Instructions for use SmartPilot View · 2020. 11. 8. · Instructions for use SmartPilot View SW...

Instructions for use

SmartPilot View

Software 3.02.nWARNINGTo properly use this medical device, read and comply with these instructions for use.

2 Instructions for use SmartPilot View SW 3.02.n

Trademarks

Safety information definitions

Trademark Trademark ownerApollo®

Dräger

Delta®

Delta XL®

DrägerService®

Infinity®

Integrated Care Manager (ICM)

IVenus®

Kappa®

Medical Cockpit®

Perseus®

SmartPilot®

Zeus® Dräger

Perfusor® Space B. Braun Melsungen AG

Injectomat® Agilia

Fresenius Kabi AGModule DPS®

Orchestra® Base Primea

Philips IntelliVue® Koninklijke Philips Electronics N.V.

Alaris® CareFusion Corporation

Terufusion® Terumo Corporation

Arcomed® ARCOMED A.G.

Trademark Trademark owner

WARNINGA WARNING statement provides important information about a potentially hazardous situation which, if not avoided, could result in death or serious injury.

CAUTIONA CAUTION statement provides important information about a potentially hazardous situation which, if not avoided, may result in minor or moderate injury to the user or patient or in damage to the medical device or other property.

NOTEA NOTE provides additional information intended to avoid inconvenience during operation.

Instructions for use SmartPilot View SW 3.02.n 3

Contents

Contents

For your safety and that of your patients . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5General safety information . . . . . . . . . . . . . . . . 6Product-specific safety information. . . . . . . . . . 9

Application . . . . . . . . . . . . . . . . . . . . . . . . . . . 13Intended use. . . . . . . . . . . . . . . . . . . . . . . . . . . 14Indications . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14Contraindications . . . . . . . . . . . . . . . . . . . . . . . 15Application . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15Supported drugs. . . . . . . . . . . . . . . . . . . . . . . . 16Supported pharmacokinetic models . . . . . . . . . 17

System overview . . . . . . . . . . . . . . . . . . . . . . 19General remarks. . . . . . . . . . . . . . . . . . . . . . . . 20System states. . . . . . . . . . . . . . . . . . . . . . . . . . 22Screen in standby mode. . . . . . . . . . . . . . . . . . 23Screen in operation mode . . . . . . . . . . . . . . . . 24Abbreviations . . . . . . . . . . . . . . . . . . . . . . . . . . 28Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29

Operating concept . . . . . . . . . . . . . . . . . . . . . 31Cursor. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32Input options. . . . . . . . . . . . . . . . . . . . . . . . . . . 32Color concept . . . . . . . . . . . . . . . . . . . . . . . . . . 33

Operation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35Starting the software. . . . . . . . . . . . . . . . . . . . . 36Standby mode . . . . . . . . . . . . . . . . . . . . . . . . . 36Operation mode . . . . . . . . . . . . . . . . . . . . . . . . 42Predictions . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48Display of parameters. . . . . . . . . . . . . . . . . . . . 50Selecting and setting . . . . . . . . . . . . . . . . . . . . 51Importing patient data and drug data . . . . . . . . 54Exiting the software . . . . . . . . . . . . . . . . . . . . . 55Uninstalling the software . . . . . . . . . . . . . . . . . 55

Configuration . . . . . . . . . . . . . . . . . . . . . . . . . 57Default patient data . . . . . . . . . . . . . . . . . . . . . 58Changing patient data . . . . . . . . . . . . . . . . . . . 58Changing the displayed drugs . . . . . . . . . . . . . 60Configuration of the drug library . . . . . . . . . . . . 61

Log files . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63Case log file. . . . . . . . . . . . . . . . . . . . . . . . . . . 64Configuration file . . . . . . . . . . . . . . . . . . . . . . . 68System log file . . . . . . . . . . . . . . . . . . . . . . . . . 69

Troubleshooting . . . . . . . . . . . . . . . . . . . . . . 71Fault – Cause – Remedy. . . . . . . . . . . . . . . . . 72Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . 73Power supply failure . . . . . . . . . . . . . . . . . . . . 76System failure . . . . . . . . . . . . . . . . . . . . . . . . . 77

Installation and connectivity . . . . . . . . . . . . 79Requirements . . . . . . . . . . . . . . . . . . . . . . . . . 80Connectivity. . . . . . . . . . . . . . . . . . . . . . . . . . . 81Installing the software . . . . . . . . . . . . . . . . . . . 83

Technical data . . . . . . . . . . . . . . . . . . . . . . . . 85General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 86Hardware requirements. . . . . . . . . . . . . . . . . . 86Classification . . . . . . . . . . . . . . . . . . . . . . . . . . 88

Literature . . . . . . . . . . . . . . . . . . . . . . . . . . . . 89Pharmacokinetics of hypnotics . . . . . . . . . . . . 90Pharmacokinetics of analgesic drugs . . . . . . . 90Pharmacokinetics of muscle relaxants . . . . . . 91Pharmacodynamics. . . . . . . . . . . . . . . . . . . . . 92Population and tolerances. . . . . . . . . . . . . . . . 95License terms . . . . . . . . . . . . . . . . . . . . . . . . . 100

Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 103Password. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 105


This page has been left blank intentionally.


For your safety and that of your patients


General safety information . . . . . . . . . . . . . . 6Strictly follow these instructions for use . . . . . . 6Patient data . . . . . . . . . . . . . . . . . . . . . . . . . . . 6Training. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7Mandatory reporting of adverse events . . . . . . 7Connection to IT network . . . . . . . . . . . . . . . . . 7

Product-specific safety information . . . . . . . 9Premedication. . . . . . . . . . . . . . . . . . . . . . . . . . 9Infusion pumps . . . . . . . . . . . . . . . . . . . . . . . . . 10Anesthesia machines . . . . . . . . . . . . . . . . . . . . 12Drugs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12



General safety information

The following WARNING and CAUTION statements apply to general operation of the medical device.

WARNING and CAUTION statements specific to subsystems or particular features of the medical device appear in the respective sections of these instructions for use or in the instructions for use of other products being used with this device.

Strictly follow these instructions for use

Patient data

WARNINGRisk of incorrect operation and of incorrect use

Any use of the medical device requires full un-derstanding and strict observation of all sec-tions of these instructions for use. The medi-cal device must only be used for the purpose specified under "Intended use" on page 14 and in conjunction with appropriate patient moni-toring.

Strictly observe all WARNING and CAUTION statements throughout these instructions for use and all statements on the product labels. Failure to observe these safety information statements constitutes a use of the medical device that is inconsistent with its intended use.

CAUTIONRisk of incorrect data

Incorrect patient data leads to incorrectly calculated data.

CAUTIONDisplay of incorrectly calculated data

SmartPilot View does not take into account pre-medication of the patient with drugs other than those specified in these instructions for use. This applies in particular to the manual dosage of drugs as well as during and after the use of a heart-lung machine.

WARNINGRisk of patient injury

The individual patient can differ from imple-mented population models.

This may lead to too high or too low predicted effect-site concentrations of drugs and to cor-responding errors with regard to the probabil-ity of a response to reference stimuli, i.e., overestimation or underestimation of the drug effect.

Dose drugs according to their individual clini-cal effect. The responsibility for the dosing of the drugs rests with the user.

NOTELimitations to demographic data

SmartPilot View limits the patient data to specific ranges based on statistic data. This applies to the height, weight, and age. If the demographic data lies outside these ranges, the software will lower the demographic values to the relevant upper limit or raise them to the lower limit.



Patient safety

The design of the medical device, the accompanying documentation, and the product labels are based on the assumption that the purchase and the use of the medical device are restricted to persons familiar with the most important inherent characteristics of the medical device.

Instructions and WARNING and CAUTION statements are therefore largely limited to the specifics of the Dräger medical device.

The instructions for use do not contain any information on the following points:

– Risks that are obvious to users

– Consequences of obvious improper use of the medical device

– Potentially negative effects on patients with different underlying diseases

Medical device modification or misuse can be dangerous.

Training

Training for users is available via the Dräger organization responsible, see www.draeger.com.

Mandatory reporting of adverse events

Serious adverse events with this product must be reported to Dräger and the responsible authorities.

Connection to IT network

In an IT network, data can be exchanged by means of wired or wireless technologies. An IT network can be any data interface (e.g., RS232, LAN, USB, printer interface) that is described in standards and conventions.

During operation, this device can exchange information with other devices by means of IT networks and supports the following functions:

– Display of parameter data

– Transfer of device settings and patient data

– Service mode, access to logbooks

Connecting this device to a network that incorporates other devices or making subsequent changes to that network can lead to new risks for patients, users, and third parties. Before the device is connected to the network or the network is changed, these risks must be identified, analyzed, and evaluated, and appropriate measures taken.

Example of subsequent changes to the network:

– Changing the network configuration

– Removing devices from the network

– Adding new devices to the network

– Performing upgrades or updates on devices that are connected to the network

WARNINGRisk of device malfunction

Any connected devices or device combinations not complying with the requirements mentioned in these instructions for use may compromise the correct functioning of the medical device.

Before operating the medical device, strictly comply with the instructions for use of all connected devices or device combinations.

CAUTIONRisk of patient injury

An incorrect diagnosis or misinterpretation of measured values or other parameters may endanger the patient.

Do not base therapy decisions on individual measured values or monitoring parameters only.



Generated network traffic

SmartPilot View generates network traffic when:

– Searching for further SmartPilot View workstations in the network (only a few kilobytes)

– Requesting meta information on available cases (some kilobytes)

– Forwarding data from the induction room to the operating room (approx. 6.5 megabytes for a case with a duration of approx. 30 minutes)

Information about connecting to a network

Prerequisites

This software must only be integrated into the network by service personnel. The IT representative of the hospital must be consulted in advance.

The following documents must be observed:

– Accompanying documents of this device

– Description of the operating organization's network

Dräger recommends complying with IEC 80001-1 (risk management for IT networks with medical devices).

LAN networks

– LAN networks are usually configured in a star topology. Individual devices can be combined into groups by means of layer-n-switches. Other data traffic is decoupled by means of separate VLAN networks. Configure the network settings of the device in accordance with these instructions for use and the network specifications.

– The network must support the following transmissions and protocols:

– TCP/IP

– Unicast (static or dynamic addressing with the ARP or RARP network protocols)

VLAN networks

If data is being exchanged within a single physical network and a clinical information system is used, an independent VLAN network must be set up for the clinical information system. Additionally, at least one of the following independent VLAN networks must be set up:

– Network for medical devices for intrahospital use

Serial ports

The following connections are possible:

– RS232 interfaces conforming to EIA RS-232 (CCITT V.24) for the following applications

– Data from connected devices

– Interfaces based on USB 1.1 or higher (e.g., USB flash drive)



Consequences of using an unsuitable network

If the network does not meet the requirements, the following situations may occur in connection with this device:

– During an interruption of the network connection:

– Data is not transmitted

– Without firewall and antivirus software:

– Possible data loss

– Device settings are changed

– Data is sent incomplete, sent to the wrong device, or not sent at all.

– Patient data is intercepted, falsified, or damaged.

– Data has incorrect time stamps.

– An overload of the device due to very high network loads (e.g., caused by denial-of-service attacks) can lead to increased system load and, consequently, to a reduced speed of execution.

Product-specific safety information

SmartPilot View provides the user with theoretical information about the estimated effect of the administered anesthetic agents on the patient.

The information provided by SmartPilot View must not be used as the sole basis for clinical decisions regarding a specific patient. This also applies to decisions regarding the dosing of the particular anesthetic agent. Always follow the dosing information and application notes on the product labels of the drugs.

Premedication

CAUTIONIncorrectly calculated data

When indicating effects on the patient, SmartPilot View does not take any premedication into account and considers only the drugs mentioned in these instructions for use.

Any drugs administered before SmartPilot View was started will only be included in the calculation of the PK/PD values if they were entered manually.

SmartPilot View provides an interface for the input of the premedication as well as manually administered drugs or additional infusion pumps with drugs listed in these instructions for use.

The correct manual input is the responsibility of the user. Note that the effect and interaction calculation takes the manual input into account.



Infusion pumps

Pumps in TCI mode


The administration of the same drug via two different infusion pumps may lead to incorrect data calculation by SmartPilot View.


Bolus doses administered via pumps can lead to incorrectly calculated PK/PD values. This is due to technical limitations in the data transmission to the connected pumps.

Before changing a drug, switch the pump off and on again.

Always check bolus doses administered by pumps and adjust manually if required.

CAUTIONDisplay of incorrectly calculated data.

The bolus volume is not reliably integrated into the calculation if the infusion pump is stopped after a bolus is administered. This is the case, for example, if no rate is in progress or the syringe runs empty while the bolus is being administered.

Enter the bolus volume manually.

NOTEIf the same drug is administered via different infusion pumps that are each connected to SmartPilot View, the drug must always have exactly the same name on each pump. Otherwise, SmartPilot View will not function properly.

NOTEThe power-on recognition period of infusion pumps can be more than one minute. During this period, SmartPilot View does not receive any data from the infusion pumps. Switch on the infusion pumps in time.

The power-off recognition period of infusion pumps can be more than one minute. During this period, SmartPilot View continues to receive data from the infusion pumps. To stop the infusion, use the stop button on the infusion pump instead of switching it off.

CAUTIONRisk of incorrect dataFor the SmartTCI function, only the Schnider PK model is supported for propofol.

NOTEWhen connecting pumps in TCI mode to SmartPilot View, the calculated concentrations may deviate slightly due to technical deviations.For TCI models supported by SmartPilot View, see "Literature" on page 89.

NOTEDue to a different implementation of the models or when using other TCI models which are not supported by SmartPilot View, the calculated concentrations can be widely divergent of each other.For TCI models supported by SmartPilot View, see "Literature" on page 89. Observe the instructions for use of the pumps operated in TCI mode.

NOTESmartPilot View supports only one concentration for each case and each drug administered by a pump.

NOTEThe display of the total drugs administered is not supported in the SmartTCI function.



IVenus infusion pumps

Fresenius pumps

Alaris pumps

B. Braun pumps

Terumo pumps


If a bolus is given manually at the IVenus syringe pumps, the Zeus anesthesia workstation does not automatically detect this bolus. This can lead to incorrectly calculated data in SmartPilot View.


If a bolus is administered manually on Fresenius Module DPS Base A or Base Primea infusion pumps before the infusion is in progress, SmartPilot View does not recognize the bolus automatically. This can lead to incorrectly calculated data in SmartPilot View.

Enter the bolus volume manually.


When switching off an Alaris pump by CareFusion, it can take more than one minute to detect that the pump has stopped.

During that time, SmartPilot View assumes that the infusion is still in progress.

NOTEThe data relating to the concentration of the drug cannot be reliably received from B. Braun pumps in TCI mode.

Enter missing concentration data manually.

NOTESmartPilot View cannot receive the complete patient data from B. Braun pumps, even when they are operating in TCI mode.

Enter missing patient data manually.


At switch-on, Terumo TE-372 pumps occasionally transfer incorrect data regarding the concentration of the drug.

The concentrations on the pump and on SmartPilot View must match. Incorrect concentration data must be corrected manually.



Anesthesia machines

Heart-lung machine

If the patient is connected to a heart-lung machine, the models on which SmartPilot View bases its calculations are not applicable. This also applies after the patient was disconnected from the heart-lung machine.

External fresh-gas outlet

If the patient is connected to the external fresh-gas outlet of an anesthesia machine, the transferred data is insufficient. The models on which SmartPilot View bases its calculations are not applicable in these cases. This also applies after the patient is disconnected from the external fresh-gas outlet.

O2 flush

If O2 flush is used on the anesthesia machine, the flow data will not be transferred correctly to SmartPilot View. This can lead to incorrectly calculated concentrations of volatile anesthetic agents and resultant effects.

Drugs


Pharmacokinetic and pharmacodynamic models are affected by some reversal agents and antibiotics. The administration of such drugs is not taken into account by the SmartPilot View models.


Application

Application

Intended use . . . . . . . . . . . . . . . . . . . . . . . . . . 14

Indications. . . . . . . . . . . . . . . . . . . . . . . . . . . . 14

Contraindications . . . . . . . . . . . . . . . . . . . . . . 15

Application . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

Supported drugs. . . . . . . . . . . . . . . . . . . . . . . 16Prerequisites. . . . . . . . . . . . . . . . . . . . . . . . . . . 16Intravenous hypnotics. . . . . . . . . . . . . . . . . . . . 16Volatile and gaseous hypnotics . . . . . . . . . . . . 16Intravenous opioids . . . . . . . . . . . . . . . . . . . . . 16Intravenous muscle relaxants. . . . . . . . . . . . . . 16

Supported pharmacokinetic models . . . . . . 17

Application


Intended use

SmartPilot View is a software which displays and logs the dosage of intravenous and volatile drugs administered to a human being. Additionally it calculates the drug effect based on pharmacokinetic models and the drug interaction based on pharmacodynamic models. These calculated effects are logged and displayed by the software.

SmartPilot View is intended to be used exclusively by trained personnel in hospitals and operating rooms. It is intended for supporting the decision-making process during the anesthesia case.

Indications

The use of SmartPilot View is indicated for anesthesia cases for which support of the decision-making process is desired.

SmartPilot View is intended for use with data from adults only. The demographic ranges for these patient data are as follows:


The SmartPilot View software is intended for use only by personnel with specific training and experience in its use.

Height 150 cm to 200 cm (59.1 in to 78.7 in)

Weight 40 kg to 140 kg (89 lbs to 308 lbs)

Age 18 to 90 years

NOTEThe limitations in the demographic data apply as a result of the scientific models on which all calculations are based.


Application

Contraindications

Furthermore the software is not intended for data from:

– Alcoholics

– Addicts

– Obese patients (BMI >35)

– Patients with severe systemic diseases (ASA

Application


Supported drugs

Prerequisites

The drug must be selected on the drug-dosing device used (e.g., B. Braun Perfusor Space syringe pumps). SmartPilot View receives the drug name, the concentration, and the infusion rate from running infusion pumps.

The mapping of the drugs from the drug-dosing device to the drug names used in SmartPilot View is defined in the SmartPilot View drug library.

The drug library contains common drug concentrations per drug. Only these concentrations are selectable per drug in the Drugs dialog window.

The drug library can be configured to match the requirements, see page 58.

Intravenous hypnotics

– Propofol

Volatile and gaseous hypnotics

– Isoflurane

– Sevoflurane

– Desflurane

– N2O

Intravenous opioids

– Fentanyl

– Remifentanil

– Sufentanil

– Alfentanil

Intravenous muscle relaxants

– Pancuronium

– Rocuronium

– Vecuronium

– Mivacurium

NOTEThe data is only automatically accepted by SmartPilot View if the drug names on the infusion pumps are identical to those in the SmartPilot View drug library.


Application

Supported pharmacokinetic models

Volatile hypnotics

– Bailey JM. J Pharmacokinet Biopharm 1989; 17(1): 109-23

Propofol

– Schnider et al., Anesthesiology, 1999, 90 (6)

Remifentanil

– Minto et al., Anesthesiology, 1997, 86 (1)

Fentanyl

– Scott et. al, J. Pharmacol Exp Ther, 1987, 240 (1)

Alfentanil

– Scott et. al, J. Pharmacol Exp Ther, 1987, 240 (1)

Sufentanil

– Gepts et al., Anesthesiology, 1995, 83 (6)

Pancuronium

– Rupp et al., Anesthesiology 1987; 67(1)

Rocuronium

– Wierda et al. Can J Anaesth, 1991; 38

Vecuronium

– Cronnelly R. et.al. Anesthesiology 58:405-408,1983

Mivacurium

– Laurin et al.; J Pharmacokinet Pharmacodyn, 2001 Feb;28(1)


System overview

System overview

General remarks . . . . . . . . . . . . . . . . . . . . . . . 20Definitions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20Combination of drugs . . . . . . . . . . . . . . . . . . . . 21

System states . . . . . . . . . . . . . . . . . . . . . . . . . 22

Screen in standby mode . . . . . . . . . . . . . . . . 23

Screen in operation mode . . . . . . . . . . . . . . . 24

Abbreviations . . . . . . . . . . . . . . . . . . . . . . . . . 28

Symbols. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29

System overview


General remarks

Definitions

Effect site

The effect site is the organ in the human organism where the administered drug has an effect. For volatile and intravenous hypnotics, the effect site is the brain.

MAC (minimum alveolar concentration)

According to scientific models, the MAC value represents the concentration of a drug or a combination of drugs in the effect-site compartment at which a certain percentage of patients (MAC 50 = 50 % and MAC 90 = 90 % of the patients) tolerate a skin incision.

Pharmacodynamics

Pharmacodynamics refer to how the administered drug affects the body of the patient.

Pharmacokinetics

Pharmacokinetics refer to how the body of the patient affects the administered drug.

Plasma

The plasma is the blood compartment in a human being. The administered drug is injected here and disperses via the blood compartment in the body.

Remifentanil equivalent

The effect-site concentrations of all opioids are displayed as Remifentanil equivalent.

Time to TOSS 50

Time to TOSS 50 represents the calculated time from switching off the infusion pumps until the effect-site concentration falls below the TOSS 50 level.

TOL (tolerance of laryngoscopy)

According to scientific models, the TOL value represents the concentration of a drug or a combination of drugs in the effect site compartment at which a certain percentage of patients (TOL 50 = 50 % and TOL 90 = 90 %) tolerates a laryngoscopy stimulus.

TOSS (tolerance of shake and shout)

According to scientific models, the TOSS value represents the concentration of a drug or a combination of drugs in the effect site compartment at which a percentage of patients (TOSS 50 = 50 % and TOSS 90 = 90 %) tolerates a shake-and-shout stimulus.

NSRI (noxious stimulus response index)

The NSRI represents the anesthetic effect, consisting of a hypnotic and an analgesic portion plus a synergy effect.

Unlike an EEG parameter, the NSRI incorporates the analgesic component.

The NSRI is calculated by the same interaction model (hypnotic drug – analgesic drug) that is used for the isoboles on the 2D diagram.

The NSRI represents the probability of a reaction to a certain stimulus.

The NSRI is displayed as a numerical value between 0 and 100.


System overview

For further information, refer to the chapter "Literature" on page 89.

Combination of drugs

SmartPilot View supports the following pharmacodynamic effects of drug combinations:

Additive pharmacodynamics

SmartPilot View calculates the additive pharmacodynamics of:

– Propofol and volatile drugs (i.e., Sevoflurane, Desflurane and Isoflurane)

The calculated effect-site concentration of the administered drug is displayed on the axes of the 2D diagram.

Synergistic pharmacodynamics

SmartPilot View calculates the synergistic pharmacodynamics of:

– Propofol and one volatile drug (i.e., Sevoflurane, Desflurane, and Isoflurane)

– N2O (nitrous oxide)

– 1 to 4 opioids

If an unknown drug is used, SmartPilot View cannot calculate the pharmacokinetic data of the unknown drug or the pharmacodynamic data of the drug combination.

NOTENSRI values under propofol-based anesthesia cannot simply be equated with NSRI values under volatile anesthetic agents.

NOTEPropofol can optionally be converted to a volatile equivalent and, conversely, the volatile drug can be converted to a propofol equivalent.

NOTEFor a list of supported drugs refer to the chapter "Supported drugs" on page 16.

System overview


System states

SmartPilot View has the following system states:

– Offline

– Standby

– Operation

Offline mode

In offline mode, the Medical Cockpit is switched off or the software is not running.

Standby mode

The standby mode is active when:

– The anesthesia machine is in standby mode

– The user has manually activated the standby mode

– The software was just started.

Operation mode

The operation mode is activated when the user starts a case or when the anesthesia machine switches into operation mode.

NOTEFor a detailed description of the system states refer to "Operation" on page 35.


System overview

Screen in standby mode

Header bar (A)

The header bar shows the date and time as well as the state of the connected devices:

– Patient monitor:

– Anesthesia machine:

– Infusion pumps:

Desktop (B)

In standby mode, the desktop displays information on the software version and the UDI (if entered by the user).

Buttons (C)

The following buttons are displayed:

– System setup...

– Export case log...

– Start

– Exit

NOTEThe actual screen layout may differ in appearance or configuration.

021

A

B

C

A Header barB DesktopC Buttons

System overview


Screen in operation mode


020

AB

C

D

E

F

G

H

I

J

K

L

A Patient data and timeB Name and version of the softwareC 2D diagram for pharmacodynamicsD Name of the administered drugs (except

muscle relaxants) and their respective concentrations

E Event marker buttonsF Connected devicesG Vital parameters (if connected to a patient

monitor)

H BIS and SQI (if connected to a patient monitor with BIS measurement)

I NSRIJ Time-based display for drug administration

with prediction

K Main menu barL Time scale


System overview

Patient data and time (A)

This function field shows the following patient data:

– Age [years]

– Height [cm] or Height [in]

– Weight [kg] or Weight [lbs]

– Gender

– Patient name/ID (if network operation is configured)

This function field can be touched. As soon as the function field is touched, the Patient dialog window opens.

Name and version of the software (B)

The latest SmartPilot View software version is 3.02.n.

2D diagram for pharmacodynamics (C)

The 2D diagram shows the calculated anesthesia level of a typical patient based on the provided data. Type and dosage of administered drugs are taken into account. The current calculated anesthesia level is represented by an orange dot that moves on the display area.

Administered drugs (D)

The following is displayed in this area:

– The color that is used to show the respective drug in the 2D diagram and in the time-based display.

– The name of the drug.

– The drug concentration.

Event marker (E)

The following event markers are available:

– LOC (loss of consciousness)

– Intub. (Intubation)

– Cut

– Move

– Extub. (Extubation)

– Other

Connected devices (F)

If successfully connected, the connected devices are shown in this area and marked with a check mark:

– Patient monitor:

– Anesthesia machine:

– Infusion pumps:

NOTEConfidential patient data such as the name or ID of the patient are transmitted encrypted by the software and are not shown in the log files.

NOTEOnly hypnotic and analgesic drugs are displayed on the 2D diagram. Administered muscle relaxants are only shown in the time-based display.

NOTEFor a list of supported drugs refer to "Supported drugs" on page 16.

System overview


Vital parameters (G)

SmartPilot View displays the following vital parameters:

BIS and SQI (H)

Noxious stimulus response index (NSRI) with prediction (I)

The NSRI is displayed as a graph and as a numerical value.

Time-based display for drug administration with prediction (J)

The time-based display is divided into sections, each representing one administered drug.

Each section displays:

– Drug name

– 2 vertical scales for the infusion rate or the calculated plasma concentration and the calculated effect-site concentration.

– The infusion rate or the plasma concentration of the administered drug as a gray line.

– A filled, colored graph for the calculated effect-site concentration.

– The calculated effect-site concentration Ce as a numerical value.

Up to 4 areas can be displayed. If more than 4 drugs are administered, SmartPilot View will display a corresponding message.

NOTEThe patient monitor measures the vital parameters.

NOTEThe Zeus anesthesia workstation always transfers the etCO2 value to SmartPilot View as BTPS (body temperature and pressure, saturated), regardless of the Zeus setting. Thus the displayed etCO2 values can differ between the Zeus anesthesia workstation and SmartPilot View.

NOTEThe unit of measurement for the blood pressure (BP) must be selected in SmartPilot View according to the setting on the patient monitor (see page 37). Otherwise, SmartPilot View may display the blood pressure incorrectly.

Parameters Displayed asHeart rate HR Graph and numerical

value

Mean non-invasive blood pressure NIBP Mormean arterial blood pressure ART M

Graph and numerical value

End-expiratory CO2 concentration etCO2

Graph and numerical value

NOTEBIS and SQI are measured by the patient monitor.

Parameters Displayed asBispectral index BIS Graph and numerical

value

BIS signal quality index SQI

Numerical value


System overview

Main menu bar (K)

The following buttons are available:

– Show events

– Show history

– Diagram settings...

– Patient...

– Drugs...

– Screen layout...

– Export screenshot

– Standby

Time scale (L)

The time scale is the reference for all time-based graphs.

The displayed interval is from –40 minutes to +20 minutes. However, the time scale is scrollable from 60 minutes before the beginning of the case until the end of the preview.

System overview


Abbreviations

The following abbreviations are used in the software and throughout these instructions for use:

Abbreviation ExplanationASA American Society of

Anesthesiologists: Physical status classification system

BIS Bispectral index

SQI Signal quality index

BMI Body mass index

BTPS Body Temperature and Pressure, Saturated37 °C (98.6 °F), ambient pressure, 100 % relative humidity

Ce Effect-site concentration

cm Centimeter

etCO2 End-tidal CO2 concentration

etVA calc. End-expiratory volatile agent concentration

Extub. Extubation

h Hour

HR Heart rate

ICM Integrated Care Manager

IE Infinity Empowered

in Inch

Intub. Intubation

IV Intravenous

kg Kilogram

kPa kilopascal

lbs Pound

LOC Loss of consciousness

MAC Minimum alveolar concentration

ART M Mean arterial blood pressure

mg Milligram

min Minute

mL Milliliter

mmHg Millimeter of mercury

MV Minute volume

N2O Nitrous oxide

ng Nanogram

NIBP M Mean non-invasive blood pressure

NSRI Noxious stimulus response index

O2 Oxygen

PD Pharmacodynamics

PK Pharmacokinetics

PV Ratio of propofol to volatiles

TOL Tolerance of laryngoscopy

TOSS Tolerance of shake and shout

TTLI Time to lowest isobole

UDI Unique device identifier

μg Microgram

USB Universal Serial Bus

Vol% Percentage gas rate in relation to total gas volume

Abbreviation Explanation


System overview

Symbols

The following symbols are used in the software and throughout these instructions for use:

Symbol Explanation

Event markerLOC (loss of consciousness)

Event markerMove

Event markerOther

Event markerCut

Event markerIntub. (Intubation)

Event markerExtub. (Extubation)

Manual infusion rate (the displayed color corresponds to the drug color)

Manual bolus (the displayed color corresponds to the drug color)

Ce target value (the displayed color corresponds to the drug color)

Cp target value

What if...

Manufacturer

Date of manufacture

Follow the instructions for use

Information on disposal, WEEE marking, Directive 2002/96/EC

Part number

Serial number

Quantity

Symbol Explanation


Operating concept

Operating concept

Cursor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32

Input options. . . . . . . . . . . . . . . . . . . . . . . . . . 32General information . . . . . . . . . . . . . . . . . . . . . 32Rotary knob (option) . . . . . . . . . . . . . . . . . . . . . 32Keyboard and mouse . . . . . . . . . . . . . . . . . . . . 33Display keyboard . . . . . . . . . . . . . . . . . . . . . . . 33

Color concept . . . . . . . . . . . . . . . . . . . . . . . . . 33

Operating concept


Cursor

The cursor is an orange line that starts at the time scale and runs upwards vertically across the entire time-based display.

The cursor is activated by selecting the time scale.

It freezes the time-based display for 15 seconds at a specific point on the time scale and serves to set the event markers.

The cursor appears with the following numerical values:

– Time in the time-based display

– Effect-site concentration for each drug

– Infusion rate or plasma concentration for each IV drug

– Expiratory concentration for each volatile anesthetic agent

– NSRI as a numerical value

– Vital parameters

– BIS

Input options

General information

Clicking on the yellow X in the dialog windows closes the window and adopts the set values.

Fields with yellow backgrounds in dialog windows require confirmation or setting.

Rotary knob (option)

022

010For illustration only.


Operating concept

The rotary knob is used to move the event markers and the cursor along the time scale and to set input parameters in the dialog windows. The rotary knob has the following functions:

Select/set = turn

Clockwise rotation moves the selected event marker or the cursor to the right or increases numerical values. Counterclockwise rotation moves the selected event marker or the cursor to the left or decreases numerical values.

Confirm = press

Pressing the rotary knob sets the selected event marker on the time scale or confirms the set values.

Keyboard and mouse

Set = arrow keys or mouse scroll wheel

Using the arrow keys or the mouse scroll wheel moves the selected event marker or the cursor and changes numerical values.

Confirm = press the enter key or mouse scroll wheel

Pressing the enter key or the mouse scroll wheel sets the selected event marker on the time scale or confirms the set values.

Display keyboard

Can be configured for improved operation with touchscreens without mouse, keyboard or rotary knob.

For further information on the display keyboard, refer to "Selecting and setting" on page 51.

Color concept

The available background color schemes are:

– Day light

– Day dark

– Night

The color scheme can be selected in the following dialog windows:

– In operation mode: Screen layout...

– In standby mode: System setup... > Screen layout....


Operation

Operation

Starting the software . . . . . . . . . . . . . . . . . . . 36

Standby mode. . . . . . . . . . . . . . . . . . . . . . . . . 36Buttons . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36

Operation mode . . . . . . . . . . . . . . . . . . . . . . . 422D diagram for pharmacodynamics . . . . . . . . . 43Event marker . . . . . . . . . . . . . . . . . . . . . . . . . . 44Time scale . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45Noxious stimulus response index (NSRI) with prediction. . . . . . . . . . . . . . . . . . . . . . . . . . 45Time-based display for drug administration with prediction . . . . . . . . . . . . . . 45Buttons . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46Cursor. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48

Predictions . . . . . . . . . . . . . . . . . . . . . . . . . . . 48Pharmacodynamics . . . . . . . . . . . . . . . . . . . . . 48Pharmacokinetics . . . . . . . . . . . . . . . . . . . . . . . 48Bolus. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49SmartTCI . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49

Display of parameters . . . . . . . . . . . . . . . . . . 50Parameters provided by SmartPilot View . . . . . 50Parameters provided by the basic device. . . . . 50

Selecting and setting . . . . . . . . . . . . . . . . . . . 51Notes on selecting and setting . . . . . . . . . . . . . 51Displaying the cursor . . . . . . . . . . . . . . . . . . . . 51Moving the cursor . . . . . . . . . . . . . . . . . . . . . . . 51Setting event markers. . . . . . . . . . . . . . . . . . . . 51Moving event markers subsequently . . . . . . . . 52Deleting an event marker . . . . . . . . . . . . . . . . . 52Showing all event markers . . . . . . . . . . . . . . . . 52Showing the history function on the 2D diagram. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52Changing the 2D diagram settings . . . . . . . . . . 52Selecting and removing a drug in the Drugs dialog window . . . . . . . . . . . . . . . . . . . . 52Setting a manually administered drug . . . . . . . 53Moving the marker of a manually administered drug. . . . . . . . . . . . . . . . . . . . . . . 53

Deleting a manually administered drug . . . . . . 53Stopping a manual infusion rate . . . . . . . . . . . 53Drug preview: What if function . . . . . . . . . . . . 54

Importing patient data and drug data . . . . . 54

Exiting the software . . . . . . . . . . . . . . . . . . . 55

Uninstalling the software . . . . . . . . . . . . . . . 55

Operation


Starting the software

Infinity C700 for IT with Infinity Explorer:

1 Select the SmartPilot View tab.

2 Double-click on the SmartPilot View symbol.

Other medical-grade PCs:

1 Select the start menu.

2 Select the SmartPilot View entry.

Standby mode

Buttons

System configuration

The System setup... button is used to open the System setup dialog window.

The following tabs are available in this dialog window:

A Screen layout

B Drug library

C System

D Service

Screen layout

On this page, the following display settings can be made:

A Display mode

– Day light, Day dark, Night

B Screen keyboard

– On, Off

C Language

Drug library

A List with drug names

B Drug name

C Active agent

D Dilution

E Color

F Smart TCI

– On

– Off

023

024

A B C D

ABC

025

A

BCDEF


Operation

System

The System page is password-protected. For further information, refer to "Password protection" on page 41.

The following vertical tabs are available:

A Data protection

B Units

C Im/Export config.

D Drug editor

On the Data protection page, the settings for protection of the patient data can be changed when network operation is configured.

A Protection by access code

– On, Off

On the Units page, the following default units can be changed:

A etCO2

– mmHg, %, kPa

B Blood pressure

– mmHg, kPa

C Weight

– kg, lbs

D Height

– cm, in

E Drugs

– μg, mg

– μg/kg / mg/kg

026

028

ABCD

A

027

NOTEetCO2 values exceeding 99 mmHg cannot be transmitted using MEDIBUS. In this case, different values are displayed on the monitor and in SmartPilot View.

CAUTIONDisplay of incorrect blood pressure

Differing units for blood pressure on the patient monitor and SmartPilot View cause incorrect values for blood pressure measurement on SmartPilot View.

ABCDE

Operation


On the Im/Export config. page, a configuration can be imported or exported from or to a USB flash drive:

A Configurations available on the system for export

B Import and Export buttonsC Configurations available on a USB flash drive

for import

On the Drug editor page, an overview of the drugs and their active agents is given. Drugs can be added or deleted:

A List with drug namesB Add and Delete buttons for adding or deleting

drugs from the list above

C Drug nameD Active agentE DilutionF ColorG Smart TCI

– On– Off

H Reset and Confirm buttons for resetting or saving the settings

Service

The Service page is password-protected. For further information, refer to "Password protection" on page 41.

The following vertical tabs are available:

A Serial number / Platform (serial number)

B Workflow Support

C Applications (applications)

D Device type setup (connected devices)

E Network setup (network configuration)

F Data sharing

G Device interface setup (detected devices)

H Software

I Service Call

On the Serial number / Platform page, the hardware can be selected and the serial number of SmartPilot View can be entered or changed:

029

030

A B C

A

B

CDEFG

H

031

ABCDEFGHI


Operation

A Platform

B Serial number

C Revision Index

D Manufacture date

E Reset and Confirm buttons to reset or confirm

The connection of SmartPilot View with other workstations can be set on the Workflow Support page.

A Network lookup mode

– Off, Manual, Automatic

B Web service port

C Adapter binding

D Reference workstation

E Reset and Confirm buttons to reset or confirm.

On the Applications page, applications can be activated or deactivated:

A Available applications (available applications)

B Activate and Deactivate buttons for activation and deactivation

C Active applications (active applications)

On the Device type setup page, the connected devices are displayed:

A Anesthesia device (anesthesia machine)

– Zeus, Primus, Apollo, Perseus A500, Atlan

B Infusion device (infusion pump)

– Zeus, B. BraunSpaceCom, FreseniusBaseA, FreseniusBPrimea, FreseniusAgilia, AlarisGateway, IVDock, TerumoTE-3XX, TerumoRack, Arcomed, Arcomed UniQue CONCEPT Box

C Hemodynamic device (patient monitor)

– Zeus, Delta XL, Kappa, IACS, PhilipsIntelliVue

D Reset and Confirm buttons to reset or confirm.

032

052

A

BC

ED

ABCD

E

033

034

A B C

ABC

D

Operation


On the Network setup page, the network configuration can be changed:

A IP address and ports for connected devices

B Reset and Confirm buttons

On the Data Share page, the settings for sharing of MediData can be changed:

A MediData data sharing

– Off

– as Provider

B MediData Port

C Reset and Confirm buttons

A table of all detected devices is displayed on the Device interface setup page:

A Configured Device (configured devices)

B Configured Interface (configured interface)

C Detected Device (detected devices)

A table with the software versions of software components used with SmartPilot View is displayed on the Software page:

A Name

B Version

On the Service Call page, the service log file can be exported to a USB flash drive:

A Export button to export the log file

036

064

B

A

A BC

035

037

038

A B C

A B

A


Operation

Export case log...

The Export case log... button serves to open the Export case log dialog window for export of the saved case log files. On this page, the following settings can be made:

A Case log files available in the System

B Export button

C Case log files on the USB flash drive

D Further information on the selected case log file

Start

The Start button starts a new case and switches from standby mode to operation mode.

Exit

The Exit button serves to close SmartPilot View and display the Infinity Explorer.

Password protection

The System and Service pages are password-protected.

If network operation is configured, the Continue case and Export case log pages can also be password-protected (see page 37).

A Change password button

B Field for entering the password

C Numeric keypad

D OK button

The 4-digit password is entered via the numeric keypad and confirmed with the OK button.

For further information, refer to "Password" on page 105.

Changing the password

The password can be changed with the Change password button. To do so, proceed as follows:

1 Touch the Change password button (A).The labeling of (B) changes from Enter password: to Enter old password:

2 Enter the old password in the field (B) and confirm with the OK button.

3 The labeling of (B) changes to Enter new password: Then, enter the new password and confirm with OK.

4 Enter the new password again and confirm with OK.

039

AB

D

C

040

NOTEThe password must be between 4 and 8 digits long.

AB

C

D

Operation


Operation mode

Switching from standby mode to operation modeAfter touching the Start button, the following actions are performed:

– The Patient dialog window opens if the patient's demographic data has not been completely transmitted by the connected basic devices or still needs to be confirmed by the user.

SmartPilot View prioritizes adopted data as follows:

– Manual settings in SmartPilot View

– Patient data from an adopted case (with network operation only)

– Patient data from infusion pumps

– Patient data from the anesthesia machine

The demographic data can be confirmed or adjusted in this dialog window. If network configuration is configured, the patient name/ID must be entered in addition (see page 58).

Manually confirmed data for this case will not be overwritten by data provided by connected devices.

– If an unknown drug is received from a connected pump, the Drugs dialog window opens.

The drugs to be displayed in the pharmacokinetics graph can be selected in this dialog window. Furthermore, the drugs from connected infusion pumps are displayed (see page 58).

– The software imports the settings from the basic device.

– The software captures the patient data from the basic device.

– The software creates and names a new logfile.

Switching from operation mode to standby modeAfter touching the Standby button, the following actions are performed:

– The software stops all time-based models.

– The software stops all pharmacodynamic models.

– The software closes the current case.

– The software saves the log file.

– If network operation is configured, the case is displayed in the Patient dialog window on the Continue case tab (see page 59).

NOTEManually administered drugs can only be entered directly in the pharmacokinetics graph.


Operation

2D diagram for pharmacodynamics

Depending on the settings made in the Diagram settings dialog window, 2 scales are available.

2D diagram for volatile drugs

The horizontal scale represents the calculated concentration of the administered analgesic drugs at the effect site (based on the analgesic potency of the given drugs compared to Remifentanil) and is named Remifentanil equivalent.The vertical axis represents the calculated effect-site concentration of the hypnotic drugs at the effect site. The scale is named according to the selected hypnotic drug. If multiple drugs are used, the concentration is displayed as an equivalent of the selected hypnotic drug.

The display area displays 4 isoboles that represent certain levels of anesthesia depending on the diagram settings:

Time to TOSS 50

The estimated Time to TOSS 50 is indicated by 5 bars and ranges from >20 minutes (all bars are filled) to

Operation


The bars for drugs with slow anesthetic effect begin directly at the zero point on the scale, while the bars for faster acting drugs are farther away from the zero point. The further to the right (X-axis) or further up (Y-axis) the bar for a drug begins, the faster it acts.

When the amount of administered drugs is changed and the calculated concentration in the effect site changes in consequence, the length of the bars changes accordingly.

Symbols on the 2D diagramWhen the administration of hypnotic drugs is started, the 2D diagram shows the following symbols:

Graphs on the 2D diagramWhen the administration of hypnotic drugs is started, the 2D diagram shows the following calculated graphs:

As soon as the amount of any administered drug is changed on the basic device, SmartPilot View calculates the prediction in real time and changes all graphs from the current time onwards.

Event marker

The event markers offer the possibility of setting different events during the surgical procedure on both the time scale and the 2D diagram. The following event markers are available:

A LOC (loss of consciousness)

B Intub. (Intubation)

C Cut

D Move

E Extub. (Extubation)

F Other

It is possible to set the same type of event marker multiple times to mark the same type of event at different stages during the surgical procedure.

When 2 or more markers are assigned to the same point in time, they are located on top of each other on the time scale. This applies both to event markers and to bolus markers. When selecting

Symbol ExplanationOrange dot Calculated current anesthesia

level (: Current)Black dot Calculated anesthesia level in

10 minutes (: 10 min)White arrow Calculated anesthesia level in

20 minutes (: 20 min)Orange colored double arrow

Cursor

Graph Color ExplanationThick line

White History over the last 10 minutes. From minute 11 onwards, the graph becomes transparent.

With Zeus anesthesia workstation or manual administration of drugs only:Thin line

Yellow "What if...":Predicted course for the next 20 minutes when settings are changed but not confirmed on the basic device. As soon as the changes are confirmed, the color of the line changes to white.

NOTEThe "What-If..." display only takes account of the drug in question and not of any dependent drugs.

After a possible manual administration of a bolus is confirmed, the subsequently calculated pharmacodynamics may deviate from the former prediction.

041

A B C

D E F


Operation

superimposed markers, a dialog window opens showing all superimposed markers that can be selected.

Time scale

The interval of the time scale is from –40 minutes to +20 minutes. However, the time scale is scrollable from 60 minutes before the beginning of the case until the end of the prediction.

A OK and Delete buttons

The Delete button is only displayed if an event marker or a manually set input was selected.

In this case, the Set button is displayed in addition, which allows the point in time to be confirmed on a screen with touch function without the need of a keyboard, mouse or rotary knob.

B Case time

The case time is the time that has elapsed since switching from standby mode to operation mode or since touching the Start button to manually start a case.

Noxious stimulus response index (NSRI) with prediction

The NSRI is displayed as a graph and as a numerical value.

The display shows the same isoboles and colored areas as the 2D diagram.

The NSRI represents the calculated anesthesia level from the 2D diagram plotted on a time scale.

Time-based display for drug administration with prediction

The time-based display shows the dosage information and the calculated effect-site concentration of the administered drug.

The time-based display for each administered drug consists of

A A section with the name of the drug (A)B A history section (B)C A prediction section (C)D A section with the current Ce value (D) and at

the same time a button for selecting the display of the infusion rate or the plasma concentration and display of the entire infused amount of drugs

The infusion rate or the plasma concentration of the administered drug is displayed as a gray line. The corresponding Rate or Cp scale is labeled according to the selected drug and scale setting.

NOTEEvent markers are manually set by the user. They do not show events or data recorded by the device itself.

046

Displayed interval Type of data–40 minutes up to the current time

History

Current time to +20 minutes Preview

A B

042

A B C D

Operation


The calculated effect-site concentration Ce is displayed as a colored area in the history and as a shaded area in the prediction. The corresponding Ce scale has the same color and is labeled according to the selected drug.

A given bolus is always displayed.

With Zeus anesthesia workstation only:

When changes are made but not confirmed on the basic device, 2 dotted lines appear (so-called "What if..." function).

Manual drug application

A manually administered drug can be taken into account by the software by touching the PK prediction area and touching the button for manual dosage of drugs in the window that opens. For further information, refer to "Setting a manually administered drug" on page 53.

A vertical line with a flag showing the bolus amount represents the bolus on the time-based display.

A gray horizontal line represents the infusion rate.

Sequence of types of drugs

The sequence of types of drugs from top to bottom is always:

– Hypnotic drug

– Analgesic

– Muscle relaxant

When one group of drugs is not administered, the corresponding section is replaced by the following section from the sequence.

The sequence of drugs from top to bottom is always:

– Volatile anesthetic

– Propofol

– Alfentanil

– Fentanyl

– Sufentanil

– Remifentanil

– Pancuronium

– Rocuronium

– Vecuronium

– Mivacurium

Buttons

Show events

The Show events button can be used to hide all event markers that were set during a surgery. This function provides a better overview of the history in the 2D diagram.

The Show events function is activated by default.

Show history

The Show history button extends the line in the 2D diagram that represents the history of the anesthesia level. In this case, not only the history over the last 10 minutes is shown but from the beginning of the case. The color of the line changes from gray to black. This allows the entire history of the anesthesia case to be shown.

The Show history function is deactivated by default.

Diagram sett. ...

The Diagram settings... button opens a small dialog window for selection of the hypnotic. The selection made here affects the hypnotic scale in the 2D diagram.

NOTEThis feature does not remotely control the admin-istration a drug. Its intention is the documentation or consideration of a manual drug.


Operation

The following hypnotics can be selected:

A Propofol, Desflurane, Sevoflurane, Isoflurane

Patient...

The Patient... button opens the Patient dialog window.

Drugs...

The Drugs... button opens the Drugs dialog window.

Screen layout...

The Screen layout... button opens a small dialog window for selection of the color scheme.

The following color schemes can be selected:

A Day light, Day dark, Night

Screenshot export

The Export screenshot button opens a screenshot and saves it as a JPG file in the case log file.

In standby mode, screenshots can be exported to a USB flash drive together with the case log file.

Standby

The Standby button switches SmartPilot View from operation mode to standby mode.

043

053

NOTEFor further information, refer to the chapter "Configuration" on page 57.

A

044

NOTEFor further information, refer to the chapter "Configuration" on page 57.

045

NOTEFor further information on switching to standby mode, refer to "Operation mode" on page 42.

A

Operation


Cursor

The cursor is used to position the following elements (see page 51):

– Event marker

– Manual drugs

The cursor can be moved to any point on the time scale, i.e., also in the history and the prediction sections, and allows scrolling through the entire case.

When positioning the cursor, explanatory notes are displayed directly at the cursor position.

Predictions

The following predictions are calculated and displayed by SmartPilot View:

Pharmacodynamics

– NSRI

The NSRI prediction area or the NSRI graph shows the history of the value over the last 40 minutes and the predicted NSRI value for the next 20 minutes.

Pharmacokinetics

– Hypnotic drug

– Analgesic drugs

– Muscle relaxant

Each prediction shows the history of the value over the last 40 minutes, the current infusion rate, or the predicted plasma concentration and the predicted effect-site concentration of the administered drug for the next 20 minutes.

Example: 4 drugs (1 x hypnotic, 2 x analgesic, and 1 x muscle relaxant) are administered.

The infusion rate is represented as a gray line. The rate can be determined from the vertical Rate scale in the time-based display. The course of the line is updated if changes are made on the basic device.



The predictions are calculations based on available data.

Premedication or unknown drugs are not included in these calculations. In this case, the predictions in the 2D diagram and of the time-based NSRI are not conclusive.


SmartPilot View does not detect whether there is actually a patient connected to the basic device. In this case, data originating from the basic device are used.

048


Operation

A Pharmacokinetics graph

– Infusion rate

– Plasma conc. (Cp)

B Manual drug / what if...

– Manual drug button

– What if... button

When the PK prediction area is selected, a dialog window opens which enables the history of plasma concentration Cp to be displayed instead of the infusion rate (A). This setting is permanently saved for each drug.

Furthermore, a manually administered drug and the What if... function can be set (B).

For more information on setting a manually administered drug or the What if... function, refer to see page 53.

The axis scale for Cp corresponds to that of Ce. The Cp history is likewise shown in gray.

The calculated effect-site concentration is represented as a colored area. The effect-site concentration can be determined from the vertical Ce scale in the time-based display.

Bolus

In addition to the current infusion rate of the IV drug, the bolus volume is also included in the calculations for the predicted effect-site concentration.

SmartTCI

SmartPilot View supports fast adaptation to supported infusion pumps that are operated in TCI mode. The prerequisite is that the SmartTCI function for the drug is switched on in the drug editor.

The following TCI models are supported:

– Schnider (for propofol)

– Minto (for remifentanil)

– Scott (for alfentanil)

– Gepts (for sufentanil)

The following values coming from the pumps are adopted:

– Current Cp and Ce value

– Cp or Ce target value

– Target mode (plasma mode or effect mode)

– Cp and Ce units

– Name of the calculation model (not provided by all basic devices)

SmartPilot View switches automatically to SmartTCI mode as soon as it has received these values. In this mode, the internal model states of SmartPilot View are matched to the states of the pump and a preview based on the currently set target value is calculated.

The target value is represented as a marker with a dotted line in the prediction section, filled in the color of the drug as the Ce target value and filled in gray as the Cp target value.

As a result of the rapid alignment with the values from the pump model, the display of the prediction graphs in SmartPilot View corresponds to the display on the infusion pumps.

If the SmartTCI function is not switched on, there are noticeable deviations between the predictions, particularly in the initial phase of the therapy.

058

NOTESmartPilot View calculates bolus doses (manual addition or administered by pump) based on a flow rate of 1800 mL/h.

A

B

Operation


In SmartTCI mode, the TCI model used by SmartPilot View is displayed in the corresponding drug prediction. If an incompatible model is detected, a corresponding message appears.

Display of parameters

Parameters provided by SmartPilot View

– Calculated effect-site concentration of administered hypnotics

– Calculated effect-site concentration of administered opioids

– Calculated effect-site concentration of administered muscle relaxants

Parameters provided by the basic device

– Heart rate HR in 1/min

– Mean non-invasive blood pressure NIBP M or mean arterial blood pressure ART M in mmHg or kPa

– End-tidal CO2 concentration etCO2 in mmHg, Vol% or kPa

– Bispectral index BIS

– BIS signal quality index SQI in %

NOTEThe display of the total drugs administered is not supported in the SmartTCI function.

NOTEThe display of infusion rate is not supported in the SmartTCI function. The plasma concentration is displayed instead.


The vital signs displayed by SmartPilot View are provided for information purposes only and must not be used for therapeutic decisions. Only use data from the connected patient monitor when making therapeutic decisions.


051

NOTEAll measured data are provided by the basic device. SmartPilot View does not take any measurements of patient data.


Operation

Selecting and setting

Notes on selecting and setting

SmartPilot View is run on a PC.

Depending on the input devices used, selecting and setting can be performed as follows:

Displaying the cursor

1 Select the screen in the area of the time scale. The cursor appears.

2 Deselect the cursor or select any point on the time scale.

Moving the cursor

1 Select the screen in the area of the time scale. The cursor appears.

2 Select the cursor or maintain selection of the cursor and move it to the desired position on the time scale.

Setting event markers

Example: Cut event marker

1 Select the Cut button in the event marker area of the screen. The color of the button changes to yellow and the cursor is displayed in yellow on the time scale.

2 The event marker can be moved to the desired position on the time scale.

3 Confirm the position of the event marker. The cursor disappears and the event marker appears on the time scale and the 2D diagram.

Selecting Deselecting Changing/moving ConfirmingTouchscreen, mouse and keyboard

Touch Touch Arrow keys Press the enter key or the mouse scroll wheel

Touchscreen and rotary knob (option)

Touch Touch Rotary knob or arrow keys

Press the rotary knob

Mouse and keyboard Click Click Scroll wheel or arrow keys

Press the enter key or the mouse scroll wheel

Touchscreen Touch Touch Touch Touch the OK button

Operation


Moving event markers subsequently


1 Select = touch the symbol of the Cut event marker on the time scale. The cursor appears and the color of the event marker changes to yellow. A note text appears at the cursor.

2 Move = turn the rotary knob (option) clockwise for adjusting the cursor to the right and turn the rotary knob (option) counter-clockwise for adjusting it to the left.

3 Confirm = press the rotary knob (option). The event marker jumps to the new position, its color changes to white again, and the cursor disappears.

Deleting an event marker


1 Select = select the symbol of the event marker to be deleted on the time scale. The cursor is displayed and the color of the event marker changes to yellow and the Delete button appears in the time scale field.

2 Delete = select the Delete button in the time scale field.

3 Confirm = press the rotary knob (option).

Showing all event markers

This feature shows all event markers and thus allows for a better visibility on the 2D diagram.

1 Show = select the Show events button on the right side of the touch screen. All event markers on the 2D diagram are displayed.

2 Hide = select the Show events button again to hide all event markers.

Showing the history function on the 2D diagram

With this function, the anesthesia level can be tracked back to the beginning of the case.

The history line becomes visible from the start of the anesthesia case and is divided into gray sections.

1 Show = select the Show history button on the right side of the touch screen. The thick white line becomes visible from the zero point on.

2 Hide = select the Show history button again to hide the history of the anesthesia level.

Changing the 2D diagram settings

This feature allows selection of the hypnotic and thus the scale of the hypnotic axis in the 2D diagram.

Example: Changing from Sevoflurane to Propofol.

1 Select the Diagram settings... button. A small dialog window appears.

2 Select Propofol and confirm the selection.

The scale changes as shown in the table on page 43.

Selecting and removing a drug in the Drugs dialog window

Example: Selecting fentanyl with a concentration of 10 mg/mL.

1 Open the Drugs dialog window.

2 Select Fentanyl.

3 The time-based display of Fentanyl is shown.

NOTEEvent markers can only be set within the history section of the time scale.

NOTEA maximum of 4 pharmacokinetics graphs can be displayed at the same time.


Operation

Setting a manually administered drug

1 Touch the pharmacokinetics area of the drug. The dialog window for the drug-specific settings opens.

2 Touch the Manual drug button (A). A dialog window opens for setting of a manually administered drug.

3 Select the button next to Dilution [mg/mL] (A). The color of the button changes to yellow.

4 Set the desired value (e.g., 10 mg/mL) and confirm.

5 Select the button next to Manual bolus [mL] (B) or Manual rate [mL/h] (C). The color of the button changes to yellow.

6 Set the desired value (e.g., 8 mL for Manual bolus or 8 mL/h for Manual rate) and confirm.

7 Confirm the set value. The yellow cursor appears.

8 If necessary, adjust the position of the manual drug administration on the time scale by moving the cursor.

9 Confirm the timing of the bolus.

Moving the marker of a manually administered drug

1 Select the corresponding bolus symbol on the time scale. The note Move or delete appears next to the cursor.

2 Move the cursor to a different time and confirm the setting. The bolus symbol appears at the new time on the time scale and the software recalculates the displayed values and graphs.

Deleting a manually administered drug

1 Select the corresponding bolus symbol on the time scale. The note Move or delete appears next to the cursor.

2 Select the Delete button next to the time scale. The bolus symbol is deleted and the software recalculates the displayed values and diagrams.

Stopping a manual infusion rate

1 Select the button for manual dosing.

2 Set the infusion rate to 0.

059

060

A

A

B CNOTEThe infusion stops automatically when a rate transferred from a connected pump is detected.

Operation


Drug preview: What if function

Based on the current pump rates and vapor settings, the What if function shows what effect a rate change or bolus would have.

1 Touch the pharmacokinetics area of the drug. The dialog window with the drug-specific settings opens.

2 Touch the What if... button (A). The Agent prediction dialog window opens.

3 Select the button below Rate [mL/h] / Fresh gas concentration (A) or Bolus [mL] / Flow (B). The color of the button changes to yellow.

4 Set the desired value (e.g., 1 μg/h for Rate [mL/h] or 1 μg for Bolus [mL]).

5 An orange cursor with the set value appears at the set time and a dotted line in the prediction area shows the effect this change would have.

6 Confirming the setting ends the preview.

Importing patient data and drug data

All drug data for monitoring the dosage of drugs is continuously imported from the basic device.

If the demographic data is not received from the basic device, it must be entered manually.

For further information, refer to the chapter "Connectivity" on page 81.

061

A

062

063

A B

NOTEThe connection between SmartPilot View and the anesthesia workstation is unidirectional, i.e., SmartPilot View can only receive data from the anesthesia workstation. No data is sent to the anesthesia workstation.


Operation

Exiting the software

To exit the software, proceed as follows:

1 In operation mode, select the Standby button (A) in the main menu bar and confirm.

2 In standby mode, select the Exit button (B) and confirm.

Uninstalling the software

The service documentation of the software describes how to uninstall SmartPilot View.

065

A

066

B


Configuration

Configuration

Default patient data . . . . . . . . . . . . . . . . . . . . 58

Changing patient data . . . . . . . . . . . . . . . . . . 58Continue Case . . . . . . . . . . . . . . . . . . . . . . . . . 59

Changing the displayed drugs . . . . . . . . . . . 60Assigning unknown drugs. . . . . . . . . . . . . . . . . 60

Configuration of the drug library . . . . . . . . . 61Changing the drug name . . . . . . . . . . . . . . . . . 61Adding drug names . . . . . . . . . . . . . . . . . . . . . 61

Configuration


Default patient data

When the device switches from standby mode to operation mode, the Patient dialog window shows the default patient data.

When a new case is started and the basic device provides the patient data, SmartPilot View imports this patient data and uses it instead of the default patient data.

After starting a new case, the patient data must first be adjusted to the actual values and then confirmed.

Changing patient data

The patient data can be changed in this dialog window. This dialog window is accessible in operation mode via the Patient... button.

If not all demographic data was received from the connected basic devices, the Patient window opens automatically.

Patient data is prioritized as follows:

A Patient name/ID

B Age [years]

C Height [cm] or Height [in]

D Weight [kg] or Weight [lbs]

E Gender (male/female)

CAUTIONUnsuitable patient data

The displayed default patient data may not match the actual patient data.

Always check the patient data displayed in the Patient dialog window before confirming.

NOTEIf the basic device does not provide sufficient data to SmartPilot View, some fields in the Patient dialog window are assigned preset values.

NOTEWrong weight values with Zeus 4.03

When switching the unit of weight to pound on a Zeus anesthesia workstation with software version 4.03, the weight is not correctly transferred to SmartPilot View. The weight must therefore be manually corrected in SmartPilot View.

1. Manual setting in SmartPilot View

2. Data from an adopted episode (with configured network operation only)

3. Data from infusion pumps

4. Data from the anesthesia machine

055

ABCDEF

G


Configuration

F BMI [kg/m²]

G Confirm button

The fields correspond to the information in "Indications" on page 14.

Continue Case

With SmartPilot View, it is possible to continue a case in the OR that was started and concluded in induction.

The patient data and drug data from the induction episode is adopted and taken into account for calculation.

The following prerequisites apply:

– A further SmartPilot View installation

– A supported anesthesia machine

– Supported infusion pumps in induction

– Configured network operation

If network operation is configured, a case that was concluded during the last 45 minutes in induction can be selected and continued via the Continue case tab.

In this case, manual entry of the patient data and manual completion of the drug data from the induction episode can be omitted. The adopted induction episode is shown shaded in the history.

A Period filter

– -15 min (If this filter is selected, only those cases are displayed that were concluded in induction during the last 15 minutes.)

B Information on the available (stored) cases

– Case time, Patient name/ID, Demographic data

NOTEPatient name/ID and the Continue case tab are only displayed if network operation is configured.


The SmartPilot View workstations in the network must be synchronized to enable transfer of cases. Deviations of up to 1 minute are tolerated.

NOTEThe case must be concluded in induction to be displayed.

057

CAUTIONPossible data loss

If the case adopted from induction that is to be continued and the current case in the OR overlap in time, the data from the current case in the OR is overwritten for the overlapping period.

The data is deleted and cannot be retrieved.

NOTEPay special attention when using the Continue case function.SmartPilot View interprets the case pause time as a period of time where no drugs are being administered to the patient.

NOTEManually administered drugs that are subsequently entered in the induction episode of a continued case are not saved when concluding the case in the induction episode.

A

B

Configuration


Changing the displayed drugs

The drugs to be displayed in the pharmacokinetics graph can be selected or changed in the Drugs dialog window. Furthermore, the drugs from connected infusion pumps are displayed.

Drugs for the Pharmacokinetics graph. The following drugs can be selected:

A Hypnotics

– Desflurane, Sevoflurane, Isoflurane, Propofol

B Analgetics

– Alfentanil, Fentanyl, Sufentanil, Remifentanil

C Muscle relaxants

– Pancuronium, Rocuronium, Vecuronium, Mivacurium

Detected Drugs from IV pumps

D Information on Name, Active agent, Dilution, Unit

– The Name column displays the following:

– Names of the administered drugs

– The Active agent column provides information on the active ingredient.

– The Dilution is a numerical value that is automatically transmitted by the infusion pumps.

– The Unit is preset according to the selected drug and cannot be changed.

Assigning unknown drugs

If an unknown drug is received from a connected pump, the Drugs dialog window opens automatically.

If the drug names on the infusion pump and in the SmartPilot View drug library do not match, the message Unknown drug detected. is displayed and the Drugs dialog window opens automatically.

An active ingredient must now be assigned to the unknown drug.

For further information on the configuration of the drug library, refer to "Configuration of the drug library" on page 61.

056

ABC

D


Drugs administered to the patient up to one hour before arrival in the operating room must also be entered.

NOTEOnce the dilution is set, it is no longer possible to change the active agent. Only the dilution can be changed again by selecting the corresponding range.


Configuration

Configuration of the drug library

The drug library is accessible in standby mode via System setup... > Drug library. However, the user only has read access.

The drug library can be imported and exported. It can be edited using the integrated drug editor (System setup... > System) by trained and experienced personnel. A keyboard is required for this.

Changing the drug name

1 Select the drug name (e.g., Prop1).

2 Enter the new name of the drug (B).

3 Confirm the new drug name with the Confirm button (E).

4 Close the dialog window with X.

Adding drug names

1 Select Add (A).

2 Enter the name of the drug (B).

3 Confirm the name.

4 Select Active agent from the list (C).

5 Set the Dilution (D).

6 Confirm the new drug with the Confirm (E) button.

7 Close the dialog window with X.

054

NOTEThe name must be identical to the drug name of the connected pump.

A

BC

E

D

NOTEThe name must be identical to the drug name of the connected pump.


Log files

Log files

Case log file . . . . . . . . . . . . . . . . . . . . . . . . . . 64Content of case log files . . . . . . . . . . . . . . . . . . 65Export of case log files . . . . . . . . . . . . . . . . . . . 68

Configur

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