MostCare Up User Manual Rev 19

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CONTENTS 1.

MOSTCAREUP HAEMODYNAMIC MONITOR... 6 1.1 1.2 1.3 1.4

2.

CONNECTORS AND INTERFACES ... 6 LIST OF SYMBOLS ... 7 ACCESSORIES SUPPLIED... 9 OPTIONAL ACCESSORIES... 9

SAFETY WARNINGS ...10 2.1 2.2 2.3 2.4 2.5 2.6

3.

ELECTRICAL SAFETY ... 10 CONTACT WITH LIQUID OR GASEOUS SUBSTANCES ... 10 CLEANING ... 10 POSITIONING, TRANSPORT AND OPERATIONAL CONDITIONS ... 11 DISPOSAL ... 11 OTHER WARNINGS... 11

INTENDED USE ...12 3.1 3.2

4.

USAGE RECOMMENDATIONS AND LIMITATIONS ... 12 WARNINGS ... 12

DESCRIPTION OF THE CALCULATION METHOD AND DEVICE OPERATION ...14 4.1 P.R.A.M. AND MOSTCAREUP ... 14 4.2 PRAM ANALYTICAL EXPRESSION ... 14 4.3 PRAM TYPICAL HAEMODYNAMIC VARIABLES ... 15 4.3.1 Cardiac cycle efficiency (CCE) ... 15 4.3.2 dP/dtmax ... 15

5.

CABLES AND CONNECTIONS ...17 5.1 5.2 5.3 5.4

STAND-ALONE USE... 17 COMBINED USE WITH ANOTHER MONITOR ... 17 COMBINED USE WITH ANOTHER MONITOR AND WITH Y CABLE ... 17 COMBINED USE WITH AN OUTPUT MONITOR, HDMI CONNECTION... 18

6.

QUICK START GUIDE...19

7.

VERSIONS ...20 7.1 MOSTCAREUP ENDLESS VERSION ... 20 7.2 MOSTCAREUP ON DEMAND VERSION ... 21 7.2.1 'Time-based' activation card... 21 7.2.2 'Use-based' activation card... 22 7.2.3 Error messages connected with card usage... 22

8.

DIRECTIONS FOR USE ...23 8.1 SWITCHING ON AND INITIAL SETTINGS... 23 8.1.1 Switching on... 23 8.1.1.1 Auto test ... 23 8.1.2 Initial screenshot... 23 8.1.3 Monitoring settings... 25 8.1.3.1

8.1.4 8.1.5 9.

Patient personal data...28

Monitoring ... 29 Stand-by/Switch-off ... 30

QUICK MENUS...31 9.1 LATERAL POP-UP MENU ... 31 9.1.1 Menu... 31 9.1.2 Monitoring Settings ... 32 9.1.3 Set Alarms ... 32 9.1.3.1

Verification of the correct functionality of the alarm system...34

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9.1.4 Physiological alarms ... 34 9.1.5 Technical alarms ... 34 9.1.6 Alarm messages ... 35 9.1.7 Record ... 36 9.1.8 Freeze... 37 9.1.9 End of monitoring ... 37 9.1.10 OFF button for system switch-off/stand-by mode... 37 9.2 CURVES ... 37 9.2.1 Zero ABP and Zero CVP ... 38 9.2.2 Optimise scale ... 38 9.2.3 Min/Max ... 38 9.2.4 Number of pulses examined... 39 9.2.5 Filter ... 39 9.2.6 Dicrotic adjustment... 40 9.2.7 Scrolling time ... 40 9.3 MARKERS AND TRENDS... 40 9.3.1 Marker area ... 41 9.3.2 Marker choice ... 41 9.3.3 Create customised marker ... 42 9.3.4 Trend area... 42 9.3.5 Time window... 42 9.3.6 Variable selection... 43 9.3.7 Layout selection ... 43 9.3.8 Optimise scale ... 43 9.3.9 View history ... 44 9.3.10 Do&Check ... 44 9.4 VARIABLES ... 45 9.4.1 Indexing... 46 9.4.2 Setting of customisable variables ... 46 9.4.3 Modify variable position ... 46 9.4.4 CVP manual entry ... 46 9.4.5 Time window for dynamic variables ... 46 10.

MAIN MENU ...47

10.1 LANGUAGE... 48 10.2 SET-UP AND PROTECTION ... 48 10.3 BRIGHTNESS ... 48 10.4 UNIT OF MEASURE ... 48 10.5 VOLUME... 48 10.6 FACTORY RESET ... 49 10.7 DATE AND TIME ... 49 10.8 CREDIT MANAGEMENT ... 50 10.9 DEVICE STATUS ... 50 10.10 MANUAL ... 50 10.11 BATTERY ... 50 10.12 ETHERNET ... 51 10.12.1 Settings for sending HL7 data in medical records... 51 10.13 WI-FI ... 52 10.14 USB STORAGE ... 52 10.15 MONITORING ARCHIVE... 53 10.16 DEMO ... 53 11. 11.1 11.2 11.3 12. 12.1

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MAINTENANCE, REPAIRS AND TECHNICAL ASSISTANCE ...53 CLEANING THE DEVICE ... 54 WASTE DISPOSAL AND CONFORMITY TO THE WEEE DIRECTIVE ... 55 TROUBLESHOOTING ... 55 TECHNICAL FEATURES ...56 GENERAL FEATURES ... 56

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12.2 TECHNICAL SPECIFICATIONS ... 56 12.2.1 Environmental specifications... 56 12.2.2 Variable specifications - Blood pressure monitoring ... 56 12.3 ELECTRICAL SPECIFICATIONS... 57 12.3.1 Electrical safety... 57 12.3.2 Power supply ... 57 12.3.3 Batteries ... 57 12.3.4 ABP and CVP (right lateral panel connectors) ... 57 12.3.4.1 12.3.4.2 12.3.4.3

ABP and CVP transducer specifications ...57 Specifications for external monitor for Y cable (ABP) connection ...58 ABP and CVP connector specifications ...58

12.3.5 IN 1, IN2, OUT connector (left side panel connector) ... 58 12.3.6 EXP... 59 12.3.7 USB ... 59 12.3.8 LAN ... 59 12.3.9 HDMI... 60 12.3.10 Wi-Fi ... 60 12.3.11 Contactless RFID interface ... 60 12.4 MECHANICAL SPECIFICATIONS ... 60 12.5 ELECTROMAGNETIC COMPATIBILITY (EMC) ... 61 12.6 USEFUL LIFE ... 63 13.

PATENTS ...64

14.

WARRANTY ...64

15.

LEGISLATIVE REFERENCES ...64

16.

APPLICABILITY OF THIS MANUAL ...65

17.

CE CERTIFICATION ...65

18.

MANUFACTURER AND DISTRIBUTOR INFORMATION ...65

18.1 18.2 18.3

MANUFACTURER ... 65 MANUFACTURED FOR ... 65 DISTRIBUTOR... 65

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1.

MOSTCAREUP HAEMODYNAMIC MONITOR 1.1

Connectors and interfaces

RFID reader

ABP CVP EXP IN 1 IN2 OUT

WiFi ON/OFF switch USB HDMI LAN

Handle

Clamp plate

O/I Switch Power inlet

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Product labels

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Connector

Position

ABP CVP EXP

Right side lateral panel

IN1 IN2

Allows MostCareUP to transmit the analogue arterial pressure signal to an external device (e.g. another patient monitor) Power ON, stand-by or shutdown switch

OUT ON/OFF switch USB HDMI

Left side lateral panel

LAN WiFi

/

RFID reader

Upper side

Handle Power switch O/I Switch

Back panel

Clamp plate

1.2

Description Allows MostCareUP to acquire a continuous arterial blood pressure signal from a pressure transducer connected to an arterial catheter (e.g. radial or femoral) Allows MostCareUP to acquire a continuous central venous pressure signal from a pressure transducer connected to a central venous catheter Allows MostCareUP to connect to an external expansion module Allow MostCareUP to receive and process an analogue arterial blood pressure signal (e.g. from the analogue output of an arterial pressure monitor) Allows MostCareUP to receive and display an analogue signal (e.g. from another medical device)

Allows the connection of a USB flash drive that can be used for storing patient data (see section 10.14) or service operations Allows to connect an external monitor to MostCareUp by means of a HDMI cable and to duplicate the screen of MostCareUp on the external monitor. Allows to enable a wired connection between MostCareUP and the hospital information network and transmit monitored patient data (see section 10.12). Allows to enable a wireless connection between MostCareUP and the hospital information network and transmit monitored patient data. Allows the reading of RFID supports (e.g. RFID card) for credits and advanced mode activation in MostCareUP model On Demand and for service operations. Handle for an easy and comfortable product transportation Connection to mains. When connected to mains and “O/I” switch is set to “I”, MostCareUP runs on mains power and battery is in charging mode Power switch (see section 8.1.1) Allows the connection of a specific clamp for mounting MostCareUP on a patient bed vertical support (e.g. IV pole or cart)

List of symbols

Symbols featured on the device Position

Symbol ABP CVP EXP

Right side panel

IN1 IN2 OUT

Description Arterial Blood Pressure Central Venous Pressure External module connector (Expansion) Input1 Input2* Output

Applied CF-type part (protected from defibrillator discharge) On/stand-by button

Left side lateral panel

Front

USB

USB input

HDMI

HDMI connector

LAN

LAN connector

CARD

Contactless area MostCareUp model Equipotential pin Fuses: T500mAL250V

Follow the operating instructions

Rear labels

Separate waste collection of this device will be necessary at the end of its operational life

IP21

IP protection rate Indicates the presence of radio emissions connected with RFID contactless card use CE marking and notified body

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08MC02 for the device (catalogue number)

Serial number (e.g. yy/Axx-n) where yy is the manufacturing year Rel: Release number

MostCareUp

Manufacturer MostCareUp model

*Future implementations

Symbols featured in the software Position

Symbol

Description Opens the vertical quick menu Patient icon ALARM DISABLED: At least one alarm (both visual and audible warnings) disabled until the end of monitoring, or until the user removes the pause

AUDIO PAUSE: at least one alarm paused (only audio) for 2 minutes or until the user removes the pause (audible warning paused with active visual warning until the alarm status ceases) ALARM SILENCED (symbol): at least one alarm silenced (audible warning silenced with active visual warning until the alarm status ceases)

Ethernet network enabled and in communication

Ethernet network enabled but not in communication

Wifi network enabled and in communication

Wifi network enabled but not in communication

Ethernet or WiFi network enabled and HL7 is active Horizontal bar Ethernet or WiFi network enabled but HL7 is not active

DEMO

A demo profile is now being displayed USB key inserted

REC ●

Recording under way Battery charge 25% The LOW BATTERY alarm switches on when this icon appears

Battery charge 50%

Battery charge 75%

Battery charge >75%

MostCareUp powered (from mains voltage) + Charging battery Charging battery with charge complete (100%) MostCareUp powered (from mains voltage)

xx:xx BSA Other

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Current time Body Surface Area Alarm

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ALARM RESET (command): at least one alarm reset (audible warning silenced with active visual warning until the alarm status ceases )

Warning: Until the full battery icon appears, the battery is charging.

Symbols featured on the packaging Position

Symbol

Description Electronic format operating instructions supplied inside

Catalogue number

Serial number MostCareUp model CE marking and notified body

Indicates the top side of the packaging

Fragile, handle with care

Protect from sunlight

Separate waste collection of this device will be necessary at the end of its operational life

Protect from rain

Storage and transportation temperature

Storage and transportation humidity

1.3

Accessories supplied

The kit includes:  MostCareUp device  Power cable  Accessory for floor-stand installation  Statement of compliance  User manual  2 fuses

1.4 

Optional accessories

Accessory for headboard installation

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2.

SAFETY WARNINGS

This device was manufactured according to current international safety standards (par. 15). Please read the following warnings, instructions and safety information carefully before using the device. The user must check the device safety and condition before use, making sure it is undamaged. Carry out inspections and maintenance as specified (par. 11).

2.1

Electrical safety

See also par. 12.3. The unit must be powered by connecting it to a 100-240 VAC 50-60 Hz power source. Use the device only if the power network corresponds to the requirements printed on the device. The device must be powered through the cable supplied. Do not use 2-pole cables or a 3-pole to 2-pole adapter to power the device. Before every use of the device, perform a visual inspection, checking the condition of the power cable and of the connection cables to the transducer or monitor. Do not step on, bend or twist the cables. The mains socket must be near the monitor and easy to reach in the event of emergency disconnections. Disconnect the unit from the mains before performing any maintenance operation or installation. Do not overload the mains sockets, any extension cables or the adapter, since this may cause fire or electric shock. Disconnect the unit if it is not expected to be used for long periods of time. Disconnect the cables by pulling the plugs from their sockets. Do not pull the cables. WARNING: When MostCareUp is connected to an external device, the system must meet the requirements of Standard 60601-1 par. 16 ‘Safety requirements for electromedical systems’.

The USB connection must be exclusively used to connect with a USB key (USB flash drive) not connected to an external power supply unit. The means to electrically isolate the power supply circuits are:  Cable  Switch in the OFF position

2.2

Contact with liquid or gaseous substances

MostCareUp has been designed with an IP21 protection rating, protecting against solids larger than 12 mm, and from the vertical fall of water drops. Do not place containers or equipment containing liquids on top of MostCareUp. Pay attention to the use of MostCareUp when close to inflammable materials. As it is an electronic device, it might trigger an electric discharge (i.e. an explosion hazard exists in rooms saturated with inflammable gas or other inflammable substances). MostCareUp has been designed to minimise the risk of liquid penetration. In any case take care that no liquid penetrates the device. Should this happen, do not connect MostCareUp to the mains.

2.3

Cleaning

Clean the device with a wet cloth and an ethyl alcohol solution, following the instructions (par.11.1).

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2.4

Positioning, transport and operational conditions

Handle the device carefully and do not expose it to temperatures higher than +40°C [+104° F] or lower than +10°C [+50° F] during operation. This may cause the detected values to be incorrect. Do not place the device near a radiator or other heat sources. MostCareUp is designed to be used:   

On a horizontal plane; With its specific accessory for coupling to a vertical floor-stand; With its specific accessory for horizontal coupling to a bed headboard.

Any accidental fall may cause serious injuries to people and damage to property and the device itself. The system cannot be used in rooms where magnetic resonance equipment is operating and, in general, it may give incorrect readings in the presence of other devices that generate radiofrequency and microwave emissions. WARNING: The accessories for vertical stand coupling and horizontal headboard coupling cannot be used as support during transport. WARNING: When transporting MostCareUp artefacts may be produced, so any variable measured during transport cannot be regarded as reliable.

2.5

Disposal

Carefully and scrupulously follow the instructions given for the disposal of the device (par. 11.2).

2.6

Other warnings

Do not open the device in case of failure but have it serviced. Make sure that any repairs or replacements, including battery replacement, are performed by qualified and authorised personnel only. Any repairs carried out by unauthorised personnel will immediately invalidate any warranty claims. In the event that other accessories are used, make sure they comply with the safety and compatibility regulations in force. The CARDS may be damaged in the presence of permanent magnets or high-power electromagnetic sources. Position the device so that it or any other equipment connected to it will not fall onto the patient. Do not lift or move the device by pulling the power cable or one of the cables connected to the patient. The use of MostCareUp is limited to one patient at a time. WARNING: Check that transducers are at the same level as the patient's phlebostatic axis before zeroing transducers on the monitor, and begin monitoring. WARNING: In order to correctly detect the values and alarms provided by the device, the operator must be in a position from which he can see the monitor with a certain clarity (front position, suggested distance: 1 m). WARNING: For the correct use of pressure transducers please refer to the specific operating instructions.

If MostCareUp does not operate according to these operating instructions, please have the device serviced and stop using it.

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3.

INTENDED USE

MostCareUp is an electro medical diagnostic device used to continuously monitor vital parameters relevant to the patient’s haemodynamic profile in real time. Therefore, the device detects and provides assessment elements on the status and physio pathological variations of the cardiovascular function, due both to pharmacological interventions and the patient's pathology. The values detected by MostCareUp should be considered as further assessment elements in addition to all other clinical and instrumental elements required to analyse vital parameters and diagnose the patient's condition. The system is therefore indicated for patients needing assessment of their cardiovascular system parameters, through either occasional or continuous monitoring. MostCareUp provides systemic and haemodynamic variables. Cardiac output and other computed variables result from analysing the pressure curve morphology during each cardiac cycle. MostCareUp is thus intended for use by specialised, adequately trained and authorised healthcare personnel, in a hospital, routine healthcare or clinic environment, or in any other similar medicallyassisted facility. MostCareUp is a PORTABLE device according to the definition of Standard 60601-1 (edition 3.1), i.e. a TRANSPORTABLE device designed to be moved from one place to another, transported by one or more persons.

3.1

Usage recommendations and limitations Up

MostCare has no specific contraindications. However, a careful use of the system is recommended in the following cases:  Severe peripheral vasodilation;  Serious malformations or cardiovascular system pathologies;  Significant pressure wave alterations (underdamping, overdamping). In such cases, the information provided by the system must be carefully evaluated because it may be affected by errors. Furthermore, MostCareUp must be used with special care in new-born patients where a correct measurement of the arterial pressure signal may be difficult. MostCareUp cannot be used to assess haemodynamic variables when the catheter tip is placed into a vein, pulmonary artery or one of the cardiac chambers.

3.2

Warnings

MostCareUp might provide incorrect values in the event that the pressure signal is affected by detection errors such as, but not limited to, the following:  Contact between the catheter tip and the artery wall;  Wrong positioning, folding or excessive angle of the catheter or the line;  Blood clots in the catheter or line;  Poor quality of the pressure signal obtained through the transducer line (underdamping; overdamping). The cardiac output indications provided by MostCareUp must be checked by the operator. The better the detection of the pressure wave morphology, the more accurate the values provided by MostCareUp will be.

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The operator must make sure that the dicrotic point is identified correctly: it is necessary to check that, on the pressure curve graph, the dicrotic indicator (vertical green bar) is positioned on the actual dicrotic incisure, and that there are no artefacts due to poor signal quality. If the dicrotic indicator is not positioned correctly (or is not displayed), both before and after manually optimising the dicrotic incisure detection point (par.9.2.6), the values displayed will not be reliable. Zero the pressure transducers connected to the monitor before every use and whenever the catheter, the pressure transducer line or the transducer positioning are changed as the patient's chest height changes. If this operation is not performed, the readings for pressure and its derived variables will not be reliable. Errors may occur if MostCareUp is used in a manner not described in this manual. The device must be connected to an electrical system that complies with the IEC standard and the national standards applicable in a medical environment. WARNING: In order to avoid the risk of electrical shock, this device must be connected only to power networks with grounding protection.

Avoid conductive connections with the applied part. In the event of a connection to an external device, the grounding connection for MostCareUp and the device connected to it must be made at the same potential equalization busbar. To perform this connection, the pin on the back of the device can also be used in accordance with the 60601-1 Standard. For fixed installations, a fixed grounding connection can be created by using the pin on the rear of the device (equipotential grounding symbol). The device is protected from damage caused by a defibrillator. Defibrillation has no effect on the device safety and operation. Haemodynamic monitoring might however suffer a brief interference during this procedure. Do not touch the device during defibrillation. When used in conjunction with electrosurgery, hemodynamic monitoring may become interfered and the shown values may not be reliable. The user must check the safety and condition of the device. Before using the device, make sure it is intact and perform a visual inspection, checking the condition of the power cable and of the cables connecting the device to the transducer or monitor. The pressure transducer used must comply with the specifications indicated in par. 12.4. It is important to check that the information entered into the initial PATIENT SETTINGS screenshot is correct, otherwise haemodynamic values may be subject to error. If the CVP option from the transducer is selected and the pressure transducer is not connected to the CVP input on the right side of MostCareUp, the system will estimate vascular resistance values (absolute and indexed) through a fixed, pre-set pressure value and, therefore, the results obtained might be incorrect. If there is no heartbeat, or if a valid ABP signal is not recognised, the transducer-generated CVP value displayed must not be considered reliable.

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4. DESCRIPTION OF THE CALCULATION METHOD AND DEVICE OPERATION 4.1

P.R.A.M. and MostCareUp

The 'Pressure Recording Analytical Method' (PRAM)1 is the method that allows for the calculation of haemodynamic variables by analysing the shape and area of the arterial pressure wave. The PRAM represents the application within the physiological sector of the 'Perturbation Theory', which is well known and largely applied in physics. MostCare (Monitor Stoke volume and Cardiac Efficiency) is the only device which integrates the full PRAM system. As the PRAM deduces all variables (both systemic and haemodynamic) from the analysis of the arterial pressure curve only, the first MostCareUp feature is to accurately acquire the analogue signal and scan it at a 1000 Hz frequency. MostCareUp works in real time, beat by beat. Each individual arterial pulse is detected and analysed by the PRAM; each variation in the patient’s condition and each reaction to a stimulus created by the operator are immediately detected, analysed and displayed by the device. The PRAM’s uniqueness consists in its ability to calculate the specific, typical cardiovascular system impedance of the subject under observation in real time. By impedance (usually indicated in formulae as Z(t)), the resultant of different forces that mutually interact and simultaneously operate in the cardiovascular system is meant. Elements, such as cardiac contractility, vascular and arterial resistances and arterial compliance exert characteristic forces that determine different, constantly changing physio pathological profiles; the shape and area of the arterial pressure curve are affected by these elements and, therefore, they describe the instantaneous interaction of all of these elements. Since impedance is constantly changing, MostCareUp does not use constant or pre-assessed values for its calculation so as to reliably follow the physio pathological variations of the impedance. Therefore, the PRAM system does not need any direct or indirect calibration.

4.2

PRAM analytical expression

The SV volume is calculated by the ratio between the surface below the systolic component of the pressure curve (A) and the characteristic impedance Z(t). So we can write:

SV 

A Z (t )

Z (t ) 

P (t )  K (t ) t Figure 1

Where A is the total area below the systolic pressure curve visible in Figure 1. The denominator P(t)/t x K(t) is the impedance Z(t) with development stopped at the first term, as described in the work by Romano SM, et al.1 K(t) is a factor inversely correlated with the instantaneous acceleration of the section area, while P(t)/t is the instantaneous power per surface unit, analytically described by the changes to the pressure profile during the cardiac cycle.

1 Romano SM, Pistolesi M. Assessment of cardiac output from systemic arterial pressure in humans. Crit Care Med.

2002 Aug;30(8):1834-41

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4.3

PRAM typical haemodynamic variables

All systemic and haemodynamic variables are listed in detail in chapter 7. The following paragraphs describe instead only two of the system typical variables.

4.3.1 Cardiac cycle efficiency (CCE) The Cardiac Cycle Efficiency (CCE) is one of PRAM exclusive variables. It describes the efficiency of the heart/vascular system relationship in terms of energy expenditure, i.e. the balance between the power developed by cardiac contraction and the dispersal of energy throughout the cardiovascular system. The CCE describes the cardiovascular system ability to maintain homoeostasis across different interaction conditions between the cardiac pump function, the arterial system, the venous return and the pulmonary cycle; the mathematical formulation for cardiac efficiency, thus, takes into account contractility, arterial compliance and vascular and arterial resistance1. Under pathological conditions, the CCE ranges between positive (<1 is the ideal maximum) and negative values, and can in some cases reach values below -1 (these operating conditions are extremely unfavourable for the cardiovascular system and are not sustainable for long periods); in this sense the CCE has a potential prognostic value11. CCE has shown it can offer a valid contribution for the assessment of the patient's physio pathological status and its potential evolution2-8. It has for example shown an inverse correlation with the pro-B N-terminal type4-5 natriuretic peptide and a direct correlation with the ejection fraction (EF)2, proving to be a predictive index in ventricular function evaluation9. Every cardiovascular system can reach and maintain its haemodynamic balance according to its own energy balance and this is reflected in different CCE values. This is why, for individual patients, assessing CCE variations over time can provide significant clinical evaluation elements along with the absolute value. For example, in patients suffering from heart failure, a variation in CCE connected to the effects of ultrafiltration and of IV-administered diuretics has been detected8. The mathematical formulation for and the significance of the CCE variable are described in depth in Romano's work1.

4.3.2 dP/dtmax The dP/dtmax variable (pressure variation compared to time interval) corresponds to the maximum velocity of pressure increase during the isovolumetric contraction phase. When dP/dtmax is detected with a catheter directly inside the ventricle, it indicates cardiac contractility. The PRAM measures dP/dtmax as the maximal ascending slope of the peripheral arterial pressure curve systolic component. Therefore it has three different components:  Cardiac contractility 1 Romano SM. Cardiac cycle efficiency. A new parameter able to fully evaluate the dynamic interplay of the cardiovascular system. Int J

Cardiol 2012 Mar;155(2): 326-7. 2 Scolletta S et al. Assessment of left ventricular function by pulse wave analysis in critically ill patients. Intensive Care Med 2013;39: 1025-33. 3 Pavoni V et al. Unsuspected Heart Failure: Usefulness of a Minimally Invasive Hemodynamic Monitoring System. J Anesth Clin Res 2012; 3(8). 4 Giglioli C et al. Effects of ULTRAfiltration vs DIureticS on clinical neurohormonal and hemodynamic variables in patients with decompensated heart failure: the ULTRADISCO study. Eur J Heart Fail 2011;13(3): 337-46. 5 Scolletta S et al. Relationship between N-terminal pro-B-type natriuretic peptide (Nt-proBNP) and cardiac cycle efficiency in cardiac surgery. Biomed Pharmacother 2010 Oct; 511-5. 6 Modesti PA et al. Response of serum proteome in patients undergoing infrarenal aortic aneurysm repair. Anesthesiology 2009 Oct;111(4): 844-54. 7 Sorbara C et al. Circulatory failure: bedside functional hemodynamic monitoring. Atlee JL, Gullo A, 2nd eds. Perioperative critical care cardiology. Springer-Verlac, Italia 2007:89-110. 8 Tulli G et al. Hemodynamic monitoring of septic patients with Pressure Recording Analytical Method (PRAM). A Gullo(Ed) 2005, vol(20), Springer; cap 28: 323-29.

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 

Vascular tonus Pressure signal quality: an inadequate and resonant pressure signal can overestimate dP/dtmax4.

Since the pressure increase velocity is determined by the ventricle-arterial relationship, the dP/dtmax value measured by MostCareUp may be correlated both to left ventricle contractility and to the rigidity of the aorta and the main blood vessels. Vascular tonus being equal, the dP/dtmax measured by MostCareUp can be correlated with ventricular contractility. It can otherwise change as vascular tonus changes. The dP/dtmax measured through the PRAM is expressed in mmHg/msec with a normal range between 0.9-1.2 mmHg/msec. Thanks to the sampling of the pressure curve at 1000 Hz, the dP/dtmax measurement is particularly accurate. The point-to-point analysis of the arterial pressure wave gives such a large amount of information that even minimal 'relative' differences of each wave-shape point are important; the propagation velocity and reflected waves, which depend on the features of the arterial vessels (rigidity, tonus, stenosis, etc.), can affect the shape of the fundamental wave differently1-6. WARNING: Be careful when dP/dtmax > 1.7 mmHg/msec because there might be an inadequate detection of the arterial pressure signal (underdamping)4. In the event of bad detection quality of the arterial pressure signal, the data processed by MostCareUp could be wrong. If dP/dtmax is higher than 1.7, the value is highlighted and displayed in RED.

1Scolletta S et al. Assessment of left ventricular function by pulse wave analysis in critically ill patients. Intensive Care Med

2013;39: 1025-33. 2Ricci Z et al. Assessment of Modified Ultrafiltration Hemodynamic Impact by Pressure Recording Analytical Method During

Paediatric Cardiac Surgery. Paediatric Care Med 2013;14: 390-95. 3Giglioli C et al. Levosimendan produces an additional clinical and hemodynamic benefit in patients with decompensated

heart failure successfully submitted to a fluid removal treatment. Congest Heart Fail 2012;18: 47-53. 4Romagnoli S et al. Dynamic response of liquid-filled catheter systems for measurement of blood pressure: precision of

measurement and reliability of the Pressure Recording Analytical Method with different disposable systems. J Crit Care 2011 Aug;26(4): 415-22. 5Romano SM et al. Blood flow assessment by arterial pressure wave without external calibration. Computers in Cardiology

2006; 33: 293-6. 6Romano SM et al. “Monitoraggio emodinamico minimamente invasivo in corso di resezione epatica maggiore in pazienti

cardiopatici. Minerva Anestesiologica 2006, Vol 72 (supp.2) 10; 36-37.

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5.

CABLES AND CONNECTIONS

MostCareUp operation is based on the analysis of the waveform of an analogue arterial pressure signal. This signal may be transmitted to MostCareUp in two different ways:  When used in stand-alone mode: directly connected to a pressure transducer linked to a catheter in a peripheral artery (par. 5.1)  When used to read the analogue pressure signal collected from a single arterial access (via a single pressure transducer) in combination with another patient monitor, using one of the following configurations: o From the analogue output of another monitoring system (par. 5.2) o Using a Y cable configuration (par. 5.3) WARNING! The compatibility between MostCareUpand the majority of pressure transducers and anaesthesia monitors on the market has been verified. Ask your area consultant for the TRANSDUCER CABLES, Y CABLES, MONITOR IN CABLES and monitors compatible with the devices in use (see par.12 for details). WARNING: Use of accessories, transducers and cables other than those specified or provided by the manufacturer of this equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation (see par. 12.5).

5.1

Stand-alone use

Select a TRANSDUCER CABLE compatible with the pressure transducer used. Connect the cable to MostCareUp. On the device, connect the cable to the ABP (or CVP) connector, on the right side of the device. The other end of the cable must be connected directly to the pressure transducer. Zero the transducer from MostCareUp (par 9.2.1).

5.2

Combined use with another monitor

The MONITOR IN CABLE allows MostCareUp to receive the analogue arterial pressure signal directly via the input from another monitor or system. Select a MONITOR IN CABLE compatible with the patient monitor to be connected to MostCareUp. Connect MostCareUp to the analogue output socket of the arterial pressure signal from the patient monitor in use with the appropriate MONITOR IN CABLE. Connect one end of the cable to the 'IN 1' connector on the right side of MostCareUp. The other end of the cable must be connected directly to the arterial pressure analogue output of the patient monitor. WARNING: When MostCareUp is connected to an external device, the system must meet the requirements of the Standard 60601-1 par. 16 'Safety requirements for electromedical systems'.

5.3

Combined use with another monitor and with Y cable

The Y CABLE allows MostCareUp to receive the same analogue arterial pressure signal coming from another monitor or system. The TRANSDUCER Y CABLE allows MostCare Up to fit in the line sequence between a generic patient monitor and a transducer.

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A Y cable has three connectors:  One for MostCareUp  One for the transducer  One for the other patient monitor (with the same connector as the transducer one). Select a TRANSDUCER Y CABLE compatible with the pressure transducer used. For the Y cable features, see par.12. Connecting the cable to MostCareUp. On the device, connect the cable to the ABP connector, on the right side of the device. One end of the cable must be directly connected to the pressure transducer, whereas the third end must be connected to the transducer cable from the monitor in question. The user will need to zero the transducer both from MostCareUp and from the patient monitor. WARNING! It is not possible to use a Y CABLE once monitoring has started: the cable will need to be configured during initial setting and connected to the device before monitoring starts. On the other hand, once monitoring using a Y CABLE has started, it will not be possible to exchange it with a standard cable during monitoring. Should such an operation be undertaken, the device will issue an error message and inhibit further use. WARNING! The Y CABLE is used to detect arterial pressure only, not venous pressure, so it cannot be used with the CVP input. WARNING! If a TRANSDUCER Y CABLE is used without connecting the patient monitor transducer cable to the Y connection, MostCareUp will not be able to read any pressure value. WARNING! To accurately read pressure values, the transducer power voltage, as supplied by the external monitor, must be stable. Otherwise, the instability condition is signalled with a technical alarm. WARNING: When MostCareUp is connected to an external device, the system must meet the requirements of Standard 60601-1, par. 16, 'Safety requirements for electromedical systems'.

5.4

Combined use with an output monitor, HDMI connection

It is possible to use MostCareUp in combination with an external screen, linked via an HDMI connection, upon which the user can display the same screenshot visible on MostCareUp. Note: Image updating on the external screen takes place with a 25 Hz frequency, hence it is normal to perceive a 'staggered' update. WARNING: If you wish to use MostCareUp via an HDMI connection with an external monitor, it will be necessary for the HDMI cable to be already connected when MostCareUp is switched on. The cable must be inserted when the device is in OFF mode; stand-by mode will not be sufficient. It will not be necessary for the external monitor to be switched on. WARNING: When MostCareUp is connected to an external device, the system must meet the requirements of Standard 60601-1 par. 16 'Safety requirements for electromedical systems'.

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6.

QUICK START GUIDE

MostCareUp is a mini-invasive haemodynamic monitor whose operation is based on the analysis of the arterial pressure wave by the patented P.R.A.M. (Pressure Recording Analytical Method) algorithm. MostCareUp detects and samples the arterial pressure signal at 1000Hz. Each individual cardiac cycle is analysed in its continuous and pulsed component to obtain measurements and calculations in real time and in a continuous mode. MostCareUp does not need calibration either by indicator injection or by nomograms deriving from estimates referred to standard patients. Each individual patient is monitored and observed for his/her specific characteristics and conditions. For a quick start please proceed as follows:   



Switch MostCareUp on via the power switch at the rear and press the start button for a few seconds. Select 'New monitoring' From the 'Monitoring Settings' menu o Enter mandatory data (weight and height) o Enter patient data using the 'PATIENT PERSONAL DATA' button o Check that other pre-set information (signal input, arterial detection site, etc.) corresponds to the type of monitoring which is about to be performed and change it if this is not the case o Access monitoring via the confirmation button Connect the transducer to MostCareUp by using the specific cable based on the chosen configuration: o If the signal is derived directly from a transducer, connect the relevant cable to the 'ABP' input o If the signal is derived from the analogue output of another patient monitor, connect the relevant cable to the 'IN 1' input.

 

o If you are using a Y cable on the device, connect the cable to the ABP connector on the right side of the device. One end of the cable must be directly connected to the pressure transducer, whereas the third end must be connected to the transducer cable from the monitor in question. Zero the transducer if the ABP input is used. Begin the monitoring

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7.

VERSIONS

MostCareUp is available in two versions:  Endless  On demand In both cases, MostCareUp can be used in its stand-alone configuration or combined with another monitor (chap. 5).

7.1

MostCareUp ENDLESS version

MostCareUp ENDLESS is enabled for monitoring in ADVANCED mode forever, with no need for a CARD. MostCareUp displays the following variables: Name

Value

Unit of measure

Dia

Diastolic Press.

mmHg

Sys

Systolic Press

mmHg

Dic

Dicrotic Press.

mmHg

MAP

Mean Press.

mmHg

PR

Pulse rate

bpm

(if transducer available)

Mean Venous Pressure

mmHg

CO

Cardiac Output

l/min

CI

Cardiac Index

l/min/m2

SVR

Systemic Vascular Resistances

SVRI

Indexed Resistances

dyne·sec·m2/ cm5

SV

Stroke Volume

ml

SVI

Stroke Volume Index

ml/m2

CCE

Cardiac Cycle Efficiency

[units]

SVV

Stroke Volume Variation

%

SPV

Systolic Pressure Variation

%

DPV

Dicrotic Pressure Variation

%

PPV

Differential Pressure Variation (Pulse Pressure Variation)

%

dP/dtmax

Pressure variation velocity

mmHg/msec

Ea

Arterial Elastance

mmHg/ml

PPV/SVV

PPV/SVV

[units]

SVkg

Stroke Volume per kg

ml/kg

DiaPEAK

Diastolic peak

mmHg

DO2

Oxygen Delivery derived value

ml/min

DO2I

Oxygen Delivery Index derived value

ml/min/m2

CVP

20

dyne·sec/cm 5

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