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

11
02
INSTRUCTIONS FOR USE

12
Mute button silences
an audible tone
Descriptions identify an
action that can be performed
Function buttons perform
the action listed above them
Sensor Test Port is where the
sensor tip of the Fiber Optic
Sensor Cable is placed for
testing or storage
Sensor Connector Port
connects the Fiber Optic
Sensor Cable to the monitor
Extension Module allows use
of the electronic SmartTouch
Sensor
USB Port downloads data
Sensor Connector Port connects
the electronic Patient Cable to the
monitor
IV Check button records when
the IV site is inspected
Power button turns the
monitor on or o
Instructions for Use
ivWatch®INSTRUCTIONS FOR USE
The ivWatch Patient Monitor and Extension Module shown below contain the soware and user
interface for the system. The components should be inspected for visible damage prior to use.
USB Port
Data Port
Wire Bale
Speaker
Pole Clamp
Power Port

13
USING THE IVWATCH PATIENT MONITOR
The ivWatch Patient Monitor attaches to an IV pole and may be
placed on the pole at a height of up to 5.5 feet. A grounded wall
outlet is required to recharge the monitor battery.
Note:
The Power Port, Data Port, and USB
Port are on the back of the ivWatch
Patient Monitor. See “Specica-
tions” section for additional infor-
mation about the monitor ports and
connectivity.
The ivWatch Patient Monitor can be used on battery power for
limited periods of time, but during normal use, the monitor
should be powered by the medical-grade AC power supply. The
ivWatch Patient Monitor should be fully charged prior to its first
use. Inspect the components for visible damage prior to use.
See “Patient Monitoring Using Battery Power” section for more
information.
The volume and display brightness settings can be changed on
the Options screen. These settings are demonstrated when the
ivWatch Patient Monitor is turned on. The time and date can also
be changed prior to beginning a monitoring run. Historical event
data can be transferred to a USB drive.
Options Menu
Use the “up” and “down” arrow buttons to highlight the desired
option to change. Press the “Select” button to go to the highlight-
ed option screen. Press the “Cancel” button to return to the pre-
vious screen.
Options Menu screen
Time & Date Menu screen
Modifying the Time & Date
To modify the Time & Date, select “Time & Date” in the Options
Menu. Press the “Select” button when “Set Time & Date” is high-
lighted.
The time cannot be changed aer a monitoring run has started.
“Hour” and “Minute” buttons are upward-adjustable only.
ivWatch®INSTRUCTIONS FOR USE

14
Press the “Next” button to accept the displayed time and view
the Month/Day screen. “Month” and “Day” buttons are up-
ward-adjustable only.
Changing the Time & Date Format
From the Time & Date Menu, select “Time & Date Format” to
choose the desired time format (12-hour or 24-hour) and date
format. Use the “up” and “down” arrow buttons to select the de-
sired time format.
Press the “Select” button to accept the change and proceed to
the Date Format screen or the “Cancel” button to return to the
Options screen without changing the time format.
Press the “Next” button to accept the displayed month and day
and to view the Year screen.
Use the “up” and “down” arrow buttons to select the year. Press
the “Done” button to accept the displayed year and to return to
the Time & Date Menu screen and then press the “Cancel” button
to return to the Options Menu screen.
ivWatch®INSTRUCTIONS FOR USE

15
Use the “up” and “down” arrow buttons to select the desired date
format.
Press the “Select” button to accept the change and proceed to
the Time & Date Menu screen or the “Cancel” button to return to
the Time & Date Menu screen without changing the date format.
Auto-Adjustment for Daylight Savings
Press the “up” and “down” arrow buttons to highlight the
desired option to enable or disable automatic daylight savings
time adjustment (US Only).
Press “Select” to return to the Time & Date Menu screen and then
“Cancel” to return to the Options Menu screen.
Changing the Volume Setting
To modify the Volume, select “Volume” in the Options Menu.Use
the “up” and “down” arrows buttons to select the volume level.
Volume is demonstrated when highlighted. There are five volume
levels. Press the “Save” button to accept the change or the “Can-
cel” button to return to the Options screen without changing the
volume level.
ivWatch®INSTRUCTIONS FOR USE

16
Changing the Screen Brightness
To modify the Brightness, select “Brightness” in the Options
Menu. Use the “up” and “down” arrow buttons to select the
brightness level. Brightness is demonstrated when highlighted.
Press the “Save” button to accept the change or the “Cancel” but-
ton to return to the Options screen without changing the screen
brightness.
Patient Monitoring Using Battery Power
The ivWatch Patient Monitor can be used on battery power for at
least 5 hours when fully charged. During normal operation, the
monitor should be powered by the medical-grade AC power sup-
ply included in the package.
While the monitoring run is on battery power, note the remaining
charge on the battery to ensure that power loss does not inter-
rupt the monitoring run.
Note:
Low-battery messages are accom-
panied by audible tones; pressing
the “Dismiss” button removes the
notication message and mutes the
audible tone.
The following message appears when there is approximately
10% of battery charge remaining:
When approximately 5% of battery charge remains, the following
message appears:
Press the “Dismiss” button to clear these notification messages.
ivWatch®INSTRUCTIONS FOR USE

17
ivWatch®INSTRUCTIONS FOR USE
Setting Up External Communications
External Communications can be setup with third-party systems
to sync real-time monitoring historical event data, which can
then be incorporated into central monitoring and documenta-
tion solutions.
Procedure:
1. Connect the ivWatch Data Cable to the Data Port in the back
of the ivWatch Patient Monitor.
2. See partner system user manual for additional information
regarding connection settings and equipment. If necessary,
connect any additional cables or adapters to the ivWatch
Data Cable.
3. On the ivWatch Patient Monitor, select “External Communi-
cations” in the Options Menu and use the “up” and “down”
arrow buttons to highlight and select “Enable.”
Patient identication data is not
entered into the ivWatch Patient
Monitor and therefore no patient
specic data is stored.
Note:
4. On the next screen, use the “up” and “down” arrows to high-
light and select the appropriate partner communications
protocol from the table on the next page.
5. Verify that the sync icon located at the top le of the screen, is
visible and not blinking.

18
Partner
System
Communica-
tions
Protocol
Selection
Supplementary
Information
Firmware
Version
Philips
IntelliBridge
EC10
ivWatch Cus-
tom Protocol
Use IntelliBridge
EC5 cable
to connect the
ivWatch Data
Cable to the
Philips
IntelliBridge
system.
4.2.0 or
higher
* If your communications partner is not listed above, please refer to the
most current release of the user manual at www.ivWatch.com.
ivWatch®INSTRUCTIONS FOR USE
Shutdown screen
To shut the monitor o, complete the following steps:
Turning O the ivWatch Patient Monitor
1. Press and hold the “Power” button. The Shutdown screen
appears.
2. Press the “Yes” button to turn o the ivWatch Patient Moni-
tor (and end a monitoring run in progress).
Note:
The monitoring history is stored and
can be seen on the “History” screen.
See “Historical Event Data” section
for information about reviewing and
saving data.
3. Unplug the electrical plug from the grounded wall outlet,
coil the power cord, and place it on the wire bale.
4. If monitoring for this patient is finished, see “Cleaning the
System for Reuse” section.
For temporary storage in patient rooms and hospital work areas:
1. Do not disconnect any cables or power plug from the
ivWatch Patient Monitor.
2. Carefully coil the Fiber Optic Sensor Cable or Patient Cable
loosely around the wire bale.
For long-term storage:
1. Disconnect any cables or power plugs from the ivWatch Pa-
tient Monitor.
2. Carefully coil the Fiber Optic Sensor Cable or Patient Cable
loosely around the wire bale.
3. Store the components in a dry environment.

19
MONITORING IVS WITH IVWATCH SENSORS
There are two sensor options when monitoring an IV with the
ivWatch system. One option is the Fiber Optic Sensor Cable, which
is a reusable 10-foot fiber optic cable that can monitor for up to
240 hours. A single-use Sensor Receptacle is used to attach the Fi-
ber Optic Sensor Cable to the patient. Another sensor option is the
SmartTouch Sensor, which is a single-use sensor that connects to a
12-foot reusable Patient Cable.
ivWatch®INSTRUCTIONS FOR USE
To set up a monitoring run, complete the following steps:
1. Use the clamp to securely mount the ivWatch Patient Moni-
tor on the IV pole.
2. Position the monitor so that the display is easily viewed.
3. Press the “Power” button on the front of the monitor. The
Start-up screen appears briefly.
Start-up Screen
Monitoring with the Fiber Optic Sensor
Cable
Setting up a monitoring run
Begin a monitoring run aer the IV has been placed and the IV
site is in accordance with facility protocols for IV administration
and management.
Dark, colored, or cloudy fluids may
reduce the system’s sensitivity.
Do not place an opaque dress-
ing under the Sensor Receptacle.
Light-blocking barriers (e.g., ban-
dages and occlusive dressings) be-
tween the patient’s skin and the
sensor may reduce the system’s sen-
sitivity.
Do not place the sensor over tat-
tooed, bruised, or scarred tissue as
these conditions may reduce the
system’s sensitivity.
Caution:
Note:
Allow the ivWatch Patient Monitor to
run in monitoring mode for at least 1
minute before starting the infusion.
This allows the monitor to take criti-
cal baseline measurements.
4. If the monitor does not turn on, insert the power plug into
the power port on the back of the monitor and connect the
electrical plug to a grounded wall outlet. Verify that the bat-
tery symbol shows that the monitor is charging.
The volume and display brightness settings are demonstrated
when the ivWatch Patient Monitor is turned on.
5. Check the time, date, and battery status as displayed on the
top of the Home screen.
Note:
During normal operation, the moni-
tor should be plugged into a power
source, but for ambulatory activi-
ties, a fully charged monitor can be
used on battery power for limited
periods of time. See “Patient Moni-
toring Using Battery Power” section.
Note:
Volume, brightness, date, and time
settings can be changed on the
Options screen. Follow the instruc-
tions on the display or see “Options
Menu” section.

20
Note:
The date and time should be verified
prior to beginning a monitoring run.
The time cannot be changed aer
a monitoring run has started. The
Time & Date options are not avail-
able during a monitoring run to pre-
vent errors in data collection.
Caution:
If you are using a new Fiber Optic
Sensor Cable (one that was just re-
moved from the packaging), be sure
to remove any dust covers which are
attached to the optical interface of
the fibers (on the proximal end) pri-
or to inserting that end of the Fiber
Optic Sensor Cable into the sensor
port on the ivWatch Patient Monitor.
ivWatch®INSTRUCTIONS FOR USE
b. Confirm that the IV site is new by pressing the “Yes” button.
8. To start monitoring a new IV site:
a. Press the “New” button to start a monitoring run with a new
IV site.
7. Press the “Start” button to begin the monitoring run.
6. Connect a Fiber Optic Sensor Cable to the ivWatch Patient
Monitor (as shown).