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Niccomo en
Niccomo en
TM
Device Manual
0197
Tel. +49 - 36 77 46 29 0
Fax +49 - 36 77 46 29 29
[email protected]
http://www.medis-de.com
Device Manual
niccomo Software Manual
Before using the niccomo monitor read both manuals carefully and
completely to ensure that you operate the system correctly.
When you set up the monitor for the first time, check to see if it has suffered any
damage during transportation.
+49 - 36 77 - 46 29-29
In the case of a request we would ask you to inform us about the serial number of
your device which you can find on the type plate on the back or bottom side of the
device.
In case of a software request the serial number of the software is needed which
can be found in the Hardware-Info screen. Press F5-Options in the Patient data
screen and then the F1-Hardware-button.
Table of Contents
1
5
6
7
8
Introduction ..................................................................................................... 6
1.1
Applications ............................................................................................ 6
1.2
Precautions and limitations ..................................................................... 9
1.3
Safety requirements............................................................................... 10
1.4
Explanation of used symbols ................................................................ 12
Description of the device .............................................................................. 13
2.1
Basic device .......................................................................................... 13
2.2
Patient cable .......................................................................................... 16
2.3
Printer.................................................................................................... 17
2.4
Optional modules .................................................................................. 19
Commissioning of the device and preparing a measurement........................ 21
3.1
Application of the electrodes ................................................................ 21
3.2
Blood Pressure Measurement (NIBP)................................................... 22
3.3
Oxygen Saturation Measurement (SpO2) ............................................. 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
4.3
Servicing the SpO2 module .................................................................. 29
Technical Data .............................................................................................. 30
5.1
Measurement channels .......................................................................... 31
Scope of delivery .......................................................................................... 34
medis Standard / Extended Warranty............................................................ 35
Manufacturer guidelines and declarations .................................................... 37
1 Introduction
1.1 Applications
The niccomo monitor is a measuring system for non-invasive monitoring of
haemodynamic parameters using methods of impedance cardiography (ICG) and
impedance plethysmography (IPG).
In impedance cardiography, pulse synchronous variations of the blood flow and
volume in the thoracic aorta are determined and used for calculating different
haemodynamic 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 haemodynamic parameters. The niccomo monitor
uses four dual sensors, which are placed on the patients 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:
It is important to note that the ECG obtained and recorded by the niccomo monitor is not a standard lead. It is, however, important for the internal signal processing. If a standard ECG lead is desired, an optional ECG cable can be connected
to the monitor for this purpose.
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 measurement of peripheral arterial pulse wave in extremities (legs, arms, head)
is based on the same principle as impedance cardiography, but it is called impedance plethysmography (IPG). Only four electrodes are used for the IPG procedure, which is also called rheography.
In the field of vascular diagnosis, the terms impedance plethysmography or rheography are also used to describe a measuring method determining the venous
blood flow or venous occlusion plethysmography (VOP). Please note, that VOP
measurements are not available on the niccomo monitor.
The niccomo monitor can be upgraded by additional modules, for example,
non-invasive blood pressure (NIBP), pulse oximetry (SpO2) or an internal database.
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 niccomo monitor can be used for following clinical
applications:
Basic impedance
Pulse wave amplitude (related to basic impedance)
Slope of the pulse wave
Crest time, pulse quotient
Propagation time (related to R-wave of ECG)
The IPG module of the niccomo monitor can be used for following clinical applications:
Measurement of the pulse wave propagation time measured from the opening of the aortic valve, rather than from the R-wave
Septic shock
Aortic valve regurgitation and defect of septum
Severe aortic sclerosis, aortic prosthesis
Severe hypertension (MAP > 130 mmHg)
Tachycardia with a heart rate higher than 200 bpm
Patient heights below 120 cm (48) or above 230 cm (90)
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
During operations on the opened thorax the current distribution can be distorted
and can lead to inaccuracies.
The niccomo monitor is not designated to monitor infants (babies) because only
insufficient experiences exist for this group of patients.
Impedance plethysmographic (IPG) measurements can be made only if a sufficient peripheral arterial blood flow (arterial pulse wave) exists. Peripheral arterial
occlusions or severe vascular sclerosis may adversely affect the accuracy of the
IPG data. Because the IPG signals are very small, IPG measurements can only be
taken while the patient is not moving.
10
Do not expose the cables to mechanic or thermic impact. Avoid temperatures above 40 C (100 F).
The monitor must be connected by a three-wire power cable to an electrical outlet
that has been properly installed and grounded.
The measuring unit should neither be placed on a surface which emits heat nor
exposed to direct sunlight. Never cover the ventilation slits.
The monitor is not protected against splashing water. Therefore, do not operate in
bathrooms or other areas where water damage is possible.
The monitor is protected against accidentally ingress of liquids. Nevertheless, in
case that water or other liquids ingress into the case, the monitor must be disconnected from the mains immediately.
The monitor is not protected against explosive substance. Therefore, do not use
the niccomo monitor in the presence of flammable anaesthetics or gases.
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.
Only cables or components specified and allowed by the manufacturer must be
used to connect to the inputs and outputs of the monitor.
The connection to an external network is prohibited if a patient is connected to the
niccomo monitor.
Other devices or components can only be connected to the monitor if they meet all
requirements of the Medical Device Directive (MDD) and the EN 60 601-1 and if
the created medical system meet all requirements of the EN 60 601-1-1.
The combination of the niccomo monitor with other medical devices is only
allowed if any harm to the patient can be excluded.
The niccomo monitor must always be kept in safe and reliable working order
and must be checked regularly.
11
12
1. Integrated printer
2. Socket for patient cable for impedance cardiography (ICG) or impedance
plethysmography (IPG) / left side
3. Socket for patient cable for impedance plethysmography (IPG) / right side
4. Socket for patient cable for ECG
5. Socket for connection of sensor for SpO2
6. Socket for connection of cuff for NIBP
7. Mains switch
13
8. Fuse compartment
9. Socket for main connecting cable
10. Connectors for computer peripherals (keyboard, network, serial interface)
11. USB-sockets
12. Charge and stand-by indicator
13. Potential equalisation connector
The main 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 optional battery), even if the monitor is switched off. The charging process
is shown by the flashing charge indicator (12) on the right side of the monitor.
When the batteries are fully charged or the device is in stand-by (if no batteries
are installed), 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 monitor, 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 monitor connectors for computer inputs/outputs (10,
11) 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):
USB
To the USB sockets several peripheral devices can be attached:
14
Storage media (i. e. 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 monitor automatically updates the screen display for use with a connected keyboard.
Analog-Interface for the analogue output of calculated and measured data
for further processing.
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.
Serial-I/O
The serial interface of the niccomo monitor is a standard RS232 interface and
can be used for connecting additional devices, which must be supported by the
niccomo software.
All sockets necessary for connecting the monitor to the patient are located on the
left hand side of the monitor. These are the sockets for: ICG patient cable (2), IPG
patient cable (2, 3), ECG patient cable (4), SpO2 sensor (5), cuff for NIBP measurement (6). 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 niccomo monitor. The use of other cables is not allowed.
All plugs are self-locking. That means 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. Never attempt to rotate the plug while it is in the socket.
The blood pressure cuff connector can be disconnected by moving the coupling
part.
15
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
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)
Patient cable has power but the software cannot access the cable;
software has not been started or is not ready for measurement
Legend:
16
The application of the sensors and the connection of patient cables are detailed
described in the software manual in sections Impedance Cardiography (ICG)
and Impedance Plethysmography (IPG).
When two patient cables for impedance plethysmography (IPG) are used for simultaneous measurement on the right and left side of the body it is important to
consider the colour coding of the patient cables (colour of the plug and the electrodes) - the yellow coded cable is for the measurement on the left hand side
and the red coded cable for the right hand side.
If only one IPG cable is being used (one channel IPG measurement, combined
ICG/IPG measurement) always use a yellow coded IPG cable. However, this
cable can be used on either side of the patients body.
2.3 Printer
Integrated strip chart printer
A thermal line printer is built into the top of the niccomo monitor. 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.
17
External printer
An external A4 or letter page printer can be connected to the USB-interface of the
niccomo monitor.
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:
Please note that through combining of the niccomo device with a printer a medical electrical system is constituted which must comply with the requirements of
IEC 60 601-1-1. It must especially be ensured that the leakage current does not
exceed safety standards (also under failure conditions).
18
SpO2 module
This module allows the measurement of the oxygen saturation of the arterial blood
and the photoplethysmographic recording of the arterial pulse.
19
20
21
Ensure that the air hose from the monitor to the cuff is not compressed, crimped
or damaged.
22
Select a suitable site for the sensor. The patient's first finger is the preferred location. Alternative sites recommended are the thumb, large toe, or
little finger.
Fit the sensor as illustrated. The patient's finger must be inserted right to
the end of the sensor. Direct the cable along the patient's finger and parallel to the arm. Affix with adhesive tape if required.
Connect the sensor cable to the monitor or to the patient cable and verify
proper operation.
23
24
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 no disinfectant gets onto the contact points of the plugs and sockets, and that
no liquid seeps into the niccomo monitor.
Caution! Never gas-sterilise the patient cables. They are covered with a PVC
shroud that can react with the gas-sterilisation procedure to form a highly toxic
ethyl nitrite. Sterilisation in an autoclave, with ultrasound or gamma rays is also
not permitted.
25
26
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
27
the NIBP module so we suggest using the 6mmHg/minute pass criteria with a
500 mL rigid volume.
Equipment
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
28
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.
Function Check
If the module detects an error or non-allowed states, these are reported. The module should be given a function check at least once a year or if malfunctioning is
suspected. A function test should be carried out with a finger sensor within the
normal saturation range (95 %98 % SpO2). Alternatively, a simulation device
(e.g. BIO-TEK Index 2 or METRON deag) can be used for the saturation range
from 70 %99 % SpO2 and for a pulse frequency range from 45 bpm250 bpm.
Please note that this function check can not be used to verify the accuracy of the
SpO2-measurement.
29
5 Technical Data
30
Mains Supply
90 260 V AC
Supply frequency
50/60 Hz
Power input
< 60 VA
Battery (optional)
Fuses external
2 x T 1.0 A
Electrical safety
Electromagnetic compatibility
EN 55011 - class A
EN 60601-1-2
Insulation voltage
Display
10.4 TFT-Colour
640 x 480 Pixel, Touch screen
Dimensions (W x H x D)
Weight
Signal I/O
Operating conditions
Temperature: 10 40 C
Humidity: 30 75 %
Bioimpedance-Plethysmography
defibrillator safe
Sensors
Measuring current
Basic impedance
0 60 ; 0 0.2 Hz
Pulse wave
1 ; 0.2 100 Hz
Bioimpedance-Plethysmography
Electrodes
Measuring current
Basic impedance
0 200 ; 0 0.2 Hz
Pulse wave
500 m; 0.2 15 Hz
ECG
Max. input voltage
10 mV AC voltage
defibrillator safe
Frequency range
0.8 160 Hz
> 90 dB
Noise voltage
< 10 V
31
Parameter
Range
0 280 mmHg
Transducer accuracy
3 mmHg
Patient safety
Max. cuff inflation time
75 s
Redundant safety
Max. cuff pressure
300 mmHg
50 100 %
Accuracy SpO2
Influences on accuracy
The following factor may negatively influence the accuracy of the SpO2-module:
Factor
Effect
Ambient light
Motion artifacts
32
Pulsation strength
Electromagnetic
interference immunity
Value
Accuracy / Comments
36 s
Measured at default settings. The worse the measurement conditions, the less reliable the first
displayed value.
33
6 Scope of delivery
To the scope of delivery of the niccomo -monitor the following components
belong:
Depending from selected device options the following components are delivered:
34
35
All units must be returned to medis or a medis Authorised Service Centre for repair or replacement.
medis does not warrant (either expressed or implied) the correctness or validity of any output information or data provided by the System, including, but
not limited to, any information relating to any medical diagnosis/treatment
or to the health and safety needs of patients. medis does not warrant that any
output of the System will meet the standards or requirements of the End Users medical practice. End User expressly acknowledges that End User is
solely responsible for verifying that any results produced by the System are
free from error and suitable for the applications for which they are to be used.
medis and its authorised Distributors shall not be liable for any special, incidental,
indirect or consequential damages arising out of the use of or inability to use the
System. Under no circumstances shall medis and its Distributors liability under
this Limited Warranty exceed the purchase price of the System and/or Software
paid by the End User.
36
Compliance
RF emissions
CISPR 11
Class A
Harmonic emissions
IEC 61000-3-2
Class A
Electromagnetic environment
guidance
The niccomo 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 niccomo monitor is intended for use in the electromagnetic environment
specified
below.
The customer or the user of the niccomo monitor should assure that it is used in
such an environment.
Compliance
level
Electromagnetic environment
guidance
Electrostatic
6kV contact 6kV contact
discharge (ESD)
8kV air
8kV air
IEC 61000-4-2
Immunity test
Electrical fast
transient / burst
IEC 61000-4-4
IEC 60601
test level
2kV for
power supply
lines
1kV for
input/output
lines
2kV for
power supply
lines
1kV for
input/output
lines
37
Surge
IEC 61000-4-5
Voltage dips,
short interruptions and voltage
variations on
power supply
input lines
IEC 61000-4-11
<5%
UT
(>95% dip in
UT) for
cycle
<5%
UT
(>95% dip in
UT) for
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
<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
NOTE: UT is the a.c. mains voltage prior to application of the test level.
38
Electromagnetic immunity
The niccomo monitor is intended for use in the electromagnetic environment
specified
below.
The customer or the user of the niccomo 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 niccomo 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
Conducted
RF
IEC
61000-4-6
Radiated
RF
IEC
61000-4-3
3 Vrms
150
kHz to
80
MHz
1 Vrms
3 V/m 1 V/m
80
MHz to
2,5
GHz
39
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.
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 niccomo monitor is used exceeds the applicable RF
compliance level above, the niccomo 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 niccomo monitor.
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than
1 V/m.
40
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
3,5
3,5
10
11
11
22
100
35
35
70
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.
41