Caretaker Medical Caretaker4 User manual

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VER 8.0 (4-19-2018) Caretaker Medical Corp. All Rights Reserved
BIOPAC Part # NIBP-A-MRI
Caretaker4 User Manual

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VER 8.0 (4-19-2018) Caretaker Medical Corp. All Rights Reserved
Caretaker4
Vital Signs Monitor for Continuous Noninvasive Blood
Pressure and Vital Signs
This manual is intended to provide information for the proper operation of the
Caretaker4 vital signs monitor for measuring Heart Rate and Continuous Non-
invasive Blood Pressure (“CNIBP”)

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VER 8.0 (4-19-2018) Caretaker Medical Corp. All Rights Reserved
Errors and Omission
If errors or omissions are found in this manual, please notify Caretaker Medical.
Trademarks
Caretaker is a registered trademark of Caretaker Medical Corp.
Illustrations
Illustrations may show design models; production units may incorporate changes.
Copyright
No part of this publication may be reproduced, transmitted, transcribed, electronically stored, or translated in any
form by any means, for any purpose other than the purchaser’s personal use, unless prior written permission from
Caretaker Medical, LLC is provided.
Software in this product is copyright© 2018 by Caretaker Medical or its vendors. All rights are reserved. The
software is protected by United States of America copyright laws and international treaty provisions applicable
worldwide. Under such laws, you are licensed to use the copy of the software incorporated with this instrument as
intended in the operation of the product in which it is embedded, but the software may not be copied,
decompiled, reverse-engineered, disassembled or otherwise reduced to human-perceivable form. This is not a sale
of the software or any copy of the software; all right, title and ownership of the software remains with Caretaker
Medical or its vendors. Caretaker Medical will make available specifications necessary for inter-operability of this
software on request; however, users should be aware that use of Caretaker Medical hardware and software with
devices or software not sold by Caretaker Medical or its authorized dealers and affiliates may lead to erroneous
results and consequent danger in patient care, and may also void Caretaker Medical's warranty.
Disclaimer of Warranties and Limitations
•The Caretaker4 wireless vital signs device is provided as is, and no oral or written advice from Caretaker’s
employees, management, or agents, shall create a warranty or modify any bona fide existing warranty.
•Caretaker Medical shall not be liable for any direct, indirect, incidental, or consequential damages,
including lost profits or damages for personal injury or property damage arising from or in connection
with the licensed rights or its use whatsoever.
•In no case shall Caretaker Medical, LLC’s liability exceed the purchase price for the Caretaker device.
Information in this document is subject to change without notice and does not represent a commitment
on the part of Caretaker Medical.
•Caretaker Medical warrants to the original retail purchaser that it will repair or replace software
contained within the Caretaker4 for a period of 12 months. Caretaker does not warrant that the software
is error free and provided that the customer gives Caretaker written notice of a breach of the forgoing
warranty during the warranty period, Caretaker shall correct any reproducible errors that cause the
breach of warranty in accordance with its technical support policies.

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VER 8.0 (4-19-2018) Caretaker Medical Corp. All Rights Reserved
Table of Contents
1Introduction...........................................................................................................................................................6
2Indications for Use.................................................................................................................................................7
3Key Features ..........................................................................................................................................................8
4User Responsibilities..............................................................................................................................................9
5Safety Considerations ..........................................................................................................................................11
5.1 Definition of Terms ....................................................................................................................................11
5.2 Before Using the Caretaker4......................................................................................................................11
5.3 Warnings ....................................................................................................................................................11
5.4 Cautions .....................................................................................................................................................12
5.5 Security ......................................................................................................................................................13
6System Overview .................................................................................................................................................14
6.1 Important Items to Remember When Using the Caretaker4:....................................................................14
7Using the Caretaker4 ...........................................................................................................................................16
7.1 Caretaker4 Single Button Commands & Display Indicators .......................................................................16
7.2 Opening the Caretaker Packaging..............................................................................................................16
7.3 Preparing the Caretaker4 Unit for Use.......................................................................................................17
7.4 Connecting the Caretaker4 Device.............................................................................................................18
7.5 Attaching the Wrist Strap to the Caretaker4 .............................................................................................18
7.6 Connecting/Disconnecting the Caretaker4 Finger Cuff..............................................................................20
7.7 Placing the Caretaker4 on the Wrist ..........................................................................................................21
7.8 Attaching the Finger Cuff to the Patient’s Finger.......................................................................................22
7.9 Removing the Caretaker Device from a Patient.........................................................................................24
7.10 Recharging the Caretaker4.........................................................................................................................24
7.11 Cleaning, Storage, And Disposal.................................................................................................................24
8Using the Caretaker App......................................................................................................................................26
8.1 Launching the Caretaker App.....................................................................................................................26
8.2 Connecting with the Caretaker4 ................................................................................................................27
8.3 Monitoring Vital Signs ................................................................................................................................30
8.4 Manual Calibration Mode ..........................................................................................................................31
8.5 Automatic Calibration Mode......................................................................................................................33
8.6 Automatic Calibration Using the Caretaker without an Android Device ...................................................35
8.7 Re-Calibration Considerations....................................................................................................................35
8.8 Connecting with the Optional Oximeter ....................................................................................................36
9Ending a Session ..................................................................................................................................................39
10 Historical Physiological Data Displays.............................................................................................................41
11 Motion artifact-related app responses & messages ......................................................................................43

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12 Settings...........................................................................................................................................................44
12.1 Patient info.................................................................................................................................................44
12.2 Alerts..........................................................................................................................................................45
12.3 Display Settings ..........................................................................................................................................46
12.4 App Settings ...............................................................................................................................................47
12.5 Data Forwarding.........................................................................................................................................48
12.6 Advanced....................................................................................................................................................51
12.7 Diagnostics .................................................................................................................................................52
12.8 About..........................................................................................................................................................53
13 Data Saving and File Structure........................................................................................................................55
14 Warranty & Support .......................................................................................................................................56
14.1 Warranty ....................................................................................................................................................56
14.2 Customer Support and Company Contact Information .............................................................................56
15 Symbols ..........................................................................................................................................................57
16 Troubleshooting and Maintenance ................................................................................................................58
16.1 Troubleshooting Guide...............................................................................................................................58
17 Technical Specifications..................................................................................................................................59
18 Appendices .....................................................................................................................................................61
18.1 Background & Description .........................................................................................................................61

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VER 8.0 (4-19-2018) Caretaker Medical Corp. All Rights Reserved
1Introduction
The Caretaker4 (“CT4”) is intended to noninvasively and continuously measure a patient's
blood pressure ("BP"), heart rate ("HR"), and respiration rate ("RSP"), which are derived
from the pulse pressure waveform using the scientific method of Pulse Decomposition
Analysis ("PDA") for use on adult patients at rest.
The Caretaker device is calibrated using a manual method or any AAMI 81060 compliant
BP device, or is automatically calibrated using its self-calibration mode. All parameters
derived by the Caretaker device are reported to an integrated LCD screen and optionally
to a remote data display monitor (RDDS) via standard radio transmission protocols.
The Caretaker4 is a passive blood pressure and vital signs monitoring system, except
during the calibration phase. Because the Caretaker device uses an algorithm to detect
and analyze each heartbeat, it may be more prone to noise interference than an active
system, such as those based on the Penaz measurement method. Adequate signal quality
from the finger cuff is critical for the system to produce reasonable results. Typically, signal
quality problems are due to:
•Inadequate coupling pressure (for weak pulses or poorly perfused or cold fingers
coupling pressures of up to 50 mmHg may be necessary)
•Excessive movement of the finger
•Excessive movement of the hose between finger cuff and the CT4, or
•Improper positioning of the finger cuff
CAUTION: The Caretaker device is available only for prescription use under the
supervision of trained medical personnel.

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2Indications for Use
The Caretaker4 is intended to noninvasively and continuously measure a patient’s blood
pressure (BP), heart rate (HR), and respiration rate (RR), which are derived from the pulse
pressure waveform using the scientific method of Pulse Decomposition Analysis (PDA) for
use on adult patients at rest. The device is intended for use by clinicians or other properly
trained medical personnel.
Contra-indications
The Caretaker4’s ability to detect Blood Pressure may be limited or difficult in some
patients who exhibit extreme or unusual arterial physiology, such as:
•Lack of perfusion of the digital arteries and arterioles in the lower arm and hand, such
as may be present in patient with Raynaud’s disease
•Tough, Calloused, or Thickened skin and tissue in the phalange area, such as may be
present in patients with Scleroderma, Dupuytren’s Contracture, or other
Rheumatology issues.
•Overly Cold fingers can make it difficult for the Finger Cuff to obtain adequate signal
quality to derive an accurate Heart Rate or Blood Pressure reading.

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VER 8.0 (4-19-2018) Caretaker Medical Corp. All Rights Reserved
3Key Features
•Continuous, noninvasive monitoring of “Beat-by-Beat”Blood Pressure (Diastolic,
Systolic, Mean Arterial Pressure), Heart Rate and Respiration Rate
•Measurements captured using a single disposable finger cuff inflated to low pressure
•Can be worn for extended periods with no discomfort or loss of circulation in the
finger
•Compact wrist-worn device with on-board display
•Automatic and manual calibration modes
•Integrated PDF report generation
•Integrated alarms for all physiological parameters
•Wireless communications using Bluetooth Low Energy technology and an AES 128-Bit
encrypted data stream
•Communicates with companion Caretaker Android application
•Compatible with select 3rd party Bluetooth SpO2 and body temperature sensors
•ANSI/AAMI/ISO 81060-2:2013 compliant
•Integration options for Android, Windows and Linux operating environments using
Software Development Kits

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VER 8.0 (4-19-2018) Caretaker Medical Corp. All Rights Reserved
4User Responsibilities
The Caretaker4 blood pressure and vital signs monitor will perform in conformance with
the description in this Operator’s Manual and accompanying documentation when
assembled, operated, maintained and repaired in accordance with the instructions
provided.
A defective product or accessory shall not be used. Parts that are missing or damaged
must be replaced immediately. Caretaker Medical accepts no responsibility for any
malfunction of the Caretaker4 that are a result of improper use, unauthorized repair or
modification by the end user.
The Caretaker4 provides readings that are to be interpreted by trained medical personal
only. Any clinical judgment is the sole responsibility of the end user and should be made in
conjunction with all other available clinical indications and data.
As with any monitored parameter, artifacts and poor signal quality may lead to
inappropriate heart rate and blood pressure values.
The following considerations must be followed when using the Caretaker Device:
•The Caretaker4 must be calibrated to obtain a baseline Blood Pressure measurement
for each patient. Self-Calibration cycles should be spaced at least 10 minutes apart to
avoid fatiguing the monitored finger. Self-calibration is not indefinite and the
Caretaker4 will periodically re-calibrate itself automatically if in Self-Calibration mode
(default = 60 minutes). The Self-Calibration process takes approximately 40-45
seconds. A clinician should be present during the calibration to assess the accuracy of
the obtained measurements.
•For additional considerations regarding calibration and re-calibration, as well as the
use of manual versus self-calibration, please refer to section 7.8.
•The Caretaker4 is a prescription device, to be prescribed by a physician and operated
by qualified clinical personnel only.
•If the accuracy of any reading seems unusual or questionable, the operator shall
validate the readings by using an alternate method of measurement.
•The Caretaker4 is intended only as an adjunct in patient health assessment, and
therefore other clinical signs and symptoms must be considered by the clinician.
•The accuracy of measurements depends on the proper application of the finger cuff
and proper calibration of the device on each patient.
•For best results, the Caretaker4 should be used on patients that are at rest, and the
hand using the finger cuff should be still and located at navel height.
•Do not drop the Caretaker4 unit or immerse in liquid.
•For maximum performance ensure that the rechargeable battery is fully charged prior
to use.

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VER 8.0 (4-19-2018) Caretaker Medical Corp. All Rights Reserved
•Take care when cutting the finger cuff’s pneumatic hose to length to avoid injury the
patient.
•The Caretaker4 unit is “MR Unsafe.” Do not use the Caretaker4 in a Magnetic
Resonance Imaging environment.