Tidal InSee User manual

INSTRUCTIONS FOR USE
Ver. 2.0

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© 2023 by Tidal Medical Technologies. ALL RIGHTS RESERVED.
Manufactured by
Tidal Medical Technologies
44 Montgomery St, Suite 2-155, San Francisco, CA 94104
T| 214.864.5629
Contact Information: [e-mail]
www.TidalMed.Tech
No part of this text shall be reproduced or transmitted in any form or by any means,
electronic or mechanical, including photocopying, recording or by any informational
retrieval system without the express written permission of Tidal Medical Technologies.
The information in this manual is confidential and may not be disclosed to third parties
without prior written consent of Tidal Medical Technologies.
YOUR SERIAL NUMBER

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WELCOME.................................................................................4
GETTING STARTED WITH INSEE...........................................6
INSEE FEATURES......................................................................11
USING THE INSEE....................................................................15
CLEAN AND STORE................................................................24
SERVICE...................................................................................26
EXPECTED LIFE......................................................................26
DISPOSAL.................................................................................27
TROUBLESHOOTING............................................................28
SPECIFICATIONS....................................................................28
EMC SPECIFICATIONS...........................................................32
TABLE of CONTENTS

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Thank you for purchasing InSee from Tidal Medical Technologies. This User’ s Guide
contains important SAFETY and TECHNICAL information. To ensure your safety while
deriving the maximum benefit from the system, please review all the sections carefully
before using the InSee for the first time.
This User Guide contains important SAFETY and TECHNICAL information. Keep this
guide in a safe place to use as a reference. With proper care, your InSee system will
reward you with a trouble-free service life. If you need assistance setting up or using
your InSee, or if you need to report unexpected problems or events, please contact
Tidal Medical Technologies using the contact information on page 2.
The InSee User’s Guide uses different font styles and symbols to quickly and clearly
convey information:
• Standard text for information.
• Bold text to emphasize words.
NOTE: Shaded Notes like this one to add or emphasize information that may affect user actions.
WARNINGS IDENTIFY INFORMATION THAT MAY
IMPACT PATIENT OR USER SAFETY. IGNORING A
WARNING RISKS PATIENT OR USER INJURY.
CAUTIONS IDENTIFY INFORMATION THAT MAY
IMPACT EQUIPMENT SAFETY. IGNORING A
CAUTION RISKS DAMAGE TO EQUIPMENT.
WARNING
CAUTION
WELCOME
Document Symbols

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Li-ion
Manufacturer Direct Current
Manufacture Date Keep Dry
Reference Number Prescription Only
Serial Number Consult Instructions
for Use
Lot Number Caution
Type BF Equipment Warning
Recycle batteries
in accordance with
local, state & federal
regulations if possible.
Humidity Limitation
Temperature limit Atmospheric Pressure
Limitation
PRODUCT SYMBOL MEANING PRODUCT SYMBOL MEANING
Waste electrical and electronic equipment; do not dispose in household waste. Dispose of equipment in
accordance with all relevant local, state and federal regulations. Source: ISO15233-1
DEVICE & LABELING SYMBOLS

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NOTE: Read all instructions before using your InSee
InSee is an accessory to the Vyaire Medical’s AirLife incentive spirometer. InSee is in-
tended to increase the effectiveness of the Vyaire Medical’s AirLife incentive spirometer
by enabling continuous monitoring, enabling patient reminders, and enabling logging of
use related data. This device is only compatible with AirLife Volumetric Incentive Spi-
rometer - 2500 & 4000 mL, manufactured by Vyaire Medical. InSee is intended for use
in the Hospital environment by clinicians and patients. The device is non-invasive, reus-
able, and intended for use by one patient at a time.
USERS OF THE SYSTEM SHOULD HAVE THE ABILITY
TO READ AND UNDERSTAND ENGLISH LANGUAGE
USED IN THE MANUAL. WE RECOMMEND THAT THE
USERS OF THE DEVICE HAVE AN 8TH GRADE READING
LEVEL OR COMPARABLE.
InSee is intended for use by the patients who have been prescribed an Incentive Spirom-
eter by a physician. InSee users are clinicians and patients in the hospital environment.
WARNING
Document Symbols
Indications for Use
Intended Patient Population
GETTING STARTED WITH INSEE

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InSee monitors Incentive Spirometer usage by tracking the piston movement. Users
can adjust the volume target and alarm setting during the treatment. All recorded
measurements can be deleted by pressing the reset button. When the reset button is
pressed, all settings will be reverted back the default values.
IF ANY CONDITIONS EXIST THAT COULD CAUSE USE
OF INSEE TO PRESENT A RISK TO THE PATIENT,
INCLUDING THE FOLLOWING
DO NOT use the system except as directed by a physician. Including the following
conditions—do NOT use the system except as directed by a physician.
Conditions:
• Patients who cannot use the Incentive Spirometer
appropriately or require supervision at all times
• Patients who are noncompliant or do not understand
or demonstrate proper use of the device
• Very young patients or pediatrics with
developmental delay
• Hyperventilation
• Hypoxaemia secondary to interruption of oxygen
therapy
• Fatigue
• Patients unable to take deep breathe effectively due
to pain, diaphragmatic dysfunction, or opiate analgesia.
• Patients who are heavily sedated or comatose
• The device is not suitable for people with severe
dyspnoea.
Pre-Cautions:
• Hyperventilation may result from improper technique.
• There is potential for barotrauma in emphysematous
lungs.
• Discomfort may occur secondary to uncontrolled pain.
• Development of bronchospasm may occur in
susceptible patients. Close monitoring of patients with
hyper-reactive airways should be maintained.
WARNING
Method
Conditions and Pre-Cautions

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Tidal Medical Technologies is committed to providing an appropriate level of InSee
training before users begin to use the product for therapy sessions. Training may include:
• Assistance with fitting your InSee • Running your first therapy session
• Setting up and configuring your InSee • Trouble-shooting and general user experience issues
For more information, please contact Tidal Medical Technologies using the
contact information on page 2
WHEN USING ELECTRICAL PRODUCTS, ESPECIALLY WHEN
CHILDREN ARE PRESENT, BASIC SAFETY PRECAUTIONS
SHOULD ALWAYS BE FOLLOWED, INCLUDING THE
FOLLOWING IMPORTANT SAFEGUARDS. TO REDUCE THE RISK
OF BURNS, ELECTROCUTION, FIRE, OR PERSONAL INJURY,
FOLLOW THESE INSTRUCTIONS. FAILURE TO DO SO COULD
CAUSE PERSONAL INJURY OR EQUIPMENT DAMAGE.
• Use this product only for its intended use
as described in this manual.
• No modification of the equipment is
allowed.
• InSee should only be used with
the included accessories. Do not
connect unapproved accessories to the
InSee device.
• Read and follow all instructions for setup, use,
and cleaning of the InSee system. Failure to
do so could cause patient injury or equipment
damage.
• Federal law restricts this device to sale by or
on the order of a physician.
• If conditions exist that prohibit use of the
InSee system, do not use the device
• The potential for electrical shock exists with
electrical equipment.
• Make sure the position of the InSee system is
such that you can quickly, without obstruction,
disconnect the power cord from the main
power supply if necessary.
• If the display on the InSee Remote is faulty, do
not use the unit.
WARNING
Training
Safety Information
Use As Intended

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• Do not use the device near a heat source
such as a fireplace or radiant heater.
• Do not use the device in a dusty
environment.
• Do not use the device in a moisture-heavy
environment such as in the bathroom.
• Do not expose the unit to excessive
moisture or immerse it in water.
• If the InSee is wet or damp, do not plug
it into a power source to charge.
• Do not use the device below 0∫ C or
above +30∫ C.
• Do not use the device above 50 %
relative humidity.
Your Environment
Cleaning
• Spot clean only, using the instructions
in the Clean and Store section.

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• Do not use an extension cord to charge
InSee.
• Keep the USB power adaptor and power
cords away from heated surfaces.
• Never pull the InSee power cords or
cables over sharp edges or allow them to
kink or bind.
• Do not lift the InSee system by its
electrical cable.
• Never disconnect the power plug from an
electrical outlet with wet hands.
• Do not charge the InSee with anything
other than the included power supply
or USB-C cable in accordance with these
instructions. The use of any other power
supplies or cables may lead to improper
operation.
• Service and maintenance of your InSee or
replacement of any parts shall only be per
formed by authorized personnel. Do not
open or attempt to open any enclosed
part of your InSee under any
circumstances.
• Do not use other types of charging
cables (e.g., micro USB cable, Apple
Lightning cable, mini USB cable).
• The system operating temperature
range is between 0°C and 30°C. The
battery will operate safely within this
range.
• Improper battery use may result in a
fire, explosion, or other hazard.
• If this device has a damaged power
cord or plug, or the product does not
operate correctly, do not use it. For
examination and repair, contact Tidal
Medical Technologies using the contact
information on page 2.
Lithium-ion batteries and products that contain lithium-ion batteries can
expose you to chemicals including cobalt lithium nickel oxide, and nickel,
which are known to the State of California to cause cancer and birth defects
or other reproductive harm. For more information, go to
www P65Warnings.ca.gov.
WARNING
Batteries, Power And Power Cord
Service, Returns And Disposal

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NOTE: If service is necessary, contact Tidal Medical Technologies using the contact information on page 2
NOTE: Save these instructions.
InSee At A Glance
A. InSee Device
Back side of InSee
Front side of InSee
When you unpack your InSee, you’ll find main components and documentation.
INSEE FEATURES
A. Main Components

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Insee Features

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The figures below show the charger and charging cable accessories which are included
in the in the InSee package.
Printed Instructions for Use (this manual)
are included with the InSee system. You
can also find the InSee User’s Guide on
our website: www.tidalmed.tech
The InSee package includes InSee,
charger, charging cable, and the user
manual.
Charger
USB-C Cable
B. Charger & Charging Cable
C. Documentation D. Packaging

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Use only the power adapter and USB-C cable provided with
the InSee device. Your InSee contains a lithium-ion battery that
is housed inside the device.
• Charge using the provided USB-C cable
• LED is solid yellow while charging
• The LED will turn to solid green when the
battery is fully charged.
• Average charge time: 2-2.5 hours
Green Solid Charging completed
Yellow Solid Charging
LED COLOR BLINK RATE DESCRIPTION
CAUTION
WARNING
NEVER ATTEMPT TO RE-
PLACE THE BATTERY.
NEVER USE THE DEVICE
FOR TREATMENT WHILE IT
IS BEING CHARGED.
Know Your Batteries
Charge Your Insee
Led Indicators

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Setting up the InSee by the Clinician
InSee is intended for use in the Hospital environment by
clinicians and patients. Therefore, it must be setup and
configured by clinicians before being used by the patients.
This device is only compatible with AirLife Volumetric Incentive Spirometer - 2500 &
CAUTION
USING THE INSEE
DO NOT CONNECT THE DEVICE TO THE CHARGER
DURING TREATMENT
WARNING
Always place the Incentive Spirometer on InSee before
turning on the unit or pressing the RESET button to
avoid erroneous data.
Remember to remove the Incentive Spirometer from
InSee only AFTER the unit has been turned off.
CAUTION
CAUTION
BEFORE USING INSEE
- Follow directions for normal spirometer use.
- Ensure the InSee does not display any errors.

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InSee screen displays various settings.
Below we describe these parameters:
“AT”:
• Indicates the number of Attempts above 250 mL
“TA”:
• Indicates the desired Target Volume.
“SU”:
• Indicates the number of Successful attempts equal or
above the inputted Target Volume (Ta) since the device
started
“MX”:
• Indicates the maximum target volume achieved since the
device was started
“AL”:
• Indicates the alarm setting: OFF/10 minutes / 20 minutes
30 min / 60 minutes / 120 minutes.
“BA”:
• Indicates the battery level. *** indicates Full Charge. **
indicates 75% charge. The RED LED will be on if the
battery level reaches 75%.
Reading the Insee Display

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InSee has four buttons. These buttons are used to configure the device in the following
ways:
“+” Button
• Increase the target tidal volume in 250 mL increments up to 4000 mL.
“A” Button (Alarm)
• Activate or deactivate the inactivity alarm. This button configures the alarm to activate
at any of the following intervals: OFF / 5 minutes / 10 minutes / 20 minutes / 30 minutes
/ 60 minutes / 120 minutes. When the alarm is set to anything other than OFF, the de-
vice will alert the patient if it remains inactive for the designated alarm interval (e.g., 10
minutes). When the inactivity alarm is triggered, the patient should inhale through the
incentive spirometer to silence the alarm.
“P” Button (Power)
• Press for 5 seconds to turn the device on or off.
“R” Button (Reset)
• Press and hold this button for three seconds to reset all the settings to the
Insee Buttons

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Step 2 – Slide spirometer into the lip. Step 3 – Release tab and secure.
Step 1 - Make sure the device is OFF
by pressing and holding P for 5 seconds
Step 1: Make sure the in see is OFF.
Step 2: Slide the AirLife Volumetric Incentive
Spirometer 4000 mL into the lip.
Step 3: Press on the tab and make sure the
spirometer is hooked and securely at-
tached to the InSee.
Attaching the Insee to Incentive Spirometer

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Step 2 – Press P for 5 seconds to
turn off the device. Step 3 – Press and pull out the
spirometer
Step 1 - Tilt the insee no more than 90
degrees.
Step 1: Tilt the InSee no more than 90 de-
grees & ensure the piston is in the rest
position at the bottom of the incentive
spirometer.
Step 2: Press and hold the power (P) button
for 5 seconds until the display turns off.
Step 3: Press on the tab on the InSee unit and
pull the incentive spirometer out
Detaching Incentive Spirometer from InSee
2-Pull
1-Press

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Step 1: Make sure the InSee is securely at-
tached to the Incentive Spirometer (IS).
Step 2: Tilt the InSee+IS no more than 90 de-
grees & ensure the piston is in the rest
position at the bottom of the incentive
spirometer.
Step 3: Press and hold the power (P) button
for 5 seconds. LED lights will flash on
the InSee. The LCD display will show
“Initializing…” for two seconds, then the
main screen is displayed.
Step 4: Place the InSee+IS upright on a flat
surface for 5 seconds so it calibrates.
Turning the InSee ON
Step 1: Make sure the InSee is securely attached to the Incentive Spirometer
Step 2: Tilt the InSee+IS no more than 90 degrees & ensure the piston is in the rest
position at the bottom of the incentive spirometer
Step 3: Press and hold the Power (P) button until the display turns off.
Turning the InSee OFF
AFTER PRESSING THE ON BUTTON
MAKE SURE THE PISTON IS IN ITS
REST POSITION TO ENSURE SELF
CALIBRATION.
WARNING