ivWatch 400 User manual

TO AID IN INTRAVENOUS INFILTRATION DETECTION
User Manual
Rx Only
MODEL 400

2
DISCLAIMER
ivWatch, LLC, verifies that the content in this document is correct and
accurate, reflecting the features of the product available at the time
of writing. However, the content is subject to change without notice.
Typographical errors; changes to screens or images; or other, minor
device changes may occur that should not affect the understanding
or operation of this device. All dimensions and values are approximate.
NOTE : For the most current release of this manual, refer to the online
version on the ivWatch website at www.ivwatch.com/manuals.
TRADEMARKS AND PATENTS
ivWatch® is a registered trademark of ivWatch, LLC.
All rights reserved. © ivWatch, LLC, 2017
Patents:
US 7826890
US 9326686
http://www.ivwatch.com/patents/
Part No. ML-0000866 REV.14
For more information, please contact:
ivWatch, LLC
1100 Exploration Way, Suite 209
Hampton, VA 23666
Tel: [phone]
Fax: [phone]
www.ivWatch.com

01 DEVICE DESCRIPTION 4
How Monitoring and 6
Detection Work
System Components 7
Safety Information 8
Indications 8
Intended Use 8
Contraindications 8
Warnings 9
Precautions 10
02 INSTRUCTIONS FOR USE 12
Using the Monitor 13
Setting Up a Monitoring Run 14
Monitoring a Patient 20
IV Monitoring: Watches and Warnings 21
Patient Monitoring Using Battery Power 23
Ending a Monitoring Run 24
Continuing a Monitoring Run 25
with an Existing Patient
Turning Off the Monitor 30
History and Event Data 31
03 TROUBLESHOOTING 32
Testing the Sensor 33
Troubleshooting Table 35
Error Message Table 36
04 APPENDICES 40
Options Screen 41
Cleaning the System for Reuse 44
Preventative Maintenance 45
Specifications 46
Symbols on the Product or Package 55
Disposal 56
MRI Safety Information 57
CONTENTS
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NOTE : For the most current release of this manual,
refer to the online version on the ivWatch website at
www.ivWatch.com/manuals.

01
DEVICE
DESCRIPTION
DEVICE DESCRIPTION 5
HOW MONITORING AND 6
DETECTION WORK
SYSTEM COMPONENTS 7
SAFETY INFORMATION 8
INDICATIONS 8
INTENDED USE 8
WARNINGS 9
PRECAUTIONS 10

MODEL 400 PATIENT MONITOR
USER MANUAL /
01 DEVICE DESCRIPTION
DEVICE DESCRIPTION
The ivWatch® Model 400 provides
continuous monitoring of peripheral
IVs to aid in the detection of conditions
that may indicate an intravenous (IV)
infiltration event. The monitoring
system is an adjunct to the healthcare
practitioner and is in no way intended to
replace regular assessment of the IV site
or any other standardized practice for IV
administration and management.
The complete system includes the
monitor, a reusable sensor cable, an
AC adapter, and a disposable adhesive
sensor receptacle used to position and
secure the sensor on the patient.
5

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MODEL 400 PATIENT MONITOR
USER MANUAL /
01 DEVICE DESCRIPTION
DEVICE DESCRIPTION
HOW MONITORING
AND DETECTION WORK
The monitoring system uses visible and near-infrared (IR) light to measure slight
changes in the optical properties of tissue near the IV insertion site. A sensor placed
adjacent to the IV insertion site on the patient’s hand or forearm takes measurements.
The monitor provides notification (audible and visual) when it detects changes
consistent with IV fluid leaking and pooling in the tissue adjacent to the IV.

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MODEL 400 PATIENT MONITOR
USER MANUAL /
01 DEVICE DESCRIPTION
DEVICE DESCRIPTION
SYSTEM COMPONENTS
1. Patient Monitor
2. Adapter and Power Cord
3. Sensor Cable and Receptacle
4. Reference Card (not shown)
1
2
3

8
MODEL 400 PATIENT MONITOR
USER MANUAL /
01 DEVICE DESCRIPTION
DEVICE DESCRIPTION
INDICATIONS FOR USE
The ivWatch Model 400 is indicated for the detection of subcutaneous infiltrations and extravasations of 10 cc or less of optically
clear infusates, as an adjunctive device to the clinical evaluation in the healthcare setting of adults and pediatrics with peripherally-
inserted catheters (PIVs). The device is indicated to assess patients for subcutaneous infiltrations and extravasations but should
not serve as a substitute for regular clinician assessment of the PIV site. The ivWatch Model 400 is intended for use by healthcare
practitioners who have been trained in the use of the device.
INTENDED USE
The ivWatch Model 400 is intended to aid in the detection of infiltrations and extravasations during peripheral IV infusion therapy in
pediatric and adult patients. The user profile is healthcare practitioners who are experienced in IV administration and management
and located at hospitals and similar medical care facilities.
CONTRAINDICATIONS
The ivWatch Model 400 is not intended for use with power injectors. The ivWatch Model 400 may have reduced sensitivity if used with
dark, colored or cloudy fluids.
The following indications, warnings, and precautions are presented by
topic and should be reviewed in their entirety prior to using this monitor.
SAFETY INFORMATION

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MODEL 400 PATIENT MONITOR
USER MANUAL /
01 DEVICE DESCRIPTION
DEVICE DESCRIPTION
USE OF THE DEVICE AS AN AID TO DETECTION OF SUBCUTANEOUS IV INFILTRATION
The ivWatch Model 400 must only be used as an adjunct to regular assessments of IV placement by clinicians.
The device cannot serve as a substitute for regular clinician assessment, and should not be used in the absence of standard clinical
supervision and procedures that are typically utilized (i.e. when the device is not used) for detection of subcutaneous infiltrations and
extravasations.
EXPLOSIVE ENVIRONMENTS
This device is not for use in an explosive environment.
OXYGEN-RICH ENVIRONMENTS
Do not use the monitor in an oxygen enriched environment, i.e. oxygen tents, hyperbaric chambers. Oxygen enriched environment
does not refer to patients on breathing tubes.
IMMERSION IN LIQUID
Do not immerse the monitor or sensor cable in liquid. The monitor must be disconnected and the sensor removed from the patient
prior to patient bathing to prevent electrical shock. Other than for bathing, the monitoring run should be stopped only when the IV
is removed.
INDOOR USE
The monitoring system is designed for indoor use and should not be exposed to extreme temperatures, humidity, or moisture.
See “Specifications” on page 46 for additional information.
MAGNETIC RESONANCE IMAGING (MRI)
The ivWatch Patient Monitor poses a safety hazard if brought into the MRI environment. The Receptacle contains no ferromagnetic
materials. Non-clinical testing has demonstrated that the ivWatch Sensor Cable is MR Conditional. Please see the MRI Safety
Information section of this manual for more information.
USE OF INTACT SKIN ONLY
The ivWatch sensor receptacle and sensor cable should only make contact with intact skin.
CHANGES OR MODIFICATIONS TO PRODUCT
Changes or modifications to the ivWatch Model 400 not expressly approved by ivWatch could void the user’s authority to
operate the equipment.
WARNINGS

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MODEL 400 PATIENT MONITOR
USER MANUAL /
01 DEVICE DESCRIPTION
DEVICE DESCRIPTION
IV INFUSIONS OF DARK, COLORED, OR CLOUDY FLUIDS
The device has not been tested for monitoring infusions of dark, colored or cloudy fluids (for example, TPN, rifampin, and multi-
vitamin “banana bags”). Dark, colored or cloudy fluids block light and may reduce the system’s sensitivity.
CABLE POSITIONING
Route the sensor cable and power cord to reduce the possibility of equipment or patient entanglement. Place excess cable length so
that it does not pose a hazard.
CLEANING
Do not immerse the monitor or the sensor in liquid. Always disconnect the monitor from the power supply prior to cleaning. Clean the
system components as directed in “Cleaning the System for Reuse” on page 44.
COMPATIBILITY
Use only components that are manufactured by ivWatch, LLC. Monitors, sensors, and receptacles made by other manufacturers have
not been tested and may reduce the system’s sensitivity.
DISPOSAL
Dispose of the packaging and material components according to local regulations.
EQUIPMENT MODIFICATION
Do not modify components of the monitoring system (eg, remove the ground pin on the electrical plug). Modifications could result
in increased electrical hazard, unknown changes in product performance, and potential risk to the user and patient.
EXCESSIVE LIGHT
Detection of infiltration events depends on the transmission of light through the patient’s skin; as such the use of the monitoring
system is preferably in normal to low-light conditions. Ambient light is measured continuously by the device, and if above a specified
threshold, shall issue an ‘Excessive Light’ notification.
LIGHT-BLOCKING BARRIERS
Do not place an opaque dressing under the sensor receptacle. Light-blocking barriers (eg, a bandage) between the patient’s skin and
the sensor may reduce the system’s sensitivity.
PRECAUTIONS