Caretaker medical Caretaker4 User manual

BIOPAC Part # NIBP-A-MRI

Caretaker4 User Manual

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”)

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.

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 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.

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

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

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.

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.

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

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.

•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.

5Safety Considerations

5.1 Definition of Terms

•Warning: advises against action that could result in personal injury.

•Caution: advises against actions that could damage equipment or produce

inaccurate data, although personal injury is unlikely.

•Note: provides useful information regarding a function or procedure.

5.2 Before Using the Caretaker4

Carefully read this manual and all other accompanying information. If any

abnormal situation occurs or if the operator suspects any unusual behavior, do

one or more of the following:

•Remove the finger cuff from the patient.

•Remove the wrist worn unit from the patient.

•Clearly mark the device as “Do Not Use” and contact Caretaker Medical

customer support.

•Attempt to use the device on a different Android tablet

5.3 Warnings

•Only charge the Caretaker device with the original power supply, using a

properly grounded AC receptacle (100V-240V, 50-60Hz)

•Use of accessories and cables other than those specified or provided by the

manufacturer of this equipment could result in increased electromagnetic

emissions or decreased electromagnetic immunity of this equipment and result

in improper operation.

•Strong magnetic fields may cause malfunction or damage to the unit. Use of

this equipment adjacent to or stacked with other equipment should be

avoided because it could result in improper operation. If such use is necessary,

this equipment and the other equipment should be observed to verify that

they are operating normally.

•Portable RF communications equipment (including peripherals such as antenna

cables and external antennas) should be used no closer than 30cm (12 inches)

to any part of the Caretaker4, including cables specified by the manufacturer

otherwise degradation of the performance of this equipment could result.

•Do not immerse the Caretaker4 in liquid. Follow the cleaning instructions in the

Operators Manual. In the case of accidental spills on the unit, remove power

and have the unit serviced by qualified personnel.

•Do not use Caretaker4 in the presence of flammable gas or in an oxygen-

enriched atmosphere.

•Internal Electrical Shock Hazard –This unit does not contain any user-

serviceable parts. Do not remove the instrument covers or enclosures.

•Do not clean the device by submersing it in liquid, or using gasoline, thinner, or

highly concentrated alcohol. Do not disinfect by autoclave or gas sterilization.

•Avoid application of the finger cuff on injured skin. Select a clean, healthy

finger.

•The device is for attended monitoring only, and must be used under the direct

supervision of a qualified health care provider.

•If the accuracy of any measurement is questionable, first check the patient’s

vital signs by alternate means then check the device for proper functioning.

•Shock Hazard: do not attempt to plug or unplug the charger with wet hands.

Make certain your hands are clean and dry before touching the charging cord.

•The Caretaker4 contains many metal components. Do not use in an Magnetic

Resonance Imaging (“MRI”) environment.

•The Caretaker Remote Display Application has the ability to transmit an initial

blood pressure calibration value to the Caretaker4 Physiological Monitor.

Entering an incorrect value can lead to inaccurate measurements being

displayed. Always verify entered values and BP readings prior to beginning a

measurement session.

5.4 Cautions

•Federal Law restricts the Caretaker4 to be sold by prescription only.

•Do not crease the finger cuff or damage the cuff’s air bladder.

•Only use original finger cuffs manufactured by Caretaker4 Medical.

•Always use a new finger cuff and wrist strap for each patient and wipe the

Caretaker4 unit with a mild antiseptic wipe to minimize infection risk.

•If blood circulation in the patient’s fingers is poor, or if the fingers are

unusually cold, the pressure waveform and resulting BP and HR measurements

may be inaccurate. It is possible to remedy this by warming the hand/fingers.

•As with all noninvasive blood pressure monitoring methods, motion artifacts

and disturbances to the cuff or hose may cause poor signal quality and

resulting measurements.

•To avoid interference, do not use Caretaker4 in close proximity to non

IEC60601-1 complaint devices. In the event of electromagnetic interference

with the BLE data stream to the Caretaker App, the Caretaker4 will continue to

operate and devise display will continue to function as expected however

there may be a potential loss of data updates on the Caretaker App. Should

such a condition occur, the numeric displays on the Caretaker App will gray

out.

•Do not expose Caretaker4 to dirty or dusty environments.

•Do not drop the device.

•Clean and store the unit after each use. Do not store above +40 °C.

•If you wish to dispose of the Caretaker4 device, protect the environment by

returning it to your nearest local electronics recycling facility.

•When using the Caretaker4's Respirator Rate function, the operating range is

limited to 6-32 breaths per minute with patient at rest. In addition, respiration

readings may not be reliable in the case of apnea or similar conditions.

•To avoid interference, do not use in close proximity to non IEC60601-1

compliant devices. In the event of electromagnetic interference interrupting

the data stream, the App will no longer display or store monitored parameters.

•Communications range will be affected by obstacles and other physical objects

such as walls or doors in the communications path. For assuring best range it

is recommended to use in an open room free of obstructions.

•Bluetooth is a short range, point-to-point communications protocol with CRC

error correction, acknowledgments, and re-transmissions in the event of

packet failure. Data integrity is maintained with degradation of wireless signal,

however the data rate can be effected resulting in slower updates of

measurements.

•The Wi-Fi interface is for data forwarding to other patient monitoring systems

only; it has not been tested to receive data from connected medical devices.

5.5 Security

•The Caretaker Monitor uses industry standard wireless protocols. Follow your

institutional protocols for wireless security. It is highly recommended that for

data forwarding applications a minimum of WPA2 wireless encryption on a

secure network is used.

•The user has the ability to store patient-identifiable information in the data

record retained by the Caretaker Remote Display Application. No patient

identifiable information is stored by the Caretaker4. Follow your institutional

protocols for handling sensitive information.

6System Overview

The Caretaker4 system consists of two components:

•The Caretaker4 patient monitor unit that senses the arterial pulsations measured with

a finger-worn cuff and analyzes them to obtain vital signs such as blood pressure,

heart rate and breathing rate. The unit can be operated in stand-alone mode using its

single multi-function button.

•The Caretaker App provides access to all commands and allows for the reconfiguration

of the Caretaker4. The Caretaker App stores both vital sign data and real-time pulse

waveform data is designed to run on either the supplied Android tablet or on an

Android device running Android version 6 or higher.

6.1 Important Items to Remember When Using the Caretaker4:

•Finger cuff placement is critical. Please pay careful attention to the instructions

shown below on how to place the cuff on the finger.

•Calibration of continuous blood pressure readings

oThe Caretaker4 requires a starting blood pressure to provide readings and

must be calibrated using either Manual or Automatic calibration methods.

oIn Manual calibration mode, the starting blood pressure is obtained using

an external device (such as an automatic brachial cuff) and entered into the

Manual calibration dialog box in Caretaker App.

CAUTION: When recalibrating in Manual Calibration Mode the previously

entered blood pressure values will be re-used automatically!! To recalibrate

using the Manual method, it is recommended that the operator obtain new

blood pressure readings using an external device (such as an automatic

brachial cuff). Stop the current session using the DONE button (bottom of the

Caretaker App screen) and start a new Manual calibration session. For details

refer to the Manual calibration mode section below.

oIn Automatic calibration mode the Caretaker4 device will calibrate itself, as

described below. IMPORTANT ITEMS TO REMEMBER WHEN USING

AUTOMATIC CALIBRATION:

▪Select the correct subject posture using the app (sitting or supine)

▪Keep the hand at navel height during calibration while sitting.

▪If the Automatic calibration fails to obtain a valid reading 2-3 times, it is

recommended that Manual Calibration mode is selected and an

external device (such as an automatic brachial cuff) is used to obtain

the starting calibration pressure. In some situations obtaining a starting

blood pressure may be too challenging for specific physiological reasons

(for example cold fingers).

•Blood pressure and vital signs data are only saved on the tablet or device

running the Caretaker App. If wireless communication is disrupted between

the Caretaker4 and the Caretaker App, the Caretaker4 will continue measuring

and displaying vital signs however THE INFORMATION WILL NOT BE SAVED.

Once wireless communication is restored, the Caretaker App will continue

storing the collected vital signs data.

•Wireless communication disruptions:

oThe system will automatically attempt to recover from brief disruptions.

oIn the event of longer disruptions, the connection WILL NOT RECOVER and

the Caretaker4 will need to be reconnected with the Caretaker App.

•IMPORTANT: If the Caretaker4 is unable to detect a pulse from the finger cuff

for 15 minutes or more, Caretaker device will reset to its starting screen. A

Manual or Automatic calibration procedure is then REQUIRED to restart vital

signs monitoring.

7Using the Caretaker4

7.1 Caretaker4 Single Button Commands & Display Indicators

Commands

Single-click

The radio advertises that the device is ready for

connection –the Bluetooth symbol in the status

bar will turn ORANGE.

Once the device connects the Bluetooth symbol in

the status bar will turn BLUE.

Double-click

The device starts a self-calibration sequence to find

the starting blood pressure for continuous blood

pressure measurement operation.

2 second button hold

Stops the current operation and returns the device

to starting mode (the Caretaker device will remain

connected to the Caretaker App).

6 second button hold

Device will display message: “Push button again to

power off”. Upon pushing the button once the

device will power off.

7.2 Opening the Caretaker Packaging

Ensure that the box contains the following items as pictured below:

Caretaker4 Device

AC Power Supply (Caution: Only use the AC-

DC adapter and optional country specific

blade kits that come with your device)

Biocompatible Finger Cuff & Wrist Strap

The Caretaker4 comes pre-packaged with

Single-Patient-Use Finger Cuff and Wrist

Straps. Additional Finger Cuffs and Wrist

Straps may be purchased from Caretaker

Medical or the nearest authorized

distributor.

7.3 Preparing the Caretaker4 Unit for Use

•Fully charge the Caretaker4 battery (see recharging instructions below).

•Keep your finger cuffs and wrist straps safely inside their plastic bags until

ready for use.

7.4 Connecting the Caretaker4 Device

Ensure the Caretaker4 unit is sufficiently charged to support the time duration

needed to measure vital signs information. The battery status is shown in the

upper part of the display as a simple bar graph. The bars will change color from

Green (fully charged) to Red (critical) as the unit is used. The below example

shows the Caretaker4 at about 75% charged:

Caretaker Battery Charge Indicator

Wipe the Caretaker4 unit with an Aseptic wipe to disinfect the unit per your

clinical protocol. Disconnect the AC cord first.

7.5 Attaching the Wrist Strap to the Caretaker4

Secure a clean, biocompatible Wrist Strap to the Caretaker4 as shown in the

following steps:

1. Insert one end of the wrist strap through one of the loops on the back of the

Caretaker 4 device.

Wrist Strap Attachment Step 1

2. Fold the Velcro attachment over and attach to the wrist strap

Wrist Strap Attachment Step 2

3. Slip the end of the wrist strap through the remaining loop on the back of the

Caretaker4

Wrist Strap Attachment Step 3

The patient's arm will go through the loop and the “tail” will be wrapped around to

secure the device.

7.6 Connecting/Disconnecting the Caretaker4 Finger Cuff

Connect a new Finger Cuff to the Caretaker device by removing the cuff from a

sealed package and sliding the plastic hose into the quick-connect on the side of

the Caretaker device. PUSH THE HOSE UNTIL IT STOPS IN THE SEAT OF THE

QUICK-CONNECT. The hose must be free of obstruction or interference during use.

Caretaker Cuff Hose Quick Connect

To disconnect the hose of the finger cuff from the Caretaker device, push on the

ring-shaped sleeve that surrounds the hose at the mouth of the quick-connect as

show by the red arrow in the image below.

Caretaker Cuff Hose Quick Connect Close-Up

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