BioZ® Cardio Profile

BioZ® Cardio Profile
BioZ® Cardio Profile
Non-invasive haemodynamic monitor
Device Manual
0197
Bio Z® Cardio Profile Device Manual, P15010-01
Document revision 1.1
Copyright © 2011 medis. Medizinische Messtechnik GmbH, Ilmenau, Germany
Medis, CP309-1
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Table of Contents
1
2
3
4
5
6
7
8
Introduction ..................................................................................................... 7
1.1
Applications ............................................................................................ 7
1.2
Intended Use.......................................................................................... 10
1.3
Warnings and Cautions ......................................................................... 11
1.4
Explanation of used symbols ................................................................ 14
Description of the device .............................................................................. 15
2.1
Basic device .......................................................................................... 15
2.2
Device cart ............................................................................................ 17
2.3
Patient cable .......................................................................................... 18
2.4
Printer.................................................................................................... 19
2.5
Modules................................................................................................. 21
Turning the device on and taking a measurement......................................... 22
3.1
Application of the electrodes ................................................................ 22
3.2
Blood Pressure Measurement (NIBP)................................................... 23
Maintenance, cleaning and disinfection........................................................ 24
4.1
Basic device and patient cable .............................................................. 24
4.2
Service Procedures of the optional Blood pressure module.................. 27
Technical Data .............................................................................................. 30
5.1
Measurement channels .......................................................................... 31
Scope of delivery........................................................................................... 32
Manufacturer guidelines and declarations .................................................... 33
Appendix ....................................................................................................... 38
8.1
Support .................................................................................................. 38
8.2
Alarm System........................................................................................ 38
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1 Introduction
1.1 Applications
Before using the Bio Z® Cardio Profile, read the manual carefully and completely
to ensure that you operate the monitor correctly.
When you set up the Bio Z® Cardio Profile for the first time, check to see if it has
suffered any damage during transportation.
The Bio Z® Cardio Profile is a measuring system for non-invasive monitoring of
hemodynamic parameters using methods of impedance cardiography (ICG). ICG
is based on a theoretical model of blood flow movement in the thorax (aorta). If
the physiological and clinical conditions of the patient are not in accordance with
the assumptions of the model, inaccuracies in the parameters may occur.
The Bio Z® Cardio Profile-monitor allows the examination of adult patients in a
resting position. The measured parameters can be used only if the ECG and ICG
waveforms have sufficient signal quality and are without artifact.
If the waveforms are of questionable quality, display the Waveform screen and
ensure that the key reference markers on the waveforms are accurately placed.
Note the hints in the Software Manual.
The cables for ICG and ECG as well as the cuff for NIBP are protected against
cardiac defibrillators. No preparation is need before the application of the defibrillator. The Bio Z® Cardio Profile will return to the standard operation within approximately ten (10) seconds after discharge.
If a measurement is to be stored, the measurement must be stopped in the Patient
data screen with the button F1 - Stop before switching off the monitor. Otherwise
storage may not be complete and data could be lost.In impedance cardiography,
pulse synchronous variations of the blood flow and volume in the thoracic aorta
are determined and used for calculating different hemodynamic parameters. More
specifically, with each beat of the heart, the volume and velocity of blood in the
aorta changes. This produces a change in the electrical resistance (impedance) of
the thorax to electrical alternating current. The change in impedance over time can
be used to measure or calculate stroke volume and several other important hemodynamic parameters. The Bio Z® Cardio Profile uses four dual sensors, which are
placed on the patient’s neck and thorax. The most upper and lower gel pads of
these sensors (the outer sensors) are used to apply a very low constant and alternating current (1.5 mA, 86 kHz) which is imperceptible to the patient. The other
four gel pads are used to receive the applied current and ECG signal:
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It is important to note that the ECG obtained and recorded by the Bio Z® Cardio
Profile is not a standard lead. It is, however, important for the internal signal
processing. If an additional ECG lead is necessary (e.g. if the signal quality is
bad), an optional ECG cable can be connected to the monitor.
Different terms are used interchangeably when discussing impedance cardiography, electrical bioimpedance or thoracic electrical impedance (TEB). In this manual the term impedance cardiography or ICG is used.
The following conditions may adversely affect the accuracy of ICG systems and
should be considered prior to use. Please note that this is not a comprehensive
listing of conditions.
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•
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•
•
•
•
•
•
•
•
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Septic shock
Aortic valve regurgitation and defect of septum
Severe aortic sclerosis, aortic prosthesis
Severe hypertension (MAP > 130 mmHg)
Cardiac arrhythmia
Tachycardia with a heart rate higher than 200 bpm
Patient heights below 120 cm (48inches) or above 230 cm (90inches)
Patient weights less than 30 kg (67 lbs.) or greater than 155 kg (341 lbs.)
Patient movement
Aortic balloon or aortic balloon pump
Simultaneous use of electrical cautery systems during surgical procedures
Operations on the opened thorax
Impedance cardiography (ICG)
Impedance cardiography allows the measurement of following parameters:
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•
•
•
•
Thoracic fluid content / inverse to thoracic basic impedance
Pre-ejection period
Left ventricular ejection time
Indexes of contractility: Velocity Index, Acceleration Index
Heart rate
Following parameters can be calculated:
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•
•
•
•
Cardiac Output
Heather index
Systolic time ratio
Systemic vascular resistance (requires blood pressure value)
Left ventricular work (requires blood pressure value)
With reference to body surface area the following indexed parameters can be calculated:
•
•
•
Cardiac Index
Systemic vascular resistance index
Left ventricular work index
The ICG module of the Bio Z® Cardio Profile can be used for following clinical
applications:
•
•
•
Non-invasive monitoring of the above hemodynamic parameters including
trend analysis
Determination and checking of the hemodynamic state of a patient including management of heart failure and hypertension therapy
Cardiologic diagnosis using hemodynamic parameters and waveform
shape analysis
Additional information and a detailed description of the measuring method, the
parameters, the application of impedance cardiography, and its limitations are
given in the software manual.
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1.2 Intended Use
The Bio Z® Cardio Profile is intended to monitor and display a patient’s hemodynamic parameters including:
Heart Rate (HR)
Systolic Blood Pressure (SBP)
Diastolic Blood Pressure (DBP)
Mean Arterial Pressure (MAP)
Stroke Volume (SV)
Stroke Index (SI)
Cardiac Output (CO)
Cardiac Index (CI)
Systemic Vascular Resistance (SVR)
Systemic Vascular Resistance Index
(SVRI)
Left Cardiac Work (LCW)
Left Cardiac Work Index (LCWI)
Velocity Index (VI)
Acceleration Index (ACI)
Heather Index (HI)
Pre-Ejection Period (PEP)
Left Ventricular Ejection Time (LVET)
Thoracic Fluid Content (TFC)
Thoracic Fluid Content Index (TFCI)
Baseline Impedance (Z0)
Total Arterial Compliance (TAC)
Total Arterial Compliance Index
(TACI)
Systolic Time Ratio (STR)
Systolic Time Ratio Index (STRI)
The Bio Z® Cardio Profile Hemodynamic Monitor in not intended to be used as a
vital sign monitor.
1.2.1 Contraindications
No known contraindications.
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1.3 Warnings and Cautions
For maximum safety, observe the following warnings and cautions:
WARNING: The Bio Z® Cardio Profile is intended for use only within hospitals
and other healthcare facilities (e.g. outpatient clinics, physician‘s office) that provide patient care.
WARNING: The Bio Z® Cardio Profile is intended for use on adult patients. It is
not intended for use on infants.
WARNING: The BioZ ® Cardio Profile Hemodynamic Monitor in not intended
to be used as a vital sign monitor.
WARNING: ECG measured with the ICG-channel as well as with the additional
ECG cable is for triggering purpose only. They are not intended for diagnoses of
any kind.
WARNING: The Bio Z® Cardio Profile is not intended to be used while exposing the patient to high-frequency current.
WARNING: The Bio Z® Cardio Profile is to be used only by or on the order of a
physician.
WARNING: All persons using the Bio Z® Cardio Profile must be qualified and
understand the measuring method and the operation of the monitor.
WARNING: To avoid the risk of an electric shock, this device must be connected
to supply mains with protective earth.
WARNING: The sensors can be placed freely on the body surface, but a direct
contact with the heart or vessels is not allowed. The Bio Z® Cardio Profile belongs to the application class BF (Body Floating).
WARNING: Only connect one patient at a time to the Bio Z® Cardio Profile.
WARNING: The sensors must not have a direct contact to other electrically conductive materials.
WARNING: ICG Sensors are single time use devices and should be replaced
after a maximum of 24 hours of use. While the patient contact materials have been
fully evaluated to the guidelines of ISO-10993-1 (Biological Evaluation of Medical Devices) for biocompatibility, skin irritation may occur at the sites of sensor
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placement. If local skin irritation occurs beneath or around any of the sensor sites,
discontinue product use and remove the sensors. Persistent use of the device in the
presence of skin irritation may be harmful.
WARNING: Before monitoring patients with pacemakers, ensure that the function of the pacemaker cannot be influenced by the measuring current used for impedance cardiography. In the case of minute ventilation pacemakers, the use of the
Do not use the Bio Z® Cardio Profile if the minute ventilation function of the
pacemaker is activated.
WARNING: The Bio Z® Cardio Profile must be connected by a three-wire
power cable to an electrical outlet that has been properly installed and grounded.
WARNING: The monitor is not protected against explosive substance. Do not
use the Bio Z® Cardio Profile in the presence of flammable anaesthetics or gases.
WARNING: To ensure that the measurement system functions safely, do not
subject it to high levels of humidity or to strong electrical or electromagnetic interference fields.
WARNING: Connecting multiple Bio Z® Cardio Profile systems and/or other
medical devices to the same patient may pose a safety hazard due to summation of
leakage currents. Any potential combination of instruments should be evaluated
by local safety personnel prior to being placed into service or applied to a patient.
WARNING: If performing a continuous monitoring session (i.e. in an ICU setting), make sure that all cabling is routed in a way so that it does not present a
strangulation hazard to the patient.
WARNING: Do not allow patients to wear ICG Sensors when undergoing Magnetic Resonance Imaging (MRI) due to risk of second and third degree burns.
WARNING: Control during operation, ensure that no long interruption of blood
circulation in the current extremity occurs. Detach the cuff if necessary.
WARNING: The Bio Z® Cardio Profile applies low-level AC current to the thorax of a patient during a monitoring session. Implanted devices with electrical
sensors (such as Minute Ventilation-based pacemakers) may detect the BioZ's
current and exhibit erratic sensor operation. It is recommended that electrical sensors of implanted devices be disabled prior to starting a BioZ monitoring session.
WARNING: Before replacing the external fuse on the unit, disconnect the unit
from the main power supply by pulling the plug out of the wall socket.
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WARNING: Before cleaning or disinfecting the measuring unit, disconnect the
unit from the main power supply by pulling the plug out of the wall socket.
WARNING: Do not modify any SonoSite products. Any modifications to the
device will void the warranty.
WARNING: Health care providers who maintain or transmit health information
are required by the Health Insurance Portability and Accountability Act (HIPAA)
of 1996 and the European Union Data Protective Directive (95/46/EC) to implement appropriate procedures: to ensure the integrity and confidentiality of information; to protect against any reasonably anticipated threats or hazards to the security or integrity of the information or unathorized uses or disclosure of the information.
CAUTION: Never gas-sterilize the patient cables. They are covered with a PVC
shroud that can react with the gas-sterilization procedure to form a highly toxic
ethyl nitrite. Sterilization in an autoclave, with ultrasound or gamma rays is also
not permitted.
CAUTION: Do not sterilize the Bio Z® Cardio Profile parts or accessories. Sterilizing the device or accessorries will void the warranty.
CAUTION: Use only cables or components recommended by SonoSite to connect to the inputs and outputs of the monitor.
CAUTION: Do not place the measuring unit on a surface which emits heat or
expose it to direct sunlight. Do not cover the ventilation slits.
CAUTION: Do not operate in bathrooms or other areas where water damage is
possible. The Bio Z® Cardio Profile is not protected against splashing water.
CAUTION: The Bio Z® Cardio Profile should be placed near the patient and
fixed in such a way that the Bio Z® Cardio Profile cannot fall down if someone
pulls on the cable.
CAUTION: The Bio Z® Cardio Profile is protected against accidental ingress of
liquids. If liquids ingress into the case, disconnect the monitor from the wall outlet.
CAUTION: Do not expose the cables to mechanical or thermal impact. Avoid
temperatures above 40 °C (100 °F). See page 32 for operating specifications.
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1.4 Explanation of used symbols
Caution, consult accompanying documents!
Do not dispose with residual waste
Device type BF, Defibrillator-proofed
Device type BF
Insulation class I
Potential equalisation connector
Caution, electrostatic sensitive devices
USB-Connector
Device Powered On
Stand-By
Connector for external keyboard
Network connector
Connector for external VGA-monitor
Connector for serial interface
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2 Description of the device
2.1 Basic device
The front of the Bio Z® Cardio Profile consists of a color TFT display with a
touch screen. Except for the operation of the main switch (5) the complete operation of the monitor is done only by the touch screen. In the Software Manual all
details are explained.
On the top side of the Bio Z® Cardio Profile a printer is built in. The use of the
printer is described in detail in section “Printer”.
The following illustration shows the left side and the right side of the device:
1.
2.
3.
4.
5.
6.
7.
8.
Integrated printer
Socket for impedance cardiography (ICG) patient cable
Socket for ECG patient cable
Socket for NIBP cuff
Power On and Off switch
Fuse compartment
Socket for power supply connecting cable
USB-sockets
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9. Connectors for computer peripherals (network, serial interface)
10. Charge and stand-by indicator
11. Potential equalisation connector
The power on and off switch is used to switch the device on and off, whereby the
internal power supply remains connected with the main power supply (for example, to charge the battery), even if the Bio Z® Cardio Profile is switched off. The
charging process is shown by the flashing charge indicator (10) on the right side
of the Bio Z® Cardio Profile. When the batteries are fully charged the indicator
lamp lights permanently and indicates that the device is connected with the main
power supply.
The type plate is located on the backside of the device. It lists important information about the Bio Z® Cardio Profile, including the value for the external fuse and
the serial number of the device. The serial number will be needed to obtain technical service assistance and warranty repairs.
On the right hand side of the Bio Z® Cardio Profile connectors for computer inputs/outputs (8, 9) are located and are labelled appropriately.
The following input/outputs are available and can be used if necessary and if the
connected components meet all requirements of the Medical Device Directive
(MDD) and United States regulation:
USB
Several peripheral devices can be attached to the USB sockets:
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•
•
Storage media (e.g. USB sticks or USB hard discs) to export measured
data.
External printer to print out reports at A4 or US-letter paper format. Please
note the instructions and safety requirements in section „External printer“.
A keyboard allows inputting the patient data. If the keyboard is attached
the Bio Z® Cardio Profile automatically updates the screen display for use
with a connected keyboard.
Network
This network connector can be connected to a 10 or 100 MBit ethernet network
using TCP/IP protocol. Please note the Safety requirements! A medical network
insulation module might be required and is available as accessory.
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Serial-I/O
The serial interface of the Bio Z® Cardio Profile monitor is a standard RS232
interface and can be used for connecting additional devices, which must be supported by the Bio Z® Cardio Profile software.
All sockets necessary for connecting the Bio Z® Cardio Profile to the patient are
located on the left side of the Bio Z® Cardio Profile. These are the sockets for:
ICG patient cable (2), ECG patient cable (3) and the cuff for NIBP (6) measurement. All patient cables are colour-coded as well mechanically coded.
Please note, that the mentioned sockets may only be connected to patient cables,
which are made for the Bio Z® Cardio Profile. The use of other cables is not allowed.
All plugs are self-locking. When the plug is inserted, the connection is secured.
The cables can be disconnected by only holding the outer casing of the plug and
pulling it out. Do not rotate the plug while it is in the socket. The blood pressure
cuff connector can be disconnected by moving the coupling part.
2.2 Device cart
The Bio Z® Cardio Profile can be mounted to the optional device cart. See the
assembly instructions delivered with the cart, to connect the device.
The cart fulfills the standard IEC 60601-1:1988/A2:1995.
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2.3 Patient cable
The patient cable for impedance cardiography (marked with ICG) contains a small
box, which includes a cable splitter with integrated electronics:
On the outside of the box, two small LEDs (green and orange) display the current
function of the patient cable, as indicated below:
green orange
Description of function
○
○
The electronic part of the patient cable is not connected with the
power supply; cable is disconnected or the device is switched off
☼
○
Patient cable is ready to use, but the measurement has not been
started
●
○
Measurement is running; sensor contact is good
☼
Bad contact between sensors and patient: at least one lead wire is
disconnected or not properly fixed; sensors are too dry (eventually new sensors are necessary)
●
●
Insufficient contact between sensors and patient: at least one
lead wire is disconnected or not properly fixed; sensors are too
dry (new sensors are necessary)
○
☼
Patient cable has power but the software cannot access the cable;
software has not been started or is not ready for measurement
●
Legend: ○ LED off
☼ LED flashing ● LED on
The application of the sensors and the connection of patient cables are detailed
described in the software manual in sections “Impedance Cardiography (ICG)”.
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2.4 Printer
Integrated strip chart printer
A thermal line printer is built into the top of the Bio Z® Cardio Profile. This
printer requires thermal paper with a width of 58 mm.
The button of the printer is for paper feed, but is not necessary for normal operation.
Changing paper
To open the paper box, lift the cover up by placing your
fingertip into the hole and moving the cover to the front.
Open the paper box.
Put the paper in the box, , with the leading edge of the
paper coming from the bottom of the roll. The paper must
come up through the printer slot.
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Press down the cover of the paper box to close it and to fix
the paper in the printer slot.
External printer
An external A4 or letter page printer can be connected to the USB-interface of the
Bio Z® Cardio Profile.
If the external printer is connected, all printouts are automatically sent to the external printer and the integrated strip chart printer is disabled.
To function properly, the external printer must meet the following requirements:
•
•
Compatibility to the PCL printer language
Following the requirements for medical devices according to IEC 60601-1
Please note that through combining of the Bio Z® Cardio Profile with a printer, a
medical electrical system is constituted, which must comply with the requirements
of IEC 60601-1 ensured that the leakage current does not exceed safety standards.
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2.5 Modules
Internal rechargeable battery
The Bio Z® Cardio Profile is equipped with a battery pack including electronics
for battery charging and control. It allows the use of the Bio Z® Cardio Profile
also without an external power supply over a period of at least 30 minutes. The
length of time the Bio Z® Cardio Profile may be operated on battery power depends on the mode of operation (for example, how often the blood pressure is
measured).
When the batteries are being charged the charge indicator on the right side of the
Bio Z® Cardio Profile (pos. (10) in section “Basic device”) flashes on and off.
When the batteries are fully charged, the indicator lamp glows continuously, indicating that the device is connected with the main power supply.
Please note, that generally rechargeable batteries have a limited lifetime and,
therefore, must be changed periodically. SonoSite recommends a technical check
after a two-year period. When the performance of the battery pack is reduced and
effects the operation time, the battery pack must be changed. When this occurs,
please contact your local distributor or SonoSite Technical Support directly.
Hard disc / internal data base
The integrated hard disc enables storage of the patient data obtained during a
monitoring session and enables an offline analysis. The optional PC software facilitates data transfer to an external PC for further evaluation or data storage
Non-invasive blood pressure (NIBP)
This module uses the oscillometric method and a pressure cuff to obtain systolic,
diastolic, and mean arterial pressure. These data may be obtained automatically, at
user-entered time intervals, or manually when activated by the user.
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3 Turning the device on and
taking a measurement
The following steps must be taken to begin a monitoring session with the Bio Z®
Cardio Profile monitor:
1. The Bio Z® Cardio Profile main power supply must be connected (unless
the optional internal battery is included with the Bio Z® Cardio Profile)
and switched on.
2. Depending on the parameters being measured (ICG, NIBP), the necessary
patient cable and cuff must be connected to the Bio Z® Cardio Profile and
properly applied to the patient.
3. Before starting the monitoring session, the patient data must be entered
and the mode of measurement selected. Now the measurement and data
recording can be started. Please note the hints in the software manual
4. At the end of the measurement, go back to the Patient data screen and stop
the measurement before switching off the device and removing the sensors
and blood pressure cuff from the patient.
3.1 Application of the electrodes
The application of the sensors and the connection of ICG cable are described in
detail in the software manual in sections “Impedance Cardiography (ICG)”.
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3.2 Blood Pressure Measurement (NIBP)
It is important to select the cuff size that is appropriate to the diameter of the patient's upper arm. Use the Range Lines on the inside of the cuff to determine the
correct size cuff to use.
Wrap the cuff around the arm making sure that the Artery Marker is aligned over
the brachial artery as shown in the Figure. If possible, do not wrap the cuff over
the patient's clothing. The cuff should fit snug to the patient's arm for maximum
oscillometric signal quality. An appropriate sized cuff should be placed on the
non-dominate arm where the lower edge of the cuff is located 2 cm above the antecubital fossa (interior bend of the elbow).
Ensure that the air hose from the Bio Z® Cardio Profile to the cuff is not compressed, crimped or damaged.
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4 Maintenance, cleaning and
disinfection
4.1 Basic device and patient cable
Maintenance
The Bio Z® Cardio Profile is a self-calibrating system so that external calibration
is not necessary. The proper function of the system can be checked using a special
signal generator (part no. N1104 for ICG channel).
The measurement system must always be kept in safe and reliable working order
and should be checked regularly, at least once a year. The check should cover a
function test and the measurement of leakage currents.
If you discover that the measurement system is faulty and/or unsafe (for example,
if any of the lines have insulation or breakage defects), repair the system and/or
replace faulty cables immediately.
Repairs may only be carried out by persons or workshops authorised to do so by
the manufacturer. Otherwise, general liability for improperly operating the measurement system and for injury, damage and consequential damage resulting therefrom will be passed on to the operator or to the persons or workshops that have
not been expressly authorised by the manufacturer.
Replacing the external fuse
Use only the prescribed type of fuses as replacements (see type plate). Do not use
repaired fuses or short-circuit the fuse holder. Please contact Sonosite Technical
Service if the external fuses fail repeatedly.
Cleaning and disinfection
It is recommended to clean and to disinfect the Bio Z® Cardio Profile and its cables regularly.
Clean the unit and the cables with a soft cloth. Do not use any abrasive or corrosive substances. We recommend neutral cleaning agents or disinfecting substances,
like ethanol (70 - 80 %), propanol (70 - 80 %) or aldehyde (2 - 4 %). Ensure that
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no disinfectant gets onto the contact points of the plugs and sockets, and that no
liquid seeps into the Bio Z® Cardio Profile
Replacing the battery
The BioZ® Cardio Profile is equipped with a rechargeable battery (part number
N1306-2). The typical lifetime of the used NiMH is 50 - 1000 charging cycles.
Depending from usage this equates up to 3 years. Afterwards the capacity reduces
and the battery should be replaced.
The following steps must be performed to replace the battery:
1. Turn off the BioZ® Cardio Profile and disconnect it from the main power
supply by pulling the plug out of the wall socket.
2. Remove 4 screws from the bottom side of the device using a crosstip
screwdriver (type PH1) as shown in the following picture:
3. Remove the battery cover.
4. Carefully take the battery and disconnect the plug-in connector while
pressing the locking mechanism.
5. Hold the new battery pack and connect the plug-in connector carefully.
6. Insert the new battery into the device. Pay attention that no cable is
squeezed.
7. Reinsert the battery cover and the 4 screws.
8. Because the batteries are delivered in empty state, connect the main power
supply to load the accumulator.
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Calibration of the touch screen
A recalibration of the touch screen may be necessary if you touch an enabled button on the screen and:
the selected function is not activated or another function (located away from the
selected function) is activated.
AND
you hear the normal click sound.
To calibrate the touch screen please carry out the following steps:
1. Turn off and turn on the Bio Z® Cardio Profile. (The calibration function
can only be activated on a freshly booted device.)
2. When the patient data screen is displayed, touch the screen on a random
place and continue pressing the screen (for approximately 5 seconds) until
the calibration menu is displayed (see next picture).
3. The calibration menu will prompt you to touch every corner of the screen
display. The touched positions will be saved as the references for the following touch screen operations.
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4.2 Service Procedures of the optional
Blood pressure module
Pressure Transducer Verification
International standards for automated NIBP devices require that the maximum
static pressure accuracy shall be ±3 mmHg. This is a stringent requirement and all
test equipment must be in excellent working order to properly perform this test. It
is important to verify the calibration before changing it. Although experience has
shown that the transducers rarely need to be re-calibrated annually the pressure
verification is required.
Equipment
•
•
•
•
•
Calibrated Manometer
Pneumatic "T" Adapters
Volume (500 mL bottle or regular-sized cuff wrapped around a solid object is suggested)
Hand Bulb
Connection Tubing
NOTE: Volume is added to the pneumatic system so that the user has more control of the pressure increments when using the hand bulb. If no volume is added, it
is quite easy to cause unwanted overpressure errors using the hand bulb.
Procedure
1. Connect a manometer, volume and the hand bulb to the Module using "T"
adapters.
2. Inflate SLOWLY when adding pressure over 200 mmHg.
3. Apply various pressures (between 0 and 280 mmHg) to the Module with
the hand bulb. Verify that the Module pressure is equal to the manometer
pressure (±3 mmHg).
If the Module pressure does not agree with the manometer pressure and need to be
calibrated please contact our support.
Leak Test
International standards for automated NIBP devices require that air leakage within
the pneumatic system must not exceed 6mmHg/minute. During manufacturing
acceptable air leakage is less than 3 mmHg/minute when using a 500 mL rigid
volume. Both of these pass criteria will not affect the performance or accuracy of
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the NIBP module so we suggest using the 6mmHg/minute pass criteria with a
500 mL rigid volume.
Equipment
•
•
•
•
•
•
Calibrated Manometer (optional may use pressure values supplied by
NIBP module)
Pneumatic "T" Adapters
Volume (500 mL rigid bottle a blood pressure cuff is not recommended)
Hand Bulb
Connection Tubing
Timer (i.e. Stop Watch)
NOTE 1: Volume is added to the pneumatic system so that the user has more control of the pressure increments when using the hand bulb. If no volume is added, it
is quite easy to cause unwanted overpressure errors using the hand bulb. Also leak
rates are exaggerated with extremely small volumes.
NOTE 2: Blood pressure cuffs have large variations in size and materials which
can cause large amounts of variation in the leak test results. To limit this effect,
we strongly urge to only use a 500 mL rigid volume.
Test Method
1. Connect a manometer, volume and the hand bulb to the Module using "T"
adapters.
2. If using a hand bulb, make sure the exhaust valve is closed.
3. Increase the pressure to approximately 250 mmHg using the hand bulb or
the pump on the module. It is difficult to slowly increase the pressure in
the pneumatic system with the pump so a hand bulb is preferred.
NOTE: When applying high pressures, take special care to increase the
pressure at a rate that will not cause unwanted overpressure errors
(300 mmHg).
4. Start the timer and wait 60 seconds for the pneumatic system to reach its
pressure equilibrium point. All pneumatic systems have some degree of
expansion and rebound which are effected by the several factors including
volume, material types and material durometers.
5. After the waiting period, record the pneumatic pressure level (P1) and wait
another 60 seconds and record the pneumatic pressure level again (P2).
NOTE: Safety circuitry on the module only allows the pressure in the
pneumatic system to remain above 10 mmHg for 180 seconds. When this
safety time limit is exceeded, the valves will open and the module will be
disabled. To reset the NIBP module, it must have the power cycled or it
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needs to be set to its sleep mode and awakened. Not all NIBP module customers have the ability to use the sleep mode.
6. Open the hand bulb valve to exhaust the air from the pneumatic system.
7. Subtract P2 from P1 and this is the leak rate per minute.
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5 Technical Data
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Mains Supply
100 – 240 V AC
Supply frequency
50/60 Hz
Power input
< 60 VA
Battery (optional)
internal NiMH-rechargeable batteries
Capacity > 60 min
Fuses external
2 x T 1.0 A
Electrical safety
IEC 60601-1
ANSI/AAMI SP10
21CFR898
FDA class II
Insulation class I
Classification for patient protection BF
Electromagnetic compatibility
IEC 60601-1-2
Insulation voltage
Patient - Main supply: 4 kVeff ; 1 min
Patient - Signal I/O: 4 kVeff ; 1 min
Display
10.4” TFT-Color
640 x 480 Pixel, Touch screen
Dimensions (W x H x D)
11.4 x 12.6 x 5.5 in
Weight
(approx. 11 lbs (with battery pack))
Signal I/O
Serial-I/O serial interface, RS232
USB interface
Network 10/100MBit Ethernet, 100Base2
Operating conditions
Temperature: 10 – 40 °C
Humidity: 30 – 75 %
Altitude: 0 - 3000 m
5.1 Measurement channels
ICG (Impedance Cardiography)
Measuring principle
Bioimpedance-Plethysmography
defibrillator safe
Sensors
4 BioZ AdvaSense disposable sensors
(solid gel)
Measuring current
1.5 mAeff; 85 kHz; Sinus
Basic impedance
0 – 60 Ω; 0 – 0.2 Hz
Pulse wave
±1 Ω; 0.2 – 100 Hz
ECG
Max. input voltage
±10 mV AC voltage, defibrillator safe
Frequency range
0.8 – 160 Hz
Common mode rejection ratio
> 90 dB
Noise voltage
< 10 µV
NIBP (non-invasive blood pressure)
Measuring principle
oscillometric with arm cuff
Parameter
systolic and diastolic pressure, arterial
mean pressure (MAP)
Range
0 – 280 mmHg
Transducer accuracy
±3 mmHg
Patient safety
Max. cuff inflation time
75 s
Max. BP reading time
130 s (Adult mode)
90 s (Pediatric mode)
Redundant safety
Max. cuff pressure
300 mmHg
Max. time with inflated cuff
180 s
31
6 Scope of delivery
To the scope of delivery of the Bio Z® Cardio Profile the following components
belong:
•
•
•
•
•
•
•
•
Measuring device Bio Z® Cardio Profile
Power cord
ICG Patient cable
ECG Patient cable
3 x NIBP-Cuffs (“Adult”, “Large Adult“ and “Small Adult“)
10 rolls thermal paper
Bio Z® Cardio Profile Device Manual
Software Manual
Accessories and expendable items
•
•
•
•
•
•
•
•
•
32
BioZ AdvaSense ICG sensors (part number BZ-1550)
ICG / ECG Patient cable (P15002-01)
ECG Patient cable (P15003-01)
Blood pressure cuffs for the following arm circumferences:
o 23 … 33 cm (“Adult”, P15006-01)
o 31 … 40 cm (“Large Adult”, P15480-01)
o 17 … 25 cm (“Small Adult”, P15481-01)
Cuff hose (P15007-01)
Internal battery replacement pack (P15086-01)
Thermal paper for the integrated strip chart printer (P15009-01)
Device manual Bio Z® Cardio Profile (P15010-01)
Power Cord – US/CAN Style (P00848-01)
7 Manufacturer guidelines and
declarations
Electromagnetic emissions
The Bio Z® Cardio Profile monitor is intended for use in the electromagnetic environment specified below.
The customer or the user of the Bio Z® Cardio Profile monitor should assure that
it is used in such an environment.
Emissions test
Compliance
RF emissions
CISPR 11
Class B
Harmonic emissions
IEC 61000-3-2
Class A
Voltage fluctuations/flicker emissions
IEC 61000-3-3
Complies
Electromagnetic environment
guidance
The Bio Z® Cardio Profile monitor is suitable for use in all establishments other than
domestic establishments and those directly
connected to the public low-voltage power
supply network that supplies buildings used
for domestic purposes.
Electromagnetic immunity
The Bio Z® Cardio Profile monitor is intended for use in the electromagnetic environment specified below.
The customer or the user of the Bio Z® Cardio Profile monitor should assure that
it is used in such an environment.
Compliance
level
Electromagnetic environment
guidance
Electrostatic
discharge
(ESD)
IEC 61000-4-2
±6kV contact ±6kV contact
±8kV air
±8kV air
Floors should be wood, concrete
or ceramic tile. If floors are covered with synthetic material the
relative humidity should be at
least 30 %.
Electrical fast
transient / burst
IEC 61000-4-4
±2kV for
power supply
lines
±1kV for
input/output
Immunity test
IEC 60601
test level
±2kV for
power supply Mains power quality should be
that of a typical commercial or
lines
hospital environment.
±1kV for
input/output
33
Surge
IEC 61000-4-5
Voltage dips,
short interruptions and voltage variations
on power supply input lines
IEC 61000-4-11
lines
lines
±1kV differential mode
±2kV common mode
±1kV differential mode
±2kV common mode
<5% UT
(>95% dip in
UT) for ½
cycle
<5% UT
(>95% dip in
UT) for ½
cycle
40% UT
(60% dip in
UT) for 5
cycles
40% UT
(60% dip in
UT) for 5
cycles
70% UT
(30% dip in
UT) for 25
cycles
70% UT
(30% dip in
UT) for 25
cycles
Main power quality should be
that of a typical commercial or
hospital environment.
Outlet (AC) power quality
should be that of a typical commercial or hospital environment.
If the user of the Bio Z® Cardio
Profile monitor requires continued operation during power
mains interruptions, it is recommended that the Bio Z®
Cardio Profile be powered from
an uninterruptible power supply
or a battery.
<5% UT
<5% UT
(>95% dip in (>95% dip in
UT) for 5s
UT) for 5s
Power frequency (50 Hz)
magnetic field
IEC 61000-4-8
3 A/m
3 A/m
Power frequency magnetic
fields should be at levels characteristics of a typical location in a
typical commercial or hospital
environment.
NOTE: UT is the a.c. mains voltage prior to application of the test level.
34
Electromagnetic immunity
The Bio Z® Cardio Profile monitor is intended for use in the electromagnetic environment specified below.
The customer or the user of the Bio Z® Cardio Profile monitor should assure that
it is used in such an environment.
Immunity
test
IEC
60601
test
level
Compliance
level
Electromagnetic environment
guidance
Portable and mobile RF communications
equipment should be used no closer to any
part of the Bio Z® Cardio Profile monitor,
including cables, than the recommended
separation distance calculated from the
equation applicable to the frequency of the
transmitter.
Recommended separation distance:
d=3,5 √P
3 Vrms
Conducted 150
RF
kHz to
80
IEC
61000-4-6 MHz
Radiated
RF
IEC
61000-4-3
1 Vrms
3 V/m 1 V/m
80
MHz to
2,5
GHz
d=3,5 √P for 80 MHz to 800MHz
d=7 √P for 800 MHz to 2,5 GHz
Where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is
the recommended separation distance in
meters (m).
Field strengths from fixed RF transmitters,
as determined by an electromagnetic site
survey,¹ should be less than the compliance
level in each frequency range,² Interference
may occur in the vicinity of equipment
marked with the following symbol:
35
NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic
propagation is affected by absorption and reflection from structures, objects and
people.
¹ Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio
broadcast and TV broadcast cannot be predicted theoretically with accuracy. To
assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the
location in which the Bio Z® Cardio Profile monitor is used exceeds the applicable RF compliance level above, the Bio Z® Cardio Profile monitor should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the Bio Z®
Cardio Profile monitor.
²Over the frequency range 150 kHz to 80 MHz, field strengths should be less than
1 V/m.
36
Recommended separation distances
Recommended Separation Distances Between Portable and Mobile RF Communications Equipment and the Bio Z® Cardio Profile
The Bio Z® Cardio Profile is intended for use in the electromagnetic environment
in which radiated RF disturbances are controlled. The customer or the user of the
Bio Z® Cardio Profile monitor can help prevent electromagnetic interference by
maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Bio Z® Cardio Profile monitor as recommended below, according to the maximum output of the communications equipment.
Separation distance according to frequency
of transmitter
in meters
Rated maximum output
power of transmitter
150 kHz to
80 MHz
d = 3,5 √P
80 MHz to
800 MHz
d = 3,5 √P
800 MHz to
2,5 GHz
d = 7 √P
0,01
0,35
0,35
0,7
0,1
1,1
1,1
2,2
1
3,5
3,5
7
10
11
11
22
100
35
35
70
W
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation
applicable to the frequency of the transmitter, where P is the maximum output
power rating of the transmitter in watts (W) according to the transmitter manufacturer.
NOTE 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic
propagation is affected by absorption and reflection from structures, objects and
people.
37
8 Appendix
8.1 Support
If you need additional information or if you have any technical, methodical or
clinical questions please contact:
21919 30th Drive SE
Bothell, WA 98021-3904
Tel. 1-800-778-4825 Option 3
www.sonosite.com
If you have questions about your device, please provide the serial number of your
device, located on the type plate on the back or bottom side of the device.
For questions about the software, provide the serial number of the software, located in the Hardware-Info screen. Press F5-Options in the Patient data screen
and then the F1-Hardware button.
8.2 Alarm System
In the measuring device an alarm system recommended in the standard IEC
60601-1-8 is used. In the following the specifications and basic settings are described.
Alarm priority
Alarms are classified regarding the
The following visual alarm priorities are used:
Alarm priority
I - low priority
occurrence
and
Indicator colour Flashing frequency Duty cycle
Cyan
II - medium priority Yellow
constant (on)
100 % on
0.71 Hz
50 % on
The following acoustic alarm priorities are used:
38
type,
risk.
Alarm priority
I - low priority
Cause Tone sequence Alarm repetition
Any
e-c
II - medium priority Cardiac c - e - g
20 s
10 s
Alarms with high priority are not used, because the system belongs to class
IIa and, therefore, is not intended for monitoring of vital physiological parameters, where the nature of variations is such that it could result in immediate danger to the patient!
If several alarms occur with the same priority, the first alarm is displayed. If this
alarm is muted the following alarm is displayed until all alarms have been shown.
If an alarm with higher priority occurs, it will be brought to front automatically.
Alarm deactivation
Following alarm deactivations are used:
Alarm deactivation
Meaning
AP - Audio Paused The acoustic alarm is deactivated for a period of 1 minute
AO - Audio Off
The acoustic alarm is deactivated
ALP - Alarm
Paused
The alarm (acoustic and visual) is deactivated for a period of
1 minute
ALO - Alarm Off
The alarm (acoustic and visual) is deactivated
Physiological alarms can only be paused. A general deactivation is not possible if
the alarm control is enabled.
Alarm condition delay
If an alarm occurs, it will be displayed immediately. But note that a high parameter averaging rate can cause delays in the alarm activation. It is also possible that
small or temporary exceeding of the parameter limits cause no alarm activation.
If instant alarm activation is required reduce the parameter averaging of the appropriate examination to "1" (averaging deactivated).
39
Physiological Alarms
The following table states the physiological parameters which can be observed by
the system. The manufacturer basic setting can only be configured for a single
measurement and can not be saved.
Alarm Condition
Physiological Alarm
Alarm PriorManufacturer Limit
ity /
Value
Alarm DeactiLower
Upper
vation
HR - Heart rate
II / AP
58
86
1/min
Z0 - Base impedance
II / AP
♂: 20,0
♀: 27,0
♂: 33,3
♀: 47,6
Ohm
TFC - Thoracic fluid
content
II / AP
♂: 30
♀: 21
♂: 50
♀: 37
1/kOhm
TFCI - Thoracic fluid
content Index
II / AP
♂: 30/BSA ♂: 50/BSA
1/kOhm/m²
♀: 21/BSA ♀: 37/BSA
SV - Stroke volume
II / AP
BSA*35
BSA*65
ml
SI - Stroke index
II / AP
35
65
ml/m²
CO - Cardiac Output
II / AP
BSA*2.5
BSA*4.7
l/min
CI - Cardiac Index
II / AP
2.5
4.7
l/min/m²
PEP - Pre ejection
period
II / AP
50
100
ms
LVET - Left ventricuII / AP
lar ejection time
200
300
ms
STR - Systolic time
ratio
II / AP
0.3
0.5
-
VI - Velocity Index
II / AP
33
65
1/1000/s
ACI - Acceleration
Index
II / AP
♂: 70
♀: 90
♂: 150
♀: 170
1/100/s²
HEATHER - Heather
Index
II / AP
7
20
Ohm/s²
BDsys - Systolic
blood pressure
II / AP
100
140
mmHg
40
Unit
BDdia - Diastolic
blood pressure
II / AP
60
90
mmHg
MAP - Mean arterial
blood pressure
II / AP
70
105
mmHg
LCWI - Left Cardiac
Work Index
II / AP
3.0
5.5
kg·m/m²
LCW - Left Cardiac
Work
II / AP
3.0*BSA
5.5*BSA
kg·m/m²
SVRI - Systemic VasII / AP
cular Resistance Index
1680
2580
5
SVR - Systemic Vascular Resistance
II / AP
1680/BSA
2580/BSA
dyn · s · cm-5
TAC - Total Arterial
Compliance
II / AP
0.7*BSA
1.4*BSA
ml/mmHg
TACI - Total Arterial
Compliance Index
II / AP
0.7
1.4
ml/mmHg/m²
PAWP - Pulmonary
artery wedge pressure
II / AP
5
15
mmHg
CVP - Central venous
pressure
II / AP
3.0
9.0
mmHg
Load
II / AP
75
225
W
Hb - Haemoglobin
II / AP
♂: 14
♀: 12
♂: 18
♀: 16
g/dl
dyn ·s·cm·m²
Legend: ♂: male, ♀: female
Technical Alarms
The following table states the physiological parameters which can be observed by
the system. The manufacturer basic setting can only be configured for a single
measurement and can not be saved.
The following table states the technical alarms implemented into the system. Regarding the operation mode two different alarm priorities are used:
•
Online: Measurement is running
41
•
Offline: No measurement is running
Alarm Priority / Alarm
Deactivation
Alarm Condition
Technical Alarm
Offline
Online
NIBP: Weak or no oscillometric signal
I / ALO
II / ALO
NIBP: Artefact / erratic oscillometric signal
I / ALO
II / ALO
NIBP: Exceeded retry count
I / ALO
II / ALO
NIBP: Exceeded measurement time limit
I / ALO
II / ALO
NIBP: Pneumatic Blockage
I / ALO
II / ALO
NIBP: Inflate Timeout, Air Leak or Loose Cuff
I / ALO
II / ALO
NIBP: Safety Timeout
I / ALO
II / ALO
NIBP: Cuff Overpressure
I / ALO
II / ALO
NIBP: Power supply out of range or other hardware problem
I / ALO
NIBP: Permission problem such as safety override
fitted or autozero out of range
I / ALO
II / ALO
NIBP: Transducer out of range
I / ALO
II / ALO
NIBP: ADC out of range
I / ALO
II / ALO
NIBP: EEPROM calibration data failure
I / ALO
II / ALO
Patient cable disconnected
-
II / ALO
Patient cable connected
-
II / ALO
Low Battery!
I / AO
II / AO
Hardware Failure!
II / ALP
II / ALP
42
II / ALO
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