CRISI Medical Systems RADIO2 Manual Injection monitoring system for anesthesia User Manual

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BD Anesthesia System
Instructions for Use Manual
Injecting Confidence™
ADD LIMITED WARRANTY AND DISCLAIMER HERE
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.
“Intelliport” and “injecting confidence” are trademarks of CRISI Medical Systems, Inc.
BD, BD Logo, and Luer‐Lok are trademarks of Becton Dickinson and Company.
CaviWipes 1 and Super Sani‐Cloth, are trademarks of their respective manufacturers.
Protected by one or more of U.S. Patent Nos. 8,394,053, 8,355,753, 8,385,972, 8,328,082.
Other patents pending.
©2014 Becton Dickinson and Company
Table of Contents
SECTION I BACKGROUND ..................................................................................................................... 8
Introduction .............................................................................................................................................. 8
Product Description .................................................................................................................................. 8
How it Works........................................................................................................................................... 10
Indications for Use .................................................................................................................................. 11
Intended Use ........................................................................................................................................... 11
SECTION II SAFETY PRECAUTIONS ...................................................................................................... 12
Warnings and Precautions ...................................................................................................................... 12
General ................................................................................................................................................ 12
Tablet computerTablet computerTablet computer ............................... Error! Bookmark not defined.
Tablet computer ................................................................................................................................. 13
Intelliport device ................................................................................................................................. 14
SECTION III DESCRIPTION OF ANESTHESIA SYSTEM COMPONENTS ..................................................... 17
Supplies and Equipment ......................................................................................................................... 17
Intelliport ................................................................................................................................................ 17
Intelliport Sensor ................................................................................................................................ 17
Intelliport Base .................................................................................................................................... 18
Recharger ................................................................................................................................................ 19
Encoded Syringes .................................................................................................................................... 19
Tablet computer ..................................................................................................................................... 20
Software Running in Standalone Mode .................................................................................................. 20
Anesthesia View .................................................................................................................................. 21
Nursing View ....................................................................................................................................... 23
Button and Menu Options .................................................................................................................. 24
Software Running in EMR‐Integrated Mode........................................................................................... 27
SECTION IV OPERATIONS ................................................................................................................... 30
Quick Guide ............................................................................................................................................. 30
Prepare the Intelliport ........................................................................................................................ 30
Set up the Tablet computer ................................................................................................................ 30
Give IV injections and View Medication Administrations ................................................................... 31
Detailed Operating Instructions .............................................................................................................. 32
Prepare the Intelliport ........................................................................................................................ 32
Set up the Tablet computer –Paper Anesthesia Record ..................................................................... 32
Give an IV injection Using the Intelliport Device ................................................................................ 37
Special Activities ..................................................................................................................................... 39
Setting User Preferences .................................................................................................................... 39
Adding Additional Intelliports ............................................................................................................. 39
Medication Delivery with Syringes Not Encoded ................................................................................ 40
Specifying a Diluted or Reconstituted Medication ............................................................................. 41
Specifying a Mixed Medication (Cocktail) ........................................................................................... 42
Adding Manual Injection (for Paper Anesthesia Records) .................................................................. 43
Adding Infusions (for Paper Anesthesia Records) ............................................................................... 43
Adding a Comment (for Paper Anesthesia Records) .......................................................................... 45
Transfer Patients from One Care Area to Another ............................................................................. 45
Working with Orders ........................................................................................................................... 46
Responding to Messages .................................................................................................................... 47
Reviewing the Medication Record (for Paper Anesthesia Records) .................................................. 48
Printing a Report (for Paper Anesthesia Records) .............................................................................. 49
Address Pending Medications (EMR Integration) ............................................................................... 49
Deactivate Intelliport, Dispose of Intelliport Sensor, and Prepare Intelliport Base for Reuse ........... 50
Power Down the Tablet computer...................................................................................................... 50
SECTION V TROUBLESHOOTING ......................................................................................................... 52
SECTION VI CARE AND MAINTENANCE ............................................................................................... 53
Care ......................................................................................................................................................... 53
Clean and Disinfect the Intelliport Base for Reuse ............................................................................. 53
Recharging the Intelliport Base for Reuse .......................................................................................... 53
Determining Useful Life for a Intelliport Base .................................................................................... 53
Cleaning the Tablet computer ............................................................................................................ 54
Storage .................................................................................................................................................... 54
Tablet computer ................................................................................................................................. 54
Intelliport Base .................................................................................................................................... 54
Intelliport Sensor ................................................................................................................................ 55
Maintenance ........................................................................................................................................... 55
Administration and Service ..................................................................................................................... 55
SECTION XIII. APPENDIX .................................................................................................................... 56
Appendix A Intelliport Technical Specifications ...................................................................................... 56
Appendix B Disinfectant Agents .............................................................................................................. 57
Appendix C Standards ............................................................................................................................. 58
Appendix D Glossary ............................................................................................................................... 59
Appendix E ASA Drug Category Color Schema ........................................................................................ 61
Appendix F Messages .............................................................................................................................. 62
Appendix G Accessories .......................................................................................................................... 65
Appendix H Radio Frequency Wireless Technology................................................................................ 66
Appendix I Reference Documents .......................................................................................................... 69
Appendix J Description of Symbols ......................................................................................................... 70
Table of Figures
Figure 1 Anesthesia System Components..................................................................................................... 8
Figure 2 Intelliport Device ............................................................................................................................. 9
Figure 3 Intelliport Sensor with last 4 digits of the Serial Number ............................................................. 17
Figure 5 Encoded Syringe Attachment........................................................................................................ 20
Figure 7 Stand Alone Mode ........................................................................................................................ 21
Figure 8 Anesthesia View ............................................................................................................................ 22
Figure 9 Unit Total....................................................................................................................................... 23
Figure 10 Nursing View ............................................................................................................................... 24
Figure 11 EMR Integrated Mode................................................................................................................. 27
Figure 12 EMR Integrated (Companion View) ............................................................................................ 28
Figure 14 Login ............................................................................................................................................ 33
Figure 15 Connecting an Intelliport ............................................................................................................ 34
Figure 16 Patient Setup ............................................................................................................................... 35
Figure 17 ADT Patient List ........................................................................................................................... 35
Figure 18 Confirm Patient Association........................................................................................................ 36
Figure 19 Patient Allergies .......................................................................................................................... 36
Figure 20 User Preferences ......................................................................................................................... 39
Figure 21 Connecting Additional Intelliports .............................................................................................. 40
Figure 22 Select Medication ....................................................................................................................... 41
Figure 23 Modify Selected Medication ....................................................................................................... 42
Figure 24 Cocktail Medication .................................................................................................................... 43
Figure 25 Add Infusion ................................................................................................................................ 44
Figure 26 Modify Infusion ........................................................................................................................... 44
Figure 27 Add Comment ............................................................................................................................. 45
Figure 28 Medication Orders ...................................................................................................................... 46
Figure 30 Review Case ................................................................................................................................ 48
Important information is highlighted by these icons and terms:
WARNING indicates a potential for personal injury or death.
CAUTION indicates either potential damage to the hardware or loss of data and
instructs how to avoid the problem.
NOTE
NOTE indicates important information to make better use of the Anesthesia System.
Section I Background
Introduction
Thank you for choosing the BD Anesthesia System (Anesthesia System). The Anesthesia System can be
used when intravenous bolus injections of medication are given to a patient by a nurse or anesthetist for
automated documentation of medication, concentration, dose, volume and time of each IV injection
during an operation, recovery and procedural event.
During treatment, the clinician connects an intelligent injection port, called the Intelliport™ device, to a
patient's fluid‐delivery line and performs standard drug‐delivery activities. The Intelliport device
automatically captures information about drugs injected, and wirelessly transmits that information in
real‐time to the Tablet computer. The Tablet computer uses that information and other manually‐
entered information to display a time‐stamped medication record. It provides the clinician with clinical
decision support. It also makes that information available for reporting and electronic recordkeeping
purposes.
The Anesthesia System has two operating modes. The first configuration is a stand‐alone system that
supports a paper anesthesia record. The second configuration involves integration with electronic
medical records or perioperative information management systems (PIMS).
This guide provides instructions for the safe and proper operation of the device, as well as set‐up,
configuration, and care information. Read this entire manual carefully and familiarize yourself with the
features and operation of the Anesthesia System prior to use.
Product Description
There are four components to the Anesthesia System:
Tablet
computer
Encoded
Syringes
Intelliport
Device
Gateway
Figure 1 Anesthesia System Components
Intelliport device is an intelligent injection port. It attaches to an injection site (“Y Site” or stop cock) for
manually administered IV injections. It is comprised of a Sensor and a Base, which snap together prior to
use. The Intelliport Sensor is a sterile disposable having an injection port and a Luer connection. The
Intelliport Sensor is supplied in a sterile package for single patient use. The Intelliport Base is a non‐
sterile, reusable device that houses the electronics and wireless transmitter. It is battery powered, and
rechargeable. A separate Recharger recharges a battery in the reusable Intelliport Base prior to each
use.
Intelliport Base
Intelliport Sensor
Figure 2 Intelliport Device
Encoded Syringes are commercially‐available drugs in prefilled syringes with a special identifier, called
“encoding”, that stores information about the medication contained within the syringe. Encoded
syringes are ready‐to‐use, passive and disposable. The Anesthesia System also accommodates syringes
not having encoding.
Tablet Computer runs the Anesthesia System software. It continuously captures and displays the
medication administration record (MAR) data from the Intelliport device 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.
Gateway is software that enables the Anesthesia System to function as an enterprise device and
information system. The Gateway provides a central hub to which all Tablet computers connect via the
hospital network. It also includes an interface engine for the Anesthesia 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 Anesthesia System to
configure the device library and Tablet computer default settings.
How it Works
The medication administration process using the Anesthesia System is illustrated in Figure XXX. Prior to
treatment, the clinician primes and connects the Intelliport device to the patient’s catheter or injection
port (y‐site). During medication administration, the clinician performs standard drug‐delivery of bolus
medications.
When a syringe is attached to the injection port, the Intelliport device identifies the medication and
concentration for an encoded syringe by optically imaging and decoding a barcode on the tip of the
syringe. This information is wirelessly transmitted to the Tablet computer, and the Tablet computer
displays and announces the drug attached. It also may perform safety checks.
As drug is pushed, the Intelliport device measures the volume dosed ultrasonically. The Intelliport
device wirelessly sends volume measurement information to the Tablet computer. The Tablet computer
uses this information to provide clinicians with clinical information. The medication administration
information is time stamped and displays for clinical reference during surgical procedures. Manually
entered infusions and other information pertaining to non‐encoded drug injections may be included in
the patient medication record.
The Tablet computer 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.
10
Indications for Use
The Anesthesia System provides a record keeping system with patient safety features.
Electronic availability of the patient’s allergies allows for proactive adverse drug event screening when
the patient is in the perioperative environment prior to any anesthesia drug delivery.
The Anesthesia System automatically documents medications in the pre‐op, intra‐op, and PACU areas
when using an encoded prefilled syringe. The clinician can enter drug medication by manually selecting
the drug from a list when using a syringe that is not encoded. A drug library, managed by pharmacy,
contains drug specific information used for documenting drugs on the anesthesia record, performing
adverse drug event checks, and submitting medication utilization information for billing purposes.
Availability of the patient’s specific drug allergies provides for pre‐screening of the medications that are
connected to the Intelliport device for injection to check for any potential adverse drug events. It also
provides a methodology for narcotics tracking through its comprehensive medication tracking and
wasting feature.
The Anesthesia System is to be used in the hospital peri‐operative environments (inpatient and
outpatient) and special procedure rooms. The Anesthesia System may also be used in nursing care units
for the treatment of pre and post surgical patient care. Surgical/procedure patients should weigh
greater than 35 kgs , and have an intravenous line established. The system may also be used in nursing
care units for the treatment of pre‐ and post‐surgical patient care.
The clinicians that are intended to use the CRISI Anesthesia System include physicians with a specialty in
anesthesiology, Certified Registered Nurse Anesthetists and Registered Nurses. These individuals are
licensed to deliver medications through a patient’s venous access point. (IFU026)
The Intelliport Sensor may be used up to 72 hours. It is not intended to be reused.
The Intelliport Base is intended for use with the Intelliport Sensor. It may be reused unless it has a
exceeded its Useful Life. It should be disinfected and fully re‐charged between patient uses.
Intended Use
The Anesthesia System is an automated record keeping system for use in perioperative and procedural
settings. The system is comprised of a injection port that measures administration of medications to
patients, and a data processing module to automate tracking. The system also incorporates patient
safety features (alerts for patient allergies) that are aligned with hospital patient records and protocols,
and it includes a methodology for narcotics tracking through a comprehensive medication tracking and
wasting feature. The Anesthesia System has both disposable and reusable parts, and the overall system
is intended for prescription use only.
The Intelliport device is intended to be used on a Y‐site, stop‐cock or IV manifold injection port of any
peripheral intravenous established line. This includes a central venous line or peripherally inserted
central catheter (PICC) line. It is not intended to be used in the intra‐arterial or epidural lines. Venous
lines can be established in the subclavian, femoral, intraosseous or various peripheral arm locations.
The Intelliport device may rest or be secured to the patient’s skin in either of these locations.
11
Section II Safety Precautions
The information contained in these Instructions for Use is intended to assist in the safe operation of the
Anesthesia System. 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.
Warnings and Precautions
General
Do not use the Anesthesia System near Magnetic Resonance Imaging (MRI) equipment,
including stereotaxis technology.(IFU017) Remove the Intelliport device from the IV Y‐
site prior to imaging.
Do not use the Anesthesia System near therapeutic radiation equipment, such as linear
accelerators. Remove the Intelliport device from the IV Y‐site prior to imaging.
Shock hazard: do not attempt to connect or disconnect the Tablet computer or
Intelliport Recharger power cord with wet hands. Make certain that your hands are
clean and dry before pressing the power cord.
Use only the power cord supplied by the manufacturer for the Tablet computer or
Intelliport Recharger. Never adapt the plug to fit a nonstandard outlet.
Inspect the power supply cord for damage prior to use. Replace the Tablet computer
power supply only with the CRISI approved power supply.
Observe requirements for proper grounding. The power receptacle must be a three‐
wire grounded outlet. A hospital grade outlet is required. Never adapt the three prong
plug from the Tablet computer to fit a two‐slot outlet. If the outlet has only two slots,
make sure that it is replaced with a three‐slot grounded outlet before attempting to
operate the Tablet computer. Provide an isolated power supply for operation.
Universal precautions should be observed to prevent contact with blood or other
potentially infectious materials. Place contaminated materials in a regulated waste
container.
Do not mix disinfecting solutions (e.g., bleach and ammonia) near the Anesthesia
System, as hazardous gases may result.
Use accessory equipment recommended by the manufacturer. The use of non‐approved
accessory equipment with the Anesthesia System is not recommended, and may lead to
unsafe conditions.
Do not modify or tamper with system components for any reason. Doing so will void the
manufacturer warranty. The system does not include serviceable components. Contact
12
your Anesthesia System representative for all repairs.
Do not use damaged equipment, frayed or damaged power cords. (IFU023)
Do not expose the Anesthesia System to gas or heat sterilization. Autoclaving will
seriously damage the Intelliport Base and Tablet computer.
Avoid liquid ingress to the Tablet computer or Intelliport Base. Fluids may interfere with
their performance.
Operation of electro convulsive therapy (ECT) equipment during use of the Anesthesia
System may temporarily result in signal loss between the Intelliport device and Tablet
computer.
NOTE
If any part of the Anesthesia System (Tablet computer, Intelliport device, Recharger) is
dropped or severely damaged, immediately remove it from use and have it inspected by
service personnel. Ensure its proper function prior to reuse.
Tablet computer
The ground leakage current is less than specified limits established for commercial
Tablet computer power supplies. As a matter of safe practice, your facility should
conduct periodic tests to verify these currents. It is recommended that the Tablet
computer AC power adapter be connected to an isolated power supply.
Electrical shock hazard: Do not remove the Tablet computer cover. There are NO
serviceable parts inside the Tablet computer.
If the integrity of the external protective earth ground is in doubt, the Tablet computer
can be operated from its internal battery power source.
Sustained contact of the Tablet computer with skin can cause discomfort or burns. Do
not allow the Tablet computer to rest directly on exposed skin for extended periods.
The surface temperature of the Tablet computer may rise during normal operation
particularly when operating under AC power.
Be sure the Tablet computer is mounted securely in place to avoid falling and sustaining
injury.
To completely remove power from the unit, disconnect the power cord from the power
receptacle of the Tablet computer.
Properly secure the Tablet computer prior to use or after positioning. Do not loosely
place the Tablet computer on other equipment. (IFU 022)
Do not block ventilation inlet holes on the underside of the Tablet computer.
13
Do not open or modify the Tablet computer for any reason. There is a seal to prevent
liquids from entering, which may be damaged if opened.
NOTE
The Tablet computer can only be used with the Anesthesia System.
NOTE
Before each use, check the volume of audible alerts to ensure they are not muted.
Silencing the alerts may adversely affect patient safety.
NOTE
Do not push any objects into the air vents or other opening on the Tablet computer.
Doing so can cause fire or electric shock.
NOTE
Do not use pressurized sprays when cleaning the Tablet computer screen.
NOTE
Do not use hard or pointed objects on the Tablet computer screen.
Intelliport device
Intelliport device should not be used with an Arterial or epidural line. This may result in
serious injury to the patient. Verify the line placement prior to Intelliport Y‐site
attachment. (IFU011)
Do not use a needle or blunt plastic tip cannula with the Intelliport Sensor. This may
result in port valve damage resulting in fluid leaks, air intake and bacterial
contamination. Replace the Intelliport Sensor immediately.
Prime the intravenous line and Intelliport Sensor with flush solution prior to beginning
an injection. Trapped air may affect Intelliport Sensor performance and the injected
volume measurement. Failure to prime the Intelliport Sensor correctly may cause the
volume of injected medication to read lower than the actual total delivered to the
patient.
Check for an blocked fluid path or leaking fittings when priming the Intelliport Sensor.
Secure the Intelliport device to the patient prior to patient transport to avoid
intravenous line disruption.(IFU 021)
Note the clarity of the IV tubing and Intelliport Sensor during use to minimize bacteria
growth. Replace the Intelliport Sensor if a high lipid medication has been injected or
blood is visible inside the lumen of the Intelliport Sensor or port.
Do not use the Intelliport Sensor with an IV line using a high pressure infusion flow
system. Verify the line placement prior to Intelliport Y‐site attachment.
14
This device complies with Part 15 of the FCC Rules. Operation is subject to the following
two conditions: (1) This device may not cause harmful interference, and (2) This device
must accept any interference received, including interference that may cause undesired
operation.
This equipment has been tested and found to comply with the limits for Class B Digital
Device, pursuant to Part 15 of the FCC Rules. These limits are designed to provide
reasonable protection against harmful interference in a residential installation. This
equipment generates and can radiate radio frequency energy and, if not installed and
used in accordance with the instructions, may cause harmful interference to radio
communications. However, there is no guarantee that interference will not occur in a
particular installation. If this equipment does cause harmful interference to radio or
television reception, which can be determined by turning the equipment off and on, the
user is encouraged to try to correct the interference by one or more of the following
measures.
•
Reorient or relocate the receiving antenna
•
Increase the separation between the equipment and receiver
•
Connect the equipment into an outlet on a circuit different from that to which
the receiver is connected
•
Consult the dealer or an experienced radio/TV technician for help
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 expressément 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 licence‐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.
Le présent appareil est conforme aux CNR d'Industrie Canada applicables aux appareils
radio exempts de licence. L'exploitation est autorisée aux deux conditions suivantes : (1)
l'appareil ne doit pas produire de brouillage, et (2) l'utilisateur de l'appareil doit
accepter tout brouillage radioélectrique subi, même si le brouillage est susceptible d'en
compromettre le fonctionnement.)
15
Do not use the Intelliport Sensor with an IV line using a high pressure infusion flow
system. Verify the line placement prior to Intelliport Y‐site attachment.
Verify the encoding label is clean and secure to the syringe tip prior to attaching to the
Intelliport Sensor.
Dispose of the Intelliport Base it according to your facility’s protocol for battery disposal
of lithium ion batteries.
Discard the Intelliport Sensor if its sterile packaging is not intact or the protector cap is
detached.
Clinicians must be familiar with and be trained in the use of the Anesthesia System. Its
use should be preceded by an established facility protocol.
Swab the injection port with 70% isopropyl alcohol (or the agent that is hospital
standard) and allow to dry prior to each syringe injection to minimize the potential for
cross contamination.
Change the Intelliport Sensor according to facility policy for IV set change or CDC (USA)
Guidelines; or if the integrity of the Intelliport device has been compromised. (IFU025)
The Anesthesia System is neither designed nor intended to detect nor alert if there are
needle infiltrations. Hospital/facility personnel must ensure the performance of the
common IV site, prior to conducting bolus injections.
NOTE
Verify that the Intelliport device is securely luer locked to the Y‐site and the IV tubing is
free from kinks before operating.
NOTE
The Intelliport Sensor does not have a stop valve (check valve); therefore, it is
recommended to close the upstream flow on the IV line during injection to limit
retrograde flow.
16
Section III Description of Anesthesia System Components
The Anesthesia System is designed with your needs, safety and workflow in mind. This section will
familiarize you with the Anesthesia System components, operational modes, display views, controls, and
indicators.
Supplies and Equipment
The Anesthesia System is designed for use with the following equipment.

IV venous line with Y‐site needleless port(s), stop cock or manifold

Intelliport device (sterile packaged Intelliport Sensor and charged Intelliport Base)

Medication syringes (having encoding and without encoding)

Tablet computer

Recharger
Intelliport
The Intelliport device is an intelligent injection port. It attaches to an injection site (“Y Site” or stop cock)
for manually administered IV injections. It is comprised of a single‐use Intelliport Sensor and a reusable
Intelliport Base, which snap together prior to use. Up to three Intelliport devices 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 Intelliport device has memory that will store
a time‐based medication history log from the time of activation to the time when the data is sent to a
Tablet computer.
Intelliport Sensor
The Intelliport Sensor is a sterile disposable having an injection port and a Luer‐lock connection. The
Intelliport Sensor is supplied in a sterile package for single patient use. (IFU020) The Intelliport Sensor
has a male Luer‐lock connection on a one‐inch IV tubing pig tail. This can be attached to an IV line at a Y‐
site or IV manifold. An Intelliport Sensor cannot be reused with a different patient. Each 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 an Intelliport Sensor within wireless range using the
Tablet computer.
Last 4 digits of
Serial Number
Figure 3 Intelliport Sensor with last 4 digits of the Serial Number
17
Figure 4 Intelliport Device Components
The Intelliport Sensor includes an injection port and an IV connection to the IV line. The injection port is
a common needleless, Luer‐lock type. It may be cleaned prior to giving an injection according to
hospital policy. Priming with an IV fluid (e.g. normal saline syringe, or pull back from IV line) is required
before use. The injection port on the Intelliport Sensor supports up to 100 injections.
The Intelliport Sensor is packaged sterile, do not use if package is damaged or protector
cap is not attached.
Do not use a needle or blunt tip plastic cannula. Replace immediately if either is
inadvertently used resulting in damage to the Intelliport Sensor (typically leaks).
Prime Intelliport Sensor before use. Attach a flush syringe to the injection port and
purge infusion fluid to remove air from the Intelliport Sensor.
Confirm the Luer lock is securely connected to a fully primed primary infusion set before
use.
Discontinue use of the Intelliport Sensor if the syringe is securely attached and you
observe leaking (droplets forming at the injection port) during an injection.
NOTE
Use Aseptic Technique when handling the Intelliport Sensor.
Intelliport Base
The Intelliport Base is a non‐sterile, reusable device that houses the battery, electronics and wireless
transmitter (called a Radio). It is battery powered, and rechargeable. Do not discard after use. An
Intelliport Base is designed to be reusable. It supports up to 500 re‐uses with different patients. Each
Intelliport Base has a unique serial number imprinted on its surface. This number is transmitted to the
Tablet computer during use. The distance between the Intelliport device and a Tablet computer should
be 10 meters or less in order for the Intelliport device to send and receive wireless communications.
The rechargeable lithium battery is not removable. The entire Intelliport Base connects to the
Recharger. A fully‐charged Intelliport Base is suitable for up to 24 hours of use, under typical conditions.
18
When the Intelliport Base is connected to a Recharger, up to 4 green light bars will illuminate. The
number of solid green light bars indicates the level of charge. The blinking light will indicate it is
recharging.
up to 25% charged
up to 50% charged
up to 75% charged
fully charged
very low battery ≤ 5 %
When the Intelliport Base is connected to a Recharger a red light indicates the Intelliport Base
has exceeded its Useful Life. Refer to Section XX Care & Maintenance for more information.
Status
The Intelliport Base is equipped with status indicators to convey the following information:
Operating
A double‐blinking, green light indicates the Intelliport device is powered on and
not yet wirelessly connected to a Tablet computer.
Error
A red light indicates an error is present. Refer to Section XX Troubleshooting for
more information.
Identify
Green/yellow lights flash for 3 seconds when an Intelliport device has been
selected at the Tablet computer.
Clinical Alert
Red/green/yellow lights flash for 3 seconds when a priority clinical alert has been
triggered. This informs the clinician of an alert message on the Tablet computer.
(e.g. a known allergy to a drug in a connected syringe). (IFU010)
End of Use
A red light in the lowest battery charge position indicates the Intelliport Base has
been used with more than 500 Intelliport Sensors.
Recharger
A separate Recharger recharges the battery in the reusable Intelliport Base prior to each use. To use the
Recharger, snap onto the Intelliport Base.
Encoded Syringes
The Anesthesia System supports injections using any Luer‐lock type syringe. In addition, the system has
been designed to work with encoded syringes that have a special barcode identifier on the syringe tip,
called “encoding”. The encoding stores information about the medication contained within the syringe.
19
When an Encoded syringes is attached to the injection port, this information is wirelessly transmitted by
the Intelliport device to the Tablet computer.
Encoded
Syringe
Figure 5 Encoded Syringe Attachment
Tablet computer
The Tablet computer is a standard, commercial Tablet computer having Anesthesia System software, a
press screen, wireless communications (Radio). It is typically mounted near the clinician’s work envelop.
It may also be removable for hand‐held use. The On‐Off switch is located at the top, right of the
Tablet computer. It includes an AC power adapter. It also supports up to 4 hours of battery‐powered
use, under typical operating conditions.
On/Off Switch
AC power adapter
Figure 6 Tablet computer Feature Layout
Review Tablet computer Warnings listed on pages XX prior to use.
The Tablet computer supports one patient at a time. So long as a case is ongoing at the Tablet computer,
no other cases or patients can be accessed. In addition, only one clinician may be logged into a Tablet
computer at a time.
Software Running in Standalone Mode
When used in a hospital having a paper anesthesia record, the Tablet computer supports features that
assist with documenting the flow sheet portion and may help with decisions by the clinician. In this
configuration, the Tablet computer complements the paper recordkeeping activities by tracking and
20
displaying injections given through the Intelliport device. It also enables clinicians to manually document
other pertinent IV drug injection and infusion information.
The software screens follow a three‐step approach consisting of 1) connecting the Intelliport device, 2)
setting up the patient, and 3) viewing medication administration in either the Anesthesia View or
Nursing View. Refer to Sections XX for information on connecting the Tablet computer to an Intelliport
device and setting up a patient.
Figure 7 Stand Alone Mode
The following section describes the basic screens on the Tablet computer:
Anesthesia View
The Anesthesia View is a primary screen for clinicians to interface with the Anesthesia System. 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. If may also
include a listing of infusions given to the patient, if recorded by the clinician.
21
Figure 8 Anesthesia View
Injection Bars ‐ Up to three injection bars display across the top of the screen, one corresponding to
each wirelessly connected Intelliport. Each injection bar is a real time representation of the medication
being administered through an Intelliport device. When an encoded syringe is attached to an Intelliport
device, the injection bar displays the drug name and concentration. When an unencoded syringe is
attached, the Injection Bar will read “Select Med” prompting the clinician 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 mediations that have been
delivered to the patient organized by care area (medications given in the transition time between care
areas, will post to the next care area) arranged in a flow sheet format. This includes all medications that
were administered to the patient since the Intelliport device has been 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 will scroll
automatically so the new medication name is visible. Hand gesturing in the flowsheet will scroll the
flowsheet to view hidden medication administrations.
NOTE
For anesthesia medications, a color tile corresponding to the American Society of
Anesthesiology (ASA) guidelines displays adjacent to the drug name. (Refer to Appendix
X for more information).
The flow sheet time scale is adjustable and it can show 1 minute, 5 minute, and 10 minute increments.
22
"Dose" is shown on a flag based on the time in which it was delivered. Pressing the flag for a specific
medication will display the “Modify Selected Medication” pop up. From this pop up, the medication
administration can be viewed and modified. A clinician can modify the concentration, dose. This screen
is also used to specify a cocktail (mixed medication), a diluted or reconstituted medication.
Pressing the “Unit Total” number for a medication will display a pop‐up screen indicating the medication
and concentration, total dose given, number of doses given by care area, and time of each dose. To
close, press “OK” on the bottom of the pop‐up screen.
Figure 9 Unit Total
The Infusion section is located above the time scale. It displays all continuous infusions recorded by the
clinician. Those that are currently active are shown with a blue bar and those that are inactive have a
black bar. This feature can be hidden to show additional injections by pressing “Hide Infusions” from
the Menu.
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 prioritized by importance and time. The
Message icon will show the number of unaddressed messages for the clinician. Clinical messages that
have higher importance, such as allergy alerts, will appear in the center of the display screen. (Figure
XX)
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 computer. The first icon to the right of the Bar
indicates if wireless communication between the Gateway and the Tablet computer are active. A
second icon
specifies whether the Tablet computer speakers are muted or unmuted. The battery
icon indicates the remaining amount of charge on the Tablet computer and lastly, the hospital network
time is shown.
Nursing View
The Nursing View is a second screen for clinicians to interact with the Anesthesia System. Like the
Anesthesia View, this view provides information about the patient, displays drug name/concentration
23
and dose for a current injection as well as a historical list of medications that have been delivered to the
patient. It may also include a listing of infusions given to the patient, if recorded by the clinician.
Figure 10 Nursing View
The Nursing View has many of the features in the Anesthesia View; however it is arranged in a tabular
format. The table headings in this view include medication with concentration, time administered, 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. Hand gesturing in the table 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 features are available from the four buttons located in the lower right corner of the screen
(Allergies, Comments, Add, Menu):
Add
Infusion
Select this option to record details about an infusion.
Refer to Section X for more information.
Add
Injection
Select this option to record details about an injection
given prior to activating an Intelliport device or given
through a port other than the Intelliport device. Refer to
Section X for more information.
Add
Comment
Select this option to record general comments. (there are
additional ways to pair a comment with an allergy or drug
24
injection). Refer to Section X for more information.
Allergies
Select this option to view the list of allergies, including
severity and type of reaction.
Pause Case
Press this button when transferring a patient to another
care area. In doing so, it disconnects all connected
Intelliport devices in preparation for transfer. Refer to
Section X for more information.
Close Case
Press this button when the case is complete and the
patient is being prepared for transfer out of the
perioperative area. In doing so, it powers down all
connected Intelliport devices. Refer to Section X for more
information.
NOTE: Pressing this button will close the case record on
the Anesthesia System. The case will no longer be
available to the next care area.
Switch User
Select this option to change the clinician logged in, if so
configured. Refer to Section X for more information.
Show/Hide Infusions
Press this button to toggle between displaying or hiding
infusions on the Anesthesia View flowsheet. Refer to
Section X for more information.
Change Time Scale
Press this button to toggle between 1 minute, 5 minute
and 10 minute time intervals on the Anesthesia View
flowsheet.
Sound/Mute
Press this button to toggle between audible
announcements and mute. Refer to Section X for more
information.
Preferences
Select this option to view and modify preferences for
announcements, volume and screen brightness. Refer to
Section X for more information.
Reports
Select this option to view and print the Controlled
Substance, Handoff, and Medication Administration
reports. Refer to Section X for more information.
Handoff View
Press this button to view the Handoff screen. Refer to
Section X for more information.
Nursing View
Press this button to view the Nursing View screen. Refer
to Section X for more information.
25
Anesthesia View
Press this button to view the Anesthesia View screen.
Refer to Section X for more information.
Help
Select this option when seeking assistance in operation. It
provides helpful information, including the Directions for
Use. (IFU028)
Shut Down
Press this button to power off the Tablet computer. Refer
to Section X for more information.
26
Software Running in EMR‐Integrated Mode
When used in a hospital having electronic medical records (EMR) in the perioperative care areas, the
Tablet computer serves as a companion to the EMR system or perioperative information management
system (called a PIMS). In this configuration, the Tablet computer provides a real‐time display while the
drug is being injected, then it sends the injections data in real time to the EMR. The clinician refers to
the EMR for a history of medications given ‐ ‐ unlike the paper anesthesia record configuration.
The software screens follow a three‐step approach consisting of 1) connecting the Intelliport device, 2)
verifying the patient information received from the EMR, and 3) giving injections. Refer to Sections XX
for information on connecting the Tablet computer to an Intelliport device and setting up a patient.
Figure 11 EMR Integrated Mode
The Companion View has a primary screen for clinicians to interface with the Anesthesia System. This
View provides information about the patient, displays drug name/concentration and dose for the
current injection and relevant clinical and system messages.
27
Figure 12 EMR Integrated (Companion View)
The Companion View consists of the following screen features: 1) Active Injection Bar; 2) Title Bar with
clinician name and location of display Tablet computer; 3) Case Header information on patient name,
MRN, Patient identification number; 4) Allergies; 5) Clinical or System Messages.
Injection Bars ‐ Up to three injection bars display on the screen, one corresponding to each wirelessly
connected Intelliport device. Each injection bar is a real time representation of the medication being
administered through an Intelliport device. When an encoded syringe is attached to an Intelliport
device, the injection bar displays the drug name and concentration. When an unencoded syringe is
attached, the Injection Bar will read “Select Med” prompting the clinician 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 the syringe push, the medication
administration will pass immediately to the EMR with a confirmation message confirming such in the
message area.
NOTE
For anesthesia medications, a color tile corresponding to the American Society of
Anesthesiology (ASA) guidelines displays adjacent to the drug name. (Refer to Appendix
X for more information).
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 prioritized by importance and time. The
Message icon will show the number of unaddressed messages for the clinician. Clinical messages that
have higher importance, such as allergy alerts, will appear in the center of the display screen. (Figure
XX)
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 computer. The first icon to the right of the Bar
indicates if wireless communication between the Gateway and the Tablet computer are active. A
28
second icon
specifies whether the Tablet computer speakers are muted or unmuted. The battery
icon indicates the remaining amount of charge on the Tablet computer and lastly, the hospital network
time is shown.
29
Section IV Operations
The Anesthesia System is designed with your needs, safety and workflow in mind. This chapter will
acquaint you with the Anesthesia System operational modes, display views, controls, and indicators. It
also provides general information on use of the device.
Quick Guide
Prepare the Intelliport
The Intelliport device must be primed, attached to an IV line and assembled in preparation for use.
1. Gather an Intelliport Sensor in its sterile packaging and a fully‐charged and disinfected Intelliport
Base.
2. Prime by flushing with sterile IV fluid before attaching to the Y‐site OR by aspirating IV solution
through a syringe attached to the port.
3. Attach the Intelliport Sensor to the Intelliport Base by joining the Intelliport Sensor (tubing side)
and Intelliport Base front sections first, then snap the two together. One should audibly hear
the “snap”.
4. Verify proper seating of Intelliport Sensor to the Intelliport Base by checking for a blinking green
light on the Intelliport device. If this is not seen, view the Intelliport device on its side to
determine if the two are properly connected. If a space is seen between the Intelliport Sensor
and Intelliport Base, then separate and re‐attach properly.
5. The Intelliport device is now ready for delivery of IV medications. Any medications given through
the Intelliport device will be saved to the Intelliport memory.
Set up the Tablet computer
The Tablet computer must be set up to wirelessly communicate with the Intelliport device and to be
associated with a patient record. Any Medications given prior to association to a Tablet computer will
be held in the Intelliport memory. Three Intelliport devices can be synchronized to one patient.
6. Power on the Tablet computer by pressing and holding the button located on top of Tablet
computer.
7. The first screen supports log‐in, if so configured. Enter Username and Password
8. Identify the 4 digit number on the Intelliport Sensor.
9. From the Intelliport Setup screen, select (highlight) the Intelliport device corresponding to the
four digits number on the Intelliport Sensor.
10. Verify the correct Intelliport device has been selected by checking that the green and yellow
lights are blinking.
11. If the identified Intelliport device is correct, press “Connect”.
12. Verify the Intelliport device flashes a single, repeating green light when it is wirelessly connected
to the Tablet computer.
13. Identify the patient’s full name, patient ID, medical record number and birth date.
14. From the Patient Setup screen, select the patient from the list. Press “Emergency” to begin a
30
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.
15. “Confirm” the correct Intelliport device and patient to complete the setup. Once confirmed,
the Anesthesia System has established a permanent association between the patient and
Intelliport Sensor.
Give IV injections and View Medication Administrations
16. Clean the Intelliport Sensor injection port by swabbing the hub according to your hospital
protocol.
17. Attach a syringe to the Intelliport Sensor injection port.
18. Verify the drug displayed and announced by the Tablet computer is the intended drug and
concentration. When using a syringe without encoding, “Select Med” will announce and display
a list of medications to identify. (Press “More” if you do not see the medication name).
a. Identify the medication before or after dose delivery. Confirm medication and press
“Save”.
b. Frequently diluted or reconstituted drugs shall display no dose value until the clinician
identifies the given dose on the “Modify Selected Medication” screen. The identified
dose will appear on the flag.
c. Cocktail (mixing two medications in one syringe) can be identified by pressing the
“Cocktail” button from the “Select Med” screen.
Use clinical judgment before proceeding when the Tablet computer announces and
displays a known allergy for the drug attached to the Intelliport device, if so configured.
19. The volume and dose will display on the Tablet computer when the syringe is removed or at end
of the injection, if the syringe is left attached to the Intelliport device.
31
Detailed Operating Instructions
Prepare the Intelliport
The Intelliport device must be primed, attached to an IV line and assembled in preparation for use.
1. Gather an Intelliport Sensor in its sterile packaging and a fully‐charged and disinfected Intelliport
Base.
NOTE
A fully‐charged Intelliport Base has sufficient power for 24 hours of use under typical
conditions. Inspect the Intelliport Base charge level. Replace an Intelliport Base with
less than 25% charge. This can be done at anytime so long as an injection is not being
given.
Verify the Intelliport Base has been cleaned and disinfected before use.
Verify the Intelliport Sensor sterile package is intact and the tubing end cap is still in
place.
2. Prime by flushing with sterile IV fluid before attaching to the Y‐site OR, by aspirating solution
from the IV line through a syringe attached to the port. (IFU01)
NOTE
After priming, visually inspect for leaks or blockage to the IV line.
3. Attach the Intelliport Sensor to the Intelliport Base by joining the Intelliport Sensor (tubing side)
and Intelliport Base front sections first, then snap the two together. One should audibly hear
the “snap”. Connecting Intelliport Sensor to Intelliport Base will automatically power on the
Intelliport device.
NOTE
The connection of Intelliport Sensor to the Intelliport Base is verified by a blinking green
light on the Intelliport device. If this is not seen, view the Intelliport device on its side to
determine if the two are properly connected. If a space is seen between the Intelliport
Sensor and Intelliport Base, then they are not attached properly. Separate the two
pieces and re‐attach.
4. Where appropriate, secure the Intelliport device to a surface in preparation for giving injections.
Avoid kinks in the line between the Intelliport device and IV line.
Secure an Intelliport device prior to patient transport.
5. The Intelliport device is now ready for delivery of IV medications. Any medications given through
the Intelliport device will be recorded in the Intelliport memory.
In the event of a System or Intelliport failure, (excluding the fluid pathway), the Intelliport device will
allow standard medication or fluid delivery.
Set up the Tablet computer –Paper Anesthesia Record
The Tablet computer must be set up to wirelessly communicate with the Intelliport device and to be
associated with a patient.
32
6. Turn on the Tablet computer by pressing and holding the power switch on top of Tablet
computer.
NOTE
The Tablet computer can operate for 4 hours on battery power (not plugged in to a
power supply) under typical conditions. Verify the Tablet computer is plugged in prior to
use by checking the power indicator on the Title bar on the Tablet computer screen.
NOTE
On start up, the initial screen will display information about the software, drug library
and configuration versions – as well as information on network connectivity. Contact
your System Administration if so instructed.
7. The Login screen will display if the Anesthesia System is configured for user login. Type the User
Name and Password, then press the “Log in” button.
Figure 13 Login
NOTE
The Tablet computer will lock the user out after several unsuccessful login attempts.
Follow the screen directions for contacting the System Administrator.(IFU029)
8. Identify the 4 digit number on the Intelliport Sensor.
Last four digits of
serial number
Figure 14 Login
9. A list of Intelliport devices within wireless range are viewable on the Intelliport Setup screen.
Select (highlight) your Intelliport device by time of initial activation and last four digits of the
serial number on the Intelliport Sensor.
33
Figure 15 Connecting an Intelliport
NOTE
A low battery icon will display for a listed Intelliport when less than 25% of battery
charge remains (approximately 4 hours under typical conditions). Consider replacing
with a fully‐charged Intelliport Base before connecting.
10. Select the Intelliport device for your patient by pressing and highlighting the appropriate
Intelliport serial number.
11. Verify that the green and yellow lights are flashing for the correct Intelliport device.
NOTE
Should you miss the visual confirmation, highlight the appropriate Intelliport device
again to initiate the blinking lights.
12. The screen will highlight your connection.
13. The Intelliport device will illuminate a single, repeating green light when it is wirelessly
connected to the Tablet computer.
14. Identify the patient’s full name, patient ID, medical record number and birthdate from the
patient and wrist band.
15. From the Patient Setup screen, select the patient from the list.
34
Figure 16 Patient Setup
If the patient is not listed, press 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. A keyboard will appear to type
the first letters of the Last Name.
Figure 17 ADT Patient List
NOTE
There is an “Emergency” button on the Tablet computer screen for patients whose
name is not known or the clinician determines an emergent situation to start
medication treatment.
16. Press the “Confirm” button to complete the setup. (IFU 027)Should any part of the association
be incorrect, there is an opportunity to press the “Remove” button and repeat the patient
identification step process. (Figure 18) Once confirmed, the Anesthesia System has established a
permanent association between the patient and Intelliport Sensor. The Intelliport Sensor can
only be paired with one patient.
35
Figure 18 Confirm Patient Association
NOTE
If the wrong patient was inadvertently confirmed to the Intelliport device, there is a
“Remove Intelliport” button on the Main Menu button that will disassociate the patient
from the Intelliport device and undo any medication administration history.
Should the Intelliport Base become disconnected from the Intelliport Sensor during
operation, reattach and verify patient association.
17. Following Patient Setup, the Tablet computer displays allergies for the selected patient, if so
configured. Known allergies, with severity and type of reaction will display (Figure XX).
Figure 19 Patient Allergies
36
NOTE
If the patient allergies are not available for the Tablet computer, the clinician will see a
message “Unable to Obtain”.
NOTE
The Tablet computer checks for updates to patient allergy information during a case.
18. There is an opportunity to type a comment for an allergy by selecting the Allergy and pressing
the Comment button. A keyboard will display to type a comment. (Figure xx)
19. Once the comment is recorded, press the “OK” button to save. This will return to the Allergy list.
Give an IV injection Using the Intelliport Device
20. Clean the injection port by swabbing the hub according to your hospital procedure. (IFU013)
21. Attach a syringe to the Intelliport injection port.
Double check each medication name and concentration on the syringe prior to
attachment to the injection port to assure “right medication.” (IFU 02)
1. Verify the drug displayed and announced by the Tablet computer is the intended drug and
concentration. (IFU 019)For syringes not having encoding, refer to Section: Special Activities;
Medication Delivery when Syringes Not Encoded, then return to this step. (IFU 04)
2. The Intelliport device will flash red, green and yellow lights if a medication allergy is detected, if
so configured.
Use clinical judgment before proceeding when the Tablet computer announces and
displays a known allergy for the drug attached to the Intelliport device. Allergy
messages will display as below:
3. There is no check valve in the Intelliport Sensor, so close or pinch the upstream IV tubing or use
a check valve IV set to prevent medication traveling towards the IV bag during injection. (IFU
009)
NOTE
Alternatives to prevent retrograde flow include: 1) attaching a three‐way stopcock onto
the Y‐site and luer locking the Intelliport Sensor onto the stopcock; 2) attaching a
manifold to the IV or extension tubing and luer lock the Sensor directly to the manifold.
4. When delivering medications, observe the graduations on the syringe to check the amount of
drug delivered. (IFU003) Verify dose shown in the active injection bar of the Tablet computer.
(IFU 007) The Intelliport device measures 0.4 mL to 55 mL per injection. (IFU 008)
37
NOTE
If the injection flow rate is very slow, a message will display on the Tablet computer.
(IFU 031) If the amount of injected medication is not measurable, the active injection
bar will indicate “dashes” for volume and dose. A message will instruct the clinician to
enter the dose manually through the “Modify Selected Medication” screen. Once
completed, the dose will display. Refer to Section XXX for more information.
NOTE
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.
5. Follow all injections through the Intelliport device with an encoded Normal Saline flush to
ensure the full dose of medications reaches the patient, especially when successively delivering
two incompatible medications. (IFU06)
NOTE
Normal Saline will appear on the active injection bar with the amount of mL delivered.
Normal saline may not display on the medication history, if so configured.
6. Make adjustments to the medication administration record on the Tablet computer for
injections involving a diluted drug, reconstituted drug, or mixed drugs, if so configured.
Injections are recorded whether or not the Intelliport device is wirelessly connected to the Tablet
computer. The Intelliport Base stores injection information in its memory and transmits this information
upon wireless connection to the Tablet computer. (IFU030)
38
Special Activities
Setting User Preferences
The Anesthesia System supports user preferences to determine the sound volume, screen brightness
and audible announcements, reminders and messages. (IFU016)The hospital has configured default
preferences that may be modified temporarily during a case. To verify the Tablet computer preferences
prior to starting a case, perform the following:
1.
Select Preferences from the Menu.
2. Adjust preference for the work environment.
3.
Press “Save” button when completed.
Check whether alerts have been muted when relieving a clinician during a case.
Preference changes are retained during the case. When the case has closed or when a new clinical user
logs in, the settings revert to the default configuration.
Figure 20 User Preferences
Selecting the “Mute” option from the Menu will override all of the above selections and
mute all drug announcements, clinical reminders and system messages. To hear the
medication announcements, select “Unmute”.
Adding Additional Intelliports
The Anesthesia System can accommodate up to 3 Intelliport devices connected to one patient at a time.
An additional Intelliport device can be added at any time during a case. The first connected Intelliport
device will display in the left most injection bar. The second in the middle, and the third the rightmost
injection bar. Refer to Figure 6.
NOTE
When an Intelliport is connected to a Tablet computer and there is no syringe attached
to the Intelliport device, the active injection bar shall read “Intelliport Connected, No
syringe attached”. A battery status icon will indicate battery charge level in the corner
of the injection bar.
39
To add an Intelliport device:
1. Prepare an Intelliport device according to the instructions in Section X.
2. Press “Tap to Connect” on any of the remaining Active Injection Bar spaces to display a pop‐up
window that lists available Intelliport devices within wireless range.
3. Identify the 4 digit number on the Intelliport Sensor.
4. Select (highlight) your Intelliport device based on the time of initial activation and the four digit
number on the Intelliport Sensor.
Figure 21 Connecting Additional Intelliports
NOTE
A low battery icon will display when the selected Intelliport device has less than 10% of
battery power remaining.
5. The selected Intelliport device will flash lights for 3 seconds.
6. Verify the green and yellow lights are flashing for the correct Intelliport device .
NOTE
Should you miss the visual confirmation, highlight the appropriate Intelliport device
again to initiate the flashing lights.
7. If the identified Intelliport device is correct, press “Connect”.
8. Verify the Intelliport device is flashing a single, repeating green blinking light indicating it is
wirelessly connected to the Tablet computer.
9. Press Confirm. An Active Injection Bar will display the connected Intelliport device.
Medication Delivery with Syringes Not Encoded
The Anesthesia System is designed to work with both encoded syringes (those having a special barcode
identifier on the syringe tip) and unencoded syringes. When an unencoded syringe is attached to the
Intelliport device, the Tablet computer will display the “Select Medication” pop‐up having a
perioperative medication list. (IFU018) A clinician can identify the medication in the syringe before
40
giving the injection (recommended) or afterwards. If postponed, the Tablet computer tracks injections
not yet identified and later prompts the clinician to resolve.
1. Select the medication and concentration from the Frequent Use list by highlighting the name.
This list includes medications previously identified during the case as given by an unencoded
syringe.
Figure 22 Select Medication
2. If the desired medication is not found on the Frequent Use list, press “More” to view a longer
list of perioperative medications.
3. Filter the list by pressing the first letters of the drug name using the keypad.
4. Highlight the desired medication and concentration, verify the information and press
“Save”.(IFU 05)
Specifying a Diluted or Reconstituted Medication
The Tablet computer provides a simple approach to document medications that require dilution or
reconstitution from a powder form prior to preparation for injection. It tracks frequently diluted and
reconstituted medications. The Tablet computer prompts the clinician to confirm whether a drug has
been diluted or reconstituted. If not, no user action is required.
NOTE
Reconstituted drugs do not display a dose value until the clinician modifies the
medication.
5. To specify a dilution or reconstitution, press “Modify” on the “Select Medication” pop up. Or
press on the dose flag (Anesthesia View flowsheet) or dose row (Nursing view) and press
Modify.
6. Change the medication concentration or dose by pressing the Concentration box, then enter the
41
concentration value using the numerical keypad.
7. Review the numbers entered, then press “Save” button to record the new value. (IFU017) This
change will be reflected in the medication administration history.
Figure 23 Modify Selected Medication
Specifying a Mixed Medication (Cocktail)
Adding two medications into one syringe is called a mixed medication or cocktail. Depending on your
institution, mixed medications may include the following:

Propofol/lidocaine

Propofol/fentanyl

Propofol/ketamine

Neostigmine methylsulfate/glycopyrrolate

Atropine/edrophonium

Narcan/edrophonium
The Tablet computer provides a simple approach to document mixed medications. It tracks frequently
mixed medications, and it prompts the clinician to confirm whether a drug has been mixed. If not, no
user action is required.
1. To specify a mixed medication, press “Cocktail” on the “Select Medication” pop up. Or press on
the dose flag (Anesthesia View flowsheet) or dose row (Nursing view) and press “Cocktail.”
2. The “Modify Selected Medication” pop up (Figure 24) displays two medication names; with the
first one already identified.
3. Select the second Medication from the list. If the intended medication is not listed, press
“More” and the clinician may identify the correct medication from the “Frequent Use” or
perioperative drug library list.
42
Figure 24 Cocktail Medication
4. Enter the volume injected for either drug. The Tablet computer will calculate the volume for the
other medication using the total volume injected.
5. Press “Save”.
Adding Manual Injection (for Paper Anesthesia Records)
The Tablet computer provides the means to document IV injections given prior to activating an
Intelliport device or given through an IV port other than the Intelliport device. (ICU016)
1. Press the “Add” button, then press “Add Injection”. The Frequent Use medication list will
display.
2. Highlight the desired medication and concentration. Indicate the volume or dose.
3. Change the time by pressing on the appropriate arrows to the correct time of administration.
4. Press “Save” and the medication will list in the medication history area at the indicated time.
NOTE
A medication administration time cannot be in the future nor more than one hour
before the first Intelliport device has been activated.
Adding Infusions (for Paper Anesthesia Records)
The Tablet computer provides the means to document infusions.
1. Press the Add button, then press “Add Infusion.”
2. The Infusion medication list will display having four categories: Fluids, Medications, Titratable
Medications, and Blood Products. Select the appropriate category.
43
Figure 25 Add Infusion
3. Select the appropriate infusion, bag size and concentration. Press ”Save”.
4. Specify a time point. To change the time, press the arrows of the hour and minutes up to
increase and down to decrease.
Figure 26 Modify Infusion
NOTE
A medication administration time for an infusion cannot be in the future nor more than
one hour before the first Intelliport device was activated.
5. Specify the amount infused as of that time (Optional).
6. Press “Save”.
A clinician can add the volume infused for a care area at any point during a case by pressing on the
infusion bar, entering volume infused and press “SAVE”. To stop an infusion, press the “Stop” button
and press “Save”. Inactive infusions will display a black bar and the time the infusion was stopped.
44
Adding a Comment (for Paper Anesthesia Records)
A comment is a free text entry that is relevant to the anesthesia record. The Tablet computer supports
four methods to add to a comment:

Allergies – comments for a specific drug allergy. To make a comment on the allergy pop‐up
screen, highlight the allergy medication, then press “Comment” button. This will automatically
display a keyboard along with standard comment options. The clinician can press one of the
standard options or type a comment and press “Save”. The recorded comment is displayed with
each allergy pop‐up. (The allergy pop‐up screen is displayed on Patient Setup or by pressing the
“Allergies” button in the lower right corner.)

Time – comments tied to a specific time during a case. To add a general comment for a case,
press the “Comment” button and a keyboard will pop‐up. Type the comment and press “Save”.
The recorded comment display whenever you press “Comment” button and will be listed as a
“Case Comment” in the clinical report.

Injections – comment for a specific drug administration. To make a comment about an injection,
press a medication administration event in the medication history. This will display the “Modify
Selected Injection” pop‐up. Press the “Comment” button in the pop up to display a keyboard.
Type the comment and press “Save”. This comment will display near the dose/time when the
comment was written.

Infusions – comment for a specific drug administration. To make a comment on an infusion,
press an infusion event. This will display the “Modify Selected Infusion” pop‐up screen. Press
the “Comment” button to display the keyboard to type a comment. Type the comment and
press “Save”. This comment will display next to the infusion event.
Figure 27 Add Comment
Transfer Patients from One Care Area to Another
It is important to prepare the patient and Tablet computer prior to moving the patient from one care
area to another. Pressing “Pause Case” from the Menu instructs the Tablet computer to disconnect the
Intelliport device thereby enabling another Tablet computer in a subsequent care area to connect to it.
The Intelliport device will remain wirelessly connected to the earlier tablet if “Pause Case” has not been
pressed and the patient has been moved to a subsequent care location that is within 30 feet of the
earlier Tablet computer. In this situation, the clinician can disconnect the Intelliport by pressing “Show
All” from the Patient Setup screen and following the screen instructions.
45
Working with Orders
The Anesthesia System supports medication orders at hospitals that use Computerized Physician Order
Entry (CPOE). When injections are given in perioperative nursing care areas that use CPOE, the Tablet
computer can match the injection to a physician order and send this information to the hospital’s clinical
information system. Observe the following steps when the Anesthesia System is configured for
medication orders in the nursing care areas:
1. Review the patient’s medication order at the clinical information system.
2. Prepare the syringe and Intelliport device for use.
3. Attach the syringe for the medication order to the Intelliport device.
For an encoded syringe, the Tablet computer compares the medication in the attached syringe to
pending medication orders and displays a pop up confirming a match. Verify the medication order
matches. If correct, press “Select”. If incorrect, press “Select Other”.
Figure 28 Medication Orders
For an unencoded syringe, the Tablet computer displays a pop up listing the active medication orders for
the patient and prompts the clinician to select the medication corresponding to the attached syringe.
Highlight the medication order and press Save.
46
Figure 29 Selecting an Order when Using Unencoded Syringes
Responding to Messages
The Anesthesia System provides two types of messages: "System" and "Clinical.” "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 Appendix X for a
list of messages. Messages display in the Message section of the Tablet computer 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, a clinician is prompted to respond/answer unresolved medication
messages generated during the case.
Clinical Messages

Allergy alert ‐ An allergy alert displays when a clinician attaches an encoded syringe or selects a
medication for an unencoded syringe to which the patient has a known allergy.

Antibiotic redosing reminder ‐ The Tablet computer tracks elapsed time since an antibiotic is
administered and displays 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.

Medication ‐ The Tablet computer tracks medications given that are reconstituted, diluted or
given as cocktails, (mixed meds) and displays a message for the clinician to specify. The
message is individual to each medication, and it is configured in the drug library.
47
Reviewing the Medication Record (for Paper Anesthesia Records)
The Anesthesia System requires the clinician to review the medication record for accuracy prior to
printing a report. This is called “finalizing” and it ensures the accuracy of the report.
NOTE
A clinician is able to correct and amend (adding information to) the patient’s the
medication record so long as an Intelliport for that patient is connected and the case
has not yet been “finalized”.
1. From the main Menu, Press “Reports”.
2. The Tablet computer will provide a pop up with messages for a clinician to verify or adjust the
following data:

Check for reconstituted, diluted or mixed medications given. A message is individual to each
medication, and it is configured in the drug library.

Check for missing infusion data

Check for medications given in nursing areas by an anesthetist that are to be charted in the
anesthesia record

Clock adjustment ‐ Press “Clock” to adjust the time for the printed reports to synchronize an
anesthetist clock with the flowsheet. A pop up displays showing a clock with up and down
arrows for hours and minute adjustment. Press “Save”
Figure 30 Review Case
3. If there are unresolved messages, the clinician can come back and answer the questions at any
time prior to Closing the case (Close Case).
4. Press “Reviewed Case and Print”. Once finalized, the medication administration history for
recorded medication administrations will no longer be editable.
If all questions are not answered prior to case closure, the clinician can come back and answer the
questions up to 24 hours after the case is closed. If the 24 hour window is exceeded, the case can only
48
be printed out and changes manually made with a pen, signed and dated by the clinician and submitted
to Medical Records to be attached to the patient’s electronic record.
Printing a Report (for Paper Anesthesia Records)
The following reports are available for printing:

Anesthesia Flow Sheet Record – This report lists of the medications and infusions provided
during the OR suite in a flowsheet format. This is comparable to the Anesthesia Record that is
manually recorded by anesthesiologists for all cases.

Controlled Substance Usage ‐This report provides a list of all controlled drugs used during the
OR case, with dose amount, mLs used and time given.

Handoff – This report is used as a communication tool to convey information pertinent to the
ongoing care of the patient, especially when the patient transfers from one care area to another
and a new primary caregiver assumes care of the patient.

Perioperative Medication Administration ‐ This report lists each medication and fluid
administered showing the time, dosage and route. It also provides a summary showing total
dosage by mediation and fluid.
1. To print a report, press Reports from the Menu.
Figure 31 Print Reports
2. Select the appropriate report to print.
3. Specify the printer, if different from default, and the number of copies.
4. Press Print.
Address Pending Medications (EMR Integration)
When configured for EMR integration, the Tablet computer sends medication administration
information in real time unless information is missing. The missing information includes the drug
name/concentration of an unencoded syringe, the dose of a reconstituted drug, or use of a cocktail. In
49
these situations, the Tablet computer retains this medication administration in a pending list until it is
resolved by the clinician.
NOTE
It is good practice to resolve medication administrations prior to a care transition or
closing a case. (IFU032)
5. From the Menu, press “Pending Meds”. A pop‐up lists medication administrations that require
resolution.
6. Press each item to resolve. As each resolution on medication occurs, the query will disappear
and a resulting medication message will indicate the information sent to the Anesthesia
Information Management System (AIMS) system.
Deactivate Intelliport, Dispose of Intelliport Sensor, and Prepare Intelliport Base for Reuse
1. When the Intelliport device is no longer in use; disconnect the Intelliport Sensor from the
Intelliport Base by squeezing together the two finger tabs on top of the Intelliport Sensor while
lifting up to disengage from the Intelliport Base.
2. When properly separated, the Intelliport device will power off and no longer transmits
wirelessly to a Tablet computer.
3. Dispose of the Intelliport Sensor according to your hospital’s medical waste protocols.
NOTE
Avoid inadvertently discarding the Intelliport Base after use. It is intended for reuse
with multiple patients.
4. Clean and disinfect the Intelliport Base. First clean it with a commercial hospital disinfectant
and secondly, disinfect it secondly with a commercial hospital disinfectant. Follow
manufacturer’s instructions. For a list of approved hospital approved products to use, refer to
Appendix X.
5. Allow it to dry.
6. Inspect the Intelliport Base for cracks or damage. If damage is evident, then dispose of it
according to your hospital’s protocols.
7. Connect the Intelliport Base to the Recharger.
NOTE
It takes approximately 2‐4 hours to fully recharge an Intelliport Base when discharged to
<25% of power.
8. If the Intelliport Base has exceeded its Useful Life, then dispose of it according to your hospital’s
protocols for electrical waste. The Intelliport Base contains a Lithium battery.
NOTE
The Intelliport Base will illuminate a red light while charging if it has exceeded its Useful
Life.
Power Down the Tablet computer
The Tablet computer may remain powered down between uses.
1. Confirm the Tablet computer does not have Intelliport devices connected and it is no longer in
use.
2. Press the “Shut down” button located on the Menu bar.
50
3. Press “Yes”, to confirm and power down the Tablet computer.
51
Section V Troubleshooting
In the event you experience difficulty operating the Anesthesia System, this section of the manual
provides a troubleshooting guide for operational problems. If the response to a specific question is not
found, contact your Service Representative:
Phone:
Website:
Email:
Question
Answer
How do I return to the Clinical
Main Screen or Home?
From Main Menu press “Anesthesia” or “Nursing” view.
What do I do if the Battery in
the Base runs out of charge
during a case?
A Base can be exchanged at any time without affecting the case.
Exchanges take less than 30 seconds. If it is more than 30 seconds, the
case will require resynchronization of Intelliport device to Tablet
computer.
What if I pressed “Close Case”
or “Shut down” by mistake
during an active case?
Once you resynchronize the patient and Intelliport device to the
Tablet computer, all information is retrievable, even if the Intelliport
Sensor is replaced.
What causes me to lose
historical medication
information? And what can I
do to retrieve it?
It is not possible to lose historical medication information if the
Intelliport device and patient have been synchronized to the Tablet
computer. Medications given prior to Intelliport synchronization are
retained in memory on the Intelliport Base.
What if I forgot to chart a
medication or identify a
“Select Med” and the patient
is now in the Med‐Surg floor or
ICU?
If it has not been more than 24 hours since the OR case, the case can
be retrieved from the hospital server and editing of the case can
occur via a Tablet computer. However, if greater than 24 hours, the
case report can be printed, and manual edits made with dates and
signatures and returned to Medical Records for a case update.
What do I do if the Intelliport
Sensor no longer is working
and the case is not over?
An Intelliport Sensor can be replaced at any time. Resynchronization
is required.
What if the case is over and I
just noticed the wrong patient
appears on the screen?
Go to Main menu and press the “Remove Patient” button. TBD.
52
Section VI Care and Maintenance
Observe the following procedures for care of the Anesthesia System. Components of the Anesthesia
System do not require user maintenance. There are no user serviceable parts.
Care
Clean and Disinfect the Intelliport Base for Reuse
1. Clean the Intelliport Base with a commercial hospital disinfectant. Then disinfect the Intelliport
Base with a commercial hospital disinfectant. (IFU0024) For a list of approved hospital cleaning
products to use on the Intelliport Base, please refer to Appendix B.
2. Allow it to dry.
3. Inspect the Intelliport Base for cracks or damage. If damage is evident, then dispose of it
according to your hospital’s protocols.
Recharging the Intelliport Base for Reuse
4. Plug the Recharger into an isolated AC outlet.
5. Attach the Recharger to a clean and disinfected Intelliport Base by joining the Recharger and
Intelliport Base front sections first, then snap the two together. One should audibly hear the
“snap”.
6. Verify proper seating of Recharger to the Intelliport Base by checking for a “charging” light on
the Intelliport Base. If this is not seen, view the Intelliport device on its side to determine if the
two are properly connected. If a space is seen between the Recharger and Intelliport Base, then
separate and re‐attached properly.
7. The Intelliport Base will illuminate showing the amount of charge in the battery. Refer to the
following section should a red indicator light illuminate.
NOTE
Four bars indicate a full charge. The Intelliport Base is not damaged when left on the
Recharger after being fully charged.
Clean and disinfect the Recharger by using the procedure used for the Intelliport Base.
Determining Useful Life for a Intelliport Base
The Intelliport Base is designed to be reusable. After 500 uses, the components may be susceptible to
wear and it is no longer suitable for use with patients. Use the following procedure to determine if an
Intelliport Base has exceeded its useful Life.
NOTE
Avoid using an Intelliport Base that has exceeded its Useful Life.
1. Connect the Intelliport Base to a Recharger.
2.
If the Intelliport Base has exceeded its Useful Life, then the Intelliport Base will illuminate a red
light while charging. If so, discontinue use.
NOTE
If an Intelliport Base has exceeded its Useful Life, then dispose of it according to your
hospital’s protocols for electrical waste. The Intelliport Base contains a Lithium battery.
53
Should an Intelliport Base be used after it has exceeded its Useful Life, a message will display when the
Intelliport device is wirelessly connected to the Tablet computer during Patient Setup. Should you
experience this message, replace the Intelliport Base with another and repeat the wireless connection to
the Tablet computer.
Cleaning the Tablet computer
1.
Turn the Tablet computer off and disconnect the power cable.
2. Clean the Tablet computer with a soft cloth dampened with water. Moisten a soft, lint‐free cloth
with either water or a display cleaner, and wipe the surface of the Tablet computer until it is
clean.
Do not use aerosol cleaners, which may contain flammable substances.
Do not allow water from the cloth to seep down to the Tablet computer ports and the
buttons.
To avoid damaging the Tablet computer or display, do not spray cleaning solution
directly onto the display.
Only use products specifically designed for cleaning Tablet computers, and follow the manufacturer’s
instructions that are included with the product. For a list of approved hospital cleaning products to use
on your Tablet computer, please refer to Appendix F.
Storage
Components of the Anesthesia System do not require user maintenance. There are no user serviceable
parts. Contact Technical Support in the event a Tablet computer or Intelliport Base is not functioning
properly.
Tablet computer
When not in use, the Tablet computer may remain mounted and powered on, when connected to an
isolated AC power source.
NOTE
Do not remove the Tablet computer from its protective case for storage.
Intelliport Base
When not in use, a clean and disinfected Intelliport Base should remain on the Charger.
NOTE
Do not place an Intelliport Base in storage without first cleaning and disinfecting
according to Hospital policy.
NOTE
For hospitals that keep a spare Intelliport Base in the OR, be sure to periodically swap
out Intelliport Base to ensure it is fully charged.
54
Intelliport Sensor
Intelliport Sensors are stored in the sterile packaging.
Intelliport Sensors have a “Use By” date to ensure sterility. Discard Intelliport Sensors
that have not been used by their Use By date.
Maintenance
Components of the Anesthesia System do not require user maintenance. There are no user serviceable
parts. Contact Technical Support in the event a Tablet computer or Intelliport Base is not functioning
properly.
Administration and Service
To Be Determined
55
Section XIII. Appendix
Appendix A Intelliport Technical Specifications
Specification
Description
Fluid connection
2 ports, Luer lock type fittings
Volume measurement accuracy
± 5%
Injection port capacity
100 injections
Prime volume
5 mL
Dead volume /retained fluid
0.3 mL following injection
Exterior size (excluding tubing)
< 4.5 cubic inches
Weight
72 gm (Intelliport Base and Intelliport Sensor)
Operation on a Single charge
24 hours
Recharge speed
Up to 4 hours from <25%
Wireless range (Intelliport device)
5m
Operating Temperature
12˚ C ‐ 40˚ C (IFU014)
Operating Humidity
20% to 85% relative humidity (IFU 015)
Shipping and Storage Temperature
‐20˚ C ‐ 60˚ C
Shipping and Storage Humidity
15% to 90% relative humidity
56
Appendix B Disinfectant Agents
The following disinfectants are suitable for use with the Intelliport Base and Recharger.
Disinfectant
Type of disinfectant
Cavi Wipes 1 (By Metrex)
Alcohol‐based quaternary ammonium
Super Sani Cloth (purple top) (by PDI)
Alcohol‐based quaternary ammonium
57
Appendix C Standards
The Anesthesia System is intended for use under the supervision of healthcare professionals only. This is
a Class II medical device. The Anesthesia 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
58
Appendix D Glossary
The following terms are used in these Instructions for Use.
Configuration
The way the Anesthesia System is set up, or the assortment of components that
make up the Anesthesia System. The Gateway manages the configuration
settings. All Tablet Computers 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)
Encoded Syringes
Syringes having a special barcode identifier on the tip
Encoding
A special barcode identifier on the tip of prefilled syringes
Gateway
A software application that enables the Anesthesia System to function as an
enterprise device and information system. The Gateway provides a central hub
to which all Tablet computers connect via the hospital network. It also includes
an interface engine for the Anesthesia 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 Intelliport Sensor where the syringe attaches
Intelliport Base
The 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 Intelliport Base prior to each use.
Intelliport device
An intelligent injection port. It attaches to an injection site (“Y Site” or stop cock)
for manually administered IV injections. It is comprised of a Intelliport Sensor
and a Intelliport Base, which snap together prior to use.
Intelliport Sensor
A Intelliport Sensor is a sterile disposable device having an injection port and a
Luer connection. The Intelliport Sensor is supplied in a sterile package for single
patient use.
Luer‐lok
A standard fitting used for making leak‐free connections. A luer fitting that
securely locks together using threads.
Non‐encoded
syringes
Syringes that do not have special encoding on the tip. The Intelliport device
cannot identify the drug contents of this type of syringe.
Perioperative Drug
Library
The Anesthesia System operates using the hospital’s perioperative drug library.
The Gateway manages the drug library. When an unencoded syringe is attached,
the pick list is derived from the perioperative drug library.
Recharger
A separate Recharger recharges the battery in the reusable Intelliport Base prior
to each use.
Stand‐alone mode
System configuration that supports a paper anesthesia record
59
Tablet computer
A commercial Tablet computer with embedded software for the Anesthesia
System operation. It continuously captures and displays the medication
administration record (MAR) data from the Intelliport device 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.
60
Appendix E ASA Drug Category Color Schema
61
Appendix F Messages
Name & Trigger
Message Text
Clearing the Message
1.
Tablet computer software is unable to
verify its configuration settings (e.g.
no wireless to Gateway)
Software configuration or
formulary versions cannot be
verified. Using current settings.
Notify your system
administrator.
‐ Persists with boot up
screen.
Will timeout in 10
seconds.
2.
While the Tablet computer software is
receiving and updating the Tablet
computer software Configuration
Profile.
Updating DPM, configuration
to version [ xx ].
‐ Persists while updating
file(s)
While the Tablet computer software is
receiving and updating the Drug
Formulary.
Updating Formulary to version
[ xx ].
‐ Persists while updating
file(s)
Configuration update not successful
New configuration settings not
updated. Using current
settings. Notify your system
administrator.
‐ Persists with boot up
screen
Intelliport Base‐ End of Life ‐
Intelliport device transmits # of uses
upon synchronization.
Intelliport device has reached
its end of life
‐ OK clears the message
‐ Confirm (completes
patient association)
Drug connected or subsequently
identified matches a contraindicated
drug based on the patient’s allergy
Screen ‐“[Drug name] ‐
Potential Allergy Reaction”
Patient has a known allergy to :
[allergy description]
“ Severity:” [severity]
“Reaction:” [reaction]
‐ OK button
‐ Automatically upon
syringe disconnect if not
pushed.
Antibiotic redosing interval exceeds
configuration value for the antibiotic.
[ Antibiotic Drug Name] given
X.X hours ago. Consider
redosing.
‐OK button
‐Automatically upon
subsequent antibiotic
injection connected/
identified.
The drug connected or injected has
been identified as frequently diluted
in configuration.
“Press Here if [Drug Name] was
diluted before given.
‐ Pressing the Dilution
message text opens the
manual injection entry
screen with volume and
dose fields editable.
The drug connected or injected has
been identified as frequently mixed in
configuration.
“Press Here” if [Drug Name]
was mixed before given.
‐ Pressing the Mixed
message text opens the
manual injection entry
62
Name & Trigger
Message Text
Clearing the Message
screen with fields for a
second drug.
10
Tablet computer software receives
unmeasured in lieu of volume from
the Intelliport device
“Amount injected not
measured”. “Press Here” to
enter the volume given.
‐ Pressing the Not
Measured message text
opens the manual
injection entry screen
with cursor focus on
volume field.
11
Intelliport device transmits a low
battery message
Low Intelliport battery (10%
remaining). Replace Intelliport
Base.
‐Automatically upon
Intelliport
unsynchronization or
Intelliport Base
replacement.
12
Intelliport device transmits a powering
down message
Low Intelliport battery.
Intelliport device powered
down.
‐Automatically upon
synchronization of
Intelliport device having
low battery.
13
Tablet computer has less than 20
minutes of power remaining
Low Tablet computer battery.
(10% remaining).
‐ Automatically when
Tablet computer on AC
power
14
Tablet computer software powering
down message
Low Tablet computer battery.
Tablet computer powering
down.
N/A
15
An Intelliport device is no longer
communicating with the Tablet
computer software after 5 seconds of
polling by the Tablet computer
software
Intelliport wireless connection
lost.
‐ Automatically upon
Intelliport
synchronization of same
serial number Intelliport
Sensor/Intelliport Base.
16
An Intelliport device has been
connected communicating with the
Tablet computer software after polling
by the Tablet computer software.
Intelliport wireless connection
restored.
‐ 1 minute timeout.
17
Intelliport error condition transmitted
to Tablet computer software
Intelliport error occurred.
Replace Intelliport Base.
‐ Press ”Clear” if
resolved
18
Intelliport error condition transmitted
to Tablet computer software
Tablet computer error
occurred. Restart Tablet
computer.
‐ OK button.
‐ Press “Clear” if
resolved
19
Tablet computer software error
condition present
Tablet computer error
occurred. Restart Tablet
computer
‐OK button
‐ Press “Clear” if
resolved
20
User presses Shut Down button with
no Intelliport devices synchronized.
Tablet computer shutting
down.
N/A
63
Name & Trigger
Message Text
Clearing the Message
21
User presses the Shut Down button
while an Intelliport device is
synchronized.
Shut Down the Tablet
computer and disconnect the
Intelliport device?
Yes – continue with
shutdown
No – cancel shutdown
22
User presses Print button on
Reporting Screen
Printing to XXX printer.
N/A
23
Failed login. User Name and Password
combination not valid
Text provided by Gateway or
Next login attempt
“Incorrect Password. Re‐enter”.
24
Dose exceeds ordered Dose
“Check dose on order”
Syringe is disconnected
25
Intelliport Sensor not primed. No
Sensor signal at initial Intelliport
Sensor attachment
“Prime Intelliport Sensor
before use”
Intelliport Sensor signal
level achieved.
26
Air detected in the Intelliport Sensor.
Occurs after proper priming with fluid
and air entrapped in the Intelliport
Sensor.
“Air detected in the Intelliport
Sensor”.
Intelliport Sensor signal
level achieved.
(returned)
64
Appendix G Accessories

Charger (part number 2284) ‐ This accessory is used to recharge the Intelliport Base in
preparation for reuse.

Radio (part number 2285) – This accessory is used by the Tablet computer to communicate with
Intelliport devices.
65
Appendix H Radio Frequency Wireless Technology
There are two wireless technologies used in the Anesthesia System as depicted in Figure X below.
Hospital
Wireless
Network
Intelliport
2.4 GHz. - Medication administration data
to/from Intelliport to Tablet Computer
Gateway
Tablet Computer
802.11 - Clinical Data
to/from Tablet to Gateway
The radio frequency (RF) signal power has been limited to a very low level to negate any
electromagnetic potential interference in co‐existence with other medical devices. Both wireless
technologies utilized have been approved for use by the (Federal Communications Commission) FCC and
meet Federal EMC and EMI guidelines. In the event of a potential signal loss of these RF
communications a “lost wireless link message” will be displayed on the Tablet computer to inform the
operator. The Tablet computer will indicate when communications are resumed. Information on proper
set‐up, configuration and performance with the Hospital Network is provided at time of system
installation. No set‐up is required for Intelliport device to Tablet computer communications.
Confirmation of appropriate patient identification is required.
Other medical equipment such as an electrosurgical unit (ESU) may briefly interfere
with these wireless communications. Communications should automatically resume
after the interference and lost messages will be resent. The Tablet computer will
indicate when lost communications exist. The Intelliport status indicator will double
blink when communication with the Tablet computer is lost.
Intelliport to Tablet computer
The Tablet computer uses an Intelliport Radio to wirelessly communicate with the Intelliport device
using an RF signal at 2.4 GHz to form a local medical device network. A number of Intelliport devices
and Tablet computers may be used in the same vicinity such as a Pre‐operative care area or a PACU. A
license has been issued by the Federal Communications Commission (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 Intelliport
device and the Tablet computer 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.
Intelliport devices using proprietary 2.4GHz technology are associated (linked) with specific patients
using the Tablet computer IEEE standards based on 802.11a/b/n (2.4GHz‐5GHz) technology. The User
identifies the Intelliport Sensor by serial number and selects a specific patient from the hospital’s patient
66
listing. All medication administration data from the Intelliport device 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 Intelliport device and transferred to the Tablet computer when communications are
resumed.
Tablet computer to Gateway through the Hospital Network
The Tablet computer 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
computer 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 Tablet computers 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 or infusion. Actual medication and fluid administration
data is sent to the Gateway and accompanied database for recordkeeping. Once recorded on the
Gateway and accompanied database this data is automatically available in other care areas when the
patient is transferred and the Intelliport device is wirelessly connected to a Tablet computer.
Summary of IEC 60601‐1‐2 Testing and Specifications
Specifications
Technology Type
Intelliport to Tablet computer
Tablet computer to Hospital
Network and Gateway
2.4 GHz proprietary messaging
802.11 a b, g, n secure wireless
connection with the correct quality of
service (QoS)
Effective transmission
distance
10 meters or less
Xx meters to hospital wireless access
point (WLAN AP)
Data throughput and
latency
Real‐time information, no delays
Subject to hospital network
performance
Lost Communications
Message on the Tablet
computer display
“Intelliport communication lost”
“Gateway communication lost”
Limitations
3 Intelliport devices to one Tablet
computer
200 Tablet computers to Hospital
Network and Gateway
FCC License
####
####
Limitations found during
testing to IEC 60601‐1‐2
Xxxx
Not tested – conforms to IEEE 802.11
standards.
Effective Power
67
Quality of Service
Wireless Coexistence
Security of wireless
signal/data
EMC information
68
Appendix I Reference Documents
Available documentation and training for the Anesthesia System includes:
Order Number
Document Name
2300
Anesthesia System Instructions for Use
XXXXX
Anesthesia System Quick Reference Cards
XXXXX
User Training Video and DVD
69
Appendix J Description of Symbols
The following symbols are used by the Anesthesia System.
Symbol
Description
Warnings
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!
Identifies the component manufacturer
Keep dry
Upper temperature limit
Expiration Date, end of shelf life December, 2013
Lot number
Sterile
EO
Supplied Sterile, Ethylene Oxide gas
70
Becton Dickinson
1 Becton Drive
Franklin Lakes, NJ 07417
Phone: (xxx) xxx‐xxxx
Fax: (xxx) xxx‐xxxx
Revision Date: 2/21/2013
Part No.:
2300_R1 FCC‐IC
71

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