Heyer ITernIS ADV Manual de usuario

Operator’s Manual

Rev. 1.0 – 07/2011

INNOVATIONS

SERVICE

THE

PATIE NT

User’s Instruction Manual

Rev. 1.0 – 07.2011

IMPORTANT

The information contained in this manual is subject to change without notice. The

manufacturer reserves the right to make any changes to the characteristics or the

design.

The use of this equipment on patients needs to be supervised by a specialized

doctor.

Carefully read the instructions contained in this document before connecting the

ventilator to a patient. The information included in this manual is aimed at des-

cribing the ventilator, what it can do and its possible settings, but it cannot, nor

should not be considered as a substitute for the required judgment by competent

professionals, who should decide and determine the mode of use for each patient

in particular.

HEYER Medical AG

Carl-Heyer-Str. 1/3

D-56130 Bad Ems - Germany

Tel.: +49 2603 791-3

Fax: +49 2603 70424

eMail: [email protected]

Internet: www.heyermedical.de

User Instruction Manual | iTernIS ADV i

Table of Contents

1. Introduction................................................................................................. 1.1

1.1 Observed Requirements and Standards ........................................... 1.3

1.2 Equipment Overview.......................................................................... 1.3

1.3 Intended Use...................................................................................... 1.3

1.4 Intended User..................................................................................... 1.3

1.5 Intended Use Environment................................................................. 1.3

1.6 Contraindications for use ................................................................... 1.3

1.7 User support....................................................................................... 1.4

1.8 Symbols used..................................................................................... 1.4

1.9 Abbreviations, acronyms and variable names ................................... 1.6

2. Warnings - Precautions - Notes ................................................................ 2.1

2.1 Denition of Terms ............................................................................ 2.3

2.2 Warnings ............................................................................................ 2.3

2.3 Cautions............................................................................................. 2.4

2.4 Notes.................................................................................................. 2.5

3. Assembly and Installation ......................................................................... 3.1

3.1 Set of Items for Complete Assembly.................................................. 3.3

3.2 Assembly of the Pedestal................................................................... 3.4

3.3 Attachment of Ventilator to the Pedestal............................................ 3.5

3.4 Connection to the Gas Source........................................................... 3.5

3.5 Connection to the Power Source ....................................................... 3.6

3.6 Patient Circuit..................................................................................... 3.7

3.7 O

2 Sensor ......................................................................................... 3.12

4. General Description - Sections of the Ventilator..................................... 4.1

4.1 General Description ........................................................................... 4.3

4.2 Front Panel......................................................................................... 4.3

4.3 Lower Block of Connections............................................................. 4.11

4.4 Rear Panel ....................................................................................... 4.12

4.5 Upper Panel ..................................................................................... 4.12

5. Start-up and Initial Calibration .................................................................. 5.1

5.1 Start-Up.............................................................................................. 5.3

5.2 STAGE 1 - Initial Automatic Control ................................................... 5.3

5.3 STAGE 2 - Patient Category Selection .............................................. 5.3

5.4 STAGE 3 - Tidal Volume (VT) Based on Ideal Body Weight (IBW) ... 5.3

5.5 STAGE 4 - Selection of Humidication System.................................. 5.6

5.6 STAGE 5 - Start Patient Circuit Calibration........................................ 5.6

5.7 STAGE 6 - Calibration in Progress..................................................... 5.8

6. Basic Operations........................................................................................ 6.1

6.1 Overall User Interface Management .................................................. 6.3

6.2 Selecting the Operative Mode............................................................ 6.3

6.3 Conguring the Operative Mode ........................................................ 6.4

6.4 Standby.............................................................................................. 6.7

6.5 Additional Functions........................................................................... 6.7

6.6 Ventilation Parameters..................................................................... 6.10

7. Menu ........................................................................................................... 7.1

7.1 General Information ........................................................................... 7.3

User Instruction Manual | iTernIS ADV

7.2 Patient’s Data..................................................................................... 7.3

7.3 Backup Ventilation.............................................................................. 7.5

7.4 Ventilation Adjuncts............................................................................ 7.6

7.5 Records............................................................................................ 7.11

7.6 Tools................................................................................................. 7.12

7.7 Intra Hospital Transport.................................................................... 7.16

8. Graphics Management............................................................................... 8.1

8.1 Ventilator Screens - [Graphics] Key ................................................... 8.3

8.2 Freeze Screen.................................................................................... 8.6

8.3 Curve Scaling..................................................................................... 8.6

8.4 Autoscale .......................................................................................... 8.6

8.5 Horizontal Axis Position (zero line)..................................................... 8.7

8.6 Reference Loops................................................................................ 8.7

9. ADL/PED Operative Modes........................................................................ 9.1

9.1 VCV - Volume Controlled Ventilation.................................................. 9.3

9.2 PCV - Pressure Controlled Ventilation ............................................... 9.4

9.3 PSV - Pressure Supported Ventilation ............................................... 9.6

9.4 CPAP - Continuous Positive Airway Pressure .................................. 9.8

9.5 SIMV (VCV) + PSV - Synchronized Intermittent Mandatory Ventilation.... 9.8

9.6 SIMV (PCV) + PSV - Synchronized Intermittent Mandatory Ventilation .. 9.10

9.7 MMV with PSV - Mandatory Minute Ventilation with Pressure Supported

Ventilation ................................................................................................ 9.11

9.8 PSV with Assured VT....................................................................... 9.13

9.9 APRV - Airway Pressure Release Ventilation .................................. 9.14

9.10 NIV - Noninvasive Ventilation........................................................... 9.16

9.11 PRVC - Pressure-Regulated, Volume-Controlled Ventilation........... 9.17

9.12 Backup Ventilation............................................................................ 9.19

10. NEO-INF Operative Modes..................................................................... 10.1

10.1 VCV - Volume Controlled Ventilation................................................ 10.3

10.2 PCV - Pressure Controlled Ventilation ............................................. 10.4

10.3 PSV/CPAP - Pressure Supported Ventilation / CPAP ...................... 10.5

10.4 SIMV (VCV) + PSV - Synchronized Intermittent Mandatory Ventilation ... 10.6

10.5 SIMV (PCV) + PSV - Synchronized Intermittent Mandatory Ventilation .... 10.8

10.6 APRV - Airway Pressure Release Ventilation .................................. 10.9

10.7 TCPL - Time-Cycled, Pressure-Limited Ventilation ........................ 10.10

10.8 SIMV (TCPL) + PSV - Synchronized Intermittent Mandatory Ventilation.. 10.11

10.9 CPAP Continuous Flow.................................................................. 10.12

10.10 PRVC - Pressure-regulated, Volume-controlled Ventilation.......... 10.13

10.11 Backup Ventilation ........................................................................ 10.15

11. Alarms...................................................................................................... 11.1

11.1 General Characteristics .................................................................. 11.3

11.2 Alarm Events Record ....................................................................... 11.3

11.3 Alarm Signals................................................................................... 11.4

11.4 Audio Paused 30/60 s...................................................................... 11.6

11.5 Alarm Limit Adjustment .................................................................... 11.6

11.6 Inop. Vent. Alarm (Inoperative Ventilator) ........................................ 11.8

11.7 High Priority Alarms.......................................................................... 11.9

11.8 Medium Priority Alarms .................................................................. 11.10

11.9 Low Priority Alarms .........................................................................11.11

12. Respiratory Mechanics ........................................................................ 12.1

12.1 auto-PEEP ....................................................................................... 12.3

User Instruction Manual | iTernIS ADV iii

12.2 Compliance and Resistance ............................................................ 12.4

12.3 Trapped Volume............................................................................... 12.6

12.4 Slow Vital Capacity .......................................................................... 12.7

12.5 P0.1.................................................................................................. 12.8

12.6 PV ex (Inection Points).................................................................. 12.10

12.7 Pimáx ................................................................................................ 12.11

12.8 VD/VT Physiologic ......................................................................... 12.13

13. Trends...................................................................................................... 13.1

13.1 General Description ......................................................................... 13.3

13.2 Access to Trends.............................................................................. 13.4

13.3 Conguration.................................................................................... 13.4

13.4 Trend Curves Management ............................................................. 13.5

14. Capnography .......................................................................................... 14.1

14.1 Capnograph ..................................................................................... 14.3

14.2 Connection of the Capnograph ....................................................... 14.4

14.3 Monitoring ........................................................................................ 14.4

14.4 Capnography Menu.......................................................................... 14.5

14.5 Messages......................................................................................... 14.6

15. Operational Verication ......................................................................... 15.1

15.1 Necessary Items .............................................................................. 15.3

15.2 Ventilator Preparation....................................................................... 15.3

15.3 Functional Verication...................................................................... 15.3

15.4 Alarms Verication ........................................................................... 15.4

15.5 Operative Verication....................................................................... 15.5

16. Cleaning and Maintenance .................................................................... 16.1

16.1 Cleaning and Sterilization ............................................................... 16.3

16.2 Assembly of the Patient Circuit ........................................................ 16.5

16.3 Maintenance..................................................................................... 16.6

16.4 Periodical Safety-Related Controls.................................................. 16.8

17. Technical Specications........................................................................ 17.1

17.1 Classication .................................................................................... 17.3

17.2 Physical Characteristics................................................................... 17.3

17.3 Screen.............................................................................................. 17.3

17.4 Environmental Requirements.......................................................... .17.3

17.5 Pneumatic Specications ................................................................. 17.3

17.6 Electrical Specications ................................................................... 17.4

17.7 Ventilatory Parameter Adjustments.................................................. 17.4

17.8 Monitored Parameters...................................................................... 17.6

17.9 Alarm Adjustment............................................................................. 17.6

17.10 Data Collection for Control and Monitoring..................................... 17.7

17.11 Electromagnetic Compatibility......................................................... 17.7

17.12 Basic Operation of the Ventilator .................................................. 17.10

17.13 Safety Mechanisms ...................................................................... 17.11

17.14 Diagram of the Pneumatic Circuit of the Ventilator ....................... 17.13

17.15 Lifetime ......................................................................................... 17.14

Appendices ......................................................................................................A.i

Warranty ...........................................................................................................G.i

Alphabetical Index............................................................................................ I.i

User Instruction Manual | iTernIS ADV

Table 3-1 Set of Items for Complete Assembly..................................................3.3

Table 4-1 Electric power source light indicators............................................... 4.11

Table 5-1 Change Increases According to the Current IBW Value ....................5.3

Table 5-2 Ideal Body Weight - Women ..............................................................5.5

Table 5-3 Ideal Body Weight - Men ...................................................................5.5

Table 7-1 Details of Parameters in Patient Information......................................7.4

Table 7-2 Requirement of Backup Ventilation Setting According to the Operative

Mode..................................................................................................7.5

Table 7-3 Leakage compensation (in L/min) ...................................................7.11

Table 7-4 Suction Conguration.......................................................................7.13

Table 7-5 Atmospheric Standard .....................................................................7.15

Table 9-1 Managing the Inspiratory Phase in PSV with Assured VT ...............9.13

Table 11-1 Colors and Flashing Frequency Based on Priority.........................11.4

Table 11-2 Light Indicators ............................................................................... 11.4

Table 11-3 Auditory Signal ............................................................................... 11.5

Table 11-4 Maintained Visual Light Signal - Alarm Signals ..............................11.5

Table 11-5 Auditory Signal (Non-Maintained)...................................................11.6

Table 11-6 Inop. Vent. Alarm signals................................................................ 11.9

Table 11-7 High Priority Alarms .......................................................................11.9

Table 11-8 Medium Priority Alarms ................................................................11.10

Table 11-9 Low Priority Alarms....................................................................... 11.11

Table 15-1 Functional Verication....................................................................15.4

Table 15-2 Alarm Verication ...........................................................................15.5

Table 16-1 Suggested Preventive Maintenance ..............................................16.6

Table 17-1 Ventilator Classications ................................................................17.3

Table 17-2 Physical Characteristics .................................................................17.3

Table 17-3 Screen............................................................................................17.3

Table 17-4 Environmental Requirements.........................................................17.3

Table 17-5 Pneumatic Specications...............................................................17.3

Table 17-6 Electrical Specications .................................................................17.4

Table 17-7 Ventilation Parameter Adjustment ..................................................17.4

Table 17-8 Monitored Parameters ...................................................................17.6

Table 17-9 Alarm Adjustment ...........................................................................17.6

Table 17-10 Data Collection for Control and Monitoring ..................................17.7

Table 17-11 Electromagnetic Emissions Statement ........................................17.8

Table 17-12 Electromagnetic Immunity Statement ..........................................17.8

Table 17-13 Electromagnetic Immunity Statement .........................................17.9

Table Index

User Instruction Manual | iTernIS ADV v

Table 17-14 Recommended Separation Distances between the Ventilator and

Mobile/Portable Communications Equipment ...............................17.10

Table 17-15 Ventilation Parameters in Emergency Ventilation .....................17.12

Table 17-16 Lifetime.......................................................................................17.14

User Instruction Manual | iTernIS ADV

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