Power Down Ports.

2. A message will prompt you to confirm.

3. Press yes. NOTE: If you do not power down an Injection site - but instead deactivate it by disengaging the Sensor from the base, the gateway will administratively close the case if a specified time has elapsed without activity. The tablet checks for updates to patient allergy information at the start of a case and upon each care transition.

Deactivating a Device, Disposing of the Sensor, and Preparing the Base for Reuse

When the injection site is no longer in use:

1. Disconnect the Sensor from the base by squeezing together the two finger tabs on top of the Sensor while lifting up to disengage from the base.

When properly separated, the base will power off and stop transmitting wirelessly to the tablet.

To remove Sensor from Base, Squeeze together white Sensor tabs

Squeeze tabs and lift

Lift Sensor from Base. Dispose of Sensor. Clean and recharge Base.

Lift up

Figure 60 - BD Intelliport™Sensor Removal

2. Dispose of the Sensor according to your hospital’s medical waste protocols.

Avoid inadvertently discarding the base after use. It is intended for reuse with multiple patients.

3. Clean and disinfect the base. The first wipe with a commercial hospital disinfectant will clean and the second wipe will disinfect. Follow the disinfectant manufacturer’s instructions.

For a list of approved hospital products to use, refer to Appendix C on page 90.

4. Allow it to dry.

5. Inspect the base for cracks or damage.

6. If damage is evident, then dispose of it according to your hospital’s protocols.

7. Insert the base into the charger.

8. If the base has reached its End of Life as indicated by a message on the tablet screen or by a persistent red light when seated on the charger, then dispose of it according to your hospital’s protocols for electrical waste.

The base contains a lithium ion battery.

The base will illuminate a red light while charging if it has exceeded its Useful Life.

Special Activities

Giving InjectionsWithout a Tablet Present

We recommend administering medications while the injection site is wirelessly connected to the tablet. The tablet provides medication announcement/identification, dose measurement, alerting and documentation. The injection site also supports medication administrations when a tablet is not present. In this situation, the injection site operates like a standard y-site. It
also retains the dose information until it later connects to a tablet.

1. Deliver medication according to the instructions described in the Section Giving an IV injection using the BD Intelliport™ Injection Site.

Avoid disconnecting the Sensor from the base and replacing it with a different Sensor before wirelessly connecting to a tablet. This will erase the medication administration data from the base.

Avoid completely depleting the battery charge on the base before wirelessly connecting to a tablet. This will erase the medication administration data from the base.

2. When the patient moves to another care area having a tablet present, follow the instructions to in Section Set up the Tablet.

Once connection to a tablet, prior medication administration history displays along with allergy alerts, if any.

3. Respond to messages, as appropriate.

Using the System With an Emergency Patient

You may often have to start medications before patient information has been entered into the system.

Some hospitals assign placeholder patient IDs for unknown emergency patients receiving treatment. In those situations, select the patient record that corresponds to the patient’s wristband.

In other situations, the Emergency button on the select patient screen may be used to identify a patient who is not known or when you do not have time to select the patient due to an emergency.

If the patient is unknown (picking up from step 7 on page 63):

1. On the Patient Setup screen, touch the Emergency button.

Figure 61 - Patient Setup Screen

Figure 62 - Unknown Patient Confirmation

Since no patient was identified, “Unknown, Patient” will display as the patient’s name during the confirmation step. Press the Confirm button to proceed.

2. The allergy screen will then display to let you know that the system is unable to obtain patient-specific allergies.

Figure 63 - Allergies Pop-up for an Unknown Patient

3. Touch the Ok button to proceed.

The Main Anesthesia Screen will display and you are ready for injections. Note the “Allergy Checking is Not Available” message is displayed on the right of the screen and patient name is listed as “Unknown”.

Identifying an Unknown Patient

Once a patient has been identified you can associate the patient’s name with an injection site.

1. From the Main Menu choose Review Case.

Figure 64 - The Review Case Option on the Main Menu

The Review Case screen opens.

Figure 65 - The Review Case Screen

2. Touch the Select Patient row.

The Patient Setup screen will display next for you to select the patient. Please note that the system updates periodically to include new additions to the ADT list.

Figure 66 - Select Patient for Sensor

3. Touch the name of the patient.

4. Touch the Confirm button to associate the patient with the injection site. The patient name will now appear instead of “Unknown Patient”.

Figure 67 - Confirm Connected Sensor and Patient

Adding Additional Sensors

The BD Intelliport™ system can accommodate up to three BD Intelliport™ Injection Sites connected to one patient at a time. An additional BD Intelliport™ Injection Site can be added at any time during a case. The first connected BD Intelliport™ Injection Site displays as the leftmost injection bar. The second in the middle and the third the rightmost injection bar. See Figure 11.

When an injection site is connected to a tablet and there is no syringe attached to the Sensor, the active injection bar reads “Sensor Connected, No syringe attached”.

A battery status icon in the upper right corner of the injection bar indicates the battery charge level of the base to which the Sensor is connected. The battery status icon in the upper right corner of the screen indicates the battery charge level of the tablet. See Figure 11.

To add an injection site:

1. Prepare an injection site according to the instructions in Preparing the Sensor on page 35.

2. Touch “Tap to Add Sensor” on a remaining Active Injection Bar space to display a pop-up window that lists available
BD Intelliport™ Injection Sites within wireless range.

3. Identify the 4-digit number on the BD Intelliport™ Sensor.

4. Highlight (select) your BD Intelliport™ Injection Site based on the time of initial activation and the four-digit number on
the BD Intelliport™ Sensor.

Figure 68 - Connecting Additional Sensors

A low battery icon displays when the selected base has less than 10% of battery power remaining. The selected base
flashes for three seconds.

5. Verify that the green and yellow lights are flashing for the correct base.

Should you miss the visual confirmation, highlight the appropriate BD Intelliport™ Injection Site again to initiate
the blinking lights.

6. If the identified Sensor is correct, touch Connect.

7. Touch Confirm.

8. Verify the base is flashing a single, repeating green blinking light indicating it is wirelessly connected to the tablet.

An Active Injection Bar displays the connected Sensor.

Adding a Comment

A comment is a free text entry that is relevant to the anesthesia record. The tablet supports three methods to add to a comment:

Figure 69 - Add Comment for Medication

Adding Manual Injection

The tablet provides the means to document IV injections given prior to activating an Injection Site, given through an IV port other than the injection site or when using a syringe without a BD Luer-Lok™.

1. Touch the Add button

2. Touch the Add Injection button.

The Frequent Use Medication list opens in the Anesthesia View and in the Nursing View.

3. Highlight the desired medication and concentration. Indicate the volume or dose on the Modify Selected medication popup.

4. Change the time delivered by touching the appropriate arrows to the correct time of administration.

5. Touch the Save button after verifying the entry and the medication will list in the medication history area at the indicated time.

A medication administration time cannot be in the future nor more than one hour before the first BD Intelliport™ Injection Site has been activated.

Responding to Messages

The BD Intelliport™ system provides two types of messages: “Clinical” and “System.” “Clinical” messages are alerts and reminders that relate directly to an aspect of patient care delivery (e.g. contraindication or a reminder that it may be time to re-dose antibiotics). System messages provide status on relevant system operating parameters.

Messages provide instructions and a button for acknowledging or resolving. Refer to Table 5 below for a description of clinical messages and Troubleshooting on page 85 for resolving system messages. Messages display in the Message chapter of the tablet until they are acknowledged or are no longer clinically relevant.

Figure 70 - Messages

Messages can be answered any time during a case. Prior to pausing or closing a case, you are prompted to respond/answer unresolved medication messages generated during the case.

Allergy Alert

An allergy alert illuminates the injection site and displays on the tablet when you attach an encoded syringe or selects a medication for a non-encoded syringe to which the patient has a known allergy. Touch the OK button to acknowledge.

  • Use clinical judgment before proceeding when the tablet announces and displays a known allergy
    for the drug attached to the injection site.

Consider redosing an antibiotic

The tablet tracks elapsed time since an antibiotic was last administered and displays and announces an antibiotic redosing message if the configured redosing interval has elapsed. The redosing interval is individual to each antibiotic, and it is configured in the drug library. Touch the OK button to acknowledge. The BD Intelliport™ injection site does not prevent or block the injection of a medication

  • Antibiotic redosing reminders are based on preconfigured, medication-specific time intervals which do not take into consideration renal or hepatic dysfunction, excessive blood loss, obesity, or other clinical factors which may affect serum drug levels.

The reminder repeats every 30 min if not acknowledged by the user.

Medication Questions

The tablet posts a message when a medication is configured as reconstituted, diluted or mixed (admixture) Touching the message text opens a screen to edit the concentration or dose.

Confirm volume
and dose

If a small volume (<0.4 mL) is administered or the volume given is not measured accurately, a message will display “Confirm volume and dose.” prompting you to confirm the amount measured.

Touching the message text opens a screen to edit the volume or dose.

Volume not measured

The tablet did not receive a volume measurement from the injection site following syringe removal. Reasons may include incorrect syringe attachment. The tablet temporarily records a placeholder dose and prompts you to specify a volume. Touching the message text opens a screen to edit the volume or dose.

Air detected, confirm dose

The dose may have been administered with air which made it difficult for the BD Intelliport™ Base to identify the full dose. Verify dose amount and adjust if needed.

Slow push, confirm dose

If the medication is administered slowly, the green lights on the base will not illuminate and a message may display “Slow push, confirm dose.” prompting you to confirm the amount measured. Refer to Chapter 4 for more information.

The dose may have been administered too slow for the BD Intelliport™ Base to identify the full dose. Verify dose amount and adjust if needed.

Table 5- Messages

Clinical messages originating in a prior care area will display in subsequent care areas, if not already acknowledged by the user.

Reviewing the Medication Record

The BD Intelliport™ system enables you to review the medication record for accuracy and completeness prior to printing a report.

You are able to correct and amend (add information to) the patient’s medication record so long as an BD Intelliport™ Injection Site for that patient is connected or if the case is within 24 hours from powering down ports but has not yet
been “finalized”.

1. From the Main menu, touch the Review Case button.

Figure 71 - Review Case

The Review Case window opens. It lists unresolved medication administrations with the time administered, medication and concentration, volume, dose and reason for review (e.g., unencoded syringe, medication identified as frequently diluted). Touching the Show All button displays all medications given to provide a context for a certain medication administration listed, if needed.

2. Read the reason for review for each med administration and indicate an answer to each question. For example, a question may prompt you to confirm whether epinephrine has been diluted.

3. Select OK if no changes are required for that medication administration.

OR

3. Touch the Edit button to modify an attribute of the medication administration (e.g. concentration, volume, or dose).

4. If the anesthetist clock is not synchronized with the tablet’s clock, touch the Change Case Time button to adjust the tablet’s time for the printed reports to synchronize them with the flowsheet. A pop up displays showing a clock with up and down arrows for hours and minute adjustment.

5. Adjust the clock as required.

6. Touch the Save button.

If there are unresolved messages, you can come back and answer the questions at any time prior to touching the Power down Port(s) button (which closes the medication administration record) on the Main menu.

If not all questions are answered prior to touching the Power down Port button you can reopen the case within 24 hours
after the Power down Port(s)” button was touched. Follow hospital procedures for editing records.

You can touch the Past Cases button on the Patient Setup screen to select the patient name to review the record. Upon completion of resolving any medication queries, touch the Exit Case button from the menu. If the 24 hour window was exceeded, follow hospital procedures for editing and finalizing the records.

Printing a Report

The following clinician reports are available for printing only if the medication record has been finalized:

1. To print a report, touch Print Report from the Main Menu.

Figure 72 - Print Reports

2. Select the appropriate report to print.

3. Specify the printer, if different from the default, and the number of copies.

4. Touch Print.A message displays indicating “Printing to XXX Printer”.

5. Touch the “Power Down Ports” button from the Main Menu to exit the case.

Viewing Controlled Drugs

The Controlled Drugs screen lists all controlled drugs administered from the beginning of the case. It’s accessed by
selecting the Controlled Drugs option on the Main Menu.

Figure 73 - Controlled Drugs Screen

The screen shows this information on each injected controlled drug

When configured with an AIMS, a print button is available.

Utilities

Shutting Down the Tablet

The tablet may remain powered down between uses. However, there may be situations in which you are instructed to power down the tablet . This includes the procedure to update the Device Drug Library.

1. Confirm the tablet does not have BD Intelliport™ Injection Sites connected and it is no longer in use.

Touch the Shut Down Tablet button located on the Patient Setup menu or the Shutdown Tablet button on the Log in screen.

Setting User Preferences

The BD Intelliport™ system supports user preferences to determine the sound volume, screen brightness and audible announcements, reminders and messages. The hospital has configured default preferences that may be modified temporarily during a case. To verify the tablet preferences prior to starting a case, perform the following:

1. From the Menu select Preferences.

2. Adjust preferences for the work environment.

3. Touch the Save button when completed.

Check whether alerts have been muted when relieving another clinician during a case.

Preference changes are retained during the case. When the case has closed or when a new clinician logs in, the settings revert to the default configuration.

Figure 74 - Preferences

Selecting the Mute option from the Menu overrides all of the above selections and mutes all drug announcements, clinical reminders and system messages. To hear the medication announcements, select Unmute.

Chapter 10. Troubleshooting

You can refer to this guide in the event you experience difficulty operating the BD Intelliport™ system. It provides troubleshooting tips for operational problems. If the BD Intelliport™ system is not working or not recording injections, use manual documentation process to capture delivered injections. If the response to a specific question is not found, contact your Service Representative:

Phone: 866-488-1408 select option 4

When talking with your Service Representative, you may be asked to provide the system’s version. Locate information about your system version by pressing About from the tablet Help menu. Alternatively, system information is displayed upon login to the gateway.

Why does the BD Intelliport™ Base show a red light while on a charger?

The BD Intelliport™ Base has reached its End of Life. It is no longer suitable for use. Dispose of it according to your hospital’s policy for electronics.

The sensor and base are connected, but the Base does not display a blinking green light.

The connection of BD Intelliport™ Sensor to the BD Intelliport™ Base is verified by a blinking green light on the BD Intelliport™ Base. If this is not seen, determine if the two are properly connected. Separate the two pieces and re-attach. If a blinking green light is not observed, replace the BD Intelliport™ Sensor and the BD Intelliport™ Base as needed.

BD Intelliport™ Injection Site has stopped displaying an intermittent green light.

A BD Intelliport™ Sensor or Base can be replaced at any time during a case. Prepare a second BD Intelliport™ Injection Site and connect it to the Tablet before disconnecting the first.

What do I do if the Battery in the Base runs out of charge during a case?

When connected to a Tablet, a low battery message displays when less than 10% charge remains. Replace the BD Intelliport™ Base with different Base. A Base can be exchanged at any time without affecting the case if it is less than 30 seconds. If it is more than 30 seconds, the case will require resynchronization of the Injection Site to Tablet.

The BD Intelliport™ Base shows a red light while in use.

The BD Intelliport™ Base has reported an error. Verify the medication record is correct if a medication was given at the time of the red light. To reset the Base to full function, first clean and disinfect it, then place it in the Charger. A BD Intelliport™ Sensor or Base can be replaced at any time during a case. Prepare a second BD Intelliport™ Injection Site and connect to the Tablet before disconnecting the first.

I powered down the Injection
Site inadvertently during a case.

Replace the BD Intelliport™ Sensor during a case. Prepare a second Injection Site and connect to the Tablet to continue. However, the historical medication information will not be available during the case.

I am unable to log in or I forgot my user name or password.

The BD Intelliport™ System uses the hospital’s active directory for login. After three unsuccessful attempts, the Tablet locks for that user. Contact the system administrator.

I cannot print my report from
the Tablet.

Tablets are assigned to a specific care area and cannot be moved. The printing of reports and routing of patient information relies on the tablet being located where it has been assigned during configuration. Contact the system administrator.

I noticed the new configuration settings were not updated.

A Tablet configuration update was not successful. Notify your system administrator.

I do not know the name of the patient or patient name is not in the ADT list.

There is an Emergency button on the Patient Set Up screen for patients whose name is not known or you determine an emergency that requires the immediate start medication treatment.

The wrong patient was inadvertently confirmed.

Select Preferences from the Main Menu button. Touch the “Remove Patient” button to disassociate the patient from the Injection Site and undo any medication administration history linked to that patient.

The wrong BD Intelliport™ Injection Site was inadvertently confirmed.

Select Preferences from the Main Menu button. Touch the “Remove Sensor” button to disassociate the Injection Site and undo any medication administration history linked to that patient.

I received the message “Unable to obtain allergies”.

The Tablet does not receive Allergy information from the network. Contact the System administrator.

“Gateway not connected” message persists in the Title Bar.

Failed communications between the Tablet and the Gateway. In the event communication between the Tablet and Gateway has been disrupted, a yellow message will display in the center of the Title Bar to inform you. Notify your system administrator. Once communications has been restored, the yellow message will hide.

NOTE: You cannot finalize the medication record when the gateway is not connected. Information regarding the patient’s allergies may be incomplete. Users cannot print clinical reports from the Tablet while communication between the Tablet and Gateway has been disrupted.

The Tablet displays a low
battery icon.

Verify the tablet is plugged in and charging on AC power.

There is no sound coming from the Tablet.

Check whether the mute icon is displayed in the title bar. If so, touch the Preferences button from the Menu, and unmute or adjust the volume.

How do I return to the main screen on the Tablet?

From the Main menu, select the “Anesthesia” or “Nursing” view.

What causes me to lose historical medication information

Medications given prior to BD Intelliport™ System synchronization are retained in memory on the BD Intelliport™ Base.

The Tablet prompts me to
confirm dose.

The BD Intelliport™ Injection Site measures injections accurately at 10ml/min or greater. Four green lights illuminate when push speeds reach this range. When a medication administration is out of the range, the Tablet prompts to confirm the volume or dose. Touch the Edit button to change the volume or dose. Touch the OK or Send button if the measurement is accurate.

BD Intelliport™ Base wireless communications lost

BD Intelliport™ Base communications to the Tablet are lost.

• Synchronization should automatically resume.
• BD Intelliport™ Base may be shielded from the Tablet
• Radio interference may be present (Electrosurgical Unit or other
device is interfering)

The Handoff Report can’t be printed because there is a communications problem

Contact the Anesthetist who administered the drugs in the OR to get an oral report.

I received the message
“Verify on record”

If more than 1hour has elapsed from the time of dose, the tablet prompts to confirm the medication administration (for Epic Anesthesia)

I received the message
“Air detected, confirm dose.”

The dose may have been administered with air which made it difficult for the BD Intelliport™ Base to identify the full dose. Verify dose amount and adjust if needed.

I received the message
“Slow push, confirm“dose. “

The dose may have been administered too slow for the BD Intelliport™ Base to identify the full dose. Verify dose amount and adjust if needed.

If a drug administered is not listed in the drug library, print the medication administration record, manually write the time, medication and dose delivered to

the patient, sign with date and time of correction and send to medical records.

Med admin does not display in the companion AIMS

Verify the tablet has the appropriate assignment. Identify the name of the companion AIMS assigned to the tablet by clicking on the About

Table 6 - Troubleshooting

Chapter 11. Appendices

Appendix A BD Intelliport™ Base and Sensor Technical Specifications

Fluid connection

2 ports, BD Luer-Lok™ type fittings

Volume measurement accuracy1

± 5% for bolus volumes > 1.0 mL to 55 mL ± 20% for bolus volumes of 0.4 to 1.0 mL Not recommended for bolus volumes <1.0 mL.

Injection Port Capacity
Dead Volume /retained fluid

100 injections
≤ 0.3 mL following injection

Exterior Size (excluding tubing)

< 4.5 cubic inches

Weight

70 gm (Base and Sensor)

Operation on a Single Charge

24 hours

Recharge speed

Up to 4 hours from < 25%

Wireless range
(BD Intelliport™ Injection Site)

10 meters maximum

Operating Temperature

12˚ C to 40˚ C

Operating Humidity

20% to 85% relative humidity

Base Shipping and Storage Temperature

-20˚ C to 60˚ C

Sensor Shipping and Storage Temperature

-20˚ C to 40˚ C excursions permitted to 60˚ C

Shipping and Storage Humidity

15% to 90% relative humidity

Operating Atmospheric Pressure

84 kPa to 101kPa (12.2 psi to 14.7psi)

Shipping and Storage Atmosphere Pressure

57 kPa to 101kPa (8.3 psi to 14.7psi)

FCC/IC Radio ID

BD Intelliport™ Base Model: B1 FCC ID: 2ABS9IPORT1 IC: 11742A-IPORT1
BD Intelliport™ Radio Model: 1 FCC ID: 2ABS9RADIO1 IC: 11742A-RADIO1
BD Intelliport™ Radio Model: 2 FCC ID: 2ABS9RADIO2 IC: 11742A-RADIO2

1NOTE: System accuracy is measured under nominal conditions

Volume range 0.4-55 mL

Table 7 - BD Intelliport™ Base and Sensor Technical Specifications

BD Intelliport™ 5-Bay Charger Specifications

Specified Cleaning Agents

PDI Super Sani-Cloth® wipes Bleach-based germicidal wipes

Operating Temperature

12˚ C – 35˚ C (54˚ F – 95˚ F)

Operating Humidity

20% – 85% RH (non-condensing)

Rated Voltage

Input: 100 – 240 VAC 50 – 60 Hz Output: 5 VDC

Rated Current

4 A

Model Number

516751

Table 8 - BD Intelliport™ 5-Bay Charger Specifications

Appendix B Tablet Technical Specifications

The tablet provides the user interface for clinicians interacting with the BD Intelliport™ Medication Management System. It consists of a standard, commercial tablet computer with embedded BD Intelliport™ system software pre-installed, a touch screen, and Radio for a wireless communications with the Injection Site. The tablet also communicates with the gateway on the hospital network. This Appendix provides information for positioning and mounting the tablet for use.

The tablet is positioned near the clinicians work envelope. Typically, it is mounted to the anesthesia machine or anesthesia
cart in the operating room, or near the patient bed or computer workstation in perioperative nursing care areas.

Figure 75 - Tablet on Mounting Arm

Frame Length

38 cm (15 in.)

Frame Width

23 cm (9 in.)

Frame Depth

3 cm (1.2 in.)

Weight

1.5 kg (3 lb.)

Power

100-230 VAC, 50-60 Hz, 0.65-1.0 A, Grounded (3-prong) 8 ft. power cord

Network

802.11 (a/g/n) Wi-Fi compatible network for communication with gateway. 100 Mb (or faster) wireless network

Mounting1

VESA2 MIS-D 100/75, C, MIS-E, MIS-F compliant

Antivirus

Windows Defender™

Wireless Communication with injection site

See Appendix G

1 Mounting not included with the BD™ Intelliport system. To be provided by customer. Available mounting equipment suppliers include:

• GCX™ (WS-0008-15, WS-0008-16, and adapters for specific anesthesia machines, if needed)

• Amico (adjustable height monitor arm)

2 Flat Display Mounting Interface (FDMI), also known as VESA Mounting Interface Standard (MIS).

Table 9 - Tablet Technical Specifications

Appendix C Cleaning and Disinfectant Agents

The following disinfectants are suitable for use with the BD Intelliport™ Base.

The following cleaning agents are suitable for use with the tablet.

Appendix D Unpacking and Setting Up the Tablet

This section describes the steps to unbox and setup a tablet delivered in its shipping box. The activities described in this Appendix should be performed only under the direction of the System Administrator. Contact your System Administrator before beginning.

Section 1. Unpackaging and Powering on the Tablet

Unboxing

1. Open shipping carton and remove the frame accessory materials. Set aside.

2. Remove the tablet from shipping carton. Place tablet on a flat surface.

3. Locate the Radio, and set it aside for later use.

Power on the Tablet

1. Remove the two sections power cable from the shipping carton. Attach the two sections together, and connect to the
AC power adapter port on the side of the tablet.

Figure 76 – Location of AC Power Adapter

2. Connect the other end of the power cable to a functioning mains outlet.

3. Power on the tablet by pressing the power button in the top left corner of the front panel.

Section 2. Updating Configuration Settings at the Tablet

There are two activities when connecting the tablet to the gateway on the hospital network. The first activity involves connecting the tablet to the network either wirelessly. The second activity involves specifying the IP address for the Production gateway.

Get to the Tablet Desktop

1. Power on the new tablet.

2. Connect a USB keyboard with touchpad to the USB port on the tablet.

3. Navigate to the desktop.

Time and Time Zone

Use the following steps to verify the time and time zone:

4. Touch the Change Date and Time Settings from menu bar at the bottom of the desktop.

5. Update the Date/Time and Time zone, to match the hospital network time.

6. Verify the Daylight Saving Time setting.

7. Touch Apply.

8. Return to the Desktop.

Wireless

Use the following steps to get the tablet on the hospital network via a wireless access point:

NOTE: Wireless setup should be performed by an individual with a system administrator role. Contact your System Administrator before continuing.

1. Touch the Start button from menu bar at the bottom of the desktop.

2. Touch the PC Settings icon. Touch the Control Panel option.

3. Touch the Network and Internet icon.

4. Touch the Network and Sharing Center option.

5. Set up and configure access to the hospital wireless network. Touch the “Setup a new connection or network” link. Then, touch the “Manually connect to a wireless network” option. Enter the following information:

a. Network name

b. Security type

c. Encryption type

d. Security Key (SSID)

Your network administrator will be able to provide you with this information.

6. Verify the tablet has wireless communications. You can do this by touching and holding (the Touchscreen equivalent to right-clicking) on the network icon in the Notification Area (system tray) on the extreme right of the taskbar and touching the Network and Sharing Center option.

7. Return to the Desktop.

Gateway Address

NOTE: Configuration changes to the gateway IP address should be performed only under the direction of the System Administrator. Contact your System Administrator before making configuration changes.

A configuration setting on the tablet allows a System Administrator or similar role responsible for the tablet inventory to specify the IP address of the gateway with which the tablet communicates. This is performed when setting up the tablet. The tablet cannot communicate with the gateway unless this setting has been configured correctly. Follow these steps to assign the configuration setting.

1. From the desktop, use the Windows Explorer to navigate to the AnesthesiaDemo.exe.config file.
C:\DPMB\ AnesthesiaDemo.exe.config

2. Right click on the file, and open the file in Notepad or Wordpad.

3. Find the setting name “GWDB-DEVVM”. To locate the setting, use Ctrl+F to open a search box and type in the setting name. It will display as below

<add name=”GWDB-DEVVM” connectionString=”Data Source=10.160.210.240;” />

Change the numerical IP value to the IP address for the Production gateway.

4. Save the file and close.

5. Return to the Desktop.

6. Remove the USB keyboard with touchpad from the USB port on the back panel of the tablet.

7. Power off the tablet.

Install Radio and Launch the Application

Use the following steps to launch the tablet software for the first time.

NOTE: Once the tablet software is launched, the tablet desktop is available only to authorized users having valid technician log in credentials. Do not launch the application without first completing all of the steps above to specify the time, time zone, wireless settings and gateway IP address.

1. Locate the Radio, and insert it in the USB Port on the side of the tablet.

2. From the tablet desktop, press Restart BD Intelliport Application.

On/Off Switch

AC power adapter

Figure 77 - Restart BD Intelliport Application Button

This launches the tablet software application.

Section 3. Registering the Tablet with the Gateway

The gateway centrally manages the tablets used for delivering perioperative care, testing, training and as replacements. The gateway maintains an inventory of the hospital’s tablets, including information on the tablet’s name, serial number, location, status and versions.

A tablet cannot be used until it is first registered on the gateway. An administrator with appropriate access privileges registers a tablet by adding it to the Device Inventory using the gateway software. Refer to the Gateway Manual for information on adding a new tablet.

Section 4. Updating the Device Drug Library and Tablet Configuration Profile

When first connecting to the gateway, the tablet loads the current version of the hospital’s Device Drug Library and the tablet Configuration Profile.

The gateway centrally manages the Device Drug Library and Tablet Configuration Profile. The gateway makes this information available to tablets on the hospital network. After properly setting the gateway IP address and registering the tablet at the gateway, the tablet will periodically communicate with the gateway to check for new versions. Updates are automatically loaded when the tablet is restarted. Upon boot up, the tablet displays a screen indicating whether the Device Drug Library and tablet Configuration Profile are up to date.

Use the following procedure to load the configuration settings from the gateway.

1. Check that the tablet has been registered at the gateway (Refer to the Gateway Manual for information).

2. Check that a Device Drug Library and tablet Configuration Profile has been published by the gateway (Refer to the Gateway Manual for information).

On power up, the tablet automatically retrieves the current version for the configuration settings and displays a message when the settings are current.

3. Confirm “Current” displays next to the Device Drug Library (Library Version) and Tablet Configuration Profile (Configuration Version) on the boot up screen.

Figure 78 - Boot Up Screen

Section 5. Positioning for Use

Typically the tablet is mounted to the anesthesia machine in operating room and adjacent to the treatment space in
the perioperative nursing care areas. Follow these instructions to position the tablet for use.

NOTE: Clean the tablet according to the instructions in Section X prior to moving it to a patient care area.

1. Provide mounting for the tablet (to be provided by customer), according to the specifications in Appendix B.

2. Assemble the frame with the tablet seated in frame the using the screws and hex key provided.

3. Secure the tablet and frame to the mount using the using the frame’s Flat Display Mounting Interface (FDMI),
also known as VESA Mounting Interface Standard (MIS).

4. Connect to the AC power adapter port on the side of the tablet.

5. Connect the other end of the power cable to a functioning mains outlet.

6. Position the tablet to be viewable when administering medications in the treatment space.

7. Power on the tablet by pressing the power button in the top left corner of the front panel.

The tablet is ready for deployment testing.

Section 6. Conducting Deployment Testing

Deployment testing is a check point to confirm that the tablet and network settings are properly configured for operation at the hospital. BD recommends that the applicable set of deployment tests be performed as a final check of the system installation in all environments, both test (not for human use – NFHU) and production environments.

Refer to the Gateway Manual for information on applicable tests to be conducted, depending on the tablet configuration at your organization. In addition, BD recommends the Device Setup Deployment Test be performed for every unit during initial system implementation and whenever a specific Labeler has been added, made inactive, or its location changed.

Appendix E Standards

The BD Intelliport™ system is intended for use under the supervision of healthcare professionals only. This is a Class II medical device. The BD Intelliport™ system conforms to the following standards.

IEC 60601-1 Medical Electrical Equipment - Part 1. General Requirements for Safety

IEC 60601-1-2 Collateral Standard: Electromagnetic compatibility - Requirements and testing

2. Attach the BD Intelliport™ Sensor to the BD Intelliport™ Base by joining the BD Intelliport™ Sensor (tubing side) and BD Intelliport™ Base front section first, and then snap the two together.

An audible snapping sound should be heard and both white tabs on the Sensor should be fully engaged to the base. Connecting the BD Intelliport™ Sensor to the BD Intelliport™ Base automatically powers on the injection site.

NOTE: Confirm that both Sensor tabs are fully engaged to base.

The connection of BD Intelliport™ Sensor to the BD Intelliport™ Base is verified by a blinking green light on the BD Intelliport™ Base. If you don’t see this, view the injection site on its side to determine if the two are properly connected. If you see a space between the BD Intelliport™ Sensor and the BD Intelliport™ Base, then they are not attached properly. Separate the two pieces and re-attach. Confirm that both Sensor tabs are fully engaged to base. If you don’t see a blinking green light, replace the BD Intelliport™ Sensor and the BD Intelliport™ Base as needed.

NOTE: the Injection Site should not be attached to the patient IV line at this point.

3. Attach the 10mL flush syringe (purged of air bubbles) to the Intelliport Site and push 4mL sterile IV fluid with full force. Wait 5 seconds, then push an additional 5ml of fluid with full force (avoid pushing the plunger to the bottom of the flush syringe).

4. As you push, watch for sequential green flow indicator lights (runway lights) on the base.

5. If the sequential green flow indicator lights do not illuminate, wait 5 seconds and repeat Steps 3 and 4 with additional flush syringes, until the runway lights illuminate.

If the sequential green flow indicator lights illuminate, then the Injection Site is ready for use.

Setting up the BD Intelliport™ Tablet

Before each use, the tablet must be set up to wirelessly communicate with the injection site and to be associated with a patient record. Any Medications given prior to association to a tablet will be retained in the BD Intelliport™ Base memory. Three BD Intelliport™ Injection Sites can be synchronized to one patient.

1. Power on the tablet by pressing and holding the button located on the tablet.

2. Enter your Username and Password, if the tablet is configured to require them.

3. Identify the last 4-digit numbers on the BD Intelliport™ Sensor.

4. From the BD Intelliport™ system Setup screen, select (highlight) the injection site corresponding to the four-digit numbers on the BD Intelliport™ Sensor.

5. Verify that the sensor is ready.

6. Verify the correct BD Intelliport™ Injection Site has been selected by checking that the green and yellow lights are blinking.

7. If the identified BD Intelliport™ Injection Site is correct, touch the Connect button.

8. Verify the injection site flashes a single, repeating green light when it is wirelessly connected to the tablet.

9. From the Patient Setup screen, select the patient from the list. Identify the patient’s full name, patient ID, medical record number and birth date.

OR

9. Touch the Emergency button to begin a case where patient demographics are not available.

NOTE: After starting a case using the Emergency button, the patient can be identified at any time prior to closing the case.

10. Confirm the correct BD Intelliport™ Injection Site and patient to complete the setup. Once confirmed, the BD Intelliport™ system has established a permanent association between the patient and BD Intelliport™ Sensor.

11. If the patient is not correct, use the Remove Patient or Remove Sensor button from the Preferences screen (accessible from the Main Menu) to disconnect the patient and select the correct patient.

12. Review the patient allergies, if any, displayed on the tablet.

13. Removing Injection Site Preparation Flushes from the Record

Because the flushes used to prepare the sensor are not administered to the patient, it is important to distinguish those at the Tablet. Each flush syringe attached to the Injection Site during preparation will display in the medication history section as a “Select Med” (if not encoded) or “Normal Saline Flush” (if encoded).

Note: Normal saline flush may not display on the medication history, if so configured.

Locate each flush and modify the volume to 0mL to remove it from the medication history.

• For syringes not having encoding refer to the Medication Delivery with Syringes Not Having Encoding section
for instruction to modify.

• For encoded flush syringes touch the Edit button. The Modify Selected Medication box will appear. Change the
volume to 0mL and tap “Save”.

Giving IV Injections and Viewing Medication Administrations

1. Clean the BD Intelliport™ Sensor injection port prior to all medication injections by swabbing the hub according to your hospital procedure.

2. Attach a syringe to the BD Intelliport™ Injection Site, starting with the barrel label visible on top. Then completely turning the syringe until it stops (graduations will be visible on top).

3. Verify the drug and concentration displayed and announced by the tablet is the intended drug and concentration.

When using a syringe without encoding, touching the Select Med button will announce and display a list of medications to identify. (Touch the More button if you do not see the medication name).

a. Identify the medication before or after dose delivery.

b. Confirm the medication and touch the Save button.

Frequently diluted or reconstituted drugs display no dose value until you identify the given dose on the Modify Selected Medication screen. The identified dose will appear on the flag.

An admixture (mixing two medications in one syringe) can be identified by touching the Admixture button from the Select Med screen.

The volume and dose will display on the tablet when the syringe is removed from the port or when flow is no longer detected while the syringe remains attached to the injection site.

4. Flush all medication injections with a Normal Saline flush to assure the patient receives the dose indicated.

NOTE: Disconnect syringe from BD Intelliport™ Injection Site when not in use.

5. When the case is complete, remove the sensor from the base. Dispose of the sensor, and clean and recharge the base.

Appendix F Glossary

The following terms are used in these Instructions for Use.

Charger

A device that recharges the battery in the reusable BD Intelliport™ Base, as needed.

Configuration

The way the BD Intelliport™ System is set up, or the assortment of components that make up the BD Intelliport™ System. The Gateway manages the configuration settings. All Tablets for a care area have the same settings, except for wireless and printers.

EMR Integrated Mode

System configuration that supports integration with electronic medical records or perioperative information management systems (PIMS). (Requires a software interface. See page 29.)

Encoded Syringes

Syringes having a special barcode identifier on the BD Luer-Lok™ collar.

Encoding

A special barcode identifier on the BD Luer-Lok™ collar of syringes.

Gateway

A software application that enables the BD Intelliport™ System to function as an enterprise device and information system. The Gateway provides a central hub to which all Tablets connect via the hospital network. It also includes an interface engine for the BD Intelliport™ System to exchange data with other networked hospital information systems, along with a suite of utilities for general Gateway implementation, operation, and maintenance.

Injection Port

The split septum port on the BD Intelliport™ Sensor where the syringe attaches

BD Intelliport™ Base

The BD Intelliport™ Base is a non-sterile, reusable device that houses the electronics and wireless transmitter. It is battery powered, and rechargeable. A separate Charger recharges the battery in the reusable BD Intelliport™ Base as needed.

BD Intelliport™
Injection Site

An intelligent injection port. It attaches to an injection site (“Y Site” or stopcock) for manually administered IV injections. It comprises a BD Intelliport™ Sensor and a BD Intelliport™ Base, which snap together prior to use.

BD Intelliport™ Sensor

A BD Intelliport™ Sensor is a sterile disposable device having an injection port and a BD Luer-Lok™ connection. The BD Intelliport™ Sensor is supplied in a sterile package for single patient use.

BD Luer-Lok™

A Becton Dickenson trademark for its patented fitting used for making leak-free connections. A BD Luer-Lok™ fitting securely locks together using threads.

Non-encoded Syringes

Syringes that do not have special encoding on the BD Luer-Lok™ collar. The BD Intelliport™ Injection Site cannot identify the drug contents of this type of syringe.

Perioperative
Drug Library

The BD Intelliport™ System operates using the hospital’s perioperative drug library. The Gateway manages the drug library. When a non-encoded syringe is attached, the pick list is derived from the perioperative drug library.

Paper Record Mode

System configuration that supports a paper anesthesia record

BD Intelliport™ Tablet

A commercial tablet computer with embedded software for the BD Intelliport™ System operation. It continuously captures and displays the medication administration record (MAR) data from the BD Intelliport™ Injection Site each time an injection occurs. It also enables clinicians to manually document other pertinent clinical information, and it provides clinical decision support to help improve safety and aid clinicians during treatment. Information technology wirelessly transfers the data to the Gateway.

Appendix G Quick Reference Operation Guide for Paper Charting Preparing the BD Intelliport™ Injection Site

Preparing the BD Intelliport™ Injection Site

The BD Intelliport™ Injection Site must be assembled, prepared and attached to an IV line before use. Follow the instructions located on the BD Intelliport™ Sensor pouch.

1. Gather a BD Intelliport™ Sensor in its sterile packaging and a fully-charged and disinfected BD Intelliport™ Base and three (3) 10mL flush syringes. Before attaching to the Y-site of the primary IV fluid line follow instructions on the BD Intelliport™ Sensor pouch.

A fully-charged BD Intelliport™ Base has sufficient power for 24 hours of use under typical conditions. Inspect the BD Intelliport™ Base charge level. Replace a BD Intelliport™ Base with less than 25% charge. This can be done at any time
so long as an injection is not being given.

Figure 79 - Connect BD Intelliport™ Sensor to BD Intelliport™ Base

Hook tab into Hole

Press Firmly Here

Tabs

Green light will flash green when the BD IntelliportSensor is properly attahced to the BD IntelliportBase

“Runway lights” — sequential green lights will illuminate during flush, when the sensor is deemed ready

Figure 80 - BD Intelliport™ Base lights

Figure 81 - BD Intelliport™Sensor Removal

To remove Sensor from Base, Squeeze together white Sensor tabs

Squeeze tabs and lift

Lift Sensor from Base. Dispose of Sensor. Clean and recharge Base.

Lift up

Appendix H Quick Reference Operation Guide for AIMS Integration

Preparing the BD Intelliport™ Injection Site

The BD Intelliport™ Injection Site must be assembled, prepared and attached to an IV line before use. Follow the instructions located on the BD Intelliport™ Sensor pouch.

1. Gather a BD Intelliport™ Sensor in its sterile packaging and a fully-charged and disinfected BD Intelliport™ Base and three (3) 10mL flush syringes. Before attaching to the Y-site of the primary IV fluid line follow instructions on the BD Intelliport™ Sensor pouch.

A fully-charged BD Intelliport™ Base has sufficient power for 24 hours of use under typical conditions. Inspect the BD Intelliport™ Base charge level. Replace a BD Intelliport™ Base with less than 25% charge. This can be done at any time so long as an injection is not being given.

2. Attach the BD Intelliport™ Sensor to the BD Intelliport™ Base by joining the BD Intelliport™ Sensor (tubing side) and BD Intelliport™ Base front section first, and then snap the two together.

An audible snapping sound should be heard and both white tabs on the Sensor should be fully engaged to the base. Connecting the BD Intelliport™ Sensor to the BD Intelliport™ Base automatically powers on the injection site.

NOTE: Confirm that both Sensor tabs are fully engaged to base.

Figure 82 - Connect BD Intelliport™ Sensor to BD Intelliport™ Base

The connection of BD Intelliport™ Sensor to the BD Intelliport™ Base is verified by a blinking green light on the BD Intelliport™ Base. If you don’t see this, view the injection site on its side to determine if the two are properly connected. If you see a space between the BD Intelliport™ Sensor and the BD Intelliport™ Base, then they are not attached properly. Separate the two pieces and re-attach. Confirm that both Sensor tabs are fully engaged to base. If you don’t see a blinking green light, replace the BD Intelliport™ Sensor and the BD Intelliport™ Base as needed.

NOTE: the Injection Site should not be attached to the patient IV line at this point.

3. Attach the 10mL flush syringe (purged of air bubbles) to the Intelliport Site and push 4mL sterile IV fluid with full force. Wait 5 seconds, then push an additional 5ml of fluid with full force (avoid pushing the plunger to the bottom of the flush syringe).

4. As you push, watch for sequential green flow indicator lights (runway lights) on the base.

5. If the sequential green flow indicator lights do not illuminate, wait 5 seconds and repeat Steps 3 and 4 with additional flush syringes, until the runway lights illuminate.

If the sequential green flow indicator lights illuminate, then the Injection Site is ready for use.

Setting up the BD Intelliport™ Tablet

Before each use, the tablet must be set up to wirelessly communicate with the injection site and to be associated with a patient record. Any Medications given prior to association to a tablet will be retained in the BD Intelliport™ Base memory. Three BD Intelliport™ Injection Sites can be synchronized to one patient.

1. Power on the tablet by pressing and holding the button located on the tablet.

2. Enter your Username and Password, if the tablet is configured to require them.

3. When a case has been started at the AIMS, the corresponding patient information displays on the tablet. Verify the patient information on their wrist band matches the information on the tablet screen.

4. From the BD Intelliport™ system Setup screen, select (highlight) the injection site corresponding to the four-digit numbers on the BD Intelliport™ Sensor.

5. Verify that the sensor is ready.

6. Verify the correct BD Intelliport™ Injection Site has been selected by checking that the green and yellow lights are blinking.

7. If the identified BD Intelliport™ Injection Site is correct, touch the Connect button.

8. Verify the injection site flashes a single, repeating green light when it is wirelessly connected to the tablet.

9. Review the patient allergies, if any, displayed on the tablet.

Giving IV Injections and Viewing Medication Administrations

1. Clean the BD Intelliport™ Sensor injection port prior to all medication injections by swabbing the hub according to your hospital procedure.

2. Attach a syringe to the BD Intelliport™ Injection Site, starting with the barrel label visible on top. Then completely turning the syringe until it stops (graduations will be visible on top).

3. Verify the drug and concentration displayed and announced by the tablet is the intended drug and concentration.

When using a syringe without encoding, touching the Select Med button will announce and display a list of medications to identify. (Touch the More button if you do not see the medication name).

a. Identify the medication before or after dose delivery.

b. Confirm the medication and touch the Save button. The tablet displays “Sent” when it receives acknowledgement from the AIMS.

c. Verify the medication administration has been recorded on the AIMS.

4. Flush all medication injections with a Normal Saline flush to assure the patient receives the dose indicated.

NOTE: Disconnect syringe from BD Intelliport™ Injection Site when not in use.

5. When the case is complete, remove the sensor from the base. Dispose of the sensor, and clean and recharge the base.

Hook tab into Hole

Press Firmly Here

Tabs

Figure 83 - BD Intelliport™ Base lights

Green light will flash green when the BD IntelliportSensor is properly attahced to the BD IntelliportBase

“Runway lights” — sequential green lights will illuminate during flush, when the sensor is deemed ready

Figure 84 - BD Intelliport™Sensor removal

To remove Sensor from Base, Squeeze together white Sensor tabs

Squeeze tabs and lift

Lift Sensor from Base. Dispose of Sensor. Clean and recharge Base.

Lift up

Appendix I Accessories

Appendix J Radio Frequency Wireless Technology

There are two wireless technologies used in the BD Intelliport™ system as depicted in Figure 47 below.

Figure 85 - BD Intelliport™ System Two Wireless Technologies

The radio frequency (RF) signal power has been limited to a very low level to negate any potential electromagnetic interference (EMI) with other medical devices. Both wireless technologies utilized have been approved for use by the Federal Communications Commission (FCC) and meet Federal electromagnetic compatibility (EMC) and electromagnetic interference guidelines. In the event of a potential signal loss of these RF communications a “lost communications” message is displayed on the tablet to inform the operator. The tablet indicates when communications are resumed. Information on proper set-up, configuration and performance with the Hospital Network is provided at the time of system installation. No set-up is required for BD Intelliport™ Injection Site-to-tablet communications. Confirmation of appropriate patient identification is required.

BD Intelliport™ Base to Tablet

The tablet uses a BD Intelliport™ Radio to wirelessly communicate with the BD Intelliport™ Injection Site using an RF signal
at 2.4 GHz to form a local medical device network. A number of BD Intelliport™ Injection Sites and tablets may be used in the same vicinity such as a Pre-operative care area or a post anesthesia care unit (PACU). A license has been issued by the FCC to operate this medical device in hospitals and clinics. Testing has been performed to demonstrate conformance to IEC 60601-1-2 for the correct, timely and secure transmission of medical data (injected drug identification codes and volume measurements) and alert messages. Alert messages are communicated between the BD Intelliport™ Injection Site and the tablet to advise the User of various operational characteristics of the system. Some of these alerts inform the operator of potential hazardous situations to allow user action to prevent harm to the patient or loss of medical data. A lost wireless communication message
will display when communication is lost between the base and the tablet. If this happens, check the event history for accuracy.

BD Intelliport™ Injection Sites using proprietary 2.4GHz technology are associated (linked) with specific patients using the
tablet IEEE standards based on 802.11a/b/n (2.4GHz-5GHz) Wi-Fi technology. The User identifies the BD Intelliport™ Sensor
by serial number and selects a specific patient from the hospital’s patient listing. All medication administration data from the
BD Intelliport™ Injection Site is transferred to the specific patient’s medical record. In the event of a communication loss, medication administration data will be stored locally at the BD Intelliport™ Injection Site and transferred to the tablet when communications are resumed.

Tablet to Gateway through the Hospital Network

The tablet wirelessly communicates with the existing Hospital Network using a standards based IEEE 802.11a/b/g/n enterprise WLAN network. The networking topology that includes this tablet will follow the best of practice deployment guidelines that complies with the right quality of service (QoS) and security. The gateway software and accompanied database will be a part of the hospital’s enterprise information system. A number of tablets may be connected to the healthcare enterprise wireless network and to the intended gateway software and database. The gateway and accompanied database provides a list of patients for the User to select and a Formulary library of medications and fluids for injection. Actual medication and fluid administration data are sent to the gateway and accompanied database for recordkeeping. Once recorded on the gateway and accompanied database these data are automatically available in other care areas when the patient is transferred and the BD Intelliport™ Injection Site is wirelessly connected to a tablet. In the event of a communication loss, medication administration data will not be sent to the gateway and therefore not available in the next care area. A message will be displayed to inform you that the gateway is down. In this situation, manual transfer of clinical information is recommended.

Table 11 - Reference Documents

Summary of IEC 60601-1-2 Testing and Specifications

Technology Type

2.4 GHz proprietary messaging

802.11 a b, g, n secure wireless connection with the correct quality
of service (QoS)

Effective Power

Charger: +5 V dc, 1 A BD Intelliport™ Base Battery: Li Ion cell – 720mAH, 3.7V dc

N/A

Effective transmission distance

10 meters or less

10 meters to hospital wireless access point (WLAN AP)

Data throughput and latency

Real-time information, no delays

Subject to hospital network performance

Table 10 - Summary of IEC 60601-1-2 Testing and Specifications

Appendix K Reference Documents

Available documentation and training for the BD Intelliport™ system includes:

Order Number

Document Name

10000143030

Essential Prescribing Information and User Manual (This document)

10000143031

BD Intelliport™ Gateway User Manual

10000121446

BD Intelliport™ 5-Bay Charger Instructions for Use

Appendix L Description of Symbols

The following symbols are used by the BD Intelliport™ system.

Symbol

Description

WARNING: Indicates a potential for personal injury or death

PRECAUTION: Indicates either potential damage to the hardware or loss of data and instructs how to avoid the problem.

IPX2

Ingress Protection from falling water drops

Refer to user operating instructions

Do not use if package is damaged or protector cap is unattached.

Type BF/Defibrillation Proof applied part

Single Use Only. Do not reuse!

Manufacturer

Identifies the component manufacturer

Keep dry

Upper temperature limit

Expiration Date

Lot number

Supplied Sterile, Ethylene Oxide gas

Radio Transmitter

Atmospheric Pressure limitation

Humidity Range

Table 12 - Description of Symbols

Appendix M ASTM Drug Category Color Schema

Color differentiated by admixture drug class.

Drug Class

Color

Induction Agents

Yellow

Benzodiazepines

Orange

Benzodiazepines Receptor Antagonists

Orange and White Diagonal Stripes

Muscle Relaxants (Depolarizer)

Red

Muscle Relaxants (Non-Depolarizer)

Red

Relaxant Antagonists (Non-Depolarizer)

Red and White Diagonal Stripes

Narcotics

Blue

Narcotics Antagonists

Blue and White Diagonal Stripes

Major Tranquilizers

Salmon

Vasopressors

Violet

Hypotensive Agents

Violet and White Diagonal Stripes

Local Anesthetics

Gray

Anticholinergic Agents

Green

Beta Blockers

Copper

Table 13 - Drug Category Color Schema

TECHNICAL SUPPORT:

Dial 866-488-1408 and select option 4

This document contains confidential information. No part of this document may be transmitted, reproduced, used, or disclosed outside of the receiving organization without the written consent of Becton, Dickinson and Company.

Becton, Dickinson and Company

1 Becton Drive

Franklin Lakes, NJ 07417 USA

1000014303001 Rev. 2015-08

MANUFACTURING SITE:

Drawing Size:

N/A

PACKAGING

GRAPHICS

Tolerances:

scale:

This controlled document and subject matter is restricted solely for the use of BD.

R E V I S I O N R E C O R D

CURRENT REVISION PREPARED BY: J. Moloughney

ARTIST: P. Drew

Rev.#

Description

ECO #

Doc. Rev. Date

01

Initial Release.

500000046874

08/28/15