CardioBelt™
System Users Manual
1800 Barton Creek Blvd
Austin, Texas 78735-1606
Telephone: +1.512.732.0235
Facsimile: +1.512.732.0285
Email: Info@monebo.com
Monebo Technologies, Inc
Version 1.1
Copyright © 2006 Monebo Technologies, Inc
All rights reserved.
No part of this manual may be reproduced, photocopied or transmitted
without
the express written consent of Monebo Technologies, Inc.
This product is covered by one or more of the following United States
Patents: 6,656,125
Additional patents are pending.
CardioBelt™ is a trademark owned by Monebo Technologies, Inc.
For more information concerning Monebo Technologies products and
systems, contact:
Monebo Technologies, Inc.
Austin, Texas
world-wide: 1-512-732-0235
internet: http://www.monebo.com
The information contained in this document is subject to change
without notice.
Monebo Technologies, Inc. makes no Warranty of any kind with
respect
to this information.
MONEBO TECHNOLOGIES, INC. EXPRESSLY DISCLAIMS ANY
IMPLIED WARRANTY OF MERCHANTABILITY AND FITNESS FOR A
PARTICULAR PURPOSE.
The Monebo CardioBelt™ complies with the following ANSI/AAMi
Standards
EC38
Printed in USA
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CardioBelt™
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Table of Contents
INTENDED USE........................................................................................................................... 6
CONTRAINDICATIONS..............................................................................................................6
ADVERSE REACTIONS............................................................................................................. 6
DEFIBRILLATOR PRECAUTIONS........................................................................................... 6
DEVICE DESCRIPTION.............................................................................................................. 7
CARDIAC SIGNAL PROCESSING UNIT ................................................................................ 8
CARDIAC SIGNAL ACQUISITION BELT................................................................................ 8
POWER SUPPLY/CHARGER.................................................................................................. 10
DETAILED DESCRIPTION....................................................................................................... 11
IDENTIFICATION.......................................................................................................................11
STANDARDS AND EQUIPMENT SYMBOLS....................................................................... 11
DIMENSIONS.............................................................................................................................. 12
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COMPOSITION........................................................................................................................... 12
PHYSICAL DESCRIPTION ...................................................................................................... 12
USAGE ENVIRONMENT.......................................................................................................... 13
PATIENT COUNSELING.......................................................................................................... 14
DIRECTIONS FOR USE............................................................................................................ 15
INSPECTION PROCEDURES ................................................................................................. 15
PATIENT FIT............................................................................................................................... 15
POWERING ON THE CARDIOBELT™ ................................................................................. 16
CHARGING THE INTERNAL BATTERY...............................................................................17
CLEANING.................................................................................................................................. 18
MAINTENANCE ......................................................................................................................... 19
CLEANING AND DISINFECTANT INSTRUCTIONS FOR THE TECHNOLOGIST........ 19
MANUFACTURER..................................................................................................................... 20
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1. INTRODUCTION – Intended Use
a. Intended Use
The Monebo CardioBelt™ is a single lead ECG acquisition device which uses a Bluetooth radio
frequency link to transmit the ECG signals to an associated electrocardiograph monitor. The
CardioBelt™ is intended to be used in general electrocardiograph situations where ECG
monitoring is deemed necessary and is ordered by a physician. The CardioBelt™ can be applied
by the patient, a caregiver, or a clinician following the directions of a physician.
b. Contraindications
The CardioBelt™ must not be used by subjects with known skin reaction s to synthetic polymers
or silver. Note that some people who display sensitivity to silver jewelry are sensitive to the
impurities present in silver alloys, and not to the silver itself. These people may not be sensitive to
the high-purity silver used in the silver electrode incorporated into the CardioBelt™ elastic chest
belt.
The CardioBelt™ should not be used in the presence of open wounds, rashes, or lesions on the
torso of the patient.
The CardioBelt™ should never be used near any flammable compounds, such as ane sthetics.
The CardioBelt™ should never be used in an explosive or potentially explosive atmosphere.
c. Adverse Reactions
The following adverse reactions may occur where the belt touches the skin, but are generally of
short duration:
• Pressure marks
• Localized redness
• Slight itching under the belt
All skin-contacting materials used in the CardioBelt™ have passed tests demonstrating
compatibility with normal skin. However, should any of the following conditions occur, discontinue
use and contact your doctor or monitoring center immediately.
• Skin rash
• Localized allergic reaction
• Any other undue discomfort
• Open Wounds
d. Defibrillator precautions
The input circuitry of the CardioBelt is not defibrillator protected. The CardioBelt should be
removed from the patient if a defibrillator is to be used. Using the CardioBelt to monitor the
patient during defibrillator discharges may damage the input stages of the amplifiers. This may
result in a safety hazard.
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e. Single user belt
The Cardiobelt consists of a reusable electronic and a single patient belt. A single patient may
reuse the same belt provided it is kept clean and in working order. Contact your caregiver if the
belt appears to be broken or the belt becomes unsafe. The belt should not be shared between
patients.
f. Radio Interference
Bluetooth™ communications can be disrupted by higher power radio transmitters in the ISM band
like portable telephones, WIFI Networks, cellular phones and other Bluetooth devices. If the
device does not connect with the receiving device or has intermittent operations check for
interfering devices by turning off other radio devices one at a time or moving the modules to a
different location.
2.0 Device Description
The CardioBelt™ is a single lead electrocardiograph (ECG) device.
The CardioBelt™ consists of the following three assemblies:
The Cardiac Signal Processing Unit (CSPU)
The Cardiac Signal Acquisition Belt (CSAB)
The power supply/charger unit.
These three assemblies comprise the complete CardioBelt™ system.
CardioBelt™ Modules
Description Model Number Size Patient Chest Size
Cardiac Signal
Processing Unit
Cardiac Signal
Acquisition Belt
Cardiac Signal
Acquisition Belt
Cardiac Signal
Acquisition Belt
Adapter/Charger CSPU/AC/3.1
Position of the modified standard Lead I electrodes shall be between left/right anterior axillary line
and left/right midaxillary line. The CardioBelt™ should be worn just below nipples (Fig2).
CSPU/3.1
CSAB/3.1S Small
CSAB/3.1M Medium
CSAB/3.1L Large
32” to 39”
81 cm to 99 cm
38” to 46”
97 cm to 117 cm
45” to 52”
114 cm to 132 cm
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Modified Standard Lead I
Reference electrode
Figure 2
a. Cardiac Signal Processing Unit
The Cardiac Signal Processing Unit, or CSPU, receives the cardiac electrical signals from the
sensors in the Cardiac Signal Acquisition Belt. These signals are very low amplitude analog
signals detected on the body surface. The CSPU contains signal amplifiers, an analo g to digital
conversion stage, a controller, and an integrated Bluetooth transceiver. A self contained
rechargeable battery powers the electronics.
b. Cardiac Signal Acquisition Belt
The Cardiac Signal Acquisition Belt, also called CSAB, captures the surface electrical signals
from the human heart. It consists of three silver chloride metal sensors strategically located in
such a way as to represent a modified Standard Lead I. The center sensor is the “common”.
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The CSAB is meant to be a single patient use device and should be properly disposed of after
use.
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c. Power supply/charger
The power supply/charger is used to recharge the self contained battery. It is ope rable on line
voltages from 100 VAC to 240 VAC, 50 or 60 hertz. It cannot be plugged in to the CSPU when
the CSPU is connected to the CSAB.
The electrical plug is replaceable and should be selected based upon the conn ection required to
the local electrical system.
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3.0 Detailed Description
a. Identification
The CSPU, CSAB, and Power Supply have been uniquely identified with a model and serial
number. These are easily identified on the assembly.
b. Standards and Equipment Symbols
The CardioBelt™ conforms to the following electrical standards:
• UL 60601-1
• IEC/60601.1 (amend. 1 and 2)
• IEC/EN 60601.1.2 (EMC)
• CAN/CSA C22.2 No. 601.1 (M90, S1-94, B-90)
• Bluetooth stack v1.1 – Serial Port Protocol - Class 2 (+4-dBm maximum power,
with a range limit of approximately 20 m) and and Class 3 (0-dBm
maximum power, with a range limit of approximately 10 m)
• FCC ID ED9LMX9820ASM
• Bluetooth Listing LMX980 from National Semiconductor Product ID 3018
The CardioBelt™ is water resistant IPX0 (International Protection Classification). The device is
not waterproof and must be removed before bathing, showering, or water activities.
The CardioBelt™ conforms to the following additional standards:
• ISO 10993 (Skin Compatibility).
Regulation Number: 21 CFR 870.2920
Regulation Name: Transmitters and Receivers, Electrocardiograph, Telephone
Regulator Class: II (Two)
Product Code: DXH
At this moment, no performance standards have been developed under FDA regulations for ECG
transmitters and receivers.
IEC 60601-1:1988, “Medical Electrical Equipment, General Requirements for Safety”
Specifically 56.3(c) is applicable to any connector or electrode.
IEC 60601-1-1:2000, “Medical Electrical Equipment – Part 1-1, General Requirements for Safety”;
Collateral standard: Safety requirements for medical electrical systems”
IEC 60601-1-2:2001, “Medical Electrical Equipment – Part 1-2; General Requirements for Safety,
Collateral Standard: Electromagnetic Compatibility”
IEC 60601-2-25:1993, “Medical Electrical Equipment, Particular requirements for the safety of
electrocardiographs”
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Symbol Explanation
Type BF (Body Floating)
Lot Number
Serial Number
Refer to accompanying documentation
Direct Current
c. Dimensions
Cardiac Signal Processing Module:
Total Weight: 1.472 oz
Total Length: 2.5 in
Total Width: 1.8 in
Total Height: 0.9 in
Cardiac Signal Acquisition Belt:
Total Width: 1.5 in
Total Length: The disposable belt is available in three sizes: Small (S) 33 in, Medium (M) 39 in,
and Large (L). 45 in
d. Composition
The CardioBelt™ electrodes and belt assembly is constructed of latex free materials which have
been tested for human skin compatibility.
e. Physical Description
The CardioBelt™ is a single lead device which consists of the combination of the CSPU and the
CSAB.
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The CardioBelt™ is used without gel or adhesives. It is capable of picking up high quality cardiac
electrical signals from unprepared skin, without electrolytic gels or skin abrasion. This enables
easy application of electrodes to the body. It also gives greater comfort and freedom for the
subject: the absence of gels or adhesives allows easy removal and re-donning without causing
skin irritation or skin shear.
All skin-contacting materials used in the CardioBelt™ have passed tests demonstrating
compatibility with normal skin. Furthermore, no natural rubber latex is present in these materials.
This allows monitoring without skin irritation.
The CardioBelt™ does not transfer energy to the body. The resistive material of the electrode
constitutes an electrical barrier between the body and the electrode and any external apparatus
to which the electrode may be connected. The adjustable elastic chest belt shown in is designed
to hold the electrode assembly snugly against the torso.
f. Usage Environment
The CardioBelt™ is ideal for use in ambulatory and at-home settings. This device complies with
electromagnetic compatibility standards (IEC/EN 6060-1-2) and does not cause electromagnetic
interference. Note that all ECG activities can occasionally be subject to electromagnetic
interference from other external sources such as power-lines, power transformers, and radio
transmitting equipment.
If any interference occurs while using the CardioBelt™, consult trouble-shooting guide in section
9 of this manual.
The CardioBelt™ must be removed for bathing, showering and water activities (note that profuse
sweating is acceptable). Failure to do so may damage the device.
The CardioBelt™ can be worn at all other times while performing usual activities, at work and at
home, day and night.
A PIN number needs to be in the application to connect with the CardioBelt™.
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4.0 Patient Counseling
In order to maximize safety, effectiveness, patient comfort, and patient compliance, ensure that
patients are instructed on the use of the CardioBelt™. In particular, emphasize the following
points:
• Remind the patient that for effective monitoring, the CardioBelt™ should be worn at all
times except while bathing, showering or when involved in other water activities.
• Suggest that when the patient removes the CardioBelt™ he/she should take the
opportunity to wipe the electrodes with a damp cloth or soapy water. This enhances
comfort.
• Remind the patient not to immerse the electrode assembly in water or other liquids.
• Remind the patient that if symptoms occur while the CardioBelt™ is off the body or
while disconnected from the recorder, their cardiac event will not be recorded.
• Reassure the patient that, although the CardioBelt™ was designed for comfort, it may
take some time to become fully accustomed to the feel of the device on their chest.
• Invite questions and encourage the patient to call your office in case of difficulties.
• Remind the patient that, if undue skin irritation occurs, the patient should discontinue
use and contact the monitoring center.
• Review the Patient Guide with the patient and remember to provide a copy of the
Patient Guide for the patient to take home.
• Remind the patient to return the CSPU at the end of their monitoring period, and to
properly discard the elastic chest belt.
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5.0 Directions for Use
Adhere to the following steps to ensure safe and effective use of the CardioBelt™:
• Inspection procedure
• Choice of elastic chest belt
• Cleaning and disinfection
• Assembly
• Patient fit
• Testing
• Patient instructions
a. Inspection Procedures
1) Upon opening the package and before first use, make sure the package contains the following:
• 1 Cardiac Signal Processing Unit (CSPU)
• 1 Cardiac Signal Acquisition Belt (CSAB)
• 1 Power Supply/Charger
• 1 User Manual (This manual)
• 1 Patient Guide
2) Ensure that a choice of elastic chest belt sizes is available for fitting. These are packaged
separately and come in three different sizes: Small (S), Medium (M) and Large (L).
3) Inspect all components of the CardioBelt™ system to ensure that no obvious damage has
occurred in transport.
4) The CardioBelt™ system is active right out of the box. The CardioBelt™ is now ready to be
fitted to a patient.
b. Patient Fit
In order to ensure proper fit it is important to select the correct size of Cardiac Signal Acquisition
Belt. There are three sizes. Measure the patient’s chest circumference and select the correct
size based upon the following table:
Small – 32” to 39” (81 cm to 99 cm)
Medium – 38” to 46” (97 cm to 117 cm)
Large – 45” to 52” (114 cm to 132 cm)
1) Wrap the assembled belt around the patient’s torso, immediately below the breast line.
2) Tighten to a comfortably snug fit using the Velcro ends to secure the belt in place. Do not over
tighten.
3) Cardiac Signal Processing Unit should be centered on the patient ’s chest, in the front with the
Monebo logo facing up and outwards.
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The flat surface of the three CardioBelt™ electrodes should be in direct contact with the patient’s
skin, and the silver fabric reference indicators “R” and “L” should be position on the right and left
side of the patient’s chest.
Figure 5:
4) Remind patient not to discard the CSPU after their monitoring period, but to return it to the
appropriate agency. .
c. Powering on the CardioBelt™
When the CardioBelt™ is correctly positioned on the patient it can be powered on. This is done
by depressing the button in the center of the CSPU. The LED will illuminate. If it illuminates
yellow, this indicates that the Bluetooth transceiver has not established contact with the Bluetooth
base unit. The patient must be within ten (10) meters, thirty (30) feet of the base unit. Once
contact is established, the LED will change to green indicating that the link has been established.
When the session has been completed, depress the center button for more than 2 seconds. The
LED will change to red and go out indicating that the unit has powered down. The unit also turns
itself off when the base unit ends the Bluetooth link.
The LED indicator illuminates in three colors. Yellow indicates
that the unit is powered up, but the Bluetooth link has not been
established. Green indicates that the link has been established
and ECG information is being transmitted. Red indicates that
the unit is powering down. Flashing red indicates the battery
needs to be charged.
This is the power button. Depress the button to turn the unit
ON and OFF.
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d. Charging the internal battery
The CSPU is a Internally Powered device. It contains an internal rechargeable battery. The
battery is not user serviceable. In the case where the battery needs replacement, this must only
be done by a properly qualified technician. If the battery is replaced, it must be disposed of
properly by conveying it to an appropriate recycling center.
The CSPU has an internal battery which can only be charged when the CSPU is separated from
the CSAB. To remove the CSPU from the CSAB, take the CardioBelt™ off of the patient. Holding
the unit in your hand, depress the latch bar and slide the CSPU to the left.
The CSPU should not be exposed to extreme cold temperatures. The battery capacity will be
significantly reduced at temperatures below 40º F (4.4º C).
Depress the latch bar and slide the CSPU
to the left
When the CSPU has cleared the lock, it can be removed.
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Charging unit should be connected to the CSPU and the charger should then be plugged into the
electrical outlet. The unit will begin charging. It should be charged for four hours.
When charging is complete, the CSPU can be reconnected to the CSAB reversing the procedure
outlined above.
A fully charged battery will provide approximately 10 hours of continuous transmission. The
ability of the battery to hold a charge will diminish with repeated charging. Cold temperature will
reduce battery capacity.
e. Cleaning
Cardiac Signal Acquisition Belt
1. Before washing the elastic chest belt, ensure the CSPU module is unsnapped
(disconnected) from the belt. DO NOT PLACE CARDIAC SIGNAL ACQUISITION BELT
ASSEMBLY IN THE WASHER OR DRYER.
2. Hand wash the elastic chest belt using ordinary laundry detergent.
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3. Hang to dry.
4. Wash chest belt as often as needed to enhance comfort.
5. Discard elastic chest belts after 30 days’ use.
Cardiac Signal Processing Unit
After the CSPU has been removed from the CSAB, it can be cleaned using a damp cloth.
DO NOT use any form of chemical cleaner.
6.0 Maintenance
This equipment does not require any servicing. There are no User Serviceable parts inside the
unit. Please return any defective unit to a qualified service center for servicing.
7.0 Cleaning and Disinfectant instructions for the Technologist
Cleaning the elastic chest belt:
• Patient is instructed to hand wash the elastic chest belt using ordinary laundry
detergent, and to hang dry or use gentle.
• Discard after each patient.
• Use only new elastic chest belts for new patients.
• Belts are available via your supplier.
Cleaning the Electrode Assembly
NOTE: THIS CLEANING PROCEDURE CONSISTS OF TWO STEPS (A) CLEANING AND (B)
DISINFECTION. FOLLOW THESE STEPS CAREFULLY. GOOD CLEANING
DURING STEP (A) IS ESSENTIAL FOR PROPER ANTIMICROBIAL ACTION DURING STEP
(B).
A) MATERIALS
You will need:
- Two pieces of clean cloth (for best results, micro-fiber is recommended).
- Disinfectant solution: isopropyl alcohol 70% to clean the electrodes
- Soapy water or mild detergent to clean the belt
- A shallow dish.
B) CLEANING PROCEDURE
1. Moisten one piece of clean cloth with soapy water or mild detergent.
2. Wipe any visible residues from the CardioBelt™. Rub electrode surface gently to
remove any residues.
3. Allow CardioBelt™ electrodes to dry.
C) DISINFECTANT PROCEDURE
4. Acceptable disinfectant solution is isopropyl alcohol 70%.
5. Moisten fresh piece of cloth with disinfectant solution and hand-wipe the CardioBelt™.
6. Place the cloth in dish and soak it with fresh disinfectant solution.
7. Place electrodes on the soaked cloth with body facing electrode surface
on the cloth.
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8.0 Manufacturer
The CardioBelt™ is manufactured by:
Monebo Technologies, Inc.
1800 Barton Creek Blvd
Austin, TX USA 78735-1606
Telephone: +1 512 732 0235
Fax: +1.512.732.0285
Email: info@monebo.com
9.0 Trouble Shooting Guide
1) There are no user serviceable parts in this unit. If the unit appears damaged please ask
you care giver for a replacement.
2) If the unit does not turn on with a yellow or amber light make sure the unit is charged. If
the unit still does not turn on ask you care giver for a replacement. If you continue to have
issues with communication then ask the caregiver to check for interferences that can
prevent communications. Turn off any portable phones or RF enabled devices and check if
the device can connect to the acquisition device.
3) If the belt gets torn, dirty or moldy ask you care giver for a replacement
4) If the ECG waveform appear noisy check that the electrodes are located in the proper
position and that the electrodes are clean and free of contaminates. If the problem
persists, replace the belt.
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