SmartCare PS Instructions for Use Supplement for Evita XL Sw 6.n Edition 4 Sept 2010

Trademarks –

Evita®

– –

Evita XL® AutoFlow®

–

SmartCare®

are trademarks owned by Dräger.

Definitions WARNING A WARNING statement provides important information about a potentially hazardous situation which, if not avoided, could result in death or serious injury. CAUTION A 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. NOTE A NOTE provides additional information intended to avoid inconvenience during operation.

Abbreviations and Symbols Please refer to "Abbreviations and Terms" on page 9 and "Symbols" on page 10 for explanations.

2

Instructions for Use SmartCare/PS SW 1.1 for Evita XL

Contents

Contents New Features of SmartCare SW 1.1...

4

For Your Safety and that of Your Patients . .

5

Application...

7

Intended Use... Indication... Recommended Settings for Alarm Limits...

7 7 8

Abbreviations and Terms...

9

Symbols... 10 Preparation... 11 Before First-time Use... 11 Switching on Evita XL... 11

Additional Explanations...

29

Upper and Lower Limits of the Main Parameters... Diagnosis – Classification of Patient Ventilation...

35

Web-based Application Service (WAS)...

36

Preparing WAS... Starting WAS... Ending WAS...

37 38 40

Bibliography...

41

Index...

42

33

Operation... 12 Requirements... 12 Before Every Use... 12 Setting SmartCare... 13 Activating SmartCare... 16 Course of the Patient Session... 17 Actions Performed on Evita XL and Their Effects on SmartCare... 18 Problems and Their Effects on SmartCare... 19 Measured Values, Graphics, and Trends . . . 20 Displaying Graphics... 20 Displaying Measured Values... 21 Configuration... 23 Selecting Initial Measured Values... 23 Ending SmartCare... 24 Alarm Messages and Related Actions... 25 Alarm – Cause – Remedy... 26

Instructions for Use SmartCare/PS SW 1.1 for Evita XL

3

New Features of SmartCare SW 1.1

New Features of SmartCare SW 1.1

Extended patient range SmartCare can now also be used for patients with a body weight between 15 and 36 kg. A supplementary medical guideline has been implemented for this patient category. The relevant category is selected based on the patient's body weight. The patient’s weight is set on a separate page prior to the start of each SmartCare session. The dialog window changes according to the specific patient category and guideline selected. For patients with a body weight of <36 kg, the "comfortable zone" for COPD and Neurologic Disorder and the setting for ΔPASB goal pressure cannot be adjusted. For this reason, the Medical History and Airway Access pages do not appear in the case of this patient category.

Use of SmartCare and ATC ATC can be activated for patients weighing 36 kg or more. In order to provide the most efficient compensation possible during a SmartCare Patient Session, the degree of compensation of ATC must be set to 100 %.

Web-based Application Service (WAS) SmartCare allows the user to view data from patient sessions on a computer and to download it. This application is web-based, i.e., it can work with standard computer software and hardware.

4

Instructions for Use SmartCare/PS SW 1.1 for Evita XL

For Your Safety and that of Your Patients

For Your Safety and that of Your Patients

Strictly follow these Instructions for Use

Networking

WARNING Any use of the medical device requires full understanding and strict observation of all portions of these Instructions for Use. The medical device is only to be used for the purpose specified under "Intended Use" on page 7 and in conjunction with appropriate patient monitoring (see "Patient monitoring" on page 6). Strictly observe all WARNING and CAUTION statements throughout these Instructions for Use and all statements on medical device labels. Failure to observe these instructions is to operate the medical device outside its intended use.

Device combinations approved by Dräger (see Instructions for Use of the individual devices or units) meet the requirements set forth by the following standards: –

IEC 60601-1 (EN 60601-1) Medical electrical equipment Part 1: General requirements for safety

–

IEC 60601-1-1 (EN 60601-1-1) Medical electrical equipment Part 1-1: General requirements for safety Collateral standard: Safety requirements for medical electrical systems

–

IEC 60601-1-2 (EN 60601-1-2) Medical electrical equipment Part 1-2: General requirements for safety Collateral standard: Electromagnetic compatibility; Requirements and tests

–

IEC 60601-1-4 (EN 60601-1-4) Medical electrical equipment Part 1-4: General requirements for safety Collateral standard: Programmable electrical medical systems

Accessories WARNING Only the accessories indicated on the list of accessories 9038780 (1st edition or higher) have been tested and approved to be used with the medical device. Accordingly it is strongly recommended that only these accessories be used in conjunction with the specific medical device. Otherwise the correct functioning of the medical device may be compromised.

If Dräger devices or units are connected to other Dräger devices or third-party devices and the resulting combination is not approved by Dräger, the correct functioning of the devices may be compromised. The operator is responsible for ensuring that the resulting system meets the requirements set forth by the above standards. Strictly follow Assembly Instructions and Instructions for Use for each networked device.

Instructions for Use SmartCare/PS SW 1.1 for Evita XL

5

For Your Safety and that of Your Patients

Patient safety

Patient monitoring

The design of the medical device, the accompanying literature, and the labeling on the medical device take into consideration that the purchase and use of the medical device are restricted to trained professionals, and that certain inherent characteristics of the medical device are known to the trained operator. Instructions for use, WARNINGS and CAUTION statements are therefore largely limited to the specifics of the Dräger medical device. This publication excludes references to various hazards which are obvious to a medical professional and operator of this medical device, to the consequences of medical device misuse, and to potentially adverse effects in patients with abnormal conditions. Medical device modification or misuse can be dangerous.

The operators of the medical device are responsible for choosing appropriate safety monitoring that supplies adequate information on medical device performance and patient condition. Patient safety may be achieved through a wide variety of means ranging from electronic surveillance of medical device performance and patient condition, to simple, direct observation of clinical signs. The responsibility for the selection of the best level of patient monitoring lies solely with the medical device operator.

CAUTION Danger to the patient. Individual measured values and monitoring parameters should not be used as the sole basis for therapeutic decisions.

6

Instructions for Use SmartCare/PS SW 1.1 for Evita XL

Application

Application

Intended Use The SmartCare/PS system is designed to stabilize the patient’s spontaneous breathing in a "comfortable zone", see page 29, and to reduce inspiratory support automatically.

The medical expertise on which SmartCare is based has been provided by specialists in intensive care, see "Additional Explanations" on page 29 and "Bibliography" on page 41.

SmartCare can be used for weaning intubated or tracheotomized patients.

The requirements for operation must be met, see "Indication" on page 7.

Patients with a body weight between 15 and <36 kg must be endotracheally intubated and ventilated using an active humidifier.

These Instructions for Use apply to Evita XL as well as to Evita 4 and Evita 2 dura with the Evita XL option.

The patients should be hemodynamically stable, sufficiently oxygenated and breathing spontaneously.

Indication SmartCare/PS can be used on patients who are suitable for weaning in the CPAP/ASB ventilation mode. The indication required for use must be determined by the attending physician and/or the relevant person responsible. SmartCare/PS assumes a physiological regulation of breathing via the patient’s respiratory center. In serious cases of COPD and/or neurological diseases impacting the respiratory center, a physiological regulation of breathing via the patient’s respiratory center is not possible or is only possible to a limited extent. In these cases, the use of SmartCare/PS should be carefully examined. If SmartCare/PS is used, the patient must be observed closely.

Instructions for Use SmartCare/PS SW 1.1 for Evita XL

From a medical point of view, the following conditions must be met –

The decision to wean has been made.

–

The decision to wean in CPAP/ASB mode has been made.

–

The decision to wean automatically using SmartCare/PS has been made.

–

The patient has been assessed to be hemodynamically stable by the physician and/or by the person responsible for the treatment.

–

The patient is able to breathe spontaneously.

–

The patient has a body weight (BW) between 15 kg and 200 kg.

7

Application

From a technical point of view, the following conditions must be met –

Evita XL is set to the Adult or Pediatric patient categories with the CPAP/ASB ventilation pattern.

–

The patient is being ventilated invasively (intubated or tracheotomized).

–

The patient has a body weight (BW) between 15 kg and 200 kg.

–

For patients with a body weight of ≥36 kg: – Endotracheal tube or tracheotomy tube – Active breathing gas humidifier or HME/filter

–

For patients with a body weight of <36 kg: – Endotracheal tube – Active breathing gas humidifier – Automatic tube compensation (ATC) is deactivated

–

Leakage compensation is activated.

–

Apnoea ventilation is active and set appropriately.

–

When using SmartCare/PS with activated automatic tube compensation (ATC), degree of compensation must be set to 100 %.

–

Blue CO2 sensor CapnoSmart (6871500) is inserted and CO2 monitoring is activated.

–

Flow and if necessary NeoFlow monitoring is activated.

–

PEEP can be set between 0 mbar and 20 mbar.

–

ΔPASB (above PEEP) is set in the range between ΔPASB goal and ΔPASB max.*.

NOTE If SmartCare is started in the case of patients with a ΔPASB outside this range, the PS is set to ΔPASB goal or ΔPASB max. after the first classification. *

For settings, see "Upper and Lower Limits of the Main Parameters" on page 33

Recommended Settings for Alarm Limits The attending physician is responsible for setting the alarm limits on Evita XL according to the patient's needs.

Parameter PAW

Alarm limit

MV

–25 % of current MV

MV

+25 % of current MV

fspn

40 bpm for a body weight of ≥36 kg 60 bpm for a body weight of <36 kg

VTi

8

12 mL/kg body weight

42 mbar (≥36 kg) 29 mbar (<36 kg)

The following settings are recommended: Parameter

Alarm limit

etCO2

18 mmHg

etCO2

57 mmHg (without COPD) 67 mmHg (with COPD)

TApnoea

60 seconds

The use of pulse oximetry is recommended so that hypoxic patient conditions can be detected and an alarm generated if the set pressure support is too low.

Instructions for Use SmartCare/PS SW 1.1 for Evita XL

Abbreviations and Terms

Abbreviations and Terms Abbreviation/Term

Definition

ATC

Automatic Tube Compensation

bpm

Breaths per minute

BW

Patient’s body weight

Comfortable zone

The zone of respiratory parameters defined by spontaneous respiratory rate, tidal volume, and end-expiratory CO2 concentration

COPD

Chronic Obstructed Pulmonary Disease, chronic bronchitis

CPAP/ASB

Spontaneous breathing with positive airway pressure (Continuous Positive Airway Pressure) and pressure support for individual breaths (Assisted Spontaneous Breathing)

Diagnosis

Classification of ventilation by SmartCare into one of eight different diagnoses: Severe Tachypnea, Tachypnea, Central Hypoventilation, Unexplained Hyperventilation, Insufficient Ventilation, Hypoventilation, Normal Ventilation, Hyperventilation

ΔPASB

Relative pressure support (above PEEP) (set value)

ΔPASB goal

Minimum inspiratory pressure support specified for the respective patient

ΔPASB start

Inspiratory pressure support when starting a Patient Session

Duration

Duration of Patient Session

etCO2

End-expiratory CO2 concentration

fspn

Spontaneous respiratory rate

HME / Filter

Heated Moisture Exchanger

Interfering operations

User operations performed on Evita XL which may lead to a conflict with SmartCare

MV

Minute volume, the volume breathed in one minute

PASB

Magnitude of inspiratory pressure support during ASB

Patient Session

Time during which pressure support is adjusted automatically

Patient Session journal

Record of the therapy session

PAW

Airway pressure

PEEP

Positive End-Expiratory Pressure

Phase

Weaning phases (Adapting, Observing, Maintain)

PS

Pressure Support

SC-etCO2

End-expiratory CO2 concentration established by SmartCare

SC-fspn

Spontaneous respiratory rate established by SmartCare

Instructions for Use SmartCare/PS SW 1.1 for Evita XL

9

Abbreviations and Terms

Abbreviation/Term

Definition

SC-PASB

ΔPASB is automatically set by SmartCare, but can be altered by the user at any time

SC-VT

Tidal volume established by SmartCare

TApnoea

Duration of an apnea

Therapy rights

Right of medical or nursing staff to specify or undertake treatment

User

SmartCare user treating a patient

VT

Inspiratory tidal volume, leakage compensated

VTe

Expiratory tidal volume

VTi

Inspiratory tidal volume

WAS

Web-based Application Service

Weaning

Gradual reduction of ventilation support with the aim of eliminating its necessity

Symbols Symbol Explanation Patient Session is running Running Patient Session is interrupted. SmartCare/PS is waiting for the end of the condition that led to the interruption. SC: Consider separation !

10

Instructions for Use SmartCare/PS SW 1.1 for Evita XL

Preparation

Preparation

Before First-time Use Installing and activating the SmartCare option May only be carried out by experts in accordance with the corresponding installation instructions.

Switching on Evita XL After switching on Evita XL, SmartCare takes approx. 90 seconds to load. During this time, SmartCare is not available.

Instructions for Use SmartCare/PS SW 1.1 for Evita XL

11

Operation

Operation

Requirements For the successful activation of a Patient Session, the relevant requirements must be met. See "Indication" on page 7.

Before Every Use z Set CPAP/ASB ventilation mode, see Evita XL Instructions for Use. z Switch on CO2 monitoring and flow monitoring, and, if necessary, NeoFlow monitoring, see Evita XL Instructions for Use.

1

Touch the Add. settings tab (A).

2

Touch the ATC... tab (B).

Deactivating ATC z Touch the Off button (C) and confirm with the rotary knob.

z Set automatic tube compensation (ATC) accordingly, see page 12. z Activate Apnoea ventilation, see page 13.

Setting degree of compensation

Automatic Tube Compensation (ATC) z Deactivate ATC for patients with a body weight of <36 kg.

1

Touch the Comp. therapy control (D).

2

Using the rotary knob, set the value to 100 % and confirm.

Activating ATC

z In the case of a body weight of ≥36 kg, ATC can be activated. The degree of compensation must be set to 100 %.

z Touch the On button (E) and confirm with the rotary knob.

In the Ventilator Settings dialog window:

B E

C

A 001

D

12

Instructions for Use SmartCare/PS SW 1.1 for Evita XL

Operation

Activating Apnoea ventilation

Evita XL displays the settings for Apnoea ventilation.

In the Ventilator Settings dialog window:

Setting values:

B E D

1

Touch the Add. settings tab (A).

2

Touch the Apnoea ventilation... tab (B).

Touch the VT (C) and f (D) therapy controls.

2

Set and confirm the values with the rotary knob.

Activating Apnoea ventilation:

A 002

C

1

z Touch the On button (E) and confirm with the rotary knob. Evita XL displays the status of Apnoea ventilation in the header bar.

Setting SmartCare Entering the body weight

When all requirements for a Patient Session are met, the user must make further settings. These settings serve to individually adjust SmartCare/PS to the patient.

In the Ventilator Settings dialog window:

Displaying settings 1

Press

1

Touch the SmartCare tab (A).

2

Touch the Patient Weight tab (B).

Ventilator Settings key.

B

The Ventilator Settings dialog window is opened. 2

Touch the SmartCare tab (A).

A 020

C B

C

D

Touch the Weight (C) therapy control.

4

Using the rotary knob, set the body weight of the patient and confirm the value.

003

A

3

In the Paed. patient category, only a body weight of up to <36 kg can be set.

Instructions for Use SmartCare/PS SW 1.1 for Evita XL

13

Evita XL displays the current settings. In the case of a body weight of <36 kg, only Patient Weight (B), Night Rest (C), and Patient Session (D) are displayed.

Operation

Entering Airway Access

Entering Medical History

In the Ventilator Settings dialog window:

On the Medical History page, additional information on the patient’s underlying diseases can be entered. These entries are only possible for patients with a body weight of ≥36 kg. Based on these entries, SmartCare determines the values fspn high, etCO2 high and VT low, see "Upper and Lower Limits of the Main Parameters" on page 33.

1

Touch the SmartCare tab (A).

2

Touch the Airway Access tab (B).

B A 004

C D The set types of Humidification (C) and Intubation (D) are displayed.

Based on these settings, SmartCare determines the value for ΔPASB goal, see "Upper and Lower Limits of the Main Parameters" on page 33.

WARNING The function of SmartCare is based on the patient’s respiratory control function working. For patients with serious COPD or a serious neurological disorder, this control function is sometimes insufficient. In these cases, check the function of SmartCare by observing the patient! The ΔPASB value may reach the limits which are determined by PAW high and MV low.

z Enter the type of Humidification, see Evita XL Instructions for Use.

In the Ventilator Settings dialog window:

Enter the type of Intubation (D):

1

Touch the SmartCare tab (A).

1

Touch the ET tab (endotracheal tube) or Trach. tab (tracheostomy tube).

2

Touch the Medical History tab (B).

2

Use the rotary knob to confirm.

B A 005

C D Enter the patient’s Medical History data: – Neurologic Disorder (C) – COPD (D)

14

3

Touch the relevant button Yes or No.

4

Use the rotary knob to confirm.

Instructions for Use SmartCare/PS SW 1.1 for Evita XL

Operation

Setting Night Rest In the Ventilator Settings dialog window: 1

Touch the SmartCare tab (A).

2

Touch the Night Rest tab (B).

B D A 006

C E F

When Night Rest is activated, SmartCare will not actively reduce the ΔPASB for weaning purposes during the set period of time. The period of time can be changed at any time, also during Night Rest. Activating or deactivating Night Rest: 1

Touch the Yes (C) or No (D) button.

2

Use the rotary knob to confirm.

Setting the period of time: 1

Touch the Begin (E) and End (F) buttons.

2

Set and confirm the times with the rotary knob.

Instructions for Use SmartCare/PS SW 1.1 for Evita XL

15

Operation

Activating SmartCare Display:

SmartCare can only be activated if – ATC is deactivated for patients with a body weight of <36 kg, see "Automatic Tube Compensation (ATC)" on page 12. – Apnoea ventilation is activated. – CO2 monitoring is activated. – Flow and if necessary NeoFlow monitoring is activated. – Leakage compensation is activated.*

E

In the Ventilator Settings dialog window: 1

Touch the SmartCare tab (A).

2

Touch the Patient Session tab (B).

F 008

D All measured values relating to SmartCare are displayed in a separate color.

B

3

Touch the On button (C) and confirm with the rotary knob.

SmartCare is activated. Calling additional information texts on SmartCare. z Touch the

button (D).

007

C

SmartCare (E) is displayed in the header bar.

A

The symbol is displayed next to the ΔPASB (F) therapy control. When SmartCare is activated, the following settings cannot be changed: – Airway Access – Medical History – ATC on/off – ATC degree of compensation – Apnoea ventilation on/off – Date/time – Tube application mode ΔPASB can be changed by the user at any time.

*

16

For additional information, see "Leakage compensation" on page 30.

Instructions for Use SmartCare/PS SW 1.1 for Evita XL

Operation

Course of the Patient Session –

The user verifies whether the patient complies with the physiological requirements (see "Indication" on page 7).

–

Ventilation parameters and alarm limits are set according to the patient’s needs.

–

SmartCare first attempts to stabilize the patient’s spontaneous respiratory rate by adjusting the pressure support.

–

Pressure support is regularly adapted to the patient’s respiratory profile (characterized by spontaneous respiratory rate, tidal volume, and end-expiratory CO2 concentration).

–

On the basis of these values, SmartCare carries out a classification of the ventilation every 2 minutes or 5 minutes.

–

When pressure support reaches a minimum value (defined by "Type of Intubation", "Type of Humidification" and "ATC on/off"), SmartCare conducts a test that is equivalent to a spontaneous breathing test.

–

Once the observation phase is concluded successfully, the system informs the user that the patient can be disconnected from Evita XL.

Instructions for Use SmartCare/PS SW 1.1 for Evita XL

17

Operation

Actions Performed on Evita XL and Their Effects on SmartCare If certain ventilation parameters must be changed for medical reasons during a Patient Session, this might lead to an interruption of the Patient Session, see page 31. After a Patient Session is interrupted, Evita XL continues ventilation with the last values set by SmartCare. The symbol appears on the screen when SmartCare is waiting for a procedure or alarm condition to be ended. If the user adjusts ΔPASB, SmartCare resumes the Patient Session with this new value. The user can "override" SmartCare in this way. The change is indicated in the logbook with the symbol . Response of the SmartCare system to user actions: Touch the O2↑ suction button

Wait for the procedure to end

Calibration of the CO2 sensor

Wait for the procedure to end

Change to standby mode

Interrupts Patient Session1)

Change of ventilation mode

Interrupts Patient Session

PEEP adjustment

Patient Session is interrupted if PEEP >20 mbar Patient Session is interrupted during the observation phase if PEEP >5 mbar

Switching off flow monitoring

Interrupts Patient Session

Switching off CO2 monitoring

Interrupts Patient Session

Change to Mask Ventilation application mode (NIV)

Interrupts Patient Session

1)

18

This alarm only appears after ending standby mode.

Instructions for Use SmartCare/PS SW 1.1 for Evita XL

Operation

Problems and Their Effects on SmartCare Problems with the patient or the device necessitating changes in the basic ventilation parameters or settings of Evita XL trigger alarms and can also cause premature termination of the Patient Session. See "Alarm Messages and Related Actions" on page 25.

Instructions for Use SmartCare/PS SW 1.1 for Evita XL

19

Measured Values, Graphics, and Trends

Measured Values, Graphics, and Trends

Displaying Graphics

Displaying 1 hr trend 1

Touch the bar.

F

E

G

Main button (A) in the main menu

C

B

A

010

D

009

Evita XL displays the trend over the last hour. The diagnoses are displayed in different colors to the left of the scale, see page 22. 2

Touch the relevant button

3

Touch the Trends tab (C).

(B).

Evita XL opens the page for selecting the parameters for the trend display. If SmartCare is available, Evita XL will also offer the parameters Diagnosis and SC-PASB. 4

20

Touch the Diagnosis button (D).

To display a diagnosis for a particular point in time: z Turn the rotary knob to position the cross-hair cursor (E) over the required point. Evita XL displays the diagnosis at the top of the trend display (F). The cross-hair cursor cannot be moved if the trend display has been frozen with the Freeze button (G).

Instructions for Use SmartCare/PS SW 1.1 for Evita XL