ivWatch 400 User manual

User Manual
1
MODEL 400 PATIENT MONITORING SYSTEM
RX ONLY
TO AID IN INTRAVENOUS INFILTRATION DETECTION

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 aect the understanding or operation of this device.
Note: For the most current release of this manual, refer to the digital version on the ivWatch website
at www.ivWatch.com.
Trademarks
ivWatch®word mark and logos are registered trademarks owned by ivWatch, LLC.
The SmartTouchTM word mark is owned by ivWatch, LLC.
All rights reserved. © ivWatch, LLC, 2020
Part No. ML-1001030 Rev. 04
For firmware version 5.1.1 and higher
To request a manual for a previous firmware version, contact ivWatch Technical Support
at 855-489-2824, Option 2 or email at [e-mail].
For more information, please contact:
ivWatch, LLC | 700 Tech Center Parkway, Suite 300 Newport News, VA 23606, USA
Tel: [phone] | Fax: [phone] | www.ivWatch.com
Australian Patent No. 2017245353
European Patent No. 2830487
Belgium Patent No. EP2830487
Switzerland Patent No. EP02830487
Germany Patent No. 602013057210.0
France Patent No. EP2830487
United Kingdom Patent No. EP2830487
Italy Patent No. 502019000074894
Netherlands Patent No. EP2830487
Japanese Patent Registration No. 6386643
Japanese Patent Registration No. 6396904
Japanese Patent Registration No. 6599948
Japanese Patent Registration No. 6599949
Japanese Patent Registration No. 6673884
United States Patent No. 7826890
ivWatch Patient Monitor, Extension Module, and Sensor Receptacle
Fiber Optic Sensor Cable, SmartTouch Sensor, and Patient Cable
Indicates the authorized representative in the European Community
CE Symbol
Australian Patent No. 2013257212
Australian Patent No. 2018211312
Canadian Patent No. 2867135
Japanese Patent Registration No. 6306572
Japanese Patent Registration No. 6555762
European Patent No. 2830488
Belgium Patent No. EP2830488
Switzerland Patent No. EP02830488
Germany Patent No. 602013042197.8
France Patent No. EP2830488
United Kingdom Patent No. EP2830488
Netherlands Patent No. EP2830488
Japanese Patent Registration No. 6301961
Japanese Patent Registration No. 6659645
United States Patent No. 9326686
Australian Patent No. 2013316021
Applicable ivWatch Devices
Patents
ivWatch, LLC is the owner of the following patents and other patents pending in the United States of
America and other jurisdictions elsewhere in the world:

Table of Contents
01 DEVICE DESCRIPTION 5
How Monitoring and Detection Work 6
ivWatch System Components 6
Safety Information 7
Warnings 7
Precautions 8
Clinical Device Sensitivity 9
02 INSTRUCTIONS FOR USE 11
Using the ivWatch Patient Monitor 13
Options Menu 13
Modifying the Time & Date 13
Changing the Time & Date Format 14
Auto-Adjustment for Daylight Savings 15
Changing the Volume Setting 15
Changing the Screen Brightness 16
Patient Monitoring Using Battery Power 16
Setting Up External Communications 17
Turning O the ivWatch Patient Monitor 18
Monitoring IVs with ivWatch Sensors 19
Monitoring with the Fiber Optic Sensor Cable 19
• Setting Up a Monitoring Run 19
• Ending a Monitoring Run 24
Monitoring with the SmartTouchTM Sensor 25
• Setting Up a Monitoring Run 25
• Ending a Monitoring Run 28
IV Monitoring 30
Yellow Notifications 31
Red Notifications 32
Historical Event Data 33
03 TROUBLESHOOTING 35
Testing the Fiber Optic Sensor Cable 36
Troubleshooting Table 37
Error Message Table 39
04 APPENDICES 43
Transferring Data to USB Drive 44
System Information 44
Cleaning the System for Reuse 44
Cleaning and Disinfection of Reusable Components 45
Preventative Maintenance 45
Specifications 47
Disposal 52
MRI Safety Information 52
Symbols on the Product or Package 54

4

5
01
DEVICE DESCRIPTION

6
Device Description
The ivWatch Model 400 Patient Monitoring System provides continuous monitoring of peripheral
intravenous (IV) sites to aid in the detection of conditions that may indicate an 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.
HOW MONITORING AND DETECTION WORK
The ivWatch Patient Monitoring System uses visible and near-infrared (IR) light to measure changes
in the optical properties of tissue near the IV insertion site. A sensor placed adjacent to the patient’s
IV site takes measurements of tissue fluid volume changes. The monitoring system provides notifi-
cations (audible and visual) when it detects changes consistent with IV fluid leaking and pooling in
the tissue adjacent to the IV.
ivWatch®DEVICE DESCRIPTION
IVWATCH SYSTEM COMPONENTS
1. ivWatch Patient Monitor
2. Extension Module
3. Fiber Optic Sensor Cable
4. Sensor Receptacle
5. Patient Cable
6. SmartTouch Sensor
7. Data Cable
8. Adapter and Power Cord
1
2
8
5
3
4
6
7
Sm a rt Tou chTM

7
SAFETY INFORMATION
The following indications, warnings, and precautions are presented by topic and should be
reviewed in their entirety prior to using the ivWatch Model 400 Patient Monitoring System.
Indications for use
The ivWatch Model 400 is indicated for the detection of subcutaneous infiltrations and extravasa-
tions 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 prac-
titioners 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.
WARNINGS
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 ivWatch Patient 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 any of the ivWatch Model 400 components in liquid. The ivWatch Patient
Monitor must be disconnected and the sensor removed from the patient prior to patient bathing to
prevent electrical shock. Other than for bathing and MRI, the monitoring run should be stopped
only when the IV is removed.
Indoor use
The ivWatch Patient Monitoring System is designed for indoor use and should not be exposed to ex-
treme temperatures, humidity, or moisture. See “Specifications” section for additional information.
Magnetic resonance imaging (MRI)
The ivWatch Patient Monitor, Extension Module, Patient Cable, and SmartTouch Sensor pose a safe-
ty hazard if brought into the MRI environment. The Sensor Receptacle contains no ferromagnetic
materials. Non-clinical testing has demonstrated that the Fiber Optic Sensor Cable is MR Conditional.
Please see the “MRI Safety Information” section of this manual for more information.
ivWatch®DEVICE DESCRIPTION

8
PRECAUTIONS
IV infusions of dark, colored, or cloudy fluids
The device has not been tested for monitoring infusions of dark, colored, or cloudy fluids. Dark,
colored, or cloudy fluids block light and may reduce the system’s sensitivity.
Cable positioning
Route all cables and power cords to reduce the possibility of equipment or patient entanglement.
Position excess cable length so that it does not pose a hazard.
Cleaning
Do not immerse any components of the ivWatch Model 400 Patient Monitoring System in liquid.
Always disconnect the ivWatch Patient Monitor from the power supply prior to cleaning. Clean the
system components as directed in “Cleaning the System for Reuse” section.
Compatibility
Use only components that are manufactured by ivWatch, LLC. Monitors, cables, sensors, and recep-
tacles 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 ivWatch Model 400 Patient Monitoring System (e.g., 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 ivWatch Patient Monitoring System is preferable in normal to low-light
conditions. Ambient light is measured continuously by the device, and if above a specified
threshold, the system will issue an ‘Excessive Light’ notification.
Light-blocking barriers
Do not place an opaque dressing under the Sensor Receptacle or SmartTouch Sensor. Light-block-
ing barriers (e.g., a bandage) between the patient’s skin and the sensor may reduce the system’s
sensitivity.
Patient movement
Minimize patient movement during a monitoring run to reduce the possibility of sensor displacement.
Prescription only
Federal law (USA) restricts this device to sale by or on the order of a physician.
Reuse
Do not reuse any of the components originally provided as a sterile product.
Use on intact skin only
The ivWatch Sensor Receptacle, Fiber Optic Sensor Cable, Patient Cable, and SmartTouch Sensor
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.
ivWatch®DEVICE DESCRIPTION

9
Sensor cable damage
Do not kink or compress the sensor cables. Kinking or compressing the cables could damage the
sensor, activating a notification on the ivWatch Patient Monitor to test the Fiber Optic Sensor
Cable. Kinking or compressing the Fiber Optic Sensor Cable could also result in the exposure of
glass fibers which can pose a safety risk.
Sensor interference
Sensor placement should not be on the same arm as a blood pressure cu.
Sterilization
Do not sterilize any components of the ivWatch Model 400 Patient Monitoring System. Sterilization
may damage or reduce the system’s sensitivity.
Tattooed, scarred, or bruised tissue
Do not place the Sensor Receptacle or SmartTouch Sensor over tattooed, scarred, or bruised tissue
as these conditions may reduce the system’s sensitivity.
Trained healthcare practitioner
Do not rely solely on the ivWatch Patient Monitoring System for IV monitoring. All monitoring runs
should be managed by a trained healthcare practitioner who is experienced in IV administration
and management. The ivWatch Patient Monitoring System is not intended to replace IV monitoring
by a trained healthcare practitioner.
Stacking the ivWatch Model 400 Monitor with other equipment
If the ivWatch Model 400 is adjacent or stacked with other equipment, monitor all the equipment to
verify they are operating normally.
ivWatch®DEVICE DESCRIPTION
CLINICAL DEVICE SENSITIVITY
In controlled clinical studies, the ivWatch Model 400 Patient Monitoring System demonstrated a
detection sensitivity of 96% of 10 cc or less of fluid in adults and adolescents 18 years of age and
older. In a clinical study in a pediatric healthcare setting, the ivWatch Model 400 Patient Monitoring
System detected 80% of infiltrations before detection by a trained clinician.

10 ivWatch®DEVICE DESCRIPTION